Страна: Мальта
Язык: английский
Источник: Medicines Authority
DEQUALINIUM CHLORIDE, TYROTHRICIN, HYDROCORTISONE ACETATE, LIDOCAINE HYDROCHLORIDE
Ferrer Internacional S.A. Gran Vía Carlos III, 94 08028 Barcelona, Spain
R02AA20
TYROTHRICIN 0.4 % (W/V) DEQUALINIUM CHLORIDE 0.1 % (W/V) HYDROCORTISONE ACETATE 0.06 % (W/V) LIDOCAINE HYDROCHLORIDE 0.1 % (W/V)
OROMUCOSAL SPRAY
TYROTHRICIN 0.4 % (W/V) DEQUALINIUM CHLORIDE 0.1 % (W/V) HYDROCORTISONE ACETATE 0.06 % (W/V) LIDOCAINE HYDROCHLORIDE 0.1 % (W/V)
POM
THROAT PREPARATIONS
Authorised
2006-05-26
1 READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Anginovag carefully to get the best results from it -- Keep this leaflet. You may need to read it again. -- Ask your pharmacist if you need more information or advice. -- You must contact a doctor if your symptoms worsen or do not improve after 3 days -- If any of side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What ANGINOVAG is and what it is used for 2. Before you use ANGINOVAG 3. How to use ANGINOVAG. 4. Possible side effects. 5. How to store ANGINOVAG 6. Further information 1. WHAT ANGINOVAG IS AND WHAT IT IS USED FOR: Anginovag is an oromucosal spray Anginovag is supplied in a white polyethylene flask containing a solution and closed by an spray dosing valve. Anginovag is used to alleviate the symptoms of buccopharyngeal affections (pain, inflammation, etc) 2. BEFORE YOU USE ANGINOVAG: DO NOT USE ANGINOVAG: - If you are allergic (hypersensitive) to active substances or any of the other ingredients of Anginovag. TAKE SPECIAL CARE WITH ANGINOVAG Do not spray on the eyes Contact your doctor if you experience blurred vision or other visual disturbances TAKING OTHER MEDICINES: You can take other medication by oral or injection route. It is advisable do not use Anginovag with other topical medication USING ANGINOVAG WITH FOOD AND DRINK It is possible to use Anginovag after the meals. It is not advisable to take foods or to drink after to use Anginovag PREGNANCY AND BREAST-FEEDING Anginovag can be used during pregnancy or breast-feeding. DRIVING AND USING MACHINES 2 Anginovag, does not produce any effect over the ability to drive and use of machines IMPORTANT INFORMATION ON SOME OF THE INGREDIENTS OF ANGINOVAG This medicine contains ethanol and sodium saccharin. 3. HOW TO USE ANGINOVAG The usual dose is: The first 3 days, 1-2 applications each 2-3 hours Прочитать полный документ
Page 1 of 3 SUMMARY PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ANGINOVAG 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 100 mL contains: _ACTIVE INGREDIENT: _ Dequalinium chloride 0.100g; Tyrothricin 0.400g; Hydrocortisone acetate 0.060g; Lidocaine hydrochloride 0.100 g; beta-Glycyrrhetinic acid 0.060 g 3. PHARMACEUTICAL FORM Oromucosal spray Is supplied in bottles containing 10 mL of solution 4. CLINICAL PARTICULARS : 4.1 THERAPEUTIC INDICATIONS : -Preventive and curative therapy of buccopharyngeal affections: ulcers, aphthae, stomatitis, laryngitis, glossitis, amygdalitis, pharyngitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION: POSOLOGY: Attack dose: 1-2 applications each 2-3 hours. Maintenance or preventive therapy: 1 application each 6 hours. METHOD OF ADMINISTRATION: It is recommended to place the flask in upright position with the cannula pointing towards the place of application, but without introducing it completely in the mouth. Press the upper part of the cap. 4.3 CONTRAINDICATIONS It must not be administered to patients with known allergy to any ingredient. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE : It is advisable not to administer Anginovag in conjunction with other topical Treatments Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids. Page 2 of 3 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Can be interacted by other oral topical products. 4.6 PREGNANCY AND LACTATION Controlled studies in woman or in the animal are not available. Nevertheless Anginovag is marketed in a flask provided with a dosing valve that permits the application of the Прочитать полный документ