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PHYSIONEAL 35 GLUCOSE 1.36% W/V 13.6 MG/ML CLEAR-FLEX SOLN

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

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PHYSIONEAL 35 CLEAR-FLEX

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ENGLISH

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ENGLISH
PACKAGE LEAFLET: INFORMATION FOR THE USER

PHYSIONEAL 35 Glucose 1.36% w/v / 13.6 mg/ml CLEAR-FLEX, Solution for Peritoneal Dialysis
PHYSIONEAL 35 Glucose 2.27% w/v / 22.7 mg/ml CLEAR-FLEX, Solution for Peritoneal Dialysis
PHYSIONEAL 35 Glucose 3.86% w/v / 38.6 mg/ml CLEAR-FLEX, Solution for Peritoneal Dialysis
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.
– If you get any side effects talk to your doctor. This includes any
possible side effects not listed in this leaflet. See section 4.



If you do not drain the unmixed solution, your blood levels of salts and
other chemicals will increase. This will cause undesirable effects such
as confusion, drowsiness and irregular heart beat.
Talk to your doctor before using PHYSIONEAL 35.
Take special care:
• If you have serious 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 have an aortic graft placement.
• If you have severe breathing difficulties.
• If you experience abdominal pain, increased body temperature or
notice cloudiness or particles in the drained fluid. This may be a sign
of peritonitis (inflamed peritoneum) or infection. You should contact
your medical team urgently. Note the batch number of the peritoneal
dialysis solution bags you were using and bring them 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, they may give you an antibiotic that
is effective against a wide number of different bacteria. This is called a
broadspectrum antibiotic.
• If you have a high level of lactate in your blood. You are at increased
risk of lactic acidosis if:
– you have profoundly low blood pressure
– you have a blood-infection
– you have acute kidney failure
– you have an inherited metabolic disease
– you are taking metformin (a medicine used to treat diabetes)
– you are taking medicines to treat HIV, especially medicines called
NRTIs.
• If you have diabetes and use this solution, the dose of your drugs
which regulate the blood sugar level (e.g. insulin) should be evaluated
on a regular basis. Especially when the peritoneal dialysis treatment
is started, or changed, the dose of your diabetes drugs may need to be
adjusted.
• If you have an allergy to corn (maize) which may result in
hypersensitivity reactions, including a serious allergic reaction called
anaphylaxis. Stop the infusion immediately and drain the solution from
the peritoneal cavity.
• 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. Particularly salts (e.g.
hydrogen carbonate, potassium, magnesium, calcium and phosphate),
parathyroid hormone and lipids.
• If you have a high level of hydrogen carbonate in your blood.
• Not to use more solution than your doctor has prescribed. Symptoms
of overinfusion include abdominal distension, feeling of fullness and
shortness of breath.
• Your doctor will check your potassium level regularly. If it falls too low
they may give you some potassium chloride to compensate.
• Improper clamping or priming sequence may result in infusion of air
into the peritoneal cavity, which may result in abdominal pain and/or
peritonitis.
• Because 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)
– Thickening of intestines that may be associated with abdominal
pain, abdominal distension or vomiting. EPS can be fatal.

What is in this leaflet:
1. What PHYSIONEAL 35 is and what it is used for
2. What you need to know before you use
PHYSIONEAL 35
3. How to use PHYSIONEAL 35
4. Possible side effects
5. How to store PHYSIONEAL 35
6. Contents of the pack and other information
1. WHAT PHYSIONEAL 35 IS AND WHAT IT IS USED FOR
PHYSIONEAL 35 is a solution for peritoneal dialysis. It removes water and waste
products from the blood. It also corrects abnormal levels of different blood
components. PHYSIONEAL 35 contains varying levels of glucose (1.36%, 2.27%
or 3.86%). The higher the strength of glucose in the solution, the greater the
amount of water that will be removed from the blood.
PHYSIONEAL 35 may be prescribed to you if you have:
• either temporary or permanent kidney failure;
• severe water retention;
• severe disturbances in the acidity or alkalinity (pH) and the level of
salts in your blood;
• certain types of drug intoxication where no other treatments are
available.
PHYSIONEAL 35 solution has an acidity (pH) close to that of your blood. Therefore
it may be particularly useful if you experience inflow pain or discomfort with
other more acidic Peritoneal Dialysis solutions.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE
PHYSIONEAL 35
Your doctor must supervise you the first time you use this product.

