Immunorho Special Precautions

Ensure that IMMUNORHO is not administered into a blood vessel, because of the risk of shock.
In case of postnatal use, the product is intended for maternal administration. It should not be given to the new-born infant.
Traceability: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Hypersensitivity: True hypersensitivity reactions are rare, but allergic type responses to anti-D immunoglobulin may occur.
IMMUNORHO contains a small quantity of IgA. Although anti-D immunoglobulin has been used successfully in selected IgA deficient individuals, individuals who are deficient in IgA have the potential for developing anti-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 IMMUNORHO against the potential risks of hypersensitivity reactions.
Rarely, human anti-D 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.
Haemolytic reactions: Patients receiving very high doses of anti-D immunoglobulin due to incompatible transfusion, should be monitored clinically and by biological parameters because of the risk of haemolytic reaction.
Thromboembolism: Arterial and venous thromboembolic events including myocardial infarction, stroke, deep venous thrombosis and pulmonary embolism have been associated with the use of immunoglobulins. Although thromboembolic events have not been observed in patients receiving IMMUNORHO, those patients should be sufficiently hydrated before use of immunoglobulins.
Caution should be exercised in patients with preexisting risk factors for thrombotic events (such as hypertension, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, patients with prolonged periods of immobilization, severely hypovolemic patients, patients with diseases which increase blood viscosity), especially when high doses of IMMUNORHO are prescribed.
Patients should be informed about first symptoms of thromboembolic events including dyspnea, pain and swelling of a limb, focal neurological deficits and chest pain, and should be advised to contact the physician immediately upon onset of symptoms.
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, e.g. A, B, D may interfere with some serological tests for red cell antibodies (e.g. Coombs' test) particularly in Rh(D) positive neonates whose mothers have received antenatal prophylaxis.
Overweight/obese patients: In overweight/obese patients, due to the possible lack of efficacy in case of intramuscular administration, an intravenous anti-D product is recommended.
Information on safety with respect to transmissible agents: 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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped hepatitis A 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 IMMUNORHO 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.
Warnings on excipients: This medicinal product contains up to 7.8 mg sodium per 2 ml prefilled syringe, equivalent to 0.38% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Effects on ability to drive and use machines: IMMUNORHO has no influence on the ability to drive and use machines.
Use in Children: No specific measures or monitoring are required for the paediatric population.