Nutridrinc Compact Fibre (Food product) Instructions for Use

Marketing Authorization Holder

N.V. Nutricia, Zoetermeer (Netherlands)

Dosage Form

Nutridrinc Compact Fibre

Liquid mixture for specialized nutrition: plastic bottle 125 ml

Dosage Form, Packaging, and Composition

Liquid mixture for specialized nutrition

Composition per 100 ml:

125 ml – plastic bottle

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 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 by reducing fluctuations in glucose levels and reducing the need for insulin.

Does not contain gluten, cholesterol and genetically modified components

Indications

• Pre- and Postoperative Care: For nutritional support in preparation for surgery and during the recovery phase post-surgery to support healing and prevent catabolism.
• Critical Illness and Trauma: For patients experiencing severe metabolic stress due to conditions such as major burns, sepsis, multiple trauma, and stroke to meet elevated energy and protein demands.
• Gastrointestinal Disorders: For use in managing various GI conditions including mucositis, enteritis (including radiation- or chemotherapy-induced), cholecystitis, pancreatitis, and intestinal fistulas where normal food intake is impaired.
• Partial Obstructions and Swallowing Difficulties: For patients with mechanical impediments to food passage, such as tumors or injuries of the head and neck, dysphagia, chewing disorders, and strictures or obstructions in different parts of the gastrointestinal tract.
• Conditions Leading to Reduced Oral Intake: For individuals with anorexia or refusal to eat associated with oncological diseases, neurological conditions, mental health disorders, liver disease, cardiopulmonary insufficiency, and advanced HIV/AIDS.
• Nutritional Deficiency: For the dietary management of malnutrition of any etiology where oral intake is insufficient to meet nutritional requirements.
• Glycemic Management: Specifically for patients with existing hyperglycemia or those at high risk of developing it, as the product’s composition aids in glycemic control.

Contraindications

• Hypersensitivity to Product Components: Absolute contraindication in patients with a known allergy to soy proteins or cow’s milk proteins, depending on the specific product variant used.
• Pediatric Age Restrictions: Not intended for use in children under 12 years of age unless a product specifically formulated and indicated for that pediatric age group is used. For children aged 3 to 6 years, a product designed for that age category must be used to align with their specific nutritional needs and the maturity of their digestive and excretory systems.
• Complete Mechanical Intestinal Obstruction: Contraindicated in cases of confirmed or suspected complete blockage of the intestines, as enteral feeding is not appropriate.
• Inborn Errors of Metabolism: Contraindicated in patients with galactosemia, a condition where the body cannot process galactose.

Dosage Regimen

The dosage must be determined by a physician or a qualified clinical dietitian based on the patient’s individual nutritional requirements, clinical condition, and tolerance.

For Oral Administration: The product is ready to use. Shake the bottle well before opening. It can be consumed directly from the bottle. The typical recommended intake for adults is 2 to 3 bottles (250 ml to 375 ml) per day, or as directed by a healthcare professional to meet specific caloric and protein goals. It can be used as a sole source of nutrition or as a nutritional supplement between meals.

For Tube Feeding: This product is suitable for administration via a nasogastric, nasoenteric, or gastrostomy/jejunostomy tube. Administer at room temperature. Hang time for the product should not exceed 4 hours. Follow the prescribed flow rate, typically starting slowly (e.g., 20-50 ml/hour) and gradually increasing as tolerated. Flush the feeding tube with water before and after administration to ensure patency and adequate hydration.

General Instructions: Do not use if the seal is broken or damaged. Once opened, the product should be consumed immediately, or the remainder must be refrigerated and used within 24 hours. Do not store partially consumed bottles at room temperature. Do not freeze the product.

Adverse Reactions

Gastrointestinal disturbances are the most commonly reported adverse reactions, particularly during the initial phase of feeding or if the infusion rate is increased too rapidly. These may include nausea, abdominal discomfort, bloating, diarrhea, or constipation. These symptoms often subside with a reduction in the rate or volume of administration.

