GAMMANORM Solution for injection (2019)

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Περιεχόμενα

1. Name of the medicinal product

GAMMANORM 165 mg/mL solution for injection.

2. Qualitative and quantitative composition

Human normal immunoglobulin (SCIg) One mL contains: Human normal immunoglobulin 165 mg. (purity of at least 95% IgG) Each vial of 6 mL contains: 1 g of human normal immunoglobulin. Each vial of ...

3. Pharmaceutical form

Solution for injection. The liquid preparation is clear or slightly opalescent and colourless or pale yellow or light-brown.

4.1. Therapeutic indications

Replacement therapy in adults, children and adolescents (0-18 years) in: Primary immunodeficiency syndromes with impaired antibody production (see section 4.4) Hypogammaglobulinaemia and recurrent bacterial ...

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 are dependent on the indication. ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in 6.1. (see section 4.4). Gammanorm must not be given intravascularly.

4.4. Special warnings and precautions for use

If Gammanorm is accidentally administered into a blood vessel, patients could develop shock. The recommended infusion rate stated under section 4.2 must be closely followed. Patients must be closely monitored ...

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 Gammanorm should therefore only be given with caution to pregnant women ...

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 Gammanorm. Patients who experience adverse reactions during treatment should wait for these to resolve ...

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.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: immune sera and immunoglobulins: immunoglobulins, normal human, for extravascular administration ATC code: J06BA01 Human normal immunoglobulin contains mainly immunoglobulin ...

5.2. Pharmacokinetic properties

Following subcutaneous administration of Gammanorm, peak serum levels are achieved after 4-6 days. Data from clinical studies show that IgG trough levels of ≥8.2 g/L (mean) can be maintained by dosing ...

5.3. Preclinical safety data

There are no relevant data.

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

3 years. After first opening, the product should be used immediately.

6.4. Special precautions for storage

Store in a refrigerator (2°C–8°C). Do not freeze. Keep the vial in the outer carton. Within its shelf-life, the product may be stored below 25°C for up to 6 months, without being refrigerated again during ...

6.5. Nature and contents of container

6 mL, 10 mL, 12 mL, 20 mL, 24 mL or 48 mL of solution in a vial (Type I glass) with a stopper (bromobutyl rubber) - pack size of 1, 10 or 20. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

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

7. Marketing authorization holder

Octapharma Limited, The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom

8. Marketing authorization number(s)

PL 10673/0029

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 31 May 1973 Date of latest renewal: 10 April 2008

10. Date of revision of the text

01/11/2019

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