MIDAZOLAM KALCEKS 5 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MIDAZOLAM

Available from:

A.L. MEDI-MARKET LTD.

ATC code:

N05CD08

Pharmaceutical form:

SOLUTION FOR INJECTION / INFUSION

Composition:

MIDAZOLAM 5 MG / 1 ML

Administration route:

I.M, I.V

Prescription type:

Required

Manufactured by:

HBM PHARMA S.R.O., SLOVAKIA

Therapeutic area:

MIDAZOLAM

Therapeutic indications:

Midazolam Kalceks 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

Authorization date:

2020-12-15

Summary of Product characteristics

DOCTOR LEAFLET
1
NAME OF THE MEDICINAL PRODUCT
Midazolam Kalceks 1 mg/ml
Midazolam Kalceks 5 mg/ml
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Midazolam Kalceks
_1 MG/ML _
1 ml of solution contains 1 mg of midazolam.
One ampoule with 5 ml of solution contains 5 mg of midazolam.
Midazolam Kalceks
_5 MG/ML _
1 ml of solution contains 5 mg of midazolam.
One ampoule with 1 ml of solution contains 5 mg of midazolam.
One ampoule with 3 ml of solution contains 15 mg of midazolam.
One ampoule with 10 ml of solution contains 50 mg of midazolam.
Excipient with a known effect
Midazolam Kalceks
_1 MG/ML _
Each ml of solution contains 3.50 mg sodium.
Midazolam Kalceks
_5 MG/ML _
Each ml of solution contains 3.15 mg sodium.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless solution.
pH 2.9-3.7.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midazolam is a short-acting sleep-inducing drug that is indicated:
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.
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 UNITS
IN 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
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
STANDARD DOSAGE
Midazolam is a potent sedat