Sirturo

দেশ: নিউ জিলণ্ড

ভাষা: ইংরেজি

সূত্র: Medsafe (Medicines Safety Authority)

সক্রিয় উপাদান:

Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg;  ;  

থেকে পাওয়া:

Janssen-Cilag (New Zealand) Ltd

INN (আন্তর্জাতিক নাম):

Bedaquiline fumarate 120.89 mg (equivalent to bedaquiline 100 mg)

ডোজ:

100 mg

ফার্মাসিউটিকাল ফর্ম:

Tablet

রচনা:

Active: Bedaquiline fumarate 120.89mg equivalent to bedaquiline 100 mg     Excipient: Colloidal silicon dioxide Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose Polysorbate 20

প্রেসক্রিপশন টাইপ:

Prescription

Manufactured by:

Janssen Pharmaceutica NV

থেরাপিউটিক ইঙ্গিত:

SIRTURO is indicated in adult (greater than or equal to 18 years) and pediatric patients (12 years to less than 18 years of age and weighing at least 30 kg) as part of combination therapy of pulmonary tuberculosis (TB) due to multi-drug resistant Mycobacterium tuberculosis.

পণ্য সারাংশ:

Package - Contents - Shelf Life: Blister pack, Alu/Alu - 24 tablets - 36 months from date of manufacture stored at or below 30°C protect from light - Bottle, HDPE - 188 tablets - 36 months from date of manufacture stored at or below 30°C protect from light

অনুমোদন তারিখ:

2015-05-15

তথ্য লিফলেট

1
SIRTURO (220729) ACMI
New Zealand Consumer Medicine Information
SIRTURO
®
_BEDAQUILINE _
100 mg tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using SIRTURO.
This leaflet answers some common questions about SIRTURO. It does not
contain
all the available information. 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 using
SIRTURO against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN.
WHAT SIRTURO IS USED FOR
SIRTURO is used to treat tuberculosis (TB) that affects the lungs when
the disease
has become resistant to other antibiotics. This is called multi-drug
resistant
tuberculosis (MDR-TB). SIRTURO is used as part of combination therapy
in adults
and adolescents (12 years to less than 18 years of age and weighing at
least 30 kg).
SIRTURO is a type of antibiotic. Antibiotics are medicines that kill
bacteria that cause
disease.
SIRTURO must always be taken together with other medicines for
treating
tuberculosis.
Your doctor may have prescribed SIRTURO for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SIRTURO HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with a doctor's prescription.
2
SIRTURO (220729) ACMI
BEFORE YOU USE SIRTURO
_ _
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE SIRTURO IF:
•
you are allergic to bedaquiline, or any of the other ingredients
listed at the end
of this leaflet
If you are not sure whether you should start using SIRTURO, talk to
your doctor.
_BEFORE YOU START TO USE IT _
Tell your doctor if you have:
•
heart problems including heart failure, slow heart rate, abnormal
heart rhythm
•
a family history of a heart problem called “congenital long QT
syndrome”
•
decreased thyroid gland function (hypothyroidism)
•
liver or kidney problems
•
human immunodeficiency v

পণ্য বৈশিষ্ট্য

14.220803
1
SIRTURO (221004) ADS
SIRTURO
®
BEDAQUILINE
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
SIRTURO 100 mg tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains bedaquiline fumarate equivalent to 100 mg of
bedaquiline.
Excipients with known effect:
Each tablet contains 145 mg of lactose (as monohydrate).
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Tablet.
SIRTURO is supplied as an uncoated, 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
ADULT AND PEDIATRIC PATIENTS (12 YEARS TO LESS THAN 18 YEARS OF AGE)
SIRTURO is indicated in adult (≥ 18 years) and pediatric patients
(12 years to less than 18 years
of age and weighing at least 30 kg) as part of combination therapy of
pulmonary tuberculosis (TB)
due to multi-drug resistant _Mycobacterium tuberculosis_.
4.2 DOSE AND METHOD OF ADMINISTRATION
SIRTURO should only be administered as part of a multi-drug resistant
tuberculosis (MDR-TB)
regimen. It is recommended that SIRTURO is administered by directly
observed therapy (DOT).
MDR-TB is defined as _in vitro_ resistance of the patient’s isolate
to at least isoniazid and rifampin.
The prescribing physician should refer to international (e.g. WHO
guidelines) and national/ local
TB treatment guidelines for direction on selection and duration of use
of companion drugs with
SIRTURO. SIRTURO should only be used in combination with at least 3
drugs to which the
patient’s isolate has been shown to be susceptible _in vitro_. If
_in vitro_ drug susceptibility testing
results are unavailable, treatment may be initiated with SIRTURO in
combination with at least 4
other drugs to which the patient's isolate is likely to be
susceptible.
Throughout treatment with, and following the last intake of SIRTURO,
patients should continue to
take
their
companion
drugs
in
accordance
with
international,
national/local
TB
treatment
guidelines and loca