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 / CALCIUM CHLORIDE DIHYDRATE / LACTIC ACID / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE / CALCIUM CHLORIDE DIHY

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

UK

IE

MT

Package Leaflet: Information for 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.

Take special care
with Hemosol B0

Pregnancy, breast-feeding
and fertility

Warnings and precautions

Driving and using machines

What is in this leaflet

Children

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
in the following cases:

There are no symptoms or conditions that make Hemosol B0
unusable.

2

As the Hemosol B0 is potassiumfree, 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.
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.
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.
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 as it may increase the risk
of excess of bicarbonate in your
blood (metabolic alkalosis).

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.
Hemosol B0 will not have any effect on your 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
the necessary corrective measures
and adjust your dose.
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.

Hemosol B0 D05787001 Ver. 3.0 S40084741

D05787001 Hemosol B0 PL w valve Non-PVC UK_IE_MT_PL_SI Ver. 3.0.indd 2

10/13/2016 11:33:43 AM

There are some undesirable
effects which can be caused by
the dialysis treatment, such as
nausea, vomiting, muscle cramps,
low blood pressure (hypotension)
and changes of levels of salt in the
blood (electrolyte disturbances).

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/
adrporta
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
United Kingdom:
Yellow Card Scheme
Website:
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.

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, 2 H2O
5.145 g
Magnesium chloride, 6 H2O 2.033 g
Lactic acid
5.4 g
1000 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 and water for injections.

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 11/2016.

What Hemosol B0 looks like
and contents of the pack

Hemosol B0 is presented in a twocompartment bag. The bag is over
wrapped 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
SE-226 43 Lund
Sweden

Hemosol B0 D05787001 Ver. 3.0 S40084741

D05787001 Hemosol B0 PL w valve Non-PVC UK_IE_MT_PL_SI Ver. 3.0.indd 3

3
10/13/2016 11:33:44 AM

MT

The following information is intended
for healthcare professionals only

Hemosol B0 solution for
haemodialysis/haemofiltration
Carefully follow the instructions for
use/ handling.
Solution A must be mixed with
solution B before use to obtain the
reconstituted solution suitable for
haemofiltration, haemodiafiltration
or continuous haemodialysis.
If heating of the solution to body
temperature (+37°C) is necessary
the procedure must be carefully
controlled verifying that the solution
is clear and without particles.
Additional sodium bicarbonate
substitution may increase the risk
of metabolic alkalosis.
Before and during treatment,
haemodynamic status, fluid balance, electrolyte and acid-base balance should be closely monitored.
As Hemosol B0 is potassium-free,
special attention should be given to
potassium levels. Phosphate and
potassium supplement might be
necessary.
The volume of Hemosol B0 used
will depend on the patient’s clinical condition and the target fluid
balance. Continued application of
haemofiltration will remove excess
fluid and electrolytes.

8

In case of fluid imbalance, the
clinical situation must be carefully
monitored and fluid balance must
be restored:
•• In case of hyperhydration, the
ultrafiltration must be increased
and the rate of administration of
the solution for haemofiltration
reduced.
•• In the case of a severe dehydration it is necessary to cease
ultrafiltration and to increase the
inflow of solution for haemofiltration appropriately.
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.
The use of contaminated haemofiltration solution may cause sepsis
and shock.

Instructions
for use / Handling

Do not use with a haemodialysis
monitor. You should only use monitors for Continuous Renal Replacement Therapies.
The solution is packaged in a two
compartment bag.
Aseptic technique should be used
throughout the administration to the
patient.

Hemosol B0 D05759001 Rev. 2015-02/1 REG 3857

D05759001 Hemosol B0 PL w pin Non-PVC UK_IE_MT_PL_SI_2015-02_1 REG.indd 8

Use only if the solution is clear and
the over wrap is undamaged. All
seals must be intact. 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. The Instructions for Use
of the medication to be added must
be consulted.
Before adding a medication, verify
it is soluble and stable in water
within the pH limits of Hemosol B0
(pH limits of reconstituted solution
is 7.0 to 8.5).
Medication should only be added to
the solution under the responsibility
of a physician in the following way:
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.



IE



UK

3/2/2015 2:59:09 PM



I

II

III

I

Remove the over wrap 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)
Push with both hands on the
large compartment until the
peel seal between the two
compartments is entirely open.
(See figure II below)
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)

II

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 and connect the
male luer lock on the dialysis or
replacement line to the female
luer receptor on the bag; tighten. Using thumb and fingers,
break the coloured frangible
pin at its base, and move it
back and forth. Do not use a
tool. Verify that the pin is completely separated and that the
fluid is flowing freely. The pin
will remain in the luer port during the treatment. (See
figure IV.a below)
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).

III

The solution should be used immediately after removal of the over
wrap and after addition of solution A
to solution B. If not used immediately, the reconstituted solution
should be used within 24 hours,
including the duration of the treatment.
The reconstituted solution is for single use only. Discard any unused
solution immediately after use.

IV.a



IV.b

Hemosol B0 D05759001 Rev. 2015-02/1 REG 3857

D05759001 Hemosol B0 PL w pin Non-PVC UK_IE_MT_PL_SI_2015-02_1 REG.indd 9

9
3/2/2015 2:59:14 PM

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide