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EXTRANEAL (ICODEXTRIN 7.5%) SOLUTION FOR PERITONEAL DIALYSIS

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / ICODEXTRIN / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM S-LACTATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

EXTRANEAL Solution for Peritoneal Dialysis
Read all of this leaflet carefully before you start using this medicine.
–– Keep this leaflet. You may need to read it again.
–– If you have any further questions, ask your doctor.
–– If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this leaflet. See section 4.



you are taking medicines to treat HIV, especially
medicines called NRTIs
• if you experience abdominal pain or notice
cloudiness, haziness or particles in the drained
fluid. This may be a sign of peritonitis (inflamed
peritoneum) or infection. You should contact your
02186
medical team urgently. Note the batch number and
bring it along with the drained fluid bag to your medical
team. They will decide if the treatment should be stopped or any
corrective treatment started. For example if you have an infection your
doctor may perform some tests to find out which antibiotic will be best
for you. Until your doctor knows which infection you have, he may give
you an antibiotic that is effective against a wide number of different
bacteria. This is called a broadspectrum antibiotic.
• during peritoneal dialysis your body may lose protein, amino acids,
vitamins. Your doctor will know if these need to be replaced.
• if you have problems affecting your abdominal wall or cavity. For
example if you have a hernia or a chronic infectious or inflammatory
condition affecting your intestines.
• if you had aortic graft placement.
• if you have severe lung disease, e.g. emphysema
• if you have breathing difficulties.
• if you have disorders precluding normal nutrition.
• if you have a potassium deficiency.
You should also take into account that:
• a disorder called encapsulating peritoneal sclerosis (EPS) is a known,
rare complication of peritoneal dialysis therapy. You – possibly together
with your doctor – should be aware of this possible complication.
EPS causes:
• inflammation in your abdomen (belly)
• the growth of sheets of fibrous tissue that cover and bind your
organs and affect their normal movement. Rarely this has been
fatal.
• you – possibly together with your doctor – should keep a record of your
fluid balance and of your body weight. Your doctor will monitor your
blood parameters at regular intervals.
• your doctor will check your potassium levels regularly. If they fall too
low he may give you some potassium chloride to compensate.
Sometimes treatment with this medicine is not recommended, such as if:
• You have acute kidney disease.

What is in this leaflet:
1. What EXTRANEAL is and what it is used for
2. What you need to know before you use EXTRANEAL
3. How to use EXTRANEAL
4. Possible side effects
5. How to store EXTRANEAL
6. Contents of the pack and other information
1. WHAT EXTRANEAL IS AND WHAT IT IS USED FOR
EXTRANEAL is a solution for peritoneal dialysis. The peritoneal cavity is the
cavity in your abdomen (belly) between your skin and the peritoneum. The
peritoneum is the membrane surrounding your internal organs such as your
intestines and liver. The EXTRANEAL solution is placed into the peritoneal cavity
where it removes water and waste products from the blood. It also corrects
abnormal levels of different blood components.
EXTRANEAL may be prescribed for you if:
• You are an adult with permanent kidney failure which needs peritoneal
dialysis.
• Standard glucose peritoneal dialysis solutions alone cannot remove
sufficient water.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE EXTRANEAL
Your doctor must supervise you the first time you use this product.

Do NOT use EXTRANEAL








if you are allergic to icodextrin or starch derivatives (e.g. maize starch)
or any of the other ingredients of EXTRANEAL
if you are intolerant to maltose or isomaltose (sugar coming from
starch)
if you have glycogen storage disease
if you already have severe lactic acidosis (too much acid in the blood)
if you have a surgically uncorrectable problem affecting your
abdominal wall or cavity or uncorrectable problem that increases risk
of abdominal infections
if you have documented loss of peritoneal function due to severe
peritoneal scarring

Children
The safety and efficacy of EXTRANEAL in children less than 18 years old has not
been demonstrated.

Other medicines and EXTRANEAL
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
• If you use other medicines, your doctor may need to increase their
dose. This is because peritoneal dialysis treatment increases the
elimination of certain medicines.
• Take care if you use heart medicines known as cardiac glycosides
(e.g. digoxin). Your heart medicine may not be so effective or its toxicity
may be increased. You may:
• need potassium and calcium supplements
• develop an irregular heartbeat (an arryhthmia)
Your doctor will monitor you closely during treatment, especially your potassium
levels.

Warnings and precautions
Talk to your doctor before using EXTRANEAL
• if you are elderly. There is a risk of dehydration.
• if you are diabetic and using this solution for the first time. You may
need to adjust your insulin dose.
• if you need to test your blood glucose level (for example if you are
diabetic). Your doctor will advise you on which test kit to use
(see “Other forms of interactions”).
• if you have a high risk of severe lactic acidosis (too much acid in the
blood). You are at increased risk of lactic acidosis if:
• you have profoundly low blood pressure
• you have a blood-infection
• you have acute severe kidney failure
• you have an inherited metabolic disease
• you are taking metformin (a medicine used to treat diabetes)

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Other forms of interactions

If you use more than one bag of EXTRANEAL in 24 hours
If you infuse too much EXTRANEAL you may get:
• abdominal distension
• a feeling of fullness and/or
• a shortness of breath.
Contact your doctor immediately. He will advise you what to do.

