Summary of Product Characteristics
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SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT NATROVIT Powder for Solution for Infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 750mg powder for solution for infusion (lyophilisate) contains: Equivalent to: Retinol palmitate 1.924mg Retinol (Vitamin A) 3500 IU Cholecalciferol 5.5μg Cholecalciferol (Vitamin D3) 220 IU all-rac-alpha-Tocopherol 10.20 mg α-Tocopherol (Vitamin E) 10.20mg Ascorbic acid 125 mg Ascorbic Acid (Vitamin C) 125 mg Cocarboxylase tetrahydrate 5.80 mg Thiamine (Vitamin B1) 3.51 mg Riboflavin sodium phosphate dihydrate 5.67 mg Riboflavin (Vitamin B2) 4.14 mg Pyridoxine hydrochloride 5.50 mg Pyridoxine (Vitamin B6) 4.53 mg Cyanocobalamin 6 μg Cyanocobalamin (Vitamin B12) 6 μg Folic acid 414 μg Folic Acid 414 μg Dexpanthenol 16.15 mg Pantothenic acid 17.25 mg D-Biotin 69 μg Biotin 69 μg Nicotinamide 46 mg Nicotinamide (Vitamin B3) 46 mg pH value: 5.0-6.0 Osmolality almost 1000mOsm/Kg (reconstituted solution) Excipient(s) with known effect: Soya lecithin. Sodium content: 25 mg (approximately 1.09 mmol) / vial. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for solution for infusion. Lyophilized orange to red sterile powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Supply of vitamins corresponding to the daily needs of adults and children over 11 years, provided that oral nutrition is contraindicated, or not possible and vitamin replacement as part of parenteral nutrition is required. 4.2 Posology and method of administration Posology Single and daily doses Unless otherwise prescribed, the following dosing guidelines apply: Adults and Children over 11 years: One vial per day reconstituted with Water for Injection (5 mL) or other compatible IV solutions (5 mL) as described under “method of administration”. Method and duration of administration For intravenous infusion. NATROVIT is intended exclusively for use as an additive to solutions for infusion. NATROVIT Powder for Solution for Infusion is a sterile preparation. Thus, aseptic procedure must be applied throughout the administration and reconstitution. The single dose vial of NATROVIT Powder for Solution for Infusion is reconstituted by adding 5mL of sterile Water for Injection or other intravenous fluids (0.9% Sodium Chloride Injection or 5% Glucose Injection). Five millilitres (5mL) of diluent should be added by means of sterile syringe into the vial and gently mixed to dissolve the lyophilised powder. The resultant solution should then be added to a solution for infusion (e.g. 0.9% Sodium Chloride or 5% Glucose) and administered by slow Intravenous Infusion (at least over one to two hours). NATROVIT can be added to certain solutions for infusion for parenteral nutrition containing carbohydrates, fats, amino acids and electrolytes, in order to meet nutritional requirements and to prevent symptoms of deficiency and complications. However, compatibility and stability with the respective solution must firstly be ensured. Reconstitution and addition to the solution for infusion must take place immediately prior to administration. Total vitamin intake from all sources must be considered, e.g. from foodstuffs, other vitamin preparations or from medicinal products containing vitamins as excipients (see section 4.5). To maintain adequate concentrations, the patient’s clinical status and vitamin levels must be monitored. It should be remembered that some vitamins, especially vitamins A, B2 and B6, react sensitively to ultraviolet light (direct or indirect sunlight). Furthermore, the concentration of vitamins A, B1, C and E may decrease with increasing oxygen levels in the solution. These factors must be considered if no adequate vitamin levels are achieved. The total duration of use (even after intermittent administration) must be restricted to 4 weeks, due to the lack of sufficient long-term studies. For instructions on reconstitution/dilution of the medicinal product before administration, see section 6.6. 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Hypervitaminosis involving any of the vitamins contained in NATROVIT. Suspected thiamine hypersensitivity. Patients in whom signs of thiamine intolerance have occurred must not be given NATROVIT. Known hypersensitivity to any of the other vitamins or soya proteins/soya products contained in NATROVIT (phospholipids are an excipient and are derived from soya beans). NATROVIT contains soya lecithin and is contraindicated in patients who have peanut or soya allergies. 