INFUKOLL N 6 Per Cent Solution for Infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE

から入手可能:

Serumwerk Bernburg AG

INN（国際名）:

POLY(O-2-HYDROXYETHYL)STARCH SODIUM CHLORIDE

投薬量:

6 Per Cent

医薬品形態:

Solution for Infusion

認証ステータス:

Withdrawn

承認日:

2007-02-01

製品の特徴

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Infukoll
®
6 % solution for infusion, bag
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless, aqueous solution.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Treatment and prevention of hypovolaemia and shock.
Normovolaemic haemodilution.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
HES must be administered intravenously.
Total dosage, duration and rate of infusion will depend upon
the amount of blood lost and/or the haemodynamic status 
and general clinical condition of the patient. Dosage will need
to be adjusted as necessary by monitoring the usual 
circulatory parameters e.g. blood pressure. 
The risk of circulatory overload by too rapid rate of infusion
or inappropriately large doses must be borne in mind. 
Due to the risk for occurrence of an anaphylactic reaction,
the first 10 ml - 20 ml of Infukoll
®
6 % should be infused 
slowly and under careful observation of the patient.
1000 ml contains:
Poly (O-2-hydroxyethyl)starch
60.0
g
(Molar substitution
0.45-0.55)
(Average molecular weight: 
200 000 Da)
Sodium chloride
9.00
g
Na
+
154
mmol
Cl
-
154
mmol
Theoretical osmolarity
309
mosmol/l
pH
5.0-7.0
For excipients, see 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/03/2006_
_CRN 2021077_
_page number: 1_
_Maximum infusion rate:_
The maximum rate of infusion should be adjusted to
the clinical situation.
_Patients with acute haemorrhagic shock:_ Up to 20 ml/kg
bodyweight/hour (equivalent to 0.33 ml/kg BW/min).
_In life-threatening situations: _500 ml as a rapid infusion
(under pressure). The rates of infusion selected for 
perioperative indications and for burns and septic shock
patients will usually be lower.
_Maximum daily dosage:_