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GAMMA anty-D 150

NAME OF THE PHARMACEUTICAL PRODUCT

GAMMA anty-D 150 (Immunoglobulinum humanum anti-D)

QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCES

Anti-D antibodies 150 μg .For excipients see the list of excipients

PHARMACEUTICAL FORM

Solution for intramuscular injections.

CLINICAL PARTICULARS

Indications

    1. Product is administered after childbirth in the following conditions:
      • Mother is Rh negative, (D-)
      • No anti-D (anti-Rh) antibodies are detected in the mother’s serum
      • Child is Rh positive (D+),
      • Immediate antiglobulin (immediate Coombs test) test in the child is negative.

      Indications are established according to the following serologic tests:

      • Qualification of AB0 and Rh group in mother, and also in a newborn infant after childbirth.
      • Test for anti-D antibodies in the mother’s serum by means of the papain test and indirect antiglobulin test.
      • Immediate antiglobulin test (Coombs test) performed after childbirth with red blood cells of the child.
    2. The product is administered during pregnancy:
      • for Rh negative women in the 28th week of pregnancy, in which no anti-D antibodies are detected by means of the papain and antiglobulin tests.
    3. The product is administered after the removal of the foetus after the 12th week of the pregnancy, in the threat of immature and premature labour, or diagnostic amniocentesis after the 12th week of the pregnancy:
      • for Rh negative women in which no anti-D antibodies are detected.

ATTENTION!:

  1. After application of the product during pregnancy no further tests against the presence of anti-D antibodies are carried out until the end of the pregnancy.
  2. Application of the product during pregnancy does not eliminate the obligation of administration of the product after childbirth.
  3. The qualification test for the administration of GAMMA anty-D 150 to women who received two doses of the product in the 28th week of their pregnancy includes only the test against antigen D in a newborn infant. No test against the presence of anti-D antibodies in the mother is carried out, nor the direct antiglobulin test in the newborn infant. Positive results of such tests do not confirm the immunization of the mother, but may result from the presence of antibodies remaining in the immunoglobulin administered during the pregnancy.
  4. The physician supervising a pregnant woman should inform her in writing on her receiving two doses of the product GAMMA anty-D 150. Afterwards, the mother should give such information to the supervising physician in the obstetrics ward. The physician ordering the qualification tests at a laboratory should provide information about the application of this product during the pregnancy.

GAMMA anty-D 50 should be used for administration after idiopathic miscarriage, abortion or removal of ectopic (extra-uterine) pregnancy up to the 12th week of pregnancy.

Posology and method of administration

    1. The product should be administered intramuscularly within 48 hours, 72 hours at the latest, in the following conditions:
    1. The product to be administered intramuscularly in the 28th week of pregnancy:
    • 1 dose (150 μg) is applied after physiological childbirth, after abortion beyond the 12th week of pregnancy, in the threat of immature or premature labour, after diagnostic amniocentesis after the 12th week of pregnancy,
    • 2 doses (300 μg) are applied after pathological childbirth e.g.: Caesarean section, manual removal of placenta, delivery of a stillbirth,
    • 2 - 3 doses (300-450 μg) are applied after the bleeding of the foetus into the mother’s circulation system (estimation of the transplacental bleeding amount and suitable individualization of a dose are indicated),
    • after a multiple childbirth the number of doses should comply with the number of newborn infants.
    • 2 doses (300 μg) are applied to Rh negative women in the 28th week of pregnancy, in which no anti-D antibodies are detected by means of the papain and antiglobulin tests.

ATTENTION!

Ref.1 Use of GAMMA anty-D 150 after childbirth is included in the program of the Minister of Health.

Ref.2 Use of GAMMA anty-D 150 during pregnancy is not included in the program of the Minister of Health.

Contraindications

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

Special warnings and special precautions for use

  • must not be administered intravenously.
  • must not be administered to newborn infants.
  • must not be administered to Rh positive individuals (D+).

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

The GAMMA anty-D 150 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 150 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 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 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 rarely occur, 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 J 06 BB 01

GAMMA anty-D 150 is produced from human plasma of a high level of anti-D antibodies.

Pharmacokinetic properties

GAMMA anty-D 150 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 in newborn infants with the product GAMMA anty-D consists of suppression of the immunological response in Rh negative woman to antigen D present in the blood cells of her foetus.

The dose of the product protects against immunization that can occur after exposure to about 7 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 in the newborn (HDS) in future pregnancy.

Preclinical safety data

No toxicity of the product GAMMA anty-D 150 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 package

Ampoule of volume 2 ml with solution, 150 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.