PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN"

Transcription

1 PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN VI.1 Summary of activities in the risk management plan The summary below was prepared based on the information included in Part II, IV and V of the present document. Summary of safety concerns Important identified risks Important potential risks Missing information Hypersensitivity to ropivacaine or other ingredients of the medicinal product or to other local anaesthetics of the amide type General contraindications related to epidural or regional anaesthesia Obstetric paracervical anaesthesia Hypovolaemia Intravascular injection Major peripheral nerve blocks Head and neck blocks Severe hepatic and renal impairment Interactions with other medicinal products such as concomitant use of other amide type drugs and strong inhibitors of CYP1A2 Medication error Acute porphyria Systemic toxicity in children Effect on the ability to drive and use machines Risk of overdose Use during pregnancy and lactation Use in premature neonates VI.1.2 Table of on-going and planned additional PhV studies/activities in the Pharmacovigilance Plan Not applicable VI.1.3 Summary of Post authorisation efficacy development plan Not applicable. Revision Date: Page 38

2 VI.1.4 Summary table of risk minimisation measures Safety concern Hypersensitivity to ropivacaine or other ingredients of the medicinal product or to other local anaesthetics of the amide type General contraindications related to epidural or regional anaesthesia Obstetric anaesthesia paracervical Revision Date: Page 39 Routine risk minimization measures Warning on the risk of hypersensitivity reactions to ropivacaine or other ingredients of the medicinal product or to other local anaesthetics of the amide type is already included in sections 4.3 and 4.8 of SmPC and sections 2 and 4 of PIL Warning on the general contraindications related to epidural or regional anaesthesia are already included in sections 4.3 of SmPC Warning on the risk of use of ropivacaine while on obstetric paracervical anaesthesia is already included in section 4.3 of SmPC and section 2 and of PIL Additional risk minimization measures Hypovolaemia Warning on the risk of ropivacaine use in hypovolaemia is already included in sections 4.3 and 4.4 of SmPC and section 2 and of PIL Other routine risk minimisation measures: Intravascular injection Warning on the increased risk of intravascular injection and its consequences is already included in sections 4.2, 4.4, 4.8 and 4.9 of SmPC and section 3 of PIL Major peripheral nerve Warning on major peripheral nerve blocks

3 blocks Head and neck blocks Severe hepatic and renal impairment Interactions with other medicinal products such as concomitant use of other amide type drugs and strong inhibitors of CYP1A2 Medication error Acute porphyria Revision Date: Page 40 included in section 4.4 of SmPC Warning on the risk of using ropivacaine injections in head and neck blocks is already included in section 4.4 of SmPC Warning on the risk of ropivacaine use in patients with severe hepatic and renal impairment is already included in sections 4.4 of SmPC and section 2 of PIL Warning on the increased risk ropivacaine interactions with other medicinal products such as concomitant use of other amide type drugs and strong inhibitors of CYP1A2 is already included in sections 4.4 and 4.5 of SmPC and sections 2 of PIL Warning on the risk of medication error is already included in sections 4.2 and 6.6 of SmPC and section 5 of the PIL Warning on the risk of ropivacaine use in acute porphyria is already included section 4.4 of SmPC and section 2 of PIL Systemic toxicity in Warning on the risk of systemic toxicity in children children is already included in sections 4.4 of SmPC and section 4 of PIL Effect on the ability to Warning on the increased risk of ropivacaine in

4 drive and use machines Risk of overdose Use during pregnancy and lactation Use in premature neonates on the ability to drive or using machines is already included in section 4.7 of SmPC and section 2 of PIL (exclusion of patients at risk as users to eliminate the risk) Warning on the increased risk of overdose and its consequences is already included in sections 4.8 and 4.9 of SmPC and sections 3 and 4 of PIL Information on the availability of limited data regarding ropivacaine influence in pregnancy and lactation is already included in section 4.6 of SmPC and in section 2 of PIL (exclusion of patients at risk as users to eliminate the risk) Information on the availability of limited data regarding ropivacaine use in premature neonates is already included in section 4.2 of SmPC (exclusion of patients at risk as users to eliminate the risk) VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Not applicable. VI.2.2 Summary of treatment benefits Revision Date: Page 41

5 [Ropivacaine] is used to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to: Numb parts of the body during surgery, including having a baby by Caesarean section. Relieve pain during childbirth, after surgery, or after an accident. Ropivacaine is a long-acting local anaesthetic. In a large number of studies ropivacaine has been revealed effective for pain relief during labour and in the postoperative period. Ropivacaine is also associated with less cardiovascular and central nervous system toxicity than other anaestetics, such as bupivacaine, and provides a greater degree of dissociation between sensory and motor effects producing less intense motor blockade and more rapid recovery to full patient mobilization. In addition, comparative studies also revealed that ropivacaine seems to be an effective and safe drug in paediatric regional anaesthesia. VI.2.3 Unknowns relating to treatment benefits In clinical studies performed in the elderly ( 65 years or and 75years old) ropivacaine was found to be safe and effective in the patients in these studies. Clinical data in one published article indicate that differences in various pharmacodynamic measures were observed with increasing age. In one study, the upper level of analgesia increased with age, the maximum decrease of mean arterial pressure (MAP) declined with age during the first hour after epidural administration, and the intensity of motor blockade increased with age. This drug and its metabolites are known to be excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Elderly patients are more likely to have decreased hepatic, renal, or cardiac function, as well as concomitant disease. Therefore, care should be taken in dose selection, starting at the low end of the dosage range, and it may be useful to monitor renal function. However, ropivacine is associated with less cardiovascular and central nervous system toxicity than other anaestetics. VI.2.4 Summary of safety concerns Risk in lay language (medical term) Important identified risks Allergy (hypersensitive) to ropivacaine hydrochloride or any of the other ingredients of ropivacaine or to any other local anaesthetics of the same class (such as lidocaine or What is known Sudden life-threatening allergic reactions (such as anaphylaxis) are rare, affecting 1 to 10 users in 10,000. Possible symptoms include sudden onset of rash, itching or lumpy rash (hives); Preventability Yes, by discontinuation of the treatment and immediate consultation of a doctor. Revision Date: Page 42

