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NUTRIFLEX SPECIAL SOLUTION FOR INFUSION

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

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

Nutriflex® special 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:

Patients with kidney or liver impairment

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

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

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

If you receive more Nutriflex special than you should
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 fedvia a tube. It is called a nutritional supplement.

2. What you need to know before you use Nutriflex
special
Do not use Nutriflex special
• if you are allergic (hypersensitive) to active substances or to any of the
other ingredients of Nutriflex special
• if you have a severe inborn disorder of amino acid metabolism, where
you need a special protein diet
• if you have any kind of poorly controlled metabolic disorder, for example severe diabetes mellitus, accumulation of sour (acidic) substances in
your blood (acidosis) or inadequate supply of oxygen to cells (hypoxia)
• if you have excessively high blood sugar level that needs more than 6
units of insulin per hour to be controlled
• if you have abnormally high blood electrolyte levels
• if you have bleeding within the skull or the spinal cord
Nutriflex special should not be given to babies and infants that are under
two years old.

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
Like all medicines, Nutriflex special can cause side effects, although not
everybody gets them.
Side effects are mainly caused by overdose or too rapid infusion. They will
usually disappear when the infusion is stopped.

If you experience any of the following side effects, contact
your doctor or hospital immediately
Not known (frequency cannot be estimated from the available
data)

• Reactions of intolerance (re-feeding syndrome) may occur if you are in
a state of severe underfeeding and too high doses are administered. The
As with other medicines of this type Nutriflex special should not be given
symptoms of these intolerance reactions are drops of serum electrolyte
if you have:
levels, sleepiness and damage to red blood cells.
• severe liver disease
• Feeling sick (nausea) and vomiting
• severe kidney disease without treatment by artificial kidney
• Excess amounts of urine: If the solution is infused too rapidly, you may
• life threatening blood circulation problems as can occur if you are in a
pass excessive amounts of urine.
state of collapse or shock
Abnormal results of liver function tests and disturbance of bile flux
• heart problems (decompensated cardiac insufficiency).
(cholestasis) have been reported in some patients receiving intravenous
(infusion through a vein) nutrition.
Warnings and precautions
If these rare side effects occur your treatment should be stopped, or if the
Talk to your healthcare professional before using Nutriflex
doctor decides, it may be continued but at a lower dose level.

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1. What Nutriflex special is and what it is used for

special

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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 special 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.

Not known (frequency cannot be estimated from the available
data)
• If your treatment is stopped abruptly 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
sweating, especially in children under 3 years, patients having diabetes
or having other problems with glucose tolerance.
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 special