EXTRANEAL interferes with the measurement of blood glucose with certain
testing kits. If you need to test your blood glucose, make sure that you use a
kit that is glucose-specific. Your doctor will advise you on which kit to use.
Using the wrong test may cause a falsely high blood glucose reading level.
This could result in administration of more insulin than needed. This can
cause hypoglycaemia (low blood glucose levels), which can result in loss
of consciousness, coma, neurological damage or death. Additionally, a
false high glucose reading may mask true hypoglycaemia and allow it to go
untreated with similar consequences.
False high glucose readings can be seen up to two weeks after you stopped
your EXTRANEAL therapy. In case you are admitted to hospital you should
warn the doctors about this possible interaction and they should carefully
review the product information of the testing kit to make sure they use a
glucose-specific one.

If you stop using EXTRANEAL
Do not stop peritoneal dialysis without the agreement of your doctor. If you stop
the treatment it may have life-threatening consequences.

4. POSSIBLE SIDE EFFECTS
Like all medicines, EXTRANEAL can cause side effects, although not everybody
gets them.
If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet.
If any of the following happen, tell your doctor or your peritoneal dialysis centre
immediately:
• Hypertension (blood pressure that is higher than usual),
• Swollen ankles or legs, puffy eyes, shortness of breath or chest pain
(hypervolaemia),
• Hypersensitivity (allergic reaction) which may include swelling of face,
throat or around the eyes (angioedema),
• Abdominal pain,
• Chills (shivering/flu-like symptoms).
These could be signs of serious side effects. You may need urgent medical
attention.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor for advice before taking this medicine.
EXTRANEAL is not recommended during pregnancy or while breast-feeding
unless your doctor advises differently.

Driving and using machines
This treatment may cause fatigue, weakness, blurred vision or dizziness.
Do not drive or operate machines if you are affected.

3. HOW TO USE EXTRANEAL
EXTRANEAL is to be administered into your peritoneal cavity. This is the cavity
in your abdomen (belly) between your skin and the peritoneum. The peritoneum
is the membrane surrounding your internal organs such as your intestines and
liver.
Always use this medicine exactly as instructed by the medical team specialised
in peritoneal dialysis. Check with your doctor if you are not sure.

Side effects commonly observed (may affect up to 1 in 10
people) in patients using EXTRANEAL:









The recommended dose is





One bag per day during the longest dwell, i.e.
• Overnight in Continuous Ambulatory Peritoneal Dialysis (CAPD).
• During the daytime in Automated Peritoneal Dialysis (APD).
Take between 10 – 20 minutes to instill the solution.
The dwell time with EXTRANEAL is between 6 – 12 hours in CAPD, and
14 – 16 hours in APD.

Other side effects related to the peritoneal dialysis procedure
or common to all peritoneal dialysis solutions:

Method of administration




Before use,
• Warm the bag to 37°C. Use the warming plate specially designed for
this purpose. Never immerse in water to warm the bag.
• Use aseptic technique throughout the administration of the solution as
you have been trained.
• Prior to beginning an exchange, ensure you clean your hands and the
area where your exchange will be performed.
• Prior to opening the overpouch, check for the correct solution type,
expiration date, and amount (volume). Lift the dialysate bag to check
for any leaks (excess fluid in the overpouch). Do not use the bag if
leaks are discovered.
• After removing the overpouch, inspect the container for signs of
leakage by pressing firmly on the bag. Do not use the bag if any leak
is detected.
• Check that the solution is clear. Do not use the bag if the solution is
cloudy or contains particles.
• Ensure all connections are secure before beginning the exchange.
• Ask your doctor if you have questions or concerns about this product
or how to use it.
Use each bag only once. Discard any unused remaining solution.
After use, check that the drained fluid is not cloudy.




















Compatibility with other drugs
Your doctor may prescribe you other injectable drugs to be added directly into
the EXTRANEAL bag. In that situation, add the drug through the medication site
located at the bottom of the bag. Use the product immediately after addition of
the drug. Check with your doctor if you are not sure.
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Redness and scaling of the skin, rash, itching (pruritus)
Feeling light headed or dizzy, thirst (dehydration)
Decreased blood volume (hypovolaemia)
Abnormal laboratory tests
Weakness, headache, fatigue
Swollen ankles or legs,
Low blood pressure (hypotension)
Ringing in the ears



