Tobi Podhaler 28mg inhalation powder capsules with device

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Tobramycin

Inapatikana kutoka:

Novartis Pharmaceuticals UK Ltd

INN (Jina la Kimataifa):

Tobramycin

Kipimo:

28mg

Dawa fomu:

Inhalation powder

Njia ya uendeshaji:

Inhalation

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 05010400; GTIN: 5010678920086 5010678920062

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
TOBI
® PODHALER
® 28 MG INHALATION POWDER, HARD CAPSULES
Tobramycin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 TOBI Podhaler is and what it is used for
2.
What you need to know before you take TOBI Podhaler
3.
How to take TOBI Podhaler
4.
Possible side effects
5.
How to store TOBI Podhaler
6.
Contents of the pack and other information
Instructions for use with the Podhaler device (
_overleaf_
)
1.
WHAT TOBI PODHALER IS AND WHAT IT IS USED FOR
WHAT TOBI PODHALER IS
TOBI Podhaler contains a medicine called tobramycin which is an
antibiotic. This antibiotic belongs
to a class called aminoglycosides.
WHAT TOBI PODHALER IS USED FOR
TOBI Podhaler is used in patients aged 6 years and older who have
cystic fibrosis to treat lung
infections caused by bacteria called
_Pseudomonas aeruginosa._
For the best results from this medicine, please use it as this leaflet
instructs you.
HOW TOBI PODHALER WORKS
TOBI Podhaler is a powder for inhalation that is filled into capsules.
When you inhale TOBI Podhaler,
the antibiotic can enter directly into your lungs to fight against the
bacteria causing the infection and to
improve your breathing.
WHAT IS _PSEUDOMONAS AERUGINOSA_
It is a very common bacterium that infects the lungs of 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. It is one of the most damaging bacteria for people
with cystic

Tabia za bidhaa

OBJECT 1
TOBI PODHALER 28 MG INHALATION POWDER, HARD
CAPSULES
Summary of Product Characteristics Updated 11-May-2018 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
TOBI
®
Podhaler
®
28 mg inhalation powder, hard capsules
2. Qualitative and quantitative composition
Each hard capsule contains 28 mg tobramycin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Inhalation powder, hard capsule
Clear colourless capsules containing a white to almost white powder,
with “NVR AVCI” printed in blue
on one part of the capsule and Novartis logo printed in blue on the
other part of the capsule.
4. Clinical particulars
4.1 Therapeutic indications
TOBI Podhaler is indicated for the suppressive therapy of chronic
pulmonary infection due to
_Pseudomonas aeruginosa_ in adults and children aged 6 years and older
with cystic fibrosis.
See sections 4.4 and 5.1 regarding data in different age groups.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 Posology and method of administration
Posology
The dose of TOBI Podhaler is the same for all patients within the
approved age range, regardless of age
or weight. The recommended dose is 112 mg tobramycin (4 x 28 mg
capsules), administered twice daily
for 28 days. TOBI Podhaler is taken in alternating cycles of 28 days
on treatment followed by 28 days off
treatment. The two doses (of 4 capsules each) should be inhaled as
close as possible to 12 hours apart and
not less than 6 hours apart.
_Missed doses_
In case of missed dose with at least 6 hours until the next dose, the
patient should take the dose as soon as
possible. Otherwise, the patient should wait for the next dose and not
inhale more capsules to make up for
the missed dose.
_Duration of treatment_
Treatment with TOBI Podhaler should be continued on a cyclical basis
for as long as the physician
considers the patient is gaining clinical benefit from the treatment
with TOBI Podhaler. If clinical
deterioration of pulmonary status is evi