Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
FENTANYL
Pfizer Healthcare Ireland
50 Microgram per hour
Transdermal Patch
2012-01-06
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fentadur 50 micrograms/hour Transdermal Patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fentanyl 50 micrograms/ hour transdermal patch contains 5.5 mg of fentanyl in a patch size of 20cm 2 , releasing 50 micrograms of fentanyl per hour. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch Fentanyl transdermal patch is a rectangular, tan coloured patch placed between two oversized, transparent protective layers which must be removed prior to the patch application. The patches will be imprinted: “Fentanyl 50 µg/h” in red 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Severe chronic pain which can be adequately managed only with opioid analgesics. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosing is individual and based on the patient’s opioid history and takes in to account: possible development of tolerance the current general condition, the medical status of the patient, and the degree of severity of the disorder The required fentanyl dosage is adjusted individually and should be assessed regularly after each administration. _Patients receiving opioid treatment for the first time_ Patches with a release rate of 12.5 micrograms/hour are available and should be used for initial dosing. In very elderly or weak patients, it is not recommended to initiate an opioid treatment with Fentanyl, due to their known susceptibility to opioid treatments. In these cases, it would be preferable to initiate a treatment with low doses of immediate release morphine and to prescribe Fentanyl after determination of the optimal dosage. _Switching from other opioids_ When changing over from oral or parenteral opioids to fentanyl treatment, the initial dosage should be calculated Прочитајте комплетан документ