6 Product Information

Transcription

1 6 Product Information 6.1 Nutrient composition Energy distribution: Table 6.1: Energy distribution and sources in Fresubin 2 kcal / fibre DRINK Energy distribution Sources Protein: 20 energy% Milk Fat: 35 energy% Sunflower oil, rapeseed oil Carbohydrates : 45 energy% Glucose syrup, sucrose Macronutrients: Protein Fresubin 2 kcal / fibre DRINK are high in protein (20% energy). The protein source is milk protein, which is a food protein of high nutritional value. Fat Fresubin 2 kcal / fibre DRINK contain 35% energy of fat. The fat composition of Fresubin 2 kcal / fibre DRINK is designed according to the recommendations of nutrition societies for a healthy diet, e.g. with a low n6:n3 ratio of 4.2:1. The fat sources are sunflower oil and rapeseed oil. Carbohydrates The carbohydrate sources are glucose syrup and sucrose, which account for 45 energy%. These are favourable sources of carbohydrates in enteral feeds because of their beneficial nutritional and technological features. The viscosity of the formula is only slightly increased. In sip feeds additionally sucrose favours a sweet taste. Micronutrients: Fresubin 2 kcal / fibre DRINK supply all vitamins, minerals, and trace elements. Already 400 ml Fresubin 2 kcal / fibre DRINK supply adults with the average daily requirements of all vitamins and 500 ml supply adults with the average daily requirements of all trace elements. KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

2 6.2 Declaration Fresubin 2 kcal fibre DRINK - Chocolate Average content per 100 ml: Caloric value 840 kj (= 200 kcal) Protein 10 g Carbohydrates 22.5 g of which sugars 5.9 g lactose 0.3 g Fat 7.8 g of which saturated fatty acids 0.7 g monounsaturated fatty acids 5.8 g polyunsaturated fatty acids 1.4 g cholesterol 5 mg Fibre 1.6 g Water 70 ml Osmolarity 590 mosmol/l Osmolality 850 mosmol/kg H 2 O Minerals and trace elements: Sodium 60 mg Potassium 160 mg Chloride 60 mg Calcium 205 mg Magnesium 16 mg Phosphorus 120 mg Iron 2.5 mg Zinc 1.6 mg Copper 380 µg Manganese 0.5 mg Iodide 37.5 µg Fluoride 0.25 mg Chromium 12.5 µg Molybdenum 18.8 µg Selenium 13.5 µg KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

3 Average content per 100 ml: Vitamins: Vit. A 150 µg ß-Carotene 375 µg Vit. D µg Vit. E 3.75 mg Vit K 1 21 µg Vit. B mg Vit. B mg Niacin 3.75 mg Vit. B mg Vit. B µg Pantothenic acid 1.5 mg Biotin 9.4 µg Folic acid 62.5 µg Vit. C 18.8 mg Energy distribution: Protein 20, Fat 35, Carbohydrates 45 energy-% Product claims: - clinically free from cholesterol - clinically free from lactose - clinically free from purine - free from gluten - contains fibre - low in sodium KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

4 Fresubin 2 kcal DRINK - Fruits of the forest Fresubin 2 kcal DRINK - Vanilla Average content per 100 ml: Caloric value 840 kj (= 200 kcal) Protein 10 g Carbohydrates 22.5 g of which sugars 5.8 g lactose 0.3 g Fat 7.8 g of which saturated fatty acids 0.6 g monounsaturated fatty acids 5.8 g polyunsaturated fatty acids 1.4 g cholesterol 5 mg Fibre 0 g Water 70 ml Osmolarity 590 mosmol/l Osmolality 850 mosmol/kg H 2 O Minerals and trace elements: Sodium 60 mg Potassium 160 mg Chloride 80 mg Calcium 205 mg Magnesium 16 mg Phosphorus 120 mg Iron 2.5 mg Zinc 1.6 mg Copper 380 µg Manganese 0.5 mg Iodide 37.5 µg Fluoride 0.25 mg Chromium 12.5 µg Molybdenum 18.8 µg Selenium 13.5 µg KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

