DECLARATION OF CONSENT to the VACCINATION AGAINST MEASLES, MUMPS and RUBELLA mit M-M-RvaxPro

Transcription

1 ENGLISCH VIENNA CITY ADMINISTRATION MAGISTRAT DER STADT WIEN Municipal Department 15 Public Health Services of the City of Vienna Magistratsabteilung 15 Gesundheitsdienst der Stadt Wien DECLARATION OF CONSENT to the VACCINATION AGAINST MEASLES, MUMPS and RUBELLA mit M-M-RvaxPro EINVERSTÄNDNISERKLÄRUNG zur SCHUTZIMPFUNG GEGEN MASERN MUMPS und RÖTELN mit M-M-RvaxPro PLEASE ANSWER THE FOLLOWING QUESTIONS: BITTE BEANTWORTEN SIE DIE NACHSTEHENDEN FRAGEN: ( Please tick as applicable) ( Zutreffendes bitte ankreuzen) Has your child ever experienced complaints or adverse effects following a yes / ja no / nein vaccination? Hatte Ihr Kind bereits einmal nach einer Impfung Beschwerden oder Nebenwirkungen? Does your child currently have a high temperature or has your child had a yes / ja no / nein high temperature within the past two weeks? Does your child currently suffer from a cough, runny nose or sore throat? Does your child currently suffer from any other form of infection? Hat Ihr Kind derzeit oder in den letzten 2 Wochen Fieber? Leidet Ihr Kind derzeit an Husten, Schnupfen, Halsschmerzen? Besteht derzeit eine andere Infektion? Does your child suffer from any allergies? If yes, which allergy? yes / ja no / nein Leidet Ihr Kind an einer Allergie? Wenn ja, an welcher?... If your child is currently receiving an injection therapy to treat allergies: When did she or he receive the last injection? When will she or he receive the next injection? Falls Ihr Kind derzeit eine Injektionstherapie gegen Allergie-auslösende Stoffe erhält: wann war die letzte Verabreichung?... wann ist die nächste Verabreichung geplant?... Does your child suffer from congenital or acquired immune deficiency / yes / ja no / nein immune system disorder? If yes, which one? Liegt bei Ihrem Kind eine angeborene oder erworbene Immunabwehrschwäche/Immunerkrankung vor? Wenn ja, welche?... Does your child take medication such as cortisone, cytostatics and blood yes / ja no / nein thinning medication on a regular basis? If yes, which medication? Nimmt Ihr Kind regelmäßig Medikamente ein (z.b. Cortison, Zytostatika, zur Blutverdünnung)? Wenn ja, welche? Is your child currently undergoing chemotherapy and/or radiotherapy? yes / ja no / nein Bekommt Ihr Kind derzeit eine Chemo- und/oder Bestrahlungstherapie? MA 15 SD Seite 1/3 Einverständniserklärung zur Schutzimpfung Hepatitis B DVR:

2 ENGLISCH Does your child suffer from a severe or chronic illness? yes / ja no / nein If yes, which one? Leidet Ihr Kind an einer schweren oder chronischen Erkrankung? Wenn ja, an welcher?... Has your child recently undergone an invasive therapy (e.g. surgery)? yes / ja no / nein Musste Ihr Kind sich vor kurzem einer eingreifenden Behandlung (z.b. einer Operation) unterziehen? Does your child suffer from a chronic inflammatory disease of the brain or yes / ja no / nein spinal cord? Has your child ever had an epileptic fit? Leidet Ihr Kind an einer chronisch entzündlichen Erkrankung des Gehirns oder Rückenmarks? Hatte Ihr Kind je epileptische Anfälle? Did your child get any other type of vaccination in the past four (4) weeks? yes / ja no / nein If yes, which and when? Hat Ihr Kind in den letzten 4 Wochen eine andere Impfung erhalten? Wenn ja welche und wann?... Did your child receive blood, blood products or immunoglobulin in the yes / ja no / nein past three (3) months? Hat Ihr Kind in den letzten 3 Monaten Blut, Blutprodukte oder Immunglobuline erhalten? Please turn the page Thank you! / Bitte wenden Danke! MA 15 SD Seite 2/3 Einverständniserklärung zur Schutzimpfung Hepatitis B DVR:

