Nutrison Advanced Diason Hehp (Food product) Instructions for Use

Marketing Authorization Holder

N.V. Nutricia, Zoetermeer (Netherlands)

Dosage Form

Nutrison Advanced Diason Hehp

Liquid mixture for special nutrition: laminated self-collapsing pouch 1000 ml

Dosage Form, Packaging, and Composition

Liquid mixture for specialized nutrition

Composition per 100 ml:

1000 ml – laminated self-collapsing pouch

Description

High-calorie mixture with dietary fibers for specialized nutrition of adults.

Products, depending on composition, contain soy Protein and/or casein.

Promotes restoration of GI tract motility.

Contains several types of soluble and insoluble dietary fibers. Insoluble fibers normalize intestinal peristalsis (prevention of diarrhea and paresis) and regulate the rate of absorption of carbohydrates, and soluble fibers provide a prebiotic effect, being a nutrient medium for normal intestinal microflora, are a source of short-chain fatty acids (local trophic effect – acceleration of regeneration and healing of the intestinal mucosa).

Products are enriched with vitamins B, C, E and trace elements (Chromium, Selenium, Copper), natural carotenoids, which provides antioxidant protection.

Composition of products is characterized by an optimal ratio of polyunsaturated fatty acids ω6:ω3, which contributes to the enhancement of antioxidant and immunomodulatory effect.

In some products the carbohydrate content is low, which improves glycemic control due to reduction of glucose level fluctuations and reduction of insulin requirement.

Does not contain gluten, cholesterol and genetically modified components

Indications

• Preoperative and Postoperative Care: For nutritional support in preparation for surgery and during the recovery phase to promote healing and prevent catabolism.
• Critical Conditions: As a primary or supplemental nutrition source for patients experiencing severe metabolic stress, including but not limited to major burns, sepsis, multiple trauma, and stroke.
• Gastrointestinal Tract Diseases: For use in patients with compromised GI function, including mucositis, enteritis of various etiologies (including radiation-induced and chemotherapy-induced), cholecystitis, pancreatitis, and intestinal fistulas.
• Partial Obstructions to Food Passage: For patients with mechanical challenges to oral intake, such as tumors and injuries of the head and neck, swallowing and chewing disorders, and strictures or obstructions in various parts of the GI tract where enteral access is possible.
• Conditions Associated with Anorexia or Reduced Intake: To address nutritional deficiencies in patients with oncological diseases, neurological diseases, mental disorders, liver diseases, cardiopulmonary insufficiency, and HIV infection in the AIDS stage.
• Nutritional Deficiency of Any Etiology: For the management of protein-energy malnutrition or specific nutrient deficiencies where enteral nutrition is indicated.
• Hyperglycemia Management: Specific formulations with a low carbohydrate profile are indicated for patients with hyperglycemia of various origins or those at significant risk of developing it, to aid in glycemic control.

Contraindications

• Hypersensitivity Reactions: Absolute contraindication in patients with a known allergy to soy proteins or cow’s milk proteins, depending on the specific product variant’s composition. A careful review of the ingredient list is mandatory prior to administration.
• Pediatric Age Restrictions: This specific product is contraindicated in children under 12 years of age due to formulation specifics not aligned with the nutritional requirements of younger children. For children aged 3 to 6 years, a product specifically designed for that age category must be used, as the immature digestive and excretory systems of young children may not adequately handle the high protein load.
• Complete Mechanical Intestinal Obstruction: Strictly contraindicated in cases of complete mechanical ileus, as enteral feeding is not feasible and can exacerbate the condition.
• Inborn Errors of Metabolism: Contraindicated in patients with galactosemia, a hereditary disorder of galactose metabolism, due to the presence of carbohydrates that may be metabolized to galactose.
• Severe Hemodynamic Instability: Use with extreme caution and under strict medical supervision in critically ill patients with compromised gut viability or severe bowel ischemia, as enteral feeding may not be tolerated.

Dosage Regimen

The dosage and administration rate must be determined individually by a physician or a qualified clinical nutritionist based on the patient’s energy and protein requirements, clinical condition, and tolerance.

Initial Administration: It is generally recommended to initiate feeding at a low rate, for example, 20-30 ml per hour via a feeding tube. The rate can be gradually increased by 20-25 ml every 8-24 hours as tolerated by the patient, until the target volume is reached. This step-wise approach helps to minimize gastrointestinal discomfort.

Target Volume Calculation: The total daily volume is calculated to meet the patient’s full or partial nutritional needs. As a guide, a standard adult requirement may range from 1500 to 2500 ml per day, providing 2250 to 3750 kcal, but this must be precisely calculated based on factors like basal metabolic rate, activity level, and disease state.

Method of Administration: This product is designed for tube feeding (nasogastric, nasojejunal, or gastrostomy/jejunostomy tubes). It is not intended for intravenous use. The administration can be continuous, cyclic, or as a bolus, depending on the patient’s clinical situation and tube placement. For continuous feeding, an infusion pump is recommended to ensure a constant and accurate delivery rate.

