SPC, UK: Evoltra 1mg/ml concentrate for solution for infusion
||1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
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Name of the medicinal product
Evoltra 1 mg/ml concentrate for solution for infusion.
Qualitative and quantitative composition
Each ml of concentrate contains 1 mg of clofarabine. Each 20 ml vial contains 20 mg of clofarabine. ...
Concentrate for solution for infusion. Clear, practically colourless solution with a pH of 4.5 to 7.5 ...
Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory ...
Posology and method of administration
Therapy must be initiated and supervised by a physician experienced in the management of patients with ...
Hypersensitivity to clofarabine or to any of the excipients (see section 6.1). Use in patients with severe ...
Special warnings and precautions for use
Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological ...
Interaction with other medicinal products and other forms of interaction
No formal interaction studies have been performed to date with clofarabine. However, there are no known ...
Fertility, pregnancy and lactation
Contraception in males and females Females of childbearing potential and sexually active males must use ...
Effects on ability to drive and use machines
No studies on the effects of clofarabine on the ability to drive and use machines have been performed. ...
The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ...
No case of overdose has been reported. However, possible symptoms of overdose are expected to include ...
Pharmacotherapeutic group: Antineoplastic agents, antimetabolites ATC code: L01BB06 Mechanism of action: ...
The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed ...
Preclinical safety data
Toxicology studies of clofarabine in mice, rats and dogs showed that rapidly proliferating tissues were ...
List of excipients
Sodium chloride Water for injections
This medicinal product must not be mixed with other medicinal products except those mentioned in section ...
3 years. The diluted concentrate is chemically and physically stable for 3 days at 2°C to 8°C and at ...
Special precautions for storage
Do not freeze. For storage conditions of the diluted medicinal product, see section 6.3.
Nature and contents of container
Type I glass vial with bromobutyl rubber stopper, polypropylene flip-off cap and aluminium overseal. ...
Special precautions for disposal and other handling
Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration. It should ...
Marketing authorization holder
Genzyme Europe BV Gooimeer 10 1411DD Naarden The Netherlands Tel: +31 (0)35 699 12 00 Fax: +31 (0) 35 ...
Marketing authorization number(s)
EU/1/06/334/001 3 vials EU/1/06/334/002 4 vials EU/1/06/334/003 10 vials EU/1/06/334/004 20 vials EU/1/06/334/005 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 May 2006 Date of latest renewal: 24 March 2011
Date of revision of the text
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.