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NUTRIFLEX BASAL 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® basal 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:

If you receive more Nutriflex basal than you should

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

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
1. What Nutriflex basal is and what it is used for
• dehydration
The product contains substances (nutrients) called amino acids, salts • unconsciousness caused by extremely high blood glucose levels.
(electrolytes) and glucose which are essential for the body to grow or to
If you have any further questions on the use of this product, ask your docrecover and calories in the form of carbohydrates.
You are given this product by a vein drip (infusion) because you are unable tor or pharmacist.
to eat adequately or cannot be fed via a tube. It is called a nutritional sup4. Possible side effects
plement.
Like all medicines, Nutriflex basal can cause side effects, although not

2. What you need to know before you use Nutriflex basal everybody gets them.

Side effects are mainly caused by overdose or too rapid infusion. They will
• if you are allergic (hypersensitive) to active substances or any of the usually disappear when the infusion is stopped.
other ingredients of Nutriflex basal
If you experience any of the following side effects, contact
• if you have a severe inborn disorder of amino acid metabolism, where your doctor or hospital immediately
you need a special protein diet
Not known (frequency cannot be estimated from the available
• if you have any kind of poorly controlled metabolic disorder, for exam- data)
ple severe diabetes mellitus, accumulation of sour (acidic) substances in • Reactions of intolerance (re-feeding syndrome) may occur if you are in
your blood (acidosis) or inadequate supply of oxygen to cells (hypoxia)
a state of severe underfeeding and too high doses are administered. The
• if you have excessively high blood sugar level that needs more than 6
symptoms of these intolerance reactions are drops of serum electrolyte
units of insulin per hour to be controlled
levels, sleepiness and damage to red blood cells.
• if you have abnormally high blood electrolyte levels
• Feeling sick (nausea) and vomiting.
• if you have bleeding within the skull or the spinal cord.
• Excessive amounts of urine: If the solution is infused too rapidly, you
Nutriflex basal should not be given to babies and infants that are under
may pass excessive amounts of urine.
two years old.
Abnormal results of liver function tests and disturbance of bile flux
(cholestasis) have been reported in some patients receiving intravenous
(infusion through a vein) nutrition.
If these rare side effects occur your treatment should be stopped, or if the
doctor decides, it may be continued but at a lower dose level.

Not known (frequency cannot be estimated from the available
data)

• If your treatment is stoppedabruptly, your blood sugar level may drop
below normal levels with symptoms such as e.g. feeling of extreme
hunger, dizziness, blurry vision, trembling or shakiness, headache and
Talk to your healthcare professional before using Nutriflex basal
sweating, especially in children under 3 years, patients having diabetes
• if you have impaired heart or kidney function
or having other problems with glucose tolerance.
• if you have disturbances in fluid, electrolyte or acid-base balance, for
example low body water and salt content (hypotonic dehydration), low If any of the side effects gets serious, or if you notice any side effects not
sodium or potassium level in your blood
listed in this leaflet, please tell your doctor or pharmacist.
• if you have high blood glucose levels.
Reporting of side effects
Special care will be taken to adjust and control your daily dose if you have If you get any side effects, talk to your healthcare professional. This
impairment of kidneys, liver, adrenal glands, heart or lungs or if you have includes any possible side effects not listed in this leaflet. You can also
altered amino acid metabolism.
report side effects directly via the Yellow Card Scheme at:
If you are in a state of severe underfeeding, special care will be taken to www.mhra.gov.uk/yellowcard.
build up your intravenous feeding gradually.
Nutriflex basal contains glucose (a sugar) so this may affect your blood
5. How to store Nutriflex basal
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 Keep this medicine out of the sight and reach of children.
levels, electrolytes, and acid-base balance are correct. For longer admin- Do not store above 25°C.
istration times, some tests on your blood as well as kidney and liver func- Keep bag in the outer carton in order to protect from light.
tion will be done as well.
Do not use Nutriflex basal after the expiry date which is stated on the bag
Special precautions will be taken when you receive this medicine to printing and on the carton label. The expiry date refers to the last day of
ensure that the product remains sterile.
that month.
Only use Nutriflex basal if the solution is clear and the bag undamaged.
Other medicines and Nutriflex basal
Please tell your doctor or pharmacist if you are taking or have recently After infusion, any remaining solution should never be stored for later use.

Warnings and precautions

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taken any other medicines, including medicines obtained without a prescription.
Nutriflex basal can interact with some other medicines. Please tell your
doctor if you are taking any of the following:
• medicines for treatment of inflammation (corticosteroids)
• hormone preparations affecting your fluid balance (‘ACTH’)
• medicines that promote urine flow such as triamterene or amiloride
• medicines for treatment of high-blood pressure (ACE-inhibitors)
• medicines used in transplant medicine such as cyclosporine and
tacrolimus.