6 bupivacaine) (Hypersensitivity to ropivacaine or other ingredients of the medicinal product or to other local anaesthetics of the amide type) Cases where local anaesthesia cannot be used (General contraindications related to epidural or regional anaesthesia) swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing. Regional anaesthesia is not indicated for everyone. A doctor should be informed if the patient has an infection at the injection site, bleeding disorders or pre-existing peripheral nerve neuropathies. Yes. Ropivacaine should not be administered in patients that cannot take local anaesthesia. The anaesthesia provider should consider when deciding on which anaesthetic techniques to present to the patient. Use of anaesthetic on each side of the cervix to relieve pain during childbirth (Obstetric anaesthesia) paracervical Ropivacaine must not be given during obstetric paracervical anaesthesia. Use of other local anesthetics in this technique has resulted in fetal bradycardia and death. Yes. This medicine is used only by experienced and trained staff. Decreased volume of blood (Hypovolaemia) Injection into the blood vessel (Intravascular injection) A general term used to refer to the injection of local anesthetic Ropivacaine must be used with caution in patients with hypovolaemia due to any cause can develop sudden and severe hypotension during epidural anaesthesia, regardless of the local anaesthetic used. Some symptoms can happen if the injection was given into a blood vessel by mistake These include fits (seizures), feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with sight (vision), problems with speech, stiff muscles, and trembling. Major peripheral nerve blocks may imply the administration Revision Date: Page 43 Yes. This medicine is used only by experienced and trained staff. Yes. The clinician responsible should take the necessary precautions to avoid intravascular injection and be appropriately trained and familiar with diagnosis and treatment of side effects, systemic toxicity and other complications such as inadvertent subarachnoid injection, which may produce a high spinal block with apnoea and hypotension. Yes. The clinician responsible should take the necessary

7 onto or near nerves for temporary control of pain. (Major peripheral nerve blocks) A procedure of regional anaesthesia called head and neck block (Head and neck blocks) Patients with severe problems with liver or kidneys (Severe hepatic and renal impairment) Taking other medicines (Interactions with other medicinal products such as concomitant use of other amide type drugs and strong inhibitors of CYP1A2) Important potential risks of a large volume of local anaesthetic in highly vascularized areas, often close to large vessels where there is an increased risk of intravascular injection and/or rapid systemic absorption, which can lead to high levels of ropivacaine. Certain local anaesthetic procedures, such as injections in the head and neck regions, may be associated with a higher frequency of serious adverse reactions, regardless of the local anaesthetic used. Caution is required to prevent injections in inflamed areas. Ropivacaine hydrochloride is metabolised in the liver and should therefore be used with caution in patients with severe liver disease; repeated doses may need to be reduced due to delayed elimination. Ropivacaine should be used with caution with: Other local anaesthetics. Strong pain killers, such as morphine or codeine. Drugs used to treat an uneven heart beat (arrhythmia), such as lidocaine and mexiletine. Medicines for depression (such as fluvoxamine) Antibiotics to treat infections caused by bacteria (such as enoxacin). precautions to avoid intravascular injection and be appropriately trained and familiar with diagnosis and treatment of side effects, systemic toxicity and other complications such as inadvertent subarachnoid injection, which may produce a high spinal block with apnoea and hypotension. Yes. The clinician responsible should take the necessary precautions to avoid intravascular injection and be appropriately trained and familiar with diagnosis and treatment of side effects, systemic toxicity and other complications such as inadvertent subarachnoid injection, which may produce a high spinal block with apnoea and hypotension. Yes, by adjusting the dose of ropivacaine. Normally there is no need to modify the dose in patients with impaired renal function when used for single dose or short-term treatment. Yes, by avoiding prolonged use of ropivacaine. What is known (including reason why it is considered a Revision Date: Page 44

8 Damaged product (Medication error) Cases where patient or someone in the family has a rare disease of the blood pigment called "porphyria" (Acute porphyria) Use in childen (Systemic toxicity in paediatric patients) potential risk) The medicinal product should be visually examined before use. The solution should only be used if it is clear and practically free from particulate matter and if the container is undamaged. The doctor or the hospital will normally store ropivacaine and they are responsible for the quality of the product when it has been opened if it is not used immediately. The medicinal product should be visually inspected prior to use. The solution should only be used if it is clear, practically free from particles and if the container is undamaged. They are also responsible for disposing of any unused ropivacaine correctly. Ropivacaine solution for injection is possibly porphyrinogenic and should only be prescribed to patients with acute porphyria when no safer alternative is available. Appropriate precautions should be taken in the case of vulnerable patients, according to standard textbooks and/or in consultation with disease area experts. Careful aspiration before and during injection is recommended to prevent intravascular injection. The patient s vital functions should be observed closely during the injection. If toxic symptoms occur, the injection should be stopped immediately. Fractionation of the calculated local anaesthetic dose is recommended, whatever the route of administration. Driving and using machines (Effect on the ability to drive and use machines) The use of ropivacaine hydrochloride in premature children has not been documented. Neonates may need special attention due to immaturity of metabolic pathways. The larger variations in plasma concentrations of ropivacaine hydrochloride observed in clinical trials in neonates suggest that there may be an increased risk of systemic toxicity in this age group, especially during continuous epidural infusion. The recommended doses in neonates are based on limited clinical data. When ropivacaine hydrochloride is used in this patient group, regular monitoring of systemic toxicity (e.g. by signs of CNS toxicity, ECG, SpO 2 ) and local neurotoxicity (e.g. prolonged recovery) is required, which should be continued after ending infusion, due to a slow elimination in neonates. The medicinal product should be visually examined before use. The solution should only be used if it is clear and practically free from particulate matter and if the container is undamaged. After have been given ropivacaine, the patient should not drive or use tools or machines until the next day due to potential risk of feeling sleepy and the speed of reactions might be affected. Revision Date: Page 45

9 Cases where too much ropivacaine been taken (Risk of overdose) Missing information Risk Use during pregnancy and lactation Use in premature neonates Serious side effects from getting too much ropivacaine need special treatment and the doctor is trained to deal with these situations. The first signs of being given too much ropivacaine are usually as follows: Feeling dizzy or light-headed. Numbness of the lips and around the mouth. Numbness of the tongue. Hearing problems. Problems with your sight (vision). More serious side effects from being given too much ropivacaine include speech problems, muscles, tremors, trembling, fits (seizures), and loss of consciousness. To reduce the risk of serious side effects, the doctor will stop giving ropivacaine as soon as these signs appear. What is known Doctor should be informed on pregnancy or intention of the patient to get pregnant or if is breast-feeding. It is not known if ropivacaine hydrochloride affects pregnancy or passes into breast milk. Apart from epidural administration for obstetrical use, there are no adequate data on the use of ropivacaine hydrochloride in human pregnancy. Experimental animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Therefore, in case of pregnancy or breast-feeding, doctor should be advised The use of ropivacaine hydrochloride in premature children has not been documented. Neonates may need special attention due to immaturity of metabolic pathways. The larger variations in plasma concentrations of ropivacaine hydrochloride observed in clinical trials in neonates suggest that there may be an increased risk of systemic toxicity in this age group, especially during continuous epidural infusion. The recommended doses in neonates are based on limited clinical data. When ropivacaine hydrochloride is used in this patient group, regular monitoring of systemic toxicity (e.g. by signs of CNS toxicity, ECG, SpO 2 ) and local neurotoxicity (e.g. prolonged recovery) is required, which should be continued after ending infusion, due to a slow elimination in neonates. Revision Date: Page 46