3 ENGLISCH Please write in CAPITAL letters. Thank you! / Bitte in Blockbuchstaben ausfüllen Danke! Surname of the child / Familienname des Kindes Name of the child / Vorname des Kindes Address / Adresse Date of birth of the child: day/month/year Geburtsdatum des Kindes: Tag/Monat/Jahr Name of parent or legal guardian / Name der oder des Erziehungsberechtigten I confirm with my signature that I have carefully read and understood the information sheet and the package leaflet for the abovementioned vaccine (M-M-RvaxPro ). I have been informed about the composition of the vaccine as well as any contraindications for its administration and any potential side effects of the vaccination and have understood this information. Mit meiner Unterschrift bestätige ich, dass ich das Informationsblatt und die Gebrauchsinformation zum obengenannten Impfstoff (M-M-RvaxPro ) sorgfältig gelesen und verstanden habe. Ich wurde dort über die Zusammensetzung des Impfstoffes, sowie Gegenanzeigen zur Verabreichung und mögliche Nebenwirkungen der Impfung aufgeklärt und habe diese Informationen verstanden. I have been given the opportunity to discuss any questions with the school physician during the opening hours. I have been informed about the benefits and risks of the vaccination and do not need a personal discussion with the physician. Ich hatte Gelegenheit während der Dienststunden des Schulärztlichen Dienstes offene Fragen mit der Ärztin/dem Arzt zu besprechen, bin aber über Nutzen und Risiko der Impfung ausreichend aufgeklärt und benötige daher kein persönliches Gespräch. I hereby consent to the vaccination. / Ich bin mit der Durchführung der Schutzimpfung einverstanden Date / Datum Signature of parent / legal guardian / Unterschrift der oder des Erziehungsberechtigten PLEASE NOTE / HINWEIS: If you wish to talk to the school physician in person during the opening hours please sign this form only after the meeting and hand it to the physician. Wenn Sie die Möglichkeit eines persönlichen Gespräches mit der Ärztin/dem Arzt während der Dienststunden des Schulärztlichen Dienstes in Anspruch nehmen möchten, ersuchen wir Sie, diese Einverständniserklärung erst nach dem erfolgten Aufklärungsgespräch zu unterfertigen und der Schulärztin bzw. dem Schularzt persönlich auszuhändigen. Remarks by physician / Ärztliche Anmerkungen: Date / Datum Stamp and signature of physician / Stempel und Unterschrift des Arztes/der Ärztin MA 15 SD Seite 3/3 Einverständniserklärung zur Schutzimpfung Hepatitis B DVR:

