CYTARABINE Solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Cytarabine 20 mg/ml Injection.
Qualitative and quantitative composition
Each 1 ml contains 20 mg of cytarabine. Presentations 100 mg/5 ml 500 mg/25 ml 1 g/50 ml Amount cytarabine present 100 mg 500 mg 1 g <u>Excipient with known effect:</u> Cytarabine 100 mg/5 ml (20 mg/ml) ...
Pharmaceutical form
Solution for injection. Clear, colourless solution.
Therapeutic indications
Cytarabine may be used alone or in combination with other antineoplastic agents. It is indicated alone or in combination for induction of remission and/or maintainance in patients with acute myeloid leukaemia, ...
Posology and method of administration
Posology Cytarabine 20 mg/ml Injection can be diluted with Sterilised Water for Injections BP, Glucose Intravenous Infusion BP or Sodium Chloride Intravenous Infusion BP. Prepared infusions, in the recommended ...
Contraindications
Hypersensitivity to cytarabine or to any of the excipients listed in 6.1. Anaemia, leucopenia and thrombocytopenia of non-malignant aetiology (e.g. bone marrow aplasia), unless the benefits outweigh the ...
Special warnings and precautions for use
Cytarabine is a potent bone marrow suppressant. Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression. Patients receiving the drug should be kept under ...
Interaction with other medicinal products and other forms of interaction
Cardiac Glycosides GI absorption of oral digoxin tablets may be substantially reduced in patients receiving combination chemotherapy regimens (including regimens containing cytarabine), possibly as a result ...
Fertility, pregnancy and lactation
Pregnancy Cytarabine is teratogenic in some animal species. It should not be used in pregnant women (especially during the first trimester) or in those who may become pregnant, unless the possible benefits ...
Effects on ability to drive and use machines
No documented effect on ability to drive or operate machinery. Nevertheless, patients receiving chemotherapy may have an impaired ability to drive or operate machinery and should be warned of the possibility ...
Undesirable effects
The following adverse events have been reported in association with cytarabine therapy. Frequencies are defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 ...
Overdose
There is no specific antidote for cytarabine overdose. Cessation of therapy followed by management of ensuing bone marrow depression including whole blood or platelet transfusion and antibiotics as required. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Pyrimidine analogues <b>ATC code:</b> L01BC01 Mechanism of action Cytarabine (ARA-C) is metabolised in vivo to ARA-CTP phosphorylated compound. This competitively inhibits ...
Pharmacokinetic properties
Absorption Oral administration is ineffective due to rapid deamination in the gut. Cytidine deaminase is concentrated in the liver and intravenous doses show biphasic elimination with half lifes of approximately ...
Preclinical safety data
There is no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Sodium chloride Water for injections Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)
Incompatibilities
Solutions of cytarabine have been reported to be incompatible with various drugs, i.e. carbenicillin sodium, cephalothin sodium, fluorouracil, gentamicin sulphate, heparin sodium, hydrocortisone sodium ...
Shelf life
Shelf life <u>Before use:</u> 18 Months. <u>In use:</u> Chemical and physical in-use stability has been demonstrated for 7 days at room temperature. From a microbiological point of view, the product should ...
Special precautions for storage
Do not store above 25°C. Keep container in the outer carton, in order to protect from light.
Nature and contents of container
Clear Type I glass vials, rubber stopper. Clear Type I Onco-Tain Vials, rubber stopper. Pack sizes 5s, 25s and 50s. Not all presentations and pack sizes may be marketed.
Special precautions for disposal and other handling
Use in the paediatric population No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Hospira UK Ltd, Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom
Marketing authorization number(s)
PL 04515/0040
Date of first authorization / renewal of the authorization
Date of first authorisation: 7<sup>th</sup> July 1992 Date of last renewal: 10<sup>th</sup> October 2006
Date of revision of the text
04/2021
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