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RUXIENCE Concentrate for solution for infusion (2020)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Ruxience 100 mg concentrate for solution for infusion. Ruxience 500 mg concentrate for solution for infusion.

2. Qualitative and quantitative composition

<u>Ruxience 100 mg concentrate for solution for infusion:</u> Each mL contains 10 mg of rituximab. Each 10 mL vial contains 100 mg of rituximab. <u>Ruxience 500 mg concentrate for solution for infusion: ...

3. Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate). Clear to slightly opalescent, colourless to pale brownish-yellow liquid.

4.1. Therapeutic indications

Ruxience is indicated in adults for the following indications: Non-Hodgkins lymphoma (NHL) Ruxience is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma ...

4.2. Posology and method of administration

Ruxience 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). ...

4.3. 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 ...

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. Progressive multifocal leukoencephalopathy ...

4.5. 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 ...

4.6. 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 ...

4.7. Effects on ability to drive and use machines

No studies on the effects of rituximab on the ability to drive and use machines have been performed, although the pharmacological activity and adverse reactions reported to date suggest that rituximab ...

4.8. 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 ...

4.9. 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 ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> antineoplastic agents, monoclonal antibodies <b>ATC code:</b> L01XC02 Ruxience is a biosimilar medicinal product. Rituximab binds specifically to the transmembrane antigen, ...

5.2. 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 ...

5.3. 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 ...

6.1. List of excipients

L-histidine L-histidine hydrochloride monohydrate Disodium edetate Polysorbate 80 (E433) Sucrose Water for injection

6.2. Incompatibilities

No incompatibilities between Ruxience and polyvinyl chloride or polyethylene bags or infusion sets have been observed.

6.3. Shelf life

<u>Unopened vial:</u> 24 months. <u>Diluted medicinal product:</u> After aseptic dilution in sodium chloride solution:<br />The prepared infusion solution of Ruxience in 0.9% sodium chloride solution is ...

6.4. 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.

6.5. Nature and contents of container

<u>Ruxience 100 mg concentrate for solution for infusion:</u> Clear Type I glass vials with chlorobutyl rubber stopper containing 100 mg of rituximab in 10 mL. Pack of 1 vial. <u>Ruxience 500 mg concentrate ...

6.6. Special precautions for disposal and other handling

Ruxience is provided in sterile, preservative-free, non-pyrogenic, single use vials. Aseptically withdraw the necessary amount of Ruxience and dilute to a calculated concentration of 1 to 4 mg/mL rituximab ...

7. Marketing authorization holder

Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium

8. Marketing authorization number(s)

Ruxience 100 mg concentrate for solution for infusion: EU/1/20/1431/001 Ruxience 500 mg concentrate for solution for infusion: EU/1/20/1431/002

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 01 April 2020

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