Sandoz Canada Inc

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Sandoz Canada Inc Drugs

Adult Infuvite Multiple...

Adult Infuvite Multiple Vitamins For Infusion

INFUVITE ADULT is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids.

INFUVITE ADULT should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

For intravenous feeding, one daily dose of INFUVITE ADULT (5 mL of Vial 1 plus 5 mL of Vial 2) added directly to not less than 500 mL, and preferably 1,000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

After INFUVITE ADULT is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution. Some of the vitamins in this product, particularly A, D, and riboflavin, are light sensitive, therefore, exposure to light should be minimized.
Pediatric Infuvite Mult...

Pediatric Infuvite Multiple Vitamins For Infusion

INFUVITE Pediatric is ready for immediate use in infants and children up to 11 years of age when added to intravenous infusion fluids.

INFUVITE Pediatric should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation.

A daily dose of INFUVITE Pediatric (4 mL of Vial 1 plus 1 mL of Vial 2) should be added directly to not less than 100 mL of intravenous dextrose, saline or similar infusion solutions.

For administration to infants weighing < 1 kg:

The daily dose is 30% of the contents of Vial 1 (1.2 mL) and of Vial 2 (0.3 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants.

For administration to infants weighing ≥1 kg and < 3 kg: The daily dose is 65% of the contents of Vial 1 (2.6 mL) and of Vial 2 (0.65 mL). Do not exceed this daily dose. Supplemental vitamin A may be required for low-birth-weight infants.

For administration to infants and children weighing ≥3 kg up to 11 years of age: The daily dose is the entire contents of Vial 1 (4 mL) and of Vial 2 (1 mL), unless there is clinical or laboratory evidence for increasing or decreasing the dosage.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

After INFUVITE Pediatric is diluted in an intravenous infusion, the resulting solution is ready for immediate use. Some of the vitamins in this product, particularly A, D, and riboflavin, are light sensitive, therefore, exposure to light should be minimized. DISCARD ANY UNUSED PORTION
Adult Infuvite Multiple...

Adult Infuvite Multiple Vitamins For Infusion Pharmacy Bulk

INFUVITE ADULT (PHARMACY BULK PACKAGE)is ready for immediate use in adults and children aged 11 years and older when added to intravenous infusion fluids. Do not administer INFUVITE ADULT (PHARMACY BULK PACKAGE)as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness, and possible tissue irritation.

2.1 Starting Dose, Dose Range and Route of Administration

The starting dose is one 10 mL daily dose that is prepared by transferring the content of vial 1 into the content of vial 2 to provide 10 single doses. One 10 mL dose is then added directly to the intravenous fluid [see Dosage and Administration (2.3)]. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated. Some patients do not maintain adequate levels of certain vitamins when this formulation in recommended amounts is the only source of vitamins

2.2 Monitoring

Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time.

2.3 Instructions for Intravenous Administration

The solution must be prepared prior to intravenous administration. Preparation of INFUVITE ADULT (PHARMACY BULK PACKAGE)for intravenous feeding should be done by transferring the contents of Vial 1 into the contents of Vial 2 to provide ten 10 mL single doses. One daily 10 mL dose should be added directly to not less than 500 mL, and preferably 1000 mL, of intravenous dextrose, saline or similar infusion solutions. Discard any unused portion.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

After INFUVITE ADULT (PHARMACY BULK PACKAGE) is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be used immediately. The solution should be used within 24 hours after dilution. Some of the vitamins in this product, particularly A, D and riboflavin, are light sensitive; therefore, exposure to light should be minimized. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours.

INFUVITE ADULT (PHARMACY BULK PACKAGE)is a pharmacy bulk package. It is not intended for direct infusion. Discard unused portion.

Directions for Dispensing from Pharmacy Bulk Vial

The Pharmacy Bulk Vial is intended for single puncture, multiple dispensing and for intravenous use only. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for infusion. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from Pharmacy Bulk Vial should be completed as soon as possible after initial entry.

2.4 Drug Incompatibilities

INFUVITE ADULT (PHARMACY BULK PACKAGE) is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium.

Folic acid is unstable in the presence of calcium salts such as calcium gluconate.

Vitamin A and thiamine in INFUVITE ADULT (PHARMACY BULK PACKAGE)may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfate. Patients should be monitored for vitamin A and thiamine deficiencies.

Consult appropriate references for listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.
Pediatric Infuvite Mult...

Pediatric Infuvite Multiple Vitamins

2.1 Important Dosage and Administration Instructions

INFUVITE PEDIATRIC is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K1, folic acid, biotin, and vitamin B12 [see Dosage and Administration (2.2)].

INFUVITE PEDIATRIC is supplied as a pharmacy bulk package, and consists of two pharmacy bulk vials which must be combined and diluted prior to intravenous administration [see Dosage and Administration (2.3)]. As a pharmacy bulk vial, INFUVITE PEDIATRIC is intended for dispensing of single doses to many patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Each closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. INFUVITE PEDIATRIC is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated. After combining contents of the two vials, a specified volume of INFUVITE PEDIATRIC is added to intravenous fluids prior to intravenous administration [see Dosage and Administration (2.3)]. Do not administer INFUVITE PEDIATRIC as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation.