In rare cases, allergic reactions may occur in susceptible individuals, manifesting as skin rash, urticaria, pruritus, or, in very rare instances, anaphylaxis. This is more likely in patients with known allergies to soy or milk proteins.

Metabolic complications, such as hyperglycemia, can occur, especially in patients with impaired glucose tolerance or diabetes. Regular monitoring of blood glucose levels is recommended during therapy. Other potential metabolic issues include fluid and electrolyte imbalances, which necessitate clinical monitoring.

As with any enteral feeding, there is a risk of aspiration, particularly in patients with impaired gag reflex or who are bedridden. Proper positioning during and after feeding is essential to minimize this risk.

Drug Interactions

Enteral nutrition can affect the bioavailability of certain orally administered drugs. The high protein, mineral, and fiber content may bind to some medications, reducing their absorption. To minimize interactions, it is generally recommended to administer medications 1 to 2 hours before or after the enteral feed, whenever possible.

Warfarin (Anticoagulant): The vitamin K content (13 mcg per 100 ml) in this product may antagonize the effect of warfarin. Patients on warfarin therapy require close monitoring of prothrombin time (INR), and vitamin K intake should be kept consistent.

Levothyroxine: Administration with enteral nutrition, particularly those containing calcium and iron, can significantly reduce the absorption of levothyroxine. A gap of at least 4 hours is recommended between administering levothyroxine and the feed.

Fluoroquinolone and Tetracycline Antibiotics: Divalent and trivalent cations (such as calcium, magnesium, aluminum, and iron) present in the formula can form insoluble complexes with these antibiotics, drastically reducing their absorption. Administer these antibiotics at least 2 hours before or 4 hours after the feed.

Phenytoin: Concurrent administration with enteral nutrition can reduce the absorption of phenytoin, leading to subtherapeutic serum levels. It is advised to hold tube feeding for 1-2 hours before and after phenytoin administration and to monitor serum levels closely.

Overdose

Overdose in the context of specialized nutritional support typically manifests as complications of overfeeding or excessive intake of specific nutrients.

Hyperglycemia is a primary concern with excessive carbohydrate intake, presenting with symptoms such as increased thirst, frequent urination, headache, and fatigue. Management involves reducing the feeding rate, administering insulin if prescribed, and frequent blood glucose monitoring.

Fluid Overload may occur if the volume administered exceeds the patient’s cardiac or renal capacity, potentially leading to edema, hypertension, or congestive heart failure. Signs include sudden weight gain, swelling, and shortness of breath. Management requires adjustment of the feeding volume and diuretic therapy under medical supervision.

Refeeding Syndrome is a serious and potentially fatal condition that can occur when nutrition is reintroduced too aggressively in severely malnourished patients. It is characterized by shifts in electrolytes (especially phosphate, potassium, and magnesium), fluid balance, and vitamin deficiencies. To prevent this, initiate feeding slowly and monitor electrolytes closely during the first week of therapy.

Vitamin and Mineral Toxicity is unlikely from oral or enteral use of this product alone but could occur if combined with high-dose supplements. Symptoms depend on the specific nutrient in excess. In case of suspected overdose, discontinue the product and seek immediate medical attention for supportive and symptomatic treatment.

Scope of Application

Preparation for surgery and postoperative period; critical conditions: burns, sepsis, multiple trauma, stroke; GI diseases: mucositis, enteritis of various etiologies, including those caused by radiation and chemotherapy, cholecystitis, pancreatitis, fistulas; partial obstructions to food passage: tumors and injuries of the 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 the AIDS stage; nutritional deficiency of any etiology.

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

Contraindications

Allergy to soy proteins or cow’s milk proteins (depending on the product used); age under 12 years (depending on the product used); complete mechanical intestinal obstruction; galactosemia.

In the age from 3 to 6 years, use the product intended for this age category, taking into account age-related needs and tolerance (the digestive and excretory systems of young children are not mature enough to adequately cope with the increased amount of protein).

Special instructions

To improve glycemic control, special products with low carbohydrate content should be used.

Before starting use, consult 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.