Title

Date

Page

Product Information

Dec. 2000

1 (7)

Product

Number

Vamin 18 EF

121-01

1.

NAME OF THE MEDICINAL PRODUCT

Vamin 18 g N/l electrolyte-free infusion fluid, solution

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1000 ml contains:
Acid. aminoacet. (Glycine.)
Acid. aspartic.
Acid. glutamic.
Alanine.
Arginine.
Cysteine. (+ Cystine.)
Histidine.
Isoleucine.
Leucine.
Lycine. acetate. respond. Lycine.
Methionine.
Phenylalanine.
Proline.
Serine.
Threonine.
Tryptophan.
Tyrosine.
Valine.

7.9 g
3.4 g
5.6 g
16.0 g
11.3 g
560 mg
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

1000 ml contains:
Amino acids: 114 g, of which 51.6 g are essential (including cysteine and tyrosine).
Nitrogen: 18.0 g
Electrolytes: approx. 110 mmol acetate added as lysine acetate and as acetic acid for pH
adjustment.
Osmolality: approx. 1130 mosm/kg water.
Energy: approx. 1.9 MJ (460 kcal)
pH: 5.6
With regard to excipients, see 6.1.

Product

Date

Vamin 18 EF

Dec. 2000

3.

2 (7)

PHARMACEUTICAL FORM

Infusion fluid, solution

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Conditions when an intravenous nutrient supply is needed.

4.2

Posology and method of administration

Up to 1000 ml intravenously per day depending on the patient's requirements. Are preferably
be administered in a central vein. In the event of a normal state of nutrition and slight
metabolic stress or none at all the nitrogen requirement is 0.10-0.15 g/kg per day, in the event
of moderately increased metabolic stress 0.15-0.20 g/kg per day and in the event of a severe
catabolic state (burns, sepsis and trauma) 0.20-0.25 g nitrogen/kg per day.
If 0.10-0.25 g nitrogen/kg per day is needed, 5-14 ml Vamin 18 g N/l electrolyte-free / kg per
day should be administered. The infusion time for 1000 ml Vamin 18 g N/l electrolyte-free
should be at least 8 hours (maximum 2.1 ml/min.).
4.3

Contraindications

Congenital disturbance of the amino-acid metabolism. Irreversible liver damage. Serious

uraemia when there is no possibility of dialysis.
4.4

Warnings and precautionary measures

Vamin 18 g N/l electrolyte-free has a high osmolality and should thus not be administered
undiluted in peripheral veins. In the event of peripheral administration, the risk of
thrombophlebitis can be reduced by means of simultaneous administration of Intralipid.
4.5

Interactions with other medicinal products and other forms of interaction

No known interactions.
4.6

Pregnancy and lactation

Clinical studies have not shown there to be any risk in pregnant and breast-feeding women.

Product

Date

Vamin 18 EF

Dec. 2000

4.7

3 (7)

Effects on ability to drive vehicles and use machinery

4.8

Undesirable effects

Common (>1/100): Thrombophlebitis

Rare (<1/1000): Shivering, nausea, flushes. Hypersensitivity reactions have been reported.
Several factors are considered to contribute to the occurrence of thrombophlebitis in the event
of infusion in a peripheral vein, incl. potassium content, infusion time, the infusion fluid's pH
and osmolality, width of vein and cannula.
Temporary changes in liver samples have been noted in connection with intravenous
nutrition, but the cause is unknown.
4.9

Overdose

Nausea and a feeling of heat may occur in the event of infusion of amino acids, especially if
the solution is infused too quickly. The symptoms usually disappear if the speed of infusion is
lowered.
5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

ATC code: B05BA01

Vamin 18 g N/l electrolyte-free contains amino acids which are included in protein in the
normal diet. To optimally utilise the amino acids supplied for protein synthesis, the energy
requirement should be covered by supplying carbohydrates (in the form of glucose) and fat.
5.2

Pharmacokinetic properties

The pharmacokinetic properties of Vamin 18 g N/l electrolyte-free are basically the same as
for amino acids supplied through the normal diet.
5.3

Preclinical safety data

Preclinical studies have shown that Vamin 18 g N/l electrolyte-free is well tolerated.

