KABIMIX 11
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
SOYA OIL GLUCOSE MONOHYDRATE ALANINE ARGININE ASPARTIC ACID CYSTEINE GLUTAMIC ACID AMINOACETIC ACID HISTIDINE ISOLEUCINE LEUCINE LYCINE ACETATE DL-METHIONINE PHENYLALANINE PROLINE SERINE THREONINE TRYPTOPHAN, L- TYROSINE VALINE CALCIUM GLYCEROPHOSPHATE ANHYDROUS SODIUM GLYCEROPHOSPHATE ANHYDROUS MAGNESIUM CHLORIDE ANHYDROUS SODIUM HYDROXIDE POTASSIUM HYDROXIDE
Available from:
Fresenius Kabi Limited
Dosage:
2000 Millilitre
Pharmaceutical form:
Emulsion for Infusion
Authorization date:
1999-09-07
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kabimix 11
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
2000 ml of the admixture contains
3 PHARMACEUTICAL FORM
Emulsion for infusion; white, opaque.
Active ingredients
Purified Soybean Oil Ph. Eur.
78.00
g
Glucose monohydrate Ph. Eur
256.00
g
_corresponding to_
Glucose (anhydrous)
233.00
g
Alanine Ph. Eur.
9.30
g
Arginine Ph. Eur.
6.50
g
Aspartic acid Ph. Eur.
1.90
g
Cysteine
0.33
g
Glutamic acid Ph. Eur.
3.30
g
Glycine (Aminoacetic acid) Ph. Eur.
4.60
g
Histidine Ph. Eur.
4.00
g
Isoleucine Ph. Eur.
3.30
g
Leucine Ph. Eur.
4.60
g
Lysine acetate USP
7.40
g
_corresponding to:_
Lysine
5.30
g
Methionine Ph. Eur.
3.30
g
Phenylalanine Ph. Eur.
4.60
g
Proline Ph. Eur.
4.00
g
Serine Ph. Eur.
2.60
g
Threonine Ph. Eur.
3.30
g
Tryptophan Ph. Eur.
1.10
g
Tyrosine Ph. Eur.
0.13
g
Valine Ph. Eur.
4.30
g
Calcium glycerophosphate Ph. Eur.
(anhydrous)
0.81
g
Sodium glycerophosphate F.P.
(anhydrous)
2.51
g
Magnesium chloride 6H
2
O Ph. Eur.
0.79
g
_corresponding to:_
Magnesium chloride
0.37
g
Sodium hydroxide (100%) Ph. Eur.
1.60
g
Potassium hydroxide (86.5%) Ph.
Eur.
3.01
g
_corresponding to_
Potassium hydroxide (100%)
2.61
g
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/04/2010_
_CRN 2081313_
_page number: 1_
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
KABIMIX 11 is indicated in patients requiring intravenous nutrition to supply energy, essential fatty acids, essential
and non-essential amino acids and electrolytes. KABIMIX 11 is particularly suitable for patients with basal or
moderately increased nutritional requirements and/or fluid restriction.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The ability to eliminate fat should govern the dosage and infusion rate. _See Section 4.4, Fat e
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