10 VI.2.5 Summary of risk minimisation measures by safety concern Safety concern Hypersensitivity to ropivacaine or other ingredients of the medicinal product or to other local anaesthetics of the amide type General contraindications related to epidural or regional anaesthesia Obstetric paracervical anaesthesia Hypovolaemia Intravascular injection Major peripheral nerve blocks Head and neck blocks Severe hepatic and renal impairment Interactions with other medicinal products such as concomitant use of other amide type drugs and string inhibitors of CYP1A2 Medication error Acute porphyria Systemic toxicity in paediatric patients Effect on the ability to drive and use machines Risk of overdose Use during pregnancy and lactation Use in premature neonates Additional risk minimization measures VI.2.6 Planned post authorisation development plan Not applicable VI.2.7 Summary of changes to the risk management plan over time Version Date Safety concerns Change NA Initial version NA NA Day 40 Deficiency Letter answers Implementation of additional clarification requested by the RMS Revision Date: Page 47

1. What Xylocaine with adrenaline is and what it is used for

1. What Xylocaine with adrenaline is and what it is used for Package leaflet: Information for the user Xylocaine 1% and 2% with adrenaline (epinephrine) 1:200,000 Solution for Injection lidocaine, adrenaline (epinephrine) Read all of this leaflet carefully before

More information

Summary of the risk management plan (RMP) for Ionsys (fentanyl)

Summary of the risk management plan (RMP) for Ionsys (fentanyl) EMA/764409/2015 Summary of the risk management plan (RMP) for Ionsys (fentanyl) This is a summary of the risk management plan (RMP) for Ionsys, which details the measures to be taken in order to ensure

More information

Draft presentation: Summary of product characteristics

Draft presentation: Summary of product characteristics Draft presentation: Summary of product characteristics What is it and what does it contain? Olayinka Fasanya Medical information - Information compliance and consistency An agency of the European Union

More information

UBISTESIN 1:200,000 and UBISTESIN FORTE 1:100,000

UBISTESIN 1:200,000 and UBISTESIN FORTE 1:100,000 UBISTESIN 1:200,000 and UBISTESIN FORTE 1:100,000 Articaine hydrochloride and adrenaline hydrochloride Consumer Medicine Information WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you

More information

If you have any concerns about being given this vaccine, ask your doctor or pharmacist.

If you have any concerns about being given this vaccine, ask your doctor or pharmacist. PNEUMOVAX 23 Pneumococcal Vaccine Single Dose Vial/Pre-filled Syringe What is in this leaflet This leaflet answers some common questions about PNEUMOVAX 23. It does not contain all the available information.

More information

CHLORPHENAMINE. The medicine you have purchased contains chlorphenamine.

CHLORPHENAMINE. The medicine you have purchased contains chlorphenamine. What is in this leaflet CHLORPHENAMINE New Zealand Consumer Medicine Information The medicine you have purchased contains chlorphenamine. This leaflet is intended to provide information on the active ingredient

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. ADRENALINE (TARTRATE) STEROP 1 mg/1 ml Solution for injection. Adrenaline (Levorenine, Epinephrine)

PACKAGE LEAFLET: INFORMATION FOR THE USER. ADRENALINE (TARTRATE) STEROP 1 mg/1 ml Solution for injection. Adrenaline (Levorenine, Epinephrine) PACKAGE LEAFLET: INFORMATION FOR THE USER ADRENALINE (TARTRATE) STEROP 1 mg/1 ml Solution for injection Adrenaline (Levorenine, Epinephrine) Read all of this leaflet carefully before you start using this

More information

Summary of the risk management plan (RMP) for Cerdelga (eliglustat)

Summary of the risk management plan (RMP) for Cerdelga (eliglustat) EMA/743948/2014 Summary of the risk management plan (RMP) for Cerdelga (eliglustat) This is a summary of the risk management plan (RMP) for Cerdelga, which details the measures to be taken in order to

More information

Epidural Continuous Infusion. Patient information Leaflet

Epidural Continuous Infusion. Patient information Leaflet Epidural Continuous Infusion Patient information Leaflet April 2015 Introduction You may already know that epidural s are often used to treat pain during childbirth. This same technique can also used as

More information

Lidocaine 2% w/v solution for injection Summary of Product Characteristics

Lidocaine 2% w/v solution for injection Summary of Product Characteristics Lidocaine 2% w/v solution for injection Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Lidocaine 2% w/v solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml

More information

Package leaflet : information for the user. Dilute Adrenaline/Epinephrine Injection 1:10,000 adrenaline (epinephrine) (as acid tartrate) 0.

Package leaflet : information for the user. Dilute Adrenaline/Epinephrine Injection 1:10,000 adrenaline (epinephrine) (as acid tartrate) 0. Package leaflet : information for the user Dilute Adrenaline/Epinephrine Injection 1:10,000 adrenaline (epinephrine) (as acid tartrate) 0.1mg per ml Because of your condition it may not be possible for

More information

Package leaflet: Information for the patient user. 2% w/v Lidocaine Hydrochloride Injection BP Lidocaine Hydrochloride

Package leaflet: Information for the patient user. 2% w/v Lidocaine Hydrochloride Injection BP Lidocaine Hydrochloride Package leaflet: Information for the patient user 2% w/v Lidocaine Hydrochloride Injection BP Lidocaine Hydrochloride Read all of this leaflet carefully before you start using this medicine because it

More information

DOXYLAMINE. Please read this leaflet and the packaging of the medicine you have purchased carefully before you start using doxylamine.

DOXYLAMINE. Please read this leaflet and the packaging of the medicine you have purchased carefully before you start using doxylamine. What is in this leaflet DOXYLAMINE New Zealand Consumer Medicine Information The medicine you have purchased contains doxylamine. This leaflet is intended to provide information on the active ingredient

More information

Yes This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative.

