GAMMANORM Solution for injection Ref.[27659] Active ingredients: Human normal immunoglobulin G

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.

Replacement therapy

The medicinal product should be administered via the subcutaneous route.

In replacement therapy the dose may need to be individualised for each patient dependent on the pharmacokinetic and clinical response. The following dosage regimens are given as a guideline.

The dosage regimen should achieve a trough level of IgG (measured before the next infusion) of at least 5 to 6 g/L and aim to be within the reference interval of serum IgG for age. A loading dose of at least 0.2-0.5 g/kg (1.2 to 3.0 mL/kg) body weight may be required. This may need to be divided over several days, with a maximal daily dose of 0.1 to 0.15 g/kg.

After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals (approximately once per week) to reach a cumulative monthly dose of the order of 0.4-0.8 g/kg. Each single dose may need to be injected at different anatomic sites.

Trough levels should be measured and assessed in conjunction with the incidence of infections. To reduce the rate of infection, it may be necessary to increase the dose and aim for higher trough levels.

Paediatric population

The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome in replacement therapy indications.

Method of administration

For subcutaneous use.

Subcutaneous infusion for home treatment should be initiated and monitored by a physician experienced in the guidance of patients for home treatment. The patient must be instructed in the use of a syringe driver, the infusion techniques, the keeping of a treatment diary, recognition of and measures to be taken in case of severe adverse reactions.

For subcutaneous infusions using a pump

Gammanorm may be injected into sites such as abdomen, thigh, upper arm, and lateral hip. It is recommended to use an initial administration speed of 15 mL/hour/site. If well tolerated (see section 4.4), for subsequent infusions, the flow rate may be gradually increased at a rate of 1-2 mL/hour/site to 25 mL per hour per site as tolerated. The maximum flow rate administered, if tolerated, can be 100 mL/hour for all sites combined. More than one infusion device can be used simultaneously. In adults doses over 30 mL may be divided according to patient preference. The maximum volume to be infused per injection site should not exceed 25 mL before the 10th infusion. After the 10th infusion, the maximum volume to be infused per injection site can be gradually increased to 35 mL, if tolerated.

The amount of product infused into a particular site varies.

In infants and children, infusion site may be changed every 5-15 mL.

There is no limit to the number of infusion sites.

For subcutaneous infusions using a syringe

Gammanorm can be administered using a syringe at a single infusion site.

The proposed maximum infusion rate is set at approximately 1-2 mL/minute.

The weekly dose could be divided into three administrations given every other day. In adults, the maximum volume to be infused per injection site should not exceed 25 mL. In children, the maximum volume to be infused per injection site should not exceed 5-15 mL.

It might be necessary to administer the daily dose at more than one injection site.

The maximum flow rate administered, if tolerated, can be 120 mL/hour for all sites combined.

Consequences of an overdose are not known.

3 years.

After first opening, the product should be used immediately.

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 this period, and must be discarded if not used after this.

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.

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 or have deposits should not be used.

Any unused product or waste material should be disposed of in accordance with local requirements.