Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Measles virus, Quantity: 3 TCID50; Mumps virus, Quantity: 4.3 TCID50; Rubella virus, Quantity: 3 TCID50; live varicella vaccine, Quantity: 3.99 PFU
Merck Sharp & Dohme (Australia) Pty Ltd
live varicella vaccine,Measles virus,Mumps virus,Rubella virus
Injection, powder for
Excipient Ingredients: potassium chloride; hydrolysed gelatin; urea; neomycin; sodium bicarbonate; Albumin; sodium chloride; sucrose; monobasic sodium phosphate; dibasic sodium phosphate; phenolsulfonphthalein; monosodium glutamate monohydrate; monobasic potassium phosphate; dibasic potassium phosphate; sorbitol; glucose monohydrate; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; water for injections; ascorbic acid; polysorbate 80; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; histidine hydrochloride; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; menadione; nicotinic acid; aminobenzoic acid; pyridoxal hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium
Subcutaneous, Intramuscular
10 vials + 10 diluent syringes, 1 vial + 1 diluent syringe
(S4) Prescription Only Medicine
ProQuad is indicated for simultaneous immunisation against measles, mumps, rubella and varicella in individuals 12 months through 12 years of age.
Visual Identification: White to faint yellow, compact crystalline powder; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2007-02-08
PROQUAD ® _Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live, Refrigerator-stable formulation_ CONSUMER MEDICINE INFORMATION 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 your child being given ProQuad against the benefits they expect it will have for your child. IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS VACCINE, ASK YOUR DOCTOR OR PHARMACIST. 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 chicken pox. It can be given to children aged 12 months to 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 causes a high fever (temperature), runny nose, cough, conjunctivitis and a rash. It usually lasts for about 1 to 2 weeks. It is very easily passed from one person to another in the tiny droplets of moisture which are expelled during coughing or sneezing. 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 causes fever, headache, and swollen, painful glands under the jaw (salivary glands) and usually lasts several days. It is easily passed from one person to another by the tiny droplets of moisture expelled during coughing or sneezing. Mumps can sometimes be a very serious disease, causing a mild inflammation of the coverings of the brain and spinal cord (meningiti Soma hati kamili
S-WPC-V221-I-ref-122019 1 AUSTRALIAN PRODUCT INFORMATION – PROQUAD® MEASLES, MUMPS, RUBELLA AND VARICELLA VIRUS VACCINE LIVE (REFRIGERATOR STABLE FORMULATION) 1 NAME OF THE MEDICINE Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live 2 QUALITATIVE AND QUANTITATIVE COMPOSITION AND 3 PHARMACEUTICAL FORM 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). ProQuad, when reconstituted as directed, is a sterile preparation for intramuscular (IM) or subcutaneous (SC) administration. Each 0.5 mL dose contains not less than 3.00 log 10 TCID 50 (50% tissue culture infectious dose) of measles virus; 4.30 log 10 TCID 50 of mumps virus; 3.00 log 10 TCID 50 of rubella virus; and a minimum of 3.99 log10 PFU (plaque-forming units) of Oka/Merck varicella virus. Powder for injection. Before reconstitution, the lyophilised vaccine is a white to pale yellow compact crystalline powder. ProQuad, when reconstituted, is a clear pale yellow to light pink liquid. Excipients with known effect: The vaccine contains 16 mg of sorbitol. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. This product also contains residual components of MRC-5 cells including DNA and protein, recombinant human albumin, bovine serum albumin and other buffer and media ingredients. This product contains no preservative. The cells, virus pools, bovine serum, and recombinant human albumin Soma hati kamili