国: 台湾
言語: 中国語
ソース: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
POLY(O-2 HYDROXYETHYL )STARCH;;SODIUM CHLORIDE
和聯生技藥業股份有限公司 台北市敦化北路311號5樓 (04270075)
B05AA
注射劑
SODIUM CHLORIDE (4012002100) MG; POLY(O-2 HYDROXYETHYL )STARCH (9600030283) MG
塑膠軟袋裝
製 劑
限由醫師使用
AKZONOBEL SALT A/S HADSUNDVEJ 17, DK-9550 MARIAGER DENMARK DK
Blood substitutes and plasma protein fractions
預防及治療血容積低下及低血容積性休克。
註銷日期: 2019/04/26; 註銷理由: 許可證已逾有效期; 有效日期: 2017/06/19; 英文品名: VitaHES Solution for Infusion
已註銷
2012-06-19
S UMMARY OF P RODUCT C HARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT VitaHES ® , solution for infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml contains: Poly(O-2-hydroxyethyl)starch (HES) 60.0 g Molar substitution: 0.42 Mean molecular weight: 130,000 Da Sodium chloride 9.0 g _Electrolyte concentration: _ Sodium 154 mmol/l Chloride 154 mmol/l pH: 4.0 − 6.5 Theoretical osmolarity: 309 mOsmol/l Titration acidity: <1.0 mmol/l For excipient, see 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Clear, colorless aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of hypovolemia and shock. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The daily dose and infusion rate depend on the extent of blood loss, maintenance or restoration of hemodynamic parameters, and the level of hemodilution. The first 10–20 ml should be infused slowly and with careful patient monitoring so that a possible anaphylactoid reaction can be detected as early as possible. _Maximum infusion rate: _ The maximum infusion rate depends on the clinical situation. Patients in acute shock may be administered up to 20 ml per kg of body weight per hour (equivalent to 0.33 ml/kg/min or 1.2 g of hydroxyethyl starch per kg of body weight per hour). In life-threatening situations, 500 ml may be administered by manual pressure infusion. Also see "Method of administration and duration of therapy". 1 _Maximum daily dose: _ Up to 50 ml of VitaHES per kg of body weight (equivalent to 3.0 g of hydroxyethyl starch and 7.7 mmol sodium per kg of body weight). This is equivalent to 3,500 ml of VitaHES for a 70-kg patient. _ _ _ _ _Method of administration and duration of therapy: _ For intravenous infusion. In life-threatening situations: 500 ml as a rapid infusion (under pressure). All air must be withdrawn from the plastic bag and infusion set prior to infusion. The rates of infusion selected for perioperative indications and for burns and septic shock patients will usually be lower. The duration of therapy depends 完全なドキュメントを読む