BUSULFAN Film-coated tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Busulfan 2 mg tablets.
Qualitative and quantitative composition
Each 2 mg tablet contains 2 mg of the active substance busulfan. Excipient with known effect: lactose. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film coated tablet. Busulfan 2 mg tablets are white, film-coated, round biconvex tablets engraved GX EF3 on one side and M on the other.
Therapeutic indications
Busulfan is indicated as conditioning treatment prior to haemopoietic progenitor cell transplantation in patients when the combination of high-dose busulfan and cyclophosphamide is considered the best ...
Posology and method of administration
General The bioavailability of oral Busulfan shows large intra-individual variations ranging from 47% to 103% (mean 80%) in adults and from 22% to 120% (mean 68%) in children (see section 5.2). There are ...
Contraindications
Busulfan should not be used in patients whose disease has demonstrated resistance to busulfan. Busulfan should not be given to patients who have previously suffered a hypersensitivity reaction to the busulfan ...
Special warnings and precautions for use
Busulfan 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 section 4.4). The effects of other cytotoxics producing pulmonary toxicity may be additive. The administration ...
Fertility, pregnancy and lactation
Fertility Busulfan can lead to suppression of ovarian function and amenorrhoea in women and suppression of spermatogenesis in men (see section 4.8 and 5.3). Pregnancy As with all cytotoxic chemotherapy, ...
Effects on ability to drive and use machines
There are no data on the effect of Busulfan 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
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 The acute dose-limiting toxicity of Busulfan in man is myelosuppression (see section 4.8). The main effect of chronic overdose is bone marrow depression and pancytopenia. Treatment ...
Pharmacodynamic properties
Busulfan (1,4-butanediol dimethanesulfonate) is a bifunctional alkylating agent. Binding to DNA is believed to play a role in its mode of action and di-guanyl derivaties have been isolated but interstrand ...
Pharmacokinetic properties
Absorption The bioavailability of oral Busulfan shows large intra-individual variations ranging from 47% to 103% (mean 80%) in adults. The area under the curve (AUC) and peak plasma concentrations (C<sub> ...
Preclinical safety data
Busulfan has been shown to be mutagenic in various experimental systems, including bacteria, fungi, Drosophila and cultured mouse lymphoma cells. In vivo cytogenetic studies in rodents have shown an increased ...
List of excipients
<u>Tablet core:</u> Lactose, anhydrous Pregelatinised starch Magnesium stearate <u>Tablet coating:</u> Hypromellose Titanium dioxide Triacetin
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Busulfan tablets are supplied in amber glass bottles with a child resistant closure containing 25 or 100 tablets.
Special precautions for disposal and other handling
Safe handling of Busulfan tablets The tablets should not be divided and provided the outer coating is intact, there is no risk in handling Busulfan tablets. Handlers of Busulfan 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 39699/0042
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 January 1986 Date of latest renewal: 30 June 2003
Date of revision of the text
September 2017
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