البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
LIVE ATTENUATED MEASLES VIRUS; LIVE ATTENUATED MUMPS VIRUS; LIVE ATTENUATED RUBELLA VIRUS
GLAXO SMITH KLINE (ISRAEL) LTD
J07BJ51
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
LIVE ATTENUATED MUMPS VIRUS 10^3.7 CCID50; LIVE ATTENUATED RUBELLA VIRUS 10^3.0 CCID50; LIVE ATTENUATED MEASLES VIRUS 10^3.0 CCID50
S.C, I.M
Required
GLAXO SMITH KLINE BIOLOGICALS S.A
RUBELLA, COMBINATIONS WITH MUMPS, LIVE ATTENUATED
RUBELLA, COMBINATIONS WITH MUMPS, LIVE ATTENUATED
Priorix is indicated for active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella.
2023-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only PRIORIX POWDER AND SOLUTION FOR PREPARATION OF A SOLUTION FOR INJECTION Each dose (0.5 ml) contains: NLT 10 3.0 CCID 50 – Live attenuated measles virus NLT 10 3.7 CCID 50 – Live attenuated mumps virus NLT 10 3.0 CCID 50 – Live attenuated rubella virus For a list of the inactive and allergenic ingredients in the preparation, see section 2 – “Important information about some of the ingredients of the medicine” and section 6 – “Further information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella. THERAPEUTIC GROUP: viral vaccines. HOW DOES THE VACCINE WORK? When a person is vaccinated with Priorix, the immune system (the body’s natural defense system) will make antibodies to protect the person from measles, mumps and rubella virus infections. Although Priorix contains live viruses, they are too weak to cause measles, mumps or rubella in healthy people. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: - you are sensitive (allergic) to one of the active ingredients or to any of the additional ingredients contained in the medicine (listed in section 6 “Further information”). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. - you are known to be allergic to neomycin (an antibiotic agent). A known contact dermatitis (skin rash when the skin is in direct contact with allergens such as neomycin) should not be a اقرأ الوثيقة كاملة
Page 1 of 10 PRIORIX 1 . NAME OF THE MEDICINAL PRODUCT PRIORIX Powder and solvent for solution for injection Measles, Mumps and Rubella vaccine (live) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, 1 dose (0.5 ml) contains: Live attenuated measles virus 1 (Schwarz strain) not less than 10 3.0 CCID 50 3 Live attenuated mumps virus 1 (RIT 4385 strain, derived from Jeryl Lynn strain) not less than 10 3.7 CCID 50 3 Live attenuated rubella virus 2 (Wistar RA 27/3 strain) not less than 10 3.0 CCID 50 3 1 produced in chick embryo cells 2 produced in human diploid (MRC-5) cells 3 Cell Culture Infective Dose 50% This vaccine contains a trace amount of neomycin. See section 4.3. Excipients with known effect: The vaccine contains 9 mg of sorbitol. The vaccine contains 6.5 nanograms of para-aminobenzoic acid per dose and 334 micrograms of phenylalanine per dose (see section 4.4). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The lyophilised Measles-Mumps-Rubella component is a white to slightly pink powder. The solvent is a clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications PRIORIX is indicated for active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella. For use in children between 9 to 12 months of age see sections 4.2, 4.4 and 5.1. 4.2 Posology and method of administration Posology The use of PRIORIX should be based on official recommendations. Individuals 12 months of age or older The dose is 0.5 ml. A second dose should be given according to official recommendations. Page 2 of 10 PRIORIX may be used in individuals who have previously been vaccinated with another monovalent or combined measles, mumps and rubella vaccine. Infants between 9 and 12 months of age Infants in their first year of life may not respond sufficiently to the components of the vaccines. In case an epidemiological situation requires vaccinating infants in their f اقرأ الوثيقة كاملة