Skip to Content

HEMOSOL B0 SOLUTION FOR HAEMOFILTRATION AND HAEMODIALYSIS

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / LACTIC ACID / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Hemosol B0
UK, IE, MT

Package leaflet: Information for the user.................................3

PL

Ulotka dołączona do opakowania:
Informacja dla użytkownika.....................................................5

SI

Navodilo za uporabo...............................................................7

UK, IE, MT

The following information is intended
for healthcare professionals only.............................................9

PL

Informacje przeznaczone wyłącznie
dla fachowego personelu medycznego................................. 11

SI

Naslednje informacije so namenjene
samo zdravstvenemu osebju.................................................13

D05787001 Ver. 4.1 REG S40084741

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 1

9/27/2017 11:45:23 AM

THIS PAGE IS INTENTIONALLY LEFT BLANK

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 2

9/27/2017 11:45:23 AM

Package leaflet: Information for the user
Hemosol B0 solution for
haemodialysis/haemofiltration
Sodium chloride/calcium chloride
dihydrate/magnesium chloride
hexahydrate/lactic acid/sodium
hydrogen carbonate.
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,
pharmacist or nurse.
• If you get any side effects,
talk to your doctor, pharmacist
or nurse. This includes any
possible side effects not listed in
this leaflet. See section 4.

WHAT IS IN THIS LEAFLET

1. What Hemosol B0 is and what it
is used for
2. What you need to know before
you use Hemosol B0
3. How to use Hemosol B0
4. Possible side effects
5. How to store Hemosol B0
6. Contents of the pack and other
information

1. WHAT HEMOSOL B0 IS
AND WHAT IT IS USED
FOR
Hemosol B0 is used in hospitals in
intensive care treatments to correct
chemical imbalance of the blood
which is caused by kidney failure.
The treatments are designed
to remove accumulated waste
products from the blood when the
kidneys are not functioning.
Hemosol B0 is used in the following
types of treatment in adult and
children of all ages:




haemofiltration,
haemodiafiltration and
haemodialysis.

2. WHAT YOU NEED TO
KNOW BEFORE YOU
USE HEMOSOL B0
DO NOT USE HEMOSOL B0:
If you are allergic to one of the
active substances or any of the
other ingredients (listed in
section 6).

UK IE MT

WARNINGS AND PRECAUTIONS

increase the risk of excess
of bicarbonate in your blood
(metabolic alkalosis).

Hemosol B0 is a product to be
used in hospitals and administered
by medical professionals only.
They will ensure a safe use of the
medicine.

When citrate is used as an
anticoagulant, it can reduce plasma
calcium levels.

Talk to your doctor, pharmacist or
nurse before using Hemosol B0.

Before and during treatment, your
blood condition will be checked,
e.g. your acid-base balance and
concentrations of salts in the blood
(electrolytes) will be monitored,
including all fluid you are given
(intravenous infusion) and that you
produce (urine production), even
those not directly related to the
therapy.
As Hemosol B0 is potassium-free,
special attention will be given
to the level of potassium in your
blood. Should you suffer from low
potassium a potassium supplement
might be necessary.

CHILDREN

There are no specific warnings
and precautions when using this
medicine for children.

OTHER MEDICINES AND
HEMOSOL B0

Tell your doctor or pharmacist if you
are taking, have recently taken or
might take any other medicines,
including medicines obtained
without a prescription.
This is because the concentration
level in the blood of some of other
medicines being taken may be
reduced during the treatment
with Hemosol B0. Your doctor will
decide if other medicines being
taken should be changed.
In particular tell your doctor if you
are using either of the following:
• Digitalis medicine (for treatment
of certain heart conditions);
as the risk of irregular or rapid
beating of the heart (cardiac
arrhythmia) caused by digitalis
is increased during a low
concentration of potassium in
the blood (hypokalaemia).
• Vitamin D and medicinal
products containing calcium, as
they can increase the risk of a
high concentration of calcium in
the blood (hypercalcaemia).
Any addition of sodium bicarbonate
(or other buffer source) may
Hemosol B0 D05787001 Ver. 4.1 REG S40084741

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 3

PREGNANCY, BREASTFEEDING AND FERTILITY

If you are pregnant or breastfeeding, think you may be pregnant
or are planning to have a baby,
ask your doctor or pharmacist for
advice before taking this medicine.
No effects on fertility or during
pregnancy or on the breast-fed
newborn/infant are anticipated.
Your doctor will decide if you should
be given Hemosol B0 if you are
pregnant or breast-feeding.

