Core RMP agreed by the PhVWP in April 2012

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1 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 RMP agreed by the PhVWP in April 2012 CORE RMP PRODUCT DETAILS Doc.Ref.: CMDh/PhVWP/052/2012, Rev.0 May 2012 MAH to complete Invented name of the medicinal product (product short name): Active substance(s) (INN or common name): Pharmaco-therapeutic group (ATC Code): Medicinal Product Code (From EudraVigilance) PARACETAMOL 10 mg/ml, solution for infusion Paracetamol (Acetaminophen) Para-aminophenol derivative ATC code : N02BE01 Authorisation procedure(s) (central, mutual recognition, decentralised, national) Name of Marketing Authorisation Holder or Applicant: Date and country of first authorisation worldwide Date and country of first launch worldwide Date and country of first authorisation in the EEA If different from above Date and country of first launch in the EEA If different from above Data lock point for EU RMP Version 1 of neonates and infants May 2012 Page 1 of 17

2 Brief description of product (chemical class, mode of action etc.) Indication(s) Para-aminophenol derivative with analgesic, Antipyretic and weak anti-inflammatory activity. PARACETAMOL 10 mg/ml, solution for infusion is indicated for the short-term treatment of moderate pain, especially following surgery and for the short-term treatment of fever, when IV administration is clinically justified by an urgent need to treat pain or hyperthermia and/or when other routes of administration are not possible. Dosage Intravenous route As per the current SmPC: - The recommended dose in adolescents and adults weighing more than 50 kg is: 1 g per administration, i.e., one 100 ml vial or one 100 ml bag, up to 4 times per day. The maximum daily dose (MDD) must not exceed 4 g for patients weighing more than 50 kg. - The recommended dose in children weighing more than 33 kg, adolescents, and adults weighing less than 50 kg is 15 mg/kg per administration, i.e., 1.5 ml solution per kg, up to 4 times a day. For all patients, the minimum interval between each administration is 4 hours. The MDD must not exceed 60 mg/kg (without exceeding 3 g) for patients weighing less than 50 kg and more than 33 kg. - The recommended dose in children weighing more than 10 kg but less than 33 kg: 15 mg/kg per administration, i.e. 1.5 ml solution per kg up to 4 times a day. The minimum interval between each administration must be 4 hours. The MDD must not exceed 60 mg/kg (without exceeding 2 g) - The recommended dose in term newborn infants, infants, toddlers, and children weighing less than 10 kg is 7.5 mg/kg per administration, i.e ml solution per kg up to 4 times a day. The minimum interval between each administration must be 4 hours. The MDD must not exceed 30 mg/kg. No safety and efficacy data are available for premature neonates. - The recommended dose in patients with severe renal insufficiency. It is recommended, when giving paracetamol to patients with severe renal impairment (creatinine clearance 30 ml/min), to increase the minimum interval between each administration to 6 hours. - The recommended MDD in adults with hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione), or dehydration must not exceed 3 g. Pharmaceutical form(s) and strength(s) of neonates and infants May 2012 Page 2 of 17

3 PART I 1. SAFETY SPECIFICATION Non-clinical <Outline of safety concerns that have not been adequately addressed by clinical data or which are of unknown significance>; <Specify need for additional non-clinical data if the product is to be used in special populations>; Clinical 1.2 Limitations of the human safety database Exposure Clinical trial exposure Epidemiological study exposure Post marketing (non study) exposure To be completed 1.3 Populations not studied in the pre-authorisation phase 1.4 Post authorisation experience <Projected post-authorisation usage data> <Actual post-authorisation usage data> To be completed <Regulatory action taken> for version Adverse events/adverse reactions Newly identified safety concerns (since EU-RMP last submitted) for version Details of important identified and potential risks (including newly identified) of neonates and infants May 2012 Page 3 of 17

4 Important identified risk Hepatobiliary disorders Seriousness/outcomes Severity and nature of risk Frequency with 95 % CI Background incidence/prevalence Risk groups or risk factors Potential mechanisms Preventability Potential public health impact of safety concern Patients with pre-existing liver disease, chronic alcoholism, malnutrition, Total parenteral nutrition (TPN) use, use of enzyme inducers, and also in combination with hepatotoxic agent Evidence source Regulatory action taken Important identified risk Abnormal liver function Seriousness/outcomes Severity and nature of risk Frequency with 95 % CI Background incidence/prevalence Risk groups or risk factors Patients with pre-existing liver disease, chronic alcoholism, malnutrition, TPN use, use of enzyme inducers, and also in combination with hepatotoxic agent Potential mechanisms Preventability Potential public health impact of safety concern Evidence source Regulatory action taken of neonates and infants May 2012 Page 4 of 17

