Obtain daily blood counts. Cytidine deaminase is concentrated in the liver and intravenous doses show biphasic elimination with half lifes of approximately 10 minutes and 1-3 hours.After 24 hours 80% of a dose has been eliminated either as the inactive metabolite or as the unchanged cytarabine, mostly in urine but some in bile.CSF levels of 50% of plasma levels are achieved with intravenous infusion. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions. Cytarabin ist ein Arzneimittel mit sowohl zytostatischer, als auch virostatischer Wirkung. 4.5 Interaction with other medicinal products and other forms of interaction6.6 Special precautions for disposal and other handling9.

Twelve doses of 4.5 g/m2 by IV infusion over one hour every 12 hours induces irreversible and fatal central nervous system toxicity. After single high intravenous doses, blood levels fall to unmeasurable levels within 15 minutes in most patients. Myelosuppression is biphasic and nadirs at 7-9 and 15-24 days. Patients treated with high doses of cytarabine should be observed for neuropathy since dose schedule alterations may be needed to avoid irreversible neurologic disorders.Severe and sometimes fatal pulmonary toxicity, sudden respiratory distress syndrome and pulmonary oedema have occurred following experimental high dose schedules with cytarabine therapy.Cases of cardiomyopathy with subsequent death have been reported following experimental high dose cytarabine and cyclophosphamide therapy when used for bone marrow transplant preparation. Results from one-hour infusions have been satisfactory in the majority of patients. Delayed progressive ascending paralysis resulting in death has been reported in children with AML following intravenous cytarabine at conventional doses in combination with other drugs.Cytarabine has been shown to be mutagenic and carcinogenic in animals. 26 9370.2000000000007. Die Substanz hemmt das Wachstum von Tumoren und Geschwülsten und nimmt Einfluss auf die Struktur der DNA. The possibility of a similar effect should be borne in mind when designing the long-term management of the patient.Peripheral motor and sensory neuropathies after consolidation with high doses of cytarabine, daunorubicin, and asparaginase have occurred in adult patients with acutenon lymphocytic leukemia.

6.0. It is a cell cycle specific antineoplastic drug.Oral administration is ineffective due to rapid deamination in the gut. There is a definite, but considerably reduced risk if therapy is initiated during the second or third trimester. Cytarabin (ARAC, ARA-C) Der folgende Text informiert über Anwendung, Wirkung und mögliche Nebenwirkungen des Cytarabins sowie darüber, welche Wechselwirkungen mit anderen Substanzen auftreten können und in welchen Fällen Cytarabin nicht oder nur eingeschränkt verabreicht werden darf. Date of first authorisation/renewal of the authorisationStart typing to retrieve search suggestions. This site uses cookies. 15 229.6. Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine or procarbazine. Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression. 110 2035. 16 1674.4. Keep container in outer carton.

Therapy should be suspended or modified when drug-induced bone marrow depression results in a platelet count of less than 50,000 or a polymorphonuclear count of under 1000 per mmWhen intravenous doses are given quickly, patients may become nauseated and may vomit for several hours afterwards. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. Cytarabine will be given to you by infusion into a vein (through a ‘drip’) or by injection under the direction of specialists in hospital.

is combined with another CNS toxic treatment such as radiation therapy or high dose of a cytotoxic agentReversible corneal lesion and haemorrhagic conjunctivitis have been described. 37.0. 4.3 Contraindications 845.0. Specialised references should be consulted for specific compatibility information.In use: Chemical and physical in-use stability has been demonstrated for 7 days at room temperature.From a microbiological point of view, the product should be used immediately. (See section 4.8). ii) 0.5 - 1.0 mg/kg/day may be given in an infusion of up to 24 hours duration. Severe and sometimes fatal pulmonary toxicity, adult respiratory distress syndrome, and pulmonary oedema have occurred following high dose schedules with cytarabine therapy. During pregnancy, cytarabine should only be administrated on strict indication, where the benefits of the drug to the mother should be weighed against possible hazards to the fetus. Results from one hour infusions have been satisfactory in the majority of patients.Evidence of bone marrow inprovement has been reported to occur 7-64 days days after the beginning of therapy.In general, if a patient shows neither remission or toxicity after a trial period, then cautiously administered higher doses can be administered.