EQUIHES 100 Mg/Ml Solution for Infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

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

Предлага се от:

B. Braun Melsungen AG

АТС код:

B05AA07

INN (Международно Name):

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

дозиране:

100 Mg/Ml

Лекарствена форма:

Solution for Infusion

Вид предписание :

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

Терапевтична област:

Blood substitutes and plasma protein fractions

Статус Оторизация:

Authorised

Дата Оторизация:

2007-01-26

Листовка

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

EQUIHES 100 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 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 fr

Данни за продукта

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, 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:
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)
Hydroxyethyl starch (HES)
100.0g
(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
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 OF ADMINISTRAT