Tobramycine Aristo, 300 mg/5 ml verneveloplossing

Negara: Belanda

Bahasa: Belanda

Sumber: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Bahan aktif:

TOBRAMYCINE 60 mg/ml

Tersedia dari:

Aristo Pharma GmbH Wallenroder Strasse 8-10 13435 BERLIJN (DUITSLAND)

Kode ATC:

J01GB01

INN (Nama Internasional):

TOBRAMYCINE 60 mg/ml

Bentuk farmasi:

Verneveloplossing

Komposisi:

NATRIUMCHLORIDE ; NATRIUMHYDROXIDE (E 524) ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZWAVELZUUR (E 513)

Rute administrasi :

Inhalatie

Area terapi:

Tobramycin

Tanggal Otorisasi:

1900-01-01

Selebaran informasi

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOBRAMYCINE ARISTO 300 MG/ 5 ML VERNEVELOPLOSSING
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 Tobramycine Aristo is and what it is used for
2.
What you need to know before you use Tobramycine Aristo
3.
How to use Tobramycine Aristo
4.
Possible side effects
5.
How to store Tobramycine Aristo
6.
Contents of the pack and other information
1.
WHAT TOBRAMYCINE ARISTO
IS AND WHAT IT IS USED FOR
Tobramycine Aristo contains a medicine called tobramycin. This is an
aminoglycoside antibiotic.
Tobramycine Aristo is used in patients aged six years and older who
have cystic fibrosis to treat chest
infections caused by a bacteria called
_Pseudomonas aeruginosa_
.
Tobramycine Aristo fights the infection caused by
_Pseudomonas_
bacteria in your lungs, and helps to
improve your breathing.
When you inhale Tobramycine Aristo, 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.
Tobramycine

Karakteristik produk

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tobramycine Aristo 300mg/ 5ml verneveloplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 5 ml contains tobramycin 300 mg as a single dose. For
the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser solution
Clear, slightly yellow solution free
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tobramycine Aristo 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
Tobramycine Aristo 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 Tobramycine Aristo 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 Tobramycine Aristo
(300 mg of tobramycin) 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.
Tobramycin Dosing Regimen in Controlled Clinical Studies
Cycle 1
Cycle 2
Cycle 3
28 Days
28 Days
28 Days
28 Days
28 Days
28 Days
Tobramycin
300 mg twice
daily plus
standard care
standard care Tobramycin
300 mg twice
daily plus
standard care
standard care Tobramycin
300 mg twice
daily plus
standard care
standard care
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 cycle