Sirturo

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

bedaquiline fumarate

Saadav alates:

Janssen-Cilag International NV

ATC kood:

J04AK05

INN (Rahvusvaheline Nimetus):

bedaquiline

Terapeutiline rühm:

Antimycobacterials

Terapeutiline ala:

Tuberculosis, Multidrug-Resistant

Näidustused:

Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Toote kokkuvõte:

Revision: 21

Volitamisolek:

Authorised

Loa andmise kuupäev:

2014-03-05

Infovoldik

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIRTURO 20 MG TABLETS
bedaquiline
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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.
WHAT IS IN THIS LEAFLET
1.
What SIRTURO is and what it is used for
2.
What you need to know before you take SIRTURO
3.
How to take SIRTURO
4.
Possible side effects
5.
How to store SIRTURO
6.
Contents of the pack and other information
1.
WHAT SIRTURO IS AND WHAT IT IS USED FOR
SIRTURO contains the active substance bedaquiline.
SIRTURO 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 and children (5 years and over, who weigh at
least 15 kg).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SIRTURO
DO NOT TAKE SIRTURO

if you are allergic to bedaquiline or any of the other ingredients of
this medicine (listed in
section 6). Do not take SIRTURO if this applies to you. If you are not
sure, talk to your doctor
or pharmacist before taking SIRTURO.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking SIR

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
SIRTURO 20 mg tablets
SIRTURO 100 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SIRTURO 20 mg tablets
Each tablet contains bedaquiline fumarate equivalent to 20 mg of
bedaquiline.
SIRTURO 100 mg tablets
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
SIRTURO 20 mg tablets
Tablet.
Uncoated, white to almost white oblong tablet (12.0 mm long x 5.7 mm
wide), with score line on both
sides, debossed with “2” and “0” on one side and plain on
other side.
The tablet can be divided into equal doses.
SIRTURO 100 mg tablets
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 and paediatric
patients (5 years to less than
18 years of age and weighing at least 15 kg) 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_.
3
Consideration should be given to WHO guidelines when selecting the
appropriate combination
regimen.
Only use SI