Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MIDAZOLAM
EUCOGEN SDN BHD
MIDAZOLAM
10 ampoules x 1 ml; 10 ampoules x 3 ml
HBM PHARMA S.R.O.
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 Lue koko asiakirja