产品特点
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Locabiotal 500 micrograms per metered dose, Nasal/Oromucosal spray solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fusafungine 1% w/v
Each metered dose delivers approximately 500 micrograms of fusafungine.
Excipients: trace amounts of ethanol (alcohol) and propylene glycol (E1520).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal/Oromucosal spray solution.
The solution is oily, colourless to pale yellow, clear, with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of local infections of the nasal passages and oropharynx due to micro-organisms sensitive to this anti-
infective.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults: 1 spray actuation by mouth and (or) 1 spray actuation in each nostril every 4 hours.
Children over 30 months: 1 spray actuation by mouth and (or) 1 spray actuation in each nostril every 6 hours.
Methods of administration:
- Intranasal
- Intra-oral
Before the very first use, press 5 times on the main adapter so as to prime the pump. The bottle must be held upright
between the thumb and index finger with the adapter uppermost.
To administer the drug, place the mouth adapter (white) in the mouth, closing the lips around it. Then press firmly and
at length on the adapter while breathing normally.
Use the same procedure for nasal administration, after fitting the nasal adapter (yellow) on the bottle.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Children under 30 months (risk of laryngospasm).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with cautions in patients with allergic tendencies and bronchospasm (see section 4.8).
Prolonged use of an anti-infective may result in
阅读完整的文件
产品特点 