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GAMMA anty-HBs 1000

NAME OF THE MEDICINAL PRODUCT

GAMMA anty-HBs 1000
(Immunoglobulinum humanum hepatitidis B)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

Human antibodies anti-HBs 1000 IU. For excipients – see the list of excipients.

PHARMACEUTICAL FORM

Solution for intramuscular injections.

CLINICAL PARTICULARS

Indications for use

Passive prophylaxis of viral hepatitis type B (HBV).The product is intended for:

  1. adults and children not vaccinated against HBV and who are especially subject to the risk of HBV hospital infection;
  2. hospital staff not vaccinated against HBV, after exposure to HBV: pricking with a needle, contamination of a wound or via mucous membranes,
  3. sexual partners of individuals suffering from acute HBV.

Posology and method of administration

GAMMA anty-HBs 1000 is administered intramuscularly to:

  1. Adults and children with a body weight of 50 kg and over should be administered a dose of 1000 IU, and in cases of prolonged hospitalization a dose of 1000 IU should be repeated every 3-4 weeks.
  2. Medical staff should be administered a dose of 1000 UI as soon as possible, but not later than 48 hours after exposure to HBV, and then after 4 weeks the second dose of 1000 IU if a cycle of vaccination against the HBV has not begun
  3. Sexual partners of individuals suffering from acute HBV should be administered a dose of 1000 IU as soon as possible, but not later than 14 days from the occurrence of HBV in the partner, and then the second dose of 1000 IU should be administered after 4 weeks, if a cycle of vaccination against the HBV has not begun

Contraindications

The product must not be administered in cases of:

  1. hypersensitivity to human immunoglobulin, especially in patients with a deficiency in immunoglobulin A and with circulating antibodies anti-IgA,
  2. observed hypersensitivity to any component of the product.

GAMMA anty-HBs 1000 must not be administered intravenously.

Special warnings and special precautions for use

The product may 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 1000 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:

  1. selection of donors on the basis of clinical anamnesis and the testing 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 of hepatitis virus type C (HCV-RNA), and antibodies against the virus HIV1 and HIV2,
  2. 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

The product can be administered to pregnant and breast feeding women.

Effect on ability to drive and use machines

No effects of GAMMA anty-HBs 1000 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 hypersensitivity in 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: J06BB04

Pharmacokinetic properties

Intramuscular administration of immunoglobulin anti-HBs in the case of infection binds the antigen HBs and prevents or softens the course of viral hepatitis of type B. Specific human immunoglobulins anti-HBs used in prophylaxis protect the organism against 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 anti-HBs 1000 has been 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

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

Nature and contents of packaging

The ampoule with the solution of 1000 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.