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5 ENGLISCH VIENNA CITY ADMINISTRATION MAGISTRAT DER STADT WIEN Municipal Department 15 Public Health Services of the City of Vienna Magistratsabteilung 15 Gesundheitsdienst der Stadt Wien INFORMATION ABOUT THE VACCINATION AGAINST MEASLES, MUMPS and RUBELLA with M-M-RvaxPro In its vaccination recommendations, the Austrian Health Council has once more emphasised the importance of providing protection against measles, mumps and rubella for all children. Protection against infection is attained by two vaccination shots against measles, mumps and rubella. The first shot is given when the child is more than 12 months old. The second shot should be given before the child is 2 years old but at least 4 weeks after the first shot. All children should have received the second vaccination shot against measles, mumps and rubella by age 13 at the latest. For this reason, schools offer free-of-charge combined vaccination against measles, mumps and rubella for all children who attend the 1 st and 7 th forms and have not yet been vaccinated twice against measles, mumps and rubella. Even if your child has already contracted one or two of these diseases in the past, the measles-mumps-rubella vaccination is recommended and not harmful. It will only be possible to eradicate these diseases in the future if more than 90% of all children have been vaccinated. Measles is a highly contagious viral disease that occurs practically everywhere across the world and is accompanied by fever, coughing, conjunctivitis and skin rash. Persons infected with measles as well as persons with acute measles excrete the virus when speaking, coughing, sneezing, etc. ( droplet infection ). Since measles is highly infectious, the disease can quickly spread within a non-vaccinated group (e.g. a class of schoolchildren). Complications may include bacterial infections such as middle ear inflammation, bronchitis or pneumonia. Meningitis that may entail permanent damage can occur in rare cases. Very rarely, a disease of the central nervous system with particularly virulent and fatal progression may occur years after the infection. In its turn, rubella is a highly contagious, febrile infectious disease accompanied by skin rash and swelling of the lymph nodes. It is triggered by the rubella virus and occurs widely throughout the world. The disease is transmitted via droplet infection. Rubella infections are hazardous for women in the first three months of pregnancy, as they may cause grave damage to the embryo with congenital deformations of the brain, eyes and heart. Vaccination can minimise this risk. However, vaccination is not possible during pregnancy; by the same token, pregnancy should not occur in the first three months after vaccination. It is therefore urgently recommended to have girls vaccinated before puberty and in any case before the 13 th birthday at the latest. Mumps is a highly contagious viral disease transmitted via droplet infection. It is characterised by painful swelling of the salivary glands, in particular of the parotid gland. In a few cases, other glands of the body are involved as well, such as the testicles, ovaries and pancreas. If mumps is contracted after puberty, a painful inflammation of the testicles occurs in roughly one out of three male adolescents or adults; in rare cases, this may lead to sterility. Approx. 10% of the persons who have contracted the disease develop meningitis. The vaccine is a live vaccine with attenuated viruses. However, vaccinated persons are not contagious and pose no hazard for pregnant women. The combination vaccine provides protection against several diseases with just one injection. The currently used combination vaccine against measles-mumps-rubella is M-M-RvaxPro. MA 15 SD /2 Information zur Schutzimpfung MMR M-M-RvaxPro

6 ENGLISCH Please turn the page! Thank you. Side effects Vaccinations may have side effects. The package leaflet, which is enclosed to this information sheet, provides more information about the composition of the vaccine as well as any contraindications for its administration and any potential side effects of the vaccination. Please inform your physician immediately of all reactions and side effects, in particular side effects that are not listed in this package leaflet. MA 15 SD /2 Information zur Schutzimpfung MMR M-M-RvaxPro

7 Package leaflet: information for the user M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live) Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or your pharmacist. - If you get any of the side effects, talk to your doctor of pharmacist. This includes any possible side effects not listed in this leaflet. What is in this leaflet: 1. What M-M-RVAXPRO is and what it is used for 2. What you need to know before you receive M-M-RVAXPRO 3. How to use M-M-RVAXPRO 4. Possible side effects 5. How to store M-M-RVAXPRO 6. Content of the pack and other information 1. What M-M-RVAXPRO is and what it is used for M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened. When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, and rubella viruses. The antibodies help protect against infections caused by these viruses. M-M-RVAXPRO is given to help protect you or your child against measles, mumps, and rubella. The vaccine may be administered to persons 12 months of age or older. M-M-RVAXPRO can be administered to infants from 9 to 12 months of age under special circumstances. M-M-RVAXPRO can also be used in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated persons older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella. Although M-M-RVAXPRO contains live viruses, they are too weak to cause measles, mumps, or rubella in healthy people. 2. What you need to know before you receive M-M-RVAXPRO Do not use M-M-RVAXPRO: - If you or your child are allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6) - If you or your child are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy) - If you or your child have any illness with fever higher than 38.5 C; however, low-grade fever itself is not a reason to delay vaccination - If you or your child have active untreated tuberculosis - If you or your child have a blood disorder or any type of cancer that affects the immune system - If you or your child are receiving treatment or taking medicines that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy) - If you or your child have a weakened immune system because of a disease (including AIDS) 50

