国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Sodium chloride; Potassium chloride; Calcium chloride dihydrate ; Sodium lactate solution 50%
Fresenius Kabi Limited
B05BB; B05BB01
Sodium chloride; Potassium chloride; Calcium chloride dihydrate ; Sodium lactate solution 50%
%v/v
Solution for infusion
Product subject to prescription which may not be renewed (A)
Solutions affecting the electrolyte balance; electrolytes
Not marketed
2005-05-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hartmann’s Solution for Infusion, PSEB bag 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _For full list of excipients, see section 6.1._ Molar formula 3 PHARMACEUTICAL FORM Solution for infusion. Osmolarity: 279 mOsm/l Osmolarity: 255 mOsm/kg pH: 5.5 to 6.3 Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Predominantly extracellular dehydration, regardless of cause (vomiting, diarrhea, fistulas, etc.). Hypovolemia regardless of cause: hemorrhagic shock, burns, peri-operative water and electrolyte loss. Mild metabolic acidosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY : This is determined by the physician according to clinical status, age and weight of the patient and according to laboratory findings. Bag : 50 ml 100 ml 250 ml 500 ml 1000 ml Sodium chloride (g) 0.30 0.60 1.50 3.00 6.00 Potassium chloride (g) 0.020 0.04 0.10 0.20 0.40 Dihydrated calcium chloride (g) 0.01 0.03 0.07 0.14 0.27 50% sodium lactate solution (g) 0.32 0.63 1.59 3.17 6.34 Bag : 50 ml 100 ml 250 ml 500 ml 1000 ml Sodium (mmol) 6.55 13.09 32.73 65.45 130.90 Potassium (mmol) 0.27 0.54 1.35 2.70 5.40 Calcium (mmol) 0.09 0.18 0.46 0.92 1.84 Chloride (mmol) 5.59 11.17 27.93 55.85 111.70 Lactate (mmol) 1.42 2.83 7.08 14.15 28.30 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _2_ _/_ _0_ _8_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _5_ _5_ _7_ _8_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 完全なドキュメントを読む