HUMAN RABIES IMMUNOGLOBULIN Solution for injection Ref.[9850] Active ingredients: Human rabies immunoglobulin

Ensure that Human Rabies Immunoglobulin is not administered into a blood vessel, because of the risk of shock.

True hypersensitivity reactions are rare.

Human rabies immunoglobulin contains a small quantity of IgA. 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.

Rarely, human rabies 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.

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 and parvovirus B19 viruses.

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 Human Rabies Immunoglobulin 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.

Live attenuated virus vaccines

Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines, such as rubella, mumps, and varicella, for a period of up to 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 4 months.

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, for example the antiglobulin test (Coombs' test).

The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

No effects on ability to drive and use machines have been observed.

There are no robust data on the frequency of undesirable effects from clinical trials.

The following undesirable effects have been reported:

Immune system disorders

Rare: Hypersensitivity, anaphylactic shock

Nervous system disorders

Rare: Headache

Cardiac disorders

Rare: Tachycardia

Vascular disorders

Rare: Hypotension

Gastrointestinal disorders

Rare: Nausea, vomiting

Skin and subcutaneous disorders

Rare: Skin reaction, erythema, pruritus

Musculoskeletal and connective tissue disorders

Rare: Arthralgia

General disorders and administration site conditions

Rare: Fever, malaise, chill, fatigue, influenza like illness, At injection site: swelling, pain, erythema, induration, warmth, pruritus, rash

Deep intramuscular injection may reduce the risk of local induration.

For safety with respect to transmissible agents, see Section 4.4.

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