Fentanyl Viatris

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fentanyl 10.2mg (Alkaloid powder)

Available from:

Viatris Limited

INN (International Name):

Fentanyl 10.2 mg (Alkaloid powder)

Dosage:

100 mcg/h

Pharmaceutical form:

Transdermal patch

Composition:

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

Units in package:

Sachet, laminate, 26# C1S paper/7.2 # LDPE/0.00035"F aluminium foil/14.4# LDPE in a carton, 5 patches

Class:

Class B3 Controlled Drug

Prescription type:

Class B1 Controlled Drug

Manufactured by:

Cambrex Charles City Inc

Therapeutic indications:

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.

Product summary:

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

Authorization date:

2008-12-22

Patient Information leaflet

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

Summary of Product characteristics

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