MYCOBUTIN

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

RIFABUTIN

Διαθέσιμο από:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

J04AB04

Φαρμακοτεχνική μορφή:

CAPSULES

Σύνθεση:

RIFABUTIN 150 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

PFIZER ITALIA S.R.L, ITALY

Θεραπευτική ομάδα:

RIFABUTIN

Θεραπευτική περιοχή:

RIFABUTIN

Θεραπευτικές ενδείξεις:

For the treatment of chronic tuberculosis where there is evidence of acid fast bacteria resistant to rifampicin or to two other alternative drugs. For the treatment of infections caused by MAC or other atypical mycobacteria where there is evidence of resistant bacteria as above. For the treatment of infections caused by MAC or other atypical mycobacteria in AIDS patients in all cases not subject to the above restrictions. For prevention of MAC infections in AIDS patients whose CD4 counts lower or eqval to 200/mm3

Ημερομηνία της άδειας:

2016-07-31

Φύλλο οδηγιών χρήσης

Mycobutin, PIL, CC 070623
1
2020-0059555
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor's prescription only
MYCOBUTIN
®
CAPSULES
EACH CAPSULE CONTAINS: RIFABUTIN 150 MG
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this
medicine’s ingredients’ and section 6 ‘Further information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm them,
even if it seems to you that their medical condition is similar to
yours.
WHAT DO I NEED TO KNOW ABOUT THE MEDICINE?
This medicine may cause changes to the colour of the skin, urine and
body secretions to red-
orange. These changes are nothing to worry about.
Please note that the medicine may permanently alter the colour of
contact lenses.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
In combination with additional medicines for treatment of infections
caused by mycobacteria.
•
Prophylactic treatment for _Mycobacterium avium complex_ (MAC)
infection in
immunocompromised patients.
THERAPEUTIC GROUP:
An ansamycin antibiotic for the treatment of tuberculosis.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
other ingredients
in this medicine (listed in section 6) or to other medicines for the
treatment of
tuberculosis.
•
You are pregnant or breast-feeding.
•
Do not use in children under 12 years of age.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH MYCOBUTIN, TELL YOUR DOCTOR IF:
•
You suffer or have suffered in the past from problems with liver or
kidney/urinary tract
function.
_ _
•
You are taking oral contraceptives. This medicine may adversely affect
the efficiency of oral
contraceptives, and therefore you

Αρχείο Π.Χ.Π.

Mycobutin ,LPD, CC 281223
Page 1 of 12
2023-0085644
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Mycobutin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150.0 mg rifabutin.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard capsule.
Opaque, red-brown, Size N°. 0 hard gelatin capsules.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Mycobutin is indicated for:
•
the treatment of chronic tuberculosis where there is evidence of acid
fast bacteria resistant to
rifampicin or to two other alternative drugs.
•
the treatment of infections caused by MAC or other atypical
mycobacteria where there is
evidence of resistant bacteria as above.
•
treatment of infections caused by MAC or other atypical mycobacteria
in AIDS patients in all
cases not subject to the above restrictions.
•
prevention of MAC infections in AIDS patients whose CD4
counts lower or eqval to 200/mm
3
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Mycobutin is generally administered as a single, daily, oral dose at
any time independently of
meals.
Adults
Mycobutin as a single agent:
•
prophylaxis of MAC infection in immunodepressed patients: 300 mg (2
capsules).
Mycobutin in combination regimens:
•
Non-tuberculous mycobacterial disease: 450-600 mg (3 to 4 capsules)
for up to 6
months after negative cultures are obtained.
•
MAC treatment: when Mycobutin is given in association with
clarithromycin, the
dosage of Mycobutin should be reduced to 300 mg after the first month
of treatment (see Section
Mycobutin ,LPD, CC 281223
Page 2 of 12
2023-0085644
4.4, Special Warnings and Special Precautions For Use, and Section
4.5, Interactions with Other
Medications & Other Forms of Interactions)
•
Pulmonary tuberculosis:
150 mg daily (1 capsule), for 6-9 months, or for at least 6 months
after negative cultures are
obtained. This dosage should be increased to 300-450 mg/day in
patients previously treated with
antituberculous drugs.
In accordance with the commonly accepted criteria for t