TOBI tobramycin 300mg/5mL solution for inhalation ampoule

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

tobramycin, Quantity: 60 mg/mL

Dostupno od:

Viatris Pty Ltd

Farmaceutski oblik:

Inhalation, conventional

Sastav:

Excipient Ingredients: water for injections; sodium hydroxide; sulfuric acid; sodium chloride

Administracija rute:

Inhalation

Jedinice u paketu:

56 x 5mL ampoules, 4 ampoules sample pack

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

TOBI is 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,<25% or >75% predicted, or patients colonised with Burkolderia cepacia (see CLINICAL TRIALS).

Proizvod sažetak:

Visual Identification: Clear, slightly yellow solution.; Container Type: Ampoule; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2000-02-18

Uputa o lijeku

TOBI
®
T
O
B
I
®
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?
TOBI contains the active ingredient tobramycin. TOBI is used for
common lung infection that occurs in patients with cystic fibrosis
(CF). For more information, see Section 1. Why am I using TOBI? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TOBI?
Do not use if you have ever had an allergic reaction to TOBI 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? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TOBI 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?
•
The recommended dose of TOBI is one 300 mg/5 mL ampoule twice daily
(every 12 hours) for 28 days.
•
To use TOBI, breathe normally through the mouthpiece of the nebuliser
until all of the TOBI solution is gone and there is no
longer any mist being produced.
More instructions can be found in Section 4. How do I use TOBI? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TOBI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TOBI.
•
Keep TOBI in the foil pouch (opened or unopened) in the pack until it
is time for your dose.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not use this medicine if the solution is cloudy or if there are
particles in the solution.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how TOBI
affects you.
•
If you feel dizzy or light-headed after using TOBI, do not drive.
DRINKING
ALCOHOL
•
TOBI may cause dizziness, ringing in the

Svojstava lijeka

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