Megalotect 100 U/mL solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human Cytomegalovirus Immunoglobulin

Available from:

Biotest Pharma GmbH

ATC code:

J06BB09

INN (International Name):

Human Cytomegalovirus Immunoglobulin

Pharmaceutical form:

Solution for infusion

Therapeutic area:

cytomegalovirus immunoglobulin

Authorization status:

Not marketed

Authorization date:

2022-10-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEGALOTECT 100 U/ML SOLUTION FOR INFUSION
Human cytomegalovirus immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Megalotect is and what it is used for
2.
What you need to know before you use Megalotect
3.
How to use Megalotect
4.
Possible side effects
5.
How to store Megalotect
6.
Contents of the pack and other information
1.
WHAT MEGALOTECT IS AND WHAT IT IS USED FOR
Megalotect

belongs to the group of immunoglobulins. These medicines contain
antibodies (antibodies are
part of the body’s immune system).

contains antibodies against the cytomegalovirus.

is a solution for infusion that is given as a “drip” (infusion)
into a vein.
Megalotect is given to patients receiving immunosuppressive treatment
(treatment to suppress the
immune system) to prevent the clinical manifestation of
cytomegalovirus infection, particularly
patients after organ transplantation.
Your doctor will consider the concomitant use of adequate virostatic
agents when administering
Megalotect.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE MEGALOTECT
DO NOT USE MEGALOTECT

if you are
ALLERGIC
to human cytomegalovirus immunoglobulin or any of the other
ingredients of
this medicine (listed in section 6).

if you have an immunoglobulin A (IgA) deficiency, especially if you
have antibodies against IgA
in your blood because this might lead to anaphylaxis..
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE MEGALOTECT IS

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00D7SS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Megalotect 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.
Health Products Regulatory Authority
22 May 2023
CRN00D7SS
Page 2 of 1