5 Average content per 100 ml: Vitamins: Vit. A 150 µg ß-Carotene 375 µg Vit. D µg Vit. E 3.75 mg Vit K 1 21 µg Vit. B mg Vit. B mg Niacin 3.75 mg Vit. B mg Vit. B µg Pantothenic acid 1.5 mg Biotin 9.4 µg Folic acid 62.5 µg Vit. C 18.8 mg Energy distribution: Protein 20, Fat 35, Carbohydrates 45 energy-% Product claims: - clinically free from cholesterol - clinically free from lactose - clinically free from purine - free from gluten - free from fibre - low in sodium KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

6 6.3 Ingredients Fresubin 2 kcal fibre DRINK- Chocolate Water, glucose syrup, milk protein, vegetable oils, sucrose, inulin (from chicory), cocoa powder (fat reduced), maltodextrin, potassium citrate, flavouring, emulsifiers (soya lecithin, E 471), sodium chloride, sodium carbonate, vit. C, stabilisers (E 460, E 466, E 407), potassium carbonate, iron pyrophosphate, magnesium oxide, niacin, zinc sulphate, pantothenic acid, manganese chloride, vit. E, copper sulphate, vit. B 2, vit. B 6, sodium fluoride, vit. B 1, ß-carotene, vit. A (with fish gelatine), folic acid, potassium iodide, chromium chloride, sodium molybdate, sodium selenite, vit. K 1, biotin, vit. D 3, vit. B 12 Fresubin 2 kcal DRINK Fruits of the forest Water, glucose syrup, milk protein, vegetable oils, sucrose, flavourings, maltodextrin, potassium citrate, emulsifiers (soya lecithin, E 471), sodium chloride, potassium carbonate, acidity regulator (E 507), sodium carbonate, vit. C, magnesium oxide, iron pyrophosphate, zinc sulphate, niacin, manganese chloride, pantothenic acid, vit. E, copper sulphate, vit. B 2, vit. B 6, sodium fluoride, vit. B 1, ß-carotene, vit. A (with fish gelatine), folic acid, chromium chloride, potassium iodide, sodium molybdate, sodium selenite,vit. K 1, biotin, vit. D 3, vit. B 12 Fresubin 2 kcal DRINK Vanilla Water, glucose syrup, milk protein, vegetable oils, sucrose, maltodextrin, flavourings, potassium citrate, emulsifiers (soya lecithin, E 471), sodium chloride, potassium carbonate, acidity regulator (E 507), sodium carbonate, vit. C, magnesium oxide, iron pyrophosphate, zinc sulphate, niacin, manganese chloride, pantothenic acid, vit. E, copper sulphate, vit. B 2, vit. B 6, sodium fluoride, vit. B 1, ß-carotene, vit. A (with fish gelatine), folic acid, chromium chloride, potassium iodide, sodium molybdate, sodium selenite, vit. K 1, biotin, vit. D 3, vit. B 12 KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

7 6.4 Detailed Nutritional Profiles For detailed Nutrient composition please see chapter Annex Scientific Rationale- Nutrient composition. 6.5 Product claims on specific nutrients Fresubin 2 kcal DRINK and Fresubin 2 kcal fibre DRINK are: Free from gluten Clinically free from purine Clinically free from lactose Clinically free from cholesterol Low in sodium Therefore Fresubin 2 kcal DRINK and Fresubin 2 kcal fibre DRINK are suitable for patients with special dietary needs for these nutrients. 6.6 Shelf Life The shelf life for Fresubin 2 kcal / fibre DRINK is 9 months. 6.7 Indications, contraindications and warnings Indications Fresenius Kabi standard oral nutritional supplements are indicated for the dietary management of patients with or at risk of malnutrition who are not able to meet their nutritional requirements with ordinary foods. The overall target population includes: Elderly patients (with poor appetite, chewing disorders, chronically degenerative diseases, after femoral shaft fracture etc.) Patients with chronic wasting diseases (cancer, HIV/AIDS etc.) Peri-operative patients Further patients with evidence-based indication for oral nutritional supplementation. KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

