Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

In the case of postpartum use, anti-D immunoglobulin is intended for maternal administration.
It should not be given to the new-born infant.
The product is neither intended for use in Rh (D)-positive individuals, nor for individuals already immunised to Rh(D) antigen.

Hypersensitivity
Allergic reactions to anti-D immunoglobulin may occur even in patients who have tolerated previous administrations. 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 treatment of shock should be observed.
If symptoms of allergic or anaphylactic type reactions occur, immediate discontinuation of the administration is required.

The concentration of IgA in Rhophylac was found to be below the detection limit of 5 micrograms/ml. Nevertheless, the product may contain trace amounts of IgA.
Although anti-D immunoglobulin has been used successfully to treat selected IgA deficient patients, individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with Rhophylac against the potential risks of hypersensitivity reactions.

Haemolytic reactions
Patients in receipt of incompatible transfusion, who receive very large doses of anti-D immunoglobulin, should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.

Obesity
There have been reports that the intramuscular administration of Rhophylac in patients with a body mass index (BMI) ≥ 30 is associated with an increased risk of lack of efficacy.
Therefore, in patients with a BMI ≥30, intravenous administration should be considered.

Excipients
Rhophylac contains less than 1 mmol sodium (23 mg) per syringe, that is to say essentially “sodium-free”.

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). They may be of limited value against non-enveloped viruses such as hepatitis A (HAV) and 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 Rhophylac 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.

Effects on Driving

4.7 Effects on ability to drive and use machines
Rhophylac has no influence on the ability to drive and use machines.