MIDAZOLAM B.BRAUN 1 MGML

Negara: Israel

Bahasa: Inggris

Sumber: Ministry of Health

Bahan aktif:

MIDAZOLAM AS HYDROCHLORIDE

Tersedia dari:

LAPIDOT MEDICAL IMPORT AND MARKETING LTD

Kode ATC:

N05CD08

Bentuk farmasi:

SOLUTION FOR INJECTION / INFUSION

Komposisi:

MIDAZOLAM AS HYDROCHLORIDE 1 MG / 1 ML

Rute administrasi :

I.M, I.V

Jenis Resep:

Required

Diproduksi oleh:

B.BRAUN MELSUNGEN AG, GERMANY

Area terapi:

MIDAZOLAM

Indikasi Terapi:

midazolam is a short-acting sleep-inducing drug that is indicated:In adults• CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia• ANAESTHESIA- Premedication before induction of anaesthesia- Induction of anaesthesia- As a sedative component in combined anaesthesia• SEDATION IN INTENSIVE CARE UNITSIn children• CONSCIOUS SEDATION before and during diagnostic or therapeutic procedures with or without local anaesthesia• ANAESTHESIA- Premedication before induction of anaesthesia• SEDATION IN INTENSIVE CARE UNITS

Tanggal Otorisasi:

2018-12-04

Karakteristik produk

DOCTOR LEAFLET
1 NAME OF THE MEDICINAL PRODUCT
MIDAZOLAM B. BRAUN 1 MG/ML
MIDAZOLAM B. BRAUN 5MG/ML
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: midazolam 1mg/ml or 5 mg/ml for i.v., i.m.
administration.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for INJECTION or INFUSION
.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midazolam is a short-acting sleep-inducing drug that is indicated:
IN ADULTS
•
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or
without local anaesthesia
•
ANAESTHESIA
o
Premedication before induction of anaesthesia
o
Induction of anaesthesia
o
As a sedative component in combined anaesthesia
•
SEDATION IN INTENSIVE CARE UNITS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
• Concomitant use of benzodiazepines and opioids may result in
profound sedation,
respiratory depression, coma, and death (see section 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.
2
IN CHILDREN
•
CONSCIOUS SEDATION before and during diagnostic or therapeutic
procedures with or
without local anaesthesia
•
ANAESTHESIA
o
Premedication before induction of anaesthesia
•
SEDATION IN INTENSIVE CARE UNITS
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
MIDAZOLAM IS A POTENT SEDATIVE AGENT THAT REQUIRES TITRATION AND SLOW
ADMINISTRATION. TITRATION IS
STRONGLY RECOMMENDED TO SAFELY OBTAIN THE DESIRED LEVEL OF SEDATION
ACCORDING TO THE CLINICAL NEED,
PHYSICAL STATUS, AGE AND CONCOMITANT MEDICATION. IN ADULTS OVER 60
YEARS, DEBILITATED OR CHRONICALLY ILL
PATIENTS AND PAEDIATRIC PATIENTS, DOSE SHOULD BE DETERMINED WITH
CAUTION AND RISK FACTORS RELATED TO
EACH PATIENT SHOULD BE TAKEN INTO ACCOUNT. STANDARD DOSAGES ARE
PROVIDED IN TABLE 1 AND ADDITIONAL
DETAILS ARE PROVIDED IN THE TEXT FOLLOWING TABLE 1.
TAB