Midazolam Kalceks 5mgml solution for injection infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

MIDAZOLAM

Available from:

EUCOGEN SDN BHD

INN (International Name):

MIDAZOLAM

Units in package:

10 ampoules x 1 ml; 10 ampoules x 3 ml

Manufactured by:

HBM PHARMA S.R.O.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Midazolam Kalceks 5 mg/ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution contains 5 mg of midazolam.
Each ampoule with 1 ml of solution contains 5 mg of midazolam.
Each ampoule with 3 ml of solution contains 15 mg of midazolam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion.
Clear, colourless or yellowish liquid.
Osmolality 275 – 305 mOsmol/kg
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midazolam Kalceks is a short-acting sleep-inducing drug that is
indicated as follows:
IN ADULTS
•
CONSCIOUS SEDATION before or 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 PAEDIATRIC
•
CONSCIOUS SEDATION before or during diagnostic or therapeutic
procedures with or without
local anaesthesia
•
ANAESTHESIA
-
Premedication before induction of anaesthesia
•
SEDATION IN INTENSIVE CARE UNITS
For dosage recommendation in specific age range see section 4.2 below,
Table 1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Midazolam is a potent sedative agent that requires slow administration
and individualization of
dosage.
The dose should be individualized and 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 of age, critically ill patients, high-risk
patients and paediatric patients, the dose
should be determined with caution and risk factors related to each
patient should be taken into
account.
The drug takes effect in about 2 minutes after intravenous injection.
Maximum effect is obtained in
about 5 to 10 minutes.
Standard dosages are provided in the Table 1 below. Additional details
are given in the text followin