TOBI 300 mg/5 mL Nebuliser SolutionTobramycin 300 mg/5 ml Nebuliser Solution

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Tobramycin

Tersedia dari:

Novartis Ireland Limited

Kode ATC:

J01GB; J01GB01

INN (Nama Internasional):

Tobramycin

Dosis:

300 mg/5ml

Bentuk farmasi:

Nebuliser solution

Jenis Resep:

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

Area terapi:

Other aminoglycosides; tobramycin

Tanggal Otorisasi:

2000-09-15

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
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
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
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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