CYTOTECT CP BIOTEST Solution for infusion Ref.[9842] Active ingredients: Cytomegalovirus immunoglobulin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Biotest Pharma GmbH, LandsteinerstraรŸe 5, 63303 Dreieich, Germany, Tel.: +49 6103 801-0, Telefax: +49 6103 801-150, Email: mail@biotest.com

Product name and form

Cytotect CP Biotest 100 U/ml solution for infusion

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.

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 โ‰ค2,000 micrograms/ml.

Produced from the plasma of human donors.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Cytomegalovirus immunoglobulin

Cytomegalovirus immunoglobulin is used as a CMV-specific polyclonal immunoglobulin preparation that binds to CMV surface antigens thereby neutralizing the potential of CMV from entering host cells and presenting the CMV particle for phagocytosis. Furthermore, cytomegalovirus immunoglobulin can activate CMV-reactive immune cells for long-lasting CMV-specific immune responses.

List of Excipients

Glycine
Water for injections

Pack sizes and marketing

10 ml or 50 ml of ready-for-use solution for intravenous infusion in a vial (type II glass) with a stopper (bromobutyl) and a cap (aluminium).

One box containing:

1 vial with 10 ml (1,000 U) solution for infusion or
1 vial with 50 ml (5,000 U) solution for infusion

Not all pack sizes may be marketed.

Marketing authorization holder

Biotest Pharma GmbH, LandsteinerstraรŸe 5, 63303 Dreieich, Germany, Tel.: +49 6103 801-0, Telefax: +49 6103 801-150, Email: mail@biotest.com

Marketing authorization dates and numbers

PL 04500/0015

06/01/2020

Drugs

Drug Countries
CYTOTECT CP Austria, Estonia, Romania, United Kingdom

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