LEUSTAT Solution for infusion (2021)
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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. It is a clear, colourless, sterile, preservative-free, isotonic solution. LEUSTAT Injection is available ...
Pharmaceutical form
A sterile, buffered solution in vials containing 10 mg (1 mg/ml) of cladribine for dilution and subsequent continuous intravenous infusion.
Therapeutic indications
LEUSTAT Injection is indicated for the primary or secondary treatment of patients with Hairy Cell Leukaemia (HCL). LEUSTAT is also indicated for the treatment of patients with B-cell chronic lymphocytic ...
Posology and method of administration
Usual dose Adults and elderly HCL The recommended treatment for Hairy Cell Leukaemia is a single course of LEUSTAT given by continuous intravenous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day ...
Contraindications
LEUSTAT Injection is contra-indicated in patients hypersensitive to cladribine or other components of this product.
Special warnings and precautions for use
LEUSTAT Injection is a potent antineoplastic agent with potentially significant toxic side effects. It should be administered under the supervision of a qualified physician experienced in the use of antineoplastic ...
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 drugs known to cause myelosuppression. Following administration of LEUSTAT Injection, caution should ...
Fertility, pregnancy and lactation
Pregnancy LEUSTAT Injection should not be given during pregnancy. Women of childbearing potential must use effective contraception during treatment with LEUSTAT and for 6 months after the last LEUSTAT ...
Effects on ability to drive and use machines
Given the patients underlying medical condition and the safety profile of LEUSTAT Injection, caution should be exercised when a patient is performing activities requiring substantial physical well-being ...
Undesirable effects
Hairy Cell Leukaemia (HCL) The safety of LEUSTAT was evaluated in 576 LEUSTAT-treated patients with hairy cell leukaemia (HCL) (studies K90-091 and L91-048, n=576). These subjects received at least 1 injection ...
Overdose
High doses of LEUSTAT have been associated with serious neurological toxicity (including irreversible paraparesis/quadraparesis), acute nephrotoxicity, and severe bone marrow suppression resulting in neutropenia, ...
Pharmacodynamic properties
LEUSTAT Injection (cladribine) is a synthetic antineoplastic agent. Cellular Resistance and Sensitivity The selective toxicity cladribine towards certain normal and malignant lymphocyte and monocyte populations ...
Pharmacokinetic properties
When LEUSTAT Injection was given by continuous intravenous infusion over 7 days the mean steady-state serum concentration was estimated to be 5.7 ng/ml with an estimated systemic clearance of 663.5 ml/h/kg. ...
Preclinical safety data
Carcinogenesis / Mutagenesis No animal carcinogenicity studies have been conducted with cladribine. However, its carcinogenic potential cannot be excluded based on demonstrated genotoxicity of cladribine. ...
List of excipients
9.0 mg (0.15 mEq) of sodium chloride as an inactive ingredient Phosphoric acid and/or dibasic sodium phosphate to adjust the pH to a range of 5.5 to 8.0
Incompatibilities
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing LEUSTAT Injection should not be mixed with other intravenous ...
Shelf life
The shelf life for LEUSTAT Injection is 2 years. When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of LEUSTAT Injection are stable until the expiration ...
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 mg/ml) of cladribine (as 10 ml) in a single-use, Ph Eur Type I glass 10 ml vial.
Special precautions for disposal and other handling
Preparation and administration of intravenous solutions: LEUSTAT Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial ...
Marketing authorization holder
Atnahs Pharma UK Limited., Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom
Marketing authorization number(s)
PL 43252/0030
Date of first authorization / renewal of the authorization
3 February 1995
Date of revision of the text
23 December 2021
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