REMIFENTANIL B.BRAUN 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

REMIFENTANIL AS HYDROCHLORIDE

Available from:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

ATC code:

N01AH06

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION / INFUSION

Composition:

REMIFENTANIL AS HYDROCHLORIDE 1 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

B.BRAUN MELSUNGEN AG, GERMANY

Therapeutic area:

REMIFENTANIL

Therapeutic indications:

Remifentanil B.Braun is indicated as an analgesic agent for use during induction and/or maintenance of general anaesthesia under close supervision .Remifentanil B.Braun is indicated for provision of analgesia and sedation in mechanically ventilated intensive care patients 18 years of age and over.

Authorization date:

2023-03-31

Summary of Product characteristics

THE FORMAT OF THIS LEAFLET WAS DETERMINED BY THE MINISTRY OF HEALTH
AND ITS
CONTENT WAS CHECKED AND APPROVED BY IT ON NOVEMBER 2018
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Remifentanil B.Braun 1 mg, 2mg, 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Remifentanil B.Braun is a white to off white, compact powder, to be
reconstituted before use.
When reconstituted as directed, solutions of Remifentanil B.Braun
contain 1
mg/ml, of remifentanil base as remifentanil hydrochloride.
Remifentanil B.Braun for injection is available in glass vials
containing 1 mg, 2
mg or 5 mg of remifentanil base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for concentrate for solution for injection/infusion
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Remifentanil B.Braun is indicated as an analgesic agent for use during
induction and/or maintenance of general anaesthesia under close
supervision.
Remifentanil B.Braun is indicated for provision of analgesia and
sedation in
mechanically ventilated intensive care patients 18 years of age and
over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Remifentanil B.Braun should be administered only in a setting fully
equipped
for the monitoring and support of respiratory and cardiovascular
function and
WARNING: RISKS FROM CONCOMITANT USE WITH 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.

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.
by persons specifically trained in the use of anaesthetic drugs and
the
recognition and management of the expected adverse effects of potent
opioids, including respiratory and cardiac resuscitation.