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

Logo VAZIGAM ® IM (solution for intramuscular injection)

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

VAZIGAM ® IM (solution for intramuscular injection)

PHARMACOLOGICAL CLASSIFICATION:
A 30.2 Biologicals (Antibodies)

COMPOSITION
Descriptive name
: Human
varicella-zoster immunoglobulin
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 (HBsAg), antibodies to the hepatitis C virus (HCV) 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. . In addition, only plasma pools tested and found non-reactive for anti-HIV-1 & -2, HBsAg and anti-HCV by serological testing; and for HIV, HCV, hepatitis B virus (HBV) and hepatitis A virus (HAV) by Nucleic Acid Amplification Techniques (NAT), are used in the manufacture of Vazigam IM.
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.
PHARMACOLOGICAL CLASSIFICATION
A 30.2 Biologicals (Antibodies)

PHARMACOLOGICAL ACTION
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:
Pregnant women with negative varicella–zoster virus immune status especially up to early in the third trimester
Neonates whose mothers developed varicella infection within 7 days before or 7 days after delivery
Neonates whose mothers have no history of varicella and/or a negative immune status
Premature infants <28 weeks of gestation or newborns with low birth weight
Adults and children with no history of varicella and/or a negative immune status, receiving immunosuppressive therapy including steroids, cytostatic agents, radiotherapy, recent stem cell transplantation, or who have congenital or acquired immunodeficiency disorders and are not receiving replacement therapy with immunoglobulin.

CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients, including excipients.
Vazigam IM is not indicated for adults and children who are immune to varicella-zoster virus.
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.

WARNINGS
This intramuscular preparation must not be given intravenously because of the risk of shock.
Intramuscular injections are not advocated for patients with bleeding disorders (Refer “Special Precautions”).

INTERACTIONS
Live attenuated virus vaccines
Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines such as rubella, mumps and varicella for a period of up to 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 5 months.
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.

PREGNANCY AND LACTATION
The safety of this medicinal product for use in human pregnancy and lactation has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

DOSAGE AND DIRECTIONS FOR USE
The recommended dose, given intramuscularly is:
>15 IU/kg body weight as soon as possible, but not more than 96 hours after exposure.

Alternative recommended doses for treatment are as follows:
* 2 mL for patients up to 5 years;
* 4 mL for patients aged 6 to 10 years;
* 5 mL for patients aged 11 to 14 years;
* 6 mL for patients 15 years and older.
Method of administration
Warm the ampoule to body temperature before injecting intramuscularly. The usual recommended site for adults is the deltoid; for infants, the lateral aspect of the thigh is preferable.
If a large volume (>2 mL for children or >5 mL for adults) is required, it is recommended that this be administered in divided doses, at different sites.
This medicinal product must not be mixed with other medicinal products.
Any unused product or waste material should be disposed of in accordance with local procedures.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
Side effects
The following undesirable effects have been reported with intramuscular immunoglobulins:
Skin & Appendages: Cutaneous reactions, local reactions
Central & Peripheral Nervous System: Headache, light-headedness
Gastro-Intestinal System: Nausea
Vascular (Extracardiac): Flushing
Body as a Whole - General: Pain and tenderness at injection site, chills, backache, fever

Special Precautions
Intramuscular injections are not advocated for persons with bleeding disorders, unless special precautions are taken.
True hypersensitivity reactions are rare.
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 immunoglobulin A (IgA) deficiency may develop antibodies to the small amount of IgA in this preparation, leading to sensitisation and subsequent reaction to IgA-containing material. The risk-benefit ratio in patients with a history of IgA deficiency or severe anaphylactic reactions to plasma products should be considered.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and pathogens. Consideration should be given to appropriate vaccination of patients receiving human blood or plasma-derived medicinal products on a routine basis.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV. The measures taken may be of limited value against non-enveloped viruses such as HAV and parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to viral safety.
It is strongly recommended that when Vazigam IM is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Effects on ability to drive and use machines
No effects on ability to drive and use machines have been observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Consequences of an overdose are not known.

IDENTIFICATION
A colourless, pale yellow to light brown liquid exhibiting a slight opalescence.

PRESENTATION
200 IU in a single dose, clear, colourless 2 mL glass ampoule.

STORAGE INSTRUCTIONS
Transport within 72 hours below 37ºC
Store between 2ºC and 8ºC.
Do not freeze.
Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER
T/30.2/749

NAME AND BUSINESS ADDRESS OF THE APPLICANT
NATIONAL BIOPRODUCTS INSTITUTE
Company Reg. No. 1994/002044/08
NPO Reg. No. 020-898-NPO
PRIVATE BAG X9043         10 EDEN ROAD
PINETOWN         PINETOWN
3600         3610
Telephone:        086 016 2472         Telefax:        (031) 708 5614


DATE OF PUBLICATION OF THIS PACKAGE INSERT
2012/03/26

NAMIBIA        S2
Reg. No.:         04/30.2/1049

2011/07P56

Updated on this site: August 2014
Source: Pharmaceutical Industry

Disclaimer:
Please note that the National 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 (031) 714 6700 or +27 082 870 3705 or +27 082 320 3306
.
Email: info@nbisa.org.za

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