GAMUNEX Solution for infusion (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Gamunex 10%, 100 mg/ml, solution for infusion.

2. Qualitative and quantitative composition

Human normal immunoglobulin (IVIg). One ml contains: human normal immunoglobulin 100 mg (purity of at least 98% IgG). Each vial of 10 ml contains: 1 g of human normal immunoglobulin. Each vial of ...

3. Pharmaceutical form

Solution for infusion. The solution is clear or slightly opalescent and colourless or pale yellow.

4.1. Therapeutic indications

Replacement therapy in adults, and children and adolescents (0-18 years) in: Primary immunodeficiency syndromes (PID) with impaired antibody production. Secondary immunodeficiencies (SID) in patients ...

4.2. Posology and method of administration

Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Posology The dose and dose regimen is dependent on the indication. ...

4.3. Contraindications

Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see sections 4.4 and 6.1). Patients with selective IgA deficiency who developed antibodies to IgA, as administering ...

4.4. Special warnings and precautions for use

All patients should be closely monitored when high rates of infusion (8.4 ml/kg/hr) are used. In children or patients at risk of renal failure, the maximum infusion rate should not exceed 4.8 ml/kg/hr. ...

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

Live attenuated virus vaccines Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines, such as measles, rubella, mumps ...

4.6. Fertility, pregnancy and lactation

Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding ...

4.7. Effects on ability to drive and use machines

The ability to drive and operate machines may be impaired by some adverse reactions associated with Gamunex 10%. Patients who experience adverse reactions during treatment should wait for these to resolve ...

4.8. Undesirable effects

Summary of the safety profile Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also Section 4.4): chills, headache, dizziness, fever, vomiting, allergic ...

4.9. Overdose

Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4).

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration ATC code: J06BA02 Human normal immunoglobulin contains mainly immunoglobulin ...

5.2. Pharmacokinetic properties

Human normal immunoglobulin is immediately and completely bioavailable in the recipients circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular ...

5.3. Preclinical safety data

Immunoglobulins are normal components of the human body. Because administration of immunoglobulins in animal studies may lead to the formation of antibodies, preclinical safety data are limited. In the ...

6.1. List of excipients

Glycine Water for injection

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store at +2°C to +8°C (in a refrigerator). Do not freeze. Keep in outer carton. The product may be stored in its outer carton for a one-off period of up to 6 months at room temperature (not above 25°C). ...

6.5. Nature and contents of container

Solution for intravenous infusion in Type I or II glass vials with chlorobutyl stoppers. Pack sizes: One vial of 10 ml contains: 1 g of human normal immunoglobulin. One vial of 50 ml contains: 5 ...

6.6. Special precautions for disposal and other handling

The product should be brought to room or body temperature before use. The solution should be clear or slightly opalescent and colourless or pale yellow. Solutions that are cloudy or have deposits should ...

7. Marketing authorization holder

Grifols Deutschland GmbH, Colmarer Straße 22, 60528 Frankfurt, Germany, Tel.: +49 69-660 593 100

8. Marketing authorization number(s)

PL 29527/0001

9. Date of first authorization / renewal of the authorization

Date of the first authorisation: 27.07.2006 Date of last renewal: 10.05.2011

10. Date of revision of the text

02/2020

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