Presentation and Status in Health Basket
Pre-filled Syringe (solution for injection)
2 ml X 160 mg/ml
Posology: The dosage and intervals of infusion are dependent on the indication.
Substitution in antibody deficiency syndrome: The product should be administered via the subcutaneous route.
The dosage 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 using the subcutaneous route should achieve a sustained plasma level of IgG. A loading dose of at least 0.2 to 0.5 g/kg (1.3 to 3.1 ml/kg) body weight – divided over several days with a maximal daily dose of 0.1 to 0.15 g/kg body weight and as indicated by the treating physician – may be required. After steady state IgG levels have been attained, maintenance doses are administered at repeated intervals, ideally weekly, to reach a cumulative monthly dose of about 0.4 to 0.8 g/kg (2.5 to 5 ml/kg) body weight.
Trough levels of IgG should be measured in order to adjust the dose and dosage interval.
Hepatitis A prophylaxis
• Short-term prophylaxis in travelers who present less than 2 weeks before possible exposure:
For stays in endemic areas of less than 3 months, a dose of 0.003 to 0.004 g/kg (0.02 ml/kg) body weight is recommended to be administered intramuscularly. Beriglobin P can be given in combination with Hepatitis A vaccine, but at different sites of the body.
• Hepatitis A prophylaxis in persons exposed less than 2 weeks previously: 0.003 to 0.004 g/kg (0.02 ml/kg) body weight administered intramuscularly
Method of Administration: Beriglobin P is already for use and should be administered at body temperature.
Do not use solutions which are cloudy or have deposits.
Depending on the indication, Beriglobin P should be administered via the subcutaneous or intramuscular route.
Subcutaneous administration: Subcutaneous infusion should be initiated and monitored by a physician experienced in the treatment of immunodeficiencies and in the guidance of patients for home treatment. The patient will be
instructed in the use of syringe driver, infusion techniques, the keeping of a treatment diary and measures to be taken in case of severe adverse events. The recommended infusion rate is 22 ml/hour. In a clinical study with 53 patients evaluated, during the training phase under supervision of a physician, the infusion rate was increased from initially 10 ml to 22 ml/hour. The product should preferably be administered in the abdominal wall, thigh and/or buttocks. No more than 15 ml should be injected into a single site. Doses over 15 ml should be divided and injected into 2 or more sites.
Intramuscular administration: Intramuscular injection must be given by a physician or nurse.
Beriglobin P should preferably be administered ventrogluteally with the patient lying down.
If larger doses are required, it is advisable to administer them in divided fractions. This applies in the case of doses above 2 ml in children of up to 20 kg of body weight and doses above 5 ml for persons above 20 kg body weight.
Do not inject intravenously! Note that there is an increased risk of inadvertent intravascular injection in patients who have repeatedly received intramuscular injections.
a) Primary antibody deficiency syndromes resulting from defective antibody synthesis.
b) Protracted transitory hypogammaglobulinaemia especially in premature infants.
Prophylaxis of hepatitis A
– Before exposure
– Within 2 weeks after exposure
Hypersensitivity to any of the components of the product.
Do not inject intravascularly!
Beriglobin P must not be administered intramuscularly in cases of disorders of haemostasis.
See prescribing information for full details.
See prescribing information for full details.
Live attenuated virus vaccines: Immunoglobulin administration may impair for a period of at least six weeks and up to three months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella vaccines.
After administration of Beriglobin P, an interval of at least three months should elapse before vaccination with live attenuated virus vaccines.
In the case of measles, this impairment may persist for up to one year. Therefore patients receiving measles vaccine should have their antibody status checked.
Interference with serological testing: It has to be considered that when serological test results are interpreted, the transitory rise of passively transferred antibodies after immunoglobulin injection may result in misleading positive test results.
Passive transmission of antibodies to erythrocyte antigens, e.g., A, B and D, may interfere with some serological tests for red cell allo-antibodies (e.g. Coombs test).
Pregnancy and Lactation
There are no controlled clinical trials on the use in human pregnancy. Therefore, the administration of this medicinal product to pregnant women or breast-feeding mothers should be carefully considered.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy or on the foetus and the neonate are to be expected.
Consequences of an overdose are not known.