Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
FUSAFUNGINE
Servier Laboratories (Ireland) Ltd
500 Microgram
Unknown
1977-04-01
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 Đọc toàn bộ tài liệu