MEGALOTECT CP

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

CYTOMEGALOVIRUS ANTIBODY; HUMAN PLASMA PROTEIN; IMMUNOGLOBULINS, NORMAL HUMAN

Tilgjengelig fra:

KAMADA LTD, ISRAEL

ATC-kode:

J06BB09

Legemiddelform:

SOLUTION FOR INFUSION

Sammensetning:

IMMUNOGLOBULINS, NORMAL HUMAN 96 %; HUMAN PLASMA PROTEIN 50 MG/ML; CYTOMEGALOVIRUS ANTIBODY 100 U/ML

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

BIOTEST PHARMA GMBH, GERMANY

Terapeutisk område:

CYTOMEGALOVIRUS IMMUNOGLOBULIN

Indikasjoner:

Prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive therapy, particularly in transplant recipients.The concomitant use of adequate virostatic agents should be considered for CMV-prophylaxis.

Autorisasjon dato:

2020-11-30

Preparatomtale

MEGALOTECT
® CP
1.
NAME OF THE MEDICINAL PRODUCT
Megalotect CP
100 U/ml solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human cytomegalovirus immunoglobulin (CMVIG)
One ml contains:
Human plasma protein……......... 50 mg (of which at least 96 % is
immunoglobulin G), with a content of
antibodies against cytomegalovirus (CMV) of 100 U*
* Units of the Paul-Ehrlich-Institut reference preparation
Each vial with 10 ml contains: 500 mg human plasma protein (of which
at least 96 % is
immunoglobulin G), with a content of antibodies against CMV of 1,000
U.
Each vial with 50 ml contains: 2,500 mg human plasma protein (of which
at least 96 % is
immunoglobulin G), with a content of antibodies against CMV of 5,000
U.
Distribution of the IgG subclasses (approx. values):
IgG1
65 %
IgG2
30 %
IgG3
3 %
IgG4
2 %
The immunoglobulin A (IgA) content is limited to

2,000 micrograms/ml.
Produced from the plasma of human donors.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear or slightly opalescent and colourless or pale yellow solution
with a pH of 5.0-5.6 and an osmolality
of 250-350 mOsm/kg.
_ _
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of clinical manifestations of cytomegalovirus infection in
patients subjected to
immunosuppressive therapy, particularly in transplant recipients.
_ _
The concomitant use of adequate virostatic agents should be considered
for CMV-prophylaxis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The single dose is 1 ml per kg body weight.
Administration should be initiated on the day of transplantation. In
case of bone marrow transplantation
an initiation of prophylaxis up to 10 days before transplantation can
also be envisaged, particularly in
CMV sero-positive patients. A total of at least 6 single doses at 2 to
3 weeks' intervals should be given.
_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 give