ZINC SULFATE INJECTION, USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ZINC (ZINC SULFATE)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

B05XA18

INN (International Name):

ZINC SULFATE

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

ZINC (ZINC SULFATE) 5MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Ethical

Product summary:

Active ingredient group (AIG) number: 0109299013; AHFS:

Authorization status:

APPROVED

Authorization date:

2022-11-25

Summary of Product characteristics

_Zinc Sulfate Injection, USP _
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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 _
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_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