ATRIANCE Solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
Atriance 5 mg/ml solution for infusion.
Qualitative and quantitative composition
Each ml of solution contains 5 mg of nelarabine. Each vial contains 250 mg of nelarabine. Excipient with known effect: Each ml of solution contains 1.725 mg (75 micromols) of sodium. For the full list ...
Pharmaceutical form
Solution for infusion. Clear, colourless solution.
Therapeutic indications
Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following ...
Posology and method of administration
Nelarabine must only be administered under the supervision of a physician experienced in the use of cytotoxic agents. Posology Complete blood counts including platelets must be monitored regularly (see ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Neurological adverse reactions Severe neurological reactions have been reported with the use of nelarabine. These reactions have included altered mental states including severe somnolence, confusion and ...
Interaction with other medicinal products and other forms of interaction
Nelarabine and ara-G did not significantly inhibit the activities of the major hepatic cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 in vitro. Concomitant ...
Fertility, pregnancy and lactation
Contraception in males and females Both sexually active men and women should use effective methods of contraception during treatment with nelarabine. Men with partners who are pregnant or could become ...
Effects on ability to drive and use machines
Atriance has major influence on the ability to drive and use machines. Patients treated with nelarabine are potentially at risk of suffering from somnolence during and for several days after treatment. ...
Undesirable effects
Summary of the safety profile The safety profile from pivotal clinical studies at the recommended doses of nelarabine in adults (1,500 mg/m²) and children (650 mg/m²) is based on data from 103 adults and ...
Overdose
No case of overdose has been reported. Nelarabine has been administered in clinical studies up to a dose of 75 mg/kg (approximately 2,250 mg/m²) daily for 5 days to a paediatric patient, up to a dose of ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites, purine analogues ATC code: L01BB07 Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Nelarabine is rapidly demethylated by ...
Pharmacokinetic properties
Nelarabine is a pro-drug of the deoxyguanosine analogue ara-G. Nelarabine is rapidly demethylated by adenosine deaminase (ADA) to ara-G and then phosphorylated intracellularly by deoxyguanosine kinase ...
Preclinical safety data
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: nelarabine caused ...
List of excipients
Sodium chloride Water for injections Hydrochloric acid (to adjust the pH) Sodium hydroxide (to adjust the pH)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years. Atriance is stable for up to 8 hours at up to 30°C once the vial is opened.
Special precautions for storage
For storage conditions after first opening of the medicinal product, see section 6.3.
Nature and contents of container
Clear glass (Type I) vial with a bromobutyl rubber stopper, and an aluminium seal with a red snap-off cap. Each vial contains 50 ml of solution. Atriance is supplied in packs of 1 vial or 6 vials.
Special precautions for disposal and other handling
The normal procedures for proper handling and disposal of cytotoxic anti-tumour medicinal products should be adopted, namely: Staff should be trained in how to handle and transfer the medicinal product. ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/07/403/001-002
Date of first authorization / renewal of the authorization
Date of first authorisation: 22 August 2007 Date of latest renewal: 16 June 2017
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