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SPC, UK: LEUKERAN Tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Aspen
Διεύθυνση :
12/13 Exchange Place , I.F.S.C., Dublin 1, Ireland
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Name of the medicinal product

Leukeran Tablets 2 mg.

Qualitative and quantitative composition

Each tablet contains 2 mg of the active ingredient chlorambucil.

Pharmaceutical form

Film-coated tablet.

Therapeutic indications

Leukeran is indicated in the treatment of Hodgkins disease, certain forms of non-Hodgkins lymphoma, chronic lymphocytic leukaemia, and Waldenstroms macroglobulinaemia.

Posology and method of administration

Adults Hodgkins Disease: Used as a single agent in the palliative treatment of advanced disease a typical dosage is 0.2 mg/kg/day for 4-8 weeks. Leukeran is usually included in combination therapy and ...

Contraindications

Hypersensitivity to chlorambucil or to any of the excipients.

Special warnings and precautions for use

Continued treatment with chlorambucil should be assessed if a rash develops since there have been reports of Stevens-Johnson Syndrome in patients receiving chlorambucil (see section 4.8). Leukeran is an ...

Interaction with other medicinal products and other forms of interaction

Vaccinations with live organism vaccines are not recommended in immunocompromised individuals (see Section 4.4 Special Warnings and Precautions for use). Patients receiving phenylbutazone may require a ...

Pregnancy and lactation

As with other cytotoxic agents Leukeran is potentially teratogenic. The use of Leukeran should be avoided whenever possible during pregnancy, particularly during the first trimester. In any individual ...

Effects on ability to drive and use machines

None known.

Undesirable effects

For this product there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending on ...

Overdose

Reversible pancytopenia was the main finding of inadvertent overdoses of Leukeran. Neurological toxicity ranging from agitated behaviour and ataxia to multiple grand mal seizures has also occurred. As ...

Pharmacodynamic properties

Chlorambucil is an aromatic nitrogen mustard derivative which acts as a bifunctional alkylating agent. Alkylation takes place through the formation of a highly reactive ethylenimonium radical. A probable ...

Pharmacokinetic properties

In a study of 12 patients administered chlorambucil 0.2 mg/kg body weight orally, the mean dose adjusted maximum plasma concentration (492 ± 160 ng/ml) occurred between 0.25 and 2 hours after administration. ...

Preclinical safety data

Mutagenicity and Carcinogenicity As with other cytotoxic agents chlorambucil is mutagenic in in vitro and in vivo genotoxicity tests and carcinogenic in animals and humans. Teratogenicity See information ...

List of excipients

Tablet Core: Microcrystalline cellulose Anhydrous lactose Colloidal anhydrous silica Stearic acid Tablet Film Coating: Hypromellose Titanium dioxide Synthetic yellow iron oxide Synthetic red iron oxide ...

Incompatibilities

None known.

Shelf life

3 years.

Special precautions for storage

Store at 2°C 8°C.

Nature and contents of container

Leukeran are brown film-coated, round, biconvex tablets engraved GX EG3 on one side and L on the other, supplied in amber glass bottles with a child resistant closure containing 25 tablets.

Special precautions for disposal and other handling

Leukeran is an active cytotoxic agent for use only under the direction of physicians experienced in the administration of such agents. Safe handling of Leukeran Tablets: The handling of Leukeran Tablets ...

Marketing authorization holder

Aspen Pharma Trading Limited 12/13 Exchange Place I.F.S.C Dublin 1 Ireland

Marketing authorization number(s)

PL 39699/0041

Date of first authorization / renewal of the authorization

22.06.2006

Date of revision of the text

May 2012