País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
HYDROMORPHONE HYDROCHLORIDE
KIMIA FARMA, Jakarta - Indonesia
HYDROMORPHONE HYDROCHLORIDE
8 MG
TABLET PELEPASAN LAMBAT
DUS @ 4 BLISTER @ 7 TABLET PELEPASAN LAMBAT
JANSSEN CILAG FARMACEUTICAL SpA - Italy
2018-01-04
JURNISTA ® HYDROMORPHONE HYDROCHLORIDE DOSAGE FORMS AND STRENGTHS 8 mg tablets: Red, round, biconvex tablet, with ‘HM 8’ printed in black ink on one side. Each tablet contains 8.72 mg and delivers 8 mg hydromorphone HCl, equivalent to 7.12 mg hydromorphone base. 16 mg tablets: Yellow, round, biconvex tablet, with ‘HM 16’ printed in black ink on one side. Each tablet contains 16.35 mg and delivers 16 mg hydromorphone HCl, equivalent to 14.24 mg hydromorphone base. For excipients, see _List of Excipients. _ CLINICAL INFORMATION INDICATIONS JURNISTA is indicated for the management of moderate to severe cancer pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. JURNISTA is NOT intended for use as an as needed analgesic. JURNISTA is not indicated for the management of acute or postoperative pain. DOSAGE AND ADMINISTRATION As with other opioid analgesics, safe and effective administration of JURNISTA to patients with pain depends upon a comprehensive assessment of the patient. The nature of the pain as well as the concurrent medical status of the patient will affect selection of the dose. Owing to the varied response observed to opioids between individuals, it is recommended that all patients be started at the lowest appropriate dose of opioid therapy and titrated to an adequate level of analgesia, balanced against an acceptable frequency of adverse reactions. The lowest effective dose should be used for the shortest period of time (see _Dosage and Administration – Stopping Treatment_). As with any strong opioid, appropriate prophylaxis for known adverse reactions (for example constipation), should be considered. Patients should be instructed to swallow the JURNISTA tablet whole with a glass of water, at approximately the same time each day, and never to chew, divide, or crush it. JURNISTA should not be taken more than once every 24 hours. If the patient did not take the regularly scheduled dose of JURNISTA, the patient should be instructed Leer el documento completo