唯代靜脈輸注液

Country: Թայվան

language: չինարեն

source: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

active_ingredient:

POLY(O-2 HYDROXYETHYL )STARCH;;SODIUM CHLORIDE

MAH:

和聯生技藥業股份有限公司 台北市敦化北路３１１號５樓 (04270075)

ATC_code:

B05AA

pharmaceutical_form:

注射劑

composition:

SODIUM CHLORIDE (4012002100) MG; POLY(O-2 HYDROXYETHYL )STARCH (9600030283) MG

units_in_package:

塑膠軟袋裝

class:

製　劑

prescription_type:

限由醫師使用

manufactured_by:

AKZONOBEL SALT A/S HADSUNDVEJ 17, DK-9550 MARIAGER DENMARK DK

therapeutic_area:

Blood substitutes and plasma protein fractions

therapeutic_indication:

預防及治療血容積低下及低血容積性休克。

leaflet_short:

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

authorization_status:

已註銷

authorization_date:

2012-06-19

PIL

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