Yes This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Title: Patient Group Direction for the administration of lidocaine hydrochloride 1% injection as infiltration anaesthesia for insertion/removal of central venous catheters by nurses/radiographers working

More information

Package leaflet: Information for the patient. Naloxone Hydrochloride 20 micrograms / ml Solution for Injection Naloxone hydrochloride

Package leaflet: Information for the patient. Naloxone Hydrochloride 20 micrograms / ml Solution for Injection Naloxone hydrochloride A leaflet will be included in each pack. The leaflet will consist of a Technical Information Leaflet and a Patient Information Leaflet. The two leaflets will be easily separatable. The text of the Technical

More information

Package leaflet: Information for the user. Ondemet 4mg and 8mg Tablets (Ondansetron)

Package leaflet: Information for the user. Ondemet 4mg and 8mg Tablets (Ondansetron) Package leaflet: Information for the user Ondemet 4mg and 8mg Tablets (Ondansetron) Read all of this leaflet carefully before you start taking this medicine because it contains important information for

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. PARACETAMOL MACOPHARMA 10 mg/ml, solution for infusion. Paracetamol

PACKAGE LEAFLET: INFORMATION FOR THE USER. PARACETAMOL MACOPHARMA 10 mg/ml, solution for infusion. Paracetamol PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL MACOPHARMA 10 mg/ml, solution for infusion Paracetamol Read all of this leaflet carefully before you start using this medicine. Keep this leaflet.

More information

Naloxone Hydrochloride Injection PRODUCT INFORMATION

Naloxone Hydrochloride Injection PRODUCT INFORMATION Naloxone Hydrochloride Injection PRODUCT INFORMATION DESCRIPTION Naloxone hydrochloride is 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride; C 19 H 21 NO 4.HCl. It is an off-white powder

More information

CLINICAL PROTOCOL FOR THE USE OF INJECTED LOCAL ANAESTHETICS IN COMMUNITY TRUST SERVICES

CLINICAL PROTOCOL FOR THE USE OF INJECTED LOCAL ANAESTHETICS IN COMMUNITY TRUST SERVICES CLINICAL PROTOCOL FOR THE USE OF INJECTED LOCAL ANAESTHETICS IN COMMUNITY TRUST SERVICES RATIONALE This clinical protocol outlines the injected local anaesthetics used by Trust services and the circumstances

More information

Influence of ph Most local anesthetics are weak bases.

Influence of ph Most local anesthetics are weak bases. Local anesthetics The agent must depress nerve conduction. The agent must have both lipophilic and hydrophilic properties to be effective by parenteral injection. Structure-activity relationships The typical

More information

Elements for a public summary. VI.2.1 Overview of disease epidemiology. VI.2.2 Summary of treatment benefits

Elements for a public summary. VI.2.1 Overview of disease epidemiology. VI.2.2 Summary of treatment benefits VI.2 Elements for a public summary VI.2.1 Overview of disease epidemiology Pain is one of the most common reasons for a patient to seek medical attention. Moderate or severe intensity pain can be acute

More information

Human Normal Immunoglobulin Solution for Intravenous Infusion.

Human Normal Immunoglobulin Solution for Intravenous Infusion. CONSUMER MEDICINE INFORMATION (CMI) OCTAGAM Human Normal Immunoglobulin Solution for Intravenous Infusion. OCTAGAM is available in single use bottles of 20 ml, 50 ml, 100 ml and 200 ml. OCTAGAM contains

More information

Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide)

Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide) EMA/467911/2014 Summary of the risk management plan (RMP) for Xultophy (insulin degludec / liraglutide) This is a summary of the risk management plan (RMP) for Xultophy, which details the measures to be

More information

Public Assessment Report. Table of Contents

Public Assessment Report. Table of Contents Public Assessment Report Lidocaine Injection BP with preservative 1% Lidocaine Injection BP with preservative 2% PL 01502/0070 PL 01502/0071 Hameln Pharmaceuticals Limited Table of Contents Page Lay Summary

More information

3% Sodium Chloride Injection, USP 5% Sodium Chloride Injection, USP

3% Sodium Chloride Injection, USP 5% Sodium Chloride Injection, USP PRESCRIBING INFORMATION 3% Sodium Chloride Injection, USP 5% Sodium Chloride Injection, USP IV Fluid and Electrolyte Replenisher Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision:

More information

See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2016 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR

See 17 for PATIENT COUNSELING INFORMATION. Revised: 3/2016 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: ADRENAL CRISIS IN THE SETTING OF SHOCK OR HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LYSODREN safely and effectively. See full prescribing information for LYSODREN. LYSODREN (mitotane)

More information

2 What you need to know before you have Ampiclox

2 What you need to know before you have Ampiclox Reason for update: GDS 14 & QRD Updates Response to questions for variation update section 4.1 of SPC MHRA Submission Date: 6 November 2014 MHRA Approval Date: Text Date: October 2014 Text Issue and Draft

More information

Common Regional Nerve Blocks Quick Guide developed by UWHC Acute Pain Service Jan 2011

Common Regional Nerve Blocks Quick Guide developed by UWHC Acute Pain Service Jan 2011 Common Regional Nerve Blocks Quick Guide developed by UWHC Acute Pain Service Jan 2011 A single shot nerve block is the injection of local anesthetic to block a specific nerve distribution. It can be placed

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. ADRENALINE (HCl) STEROP 0,8mg/1ml. Solution for injection. Adrenaline (Levorenine, Epinephrine)

PACKAGE LEAFLET: INFORMATION FOR THE USER. ADRENALINE (HCl) STEROP 0,8mg/1ml. Solution for injection. Adrenaline (Levorenine, Epinephrine) PACKAGE LEAFLET: INFORMATION FOR THE USER ADRENALINE (HCl) STEROP 0,4mg/1ml ADRENALINE (HCl) STEROP 0,8mg/1ml Solution for injection Adrenaline (Levorenine, Epinephrine) Read all of this leaflet carefully

More information

NEW ZEALAND DATA SHEET NAPHCON-A Naphazoline hydrochloride and pheniramine maleate.

