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1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOCABIOTAL 1 %, NASAL/OROMUCOSAL SPRAY, SOLUTION
Fusafungine
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.
IN THIS LEAFLET:
1.
What LOCABIOTAL is and what it is used for
2.
What you need to know before you take LOCABIOTAL
3.
How to take LOCABIOTAL
4.
Possible side effects
5.
How to store LOCABIOTAL
6.
Contents of the pack and other information
1.
WHAT LOCABIOTAL IS AND WHAT IT IS USED FOR
LOCABIOTAL is recommended as adjuvant treatment for certain conditions affecting the upper respiratory
tract.
LOCABIOTAL is indicated in adults and adolescents aged 12 years and
over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOCABIOTAL
DO NOT TAKE LOCABIOTAL
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if you are allergic (hypersensitive) to fusafungine
or any of the other ingredients of LOCABIOTAL.
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for use in children under 12 years.
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if you have allergic tendencies or if you have already had a feeling of breathlessness following a
contraction of the airways (bronchospasm).
WARNING AND PRECAUTIONS
LOCABIOTAL is not suitable for prolonged treatment as it could produce an imbalance in your normal
microbial flora with a risk of bacterial growth. Therefore, the duration of the treatment shoul
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製品の特徴
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
LOCABIOTAL 1 %, nasal/oromucosal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusafungine ........................................................................................................ 50 mg for 5 ml of
solution.
Each metered dose contains 50 µg of solution
which is equivalent to 500 µg of fusafungine.
Excipients with known effect: ethanol and propylene glycol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal/oromucosal spray, solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local antibacterial adjuvant treatment of diseases of the
upper respiratory tract.
It is advisable to follow the official recommendations
concerning the appropriate use of antibacterials.
LOCABIOTAL is indicated in adults and adolescents aged 12 years and
over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One spray actuation through the mouth or in each nostril every 4
hours.
Usual treatment should not exceed 7 days; beyond
this, treatment management should be reassessed.
Method of administration
Prime the pump before using for the very first time
(see section 6.5).
4.3
CONTRAINDICATIONS
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Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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Children under 12 years (see section 4.8).
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Patients with allergic tendencies and bronchospasm (see section 4.8).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In case of allergic reaction, LOCABIOTAL should be stopped and not be readministered (see section
4.8).
Due to risk of anaphylactic shock, in case of respiratory, laryngeal or cutaneous (pruritus, generalised
erythema) signs, an intramuscular injection of
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