Vamin 18 EF QUALITATIVE AND QUANTITATIVE COMPOSITION

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1 Title Page Information Dec (7) Number Vamin 18 EF 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 16.0 g 11.3 g 560 mg 6.8 g 7.9 g 9.0 g 7.9 g 6.8 g 4.5 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 mosm/kg water. Energy: approx. 1.9 MJ (460 kcal) ph: 5.6 With regard to excipients, see 6.1.

2 Vamin 18 EF Dec (7) 3. 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 g/kg per day, in the event of moderately increased metabolic stress g/kg per day and in the event of a severe catabolic state (burns, sepsis and trauma) g nitrogen/kg per day. If 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.

3 Vamin 18 EF Dec (7) 4.7 Effects on ability to drive vehicles and use machinery 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.

4 Vamin 18 EF Dec (7) 6. PHARMACEUTICAL PARTICULARS 6.1 List of excipients 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 Shelf life Shelf life in unopened glass bottle: 2 years. 6:4 Special precautions for storage To be kept at maximum 25 o 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 Ca 2+ as glubionate and 48 mmol Mg 2+ 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 CaCl 2 ) or up to 60 ml Addiphos with or without further additions of Na mmol, K mmol as chlorides and Mg 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.

5 Vamin 18 EF Dec (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 mg/ml Tracel Addiphos or Glycophos Vitalipid Adult Soluvit ml ml 1000 ml 0-10 ml 0-15 ml 0-30 ml 10 ml 1 bottle

6 Vamin 18 EF Dec (7) Intralipid 300 mg/ml Vamin 18 g N/l electrolyte-free 500 ml 1000 ml 500 ml Intralipid ml ml ml Glucose 100 mg/ml 1000 ml Glucose mg/ml 1000 ml 1000 ml Tracel 0-10 ml 0-10 ml 0-10 ml Addiphos or 0-15 ml 0-15 ml 0-15 ml Glycophos 0-30 ml 0-30 ml 0-30 ml Vitalipid Adult 10 ml 10 ml 10 ml Soluvit 1 bottle 1 bottle 1 bottle Electrolyte limits in ready-made mixture in bag: mmol/1000 ml Sodium Potassium Calcium Magnesium Phosphate* 15 Chloride Acetate Zinc * 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.

7 Vamin 18 EF Dec (7) 7. MARKETING AUTHORISATION HOLDER Fresenius Kabi AB SE Uppsala Sweden This Information is valid and approved only in Sweden. The 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