Mycobutin 150mg capsules

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Rifabutin

Доступно од:

Pfizer Ltd

АТЦ код:

J04AB04

INN (Међународно име):

Rifabutin

Дозирање:

150mg

Фармацеутски облик:

Oral capsule

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 05010900; GTIN: 5013457026603

Информативни летак

MYCOBUTIN
® 150 MG CAPSULES
(rifabutin)
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. See
section 4.
Your medicine is available using the above name but will be referred
to as
Mycobutin throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Mycobutin is and what it is used for
2. What you need to know before you take Mycobutin
3. How to take Mycobutin
4. Possible side effects
5. How to store Mycobutin
6. Contents of the pack and other information
1. WHAT MYCOBUTIN IS AND WHAT IT IS USED FOR
Mycobutin contains the active substance rifabutin, which is an
antibiotic. It is
used to treat infections caused by germs (bacteria) called
mycobacteria.
These are bacteria which cannot be destroyed with usual antibiotics.
-
One of the most common mycobacterial infections is _Mycobacterium _
_tuberculosis_. Mycobutin can be used in combination with other
antibiotics
for the treatment of tuberculosis of the lung.
-
Mycobutin can also be used to treat other mycobacterial infections
such
as _Mycobacterium avium intracellulare _(MAI, also known as MAC) or
_Mycobacterium xenopi_.
-
People who are unable to fight infection (such as those with HIV) are
more likely to be infected with mycobacteria; especially MAC.
Mycobutin
can be given (on its own) to people with HIV disease when the number
of
CD4 cells (part of the immune system) falls below 75 per microlitre of
blood. This will help to stop them from developing MAC infections.
You should consult your doctor if you are unsure why you have been
given Mycobutin.
2.

Карактеристике производа

OBJECT 1
MYCOBUTIN
Summary of Product Characteristics Updated 21-Mar-2018 | Pfizer
Limited
1. Name of the medicinal product
Mycobutin 150 mg capsules.
2. Qualitative and quantitative composition
Each capsule contains 150.0 mg of 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 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 disease (such as that
caused by MAC and M. xenopi).
- pulmonary tuberculosis.
4.2 Posology and method of administration
Mycobutin can be administered as a single, daily, oral dose at any
time independently of meals.
POSOLOGY
ADULTS
- prophylaxis of _M. avium intracellulare complex_ (MAC) infections in
patients with HIV disease with
CD4 counts lower than 75 cells/mcl:
300 mg (2 capsules) as a single agent.
- treatment of non-tuberculous mycobaterial disease:
450 - 600 mg (3 - 4 capsules) in combination regimens for up to 6
months after negative cultures are
obtained.
When Mycobutin is given in association with clarithromycin (or other
macrolides) and/or fluconazole (or
related compounds) the Mycobutin dosage may need to be reduced to 300
mg (see Section 4.5).
- treatment of pulmonary tuberculosis:
150 - 450 mg (1 - 3 capsules) in combination regimens for at least 6
months.
In accordance with the commonly accepted criteria for the treatment of
mycobacterial infections,
Mycobutin should always be given in combination with other
anti-mycobacterial drugs not belonging to
the family of rifamycins.
_PAEDIATRIC POPULATION_
There are inadequate data to support the use of Mycobutin in children
at the present time.
_ELDERLY_
No specific recommendations for dosage alterations in the elderly are
suggested.
4.3 Contraindications
Hypersensitivity or history of hypersensitivity to the active