Pasteur Mérieux

Name of Product: Adsorbed diphtheria tetanus and pertussis vaccine BP, Pasteur Mérieux (DTPer/Vac/Ads).

Presentation:

Adsorbed diphtheria, tetanus and pertussis vaccine is a sterile aqueous suspension containing a mixture of purified diphtheria and tetanus toxoids and killed Bordetella pertussis organisms adsorbed onto aluminium hydroxide with thiomersal added as preservative. Each 0,5ml dose has a potency of not less than 30IU of diphtheria toxoid, not less than 60IU of tetanus toxoid and not less than 4IU of Bordetella pertussis cells.

Indications:

For active immunisation against diphtheria, tetanus and pertussis.

Dosage and Method of AdmInistration:

Adminster by intramuscular or deep subcutaneous injection.

Primary lmmunisation:

Three injections each of 0.5ml with an interval of at least 4 weeks between the first and second doses and at least 4 weeks between the second and the third doses. The vaccine may be administered to infants from 2 months of age. If a primary course is interrupted it should be resumed allowing appropriate intervals between the remaining doses.

Reinforcing Doses:

Once primary immunisation is completed, a single reinforcing dose of adsorbed diphtheria and tetanus vaccine may be administered preferably at least 3 years after the last dose of the primary course. Where adsorbed diphtheria and tetanus vaccine has been administered at the start of a primary course, adsorbed diphtheria, tetanus and pertussis vaccine may be administered for subsequent doses. Once three doses of adsorbed diphtheria and tetanus have been administered, monovalent pertussis vaccine may be given at monthly intervals to complete the course. Children presenting for their pre-school diphtheria and tetanus booster who have not previously been immunised against pertussis may be given a single dose of adsorbed diphtheria, tetanus and pertussis vaccine with 2 subsequent doses of monovalent pertussis vaccine given at monthly intervals.

Children aged 10 years and over, Adults and Elderly:

Adsorbed diptheria, tetanus and pertussis vaccine is not recommended for persons aged 10 years or over.

Contra-indications, warnings, etc:

Department of Health Recommendations:

These recommendations are from the 1992 guidelines "Immunisation against Infectious Diseases" (HMSO).

Specialist Advice:

No child should be either immunised or denied immunisation without serious thought as to the consequences, both for the individual child and the community. Where there is any doubt, advice should be sought from a Consultant Paediatrician, Consultant in Public Health Medicine or District (Health Board) Immunisation Co-ordinator.

Alternative Vaccination:

If pertussis vaccine is contraindicated or refused by parents, then DT/Vac/Ads should be offered.

Acute Illness:

If the child is suffering from any acute illness, immunisation should be postponed until the child has recovered. Minor infections without fever or systemic upset are not reasons to postpone immunisation.

Local or general reactions:

Immunisation should not be carried out in children who have a history of severe local or general reaction to a preceding dose. Immunisation should be completed with DT vaccine. The following reactions should be regarded as severe:

Local:

An extensive area of redness and swelling which becomes indurated and involves most of the antero-lateral surface of the thigh or a major part of the circumference of the upper arm.

General:

Fever equal to or more than 39.5C within 48 hours of vaccine; anaphylaxis; bronchospasm; laryngeal oedema; generalised collapse. Prolonged unresponsiveness: prolonged inconsolable or high-pitched screaming for more than 4 hours; convulsions or encephalopathy occurring within 72 hours.

Personal history of epilepsy:

Specialist advice should be sought prior to performing immunisahon on children with a personal history of epilepsy (see above).

Family history of epilepsy:

In a recent British study, children with a family history of epilepsy were immunised with pertussis vaccine without any significant adverse events. These children’s developmental progress has been normal. In children with a close family history (first degree relative) of idiopathic epilepsy, there may be a risk of developing a similar condition, irrespective of vaccine. Immunisation is recommended for these children.

Febrile convulsions:

When there is a personal or family history of febrile convulsions, there is an increased risk of these occurring after pertussis immunisation. In such children, immunisation is recommended but advice on the prevention of fever should be given at the time of immunisation.

Evolving neurological disease:

Where there is an ongoing evolving neurological problem, immunisation should be deferred until the condition is stable.

Stable neurological disease:

Stable neurological conditions such as occur in certain patients with cerebral palsy or spina bifida are not a contraindication to immunisation.

Cerebral damage in the neonatal period:

When there has been a documented history of cerebral damage in the neonatal period, immunisation should be carried out unless there is evidence of an evolving neurological abnormality. If immunisation is to be deferred, then this should be stated on the neonatal discharge summary.

Allergy:

A personal or family history of allergy is not a contraindication to immunisation.

HIV:

HIV positive individuals may receive DTP vaccine but pertussis efficacy may be reduced.

Warnings:

Not for intradermal injection.

Side Effects: Pain, tenderness, swelling or redness may occur at the injection site. Generalised reactions may include headache, malaise, pallor, crying, screaming and fever. Attacks of high pitched screaming, limpness and convulsions may occur. More severe neurological conditions including encephalopathy and prolonged convulsions have been reported after pertussis vaccine. Acute allergic reactions may occur, including anaphylaxis, dyspnoea and bronchospasm, urticana and laryngeal oedema. Peripheral neuropathy has been reported. A persistent nodule may occur at the site of injection particularly if the vaccine is administered into superficial layers of the subcutaneous tissue.

Precautions: Although anaphylaxis is rare, facilities for its management should always be available during vaccination.

Use in Pregnancy and Lactation: No reproductive studies have been conducted in animals. There are no data on the use of this vaccine in pregnancy or lactation. The vaccine should not normally be used in pregnancy or during lactation.

Overdose: Not applicable.

Pharmaceutical precautions: Store at +2’ to +8’C. Do not freeze. Shake before use.

Legal category: POM.

Package quantities: 0.5ml single dose prefilled syringe (unit pack). 0.5ml single dose ampoule (pack of 5).

Further information: Use of adsorbed diphtheria, tetanus and pertussis vaccine in individuals aged 10 years or over may be associated with severe hypersensitivity reactions. Oral poliomyelitis vaccine may be given simultaneousely.

Product Licence No: 6745/0043.

Date of preparation: January 1995.

©Pasteur Mérieux MSD Ltd

DTP/0387/1 95/A

UK Product Licence Holder: Pasteur Mérieux MSD Ltd,. Clivemont House, Clivemont Road, Maidenhpad, Berkshire SL6 7BU. Tel:Maidenhead (01628) 785291.

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