VAMIN 14 ELECTROLYTE FREE

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Active ingredient:
ACETIC ACID 5.6 ML/L; ARGININE 8.4 G/L
Available from:
CURE MEDICAL & TECHNICAL SUPPLY
ATC code:
B05BA01
Pharmaceutical form:
SOLUTION FOR INFUSION
Administration route:
I.V
Manufactured by:
FRESENIUS KABI AUSTRIA GmbH
Therapeutic group:
AMINO ACIDS
Therapeutic indications:
Vamin 14EF is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Vamin 14EF is particulary suitable for patients with moderaterly increased amino acid requirements.
Authorization number:
105332362705
Authorization date:
2009-02-01

Vamin™ 14 Electrolyte-Free

Description

Amino acid solution for intravenous nutrition.

Vamin 14 EF is an electrolyte-free, clear colourless to slightly yellow solution of amino acids, for intravenous nutrition.

Composition

Acetic acid to pH 5.6

Water for injection to 1000 ml.

Total amount of amino acids: 85 g/l of which 38.7 g, including cysteine and tyrosine, are essential.

pH: 5.6

Osmolality: 810 mosmol per kg water

Nitrogen content: 13.5 g/l

Electrolytes:About 90 mmol acetate added as acetic acid for pH adjustment and lysine acetate (45 mmol).

Energy content: 1.4 MJ (350 kcal).

Antioxidant additives: none

Clinical Pharmacology

The Vamin solutions contain all 18 essential and non-essential amino acids needed for protein synthesis.The amino-

acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during

extended periods of intravenous nutrition.Toensure optimal utilization of the infused amino acids, the patients

requirements of energy (given as carbohydrate and fat), trace elements and vitamins should be met.

Indications

Vamin 14 EF is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition.

Vamin 14 EF is particularly suitable for patients with moderately increased amino acid requirements.

Contraindications

The Vamin solutions are contra-indicated in patients with inborn errors of amino acid metabolism, irreversible liver

damage and in severe uremia when dialysis facilities are not available.

Caution

Care must be exercised in the administration of large volume infusion fluids to patients with cardiac insufficiency.

Amino acid infusions must also be administered with caution to patients with disturbances in protein metabolism.

Hyperkalaemia, hypernatraemia, and acidosis should be corrected prior to commencement of intravenous nutrition.

Serum electrolytes, blood glucose levels and acid-base balance should be regularly monitored. Fluid balance should

also be monitored since hypertonic dehydration may occur.Amino acid solution may precipitate acute folate deficiency

and folic acid should be given daily.

Intravenous infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper

and, in particular zinc, which should be taken into account in the dosing of trace elements, particularly during long

term intravenous nutrition.

Pregnancy

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with the Vamin

solutions.There are, however, published reports of the successful and safe administration of amino acid solutions

during pregnancy in the human.

Adverse Events

Nausea occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Vamin at rates

exceeding the recommended maximal rate.Transient increases in liver tests during intravenous nutrition have been

reported.The reasons are at present unclear.The underlying disease and the components and their amounts in

the intravenous feeding regimens have been suggested.As with all hypertonic infusion solutions, thrombophlebitis

may occur when peripheral veins are used.The incidence may be reduced by the simultaneous infusion of intralipid ® .

Amino acids and electrolytes (g/l):

Alanine …………………... 12.0

Arginine ………………….. 8.4

Aspartic acid …………...... 2.5

Cysteine/cystine ……….... 0.42

Glutamic acid …………..... 4.2

Glycine …………………… 5.9

Histidine …………………. 5.1

Isoleucine …………….….. 4.2

Leucine …………………... 5.9 Lysine (as Lysine acetate) ……...6.8

L-Methionine ……………………..4.2

Phenylalanine …………………....5.9

Proline …………………………….5.1

Serine ……………………………..3.4

Threonine ………………………....4.2

Tryptophan ………………………..1.4

Tyrosine …………………………...0.17

Valine ……………………………....5.5

Drug interactions

At the recommended dosage, the amino acids in Vamin solutions have no pharmacological effects per se and is

not expected to interact with other medicaments.