Product

Date

Vamin 18 EF

Dec. 2000

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

4 (7)

Acid. acetic. glaciale

Aqua ad iniect.
6.2

Compatibility

Only additives for which compatibility has been documented are permissible with Vamin 18 g
N/l electrolyte-free.
Mixing in phthalate-free plastic bag, see 6.6.
6.3

Shelf life

Shelf life in unopened glass bottle: 2 years.

6:4

Special precautions for storage

To be kept at maximum 25o C. Must not be frozen.

6.5

Type and contents of pack

Glass bottle
Pack sizes:
500 ml
1000 ml
6.6

Instructions for use and handling, and disposal

Additives:
One can simultaneously or separately add to 1000 ml Vamin 18 g N/l electrolyte-free up to
20 ml Tracel, 480 mmol Na+ and 480 mmol K+ as chlorides, 24 mmol Ca2+ as glubionate and
48 mmol Mg2+ as sulphate. When the addition of phosphate is required one can add to
1000 ml Vamin 18 g N/l electrolyte-free up to 120 ml Glycophos with or without the addition
of 48 mmol calcium (as CaCl2) or up to 60 ml Addiphos with or without further additions of
Na+ 480 mmol, K+ 480 mmol as chlorides and Mg2+ 48 mmol as sulphate. Note that because
of the risk of precipitation Tracel must not be added to a solution containing non-organic
phosphate (e.g. Addiphos). Additives must be added aseptically.

Product

Date

Vamin 18 EF

Dec. 2000

5 (7)

Mixing in phthalate-free plastic bag.

By using a strictly aseptic technique in the LAF bench the following mixing routine can be
applied:
I.

One should add to Vamin 18 g N/l electrolyte-free:

Tracel
Glycophos
Electrolytes

II.

One should add to the glucose solution:

Addiphos or another non-organic phosphate source (see Tracel under
Additives above).
III.

One should add to Intralipid:

Soluvit
Vitalipid Adult

Mixtures I and II should be transferred to a phthalate-free plastic bag. Mixture III should then
be transferred to the bag, which should carefully be turned until a homogeneous mixture has
been attained.
In the mixture vitamin C is oxidised by oxygen, thus the content drops. However, no clinical
vitamin C deficiencies have been reported in connection with long-term intravenous nutrition
including Soluvit.
Limits for components included in the mixture:
Intralipid 200 mg/ml
Vamin 18 g N/l electrolyte-free
Intralipid
Glucose 100-300 mg/ml
Tracel
Addiphos or
Glycophos
Vitalipid Adult
Soluvit

500-1000 ml
500-1000 ml
1000 ml
0-10 ml
0-15 ml
0-30 ml
10 ml
1 bottle

Product

Date

Vamin 18 EF

Dec. 2000

6 (7)

Intralipid 300 mg/ml

Vamin 18 g N/l
electrolyte-free
Intralipid
Glucose 100 mg/ml
Glucose 100-200 mg/ml
Tracel
Addiphos or
Glycophos
Vitalipid Adult
Soluvit

500 ml
250-500 ml
1000 ml
0-10 ml
0-15 ml
0-30 ml
10 ml
1 bottle

1000 ml
250-500 ml

500 ml
350-500 ml

1000 ml
0-10 ml
0-15 ml
0-30 ml
10 ml
1 bottle

1000 ml
0-10 ml
0-15 ml
0-30 ml
10 ml
1 bottle

Electrolyte limits in ready-made mixture in bag:

mmol/1000 ml
Sodium
Potassium
Calcium
Magnesium
Phosphate*
Chloride
Acetate
Zinc

0-150
0-150
1.0-5.0
0.5-5.0
15
0-300
0-150
0-0.1

* includes the amount of phosphate to be found in Intralipid.

Shelf life:
Because of the risk of microbial contamination in connection with additions to the infusion
fluid in the department, the infusion fluid must be used immediately following preparation.
Any remaining infusion fluid in a broken pack must be discarded and must not be saved for
later use.
Mixtures prepared aseptically in a phthalate-free plastic bag at the pharmacy must be used up
within 96 hours of preparation. An infusion of any such mixture must be completed within 24
hours of the bag's removal from the fridge.

Product

Date

Vamin 18 EF

Dec. 2000

7.

7 (7)

MARKETING AUTHORISATION HOLDER

Fresenius Kabi AB
SE-751 74 Uppsala
Sweden

This Product Information is valid and approved only in Sweden. The Product Information
applicable in your country may differ from this version. For detailed information valid and
approved for your country, please refer to the local/national Fresenius Kabi affiliate