Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
CHROMIC CHLORIDE (UNII: KB1PCR9DMW) (CHROMIC CATION - UNII:X1N4508KF1)
Fresenius Kabi USA, LLC
CHROMIC CHLORIDE
CHROMIC CATION 1 ug in 1 mL
PRESCRIPTION DRUG
Unapproved drug for use in drug shortage
ADDAMEL N- CHROMIUM, COPPER, IRON, MANGANESE, IODINE, FLUORINE, MOLYBDENUM, SELENIUM, AND ZINC INJECTION, SOLUTION FRESENIUS KABI USA, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- ADDAMEL N 1. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of ADDAMEL N contains: Active ingredients Quantity Chromic chloride 6 H O 5.33 µg Copper chloride 2 H O 0.34 mg Ferric chloride 6 H O 0.54 mg Manganese chloride 4 H O 99.0 µg Potassium iodide 16.6 µg Sodium fluoride 0.21 mg Sodium molybdate 2 H O 4.85 µg Sodium selenite anhydrous 6.90 µg Zinc chloride 1.36 mg The active ingredients in 1 ml of ADDAMEL N correspond to: Cr 0.02 µmol Cu 2 µmol Fe 2 µmol Mn 0.5 µmol I 0.1 µmol F 5 µmol Mo 0.02 µmol Se 0.04 µmol Zn 10 µmol The content of sodium and potassium correspond to Sodium 118 µg 5.12 µmol Potassium 3.9 µg 0.1 µmol PRODUCT PROPERTIES 2 2 2 2 2 • Osmolality: approx. 3100 mosm/kg water • pH: 2.2 2. PHARMACEUTICAL FORM Concentrate for solution for infusion 3. CLINICAL PARTICULARS 3.1 THERAPEUTIC INDICATIONS ADDAMEL N is indicated in patients as a supplement in intravenous nutrition to meet basal to moderately increased requirements of trace elements. 3.2 POSOLOGY AND METHOD OF ADMINISTRATION ADDAMEL N must not be given undiluted. The recommended daily dosage of ADDAMEL N in adult patients with basal to moderately increased requirements is 10 ml (one ampoule). For children weighing 15 kg or more, the recommended dosage is 0.1 ml ADDAMEL N/kg body weight/day. 3.3 CONTRAINDICATIONS Total biliary obstruction. 3.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE ADDAMEL N should be used with caution in patients with impaired biliary and/or renal function in whom the excretion of trace elements may be significantly decreased. ADDAMEL N should also be used with caution in patients with biochemical or clinical evidence of liver dysfunction (especially cholestasis). Đọc toàn bộ tài liệu