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CHLORAMBUCIL Film-coated tablets (2015)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Chlorambucil 2 mg tablets.

Qualitative and quantitative composition

Each tablet contains 2 mg of the active ingredient chlorambucil. Excipient(s) with known effect: Each tablet also contains 67.65 mg of lactose. For the full list of excipients, see section 6.1.

Pharmaceutical form

Brown, round, biconvex, film-coated tablets, one side engraved with L and the other side engraved GX EG 3.

Therapeutic indications

Chlorambucil 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

The relevant literature should be consulted for full details of the treatment schedules used. Chlorambucil is an active cytotoxic agent for use only under the direction of physicians experienced in the ...

Contraindications

Hypersensitivity to chlorambucil or to any of the excipients listed in section 6.1.

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). Safe Handling ...

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). Purine nucleoside analogues (such as fludarabine, pentostatin and cladribine) increased ...

Fertility, pregnancy and lactation

Pregnancy As with all cytotoxic therapy chemotherapy, adequate contraceptive precautions should be advised when either partner is receiving Chlorambucil. The use of Chlorambucil should be avoided whenever ...

Effects on ability to drive and use machines

No information on the effects of Chlorambucil on the ability to drive and use machines is available.

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

Symptoms and signs Reversible pancytopenia was the main finding of inadvertent overdoses of Chlorambucil. Neurological toxicity ranging from agitated behaviour and ataxia to multiple grand mal seizures ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, antineoplastic agents, alkylating agents, nitrogen mustard analogues ATC code: L01AA02 Mechanism of action Chlorambucil is an aromatic ...

Pharmacokinetic properties

Absorption Chlorambucil is well absorbed by passive diffusion from the gastrointestinal tract and is measurable within 15-30 minutes of administration. The bioavailability of oral chlorambucil is approximately ...

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. Reproductive toxicology In rats, ...

List of excipients

Tablet Core: Microcrystalline cellulose (E460) Anhydrous lactose Colloidal anhydrous silica Stearic acid (E570) Tablet Film Coating: Hypromellose Titanium dioxide (E171) Synthetic yellow iron oxide (E172) ...

Incompatibilities

None known.

Shelf life

Shelf life: 3 years.

Special precautions for storage

Store in a refrigerator (2°C-8°C).

Nature and contents of container

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

Special precautions for disposal and other handling

Chlorambucil is an active cytotoxic agent for use only under the direction of physicians experienced in the administration of such agents. The handling of Chlorambucil Tablets should follow guidelines ...

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization number(s)

PL 39699/0041

Date of first authorization / renewal of the authorization

22 June 2006

Date of revision of the text

03/2015

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