CYTOTECT CP BIOTEST Solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Cytotect CP Biotest 100 U/ml solution for infusion
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 ...
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.
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 ...
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 ...
Contraindications
Hypersensitivity to the active substance (human cytomegalovirus immunoglobulin) or to any of the excipients listed in section 6.1. Patients with selective IgA deficiency who developed antibodies to IgA, ...
Special warnings and precautions for use
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Precautions for use Potential complications ...
Interaction with other medicinal products and other forms of interaction
Live attenuated virus vaccines Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps ...
Fertility, pregnancy and lactation
Pregnancy The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding ...
Effects on ability to drive and use machines
Cytotect CP Biotest may have a minor influence on the ability to drive and use machines. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating ...
Undesirable effects
Summary of the safety profile Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4): chills, headache, dizziness, fever, vomiting, allergic ...
Overdose
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).
Pharmacodynamic properties
Pharmacotherapeutic group: immune sera and immunoglobulins, specific immunoglobulins ATC code: J06BB09 Cytotect CP Biotest is an immunoglobulin preparation from plasma of donors with a high antibody titer ...
Pharmacokinetic properties
Cytotect CP Biotest is immediately and completely bioavailable in the recipients circulation after intravenous administration. It is distributed relatively rapidly between plasma and extravascular fluid; ...
Preclinical safety data
Immunoglobulins are normal constituents of the human body. Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies. Since ...
List of excipients
Glycine Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products, nor with any other IVIg products.
Shelf life
3 years. The medicinal product should be used immediately after first opening.
Special precautions for storage
Store in a refrigerator (2°C-8°C). Keep the vial in the outer carton in order to protect from light. Do not freeze.
Nature and contents of container
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 ...
Special precautions for disposal and other handling
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 ...
Marketing authorization holder
Biotest Pharma GmbH, Landsteinerstraße 5, 63303 Dreieich, Germany, Tel.: +49 6103 801-0, Telefax: +49 6103 801-150, Email: mail@biotest.com
Marketing authorization number(s)
PL 04500/0015
Date of first authorization / renewal of the authorization
06/01/2020
Date of revision of the text
06/01/2020
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