Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FENTANYL
Lavipharm S.A.
FENTANYL
25 Microgram per hour
Transdermal Patch
Product subject to prescription which may not be renewed (A)
Withdrawn
2012-08-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fentanyl Lavipharm 25 microgram/hour transdermal patch 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fentanyl Lavipharm 25 micrograms/ hour transdermal patch contains 2.75 mg of fentanyl in a patch size of 10cm 2 , releasing 25 micrograms of fentanyl per hour. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Transdermal Patch Fentanyl Lavipharm transdermal patch consists of an impermeable tan coloured backing, a drug reservoir, a rate- controlling membrane, and a skin adhesive, along with a release liner that covers the skin adhesive until it is removed prior to application by the patient. The patches will be imprinted: “Fentanyl 25 µg/h” in red ink 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: The product is indicated in 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 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. Adults: _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 a treatment with Fentanyl Lavipharm, due to their known susceptibility to opioid treatments. In these cases, it would be preferable to in Read the complete document