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Primene must not be given to your child if:
• your child is allergic (hypersensitive) to any of the
ingredients of Primene (see section 6)
• Your child's body has problems using the building
blocks of proteins.



(and pages ___ to ___ for TIL)



Errors: Yes / No PR2:
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Date: 22AUG2016

Draft: 3rd

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2 What you need to know before your child is
given Primene


Primene is used in Children, infants and the newborn
at term or born prematurely to give your child food
(nutrition) straight into the blood, when your child cannot
take enough food by his or her mouth.
The doctor will check your body has all the nutrition that
it needs for good health. If necessary, your child 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.


Primene is a sterile solution which contains:
• amino acids – these are the building blocks
which your body uses to make proteins


1 What Primene is and what it is used for


Throughout this leaflet Primene 10% Solution for
Infusion will be called Primene.


In this leaflet:
1 What Primene is and what it is used for
2 What you need to know before your child is given
3 How Primene is given
4 Possible side effects
5 How Primene is stored
6 Contents of the pack and other information

Talk to the doctor or nurse before Primene is given to
your child.
• Your child will have regular blood and urine tests
while being given Primene. This will make sure that
your child is getting the right amount of solution and
if necessary your child will be given other treatments
• Your child will be monitored more closely if you have
kidney, heart, liver or breathing problems. Please tell
your doctor if your child has any problems with his or
her 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 your child starts to have difficulty
breathing or feel short of breath, tell the doctor or the
nurse: the infusion will be stopped immediately and
your child 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
child's vein. The doctor will carefully watch your
child 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 your child is severely malnourished such that
they 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
child's blood. The doctor will check your child's blood
tests for this.
• The doctor should also be aware of severe conditions
affecting how your child's body handles fluid, sugars,
fats, proteins or salt (metabolic disorders). These
conditions will be corrected before your child is given


Warnings and precautions

Version: 02

Your child will not be given Primene if any of the above

Artworker: Leroi C.

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 the doctor or
• If you get any side effects, talk to the doctor or nurse.
This includes any possible side effects not listed in
this leaflet, see section 4.


Primene 10% Solution for Infusion

• your child will not have Primene through the same
tubes and equipment used for any blood tranfusion.

Like all medicines, Primene can cause side effects,
although not every child gets them. If you notice any
changes in the way your child feels during or after the
treatment, tell the doctor or nurse right away. The tests
the doctor will perform while your child is taking the
medicine minimise the risk of side effects.

There are no known problems when Primene is used
with other medicines.
Pregnancy and breast-feeding
If your child is pregnant, think she might be pregnant or
is breast-feeding, tell the doctor. They will decide if she
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, joint pain, muscle pain, vomiting, nausea,
skin rashes, raised body temperature, excessive
sweating chills, and shivering, the infusion will be
stopped immediately.

3 How Primene is given
The doctor will decide how much Primene your child
should be given. It will depend on:
– age and weight
– what his or her body needs
– why he or she is 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 your child may be given more or less
• Primene is given as an infusion into a large vein in
your child's chest (called the vena cava). When mixed
with other solutions it may be given into a vein in your
child's arm. The solution is slowly given to your child
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
• 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
• 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 your child is given too much
The doctor will give your child Primene so it is unlikely
that your child will be given too much. If you are worried
that your child has had too much, tell the doctor or
If the dose given is too high or the infusion too fast, your
child may have an increased volume of circulating blood,
your child's blood may become too acidic or the nitrogen
content in your child's 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 your child gets any side effects, talk to the 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:

The doctor will decide if additional actions are required.
To prevent these events from occurring, the doctor will
regularly monitor your child's condition and test your
child's 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.


Version: 02

Use with other medicines


4 Possible side effects

This leaflet was last revised 08/2016

5 How Primene is stored

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.


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
when not being administered.

Baxter and Primene are trademarks of
Baxter International Inc.

Version: 02

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
Primene is a solution for infusion. It is a clear sterile
solution. It is available in glass bottles containing
100 ml, 125 ml, 200 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
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




Version: 02


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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.