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Logo BERIGLOBIN® P 2 mL Ampoule
BERIGLOBIN® P 5 mL Ampoule

REGISTRATION NUMBERS:
Beriglobin
® P 2 mL –T/30.2/608
Beriglobin
® P 5 mL –T/30.2/609

PROPRIETARY NAME
(and dosage form):

BERIGLOBIN® P 2 mL Ampoule
BERIGLOBIN
® P 5 mL Ampoule

DESCRIPTIVE NAME OF THE MEDICINE:
Polyvalent immunoglobulin –Pasteurized (P)

PHARMACOLOGICAL CLASSIFICATION:
A 30.2 Biologicals (Antibodies)

SCHEDULING STATUS:
S4

COMPOSITION:
1 mL contains:
Human immunoglobulin about 160 mg

Beriglobin
® P is a sterile non-pyrogenic liquid preparation of globulins that contains several antibodies normally present in adult human blood, with a protein content of 16 per cent.

Each unit of plasma from which it is derived has been tested and found to be non-reactive for hepatitis B surface antigen and for human immunodeficiency virus.

The preparation contains no preservatives.

The special fractionation and processing steps eliminate and inactivate HIV. Beriglobin
® P is pasteurized in aqueous solution at 60°C. for 10 hours to inactivate HIV 1 and HIV 2 and hepatitis B surface antigen.

IDENTIFICATION:
Clear colourless liquid in 2 mL or 5 mL clear glass ampoules

PHARMACOLOGICAL ACTION OF THE MEDICINE:
Human immunoglobulin confers passive immunity.

INDICATIONS:
a) Prophylaxis
Hepatitis A
Measles
b) Substitution and therapy
Antibody deficiency syndrome such as:
Agammaglobulinemia and hypogammaglobulinemia, including therapy induced.
It is not indicated for the routine prophylaxis or treatment of rubella, poliomyelitis or mumps, or for allergy or asthma in patients who have normal levels of immunoglobulin.

CONTRA-INDICATIONS:
Immunoglobulins contain low concentrations of IgA and should not be used in patients who are known to have anti-IgA antibodies.
Hypersensitivity to homologous immunoglobulins.
Intramuscular injections are not advocated for patients with bleeding disorders and severe thrombocytopenia.
Safety in pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
a) Prophylaxis
  Post exposure to hepatitis A: 0,02 –0,04 mL/kg body mass within two weeks of exposure
  For travellers to epidemic areas: 0,06 –0,12 mL/kg body mass.
  When used to confer passive immunity, the duration of immunity is three to four months.
  For the prevention or modification of measles in non-immune individuals within six days of exposure: 0,2 –0,25 mL/kg body mass.

b) Substitution and therapy 
  Antibody-deficiency syndrome such as: agammaglobulinemia and hypogammaglobulinemia, including therapy induced Initially 1 mL/kg body mass.
Maintenance dose about every four weeks: 0,5 mL/kg body mass.

Administration
Beriglobin
® P should be warmed before use.
Beriglobin
® P should only be injected intramuscularly preferably in the gluteal region
If larger total doses are required, it is advisable to give them in divided doses.
Once an ampoule has been opened, the contents should be used immediately. Discard any unused portion.

WARNINGS:
The preparation must not be administered intravenously.
It should be ensured by aspiration that no vessel has been penetrated.

After administration of immunoglobulins, an interval of at least three months should be allowed before vaccinations with parenteral live virus vaccines (eg. mumps, measles, rubella).

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
There is an increased risk of intravascular injection in patients who have repeatedly received intramuscular injections. An intravascular injection may cause the patient to develop shock-type syndrome.

Tenderness at the injection site and/or elevations in temperature may occur. Skin reactions have occurred.

Repeated administration of whole blood, plasma or immunoglobulin preparations can lead to sensitization. This applies especially to people with selective IgA deficiency, hypogammaglobulinemia or Aids. Various genetic determinants of the immunoglobulins have also been discussed as cause of sensitization. On renewed administration of the above-mentioned preparations sensitized subjects can react with anaphylactic manifestations up to and including shock.

Adrenalin should always be at hand when administering this product.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
There are no known symptoms of overdosage.

PRESENTATION:
Ampoule with 2 mL
Ampoule with 5 mL

STORAGE DIRECTIONS:
Beriglobin
® P should be stored in the refrigerator between 2°C and 10°C, and should be used on or before the date of expiry given on the pack.
Once an ampoule has been opened it should be used immediately.
KEEP OUT OF REACH OF CHILDREN.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
NORISTAN LIMITED
326 Marks Street, Waltloo, Pretoria

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 September 1992

Hoechst Pharmaceuticals
Division of
NORISTAN LIMITED, WALTLOO, PRETORIA
H10/05

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