STAY SAFE BALANCE 4.25% glucose 1.25 mmolL calcium peritoneal dialysis solution bag

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Sodium Chloride Ph Eur; calcium chloride dihydrate Ph. Eur.; magnesium chloride hexahydrate PhEur; glucose monohydrate, Ph Eur; Sodium Lactate Solution (50%)

Available from:

FRESENIUS MEDICAL CARE MALAYSIA SDN BHD

INN (International Name):

Sodium Chloride Ph Eur; calcium chloride dihydrate Ph. Eur.; magnesium chloride hexahydrate PhEur; glucose monohydrate, Ph Eur; Sodium Lactate Solution (50%)

Units in package:

2000ml4Units mL; 2500ml4Units mL

Manufactured by:

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

Patient Information leaflet

STAY SAFE BALANCE
4.25% GLUCOSE, 1.25 MMOL/L CALCIUM
Balance 4.25% glucose, 1.25 mmol/l calcium solution for peritoneal
dialysis
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_balance_
is used for
2.
How
_balance _
works
3.
Before you use
_balance_
4.
How to use
_balance_
5.
Side effects
6.
Storage
_balance_
7.
Product Description
8.
Manufacturer
9.
Product Registration Holder
10.
Date of revision
WHAT _BALANCE_ IS USED FOR
_BALANCE _ IS USED FOR CLEANING THE BLOOD
via the peritoneum in patients with end-
stage chronic kidney failure. This type of
blood
cleaning
is
called
peritoneal
dialysis.
HOW _BALANCE_ WORKS
_STAY•SAFE® _
SYSTEM
FOR
CONTINUOUS
AMBULATORY
PERITONEAL
DIALYSIS
(CAPD):
The solution bag is first warmed to body
temperature.
This
should
be
done
by
using an appropriate bag warmer. More
detailed
information
can
be
obtained
from the operating instructions of the bag
warmer. A microwave oven must not be
used to warm the solution due to the risk
of local overheating. After warming the
solution, you can start with the exchange
of the bags.
1.
PREPARATION OF THE SOLUTION
→
Check
the
warmed
solution
bag
(label,
expiry
date,
clearness
of
the
solution,
bag
and
over
wrap
not
damaged, peel seams intact).
→
Place
the bag on a solid surface.
→
Open the
over wrap of the bag and the packaging
of the disinfection cap
→
Wash your
hands with an antimicrobial washing
lotion.
→
Roll
up
the
bag,
which
is
lying on the over wrap, from one of the
side edges until the middle seam opens.
The solutions in the two chambers are
mixed automatically.
→
Now roll up
the bag from the upper edge until the
peel
seams
of
the
lower
triangle
is
completely open.
→
Check that all peel
seams are completely open.
→
Check
that the solution is clear and that the
bag is not leaking.
2.
PREPARATION OF THE BAG EXCHANGE
→
Hang the solution bag in the upper
hole
of
the
infusion
pole,
unroll
the
tubing line of the solution bag, and place
the
DISC
into
the
organizer.
After
unrolling the tubing

Summary of Product characteristics

Uputa o lijeku
balance 4,25% glukoze 1,25 mmol/l kalcija,
otopina za peritonealnu dijalizu
ИНСТРУКЦИЯ
баланс 1,5%/2,3%/4,25% глюкозы, 1,25/1,75 ммоль/л
кальция
Раствор для перитонеального диализа
Упатство за употреба
баланс 4,25% глукоза, 1,25 mmol/l калциум,
раствор за перитонеална дијализа
Package leaflet
balance 4.25% glucose, 1.25 mmol/l calcium,
solution for peritoneal dialysis
包裝說明書
"費森尤斯"均衡腹膜透析液4.25%葡萄糖, 1.25 mmol/L 鈣
ІНСТРУКЦІЯ для медичного
застосування лікарського засобу
Баланс 4,25% глюкози 1,25 ммоль/л кальцію
Розчин для перитонеального діалізу
Uputstvo za lek
Balance 4.25% glukoze, 1.25 mmol/l kalcijuma,
rastvor za peritonealnu dijalizu
Freigabeversion vom: 30.11.22
_0875484/05_
0875484_05_jd_ETW_Korr1.indd 1
0875484_05_jd_ETW_Korr1.indd 1
30.11.22 14:51
30.11.22 14:51
1.25 mmol/l kalcijuma
_Balance_
4.25% glukoze
Uputstvo za lek
_Balance_ 4.25% glukoze, 1.25 mmol/l kalcijuma,
0,1838 g/L + 5,64 g/L + 3,925 g/L + 0,1017 g/L + 42,5 g/L,
rastvor za peritonealnu dijalizu
kalcijum-hlorid, natrijum-hlorid, natrijum-laktat, magnezijum-hlorid,
glukoza
U оvоm uputstvu pročitaćete:
1. Štа је lek _Balance_ 4.25% glukoze, 1.25 mmol/l
kalcijuma i čemu је nаmеnjеn
2.
Štа trеbа dа znаtе prе nеgо štо primenitе lеk
_Balance_ 4.25% glukoze, 1.25 mmol/l kalcijuma
3.
Kаkо sе primenjuje lеk _Balance_ 4.25% glukoze,
1.25 mmol/l kalcijuma
4. Mоgućа nеžеljеnа dејstvа
5.
Kаkо čuvаti lеk _Balance_ 4.25% glukoze,
1.25 mmol/l kalcijuma
6. Sadržaj pakovanja i ostale infоrmаcijе
• Ako imate previše niske nivoe kalcijuma u krvi.
Vaša terapija treba da obuhvati primenu supstanci
koje vezuju fosfate koje sadrže kalcijum i/ili vitamin D
ili upotrebu rastvora za peritonealnu dijalizu sa
većom koncent