KETOCAL 4: 1 Neutral oral nutriment B/300g

VIDAL
Parapharmacy
Update of 27/08/2023

KETOCAL^® 4:1 and KETOCAL^® 3:1

Forms and presentations 

Foods for special medical purposes (FSMP):  
The KetoCal range includes 3 references:

• KetoCal 4:1:
  High-fat product with a fat/(carbohydrate + protein) ratio of 4/1: Boxes of 300 g.
  2 references: unflavored (EAN 4008976671763), vanilla flavor (EAN 4008976671725).
  
• KetoCal 3:1:
  High-fat product with a fat/(carbohydrate + protein) ratio of 3/1: Box of 300 g.
  1 reference: unflavored (EAN 4008976671664).
  

Composition 

KetoCal 4:1:
KetoCal 4:1 unflavored ingredients:
Refined vegetable oils (palm, soy, sunflower), proteins of milk (casein, whey), soy lecithin of soy, dietary fibers (cellulose, inulin, fructo-oligosaccharides, gum arabic, resistant starch, polysaccharides of soy), calcium carbonate, dehydrated glucose syrup, anti-caking agent (E551), silicon dioxide, calcium triphosphate, tripotassium citrate, potassium chloride, sodium chloride, magnesium acetate, L-arginine, L-cystine, choline bitartrate, arachidonic acid derived from Mortierella alpina, highly refined docosahexaenoic acid derived from Crypthecodinium cohnii, L-tryptophan, dextrin-maltose, sodium caseinate (derived from milk cow's milk), sodium L-ascorbate, L-phenylalanine, L-ascorbic acid, L-valine, L-tyrosine, L-carnitine, taurine, ferrous sulfate, emulsifier (E471), DL-α-tocopherol, inositol, L-histidine, zinc sulfate, nicotinamide, calcium D-pantothenate, manganese sulfate, copper sulfate, thiamine hydrochloride, pyridoxine hydrochloride, riboflavin, retinol acetate, antioxidants (E304, E306), pteroylmonoglutamic acid, potassium iodide, sodium molybdate, chromium chloride, sodium selenite, vitamin K1, D-biotin, cholecalciferol, cyanocobalamin.
 
KetoCal 4:1 vanilla flavor ingredients:
Vegetable oils (palm oil, palm oil, soy, sunflower oil), proteins of milk cow's milk (casein, whey), soy lecithin of soy, cellulose, glucose syrup, inulin, calcium carbonate, potassium chloride, oligofructose, gum arabic, tricalcium phosphate, anti-caking agent (silicon dioxide), resistant starch, sodium chloride, potassium citrate, choline bitartrate, L-arginine, L-cystine, oil derived from Mortierella alpina, oil derived from Crypthecodinium cohnii, fiber from soy, magnesium acetate, flavor, L-tryptophan, sodium caseinate (from milk cow), sodium L-ascorbate, dextrin-maltose, magnesium oxide, L-phenylalanine, L-carnitine, L-ascorbic acid, taurine, ferrous sulfate, L-valine, inositol, L-tyrosine, sweetener (sucralose), emulsifier (mono- and diglycerides of fatty acids), zinc sulfate, DL-α-tocopherol acetate, nicotinamide, calcium D-pantothenate, copper sulfate, pyridoxine hydrochloride, manganese sulfate, thiamine hydrochloride, riboflavin, retinol acetate, antioxidants (ascorbyl palmitate, mixed tocopherols), pteroylmonoglutamic acid, potassium iodide, chromium chloride, sodium selenite, sodium molybdate, D-biotin, cholecalciferol, cyanocobalamin.

