LANVIS (2013)

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

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

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Name of the medicinal product

Lanvis 40mg Tablets.

Qualitative and quantitative composition

Tablet containing 40 mg tioguanine. Excipients: Also contains 150mg Lactose Monohydrate For a full list of excipients, see section 6.1.

Pharmaceutical form

Tablets. Lanvis Tablets are white to off white tablet, round, biconvex scored and imprinting T40 on upper side, without score and debossing on lower side. The scoreline is only to facilitate breaking for ...

Therapeutic indications

In the treatment of leukaemias, particularly acute myeloblastic leukaemia and acute lymphoblastic leukaemia. Lanvis is also used in the treatment of chronic granulocytic leukaemia.

Posology and method of administration

The exact dose and duration of administration will depend on the nature and dosage of other cytotoxic drugs given in conjunction with Lanvis. Lanvis is variably absorbed following oral administration and ...

Contraindications

Hypersensitivity to any component of the preparation. Use in the management of non-malignant disease.

Special warnings and precautions for use

LANVIS IS AN ACTIVE CYTOTOXIC AGENT FOR USE ONLY UNDER THE DIRECTION OF PHYSICIANS EXPERIENCED IN THE ADMINISTRATION OF SUCH AGENTS. Immunisation using a live organism vaccine has the potential to cause ...

Interaction with other medicinal products and other forms of interaction

Vaccinations with live organism vaccines are not recommended in immunocompromised individuals (see Warnings and Precautions). The concomitant use of allopurinol to inhibit uric acid formation does not ...

Fertility, pregnancy and lactation

Teratogenicity and effects on fertility Lanvis, like other cytotoxics is potentially teratogenic. There have been isolated cases where men, who have received combinations of cytotoxic agents including ...

Effects on ability to drive and use machines

There are no data on the effect of tioguanine on driving performance or the ability to operate machinery. A detrimental effect on these activities cannot be predicted from the pharmacology of the drug. ...

Undesirable effects

The following convention has been utilised for the classification of frequency of undesirable effects:- Very common ≥1/10 (≥10%), Common ≥1/100 and <1/10 (≥1% and <10%), Uncommon ≥1/1000 and <1/100 (≥0.1% ...

Overdose

Signs: The principal toxic effect is on the bone-marrow and haematological toxicity is likely to be more profound with chronic overdosage than with a single ingestion of Lanvis. Treatment: As there is ...

Pharmacodynamic properties

ATC code: L0JBB03 Mode of Action Tioguanine is a sulphydryl analogue of guanine and behaves as a purine antimetabolite. It is activated to its nucleotide, thioguanylic acid. Tioguanine metabolites inhibit ...

Pharmacokinetic properties

Tioguanine is extensively metabolised in vivo. There are two principal catabolic routes: methylation to 2-amino-6- methyl-thiopurine and deamination to 2-hydroxy-6-mercaptopurine, followed by oxidation ...

Preclinical safety data

Mutagenicity and carcinogenicity Tioguanine has been shown to be carcinogenic in animals. The theoretical possibility of a similar effect should be borne in mind when designing the long-term management ...

List of excipients

Lactose monohydrate Potato starch Acacia Stearic acid Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

5 years.

Special precautions for storage

Do not store above 25°C. Store in the original bottle and in the carton in order to protect from light. Keep the bottle tightly closed in order to protect from moisture.

Nature and contents of container

Lanvis tablets are supplied in amber (Type III) glass bottles with a polypropylene/HDPE child-resistant closure, containing 25 tablets.

Special precautions for disposal and other handling

Safe handling of Lanvis It is recommended that the handling of Lanvis tablets follows the Guidelines for the Handling of Cytotoxic Drugs issued by the Royal Pharmaceutical Society of Great Britain Working ...

Marketing authorization holder

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

Marketing authorization number(s)

PA 1691/6/1

Date of first authorization / renewal of the authorization

Date of first authorisation: 1 April 1979 Date of last renewal: 1 April 2009

Date of revision of the text

December 2013