RHESONATIV Solution for injection (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Rhesonativ 625 IU/ml, solution for injection.

2. Qualitative and quantitative composition

Human anti-D immunoglobulin. 1 ml contains: Human anti-D immunoglobulin 625 IU (125 micrograms). Human protein content: 165 mg there of immunoglobulin G, at least 95%. The content of IgA does not ...

3. Pharmaceutical form

Solution for injection. The colour of the solution can vary from colourless to pale-yellow up to light brown.

4.1. Therapeutic indications

Prevention of Rh(D) immunisation in Rh(D) negative childbearing age women. Antenatal prophylaxisPlanned antenatal prophylaxis Antenatal prophylaxis following complications of pregnancy including ...

4.2. Posology and method of administration

Posology The dose of anti-D immunoglobulin should be determined according to the level of exposure to Rh(D) positive red blood cells and based on the knowledge that 0.5 ml of packed Rh(D) positive red ...

4.3. Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA.

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administrated product should be clearly recorded. Ensure that Rhesonativ is not ...

4.5. Interaction with other medicinal products and other forms of interaction

Live attenuated virus vaccines Active immunisation with live virus vaccines (e.g. measles, mumps or rubella) should be postponed for 3 months after the last administration of anti-D immunoglobulin, as ...

4.6. Pregnancy and lactation

Pregnancy This medicinal product is intended for use in pregnancy. Breastfeeding This medicinal product can be used during breastfeeding. Immunoglobulins are excreted in human milk. No study drug-related ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

Summary of the safety profile Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally. ...

4.9. Overdose

Consequences of an overdose are not known. Patients in receipt of incompatible transfusion, who receive very large doses anti-D immunoglobulin, should be monitored clinically and by biological parameters, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins, immunoglobulins, specific immunoglobulins: - anti-D (Rh) immunoglobulin ATC code: J06BB01 Anti-D immunoglobulin contains specific ...

5.2. Pharmacokinetic properties

Human anti-D immunoglobulin for intramuscular administration is slowly absorbed into the recipients circulation and reaches a maximum after a delay of 2-3 days. Human anti-D immunoglobulin has a half-life ...

5.3. Preclinical safety data

There are no nonclinical safety data for human anti-D immunoglobulin.

6.1. List of excipients

Glycine Sodium chloride Sodium acetate Polysorbate 80 Water for injections

6.2. Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3. Shelf life

30 months. The content of an opened ampoule should be used immediately.

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze. Keep the ampoule in the outer carton in order to protect from light. Within its shelf-life, the product may be stored below 25°C for up to 1 month, without ...

6.5. Nature and contents of container

1 ml and 2 ml of solution in an ampoule (type I glass). Pack sizes: 1x1 ml, 1x2 ml and 10x2 ml. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

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. Do not use solutions that are cloudy or have deposits. Any unused ...

7. Marketing authorization holder

Octapharma (IP) SPRL, Allée de la Recherche 65, 1070 Anderlecht, Belgium

8. Marketing authorization number(s)

PA2219/003/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 28th April 2006 Date of last renewal: 1st January 2012

10. Date of revision of the text

June 2021

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