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
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.
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.
The posology in children and adolescents (0-18 years) is not different to that of adults as the posology for each indication is given by body weight and adjusted to the clinical outcome of the above mentioned conditions.
No evidence is available to require a dose adjustment.
No dose adjustment unless clinically warranted, see section 4.4.
No dose adjustment unless clinically warranted, see section 4.4.
Intravenous use.
Cytotect CP Biotest should be infused intravenously at an initial rate of 0.08 ml/kg BW/hr for 10 minutes. See section 4.4. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased to a maximum of 0.8 ml/kg BW/hr for the remainder of the infusion.
Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4).
3 years.
The medicinal product should be used immediately after first opening.
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light. Do not freeze.
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.
The medicinal product should be brought to room or body temperature before use.
Products should be inspected visually for particular matter and discoloration prior to administration. The solution should be clear or slightly opalescent and colourless or pale yellow. Do not use solutions which are cloudy or which have deposits.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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