Tymbrineb 300 mg/5 ml Nebuliser Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Tobramycin

Available from:

Teva Pharma B.V.

ATC code:

J01GB; J01GB01

INN (International Name):

Tobramycin

Dosage:

300 mg/5ml

Pharmaceutical form:

Nebuliser solution

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other aminoglycosides; tobramycin

Authorization status:

Marketed

Authorization date:

2012-11-23

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING 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 Tymbrineb Nebuliser Solution is and what it is used for
2. What you need to know before you use Tymbrineb Nebuliser Solution
3. How to use Tymbrineb Nebuliser Solution
4. Possible side effects
5. How to store Tymbrineb Nebuliser Solution
6. Contents of the pack and other information
1 WHAT TYMBRINEB NEBULISER SOLUTION IS AND WHAT IT IS USED FOR
Tymbrineb Nebuliser Solution contains a medicine called tobramycin.
This is
an aminoglycoside antibiotic.
Tymbrineb Nebuliser Solution is used in patients aged six years and
older
who have cystic fibrosis to treat chest infections caused by a
bacteria called
Pseudomonas aeruginosa.
Tobramycin fights the infection caused by Pseudomonas bacteria in your
lungs, and helps to improve your breathing.
When you inhale tobramycin, the antibiotic can get directly into your
lungs
to fight against the bacteria causing the infection. For the best
results of this
medicine, use 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.
Tobramycin kills the bacteria t

Summary of Product characteristics

Health Products Regulatory Authority
26 April 2022
CRN00CL9Z
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Tymbrineb 300 mg/5 ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule of 5mL contains 300 mg tobramycin as a single dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
Clear to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tymbrineb Nebuliser Solution 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
Tymbrineb Nebuliser Solution is for inhalation use and is not intended
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 tobramycin 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 tobramycin 300 mg twice daily.
Controlled clinical studies, conducted for a period of 6 months using
the following tobramycin dosage regimen, have shown
that improvement in lung function was maintained above baseline during
the 28 day rest periods.
Tymbrineb Dosing Regimen in Controlled Clinical Studies
CYCLE 1
​
CYCLE 2
​
CYCLE 3
​
28 days
28 days
28 days
28 days
28 days
28 days
Tymbrineb 300 mg
twice daily plus
standard care
Standard care only
Tymbrineb 300 mg
twice daily plus
standard care
Standard care only
Tymbrineb 300 mg
twice daily plus
standard care
Standard care only
Safety and efficacy for long-term management of chronic pulmonary
infection due to Pseudomonas aeruginosa have been
assessed in c