Aminoven 8, solution for infusion, bottle

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Isoleucine; Leucine; Lysine acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine

Beszerezhető a:

Fresenius Kabi Limited

ATC-kód:

B05BA; B05BA01

INN (nemzetközi neve):

Isoleucine; Leucine; Lysine acetate; Methionine; Phenylalanine; Threonine; Tryptophan; Valine; Arginine; Histidine; Alanine; Glycine; Proline; Serine; Tyrosine; Taurine

Adagolás:

5 gram(s)/litre

Gyógyszerészeti forma:

Solution for infusion

Recept típusa:

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

Terápiás terület:

Solutions for parenteral nutrition; amino acids

Engedélyezési státusz:

Not marketed

Engedély dátuma:

1999-09-07

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMINOVEN
® 8 SOLUTION FOR INFUSION
AMINOVEN
® 16 SOLUTION FOR INFUSION
AMINOVEN
® 25 SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 of the 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 Aminoven is and what it is used for
2. What you need to know before you receive Aminoven
3. How to use Aminoven
4. Possible side effects
5. How to store Aminoven
6. Contents of the pack and other information
1. WHAT AMINOVEN IS AND WHAT IT IS USED FOR
Aminoven provides nourishment straight into your blood stream when you
cannot eat normally. It provides
amino acids which your body will use to make proteins (to build and
repair muscles, organs, and other body
structures).
Aminoven is typically mixed in a pharmacy with fat, carbohydrates,
salts and vitamins, which together
provide your complete nutritional needs.
This leaflet covers 3 products:
• Aminoven 8 Solution for Infusion
• Aminoven 16 Solution for Infusion
• Aminoven 25 Solution for Infusion
In this leaflet the three solutions are collectively referred to as
Aminoven.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE AMINOVEN
YOU SHOULD NOT RECEIVE AMINOVEN IF YOU ARE SUFFERING FROM, OR HAVE
SUFFERED FROM THE FOLLOWING.:
DO NOT USE AMINOVEN:
• if you have a condition where your BODY HAS PROBLEMS USING
PROTEINS OR AMINO ACIDS
• if you have METABOLIC ACIDOSIS (the acid levels of your body
fluids and tissues become too high)
• if you have reduced KIDNEY function and are not on dialysis or
another form of blood filtration treatment
• if you have seriously reduced LIVER FUNCTION
• inf you have FLUID RETENTION
• if you suffer from SHOCK
• if you have HYPOXIA (low

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aminoven 8, solution for infusion, bottle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1000 ml solution for infusion contain:
Isoleucine
2. 50
g
Leucine 3.
70
g
Lysine acetate
4. 655
g
= Lysine 3.30 g
Methionine
2. 15
g
Phenylalanine
2. 55
g
Threonine
2. 20
g
Tryptophan
1. 00
g
Valine
3.
10
g
Arginine
6. 00
g
Histidine
1. 50
g
Alanine 7.
00
g
Glycine 5.
50
g
Proline
5.
60
g
Serine
3.
25
g
Tyrosine 0.
20
g
Taurine 0.
50
g
Total amino acids:
50.0 g/l
Total nitrogen:
8.1 g/l
Total energy:
840 kJ/l (= 200kcal/l)
Titratable acidity
:
12 mmol NaOH/l
3 PHARMACEUTICAL FORM
Solution for infusion
The solution is clear and colourless to slightly yellow
pH:
5.5 - 6.3
Theoretical osmolarity:
495 mosm/l
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For supply of amino acids as part of a parenteral nutrition regimen.
Amino acid solutions should be administered generally in combination
with adequate amount of energy supplements.
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4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The daily requirement of amino acids depends on the body weight and
the metabolic conditions of the patient.
The maximum daily dose varies with the clinical condition of the
patient and may even change from day to day.
The recommended infusion period is to provide a con