Dosage

Electrolyte, fluid, acid-base imbalance and shock should be corrected prior to commencement of intravenous nutrition.

In the metabolic and nutritional management of the seriously ill patient specific preliminary investigations and

continuous monitoring are essential, particularly of electrolyte levels. Monitoring of vitamin and trace element levels

should be included, especially in patients receiving long-term intravenous nutrition.

Toachieve an optimal utilization of administered amino acids, adequate energy sources, e.g. glucose solutions

and fat emulsion (Intralipid) should be provided together with electrolytes, trace elements (Additrace) and vitamins

(Solovit N and Vitalipid NAdult).

Adults: the nitrogen requirement for maintenance of body protein mass depends on the patients' condition (nutritional

state and degree of metabolic stress).The requirements are 0.10 – 0.15 g nitrogen/kg/day (no or minor metabolic

stress and normal nutritional sate), 0.15-0.20 g nitrogen/kg/day (moderate metabolic stress with or without malnutrition)

and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma).The dosage range 0.10-

0.25 g nitrogen/kg/day corresponds to 7-18 ml Vamin 14 EF/kg/day. In obese patients, the dose should be based

on the estimated ideal weight. In conditions of pure malnutrition without metabolic stress, up to 0.40-0.50 g

nitrogen/kg/day may be given if the patient is adequately monitored.

Depending upon patients requirements, up to 1000 ml of Vamin 14 EF may be infused intravenously per 24 hours.

In patients with markedly increased amino acid requirements, the more concentrated Vamin 18 EF may be used.

Vamin 14 EF should be infused slowly, at a rate not exceeding 1000 ml in 8 hours corresponding to approximately

2 ml per minute.

Infant dosage: 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.

Administration

Hypertonic preparations such as amino acid solutions and concentrated glucose solutions are commonly infused

into a central vein.As with all infusions, care should be taken to avoid complications of catheterisation including

air embolism and central venous thrombosis.

The Vamin solutions may be infused into the same central or peripheral vein as carbohydrates and fat emulsion

by means of aY-connector near the infusion site.

The Vamin solutions may also be given in a phthalate-free plastic bag as a part of anAll in One admixture containing

carbohydrates, fat emulsion, electrolytes, trace elements and vitamins. Each component of the admixture must

fall within the concentration range for which stability has been documented.

The risk of serious thoracic complications can be avoided by the use of a peripheral catheter if Vamin 14 EF is given

simultaneously with Intralipid through the same cannula, since the reduced osmolality of the overall mixture may

reduce the risk of thrombophlebitis.

Strict asepsis should be maintained especially in the immuno-supressed patient. For safe administration of intravenous

fluids from non-collapsible containers a giving set with an integral airway is recommended.

Compatibility

Additives:The following can be added to 1000 ml Vamin 14 EF, separately or together, without risk of precipitation:

Up to 20 mlAddamel ™ orAddamel N, 480 mmol NaCl, 480 mmol KCl, 24 mmol Ca-glubionate and 48 mmol MgSO

When phosphate is needed, up to 60 mlAddiphos ™ alone or in combination with 480 mmol NaCl, 480 mmol KCl

and 48 mmol MgSO

. Please note thatAddamel orAddamel N should not be added to a solution containing phosphate

owing to the risk of precipitation additions should be performed asceptically immediately before the start of the infusion.

Discard any unused contents.

Shelf-life and Storage

Storage instructions are stated on the label.

Pack Sizes

Bottles of 500 ml and 1000 ml.

Manufacturer

See outer packaging.

Registration Holder

Cure Medical &Technical Supply

4 Baltimore St., PetachTiqva

SH Z15711702K305B/VAM NOV08

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