Primene 10% Solution for Infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

L-isoleucine; L-leucine; L-valine; L-lysine; L-methionine; L-threonine; L-tryptophan; L-arginine; L-histidine; L-alanine; L-aspartic acid; Cysteine; L-glutamic acid; Glycine; L-proline; L-serine; L-tyrosine; Ornithine hydrochloride; Taurine; L-phenylalanine

Available from:

Baxter Holding B.V.

ATC code:

B05BA; B05BA01

INN (International Name):

L-isoleucine; L-leucine; L-valine; L-lysine; L-methionine; L-threonine; L-tryptophan; L-arginine; L-histidine; L-alanine; L-aspartic acid; Cysteine; L-glutamic acid; Glycine; L-proline; L-serine; L-tyrosine; Ornithine hydrochloride; Taurine; L-phenylalanine

Dosage:

10 percent

Pharmaceutical form:

Solution for infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Solutions for parenteral nutrition; amino acids

Authorization status:

Marketed

Authorization date:

1995-05-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRIMENE 10% SOLUTION FOR INFUSION
Amino Acid Intravenous Infusion
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS GIVEN THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOUR CHILD

Keep this leaflet. You may need to read it again.

If you have any further questions, ask the doctor or nurse.

If your child gets any side effects talk to the doctor or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Primene is and what it is used for
2.
What you need to know before your child is given Primene
3.
How your child will be given Primene
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. The
amino acids in Primene are listed in section 6.
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.
Your doctor will check your child has all the nutrition that they need
for good health. If
necessary, your child may also have 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 YOUR CHILD IS GIVEN PRIMENE
PRIMENE MUST NOT BE GIVEN TO YOUR CHILD IF:

Your child is allergic (hypersensitive) to any of the ingredients of
this medicine (listed in
section 6).

Your child’s body has a problem s using the building blocks of
proteins.
Your child will not be given Primene if any of the above applies.
WARNINGS AND PRECAUTIONS
Talk to the doctor or nurse before Primene.
Your doctor will make sure t

Summary of Product characteristics

Health Products Regulatory Authority
22 October 2019
CRN009D2X
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Primene 10% Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each litre of infusion solution contains:
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‐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
0.60 g
L‐Phenylalanine
4.20 g
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
A clear, colourless solution.
Primene 10% has an osmolarity of 780 mOsmol/L
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the prophylaxis and therapy of protein deficiency in neonates,
infants and children, when adequate oral administration is not
possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Parenteral nutrition initiation and duration as well as dosage (dose
and rate of administration) depends on a patient's
• age, weight, clinical condition,
• nitrogen requirements,
Health Products Regulatory Authority
22 October 2019
CRN009D2X
Page 2 of 8
• ability to metabolize the constituents of Primene,
• additional nutrition that may be provided parenterally and/or
enterally.
The usual range is
1.5 – 3.5g amino‐acids/kg/day
0.230 – 0.53g nitrogen/kg/24 hours
15–30ml of solution/kg/day
The infusion rate should not exceed 0.05ml/kg/min.
The infusion rate should be started at a reduced flow rate and then
can be increased gradually during the first hour.
The flow rate must be adjusted taking into account the dose being
administered, the daily volume intake, and the duration of
the infusion.
Neonates and Infants: continuous infusion (over 24 hours).
Children: continuous infusion (over 24 hours) or cyclic infusion (over
about 1