Igamad administration is indicated for:
Prevention of RhD immunisation in RhD negative women:
- Pregnancy/delivery of a RhD positive baby.
- Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.
- After ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy or obstetric manipulative procedure e.g. external version, or abdominal trauma, which may cause transplacental haemorrhage (TPH).

Treatment of RhD negative patients after transfusions of RhD positive blood or other products containing RhD positive red blood cells (e.g. platelets).

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 of1000 - 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.

Method of administration
Slow injection by the i.m. route.
If large total doses (> 5 ml) are required, it is advisable to administer them in divided doses at different sites.

Do not administer Igamad intravenously because of the risk of shock.
In the case of postnatal use, the product is intended for maternal administration. It should not be given to the newborn infant.
The product is neither intended for use in Rh(D) positive women nor for women already immunised to Rh(D) antigen.
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.
Igamad contains a small quantity of IgA. Although human anti-D (Rh) immunoglobulin has been used successfully to treat selected IgA deficient individuals, individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of plasma derived medicinal products containing IgA. The physician must therefore weigh the benefit of treatment with Igamad against the potential risks of hypersensitivity reactions.
Rarely, human anti-D (Rh) immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.
Patients in receipt of incompatible transfusion, who receive very large doses of human anti-D (Rh) immunoglobulin, should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped virus HAV. The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that Igamad is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Special warnings about excipients: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, ie essentially “sodium-free”.

Live attenuated virus vaccines
Active immunisation with live attenuated virus vaccines (eg measles, mumps or rubella) should be postponed for 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.
Interference with serological testing
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, eg A, B, D may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs' test) particularly in Rh(D) positive neonates whose mothers have received antenatal prophylaxis.

Igamad is intended for use in pregnancy.

Igamad has no influence on the ability to drive and use machines.

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.
There are no robust data on the frequency of undesirable effects from clinical trials and post-marketing experience.
For safety with respect to transmissible agents, see 4.4.
To report any side effect(s):
- The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.
Toll free phone: 8002490000
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

Consequences of an overdose are not known.

Pharmacotherapeutic group: immune sera and immunoglobulins: anti-D (Rh) immunoglobulin, ATC code: J06BB01.
Human anti-D (Rh) immunoglobulin contains specific antibodies (IgG) against the D (Rh) antigen of human erythrocytes.
It can also contain antibodies to other Rh antigens eg anti-Rh C antibodies.
During pregnancy, and especially at the time of childbirth, foetal red blood cells may enter the maternal circulation. When the woman is Rh(D)-negative and the foetus Rh(D)-positive, the woman may become immunised to the Rh(D) antigen and produce anti-Rh(D) antibodies which cross the placenta and may cause haemolytic disease of the newborn. Passive immunisation with human anti-D (Rh) immunoglobulin prevents

Rh(D) immunisation in more than 99% of cases provided that a sufficient dose of human anti-D (Rh) immunoglobulin is administered soon enough after exposure to Rh(D)-positive foetal red blood cells.
The mechanism by which human anti-D (Rh) immunoglobulin suppresses immunisation to Rh(D)-positive red cells is not known. Suppression may be related to the clearance of the red cells from the circulation before they reach immunocompetent sites or, it may be due to more complex mechanisms involving recognition of foreign antigen and antigen presentation by the appropriate cells at the appropriate sites in the presence or absence of antibody.

Human anti-D (Rh) immunoglobulin for intramuscular administration is slowly absorbed into the recipient's circulation and reaches a maximum after a delay of 2 - 3 days.
Human anti-D (Rh) immunoglobulin has a half-life of about 3 - 4 weeks. This half-life may vary from patient to patient.
IgG and IgG-complexes are broken down in cells of the reticulo-endothelial system.

Immunoglobulins are normal constituents of the human body. In animals, single dose toxicity testing is of no relevance since higher doses result in overloading.
Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to interference with antibodies. Effects of the product on the immune system of the newborn have not been studied.
Since clinical experience provides no hint for tumorigenic and mutagenic effects of immunoglobulins, experimental studies, particularly in heterologous species, are not considered necessary.

- Glycine
- Sodium chloride
- Water for injections

This medicinal product must not be mixed with other medicinal products.

Store in a refrigerator (2 ºC - 8 ºC). Do not remove the pre-filled syringe from the outer carton before it is ready to use in order to protect from light.
Do not use after expiry date.

Igamad is supplied in type I glass syringes containing 1500 IU (300 μg)/2 ml of human anti-D (Rh) immunoglobulin solution.

The product should be brought to room or body temperature before use.
The colour can vary from colourless to pale-yellow up to light brown. The solution should be clear or slightly opalescent and it may show a small amount of particulate matter during storage. Dissolved products should be inspected visually prior to administration. Do not use solutions that are cloudy or have deposits.
Any unused product or waste material should be disposed of in accordance with local requirements.