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NUTRIFLEX PERI SOLUTION FOR INFUSION

Active substance(s): CALCIUM CHLORIDE / GLUCOSE MONOHYDRATE / GLYCINE / MAGNESIUM ACETATE TETRAHYDRATE / POTASSIUM DIHYDROGEN PHOSPHATE MONOBASIC / POTASSIUM HYDROXIDE / SODIUM ACETATE TRIHYDRATE / SODIUM CHLORIDE / SODIUM HYDROXIDE / CALCIUM CHLORIDE / GLUCOSE MONOHYDRATE / GLYCINE / MA

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PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG · 34209 Melsungen, Germany

Nutriflex® peri Solution for Infusion
Amino acids / Glucose / Electrolytes

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, please ask your healthcare professional.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your healthcare professional. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

Route of administration

1. What Nutriflex peri is and what it is used for
2. What you need to know before you use Nutriflex peri
3. How to use Nutriflex peri
4. Possible side effects
5. How to store Nutriflex peri
6. Contents of the pack and other information

Nutriflex peri will be administered to you by infusion into a vein. It can be
infused into smaller veins (peripheral veins).

1. What Nutriflex peri is and what it is used for
The product contains substances (nutrients) called amino acids, salts
(electrolytes) and glucose which are essential for the body to grow or to
recover and calories in the form of carbohydrates.
You are given this product by a vein drip (infusion) because you are unable
to eat adequately or cannot be fed via a tube. It is called a nutritional supplement.
Nutriflex peri can be also used via a small vein (peripheral venous
catheter) when administration via a large vein (central venous catheter) is
not possible.

If you receive more Nutriflex peri than you should
If you think that you have been given an overdose, please talk to a doctor
or pharmacist immediately.
If you are given too much of this medicine this may lead to symptoms
including:
• swelling caused by excess body fluid
• changes in your blood, which can be measured in a blood test
• sickness, vomiting, shivering
• high blood sugar level and glucose in urine
• dehydration
• unconsciousness caused by extremely high blood glucose levels.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
2. What you need to know before you use Nutriflex peri Like all medicines, Nutriflex peri can cause side effects, although not
everybody gets them.
• if you are allergic (hypersensitive) to active substances or any of the Side effects are mainly caused by overdose or too rapid infusion. They will
usually disappear when the infusion is stopped.
other ingredients of Nutriflex peri
• if you have severe inborn disorder of amino acid metabolism, where you If you experience any of the following side effects, contact
need a special protein diet
your doctor or hospital immediately
• if you have any kind of poorly controlled metabolic disorder, for exam- Not known (frequency cannot be estimated from the available
ple severe diabetes mellitus, accumulation of sour (acidic) substances in data)
your blood (acidosis) or inadequate supply of oxygen to cells (hypoxia) • Reactions of intolerance (re-feeding syndrome) may occur if you are in
• if you have excessively high blood sugar level that needs more than 6
a state of severe underfeeding and too high doses are administered. (The
units of insulin per hour to be controlled
symptoms of these intolerance reactions are drops of serum electrolyte
• if you have abnormally high blood electrolyte levels
levels, sleepiness and damage to red blood cells.
• if you have bleeding within the skull or the spinal cord.
• Feeling sick (nausea) and vomiting
Nutriflex peri should not be given to babies and infants that are under two • Excessive amounts of urine: If the solution is infused too rapidly, you
years old.
may pass excessive amounts of urine.
As with other medicines of this type Nutriflex peri should not be given if Abnormal results of liver function tests and disturbance of bile flux
(cholestasis) have been reported in some patients receiving intravenous
you have:
(infusion through a vein) nutrition.
• severe liver disease
If these rare side effects occur your treatment should be stopped, or if the
• severe kidney disease without treatment by artificial kidney
• life threatening blood circulation problems as can occur if you are in a doctor decides, it may be continued but at a lower dose level.
state of collapse or shock
Not known (frequency cannot be estimated from the available
• heart problems (decompensated cardiac insufficiency).
data)

