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

Logo TETANUS VACCINE (Adsorbed)

ADSORBED TETANUS VACCINE
Tet/Vac/Ads.
PROPRIETARY NAME
TETANUS VACCINE (Adsorbed)

DESCRIPTIVE NAME
A Bacterial Adsorbed Tetanus Prophylactic Vaccine

REGISTRATION NUMBER:
T528 (Wet/Act 101/1965)

PHARMACOLOGICAL CLASSIFICATION:
A30.1 Antigens

SCHEDULING STATUS:
S2

COMPOSITION:
Contains 10 Lf of purified
Tetanus toxoid, 2,5 mg Aluminium phosphate and 0,01% Thiomersal in 0,5 mL

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 tetanus.

INDICATIONS:
For active immunisation against tetanus.

CONTRA-INDICATIONS:
Avoid vaccination during an acute infection.
Should be used with great caution if there has been a history of allergy to previous vaccination.

DOSAGE AND DIRECTIONS FOR USE:
The adsorbed vaccine is the antigen of choice for primary immunisation. Unimmunized persons should receive two (2) intramuscular injections each of 0,5 mL. The recommended interval between doses is 6 (six) to 8 (eight) weeks. A third dose of 0,5 mL is recommended after six months in all cases, and must be given when immunization is begun in conjunction with passive protection by means of tetanus Antitoxin. The vaccine in this case must not be injected in the same limb as the antitoxin, and the same syringe must not be used.

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. May cause transient local 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 vials (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.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1991

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