国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
mesalazine, Quantity: 1 g
Dr Falk Pharma Australia Pty Ltd
Foam
Excipient Ingredients: propane; cetostearyl alcohol; disodium edetate; propylene glycol; butane; polysorbate 60; isobutane; sodium metabisulfite
Rectal
14 actuations/can
(S4) Prescription Only Medicine
Salofalk foam enemas are indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis.
Visual Identification: White-greyish to slightly reddish violet, creamy firm foam; Container Type: Aerosol Can; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-10-05
SALOFALK ® foam (1 g/application) – Consumer Medicine Information _ _ Page 1 of 5 _ _ SALOFALK ® FOAM _mesalazine (1 g/application) _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SALOFALK foam. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the possible risks of using SALOFALK foam against the expected benefits. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT USING SALOFALK FOAM. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT SALOFALK FOAM IS USED FOR SALOFALK foam contains the active ingredient, mesalazine (5-aminosalicylic acid), which is used to treat, and prevent relapses of mild to moderate attacks of ulcerative colitis (inflammation of the large bowel). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY SALOFALK FOAM HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed SALOFALK foam for another reason. SALOFALK foam is not addictive. SALOFALK foam is only available on a doctor’s prescription. BEFORE YOU USE IT _WHEN YOU MUST NOT USE IT _ DO NOT USE SALOFALK FOAM IF: • you are allergic to mesalazine or aspirin-like medicines, sulfites or any of the ingredients listed at the end of this leaflet. Signs of allergic reactions may include itchy skin rash, shortness of breath and swelling of the face or tongue. • you suffer from a severe kidney or liver problem. • the expiry date (EXP) printed on the pack has passed. If you use this medicine after the expiry date has passed, it may not work as well. • the package is torn or shows signs of tampering. DO NOT GIVE SALOFALK FOAM TO A CHILD 12 YEARS OLD OR UNDER. The safety and effectiveness of SALOFALK foam in this age group has not been established. TALK TO YOUR DOCTOR IF YOU ARE NOT SURE WHETHER YOU SHOULD START TO USE SALOFALK FOAM. _BEFORE YOU START TO USE IT _ TELL YOUR DOCTOR IF: • Y 阅读完整的文件
SALOFALK ® foam - Product Information Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION SALOFALK ® FOAM (MESALAZINE) 1 NAME OF THE MEDICINE Mesalazine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION SALOFALK foam contains 1 g/application mesalazine as the active ingredient. Excipients with known effect: sulphites See section 4.4 Special warnings and precautions for use For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM SALOFALK foam is a white-greyish to slightly reddish violet, creamy firm foam. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SALOFALK foam is indicated in the treatment of acute ulcerative colitis of mild to moderate severity and for the maintenance treatment of ulcerative colitis. 4.2 DOSE AND METHOD OF ADMINISTRATION Unless otherwise advised a dose of 2 g or 4 g mesalazine as SALOFALK foam once a day is used for the treatment of acute ulcerative colitis or maintenance of remission. A dose of 2 g SALOFALK foam is equivalent to 2 applications. SALOFALK foam should be used at room temperature, 20 – 25°C (please also see section 6.4 Special Precautions for Storage). 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. To administer a dose of SALOFALK foam, the pump dome is fully pushed down and released. Note the spray can will only work properly when held with the pump dome pointing down. Following the second activation, the applicator should be held in position for 10-15 seconds before being withdrawn from the rectum. The best results are achieved if the bowels are evacuated prior to instillation of SALOFALK foam. The dosage should be adjusted to suit the progress of the condition. Discontinuation of treatment should be under supervision of the physician. Due to the considerable variation in the severity of the ulcerative colitis and the extent of the affected area it is not possible to recommend a uniform dose of mesalazine which will provide optimal effe 阅读完整的文件