Igamad Special Precautions

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.