5 Important identified risk Drug interaction with anticoagulants Seriousness/outcomes Severity and nature of risk Frequency with 95 % CI Background incidence/prevalence Risk groups or risk factors Potential mechanisms Preventability Potential public health impact of safety concern Evidence source Regulatory action taken Important identified risk Drug interaction with enzyme inducers Seriousness/outcomes Severity and nature of risk Frequency with 95 % CI Background incidence/prevalence Risk groups or risk factors Potential mechanisms Preventability Potential public health impact of safety concern Evidence source Regulatory action taken 1.6 Identified and potential interactions with other medicinal products, food and other substances The identified interactions for Paracetamol solution for infusion are a drug-drug interaction with anticoagulants and an interaction with enzyme inducers. of neonates and infants May 2012 Page 5 of 17

6 1.7 Epidemiology of the indication(s) and important adverse events For each indication, discuss the incidence, prevalence, mortality and demographic profile of the target population For each indication, discuss the important co-morbidity in the target population For each identified or potential risk e.g. hepatic failure, provide the epidemiology of the condition in the target population when unexposed to the product 1.8 Pharmacological class effects Acetaminophen is the principal para-aminophenol derivative in use. Thus, any safety concerns within this pharmacological class are addressed by the safety profile of acetaminophen. 1.9 Additional EU Requirements Potential for overdose - Many cases of overdose are caused by patients inadvertently treated with more than the recommended dose (i.e., 4 grams a day), or by taking one product containing acetaminophen or more, associated with treatment with acetaminophen solution for infusion. - Cases of overdose reported in the paediatric population weighing 10kg due to confusion between mg and ml resulting in the administration of a 10 times higher dose than the prescribed dose. - Cases of accidental overdose in under weight adults also highlighted the importance of adhering closely to the weight based dosing recommendations - There is a risk of poisoning, particularly in elderly subjects, in young children, in patients with liver disease, in cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers Potential for transmission of infectious agents Potential for misuse for illegal purposes Potential for off-label use Potential for off-label-paediatric use Potential for use in premature neonate of neonates and infants May 2012 Page 6 of 17

7 1.10 Summary Ongoing safety concerns Important identified risks Potential risk: Important missing information Other safety concern Hepatobiliary disorders (cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers); Abnormal liver function (cases of chronic alcoholism, in patients with chronic malnutrition and in patients receiving enzyme inducers), Drug interaction with anticoagulants Drug interaction with enzyme inducers. NA Neonates and premature neonates, pregnant and lactating women Medication errors (overdose due to confusion between ml and mg in neonates, and overdose in underweight adult patients), air embolism with glass vial. of neonates and infants May 2012 Page 7 of 17

8 2. PHARMACOVIGILANCE PLAN 2.1 Routine pharmacovigilance practices To be completed 2.2 Summary of safety concern and planned pharmacovigilance actions Safety Concern Important Identified Risks Hepatobiliary Disorders Abnormal Liver Function Drug Interaction With Anticoagulants Drug Interaction With Enzyme Inducers Important Missing Information Neonates and premature neonates Pregnant and lactating women Planned action(s) 1) Routine pharmacovigilance: - Single AE report analysis, Signal detection, Aggregate Reports - Review in PSURs 2) Active follow up of all potentially severe hepatobiliary disorders associated with acetaminophen IV administration (e.g. fulminant hepatitis, liver failure, hepatic encephalopathy and hepatic necrosis). 1) Routine pharmacovigilance: - Single AE report analysis, Signal detection, Aggregate Reports - Review in PSURs 2) Active follow up of reports of all potentially severe elevations of hepatic laboratory tests that occur during all potentially severe elevations of hepatic laboratory tests that occur during Routine pharmacovigilance - Monitoring, evaluation and reporting of single ICSR; Aggregate Reports - Review in PSURs Routine pharmacovigilance: - Monitoring, evaluation and reporting of ICSR; Aggregate Reports - Review in PSURs Routine pharmacovigilance: - Monitoring, evaluation and reporting of single ICSR; Aggregate Reports - Review in PSURs 2.3 Detailed action plan for specific safety concerns For each important identified or potential risk or missing information: Safety Concern Safety concerns: identified Action(s) proposed Planned action(s) Hepatobiliary disorders Ongoing PV analysis of post marketing safety data Active follow-up of all potentially severe hepatobiliary disorders that occur during acetaminophen IV administration. Data will be obtained from health professional confirmed spontaneous, literature and related events from clinical study of neonates and infants May 2012 Page 8 of 17

