THYMOGLOBULINE Powder for solution for infusion (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Thymoglobuline 25 mg powder for solution for infusion.
Qualitative and quantitative composition
Rabbit anti-human thymocyte immunoglobulin 25 mg per vial. 1 ml reconstituted solution contains 5 mg rabbit, anti-human thymocyte immunoglobulin. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder for solution for infusion.
Therapeutic indications
Immunosuppression in solid organ transplantationPrevention of graft rejection in renal transplantation Treatment of steroid resistant graft rejection in renal transplantation Prevention of graft rejection ...
Posology and method of administration
Thymoglobuline must always be used under strict medical supervision and prescribed by physicians with experience in using immunosuppressive agents. Posology The posology depends on the indication, the ...
Contraindications
Hypersensitivity to rabbit proteins or to any of the excipients listed in section 6.1. Active acute or chronic infections, which would contraindicate any additional immunosuppression.
Special warnings and precautions for use
Thymoglobuline should be used under strict medical supervision in a hospital setting. Thymoglobuline must only be administered according to the instructions of a physician with experience of immunosuppressive ...
Interaction with other medicinal products and other forms of interaction
No drug interaction studies have been performed. Interactions with food and drink are unlikely. Thymoglobuline has not been shown to interfere with any routine clinical laboratory tests which use immunoglobulins. ...
Pregnancy and lactation
Pregnancy Animal reproduction studies have not been conducted with Thymoglobuline. It is not known whether Thymoglobuline can cause foetal harm or can affect reproductive capacity. Thymoglobuline should ...
Effects on ability to drive and use machines
Given the possible adverse events which can occur during the period of Thymoglobuline infusion, in particular cytokine release syndrome, it is recommended that patients should not drive or operate machinery. ...
Undesirable effects
Tabulated list of adverse reactions The adverse reactions observed in clinical studies and reported in post-marketing experience are detailed below. Adverse reactions frequency is defined using the following ...
Overdose
Inadvertent overdose may induce leucopenia (including lymphopenia and neutropenia) and thrombocytopenia.
Pharmacodynamic properties
Pharmacotherapeutic group: Immunosuppressive agents ATC code: L04AA04 Rabbit anti-human thymocyte globulin is a selective immunosuppressive agent (mostly acting on T lymphocytes). Lymphocyte depletion ...
Pharmacokinetic properties
Following the first infusion of 1.25 mg/kg of Thymoglobuline (in kidney transplant recipients), total serum rabbit IgG levels of between 10 and 40 µg/ml are obtained. The serum levels decline steadily ...
Preclinical safety data
No mutagenicity, reproduction or genotoxicity studies have been conducted due to the nature and intended use of the medicinal product.
List of excipients
Glycine Sodium chloride Mannitol Other components: Thymoglobuline may also contain residues of polysorbate, from the manufacturing process.
Incompatibilities
Based on a single compatibility study (Trissel LA,. 2003; Am J Health Syst Pharm) the combination of Thymoglobuline, heparin and hydrocortisone in a dextrose infusion solution has been noted to precipitate ...
Shelf life
3 years. Immediate use after dilution is recommended in order to prevent microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the ...
Special precautions for storage
Store and transport refrigerated (at 2°C to 8°C). Do not freeze. During transport a temperature excursion up to 25°C for 3 days will not alter the medicinal product characteristics. For storage conditions ...
Nature and contents of container
Powder in a vial (type I glass) closed with a stopper (chlorobutyl). Each pack contains one 10 ml vial.
Special precautions for disposal and other handling
Reconstitute the powder with 5 ml of sterile water for injections to obtain a solution containing 5 mg protein per ml. The solution is clear or slightly opalescent. Reconstituted medicinal product should ...
Marketing authorization holder
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP, Amsterdam, The Netherlands
Marketing authorization number(s)
PL 12375/0021
Date of first authorization / renewal of the authorization
18/03/2013
Date of revision of the text
28/06/2019
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