gammanorm® (Human normal immunoglobulin SCIg)

Ireland

Summary of Product Characteristics gammanorm®

Patient Information Leaflet gammanorm®

Republic of Ireland: Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the HPRA website at www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

UK/P/IRG/C/V2 August 2020

This site is intended for Ireland healthcare professionals and may contain promotional information.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Octapharma in the United Kingdom by telephoning 1890 920 522.

Product Information

Summary of Product Characteristics gammanorm®

Therapeutic Indications

Gammanorm is indicated for subcutaneous administration (SCIg). Replacement therapy in adults, children and adolescents (0-18 years) in:

  • Primary immunodeficiency syndromes such with impaired antibody production.

  • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.

  • Hypogammaglobulinaemia and recurrent bacterial infections in multiple myeloma (MM) patients.

  • Hypogammaglobulinaemia in patients pre- and post- allogenic haematopoietic stem cell transplantation (HSCT).

Shelf Life & Storage

Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vial in the outer carton. Within its three year 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.

Vial Sizes

Our licensed vial sizes are listed below:

One mL contains : Human normal immunoglobulin 165 mg

  • Each vial 6 mL contains: 1 g of human normal immunoglobulin

  • Each vial of 10 mL contains: 1.65 g of human normal immunoglobulin

  • Each vial of 12 mL contains: 2 g of human normal immunoglobulin

  • Each vial of 20 mL contains: 3.3 g of human normal immunoglobulin

  • Each vial of 24 mL contains: 4 g of human normal immunoglobulin

  • Each vial of 48 mL contains: 8 g of human normal immunoglobulin

For questions about availability please contact customer services.

UK/PIRGHCP/C/V3 August 2020