Properties
What is it?
Composition: Active substance: One vial contains Retinol palmitate equivalent to retinol (Vitamin A) 3500 IU Cholecalciferol (Vitamin D3) 220 IU DL-alpha-tocopherol 10.20 mg equivalent to alpha-tocopherol (Vitamin E) 11.20 IU Ascorbic acid (Vitamin C) 125 mg Cocarboxylase tetrahydrate 5.80 mg equivalent to thiamine (Vitamin B1) 3.51 mg Riboflavin sodium phosphate dihydrate 5.67 mg equivalent to riboflavin (Vitamin B2) 4.14 mg Pyridoxine hydrochloride 5.50 mg equivalent to pyridoxine (Vitamin B6) 4.53 mg Cyanocobalamin (Vitamin B12) 0.006 mg Folic acid 0.414 mg Dexpanthenol 16.15 mg equivalent to pantothenic acid 17.25 mg D-biotin 0.069 mg Nicotinamide (Vitamin PP, Niacin) 46 mg Excipients: Glycine, Glycocholic acid, Soy lecithin, Sodium hydroxide and/or Hydrochloric acid. Description Packaging: Demeton-D is a lyophilized powder for preparation of solution for injection. The product is packed in glass vials with a rubber stopper and an aluminum/plastic cap and placed in cardboard boxes, each containing 1 vial or 10 vials. Not all pack sizes may be available. Pharmacotherapeutic group: Multivitamin preparation. General information Demeton-D is a balanced combination of water- and fat-soluble vitamins, except for Vitamin K, which is necessary for the metabolism of children over 11 years of age and adults. Therapeutic indications Supply of vitamins corresponding to daily requirements for children over 11 years of age and adults requiring multivitamin supplementation parenterally, when oral nutrition is contraindicated, impossible or insufficient (e.g., malnutrition, gastrointestinal malabsorption, parenteral nutrition, etc.). Contraindications Demeton-D must not be administered in the following cases: - Hypersensitivity to the active substances, particularly Vitamin B1, or to any of the excipients listed in the composition, including soy protein/products (lecithin in the mixed micelle is derived from soy) or peanut protein/products, - Hypervitaminosis associated with any of the vitamins included in the formula. Special warnings and precautions for use Due to the presence of Vitamin A (retinol), the daily recommended dose of Demeton-D requires adjustment in case of concomitant use with other preparations containing Vitamin A. Demeton-D does not contain Vitamin K, however, if necessary, Vitamin K can be administered separately. In patients with progressive inflammatory enterocolitis receiving intravenous administration of the preparation, a moderate increase in SGPT transaminases has been observed. This increase is reversible after discontinuation of treatment. Therefore, monitoring of transaminase levels is necessary in these cases. Due to the presence of glycocholic acid, in patients with jaundice or severe cholestasis, after repeated and prolonged treatment with Demeton-D, liver function monitoring is necessary. Fertility, pregnancy and lactation Before prescribing Demeton-D, the physician must carefully consider the potential risks and benefits for each specific patient. Safety data for Demeton-D in pregnant or breastfeeding women are not available. If necessary, the drug may be prescribed during pregnancy provided that indications and doses are respected, to avoid vitamin overdose. Use during breastfeeding is not recommended due to the risk of vitamin A overdose in the newborn. Regarding fertility, there is no adequate data on the use of Demeton-D in male or female patients. Children Demeton-D is contraindicated in children under 11 years of age. Elderly No special precautions are necessary regarding the elderly. Effects on ability to drive and use machines There is no information on the effect of Demeton-D on the ability to drive or operate heavy machinery. Precautions regarding excipients This preparation contains less than 1 mmol of sodium (23 mg) per vial, i.e., it is essentially "sodium-free". Interactions with other medicinal products and other forms of interaction Interactions between specific vitamins contained in Demeton-D and other agents should be managed accordingly. Such interactions include: alcohol, anticonvulsants, antithrombotic agents, aspirin, certain anticonvulsants (e.g., phenytoin, carbamazepine, phenobarbital, valproate), certain antiretroviral agents, chloramphenicol, deferoxamine, ethionamide, fluoropyrimidines, folate antagonists, folate antimetabolites, levodopa. Dosage and method of administration Dosage Adults and children over 11 years of age: 1 vial/day. Method of administration Intravenous: By slow intravenous injection (over at least 10 minutes) or infusion in 5% glucose or 0.9% sodium chloride infusion solution. Demeton-D can be incorporated into nutritional mixtures combining carbohydrates, lipids, amino acids, and electrolytes, provided that compatibility and stability are confirmed for each nutritional mixture, to meet nutritional needs and avoid deficiencies and complications. The total amount of vitamins received from all sources, such as food sources, other vitamin supplements or medications containing vitamins as inactive ingredients, should be taken into account. Monitoring of the patient's clinical status and vitamin levels is required to maintain adequate levels. It should be noted that some vitamins, particularly A, B2, and B6, are sensitive to ultraviolet light (e.g., direct or indirect sunlight). In addition, losses of vitamins A, B1, C, and E may increase with high oxygen content in the solution. These factors should be taken into account if adequate vitamin levels are not achieved. Intramuscular administration: The lyophilized content of the vial is dissolved in 2.5 ml of solvent (water for injection). Overdose Acute or chronic overdose of vitamins (particularly A, B6, D, and E) can lead to symptomatic hypervitaminosis. The risk of overdose is particularly high if the patient receives vitamins from multiple sources and the total vitamin supplement does not correspond to the patient's individual requirements, as well as in patients with increased sensitivity to hypervitaminosis. Treatment of vitamin overdose usually involves withdrawal of the vitamin and other measures, according to clinical indications. Side effects Adverse drug reactions (ADRs) developed after administration of Demeton-D are presented by their relative frequency; this includes side effects observed in clinical trials and in the post-marketing period. Demeton-D was used in 3 clinical trials in 267 adult patients requiring parenteral vitamin supplementation. The frequency of side effects is presented as follows: very common (≥1/10); common (≥1/100; <1/10); uncommon (≥1/1000; <1/100); rare (≥1/10000; <1/1000); very rare (<1/10000); and unknown (cannot be estimated from available data). Missed dose is not described. Expiry date is indicated on the label and the cardboard box. The preparation must not be taken after the expiry date. Dispensing regime Pharmaceutical product group II, dispensed with prescription form No. 3. Special storage conditions The preparation should be stored out of reach of children. Store below 25ºC, protected from light and moisture. Pharmaceutical form Powder for preparation of solution for injection. Marketing authorization holder – manufacturer Demo S.A. Pharmaceutical Industry, Athens-Lamia National Road 21st km, 145 68 Kryoneri, Attica, Greece, Tel.: +30 (210) 81 61 802, Fax: +30 (210) 81 61 587