9 Objective of proposed actions Rationale for proposed action(s) Detail further measures which may be adopted on the basis of the results of this action and the decision criteria for initiating such measures Milestones for evaluation and reporting including justification for choice of milestones Titles of protocols (Annex full study protocols and provide cross reference to position in annex 5) Safety Concern Safety concerns: identified Action(s) proposed Objective of proposed actions Rationale for proposed action(s) Detail further measures which may be adopted on the basis of the results of this action and the decision criteria for initiating such measures Milestones for evaluation and reporting including justification for choice of milestones reports. The product information communicates risk. Cumulative review of events of interest evaluated as requested by health authorities Any significant changes in frequency will be described in the PSUR with appropriate modifications to product labeling. Estimated reporting rates are determined on an annual basis, and any important changes in frequency or severity of outcome are addressed with appropriate modifications to product labeling. Annual and periodic safety reporting includes updated aggregated safety information including cumulative safety review of safety events of interest. The review will be presented with the submission of each PSUR. Planned action(s) Abnormal liver function Ongoing PV analysis of post marketing safety data Active follow-up of all potentially severe elevations of hepatic laboratory tests that occur during acetaminophen IV administration. Data will be obtained from health professional confirmed spontaneous, literature and related events from clinical study reports. The product information communicates risk. Cumulative review of events of interest evaluated as requested by health authorities Any significant changes in frequency will be described in the PSUR with appropriate modifications to product labeling. Estimated reporting rates are determined on an annual basis, and any important changes in frequency or severity of outcome are addressed with appropriate modifications to product labeling. Annual periodic safety reporting includes updated aggregated safety information including cumulative safety review of safety events of interest. The review will be presented with the submission of each PSUR. Titles of protocols (Annex full study protocols and provide cross reference to position in annex 5) Safety Concern Safety concerns: identified Planned action(s) Drug interaction with anticoagulants of neonates and infants May 2012 Page 9 of 17

10 Action(s) proposed Objective of proposed actions Rationale for proposed action(s) Detail further measures which may be adopted on the basis of the results of this action and the decision criteria for initiating such measures Milestones for evaluation and reporting including justification for choice of milestones Titles of protocols (Annex full study protocols and provide cross reference to position in annex 5) Safety Concern Safety concerns: identified Action(s) proposed Objective of proposed actions Rationale for proposed action(s) Detail further measures which may be adopted on the basis of the results of this action and the decision criteria for initiating such measures Milestones for evaluation and reporting including justification for choice of milestones Titles of protocols (Annex full study protocols and provide cross reference to position in annex 5) Routine pharmacovigilance Any significant changes in frequency will be described in the PSUR with appropriate modifications to product labeling. Estimated reporting rates are determined on an annual basis, and any important changes in frequency or severity of outcome are addressed with appropriate modifications to product labeling. Annual and periodic safety reporting includes updated aggregated safety information including cumulative safety review of safety events of interest. The review will be presented with the submission of each PSUR. Planned action(s) Drug interaction with enzyme inducers. Routine pharmacovigilance Any significant changes in frequency will be described in the PSUR with appropriate modifications to product labeling. Estimated reporting rates are determined on an annual basis, and any important changes in frequency or severity of outcome are addressed with appropriate modifications to product labeling. Annual and periodic safety reporting includes updated aggregated safety information including cumulative safety review of safety events of interest. The review will be presented with the submission of each PSUR. 2.4 Overview of study protocols for the pharmacovigilance plan 2.5 For updates to the EU-RMP for version 1 of neonates and infants May 2012 Page 10 of 17

11 2.6 Summary of outstanding actions, including milestones Actions Milestones/Exposure Milestone/Calendar Time MAH will monitor spontaneous reports. MAH will provide cumulative review of cases of non intentional overdoses in aggregate reports. Active surveillance of non intentional overdoses whatever the reason Reports on a monthly basis and cumulative case count update on a quarterly basis. Periodic safety report. Monthly review to be continued until necessary Annual safety reports. of neonates and infants May 2012 Page 11 of 17

