Kabiven emulsion for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Soya bean oil ; Glucose monohydrate; Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride 2 h2o; Sodium glycerophosphate anhydrous; Magnesium sulphate 7h2o; Potassium chloride; Sodium acetate 3 H20 ; Amino acids; Nitrogen; Fat; Glucose; Glucose (dextrose); Sodium; Potassium; Magnesium; Calcium; Phosphate; Sulphate; Chloride; Acetate

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

B05BA; B05BA10

INN (International Name):

Soya bean oil ; Glucose monohydrate; Alanine; Arginine ; Aspartic Acid; Glutamic acid ; Glycine; Histidine; Isoleucine; Leucine ; Lysine hydrochloride; Methionine; Phenylalanine; Proline; Serine; Threonine; Tryptophan; Tyrosine; Valine; Calcium chloride 2 h2o; Sodium glycerophosphate anhydrous; Magnesium sulphate 7h2o; Potassium chloride; Sodium acetate 3 H20 ; Amino acids; Nitrogen; Fat; Glucose; Glucose (dextrose); Sodium; Potassium; Magnesium; Calcium; Phosphate; Sulphate; Chloride; Acetate

Pharmaceutical form:

Emulsion for infusion

Therapeutic area:

Solutions for parenteral nutrition; combinations

Authorization status:

Marketed

Authorization date:

2006-07-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
KABIVEN, EMULSION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Kabiven is and what it is used for
2.
What you need to know before you are given Kabiven
3.
How you are given Kabiven
4.
Possible side effects
5.
How to store Kabiven
6.
Contents of the pack and other information
1.
WHAT KABIVEN IS AND WHAT IT IS USED FOR
Kabiven comes in a three chamber bag in an overpouch. Kabiven contains
the following medicines:
amino acids (components used to build proteins), fat, glucose and
electrolyte solutions. It provides
energy (as sugar and fat) and amino acids into your bloodstream when
you cannot eat normally.
It is used as part of a balanced intravenous diet, together with
salts, trace elements and vitamins which
together provide your complete nutritional needs.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN KABIVEN
YOU SHOULD NOT RECEIVE KABIVEN:
•
if you are allergic to any of the active substances or any of the
other ingredients of this
medicine (listed in section 6).
•
if you are allergic to products containing
EGG, SOYA OR PEANUT
•
if you have too much fatty substances (like cholesterol) in your blood
•
if you have seriously reduced
LIVER
function
•
if you suffer from
ACUTE SHOCK
(resulting from heavy blood loss or allergic reaction)
•
if you have a
DEFECT IN YOUR BLOOD CLOTTING SYSTEM
(haemophagocytotic syndrome) or if your
BLOOD IS NOT CLOTTING PROPERLY
•
if you have a condition where your body has problems using
PROTEINS OR AMINO ACIDS
•
if you have severe problems with your
KIDNEYS
•
if you have hyperglycaemia (
TOO MUCH SUGAR IN YOUR BLOOD
) whe

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2023
CRN00DLVS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kabiven emulsion for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Kabiven is available in a three chamber bag system. Each bag contains
the following different volumes depending on the pack
size.
2566 ML
2053 ML
1540 ML
1026 ML
Glucose (Glucose 19%)
1316 ml
1053 ml
790 ml
526 ml
Amino acids and electrolytes (Vamin 18 Novum)
750 ml
600 ml
450 ml
300 ml
Fat emulsion (Intralipid 20%)
500 ml
400 ml
300 ml
200 ml
This corresponds to the following total compositions:
ACTIVE INGREDIENTS
2566 ML
2053 ML
1540 ML
1026 ML
Purified soybean oil
100 g
80 g
60 g
40 g
Glucose monohydrate
corresponding to
Glucose (anhydrous)
275 g
250 g
220 g
200 g
165 g
150 g
110 g
100 g
Alanine
12.0 g
9.6 g
7.2 g
4.8 g
Arginine
8.5 g
6.8 g
5.1g
3.4 g
Aspartic acid
2.6 g
2.0 g
1.5 g
1.0 g
Glutamic acid
4.2 g
3.4 g
2.5 g
1.7 g
Glycine
5.9 g
4.7 g
3.6 g
2.4 g
Histidine
5.1 g
4.1 g
3.1 g
2.0 g
Isoleucine
4.2 g
3.4 g
2.5 g
1.7 g
Leucine
5.9 g
4.7 g
3.6 g
2.4 g
Lysine hydrochloride
8.5 g
6.8 g
5.1 g
3.4 g
corresponding to Lysine
6.8 g
5.4 g
4.1 g
2.7 g
Methionine
4.2 g
3.4 g
2.5 g
1.7 g
Phenylalanine
5.9 g
4.7 g
3.6 g
2.4 g
Proline
5.1 g
4.1 g
3.1 g
2.0 g
Serine
3.4 g
2.7 g
2.0 g
1.4 g
Threonine
4.2 g
3.4 g
2.5 g
1.7 g
Tryptophan
1.4 g
1.1 g
0.86 g
0.57 g
Tyrosine
0.17 g
0.14 g
0.10 g
0.07 g
Valine
5.5 g
4.4 g
3.3 g
2.2 g
Health Products Regulatory Authority
14 December 2023
CRN00DLVS
Page 2 of 10
ACTIVE INGREDIENTS
2566 ML
2053 ML
1540 ML
1026 ML
Calcium chloride 2 H
2
O
0.74 g
0.59 g
0.44 g
0.29 g
corresponding to Calcium chloride
0.56 g
0.44 g
0.33 g
0.22 g
sodium glycerophosphate (anhydrous)
3.8 g
3.0 g
2.3 g
1.5 g
Magnesium sulphate 7H
2
O
corresponding to Magnesium sulphate
2.5 g
1.2 g
2.0 g
0.96 g
1.5 g
0.72 g
0.99 g
0.48 g
Potassium chloride
4.5 g
3.6 g
2.7 g
1.8 g
Sodium acetate 3 H
2
0
6.1 g
4.9 g
3.7 g
2.5 g
corresponding to Sodium acetate
3.7 g
2.9 g
2.2 g
1.5 g
Corresponding to
2566 ML
205