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SPC, UK: MYCOBUTIN Capsules (2015)

Αναφορές

Βιβλιογραφική αναφορά

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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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