12 PART II 3. EVALUATION OF THE NEED FOR RISK MINIMISATION ACTIVITIES 3.1 For each safety concern from section 1.10, provide a summary table of planned actions Safety Concern Routine Risk Minimization If yes, provide description of routine Activities Sufficient (Yes/No) activity and justification Important Identified Risk Hepatobiliary Disorders Yes Warnings & Precautions section 4.4 of the SmPC Abnormal Liver Function Yes Warnings & Precautions section 4.4 of the SmPC Drug Interaction With Anticoagulants Yes Overdose section 4.9 of SmPC Drug interaction information in section 4.5 of the SmPC: Drug Interaction With Enzyme Yes Drug interaction information in section Inducers 4.5 of the SmPC: Important Potential Risk: Not Applicable Important Missing Information Neonates and premature neonates Yes Posology and method of administration in section 4.2 of the SmPC. Pregnant and lactating women Yes Pregnancy and lactation in section 4.6 of the SmPC. Clinical experience of IV administration of paracetamol is limited. However, epidemiological data from the use of oral therapeutic doses of paracetamol indicate no undesirable effects on the pregnancy or on the health of the foetus / newborn infant. Prospective data on pregnancies exposed to overdoses did not show an increase in malformation Safety concern Risk of non-intentional overdose (due to confusion between ml and mg in neonates, and overdose in underweight adult patients) No Additional risk minimisation activities are described in Section 4. In particular these include: - A specific presentation for infants/children - Educational materials for HCPs of neonates and infants May 2012 Page 12 of 17

13 3.2 Potential for medication errors - Overdose There are 2 types of medication errors which can lead to an overdose: * in the paediatric population due to confusion between mg and ml * in adult underweight patients weighing 50 kgs. Underweight patients (adults weighing 50 kgs) may be at enhanced risk of experiencing overdose with paracetamol. For these patients, the prescribed dose must be based on the patient s weight, taking also into account individual risk factors for hepatotoxicity which includes: hepatocellular insufficiency, chronic alcoholism, chronic malnutrition (low reserves of hepatic glutathione) and dehydration. Several measures have been requested to minimise these risks (see section 4 for details): - Update of SmPC and PIL - Labelling : The labeling will be implemented with regards of national request after user testing in order to evaluate at a national level the appropriate additional information. - Further development of educational materials for healthcare professionals, such as a poster and a dosing guide strip (including increments from 1 to 10 kg and correspondences between mg and ml). - Active surveillance of cases of overdose (whatever the cause: e.g. confusion between mg and ml; nonintentional overdose in adult weighing 50kgs) : need of a monthly report to be addressed to the NCA/RMS and a study to evaluate the effectiveness of the minimisation measures taken. The effectiveness of measures implemented will be evaluated six months after by comparing the incidence in reporting rate of events of nonintentional overdose before and after implementation of risk minimisation measures. A report on this analysis will be submitted to the NCA/RMS. - Risk of air embolism with glass vials : a warning in the SmPC and the PIL has been added to emphasize the need to monitor infusions as usually recommended for solutions for infusion contained in glass vials. of neonates and infants May 2012 Page 13 of 17

14 4. RISK MINIMISATION PLAN Safety concern : Risk of non-intentional overdose (due to confusion between ml and mg in neonates, and overdose in underweight adult patients) The routine risk minimization activities included Product information (SmPC, PIL, vial labels) update. Plan 1) SmPC and PIL : - For the preparation and administration instructions for patients 10 kg : Section 4.2 must indicate that : * The dose in these patients is 7.5 mg/kg * The volume should be withdrawn from the vial/bag and diluted as recommended in the SmpC and administered over 15 min * A syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume * A statement should appear on the vial/bag prohibiting hanging of the product in children< 10 kg and the user should be referred to the product information for dosing guidelines - Remove references to patient age from the SmPC and PIL to ensure that patient weight and not age is used when calculating the dose. - Incorporate clarification of the dose when the patient s weight is exactly 50kg, 33kg or 10 kg. - Incorporate clarification to the SmPC and PIL regarding the MDD which takes into account all medicines containing paracetamol - For children, adolescents and adults weighing >33 kg but 50 kg: The dose in these patients is 15mg/kg. The maximum daily dose in these patients should not exceed 3g in 24 hours. The volume of Paracetamol 10mg/mL administered should never exceed 75mL per dose. 2) A dosing table based on patient weight ( 10kg to >50kg) in the SmPC and the PIL (Patient weight, Dose per administration, Volume per administration, Maximum volume (ml) per administration based on upper weight limits of group and the Maximum Daily Dose) 3) Labelling :The labeling will be implemented with regards of national request after user testing in order to evaluate at a national level the appropriate additional information. Additional risk minimisation activity. 1 - Objective and rationale: the prevention of non-intentional overdose cases due to confusion between (mg) and (ml) Additional risk minimisation activity. 2 A study to analyse the effectiveness of the new paediatric presentation on risk of medication errors (six months after by comparing the incidence in reporting rate of events of non-intentional overdose before and after implementation of the specific paediatric presentation) Proposed review period: Monthly review on safety database and cumulative case count update to NCA/RMS on a quarterly basis. - Objective and rationale: the prevention of non-intentional overdose (whatever the reason) using communication materials dosing guide ( strip of neonates and infants May 2012 Page 14 of 17

