MYCOBUTIN Capsules (2015)
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Περιεχόμενα
Name of the medicinal product
Mycobutin 150 mg capsules.
Qualitative and quantitative composition
Each capsule contains 150.0 mg of rifabutin. For the full list of excipients, see section 6.1.
Pharmaceutical form
Hard capsule. Opaque, red-brown, Size N°. 0 hard gelatin capsules.
Therapeutic indications
Mycobutin is indicated for: the prophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl. the treatment of non-tuberculous mycobacterial ...
Posology and method of administration
Mycobutin can be administered as a single, daily, oral dose at any time independently of meals. Posology Adults Pprophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease ...
Contraindications
Hypersensitivity or history of hypersensitivity to the active substance, other rifamycins (e.g. rifampicin) or to any of the excipients listed in section 6.1. Due to insufficient clinical experience in ...
Special warnings and precautions for use
Before starting Mycobutin prophylaxis, patients should be assessed to ensure that they do not have active disease caused by pulmonary tuberculosis or other mycobacteria. Prophylaxis against MAC infection ...
Interaction with other medicinal products and other forms of interaction
Rifabutin has been shown to induce the enzymes of the cytochrome P450 3A subfamily and therefore may affect the pharmacokinetic behaviour of drugs metabolised by the enzymes belonging to this subfamily. ...
Pregnancy and lactation
Due to lack of data in pregnant women, as a precautionary measure, Mycobutin should not be administered to pregnant women or those breast-feeding children even though in experimental animal studies the ...
Effects on ability to drive and use machines
There have been no reports of adverse effects on ability to drive and use machines.
Undesirable effects
The tolerability of Mycobutin in multiple drug regimens, was assessed in both immunocompetent and immunocompromised patients, suffering from tuberculosis and non-tuberculous mycobacteriosis in long term ...
Overdose
Gastric lavage and diuretic treatment should be carried out. Supportive care and symptomatic treatment should be administered.
Pharmacodynamic properties
Pharmacotherapeutic group: Antibiotics ATC code: J04AB04 In vitro activity of rifabutin against laboratory strains and clinical isolates of M. tuberculosis has been shown to be very high. In vitro studies ...
Pharmacokinetic properties
Absorption In man, rifabutin is rapidly absorbed and maximum plasma concentrations are reached around 2-4 hours after oral administration. The pharmacokinetics of rifabutin is linear after single administration ...
Preclinical safety data
Preclinical safety studies of rifabutin indicate a good safety margin in rodents and in monkeys. In repeated dose studies, target organs were identified at doses producing blood levels higher than those ...
List of excipients
Microcrystalline cellulose Sodium lauryl sulfate Magnesium stearate Silica gel
Incompatibilities
Not applicable.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Transparent PVC/Al blisters in cardboard cartons containing 30 capsules.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/1017
Date of first authorization / renewal of the authorization
15<sup>th</sup> January 2003
Date of revision of the text
12/2015
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