MICRO+6 REGULAR

1 Dosing Considerations Routine monitoring of zinc, copper, manganese, chromium, selenium and iodine plasma levels is suggested as a guideline for administration. For iodine, routine monitoring of thyroid function is also indicated.

Zinc Normal plasma levels vary from approximately 68 to 136 mcg per 100 mL. Frequently monitor the blood zinc levels for those patients receiving more than the usual maintenance dosage level of zinc. Copper While the normal adult plasma levels range from 90 to 130 mcg/100 mL, the normal full- term newborn’s serum levels are about one-third of this.

These values were found to rise gradually during the first week of life, fall to below adult levels at two months of age, rise to within the adult range at three months of age, and to rise still higher above the adult range at eight months of age, at which levels the values persisted throughout the MICRO+ 6 REGULAR (6 Trace Elements Injection) Page 4 of 26 Unclassified / Non classifié remainder of infancy.

Manganese Manganese is bound in both the serum and the erythrocytes. Normal human blood values have been recognized as 6 to 10 mcg/mL. Chromium Changes in serum chromium following glucose loading or insulin injection should be regarded with caution as indicators of chromium status.

Serum levels of 1 to 31 ng/mL have been reported. 75 mcg chromium/g of hair in nulliparous women reported. Selenium The range for selenium blood levels has been reported as 78 to 157 ng/mL of plasma, and 70 to 229 ng/mL of whole blood.

60 mcg/100 mL. Thyroid function is a more realistic indicator of iodine requirements, with the protein-bound iodine (PBI) or butanol extractable iodine (BEI) of the serum corresponding reasonably well with the level of thyroid activity; limits of normality have been placed at 3-8 mcg/100 mL of serum.

5 to 5 mg of zinc per day. For acute catabolic states an additional 2 mg of zinc per day is suggested. 1 mg of zinc per kg of stool or ileostomy output is recommended. Pediatrics (≤ 18 years of age) For full-term infants, 50 to 250 mcg zinc/kg/day is recommended.

For infants, 50 mcg zinc/kg/day is recommended. For premature infants weighing up to 3 kg in body weight, 400 mcg zinc/kg/day is recommended. 5 mg copper per day. Pediatrics (≤ 18 years of age) For premature infants weighing up to 3 kg in body weight, full-term infants and infants, the suggested dosage level is 20 mcg copper per kg daily.

MICRO+ 6 REGULAR (6 Trace Elements Injection) Page 11 of 26 Unclassified / Non classifié No adverse reactions have been reported for the amount of zinc, copper, manganese, chromium or selenium present in this product. The amounts are small and toxicity symptoms are not likely to occur at the suggested dosage level.

However, adverse reactions have been reported for iodine. Iodine and iodides can produce goitre and hypothyroidism as well as hyperthyroidism. Goiter and hypothyroidism have also occurred in infants born to mothers who had taken iodides during pregnancy.

Iodine can give rise to allergic reactions which may include urticaria, angioedema, cutaneous hæmorrhage or purpuras, fever, arthralgia, lymphadenopathy, and eosinophilia. Prolonged administration may lead to iodism, although some of the effects could be considered to be due to hypersensitivity.

These include adverse effects on the mouth such as metallic taste, increased salivation, burning or pain, and coryza; there may be swelling and inflammation of the throat. Eyes may be irritated and swollen. Pulmonary œdema may develop.

Skin reactions include acneform or severe eruptions (iododerma). Other reported effects include gastrointestinal upsets and diarrhea. Symptomatic treatment may be required for allergic reactions and iodism, although symptoms usually subside rapidly when administration of iodine is discontinued.

Chromium Adults For the metabolically stable adult receiving TPN, 10 to 15 mcg of chromium per day is suggested as the additive dosage level. The metabolically stable adult with intestinal fluid loss may require 20 mcg of chromium daily with frequent monitoring of blood levels as a guideline for subsequent administration.

2 mcg chromium/kg/day are recommended as the additive dosage level. Selenium Adults For the metabolically stable adult receiving TPN, the suggested additive dosage level is 60 to 100 mcg selenium per day. Pediatrics (≤ 18 years of age) For premature infants < 3kg, the suggested selenium level is 2 to 3 mcg/kg/day.

For MICRO+ 6 REGULAR (6 Trace Elements Injection) Page 6 of 26 Unclassified / Non classifié infants and children, the suggested dosage level is 2 mcg selenium per kg per day. Iodine Adults For adults who are metabolically stable, the recommended dosage level is 1 to 2 mcg iodine/kg/day.

For normal adults this would be 75-150 mcg/day. Pediatrics (≤ 18 years of age) For growing children, the recommended dosage level is 2 to 3 mcg iodine/kg/day. For premature infants < 3kg, infants and children, the recommended dosage is 1 mcg iodine/kg/day For pregnant or Lactating Women For pregnant or lactating mothers, the recommended dosage level is 2 to 3 mcg iodine/kg/day.

4 Administration Aseptic addition of MICRO+ 6 REGULAR to the amino acid or dextrose component of a TPN solution under a laminar flow hood is recommended. Micro+ 6 Regular must be diluted before use. Micro+ 6 Regular is used as an additive to parenteral admixtures in compounded bags where data are available.

9% Sodium Chloride Injection USP, 10% Dextrose Injection USP, 10% Travasol Amino Acid Injection or Intralipid 20% Injection. The vial is a single use vial. Discard unused portion of the solution. Visually inspect parenteral drug products for particulate matter, precipitate, discolouration and leakage prior to administration whenever container and solution permit.

• MICRO+ 6 REGULAR is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.