8 Due to the high energy and high protein concentration, Fresubin 2 kcal / fibre DRINK are particularly suitable for patients with increased energy and protein needs or fluid restriction, e.g. patients with: Renal failure requiring dialysis Liver failure and ascites Cardiovascular diseases COPD Pressure ulcers or at risk of developing it. Contraindications Fresubin 2 kcal fibre DRINK and Fresubin 2 kcal DRINK are not suitable for infants under 1 year. The nutrition requirements of infants differ in many aspects from those of children and adults because of the special characteristics of growth and development in the first months of life. Oral nutritional supplementation is not suitable when enteral nutrition in general is not permitted: Gut atonia Occlusive (mechanical) ileus Small bowel necrosis Severe organ diseases, e.g. severe liver or kidney insufficiency Congenital pathologic metabolism of nutrients contained in the supplements. Enteral nutrition can further be contraindicated depending on the severity of the following conditions: Abdominal distension and cramps Reflux, nausea, and vomiting Diarrhoea Intestinal fistulas Paralytic ileus. Important notes and warnings Fresubin 2 kcal / fibre DRINK have to be used under medical supervision. The doctor in attendance has to choose the suitable enteral product and adapt the daily dosage to the individual patient s needs. During complete nutrition in children, special attention has to be given to the protein and micronutrient status. We recommend the Frebini product range for complete nutrition in small children. KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

9 Fresubin nutrition. 2 kcal / fibre DRINK are only suitable for enteral but not for parenteral Monitoring of adequate fluid supply is mandatory. Fresubin 2 kcal / fibre DRINK contain only 70 ml water per 100 ml. The normal daily fluid requirement is about 30 to 40 ml/ kg body weight. The fluid requirements further depend on several factors, e.g. fever, sweating, hyperventilation, and extraordinary gastric and/ or renal losses. In long-term complete nutrition with Fresubin 2 kcal / fibre DRINK, sodium levels should be carefully monitored. Supplementation of sodium, potassium and magnesium might be needed. 6.8 Mode of application, dosage and storage recommendation Supplementary nutrition The recommended daily dosage for supplementary nutrition is ml of Fresubin 2 kcal / fibre DRINK, which provide kcal and g protein. Complete nutrition The recommended daily dosage of Fresubin 2 kcal / fibre DRINK for complete enteral nutrition is ml providing kcal and g protein. Application recommendation for sip feeds Sip feeds should be consumed as in between meal, about 60 minutes before a meal in order to avoid spoiling of appetite and to maintain the normal and complete food intake. Shake well before use Drink slowly Handling and storage Opened cartons may be stored in a refrigerator for up to 24 hours. Closed cartons can be stored at room temperature (20 25 C). Tips for sips Generally, sip feeds taste best if served chilled. Sip feeds could be integrated into recipes instead of milk for recipe ideas with FK sip feeds please refer to the FK recipe brochure. Fresubin 2 kcal / fibre DRINK can also be frozen and used as ice cream. Please make sure that the sides of the Tetra Brik are flapped before placing in the freezer. KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

10 6.9 FAQs 1) Are Fresubin 2 kcal / fibre DRINK suitable for vegetarians? As Fresubin 2 kcal / fibre DRINK contain milk protein, they are suitable for lactovegetarians, but not for strict vegetarians. The suitability has therefore to be decided individually. 2) Are Fresubin 2 kcal / fibre DRINK suitable for diabetics? As Fresubin 2 kcal / fibre DRINK contain glucose syrup and sucrose they should only be used if no other suitable product is available and may only be used in diabetics under strict medical supervision. 3) Are Fresubin 2 kcal / fibre DRINK suitable for children? Fresubin 2 kcal / fibre DRINK are not suitable for infants under 1 year of age. We recommend the Frebini range for complete nutrition in small children. 4) Are Fresubin 2 kcal / fibre DRINK suitable for pregnant women? Yes, if they are in need of extra calories and protein in accordance with medical advice and to be used under medical supervision. 5) Are Fresubin 2 kcal / fibre DRINK lactose free? Fresubin 2 kcal / fibre DRINK are clinically free from lactose, as they contain less than 0.3 g/100 ml product. 6) What does clinically free from lactose mean? There are no European legal regulations on quantitative claims for lactose available until now. Some countries have national regulations, which should be considered individually. For those countries where no national definition is available, the FK definition is valid: based on literature and clinical facts, a maximal intake of 6 g lactose per day is defined as clinically free from lactose. 7) Do Fresubin 2 kcal / fibre DRINK contain any fructose? As the disaccharide saccharose contained in both Fresubin 2 kcal fibre DRINK and in Fresubin 2 kcal DRINK - consists of glucose and fructose, Fresubin 2 kcal KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

