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DEPOCYTE Suspension for injection (2017)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης Napp Pharmaceuticals Limited
Διεύθυνση Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
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Περιεχόμενα

Name of the medicinal product

DepoCyte 50 mg suspension for injection.

Qualitative and quantitative composition

One ml of suspension contains 10 mg cytarabine. Each 5 ml vial contains 50 mg cytarabine. For a full list of excipients, see section 6.1.

Pharmaceutical form

Suspension for injection. White to off-white suspension.

Therapeutic indications

Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.

Posology and method of administration

DepoCyte should be administered only under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Posology Paediatric population Safety and efficacy in children aged under ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Patients with active meningeal infection.

Special warnings and precautions for use

Patients receiving DepoCyte should be concurrently treated with corticosteroids (e.g. dexamethasone) to mitigate the symptoms of arachnoiditis (see section 4.8), which is a very common adverse reaction. ...

Interaction with other medicinal products and other forms of interaction

No definite interactions between DepoCyte delivered intrathecally and other medicinal products have been established. Concomitant administration of DepoCyte with other antineoplastic agents administered ...

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females Despite the low apparent risk women of childbearing potential should not receive treatment until pregnancy is excluded and should be advised ...

Effects on ability to drive and use machines

There have been no reports explicitly relating to effects of DepoCyte treatment on the ability to drive or use machines. However, on the basis of reported adverse reactions, patients should be advised ...

Undesirable effects

In Phase 1-4 studies the most commonly reported adverse reactions associated with DepoCyte were headache (23%), arachnoiditis (16%), pyrexia (14%), weakness (13%), nausea (13%), vomiting (12%), confusion ...

Overdose

No overdoses with DepoCyte have been reported. An overdose with DepoCyte may be associated with severe arachnoiditis including encephalopathy. In an early uncontrolled study without dexamethasone prophylaxis, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimetabolites, pyrimidine analogues ATC code: L01BC01 Mechanism of action DepoCyte is a sustained-release formulation of cytarabine, designed for direct administration into ...

Pharmacokinetic properties

Absorption Analysis of the available pharmacokinetic data shows that following intrathecal DepoCyte administration in patients, either via the lumbar sac or by intraventricular reservoir, peaks of free ...

Preclinical safety data

A review of the toxicological data available for the constituent lipids (DOPC and DPPG) or similar phospholipids to those in DepoCyte indicates that such lipids are well tolerated in various animal species ...

List of excipients

Cholesterol Triolein Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium chloride Water for injections

Incompatibilities

No formal assessments of pharmacokinetic drug-drug interactions between DepoCyte and other agents have been conducted. DepoCyte should not be diluted or mixed with any other medicinal products, as any ...

Shelf life

18 months. <u>After first opening:</u> from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility ...

Special precautions for storage

Store in a refrigerator (2°C-8°C). Do not freeze.

Nature and contents of container

Type I glass vial closed with a fluororesin faced butyl rubber stopper and sealed with an aluminium flip-off seal containing 50 mg cytarabine in 5 ml suspension. DepoCyte is supplied in individual cartons ...

Special precautions for disposal and other handling

Preparation of DepoCyte Given its toxic nature, special precautions should be taken in handling DepoCyte. See Precautions for the handling and disposal of DepoCyte below. Vials should be allowed to warm ...

Marketing authorization holder

Pacira Limited, Wessex House, Marlow Road, Bourne End, Buckinghamshire, SL8 5SP, United Kingdom

Marketing authorization number(s)

EU/1/01/187/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 11 July 2001 Date of latest renewal: 11 July 2011

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