TRUXIMA Concentrate for solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Truxima 100 mg concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 100 mg of rituximab. Each mL of concentrate contains 10 mg of rituximab. Rituximab is a genetically engineered chimeric mouse/human monoclonal antibody representing a glycosylated immunoglobulin ...
Pharmaceutical form
Concentrate for solution for infusion. Clear, colourless liquid.
Therapeutic indications
Truxima is indicated in adults for the following indications: Non-Hodgkins lymphoma (NHL): Truxima is indicated for the treatment of previously untreated patients with stage III-IV follicular lymphoma ...
Posology and method of administration
Truxima should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4). ...
Contraindications
Contraindications for use in non-Hodgkins lymphoma and chronic lymphocytic leukaemia Hypersensitivity to the active substance or to murine proteins, or to any of the other excipients listed in section ...
Special warnings and precautions for use
In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file. Progressive multifocal ...
Interaction with other medicinal products and other forms of interaction
Currently, there are limited data on possible medicinal product interactions with Truxima. In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of ...
Fertility, pregnancy and lactation
Contraception in males and females Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during and for 12 ...
Effects on ability to drive and use machines
No studies on the effects of Truxima on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab would ...
Undesirable effects
Summary of the safety profile (non-Hodgkins lymphoma and chronic lymphocytic leukaemia) The overall safety profile of rituximab in non-Hodgkins lymphoma and CLL is based on data from patients from clinical ...
Overdose
Limited experience with doses higher than the approved dose of intravenous rituximab formulation is available from clinical trials in humans. The highest intravenous dose of rituximab tested in humans ...
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplastic agents, monoclonal antibodies ATC code: L01XC02 Truxima is a biosimilar medicinal product. Rituximab binds specifically to the transmembrane antigen, CD20, a non-glycosylated ...
Pharmacokinetic properties
Non-Hodgkins lymphoma Based on a population pharmacokinetic analysis in 298 NHL patients who received single or multiple infusions of rituximab as a single agent or in combination with CHOP therapy (applied ...
Preclinical safety data
Rituximab has shown to be highly specific to the CD20 antigen on B cells. Toxicity studies in cynomolgus monkeys have shown no other effect than the expected pharmacological depletion of B cells in peripheral ...
List of excipients
Sodium chloride Tri-sodium citrate dihydrate Polysorbate 80 Water for injections
Incompatibilities
No incompatibilities between rituximab and polyvinyl chloride or polyethylene bags or infusion sets have been observed.
Shelf life
<u>Unopened vial:</u> 3 years. <u>Diluted product:</u> The prepared infusion solution of rituximab in 0.9% sodium chloride solution is physically and chemically stable for 30 days at 2°C-8°C and subsequently ...
Special precautions for storage
Store in a refrigerator (2°C–8°C). Keep the container in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section 6.3.
Nature and contents of container
Clear Type I glass vials with butyl rubber stopper containing 100 mg of rituximab in 10 mL. Pack of 2 vials.
Special precautions for disposal and other handling
Truxima is provided in sterile, preservative-free, non-pyrogenic, single use vials. Aseptically withdraw the necessary amount of Truxima, and dilute to a calculated concentration of 1 to 4 mg/mL rituximab ...
Marketing authorization holder
Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary
Marketing authorization number(s)
EU/1/16/1167/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 February 2017
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