MEGALOTECT 50 Units/ml Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN CYTOMEGALOVIRUS
Available from:
Biotest Pharma GmbH
INN (International Name):
HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN CYTOMEGALOVIRUS
Dosage:
50 Units/ml
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2012-07-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Megalotect 50 U/ml Solution for Infusion, glass infusion bottle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg) with antibodies to cytomegalovirus.
3 PHARMACEUTICAL FORM
Solution for Infusion.
The solution is clear to slightly opalescent and colourless to pale yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylaxis of clinical manifestations of cytomegalovirus infection in patients subjected to immunosuppressive
therapy, particularly in transplant recipients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
As a rule doses containing 50 units of (PEI) per kg body weight should be administered. Administration should be
initiated on the day of transplantation or the day prior to this (bone marrow transplantation).
1 ml contains:
_Active substance:_
Human plasma protein
100.0
mg
thereof immunoglobulin G (IgG)
95.0
%
with antibodies to cytomegalovirus
50.0
U*
*Units of the Paul-Ehrlich-Institut reference preparation
Distribution of IgG subclasses:
IgG1
ca. 62.0
%
IgG2
ca. 34.0
%
IgG3
ca. 0.5
%
IgG4
ca. 3.5
%
Immunoglobulin A (IgA) content
max.5.0
mg/ml
_Excipients_
Sodium chloride
155.0
micromol
For full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 17/10/2012_
_CRN 2050716_
_page number: 1_
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 doses at 2 to 3 weeks’ intervals should be given.
_Method of administration:_
Megalotect should be infused intravenously at a rate of max. 20 drops (1 ml) per minute.
4.3 CONTRAINDICATIONS
Megalotect is contra-indicated in patien
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