Vamin 18 Electrolyte-Free

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PHENYLALANINE; ARGININE; ASPARTIC ACID; ALANINE; THREONINE; VALINE; GLUTAMIC ACID; GLYCINE; ISOLEUCINE; L-LYSINE; L-METHIONINE; L-TRYPTOPHAN; L-TYROSINE; SERINE; L-CYSTEINE; LEUCINE; L-HISTIDINE; PROLINE

Available from:

Fresenius Kabi Limited

ATC code:

B05BA01

INN (International Name):

PHENYLALANINE; ARGININE; ASPARTIC ACID; ALANINE; THREONINE; VALINE; GLUTAMIC ACID; GLYCINE; ISOLEUCINE; L-LYSINE; L-METHIONINE;

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

PHENYLALANINE 7.9 g/l; ARGININE 11.3 g/l; ASPARTIC ACID 3.4 g/l; ALANINE 16 g/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; L-METHIONINE 5.6 g/l; L-TRYPTOPHAN 1.9 g/l; L-TYROSINE 230 mg/l; SERINE 4.5 g/l; L-CYSTEINE 560 mg/g; LEUCINE 7.9 g/l; L-HISTIDINE 6.8 g/l; PROLINE 6.8 g/l

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Authorization status:

Authorised

Authorization date:

2007-09-11

Patient Information leaflet

M095710/04 GB
V002
Schwarz
Product Name:
Type of Packaging:
Dosage:
Territory:
Pharma-Code (Laetus)
EAN Code:
-
Font:
Smallest Size:
2-D-Matrix Code
Material number:
Colour:
1. Draft
30.11.2015, 19:15
1. Corr
02.12.2015, 13:15
2. Corr
15.12.2015, 17:00
3. Corr
17.10.2016, 10:30
4. Corr
27.10.2016, 09:30
Variable Data:
Operator: PETER SCHAFFER [phone]
VAMIN 18 EF
GB
LEAFLET
-
M095710/04 GB
-
M095710/04 GB
Antique Olive
8
Dimension:
180 X 294 MM
M095710/04 GB
PACKAGE LEAFLET: INFORMATION FOR THE 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 a

Summary of Product characteristics

MT SmPC Vamin 18EF_V002
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
MT SmPC Vamin 18EF_V002
Page 2 of 5
Posology_ _
_ _
ADULTS
Depending upon patient requirements up to one litre intravenously per
24 hours.
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.
Method of administration
For intravenous use only.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
Vamin
18
Electrolyte-Free
is
contraindicated
in
patients
with
irreversible
liver
damage and in severe uraemia when