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BIPHOZYL SOLUTION FOR HAEMODIALYSIS / HAEMOFILTRATION

Active substance(s): DISODIUM PHOSPHATE DIHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE

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Biphozyl
UK, IE, MT

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

HU

Betegtájékoztató: Információk a felhasználó számára............6

RO

Prospect: Informaţii pentru utilizator........................................9

BG

Листовка: информация за потребителя.............................12

UK, IE, MT

The following information is intended
for healthcare professionals only...........................................15

HU

Az alábbi információk kizárólag
egészségügyi szakembereknek szólnak...............................17

RO

Următoarele informaţii sunt destinate
numai profesioniştilor din domeniul sănătăţii.........................19

BG

Посочената по-долу информация
е предназначена само за медицински специалисти.........21

D13000344 Ver. 2.1 REG S40084809

D13000344 Biphozyl PL non-PVC with valve UK_IE_MT_HU_RO_BG Ver. 2.1 REG.indd 1

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Package leaflet: Information for the user
BIPHOZYL

Solution for haemodialysis /
haemofiltration
Magnesium chloride
hexahydrate, Sodium chloride,
Sodium hydrogen carbonate,
Potassium chloride, Disodium
phosphate dihydrate
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 Biphozyl is and what it is
used for
2. What you need to know before
you use Biphozyl
3. How to use Biphozyl
4. Possible side effects
5. How to store Biphozyl
6. Contents of the pack and other
information

1. WHAT BIPHOZYL IS
AND WHAT IT IS USED
FOR
This medicine is a solution for
dialysis treatment (haemofiltration,
haemodialysis and
haemodiafiltration) which is used
to remove waste products from the
blood when the kidneys are not
functioning. This medicine is used
in hospitals during intensive care
treatment using Continuous Renal
Replacement Therapy (CRRT).
This medicine is particularly used to
treat critically ill patients with acute
kidney injury having:






a normal concentration of
potassium (normal kalaemia) in
the blood
a normal pH in the blood
a normal or low concentration
of phosphate (normal or
hypophosphataemia) in the
blood
a high concentration of calcium
(hypercalcaemia) in the blood

UK IE MT

2. WHAT YOU NEED TO
KNOW BEFORE YOU
USE BIPHOZYL

a glucose-containing solution.
Other corrective measures may
be necessary to maintain desired
blood glucose concentration.

DO NOT USE BIPHOZYL IN
CASE OF:

Your doctor will regularly monitor
electrolyte and blood acid–base
parameters in patients treated
with Biphozyl. Biphozyl contains
hydrogen phosphate, a weak acid
that can influence your acid-base
balance. If a reduction of the
plasma bicarbonate concentration
develops or worsens during therapy
with Biphozyl, your doctor will
decrease the infusion rate. If the
condition does not resolve, the
doctor must stop the administration
immediately.






allergy to one of the active
substances or any of the other
ingredients (listed in section 6)
a low concentration of calcium
(hypocalcaemia) in the blood
a high concentration of
potassium (hyperkalaemia) in
the blood
a high concentration
of phosphate
(hyperphosphataemia) in the
blood

WARNINGS AND
PRECAUTIONS
WARNINGS

Talk to your doctor, pharmacist or
nurse before using Biphozyl.
Biphozyl should not be used in
patients with high blood potassium
concentration. The level of your
blood potassium concentration will
be monitored regularly before and
during treatment.
Because Biphozyl contains
potassium, high blood potassium
level may occur shortly after
starting the treatment. Your doctor
will decrease the infusion rate
and confirm that the potassium
concentration has returned to
desired level. If the condition does
not resolve, the doctor must stop
the administration immediately. The
use of a potassium-free solution
may be used transiently to restore
your blood potassium level.
Because Biphozyl contains
phosphate, high blood phosphate
level may occur shortly after
starting the treatment. Your doctor
will decrease the infusion rate
and confirm that the phosphate
concentration has returned to
desired level. If the condition does
not resolve, the doctor must stop
the administration immediately.
Because Biphozyl contains no
glucose, low blood glucose level
may occur during treatment. Blood
glucose levels will be monitored
regularly. If low blood glucose
develops, your doctor may use
Biphozyl D13000344 Ver. 2.1 REG S40084809

D13000344 Biphozyl PL non-PVC with valve UK_IE_MT_HU_RO_BG Ver. 2.1 REG.indd 3

The instructions for use must be
strictly followed.
The solutions in the two
compartments must be mixed
before use.
Use only with a dialysis machine
for CRRT.
Use only if the overwrap and
solution bag are undamaged. All
seals must be intact. Use of a
contaminated solution may cause
sepsis and shock.
Use only with an appropriate
extracorporal renal replacement
equipment.

