देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Salmonella typhi Vi polysaccharide 25ug (Salmonella typhi Vi polysaccharide (Ty2 strain)); Hepatitis A virus formaldehyde inactivated, GBM strain 160 U
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Salmonella typhi Vi polysaccharide 25 µg (Salmonella typhi Vi polysaccharide (Ty2 strain))
Solution for injection
Active: Salmonella typhi Vi polysaccharide 25ug (Salmonella typhi Vi polysaccharide (Ty2 strain)) Excipient: Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Sodium chloride Water for injection Active: Hepatitis A virus formaldehyde inactivated, GBM strain 160 U Excipient: Aluminium hydroxide as aluminium Formaldehyde Medium 199 Phenoxyethanol as 2-phenoxyethanol solution 2.5µL
Syringe, glass, Dual chamber syringe, 1 mL
Prescription
Prescription
Sanofi Pasteur SA
VIVAXIM® is indicated for simultaneous active immunisation against typhoid fever and hepatitis A virus infections in subjects aged 16 and older.
Package - Contents - Shelf Life: Syringe, glass, Dual chamber syringe - 1 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2001-11-20
VIVAXIM ® 1 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-term protection against hepatitis A virus a booster vaccination with an inactivated 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 hepati पूरा दस्तावेज़ पढ़ें
viv-ccdsv9-dsv3-20jun22 Page 1 NEW ZEALAND DATA SHEET 1 VIVAXIM SOLUTION FOR INJECTION VIVAXIM ® , Solution for injection _Salmonella typhi_ Vi polysaccharide and hepatitis A virus 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Vivaxim contains a sterile suspension of purified Salmonella typhi Vi polysaccharide and formaldehyde inactivated hepatitis A virus 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* 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. Contains phenylalanine. 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-ccdsv9-dsv3-20jun22 Page 2 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 hepatitis A. A single dose of Vivaxim does not ensure long-term protection against infection with hepatitis A virus. For long-term protection पूरा दस्तावेज़ पढ़ें