Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM CHLORIDE (SALT); POTASSIUM CHLORIDE; Magnesium Chloride; Calcium chloride; GLACIAL ACETIC ACID
B.BRAUN MEDICAL INDUSTRIES SDN BHD
SODIUM CHLORIDE (SALT); POTASSIUM CHLORIDE; Magnesium Chloride; Calcium chloride; GLACIAL ACETIC ACID
5000ml mL; 10000ml mL
B.BRAUN MEDICAL INDUSTRIES SDN BHD
INDICATIONS INDICATIONS INDICATIONS INDICATIONS INDICATIONS The indications below apply exclusively to the ready-for-use bicarbonate haemodialysis solution prepared from acid concentrate and bicarbonate concentrate following the specified dilution procedure: - Acute renal failure - Chronic renal failure - Overhydration - Intoxications - Adjustment of acid-base and electrolyte balance CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS CONTRAINDICATIONS Hyperkalaemia Intractable coagulopathy In patients with unstable circulation and/or unstable blood pressure, another extracorporeal haemodialysis method may be indicated. USAGE IN PREGNANCY USAGE IN PREGNANCY USAGE IN PREGNANCY USAGE IN PREGNANCY USAGE IN PREGNANCY Safety of HDM303 for haemodialysis treatment has not been determined in pregnant women. The products should be used only when clearly needed as prescribed by the physician. ADVERSE REACTIONS ADVERSE REACTIONS ADVERSE REACTIONS ADVERSE REACTIONS ADVERSE REACTIONS During haemodialysis, hypotension, nausea, vomiting and convulsions may occur. DOSAGE DOSAGE DOSAGE DOSAGE DOSAGE Unless otherwise directed, mix 1L HDM303 (acid concentrate) and 2.1L 5% bicarbonate concentrate or 1.222L 8.4% bicarbonate concentrate with 34L water of suitable quality (see Composition of the ready-for-use bicarbonate haemodialysis solution). ADMINISTRATION ADMINISTRATION ADMINISTRATION ADMINISTRATION ADMINISTRATION For extracorporeal bicarbonate haemodialysis or bicarbonate haemodiafiltration. The duration of administration must be determined on an individual basis. PRECAUTION PRECAUTION PRECAUTION PRECAUTION PRECAUTION • HDM303 (acid concentrate) may only be used in combination with 5% bicarbonate concentrate or 8.4% bicarbonate concentrate following a specified dilution procedure. • The ready-for-use bicarbonate haemodialysis solution must be tested before use by a suitable gas analysis method. • Acid concentrate and bicarbonate concentrate should be diluted only immediately before use. Discard unused po Læs hele dokumentet