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Uses
M.V.I.-12™ Pharmacy Bulk Package (Multi-Vitamin Infusion without vitamin K) is indicated for the prevention of vitamin deficiency in adults and children aged 11 years and above on warfarin anticoagulant therapy receiving parenteral nutrition.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
History
There is currently no drug history available for this drug.
Other Information
M.V.I.-12™ Pharmacy Bulk Package: A sterile product consisting of two Type 1, amber glass vials labeled Vial 1 (50 mL) and Vial 2 (50 mL). The mixed solution will provide ten single doses of 10 mL each.
* With 30% propylene glycol and 2% gentisic acid ethanolamide as stabilizers and preservatives; sodium hydroxide for pH adjustment; 1.6% polysorbate 80; 0.028% polysorbate 20; 0.002% butylated hydroxytoluene; 0.0005% butylated hydroxyanisole. ** Fat-soluble vitamins A, D, and E are water solubilized with polysorbate 80. |
|
Vial 1* |
|
Ingredient |
Amount per Unit Dose |
Fat Soluble Vitamins** |
|
Vitamin A (retinol) |
1 mg (3,300 USP units) |
Vitamin D (ergocalciferol) |
5 mcg (200 USP units) |
Vitamin E (dl-alpha-tocopheryl acetate) |
10 mg (10 USP units) |
Water Soluble Vitamins |
|
Vitamin C (ascorbic acid) |
200 mg |
Niacinamide |
40 mg |
Vitamin B2 (as riboflavin 5-phosphate sodium) |
3.6 mg |
Vitamin B1(thiamine) |
6 mg |
Vitamin B6 (pyridoxine HCl) |
6 mg |
Dexpanthenol (d-pantothenyl alcohol) |
15 mg |
* With 30% propylene glycol; and citric acid, sodium citrate, and sodium hydroxide for pH adjustment | |||
Ingredient |
Amount per Unit Dose |
||
Biotin |
60 mcg |
||
Folic acid |
600 mcg |
||
Vitamin B12 (cyanocobalamin) |
5 mcg |
“Aqueous” multivitamin formula for intravenous infusion: M.V.I.-12™ (Multi-Vitamin Infusion without vitamin K) makes available a combination of important fat-soluble and water-soluble vitamins in an aqueous solution, formulated specially for incorporation into intravenous infusions. Through special processing techniques, the liposoluble vitamins A, D, and E have been solubilized in an aqueous medium with polysorbate 80, permitting intravenous administration of these vitamins.
Sources
Multi Vitamin Infusion Manufacturers
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Hospira Worldwide, Inc.
Multi Vitamin Infusion | Hospira Worldwide, Inc.
• M.V.I.-12™ is ready for immediate intravenous use in adults and children aged 11 years and above when added to intravenous infusion fluids. Do not administer M.V.I.-12™ as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and tissue irritation. 2.1 Starting Dose, Dose Range and Route of AdministrationThe starting dose is one 10 mL daily dose added directly to an intravenous fluid. 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 MonitoringBlood 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 AdministrationThe solution must be prepared prior to intravenous administration.
• Aseptically transfer the contents of the 50 mL Vial 1 into 50 mL Vial 2. The mixed solution will provide ten 10 mL single doses. Once closure system has been compromised, withdrawal of container contents should be completed within 4 hours. Mixed solution may be stored for up to 4 hours refrigerated. Discard unused portion.
• Do not administer M.V.I.-12™ as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and tissue irritation.
• Utilizing a suitable sterile automated compounding device or dispensing pin for accuracy, aseptically transfer each 10 mL dose into a plastic or glass bottle containing at least 500 - 1000 mL intravenous total parenteral nutrition solution containing dextrose or saline. Discard unused portions. This infusion solution may be stored up to 24 hours refrigerated.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Handling of M.V.I.-12™ solution, including preparation of the Pharmacy Bulk Pack, should be restricted to a suitable work area, such as a laminar flow hood.
2.4 Drug Incompatibilities• M.V.I.-12™ (Multi-Vitamin Infusion without vitamin K) 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, and chlorothiazide sodium.
• Folic acid is unstable in the presence of calcium salts such as calcium gluconate.
• Vitamin A and thiamine in M.V.I.-12™ 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.
2.1 Starting Dose, Dose Range and Route of AdministrationThe starting dose is one 10 mL daily dose added directly to an intravenous fluid. 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.
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Hospira Worldwide, Inc.
Multi Vitamin Infusion | Hospira Worldwide, Inc.
M.V.I.–12™ is ready for immediate intravenous use in adults and children aged 11 years and above when added to intravenous infusion fluids. Do not administer M.V.I.-12™ as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and tissue irritation.
2.1 Starting Dose, Dose Range and Route of AdministrationThe starting dose is one 10 mL daily dose added directly to an intravenous fluid. Patients with multiple vitamin deficiencies or with markedly increased 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 MonitoringBlood 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 AdministrationThe solution must be prepared prior to intravenous administration.
• Remove the protective plastic cap, turn the plunger-stopper 90° and press down firmly to force liquid in the upper chamber and the center seal into the lower compartment. Gently agitate to mix solution. Disinfect the rubber stopper in the usual manner before inserting needle squarely through the center of the plunger-stopper until tip is just visible. Vial should be mixed just prior to use. Invert vial and withdraw a 10 mL dose in the usual manner.
• Do not administer M.V.I.–12™ as a direct, undiluted intravenous injection as it may cause dizziness, faintness, and possible tissue irritation.
• Aseptically transfer each sterile 10 mL dose into a plastic or glass bottle containing at least 500-1000 mL of intravenous dextrose or saline.
• Withdraw container contents without delay.
• After M.V.I.–12™ is diluted in an intravenous fluid, the resulting solution is ready for immediate use. Use the prepared solution within 4 hours after dilution.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Handling of M.V.I-12 solution should be performed in a suitable work area, such as a laminar flow hood.• M.V.I.–12™ (Multi-Vitamin Infusion without vitamin K) 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, and chlorothiazide sodium.
• Folic acid is unstable in the presence of calcium salts such as calcium gluconate.
• Vitamin A and thiamine in M.V.I.–12™ 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.The starting dose is one 10 mL daily dose added directly to an intravenous fluid. Patients with multiple vitamin deficiencies or with markedly increased 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.
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