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Logo ADSORBED DIPHTHERIA VACCINE

ADSORBED DIPHTHERIA VACCINE
Dip/Vac/Ads

PROPRIETARY NAME:
ADSORBED DIPHTHERIA VACCINE

DESCRIPTIVE NAME:
A Bacterial Adsorbed Diphtheria Prophylactic

REGISTRATION NUMBER:
T521 (Act 101/1965)

PHARMACOLOGICAL CLASSIFICATION:
A30.1 Antigens

SCHEDULING STATUS:
S2

COMPOSITION:
Each 0,5 mL contains purified
diphtheria toxoid 25 Lf; Aluminium phosphate 2,5 mg; thiomersal 0,01% as preservative.

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

PHARMACOLOGICAL ACTION:
Induces in the recipient a specific active immunity to diphtheria.

INDICATIONS:
For active immunisation against diphtheria.

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

DOSAGE AND DIRECTIONS FOR USE:
Basic immunisation: 0,5 mL intramuscularly, to be repeated after an interval of six weeks. Those immunized during their first years of life should receive a booster of 0,5 mL one or two years later.
Sterilize rubber closure and shake the bottle vigorously before withdrawing a dose.
Withdraw only one dose at a time. Inject intramuscularly and massage 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 OTHERWISE. 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

105-893

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