4.4 Special warnings and precautions for use Warnings Hypersensitivity reactions Severe systemic hypersensitivity reactions have been described in connection with multivitamin, other multivitamin preparations and individual vitamins (including vitamins B1, B2, B12 and folic acid). In association with multivitamin and other parenteral vitamin preparations, reactions with fatal outcome have been reported (see section 4.8). In some cases, manifestation of a hypersensitivity reaction during intravenous multivitamin administration might be linked to the infusion rate. Therefore NATROVIT should be infused slowly. In the event of signs or symptoms of a hypersensitivity reaction, discontinue the infusion immediately. Vitamin toxicity To avoid overdose and toxicity, the patient’s clinical status and vitamin blood levels must be monitored, particularly with regard to vitamins A, D and E. This particularly applies to patients receiving additional vitamins from other sources or who are using substances that increase the risk for the onset of vitamin toxicity. Monitoring is particularly important in long-term replacement. Hypervitaminosis, vitamin A There is an increased risk for the onset of vitamin A hypervitaminosis and vitamin A toxicity (e.g. skin and bone changes, diplopia, cirrhosis), for instance, in: patients with protein malnutrition patients with impaired renal function (even without vitamin A replacement) patients with impaired hepatic function patients of short stature (e.g. children) patients on long-term treatment In patients whose hepatic vitamin A storage capacity is exhausted, acute liver disease may lead to the manifestation of vitamin A toxicity. Refeeding syndrome in patients on parenteral nutrition In severely malnourished patients, the introduction of nutrition may trigger a refeeding syndrome. This is characterised by a shift of potassium, phosphorus and magnesium into the intracellular space, whilst the patient becomes anabolic. Furthermore, thiamine deficiency and fluid retention may occur. Such complications can be prevented by careful monitoring and a slow increase in nutrient intake, whilst avoiding overfeeding. In the event of a nutrient deficiency, appropriate replacement may be indicated. Precipitates in patients on parenteral nutrition In patients on parenteral nutrition, precipitates have been observed in the pulmonary vessels. Some of these cases had a fatal outcome. Excessive addition of calcium and phosphate increases the risk for the formation of calcium phosphate precipitates. Precipitates have also been observed with solutions free from phosphate salts. Furthermore, precipitates have been found distal to the integrated filter and suspected cases of precipitate formation in the bloodstream have been reported. In addition to the solution, the infusion set and catheter should also be checked for precipitates at regular intervals. If signs of pulmonary respiratory distress occur, discontinue the infusion and arrange for a medical examination. Precautions Hepatic effects Monitoring of liver function tests is recommended during the use of NATROVIT. Particularly close monitoring is recommended in patients with hepatic jaundice or signs indicative of cholestasis. In some cases, elevation of liver function tests has been described during the use of NATROVIT; including an isolated rise in alanine aminotransferase (ALT) in patients with inflammatory bowel disease (see section 4.8). Furthermore, an increase in the concentration of bile acids has been described with NATROVIT (total and individual, including glycocholic acid). It is known that hepatobiliary disorders may occur with parenteral nutrition in some cases (even with additional vitamin replacement). These include cholestasis, steatosis, fibrosis and cirrhosis possibly resulting in hepatic insufficiency, as well as cases of cholecystitis and cholelithiasis. These diseases probably have an underlying multifactorial aetiology, which can vary from patient to patient. In the event of conspicuous laboratory findings or other signs of hepatobiliary disease, arrangements must be made for a prompt investigation by a physician experienced in hepatopathology, in order to identify potentially causative or contributing factors and to initiate therapeutic and prophylactic measures. Use in patients with impaired hepatic function Patients with impaired hepatic function may require individually tailored vitamin replacement. Particular attention should be given to the prevention of vitamin A toxicity, as the presence of hepatic disease is associated with increased susceptibility to vitamin A toxicities, especially in the presence of chronic excessive alcohol consumption (see above sections “Hypervitaminosis, vitamin A” and “Hepatic effects”). Due to the glycocholic acid content, careful monitoring of liver function is required with repeated administration or long-term administration of NATROVIT to patients with hepatic jaundice or