Vantobra 170mg1.7ml nebuliser solution 1.7ml ampoules

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Tobramycin

Fáanlegur frá:

Pari Medical Ltd

ATC númer:

J01GB01

INN (Alþjóðlegt nafn):

Tobramycin

Skammtar:

100mg/1ml

Lyfjaform:

Nebuliser liquid

Stjórnsýsluleið:

Inhalation

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 05010400; GTIN: 9120073453013

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VANTOBRA
® 170 MG 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 Vantobra
®
is and what it is used for
2.
What you need to know before you use Vantobra
®
3.
How to use Vantobra
®
4.
Possible side effects
5.
How to store Vantobra
®
6.
Contents of the pack and other information
1.
WHAT VANTOBRA
® IS AND WHAT IT IS USED FOR
WHAT VANTOBRA
® IS
Vantobra
®
contains an antibiotic medicine called tobramycin. It belongs to a
class of antibiotic medicines
called aminoglycosides.
WHAT VANTOBRA
® IS USED FOR
Vantobra
®
is used in patients with cystic fibrosis aged 6 years and older to
treat lung infections caused by
bacteria named _Pseudomonas aeruginosa_.
_Pseudomonas aeruginosa_ is a bacterium that frequently infects the
lungs of cystic fibrosis patients at some
time during their lives. If the infection is not properly treated, it
continues to damage the lungs, causing
further problems with breathing.
HOW VANTOBRA
® WORKS
When you inhale Vantobra
®
, the antibiotic can enter directly into your lungs to fight the
bacteria causing the
infection. It works by disrupting the production of proteins that the
bacteria need to build their cell walls.
This damages the bacteria and eventually kills them.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VANTOBRA
®
_ _
DO NOT USE VANTOBRA
®
if you are allergic (hypersensitive) to tobramycin, to any type of
aminoglycoside antibiotics, or to any of the
other ingredients of Vantobra
®
(l

Vara einkenni

OBJECT 1
VANTOBRA 170MG NEBULISER SOLUTION
Summary of Product Characteristics Updated 01-Sep-2016 | PARI Pharma
GmbH
1. Name of the medicinal product
Vantobra 170 mg nebuliser solution
2. Qualitative and quantitative composition
Each single-dose ampoule of 1.7 ml contains 170 mg tobramycin.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nebuliser solution.
A clear to slightly yellow solution.
4. Clinical particulars
4.1 Therapeutic indications
Vantobra is indicated for the management of chronic pulmonary
infection due to _Pseudomonas _
_aeruginosa_ in patients aged 6 years and older with cystic fibrosis
(CF).
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 Vantobra is the same for all patients within the approved
age range, regardless of age or
weight. The recommended dose is one ampoule (170 mg/1.7 ml)
administered twice daily (i.e. total daily
dose is 2 ampoules) for 28 days. The dose interval should be as close
as possible to 12 hours and not less
than 6 hours.
Vantobra is taken in alternating cycles of 28 days. A cycle of 28 days
of active therapy (on-treatment
period) and 28 days of rest from treatment (off-treatment period)
should be maintained.
_Missed doses_
In case of a missed dose with at least 6 hours remaining until the
next dose, the patient should inhale the
dose as soon as possible. If less than 6 hours remain to the next
planned dose, the patient should wait for
the next dose and not inhale more to make up for the missed dose.
_Duration of treatment_
Treatment should be continued on a cyclical basis for as long as the
physician considers the patient is
gaining clinical benefit from the treatment taking into account that
long-term safety data are not available
for Vantobra. If clinical deterioration of pulmonary status is
evident, additional or alternative anti-
pseudomonal therapy should be considered. See also information on
clinical benefit and tolerability