EQUIHES 100 Mg/Ml Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

B. Braun Melsungen AG

ATC code:

B05AA07

INN (International Name):

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

Dosage:

100 Mg/Ml

Pharmaceutical form:

Solution for Infusion

Prescription type:

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

Therapeutic area:

Blood substitutes and plasma protein fractions

Authorization status:

Authorised

Authorization date:

2007-01-26

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

EQUIHES 100 MG/ML SOLUTION FOR INFUSION ECOBAG
®


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 100 mg/ml is and what it is used for 
2. 
What you need to know before you use EquiHes 100 mg/ml 
3. 
How to use EquiHes 100 mg/ml 
4. 
Possible side effects 
5. 
How to store EquiHes 100 mg/ml 
6. 
Contents of the pack and other information

1. 
WHAT EQUIHES 100 MG/ML IS AND WHAT IT IS USED FOR 
EquiHes 100 mg/ml is an infusion solution which is administered via
a cannula into a 
vein. 
EquiHes  100  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 100 MG/ML 
DO NOT USE EQUIHES 100 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 seri

Summary of Product characteristics

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 100 mg/ml solution for infusion, Ecobag
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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:
297 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)
1000 ml of solutioncontains:
Hydroxyethyl starch (HES)
100.0 g
(Molar substitution:
0.42)
(Average molecular weight:
130,000 Da)
Sodium chloride
6.25 g
Potassium chloride
0.30 g
Calcium chloride dihydrate
0.37 g
Magnesium chloride hexahydrate
0.20 g
Sodium acetate trihydrate
3.27 g
L-Malic acid
0.67 g
_Electrolyte concentrations:_
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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_3_
_/_
_0_
_1_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_1_
_9_
_5_
_6_
_9_
_7_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.2 POSOLOGY AND METHOD