Valsts: Indonēzija
Valoda: indonēziešu
Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 60 SACHET @ GRANUL PELEPASAN LAMBAT 2 G
2022-06-10
1 PROPOSED PACKAGING MATERIAL Code PENSAC2-I-ID-01.03 Size NA Submission ☒ NDA ☐ Renewal ☐ Variation change detail no.: Code of previous version NA Changes NA Reference ☒ CCDS version: CCDS Ver.17 (Jan 2021) ☐ Core PIL version: ☐ SPC country/version/date: ☐ LAC no.: Name & Date IRM, 24-Jan-2022 PENTASA ® MESALAZINE Prolonged release granules 2g COMPOSITION Each sachet contains 2 g mesalazine. Excipients: Ethylcellulose, povidone. PHARMACEUTICAL DOSAGE FORM Prolonged release granules. White-grey to pale white-brown granules. INDICATIONS Treatment of mild to moderate ulcerative colitis. POSOLOGY AND METHOD OF ADMINISTRATION _Posology: _ ULCERATIVE COLITIS Treatment of active disease: Adults: Individual dosage, up to 4 g given once daily or in divided doses. Maintenance treatment: Adults: Individual dosage. Recommended dosage, 2 g mesalazine once daily. Can also be taken in divided doses. _Method of administration: _ PENTASA granules must not be chewed. The contents of the sachet should be emptied onto the tongue and washed down with some water or juice. Alternatively the entire content of the sachet can be taken with yogurt and consumed immediately. CONTRAINDICATIONS 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 rash, mucosal lesions, or any other signs of hypersensitivity, therapy should be discontinued immediatel Izlasiet visu dokumentu