NEW ZEALAND DATA SHEET NAPHCON-A Naphazoline hydrochloride and pheniramine maleate. NEW ZEALAND DATA SHEET NAPHCON-A Naphazoline hydrochloride and pheniramine maleate. PRESENTATION Eye Drops: NAPHCON-A Eye Drops are a combination of an antihistamine (pheniramine maleate) and a decongestant

More information

Thioctacid 600 T Solution for Injection contains 600 mg alpha-lipoic acid

Thioctacid 600 T Solution for Injection contains 600 mg alpha-lipoic acid Package Leaflet: Information for the User Thioctacid 600 T Solution for Injection contains 600 mg alpha-lipoic acid For use in adults Active substance: Alpha-lipoic acid, Trometamol salt (1:1) Read all

More information

PHENYLEPHRINE HYDROCHLORIDE INJECTION USP

PHENYLEPHRINE HYDROCHLORIDE INJECTION USP PRESCRIBING INFORMATION PHENYLEPHRINE HYDROCHLORIDE INJECTION USP 10 mg/ml Sandoz Canada Inc. Date of Preparation: September 1992 145 Jules-Léger Date of Revision : January 13, 2011 Boucherville, QC, Canada

More information

There is a risk of renal impairment in dehydrated children and adolescents.

There is a risk of renal impairment in dehydrated children and adolescents. PACKAGE LEAFLET: INFORMATION FOR THE USER MELFEN 200mg FILM-COATED TABLETS MELFEN 400mg FILM-COATED TABLETS Ibuprofen Read all of this leaflet carefully before you start taking this medicine because it

More information

Summary of the risk management plan (RMP) for Rasagiline ratiopharm (rasagiline)

Summary of the risk management plan (RMP) for Rasagiline ratiopharm (rasagiline) EMA/744222/2014 Summary of the risk management plan (RMP) for Rasagiline ratiopharm (rasagiline) This is a summary of the risk management plan (RMP) for Rasagiline ratiopharm, which details the measures

More information

NHSG/PGD/lido_eton/MGPG412 Organisation Wide

NHSG/PGD/lido_eton/MGPG412 Organisation Wide Title: Patient Group Direction For The Administration Of Lidocaine 2% Injection For The Insertion/Removal Of The 68mg Etonogestrel Contraceptive Implant By Nurses And Midwives Working Within NHS Grampian

More information

Zomig Nasal Spray. Zolmitriptan 5 mg Nasal Spray Solution. CONSUMER MEDICINE INFORMATION

Zomig Nasal Spray. Zolmitriptan 5 mg Nasal Spray Solution. CONSUMER MEDICINE INFORMATION Zomig Nasal Spray Zolmitriptan 5 mg Nasal Spray Solution. CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some of the common questions people ask about It does not contain all

More information

Perfalgan 10 mg/ml, solution for infusion

Perfalgan 10 mg/ml, solution for infusion PACKAGE LEAFLET: INFORMATION FOR THE USER Perfalgan 10 mg/ml, solution for infusion Paracetamol Read all of this leaflet carefully before you start using this medicine. Keep this leaflet. You may need

More information

A Patient s Guide to PAIN MANAGEMENT. After Surgery

A Patient s Guide to PAIN MANAGEMENT. After Surgery A Patient s Guide to PAIN MANAGEMENT After Surgery C o m p a s s i o n a n d C o m m i t m e n t A Patient s Guide to Pain Management After Surgery If you re facing an upcoming surgery, it s natural to

More information

Elements for a Public Summary

Elements for a Public Summary VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Asthma CHF 1535 pressurised metered dose inhaler (pmdi) and CHF 1535 NEXThaler are approved for regular treatment of adult patients

More information

Epinephrine Administration Training for Unlicensed School Personnel

Epinephrine Administration Training for Unlicensed School Personnel Epinephrine Administration Training for Unlicensed School Personnel Management of Life-Threatening Allergies in the School Setting Dover and Sherborn Schools EpiPen Administration This program is designed

More information

Australian and New Zealand College of Anaesthetists (ANZCA) Guidelines for the Management of Major Regional Analgesia

Australian and New Zealand College of Anaesthetists (ANZCA) Guidelines for the Management of Major Regional Analgesia PS03 2014 Australian and New Zealand College of Anaesthetists (ANZCA) Faculty of Pain Medicine Guidelines for the Management of Major Regional Analgesia 1. OVERVIEW This document is intended to apply to

More information

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

2 QUALITATIVE AND QUANTITATIVE COMPOSITION Temporary Core Product Information Inde- (13May2013) Page 1 / 7 1 NAME OF THE MEDICINAL PRODUCT XYLONOR SPRAY, oromucosal spray, solution. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains:

More information

Patient Information Tekturna HCT (tek-turn-a HCT) (aliskiren and hydrochlorothiazide) Tablets Read the Patient Information that comes with Tekturna

Patient Information Tekturna HCT (tek-turn-a HCT) (aliskiren and hydrochlorothiazide) Tablets Read the Patient Information that comes with Tekturna Patient Information Tekturna HCT (tek-turn-a HCT) (aliskiren and hydrochlorothiazide) Tablets Read the Patient Information that comes with Tekturna HCT before you start taking it and each time you get

More information

Intraosseous Vascular Access and Lidocaine

Intraosseous Vascular Access and Lidocaine Intraosseous Vascular Access and Lidocaine Intraosseous (IO) needles provide access to the medullary cavity of a bone. It is a technique primarily used in emergency situations to administer fluid and medication

More information

White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other.

White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other. Nausicalm Cyclizine hydrochloride Ph. Eur. 50 mg Presentation White, circular, biconvex, uncoated tablets with a score line on one side, plain on the other. Uses Actions The active ingredient-cyclizine

More information

Risk Management Plan

Risk Management Plan Risk Management Plan Active substance: Drospirenone/ethinylestradiol Version number: 4.0 VI.2 Elements for a Public Summary VI.2.1 Overview of disease epidemiology Oral contraception Effective control

More information

Information for you Treatment of venous thrombosis in pregnancy and after birth. What are the symptoms of a DVT during pregnancy?

Information for you Treatment of venous thrombosis in pregnancy and after birth. What are the symptoms of a DVT during pregnancy? Information for you Treatment of venous thrombosis in pregnancy and after birth Published in September 2011 What is venous thrombosis? Thrombosis is a blood clot in a blood vessel (a vein or an artery).

