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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: DepoCyte 50 mg suspension for injection (2011)

Εκδότης

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 ...

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 ...

Posology and method of administration

DepoCyte should be administered only under the supervision of a physician experienced in the use of cancer ...

Contraindications

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

Special warnings and precautions for use

Patients receiving DepoCyte should be concurrently treated with corticosteroids (e.g. dexamethasone) ...

Interaction with other medicinal products and other forms of interaction

No definite interactions between DepoCyte delivered intrathecally and other medicinal products have been ...

Fertility, pregnancy and lactation

Pregnancy Teratology studies in animals have not been conducted with DepoCyte and there are no adequate ...

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 ...

Undesirable effects

In Phase 1-4 studies the most commonly reported adverse reactions associated with DepoCyte were headache ...

Overdose

No overdoses with DepoCyte have been reported. An overdose with DepoCyte may be associated with severe ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antimetabolites, pyrimidine analogues ATC code: L01BC01 DepoCyte is a sustained-release ...

Pharmacokinetic properties

Analysis of the available pharmacokinetic data shows that following intrathecal DepoCyte administration ...

Preclinical safety data

A review of the toxicological data available for the constituent lipids (DOPC and DPPG) or similar phospholipids ...

List of excipients

Cholesterol Triolein Dioleoylphosphatidylcholine (DOPC) Dipalmitoylphosphatidylglycerol (DPPG) Sodium ...

Incompatibilities

No formal assessments of pharmacokinetic drug-drug interactions between DepoCyte and other agents have ...

Shelf life

18 months. After first opening: from a microbiological point of view, the product should be used immediately. ...

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 ...

Special precautions for disposal and other handling

Preparation of DepoCyte Given its toxic nature, special precautions should be taken in handling DepoCyte ...

Marketing authorization holder

Pacira Limited 3 Glory Park Avenue Wooburn Green High Wycombe Buckinghamshire HP10 0DF 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 revision of the text

7th July 2011

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