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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 / DISODIUM PHOSPHATE DIHYDRATE / MAGNESIUM CHLORIDE HEXAHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM HYDROGEN CARBONATE / DIS

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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

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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

The solutions in the two compartments must be mixed before use.

DO NOT USE BIPHOZYL IN
CASE OF:
•• 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

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.

WARNINGS AND PRECAUTIONS

BIPHOZYL may be warmed to
37°C to enhance patient comfort.
However, only dry heat should
be used. 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.

Warnings
Talk to your doctor, pharmacist or
nurse before using BIPHOZYL.
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.
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.
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.
The instructions for use must be
strictly followed.

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Use only with a dialysis machine
for CRRT.

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.

Your doctor will closely monitor
your haemodynamic status, fluid
balance, electrolyte and acid-base
balance throughout the procedure,
including all fluid inputs (intravenous infusion) and outputs (urine
output), even those not directly
related to CRRT.
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.

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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.
Older people
No specific adverse effect on older
people 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).
•• Vitamin D and medicinal products containing calcium chloride
or calcium gluconate; as they
can increase the risk of a high
concentration of calcium in the
blood (hypercalcaemia).
•• Sodium bicarbonate; as this
may increase the risk of excess
of bicarbonate in your blood
(metabolic alkalosis).
Pregnancy, breast-feeding and
fertility
Pregnancy and breast-feeding:
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.
Fertility:
No effects on fertility are anticipated, since sodium, potassium,
magnesium, chloride, hydrogen
phosphate and hydrogen carbonate
are normal constituents of the body.

3. HOW TO USE BIPHOZYL

4. POSSIBLE SIDE EFFECTS

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.

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)

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:
Adult and
adolescents:
500 – 3000 ml/h
Children:
15 – 35 ml/kg/h
The range of flow rates when used
as dialysate in continuous haemodialysis and continuous haemodiafiltration are:
Adult and
adolescents:
500 – 2500 ml/h
Children:
15 – 30 ml/kg/h
INSTRUCTIONS FOR USE
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.
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.

There are also some side effects
which can be caused by dialysis
treatments, such as:
•• 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:
United Kingdom:
Yellow Card Scheme
www.mhra.gov.uk/yellowcard
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
Malta:
ADR Reporting
Website: www.medicinesauthority.
gov.mt/adrportal
By reporting side effects you can
help provide more information on
the safety of this medicine.

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

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

6. CONTENTS OF THE PACK
AND OTHER INFORMATION
WHAT BIPHOZYL CONTAINS
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,
HPO421
2
Hydrogen carbonate,
HCO3−
22
22

The other ingredients are:
•• 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. Each bag contains
5000 ml solution and the bag is
overwrapped with a transparent
film. 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, Croatia, Cyprus,
Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, 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
11/2016

Theoretical osmolarity: 290 mOsm/l
pH: 7.0 – 8.0

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The following information is intended
for healthcare professionals only
POSOLOGY
The volume and rate at which
BIPHOZYL is administered
depends on the blood concentration of phosphate and other
electrolytes, acid–base balance,
and overall clinical condition of the
patient. Administration (dose, infusion rate and cumulative volume) of
BIPHOZYL should be established
by a physician.
The range of flow rates when used
as replacement solution in haemofiltration and haemodiafiltration are:
Adult and
adolescents:
500 – 3000 ml/h
Children:
15 – 35 ml/kg/h
The range of flow rates when used
as dialysate in continuous haemodialysis and continuous haemodiafiltration are:
Adult and
adolescents:
500 – 2500 ml/h
Children:
15 – 30 ml/kg/h

UK

IE

MT

OVERDOSE
SYMPTOMS OF OVERDOSE
Overdose of BIPHOZYL can lead
to severe clinical condition, such as
congestive heart failure, electrolyte
or acid-base disturbances.
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.

Commonly used flow rates in adults
are approximately 2000 ml/h which
correspond to a daily replacement
fluid volume of approximately
20 – 25 ml/kg/h.
Paediatric population
Children < 16 years of age:
Evidence from clinical studies and
experience suggests that use in the
paediatric population is not associated with differences in safety or
effectiveness.



Older people
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.

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PREPARATION
AND/OR HANDLING
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.
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 precipita-

I

II

tion, insoluble complexes or crystals. Before adding a medication,
verify if it is soluble and 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

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Gambro and Biphozyl are trademarks of Baxter International Inc., or its subsidiaries
Gambro Lundia AB
P.O. Box 10101
SE-220 10 Lund
Sweden
Visiting address: Magistratsvägen 16, Lund
Tel: +46 46 16 90 00
www.gambro.com

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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.

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