VIVOTIF® Oral Product Information NAME OF THE MEDICINE Oral Typhoid Vaccine DESCRIPTION Vivotif Oral is an oral, live, attenuated typhoid vaccine for active immunization against typhoid and contains Salmonella typhi strain Ty21a. Each enteric coated capsule contains not fewer than 2 x 109 viable organisms. Each capsule also contains the following excipients: ethylene glycol, sucrose, ascorbic acid, protein hydrolysate, lactose, magnesium stearate, hydroxypropyl methylcellulose phthalate, gelatin, titanium dioxide, erythrosine ci45430, iron oxide yellow ci77492, iron oxide red ci77491, dibutyl phthalate, diethyl phthalate. PHARMACOLOGY The attenuated Ty21a strain is a mutant of Salmonella typhi, which is deficient in the enzyme UDP-4-galactose epimerase. This results in the organisms being unable to effectively metabolize galactose. When grown in the presence of adequate amounts of galactose, the organism accumulates galactose-containing metabolites and ultimately undergoes spontaneous lysis. In the presence of a restricted supply of galactose the organism develops the smooth lipopolysaccharide coat believed to be necessary for immune response. In the intestine, where galactose is normally present, it is however unable to survive for long. The vaccine strain cannot be detected in the stools after 3 days following oral ingestion. CLINICAL TRIALS
In one clinical study conducted in Egypt, in children above 6 years of age, oral ingestion of the vaccine as a solution preceded by a dose of sodium bicarbonate to reduce gastric activity (in order to reduce lysis of the organism in the stomach), provided approximately 95% protection against typhoid. In another study, conducted in Chile, enteric coated capsules provided approximately 70% protection. The duration of protection conferred by Vivotif Oral remains to be fully established. However, repeat vaccination is not considered necessary within 12 months after initial vaccination.
INDICATIONS Vivotif Oral is indicated for active immunisation against typhoid in adults and children above 6 years of age. Effectiveness in children below 6 years of age is not known at present. VIVOTIF® Oral Product Information CONTRA-INDICATIONS Primary and acquired immunodeficiency, including that from treatment with immunosuppressive and antimitotic drugs, acute febrile illness: acute intestinal infection, allergic reactions to a previous dose, and hypersensitivity to the vaccine or to any of the inactive components. PRECAUTIONS
No data are currently available about the efficacy of Vivotif Oral in individuals with blood dyscrasias, leukaemia, lymphoma or any type of malignant neoplasm affecting the bone marrow or lymphatic system. These individuals may fail to develop protection because of their disturbed immune functions. In the case of acute febrile illnesses and acute gastro-intestinal illness as well as during and up to 3 days after treatment with antibiotics, Vivotif Oral should not be taken due to possible inhibition of the growth of the vaccine organisms. The capsules must be swallowed whole and not chewed because of the destruction of the organism by gastric acid. See also “Interactions with Other Medicines.” Pregnancy - Category B2
Studies in animals are inadequate but available data show no evidence of an increased occurrence of foetal damage. Interactions with Other Medicines The vaccine should not be administered concurrently with antibiotics or other drugs (eg. sulphonamides) that are active against salmonellae. The vaccine should be administered first and at least 3 days should elapse between the final dose of the vaccine and such drugs. The simultaneous administration of Vivotif Oral Typhoid Vaccine and parenteral (live attenuated) yellow fever vaccine, or inactivated vaccines, or oral polio vaccines, or parenteral immunoglobulin preparations, has been reported not to interfere with the immune response. See also under “Anti-Malaria Prophylaxis” in “Interactions with Other Medicines”. Anti-Malaria Prophylaxis General In the case of planned anti-malarial prophylaxis, immunisation with Vivotif Oral Typhoid Vaccine should precede anti-malaria prophylaxis. The interval between the last dose of Vivotif Oral Typhoid Vaccine and the beginning of anti-malarial prophylaxis should, in general, be at least 3 days. VIVOTIF® Oral Product Information If anti-malaria prophylaxis has been started, the minimum interval between the last dose of anti-malaria prophylaxis and the first dose of Vivotif Oral Typhoid Vaccine should be at least 3 days. This 3-day interval should generally be regarded as optimal. Chloroquine and/or pyrimethamine/sulfadoxine Vivotif Oral Typhoid Vaccine can be given with chloroquine and/or pyrimethamine/sulfadoxine. In these studies, the anti-malarials were given first, followed 12 hours later by Vivotif Oral Typhoid capsule. Mefloquine Mefloquine can be given concomitantly with Vivotif Oral Typhoid Vaccine. A lower IgG response was observed compared to taking Vivotif Oral Typhoid Vaccine alone, however the immune response was not affected and vaccine efficacy was not compromised. Atavoquone and proguanil, fixed combination Atavaquone and proguanil (fixed combination formulation) may be given concomitantly with Vivotif Oral Typhoid Vaccine. Proguanil Proguanil, when given alone, should be administered only if 10 days or more have elapsed since the final dose of Vivotif Oral Typhoid Vaccine. ADVERSE EFFECTS Clinical Trials
The following adverse effects were reported as common (in accordance with CIOMS definition of <1/10 and >1/100) and were generally mild – constipation, abdominal cramps, diarrhoea, nausea, vomiting, anorexia, fever, headache and urticarial exanthema. Postmarketing Data
The following additional adverse effects have been reported very rarely (CIOMS definition: <1/10,000) during postmarketing surveillance. Skin reactions such as dermatitis, exanthema, pruritus and urticaria, anaphylaxis, asthenia, malaise, tiredness, shivering, paraesthesia, dizziness, arthralgia and myalgia. DOSAGE AND ADMINISTRATION The Vivotif Oral Typhoid Vaccine capsule should be swallowed whole and must not be chewed. The capsule should be taken approximately one hour before a meal, VIVOTIF® Oral Product Information with cold or lukewarm (temperature not to exceed body temperature e.g. 37º C (98.6º F) drink, on alternate days, 1, 3 and 5. The complete immunisation schedule, irrespective of age, for adults and children above 6 years of age, is the ingestion of one capsule on each of days 1, 3 and 5. Re-immunisation An optimal booster schedule for Vivotif Oral Typhoid Vaccine has not been determined. Booster doses, consisting of 3 capsules on Days 1, 3 and 5 are recommended every 3 years. See also “Interactions with Other Medicines”.
Doses five-fold higher than the recommended dose caused only mild, mainly gastro- intestinal adverse reactions which did not require medical treatment. Overdosing can increase the possibility of shedding S. typhi Ty21a organism in the faeces. PRESENTATION AND STORAGE CONDITIONS
Store between +2 and +8°C in a dry place and protected from light. Every package shows an expiry date and the product should not be used after this date. Each carton contains 3 capsules in a blister pack. Each enteric coated capsule contains not fewer than 2 x 109 viable cells of Salmonella typhi strain Ty21a. NAME AND ADDRESS OF MANUFACTURER AND SPONSOR MANUFACTURED BY: Crucell Switzerland AG Rehhagstrasse 79 CH-3018 Bern SWITZERLAND SPONSOR: Australia CSL Limited ABN 99 051 588 348 45 Poplar Road Parkville Victoria 3052 Australia VIVOTIF® Oral Product Information New Zealand CSL Biotherapies (NZ) Ltd 666 Great South Road Penrose Auckland 6 NEW ZEALAND POISONS SCHEDULE
S4 DATE OF APPROVAL
7 July 2010 Vivotif® is a Registered Trademark of Crucell Switzerland AG
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