País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Salmonella typhi
CSL Limited
Medicine Registered
VIVOTIF ® ORAL _Oral Typhoid Vaccine_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Vivotif ® Oral. 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 Vivotif ® Oral against the benefits expected. 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 VIVOTIF ® ORAL IS USED FOR Vivotif ® Oral is a vaccine used to prevent typhoid fever. Typhoid fever is a severe form of infection caused by a type of Salmonella bacteria. Vaccination with Vivotif ® Oral is recommended for adults and children over 6 years of age who live in or travel through areas where typhoid fever occurs. _HOW IT WORKS_ Vivotif ® Oral contains live bacteria called Salmonella typhi strain Ty21a, which do not cause typhoid fever. Vivotif ® Oral works by causing your body to produce its own protection against the bacteria (germs) which cause typhoid fever. The body makes substances, called antibodies, which destroy the Salmonella typhi bacteria. If you have been vaccinated against Salmonella typhi, your body is able to attack the bacteria if you come in contact with it. Protection with Vivotif ® Oral requires a full course of 3 doses. After a full course most people will produce enough antibodies to prevent typhoid fever. However, as with all vaccines, 100% protection cannot be guaranteed. The vaccine cannot give you or your child typhoid fever. The chance of a severe reaction from Vivotif ® Oral is very small, but the risks from not being vaccinated against typhoid fever may be very serious. BEFORE YOU TAKE VIVOTIF ® ORAL _WHEN YOU OR YOUR CHILD_ _MUST NOT TAKE VIVOTIF_ _®_ _ ORAL_ DO NOT TAKE VIVOTIF ® ORAL IF YOU HAVE AN ALLERGY TO: • Vivotif ® Oral or any of the in Leer el documento completo
VIVOTIF ® ORAL Product Information Version 4.3 AUST R 158130 Page 1 of 5 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 10 9 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. H Leer el documento completo