Do NOT use PHYSIONEAL 35


If you are allergic to the active substances or any of the other
ingredients of this medicine (listed in section 6)
• 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.
Sometimes treatment with PHYSIONEAL 35 in the CLEAR-FLEX container is not
recommended:
• Children requiring fill volumes less than 1600 ml.

Warnings and precautions
Before use, you must:
• Firstly mix the content of the two chambers by opening the long seal;
• Secondly open the short SafetyMoon seal.
• If you infuse unmixed solution (the long-seal between the two
chambers is not opened), you may experience abdominal pain. Drain
the solution immediately, use a newly mixed bag and inform your
doctor straight away.

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Children
Your doctor will assess the risk against the benefit of using this product if you
are under 18 years old.




Other medicines and PHYSIONEAL 35





Compatibility with other drugs

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
(eg. digoxin). you may:
– need potassium and calcium supplements
– develop an irregular heartbeat (an arrhythmia)
– your doctor will monitor you closely during treatment, especially
your potassium level.

Your doctor may prescribe you other injectable drugs to be added directly into
the PHYSIONEAL 35 bag. In that situation, add the drug through the medication
site located on the large chamber before opening the long-seal. Use the product
immediately after addition of the drug. Check with your doctor if you are not
sure.

If you use more bags of PHYSIONEAL 35 than you should
in 24 hours
If you infuse too much PHYSIONEAL 35 you may get:
• abdominal distension
• a feeling of fullness and/or
• a shortness of breath.
Contact your doctor immediately. They will advise you what to do.
If you have any further questions on the use of this product, ask your doctor.

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.
Physioneal is not recommended during pregnancy or while breast-feeding
unless your doctor advises differently.

4. POSSIBLE SIDE EFFECTS

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

Like all medicines, this medicine can cause side effects, although not everybody
gets them.

If any of the following happens, tell your doctor or your
peritoneal dialysis centre immediately:

3. HOW TO USE PHYSIONEAL 35




Hypertension (blood pressure that is higher than usual),
Swollen ankles or legs, puffy eyes, shortness of breath or chest pain
(hypervolaemia),
• Abdominal pain,
• Chills (shivering/flu-like symptoms), fever,
• Inflamed peritoneum (peritonitis).
These are all serious side effects. You may need urgent medical attention.

PHYSIONEAL 35 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.
It is not for intravenous use.
Always use this medicine exactly as instructed by the medical team specialised
in peritoneal dialysis. Check with your doctor if you are not sure.
If the bag is damaged, you must discard it.

If you get any side effects talk to your doctor or your
peritoneal dialysis centre. This includes any side effects not
listed in this leaflet.

How much and how often
Your doctor will prescribe the appropriate glucose strength and the number of
bags you must use every day.

Common (may affect up to 1 in 10 people)
• Modification of your blood tests:
– increase of calcium (hypercalcaemia)
– decrease of potassium (hypokalaemia) which can cause muscle
weakness, twitching or abnormal heart rhythm
• Weakness, fatigue
• Fluid retention (oedema)
• Weight increase

Use in children and adolescents
If you are below 18 years old, your doctor will assess carefully the prescription
of this medicine.

If you stop using PHYSIONEAL 35
Do not stop peritoneal dialysis without the agreement of your doctor. If you stop
the treatment, it may have life-threatening consequences.

Method of administration
Before use,
• Warm the bag to 37°C. Use the warming plate specially designed for
this purpose. Never immerse in water. Never use a microwave oven 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. Check that the long and short
seals are not opened at any point. If one of the seals is opened, even
partially, discard 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.
• Mix the two chambers thoroughly, by opening the long seal first and
then the short SafetyMoon seal.
• 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.
The solution must be infused within 24 hours after mixing.
After use, check that the drained fluid is not cloudy.

