Plasmafabriek Sanquin

GammaQuin

To treat immunodeficiency disorders without a known cause and to prevent hepatitis A

Description

GammaQuin is used to treat immunodeficiency disorders without a known cause and to prevent hepatitis A

GammaQuin is used for hereditary (congenital) or acquired immunodeficiency disorders without a known cause, whereby regular infections occur. Through treatment using GammaQuin infections can be prevented or treated.

Product information

Currently GammaQuin 2 ml is not available due to production problems. 

in consultation with the Inspectorate for Health and Youth Care (IGJ), we can provide you with an equivalent alternative product called Beriglobin P from CSL-Behring with ZI number 16902599. Beriglobin P comes in a pre-filled syringe of 2 ml.  It will be reimbursed by the healthcare insurer.

GammaQuin and Beriglobin P are human immunoglobulin products, containing at least 100 IU/ml Hepatitis A antibody. They are administered intramuscularly and indicated for Hepatitis A prophylaxis:

  • Hepatitis A prophylaxis in travelers who present less than 2 weeks before possible exposure, preferably in combination with vaccination. For long term hepatitis A prophylaxis active immunization is recommended. 
  • Hepatitis A prophylaxis in persons exposed less than 2 weeks previously (after 28 days immunisation is no longer considered useful).

Concerning the measles indication, please contact the Medical Department. Tel. 020 - 512 32 39 e-mail; plasmaproductadvice@sanquin.nl

Below you will find the dosing advice for Beriglobin P, as prepared in collaboration with the Centre for Infectious Diseases, Epidemiology and Surveillance (LCI) of the National Institute for Public Health and the Environment (RIVM).

For Beriglobin P, it is recommended to maintain the following dosing schedule:

Hepatitis A prophylaxis in travelers who present less than 2 weeks before possible exposure 
- Duration of stay  ≤ 1 month        0.02 ml/kg
- Duration of stay ≤ 6 weeks          0,03 ml/kg
- Duration of stay ≤ 3 months       0,06 ml/kg
Hepatitis A prophylaxis in persons exposed less than 2 weeks previously for 6 weeks of protection time     0.03 ml/kg 

For clarification the dosing schedule depending on duration of protection and age/weight: 
 

Age/Weight Minimal protectiontime 
4 weeks 6 weeks   13 weeks
Children < 10 year       
< 25 kg  1 ml  1 ml  2 ml
25 – 50 kg  1 ml  2 ml  3 ml
Adults 0.02 ml/kg 0.03 ml/kg  0.06 ml/kg
25 – 50 kg  1 ml  2 ml  3 ml
50 – 80 kg  2 ml  3 ml  5 ml
 80 – 100 kg  2 ml  3 ml  5 ml
> 100 kg  3 ml  4 ml Active

Adaptation of LCR table Hepatitis A

It is advised to always administer the full dose of the pre-filled syringe. The dose administered may then exceed the recommended minimum dose. For example, the table indicates 3 ml, yet 4 ml is administered. This is not harmful: there is no risk of overdose in this product.

SmPC Beriglobin P

  • When is GammaQuin used?

    GammaQuin is used for hereditary (congenital) or acquired immunodeficiency disorders without a known cause, whereby regular infections occur. Through treatment using GammaQuin infections can be prevented or treated.

    GammaQuin is also used to prevent or moderate hepatitis A.

    GammaQuin is also used to prevent measles or to reduce the symptoms of the illness.
    Read more in the GammaQuin leaflet (pdf).

  • How is GammaQuin used?

    GammaQuin is a solution for an injection.

    To treat an immunodeficiency disorder, a subcutaneous injection of GammaQuin can be administered.

    To prevent a hepatitis A infection and measles, an intramuscular injection of GammaQuin can be administered. 

  • What dosage of GammaQuin is administered?

    The physician specifies the dosage of GammaQuin. The quantity of GammaQuin required depends on the reason the patient is receiving GammaQuin.

  • How is GammaQuin administered?

    To prevent hepatitis A, the medical practitioner administers an intramuscular injection of GammaQuin. This is slowly injected into the patient’s upper arm or buttock. If more than 5 ml is required, the dosage should be distributed over multiple injection spots.

    Larger quantities of GammaQuin are required to treat immunodeficiency disorders. These can be administered via a subcutaneous infusion pump containing GammaQuin. It is also possible to administer the quantity of GammaQuin over several injection sites.

    • Remove the vial from the refrigerator and allow it to reach room temperature.
    • It is a clear solution.
    • During the period of storage, slight turbidity or a small amount of precipitation may occur. This will not affect the efficacy of the product.
    • Dependent on the dosage, more than one vial may be used. 
    • The content of several vials can be mixed for administration to the patient.
    • The product should be suctioned into a sterile syringe.
  • What are the side effects of GammaQuin?

    GammaQuin can cause side effects, in the same way as all other medicines. The patient may feel some pain or sensitivity at the site of the injection.

    Rarely
    Very rarely the patient could develop a fever and/or a skin rash. Side effects include nausea, vomiting, low blood pressure, a rapid heartbeat and hypersensitivity reactions.   
     

  • How is GammaQuin stored?

    • out of reach and sight of children
    • in the refrigerator at 2 - 8 °C (therefore, do not freeze)
    • in the original packaging to protect it from the light


    Not to be used after the expiry date
    Do not use GammaQuin after its expiry date. This is stipulated on the label (on the vial) and on the box.

    Disposal
    Patients can hand any used medicines over to a pharmacy. By not disposing of medicines via waste water or household waste, we are helping to protect the environment.

    Read more in the GammaQuin leaflet (pdf).