EQUIHES 60 Mg/Ml Solution for Infusion

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, SODIUM ACETATE TRIHYDRATE, L-MALIC ACID DAB

Beschikbaar vanaf:

B. Braun Melsungen AG

ATC-code:

B05AA07

INN (Algemene Internationale Benaming):

POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM CHLORIDE HEXAHYDRATE, S

Dosering:

60 Mg/Ml

farmaceutische vorm:

Solution for Infusion

Prescription-type:

Product subject to prescription which may not be renewed (A)

Therapeutisch gebied:

Blood substitutes and plasma protein fractions

Autorisatie-status:

Authorised

Autorisatie datum:

2007-01-26

Bijsluiter

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

EQUIHES 60 MG/ML SOLUTION FOR INFUSION ECOFLAC PLUS
®

This medicine is subject to additional monitoring. This will allow
quick identification 
of new safety information. You can help
by reporting any side effects you may get. See 
the end of section 4 for how to report side effects.  

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU. 
_●  _Keep this leaflet. You may need to read it again. 
_●  _If you have any further questions, ask your doctor,
nurse or pharmacist. 
_●  _This medicine has been prescribed for you only. Do not
pass it on to others. It 
may harm them, even if their signs of illness
are the same as yours. 
_●  _If you get any side effects, talk to your doctor,
nurse or pharmacist. This includes 
any possible side effects not listed in this leaflet. See section
4. 

WHAT IS IN THIS LEAFLET:  
1. 
What EquiHes 60 mg/ml is and what it is used for 
2. 
What you need to know before you use EquiHes 60 mg/ml 
3. 
How to use EquiHes 60 mg/ml 
4. 
Possible side effects 
5. 
How to store EquiHes 60 mg/ml 
6. 
Contents of the pack and other information 
1. 
WHAT EQUIHES 60 MG/ML IS AND WHAT IT IS USED FOR 
EquiHes 60 mg/ml is an infusion solution which is administered via
a cannula into a vein. 
EquiHes 60 mg/ml is a plasma volume substitute that is used to restore the blood volume 
when  you  have  lostblood  when  other  products  called  crystalloids  are  not  considered 
sufficient alone. 
2. 
WHAT YOU NEED TO KNOW BEFORE YOU USE EQUIHES 60 MG/ML 
DO NOT USE EQUIHES 60 MG/ML IF YOU: 


are allergic to any of the active substances or any of the
other ingredients of this 
medicine (listed in section 6). 


suffer from serious generalised infection (sepsis

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
EquiHes 60 mg/ml solution for infusion, Ecoflac Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml contains:
_Electrolyte concentration:_
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless, aqueous solution
pH:
5.6 6.4
Theoretical osmolarity:
296 mOsmol/l
Acidity (titration to pH 7.4):
<2.0 mmol/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypovolaemia
due to acute blood loss when crystalloids alone are not considered
sufficient. (see sections 4.2, 4.3
and 4.4).
Hydroxyethyl starch (HES)
60.0g
(Molar substitution:
0.42)
(Average molecular weight:
130,000Da)
Sodium chloride
6.25g
Potassium chloride
0.30g
Calcium chloride dihydrate
0.37g
Magnesium chloride hexahydrate
0.20g
Sodium acetate trihydrate
3.27g
L-Malic acid
0.67g
Sodium
140 mmol/l
Potassium
4.0 mmol/l
Calcium
2.5 mmol/l
Magnesium
1.0 mmol/l
Chloride
118 mmol/l
Acetate
24
mmol/l
L-Malate
5.0 mmol/l
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4.2 POSOLOGY AND METHOD OF ADMINISTRATI