Hang Time and Handling: Once the pouch is opened or spiked for administration, the product should be used immediately. If not used immediately, the hang time for a ready-to-hang system should not exceed the manufacturer’s recommendation, typically up to 24 hours at room temperature, provided strict aseptic techniques are maintained. Discard any unused portion. Do not mix with other liquid or powdered formulas in the same administration set to avoid physical or chemical incompatibilities and microbial contamination. Shake the pouch gently before use.

Adverse Reactions

Gastrointestinal disturbances are the most commonly reported adverse reactions, particularly during the initial phase of feeding or with rapid advancement of the infusion rate.

These may include nausea, vomiting, abdominal distension, cramping, diarrhea, or constipation. Slowing the infusion rate or temporarily halting feeding often alleviates these symptoms. The fiber content is intended to regulate bowel function, but individual tolerance varies.

Mechanical Complications: Related to the feeding tube itself, such as tube occlusion, nasopharyngeal irritation, or sinusitis. Metabolic Complications: Close monitoring of fluid and electrolyte balance, blood glucose levels, and liver and renal function tests is essential. Complications may include hyperglycemia, dehydration, fluid overload, electrolyte imbalances, or refeeding syndrome in severely malnourished patients. Pulmonary Aspiration: A serious risk, particularly in patients with impaired gag reflex, altered consciousness, or gastroesophageal reflux. Proper tube placement verification and head-of-bed elevation during and after feeding are critical preventive measures.

Allergic Reactions: Although rare, hypersensitivity reactions can occur in susceptible individuals, manifesting as rash, urticaria, pruritus, or, in severe cases, anaphylaxis, particularly in patients with known allergies to soy or milk proteins. Discontinue use immediately if an allergic reaction is suspected.

Drug Interactions

Enteral nutrition formulas can interact with orally administered medications, primarily through binding or chelation, which can reduce the bioavailability of the drug.

Binding Interactions: The mineral content (e.g., calcium, magnesium, iron, zinc) and dietary fiber in the formula can bind to certain drugs in the GI tract, forming insoluble complexes. This is a well-known concern for fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin), tetracycline antibiotics, phenytoin, levothyroxine, and bisphosphonates. To minimize this interaction, it is recommended to administer these drugs at least 2 hours before or 4-6 hours after the administration of the enteral formula, if clinically feasible.

Altered Absorption: The fat content may affect the absorption of fat-soluble drugs (Vitamins A, D, E, K) and other lipophilic medications. Conversely, the formula’s effect on GI motility can alter the transit time of drugs, potentially affecting their absorption profile. Warfarin: The vitamin K content (7.71 mcg/100 ml) is significant and can antagonize the anticoagulant effect of warfarin. Patients on warfarin therapy require consistent vitamin K intake and frequent monitoring of INR (International Normalized Ratio). Any change in the enteral formula or its volume should be communicated to the managing physician for potential warfarin dose adjustment.

General Recommendation: When administering any medication via a feeding tube, the tube should be flushed with at least 30 ml of water before and after drug administration to prevent physical interactions and tube clogging. A thorough review of the patient’s medication profile is essential to identify and manage potential interactions.

Overdose

Overdose in the context of enteral nutrition is characterized by the administration of a volume or nutrient load that exceeds the patient’s metabolic capacity or tolerance, leading to complications rather than acute toxic poisoning.

Clinical Manifestations: Signs of overfeeding may include severe nausea and vomiting, profound diarrhea, abdominal cramping and distension, hyperglycemia, glycosuria, electrolyte shifts (particularly hypokalemia, hypophosphatemia, hypomagnesemia), fluid overload presenting as edema or congestive heart failure, and in severe cases, hepatic steatosis due to excessive carbohydrate or fat delivery.

Refeeding Syndrome: This is a critical and potentially fatal complication that can occur when nutrition is reintroduced too aggressively in severely malnourished patients. It is characterized by severe shifts in electrolytes, particularly hypophosphatemia, along with hypokalemia and hypomagnesemia, leading to cardiac, respiratory, and neurological complications. Prevention is key, involving a slow initiation of feeding with careful monitoring and aggressive electrolyte repletion.

Management: Management of overfeeding or refeeding syndrome involves immediately reducing or temporarily stopping the enteral feeding, providing supportive care, correcting fluid and electrolyte imbalances under close laboratory monitoring, and gradually reintroducing nutrition at a much slower, tolerated rate once the patient is metabolically stable.

Scope of Application

Preparation for surgery and postoperative period; critical conditions: burns, sepsis, multiple trauma, stroke; GI tract diseases: mucositis, enteritis of various etiologies, including those caused by radiation and chemotherapy, cholecystitis, pancreatitis, fistulas; partial obstacles to food passage: tumors and injuries of head and neck, swallowing and chewing disorders, strictures and obstructions of various parts of the GI tract; conditions associated with loss of appetite and/or refusal to eat: oncological diseases, neurological diseases, mental disorders, liver diseases, cardiopulmonary insufficiency, HIV infection in AIDS stage; nutritional deficiency of any etiology.

Hyperglycemia of various genesis or risk of its occurrence (for the corresponding product).

Special instructions

For improvement of glycemic control special products with low carbohydrate content should be used.

Before starting use it is necessary to consult with a specialist.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.