11 / fibre DRINK contain fructose. Additionally, Fresubin 2 kcal fibre DRINK contains fructose coming from the inulin. 8) Are Fresubin 2 kcal / fibre DRINK free from gluten? Yes. 9) What does free from gluten mean? Foods claimed as gluten-free are permitted to contain gluten below 2 mg/100 g dry matter according to the draft revised standard of the Codex Alimentarius Commission of the United Nations and the FAO/WHO (2003). According to the Codex Alimentarius (2000) the recommended maximum daily intake of gluten in patients with celiac disease is 20 mg. As Fresubin 2 kcal/ fibre DRINK are gluten-free, there is no risk for gluten sensitive / celiac disease patients. 10) Do Fresubin 2 kcal / fibre DRINK contain any wheat or other cereals which might cause difficulties in gluten sensitive enteropathies? No. 11) Do Fresubin 2 kcal / fibre DRINK contain any cholesterol? Fresubin 2 kcal/ fibre DRINK are clinically free from cholesterol and contain 5 mg/ 100 ml. 12) Do Fresubin 2 kcal / fibre DRINK contain carrageenan? Fresubin 2 kcal DRINK Vanilla and Fruits of the forest do not contain carrageenan. Fresubin 2 kcal fibre DRINK Chocolate does contain carrageenan as stabilizer (0.6 mg/100ml). 13) Do Fresubin 2 kcal / fibre DRINK contain any preservatives? Fresubin 2 kcal / fibre DRINK do not contain any preservatives as they are UHT processed. 14) Can Fresubin 2 kcal / fibre DRINK be heated? Fresubin 2 kcal / fibre DRINK can be shortly heated up to a maximum of 70 C (Microwave: 1 minute at 700 W; heating up of the pure product on hot plate is not recommended due to caking and loss of flavour). Please note: The sip feed should not be boiled up! KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

12 15) Can Fresubin 2 kcal / fibre DRINK kept chilled? Fresubin 2 kcal / fibre DRINK can be stored at 4 C for up to 3 months. Please note: The sip feed should be adapted to room temperature before using it with the straw! 16) Can Fresubin 2 kcal / fibre DRINK be frozen? For how long could it be kept frozen? Fresubin 2 kcal / fibre DRINK can be frozen for up to 1 week. 17) Are Fresubin 2 kcal / fibre DRINK designed according to FSMP directive? Yes. Fresubin 2 kcal / fibre DRINK are conform with the FSMP directive. 18) What are the ph values of Fresubin 2 kcal / fibre DRINK? Fresubin 2 kcal DRINK Vanilla and Fruits of the forest: ph Fresubin 2 kcal fibre DRINK Chocolate: ph ) Are the flavours natural or synthetic? All flavours used for Fresubin 2 kcal / fibre DRINK are either natural or natural identical. 20) Are Fresubin 2 kcal / fibre DRINK kosher foods? Are they kosher certificated? The raw materials and processing are according to kosher demands. As Fresubin 2 kcal / fibre DRINK are new, they have not yet been released by the Rabbi (depending on the next date of his visit, the kosher certificate should be available in June 2008). 21) Are Fresubin 2 kcal / fibre DRINK free of any TSE contaminated raw materials? Yes (Certificate see Appendix). 22) Are Fresubin 2 kcal / fibre DRINK free from Genetically Modified Organisms (GMO)? Yes (Certificate see Appendix). 23) How are Fresubin 2 kcal / fibre DRINK processed? They are heat treated by UHT processing, which ensures a shelf life of 9 months for launch (December 2007). 24) What material is the tetra carton / made of? The tetra packaging is made of paper, aluminium foil and polyethylene. KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only

13 25) Can you add drugs to Fresubin 2 kcal / fibre DRINK? We do not recommend adding any drugs to Fresubin 2 kcal / fibre DRINK because there are no tests conducted concerning the stability of such a mixture. 26) Are Fresubin 2 kcal / fibre DRINK cariogenic? Oral nutrition supplements do contain cariogenic sugars like sucrose, glucose, maltose or fructose. The sugar content of the nutrition supplements therefore bears the potential risk to contribute to tooth decay. However, e.g. 400 ml of Fresubin 2 kcal/ fibre DRINK provide 1 mg fluoride which has an acknowledged protective effect against caries. Furthermore, oral nutritional supplements are mostly drunk through the attached straw so that there is not much contact to the teeth. KIC-Strategic Marketing EN - Launch Binder Fresubin 2 kcal / fibre DRINK - Oct For internal use only