Tobi 300mg/5ml Nebuliser Solution / Tobramycin 300mg/5ml Nebuliser Solution

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland

ATC code:

J01GB01

INN (International Name):

TOBRAMYCIN 300 ml/5ml

Pharmaceutical form:

NEBULISER SOLUTION

Composition:

TOBRAMYCIN 300 ml/5ml

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2018-11-27

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
TOBI® 300 MG/5 ML NEBULISER SOLUTION
Tobramycin
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 or pharmacist.
•
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Tobi is and what it is used for
2.
What you need to know before you use Tobi
3.
How to use Tobi
4.
Possible side effects
5.
How to store Tobi
6.
Contents of the pack and other information
1.
WHAT TOBI IS AND WHAT IT IS USED FOR
WHAT IS TOBI FOR?
Tobi contains a medicine called tobramycin. This is an aminoglycoside
antibiotic.
Tobi is used in patients aged six years and older who have cystic
fibrosis to treat chest infections
caused by a bacteria called Pseudomonas aeruginosa
Tobi fights the infection caused by Pseudomonas bacteria
_ _
in your lungs, and helps to improve your
breathing.
When you inhale Tobi, the antibiotic can get directly into your lungs
to fight against the bacteria
causing the infection. For the best results of this medicine, take it
as this leaflet instructs you.
WHAT IS PSEUDOMONAS AERUGINOSA?
This is a very common bacteria that infects nearly everyone with
cystic fibrosis at some time during
their lives. Some people do not get this infection until later on in
their lives, while others get it very
young.
This is one of the most damaging bacteria for people with cystic
fibrosis. If the infection is not
properly controlled, it will continue to damage your lungs causing
further problems to your breathing.
Tobi
kills the bacteria that cause infections in the lungs. The infection
can be controlled successfully if
the p

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
TOBI
®
300 mg/5 mL Nebuliser Solution
Tobramycin 300 mg/5 ml Nebuliser Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 5mL contains tobramycin 300mg as a single dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser solution.
Clear, slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TOBI is indicated in cystic fibrosis (CF) patients aged 6 years and
older for long-term management of
chronic pulmonary infection due to
_Pseudomonas aeruginosa_
.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
TOBI is supplied for use via inhalation and is not for parenteral use.
POSOLOGY
The recommended dose for adults and children is one ampoule twice
daily for 28 days. The dose
interval should be as close as possible to 12 hours and not less than
6 hours. After 28 days of therapy,
patients should stop TOBI therapy for the next 28 days. A cycle of 28
days of active therapy and 28
days of rest from treatment should be maintained.
Dosage is not adjusted for weight. All patients should receive one
ampoule of TOBI (300 mg of
tobramycin) twice daily.
Controlled clinical studies, conducted for a period of 6 months using
the following TOBI dosage
regimen, have shown that improvement in lung function was maintained
above baseline during the 28
day rest periods.
TOBI Dosing Regimen in Controlled Clinical Studies
Cycle 1
Cycle 2
Cycle 3
28 Days
ys
ys
ys
ys
ys
300 mg twice
plus
rd care
rd
300 mg
daily plus
rd care
rd
300 mg
daily plus
rd care
rd
Safety and efficacy for long-term management of chronic pulmonary
infection due to
_Pseudomonas _
_aeruginosa_
have been assessed in controlled and open label studies for up to 96
weeks (12 cycles), but
have not been studied in patients under the age of 6 years, patients
with forced expiratory volume in 1
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