Average analysis		p 100 g of unflavored powder	p 100 ml at 1,5 kcal/mL	p 100 ml at 1,0 kcal/mL
Energy	kcal	704	150	100
	kJ	2906	619	413
Lipids (88,5 % TEA*)	g	69,2	14,7	9,8
- Of which saturated fatty acids	g	26,1	5,6	3,7
- Of which monounsaturated fatty acids	g	22,7	4,8	3,2
- Of which polyunsaturated fatty acids	g	20,4	4,3	2,9
- of which arachidonic acid (ARA)	mg	120	25,5	17,0
- of which docosahexaenoic acid (DHA)	mg	110	23,4	15,6
Carbohydrates (1,9 % TEA*)	g	2,8	0,60	0,40
- Of which sugars	g	0,68	0,14	0,10
Fibers (1,5 % TEA*)	g	5,4	1,2	0,77
Proteins (8,1 % TEA*)	g	14,3	3,0	2,0
Salt	g	1,3	0,29	0,19
Vitamins
- A	µg	320	68,2	45,4
- D	µg	10,5	2,2	1,49
- E	mg (α-ET)	11,7	2,5	1,66
- K1	µg	51,4	10,9	7,30
- Thiamine (B1)	mg	0,70	0,15	0,10
- Riboflavin (B2)	mg	0,87	0,18	0,12
- Niacin (B3)	mg (mg-EN)	4,9 (10,6)	1,0 (2,3)	0,70 (1,51)
- Pantothenic acid (B5)	mg	2,9	0,62	0,41
- B6	mg	0,87	0,19	0,12
- Folic acid	µg	116	24,7	16,5
- B12	µg	1,3	0,28	0,18
- Biotin	µg	19,1	4,1	2,71
- C	mg	60,0	12,8	8,52
Minerals and trace elements
- Sodium	mg	529	112,7	75,2
- Potassium	mg	855	182,1	121
- Chlorine	mg	800	171	114
- Calcium	mg	780	166,5	111
- Phosphorus	mg	462	98,4	65,6
- Magnesium	mg	107	22,8	15,2
- Iron	mg	8,0	1,7	1,14
- Zinc	mg	4,40	0,9	0,62
- Copper	mg	0,55	0,12	0,078
- Manganese	mg	0,44	0,09	0,062
- Molybdenum	µg	31,7	6,8	4,50
- Selenium	µg	30,0	6,4	4,26
- Chromium	µg	15,7	3,3	2,23
- Iodine	µg	86,2	18,4	12,2
Other
- L-carnitine	mg	45,0	10	6,39
- Choline	mg	324	69	46,0
- Inositol	mg	22,1	4,7	3,1
- Taurine	mg	33,0	7,0	4,7
Osmolarity	mOsmol/l	NA	NA	150

^* TEE: Total Energy Intake.
 
KetoCal 3:1:
KetoCal 3:1 unflavoured ingredients:
Vegetable oils (palm oil, palm oil, soy, sunflower oil), proteins derived from milk cow (casein, whey), lactose (derived from milk cow), glucose syrup, tricalcium phosphate, potassium citrate, potassium chloride, calcium hydrogen phosphate, choline bitartrate, glycine, oil derived from Mortierella alpina, oil derived from Crypthecodinium cohnii, magnesium chloride, L-cystine, L-leucine, sodium caseinate (derived from milk cow), L-tryptophan, inositol, magnesium acetate, L-valine, sodium L-ascorbate, L-carnitine, taurine, ferrous sulfate, zinc sulfate, emulsifier (mono- and diglycerides of fatty acids), calcium D-pantothenate, nicotinamide, DL-α-tocopherol acetate, copper sulfate, thiamine hydrochloride, pyridoxine hydrochloride, riboflavin, retinol acetate, manganese sulfate, antioxidants (DL-α-tocopherol acetate, ascorbyl palmitate), chromium chloride, pteroylmonoglutamic acid, potassium iodide, sodium molybdate, sodium selenite, cholecalciferol, D-biotin, cyanocobalamin.

