TOBRAMYCIN WKT tobramycin 300mg/5mL solution for inhalation ampoules

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

tobramycin, Quantity: 60 mg/mL

थमां उपलब्ध:

Luminarie Pty Ltd

फार्मास्यूटिकल फॉर्म:

Inhalation, conventional

रचना:

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

प्रशासन का मार्ग:

Inhalation

पैकेज में यूनिट:

56 x 5mL ampoules (7 Single-Use Ampoules per pouch, 8 sealed foil pouches per carton)

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

TOBRAMYCIN WKT solution 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 FEV1 less than or equal to 25 percent or more than or equal to 80 percent predicted at screening, or patients colonized with Burkholderia cepacia (see CLINICAL TRIALS).

उत्पाद समीक्षा:

Visual Identification: Clear, slightly yellow solution.; Container Type: Ampoule; Container Material: LDPE; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2018-02-23

सूचना पत्रक

480mm
_TOBRAMYCIN_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN
THIS LEAFLET
TOBRAMYCIN WKT
SOLUTION TOR INHALATION
DO THIS EVEN IF THERE ARE NO SIGNS OF DISCOMFORT OR POISONING.
Signs of an overdose may include:
•
dizziness
•
ringing in the ears
This leaflet answers some common questions about T
OBRAMYCIN WKT
It does not contain all the available information. It does not take
the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on
the final page. More recent information on the medicine may be
available.
YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE INFORMATION ON THE MEDICINE.
All medicines have benefits and risks. Your doctor has weighed the
risks of using TOBRAMYCIN WKT against the benefits it is expected to
have for you.
If
YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TOBRAMYCIN WKT IS USED TOR
TOBRAMYCIN WKT contains an antibacterial agent, tobramycin, which is
active against a common lung infection that occurs in patients with
cystic fibrosis (CF).
Tobramycin belongs to a class of antibiotics called aminoglycosides.
It works by killing or stopping the growth of the bacteria that cause
the infection. The bacterium that commonly infects the lung
of
most cystic fibrosis patients at some stage of their lives is
Pseudomonas aeruginosa. It is one of the most damaging bacteria for
people with CF.
Some people do not get this infection until later on in their lives,
while others get very young. If the infection is not properly fought,
it will continue to damage your lungs, causing further problems
with your breathing. TOBRAMYCIN WKT solution has been specially
formulated for administration by inhalation via a nebuliser and
compressor. When you inhale TOBRAMYCIN WKT the
antibiotic can get straight into your lungs to fight against the
infection and to improve your breathing.
FOR BEST RESULTS, PLEA

उत्पाद विशेषताएं

1
AUSTRALIAN PRODUCT INFORMATION – TOBRAMYCIN WKT (TOBRAMYCIN)
SOLUTION FOR INHALATION
1
NAME OF THE MEDICINE
Tobramycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOBRAMYCIN WKT solution for inhalation is formulation of tobramycin
specifically developed for
administration by inhalation.
TOBRAMYCIN WKT 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.
Each TOBRAMYCIN WKT 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 Ph
Eur. requirements. The formulation
contains no preservatives.
3
PHARMACEUTICAL FORM
4
CLEAR SLIGHTLY YELLOW SOLUTION.
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TOBRAMYCIN WKT solution 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
1
≤ 25 % or ≥ 80 % predicted at screening, or patients colonized
with _Burkholderia cepacia _
(see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Dosage is not adjusted by age or weight. The doses should be taken as
close to 12 hours apart as
possible; they should not be taken less than six hours apart. In case
of a missed dose with at least 6
hours until the next dose, the patient should take the dose as soon as
possible.
Otherwise, the patient should wait for the next dose and not inhale
more medication to make up for
the missed dose.
TOBRAMYCIN WKT solution is administered twice daily in alternating
periods of 28 days. After 28 days
of therapy, patients should stop therapy for the next 28 days, and
then resume therapy for the next
28 day on/28 day off cycle.
Therapy should be initiated by a physician experienced in