TRUXIMA Concentrate for solution for infusion (2023)
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Περιεχόμενα
Name of the medicinal product
Truxima 100 mg concentrate for solution for infusion. Truxima 500 mg concentrate for solution for infusion.
Qualitative and quantitative composition
<u>Truxima 100mg concentrate for solution for infusion:</u> Each mL contains 10 mg of rituximab. Each 10 mL vial contains 100 mg of rituximab. <u>Truxima 500 mg concentrate for solution for infusion:</u> ...
Pharmaceutical form
Concentrate for solution for infusion. Clear, colourless liquid with pH of 6.3-6.8 and osmolality of 329-387 mOsmol/kg.
Therapeutic indications
Truxima is indicated in adults for the following indications. Non-Hodgkins lymphoma (NHL) Truxima is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma ...
Posology and method of administration
Rituximab 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 ...
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
Traceability 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 ...
Interaction with other medicinal products and other forms of interaction
Currently, there are limited data on possible drug interactions with rituximab. In CLL patients, co-administration with rituximab did not appear to have an effect on the pharmacokinetics of fludarabine ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception Due to the long retention time of rituximab in B cell depleted patients, women of childbearing potential should use effective contraceptive methods during ...
Effects on ability to drive and use machines
Rituximab has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Experience from non-Hodgkins lymphoma and chronic lymphocytic leukaemia in adults Summary of the safety profile The overall safety profile of rituximab in non-Hodgkins lymphoma and CLL is based on data ...
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
<b>Pharmacotherapeutic group:</b> antineoplastic agents, monoclonal antibodies <b>ATC code:</b> L01FA01 Truxima is a biosimilar medicinal product. Rituximab binds specifically to the transmembrane antigen, ...
Pharmacokinetic properties
Adult 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 ...
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 (E331) Polysorbate 80 (E433) 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> 4 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 vial 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
<u>Truxima 100 mg concentrate for solution for infusion:</u> Clear Type I glass vial with butyl rubber stopper containing 100 mg of rituximab in 10 mL. Pack of 2 vials. <u>Truxima 500 mg concentrate for ...
Special precautions for disposal and other handling
Truxima is provided in sterile, preservative-free, non-pyrogenic, single use vials. Use sterile needle and syringe to prepare Truxima. Aseptically withdraw the necessary amount of Truxima, and dilute to ...
Marketing authorization holder
Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary
Marketing authorization number(s)
<u>Truxima 100 mg concentrate for solution for infusion:</u> EU/1/16/1167/002 <u>Truxima 500 mg concentrate for solution for infusion:</u> EU/1/16/1167/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 17 February 2017 Date of latest renewal: 15 November 2021
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