Vamin 18 Electrolyte-Free Solution for Infusion

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

PHENYLALANINE, ARGININE, ASPARTIC ACID, THREONINE, VALINE, GLUTAMIC ACID, GLYCINE, ISOLEUCINE, LYSINE, METHIONINE, TRYPTOPHAN, TYROSINE, SERINE, CYSTEINE, HISTIDINE, PROLINE

Tilgjengelig fra:

Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy

ATC-kode:

B05BA01

INN (International Name):

L-THREONINE 5.6 g/l VALINE 7.3 g/l GLUTAMIC ACID 5.6 g/l GLYCINE 7.9 g/l ISOLEUCINE 5.6 g/l L-LYSINE 9 g/l PROLINE 6.8 g/l L-CYSTEINE 560 mg/g PHENYLALANINE 7.9 g/l ARGININE 11.3 g/l LEUCINE 7.9 g/l SERINE 4.5 g/l L-METHIONINE 5.6 g/l ASPARTIC ACID 3.4 g/l L-TRYPTOPHAN 1.9 g/l L-HISTIDINE 6.8 g/l ALANINE 16 g/l L-TYROSINE 230 mg/l

Legemiddelform:

SOLUTION FOR INFUSION

Sammensetning:

L-THREONINE 5.6 g/l VALINE 7.3 g/l GLUTAMIC ACID 5.6 g/l GLYCINE 7.9 g/l ISOLEUCINE 5.6 g/l L-LYSINE 9 g/l PROLINE 6.8 g/l L-CYSTEINE 560 mg/g PHENYLALANINE 7.9 g/l ARGININE 11.3 g/l LEUCINE 7.9 g/l SERINE 4.5 g/l L-METHIONINE 5.6 g/l ASPARTIC ACID 3.4 g/l L-TRYPTOPHAN 1.9 g/l L-HISTIDINE 6.8 g/l ALANINE 16 g/l L-TYROSINE 230 mg/l

Resept typen:

POM

Terapeutisk område:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2007-09-11

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR USER
VAMIN 18 ELECTROLYTE-FREE SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any side effects
not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What is Vamin 18 EF and what it is used for
2.
What you need to know before you receive Vamin 18 EF
3.
How you are given Vamin 18 EF
4.
Possible side effects
5.
How to store Vamin 18 EF
6.
Contents of the pack and other information
1.
WHAT VAMIN 18 EF IS AND WHAT IT IS USED FOR
Vamin 18 EF provides nourishment 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).
Vamin 18 EF is typically mixed with salts, fats, carbohydrates and
vitamins, which together
provide complete nutritional needs.
In this leaflet this solution will be referred to as Vamin 18 EF.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VAMIN 18 EF
_ _
DO NOT USE VAMIN 18 EF IF:
• a known allergy (hypersensitivity) to Vamin 18 EF or any of the
ingredients of Vamin 18 EF
mentioned in section 6 (for
symptoms of an allergic reaction please refer to section 4).
• seriously reduced liver function
• reduced kidney function (ureamia) and are not on dialysis or
another form of blood filtration
treatment
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Vamin 18EF
• cardiac insufficiency - the heart can’t pump enough blood
throughout the body or any other
heart problems
• a condition where your body has problems using proteins or amino
acids
• high potassium levels (hyperkalaemia)
• high sodium levels (hypernatraemia)
• acidosis - higher than normal blood pH levels
• any liver and kidney problems

Preparatomtale

Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vamin 18 Electrolyte-Free solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A 1000ml solution for infusion contains:
Alanine
Arginine
Aspartic Acid
L-Cysteine/Cystine
Glutamic Acid
Glycine
L-Histidine
Isoleucine
Leucine
L-Lysine
L-Methionine
Phenylalanine
Proline
Serine
L-Threonine
L-Tryptophan
L-Tyrosine
Valine
16.0 g
11.3 g
3.4 g
560 mg
5.6 g
7.9 g
6.8 g
5.6 g
7.9 g
9.0 g
5.6 g
7.9 g
6.8 g
4.5 g
5.6 g
1.9 g
230 mg
7.3 g
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless to straw coloured solution of amino acids.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the prophylactic or therapeutic treatment of protein depletion,
where sufficient
enteral feeding is impossible or impracticable.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ _
ADULTS
Depending upon patient requirements up to one litre intravenously per
24 hours.
Page 2 of 5
Vamin
18
Electrolyte-Free
is
administered
by
slow
intravenous
infusion
at
approximately 40 drops per minute or slower corresponding to an
infusion time of at
least eight hours per litre.
_ _
ELDERLY
Age per se requires no adjustment of the adult dosage.
However, caution should be exercised in the “frail” elderly, and
indeed in all patients
with poor renal, cardiac or liver function, where smaller volumes
should be used
depending on the individual patient’s requirements and condition.
PAEDIATRIC POPULATION
Can be administered at the physician’s discretion. An amino acid
solution containing
larger amounts of cysteine/cystine and tyrosine may be considered more
appropriate in
infants.
When used in children below 2 years, the solution (in bags and
administration sets)
should
be
protected
from
light
exposure
until
administration
is
completed
(see
sections 4.4, 6.3 and 6.6).
Method of administration
For intravenous use only.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the exci