DRIVING AND USING
MACHINES

Hemosol B0 will not have any effect
on the ability to drive or use machines.

3. HOW TO USE
HEMOSOL B0
Hemosol B0 is a product to be used
in hospitals and administered by
medical professionals only.
The volume of Hemosol B0, and
therefore the dose used, will
depend on your condition. The
dose volume will be determined by
the physician responsible for your
treatment.
Hemosol B0 can be administered
directly into the bloodstream
(intravenously) or via
haemodialysis, where the solution
flows on one side of a dialysis
membrane while the blood flows on
the other side.

IF YOU USE MORE
HEMOSOL B0 THAN YOU
SHOULD

Hemosol B0 is a product to be
used in hospitals and administered
by medical professionals only and
your fluid balance, electrolyte and
acid-base balance will be carefully
monitored.
Therefore, it is unlikely that you
will use more Hemosol B0 than
you should.
In the unlikely event that an
overdose occurs, your doctor
will take necessary corrective
measures and adjust your dose.

3
9/27/2017 11:45:23 AM

Overdose may result in:



fluid overload in your blood,
elevation of the bicarbonate
blood level (metabolic alkalosis),
• and/or reduction of levels
of salts in the blood
(hypophosphataemia,
hypokaliemia).
For instructions for use, please see
section “The following information
is intended for healthcare
professionals only”.
If you have any further questions
on the use of this medicine, ask
your doctor, pharmacist or nurse.

4. POSSIBLE SIDE
EFFECTS
Like all medicines, this medicine
can cause side effects, although
not everybody gets them.
The following side effects have
been reported:
Not known: frequency cannot be
estimated from the available data


Changes of levels of salts in the
blood (electrolyte imbalances
such as hypophosphataemia,
hypokalaemia)
Elevation of the plasma
bicarbonate concentration
(metabolic alkalosis) or
reduction of the plasma
bicarbonate concentration
(metabolic acidosis)
Abnormally high or low volume
of water in the body (hyper or
hypovolemia)
Nausea
Vomiting
Muscle cramps
Low blood pressure (hypotension).









REPORTING OF SIDE
EFFECTS

If you get any side effects, talk to
your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet.
You can also report side effects
directly via:
Malta:
ADR Reporting Website:
www.medicinesauthority.gov.mt/
adrportal
Republic of Ireland:
HPRA Pharmacovigilance Earlsfort
Terrace, IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie

4

United Kingdom:
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
By reporting side effects you can
help provide more information on
the safety of this medicine.

5. HOW TO STORE
HEMOSOL B0
Keep this medicine out of the sight
and reach of children
Do not use this medicine after the
expiry date which is stated on the
back of the bag and the box label
after EXP. The expiry date refers to
the last day of that month.
Do not store below 4°C.
Chemical and physical in-use
stability of the reconstituted
solution has been demonstrated
for 24 hours at 22°C. From a
microbiological point of view, the
reconstituted solution should be
used immediately. If not used
immediately in-use storage times
and conditions prior to use are
the responsibility of the user and
should not be longer than 24
hours including the duration of the
treatment.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect
the environment.

6. CONTENTS OF THE
PACK AND OTHER
INFORMATION
WHAT HEMOSOL B0
CONTAINS

The active substances before and
after reconstitution are shown
below.

ACTIVE SUBSTANCES
BEFORE RECONSTITUTION:

1000 ml of solution from the small
compartment (A) contains:
Calcium chloride, 2H2O
5.145 g
Magnesium chloride, 6 H2O 2.033 g
Lactic acid
5.4 g
1 000 ml of solution from the large
compartment (B) contains:
Sodium hydrogen carbonate 3.09 g
Sodium chloride
6.45 g

ACTIVE SUBSTANCES AFTER
RECONSTITUTION:

The solutions in the compartments
A (250 ml) and B (4750 ml) are

mixed to give one reconstituted
solution (5000 ml) which
composition is:
mmol/l
Calcium, Ca2+
1.75
Magnesium, Mg2+
0.5
Sodium, Na+
140
Chloride, Cl−
109.5
Lactate
3
Hydrogen carbonate, HCO3−
32
Theoretical Osmolarity:
287 mOsm/l
The other ingredients are: carbon
dioxide (E 290) and water for
injections.

