देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
Salmonella typhi Vi polysaccharide, Quantity: 0.025 mg
Sanofi-Aventis Australia Pty Ltd
Injection, solution
Excipient Ingredients: monobasic sodium phosphate; phenol; water for injections; sodium chloride; dibasic sodium phosphate dihydrate
Intramuscular
1 x 0.5mL (single dose)
(S4) Prescription Only Medicine
For the active immunisation against typhoid fever, in subjects over 5 years of age. INDICATIONS AS AT 9 OCTOBER 2000: TYPHIM Vi is indicated for active immunisation against typhoid fever in subjects 2 years of age and over.
Visual Identification: Clear colourless solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1993-12-13
TYPHIM VI™ _Salmonella typhi Vi polysaccharide vaccine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Typhim Vi. 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 or your child having Typhim Vi 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 TYPHIM VI IS USED FOR Typhim Vi is a vaccine used to help prevent typhoid fever, which is caused by a bacterium called Salmonella typhi. The organism which causes typhoid fever can be passed on through contaminated food or water. If you are in an area where there is a risk of getting typhoid fever, in addition to having Typhim Vi, it is also very important to be careful with your personal, food and water hygiene. Hygiene will also help avoid illness caused by other bacteria in the water. Typhim Vi may be given to people aged 2 years and older. IF YOU WANT MORE INFORMATION ON PERSONAL CARE IN AREAS WHERE THERE IS A RISK OF GETTING TYPHOID FEVER, TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. HOW TYPHIM VI WORKS Typhim Vi works by causing your body to produce its own protection against typhoid fever. It does this by making substances, called antibodies, which destroy the Salmonella typhi organism. If you have been vaccinated against Salmonella typhi, your body is able to attack that organism if you come in contact with it. Your body usually takes several weeks after vaccination to fully develop this protection against typhoid fever. You must have one dose at least 2 weeks before you may be exposed to typhoid fever. If you are continually or repeatedly exposed to the Salmonella typhi organism, it is recommended that you have an injection of Typhim Vi every 3 years. Most people will make enough antibodies against Salmonella t पूरा दस्तावेज़ पढ़ें
typhim-ccdsv11-piv3-20jul20 Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION – TYPHIM VI™, SALMONELLA TYPHI VI POLYSACCHARIDE 1 NAME OF THE MEDICINE Typhim VI ™ _Salmonella typhi_ VI polysaccharide vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mL dose contains: Salmonella typhi Vi polysaccharide …………………………………….25 micrograms Typhim Vi is a sterile solution, prepared from the purified Vi capsular polysaccharide of _Salmonella typhi_ (Ty 2 strain). The purified Vi capsular polysaccharide is diluted in isotonic buffer solution which contains phenol as preservative. For the full list of excipients, see Section 6.1 List of excipients. The manufacture of this product includes exposure to bovine materials. 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. 3 PHARMACEUTICAL FORM Solution for injection 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Typhim Vi is indicated for active immunisation against typhoid fever caused by _Salmonella _ _typhi_ in individuals 2 years of age and over. 4.2 DOSE AND METHOD OF ADMINISTRATION A single dose of 0.5 mL for adults is given intramuscularly in the deltoid, and the dose for children is given intramuscularly either in the deltoid or the vastus lateralis. The vaccine should not be injected into the gluteal area or areas where there may be a nerve trunk. The vaccination dose is the same for adults and children. TyphimVi should be administered at least 14 days prior to potential exposure to infection with _Salmonella typhi_ . typhim-ccdsv11-piv3-20jul20 Page 2 of 11 An optimal revaccination schedule has not been established. Revaccination consisting of a single dose every three years for individuals under conditions of repeated or continued exposure to the _Salmonella typhi _ organism is recommended at this time. Product is for single use only and must not be used in more than one individual. Discard any remaining unused पूरा दस्तावेज़ पढ़ें