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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Leustat Injection (2012)

Εκδότης

Εκδότης Janssen-Cilag Ltd
Διεύθυνση 50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
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Περιεχόμενα

Name of the medicinal product

Leustat Injection.

Qualitative and quantitative composition

LEUSTAT (cladribine) Injection is a synthetic antineoplastic agent for continuous intravenous infusion. ...

Pharmaceutical form

A sterile, buffered solution in vials containing 10 mg (1 mg/ml) of cladribine for dilution and subsequent ...

Therapeutic indications

LEUSTAT Injection is indicated for the primary or secondary treatment of patients with Hairy Cell Leukaemia ...

Posology and method of administration

Usual dose Adults and elderly HCL: The recommended treatment for Hairy Cell Leukaemia is a single course ...

Contraindications

LEUSTAT Injection is contra-indicated in patients hypersensitive to cladribine or other components of ...

Special warnings and precautions for use

LEUSTAT Injection is a potent antineoplastic agent with potentially significant toxic side effects. It ...

Interaction with other medicinal products and other forms of interaction

Caution should be exercised if LEUSTAT Injection is administered following or in conjunction with other ...

Pregnancy and lactation

Pregnancy LEUSTAT Injection should not be given during pregnancy. Women of childbearing potential must ...

Effects on ability to drive and use machines

Given the patients underlying medical condition and the safety profile of LEUSTAT Injection, caution ...

Undesirable effects

Hairy Cell Leukaemia (HCL) The safety of LEUSTAT was evaluated in 576 LEUSTAT-treated patients with hairy ...

Overdose

High doses of LEUSTAT have been associated with serious neurological toxicity (including irreversible ...

Pharmacodynamic properties

LEUSTAT Injection (cladribine) is a synthetic antineoplastic agent. Cellular Resistance and Sensitivity: ...

Pharmacokinetic properties

When LEUSTAT Injection was given by continuous intravenous infusion over 7 days the mean steady-state ...

Preclinical safety data

Carcinogenesis/Mutagenesis: No animal carcinogenicity studies have been conducted with cladribine. However, ...

List of excipients

9.0 mg (0.15 mEq) of sodium chloride as an inactive ingredient. Phosphoric acid and/or dibasic sodium ...

Incompatibilities

Since limited compatibility data are available, adherence to the recommended diluents and infusion systems ...

Shelf life

The shelf life for LEUSTAT Injection is 2 years. When stored in refrigerated conditions between 2° to ...

Special precautions for storage

Store refrigerated at 2° to 8°C (36° to 46°F). Protect from light during storage.

Nature and contents of container

LEUSTAT Injection is supplied as a sterile, preservative-free, isotonic solution containing 10 mg (1 ...

Special precautions for disposal and other handling

Preparation and administration of intravenous solutions: LEUSTAT Injection must be diluted with the designated ...

Marketing authorization holder

Janssen-Cilag Ltd 50-100 Holmers Farm Way High Wycombe Bucks HP12 4EG

Marketing authorization number(s)

PL 0242/0232

Date of first authorization / renewal of the authorization

3 February 1995

Date of revision of the text

01 May 2012
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.