Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Measles vaccine 1000 TCID50 (Edmonston B strain (3 log per dose)); Mumps virus, Jeryl-Lynn strain 19952 TCID50 (B Level (4.3 log per dose)); Rubella virus, Wistar RA27/3 strain 1000 TCID50 ((3 log per dose) ); Varicella vaccine 9772 PFU (Oka/Merck strain (3.99 log per dose));
Merck Sharp & Dohme (New Zealand) Limited
Measles vaccine 1000 TCID50 (Edmonston B strain (3 log per dose))
0.5 mL
Injection with diluent
Active: Measles vaccine 1000 TCID50 (Edmonston B strain (3 log per dose)) Mumps virus, Jeryl-Lynn strain 19952 TCID50 (B Level (4.3 log per dose)) Rubella virus, Wistar RA27/3 strain 1000 TCID50 ((3 log per dose) ) Varicella vaccine 9772 PFU (Oka/Merck strain (3.99 log per dose)) Excipient: Dibasic potassium phosphate Dibasic sodium phosphate Gelatin Minimum Essential Medium Eagle Medium 199 Monosodium glutamate Phenolsulfonphthalein Potassium chloride Sodium bicarbonate Sodium chloride Sorbitol Sucrose Urea Water for injection
Combination pack, active plus diluent in separate vials, 1 dose unit
Prescription
Prescription
Merck Sharp & Dohme Corp
ProQuad is indicated for vaccination against measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age.
Package - Contents - Shelf Life: Combination pack, active plus diluent in separate vials - 1 dose units - 60 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, active plus diluent in separate vials - 10 dose units - 60 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 150 minutes reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, diluent only - 0.5 mL - 36 months from date of manufacture stored at or below 25°C - Vial, glass, single dose, active (vaccine) only - 1 dose units - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 60 minutes reconstituted (not refrigerated) stored at or below 25°C protect from light 150 minutes reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2004-11-17
PROQUAD ® _Measles, Mumps, Rubella and Varicella Virus Vaccine Live _ Single dose vial WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ProQuad. 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 or your child being given ProQuad 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 PROQUAD IS USED FOR ProQuad is a vaccine used to help protect people from getting measles, mumps, rubella (German measles) and varicella (chickenpox). It should be given to children 12 months through 12 years of age. 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 pa Citiți documentul complet
NAME OF MEDICINE PROQUAD ® _Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live _ Subcutaneous injection PRESENTATION The vaccine is supplied in vials as a sterile lyophilised preparation together with vials of diluent containing sterile water. Before reconstitution, the lyophilised vaccine is a white to pale yellow compact crystalline plug. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid. THERAPEUTIC CLASS ProQuad is a combined attenuated live virus vaccine containing measles, mumps, rubella, and varicella viruses. ProQuad is a sterile lyophilised preparation of (1) the components of M-M-R ® II (Measles, Mumps and Rubella Virus Vaccine Live): Measles Virus Vaccine Live, a more attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in chick embryo cell culture; Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts; and (2) Varicella Virus Vaccine Live (Oka/Merck), the Oka/Merck strain of varicella-zoster virus propagated in MRC-5 cells (hereafter referred to as VARIVAX ® ). INDICATIONS ProQuad is indicated for vaccination against measles, mumps, rubella, and varicella in individuals 12 months through 12 years of age. DOSAGE AND ADMINISTRATION DOSAGE Individuals 12 months through 12 years of age should receive a single dose of ProQuad administered subcutaneously. If a second dose of measles-containing vaccine is to be administered according to applicable official recommendations, then ProQuad may be used for this dose. If the first dose of a measles-containing vaccine is given between 6 months of age and less than 12 months of age (in an at-risk situation such as measles outbreak, or due to official recommendations) the response to t Citiți documentul complet