PACKAGE LEAFLET: 710/NP71032/0714

INFORMATION FOR THE USER

B. Braun Melsungen AG ■ 34209 Melsungen ■ Germany

Read all of this leaflet carefully before use of this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others.

-    If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you use Nutriflex basal

3.    How to use Nutriflex basal

4.    Possible side effects

5.    How to store Nutriflex basal

6.    Further information

1.    WHAT NUTRIFLEX BASAL IS AND WHAT IT IS USED FOR

This product is a nutritional supplement. It contains substances called amino acids, electrolytes and glucose which are essential for the body to grow or to recover. It also contains calories in the form of carbohydrates.

You will receive this product because you are unable to eat food adequately or cannot be fed directly into the stomach or gut by tube.

There are many situations in which you may need this product, such as following surgery, injury, burns or if your gut is unable to absorb food.

The solution will be administered to you as a vein drip (intravenous infusion) by a health professional.

2.    BEFORE YOU USE NUTRIFLEX BASAL

DO NOT USE NUTRIFLEX BASAL

ifyou are suffering from the following conditions:

•    acute shock

•    inborn disorders of protein metabolism

•    irreversible liver failure

•    kidney failure where no dialysis facilities are available.

Babies and children under two years should not receive Nutriflex basal because they have different nutritional requirements.

Nutriflex basal

Solution for Infusion

Amino acids / Glucose / Electrolytes

TAKE SPECIAL CARE WITH NUTRIFLEX BASAL

•    Ifyou have heart, liver or kidney problems or suffer from certain types of metabolic disorders, special care will be taken when this product is given to you.

•    Nutriflex basal contains glucose (a sugar) and this may affect the glucose levels in the blood. Blood samples may have to be taken to check this.

•    Additional tests may be carried out to check for the lack of a vitamin called folic acid and the vitamin B_|2 levels. If the levels are low you may be given extra folic acid and/or vitamin B_|2.

•    Other tests may also be performed in order to ensure that your fluid levels, electrolytes, and acid base balance are correct.

•    Special precautions will be taken when you receive this medicine to ensure that the product remains sterile.

TAKING OR USING OTHER MEDICINES

Please tell your doctor or pharmacist ifyou are taking or have recently taken any other medicines, including medicines obtained without a prescription.

PREGNANCY AND BREAST-FEEDING

Ask your doctor or pharmacist for advice before taking any medicine.

Your doctor will administer Nutriflex basal while you are pregnant or breast feeding only if he considers it essential to your recovery.

DRIVING AND USING MACHINES

Not relevant. Nutriflex basal is normally given to immobile patients in a controlled setting (e.g. a hospital or a clinic) and this excludes the likelihood of driving and using machines.

3. HOW TO USE NUTRIFLEX BASAL

The amount of product you receive will be determined by your doctor.

The normal amount is between 1000 ml - 2000 ml of Nutriflex basal per day.

The product will be administered to you by a vein drip (infusion).

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IF YOU USE MORE NUTRIFLEX BASAL THAN YOU SHOULD

If you think that you have been given an overdose, please talk to a doctor or pharmacist immediately.

IF YOU FORGET TO USE NUTRIFLEX BASAL

If you think that a dose has been missed, please talk to a doctor or pharmacist immediately.

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 basal can cause side effects, although not everybody gets them.

Nutriflex basal may occasionally cause unwanted effects, including occasional nausea (feeling sick).

If the recommended infusion rate is exceeded, vomiting, sweating and flushing may occur.

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 any of the side effects becomes 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 doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE NUTRIFLEX BASAL

•    Keep out of the reach and sight of children.

•    Do not store above 25 °C.

•    Keep bags in the outer carton in order to protect from light.

•    Once it has been mixed, the product should be used immediately. In special circumstances it can be stored at room temperature for up to seven days, or at 2 -8°C (in a refrigerator) for up to fourteen days. The doctor or nurse will have checked to ensure that the solution is properly mixed.

•    Do not use Nutriflex basal after the expiry date which is stated on the carton and the bag The expiry date refers to the last day of that month.

•    Do not use Nutriflex basal if you notice cloudiness, particles in the solution, discoloration, leaking of the bag, leaking, i.e. liquid between inner bag and outer protective bag.

•    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Nutriflex basal contains

• The active substances are amino acids, glucose and electrolytes

Each 1000 ml of the solution contains
Isoleucine	1.88 g
Leucine	2.50 g
Lysine	1.82 g
Methionine	1.56 g
Phenylalanine	2.81 g
Threonine	1.45 g
Tryptophan	0.46 g
Valine	2.08 g
Arginine	2.16 g
Histidine	1.00 g
Alanine	3.88 g
Aspartic Acid	1.20 g
Glutamic Acid	2.80 g
Glycine	1.32 g
Proline	2.72 g
Serine	2.40 g
Total Amino Acids	32.0 g
Anhydrous Glucose	125.0 g
Electrolytes Na+	49.9 mmol/l
K+	30.0 mmol/l
Ca++	3.6 mmol/l
Mg++	5.7 mmol/l
Cl-	50.0 mmol/l
H/O4-	12.8 mmol/l
Acetate	35.0 mmol/l

• The other ingredients are

Citric Acid Monohydrate and water for injections.

What Nutriflex basal looks like and contents of the pack

Nutriflex basal is a clear, colourless or faintly straw-coloured solution of above mentioned substances in water. It is supplied in two-chamber plastic bags, the total fluid content of the bag being 1000 ml or 2000 ml.

It comes in packs of 5 bags.

Marketing Authorisation Holder and Manufacturer

B. Braun Melsungen AG,

Carl-Braun-StraBe 1,    Postal address

34212 Melsungen,    34209 Melsungen,

Germany;    Germany.

Tel.: +49-5661-71-0 +49-5661-71-4567

This leaflet was last approved in June 2014.

B. Braun Melsungen AG

34209 Melsungen, Germany

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