15 and Poster reminding doses to be administered). - Development of educational materials for healthcare professionals, such as a poster and a dosing guide strip (including increments from 1 to 10 kg and correspondences between mg and ml). This is to ensure that the revised dosing table in the SmPC and Package leaflet is well known by healthcare professionals and easily accessible. A study to evaluate the effectiveness of measures implemented will be evaluated six months after by comparing the incidence in reporting rate of events of non-intentional overdose before and after implementation of risk minimisation measures. A report on this analysis will be submitted to the NCA/RMS. Proposed review period: Monthly review on safety database and cumulative case count update to be addressed to NCA/RMS on a quarterly basis. of neonates and infants May 2012 Page 15 of 17

16 5. SUMMARY OF THE EU RISK MANAGEMENT PLAN Safety concern Proposed pharmacovigilance activities (routine and additional) Important Identified Risk Hepatobiliary Disorders - Routine pharmacovigilance, review in PSURs - Active follow up of reports - Abnormal Liver Function - Routine pharmacovigilance, review in PSURs - Active follow up of reports Drug Interaction With Anticoagulants - Routine pharmacovigilance, review in PSURs Drug Interaction With Enzyme - Routine pharmacovigilance, Inducers review in PSURs Important Potential Risk: Not Applicable Important Missing Information Neonates and premature neonates - Routine pharmacovigilance, review in PSURs Pregnant and lactating women - Routine pharmacovigilance, review in PSURs Proposed risk minimisation measures (routine and additional) Warnings & Precautions section 4.4 of the SmPC Warnings & Precautions section 4.4 of the SmPC Overdose section 4.9 of SmPC Drug interaction information in section 4.5 of the SmPC: Drug interaction information in section 4.5 of the SmPC Posology and method of administration in section 4.2 of the SmPC. Information on Pregnancy and lactation in section 4.6 of the SmPC. Safety concerns Medication errors (due to confusion between ml and mg in neonates, and overdose in underweight adult patients) - Routine PV: Single AE report analysis-signal detection- Aggregate Reports-Label update, as indicated. - Active follow-up of reports of individual AEs related to medication errors of Paracetamol 10mg/mL solution for infusion; Reporting to NCA/RMS through the PSUR for all overdoses cases - Monthly review of safety database for Individual Case Safety Report (ICSR) of events related to / or suggestive of medication errors associated with Paracetamol 10mg/mL solution for infusion with report of new cases to RMS/NCA on a monthly basis and cumulative case count update on a quarterly basis. 1) SmpC, PIL : - Section 4.2 for preparation and administration instructions for patients 10 kg : -The dose in these patients is 7.5 mg/kg - The volume should be withdrawn from the vial/bag and diluted as recommended in the SmPC and administered over 15 min - A syringe should be used to measure the dose as appropriate for the weight of the child and the desired volume - A statement should appear on the vial/bag prohibiting hanging of the product in children< 10 kg and the user should be referred to the product information for dosing guidelines - Remove references to patient age from the SmPC and PIL to ensure that patient weight and not age is used when calculating the dose. - Incorporate clarification of the of neonates and infants May 2012 Page 16 of 17

17 dose : when the patient s weight is exactly 50kg, 33kg or 10 kg. - regarding the MDD which takes into account all medicines containing paracetamol - For children, adolescents and adults weighing >33 kg but 50 kg: The dose in these patients is 15mg/kg. The maximum daily dose in these patients should not exceed 3g in 24 hours. The volume of Paracetamol10mg/mL administered should never exceed 75mL per dose. - a dosing table based on patient weight ( 10kg to >50kg) in the SmPC and the PIL (Patient weight, Dose per administration, Volume per administration, Maximum volume (ml) per administration based on upper weight limits of group and the Maximum Daily Dose) 2) Labelling The labeling will be implemented with regards of national request after user testing in order to evaluate at a national level the appropriate additional information. 3) Development of educational materials for healthcare professionals, such as a poster and a dosing guide strip (including increments from 1 to 10 kg and correspondences between mg and ml). 6. CONTACT PERSON FOR THIS EU-RMP -MAH to complete Names < > Position < > Qualifications < > Signature < > of neonates and infants May 2012 Page 17 of 17

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