Primene 10%
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRIMENE 10% Solution for Infusion
Read all of this leaflet carefully before this medicine is given to you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1 What PRIMENE is and what it is used for
2 Before PRIMENE is given
3 How PRIMENE is given
4 Possible side effects
5 How to store PRIMENE
6 Further information
Throughout this leaflet PRIMENE 10% Solution for Infusion will be called PRIMENE.
1 What PRIMENE is and what it is used for
PRIMENE is a sterile solution which contains:
• amino acids - these are the building blocks which your body uses to make proteins.
PRIMENE is used in Children, infants and the newborn at term or born prematurely to give you food (nutrition) straight into your blood, when you cannot take enough food by your mouth. It is usually given with other nutrition solutions and compounds like minerals and vitamins.
2 Before PRIMENE is given
PRIMENE must not be given to you if:
• you are allergic (hypersensitive) to any of the ingredients of PRIMENE (see section 6: Further information)
• you have a problem metabolising one or more amino-acids.
You will not be given PRIMENE if any of the above
apply to you.
Your doctor will make sure that:
• PRIMENE will only be used if the solution is clear and the container is not damaged.
• you have regular blood and urine tests. This will make sure that you are getting the right amount of solution and if necessary you will be given other treatments.
• you are monitored more closely if you have kidney, heart, liver or breathing problems. Please tell your doctor if you have any problems with your kidneys, heart, liver or breathing.
• your body has all that it needs for good health. If necessary, you may also have vitamins (such
as folic acid), minerals, fatty acids (the building blocks of fats), electrolytes (salts) and sugar solutions (such as glucose).
• you will not have PRIMENE through the same tubes and equipment used for any blood tranfusion.
Use with other medicines
There are no known problems when PRIMENE is used
with other medicines.
Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or
are breast-feeding, tell your doctor. They will decide if
you can be given PRIMENE.
3 How PRIMENE is given
Your doctor will decide how much PRIMENE you should be given. It will depend on:
- how much you weigh.
- what your body needs.
- why you are being given it.
• the usual daily dose is 15 to 35 ml of PRIMENE per kilogram of body weight.
• these are the recommended amounts to have each day, but you may be given more or less.
Turn over leaflet for further information.
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• PRIMENE is given as an infusion into a large vein in your chest (called the vena cava). When mixed with other solutions it may be given into a vein in your arm. The solution is slowly given to you at a rate which will not be more than 0.05 ml per kg per minute.
• You will not be given more than 40 millilitres for every kilogram of your bodyweight in a day.
If you are given too much
Your doctor will give you PRIMENE so it is unlikely that you will be given too much. If you are worried that you have had too much, tell your doctor or nurse.
4 Possible side effects
• Like all medicines, PRIMENE can cause side effects, although not everybody gets them.
• There have been reports of a stinging pain and redness at the place where it goes into your vein.
• If this gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5 How to store PRIMENE
Keep out of the reach and sight of children.
PRIMENE should be stored as follows:
Do not store above 25°C and protect it from light.
Do not use PRIMENE after the expiry date which is stated on the label after Exp. The expiry date means the last day of that month.
Partly used bags should not be used again. Any left over solution should be thrown away safely by a healthcare professional. All equipment will be thrown away safely by a healthcare professional after use.
6 Further information
What PRIMENE contains • The active substances are L-Isoleucine 6.70 g, L-Leucine 10.00 g, L-Valine 7.60 g, L-Lysine
11.00 g, L-Methionine 2.40 g, L-Phenylalanine 4.20 g, L-Threonine 3.70 g, L-Tryptophan 2.00 g, L-Arginine 8.40 g, L-Histidine 3.80 g, L-Alanine
8.00 g, L-Aspartic Acid 6.00 g, L-Cysteine 1.89 g, L-Glutamic Acid 10.00 g, Glycine 4.00 g, L-Proline
3.00 g, L-Serine 4.00 g, L-Tyrosine 0.45 g, L-Ornithine Hydrochloride 3.18 g, Taurine 0.6 g in 1000 ml of solution.
• The other ingredients are sterile water (called ‘water for injections’) and L-Malic acid.
What PRIMENE looks like and the contents of the pack
PRIMENE is a solution for infusion. It is a clear sterile solution. It is available in glass bottles containing 100 ml, 125 ml, 250 ml, 500 ml, 1,000 ml or 2,000 ml of solution.
Marketing Authorisation Holder and Manufacturers
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
Send all enquiries to this address.
PRIMENE can be made at any of these places:
Bieffe Medital S.p.A.
Via Nuova Provinciale I-23034 Grosotto Italy
This leaflet was last approved in November 2009
For information about PRIMENE or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder:
Tel: 01635 206345.
Baxter and Primene are trademarks of Baxter International Inc.
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