8 - If you or your child have a family history of congenital or hereditary immunodeficiency, unless the immune competence of your or your child is demonstrated. Warnings and precaution Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have experienced any of the following: - If you or your child have an allergic reaction to eggs or anything that contained egg - If you or your child have a history or family history of allergies or of convulsions (fits) - If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising or bleeding for longer than usual - If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease. You or your child should be monitored closely for measles, mumps, and rubella because vaccination may be less effective than for uninfected persons (see section Do not use M-M-RVAXPRO). As with other vaccines, M-M-RVAXPRO may not completely protect all persons who are vaccinated. Also, if the person who is to be vaccinated has already been exposed to the measles, mumps, or rubella virus but is not yet ill, M-M-RVAXPRO may not be able to prevent the illness from appearing. M-M-RVAXPRO can be given to persons who have been in recent (within 3 days) contact with a case of measles and may be incubating the disease. However, M-M-RVAXPRO may not always be able to prevent measles developing in these cases. Other medicines and M-M-RVAXPRO: Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines). The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or immune globulin (known as IG). After vaccination with M-M-RVAXPRO, IG should not be given for 1 month, unless your doctor tells you otherwise. If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, 4 to 6 weeks after vaccination with M-M-RVAXPRO. M-M-RVAXPRO may be given with Prevenar and/or hepatitis A vaccine at the same visit at a separate injection site (e.g. the other arm or leg). M-M-RVAXPRO may be given with some routine childhood vaccines that may be due to be given at the same time. For vaccines that cannot be given at the same time, M-M-RVAXPRO should be given 1 month before or after administration of those vaccines. Pregnancy and breast-feeding M-M-RVAXPRO should not be given to pregnant females. Females of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month, or according to doctor s recommendation, after they have been given the vaccine. Persons who are breast-feeding or intend to breast-feed should tell the doctor. The doctor will decide M-M-RVAXPRO should be given. If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, a sk your doctor or pharmacist for advice before taking this vaccine. Driving and using machines There is no information to suggest that M-M-RVAXPRO affects the ability to drive or operate machinery. 51 or if

9 M-M-RVAXPRO contains sorbitol. If you have been told by your doctor that you or your child have an intolerance to some sugars, inform your doctor before you or your child receive this vaccine. 3. How to use M-M-RVAXPRO M-M-RVAXPRO should be injected into the muscle or under the skin either in the area of the outer thigh or of the upper arm. Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site. M-M- RVAXPRO is not to be injected directly into any blood vessel. M-M-RVAXPRO is given as follows: One dose is given at an elected date usually from 12 months of age. Under special circumstances, it can be given from 9 months of age. Further doses should be administered according to your doctor s recommendation. The interval between 2 doses should be at least 4 weeks. Reconstitution instructions intended for medical and healthcare professionals are included at the end of the package leaflet. 4. Possible side effects Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them. The following side effects were reported with the use of M-M-RVAXPRO: Frequency Side effect Very common (may affect more than 1 in 10 vaccinees) Common (may affect 1 to 10 in 100 vaccinees) Fever (38.5 C or higher). Injection-site redness; injection-site pain; injection-site swelling. Rash (including measles-like rash). Injection-site bruising. Uncommon (may Nasal congestion and sore throat; upper respiratory tract infection affect 1 to 10 in 1000 or viral infection; runny nose. vaccinees) Diarrhoea, vomiting. Hives. Injection-site rash. Not known Aseptic meningitis (fever, feeling sick, vomiting, headache, stiff (Frequency cannot be neck, and sensitivity to light); swollen testicles; infection of the estimated from the middle ear; inflamed salivary glands; atypical measles (described available data)* in patients who received a killed measles virus vaccine, usually given before 1975). Swollen lymph nodes. Bruising or bleeding more easily than normal. Severe allergic reaction that may include difficulty in breathing, facial swelling, localised swelling, and swelling of the limbs. Irritability. Seizures (fits) without fever; seizures (fits) with fever in children; walking unsteadily; dizziness; illnesses involving inflammation of the nervous system (brain and/or spinal cord). 52