2.2 Dosage Information

The recommended daily dosage volume of 1.5 mL, 3.25 mL, or 5 mL of the combined contents of Vials 1 and 2 is based on the patient's actual weight of less than 1 kg, 1 kg to less than 3 kg, and more than or equal to 3 kg, respectively (see Table 1). One daily dose of combined content of vials 1 and 2 (1.5 mL, 3.25 mL or 5 mL) is then added directly to the intravenous fluid [see Dosage and Administration (2.3)]. Patients with multiple vitamin deficiencies or with increased vitamin requirements may need multiple daily dosages as indicated or additional doses of individual vitamins. However, additional daily dosages in infants are not recommended [see Warnings and Precautions (5.8)]. Supplemental vitamin A may be required for low-birth weight infants.
Table 1: Recommended Weight-Based Dosage of INFUVITE PEDIATRIC
Less than 1 kg

≥ 1 kg and < 3 kg

More than or equal to 3 kg

Daily Dosage Volume

1.5 mL

3.25 mL

5 mL

Ascorbic acid (Vitamin C)

24 mg

52 mg

80 mg

Vitamin A (as palmitate)

690 IU (equals 0.2 mg)

1495 IU (equals 0.5 mg)

2,300 IU (equals 0.7 mg)

Vitamin D3 (cholecalciferol)

120 IU (equals 3 mcg)

260 IU (equals 7 mcg)

400 IU (equals 10 mcg)

Thiamine (Vitamin B1) (as the hydrochloride)

0.4 mg

0.8 mg

1.2 mg

Riboflavin (Vitamin B2) (as riboflavin 5-phosphate sodium)

0.4 mg

0.9 mg

1.4 mg

Pyridoxine HCl (Vitamin B6)

0.3 mg

0.7 mg

1 mg

Niacinamide

5.1 mg

11.1 mg

17 mg

Dexpanthenol (as d-pantothenyl alcohol)

1.5 mg

3.3 mg

5 mg

Vitamin E (dl-α-tocopheryl acetate)

2.1 IU (equals 2 mg)

4.6 IU (equals 5 mg)

7 IU (equals 7 mg)

Vitamin K1

0.1 mg

0.1 mg

0.2 mg

Folic acid

42 mcg

91 mcg

140 mcg

Biotin

6 mcg

13 mcg

20 mcg

Vitamin B12 (cyanocobalamin)

0.3 mcg

0.7 mcg

1 mcg

2.3 Preparation and Administration Instructions
INFUVITE PEDIATRIC is supplied as a pharmacy bulk package. It consists of two pharmacy bulk vials that must be combined and diluted prior to intravenous administration. (a) Transfer the contents of Vial 2 (10 mL of solution) into the contents of Vial 1 (40 mL of solution). The mixed solution (50 mL) will provide thirty-three 1.5 mL single doses, fifteen 3.25 mL single doses or ten 5 mL single doses. (b) Add one dose directly to at least 100 mL of intravenous dextrose or saline solution for each patient. INFUVITE PEDIATRIC must be diluted in an intravenous infusion; it is not intended for direct infusion. (c) Visually inspect for particulate matter and discoloration prior to administration. (d) After puncture, complete dispensing from the pharmacy bulk vial should be completed within 4 hours. (e) After INFUVITE PEDIATRIC is diluted in an intravenous infusion, refrigerate the resulting solution unless it is to be used immediately, and use the solution within 24 hours after dilution. (f) Minimize exposure to light because some of the vitamins in INFUVITE PEDIATRIC, particularly A, D and riboflavin, are light sensitive. (g) Discard unused portion.
2.4 Monitoring Vitamin Blood Levels

Blood vitamin concentrations should be monitored to ensure maintenance of adequate levels, particularly in patients receiving parenteral multivitamins as the only source of vitamins for long periods of time.

2.5 Drug Incompatibilities
• INFUVITE PEDIATRIC is not physically compatible with moderately alkaline solutions such as a sodium bicarbonate solution and other alkaline drugs such as acetazolamide sodium, aminophylline, ampicillin sodium, tetracycline HCl and chlorothiazide sodium. • Folic acid is unstable in the presence of calcium salts such as calcium gluconate. • Vitamin A and thiamine in INFUVITE PEDIATRIC may react with bisulfite solutions such as sodium bisulfite or vitamin K bisulfate. • Do not add INFUVITE PEDIATRIC directly to intravenous fat emulsions. • Consult appropriate references for listings of physical and chemical compatibility of solutions and drugs with the vitamin infusion. In such circumstances, admixture or Y-site administration with vitamin solutions should be avoided.

Sandoz Canada Inc

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Sandoz Canada Inc Drugs