देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
budesonide, Quantity: 2 mg
Dr Falk Pharma Australia Pty Ltd
Budesonide
Foam
Excipient Ingredients: propylene glycol; purified water; emulsifying wax; cetyl alcohol; citric acid monohydrate; disodium edetate; butane; isobutane; propane; steareth-10
Rectal
2 can pack, 1 can pack
(S4) Prescription Only Medicine
BUDENOFALK foam is indicated in the treatment of active rectal and rectosigmoid disease in ulcerative colitis.
Visual Identification: Aluminium canisters with metering valve; Container Type: Jar/Can; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2012-06-12
BUDENOFALK foam – Consumer Medicine Information Page 1 of 5 BUDENOFALK ® FOAM _BUDESONIDE _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BUDENOFALK foam. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using BUDENOFALK foam against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. Keep this leaflet with the medicine. You may need to read it again. WHAT BUDENOFALK FOAM IS USED FOR BUDENOFALK foam contains the active ingredient, budesonide. Budesonide belongs to a group of medications called corticosteroids. BUDENOFALK foam is used to treat ulcerative colitis (inflammation) of the rectum (back passage) and the lower part of the large bowel. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is not addictive. This medicine is not expected to affect your ability to drive a car or operate machinery. BUDENOFALK foam is only available on a doctor’s prescription. There is not enough information to recommend the use of this medicine for children or adolescents. BEFORE YOU USE IT _WHEN YOU MUST NOT USE IT _ DO NOT USE BUDENOFALK FOAM IF YOU HAVE AN ALLERGY TO: • any medicine containing budesonide • any of the ingredients listed at the end of this leaflet. Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT USE BUDENOFALK FOAM IF YOU SUFFER FROM A SEVERE LIVER DISEASE (LIVER CIRRHOSIS). DO NOT USE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharma पूरा दस्तावेज़ पढ़ें
1 AUSTRALIAN PRODUCT INFORMATION BUDENOFALK® (BUDESONIDE) FOAM 1 NAME OF THE MEDICINE Budesonide 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BUDENOFALK® foam contains the active ingredient budesonide. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Foam 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BUDENOFALK® foam is indicated in the treatment of active rectal and rectosigmoid disease in ulcerative colitis. 4.2 DOSE AND METHOD OF ADMINISTRATION For adults aged >18 years of age: Apply one actuation of 2 mg budesonide daily. BUDENOFALK® 2 mg foam can be applied in the morning or evening. BUDENOFALK® 2 mg foam should be in room temperature when applied. The canister is first fitted with an applicator and then shaken for about 15 seconds before the applicator is inserted into the rectum as far as comfortable. Note that the dose is only sufficiently accurate when the pump dome is held downwards as vertically as possible. To administer a dose of BUDENOFALK® 2 mg foam , the pump dome is fully pushed down and very slowly released. Following the activation the applicator should be held in position for 10-15 seconds before being withdrawn from the rectum. The best results are obtained when the intestine is evacuated prior to administration of BUDENOFALK® 2mg foam. The attending physician determines the duration of use. An acute episode generally subsides after 6 to 8 weeks. Treatment may be continued in patients showing progressive improvement, but it should not be persisted with if the response has been inadequate. Continuous treatment beyond 8 2 weeks has not been assessed. BUDENOFALK® 2 mg foam should not be used after this time. Topical steroids including BUDENOFALK® have not been shown to be effective in the maintenance of remission of ulcerative colitis. Do not use BUDENOFALK® foam after 4 weeks of first opening the container. 4.3 CONTRAINDICATIONS BUDENOFALK® foam is contraindicated in patients with the following: • hypersensitivity to budesonide or any of पूरा दस्तावेज़ पढ़ें