Primene 10%
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRIMENE 10% Solution for Infusion
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Read all of this leaflet carefully before you are given 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, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet, see section 4.
In this leaflet:
1 What PRIMENE is and what it is used for
2 What you need to know before you are given PRIMENE
3 How PRIMENE is given
4 Possible side effects
5 How PRIMENE is stored
6 Contents of the pack and other 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.
Your doctor will check your body has all the nutrition that it needs for good health. If necessary, you may also have a vitamins (such as folic Acid), minerals, fatty acids (the building blocks of fats), electrolytes (salts) and sugar solutions (such as glucose) at the same time as PRIMENE.
2 What you need to know before you are given PRIMENE
PRIMENE must not be given to you if:
• you are allergic (hypersensitive) to any of the ingredients of PRIMENE (see section 6)
• you have a problem metabolising one or more amino-acids
You will not be given PRIMENE if any of the above
apply to you.
Warnings and precautions
Talk to your doctor or nurse before PRIMENE is given to
you.
• You will have regular blood and urine tests while being given PRIMENE. This will make sure that you are getting the right amount of solution and if necessary you will be given other treatments
• You will be 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.
• If any abnormal signs or symptoms of an allergic reaction develop, such as fever, chills, skin rashes or difficulty in breathing, excessive sweating, nausea or headache, tell the doctor or the nurse: the infusion will be stopped immediately.
• PRIMENE can cause the formation of small particles in your blood. If you start to have difficulty breathing or feel short of breath, tell the doctor or the nurse: the infusion will be stopped immediately and you may need other treatment.
• Certain medications and illnesses can increase the risk of developing infection or sepsis (bacteria in the blood). There is a particular risk of infection or sepsis when a tube (intravenous catheter) is placed in your vein. Your doctor will carefully watch you for any signs of infection. Using aseptic “germ free” techniques when placing and maintaining the catheter and when making the nutritional formula can reduce the risk of infection.
• If you are severely malnourished such that you need to receive feeding through a vein, it is recommended that parenteral nutrition is started slowly and carefully.
• Amino acid solutions can increase the level of ammonia or nitrogen-containing compounds in your blood. Your doctor will check your blood tests for this.
• Your doctor should also be aware of severe conditions affecting how your body handles fluid, sugars,
fats, proteins or salt (metabolic disorders). These conditions will be corrected before you are given
• 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:
- your age and 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
• 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.
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.
If the dose given is too high or the infusion too fast, you may have an increased volume of circulating blood, your blood may become too acidic or the nitrogen content in your blood and urine may increase. Symptoms may include nausea, vomiting, shivering, confusion and rapid heart rate. In such situations, the infusion must be stopped immediately.
Your doctor will decide if additional actions are required.
To prevent these events from occurring, your doctor will regularly monitor your condition and test your blood levels during treatment.
4 Possible side effects
Like all medicines, PRIMENE can cause side effects, although not everybody gets them. If you notice any changes in the way you feel during or after the treatment, tell your doctor or nurse right away. The tests your doctor will perform while the medicine is administered to you should minimise the risk of side effects.
If any abnormal signs or symptoms of an allergic reaction develop, such as abnormally low or high blood pressure, appearance of a blue or purple coloration of the skin, abnormally high heart rate, breathing difficulties, vomiting, nausea, skin rashes, raised body temperature, excessive sweating chills, and shivering, the infusion will be stopped immediately.
The following side effects have been reported with similar products:
• High blood level of ammonia and nitrogen-containing compounds
• Anaphylactic reactions, a serious allergic shock reaction that is rapid in onset and if not treated can be life-threatening.
• Impairment of liver functions, abnormal blood test for the liver function
• Inflammation of the gall bladder, the presence of gallstones in the gallbladder
• Increase in the acidity of the blood
• Formation of small particles blocking lung blood vessels
• Vein inflammation at infusion site, venous irritation, pain, warmth, swelling and induration
• Severe local reactions can occur in case of leakage of the infusion fluid in the tissues surrounding the infusion site: death of skin tissue, blistering, swelling, scarring, skin discoloration.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medicines and Healthcare products Regulatory Agency via the Yellow Card Scheme: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
Turn over leaflet for further information.
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5 How PRIMENE is stored
Keep the medicine out of the sight and reach 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 containers 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.
This leaflet was last revised 11/2014
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.
6 Contents of the pack and other 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 Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE
United Kingdom
Send all enquiries to this address.
PRIMENE is made at the following place:
Bieffe Medital S.p.A.
Via Nuova Provinciale I-23034 Grosotto
Italy GR-30-01-631
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