Cloudy solution drained from the peritoneum, stomach-ache
Peritoneal bleeding, pus, swelling, pain or infection around the exit site
of your catheter, catheter blockage, injury, interaction with the catheter.
Low blood sugar concentration (hypoglycaemia)
Shock or coma caused by low blood sugar concentration
High blood sugar concentration (hyperglycaemia)
Nausea, vomiting, loss of appetite, dry mouth, constipation, diarrhoea,
flatulence (passing wind), disorder of the stomach or intestines such as
blockage in your intestine, gastric ulcer, gastritis (inflamed stomach),
indigestion.
Abdominal swelling, hernia of the abdominal cavity (this causes a lump
in the groin)
Modification of your blood tests
Abnormal liver function test
Weight increase or decrease
Pain, fever, malaise
Heart disease, faster heart beat, shortness of breath or chest pain
Anaemia (reduction in red blood cells which can make the skin pale
and cause weakness or breathlessness); increase or decrease of white
blood cell count; reduction in blood platelets, which increases risk of
bleeding or bruising
Numbness, tingling, burning sensation
Hyperkinesia (increased movements and inability to keep still)
Blurred vision
Loss of the sense of taste
Fluid on the lungs (pulmonary oedema), shortness of breath, difficulty
in breathing or wheezing, cough, hiccups
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Nail disorder
Skin disorders such as hives (urticaria), psoriasis, skin ulcer, eczema,
dry skin, skin discoloration, blistering of the skin, allergic or contact
dermatitis, rashes and itching.
Rashes may be itchy with red spots covered with bumps, or with
eruptions or shedding of the skin. The following three severe types of
skin reaction may occur:
• Toxic epidermal necrolysis (TEN). This causes:
–– a red rash over many parts of the body
–– the shedding of the outer layer of skin
• Erythema multiforme. An allergic skin reaction causing spots, red
welts or purple or blistered areas. It can also affect the mouth,
eyes and other moist body surfaces.
• Vasculitis. Inflammation of certain blood vessels within the body.
Clinical symptoms will depend on the part of the body involved,
but may be characterized on the skin as red or violet spots or
welts or have symptoms similar to an allergic reaction, including
rash, joint pain and fever.
Muscle cramps, pain in bones, joints, muscles, back, neck
Fall in blood pressure on standing up (orthostatic hypotension)
Peritonitis (inflamed peritoneum) including peritonitis caused by fungal
or bacterial infection
Infections including flu syndrome, boil
Abnormal thinking, anxiety, nervousness

Sodium
Calcium
Magnesium
Chloride
Lactate

The other ingredients are:
• Water for injections.
• Sodium hydroxide or hydrochloric acid.

What EXTRANEAL looks like and contents of the pack


EXTRANEAL is packaged in flexible plastic bags of 1.5 litres, 2.0 litres
or 2.5 litres capacity.
• The solution in the bags is clear and colourless.
• Each bag is over-wrapped in an overpouch and supplied in carton
boxes.
Volume
Number of
Product configuration
Type of connector(s)
units per box
1.5L
8
Single bag (APD)
luer / spike
1.5L
8
Twin bag (CAPD)
luer / spike
1.5L
6
Single bag (APD)
luer / spike
1.5L
6
Twin bag (CAPD)
luer / spike / lineo
2.0L
8
Single bag (APD)
luer / spike
2.0L
8
Twin bag (CAPD)
luer / spike
2.0L
6
Single bag (APD)
luer / spike
2.0L
6
Twin bag (CAPD)
luer / spike
2.0L
5
Single bag (APD)
luer / spike
2.0L
5
Twin bag (CAPD)
luer / spike / lineo
2.5L
5
Single bag (APD)
luer / spike
2.5L
5
Twin bag (CAPD)
luer / spike
2.5L
4
Single bag (APD)
luer / spike
2.5L
4
Twin bag (CAPD)
luer / spike / lineo

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, IRE – Dublin 2.
Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie;
E-mail: medsafety@hpra.ie

The Lineo connector contains iodine.
Not all configurations may be marketed.
For any information about this medicine, please contact the local representative
of the Marketing Authorisation Holder:

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

Marketing Authorisation Holder
Baxter Healthcare Ltd
Caxton Way
Thetford, Norfolk, IP24 3SE
United Kingdom

5. HOW TO STORE EXTRANEAL

Manufacturer

Baxter Healthcare S.A.
Moneen Road
Castlebar, County Mayo
Republic of Ireland






Keep out of the sight and reach of children.
Store in the original package.
Do not store below 4°C.
Do not use EXTRANEAL after the expiry date. The date is stated on the
carton label and on the bag after the abbreviation Exp. and the
symbol E. The expiry date refers to the last day of that month.
Dispose of EXTRANEAL as you have been trained.

Baxter Healthcare Ltd
Caxton Way
Thetford, Norfolk, IP24 3SE
United Kingdom

This leaflet was last revised in 04/2016

6. CONTENTS OF THE PACK AND OTHER INFORMATION

For information about EXTRANEAL or
to request this leaflet in formats such
as audio or large print please contact
the Marketing Authorisation Holder:
Tel: +44 (0)1635 206345.

This leaflet does not contain all the information about this medicine. If you have
any questions or are not sure about anything, ask your doctor.

What EXTRANEAL contains
The active substances are:
Icodextrin
Sodium chloride
Sodium S-lactate
Calcium chloride
Magnesium chloride

133 mmol/l
1.75 mmol/l
0.25 mmol/l
96 mmol/l
40 mmol/l

75 g/l
5.4 g/l
4.5 g/l
0.257 g/l
0.051 g/l

Baxter and Extraneal are trademarks of Baxter International Inc.

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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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