KABIVEN PERIPHERAL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SOYBEAN OIL ; GLUCOSE ANHYDROUS ; ALANINE ; ARGININE ; ASPARTIC ACID ; GLUTAMIC ACID ; GLYCINE; HISTIDINE ; ISOLEUCINE ; LEUCINE ; LYSINE ; METHIONINE; PHENYLALANINE ; PROLINE ; SERINE ; THREONINE ; TRYPTOPHAN, L- ; TYROSINE ; VALINE ; CALCIUM CHLORIDE DIHYDRATE ; SODIUM GLYCEROPHOSPHATE ANHYDROUS ; POTASSIUM CHLORIDE; SODIUM ACETATE

Available from:

Fresenius Kabi Limited

ATC code:

B05BA10

INN (International Name):

SOYBEAN OIL ; GLUCOSE ANHYDROUS ; ALANINE ; ARGININE ; ASPARTIC ACID ; GLUTAMIC ACID ; GLYCINE; HISTIDINE ; ISOLEUCINE ; LEUCINE

Dosage:

%w/v

Pharmaceutical form:

Emulsion for Infusion

Prescription type:

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

Therapeutic area:

combinations

Authorization status:

Not Marketed

Authorization date:

2000-09-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KABIVEN PERIPHERAL, 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 doctore, 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 Peripheral is and what it is used for
2.
What you need to know before you are given Kabiven Peripheral
3.
How you are given Kabiven Peripheral
4.
Possible side effects
5.
How to store Kabiven Peripheral
6.
Contents of the pack and otherinformation
1.
WHAT KABIVEN PERIPHERAL IS AND WHAT IT IS USED FOR
Kabiven Peripheral comes in a three chamber bag in an overpouch.
Kabiven Peripheral 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 PERIPHERAL
YOU SHOULD NOT RECEIVE KABIVEN PERIPHERAL:
•
if you are ALLERGIC to any of the active substances or any of the
other ingredients of this medicine
(listen 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kabiven Peripheral emulsion for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Kabiven Peripheral 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:
2400 ML
1920 ML
1440 ML
Glucose (Glucose 11%)
1475 ml
1180 ml
885 ml
Amino acids and electrolytes
(Vamin 18 Novum)
500 ml
400 ml
300 ml
Fat emulsion (Intralipid 20%)
425 ml
340 ml
255 ml
ACTIVE INGREDIENTS
2400 ML
1920 ML
1440 ML
Purified soybean oil
85.0
g
68.0
g
51.0
g
Glucose monohydrate
Corresponding to
Glucose (anhydrous)
178.0
g
162.0
g
143.0
g
130.0
g
107.0
g
97.0
g
Alanine
8.0
g
6.4
g
4.8
g
Arginine
5.6
g
4.5
g
3.4
g
Aspartic acid
1.7
g
1.4
g
1.0
g
Glutamic acid
2.8
g
2.2
g
1.7
g
Glycine
4.0
g
3.2
g
2.4
g
Histidine
3.4
g
2.7
g
2.0
g
Isoleucine
2.8
g
2.2
g
1.7
g
Leucine
4.0
g
3.2
g
2.4
g
Lysine hydrochloride
5.6
g
4.5
g
3.4
g
Corresponding to Lysine
4.5
g
3.6
g
2.7
g
Methionine
2.8
g
2.2
g
1.7
g
Phenylalanine
4.0
g
3.2
g
2.4
g
Proline
3.4
g
2.7
g
2.0
g
Serine
2.2
g
1.8
g
1.4
g
Threonine
2.8
g
2.2
g
1.7
g
Tryptophan
0.95 g
0.76
g
0.57
g
Tyrosine
0.12 g
0.092 g
0.069 g
Valine
3.6
g
2.9
g
2.2
g
ACTIVE INGREDIENTS
2400ML
1920ML
1440ML
Calcium chloride 2 H
2
O
0.49 g
0.39 g
0.29 g
Corresponding to Calcium
chloride
0.37 g
0.30 g
0.22 g
Sodium glycerophosphate
(anhydrous)
2.5
g
2.0
g
1.5
g
Magnesium sulphate 7H
2
O
Corresponding to Magnesium
1.6
g
1.3
g
0.99 g
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