SIRTURO 100MG TABLETS

Nchi: Malesia

Lugha: Kiingereza

Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Viambatanisho vya kazi:

Bedaquiline Fumarate

Inapatikana kutoka:

JOHNSON & JOHNSON SDN. BHD.

INN (Jina la Kimataifa):

Bedaquiline Fumarate

Vitengo katika mfuko:

188 Tablets

Viwandani na:

Recipharm Pharmaservices Private Limited

Taarifa za kipeperushi

SIRTURO
® TABLETS
Bedaquiline fumarate (100mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What SIRTURO
®
is used for
2.
How SIRTURO
®
works
3.
Before you use SIRTURO
®
4.
How to use SIRTURO
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SIRTURO
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT SIRTURO
® IS USED FOR
SIRTURO
®
contains the active substance
bedaquiline, which is a type of antibiotic.
Antibiotics are medicines that kill
bacteria that cause disease.
SIRTURO
®
is used to treat tuberculosis
that affects the lungs when the disease
has become resistant to other antibiotics.
This is called multi-drug resistant
pulmonary tuberculosis.
SIRTURO
®
must always be taken
together with other medicines for treating
tuberculosis. It is used in adults aged 18
years and older.
_This _
_indication _
_is _
_approved _
_under _
_conditional registration which is based _
_on time to sputum culture conversion. _
_Continued approval for this indication _
_may be based on the outcome of clinical _
_benefit in confirmatory trial/s. _
HOW SIRTURO
® WORKS
In multi-drug resistant pulmonary
tuberculosis, SIRTURO
®
acts by
inhibiting the enzyme responsible for the
generation of energy in the bacteria
causing the disease, thereby killing the
bacteria.
BEFORE YOU USE SIRTURO
®
-
_When you must not use it _
•
You are allergic to bedaquiline or any
other ingredients of this medicine. Do
not take SIRTURO if this applies to
you. If you are not sure, talk to your
doctor or pharmacist before taking
SIRTURO
®
.
•
If you are pregnant or breast-feeding,
think you may be pregnant or planning
to have a baby, ask your doctor or
pharmacist before taking this
medicine.
•
Do not give this medicine to children
and adolescent (under 18 years of age).
This is because this medicine has not
been studied in these patients.
-
_Before you start to use it _
Talk to your doctor, pharmacist or
nurse if:
•
you ha

Tabia za bidhaa

1
1. NAME OF THE MEDICINAL PRODUCT
SIRTURO 100 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bedaquiline fumarate equivalent to 100 mg of
bedaquiline.
Excipient with known effect
Each tablet contains 145 mg of lactose (as monohydrate).
For the full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
Uncoated, white to almost white round biconvex tablet, 11 mm in
diameter, with debossing of "T"
over "207" on one side and "100" on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SIRTURO is indicated for use as part of an appropriate combination
regimen for pulmonary
multidrug-resistant tuberculosis (MDR-TB) in adult patients when an
effective treatment regimen
cannot otherwise be composed for reasons of resistance or tolerability
(see sections 4.2, 4.4 and
5.1). Consideration should be given to official guidance on the
appropriate use of antibacterial
agents.
_This indication is approved under conditional registration which is
based on time to sputum _
_culture conversion. Continued approval for this indication may be
based on the outcome of _
_clinical benefit in confirmatory trial/s._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with SIRTURO should be initiated and monitored by a
physician experienced in the
management of multi-drug resistant
_Mycobacterium tuberculosis_
.
SIRTURO should be used in combination with at least three medicinal
products to which the
patient’s isolate has been shown to be susceptible
_in vitro_
. If
_in vitro _
testing results are unavailable,
treatment may be initiated with SIRTURO in combination with at least
four medicinal products to
which the patient's isolate is likely to be susceptible. Consideration
should be given to WHO
guidelines when selecting the appropriate combination regimen.
Treatment with the other agents in
the regimen should continue after completion of treatment with
SIRTURO. Refer to the product
information of the medicinal products used in combination with SIRTURO
for their specific
dosing