Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Measles vaccine 1000 TCID50 (at end of expiry); Mumps vaccine 12500 TCID50 (at end of expiry); Rubella vaccine 1000 TCID50 (at end of expiry)
Merck Sharp & Dohme (New Zealand) Limited
Measles vaccine 1000 TCID50 (at end of expiry)
Suspension for injection
Active: Measles vaccine 1000 TCID50 (at end of expiry) Mumps vaccine 12500 TCID50 (at end of expiry) Rubella vaccine 1000 TCID50 (at end of expiry) Excipient: Dibasic potassium phosphate Dibasic sodium phosphate monohydrate Eagle Minimum Essential medium Gelatin Medium 199 Monobasic potassium phosphate Monobasic sodium phosphate monohydrate Monosodium glutamate Neomycin Phenolsulfonphthalein Sodium bicarbonate Sorbitol Sucrose Water for injection
Combination pack, vaccine + diluent, 1 dose unit
Prescription
Prescription
Merck Sharp & Dohme Corp
M-M-R II is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months of age or older.
Package - Contents - Shelf Life: Combination pack, vaccine + diluent - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 5 x vaccine + 5 x diluent - 5 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, 10 x vaccine + 10 x diluent - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Diluent - 0.7 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, multi-dose, vaccine - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, vaccine - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, vaccine - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
1990-05-17
M-M-R ® II _Measles, mumps and rubella virus vaccine live _ Single dose vial WHAT IS IN THIS LEAFLET This leaflet answers some common questions about M-M-R II. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines and vaccines have risks and benefits. Your doctor has weighed the risks of you being given M-M-R II against the benefits they expect it will have for you. If you have any concerns about being given this vaccine, ask your doctor. Keep this leaflet with the medicine. You may need to read it again. WHAT M-M-R II IS USED FOR M-M-R II is a vaccine used to help protect people from getting measles, mumps and rubella (German measles). It should be given to children 12 months of age or older. However, your doctor may recommend that M-M-R II be given to infants between 6-12 months of age in special situations. Protection against these infections is important as they can cause serious problems in some people. Measles is a serious disease that is very easily passed from one person to another. It causes a high fever (temperature), cough and a rash and lasts for 1 to 2 weeks. One out of every 10 children who catch measles will also have an ear infection or pneumonia. On rare occasions, measles can also cause an infection of the brain that could lead to seizures, hearing loss, mental retardation, and even death. Babies and adults who catch measles are often much sicker for a longer time or are more likely to die than school children and teenagers who catch measles. Mumps is easily passed from one person to another and causes fever, headache, and swollen, painful glands under the jaw (salivary glands). Mumps can sometimes be a very serious disease and usually lasts for several days. Mumps can cause a mild inflammation of the coverings of the brain and spinal cord (meningitis) in about one person in every 10 who catch it. About one out of every 4 teenage or adult males with mumps will have a painful swelling of the testicles for several days Pročitajte cijeli dokument
S-IPC-V205C-I-022020 Page 1 of 11 NEW ZEALAND DATA SHEET 1 PRODUCT NAME M-M-R ® II 0.5 mL Suspension for injection Measles mumps and rubella virus vaccine live 2 QUALITATIVE AND QUANTITATIVE COMPOSITION M-M-R II is a sterile lyophilised preparation of (1) ATTENUVAX ® (Measles Virus Vaccine Live, MSD), a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) MUMPSVAX ® (Mumps Virus Vaccine Live, MSD), the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) MERUVAX ® II (Rubella Virus Vaccine Live, MSD), the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts. The reconstituted vaccine is for subcutaneous administration. When reconstituted as directed, the dose for injection is 0.5 mL and contains not less than 1,000 CCID 50 (50% cell culture infectious dose) of measles virus; 12,500 CCID 50 of mumps virus; and 1,000 CCID 50 of rubella virus. Excipients with known effect: Sorbitol For the full list of excipients, see Section 6.1. The growth medium for measles and mumps is Medium 199 (a buffered salt solution containing vitamins and amino acids and supplemented with foetal bovine serum) containing SPGA (sucrose, phosphate, glutamate, and recombinant human albumin) as stabiliser and neomycin. The growth medium for rubella is Minimum Essential Medium (MEM) [a buffered salt solution containing vitamins and amino acids and supplemented with foetal bovine serum] containing recombinant human albumin and neomycin. Sorbitol and hydrolysed gelatin stabiliser are added to the individual virus harvests. The cells, virus pools, and foetal bovine serum are all screened for the absence of adventitious agents. The product contains no preservative. 3 PHARMACEUTICAL FORM Suspension for injection The vaccine is supplied in vials as a sterile lyophilised preparation together with vials of diluent containing sterile water for injection BP. Before reconstituti Pročitajte cijeli dokument