唯代靜脈輸注液

Kraj: Tajwan

Język: chiński

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

Składnik aktywny:

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

Dostępny od:

和聯生技藥業股份有限公司 台北市敦化北路３１１號５樓 (04270075)

Kod ATC:

B05AA

Forma farmaceutyczna:

注射劑

Skład:

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

Sztuk w opakowaniu:

塑膠軟袋裝

Klasa:

製　劑

Typ recepty:

限由醫師使用

Wyprodukowano przez:

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

Dziedzina terapeutyczna:

Blood substitutes and plasma protein fractions

Wskazania:

預防及治療血容積低下及低血容積性休克。

Podsumowanie produktu:

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

Status autoryzacji:

已註銷

Data autoryzacji:

2012-06-19

Ulotka dla pacjenta

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