M.V.I. PEDIATRIC- ascorbic acid, retinol, ergocalciferol, thiamine hydrochloride, riboflavin 5′-phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, .alpha.-tocopherol acetate, dl-, biotin, folic acid, cyanocobalamin and phytonadione injection, powder, lyophilized, for solution
M.V.I. Pediatric is a combination of vitamins indicated for the prevention of vitamin deficiency in pediatric patients up to 11 years of age receiving parenteral nutrition.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy.
M.V.I. Pediatric is a combination product that contains the following vitamins: ascorbic acid, vitamin A, vitamin D, thiamine, riboflavin, pyridoxine, niacinamide, dexpanthenol, vitamin E, vitamin K, folic acid, biotin, and vitamin B12 [see Dosage and Administration (2.2)].
M.V.I. Pediatric is supplied as a single-dose vial of lyophilized powder for reconstitution and intended for administration by intravenous infusion after dilution.
Do not administer M.V.I. Pediatric as a direct, undiluted intravenous injection as it may cause dizziness, faintness and tissue irritation.
- The recommended daily dosage volume of 1.5 mL, 3.25 mL, or 5 mL of the reconstituted solution 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).
| Less than 1 kg||1 kg to less than 3 kg||More than or equal to 3 kg|
| Daily Dosage Volume||1.5 mL||3.25 mL||5 mL|
| Vitamin A * (retinol)||690 IU † (equals approx. 0.207 mg)||1,495 IU (equals approx. 0.449 mg)||2,300 IU (equals approx. 0.690 mg)|
| Vitamin D ‡ (ergocalciferol)||120 IU (equals 3 mcg)||280 IU (equals 7 mcg)||400 IU (equals 10 mcg)|
| Vitamin E § (dl -alpha-tocopheryl acetate)||2.1 IU (equals 2 mg)||4.6 IU (equals 5 mg)||7 IU (equals 7 mg)|
| Vitamin K1 (phytonadione)||0.1 mg||0.1 mg||0.2 mg|
| Vitamin B2 (as riboflavin 5-phosphate sodium)||0.4 mg||0.9 mg||1.4 mg|
| Vitamin C (ascorbic acid)||24 mg||52 mg||80 mg|
| Vitamin B6 (pyridoxine hydrochloride)||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 B1 (thiamine hydrochloride)||0.4 mg||0.8 mg||1.2 mg|
| Biotin||6 mcg||13 mcg||20 mcg|
| Folic acid||42 mcg||91 mcg||140 mcg|
| Vitamin B12 (cyanocobalamin)||0.3 mcg||0.7 mcg||1 mcg|
- One daily dose of the reconstituted solution (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.
- M.V.I Pediatric is to be reconstituted and diluted only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
- Reconstitue the single-dose vial of M.V.I. Pediatric by adding 5 mL of Sterile Water for Injection USP, or Dextrose Injection USP 5%, or Sodium Chloride Injection USP to the 10 mL vial.
- Swirl the vial gently after the addition of the diluent to hasten reconstitution. The reconstituted solution is ready within three minutes for use.
- Visually inspect for particulate matter and discoloration prior to administration.
- Once reconstituted, immediately withdraw the dose to be added to the appropriate intravenous fluids [see Dosage Information (2.2)] and discard any unused portion. After reconstitution, complete withdrawal of vial contents within 4 hours. The reconstituted solution may be refrigerated and stored for up to 4 hours.
- After M.V.I. 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.
- Minimize exposure to light because some of the vitamins in M.V.I.Pediatric, particularly A, D and riboflavin, are light sensitive.
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