Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Biotest Pharma GmbH, Landsteinerstraße 5, 63303 Dreieich, Germany, Tel.: +49 6103 801-0, Telefax: +49 6103 801-150, Email: mail@biotest.com
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. |
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.
| 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 |
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.
Biotest Pharma GmbH, Landsteinerstraße 5, 63303 Dreieich, Germany, Tel.: +49 6103 801-0, Telefax: +49 6103 801-150, Email: mail@biotest.com
PL 04500/0015
06/01/2020
| Drug | Countries | |
|---|---|---|
| CYTOTECT CP | Austria, Estonia, Croatia, Romania, United Kingdom |
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