MEGALOTECT CP SOLUTION FOR INFUSION 100 UML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Human Cytomegalovirus Immunoglobulin in 50mg/ml Human Plasma Protein (IgG ≥ 96%)

Available from:

GRIFOLS ASIA PACIFIC PTE. LTD.

ATC code:

J06BB09

Dosage:

100 U/ml

Pharmaceutical form:

INJECTION

Composition:

Human Cytomegalovirus Immunoglobulin in 50mg/ml Human Plasma Protein (IgG ≥ 96%) 100 U/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Biotest AG

Authorization status:

ACTIVE

Authorization date:

2013-12-04

Patient Information leaflet

184749
001
INSTRUCTIONS FOR USE
Megalotect CP 
100 U/ml solution for infusion
ACTIVE SUBSTANCE
Human cytomegalovirus immunoglobulin for intravenous administration
COMPOSITION
1 ml solution contains:
-  Active substances:
  Human plasma protein  
     50 mg
  Of which immunoglobulin G 
 ≥ 96%
  Content of antibody to cytomegalovirus     100 U*
  * Units of the Paul-Ehrlich-Institut reference preparation
-  Excipients:
  Glycine and water for injections.
The IgG subclass distribution is defined around 65 % IgG1, 30 % IgG2, 3 % 
IgG3, 2 %, IgG4.
The IgA content is ≤ 2 mg/ml.
PHARMACEUTICAL FORM
Solution for infusion
PRESENTATIONS
Infusion vial of 10ml
Infusion vial of 50ml 
PHARMACOTHERAPEUTIC GROUP
Human cytomegalovirus immunoglobulin for intravenous administration
NAME AND ADDRESS OF MANUFACTUREr
Biotest Pharma GmbH
Landsteinerstraße 5
63303 Dreieich, Germany
INDICATIONS
Prophylaxis of clinical manifestations of cytomegalovirus infection in pa-
tients receiving immunosuppressive therapy, particularly in transplant re-
cipients.
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21.11.13   09:02
CONTRAINDICATIONS
Hypersensitivity to any ingredient in Megalotect CP.
Hypersensitivity to homologous immunoglobulins, especially in very rare cases of 
IgA deficiency, when the patient has antibodies against IgA.
PREGNANCY AND LACTATION
The safety of this product for use in human pregnancy has not been
established in 
controlled clinical trials and therefore should only be given with caution to preg-
nant women and breast-feeding mothers. Clinical experience with immunoglobu-
lins suggests that no harmful effects on the course of pregnancy, or on the foetus 
and the neonate are to be expected. Immunoglobulins are excreted into the milk 
and may contribute to the transfer of protective
antibodies to the neonate.
PRECAUTIONS FOR USE
Take special care with Megalotect CP
-  when the infusion ra

Summary of Product characteristics

1
INSTRUCTIONS FOR USE
Megalotect CP 100 U/ml solution for infusion
ACTIVE SUBSTANCE
Human cytomegalovirus immunoglobulin (CMVIG)
COMPOSITION
One ml contains:
Human plasma protein 50mg (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
Distribution of the IgG subclasses (approx.. values):
IgG1
65 %
IgG2
30 %
IgG3
3 %
IgG4
2 %
The immunoglobin A (IgA) content is ≤ 2000 micrograms/ml.
Excipients:
Glycine, water for injections.
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.
PRESENTATIONS
10 ml or 50 ml of ready-for-use solution for intravenous infusion in
vial (type II glass) with a stopper
(bromobutyl) and a cap (aluminium).
Each vial with 10ml contains: 500mg 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 50ml contains: 2,500mg human plasma protein (of which
at least 96 % is immunoglobulin
G), with a content of antibodies against CMV of 5,000 U.
PHARMACOTHERAPEUTIC GROUP
Human cytomegalovirus immunoglobulin for intravenous administration
NAME AND ADDRESS OF MANUFACTURER
Biotest Pharma GmbH
Landsteinerstraße 5
63303 Dreieich, Germany
INDICATIONS
Prophylaxis of clinical manifestations of cytomegalovirus infection in
patients receiving
immunosuppressive therapy, particularly in transplant recipients.
The concomitant use of adequate virostatic agents should be considered
for CMV-prophylaxis.
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2
CONTRAINDICATIONS
•
Hypersensitivity to the active substance (human cytomegalovirus
immunoglobulin) or to any of
the excipients listed above.
•
Patients with selective IgA deficiency who developed antibodies to
IgA, as administering an IgA-
containing product can result in anaphylaxis.
FERTILITY, PREGNANCY AND LACTATION
Pregnancy
The safety of this medicinal product