REMIFENTANIL BIOAVENIR 1 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

REMIFENTANIL AS HYDROCHLORIDE

Available from:

BIOAVENIR LTD, ISRAEL

ATC code:

N01AH06

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

REMIFENTANIL AS HYDROCHLORIDE 1 MG

Administration route:

I.V

Prescription type:

Required

Manufactured by:

LABORATORIO REIG JOFRE S.A., SPAIN

Therapeutic area:

REMIFENTANIL

Therapeutic indications:

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

Authorization date:

2019-04-30

Patient Information leaflet

12/2021
אפור
/
,ה/דבכנ ת/חקור ,ה
ולעב ןוכדע לע ךעידוהל וננוצרב
םינ
רישכתה לש
םי
:
REMIFENTANIL BIOAVENIR 1 MG לינטנפימר רינבאויב
1
ג"מ
REMIFENTANIL BIOAVENIR 2 MG רינבאויב לינטנפימר
2
ג"מ
REMIFENTANIL BIOAVENIR 5 MG רינבאויב לינטנפימר
5
ג"מ
:ןונימ תרוצ
POWDER FOR SOLUTION FOR INJECTION
:ליעפה ביכרמה
REMIFENTANIL ( AS HYDROCHLORIDE ) ןולעב םייתוהמ םינוכדע ןולע תנוכתמב ןכרצל
:אפורל
היוותה תינכדעה
:
Remifentanil Bioavenir is indicated as an analgesic agent for use
during induction and/or
maintenance of general anaesthesia under close supervision .
Remifentanil Bioavenir is indicated for provision of analgesia and
sedation in mechanically
ventilated intensive care patients 18 years of age and over.
3. PHARMACEUTICAL FORM
…
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 4.4 AND 4.5]
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
…
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
(…)
ANAESTHESIA IN SPONTANEOUSLY BREATHING ANAESTHETISED PATIENTS WITH A
SECURED AIRWAY (E.G.
LARYNGEAL MASK ANAESTHESIA): (…)
Remifentanil should not be used as an analgesic in procedures where
patients remain
conscious or do not receive any airway support during the procedure.
(…)
ESTABLISHMENT OF ALTERNATIVE ANALGESIA PRIOR TO DISCONTINUATION OF
REMIFENTANIL:
Due to the very rapid offset of action of remifentanil, no residual
opioid activity will be
present within 5 to 10 minutes after discontinuation.
Prior to discontin

Summary of Product characteristics

1
REMIFENTANIL BIOAVENIR
1. NAME OF THE MEDICINAL PRODUCT
Remifentanil BioAvenir 1 mg powder for solution for injection
Remifentanil BioAvenir 2 mg powder for solution for injection
Remifentanil BioAvenir 5 mg powder for solution for injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1-mg vial: each vial contains 1 mg of Remifentanil (as hydrochloride)
2-mg vial: each vial contains 2 mg of Remifentanil (as hydrochloride)
5-mg vial: each vial contains 5 mg of Remifentanil (as hydrochloride)
When reconstituted as directed, solutions of Remifentanil for
injection are clear and
colourless and contain 1 mg/ml of Remifentanil base as Remifentanil
hydrochloride.
Remifentanil for injection is available as 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 solution for i.v
injection
White to off-white, lyophilized powder, to be reconstituted before use
pH of reconstituted solution: from 2.5 to 3.5.
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 4.4 and 4.5]. Reserve concomitant
prescribing of these drugs
2
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. CLINICAL DATA
4.1. THERAPEUTIC INDICATIONS
Remifentanil Bioavenir is indicated as an analgesic agent for use
during induction and/or
maintenance of general anaesthesia under close supervision.
Remifentanil Bioavenir 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 SHOULD BE ADMINISTERED ONLY IN A SETTING FULLY EQUIPPED
FOR THE
MONITORING AND SUPPORT