10 An illness consisting of muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body (Guillain-Barré syndrome). Headache; fainting; nerve disorders which can cause weakness, tingling, or numbness; eye nerve disturbances. Discharge and itching of the eyes with crusting of eyelids (conjunctivitis). Inflammation of the retina (in the eye) with changes in sight. Deafness. Cough; lung infection with or without fever. Feeling sick (nausea). Itching; inflammation of the fatty tissue under the skin; red or purple, flat, pinhead spots under the skin; hardened, raised area of the skin; serious illness with ulcers or blistering of the skin, mouth, eyes, and/or genitals (Stevens-Johnson syndrome). Joint pain and/or swelling (usually transient and rarely chronic); muscle pain. Burning and/or stinging of short duration at the injection site; blisters and/or hives at the injection site. Generally feeling unwell (malaise); swelling; soreness. Inflammation of blood vessels. *These side effects were reported with the use of M-M-RVAXPRO or with the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or with its monovalent (single) components, during post-marketing use and/or during clinical studies. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 5. How to store M-M-RVAXPRO Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the outer carton after EXP. The expiry dates refers to the last day of that month. Store and transport refrigerated (2 C- 8 C). Keep the vial of powder in the outer carton in order to protect from light. Do not freeze the vaccine. Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within 8 hours. Do not throw away any vaccines via wastewater or household waste. Ask your pharmacist how to throw away vaccines you no longer use. These measures will help to protect the environment. 6. Contents of the pack and other information What M-M-RVAXPRO contains The active substances are: After reconstitution, one dose (0.5 ml) contains: Measles virus 1 Enders Edmonston strain (live, attenuated)....not less than 1x10 3 CCID 50 * 53

11 Mumps virus 1 Jeryl Lynn [Level B] strain (live, attenuated) not less than 12.5x10 3 CCID 50 * Rubella virus 2 Wistar RA 27/3 strain (live, attenuated)...not less than 1x10 3 CCID 50 * * 50% cell culture infectious dose 1 produced in chick embryo cells. 2 produced in WI-38 human diploid lung fibroblasts. The other ingredients are: Powder: sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust ph), and sodium hydroxide (to adjust ph) Solvent: water for injections What M-M-RVAXPRO looks like and contents of the pack The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided. The solvent is a clear and colourless liquid. The powder is a light yellow compact crystalline cake. M-M-RVAXPRO is available in packs of 1, 10 and 20, with or without needles. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F Lyon, France Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien Luxembourg/Luxemburg Sanofi Pasteur MSD, Tél/Tel: Sanofi Pasteur MSD, Tél: Magyarország MSD Pharma Hungary Kft., Tel.: Malta Merck Sharp & Dohme s.r.o. Tel.: Merck Sharp & Dohme Cyprus Limited., Tel: ( ) Danmark Nederland Sanofi Pasteur MSD, Tlf: Sanofi Pasteur MSD, Tel: Deutschland Norge Sanofi Pasteur MSD GmbH, Tel: Sanofi Pasteur MSD, Tlf: Eesti Österreich Merck Sharp & Dohme OÜ, Tel: Sanofi Pasteur MSD GmbH, Tel: Polska MSD Polska Sp. z o.o., Tel.:

12 España Portugal Sanofi Pasteur MSD S.A., Tel: Sanofi Pasteur MSD, SA, Tel: France România Sanofi Pasteur MSD SNC, Tél: Merck Sharp & Dohme Romania S.R.L. Tel: Ireland Slovenija Sanofi Pasteur MSD Ltd, Tel: Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: Ísland Slovenská republika Sanofi Pasteur MSD, Sími: Merck Sharp & Dohme, s. r. o., Tel: Italia Suomi/Finland Sanofi Pasteur MSD Spa, Tel: Sanofi Pasteur MSD, Puh/Tel: Sverige Merck Sharp & Dohme Cyprus Limited Sanofi Pasteur MSD, Tel: : ( ) Latvija United Kingdom SIA "Merck Sharp & Dohme Latvija" Sanofi Pasteur MSD Ltd, Tel: Tel: Lietuva UAB Merck Sharp & Dohme, Tel.: This leaflet was last revised in: Other sources of information Detailed information on this vaccine is available on the European Agency website: The following information is intended for healthcare professionals only: Reconstitution instructions The solvent is a clear colourless liquid. Before mixing with the solvent, the powder is a light yellow compact crystalline cake. When completely reconstituted, the vaccine is a clear yellow liquid. Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above. Inject the entire content of the pre-filled syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume. If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated. It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency. Discard if reconstituted vaccine is not used within 8 hours. Do not freeze the reconstituted vaccine. Any unused product or waste material should be disposed of in accordance with local requirements. 55

13 See also section 3 How to use M-M-RVAXPRO. 56