Nulanza®
Intravenous oligometals, injectable solution.
| Chromic chloride hexahydrate | Chrome | 53.3 | µg |
| Copper chloride dihydrate | Copper | 1.02 | mg |
| Femic chloride hexahydrate | Iron | 5.40 | mg |
| Manganese chloride tetrahydrate | Manganese | 198 | µg |
| Potassium iodide | Iodine | 166 | µg |
| Potassium fluoride | Fluorine | 2.10 | mg |
| Sodium molybdate dihydrate | Molybdenum | 48.5 | µg |
| Anhydrous sodium selenite | Selenium | 173 | µg |
| Zinc Chloride | Zinc | 10.5 | mg |
Indications:
Intravenous trace metals are indicated to meet basal to moderately increased requirements for trace elements in intravenous nutrition.
Contraindications:
Hypersensitivity to the active ingredients or to any of the components of the product. Conditions with total biliary obstruction. Renal insufficiency. Pre-existing zinc poisoning. Disorders in which iron is used (hemochromatosis, hemosiderosis). Metabolic disorders where copper is involved (Wilson’s disease). High plasma levels of trace elements that are present in the intravenous trace metal solution. Possible manganese intoxication in patients with hepatic dysfunction, particularly cholestasis
Dosage and route of administration:
Dosage Individual trace element deficiencies should be treated selectively. Adults: The recommended daily dose of intravenous trace metals in adult patients with moderately increased basal requirements is 10 ml (one vial) per day diluted in a compatible carrier solution. The dose should be adapted in patients with kidney or liver damage, or with mild cholestasis. The addition of the intravenous trace metal solution must be carried out under hygienic conditions immediately before the infusion. After dilution, the solution for infusion should be used immediately. Method of administration: The intravenous trace metal solution should be administered as an intravenous infusion, diluted in a solution/emulsion for parenteral nutrition. It should not be administered undiluted.
Indications:
Intravenous trace metals are indicated to meet basal to moderately increased requirements for trace elements in intravenous nutrition.
Contraindications:
Hypersensitivity to the active ingredients or to any of the components of the product. Conditions with total biliary obstruction. Renal insufficiency. Pre-existing zinc poisoning. Disorders in which iron is used (hemochromatosis, hemosiderosis). Metabolic disorders where copper is involved (Wilson’s disease). High plasma levels of trace elements that are present in the intravenous trace metal solution. Possible manganese intoxication in patients with hepatic dysfunction, particularly cholestasis
Dosage and route of administration:
Dosage Individual trace element deficiencies should be treated selectively. Adults: The recommended daily dose of intravenous trace metals in adult patients with moderately increased basal requirements is 10 ml (one vial) per day diluted in a compatible carrier solution. The dose should be adapted in patients with kidney or liver damage, or with mild cholestasis. The addition of the intravenous trace metal solution must be carried out under hygienic conditions immediately before the infusion. After dilution, the solution for infusion should be used immediately. Method of administration: The intravenous trace metal solution should be administered as an intravenous infusion, diluted in a solution/emulsion for parenteral nutrition. It should not be administered undiluted.
Intravenous trace metals can only be added to medicines or nutritional solutions whose compatibility has been documented.
Because the intravenous trace metals solution is a specific additive solution (concentrate for infusion) for addition to multi-chamber bags or other parenteral nutrition mixtures, the trace elements included in the intravenous trace metals solution are established as additives in the mixtures for parenteral nutrition and are recognized as essential nutrients. Compatibility studies of intravenous trace metal solutions in mixtures for parenteral nutrition have confirmed that the solution has mixing properties that are suitable for this purpose.
Storage Recommendations:
Store at no more than 25°C
Presentation: Box with 20 vials with 10 mL.
Sanitary Registry: 326M2016 SSA, IV