PRECAUTIONS

This medicine is calcium free
and could cause hypocalcaemia.
Infusion of calcium might be
necessary.
Biphozyl 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. Biphozyl should
be inspected visually for particulate
matter and discoloration prior to
administration.Do not administer
unless the solution is clear and the
seal is intact.
Your doctor will closely monitor
your haemodynamic status, fluid
balance, electrolyte and acidbase balance throughout the
procedure, including all fluid inputs
(intravenous infusion) and outputs
(urine output), even those not
directly related to CRRT.

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This medicine has a hydrogen
carbonate content at the lower end
of the normal concentration range
in the blood. This is appropriate
when using citrate anticoagulation,
as citrate is metabolized to
hydrogen carbonate, or when
normal pH values have been
restored. Assessment of buffer
needs, through repeated
measurement of blood acid/base
parameter and review of the overall
therapy, is mandatory. A solution
with higher hydrogen carbonate
content may be required.
In case of abnormally high volume
of fluid in the body (hypervolaemia),
the net ultrafiltration rate
prescribed for the CRRT device
can be increased and/or the rate
of administration of solutions other
than replacement fluid and/or
dialysate can be reduced.
In case of abnormally low volume
of fluid in the body (hypovolaemia),
the net ultrafiltration rate
prescribed for the CRRT device
can be reduced and/or the rate of
administration of solutions other
than replacement fluid and/or
dialysate can be increased.

CHILDREN

No specific adverse effect on
children is expected when using
this medicine.

ELDERLY PATIENTS

No specific adverse effect on
elderly patients is expected when
using this medicine.

OTHER MEDICINES AND
BIPHOZYL

Tell your doctor, pharmacist or
nurse if you are taking, have
recently taken or might take
any other medicines including
medicines obtained without a
prescription. This is because the
concentration of other medicines
may be reduced during dialysis
treatment. Your doctor will decide if
any changes in the dosage of your
medicines should be made.
In particular, tell your doctor if you
are using either of the following:


Additional sources of phosphate
(e.g. nutritional fluids); as this
may increase the risk of a high
concentration of phosphate in
the blood (hyperphosphatemia).

4





Sodium bicarbonate; as this
may increase the risk of excess
of bicarbonate in your blood
(metabolic alkalosis).
When citrate is used as an
anticoagulant, as it can reduce
plasma calcium levels.

PREGNANCY, BREASTFEEDING AND FERTILITY

Pregnancy and breast-feeding:

Adult:
500 - 3000 ml/h
Children < 18 years old:
1000 to 4000 ml/h/1.73 m²
The range of flow rates when used
as dialysate in continuous
haemodialysis and continuous
haemodiafiltration are:
Adult:
500 - 2500 ml/h
Children < 18 years old:
1000 to 4000 ml/h/1.73 m²

There is no documented clinical
data on the use of this medicine
during pregnancy and lactation.
This medicine should only be
administered to pregnant and
lactating women if clearly needed.

For adolescents (12-18 years), the
adult dose recommendation should
be used when the paediatric
dose is calculated to exceed the
maximum adult dose.

FERTILITY:

This medicine will be given to you
in a hospital. Your doctor will know
how to use it.
For instructions for use see the end
of this leaflet.

No effects on fertility are
anticipated, since sodium,
potassium, magnesium, chloride,
hydrogen phosphate and hydrogen
carbonate are normal constituents
of the body.

DRIVING AND USING
MACHINES

This medicine is not known to affect
the ability to drive or use machines.

3. HOW TO USE
BIPHOZYL
For intravenous use and use in
haemodialysis. This medicine
is to be used in hospitals
and administered by medical
professionals only. The volume
used, and therefore the dose of
this medicine, will depend on your
condition. The dose volume will be
determined by your doctor.
Always use this medicine exactly
as your doctor, pharmacist or nurse
has told you. Check with your
doctor, pharmacist or nurse if you
are not sure.
It is the responsibility of the
physician to determine the
compatibility of an additive
medication with this medicine by
checking for possible colour change
and/or possible precipitation.
Before adding a medication, verify
if it is soluble and stable in this
medicine.

