Tobramycin 300mg5ml nebuliser liquid ampoules

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Tobramycin

Disponibil de la:

Sun Pharmaceutical Industries Europe B.V.

Codul ATC:

J01GB01

INN (nume internaţional):

Tobramycin

Dozare:

60mg/1ml

Forma farmaceutică:

Nebuliser liquid

Calea de administrare:

Inhalation

Clasă:

No Controlled Drug Status

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 05010400; GTIN: 8718531946040

Prospect

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TOBRAMYCIN 300 MG/ 5 ML 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 Tobramycin is and what it is used for
2.
What you need to know before you use Tobramycin
3.
How to use Tobramycin
4.
Possible side effects
5.
How to store Tobramycin
6.
Contents of the pack and other information
1.
WHAT TOBRAMYCIN IS AND WHAT IT IS USED FOR
Tobramycin contains an antibiotic medicine called tobramycin. It
belongs to a class of antibiotic
medicines called aminoglycosides.
Tobramycin is used in patients aged 6 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 while
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 that cause infec

Caracteristicilor produsului

OBJECT 1
TOBRAMYCIN 300 MG/ 5 ML NEBULISER SOLUTION
Summary of Product Characteristics Updated 08-Jun-2017 | Ranbaxy (UK)
Limited a Sun Pharmaceutical
Company
1. Name of the medicinal product
Tobramycin 300 mg/ 5 ml nebuliser solution
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, colourless to light yellow solution free from visible
particulate matter with a pH between 4.5 to 6.5
and an osmolality between 135 to 285 mOsm/kg.
4. Clinical particulars
4.1 Therapeutic indications
Long-term management of chronic pulmonary infection due to
_Pseudomonas aeruginosa_ in cystic fibrosis
(CF) patients 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
Tobramycin 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 therapy with tobramycin 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 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 effic