Average analysis		p 100 g of unflavored powder	per 100 kcal	per 100 ml at 0,66 kcal/mL (9,3 %)
Energy	kcal	711	100	66
	kJ	2935	413	273
Lipids (87,2 % TEE*)	g	68,6	9,7	6,4
- Of which saturated fatty acids	g	26,6	3,7	2,5
- Of which monounsaturated fatty acids	g	24,0	3,4	2,2
- Of which polyunsaturated fatty acids	g	18,0	2,5	1,7
- of which linoleic acid (LA)	mg	15 500	2183	1443
- of which alpha-linolenic acid (ALA)	mg	1280	181	119
- of which arachidonic acid (ARA)	mg	180	25,0	16,5
- of which docosahexaenoic acid (DHA)	mg	180	25,0	16,5
Carbohydrates (4,1 % TEE*)	g	7,2	1,0	0,67
- Of which sugars	g	5,4	0,76	0,50
- of which lactose	g	5,09	0,72	0,47
Fibres (0 % TEE*)	g	-	-	-
Proteins (8,7 % TEE*)	g	15,4	2,2	1,4
Salt	g	0,89	0,13	0,08
Vitamins
- A	µg	389	54,7	36,2
- D	µg	17,0	2,40	1,58
- E	mg (α-ET)	9,02	1,27	0,84
- K	µg	55,4	7,79	5,15
- Thiamine (B1)	mg	0,71	0,10	0,07
- Riboflavin (B2)	mg	0,71	0,10	0,07
- Niacin (B3)	mg (mg-EN)	4,97 (11,3)	0,70 (1,59)	0,46 (1,05)
- Pantothenic acid (B5)	mg	6,03	0,85	0,56
- B6	mg	0,71	0,10	0,07
- Folates	µg	177	25,0	16,5
- Folic acid	µg	106	15,0	9,90
- B12	µg	1,40	0,20	0,13
- Biotin	µg	14,2	2,00	1,32
- C	mg	95,6	13,5	8,89
Minerals and trace elements
- Sodium	mg	355	50,0	33,1
- Potassium	mg	920	129	85,6
- Chlorine	mg	545	76,7	50,7
- Calcium	mg	810	114	75,3
- Phosphorus	mg	546	76,9	50,8
- Phosphates	mg	1676	236	156
- Magnesium	mg	78,1	11,0	7,27
- Iron	mg	12,1	1,70	1,12
- Zinc	mg	8,53	1,20	0,79
- Copper	mg	0,51	0,072	0,048
- Manganese	mg	0,14	0,020	0,013
- Molybdenum	µg	34,9	4,91	3,25
- Selenium	µg	27,0	3,80	2,51
- Chromium	µg	29,0	4,08	2,70
- Iodine	µg	104	14,6	9,66
Other
- L-carnitine	mg	48,8	6,87	4,54
- Choline	mg	225	31,6	20,9
- Inositol	mg	155	21,9	14,5
- Taurine	mg	48,7	6,85	4,53
Osmolarity	mOsmol/l	NA	NA	95

^*  TEE: Total Energy Intake.

Indications 

Clinical nutrition products for oral or tube administration. For the nutritional management of patients with drug-resistant epilepsy or with an inherited metabolic disease when a ketogenic diet is indicated.
 
KetoCal 4:1 enables the initiation and monitoring of a ketogenic diet in cases of severe epilepsy refractory and resistant to drug treatments in patients:

• over 1 year (KetoCal 4:1 unflavoured) or 3 years (KetoCal 4:1 vanilla flavour) and up to 18 years;
  
• adults for whom treatment with KetoCal was initiated before the age of 18 years.
  

KetoCal 3:1 enables the initiation and monitoring of a ketogenic diet in patients aged 0 to 3 years with drug-resistant epilepsy or with an inherited metabolic disease such as:

• pyruvate dehydrogenase deficiencies (PDH deficiency);
  
• glucose transporter type 1 deficiencies (GLUT1 deficiency/De Vivo disease);
  
• mitochondrial cytopathies.
  

Precautions for use 

Important notice:

Do not administer parenterally.

To be used under medical supervision.

Ensure daily fluid requirements are covered.

Not suitable for healthy individuals.

KetoCal 4:1:

• Unflavoured: Suitable as the sole source of nutrition in patients aged 1 to 10 years, or as a dietary supplement in patients over 1 year.
  
• Vanilla flavour: Suitable as the sole source of nutrition in patients aged 3 to 10 years (due to the presence of sucralose), or as a dietary supplement in patients over 3 years.
  

KetoCal 3:1:

Suitable as the sole source of nutrition or as a nutritional supplement for infants and children up to 3 years.

Directions for use 

The dosage must be determined according to the patient's needs by a physician or dietitian. An alternative reconstitution ratio may be prescribed.

Quantity of powder	Water	Final volume	Energy	Dilution
KetoCal 4:1:
21,3 g	79 mL	100 mL	150 kcal	1,5 kcal/mL
14,2 g	86 mL	100 mL	100 kcal	1,0 kcal/mL
KetoCal 3:1:
9,3 g	90 mL	100 mL	66 kcal	0,66 kcal/mL
14,1 g	86 mL	100 mL	100 kcal	1,0 kcal/mL

STORAGE CONDITIONS 

Preferably store in a cool, dry place, protected from light.
After opening, use within one month.
Always replace the lid after each use.
For infants under 1 year, the preparation must be consumed within the following hour.
For children between 1 and 3 years, the preparation must be consumed immediately or stored in the refrigerator for a maximum of 4 hours.
For children from 3 years, adolescents and adults, the preparation must be consumed immediately or stored in the refrigerator for a maximum of 24 hours.

ADMINISTRATIVE INFORMATION 

NUTRICIA Clinical Nutrition
17-19, rue des Deux-Gares. CS 50149. 92565 Rueil-Malmaison cedex
Switchboard telephone: 01 49 48 47 00
www.nutricia.fr