Primene 10% solution for infusion 100ml bottles

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

L-Leucine; L-Valine; L-Lysine; L-Phenylalanine; L-Threonine; Tryptophan; L-Isoleucine; L-Arginine; L-Histidine; L-Aspartic acid; L-Cysteine; L-Glutamic acid; Glycine; L-Proline; L-Serine; L-Tyrosine; L-Ornithine hydrochloride; Taurine; L-Alanine; L-Methionine

Available from:

Baxter Healthcare Ltd

INN (International Name):

L-Leucine; L-Valine; L-Lysine; L-Phenylalanine; L-Threonine; Tryptophan; L-Isoleucine; L-Arginine; L-Histidine; L-Aspartic acid; L-Cysteine; L-Glutamic acid; Glycine; L-Proline; L-Serine; L-Tyrosine; L-Ornithine hydrochloride; Taurine; L-Alanine; L-Methionine

Dosage:

10gram/1litre ; 7.6gram/1litre ; 11gram/1litre ; 4.2gram/1litre ; 3.7gram/1litre ; 2gram/1litre ; 6.7gram/1litre ; 8.4gram/1litre ; 3.8gram/1litre ; 6gram/1litre ; 1.89gram/1litre ; 10gram/1litre ; 4gram/1litre ; 3gram/1litre ; 4gram/1litre ; .45gram/1litre ; 3.18gram/1litre ; .6gram/1litre ; 8gram/1litre ; 2.4gram/1litre

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 09030000; GTIN: 05413760278469

Summary of Product characteristics

OBJECT 1
PRIMENE 10%
Summary of Product Characteristics Updated 15-Mar-2017 | Baxter
Healthcare Ltd
1. Name of the medicinal product
PRIMENE 10%
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
6.70 g
10.00 g
7.60 g
11.00 g
2.40 g
4.20 g
3.70 g
2.00 g
8.40 g
3.80 g
8.00 g
6.00 g
1.89 g
10.00 g
4.00 g
3.00 g
4.00 g
0.45 g
3.18 g
0.60 g
Taurine
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
A clear, colourless solution.
Primene 10% has a pH of 5.5 and an osmolarity of 780 mOsmol/L.
4. Clinical particulars
4.1 Therapeutic indications
Primene 10% 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
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,
• 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/24 hours
0.230 – 0.53g nitrogen/kg/24 hours
15 – 35ml of Primene 10%/kg/24 hours
The infusion rate should not exceed 0.05ml/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.
The flow rate should be increased gradually during the first hour.
Method of administration
Pri