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PRIMENE 10%

Active substance(s): GLYCINE / TAURINE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRIMENE 10% Solution for Infusion
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.

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
PRIMENE.

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
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• you will not have PRIMENE through the same tubes
and equipment used for any blood tranfusion.

4 Possible side effects

Use with other medicines

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.

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.

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.

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.

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 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.

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

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.

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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This leaflet was last revised 11/2014

5 How PRIMENE is stored

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.

Keep the medicine out of the sight and reach of children.
PRIMENE should be stored as follows:
Do not store above 25ºC 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.

Baxter and Primene are trademarks of
Baxter International Inc.

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.

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

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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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