MYTANYL 50 Microgram per hour Transdermal Patch
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
08-05-2024
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Active ingredient:
FENTANYL
Available from:
Lavipharm S.A.
INN (International Name):
FENTANYL
Dosage:
50 Microgram per hour
Pharmaceutical form:
Transdermal Patch
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
2012-08-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fentanyl Lavipharm 50 microgram/hour transdermal patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Fentanyl Lavipharm 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 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 50 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 ini
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