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GAMMA anty-D 50

NAME OF THE MEDICINAL PRODUCT

GAMMA anty-D 50
(Immunoglobulinum humanum anti-D)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

Anti-D 50 μg antibodies, for excipients see the list of excipients.

PHARMACEUTICAL FORM

Solution for intramuscular injections.

CLINICAL PARTICULARS

Indications

The product is for use after idiopathic miscarriage, abortion, or after the removal of ectopic pregnancy (extra-uterine).

The product is for administration to Rh negative women without anti-D (anti-Rh) antibodies in their serum.

Indications are established on the grounds of the following serologic tests:

  1. Qualification of the group AB0 and Rh in a woman.
  2. Test for anti-D antibodies in the serum of a woman by means of the papain test and indirect antiglobulin test.

The product GAMMA anty-D 150 should be used for administration after childbirth, during pregnancy and after the abortion of a foetus after the 12th week of gestation, in the threat of immature or premature labour, and after diagnostic amniocentesis after the 12th week of pregnancy.

Posology and method of administration

1 ampoule of the product should be administered intramuscularly up to the 12th week of pregnancy within 48 hours, 72 hours at the latest after:

  1. idiopathic miscarriage,
  2. abortion,
  3. removal of ectopic (extra-uterine) pregnancy.

Contraindications

Do not use in cases of known hypersensitivity to any components of the product.

Special warnings and special precautions for use

  1. must not be administered intravenously.
  2. must not be administered to newborn infants.
  3. must not be administered to Rh positive women (D+).

The patient should be observed for at least 20 minutes after the administration. If any symptoms of anaphylactic reaction occur, the administration of the product should be stopped immediately and a suitable medical procedure followed.

Real hypersensitivity reactions seldom occur. However, an allergic response after administration of the immunoglobulin anti-D can occur.

Patients should be informed about early symptoms of hypersensitivity reaction, including general nettle rash, pressure in the chest, a drop in blood pressure and whistling breath. The treatment is dependent on the cause and severity of the undesirable effect. In the case of shock appropriate obligatory medical procedure should be followed.

The GAMMA anty-D 50 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 GAMMA anty-D 50 product 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 reactions

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 GAMMA anty-D 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 the administration of immunoglobulin can be false-positive due to the passive transmission of antibodies from a donor.

Pregnancy and lactation

The product is used in pregnant and breast feeding women.

Effects on ability to drive and use machines

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

Undesirable effects

A local reaction may occur rarely, including redness or mild pain at the site of injection, or a general reaction manifested by a slight elevation of body temperature. An allergic reaction may occur in very rare cases.

Overdose

The consequences of an overdose in humans are not known.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins, ATC code J06BB01

GAMMA anty-D 50 is produced from human plasma of a high level of anti-D antibodies.

Pharmacokinetic properties

GAMMA anty-D 50 contains specific antibodies (IgG) against the antigen D (Rh) of human red blood cells.

IgG antibodies and complexes of IgG antibodies are destroyed in the cells of the reticuloendothelial system.

The prophylaxis of haemolytic disease of the newborn (HDN) with the product GAMMA anty-D consists of the suppression of the immunological response to antigen D present in the blood cells of the foetus in a Rh negative woman.

The dose of the product protects against immunization that can occur after exposure to about 2.5 ml Rh-positive red blood cells.

The product administered intramuscularly to a woman within 72 hours after miscarriage prevents the production of anti-D antibodies, and consequently prevents the occurrence of haemolytic disease of the newborn (HDS) in future pregnancy.

Preclinical safety data

No toxicity of the product GAMMA anty-D 50 has been 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

1 year.

Special precautions for storage

Store at 2°C - 8°C (in a refrigerator). Protect from light.

Nature and contents of packaging

Ampoule of volume 2 ml with solution, 50 μg each, in a cardboard box.

Instructions for use and handling and disposal of 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.