FENTANYL-PIRAMAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FENTANYL AS CITRATE

Available from:

PHARMA MEDIS

ATC code:

N01AH01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FENTANYL AS CITRATE 0.05 MG/ML

Administration route:

EPIDURAL, I.V

Prescription type:

Required

Manufactured by:

GLAXO SMITHKLINE MANUFACTURING S.P.A., ITALY

Therapeutic group:

FENTANYL

Therapeutic area:

FENTANYL

Therapeutic indications:

For analgesic action of short duration during anesthtic periods (premedication dinduction and maintenance) and in the immediate postoperative period as need arises. As a narcotic analgesic supplement in general or regional anesthesia. For administration with neuroleptics (such as droperidol) as an anesthetic premedication for the induction of anesthesia and as an adjunct in the maintenance of general or regional anesthesia. For use as an anesthetic agent with oxygen in selected high-risk patients (open heart surgery or certain neurological or orthopedic procedures). By the epidural route for the postoperative management of pain following general surgical procedures and cesarean sections and as adjunct to general anesthesia.

Authorization date:

2022-04-30

Patient Information leaflet

םייפש ץוביק
60990
לארשי
09-9591111
לט
'
09-9583636
להונ
תשגהל
תושקב
יוניש ,םושירל
שודיחו
םירישכת
םייאופר
הקלחמל
םושירל
םירישכת
טסוגוא
2012
חפסנ
16
םיספט
תשגהל
תורמחה
םינולעב
להונ
תשגהל
תושקב
יוניש ,םושירל
שודיחו
םירישכת
םייאופר
הקלחמל
םושירל
םירישכת
טסוגוא
2012
העדוה
לע
הרמחה
עדימ(
ןולעב )תוחיטב
אפורל
:ךיראת
29-10-2014
םש
רישכת
תילגנאב
רפסמו
:םושירה
FENTANYL JANSSEN 254121376
םש
לעב
:םושירה
J-C HEALTH CARE LTD
.
!דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
Dosage and
administration
To avoid bradycardia, it is recommended to administer a
small intravenous dose of an anti-cholinergic just before
induction. _[Droperidol may be given to prevent nausea_
_and vomiting.]_
_- USE AS AN ANALGESIC SUPPLEMENT TO GENERAL _
_ANAESTHESIA_
Low dose: 2 µg/kg
Fentanyl in small doses is most useful for minor, but
painful, surgery.
_-- Use in the elderly _
As with other opioids, the dose should be reduced in
elderly or debilitated patients.
To avoid bradycardia, it is recommended to administer a small
intravenous dose of an anti-cholinergic just before anesthetic
induction. _[Droperidol may be given to prevent nausea and vomiting.]_
_- USE AS AN ANALGESIC SUPPLEMENT TO GENERAL ANAESTHESIA_
Low dose: 2 µg/kg
Fentanyl in small doses is most useful for minor, but painful,
surgery.
SPECIAL POPULATIONS
_- Use in the elderly Elderly and debilitated patients _
As with other opioids, the initial dose should be reduced in elderly
(>65 years of age) and in or debilitated patients. The effect of the
initial dose should be taken into account in determining supplemental
ץוביק
םייפש
60990
,
:ןופלט
09-9591111
,
:סקפ
09-9583636
Kibbutz Shefayim 60990, Tel: [phone], Fax

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fentanyl-Piramal
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains 78.5 micrograms fentanyl citrate
equivalent to 50
micrograms per ml fentanyl base.
Excipient(s) with known effect:
Sodium 3.5 mg/ml.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Fentanyl-Piramal is indicated:
-
For analgesic action of short duration during anesthetic periods
(premedication,
induction and maintenance) and in the immediate postoperative period,
as need
arises.
-
As a narcotic analgesic supplement in general or regional anesthesia.
-
For administration with a neuroleptic _[such as droperidol] _as an
anesthetic
premedication, for the induction of anesthesia, and as an adjunct in
the
maintenance of general and regional anesthesia.
-
For use as an anaesthetic agent with oxygen in selected, high-risk
patients (open
heart surgery or certain neurological or orthopedic procedures).
-
By the epidural route for the postoperative management of pains
following
general surgical procedures and cesarean sections and as adjunct to
general
anesthesia.
4.2
Posology and method of administration
The dosage of Fentanyl should be individualized according to age, body
weight,
physical status, underlying pathological condition, use of other
drugs, and type of
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.,
Interactions).
•
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.
surgery and ane