Vivotif

/ Kamada

One capsule is taken on each of Days 1, 3 and 5.
Revaccination
Revaccination is recommended at three years following the most recent vaccination for all individuals. It comprises the ingestion of three capsules on Days 1, 3, and 5, as for the original vaccination schedule.

The drug is indicated for active oral immunisation against typhoid fever, caused by Salmonella enterica serovar Typhi, (S. Typhi), in adults and children aged five years and older. This vaccine should be used in accordance with official recommendations.

Hypersensitivity to the active substance or to any of the excipients of the product.
Allergic reaction to previous ingestion of the product.
Congenital or acquired immune deficiency (including patients receiving immunosuppressive or antimitotic drugs).
Acute febrile illness or acute gastrointestinal illness. Vaccination should be postponed until after recovery.

Protection against typhoid fever commences approximately seven to ten days after ingesting the third dose of vaccine. The entire vaccination schedule should be completed at least one week prior to travel to an endemic area.
The product does not provide 100% protection against typhoid fever. Vaccinees should adhere to hygiene advice and exercise caution regarding food and water consumed in typhoid-affected areas.
The capsules contain lactose and sucrose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, glucose-galactose malabsorption, fructose intolerance, or sucrase-isomaltase insufficiency should not take this vaccine.

Common: Headache, abdominal pain, nausea, vomiting, diarrhea, rash, pyrexia.

Vaccination should be postponed during and for at least three days before and after antibiotic or antibacterial sulfonamide treatment, due to possible inhibition of the growth of the vaccine organisms and potential attenuation of the immune response. A longer interval should be considered for long-acting antibiotics (e.g., azithromycin).
Combination with malaria prophylaxis
If malaria prophylaxis is needed, it is recommended to complete the vaccination prior to malaria prophylaxis. In this case, an interval of at least three days should be kept between the last dose of Vivotif and the start of malaria prophylaxis.
The product may be administered concomitantly with yellow fever vaccine, CVD 103-HgR cholera vaccine and oral polio vaccine. No data are available regarding interaction between Vivotif and other live attenuated vaccines.

Pregnancy: Animal reproduction studies have not been conducted. It is not known whether the product causes foetal harm when administered to pregnant women or can affect reproduction capacity. The product should not be administered during pregnancy unless clearly needed, like in cases of increased risk of infection.
Breast-feeding: There are no data regarding administration to nursing mothers. S. Typhi Ty21a is not absorbed systemically, therefore it is not expected to be excreted in human milk. The product should not be administered during breast-feeding unless clearly needed, like in cases of increased risk of infection.

Occasional reports of overdose have been received, i.e. consumption of two or more capsules at the same time. The symptoms reported were not different from those at the recommended dosage.

Store in a refrigerator (2°– 8°). Keep the blister in the outer carton in order to protect from light.