ARZERRA Concentrate for solution for infusion (2017)
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Περιεχόμενα
Name of the medicinal product
Arzerra 100 mg concentrate for solution for infusion. Arzerra 1000 mg concentrate for solution for infusion.
Qualitative and quantitative composition
One ml of concentrate contains 20 mg of ofatumumab. Arzerra 100 mg concentrate for solution for infusion: Each vial contains 100 mg of ofatumumab in 5 ml. Arzerra 1000 mg concentrate for solution for infusion: ...
Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate). Clear to opalescent, colourless to pale yellow liquid.
Therapeutic indications
Previously untreated chronic lymphocytic leukaemia (CLL) Arzerra in combination with chlorambucil or bendamustine is indicated for the treatment of adult patients with CLL who have not received prior therapy ...
Posology and method of administration
Arzerra should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available. Monitoring ...
Contraindications
Hypersensitivity to ofatumumab or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Infusion-related reactions Intravenous ofatumumab has been associated with infusion-related reactions. These reactions may result in temporary interruption or withdrawal of treatment. Pre-medication attenuates ...
Interaction with other medicinal products and other forms of interaction
Although limited formal drug-drug interaction data exist for ofatumumab, there are no known clinically significant interactions with other medicinal products. No clinically relevant pharmacokinetic interactions ...
Fertility, pregnancy and lactation
Women of child-bearing potential Since ofatumumab may cause foetal B-cell depletion, effective contraception (methods that result in less than 1% pregnancy rates) has to be used during Arzerra therapy ...
Effects on ability to drive and use machines
No studies on the effects of Arzerra on the ability to drive and use machines have been performed. No detrimental effects on such activities are predicted from the pharmacology of ofatumumab. The clinical ...
Undesirable effects
Summary of the safety profile The overall safety profile of ofatumumab is based on data from 1,168 patients in clinical trials in CLL (see section 5.1). This includes 643 patients treated with ofatumumab ...
Overdose
No case of overdose has been reported.
Pharmacodynamic properties
Pharmacotherapeutic group: antineoplasic agents, monoclonal antibodies ATC code: L01XC10 Mechanism of action Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope ...
Pharmacokinetic properties
Overall, the pharmacokinetics of ofatumumab were consistent across the indications, whether given as a single agent or in combination with fludarabine and cyclophosphamide or chlorambucil. Ofatumumab had ...
Preclinical safety data
Preclinical data reveal no special hazards for humans. Intravenous and subcutaneous administration to monkeys resulted in the expected depletion of peripheral and lymphoid tissue B-cell counts with no ...
List of excipients
Arginine Sodium acetate (E262) Sodium chloride Polysorbate 80 (E433) Edetate disodium (E386) Hydrochloric acid (E507) (for pH-adjustment) Water for injections
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Vial: 3 years. Diluted infusion solution: Chemical and physical in-use stability has been demonstrated for 48 hours at ambient conditions (less than 25°C). From a microbiological point of view, ...
Special precautions for storage
Store and transport refrigerated (2°C–8°C). Do not freeze. Keep the vial in the outer carton in order to protect from light. For storage conditions after dilution of the medicinal product, see section ...
Nature and contents of container
Arzerra 100 mg concentrate for solution for infusion: Clear Type I glass vial with a bromobutyl rubber stopper and aluminium over-seal, containing 5 ml of concentrate for solution for infusion. Arzerra ...
Special precautions for disposal and other handling
Dilution Arzerra concentrate for solution for infusion does not contain a preservative; therefore dilution should be carried out under aseptic conditions. The diluted solution for infusion must be used ...
Marketing authorization holder
Novartis Europharm Limited, Frimley Business Park, Camberley GU16 7SR, United Kingdom
Marketing authorization number(s)
Arzerra 100 mg concentrate for solution for infusion: EU/1/10/625/001 Arzerra 1000 mg concentrate for solution for infusion: EU/1/10/625/003
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 April 2010 Date of latest renewal: 17 February 2015
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