FENTA INJECTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

FENTANYL AS CITRATE

Available from:

RAFA LABORATORIES LTD

ATC code:

N01AH01

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FENTANYL AS CITRATE 0.05 MG/ML

Administration route:

I.V, EPIDURAL

Prescription type:

Required

Manufactured by:

RAFA LABORATORIES LTD, JERUSALEM

Therapeutic group:

FENTANYL

Therapeutic area:

FENTANYL

Therapeutic indications:

For analgesic action of short duration during anesthtic 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 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:

2018-03-31

Patient Information leaflet

ראוני
2019
,ה/דבכנ ת/חקור ,ה/אפור
INJECTION
FENTA
-
אפורל ןולע ןוכדע
רישכתה לש אפורל ןולעה ןכדוע יכ
םכתעידיל איבהל תשקבמ אפר תודבעמ
ה ביכרמ
ה
ליעפ
:
Fentanyl (as citrate) 0.05 mg/ml
יוותה
תו
:

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 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 surgical
procedures and cesarean sections, and as adjunct to general
anesthesia.
םידיאויפואה תצובקמ םירישכתה לכל
ףיסוהל תואירבה דרשמ תשירדל םאתהב
Black box
יבגל
ףסוה ,םיניפזאידוזנב םע היצקארטניא
אבה עדימה
:ןולעב
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 '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.
אפורל ןולעל רושיק ב"צמ
–
עבצב ןמוסמ יונישה
.
תואירבה דרשמ רתאבש תופורתה רגאמב
םוסרפל חלשנ אפורל ןולעה
)
.gov

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
FENTA INJECTION
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.05 mg/ml (50 mcg/ml) Fentanyl (as citrate).
Excipient(s) with known effect: Sodium (about 3.5 mg/ml).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection for IV and epidural administration.
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- 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.
4.1
THERAPEUTIC INDICATIONS
Fenta Injection 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 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.
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
surgery and anesthesia.
2
To avoid bradycardia, it