Igamad

Human anti-D immunoglobulin.

Active ingredient: Human anti-D (Rh) immunoglobulin 1500 IU (300 µg), Human protein 320 mg, Human immunoglobulin percentage ≥ 95% Ig.
Excipients/Inactive Ingredients: Glycine, Sodium chloride, Water for injection q.s. 2 ml.

Pharmacotherapeutic group: Immune sera and immunoglobulins: anti-D (Rh) immunoglobulin. ATC code: J06BB01.
Pharmacology: Igamad is a solution for injection of human anti-D (Rh) immunoglobulin that contains specific antibodies (IgG) against the D (Rh) antigen of human erythrocytes and that has been subjected to a pasteurisation process.
Measurable levels of antibodies are obtained approximately 20 minutes after human anti-D (Rh) immunoglobulin i.m. injection. Peak serum levels are usually achieved 2 to 3 days later.
The half-life in the circulation of individuals with normal IgG levels is 3 to 4 weeks.
IgG and IgG-complexes are broken down in cells of the reticulo-endothelial system.

Prevention of Rh(D) immunisation in Rh(D) negative women.
Pregnancy/delivery of a Rh(D) positive baby.
Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.
Transplacental haemorrhage resulting from antepartum haemorrhage, amniocentesis, chorionic biopsy or obstetric manipulative procedures (eg external version or abdominal trauma).
Treatment of Rh(D) negative persons after incompatible transfusions of Rh(D) positive blood or other products containing red blood cells.

Slow injection by the i.m. route.
In case of haemorrhagic disorders where intramuscular injections are contraindicated, human anti-D (Rh) immunoglobulin may be administered subcutaneously. Careful manual pressure with a compress should be applied to the site after injection.
If large total doses (> 5 ml) are required, it is advisable to administer them in divided doses at different sites.
1. In connection with pregnancy, child birth and gynaecological interventions: Postpartum prophylaxis: 1000 - 1500 IU (200 - 300 µg) is recommended as an optimal standard dose without previous testing for infiltration of HbF cells (Kleihauer-Betke test).
The injection should be given to the mother as soon as possible after delivery, but not later than 72 hours postpartum.
If a large foeto-maternal haemorrhage is suspected, its extent should be determined by a suitable method and additional doses of anti-D should be administered as indicated.
Antepartum and postpartum prophylaxis: 1000 - 1500 IU (200 - 300 µg) in the 28th week of pregnancy; in some cases, it is justified to initiate prophylaxis earlier. A further dose of 1000 - 1500 IU (200 - 300 µg) should be given within 72 hours after delivery if the newborn is Rh(D) positive.
If a large foeto-maternal haemorrhage is suspected, its extent should be determined by a suitable method and additional doses of anti-D should be administered as indicated.
After interruption of pregnancy, extrauterine pregnancy or hydatidiform mole: before the 12th week of pregnancy: 600 - 750 IU (120 to 150 µg) if possible within 72 hours of the event; after the 12th week of pregnancy: 1250 - 1500 IU (250 to 300 µg) if possible within 72 hours of the event.
After amniocentesis or chorion biopsy: 1250 - 1500 IU (250 to 300 µg) if possible within 72 hours of the intervention.
2. Following a transfusion of Rh-incompatible blood: Per 10 ml of transfused blood administer 500 IU to 1250 IU (100 to 250 µg) over a period of several days.

No data are available on overdosage. Patients with incompatible transfusion who receive an overdose of human anti-D (Rh) immunoglobulin should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.
In other Rh(D) negative individuals overdosage should not lead to more frequent or more severe undesirable effects than the normal dose.

Hypersensitivity to any of the components.

Use in Pregnancy & Lactation: Igamad is used in pregnancy.

Do not inject this product intravenously (risk of shock). Injections have to be made intramuscularly, and care should be taken to draw back the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel.
In the case of postpartum use, the product is intended for maternal administration. It should not be given to the newborn infant.
The product is not intended for use in Rh(D) positive individuals.
Patients should be observed for at least 20 minutes after administration.
If symptoms of allergic or anaphylactic type reactions occur, immediate discontinuation of the administration is required.
True hypersensitivity reactions are rare but allergic type responses to human anti-D (Rh) immunoglobulin may occur. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The treatment required depends on the nature and severity of the side effect. In case of shock, the current medical standards for shock treatment should be observed.
Igamad contains a small quantity of IgA. Although human anti-D (Rh) immunoglobulin has been used successfully to treat selected IgA deficient individuals, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions. Individuals deficient in IgA have a potential for development of IgA antibodies and anaphylactic reactions after administration of blood components containing IgA.
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
It is strongly recommended that every time the patient receives a dose of Igamad the name and batch number of the product are recorded in order to maintain a record of the batches used.
Effects on ability to drive: No effects on ability to drive and use machines have been observed.

Igamad is used in pregnancy.

Local pain and tenderness can be observed at the injection site; this can be prevented by dividing larger doses over several injection sites.
Occasionally fever, malaise, headache, cutaneous reactions and chills occur. In rare cases: nausea, vomiting, hypotension, tachycardia and allergic or anaphylactic type reactions, including dyspnoea and shock, are reported, even when the patient has shown no hypersensitivity to previous administration.
For information on viral safety see Precautions.
If any adverse reaction not enclosed in this item appears, inform the physician or pharmacist.

Active immunisation with live attenuated virus vaccines (eg measles, mumps or rubella) should be postponed until 3 months after the last administration of human anti-D (Rh) immunoglobulin, as the efficacy of the live attenuated virus vaccine may be impaired.
If human anti-D (Rh) immunoglobulin needs to be administered within 2 - 4 weeks of a live attenuated virus vaccination, then the efficacy of such a vaccination may be impaired.
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patients' blood may result in misleading positive results in serological testing. The results of blood typing and antibody testing including the Coombs or antiglobulin test are significantly affected by the administration of human anti-D (Rh) immunoglobulin.
Incompatibilities: This medicinal product must not be mixed with other medicinal products.

Instructions for use: The product should be brought to room or body temperature before use.
The solution should be clear or slightly opalescent. Do not use solutions that are cloudy or have deposits. Dissolved products should be inspected visually for particulate matter and discoloration prior to administration.
Any unused product or waste material should be disposed of in accordance with local requirements.

Store between 2-8°C.

Vaccines, Antisera & Immunologicals

J06BB01 - anti-D (rh) immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.

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