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DIANEAL PD4 GLUCOSE 3.86% W/V / 38.6MG/ML

Active substance(s): ANHYDROUS GLUCOSE / CALCIUM CHLORIDE / MAGNESIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

DIANEAL PD4 Glucose 1.36% w/v / 13.6 mg/ml
DIANEAL PD4 Glucose 2.27% w/v / 22.7 mg/ml
DIANEAL PD4 Glucose 3.86% w/v / 38.6 mg/ml
Solutions 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 experience abdominal pain, increased body
temperature or notice cloudiness or particles in the drained
fluid. This may be a sign of peritonitis (inflamed peritoneum)
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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 broad-spectrum antibiotic.
• 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 or blood-infection that
can be associated with 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 allergy to corn. 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. bicarbonate, potassium, magnesium, calcium and phosphate)
– Parathyroid hormone – responsible for maintaining calcium levels in
your body
– Fats in your blood (lipids).
• if you have high or low levels of calcium in your blood. This solution
may influence your calcium levels further.
• not to use more solution than your doctor has prescribed. Symptoms
of overinfusion include abdominal distension, a 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.
• 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 DIANEAL PD4 is and what it is used for
2. What you need to know before you use DIANEAL PD4
3. How to use DIANEAL PD4
4. Possible side effects
5. How to store DIANEAL PD4
6. Contents of the pack and other information
1. WHAT DIANEAL PD4 IS AND WHAT IT IS USED FOR
DIANEAL PD4 is a solution for peritoneal dialysis.
It removes water and waste products from the blood. It also corrects abnormal
levels of different blood components. DIANEAL PD4 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.
DIANEAL PD4 may be prescribed to you if you have:
• either temporary or permanent kidney failure
• severe water retention
• severe disturbances in the acidity or alkalinity and the level of salts in
your blood
• certain types of drug intoxication where no other treatments are
available.
DIANEAL PD4 is particularly indicated for the control of your serum calcium and
phosphate levels if you receive calcium or magnesium containing phosphate
binders.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE DIANEAL PD4

Do not use DIANEAL PD4






UK/Ireland/Malta
(English)

if you are allergic to active substances or any of the other ingredients
of this medicine (listed in section 6).
if you have severe lactic acidosis (too much acid in the blood) before
you use this solution for the first time.
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.

Warnings and precautions

Other medicines and DIANEAL PD4

Talk to your doctor before using DIANEAL PD4.
Take special care:
• if you have serious problems affecting your abdominal wall or cavity.
For example if you have a hernia or inflammatory condition affecting
your intestines.
• if you have an aortic graft placement.
• if you have breathing difficulties.






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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), you may:
– need potassium and calcium supplements
– develop an irregular heartbeat (an arrhythmia)
– your doctor will monitor you closely during treatment, especially
your potassium, calcium and magnesium levels.
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Pregnancy and breast-feeding

Side effects that have been reported (occurs in an
unknown number of patients treated with DIANEAL PD4):

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. They will
advise if this treatment is suitable or not for you.



Modification of your blood tests:
– decrease of potassium (hypokalaemia) which can cause muscle
weakness, twitching or abnormal heart rhythm
– decrease in sodium (hyponatraemia) which can cause fatigue,
coma, confusion or nausea
– decrease of chloride (hypochloraemia) which can cause fatigue,
coma, confusion or nausea
• Infusion site pain
• Nausea, vomiting, diarrhoea, constipation, dehydration (thirst, dry
mouth)
• Decreased blood volume (hypovolaemia)
• Low blood pressure (hypotension)
• Muscle spasms, aching in muscles or bones
• Fluid retention (oedema)
• Distension or discomfort of your abdomen
• Fainting
• Skin disorders such as hives (urticaria), rashes or itching
• Shortness of breath.

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

3. HOW TO USE DIANEAL PD4
DIANEAL PD4 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. Improper
clamping or priming sequence may result in infusion of air into the peritoneum,
which may result in abdominal pain and/or peritonitis.
If the bag is damaged, you must discard it.

How much and how often

Other side effects related to the peritoneal procedure
(occurs in an unknown number of patients treated with
DIANEAL PD4):

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

If you stop using DIANEAL PD4

• Infection around the exit site of your catheter, catheter blockage.
If you get any side effects, talk to your doctor or your peritoneal dialysis centre.
This includes any possible side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side effects you can
help provide more information on the safety of this medicine.

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.
• Remove the overpouch and administer immediately.
• Check that the solution is clear. Do not use the bag if it’s not clear.
• Use each bag only once. Discard any unused remaining solution.
Use aseptic technique throughout the administration of the solution as you have
been trained.
After use, check that the drained fluid is not cloudy.

Republic of Ireland:
Via 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
www.medicinesauthority.gov.mt/adrportal

Compatibility with other drugs

United Kingdom

Your doctor may prescribe you other injectable drugs to be added directly into
the DIANEAL PD4 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.

Yellow Card Scheme
www.mhra.gov.uk/yellowcard

If you use more bags of DIANEAL PD4 than you should in
24 hours

5. HOW TO STORE DIANEAL PD4





Keep this medicine out of the sight and reach of children.
Store in the original package.
Do not store above 25°C. Do not refrigerate or freeze.
Once removed from the overpouch use immediately. Discard any
unused solution.
• 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 DIANEAL PD4 as you have been trained.

If you infuse too much DIANEAL PD4 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody
gets them.
If any of the following happen, tell your doctor or your peritoneal dialysis centre
immediately:
• Blood pressure that is higher than usual (Hypertension)
• Swollen ankles or legs, puffy eyes, shortness of breath or chest pain
(hypervolaemia)
• Serious illness with blistering of the skin, mouth, eyes and genitals
(Stevens–Johnson syndrome)
• Abdominal pain
• Fever
• Inflamed peritoneum (peritonitis).
These are all serious side effects. You may need urgent medical attention.

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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 DIANEAL PD4 contains
Dianeal PD4 is available in 3 different strengths of glucose.
The formulae are:
DIANEAL PD4

1.36%
Formula g/l

2.27%

3.86%

13.6
5.4
0.184
0.051
4.5
mmol/l
132
1.25
0.25
40
95

22.7
5.4
0.184
0.051
4.5

38.6
5.4
0.184
0.051
4.5

132
1.25
0.25
40
95

132
1.25
0.25
40
95

Glucose monohydrate equivalent
to Glucose anhydrous
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium lactate
Sodium
Calcium
Magnesium
Lactate
Chloride

The other ingredient is Water for Injections.

What DIANEAL PD4 looks like and contents of the pack
DIANEAL PD4 is packed in a plastic bag available in different volumes.
The solution in the bags is clear and colourless.
Each bag is over-wrapped in an overpouch and supplied in carton boxes.
Volume
1.5 L
2.0 L
2.5 L
3.0 L
5.0 L

Product configuration
Single and twin bags
Single and twin bags
Single and twin bags
Single and twin bags
Single bag

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, UK

Manufacturer

Baxter Healthcare S.A., Moneen Road, Castlebar, County Mayo, Ireland
Baxter Manufacturing Sp. z.o.o., 42 B Wojciechowska Str. 20-704 Lublin,
Poland
Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE, UK

This leaflet was last revised 07/2016
For information about DIANEAL PD4 or to request this
leaflet in formats such as audio or large print please
contact the Marketing Authorisation Holder:
Tel: +44 (0)1635 206345.
Baxter and Dianeal 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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