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KetoVOLVE® KetoVOLVE is a very high fat, adequate protein and low carbohydrate formula, with an off white colour and bland milky flavor. KetoVOLVE consists of palm fruit oil, fractionated coconut oil, whey protein, maltodextrin, vitamins and minerals. KetoVOLVE is a powdered ketogenic diet suitable for tube feeding and as an oral supplement. KetoVOLVE® has no added gluten, sucrose, fructose, casein, artificial sweeteners or flavourants and is trans-fat free.

Indication

KetoVOLVE is a nutritionally complete powdered formula that is suitable for the administration or supplementation of the Ketogenic diet, which is used in the management of refractory epilepsy. KetoVOLVE is suitable for use as a sole source of nutrition in children between 1 and 8 years of age. It is particularly effective in the management of: West syndrome/Infantile spasm Lennox-Gastaut syndrome GLUT-1 Deficiency syndrome Doose Syndrome/ MAE – Myoclonic astatic epilepsy Dravet Syndrome Pyruvate Dehydrogenase deficiency Mitochondrial deficiencies

Contraindications

KetoVOLVE is contraindicated in individuals with certain metabolic deficiencies:

1. L-Carnitine deficiencies 2. Pyruvate carboxylase deficiencies 3. Porphyria 4. Inborn errors of fat metabolism 5. Diabetes mellitus

Precautions

KetoVOLVE is a complete feed suitable for the administration of the Ketogenic diet. Therefore KetoVOLVE has the same precautions as the Ketogenic diet, namely: Constipation

KetoVOLVE fatty acids

Failure to gain weight Low grade acidosis Hypoglycaemia – if the diet is initiated with a fast Increased cholesterol Possible formation of renal stones

Nutritional information for KetoVOLVE Per 100g powder Energy kCal

KJ

Protein1 g Carbohydrates g Sugars g Fats

LCT2 g MCT3 g

Trans Fat g Fibre g Vitamins4 Vitamin A µg RE Vitamin C mg Vitamin D µg Vitamin E5 mg Vitamin K µg Thiamin (B1) mg Riboflavin (B2) mg Niacin (B3) mg Pyridoxine (B6) mg Folic Acid µg M-Inositol mg Cobalomin (B12) µg Pantothenate (B5) mg D-Biotin µg Choline mg Minerals Calcium6 mg Chromium µg Copper µg Iodine µg Iron mg Magnesium mg Manganese mg Molybdenum µg Phosphorus mg Selenium µg Zinc mg Potassium mg Sodium mg Chloride mg

Per 100kCal

700 2926

100 418

14.5 2.5 1.1

2.1 0.4 0.2

57.0 15.0 <0.5

1

In accordance with Codex stan 72-1981 protein content is determined as follows: nitrogen (g) X 6.38

2

Long Chain Triglycerides

8.1 2.1 <0.07

3

Medium Chain Triglycerides

4

Common names of vitamins in brackets

Nil

Nil

5

Vitamin E levels comply with EU Directive

445 75 10 7 55 0.6 0.6 6.7 0.6 200 58 1.2 3 12 250

63.6 10.71 1.4 1.0 7.9 0.085 0.085 0.957 0.085 28.57 8.3 0.171 0.429 1.714 35.71

800 15 440 90 10 100 1 25 550 30 5 889.4 309 723.3

114.3 2.143 62.86 12.86 1.429 14.28 0.143 3.571 78.57 4.285 0.714 127.0 44.14 103.3

2006/141/EC requiring min 0.5mg/g PUFA

6

Calcium to Phosphorus ratio is 1.45:1

KetoVOLVE contains a blend of fractionated coconut oil and palm fruit oil, which is blended to yield the fatty acid profile in the table below. KetoVOLVE’s fatty acid profile is free of trans fats, GM organisms and has a LA:α-LA = 6:1 Fatty acid

g per 100g

% fatty acids

0 8 7 0 0 23 3 24 6 1 72

0 11 10 0 0 32 4 33 8 2 100

Caproic acid (C6:0) Caprylic acid (C8:0) Capric acid (C10:0) Lauric acid (C12:0) Myristic acid (C14:0) Palmitic acid (C16:0) Stearic acid (C18:0) Oleic acid (C18:1) Linoleic acid (C18:2) α-Linolenic acid (C18:3) Total

compliant with EU Directive 2006/141/EC

Pie distribution of fatty acids in grams 9%

33%

21%

MCT Oils

Saturated

37%

Monounsaturated

Polyunsaturated

Preparation and administration

The recommended intake of KetoVOLVE is dependent on age, bodyweight and medical condition of the patient. The recommended dilution is 1:4 eg: 20g KetoVOLVE powder plus 80ml of water to yield 100ml. This results in a caloric density of 1.40 kCal per ml.


Mixing instructions 1. Weigh out prescribed amount of powder and place into sealable container 2. KetoVOLVE dissolves in hot tap water 3. Make up to required volume 4. Stir, shake or whisk vigorously until all the powder is dissolved 5. Remove carefully, chill in refrigerator 6. Stir before use KetoVOLVE (g) 20 50 100 200

Dilution Table Water (ml) Final Volume (ml) 80 100 200 250 400 500 800 1000

Kcal/ml 1.40 1.40 1.40 1.40

Some separation is likely to occur when solubilised KetoVOLVE is left to stand. This is a normal characteristic of KetoVOLVE and can be remedied by stirring. Potential Renal Solute Load (PRSL)

2.56 mOsm/100kJ 10.68 mOsm/100kcal

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