TOBI PODHALER tobramycin 28 mg hard capsule for inhalation blister pack with Podhaler device

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

tobramycin, Quantity: 28 mg

থেকে পাওয়া:

Viatris Pty Ltd

INN (আন্তর্জাতিক নাম):

Tobramycin

ফার্মাসিউটিকাল ফর্ম:

Capsule, hard

রচনা:

Excipient Ingredients: hypromellose; titanium dioxide; calcium chloride dihydrate; Carnauba Wax; carrageenan; potassium chloride; butan-1-ol; distearoylphosphatidylcholine; isopropyl alcohol; indigo carmine aluminium lake; sulfuric acid; Shellac; purified water; propylene glycol

প্রশাসন রুট:

Inhalation

প্যাকেজ ইউনিট:

8 capsules + 1 Podhaler, 224 capsules + 5 Podhalers

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

TOBI solution and TOBI Podhaler are indicated for the management of cystic fibrosis patients with P. aeruginosa infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 less than or equal to 25 % or greater than or equal to 80 % predicted at screening, or patients colonized with Burkholderia cepacia. (See CLINICAL TRIALS)

পণ্য সারাংশ:

Visual Identification: Clear, colourless capsule marked in blue with Mylan logo and "MYL TPH"; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2012-03-06

তথ্য লিফলেট

TOBI
®
PODHALER
®
T
O
B
I
®
P
o
d
h
a
l
e
r
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TOBI PODHALER?
TOBI Podhaler contains the active ingredient tobramycin. TOBI Podhaler
is used to treat lung infections caused by a bacterium
called Pseudomonas aeruginosa, in patients who have cystic fibrosis.
For more information, see Section 1. Why am I using TOBI Podhaler? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TOBI PODHALER?
Do not use if you have ever had an allergic reaction to tobramycin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TOBI Podhaler? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TOBI Podhaler and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TOBI PODHALER?
•
The usual dose for all patients aged 6 years and older is 4 capsules
for inhalation taken every 12 hours (each morning and
evening).
•
Do not exceed the recommended dose.
More instructions can be found in Section 4. How do I use TOBI
Podhaler? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TOBI PODHALER?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TOBI Podhaler.
•
Once removed from the blister strip, use the capsule immediately.
•
Use a new Podhaler device after 7 days. Discard the old one.
•
Tell your doctor if you become pregnant while using TOBI Podhaler.
•
Keep all of your doctor's appointments so that your progress can be
checked.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that you are
using TOBI Podhaler.
THINGS

পণ্য বৈশিষ্ট্য

AUSTRALIAN PRODUCT INFORMATION
TOBI
® & TOBI
® PODHALER
®
_Tobramycin_
_ _
1
NAME OF THE MEDICINE
Tobramycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOBI solution for inhalation (TOBI solution) and TOBI Podhaler
capsules for inhalation (TOBI Podhaler)
are two different formulations of tobramycin specifically developed
for administration by inhalation.
TOBI SOLUTION FOR INHALATION
Each TOBI solution single-use 5 mL ampoule contains 300 mg tobramycin
and 11.25 mg sodium
chloride in sterile water for injections. Sulfuric acid and sodium
hydroxide are added to adjust the pH
to 6.0. Nitrogen is used for sparging. All ingredients meet USP
requirements. The formulation contains
no preservatives.
TOBI PODHALER
Each TOBI Podhaler capsule contains tobramycin 28 mg,
distearoylphosphatidylcholine, calcium
chloride dihydrate, and sulfuric acid. The hard capsule shell contains
hypromellose, potassium
chloride, carrageenan, carnauba wax, butan-1-ol, indigo carmine
aluminium lake, isopropyl alcohol,
propylene glycol, purified water, shellac, titanium dioxide.
3
PHARMACEUTICAL FORM
TOBI SOLUTION FOR INHALATION AMPOULE
TOBI solution is a sterile, clear, slightly yellow, non-pyrogenic,
aqueous solution with the pH and
salinity adjusted specifically for administration by a compressed air
driven reusable nebuliser.
TOBI PODHALER CAPSULES FOR INHALATION
TOBI Podhaler includes clear, colorless hypromellose capsules
containing a white to almost-white
powder for inhalation. The capsules have ”MYL TPH” in blue radial
imprint on one part of the capsule
and the Mylan logo in blue radial imprint on the other part of the
capsule. The capsules must be
administered specifically with a Podhaler® device provided in the
same pack.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TOBI solution and TOBI Podhaler are indicated for the management of
cystic fibrosis patients with _P. _
_aeruginosa _infections.
Safety and efficacy have not been demonstrated in patients under the
age of 6 years, patients with
FEV
1
< 25 % or > 80 % predicte