LITAK Solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
LITAK 2 mg/ml solution for injection.
Qualitative and quantitative composition
Each ml of solution contains 2 mg of cladribine (2-CdA). Each vial contains 10 mg of cladribine in 5 ml of solution. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, colourless solution.
Therapeutic indications
LITAK is indicated for the treatment of hairy cell leukaemia.
Posology and method of administration
Therapy with LITAK should be initiated by a qualified physician with experience in cancer chemotherapy. Posology The recommended posology for hairy cell leukaemia is a single course of LITAK given by subcutaneous ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Pregnancy and lactation. Patients less than 18 years of age. Moderate to severe renal impairment (creatinine clearance ...
Special warnings and precautions for use
Cladribine is an antineoplastic and immunosuppressive substance that can induce considerable toxic adverse reactions, such as myelo- and immunosuppression, long-lasting lymphocytopenia, and opportunistic ...
Interaction with other medicinal products and other forms of interaction
Due to a potential increase of haematological toxicity and bone marrow suppression, cladribine must not be used concomitantly with other myelosuppressive medicinal products. An influence of cladribine ...
Fertility, pregnancy and lactation
Pregnancy Cladribine causes serious birth defects when administered during pregnancy. Animal studies and in vitro studies with human cell lines demonstrated the teratogenicity and mutagenicity of cladribine. ...
Effects on ability to drive and use machines
LITAK has a major influence on the ability to drive and use machines. In case certain adverse reactions with a potential impact on performance occur (e.g. dizziness, very common, or drowsiness, which may ...
Undesirable effects
Summary of the safety profile Very common adverse reactions observed during the three most relevant clinical trials with cladribine in 279 patients treated for various indications and in 62 patients with ...
Overdose
Frequently observed symptoms of overdose are nausea, vomiting, diarrhoea, severe bone marrow depression (including anaemia, thrombocytopenia, leukopenia, and agranulocytosis), acute renal insufficiency, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Purine analogues ATC code: L01BB04 Cladribine is a purine nucleoside analogue acting as an antimetabolite. The single substitution of hydrogen for chlorine at position 2 distinguishes ...
Pharmacokinetic properties
Absorption Cladribine shows complete bioavailability after parenteral administration; the mean area under the plasma concentration versus time curve (AUC) is comparable after continuous or intermittent ...
Preclinical safety data
Cladribine is moderately acutely toxic to mice, with an LD<sub>50</sub> of 150 mg/kg by intraperitoneal administration. In 7- to 14-day continuous intravenous infusion studies in cynomolgus monkeys, the ...
List of excipients
Sodium chloride Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Incompatibilities
LITAK must not be mixed with other medicinal products.
Shelf life
Shelf life: 4 years. From a microbiological point of view, unless the opening precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze.
Nature and contents of container
10 ml type I glass vial with rubber stopper (bromobutyl) and flip-off aluminium cap. Packs contain 1 or 5 vials, each with 5 ml of solution. Not all pack-sizes may be marketed.
Special precautions for disposal and other handling
Procedures for proper handling and disposal of antineoplastic medicinal products should be used. Cytotoxic medicinal products should be handled with caution. Avoid contact by pregnant women. The use of ...
Marketing authorization holder
Lipomed GmbH, Hegenheimer Strasse 2, D-79576, Weil/Rhein, Germany
Marketing authorization number(s)
EU/1/04/275/001 EU/1/04/275/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 14/04/2004 Date of last renewal: 27/03/2009
Date of revision of the text
15.01.2018
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