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SPC, UK: FLUDARA Film-coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Fludara oral 10 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 10mg fludarabine phosphate. Excipients: Lactose monohydrate 74.75 mg. For the full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablets. Salmon-pink, capsule-shaped tablet marked with LN in a regular hexagon on one side.

Therapeutic indications

Treatment of B-cell chronic lymphocytic leukaemia (CLL) in adult patients with sufficient bone marrow reserves. First line treatment with Fludara oral should only be initiated in adult patients with advanced ...

Posology and method of administration

Posology The recommended dose is 40 mg fludarabine phosphate/m² body surface given daily for 5 consecutive days every 28 days by oral route. This dose corresponds to 1.6 times the recommended intravenous ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Renal impairment with creatinine clearance <30 ml/min. Decompensated haemolytic anaemia. Lactation.

Special warnings and precautions for use

Myelosuppression Severe bone marrow suppression, notably anaemia, thrombocytopenia and neutropenia, has been reported in patients treated with Fludara. In a Phase I intravenous study in adult solid tumour ...

Interaction with other medicinal products and other forms of interaction

In a clinical investigation using intravenous Fludara in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukaemia (CLL), there was an unacceptably high ...

Fertility, pregnancy and lactation

Fertility Women of childbearing potential must be apprised of the potential hazard to the foetus. Both sexually active men and women of childbearing potential must take effective contraceptive measures ...

Effects on ability to drive and use machines

Fludara may reduce the ability to drive and use machines, since e.g. fatigue, weakness, visual disturbances, confusion, agitation and seizures have been observed.

Undesirable effects

Summary of safety profile Based on the experience with the use of Fludara, the most common adverse events include myelosuppression (neutropenia, thrombocytopenia and anaemia), infection including pneumonia, ...

Overdose

High doses of Fludara given intravenously have been associated with leukoencephalopathy, acute toxic leukoencephalopathy, or reversible posterior leukoencephalopathy syndrome (RPLS). Symptoms may include ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, purine analogues ATC Code: L01BB05 Mechanism of action Fludara contains fludarabine phosphate, a water-soluble fluorinated nucleotide analogue of the antiviral ...

Pharmacokinetic properties

Plasma and urinary pharmacokinetics of fludarabine (2F-ara-A) The pharmacokinetics of fludarabine (2F-ara-A) have been studied after intravenous administration by rapid bolus injection and short-term infusion ...

Preclinical safety data

Systemic toxicity In acute toxicity studies, single doses of fludarabine phosphate produced severe intoxication symptoms or death at dosages about two orders of magnitude above the therapeutic dose. As ...

List of excipients

Tablet core: Cellulose, microcrystalline Lactose, monohydrate Silica, colloidal anhydrous Croscarmellose sodium Magnesium stearate Film-coat: Hypromellose Talc Titanium dioxide (E171) Ferric oxide pigment, ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in the original package to protect from moisture. This medicinal product does not require any special temperature storage conditions.

Nature and contents of container

Blisters of 5 tablets each, comprising polyamide/aluminium/polypropylene thermoformable foil with a lidding foil of aluminium. The blisters are packed in a polyethylene tablet container with a child-resistant ...

Special precautions for disposal and other handling

Handling and disposal Fludara should not be handled by pregnant staff. Procedures for proper handling should be followed according to local requirements for cytotoxic drugs. Waste material may be disposed ...

Marketing authorization holder

Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands

Marketing authorization number(s)

PL 12375/0040

Date of first authorization / renewal of the authorization

Date of first authorisation: 24 October 2000 Date of last renewal: 11 October 2010

Date of revision of the text

10 March 2019

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