Ülke: Yeni Zelanda
Dil: İngilizce
Kaynak: Medsafe (Medicines Safety Authority)
Fentanyl 10.2mg (Alkaloid powder)
Viatris Limited
Fentanyl 10.2 mg (Alkaloid powder)
100 mcg/h
Transdermal patch
Active: Fentanyl 10.2mg (Alkaloid powder) Excipient: Dimeticone Polyolefin Film (Mediflex 1000) 25 square centimeters Polyester release liner (Scotchpak 1022) 37.34 square centimeters No-Tox White FGN-4194 NT23 Silicone adhesive
Sachet, laminate, 26# C1S paper/7.2 # LDPE/0.00035"F aluminium foil/14.4# LDPE in a carton, 5 patches
Class B3 Controlled Drug
Class B1 Controlled Drug
Cambrex Charles City Inc
Mylan Fentanyl Patch is indicated in the management of chronic cancer pain. Mylan Fentanyl Patch is also indicated in the management of opioid-responsive chronic severe pain of non-malignant origin in opioid tolerant patients, after other conservative methods of analgesia have been tried. It is indicated for use in accordance with NZMA guidelines on chronic pain management and where there is no psychological contraindication, drug seeking behaviour or history of drug misuse.
Package - Contents - Shelf Life: Sachet, laminate, 26# C1S paper/7.2 # LDPE/0.00035"F aluminium foil/14.4# LDPE in a carton - 5 patches - 24 months from date of manufacture stored at or below 25°C
2008-12-22
Page 1 of 5 NEW ZEALAND CONSUMER MEDICINE INFORMATION MYLAN FENTANYL PATCH _FENTANYL TRANSDERMAL PATCH _ _12.5, 25, 50, 75 & 100 MICROGRAMS PER HOUR _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers same common questions about Mylan Fentanyl Patch. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you using Mylan Fentanyl Patch against the benefits they expect it will have for you. If you have any concerns about taking this medicine, talk to your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT MYLAN FENTANYL PATCH IS USED FOR Mylan Fentanyl Patch is used to relieve chronic or long-lasting pain, which requires strong painkillers. The patches contain a medicine called fentanyl. This strong pain reliever belongs to a group of medicines known as opioid analgesics. Fentanyl relieves pain by blocking the nerves that recognize pain messages from the body. Each patch is applied onto the skin every 72 hours (3 days). The patch releases a continuous amount of fentanyl that is absorbed through the skin in contact with the patch (see FENTANYL PATCH DIAGRAM). Your doctor may have prescribed Mylan Fentanyl Patch for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. _WARNING_ MYLAN FENTANYL PATCH MAY BE RETRIEVED AND ABUSED BY ADDICTS. PLEASE ENSURE THAT USED PATCHES ARE CONCEALED AND DISPOSED OF CAREFULLY. RETURN UNUSED PATCHES TO THE PHARMACY (SEE DISPOSAL AT THE END OF THIS LEAFLET). KEEP USED AND UNUSED PATCHES WHERE CHILDREN CANNOT REACH THEM. BEFORE YOU USE MYLAN FENTA Belgenin tamamını okuyun
Page 1 of 16 NEW ZEALAND DATA SHEET MYLAN FENTANYL PATCH _FENTANYL TRANSDERMAL PATCH _ _12.5 MICROGRAMS/HOUR, 25 MICROGRAMS/HOUR, _ _50 MICROGRAMS/HOUR, 75 MICROGRAMS/HOUR, 100 MICROGRAMS/HOUR _ _ _ PRESENTATION Mylan Fentanyl Patch is a transdermal system (patch), which provides continuous systemic delivery of fentanyl, a potent opioid analgesic, for the intended duration of application (72 hours). Mylan Fentanyl Patch is a translucent rectangular patch with rounded corners comprising a protective liner and two functional layers. _ Diagram 1: Fentanyl Patch (not to scale) _ Proceeding from the outer surface toward the surface adhering to skin, these layers are: 1. A backing layer of polyolefin film with white imprinting ink; and 2. A fentanyl containing silicone adhesive layer. Before use, a protective polyester release liner that is attached to and covering the adhesive layer is removed and discarded. Mylan Fentanyl Patch systems are packaged with additional pieces of protective polyester film above and below the system within each pouch. These are also discarded at the time of use. Mylan Fentanyl Patch is available in five different strengths, the composition of which is identical per unit area. The 3.13, 6.25, 12.5, 18.75, 25 cm 2 systems are designed to deliver 12.5, 25, 50, 75 and 100 micrograms/hour fentanyl. The other components are pharmacologically inactive. USES _ACTIONS _ Fentanyl is an opioid analgesic, interacting predominantly with the mu-opioid receptor. Its primary therapeutic actions are analgesia and sedation. Minimum effective analgesic serum concentrations of fentanyl in opioid-naïve patients range from 0.3 to 1.5 nanograms/mL; side effects increase in frequency at serum levels above Belgenin tamamını okuyun