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ZAVEDOS Capsules (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Zavedos 5 mg Capsules.

Qualitative and quantitative composition

Idarubicin Hydrochloride 5.0 mg HSE.

Pharmaceutical form

Opaque red cap and body, self-locking, hard gelatin capsules, size no. 4, containing an orange powder.

Therapeutic indications

Whenever intravenous idarubicin hydrochloride cannot be employed e.g. for medical, psychological or social reasons, oral idarubicin can be used for remission induction in patients with previously untreated, ...

Posology and method of administration

Route of Administration Oral. Dosage is usually calculated on the basis of body surface area. In adult acute non-lymphocytic leukaemia (ANLL) also referred to as acute myelogenous leukaemia (AML), the ...

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 Severe cardiomyopathy Uncontrolled ...

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 myelosuppressant effects (see section 4.4). The ...

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 anthracyclines ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anthracyclines and related substances ATC code: L01DB06 Idarubicin is an antimitotic and cytotoxic agent which intercalates with DNA and interacts with topoisomerase II and has ...

Pharmacokinetic properties

After oral administration to patients with normal renal and hepatic function, idarubicin is rapidly absorbed, with a peak time of 2-4 hours., is eliminated from systemic circulation with a terminal plasma ...

Preclinical safety data

No further preclinical safety data are available.

List of excipients

Microcrystalline cellulose Ph. Eur. Glyceryl palmito-stearate HSE Capsule shell: Red iron oxide (E172) FP Titanium dioxide (E171) Ph. Eur. Gelatin Ph. Eur. Sodium dodecyl sulfate Ph. Eur. Printing ink: ...

Incompatibilities

Not known.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in a dry place.

Nature and contents of container

Type III amber glass bottles closed with an aluminium screw cap with a polyethylene gasket and a polyethylene cover cap. Aluminium/aluminium strips. Pack size: 1.

Special precautions for disposal and other handling

None stated.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK

Marketing authorization number(s)

PL 00057/1064

Date of first authorization / renewal of the authorization

10<sup>th</sup> May 2002

Date of revision of the text

08/2018

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