POSOLOGY

The range of flow rates when
used as replacement solution
in haemofiltration and
haemodiafiltration are:

INSTRUCTIONS FOR USE

IF YOU USE MORE OF
BIPHOZYL THAN YOU
SHOULD

Contact your doctor or nurse
immediately if you have taken more
of this medicine than recommended
in this package leaflet or than
prescribed by your doctor and you
feel uncomfortable.
The symptoms of overdose are
tiredness, oedema or shortness of
breath.

4. POSSIBLE SIDE
EFFECTS
Like all medicines, this medicine
can cause side effects, although
not everybody gets them. Your
blood tests and clinical condition
will be regularly monitored by a
doctor or nurse in order to find
possible side effects. Use of this
solution could cause:


Changes of levels of salts in the
blood (electrolyte imbalances)
such as: low calcium level
(hypocalcaemia), high
potassium level (hyperkalaemia)
and high phosphate level
(hyperphosphataemia)
• Reduction of the plasma
bicarbonate concentration
(metabolic acidosis)
There are also some side effects
which can be caused by dialysis
treatments, such as:

Biphozyl D13000344 Ver. 2.1 REG S40084809

D13000344 Biphozyl PL non-PVC with valve UK_IE_MT_HU_RO_BG Ver. 2.1 REG.indd 4

2017. 09. 26. 15:47:08







Abnormally high
(hypervolaemia) or low volume
(hypovolaemia) of fluid in the
body
Decreased blood pressure
Nausea, vomiting
Muscle cramps

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
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
BIPHOZYL
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
label and the packaging. The expiry
date refers to the last day of that
month.
This medicinal product does
not require any special storage
conditions.
Do not freeze.
Chemical and physical in-use
stability of the reconstituted
solution has been demonstrated
for 24 hours at +22°C. 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.

The solution can be disposed of
via wastewater without harming the
environment.

Each bag contains 5000 ml solution
and the bag is overwrapped with a
transparent film.

Do not use this medicine if you
notice damage to the product or
visible particles in the solution. All
seals must be intact.

Each box contains two bags and
one package leaflet.

6. CONTENTS OF THE
PACK AND OTHER
INFORMATION

Gambro Lundia AB

WHAT BIPHOZYL CONTAINS

Sweden

Before reconstitution
In the small compartment,
A (250 ml):
Magnesium chloride
hexahydrate
3.05 g/l
In the large compartment,
B (4750 ml):
Sodium chloride
7.01 g/l
Sodium hydrogen
carbonate
2.12 g/l
Potassium chloride
0.314 g/l
Disodium phosphate
dihydrate
0.187 g/l
After reconstitution
the reconstituted solution, A+B:
Active substances
mmol/l mEq/l
Sodium, Na+
140
140
Potassium, K+
4
4
Magnesium, Mg2+
0.75
1.5
Chloride, Cl−
122
122
Hydrogen phosphate,
HPO42−
1
2
Hydrogen carbonate,
HCO3−
22
22
Theoretical osmolarity: 290 mOsm/l
pH = 7.0 – 8.0
The other ingredients are:




MARKETING
AUTHORISATION HOLDER

Magistratsvägen 16
226 43 Lund

MANUFACTURER

Bieffe Medital S.p.A.
Via Stelvio, 94
23035 Sondalo (SO)
Italy

This medicinal product is author­
ised in the Member States of the
EEA under the following names:
Austria, Belgium, Croatia, Cyprus,
Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Lat­
via, Lithuania, Luxembourg, Malta,
the Netherlands, Norway, Poland,
Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, United
Kingdom: BIPHOZYL
Bulgaria: BIPHOZYL (Бифозил)
This leaflet was last revised in
09/2017

Dilute hydrochloric acid (for pH
adjustment) E 507
Water for injections
Carbon dioxide (for pH
adjustment) E 290

WHAT BIPHOZYL LOOKS
LIKE AND CONTENTS OF
THE PACK

This medicine is a solution for
haemodialysis / haemofiltration and
is packed in a two-compartment
bag of a multilayer film containing
polyolefins and elastomers. The
final solution is obtained after
opening the peel seal and mixing
the solutions in the small and large
compartments. The solution is clear
and colourless.

