Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
mesalazine, Quantity: 2000 mg
Dr Falk Pharma Australia Pty Ltd
Enema
Excipient Ingredients: sodium benzoate; carbomer 934P; disodium edetate; potassium acetate; potassium metabisulfite; xanthan gum; purified water
Rectal
7 enemas per carton
(S4) Prescription Only Medicine
Salofalk 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: Very light tan to brown suspension.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2002-05-15
SALOFALK ® enema (2 g/30 mL, 2 g/60 mL & 4 g/60 mL) – Consumer Medicine Information Page 1 of 4 _ _ SALOFALK ® ENEMA _mesalazine _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SALOFALK. 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 against the expected benefits. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT USING SALOFALK. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT SALOFALK IS USED FOR SALOFALK enemas contain 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 ENEMAS HAVE BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed SALOFALK for another reason. SALOFALK is not addictive. SALOFALK is not expected to affect your ability to drive a car or operate machinery. SALOFALK is only available on a doctor’s prescription. BEFORE YOU USE IT _WHEN YOU MUST NOT USE IT _ DO NOT USE SALOFALK IF: • you are allergic to mesalazine or aspirin-like medicines, 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 TO A CHILD BELOW 12 YEARS OF AGE. The safety and effectiveness of SALOFALK in this group have not been established. _BEFORE YOU START TO USE IT _ TELL YOUR DOCTOR IF: • YOU HAVE ANY ALLERGIES • YOU ARE PREGNANT OR INTEND TO BECOME Prečítajte si celý dokument
SALOFALK enemas – Product Information Page 1 of 11 AUSTRALIAN PRODUCT INFORMATION SALOFALK ® ENEMAS (MESALAZINE) 1. NAME OF THE MEDICINE Mesalazine. 2 . QUALITATIVE AND QUANTITATIVE COMPOSITION SALOFALK enemas contain either 2 g/30 mL, 2 g/60 mL or 4 g/60 mL mesalazine as the active ingredient. Excipients with known effect: sulphites and benzoates 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 2 g/30 mL, 2 g/ 60 mL and 4 g/60 mL enemas are presented as a very light tan to brown, homogeneous suspension. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SALOFALK enemas are 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 enema once a day is used for the treatment of acute ulcerative colitis or maintenance of remission. The content of one enema bottle (2 g/30 mL, 2 g/60 mL, or 4 g/60 mL) is instilled in the rectum once every evening prior to going to bed. The best results are achieved if the bowels are evacuated prior to instillation of SALOFALK enema. The action of SALOFALK is enhanced if the patient lies on the left side when introducing the enema. 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 effects. In clinical trials, rectal doses of 2-4 g mesalazine/day as enemas have been used in the therapy of both acute ulcerative colitis and maintenance of remission. SALOFALK enemas – Product Information Page 2 of 11 USE IN CHILDREN SALOFALK enemas should not be used in children 12 years old and under, as there is lit Prečítajte si celý dokument