WHAT HEMOSOL B0 LOOKS
LIKE AND CONTENTS OF
THE PACK

Hemosol B0 is presented in a
two-compartment bag. The bag is
overwrapped with a transparent
film.
The final reconstituted solution is
obtained after breaking the peel
seal and mixing both solutions.
The reconstituted solution is clear
and colourless. Each bag (A+B)
contains 5000 ml solution for
haemofiltration, haemodiafiltration
and/or haemodialysis.
Each box contains two bags and
one package leaflet.

MARKETING AUTHORISATION
HOLDER:
Gambro Lundia AB,
Magistratsvägen 16,
226 43 Lund,
Sweden

MANUFACTURER:

Bieffe Medital S.p.A.,
Via Stelvio 94,
23035 Sondalo (SO),
Italy
This medicinal product is
authorised in the Member States
of the EEA under the following
names:
Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany,
Greece, Iceland, Ireland, Latvia,
Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland,
Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, United
Kingdom: Hemosol B0.
Hungary: Hemosol káliummentes.
This leaflet was last revised in
09/2017.

Hemosol B0 D05787001 Ver. 4.1 REG S40084741

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 4

9/27/2017 11:45:23 AM



The following information is intended
for healthcare professionals only
Hemosol B0 solution for
haemodialysis/haemofiltration

PRECAUTIONS
The instructions for use / handling
for Hemosol B0 must be strictly
followed.
The solutions in the two
compartments must be mixed
before use.
Use of a contaminated solution
may cause sepsis, shock and fatal
conditions.
Hemosol B0 may be warmed to
37°C to enhance patient comfort.
Warming of the solution prior
to use should be done before
reconstitution with dry heat only.
Solutions should not be heated
in water or in a microwave oven.
The solution should be inspected
visually for particulate matter and
discoloration prior to administration,
whenever solution and container
permit. Do not administer unless
the solution is clear and the seal
is intact.
Additional sodium bicarbonate
substitution may increase the risk
of metabolic alkalosis.
Before and during treatment,
electrolyte and acid-base balance
should be closely monitored.
As Hemosol B0 is potassiumfree, the serum potassium
concentration must be monitored
before and during hemofiltration
and/or hemodialysis. Potassium
supplement might be necessary.

The volume and rate at which
Hemosol B0 is used will depend
on the blood concentration of
electrolytes, acid-base balance,
and overall patient’s clinical
condition. Administration (dose,
infusion rate and cumulative
volume) of Hemosol B0 should
be established by a physician.
Continued application of
haemofiltration will remove excess
fluid and electrolytes.
In case of fluid imbalance, the
clinical situation must be carefully
monitored and fluid balance should
be corrected as needed.
Overdose will result in fluid
overload if the patient is suffering
from renal failure, and it could lead
to severe consequences, such as
congestive heart failure, electrolyte
or acid-base disturbances.
Because the solution contains
no glucose, administration may
lead to hypoglycaemia. Blood
glucose levels should be monitored
regularly.
Hemosol B0 contains hydrogen
carbonate (bicarbonate), and
lactate (a hydrogen carbonate
precursor) which can influence
the patient’s acid-base balance.
If metabolic alkalosis develops or
worsens during therapy with the
solution, the administration rate
may need to be decreased, or the
administration stopped.

UK IE MT
POSOLOGY
Commonly used flow rates
for the substitution solution
in haemofiltration and
haemodiafiltration are:
Adult
500-3000 mL/h
Commonly used flow rates for
the dialysis solution (dialysate) in
continuous haemodialysis are:
Adult
500-2500 mL/h
Commonly used flow rates in adults
are approximately 2000 to 2500
ml/h which correspond to a daily
fluid volume of approximately 48
to 60 L.

