BERIGLOBIN P

Pays: Israël

Langue: anglais

Source: Ministry of Health

Ingrédients actifs:

IMMUNOGLOBULINS, NORMAL HUMAN

Disponible depuis:

CSL BEHRING LTD., ISRAEL

Code ATC:

J06BA01

forme pharmaceutique:

SOLUTION FOR INJECTION

Composition:

IMMUNOGLOBULINS, NORMAL HUMAN 160 MG/ML

Mode d'administration:

I.M, S.C

Type d'ordonnance:

Required

Fabriqué par:

CSL BEHRING GmbH, GERMANY

Groupe thérapeutique:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.

Domaine thérapeutique:

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASCULAR ADM.

indications thérapeutiques:

Substitution in - Primary antibody deficiency syndromes resulting from defective antibody synthesis. - Protracted transitory hypogammaglobulinaemia especially in premature infants .Prophylaxis of hepatitis A- Before exposure- Within 2 weeks after exposure בקשה לתוספת התוויה 28/4/2019Indications for subcutaneous administration (SCIg)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 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- allogeneic haematopoietic stem cell transplantation (HSCT)Indications for intramuscular administration (IMIg)Hepatitis A prophylaxisIn adults and children and adolescents (0-18 years)• Pre-exposure prophylaxis, preferably in combination with vaccination, in unvaccinated individuals travelling in less than 2 weeks to areas of hepatitis A risk.• Post-exposure prophylaxis in unvaccinated individuals within 2 weeks of hepatitis A virus (HAV) exposure.Consideration should also be given to other official guidance on the appropriate use in hepatitis A prophylaxis. For long term hepatitis A prophylaxis, vaccination is recommended. הערה: הבקשה הינה בהתאם לנוהל EMA (25.2.15)- Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration

Date de l'autorisation:

2022-05-31

Résumé des caractéristiques du produit

Page 1 of 12
BERIGLOBIN P
1.
NAME OF THE MEDICINAL PRODUCT
Beriglobin
®
P
Solution for injection for subcutaneous or intramuscular
administration
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin
One ml contains:
Human normal immunoglobulin
160 mg
(of which at least 95 % IgG)
Each prefilled syringe of 2 ml contains: 320 mg of human normal
immunoglobulin.
Each prefilled syringe of 5 ml contains 800 mg of human normal
immunoglobulin.
Antibodies to hepatitis A virus at least 100 IU/ml
Distribution of IgG subclasses:
IgG
1
ca. 61 %
IgG
2
ca. 28 %
IgG
3
ca. 5 %
IgG
4
ca. 6 %
The maximum IgA content is 1700 micrograms/ml.
Produced from the plasma of human donors.
Excipients with known effects:
Sodium (as chloride and hydroxide): 0.8 to 1.6 mg/ml.
For the full list of excipients, see 6.1
3.
PHARMACEUTICAL FORM
Solution for injection for subcutaneous or intramuscular
administration.
Beriglobin P is a clear solution. The colour can vary from colourless
to pale-yellow up to
light brown during shelf life.
Page 2 of 12
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Substitution
in
- Primary antibody deficiency syndromes resulting from defective
antibody synthesis.
- Protracted transitory hypogammaglobulinaemia especially in premature
infants
Prophylaxis of hepatitis A
- Before exposure
- Within 2 weeks after exposure
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 phy