देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
Hepatitis a virus antigen, Quantity: 160 ELISA unit
Sanofi-Aventis Australia Pty Ltd
Injection, suspension
Excipient Ingredients: neomycin; formaldehyde; bovine serum albumin; polysorbate 80; aluminium hydroxide hydrate; phenoxyethanol; glucose monohydrate; ascorbic acid; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; 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; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium
Intramuscular
1 x single dose pre-filled dual-chamber syringe
(S4) Prescription Only Medicine
VIVAXIM is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infections in subject's aged 16 and older.
Visual Identification: CLOUDY, WHITISH SUSPENSION.; Container Type: Syringe; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2002-09-24
VIVAXIM ® _Salmonella typhi Vi polysaccharide and inactivated hepatitis A virus antigen vaccine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Vivaxim. 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 you having Vivaxim against the benefits they expect it will have for you. 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 VIVAXIM IS USED FOR Vivaxim is a vaccine used to help prevent typhoid fever and hepatitis A disease in adults aged 16 years and older who are at risk of these diseases. _HOW IT WORKS_ Vivaxim works by causing your body to produce its own protection against typhoid fever and hepatitis A infection. It does this by making substances called antibodies in the blood, which fight the typhoid bacteria and hepatitis A virus. If a vaccinated person comes into contact with the typhoid or hepatitis A organisms, the body is usually ready to destroy them. Your body usually takes two weeks after vaccination to develop protection against typhoid fever and hepatitis A infection. Initial protection is provided by one dose of Vivaxim. For long-lasting protection against hepatitis A virus a booster vaccination with a hepatitis A vaccine will be required 6 to 36 months after vaccination with Vivaxim. The body does not develop long-term protection against typhoid fever and repeat vaccinations are required to maintain protection. Most people will produce enough antibodies against typhoid fever and hepatitis A infection. However, as with all vaccines, 100% protection cannot be guaranteed. The vaccine will not give you typhoid fever or hepatitis A infection. The chance of a severe reaction from Vivaxim is very small, but the risks from not being vaccinated against typhoid fever or hepatitis A infection may be ve पूरा दस्तावेज़ पढ़ें
viv-ccdsv09-piv4-05mar20 Page 1 of 14 AUSTRALIAN PRODUCT INFORMATION – VIVAXIM (_SALMONELLA _ _TYPHI_ VI POLYSACCHARIDE & HEPATITIS A VIRUS ANTIGEN) VACCINE 1 NAME OF THE MEDICINE _Salmonella typhi_ Vi polysaccharide and hepatitis A virus antigen. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vivaxim contains a sterile suspension of purified _Salmonella typhi _ Vi polysaccharide and formaldehyde-inactivated hepatitis A virus (HAV) antigen (GBM strain) adsorbed onto aluminium hydroxide. Vivaxim is presented in a dual-chamber by-pass syringe. The contents of both chambers are mixed immediately prior to injection by slowly pressing the plunger. Each 1.0 mL dose of mixed vaccine contains: ACTIVE INGREDIENTS: _Salmonella typhi_ Vi polysaccharide (Ty 2 strain) 25 micrograms Hepatitis A virus antigen* 160 antigen units** * GBM strain cultured on MRC-5 human diploid cells. MRC-5 is a cell line that was derived from human embryonic lung tissue in the 1960s. ** In the absence of an international standardised reference, the antigen content is expressed using an in-house reference. Excipients with known effects: phenylalanine and residual neomycin. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM The typhoid polysaccharide component is a clear and colourless solution, the hepatitis A component (inactivated, adsorbed) is a cloudy whitish suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vivaxim is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infections in subjects aged 16 and older. viv-ccdsv09-piv4-05mar20 Page 2 of 14 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dosage is 1 mL of the mixed vaccine. Vivaxim should be administered by slow intramuscular injection in the deltoid region. Vivaxim must not be administered intradermally or intravenously. Primary immunisation is achieved with a single dose of Vivaxim. The vaccine should be administered at least 14 days prior to risk of exposure to both typhoid fever and hepat पूरा दस्तावेज़ पढ़ें