País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
FENTANYL
KIMIA FARMA, Jakarta - Indonesia
FENTANYL
8,4 MG/PATCH (MATRIX)
TRANSDERMAL
DUS, 5 PATCH
ALZA IRELAND Ltd - Ireland
2016-07-11
Page 1 DUROGESIC ® NAME OF THE MEDICINAL PRODUCT Trade Name DUROGESIC Fentanyl Transdermal System INTERNATIONAL NON-PROPRIETARY NAME Fentanyl (Chemical Name) (N-Phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide) DOSAGE FORMS AND STRENGTHS DUROGESIC ® patches are for transdermal use only. Transdermal patch providing continuous systemic delivery of fentanyl, a potent opioid analgesic, for 72 hours. DUROGESIC ® Dose (mcg/h) Active Surface Area (cm 2 ) Fentanyl Content in Patch (mg) DUROGESIC ® 12* 5.25 2.1 DUROGESIC ® 25 10.5 4.2 DUROGESIC ® 50 21.0 8.4 * The lowest dose is designed as 12 mcg/h (however, the actual dose is 12.5 mcg/h) to distinguish it from a 125 mcg/h dose that could be prescribed by using multiple patches. For excipients, see list of Excipients CLINICAL INFORMATION INDICATIONS DUROGESIC ® is indicated in the management of chronic pain and intractable pain that requires continuous opioid administration for an extended period of time. DOSAGE AND ADMINISTRATION DUROGESIC ® doses should be individualized based upon the status of the patient and should be assessed at regular intervals after application. The patches are designed to deliver approximately 12, 25, 50, 75, and 100 mcg/hour fentanyl to the systemic circulation, which represent about 0.3, 0.6, 1.2, 1.8, and 2.4 mg per day (see _Dosage Forms and Strengths_), respectively. ID : EREG10030312100092; EREG10030312100093; EREG10030312100094 DISETUJUI BPOM : 6/1/2022 Page 2 INITIAL DOSE SELECTION The appropriate initiating dose of DUROGESIC ® should be based on the patient’s current opioid use. It is recommended that DUROGESIC ® be used in patients who have demonstrated opiod tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance. DOSAGE - ADULTS OPIOID-TOLERANT PATIENTS To convert opioid-tolerant patients from oral or parenteral opioids to DUROGESIC ® refer to _Equianalgesic _ _potency c Llegiu el document complet