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Do not use Nutriflex peri

• If your treatment is stopped abruptly, your blood sugar level may drop
Warnings and precautions
below normal levels with symptoms such as e.g. feeling of extreme
Talk to your healthcare professional before using Nutriflex peri

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• if you have impaired heart or kidney function
• if you have disturbances in fluid, electrolyte or acid-base balance, for
example low body water and salt content (hypotonic dehydration), low
sodium or potassium level in your blood
• if you have high blood glucose levels.
Special care will be taken to adjust and control your daily dose if you have
impairment of kidneys, liver, adrenal glands, heart or lungs or if you have
altered amino acid metabolism.
If you are in a state of severe underfeeding, special care will be taken to
build up your intravenous feeding gradually.
Nutriflex peri contains glucose (a sugar) so this may affect your blood
sugar level. Blood samples may have to be taken to check this.
Moreover other tests may be performed in order to ensure that your fluid
levels, electrolytes, and acid-base balance are correct. For longer administration times, some tests on your blood as well as kidney and liver function will be done as well.
Special precautions will be taken when you receive this medicine to
ensure that the product remains sterile.

hunger, dizziness, blurry vision, trembling or shakiness, headache and
sweating, especially in children under 3 years, patients having diabetes
or having other problems with glucose tolerance.
• Vein irritation or inflammation of the wall of a vein at the site of infusion may occur a few days after starting your treatment.
If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your healthcare professional. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

5. How to store Nutriflex peri

B|BRAUN

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Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep bag in the outer carton in order to protect from light.
Do not use Nutriflex peri after the expiry date which is stated on the bag
Other medicines and Nutriflex peri
printing and on the carton label. The expiry date refers to the last day of
Please tell your doctor or pharmacist if you are taking or have recently that month.
taken any other medicines, including medicines obtained without a pre- Only use Nutriflex peri if the solution is clear and the bag undamaged.
scription.
After infusion, any remaining solution should never be stored for later use.
Nutriflex peri can interact with some other medicines. Please tell your
doctor if you are taking any of the following:
6. Contents of the pack and other information
• medicines for treatment of inflammation (corticosteroids)
What Nutriflex peri contains
• hormone preparations affecting your fluid balance (‘ACTH’)
- The active substances are amino acids, glucose and electrolytes.
• medicines that promote urine flow such as triamterene or amiloride
• medicines for treatment of high-blood pressure (ACE-inhibitors)
Each bag contains after mixing:
• medicines used in transplant medicine such as cyclosporine and
1000 ml
2000 ml
tacrolimus.
Isoleucine
2.34 g
4.68 g
Leucine
3.13 g
6.26 g
Pregnancy, breast-feeding and fertility
2.84 g
5.68 g
If you are pregnant or breast-feeding, think you may be pregnant or are Lysine hydrochloride
equivalent
to
lysine
2.27
g
4.54
g
planning to have a baby, ask your doctor for advice before taking this
Methionine
1.96 g
3.92 g
medicine.
Phenylalanine
3.51 g
7.02 g
Pregnancy
Threonine
1.82 g
3.64 g
If you are pregnant, you will receive this medicine only if the doctor con- Tryptophan
0.57 g
1.14 g
siders it absolutely necessary for your recovery.
Valine
2.60 g
5.20 g
Arginine monoglutamate
4.98 g
9.96 g
Breast-feeding
equivalent
to
arginine
2.70
g
5.40
g
Breast-feeding is not recommended during treatment with this medicine.
equivalent to glutamic acid
2.28 g
4.56 g
Driving and using machines
Histidine hydrochloride monohydrate
1.69 g
3.38 g
This medicine is normally given to immobile patients, e.g. in a hospital or equivalent to histidine
1.25 g
2.50 g
clinic which would exclude driving and using machines. However, the Alanine
4.85 g
9.70 g
medicine itself has no effect on the ability to drive or use machines.
Aspartic acid
1.50 g
3.00 g
Glutamic acid
1.22 g
2.44 g
Glycine
1.65 g
3.30 g
3. How to use Nutriflex peri
Proline
3.40 g
6.80 g
Dosage
Serine
3.00 g
6.00 g
Your doctor will decide how much of this medicine you need and for how Magnesium acetate tetrahydrate
0.86 g
1.72 g
long you will require treatment with this medicine.
Sodium acetate trihydrate
1.56 g
3.12 g
Potassium dihydrogen phosphate
0.78 g
1.56 g
Adults
0.52 g
1.04 g
The daily dose for this age group is up to 40 ml of solution for infusion Potassium hydroxide
0.50 g
1.00 g
per kg body weight ( BW) per day. This solution will be administered to you Sodium hydroxide
Glucose monohydrate
88.0 g
176.0 g
at a maximum rate of 2 ml per kg BW per hour.
equivalent to glucose
80.0 g
160.0 g
Patients with kidney or liver impairment
Sodium chloride
0.17 g
0.34 g
The doses will be adjusted according to your individual requirements if you Calcium chloride dihydrate
0.37 g
0.74 g
have a liver or kidney disease.
- The other ingredients are citric acid monohydrate and water for injections.