Pregnancy, breast-feeding and fertility
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.
Pregnancy
If you are pregnant, you will receive this medicine only if the doctor considers it absolutely necessary for your recovery.
Breast-feeding
Breast-feeding is not recommended during treatment with this medicine.

Driving and using machines
This medicine is normally given to immobile patients, e.g. in a hospital or
clinic which would exclude driving and using machines. However, the
medicine itself has no effect on the ability to drive or use machines.

3. How to use Nutriflex basal
Dosage
Your doctor will decide how much of this medicine you need and for how
long you will require treatment with this medicine.

Adults
The daily dose for this age group is up to 40 ml of solution for infusion per
kg body weight (BW) per day. This solution will be administered to you at
a maximum rate of 2 ml per kg BW per hour.

Patients with special conditions
If you have any condition where you have an abnormally high blood sugar
level, e.g. after injury, if you have oxygen deficiency or otherwise impaired
organ function, your glucose dose will be reduced accordingly.

Patients with kidney or liver impairment
The doses will be adjusted according to your individual requirements if you
have a liver or kidney disease.

Route of administration
Nutriflex basal will be administered to you by infusion into a large central
vein.

6. Contents of the pack and other information
What Nutriflex basal contains
- The active substances are amino acids, glucose and electrolytes.
Each bag contains after mixing:
1000 ml
2000 ml
Isoleucine
1.88 g
3.76 g
Leucine
2.50 g
5.00 g
Lysine hydrochloride
2.27 g
4.54 g
equivalent to lysine
1.82 g
3.64 g
Methionine
1.56 g
3.12 g
Phenylalanine
2.81 g
5.62 g
Threonine
1.45 g
2.90 g
Tryptophan
0.46 g
0.92 g
Valine
2.08 g
4.16 g
Arginine monoglutamate
3.98 g
7.96 g
equivalent to arginine
2.16 g
4.32 g
equivalent to glutamic acid
1.82 g
3.64 g
Histidine hydrochloride monohydrate
1.35 g
2.70 g
equivalent to histidine
1.00 g
2.00 g
Alanine
3.88 g
7.76 g
Aspartic acid
1.20 g
2.40 g
Glutamic acid
0.98 g
1.96 g
Glycine
1.32 g
2.64 g
Proline
2.72 g
5.44 g
Serine
2.40 g
4.80 g
Magnesium acetate tetrahydrate
1.23 g
2.46 g
Sodium acetate trihydrate
3.20 g
6.40 g
Potassium dihydrogen phosphate
1.74 g
3.48 g
Potassium hydroxide
0.96 g
1.92 g
Sodium hydroxide
0.10 g
0.20 g
Glucose monohydrate
137.5 g
275.0 g
equivalent to glucose
125.0 g
250.0 g
Sodium chloride
1.40 g
2.80 g
Calcium chloride dihydrate
0.53 g
1.06 g
- The other ingredients are citric acid monohydrate and water for injections.
Electrolytes:
1000 ml
2000 ml
Sodium
49.9 mmol
99.8 mmol
Potassium
30.0 mmol
60.0 mmol
Calcium
3.6 mmol
7.2 mmol
Magnesium
5.7 mmol
11.4 mmol
Chloride
50.0 mmol
100.0 mmol
Phosphate
12.8 mmol
25.6 mmol
Acetate
35.0 mmol
70.0 mmol

B|BRAUN

Schwarz
210x594 mm
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Lätus: 620
Großbritannien
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As with other medicines of this type Nutriflex basal should not be given if
you have:
• severe liver disease
• severe kidney disease without treatment by artificial kidney
• life threatening blood circulation problems as can occur if you are in a
state of collapse or shock
• heart problems (decompensated cardiac insufficiency).

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Do not use Nutriflex basal

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Amino acid content
Nitrogen content
Carbohydrate content
Non-protein energy [kJ (kcal)]
Total energy [kJ (kcal)]
Osmolarity
pH

1000 ml
32 g
4.6 g
125 g
1000 ml
2095 (500)
2640 (630)
1150 mOsm/l
4.8 – 6.0

2000 ml
64 g
9.2 g
250 g
2000 ml
4190 (1000)
5255 (1255)
1150 mOsm/l
4.8 – 6.0

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 basal looks like and contents of the pack
Nutriflex basal 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 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.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL An additive port is provided for admixing of supplements to Nutriflex
basal.
OR HEALTHCARE PROFESSIONALS ONLY:
The solution should always be brought to room temperature prior to infusion.
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.

Storage after mixing of the contents
Ideally after mixing the two solutions, Nutriflex basal 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.

When admixing other solutions or fat emulsions to Nutriflex basal, aseptic precautions must be strictly observed. Fat emulsions can be easily
admixed by means of a special transfer set.

Schwarz
210x594 mm
710/NP71032/0517
Lätus: 620
Großbritannien
Font size 9

B. Braun Melsungen AG
34209 Melsungen
Germany

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B|BRAUN

Expand Transcript

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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