FENTANYL PANPHARMA 0.05 MGML

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

FENTANYL AS CITRATE

Tilgængelig fra:

PHARMALOGIC LTD

ATC-kode:

N01AH01

Lægemiddelform:

SOLUTION FOR INJECTION

Sammensætning:

FENTANYL AS CITRATE 0.05 MG/ML

Indgivelsesvej:

EPIDURAL, I.V

Recept type:

Required

Fremstillet af:

PANPHARMA, FRANCE

Terapeutisk område:

FENTANYL

Terapeutiske 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.

Autorisation dato:

2019-07-31

Produktets egenskaber

FENTANYL PANPHARMA
FENTANYL PANPHARMA 0.05 MG/ML
1.
PRODUCT NAME
FENTANYL PANPHARMA 100 MCG/2 ML
FENTANYL PANPHARMA 500 MCG/10 ML
SOLUTION FOR INJECTION FOR I.V. AND EPIDURAL ADMINISTRATION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 50 mcg fentanyl (as fentanyl citrate) – ampoules
of 2 ml and 10 ml
3.
PHARMACEUTICAL FORM
Solution for injection for I.V. 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
Fentanyl Panpharma is indicated:
• For analgesic action of short duration during anaesthetic periods
(premedication, induction and maintenance) and in the immediate
postoperative period, as need arises.
• As a narcotic analgesic supplement in general or regional
anaesthesia.
• For administration with a neuroleptic (such as droperidol) as an
anaesthetic premedication, for the induction of anaesthesia, and as
an adjunct in the maintenance of general and regional anaesthesia.
• For use as an anaesthetic agent with oxygen in selected high-risk
patients (open-heart surgery or certain neurological or orthopaedic
procedures).
• By the epidural route for the postoperative management of pains
following surgical procedures and Caesarean sections, and as adjunct
to general anesthesia.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
The dosage of Fentanyl Panpharma should be individualized according
to age, body weight, physical status, underlying pathological
condition,
use of other drugs, and type of su