Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
FENTANYL
Nycomed UK Limited
50 Microgram per hour
Transdermal Patch
2006-10-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Matrifen, 50 micrograms/hour Transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Matrifen 50 micrograms/hour: Each transdermal patch contains 5.50 mg fentanyl in a patch of 16.8 cm 2 and releases fentanyl 50 micrograms/hour For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal patch. Rectangular, translucent patch on a removable protective film. The protective film is larger than the patch. The patches are equipped with a coloured imprint with trade name, active substance and strength: Matrifen 50 micrograms/hour patch: green imprint. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Severe chronic pain, which can be adequately managed only with opioid analgesics. Children: Long term management of severe chronic pain in children receiving opioid therapy from 2 years of age. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fentanyl transdermal patches release the active substance over 72 hours. The fentanyl release rate is 50 microgram/hour and the corresponding active surface area is 16.8 cm 2 . _Method of administration_ For transdermal use. Fentanyl transdermal patch should be applied to non-irritated and non-irradiated skin on a flat surface of the torso or upper arm. In young children the upper back is the preferred location to apply the patch, to minimize the potential of the child removing the patch. Hair at the application site (hairless area is preferred) should be clipped (not shaved) prior to system application. If the site requires to be cleansed prior to application of the patch, this should be done with water. Soaps, oils, lotions, alcohol or any other agent that might irritate the skin or alter its characteristics should not be used. The skin should be co Прочитајте комплетан документ