INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ADSORBED DIPHTHERIA and TETANUS VACCINE

ADSORBED DIPHTHERIA AND TETANUS VACCINE
DT/Vac/Ads

PROPRIETARY NAME:
ADSORBED DIPHTHERIA and TETANUS VACCINE

DESCRIPTIVE NAME:
Mixed bacterial vaccine.

REGISTRATION NUMBER:
T522 (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; 2,5 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 and tetanus.

INDICATIONS:
Booster: Children immunised early in life with either this vaccine or DTP should be given a reinforcing dose after 2 years, and/or before school entry.

Basic immunisation: For active immunisation of young children against Diphtheria and Tetanus simultaneously, where immunisation against pertussis is not advisable.

CONTRA-INDICATIONS:
Avoid vaccination during an acute infection. Should be used with great caution, if at all, if the child has been allergic to previous injections.

DOSAGE AND DIRECTIONS FOR USE:
A single intramuscular injection of 0,5 mL is given as a reinforcing (booster) dose, or three injections of 0,5 mL, at intervals of six weeks, are given for basic immunisation.
Sterilize 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:
Enquiry regarding previous hypersensitivity should precede the administration of a vaccine, and measures to treat reactions should be immediately available. 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, and malaise. Local tenderness at the site of injection may persist for several days, which may be followed by sterile abscess formation in rare cases.

Infants are unlikely to show sensitivity reactions, but older children, adolescents and adults should preferably be Schick-tested to determine immunity and sensitivity before immunization with any vaccine containing diphtheria toxoid is undertaken. 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 doses) packed singly and in 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:
June 1990

10-793

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