Šalis: Indonezija
kalba: indoneziečių
Šaltinis: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MESALAZINE
ABBOTT INDONESIA - Indonesia
MESALAZINE
1 G
SUPPOSITORIA
Dus, 4 blister @ 7 suppositoria
FERRING INTERNATIONAL CENTER SA - Switzerland
2019-09-28
PROPOSED PACKAGING MATERIAL Code PENSUP-I-ID-04.03 Size NA Submission ☐ NDA ☐ Renewal ☒ Variation change detail no.: CR 188030, 129438, 165591 Code of previous version PENSUP-I-ID-04.02 Changes BPOM Deficiency letter date 19Mar2021 (Revision on contraindication and interactions) Reference ☒ CCDS version: CCDS Ver.17 (Jan 2021) ☐ Core PIL version: ☐ SPC country/version/date: ☐ LAC no.: Name & Date IRM, 07-Dec-2021 1 | P a g e PENTASA ® _Mesalazine _ Suppositories 1g COMPOSITION Each suppository contains 1 g mesalazine. Excipients: magnesium stearate, talc, povidone, macrogol 6000. PHARMACEUTICAL DOSAGE FORM Suppositories INDICATIONS Treatment of ulcerative proctitis. DOSAGE AND ADMINISTRATION Adults : 1 suppository 1-2 times daily. INSTRUCTION FOR USE 1. A visit to the toilet is recommended before inserting a suppository. 2. Open the foil bag at the tear mark. 3. The suppository is inserted in the rectum until resistance is felt and disappeared again. 4. In order to facilitate the administration, the suppository can be moistured with water or moisture cream. 5. If the suppository is discharged within the first 10 minutes, another can be inserted. CONTRAINDICATIONS Children under the age of 15 years. Hypersensitivity to mesalazine, any of the excipients, or salicylates Severe liver or renal impairment SPECIAL WARNINGS AND PRECAUTIONS FOR USE Most patients who are intolerant or hypersensitive to sulphasalazine are able to take PENTASA without risk of similar reactions. However, caution is recommended when treating patients allergic to sulphasalazine (risk of allergy to salicylates). Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment. In case of acute intolerance reactions such as abdominal cramps, acute abdominal pain, fever and severe headache and/or the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hyp Perskaitykite visą dokumentą