Ország: Kanada
Nyelv: angol
Forrás: Health Canada
ZINC (ZINC SULFATE)
FRESENIUS KABI CANADA LTD
B05XA18
ZINC SULFATE
1MG
SOLUTION
ZINC (ZINC SULFATE) 1MG
INTRAVENOUS
100
Ethical
Active ingredient group (AIG) number: 0109299014; AHFS:
APPROVED
2022-11-25
_Zinc Sulfate Injection, USP _ _ _ _Page 1 of 9 _ PRODUCT MONOGRAPH ZINC SULFATE INJECTION, USP Zinc Sulfate Injection (Zn 2+ 1 mg/mL and 5 mg/mL) Electrolyte Fresenius Kabi Canada Ltd. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W0C8 Date of Initial Authorization: November 21, 2022 Submission Control Number: 262908 _Zinc Sulfate Injection, USP _ _ _ _Page 2 of 9 _ ZINC SULFATE INJECTION, USP Zinc Sulfate Injection (Zn 2+ 1 mg/mL and 5 mg/mL) Electrolyte CLINICAL PHARMACOLOGY Zinc is an essential nutritional element that is important in many enzyme systems either as a metalloenzyme or as an enzyme activator. More than 70 different zinc metalloenzymes have been characterized including carbonic anhydrase, alkaline phosphatase, alcohol dehydrogenase, procarboxypeptidase, superoxide dismutase, glyceraldehydes-3-P dehydrogenase and retinene reductase. A zinc metalloenzyme is also involved in the synthesis of RNA and DNA, making it important in the normal growth and development process. Zinc facilitates wound healing and helps maintain the senses of taste and smell and normal skin hydration. The distribution of zinc is wide and nonuniform with the highest concentrations found in the eye, prostate, kidney, liver, muscle, bones, teeth (dental enamel), hair, nails and skin. Zinc is also present in the blood with 75-88% of the total zinc of normal human blood in the red cells, 12-22% in the plasma and 3% in the leukocytes. Normal zinc levels are 8.8 mcg/mL in whole blood, 1.21 mcg/mL in plasma, 14.4 mcg/mL in erythrocytes and 1.0 mcg/mL in serum. In a study with 99 healthy young men, a mean serum zinc concentration of 102 mcg/100 mL (range 68-136) was reported. Thirty to forty percent of plasma zinc is bound to alpha 2 macroglobulin and sixty to seventy percent is loosely bound to albumin. Profound changes in zinc blood levels are seen in various disease states and under stress conditions. Subnormal plasma zinc levels have been reported in patients with malignant tumours, atherosclerosis, postalcoholic cirrhosis of the liver Olvassa el a teljes dokumentumot