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Vivotif prescribing information

 

Vivotif® (Live vaccine for active oral immunisation against typhoid fever). (Please consult the full Summary of Product Characteristics before prescribing.)

 

Active ingredients: A single dose of Vivotif® contains at least 2x 109 Salmonella typhi Ty21a in a lyophilised form. Quantities expressed per capsule.

 

Pharmaceutical form: Enteric-coated capsule.

 

Therapeutic indications: For active oral immunization against typhoid fever in children aged 6 years and over, adults and elderly.

 

Dosage and administration: One dose of Vivotif® is to be taken on days 1, 3 and 5, with lukewarm water at least 1 hour before meals. The protection becomes effective 7–10 days after ingestion of the third dose of vaccine. Under conditions of repeated or continuous exposure to S. typhi protection persists

for at least 3 years. In the case of travel from a non-endemic area to an area where typhoid fever is endemic, an annual booster consisting of 3 doses is recommended.

 

Contraindications: Vivotif® must not be administered: to persons known to be hypersensitive to any component of the vaccine or the enteric-coated capsule, to persons with congenital or acquired immune deficiency (including patients

receiving immunosuppressive or antimitotic drugs), during an acute febrile illness or during an acute gastrointestinal illness. Vaccination should be postponed until after recovery.

 

Warnings and precautions: None known.

 

Interactions with other medicinal products and other forms of interaction: An interval of 3 days should be allowed between the treatment with any antibacterial agents andVivotif® vaccination. If malaria prophylaxis is also required,the fixed combination of atovaquone and proguanil can begiven  concomitantly with Vivotif®. Doses of mefloquine andVivotif® should be separated by at least 12 hours. For otherantimalarials, there should be an interval of at least 3 days.Vivotif® may be administered concomitantly with the liveattenuated vaccines: yellow fever vaccine and oral poliovaccine.

 

Pregnancy and lactation: Animal reproduction studies have not been conducted with Vivotif®. It is not known whether Vivotif® can cause foetal harm when administered to pregnant women or can affect reproduction capacity. Vivotif® should be given to a pregnant woman only if clearly needed.There are no data regarding administration of Vivotif® to nursing mothers. It is not known if Vivotif® is excreted in human milk.

 

Undesirable effects: The following adverse reactions were reported commonly (<1/10 but >1/100) in clinical studies: Gastrointestinal disorders: Abdominal pain, nausea, diarrhoea, vomiting. General disorders and administration site conditions: Fever, influenza-like illness. Nervous system disorders: Headache. Skin and subcutaneous tissue disorders: Rash. The following additional adverse reactions have been reported very rarely (approximately <1/10,000) during postmarketing surveillance: Skin reactions such as dermatitis, exanthema, pruritus, urticaria. Anaphylaxis. Asthenia, malaise, tiredness, shivering. Paraesthesiae, dizziness. Arthralgia, myalgia. Overdose: Doses five-fold higher than the recommended dose do not produce vomiting, abdominal distress or fever. However overdosing can increase the possibility of shedding the S. typhi Ty21a organisms in the faeces.

 

Special precautions for storage: Store at 2°C – 8°C. Protect from light.

 

Package quantities and basic NHS cost: 3 x 1 dose, basic NHS cost £14.77.

 

Legal category: POM.

 

Marketing authorisation number: PL 15747/0001.

 

Marketing authorisation holder: Crucell Italy S.r.l, Via Zambeletti 25, I – 20021 Baranzate (MI), ltaly.

 

Date of last revision of Prescribing Information: June 2010.

 

Adverse events should be reported.

Reporting forms and information can be found at

www.yellowcard.gov.uk

Adverse events should also be reported to Crucell at

pharmacovigilance@crucell.com