More information

Summary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole)

Summary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole) EMA/303592/2015 Summary of the risk management plan (RMP) for Aripiprazole Pharmathen (aripiprazole) This is a summary of the risk management plan (RMP) for Aripiprazole Pharmathen, which details the measures

More information

Summary of the risk management plan (RMP) for Xadago (safinamide)

Summary of the risk management plan (RMP) for Xadago (safinamide) EMA/3163/2015 Summary of the risk management plan (RMP) for Xadago (safinamide) This is a summary of the risk management plan (RMP) for Xadago, which details the measures to be taken in order to ensure

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER Omeprazol XXX 40 mg powder for solution for infusion omeprazole

PACKAGE LEAFLET: INFORMATION FOR THE USER Omeprazol XXX 40 mg powder for solution for infusion omeprazole PACKAGE LEAFLET: INFORMATION FOR THE USER Omeprazol XXX 40 mg powder for solution for infusion omeprazole Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You

More information

MEDICATION GUIDE SUBOXONE (Sub OX own) (buprenorphine and naloxone) Sublingual Tablets (CIII)

MEDICATION GUIDE SUBOXONE (Sub OX own) (buprenorphine and naloxone) Sublingual Tablets (CIII) MEDICATION GUIDE SUBOXONE (Sub OX own) (buprenorphine and naloxone) Sublingual Tablets (CIII) IMPORTANT: Keep SUBOXONE in a secure place away from children. Accidental use by a child is a medical emergency

More information

JANUMET sitagliptin phosphate/metformin HCl 50 mg/500 mg, 50 mg/850 mg, 50 mg/1000 mg tablets

JANUMET sitagliptin phosphate/metformin HCl 50 mg/500 mg, 50 mg/850 mg, 50 mg/1000 mg tablets JANUMET sitagliptin phosphate/metformin HCl 50 mg/500 mg, 50 mg/850 mg, 50 mg/1000 mg tablets What is in this leaflet This leaflet answers some common questions about JANUMET. It does not contain all the

More information

VALIUM PRODUCT MONOGRAPH. diazepam. 5 mg Tablets. Anxiolytic-sedative. Date of Revision: February 7, 2014

VALIUM PRODUCT MONOGRAPH. diazepam. 5 mg Tablets. Anxiolytic-sedative. Date of Revision: February 7, 2014 PRODUCT MONOGRAPH VALIUM diazepam 5 mg Tablets Anxiolytic-sedative Hoffmann-La Roche Ltd. 7070 Mississauga Road Mississauga, Ontario L5N 5M8 Date of Revision: February 7, 2014 www.rochecanada.com Submission

More information

Summary of the risk management plan (RMP) for Otezla (apremilast)

Summary of the risk management plan (RMP) for Otezla (apremilast) EMA/741412/2014 Summary of the risk management plan (RMP) for Otezla (apremilast) This is a summary of the risk management plan (RMP) for Otezla, which details the measures to be taken in order to ensure

More information

PATIENT INFORMATION LEAFLET. CEFALEXIN 250 mg AND 500 mg CAPSULES CEFALEXIN

PATIENT INFORMATION LEAFLET. CEFALEXIN 250 mg AND 500 mg CAPSULES CEFALEXIN PATIENT INFORMATION LEAFLET CEFALEXIN 250 mg AND 500 mg CAPSULES CEFALEXIN Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again.

More information

MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules. What is the most important information I should know about POMALYST?

MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules. What is the most important information I should know about POMALYST? MEDICATION GUIDE POMALYST (POM-uh-list) (pomalidomide) capsules What is the most important information I should know about POMALYST? Before you begin taking POMALYST, you must read and agree to all of

More information

FAQs on Influenza A (H1N1-2009) Vaccine

FAQs on Influenza A (H1N1-2009) Vaccine FAQs on Influenza A (H1N1-2009) Vaccine 1) What is Influenza A (H1N1-2009) (swine flu) 1? Influenza A (H1N1-2009), previously known as "swine flu", is a new strain of influenza virus that spreads from

More information

patient group direction

patient group direction DICLOFENAC v01 1/8 DICLOFENAC PGD Details Version 1.0 Legal category Staff grades Approved by POM Paramedic (Non-ECP) Nurse (Non-ECP) Emergency Care Practitioner (Paramedic) Emergency Care Practitioner

More information

MEDICATION GUIDE KOMBIGLYZE XR (kom-be-glyze X-R) (saxagliptin and metformin HCl extended-release) tablets

MEDICATION GUIDE KOMBIGLYZE XR (kom-be-glyze X-R) (saxagliptin and metformin HCl extended-release) tablets MEDICATION GUIDE KOMBIGLYZE XR (kom-be-glyze X-R) (saxagliptin and metformin HCl extended-release) tablets Read this Medication Guide carefully before you start taking KOMBIGLYZE XR and each time you get

More information

PATIENT MEDICATION INFORMATION

PATIENT MEDICATION INFORMATION READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Pr CYRAMZA ramucirumab Read this carefully before you receive CYRAMZA (pronounced "si ram - ze"). This leaflet is a

More information

Data Sheet 2% Xylocaine DENTAL with Adrenaline 1:80,000

Data Sheet 2% Xylocaine DENTAL with Adrenaline 1:80,000 Data Sheet 2% Xylocaine DENTAL with Adrenaline 1:80,000 (lignocaine 2% with adrenaline 1:80,000) Presentation 2% Xylocaine DENTAL with Adrenaline 1:80,000 solution for injection is a sterile, isotonic

More information

1 What Anapen is and what it is used for?

1 What Anapen is and what it is used for? PACKAGE LEAFLET: INFORMATION FOR THE USER Anapen 500 micrograms in 0.3 ml solution for injection (pre-filled syringe) Adrenaline (Epinephrine) Auto-Injector Read all of this leaflet carefully before you

More information

Pain Relief during Labour and Delivery: What Are My Options?

