البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
dextromethorphan hydrobromide monohydrate, Quantity: 2 mg/mL
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
dextromethorphan hydrobromide monohydrate
Oral Liquid
Excipient Ingredients: propylene glycol; purified water; maltitol solution; methyl hydroxybenzoate; saccharin sodium; Flavour; Fragrance (perfume)
Oral
125mL, 200mL
(S2) Pharmacy Medicine
Cough suppressant
Visual Identification: Syrupy, clear, colourless liquid with odour of apricot and vanilla; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
1999-03-19
BISOLVON ® DRY ORAL LIQUID B i s o l v o n ® D r y O r a l L i q u i d ACTIVE INGREDIENT(S): Dextromethorphan hydrobromide monohydrate CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using Bisolvon Dry Oral Liquid. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING BISOLVON DRY ORAL LIQUID. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using Bisolvon Dry Oral Liquid? 2. What should I know before I use Bisolvon Dry Oral Liquid 3. What if I am taking other medicines? 4. How do I use Bisolvon Dry Oral Liquid? 5. What should I know while using Bisolvon Dry Oral Liquid? 6. Are there any side effects? 7. Product details 1. WHY AM I USING BISOLVON DRY ORAL LIQUID? BISOLVON DRY ORAL LIQUID CONTAINS THE ACTIVE INGREDIENT DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE. Dextromethorphan hydrobromide monohydrate is a cough suppressant that acts on the cough centre in the brain to suppress a dry cough BISOLVON DRY ORAL LIQUID IS USED FOR THE TREATMENT OF DRY, IRRITATING COUGHS. Bisolvon Dry Oral Liquid does not have any pain-relieving (analgesic) properties. 2. WHAT SHOULD I KNOW BEFORE I USE BISOLVON DRY ORAL LIQUID WARNINGS TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. DO NOT USE BISOLVON DRY ORAL LIQUID IF: YOU ARE ALLERGIC TO: • ANY MEDICINE CONTAINING DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE (ACTIVE INGREDIENT) • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some of the symptoms of an allergic reaction may include: o shortness of breath o wheezing or difficulty breathing o swelling of the face, lips, tongue or other parts of the body o rash, itching or hives on the skin. • YOU HAVE THE FOLLOWING MEDICAL CONDITIONS: o Asthma o a lung condition called chronic obstructive airways disease (COAD or COPD) o respiratory failure o pneumonia o shallow breathing (respiratory depression) o fructose intolerance o mastocytosis. • YOU A اقرأ الوثيقة كاملة
bis-ccdsv5-piv10-25mar21 1 AUSTRALIAN PRODUCT INFORMATION – BISOLVON ® DRY (DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE) 1 NAME OF THE MEDICINE Dextromethorphan hydrobromide monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of Bisolvon Dry Oral Liquid contains dextromethorphan hydrobromide monohydrate 10 mg. Excipients with known effect: methyl hydroxybenzoate, maltitol, saccharin sodium Each Bisolvon Dry Pastille contains dextromethorphan hydrobromide monohydrate 10.5 mg (equivalent to dextromethorphan hydrobromide anhydrous 10 mg). Excipients with known effect: maltitol, saccharin sodium For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Bisolvon Dry Oral Liquid is a clear, colourless, syrupy liquid with an aroma of apricot and vanilla. Bisolvon Dry Pastille is a yellow, round pastilles with a honey lime flavour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles are used for the symptomatic treatment of dry, irritant, unproductive coughs. Bisolvon Dry Pastilles also helps soothe the throat. 4.2 DOSE AND METHOD OF ADMINISTRATION Bisolvon Dry Oral Liquid and Bisolvon Dry Pastilles are preparations for oral administration. The following dosage regimen is recommended: In the case of self treatment, the maximum duration of treatment is 5 days. bis-ccdsv5-piv10-25mar21 2 BISOLVON DRY ORAL LIQUID _ADULTS AND CHILDREN 12 YEARS AND OVER: _ 5 – 15 mL of Bisolvon Dry Oral Liquid, every 4 – 6 hours when necessary. The maximum total daily dose is 60 mL of Bisolvon Dry Oral Liquid (equivalent to 120 mg dextromethorphan hydrobromide). Do not exceed 4 doses in a 24 hour period. _CHILDREN 6 – 11 YEARS: _ 2.5 – 7.5 mL of Bisolvon Dry Oral Liquid, every 4 – 6 hours when necessary. The maximum total daily dose is 30 mL of Bisolvon Dry Oral Liquid (equivalent to 60 mg of dextromethorphan hydrobromide). Do not exceed 4 doses in a 24 hour period. BISOLVON DRY PASTILLES _ADULTS AND CHILDREN 12 YEARS AND OVER: _ Slowly اقرأ الوثيقة كاملة