INTRAFUSIN® 11

PATIENT INFORMATION LEAFLET

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What you should know about Intrafusin 11

Please read this carefully before you use this medicine. This leaflet provides some useful information for you on this medicine. If you have any questions or are not sure about anything, please ask your doctor or pharmacist (chemist).

Remember this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

The name of your medicine is Intrafusin® 11.

What is in your medicine?

Intrafusin® 11 is a clear, sterile solution of amino acids with electrolytes. Amino acids are the building blocks the body uses to make protein. Electrolytes are essential for normal body processes having a variety of functions, for example, sodium and potassium help maintain normal heart rhythm.

1000 ml of Intrafusin® 11 contains the following:

Isoleucine	Ph Eur	2.10 grams
Leucine	Ph Eur	2.85 grams
Lysine-L-glutamate 2H2O		7.58 grams
Methionine	Ph Eur	2.70 grams
Phenylalanine	Ph Eur	2.03 grams
Threonine	Ph Eur	2.70 grams
Tryptophan	DAB	1.05 grams
Valine	Ph Eur	2.33 grams
Arginine	Ph Eur	6.98 grams
Histidine	Ph Eur	1.73 grams
N-Acetyl-L-cysteine	Ph Eur	0.53 grams
Glycine	Ph Eur	7.80 grams
Alanine	Ph Eur	12.97 grams
Glutamic acid	Ph Eur	4.70 grams
Proline	Ph Eur	7.05 grams
Serine	Ph Eur	7.05 grams
N-Acetyl-L-tyrosine	DAB	1.13 grams

Glycerol-1(2)-dihydrogen phosphate

mixture of disodium salt 5H2O	FP	6.11 grams
Potassium hydrogen glutamate H2O	-	4.06 grams
Sodium chloride	Ph Eur	2.34 grams
Potassium chloride	Ph Eur	1.49 grams
Citric acid	Ph Eur	1.15 grams

Magnesium chloride 6H2O	Ph Eur	1.02 grams
Calcium chloride 2H2O	Ph Eur	0.44 grams
This provides the following electrolytes: Sodium		80.0 mmol
Calcium		3.0 mmol
Potassium		40.0 mmol
Magnesium		5.0 mmol
Chloride		76.0 mmol
Phosphate		20.0 mmol
Citrate		6.0 mmol

These ingredients are dissolved in Water for Injections Ph Eur. Each bottle holds 1000 ml of solution.

Intrafusin® 11 is one of a group of medicines called intravenous (given into the bloodstream) amino acid solutions with electrolytes. It gives you some of the goodness you would normally get from the food in your diet. It is used with other solutions to form a balanced intravenous feed.

The company responsible for Intrafusin^® 11 in the UK (also known as the product licence holder) is Fresenius Kabi Limited, Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT, UK. The product is made by Baxter Deutschland GmbH, Dr-Wandinger-Str.1, D-94447 Plattling, Germany

What is your medicine for?

Intrafusin^® 11 helps provide nourishment straight into your bloodstream when you cannot eat normally. It gives amino acids which your body will use to make proteins. These will build and repair parts of the body. It also contains electrolytes which help prevent deficiencies which would otherwise disrupt normal body functions. It is usually used as part of a balanced intravenous food diet, together with fat, carbohydrates, salts and vitamins.

Things to remember about Intrafusin 11

It should not be given to children.

Nothing should be added to Intrafusin^® 11 unless it is safe to do so. Before giving you Intrafusin 11 - your doctor should know

-    Whether you have collapsed with very low blood pressure.

-    Whether you have or have had any kidney or liver problems.

-    Whether you have or have had high levels of potassium in your blood.

-    Whether your body has problems using amino acids or protein.

-    Whether you are pregnant, likely to become pregnant or are breast feeding

Your doctor may want to do blood tests to check your vitamin levels before or during treatment.

How your treatment will be given Dose:

-    The dose is dependent upon your individual needs. The recommended dose of Intrafusin® 11 for adults is between 1-2g of amino acids per kg body weight each day. Another way of saying this is 1000-2000 ml of Intrafusin® 11 daily for an average sized patient (70 kg).

-    For pregnant women and for people who have just had surgery, the dose is 1.6-2.0 g amino acids per kg body weight each day.

Method:

-    Intrafusin® 11 will be given slowly by drip through a small plastic tube, called a catheter, into your bloodstream. An electronic pump may be used to control the speed of your drip.

-    One litre of a solution containing Intrafusin ® 11 should be given over at least 7-8 hours. The rate of infusion should be carefully controlled in patients who tend to develop high blood potassium or urea levels.

How often will your medicine be given?

Intrafusin® 11 will usually be given every day until you can start eating again.

How long should you take your medicine for?

As long as it takes for you to start eating normally. This could take some time depending on your illness.

What you should do in case of overdose

In the extremely unlikely event of overdose either in the hospital or home, tell your doctor or nurse immediately if you are worried.

What should you do if you miss a dose?

Do not worry, but remember to take the next dose as usual. Do not double the dose next time.

Sometimes your doctor may tell you to cut short or miss a dose but this will be in your best interest.

Side effects are not expected with Intrafusin® 11, but too rapid an infusion may result in kidney problems and nausea in sensitive patients. If you suffer any unwanted effects while taking Intrafusin^® 11 please tell your doctor or pharmacist (chemist).

How should you store your medicine?

•    If you are storing Intrafusin® 11, keep it away from light at room temperature (15-25°C).

•    The bottle label has an expiry date. Do not use Intrafusin® 11 after this date.

•    Do not use the solution if the bottle is leaking.

• Do not use the solution if it is cloudy or has bits in it.

• Do not use the solution if it is an unusual colour - it should be colourless.

•    If you do not use all the solution in the bottle, throw the rest of it away. Do not re-use it.

Date of revision: August 2006

PL 08828/0106