Pain Relief during Labour and Delivery: What Are My Options? Pain Relief during Labour and Delivery: What Are My Options? To help you prepare for the birth of your baby, this booklet answers some of the questions you may have about pain relief options. You should

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. Dalacin C 150 mg Capsules. clindamycin hydrochloride. Dalacin C 150mg Capsules clindamycin hydrochloride

PACKAGE LEAFLET: INFORMATION FOR THE USER. Dalacin C 150 mg Capsules. clindamycin hydrochloride. Dalacin C 150mg Capsules clindamycin hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER PFIZER Dalacin C 150 mg Capsules clindamycin hydrochloride Dalacin C 150mg Capsules clindamycin hydrochloride PFIZER Read all of this leaflet carefully before

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER

PACKAGE LEAFLET: INFORMATION FOR THE USER PACKAGE LEAFLET: INFORMATION FOR THE USER Metformine HCl Ceft 500 mg film-coated tablets Metformine HCl Ceft 850 mg film-coated tablets Metformine HCl Ceft 1000 mg film-coated tablets metformin hydrochloride

More information

Paracetamol apollo +9191 46 950 950. Paracetamol apollo +9191 46 950 950. Paracetamol

Paracetamol apollo +9191 46 950 950. Paracetamol apollo +9191 46 950 950. Paracetamol Paracetamol apollo +9191 46 950 950 Paracetamol apollo +9191 46 950 950 Paracetamol CAS Number : 103-90-2 Molecular Weight : 151.17 g/mol Molecular Formula : C8H9NO2 Systematic (IUPAC) : N-(4- hydroxyphenyl)ethanamide

More information

Pain Management after Surgery Patient Information Booklet

Pain Management after Surgery Patient Information Booklet Pain Management after Surgery Patient Information Booklet PATS 509-15-05 Your Health Care Be Involved Be involved in your healthcare. Speak up if you have questions or concerns about your care. Tell a

More information

Gilenya. Exceptional healthcare, personally delivered

Gilenya. Exceptional healthcare, personally delivered Gilenya Exceptional healthcare, personally delivered Your Consultant Neurologist has suggested that you may benefit from treatment with Gilenya. The decision to start this form of treatment can be difficult.

More information

Adjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour.

Adjunctive psychosocial intervention. Conditions requiring dose reduction. Immediate, peak plasma concentration is reached within 1 hour. Shared Care Guideline for Prescription and monitoring of Naltrexone Hydrochloride in alcohol dependence Author(s)/Originator(s): (please state author name and department) Dr Daly - Consultant Psychiatrist,

More information

Share the important information in this Medication Guide with members of your household.

Share the important information in this Medication Guide with members of your household. MEDICATION GUIDE BUPRENORPHINE (BUE-pre-NOR-feen) Sublingual Tablets, CIII IMPORTANT: Keep buprenorphine sublingual tablets in a secure place away from children. Accidental use by a child is a medical

More information

Division of Surgery Plastic and Reconstructive Surgery. Botox Cosmetic Injection: Consent Form INSTRUCTIONS

Division of Surgery Plastic and Reconstructive Surgery. Botox Cosmetic Injection: Consent Form INSTRUCTIONS Division of Surgery Plastic and Reconstructive Surgery Botox Cosmetic Injection: Consent Form INSTRUCTIONS This is an informed-consent document that has been prepared to help inform you about BOTOX (Botulina

More information

IVC Filter Insertion PROCEDURAL CONSENT FORM. A. Interpreter / cultural needs. B. Procedure. C. Risks of the procedure

IVC Filter Insertion PROCEDURAL CONSENT FORM. A. Interpreter / cultural needs. B. Procedure. C. Risks of the procedure DO NOT WRITE IN THIS BINDING MARGIN V4.00-03/2011 SW9264 Facility: A. Interpreter / cultural needs An Interpreter Service is required? Yes No If Yes, is a qualified Interpreter present? Yes No A Cultural

More information

MEDICATION GUIDE. PROCRIT (PRO KRIT) (epoetin alfa)

MEDICATION GUIDE. PROCRIT (PRO KRIT) (epoetin alfa) MEDICATION GUIDE PROCRIT (PROKRIT) (epoetin alfa) Read this Medication Guide: before you start PROCRIT. if you are told by your healthcare provider that there is new information about PROCRIT. if you are

More information

Clinical Performance Director of Nursing Allison Bussey

Clinical Performance Director of Nursing Allison Bussey PGD 0314 Patient Group Direction Administration of Adrenaline (Epinephrine) 1:1000 (1mg/ml) Injection By Registered Nurses employed by South Staffordshire & Shropshire Healthcare Foundation NHS Trust This

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. <invented name> 1 mg Ear drops, solution Ciprofloxacin

PACKAGE LEAFLET: INFORMATION FOR THE USER. <invented name> 1 mg Ear drops, solution Ciprofloxacin PACKAGE LEAFLET: INFORMATION FOR THE USER 1 mg Ear drops, solution Ciprofloxacin Read all of this leaflet carefully before you start using this medicine because it contains important information

More information

PATIENT INFORMATION LEAFLET

PATIENT INFORMATION LEAFLET PATIENT INFORMATION LEAFLET CHLORDIAZEPOXIDE 5mg AND 10mg CAPSULES Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have

More information

Core RMP agreed by the PhVWP in April 2012

Core RMP agreed by the PhVWP in April 2012 Paracetamol, solution for infusion (MRP Perfalgan (FR) and generic products) and risk of accidental overdosing of neonates and infants (due to medication errors following confusion between mg and ml) Core

More information

Doxylamine succinate belongs to the ethanolamine class of antihistamines with sedative properties.

Doxylamine succinate belongs to the ethanolamine class of antihistamines with sedative properties. Data Sheet MERSYNDOL Tablet Paracetamol 450mg per tablet Codeine Phosphate 9.75mg per tablet Doxylamine Succinate 5mg per tablet MERSYNDOL FORTE Tablet Paracetamol 450mg per tablet Codeine Phosphate 30mg

More information

Prodeine Forte Tablets Paracetamol & Codeine Phosphate Hemihydrate

Prodeine Forte Tablets Paracetamol & Codeine Phosphate Hemihydrate Prodeine Forte Tablets Paracetamol & Codeine Phosphate Hemihydrate CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about Prodeine Forte tablets. It does

More information

Package leaflet: Information for the patient. Bricanyl Tablets 5 mg terbutaline sulfate

Package leaflet: Information for the patient. Bricanyl Tablets 5 mg terbutaline sulfate Package leaflet: Information for the patient Bricanyl Tablets 5 mg terbutaline sulfate Read all of this leaflet carefully before you start taking this medicine because it contains important information

More information

Liver Disease & Hepatitis Program Providers: Brian McMahon, MD, Steve Livingston, MD, Lisa Townshend, ANP. Primary Care Provider:

Liver Disease & Hepatitis Program Providers: Brian McMahon, MD, Steve Livingston, MD, Lisa Townshend, ANP. Primary Care Provider: Liver Disease & Hepatitis Program Providers: Brian McMahon, MD, Steve Livingston, MD, Lisa Townshend, ANP Primary Care Provider: If you are considering hepatitis C treatment, please read this treatment

More information

PACKAGE LEAFLET: INFORMATION FOR THE USER. VITAMINE B12 STEROP 1mg/1ml Solution for injection / oral solution. Cyanocobalamin

