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PRIMENE 5%

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Product Summary
1.

Trade Name of the Medicinal Product
PRIMENE 5%

2.

Qualitative and Quantitative Composition
Each litre of the infusion solution contains:
L-Isoleucine
L-Leucine
L-Valine
L-Lysine
L-Methionine
L-Phenylalanine
L-Threonine
L-Tryptophan
L-Arginine
L-Histidine
L-Alanine
L-Aspartic Acid
L-Cysteine
L-Glutamic Acid
Glycine
L-Proline
L-Serine
L-Tyrosine
L-Ornithine Hydrochloride
Taurine

3.35g
5.00g
3.80g
5.50g
1.20g
2.10g
1.85g
1.00g
4.20g
1.90g
4.00g
3.00g
0.95g
5.00g
2.00g
1.50g
2.00g
0.45g
1.44g
0.30g

In a formulation also containing L-malic acid, as described in the application.

3.

Pharmaceutical Form
Solution for infusion.

Clinical Particulars
4.1.

Therapeutic Indications
Primene 5% is indicated in 1) children and infants 2) neonates, at term or premature, of
normal or low birth weight when oral or enteral nutrition is impossible, insufficient or
contraindicated.

4.2.

Posology and Method of Administration

Dosage depends on the age, weight and protein catabolism of the child:
The usual range is
1.5 - 3.5g amino-acids/kg/24 hours
0.230 - 0.53g nitrogen/kg/24 hours
30 - 70ml of solution/kg/24 hours
The infusion rate should not exceed 0.1ml/kg/min.
Recommended flow rates:
Neonates and Infants : continuous infusion (over 24 hours).
Children : continuous infusion (over 24 hours) or cyclic infusion (over about 12 hours
in 24).
The flow rate should be adjusted according to the dosage, the characteristics of the infusion
solution, the total volume intake per 24 hours and the infusion duration.
Route of administration:
Primene 5% alone should be administered in a central vein.
Primene 5% in co-administration or as a mixture should be administered according to the
final osmolarity of the solution infused, in a peripheral or central vein.
Mode of administration:
Primene 5% is usually administered with a source of energy appropriate for the needs of the
child, either by co-administration or as a mixture.
Primene 5% may be included in the composition of nutritive mixtures combining
carbohydrates, lipids, electrolytes, trace elements and vitamins when compatibility and
stability are known.

4.3.

Contra-indications
Use in children with a congenital abnormality in the metabolism of one or more aminoacids.

4.4.

Special Warnings and Special Precautions for Use
1.

Primene 5% must be used with caution where severe restriction of water intake is
necessary, eg. cardiac, respiratory or renal failure.

2.

In cases of renal insufficiency, the nitrogen intake must be adjusted according to the
childs renal clearance.

3.

Caution should be exercised in cases of hepatic insufficiency with careful monitoring
of blood ammonia levels.

4.

Careful monitoring of the infusion and of the clinical and biochemical conditions (with
acid-balance monitoring) of the child is essential.

5.

In view of its osmolarity, Primene 5% should not be infused alone into a superficial

vein during short term parenteral nutriton.

4.5.

Interaction with Other Medicinal Products and Other Forms of Interaction
The compatibility and stability of nutritive mixtures should be confirmed before
administration.

4.6.

Pregnancy and Lactation
Not applicable.

4.7.

Effects on Ability to Drive and Use Machines
Not applicable.

4.8.

Undesirable Effects
In cases of excessive administration, there is a possibility of metabolic acidosis and raised
blood urea nitrogen in children with renal insufficiency.
Amino acid solutions may precipitate acute folic acid deficiency which should be corrected
by supplements.
Thrombophlebitis may occur when infused into superficial veins.

4.9.

Overdose
Not applicable.

Pharmacological Properties
5.1.

Pharmacodynamic Properties
Primene 5% is a solution of 20 L-Amino Acids, intended to correspond qualitatively and
quantitatively to the protein needs of the child:
-

contains all essential or semi-essential amino acids for the child;
contains relatively high lysine content;
contains taurine;
contains relatively low methionine content;
contains reduced phenylalanine and proline content.

8 Essential Amino Acids
Total Amino Acids

= 47.5 per cent

Branched Chain Amino Acids
Total Amino Acids

= 24 per cent

Clinical Trials have shown that in combination with a balanced energy supply Primene 5%
allows for satisfactory growth in terms of height and weight as well as satisfactory
psychomotor development in the child.
Primene 5% is deliberately formulated without electrolytes in order not to interfere with
specific electrolyte therapy.

5.2.

Pharmacokinetic Properties
Primene 5% is administered intravenously and is therefore immediately available in the
blood stream.

5.3.

Preclinical Safety Data
Not applicable.

Pharmaceutical Particulars
6.1.

List of Excipients
L-Malic Acid
Water for Injections

6.2.

Incompatibilities
No other medication or substance should be added to this fluid unless compatibility is
known.

6.3.

Shelf Life
24 Months.

6.4.

Special Precautions for Storage
Store at room temperature, protected from light

6.5.

Nature and Contents of Container
Type II Glass Bottles with an elastomeric stopper containing 100, 125, 200, 250, 500, 1000,
2000ml of solution.

6.6.

Instructions for Use/Handling
Discard if container is leaking, or if solution is cloudy or is in any other way suspicious.
Discard any unused contents.

Administrative Data
7.

Marketing Authorisation Holder
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
United Kingdom, IP24 3SE

8.

Marketing Authorisation Number
PL 0116/0284

9.

Date of First Authorisation/Renewal of Authorisation
1 November1997

10.

Date of (Partial) Revision of the Text
March 2000

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