TIOGUANINE Tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Tioguanine 40 mg Tablets.
Qualitative and quantitative composition
40 mg tioguanine BP per tablet. Excipients: This product contains lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tioguanine 40 mg 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 ...
Therapeutic indications
Tioguanine is indicated primarily for the treatment of acute leukaemias especially acute myelogenous leukaemia and acute lymphoblastic leukaemia.
Posology and method of administration
Posology The exact dose and duration of administration will depend on the nature and dosage of other cytotoxic drugs given in conjunction with tioguanine. Tioguanine is variably absorbed following oral ...
Contraindications
Hypersensitivity to tioguanine or to any of the excipients listed in section 6.1. In view of the seriousness of the indications there are no absolute contra-indications.
Special warnings and precautions for use
Tioguanine 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 ...
Interaction with other medicinal products and other forms of interaction
Vaccines Vaccinations with live organism vaccines are not recommended in immunocompromised individuals (see section 4.4). Other myelotoxic substances or radiation therapyDuring concomitant administration ...
Fertility, pregnancy and lactation
Tioguanine, like other cytotoxic agents is potentially teratogenic. Fertility There have been isolated cases where men, who have received combinations of cytotoxic agents including tioguanine, have fathered ...
Effects on ability to drive and use machines
None known.
Undesirable effects
For this product there is a lack of modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Tioguanine is usually one component of combination chemotherapy ...
Overdose
Symptoms 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 tioguanine. Management As there ...
Pharmacodynamic properties
Pharmacotherapeutic group: anti-neoplastic and immunomudulating agent/purine analogue ATC code: L01BB03 Mechanism of action Tioguanine is a sulphydryl analogue of guanine and behaves as a purine antimetabolite. ...
Pharmacokinetic properties
Absorption Studies with radioactive tioguanine show that peak blood levels of total radioactivity are achieved about 8-10 hours after oral administration and decline slowly thereafter. Later studies using ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Lactose monohydrate NF Starch, potato HSE Acacia NF Stearic acid NF Magnesium stearate NF Purified water USP
Incompatibilities
None known.
Shelf life
Shelf life: 24 months (unopened).
Special precautions for storage
Store below 25°C. Keep dry. Protect from light.
Nature and contents of container
Amber glass bottles with child-resistant polyethylene/polypropylene closures. Pack size 25.
Special precautions for disposal and other handling
It is recommended that the handling of Tioguanine tablets follows the Guidelines for the handling of cytotoxic drugs issued by the Royal Pharmaceutical Society of Great Britain Working Party on the handling ...
Marketing authorization holder
Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PL 39699/ 0045
Date of first authorization / renewal of the authorization
29 October 1997/1 December 2008
Date of revision of the text
15/11/2017
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