Biphozyl D13000344 Ver. 2.1 REG S40084809

D13000344 Biphozyl PL non-PVC with valve UK_IE_MT_HU_RO_BG Ver. 2.1 REG.indd 5

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The following information is intended
for healthcare professionals only
POSOLOGY

OVERDOSE

The volume and rate at which
Biphozyl is administered depends
on the blood concentration of
phosphate and other electrolytes,
acid–base balance, fluid balance
and overall clinical condition of the
patient. The volume of replacement
solution and/or dialysate to be
administered will also depend on
the desired intensity (dose) of the
treatment. Administration (dose,
infusion rate and cumulative
volume) of Biphozyl should only
be established by a physician
experienced in critical care
medicine and CRRT (Continuous
Renal Replacement Therapy).
The range of flow rates
when used as replacement
solution in haemofiltration and
haemodiafiltration are:
Adult:
500 - 3000 ml/h

Symptoms of overdose
Overdose of Biphozyl can lead to
severe clinical condition, such as
congestive heart failure, electrolyte
or acid-base disturbances.

UK IE MT

Treatment of overdose
• Hypervolaemia / Hypovolaemia
• If hypervolaemia or
hypovolaemia occur, instruction
for handling of hypervolaemia
or hypovolaemia in Warnings
(Section 2) must be strictly
followed. Metabolic acidosis
If metabolic acidosis and/or
hyperphosphatemia occur in
the event of an overdose, stop
administration promptly. There is
no specific antidote for overdose.
The risk can be minimized by close
monitoring during treatment.

The range of flow rates when
used as dialysate in continuous
haemodialysis and continuous
haemodiafiltration are:
Adult:
500 - 2500 ml/h



Commonly used combined total
flow rates for CRRT (dialysate and
replacement solutions) in adults are
approximately 2000 to 2500 ml/h
which correspond to a daily fluid
volume of approximately 48 to 60 l.
Paediatric population
In children from neonates to
adolescents to 18 years, the range
of flow rates used as substitution
solution in haemofiltration and
haemodiafiltration and as dialysis
solution (dialysate) in continuous
haemodialysis and continuous
haemodiafiltration are 1000 to 4000
ml/h/1.73 m².
For adolescents (12-18 years),
the adult dose recommendation
should be used when the paediatric
dose is calculated to exceed the
maximum adult dose
Elderly patients Adults > 65 years
of age: Evidence from clinical
studies and experience suggests
that use in the elderly population is
not associated with differences in
safety or effectiveness.

Biphozyl D13000344 Ver. 2.1 REG S40084809

D13000344 Biphozyl PL non-PVC with valve UK_IE_MT_HU_RO_BG Ver. 2.1 REG.indd 15

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The solution in the small
compartment is added to the
solution in the large compartment
after breaking the peel seal
immediately before use. The
reconstituted solution shall be clear
and colourless.
Aseptic technique should be used
throughout 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 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 user to judge the compatibility
of an additive medication with
Biphozyl by checking for eventual
colour change and/or eventual
precipitation, insoluble complexes
or crystals. Before adding a
medication, verify if it is soluble and

I

II

stable in this medicine and that the
pH range of Biphozyl is appropriate
(pH of reconstituted solution
is 7.0–8.0). Additives may be
incompatible. The instructions for
use of the medication to be added
must be consulted.
Mix the solution thoroughly when
additives have been introduced.
I
Open the seal by holding the
small compartment with both
hands and squeezing 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 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.

III

IV.a If the luer connector is used,
remove the cap with a twist and
pull motion, and connect the
male luer lock on the dialysis or
replacement line to the female
luer connector 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 connector (or
spike connector) is used,
first remove the snap-off cap.
Introduce the spike through
the rubber septum. Verify that
the fluid is flowing freely. (See
figure IV.b below)
The reconstituted solution is for
single use only. Any unused
solution must be discarded.
The solution can be disposed of
via wastewater without harming the
environment.

IV.a

IV.b

16

Biphozyl D13000344 Ver. 2.1 REG S40084809

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PREPARATION AND/OR
HANDLING

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