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SPC, UK: Evoltra 1mg/ml concentrate for solution for infusion (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
SANOFI
Διεύθυνση :
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. Excipient: Each 20 ml vial contains 180 mg of sodium chloride. For a full list of excipients, see section ...

Pharmaceutical form

Concentrate for solution for infusion. Clear, practically colourless solution with a pH of 4.5 to 7.5 and an osmolarity of 270 to 310 mOsm/l.

Therapeutic indications

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated ...

Posology and method of administration

Therapy must be initiated and supervised by a physician experienced in the management of patients with acute leukaemias. Posology Adult population (including the elderly) There are currently insufficient ...

Contraindications

Hypersensitivity to clofarabine or to any of the excipients (see section 6.1). Use in patients with severe renal insufficiency or severe hepatic impairment. Breast-feeding should be discontinued prior ...

Special warnings and precautions for use

Evoltra is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8). The following parameters should be closely monitored in ...

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 clinically significant interactions with other medicinal products or laboratory tests. Clofarabine ...

Fertility, pregnancy and lactation

Contraception in males and females Females of childbearing potential and sexually active males must use effective methods of contraception during treatment. Pregnancy There are no data on the use of clofarabine ...

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. However, patients should be advised that they may experience undesirable effects such as dizziness, ...

Undesirable effects

The information provided is based on data generated from clinical trials in which 115 patients (> 1 and ≤ 21 years old) with either ALL or acute myeloid leukaemia (AML) received at least one dose of clofarabine ...

Overdose

No case of overdose has been reported. However, possible symptoms of overdose are expected to include nausea, vomiting, diarrhoea and severe bone marrow suppression. To date, the highest daily dose administered ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, antimetabolites ATC code: L01BB06 Mechanism of action: Clofarabine is a purine nucleoside anti-metabolite. Its antitumour activity is believed to be due ...

Pharmacokinetic properties

The pharmacokinetics of clofarabine were studied in 40 patients aged between 2 to 19 years old with relapsed or refractory ALL or AML. The patients were enrolled into a single phase I (n = 12) or two phase ...

Preclinical safety data

Toxicology studies of clofarabine in mice, rats and dogs showed that rapidly proliferating tissues were the primary target organs of toxicity. Cardiac effects were observed in rats consistent with cardiomyopathy ...

List of excipients

Sodium chloride Water for injections

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

3 years. The diluted concentrate is chemically and physically stable for 3 days at 2°C to 8°C and at room temperature. From a microbiological point of view, it should be used immediately. If not used immediately, ...

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. The vials contain 20 ml concentrate for solution for infusion and are packaged in a box. Each box contains ...

Special precautions for disposal and other handling

Evoltra 1 mg/ml concentrate for solution for infusion must be diluted prior to administration. It should be filtered through a sterile 0.2 micrometre syringe filter and then diluted with sodium chloride ...

Marketing authorization holder

Genzyme Europe BV Gooimeer 10 1411DD Naarden The Netherlands Tel: +31 (0)35 699 12 00 Fax: +31 (0) 35 694 32 14

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 1 vial

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

11/2011