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

国家: 马耳他

语言: 英文

来源: Medicines Authority

有效成分:

TOBRAMYCIN

可用日期:

Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC代码:

J01GB01

INN（国际名称）:

TOBRAMYCIN 300 ml/5ml

药物剂型:

NEBULISER SOLUTION

组成:

TOBRAMYCIN 300 ml/5ml

处方类型:

POM

治疗领域:

ANTIBACTERIALS FOR SYSTEMIC USE

授权状态:

Authorised

授权日期:

2018-11-27

资料单张

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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 probl

产品特点

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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
28 Days
28 Days
28 Days
28 Days
28 Days
TOBI 300 mg twice
daily plus
standard care
standard
care
TOBI 300 mg
twice daily plus
standard care
standard
care
TOBI 300 mg
twice daily plus
standard care
standard
care
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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, patient