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Other medicines and Nutriflex special
Keep bag in the outer carton in order to protect from light.
Please tell your doctor or pharmacist if you are taking or have recently
Do not use Nutriflex special after the expiry date which is stated on the
taken any other medicines, including medicines obtained without a prebag printing and on the carton label. The expiry date refers to the last day
scription.
of that month.
Nutriflex special can interact with some other medicines. Please tell your Only use Nutriflex special if the solution is clear and the bag undamaged.
doctor if you are taking any of the following:
After infusion, any remaining solution should never be stored for later use.
• medicines for treatment of inflammation (corticosteroids)
• hormone preparations affecting your fluid balance (‘ACTH’)
6. Contents of the pack and other information
• medicines that promote urine flow such as triamterene or amiloride
What Nutriflex special contains
• medicines for treatment of high-blood pressure (ACE-inhibitors)
• medicines used in transplant medicine such as cyclosporine and - The active substances are amino acids, glucose and electrolytes.
tacrolimus.
Each bag contains after mixing:
1000 ml
1500 ml
4.11 g
6.17 g
If you are pregnant or breast-feeding, think you may be pregnant or are Isoleucine
5.48 g
8.22 g
planning to have a baby, ask your doctor for advice before taking this Leucine
Lysine hydrochloride
4.97 g
7.46 g
medicine.
equivalent to lysine
3.98 g
5.97 g
Pregnancy
Methionine
3.42 g
5.13 g
If you are pregnant, you will receive this medicine only if the doctor con- Phenylalanine
6.15 g
9.23 g
siders it absolutely necessary for your recovery.
Threonine
3.18 g
4.77 g
Tryptophan
1.00 g
1.50 g
Breast-feeding
4.54 g
6.81 g
Breast-feeding is not recommended during treatment with this medicine. Valine
Arginine monoglutamate
8.72 g
13.08 g
Driving and using machines
equivalent to arginine
4.73 g
7.10 g
This medicine is normally given to immobile patients, e.g. in a hospital or equivalent to glutamic acid
3.99 g
5.99 g
clinic which would exclude driving and using machines. However, the Histidine hydrochloride monohydrate
2.96 g
4.44 g
medicine itself has no effect on the ability to drive or use machines.
equivalent to histidine
2.19 g
3.29 g
Alanine
8.49 g
12.74 g
3. How to use Nutriflex special
Aspartic acid
2.63 g
3.95 g
Glutamic acid
2.15 g
3.23 g
Dosage
Glycine
2.89 g
4.34 g
Your doctor will decide how much of this medicine you need and for how
Proline
5.95 g
8.93 g
long you will require treatment with this medicine.
Serine
5.25 g
7.88 g
Adults
Magnesium acetate tetrahydrate
1.08 g
1.62 g
The daily dose for this age group is up to 25 ml of solution for infusion per Sodium acetate trihydrate
1.63 g
2.45 g
kg body weight (BW) per day. This solution will be administered to you at Potassium dihydrogen phosphate
2.00 g
3.00 g
a maximum rate of 1 ml per kg BW per hour.
Potassium hydroxide
0.62 g
0.93 g
Sodium hydroxide
1.14 g
1.71 g
Patients with special conditions
Calcium chloride dihydrate
0.60 g
0.90 g
If you have any condition where you have an abnormally high blood sugar
Glucose monohydrate
264.0 g
396.0 g
level, e.g. after injury, if you have oxygen deficiency or otherwise impaired
equivalent to glucose
240.0 g
360.0 g
organ function, your glucose dose will be reduced accordingly.
- The other ingredients are citric acid monohydrate and water for injections.

B|BRAUN

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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
40.5 mmol
25.7 mmol
4.1 mmol
5.0 mmol
49.5 mmol
14.7 mmol
22.0 mmol
1000 ml
70 g
10 g
240 g
1000 ml
4020 (960)
5190 (1240)
2100 mOsm/l
4.8 – 6.0

1500 ml
60.8 mmol
38.6 mmol
6.2 mmol
7.5 mmol
74.3 mmol
22.1 mmol
33.0 mmol
1500 ml
105 g
15 g
360 g
1500 ml
6030 (1440)
7790 (1860)
2100 mOsm/l
4.8 – 6.0

What Nutriflex special looks like and contents of the pack
Nutriflex special 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 (500 ml of amino acids solution + 500 ml of glucose solution)
• 1500 ml (750 ml of amino acids solution + 750 ml of glucose solution)
Pack sizes: 5 × 1000 ml, 5 × 1500 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.

THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL An additive port is provided for admixing of supplements to Nutriflex special.
OR HEALTHCARE PROFESSIONALS ONLY:
The solution should always be brought to room temperature prior to infu- When admixing other solutions or fat emulsions to Nutriflex special, asepsion.
tic precautions must be strictly observed. Fat emulsions can be easily
admixed by means of a special transfer set.
Preparation of the mixed solution:
Immediately before use the internal peel seam between the two compart- Storage after mixing of the contents
ments must be opened allowing the respective contents to be aseptically Ideally after mixing the two solutions, Nutriflex special should be adminmixed.
istered 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
Remove the bag from its protective bag and proceed as follows:
(including administration time). Partially used containers must not be
• Open out the bag and lay on a solid surface
stored for later use.
• Open the peel seam by using pressure with both hands

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• Briefly mix the contents of the bag together.

Schwarz
210x594 mm
725/NP72532/0517
Lätus: 622
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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