PAEDIATRIC POPULATION
The range of flow rates for
the substitution solution
in haemofiltration and
haemodiafiltration and for the
dialysis solution (dialysate) in
continuous haemodialysis are:
Children (from neonates to
adolescents to 18 years):
1000 to 2000 ml/h/1.73m2.
Flow rates up to 4,000 mL/h/1.73
m2 may be needed, especially in
younger children (≤10 kg). The
absolute flow rate (in mL/h) in
the paediatric population should
generally not exceed the maximum
adult flow rate.



Phosphate up to 1.2 mmol/L
may be added to the solution. If
potassium phosphate is added,
the total potassium concentration
should not exceed 4 mEq/L (4
mmol/L).

Hemosol B0 D05787001 Ver. 4.1 REG S40084741

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 9

9
9/27/2017 11:45:24 AM

The electrolyte solution (small
compartment A) is added to the
buffer solution (large compartment
B) after opening the peel seal
immediately before use to obtain
the reconstituted solution.
Use only with appropriate
extracorporeal renal replacement
equipment.
Aseptic technique should be
used throughout the handling and
administration to the patient.
Use only if the overwrap is
undamaged, all seals are intact,
peel seal is not broken and the
solution is clear. Press bag firmly
to test for any leakage. If leakage
is discovered, discard the solution
immediately since sterility can no
longer be assured.
The large compartment B is
fitted with an injection port
for the possible addition of
other necessary drugs after
reconstitution of the solution. It is
the responsibility of the physician
to judge the compatibility of an
additive medication with Hemosol
B0 by checking for eventual
colour change and/or eventual
precipitation, insoluble complexes
or crystals. Before adding a
medication, verify it is soluble
and stable in water within the pH
limits of Hemosol B0 (pH limits of

I

II

reconstituted solution is 7.0 to 8.5).
Additives may be incompatible.
The Instructions for Use of the
medication to be added must be
consulted.
Remove any fluid from the injection
port, hold the bag upside down,
insert the drug through the injection
port and mix thoroughly. The
solution must be administered
immediately.
I

Remove the overwrap from
the bag immediately before
use and discard any other
packaging materials. Open
the seal by holding the small
compartment with both
hands and squeeze it until
an opening is created in the
peel seal between the two
compartments. (See figure I
below)
II Push with both hands on the
large compartment until the
peel seal between the two
compartments is entirely open.
(See figure II below)
III Secure complete mixing of the
solution by shaking the bag
gently. The solution is now
ready for use and the bag can
be hung on the equipment.
(See figure III below)
IV The dialysis or replacement
line may be connected to either
of the two access ports.
IV.a If the luer access is used,
remove the cap with a twist and
pull motion, and connect the

III

male luer lock on the dialysis
or replacement line to the
female luer receptor on the bag
using a push and twist motion.
Ensure that the connection is
fully seated and tighten. The
connector is now open. Verify
that the fluid is flowing freely.
(See figure IV.a below)
When the dialysis or
replacement line is
disconnected from the luer
connector, the connector
will close and the flow of the
solution will stop. The luer port
is a needle-less and swabbable
port.
IV.b If the injection port is used, first
remove the snap-off cap. Then
introduce the spike through
the rubber septum. Verify that
the fluid is flowing freely. (See
figure IV.b below).
The solution should be used
immediately after removal of the
overwrap. If not used immediately,
the reconstituted solution should
be used within 24 hours, including
the duration of the treatment after
addition of the electrolyte solution
to the buffer solution.
The reconstituted solution is
for single use only. Discard any
unused solution immediately after
use.
Any unused medicinal product or
waste material should be disposed
of in accordance with local
requirements.

IV.a

IV.b

10

Hemosol B0 D05787001 Ver. 4.1 REG S40084741

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 10

9/27/2017 11:45:27 AM



INSTRUCTION FOR USE /
HANDLING

THIS PAGE IS INTENTIONALLY LEFT BLANK

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 15

9/27/2017 11:45:27 AM

Baxter, Gambro and Hemosol B0 are trademarks of Baxter International Inc., or its subsidiaries

9/27/2017 11:45:29 AM

D05787001 Hemosol B0 PL Non-PVC UK_IE_MT_PL_SI Ver. 4.1 REG.indd 16

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide