Mycobutin

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Rifabutin 150mg

Tillgänglig från:

Pfizer New Zealand Limited

INN (International namn):

Rifabutin 150 mg

Dos:

150 mg

Läkemedelsform:

Capsule

Sammansättning:

Active: Rifabutin 150mg

Enheter i paketet:

Blister pack, 30 capsules

Klass:

Prescription

Receptbelagda typ:

Prescription

Tillverkad av:

Olon SpA

Terapeutiska indikationer:

Mycobutin is indicated for infections caused by mycobacteria, such as M. tuberculosis, M. avium intracellulare complex (MAC) and other atypical mycobacteria. In infections caused by MAC and other atypical mycobacteria such as M. xenopi, Mycobutin has been shown to be effective for the treatment of both disseminated and localised disease, also in immunocompromised HIV positive patients. Mycobutin is also indicated for the prophylaxis of M. avium intracellulare complex (MAC) infections in immunodepressed patients with CD4 counts lower than or equal to 100/ml. In the treatment of tubercular disease, Mycobutin has been shown to be effective for the treatment of patients with chronic pulmonary tuberculosis, even if caused by multidrug-resistant M. tuberculosis strains. In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin therapy should always be given in combination with other antimycobacterial drugs not belonging to the family of rifamycins.

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, - 30 capsules - 24 months from date of manufacture stored at or below 25°C

Tillstånd datum:

1992-03-25

Bipacksedel

MYCOBUTIN
®
1
MYCOBUTIN
®
CAPSULES
_Rifabutin _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before taking Mycobutin. This
leaflet answers some common
questions about Mycobutin. It does
not contain all the available
information and it does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Mycobutin
against the expected benefits it will
have for you.
Ask your doctor if you have any
concerns about taking this medicine.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT MYCOBUTIN IS
USED FOR
Mycobutin contains the active
ingredient, rifabutin. It is an
antibiotic, an agent used to kill
certain types of germs, known as
mycobacteria.
Mycobutin is used in combination
with other medicines to treat
mycobacterial infections e.g.
tuberculosis (TB) or Mycobacteria
avium-intracellulare complex
(MAC). It may also be used to
prevent infections in patients with
HIV disease.
Your doctor, however, may prescribe
Mycobutin for another purpose. Ask
your doctor if you have any questions
about why Mycobutin has been
prescribed for you.
Mycobutin can only be obtained on
prescription from a doctor.
BEFORE TAKING
MYCOBUTIN
Some information is provided below.
However, always talk to your doctor
if you have concerns or questions
about your treatment.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE MYCOBUTIN AND TALK TO
YOUR DOCTOR OR PHARMACIST IF:
•
you are allergic to rifabutin or
other rifamycin antibiotics (e.g.
rifampicin)
•
you are allergic to any of the
other ingredients listed at the end
of this leaflet
•
the packaging is torn or shows
signs of tampering
Do not take Mycobutin capsules after
the expiry date printed on the pack
has passed.
Do not give Mycobutin to children.
Do not take Mycobutin capsules if
you are taking treatments that
include:
•
injections containing prolonged-
release rilpivirine
_BEFORE YOU TAKE MYCOBUTIN _
YOU SHOULD TELL YOUR DOCTOR IF YOU:
•
h

Produktens egenskaper

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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ _
Mycobutin 150 mg capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule for oral administration contains 150 mg rifabutin.
EXCIPIENT(S) WITH KNOWN EFFECT
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule
Capsules are opaque, red-brown, hard gelatin Size No. 0 capsules.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mycobutin is indicated for infections caused by mycobacteria, such as
_M. tuberculosis, M. _
_avium intracellulare _
complex (MAC) and other atypical mycobacteria.
In infections caused by MAC and other atypical mycobacteria such as
_M. xenopi_
, Mycobutin
has been shown to be effective for the treatment of both disseminated
and localised disease,
also in immunocompromised HIV positive patients.
Mycobutin is also indicated for the prophylaxis of
_M. avium intracellulare_
complex (MAC)
infections in immunodepressed patients with CD4 counts lower than or
equal to 100/mL.
In the treatment of tubercular disease, Mycobutin has been shown to be
effective for the
treatment of patients with chronic pulmonary tuberculosis, even if
caused by multidrug-
resistant
_M. tuberculosis_
strains. In accordance with the commonly accepted criteria for the
treatment
of
mycobacterial
infections,
Mycobutin
therapy
should
always
be
given
in
combination with other antimycobacterial drugs not belonging to the
family of rifamycins.
_ _
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
Mycobutin can be administered as a single daily dose at any time
independent of meals.
_ADULTS _
Mycobutin as a single agent:
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- Prophylaxis of MAC infection in immunodepressed patients:
300 mg (2 capsules) per day.
Mycobutin in combination regimens:
- in non-tuberculosis mycobacterial disease:
450-600 mg (3 to 4 capsules) for up to 6 months after negative
cultures are obtained.
- in chronic, multidrug-resistant pulmonary tuberculosis:
300-450 mg (2 to