Welcome to „BIOMED-LUBLIN" S.A.

  • Increase font size
  • Default font size
  • Decrease font size
1 2 3 4 5

Human gamma globulin


NAME OF THE PHARMACEUTICAL PRODUCT

Gamma Globulina ludzka
(Immunoglobulinum humanum normale)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

1 ml of solution contains:

  • Human gamma globulin 150 mg
  • For excipients see the list of excipients.

PHARMACEUTICAL FORM

Solution for intramuscular injections

CLINICAL PARTICULARS

Indications

Human Gamma Globulin is used in the prophylaxis and treatment of infectious diseases such as: measles and viral hepatitis type A.

Posology and method of administration

The product must be used in compliance with the recommendations of a physician. Human Gamma Globulin is administered intramuscularly.

  1. After the contact of an infant with an individual suffering from measles:
    • a preventive dose of 0.25 ml/kg of the infant’s body weight - not later than 3 - 5 days from the day of the contact with the ill individual. Passive immunity after the injection of the product remains for about 3 to 4 weeks and can protect against falling ill.
    • a palliative dose of 0.05 ml/kg of body weight - not later than 3 - 5 days from the day of the contact with an ill individual, which can cloak the disease or extend the period of the measles virus incubation up to 28 days.
  2. Human Gamma Globulin should not be administered in cases of exposure to measles to babies up to the 3rd month of life on account of possessed immunity passively transmitted from the mother.
  3. After the contact with an individual suffering from hepatitis type A (HAV) a preventive dose of 0.03 ml/for each kg of body weight of an ill individual is administered.

Contraindications

  1. Do not use in cases of known hypersensitivity to any components of the product.
  2. Severe thrombocytopenia and other blood coagulation disorders.
  3. IgA immunodeficiency
  4. The product must not be administered intravenously.

Special warnings and special precautions for use

The products must not be administered intravenously on account of the risk of anaphylactic shock occurrence. The recommended dose should be strictly followed. The patient should be observed during the injection.

Adverse effects may occur in patients who are administered human Gamma Globulin for the first time, and also in rare cases when the medicinal product is reintroduced into the treatment after a pause longer than 8 weeks.

Real hypersensitivity reactions, due to immunoglobulin A deficiency and present anti-IgA antibodies, seldom occur. Such patients should be carefully observed.

Complications can often be avoided by:

  1. slow injecting, during which potential hypersensitivity may be detected
  2. careful observation of the patient during injection and for 1 hour after the administration of the product.

In cases of suspected anaphylactic reaction the injection must be immediately stopped. In the case of shock the appropriate obligatory medical procedure should be followed.

Human Gamma Globulin is produced from human plasma. The manufacturing technique is based on the fractionation of plasma with cold ethyl alcohol according to the Cohn procedure. In the case of the administration of products obtained from human blood or plasma the transmission of infectious agents cannot be completely excluded. This refers also to unknown pathogens. However, the risk of transmitting infectious agents is minimized by:

  1. selection of donors based on clinical anamnesis and the testing of both single plasma unit as well as the plasma pool against the presence of the superficial antigen of hepatitis virus type B (HBsAg), genetic material of hepatitis virus type C (HCV-RNA) and antibodies against the virus HIV1 and HIV2,
  2. testing each series of human Gamma Globulin for the presence of HBsAg and antibodies against the virus HIV1 and HIV2 and genetic material from the virus of hepatitis type C (HCV-RNA).

Undertaken safety measures are considered as efficient for enveloped viruses, such as: HIV, HCV, HBV. However, they can have a limited efficiency for non-enveloped viruses, such as virus of hepatitis type A (HAV) or parvovirus B19.

Interactions with other medicinal products and other forms of interactions

Administration of immunoglobulin can affect for a period of at least 6 weeks and up to 3 months the efficiency of administered vaccines containing the live attenuated viruses of: measles, rubella, mumps and chickenpox. The administration of human Gamma Globulin should be followed by a 3 month pause before the administration of a vaccine containing live attenuated viruses.

In vaccination against measles the efficiency can be decreased for 1 year, and for that reason in patients vaccinated against measles a test for the level of antibodies against the measles virus is recommended.

The results of serologic tests in patients after administration of immunoglobulin can be false- positive due to the passive transmission of antibodies from a donor.

Pregnancy and lactation

The safety of human Gamma Globulin in pregnant and breast feeding women was not ascertained in the clinical research. The product can be administered to pregnant and breast feeding women with a high degree of caution. No negative effect on pregnancy, the foetus and the newborn have been observed.

Effects on ability to drive and use machines

No effects on the ability to drive or use machines have been observed.

Undesirable effects

Human Gamma Globulin is generally well tolerated by infants and adults. Adverse effects may occur rarely, such as headache, chill, fever, nausea. Minor redness and swelling may sometimes occur at the site of injection. Anaphylactic shock may occur rarely. In such cases the injection should be stopped and appropriate medical procedure followed.

Overdose

The consequences of an overdose in humans are not known.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins, ATC code J06BA01

Pharmacokinetic properties

Human Gamma Globulin contains mostly immunoglobulins (IgG) with a wide spectrum of antibacterial and antiviral antibodies, created as a result of passed infectious diseases or preventive vaccinations. It is bioaccessible in the circulation system of a recipient 2-3 days after the administration.

Human Gamma Globulin contains IgG antibodies as in the normal population. It is usually prepared from plasma obtained from at least 1000 donations and contains different subclasses of G immunoglobulin reflecting the normal composition of human plasma. The product administered intramuscularly in an appropriate dose assists the immune system.
Passive immunity remains for about 3-4 weeks.

Preclinical safety data

No toxicity of the product Human Gamma Globulin was observed in research on laboratory animals (guinea pigs and mice).

PHARMACEUTICAL PARTICULARS

List of excipients

  1. Glycocol
  2. Sodium chloride
  3. Thiomersal
  4. Water for injections

Pharmaceutical incompatibilities

The product must not be used together with other medicinal products.

Shelf life

3 years.

Special precautions for storage

  1. Store at 2°C - 8°C (in a refrigerator).
  2. Protect from light.
  3. Keep away from children.
  4. Do not use the product after the expiry date give on the package.

Nature and contents of packaging

Ampoule with solution of volume 1.5 ml, made of neutral glass, in a cardboard box.

Instructions for use and handling and disposal of medicinal product

Human Gamma Globulin should be administered in an intramuscular injection by a physician or nurse. The product should be brought to room or body temperature before use. The solution in an ampoule should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Any unused product or waste material should be disposed of in accordance with local regulations.