Uncommon (may affect up to 1 in 100 people)
• Decrease in fluid removal on dialysis
• Fainting, dizziness or headache
• Cloudy solution drained from the peritoneum, stomach-ache
• Peritoneal bleeding, pus, swelling or pain around the exit site of your
catheter, catheter blockage.
• Nausea, loss of appetite, indigestion, flatulence (passing wind), thirst,
dry mouth
• Distension or inflammation of your abdomen, shoulder pain, hernia of
the abdominal cavity (groin lump).
• Modification of your blood tests:
– lactic acidosis
– increased level of carbon dioxide
– increase in sugar (hyperglycaemia)
– increase in white blood cells (eosinophilia)
• Difficulty in sleeping
• Low blood pressure (hypotension)
• Cough
• Aching in muscles or bones
• Swelling of the face or throat
• Rash.

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Other side effects related to the peritoneal procedure:
• Infection around the exit site of your catheter, catheter blockage.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the
national reporting system.
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

The other ingredients are Water for Injections, sodium hydroxide, hydrochloric
acid.
The composition in mmol/l in the mixed solution is:
1.36%
2.27%
3.86%
Glucose anhydrous (mmol/l)
75.5
126
214
Sodium (mmol/l)
132
Calcium (mmol/l)
1.75
Magnesium (mmol/l)
0.25
Chlorides (mmol/l)
101
Hydrogen bicarbonate (mmol/l)
25
Lactate (mmol/l)
10

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

What PHYSIONEAL 35 Clear-Flex looks like and contents
of the pack

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.




5. HOW TO STORE PHYSIONEAL 35






Keep this medicine out of the sight and reach of children.
Do not store below 4°C.
Do not use this medicine after the expiry date which 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 PHYSIONEAL 35 as you have been trained.

Volume Number of
units per box
1.5 L
5/6
1.5 L
5/6
2.0 L
4/5
2.0 L
4/5
2.5 L
3/4
2.5 L
3/4
3.0 L
3
3.0 L
3
4.5 L
2
5.0 L
2

6. CONTENTS OF THE PACK AND OTHER INFORMATION
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 PHYSIONEAL 35 contains
The active substances in the mixed peritoneal dialysis solution are:
Glucose monohydrate (g/l)
equivalent to Glucose anhydrous (g/l)
Sodium chloride (g/l)
Calcium chloride dihydrate (g/l)
Magnesium chloride hexahydrate (g/l)
Sodium hydrogen carbonate (g/l)
Sodium (S)-lactate solution equivalent
to sodium (S)-lactate (g/l)

1.36%
15.0
13.6

2.27%
25.0
22.7
5.67
0.257
0.051
2.10

PHYSIONEAL 35 is a clear, colourless, sterile solution for peritoneal
dialysis.
PHYSIONEAL 35 is packed in a non-PVC bag with two chambers. The
two chambers are separated by non-permanent seals.
You must only infuse PHYSIONEAL 35 once the solutions of the two
chambers are fully mixed. Only then should you open the short
SafetyMoon seal.
Each bag is over-wrapped in an overpouch and supplied in a carton
box.

3.86%
42.5
38.6

Product configuration Type of connector(s)
Single bag (APD)
Twin bag (CAPD)
Single bag (APD)
Twin bag (CAPD)
Single bag (APD)
Twin bag (CAPD)
Single bag (APD)
Twin bag (CAPD)
Single bag (APD)
Single bag (APD)

luer
luer/lineo
luer
luer/lineo
luer
luer/lineo
luer
luer/lineo
luer
luer/luer and Homechoice
APD set luer or lineo

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:

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

1.12

Manufacturer
Baxter Healthcare S.A.
Moneen Road
Castlebar
County Mayo – Ireland

Bieffe Medital S.p.A.
Via Nuova Provinciale
23034 Grosotto
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, Hungary, Iceland, Ireland, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia,
Slovenia, Spain, Sweden, United Kingdom: PHYSIONEAL 35 CLEAR-FLEX
Italy: FIXIONEAL 35

02164

This leaflet was last revised in 03/2016
Baxter, Physioneal and Clear-Flex are trademarks of Baxter International Inc.
For information about PHYSIONEAL 35 or to request this leaflet in formats such
as audio or large print please contact the Marketing Authorisation Holder:
Tel: +44 (0)1635 206345.

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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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