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Logo ADSORBED DIPHTHERIA TETANUS and PERTUSSIS VACCINE

ADSORBED DIPHTHERIA TETANUS AND PERTUSSIS VACCINE
DTPer/Vac/Ads
PROPRIETARY NAME:
ADSORBED DIPHTHERIA TETANUS and PERTUSSIS VACCINE

DESCRIPTIVE NAME:
Mixed bacterial vaccine

REGISTRATION NUMBER:
T532 (Act 101/1965)

PHARMACOLOGICAL CLASSIFICATION:
A30.1 Antigens

SCHEDULING STATUS:
S2

COMPOSITION:
Each 0,5 mL contains 25 Lf
Diphtheria Toxoid; 6 Lf Tetanus Toxoid; 10,000 million Borditella Pertussis; 1,25 mg Aluminium Phosphate; 0,01% Thiomersal as preservative.

IDENTIFICATION:
A markedly turbid whitish liquid, having a faint odour due to the preservative.

PHARMACOLOGICAL ACTION:
Induces in the recipient a specific active immunity to diphtheria, tetanus and whooping cough.

INDICATIONS:
For active immunisation of young children against diphtheria, tetanus and whooping cough simultaneously.

CONTRA-INDICATIONS:
Should not be injected if the child is febrile and it should be used with great caution, if at all, if the child has been allergic to previous injections, or has suffered from convulsions, or if there is a family history of neurological disorder. Not recommended for children older than 3 - 5 years of age.

DOSAGE AND DIRECTIONS FOR USE:
Three intramuscular injections of 0,5 mL, with an interval of 6 (six) weeks between injections. A further intramuscular reinforcing dose of 0,5 mL may be given 1 - 2 years later.

Sterilise the rubber closure of the vial and shake vial vigorously, before withdrawing not more than one dose at a time. Massage the site of injection gently.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Anaphylactic reactions, which are rare, should be treated with adrenaline, possibly in association with antihistamine and corticosteroid therapy. Reactions following administration may include anorexia, fever, vomiting, malaise and rarely, uncontrollable screaming, collapse and convulsions. Local tenderness at the site of injection may persist for several days, which may be followed by sterile abscess formation in rare cases.

It is considered that D.T.P. should not be given to children with a history of seizures, convulsions or cerebral irritation in the neo-natal period. Diphtheria and tetanus vaccine may be preferred in such cases. May cause exaggerated local and general reactions for which symptomatic treatment should be given.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms

PRESENTATION:
Single dose ampoules containing 0,5 mL.
Multidose 10 mL vial (20 dose) packed singly and 10 x 10 mL packs.

STORAGE INSTRUCTIONS:
Store at 2° C to 10° C. DO NOT FREEZE. Protect from light.

VACCINE AFTER SHAKING MUST BE FREE FROM EVIDENT CLUMPS OR PARTICLES.
DISCARD IF PRESENT
FREEZING CAUSES IRREVERSIBLE CLUMPING.

NAME AND BUSINESS ADDRESS OF APPLICANT:
The South African Institute for Medical Research.
Rietfontein, Edenvale, Transvaal.
P.O. Box 28999, Sandringham, 2131

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1991

109-391

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