ZAVEDOS Powder for solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
Zavedos 5 mg Powder for Solution for Injection.
Qualitative and quantitative composition
Each vial contains 5mg idarubicin hydrochloride. The reconstituted solution contains 1mg/ml. Excipients with known effect: Each vial contains 50mg of lactose monohydrate. For the full list of excipients, ...
Pharmaceutical form
Powder for Solution for Injection. Sterile, pyrogen-free, orange-red, freeze-dried powder in vial containing 5 mg of idarubicin hydrochloride, with 50 mg of lactose monohydrate.
Therapeutic indications
Adults For the treatment of acute myeloid leukaemia (AML), for remission induction in untreated patients or for remission induction in relapsed or refractory patients. For second line treatment of relapsed ...
Posology and method of administration
For intravenous use only. Not for intrathecal use. Dosage is calculated on the basis of body surface area. Acute myeloid leukaemia (AML) Adults: 12 mg/m²/day i.v. daily for 3 days in combination with cytarabine. ...
Contraindications
Hypersensitivity to idarubicin or to any of the excipients listed in section 6.1, other anthracyclines or anthracenediones Severe hepatic impairment Severe renal impairment Uncontrolled infections Severe ...
Special warnings and precautions for use
General Idarubicin should be administered only under the supervision of physicians experienced in the use of cytotoxic chemotherapy. This ensures that immediate and effective treatment of severe complications ...
Interaction with other medicinal products and other forms of interaction
Idarubicin is a potent myelosuppressant and combination chemotherapy regimens including other agents with similar action may be expected to induce additive myelosuppressive effects (see section 4.4). ...
Fertility pregnancy and lactation
Fertility Idarubicin can induce chromosomal damage in human spermatozoa. For this reason, males undergoing treatment with idarubicin should use effective contraceptive methods up to 3 months after treatment ...
Effects on ability to drive and use machines
The effect of idarubicin on the ability to drive or use machinery has not been systematically evaluated.
Undesirable effects
The frequencies of undesirable effects are based on the following categories: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), ...
Overdose
Very high doses of idarubicin may be expected to cause acute myocardial toxicity within 24 hours and severe myelosuppression within one to two weeks. Delayed cardiac failure has been seen with the anthracyclines ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anthracyclines and related substances ATC Code: L01DB06 Idarubicin is a DNA intercalating anthracycline which interacts with the enzyme topoisomerase II and has an inhibitory ...
Pharmacokinetic properties
In adults, following oral administration of 10 to 60 mg/m² idarubicin, idarubicin was rapidly absorbed with the maximum plasma concentrations of 4-12.65 ng/mL achieved in 1 to 4 hours after dosing. The ...
Preclinical safety data
Idarubicin has mutagenic properties and it is carcinogenic in rats. Reproduction studies in animals have shown that idarubicin is embryotoxic and teratogenic in rats but not rabbits.
List of excipients
Lactose monohydrate
Incompatibilities
Prolonged contact with any solution of an alkaline pH should be avoided as it will result in degradation of the drug. Zavedos should not be mixed with heparin as a precipitate may form and it is not recommended ...
Shelf life
Shelf life: The shelf-life expiry date for this product shall not exceed three years from the date of its manufacture.
Special precautions for storage
Unreconstituted solution: No special storage conditions Reconstituted solution: The reconstituted solution is chemically stable when stored for at least 48 hours at 2-8°C and 24 hours at room temperature ...
Nature and contents of container
Colourless glass vial, type I, with chlorobutyl rubber bung and aluminium seal with insert yellow polypropylene disk. Zavedos 5mg Powder for Solution for Injection vials are available as single vials. ...
Special precautions for disposal and other handling
The following protective recommendations are given due to the toxic nature of this substance: This product should be handled only by personnel who have been trained in the safe handling of such preparations. ...
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Marketing authorization number(s)
PL 00057/1061
Date of first authorization / renewal of the authorization
23 May 2002
Date of revision of the text
08/2018
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