INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
VAZIGAM ® IM solution for intramuscular injection

REGISTRATION NUMBER
T/30.2/749

PROPRIETARY NAME
(and dosage form):

VAZIGAM ^® IM solution for intramuscular injection

DESCRIPTIVE NAME OF MEDICINE
Human varicella-zoster immunoglobulin

PHARMACOLOGICAL CLASSIFICATION:
A 30.2 Biologicals (Antibodies)

SCHEDULING STATUS
S4

COMPOSITION
Vazigam IM contains gammaglobulin derived from pooled human plasma, sourced from non-remunerated healthy donors, with a high titre of antibodies to the varicella-zoster virus.
Each unit of plasma has been individually tested and found non-reactive for hepatitis B surface antigen, antibodies to the hepatitis C virus and antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2, using approved methods.
Vazigam IM is prepared by cold ethanol fractionation to further reduce the risk of viral
transmission.
Each 2 mL ampoule contains at least 200 IU (100 IU/mL) varicella-zoster virus antibodies.
This preparation contains no antimicrobial preservative and is stabilised with glycine.

IDENTIFICATION
A clear, pale yellow or light brown liquid exhibiting a slight opalescence.

PHARMACOLOGICAL ACTION OF THE MEDICINE
Varicella-zoster immunoglobulin confers passive immunity against chickenpox caused by the acute invasive phase of the varicella-zoster virus.

INDICATIONS
Vazigam IM is indicated for the prophylaxis of varicella (chickenpox) in high risk patients who have been EXPOSED to the varicella-zoster virus.
High risk patients for whom passive immunisation should be considered are:

•	Premature neonates of less than 28 weeks gestation or with a birth weight of 1000 g or less, who have had exposure to the varicella-zoster virus
•	Neonates if exposure to the varicella-zoster virus occurred 5 days or less before delivery or within 48 hours after delivery
•	Bone marrow transplant recipients despite a history of chickenpox, who have had exposure to the varicella-zoster virus
•	Immunocompromised patients, who have had exposure to the varicella-zoster virus, including: -        patients currently being treated with chemotherapy or generalised radiotherapy or within 6 months of terminating such therapy. -        patients who have received high dose steroids in the preceding 3 months -        symptomatic HIV-positive patients who have no history of chickenpox -        patients who have received an organ transplant and are currently on immunosuppressive treatment.

CONTRA-INDICATIONS
Vazigam IM is not indicated for adults and children who are immune.
Although Vazigam IM may prevent infection in healthy children, it is not indicated, as the ensuing natural infection is usually mild. Vazigam IM is not indicated for the treatment of clinical varicella (chickenpox) or herpes zoster (shingles), or for the prevention of disseminated zoster.
Intramuscular injections are not advocated for patients with bleeding disorders.
The risk-benefit ratio in patients with a history of immunoglobulin A (IgA) deficiency or severe anaphylactic reactions to plasma products should be considered.
The safety of intramuscular immunoglobulins in pregnancy has not been established in controlled clinical trials.

WARNING:
This intramuscular preparation must not be given intravenously.

DOSAGE AND DIRECTIONS FOR USE
The recommended doses, given intramuscularly are:

*	2 mL for patients up to 5 years;
*	4 mL for those aged 6 to 10 years;
*	5 mL for those aged 11 to 14 years;
*	6 mL for patients 15 years and older.

Vazigam IM should be administered as soon as possible, but not more than 96 hours after exposure.
Warm the ampoule to body temperature before injecting intramuscularly.
Discard any unused portion.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Local reactions, with pain and tenderness, may occur at the injection site. Headache, fever, chills, flushing, lightheadedness, backache, nausea and cutaneous reactions have also been reported.
Anaphylactic reactions may occur, especially if this intramuscular preparation is given intravenously. Measures to treat anaphylaxis, including adrenaline, should be immediately available when administering Vazigam IM.
Persons with a selective IgA deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material.
Infectious diseases due to the transmission of infectious agents, cannot be totally excluded. Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products.
Immunoglobulin administration may impair, for a period of at least 6 weeks and up to 3 months, the efficacy of live attenuated virus vaccines such as measles, mumps, rubella and varicella.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT
None known.

PRESENTATION
2 mL, single dose, clear, colourless glass ampoule.

STORAGE DIRECTIONS
Transport within 72 hours below 37°C.
Store below 2°C and 8°C.
Do not freeze.
Protect from light.
Keep out of reach of children

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATAL BIOPRODUCTS INSTITUTE
Reg. No. 94/02044/08

PRIVATE BAG X9043
PINETOWN
3600

10 EDEN ROAD
PINETOWN
3610

Telephone:. (031) 719 6789        Telefax. (031) 708 5614

DATE OF PUBLICATION OF PACKAGE INSERT
10/94

P1279 8/98

Date of Approval: 01 October 1998
Updated on this site: September 1999

Please note that the Natal Bioproducts Institute cannot be held responsible for the accuracy of the text. The package insert on the screen may not be the latest version. We therefore recommend that an alternative source of information be consulted, particularly when confirmation of dosages and indications are required. Please refer to the printed package inserts inside the packs, recognised reference books or alternatively, you may contact the NBI Information Centre at (+27)(+31) 719 6789 or 082 870 3705 or 082 895 0056.
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