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GAMMA anty-HBs 200

NAME OF THE MEDICINAL PRODUCT

GAMMA anty-HBs 200
(Immunoglobulinum humanum hepatitidis B)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

Human antibodies anti-HBs 200 IU. For excipients – see the list of excipients.

PHARMACEUTICAL FORM

Solution for intramuscular injections.

CLINICAL PARTICULARS

Indications

Passive prophylaxis of viral hepatitis type B (HBV).

The product is intended for newborn infants whose mothers have a history of viral hepatitis B during their pregnancy or are carriers of the HBs antigen, and for children with a body weight under 50kg, especially those subject to the risk of HBV hospital infection.

Posology and method of administration

GAMMA anty-HBs 200 is administered intramuscularly:

  1. newborn infants whose mothers have a history of viral hepatitis B during their pregnancy or are carriers of the antigen HBs, should be administered with 200 IU not later than 12 hours postnatally.
  2. newborn infants not vaccinated with vaccine against HBV; after an interval of 1 month from the first dose (200 IU) the second dose of 200 IU should be administered,
  3. regimen of administration in children with a body weight under 50kg should follow the schedule:
    • for newborn infants, babies and infants with a body weight under 10kg – dose of 200 IU (contents of 1 ampoule),.
    • for children with a body weight from 10 kg to 20 kg – dose of 400 IU (contents of 2 ampoules),
    • for children with a body weight from 20 kg to 30 kg - dose of 600 IU (contents of 3 ampoules),
    • for children with a body weight from 30 kg to 50 kg - dose of 800 IU (contents of 4 ampoules).

In the case of the prolonged hospitalization of a child the dose should be repeated every 3 - 4 weeks. If a dose higher than 400 IU is administered (contents of more than 2 ampoules) it should be injected intramuscularly in 2 different places.

Contraindications

The product must not be administered in cases of: hypersensitivity to human immunoglobulin, especially in patients with a deficiency in immunoglobulin A and with circulating antibodies anti-IgA and observed hypersensitivity to any component of the product. GAMMA anty-HBs 200 must not be administered intravenously.

Special warnings and special precautions for use

The product must not be administered intravenously on account of the risks of anaphylactic shock. Hypersensitive reactions may occur in very rare cases of immunoglobulin A deficiency accompanied by anti-IgA antibodies.

In the case of shock suitable medical procedures should be applied. GAMMA anty-HBs 200 is produced from human plasma with a high level of anti-HBs antibodies. The product 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:

  • selection of donors on the basis of clinical anamnesis and the testing of both single plasma unit as well as the plasma pool obtained from a donor against the presence of the superficial antigen of hepatitis virus type B (HBsAg), genetic material from virus of hepatitis type C (HCV-RNA) and antibodies against the virus HIV1 and HIV2,
  • testing each series of GAMMA anty-HBs against the presence of antigen 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: measles, rubella, mumps and chickenpox.

Administration of GAMMA anty-HBs should be followed by a 3 month interval before the administration of a vaccine containing live attenuated viruses.

GAMMA anty-HBs should be given 3 - 4 weeks after vaccination with a vaccine containing live attenuated viruses. If the administration of GAMMA anty-HBs is necessary in the course of 3 - 4 weeks from the vaccination, revaccination should be performed 3 months after the administration of the immunoglobulin.

If a simultaneous administration of the immunoglobulin and vaccine is necessary, the injections should be given in 2 different places.

Pregnancy and lactation

Does not apply.

Effect on ability to drive and use machines

No effects of GAMMA anti-HBs 200 on the ability to drive or use machines have been observed.

Undesirable effects

In rare cases a local reaction can appear in the form of skin redness, swelling, induration, bruising, itching, exanthema and pain, or a general reaction in the form of a short-term rise in body temperature, headache, arthritis, nausea, allergic reactions or lowered blood pressure.

Rarely, after the administration of immunoglobulin anaphylactic shock may be observed, even when the patient did not show the hypersensitivity in an earlier administration. Such cases require appropriate medical procedure.

Overdose

The consequences of an overdose are not known.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins, ATC code: J06BB06

Pharmacokinetic properties

Intramuscular administration of immunoglobulin anti-HBs in the case of infection bind the antigen HBs and prevents or softens the course of viral hepatitis type B. Specific human immunoglobulins anty -HBs used in prophylaxis protect the organism from the infection for a relatively short time. Passive immunity lasts for about 3 to 4 weeks.

GAMMA anty-HBs contains mostly immunoglobulins G with a high content of antibodies against the superficial antigen of the virus HBV (to antigen HBs).

Preclinical safety data

In research on laboratory animals (guinea pigs and mice) no toxicity of the product Gamma anty-HBs 200 was observed.

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

12 months.

Special precautions for storage

  1. Product should be kept at 2°C - 8°C (in a refrigerator).
  2. Protect from light.

Nature and contents of packaging

The ampoule with the solution of 200 IU in a cardboard box.

Instructions for use and handling and disposal of the medicinal product

The product 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.