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NUTRINEAL PD4 1.1% AMINO ACIDS CLEAR-FLEX SOLUTION FOR PERITONEAL DIALYSIS

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / GLYCINE / MAGNESIUM CHLORIDE HEXAHYDRATE / SODIUM CHLORIDE / SODIUM LACTATE SOLUTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NUTRINEAL PD4 1.1% Amino Acids 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.



What is in this leaflet
1.
2.
3.
4.
5.
6.






What NUTRINEAL is and what it is used for
What you need to know before you use NUTRINEAL
How to use NUTRINEAL
Possible side effects
How to store NUTRINEAL
Contents of the pack and other information





1. WHAT NUTRINEAL IS AND WHAT IT IS USED FOR
NUTRINEAL is a solution for peritoneal dialysis which does not contain glucose.
It removes water and waste products from the blood and corrects different
abnormal components of blood.
NUTRINEAL may be prescribed for you:
• if you have kidney failure which needs peritoneal dialysis
• in particular if you are malnourished.




2. WHAT YOU NEED TO KNOW BEFORE YOU USE NUTRINEAL



Your doctor will assess whether NUTRINEAL is a suitable solution for your
peritoneal dialysis treatment. He will have taken into account any factors in your
medical history which might exclude the use of peritoneal dialysis solutions.

If you experience a hypersensitivity reaction (an allergic reaction) – see
also section 4. Your doctor may need to stop NUTRINEAL treatment
Since, 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 use insulin or any other treatments for correcting
hyperglycaemia. Your doctor may need to adjust their dose.
If you are undergoing treatment for secondary hyperparathyroidism,
your doctor will decide if you can use a dialysis solution with a low
calcium content.
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.
Your doctor will check your potassium levels regularly. If they fall too
low he may give you some potassium chloride to compensate.
Your doctor will advise you about particular precautions as it applies to
you. He will monitor your blood parameters at regular intervals. He will
ensure that they are adequate during your treatment.
You – possibly together with your doctor – should keep a record of your
dietary protein intake, your fluid balance and your body weight.

Other medicines and NUTRINEAL


Do not use NUTRINEAL
You must NOT use NUTRINEAL
• If you are allergic to any amino acids or any of the other ingredients of
this medicine (listed in section 6).
• If your blood urea level is above 38 mmol/l.
• If you suffer from a disorder affecting amino acid metabolism.
• If your blood potassium level is too low.
• If you show uraemic symptoms such as loss of appetite, nausea or
vomiting.
• If your blood bicarbonate levels are too low.
• If you suffer from liver insufficiency.
• 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.



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 arrhythmia)
Your doctor will monitor you closely during treatment, especially your
potassium, calcium and magnesium levels.

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

Driving and using machines
This treatment may cause weakness, malaise or reduction in body fluid volume
(hypovolaemia). Do not drive or operate machines if you are affected.

Warnings and precautions
Talk to your doctor:
• If you experience loss of appetite, nausea or vomiting. Your doctor
may need to reduce the number of NUTRINEAL exchanges or stop
NUTRINEAL treatment.
• 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 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.

3. HOW TO USE NUTRINEAL
NUTRINEAL 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.
NUTRINEAL is not for intravenous use.
Always use this medicine exactly as instructed by the medical team specialised
in peritoneal dialysis. Check with them if you are not sure.
In case of damage, you should discard the bag.

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How much and how often

Common side effects (occurs in more than 1 in 100 patients
treated with NUTRINEAL):

Your doctor will prescribe you the appropriate number of bags you must use.
Usually, it varies from one bag of 2.0 litres to one bag of 2.5 litres every day.









Use in children and adolescents

If you are below 18 years, your doctor will assess carefully the prescription of
NUTRINEAL.
Your doctor will re-evaluate your treatment after 3 months if there is no
improvement in your nutritional status.

Method of administration

Anaemia
Depression
Shortness of breath
Abdominal pain
Reduction in body fluid volume (hypovolaemia)
Decrease in potassium salt blood level (hypokalaemia).
Infection

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

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. 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. 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.










Peritonitis
Peritoneal Cloudy effluent
Abdominal discomfort
Fever
Malaise
Itching
Hypersensitivity reaction (an allergic reaction)
Serious allergic reaction which causes swelling of the face or throat
(angioedema)

Other side effects related to the peritoneal procedure:
• Infection around the exit site of your catheter,
• Catheter related complication
• Decrease in calcium blood level (hypocalcaemia)
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.

IRELAND
Via the internet at www.imb.ie
By emailing imbpharmacovigilance@imb.ie
By contacting the offices of the Irish Medicines Board
Kevin O’Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland.
Tel: +353 1 6764971.

Compatibility with other drugs
Your doctor may prescribe you other injectable drugs to be added directly into
the NUTRINEAL bag. In that situation, add the drug through the medication site.
Use the product immediately after addition of the drug. Check with your doctor
if you are not sure.

UK

If you use more than one bag of NUTRINEAL in
24 hours

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

If you infuse too much NUTRINEAL you may get:
• abdominal distension
• a feeling of fullness
Contact your doctor immediately. He will advise what to do.

5. HOW TO STORE NUTRINEAL





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

If you stop taking NUTRINEAL
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, this medicine 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 center
immediately:
• Abdominal pain

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.

Very common side effects (occurs in more than 1 in 10
patients treated with NUTRINEAL):







Nausea, vomiting
Anorexia (prolonged disorder of eating due to loss of appetite)
Gastritis (inflamed stomach)
Feeling of weakness
increase in body fluid volume (hypervolaemia)
High level of acidic substances in the body (acidosis)

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What NUTRINEAL PD4 1.1% AMINO ACIDS contains

This leaflet was last revised in 09/2013.

The formula is

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

NUTRINEAL PD4 1.1% Amino Acids
Formula in mg/l
Blend of Amino Acids:
Alanine
Arginine
Glycine
Histidine
Isoleucine
Leucine
Lysine, HCl
Methionine
Phenylalanine
Proline
Serine
Threonine
Tryptophan
Tyrosine
Valine

951
1071
510
714
850
1020
955
850
570
595
510
646
270
300
1393

Sodium chloride

5380

Calcium chloride dihydrate

184

Magnesium chloride hexahydrate

51

Sodium lactate

4480

Composition in mmol/l
Amino Acids

87.16

Sodium

132

Calcium

1.25

Magnesium

0.25

Lactate

40

Chloride

105

Baxter, Nutrineal and Clear-Flex are trademarks of Baxter International Inc.

The other ingredients are:
• Water for Injections
• Hydrochloric acid, concentrated.

What NUTRINEAL looks like and contents of the
pack



NUTRINEAL is packed in a non-PVC plastic bag of 2.0 litres or
2.5 litres capacity.
Each bag is over-wrapped in an overpouch and supplied in carton
boxes.

Volume

Number of units per box

Product configuration

2.0 L
2.0 L
2.0 L
2.0 L
2.5 L
2.5 L
2.5 L
2.5 L

4
5
4
5
3
4
3
4

Single bag
Single bag
Twin bag
Twin bag
Single bag
Single bag
Twin bag
Twin bag

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 Limited
Caxton Way, Thetford,
Norfolk, IP24 3SE,
United Kingdom

Manufacturers

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

Bieffe Medital SpA
Via Nuova Provinciale
23034 Grosotto
Italy

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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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