FENTA 25

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

FENTANYL

Commercializzato da:

RAFA LABORATORIES LTD

Codice ATC:

N02AB03

Forma farmaceutica:

PATCHES

Composizione:

FENTANYL 25 MCG/HOUR

Via di somministrazione:

TRANSDERMAL

Tipo di ricetta:

Required

Prodotto da:

TESA LABTEC GMBH, GERMANY

Gruppo terapeutico:

FENTANYL

Area terapeutica:

FENTANYL

Indicazioni terapeutiche:

Management of chronic pain and intractable pain requiring opioid analgesia.Fenta should only be used in patients who are already receiving opioid therapy who have demonstrated opioid tolerance.

Data dell'autorizzazione:

2022-02-28

Foglio illustrativo

Patient Leaflet According to the Pharmacists' Regulations
(Preparations) - 1986
1
This medicine requires a doctor's prescription
Fenta 12, Fenta 25, Fenta 50, Fenta 75, Fenta 100
Transdermal Patches
Active ingredient:
Each patch of Fenta 12 contains 2.063 mg Fentanyl and releases 12.5
mcg/hr.
Each patch of Fenta 25 contains 4.125 mg Fentanyl and releases 25
mcg/hr.
Each patch of Fenta 50 contains 8.25 mg Fentanyl and releases 50
mcg/hr.
Each patch of Fenta 75 contains 12.375 mg Fentanyl and releases 75
mcg/hr.
Each patch of Fenta 100 contains 16.5 mg Fentanyl and releases 100
mcg/hr.
For the list of the additional ingredients, see section 6.
•
The patches contain a strong painkiller (opioid).
•
Ensure that the old patch is removed before applying a new patch.
•
Do not cut the patches.
•
Do not expose the patches to a heat source (such as hot water
bottles).
•
If you develop a fever tell your doctor immediately.
•
Follow the dosage usage instructions carefully and change the patch
every 3 days
(72 hours).
•
If your breathing becomes shallow and weak remove the patch and seek
medical
attention immediately.
Read the entire leaflet carefully before using the medicine.
This leaflet contains concise information about the medicine. If you
have any further questions,
please refer to your doctor or pharmacist.
This medicine has been prescribed to treat your condition. Do not pass
it on to others. It may
harm them, even if it seems to you that their medical condition is
similar to yours.
Medicines of the opioids group may cause addiction, especially with
prolonged use, and they
have a potential for misuse and overdose. A reaction to an overdose
may be manifested by slow
breathing and may even cause death.
Make sure you know the name of the medicine, the dosage that you take,
how often you take it,
the duration of treatment, potential side effects and risks.
Additional information regarding the risk of dependence and addiction
can be found at the
following link:
https://www.health.gov.il/UnitsOffice/HD/MTI/Dru

Scheda tecnica

Fenta-DL-Dec 2022-04
1. NAME OF THE MEDICINAL PRODUCT
Fenta 12, Fenta 25, Fenta 50, Fenta 75, Fenta 100
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
FENTA 12*: Each patch releases 12.5 micrograms fentanyl per hour. Each
patch of 3.75 cm
2
contains 2.063 mg fentanyl.
FENTA 25: Each patch releases 25 micrograms fentanyl per hour. Each
patch of 7.5 cm
2
contains 4.125 mg fentanyl.
FENTA 50: Each patch releases 50 micrograms fentanyl per hour. Each
patch of 15 cm
2
contains 8.25 mg fentanyl.
FENTA 75: Each patch releases 75 micrograms fentanyl per hour. Each
patch of 22.5 cm
2
contains 12.375 mg fentanyl.
FENTA 100: Each patch releases 100 micrograms fentanyl per hour. Each
patch of 30 cm
2
contains 16.5 mg fentanyl.
For the full list of excipients, see section 6.1.
*The lowest dose is stated as “Fenta12”,however, the actual dose
is 12.5 µg/hour, in order to distinguish it from a dose
of 125 µg/hour that could be prescribed by using multiple patches.
3. PHARMACEUTICAL FORM
Transdermal patch (TDP).
Each patch is marked:
FENTA 12:Transparent and colourless patch with blue imprint on the
backing foil: “fentanyl 12 µg/h“.
FENTA 25:Transparent and colourless patch with blue imprint on the
backing foil: “fentanyl 25 µg/h“.
FENTA 50:Transparent and colourless patch with blue imprint on the
backing foil: “fentanyl 50 µg/h“.
FENTA 75:Transparent and colourless patch with blue imprint on the
backing foil: “fentanyl 75 µg/h“.
FENTA 100:Transparent and colourless patch with blue imprint on the
backing foil: “fentanyl 100 µg/h“.
4.
CLINICAL PARTICULARS
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS
DEPRESSANTS
•
Concomitant use of opioids with benzodiazepines or other central
nervous system (CNS) depressants, including
alcohol, may result in profound sedation, respiratory depression,
coma, and death _[_see sections _4.4, 4.5]_.
•
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative treatment options are
inadequate.
•
Limit dosages and du