PACKAGE LEAFLET: INFORMATION FOR THE USER. VITAMINE B12 STEROP 1mg/1ml Solution for injection / oral solution. Cyanocobalamin PACKAGE LEAFLET: INFORMATION FOR THE USER VITAMINE B12 STEROP 1mg/1ml Solution for injection / oral solution Cyanocobalamin Read all of this leaflet carefully before you start using this medicine because

More information

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

If you have any concerns about taking this medicine, ask your doctor or pharmacist. EZETROL ezetimibe 10 mg tablet What is in this leaflet This leaflet answers some common questions about EZETROL. It does not contain all the available information. It does not take the place of talking

More information

INITIATING ORAL AUBAGIO (teriflunomide) THERAPY

INITIATING ORAL AUBAGIO (teriflunomide) THERAPY FOR YOUR PATIENTS WITH RELAPSING FORMS OF MS INITIATING ORAL AUBAGIO (teriflunomide) THERAPY WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY Severe liver injury including fatal liver failure has been

More information

Thrombolytics (Reteplase, Tenecteplase) Rpa/Tnk and Adjunctive Heparin

Thrombolytics (Reteplase, Tenecteplase) Rpa/Tnk and Adjunctive Heparin PRESENTATION Vials of reteplase 10 units for reconstitution with 10ml water for injection. Vials of tenecteplase 10,000 units for reconstitution with 10ml water for injection, or 8,000 units for reconstitution

More information

MEDICATION GUIDE. These serious side effects are described below:

MEDICATION GUIDE. These serious side effects are described below: MEDICATION GUIDE LYRICA (LEER-i-kah) (pregabalin) Capsules and Oral Solution, CV Read this Medication Guide before you start taking LYRICA and each time you get a refill. There may be new information.

More information

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. [new-ka la]

READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION. [new-ka la] READ THIS FOR SAFE AND EFFECTIVE USE OF YOUR MEDICINE PATIENT MEDICATION INFORMATION Pr NUCALA [new-ka la] mepolizumab lyophilized powder for subcutaneous injection Read this carefully before you start

More information

Cortisol - contains the active ingredient hydrocortisone

Cortisol - contains the active ingredient hydrocortisone Cortisol - contains the active ingredient hydrocortisone Consumer Medicine Information What is in this leaflet This leaflet answers some common questions about Cortisol. It does not contain all of the

More information

Package leaflet: Information for the patient

Package leaflet: Information for the patient Package leaflet: Information for the patient Mimpara 30 mg film-coated tablets Mimpara 60 mg film-coated tablets Mimpara 90 mg film-coated tablets Cinacalcet Read all of this leaflet carefully before you

More information

IMPORTANT: PLEASE READ

IMPORTANT: PLEASE READ PART III: CONSUMER INFORMATION combined hepatitis A (inactivated) and hepatitis B (recombinant) vaccine This leaflet is part III of a three-part "Product Monograph" published when was approved for sale

More information

Each ml of solution contains 20 mg lidocaine hydrochloride and 0.0125 mg epinephrine

Each ml of solution contains 20 mg lidocaine hydrochloride and 0.0125 mg epinephrine 1. NAME OF THE MEDICINAL PRODUCT XILONIBSA 20 mg/ml + 0.0125 mg/ml, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 20 mg lidocaine hydrochloride and 0.0125

More information

Pain Relief Options for Labor. Providing You with Quality Care, Information and Support

Pain Relief Options for Labor. Providing You with Quality Care, Information and Support Pain Relief Options for Labor Providing You with Quality Care, Information and Support What can I expect during my labor and delivery? As a patient in the Labor and Delivery Suite at Lucile Packard Children

More information

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Methadone 10mg/ml Injection / Physeptone 10mg/ml Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains: Methadone Hydrochloride

More information

Epidurals for pain relief after surgery

Epidurals for pain relief after surgery Epidurals for pain relief after surgery This information leaflet is for anyone who may benefit from an epidural for pain relief after surgery. We hope it will help you to ask questions and direct you to

More information

Pain Management for Labour & Delivery

Pain Management for Labour & Delivery Pain Management for Labour & Delivery Departments of Anesthesia, Obstetrics, and Obstetrical Nursing December 2008 This pamphlet has been prepared to provide you, members of your family, and others who

More information

MEDICATION GUIDE SUBOXONE (Sub-OX-own) (buprenorphine and naloxone) Sublingual Film for sublingual or buccal administration (CIII)

MEDICATION GUIDE SUBOXONE (Sub-OX-own) (buprenorphine and naloxone) Sublingual Film for sublingual or buccal administration (CIII) MEDICATION GUIDE SUBOXONE (Sub-OX-own) (buprenorphine and naloxone) Sublingual Film for sublingual or buccal administration (CIII) IMPORTANT: Keep SUBOXONE in a secure place away from children. Accidental

More information

calendar Your treatment for VELCADE (bortezomib) For the treatment of patients with multiple myeloma

calendar Your treatment for VELCADE (bortezomib) For the treatment of patients with multiple myeloma For the treatment of patients with multiple myeloma Your treatment calendar for VELCADE (bortezomib) VELCADE (bortezomib) is approved for the treatment of patients with multiple myeloma (a cancer of the

More information

Paediatric fluids 13/06/05

Paediatric fluids 13/06/05 Dr Catharine Wilson Consultant Paediatric Anaesthetist Sheffield Children s Hospital. UK Paediatric fluids 13/06/05 Self assessment: Complete these questions before reading the tutorial. Discuss the answers

More information

MINISTRY OF HEALTH PANDEMIC INFLUENZA A / H1N1 2009 VACCINE FREQUENTLY ASKED QUESTIONS

MINISTRY OF HEALTH PANDEMIC INFLUENZA A / H1N1 2009 VACCINE FREQUENTLY ASKED QUESTIONS Government of the Republic of Trinidad and Tobago MINISTRY OF HEALTH PANDEMIC INFLUENZA A / H1N1 2009 VACCINE FREQUENTLY ASKED QUESTIONS Influenza vaccines are one of the most effective ways to protect

More information

GUIDELINES FOR DRUG PRESCRIBING AND MONITORING

GUIDELINES FOR DRUG PRESCRIBING AND MONITORING GUIDELINES FOR DRUG PRESCRIBING AND MONITORING B. THERAPEUTIC GUIDELINES 1. LOCAL ANAESTHETIC (LA) AGENTS - STRUCTURAL CLASS & ALLERGY: Local anaesthetics are grouped into two categories depending on their

More information