Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Rotavirus G2 human-bovine reassortant, Quantity: 1400000 Infectious unit/mL; Rotavirus G3 human-bovine reassortant, Quantity: 1100000 Infectious unit/mL; Rotavirus G1 human-bovine reassortant, Quantity: 1100000 Infectious unit/mL; Rotavirus G4 human-bovine reassortant, Quantity: 1000000 Infectious unit/mL; Rotavirus P1 [8] human-bovine reassortant, Quantity: 1150000 Infectious unit/mL
Merck Sharp & Dohme (Australia) Pty Ltd
Rotavirus G1 human-bovine reassortant,Rotavirus G2 human-bovine reassortant,Rotavirus G3 human-bovine reassortant,Rotavirus G4 h
Oral Liquid
Excipient Ingredients: polysorbate 80; sucrose; sodium citrate dihydrate; sodium hydroxide; monobasic sodium phosphate; glucose monohydrate; sodium ascorbate; sodium chloride; ammonium metavanadate; calcium chloride dihydrate; cupric sulfate pentahydrate; ferric nitrate nonahydrate; ferrous sulfate heptahydrate; magnesium chloride hexahydrate; dried magnesium sulfate; manganese sulfate tetrahydrate; ammonium molybdate; potassium chloride; sodium acetate; sodium bicarbonate; dibasic sodium phosphate; zinc sulfate heptahydrate; alanine; arginine hydrochloride; asparagine; aspartic acid; cysteine hydrochloride; cystine dihydrochloride; glutamic acid; glycine; histidine hydrochloride monohydrate; hydroxyproline; isoleucine; leucine; lysine hydrochloride; methionine; phenylalanine; proline; serine; threonine; tryptophan; tyrosine disodium; valine; Biotin; ergocalciferol; choline chloride; folic acid; inositol; menadione; nicotinamide; nicotinic acid; aminobenzoic acid; calcium pantothenate; pyridoxal hydrochloride; pyridoxine hydrochloride; retinol acetate; riboflavine; dl-alpha-tocopheryl phosphate disodium; thiamine hydrochloride; cyanocobalamin; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine monophosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride; sodium hypoxanthine; linoleic acid; alpha lipoic acid; phenolsulfonphthalein; putrescine dihydrochloride; sodium pyruvate; ribose; thymidine; thymine; uracil; sodium xanthine; monoethanolamine; 2-mercaptoethanol; adenosine; uridine; cytidine; guanosine; dexamethasone; Epidermal growth factor; hydrocortisone; insulin; alprostadil; liothyronine; ascorbic acid; magnesium sulfate heptahydrate; monobasic sodium phosphate monohydrate; zinc sulfate; arginine; cysteine; cystine; histidine; lysine; tyrosine; adenosine triphosphate; guanine; putrescine
Oral
SINGLE UNIT-DOSE PACK, 10 UNIT-DOSE PACK
(S4) Prescription Only Medicine
RotaTeq is indicated for the prevention of rotavirus gastroenteritis (see Clinical Trials).
Visual Identification: Pale yellow, pink tint clear liquid.; Container Type: Tube; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2006-05-11
ROTATEQ ® _Rotavirus vaccine, live, oral, pentavalent_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about RotaTeq. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of your child taking RotaTeq against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT THIS VACCINE, ASK YOUR DOCTOR, NURSE OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ROTATEQ IS USED FOR RotaTeq is a viral vaccine that helps protect your child against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection. Rotavirus gastroenteritis may cause fever, vomiting, and diarrhoea. These symptoms can lead to the loss of body fluids (dehydration) and even death. Rotavirus is the chief cause of severe dehydrating diarrhoea among infants and young children around the world. Before the vaccine was used, the virus was the cause for about 25 million physician visits per year. It also accounted for 2.1 million hospital admissions, and 352,000 to 592,000 deaths per year worldwide. Rotavirus infects the small intestine and usually starts with fever and vomiting, followed by diarrhoea. The diarrhoea can be mild to severe and generally lasts 3-9 days. Severe vomiting and diarrhoea (more than 5 times each day) lasts an average of 3-6 days. Nearly all children are infected with rotavirus by the time they are 5 years old. This is true even where standards of hygiene are high. _HOW IT WORKS_ RotaTeq works by causing your body to produce its own protection (antibodies) against the most common types or "strains" of rotavirus. As with other vaccines, RotaTeq may not fully protect all those who get it. Some children may already have the virus but not yet show signs of being sick. In those cases, the vaccine may not be able to prevent the illness. RotaTeq helps protect against diarrhoea and vomiting only i Прочетете целия документ
RotaTeq ® WPC-V260-OS-082016 Page 1 of 16 AUSTRALIAN PRODUCT INFORMATION ROTATEQ ® (ROTAVIRUS VACCINE, LIVE, ORAL, PENTAVALENT) 1 NAME OF THE MEDICINE Rotavirus G1 human-bovine reassortant Rotavirus G2 human-bovine reassortant Rotavirus G3 human-bovine reassortant Rotavirus G4 human-bovine reassortant Rotavirus P1 [8] human-bovine reassortant 2 QUALITATIVE AND QUANTITATIVE COMPOSITION RotaTeq is a live, oral pentavalent reassortant vaccine for use in the prevention of rotavirus gastroenteritis. Each 2 mL dose of RotaTeq contains the following rotavirus reassortants: G1, G2, G3, G4, and P1A[8] derived from rotaviruses infecting human and bovine species. The minimum dose levels of the reassortants are as follows: G1 2.2 X 10 6 infectious units G2 2.8 X 10 6 infectious units G3 2.2 X 10 6 infectious units G4 2.0 X 10 6 infectious units P1A[8] 2.3 X 10 6 infectious units The reassortants are propagated in Vero cells using standard tissue culture techniques in the absence of antifungal agents. The reassortants are suspended in a buffered stabilizer solution. List of excipients with known effect: sucrose, sugars, benzoates, phenylalanine For the full list of Excipients, see Section 6.1 List of Excipients. The manufacture of this product includes exposure to bovine derived material. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product. DNA fragments from porcine circoviruses (PCV) 1 and 2 have been detected in RotaTeq. The source is porcine-derived material used in the manufacture of the vaccine. PCV-1 and PCV-2 are not known to cause disease in humans. 3 PHARMACEUTICAL FORM RotaTeq is a pale yellow clear liquid that may have a pink tint. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS RotaTeq is indicated for the prevention of rotavirus gastroenteritis (see Section 5.1 Pharmacodynamic Properties, Clinical trials). RotaTeq ® WPC-V260-OS-082016 Page 2 of 16 4.2 DOSE AND METHOD OF ADMINISTRATION FOR Прочетете целия документ