BOOSTRIX Suspension for injection in pre-filled syringe Ref.[50806] Active ingredients: Diphtheria toxoid Pertactin Pertussis filamentous hemagglutinin Pertussis toxoid Tetanus toxoid

Posology

A single 0.5 ml dose of the vaccine is recommended.

Boostrix-IPV may be administered from the age of three years onwards.

Boostrix-IPV contains reduced content of diphtheria, tetanus and pertussis antigens in combination with poliomyelitis antigens. Therefore, Boostrix-IPV should be administered in accordance with official recommendations and/or local practice.

Boostrix-IPV can be administered to pregnant women during the second or the third trimester in accordance with official recommendations (see sections 4.1, 4.6 and 5.1).

Boostrix-IPV may also be administered to adolescents and adults with unknown vaccination status or incomplete vaccination against diphtheria, tetanus and pertussis as part of an immunisation series against diphtheria, tetanus, pertussis and poliomyelitis. Based on data in adults, two additional doses of a diphtheria and tetanus containing vaccine are recommended one and six months after the first dose to maximize the vaccine response against diphtheria and tetanus (see section 5.1).

Boostrix-IPV can be used in the management of tetanus prone injuries in persons who have previously received a primary vaccination series of tetanus toxoid vaccine and for whom a booster against diphtheria, pertussis and poliomyelitis is indicated. Tetanus immunoglobulin should be administered concomitantly in accordance with official recommendations.

Repeat vaccination against diphtheria, tetanus, pertussis and poliomyelitis should be performed at intervals as per official recommendations.

Paediatric population

The safety and efficacy of Boostrix-IPV in children below 3 years of age have not been established.

Method of administration

Boostrix-IPV is for deep intramuscular injection preferably in the deltoid region (see section 4.4).

Cases of overdose have been reported during post-marketing surveillance. Adverse events following overdosage, when reported, were similar to those reported with normal vaccine administration.

3 years.

Store in a refrigerator (2°C-8°C).

Upon removal from the refrigerator, the vaccine is stable for 8 hours at 21°C. Discard the vaccine if it was not used during this period. This information is intended to guide healthcare professionals in case of temporary temperature excursion only.

Do not freeze.

Store in the original package in order to protect from light.

0.5 ml of suspension in a pre-filled syringe (Type I glass) with a stopper (butyl rubber) with or without needles in pack sizes of 1 or 10.

Not all pack sizes may be marketed.

Prior to use, the vaccine should be at room temperature, and well shaken in order to obtain a homogeneous turbid white suspension. Prior to administration, the vaccine should be visually inspected for any foreign particulate matter and/or variation of physical aspect. In the event of either being observed, do not administer the vaccine.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.