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Electrolytes:
Sodium
Potassium
Calcium
Magnesium
Chloride
Phosphate
Acetate
Amino acid content
Nitrogen content
Carbohydrate content
Non-protein energy [kJ (kcal)]
Total energy [kJ (kcal)]
Osmolarity
pH

1000 ml
27.0 mmol
15.0 mmol
2.5 mmol
4.0 mmol
31.6 mmol
5.7 mmol
19.5 mmol
1000 ml
40 g
5.7 g
80 g
1000 ml
1340 (320)
2010 (480)
900 mOsm/l
4.8 – 6.0

2000 ml
54.0 mmol
30.0 mmol
5.0 mmol
8.0 mmol
63.2 mmol
11.4 mmol
39.0 mmol
2000 ml
80 g
11.4 g
160 g
2000 ml
2680 (640)
4020 (960)
900 mOsm/l
4.8 – 6.0

The product is supplied in two-chamber plastic bags containing:
• 1000 ml (400 ml of amino acids solution + 600 ml of glucose solution)
• 2000 ml (800 ml of amino acids solution + 1200 ml of glucose solution)
Pack sizes: 5 × 1000 ml, 5 × 2000 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

Postal address
34209 Melsungen, Germany

This leaflet was last revised in April 2017.

What Nutriflex peri looks like and contents of the pack
Nutriflex peri is presented in an infusion bag with two compartments. The
lower compartment contains glucose while the upper compartment contains the amino acid solution. The glucose and the amino acid solution are
clear, colourless or faintly straw-coloured.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL An additive port is provided for admixing of supplements to Nutriflex peri.
When admixing other solutions or fat emulsions to Nutriflex peri, aseptic
OR HEALTHCARE PROFESSIONALS ONLY:
The solution should always be brought to room temperature prior to infu- precautions must be strictly observed. Fat emulsions can be easily
admixed by means of a special transfer set.
sion.
Preparation of the mixed solution:
Immediately before use the internal peel seam between the two compartments must be opened allowing the respective contents to be aseptically
mixed.

Ideally after mixing the two solutions, Nutriflex peri should be administered immediately but in special circumstances it can be stored for up to
7 days at room temperature and up to 14 days if stored in a refrigerator
(including administration time). Partially used containers must not be
stored for later use.

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Remove the bag from its protective bag and proceed as follows:
• Open out the bag and lay on a solid surface
• Open the peel seam by using pressure with both hands
• Briefly mix the contents of the bag together.

Storage after mixing of the contents

Schwarz
210x594 mm
730/NP73032/0517
Lätus: 1061
Großbritannien
Font size 9

B. Braun Melsungen AG
34209 Melsungen
Germany

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B|BRAUN

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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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