PRIMENE 10 %

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLYCINE; L- ALANINE; L- ASPARTIC ACID; L- CYSTEINE; L- GLUTAMIC ACID; L- ISOLEUCINE; L- LEUCINE; L- LYSINE; L- METHIONINE; L- ORNITHINE HYDROCHLORIDE; L- PHENYLALANINE; L- PROLINE; L- SERINE; L- THREONINE; L- TRYPTOPHAN; L- TYROSINE; L- VALINE; L-ARGININE; L-HISTIDINE; TAURINE

Available from:

REMEDIX CARE LTD

ATC code:

B05XB03

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

L- VALINE 0.76 G / 100 ML; L- TYROSINE 0.045 G / 100 ML; L- TRYPTOPHAN 0.2 G / 100 ML; L- THREONINE 0.37 G / 100 ML; TAURINE 0.06 G / 100 ML; L- SERINE 0.4 G / 100 ML; L- PROLINE 0.3 G / 100 ML; L- PHENYLALANINE 0.42 G / 100 ML; L- ORNITHINE HYDROCHLORIDE 0.318 G / 100 ML; L- METHIONINE 0.24 G / 100 ML; L- LYSINE 1.1 G / 100 ML; L- LEUCINE 1.0 G / 100 ML; L- ISOLEUCINE 0.67 G / 100 ML; L-HISTIDINE 0.38 G / 100 ML; GLYCINE 0.4 G / 100 ML; L- GLUTAMIC ACID 1.0 G / 100 ML; L- CYSTEINE 0.189 G / 100 ML; L- ASPARTIC ACID 0.6 G / 100 ML; L-ARGININE 0.84 G / 100 ML; L- ALANINE 0.8 G / 100 ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

BAXTER S.A., BELGIUM

Therapeutic group:

LYSINE

Therapeutic area:

LYSINE

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.משטר מינון: 3/7/2019 שינוי בפרק 4.2 בעלון ללא שינוי ברשיון הנמוקים לבקשה: בהתאם לעלון רפרנס SPC-UK ו-Clinical overview

Authorization date:

2014-08-31

Patient Information leaflet

_ _
_:ךיראת_
_ _
_רבוטקוא_
_ _
_2019_
_ _ ה/דבכנ ת/חקור ,ה/אפור ןולעב םיאבה םינוכדעה לע העידומ עבט
תרבח
אפורל
רישכתה לש
_ _
ןמירפ
®
%
10
PRIMENE
® 10% SOLUTION FOR INFUSION
CONTAINS:_ _
Each liter of the infusion solution contains:
L-Isoleucine
6.70 g
L-Leucine
10.0 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
אפורל ןולעב םינוכדע
------------------------------------------------------------------------------------------------------------ :םושירה תדועתב הרשואש יפכ היוותה
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. עידוהל וננוצרב
םינולעהש
כדוע
ונ
םיירקיעה םינוכדעה םילולכ ןלהלש טוריפב
, תונמוסמ תופסות( דבלב
םודאב :)
:אפורל ןולעב םינוכדע
[…]
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Allergic Reactions / Hypersensitivity Reactions _
Anaphylactic/anaphylactoid reactions and other
hypersensitivity/infusion reactions have been
reported with amino acid solutions administered as a component of
parenteral nutrition (see
section 4.8). The infusion must be stopped immediately if any signs or
symptoms of a
reaction develop.
_Precipitates in Patients Receiving Parenteral Nutrition _
Pulmonary vascular precipitates have been reported in patients
receiving parenteral nutrition.
In some cases, fatal outcomes have occurred. Excessive addition of
calcium and phosphate
increases the risk of the formation of calcium phosphate precipitates.
Precipitates have been
rep

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
Primene 10% Solution for Infusion
1.
NAME OF THE MEDICINAL PRODUCT
Primene 10%
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each liter of the infusion solution contains:
L-Isoleucine
6.70 g
L-Leucine
10.0 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
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 10%,
• additional nutrition that may be provided parenterally and/or
enterally.
The usual range is:
POSOLOGY
MAXIMAL
ADMINISTRATION RATE
g/kg/day (24 hours)
ml/kg/day (24 hours)
ml/kg/min
1.5 to 3.5 g of amino acids or
0.23 to 0.53 g of nitrogen
15 to 35
0.05
The administration rate should never exceed 0.05 ml/kg/min.
Recommended flow rates
Neonates and infants: continuous infusion (over 24 hours).
Children up to 12 years:
- continuous infusion over 24 hours;
- 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 t