Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
MESALAZINE
RAFA LABORATORIES LTD
A07EC02
ENEMA
MESALAZINE 4 G / 60 G
RECTAL
Required
RAFA LABORATORIES LTD, JERUSALEM
MESALAZINE
MESALAZINE
Treatment and prevention of ulcerative colitis and Crohn's disease.
2022-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ 1986 - REGULATIONS (PREPARATIONS) The medicine is dispensed with a doctor’s prescription only Rafassal ® 1 gram Enema Rafassal ® 4 gram Enema Active ingredient: Each Rafassal 1 gram Enema contains: mesalazine 1 gram. Each Rafassal 4 gram Enema contains: mesalazine 4 gram. The active ingredient is also called mesalamine or 5-aminosalicylic acid. For the list of the additional ingredients, see section 6. See also ‘Important information about some of the medicine’s ingredients’ in section 2. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any further questions, please refer to the doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. What is the medicine intended for? The medicine is intended for treatment and prevention of ulcerative colitis (ulcerative inflammation of the large intestine) and Crohn's disease. Therapeutic group: anti-inflammatory medicine from the salicylate group. 2. Before using the medicine Do not use the medicine if: • You are sensitive (allergic) to the active ingredient, to salicylic acid, to salicylates such as acetylsalicylic acid (aspirin) or to any of the additional ingredients the medicine contains (for the list of the additional ingredients, see section 6). • You suffer from severe impairment of liver or kidney function. Special warnings regarding the use of the medicine: Before (and during) treatment with the medicine, tell your doctor if: • You suffer or have suffered in the past from lung problems, particularly if you suffer from asthma (bronchial). • You suffer or have suffered in the past from allergy to a substance named sulphasalazine, which is a substance related to the active ingredient mesalazine. In such a case, close medical supervision will be required. (If acute symptoms of Soma hati kamili
1 Rafassal Enema-DL-July 2023-04 1 NAME OF THE MEDICINAL PRODUCT RAFASSAL ® 1 GRAM ENEMA. RAFASSAL ® 4 GRAM ENEMA 2 QUALITATIVE AND QUANTITATIVE COMPOSITION RAFASSAL 1 GRAM ENEMA: Each enema contains mesalazine (5-aminosalicylic acid) 1 gram. RAFASSAL 4 GRAM ENEMA: Each enema contains mesalazine (5-aminosalicylic acid) 4 gram. Each enema contains 60 gram suspension. Excipients with known effect: Rafassal Enemas contain potassium metabisulphite (281 mg per bottle). Rafassal Enemas contain sodium benzoate (60 mg per bottle). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Enema for rectal use. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Treatment and prevention of ulcerative colitis and Crohn's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology (oral and rectal) During the acute inflammatory stage and in long-term maintenance therapy, Rafassal must be taken reliably and consistently by the patient. This is essential in order to attain the desired therapeutic success. _Rafassal Caplets _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ For acute inflammatory symptoms: Individual dosage up to 4 gram/day, divided into 2 or 3 doses. Rafassal Caplets should be taken with an ample amount of fluid 1 hour before meals. As soon as remission occurs, the dose should be reduced (to 2 g divided into 2 or 3 doses, to avoid recurrence. Children_ _ There is only limited documentation for an effect in children (age 6-18 years). Children 6 years of age and older ACTIVE DISEASE: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day. The total dose should not exceed the maximum adult dose (4 grams). 2 MAINTENANCE TREATMENT (ULCERATIVE COLITIS): To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed the recommended adult dose (2 grams). It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg. _Rafass Soma hati kamili