FENTANYL - KALCEKS 0.05 MGML

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

FENTANYL AS CITRATE

Tillgänglig från:

A.L. MEDI-MARKET LTD.

ATC-kod:

N01AH01

Läkemedelsform:

SOLUTION FOR INJECTION

Sammansättning:

FENTANYL AS CITRATE 0.05 MG / 1 ML

Administreringssätt:

EPIDURAL, I.V

Receptbelagda typ:

Required

Tillverkad av:

HBM PHARMA S.R.O., SLOVAKIA

Terapiområde:

FENTANYL

Terapeutiska indikationer:

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.

Tillstånd datum:

2020-11-22

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Fentanyl-Kalceks 0.05 mg/ml
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 0.05 mg (50 mcg) of fentanyl (as fentanyl
citrate).
Each ampoule of 2 ml contains 0.1 mg (100 mcg) of fentanyl (as
fentanyl citrate).
Each ampoule of 10 ml contains 0.5 mg (500 mcg) of fentanyl (as
fentanyl citrate).
Excipient with known effect
Each ampoule of 2 ml contains 7.08 mg (0.31 mmol) sodium.
Each ampoule of 10 ml contains 35.41 mg (1.54 mmol) sodium.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution for injection, free from visible particles.
The pH of the solution is 4.0 to 7.5.
Osmolality is approximately 285 mOsmol/kg.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Fentanyl-Kalceks 0.05 mg/ml 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
WARNING: RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINS OR
OTHER CNS DEPRESSANTS
•
Concomitant use of opioids with benzodiazepins or other central
nervous
system (CNS) depressants, including alcohol, may result in profound
sedation,
respiratory depression, coma, and death (see section 4.5., Interaction
with
other medicinal products and other forms of interaction).
•
Reserve concomitant prescribing of these drugs for use in patients for
whom
alternative treatment options are inadequate.