SIRTURO

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

BEDAQUILINE AS FUMARATE

Tillgänglig från:

J-C HEALTH CARE LTD

ATC-kod:

J04AK05

Läkemedelsform:

TABLETS

Sammansättning:

BEDAQUILINE AS FUMARATE 100 MG

Administreringssätt:

PER OS

Receptbelagda typ:

Required

Tillverkad av:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Terapiområde:

BEDAQUILINE

Terapeutiska indikationer:

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.

Tillstånd datum:

2019-10-28

Bipacksedel

1
1.
NAME OF THE MEDICINAL PRODUCT
SIRTURO
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.
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.
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
Summary of Product
Characteristics of the medicinal products used in combination with
SIRTURO for their specific dosing
recommendations.
It is recommended that SIRTURO is administered by directly observed
therapy (DOT).
2
Posology
The recommended dosage is:
•
Weeks 1-2: 400 mg (4 tablets of 100 mg)
ONCE DAILY
•
Weeks 3-24: 200 mg (2 tablets of 100 mg)
THREE

Produktens egenskaper

1
1.
NAME OF THE MEDICINAL PRODUCT
SIRTURO
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.
White to almost white round biconvex tablet, 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.
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
Summary of Product
Characteristics of the medicinal products used in combination with
SIRTURO for their specific dosing
recommendations.
It is recommended that SIRTURO is administered by directly observed
therapy (DOT).
Posology
The recommended dosage is:
•
Weeks 1-2: 400 mg (4 tablets of 100 mg)
once daily
•
Weeks 3-24: 200 mg (2 tablets of 100 mg)
three times per week
(with