Vantobra
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
29-03-2019
Valmisteyhteenveto
(SPC)
29-03-2019
Julkisesta arviointikertomuksesta
(PAR)
29-03-2019
Aktiivinen ainesosa:
Tobramycin
Saatavilla:
Pari Pharma GmbH
ATC-koodi:
J01GB01
INN (Kansainvälinen yleisnimi):
tobramycin
Terapeuttinen ryhmä:
Antibacterials for systemic use, , Aminoglycoside antibacterials
Terapeuttinen alue:
Cystic Fibrosis; Respiratory Tract Infections
Käyttöaiheet:
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.
Tuoteyhteenveto:
Revision: 3
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2015-03-18
Pakkausseloste
24
B. PACKAGE LEAFLET
Medicinal product no longer authorised
25
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 ingr
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
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 in sections 4.4, 4.8
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