Kabiven emulsion for infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

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

Dostopno od:

Fresenius Kabi Limited

Koda artikla:

B05BA; B05BA10

INN (mednarodno ime):

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

Odmerek:

percent weight/volume

Farmacevtska oblika:

Emulsion for infusion

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

Solutions for parenteral nutrition; combinations

Status dovoljenje:

Marketed

Datum dovoljenje:

2006-07-28

Navodilo za uporabo

1
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) wher

Lastnosti izdelka

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.
This corresponds to the following total compositions:
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
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
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_1_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_8_
_C_
_R_
_N_
_ _
_2_
_2_
_0_
_6_
_0_
_