FENTA 100

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

FENTANYL

Διαθέσιμο από:

RAFA LABORATORIES LTD

Φαρμακολογική κατηγορία (ATC):

N02AB03

Φαρμακοτεχνική μορφή:

PATCHES

Σύνθεση:

FENTANYL 100 MCG/HOUR

Οδός χορήγησης:

TRANSDERMAL

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

TESA LABTEC GMBH, GERMANY

Θεραπευτική περιοχή:

FENTANYL

Θεραπευτικές ενδείξεις:

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.

Ημερομηνία της άδειας:

2014-12-16

Φύλλο οδηγιών χρήσης

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is sold with a doctor's prescription only
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 delivers 12.5
mcg/hr.
Each patch of Fenta 25 contains 4.125 mg Fentanyl and delivers 25
mcg/hr.
Each patch of Fenta 50 contains 8.25 mg Fentanyl and delivers 50
mcg/hr.
Each patch of Fenta 75 contains 12.375 mg Fentanyl and delivers 75
mcg/hr.
Each patch of Fenta 100 contains 16.5 mg Fentanyl and delivers 100
mcg/hr.
For a list of inactive ingredients, please see section 6.
PLEASE READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICATION.
This leaflet contains concise information about the medicine. If you
have any further questions,
refer to the doctor or pharmacist.
This medicine has been prescribed for treating 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/Drugs/risk/DocLib/opioids_en.pdf
Taking this medicine along with medicines from the benzodiazepines
group, other medicines which
depress the central nervous system (including drugs) or alcohol may
cause a feeling of profound
drowsiness, breathing difficulties (respiratory depression), coma and
death.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for relief of strong chronic pain requiring
opioid analgesia.
Fenta is indicated for patients who are already

Αρχείο Π.Χ.Π.

Fenta-DL-Jan 2015-May 2019_box_02
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 a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Transdermal matrix patch.
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 section _4.5]_.

Reserve concomitant prescribing of these drugs for use in patients for
whom
alternative treatment options are inadequate.

Limit dosages and durations to the minimum required.

Follow patients for signs and symptoms of respiratory depression and
sedation.
_ _
4.1 THERAPEUTIC INDICATIONS
Management of chronic pain and intractabl