SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 Registration No. 2A 94/46 Importer / Manufacturer: GPO-MBP SUMMARY OF PRODUCT CHARACTERISTICS 1. ME OF THE MEDICAL PRODUCT MEASLES MUMPS AND RUBELLA VACCINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION A single dose of lyophilised vaccine contains: - Live hyperattenuated measles virus (Schwarz strain) not less than 1000 TCID 50 - Live attenuated mumps virus (Urabe AM 9 strain) not less than 5000 TCID 50 - Live attenuated rubella virus (Wistar RA 27/3M strain)not less than 1000 TCID 50 - Stabilizer excipient (containing human albumin) quantity for 1 dose Diluent: Sterile water for injection: 0.5 ml for single dose TCID50 = CCID50 = Cell Culture Infectious Doses 50% 3. PHARMACEUTICAL FORM Vaccine: Solution for injection (Box of ten dose vials of freeze dried vaccine each vial should be reconstituted with 5 ml of diluent) 4. CLINICAL PARTICULARS 4.1 Therapeutic indications This medicine is a vaccine It is indicated for the combined prevention of measles mumps and rubella, from 9 months of age. 1

2 For adult vaccination, Rubella vaccine and Mumps vaccine should be preferred for rubella immunization and for mumps immunization, respectively. 4.2 Posology and method of administration IN ANY CASE, DO STRICTLY CONFORM TO YOUR DOCTOR S PRESCRIPTION. Measles Mumps and Rubella vaccine may be given by subcutaneous or intramuscular The first injection is administered from the age of 9 months and the second injection is recommended between 4 and 6 years of age. Measles Mumps and Rubella vaccine is in the form of a powder. After reconstitution, it is clear, yellow to pinkish yellow. Any reconstituted vaccine should be used immediately. 4.3 Contraindication Congenital or acquired immunosuppressions (including infections by the human immunodeficiency virus HIV). An infection by the HIV should not be a contra indication to the vaccination against measles mumps and rubella, but in such a case, it is nevertheless recommended to seek advice from a specialized pediatric team. True allergy to egg proteins: (anaphylactic reaction after eating eggs). Recent injection of immunoglobulins. 4.4 Special warnings and precautions for use Due to its rubella component, post pubertal women should not be given Measles Mumps and Rubella vaccine in case of pregnancy at the time of the planned They should be advised not to get pregnant during both months following the If in doubt, do not hesitate to seek advice form your doctor or pharmacist. Always keep out of reach of children. 4.5 Interaction with other medical products and forms of interaction Due to the risk of inactivation, the rubella vaccine should not be given within the 6 weeks, and if it is possible the 3 months, after an injection of immunoglobulins or blood product containing immunoglobulins (blood, plasma). For the same reason, immunoglobulins should not be administered within the two weeks after the vaccination. 2

3 Tuberculin positive individuals may transitionally become tuberculin negative after vaccination. In order to avoid potential interactions between several medicines, any other ongoing treatment should systematically be pointed out to your doctor. 4.6 Pregnancy and lactation Due to its rubella component, post pubertal women should not be given Measles Mumps and Rubella vaccine in case of pregnancy at the time of the planned They should be advised not to get pregnant during both months following the Vaccination during an unknown pregnancy does not justify advising termination of the pregnancy 4.7 Effects on the ability to drive and use machines 4.8 Undesirable effects Skin eruptions may occur, which consist of small red spots or purplish marks of variable size. The combined vaccination is well tolerated in children. Minor reactions might be observed from the 5 th day after injection: hyperthermia (which may be prevented by using antipyretic drugs), short lasting rhinopharyngeal or respiratory symptoms, mild exanthema. Hyperthermia convulsions have been rarely observed. Adenopathies or parotitis have been more rarely observed. Rare cases of neurological diseases, like meningitis or meningo encephalitis and unilateral deafness have been reported. Meningitis occurs during the 30 days following the administration of the vaccine. A mumps virus was sometimes isolated form the cerebro spinal fluid. In a few rare cases, a characterization method based upon viral amplification and nucleotidic has allowed the identification of the vaccine virus (Urabe AM9 strain). The frequency of non bacterial meningitis is greatly less than those caused by wild mumps virus. A complete recovery without any sequelae has been usually recorded. The occurrence of orchitis has been very rarely reported. A few cases of thrombocytopenia have been observed during trivalent vaccination measles, rubella, mumps. 4.9 Overdose 3

4 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties 5.2 Pharmacokinetic properties 5.3 Preclinical safety data 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients Stabilizer excipient containing human albumin 3 years* 6.2 Incompatibilities 6.3 Shelf life * The 3-year shelf-life of this vaccine received the approval from the Thai Food and Drug Administration as of 31 March Special precautions for storage Store between +2 o C and +8 o C, protected from light. 6.5 Nature and contents of container Vials of both vaccine and diluent: Type I borosilicate glass. 6.6 Special precautions for disposal and other handling 7. MARKETING AUTHORISATION HOLDER 4

5 Government Pharmaceutical Organization Mérieux Biological Products Co., Ltd. 8. MARKETING AUTHORISATION NUMBER(S) 2A 94/46 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 15 August DATE OF REVISION OF THE TEXT April