Bramitob 300mg/4ml Nebuliser Solution

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Tobramycin

Disponible des:

Chiesi Farmaceutici S.p.A.

Codi ATC:

J01GB; J01GB01

Designació comuna internacional (DCI):

Tobramycin

Dosis:

300/4 milligram(s)/millilitre

formulario farmacéutico:

Nebuliser solution

Área terapéutica:

Other aminoglycosides; tobramycin

Estat d'Autorització:

Marketed

Data d'autorització:

2007-06-01

Informació per a l'usuari

Pl (V8.1) 2023-06
- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRAMITOB 300MG/4ML NEBULISER SOLUTION
tobramycin
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 Bramitob is and what it is used for
2.
What you need to know before you use Bramitob
3.
How to use Bramitob
4.
Possible side effects
5.
How to store Bramitob
6.
Contents of the pack and other information
1.
WHAT BRAMITOB IS AND WHAT IT IS USED FOR
Bramitob contains tobramycin which is an antibiotic belonging to a
family called the
aminoglycosides. It fights infections caused by
_Pseudomonas aeruginosa_
.
Bramitob is used for treating chronic chest infections in patients
with cystic fibrosis caused by
_Pseudomonas _
bacteria. It kills the bacteria and helps to improve your breathing.
_Pseudomonas_
is a
very common bacterium that infects nearly all patients 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. If infection is not properly controlled it will continue to
damage the lungs causing further
problems. As Bramitob is breathed-in the antibiotic, tobramycin, can
get straight into your lungs to
work against the bacteria causing the infection.
Bramitob is indicated only for patients aged 6 years and older.
To achieve the best results please make every effort to use your
medicine as instructed.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRAMITOB
DO NOT USE BRAMITOB:
•
If you are allergic (hypersensitive) to tobramycin, any of the other

Fitxa tècnica

Health Products Regulatory Authority
19 January 2022
CRN00CLH1
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bramitob 300mg/4ml Nebuliser Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 ml single-dose container contains tobramycin 300 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
Clear, yellowish solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of chronic pulmonary infection due to
_Pseudomonas aeruginosa _
in patients with cystic fibrosis aged 6 years and
older.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Bramitob is intended for inhalation only and not for parenteral use.
Therapy should be initiated by a physician experienced in the
management of cystic fibrosis.
The recommended dose for adults and children above 6 years is one
single-dose container (300mg) twice daily (morning and
evening) for 28 days. The dose interval should be as close as possible
to 12 hours. After 28 days of therapy with Bramitob,
patients should stop treatment for the next 28 days. Alternate cycles
of 28-days of active therapy followed by 28 days without
treatment should be maintained (a cycle of 28 days with therapy and 28
days without treatment).
CHILDREN UNDER 6 YEARS OLD
The efficacy and safety of Bramitob have not been demonstrated in
patients less than 6 years of age.
ELDERLY PATIENTS
Tobramycin should be used with caution in elderly patients who may
have reduced renal function (see section 4.4).
PATIENTS WITH RENAL IMPAIRMENT
Tobramycin should be used with caution in patients with known or
suspected renal, dysfunction. Bramitob should be
discontinued in the case of nephrotoxicity until serum concentration
of tobramycin fall below 2 µg/mL (see section 4.4).
PATIENTS WITH HEPATIC INSUFFICIENCY
No changes in Bramitob dose are required in hepatic insufficiency.
Dosage is not adjusted for body weight. All patients should be
ad