Pediatric Infuvite Multiple Vitamins

Pediatric Infuvite Multiple Vitamins Manufacturers

• Sandoz Canada Inc
  

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  Pediatric Infuvite Multiple Vitamins | Sandoz Canada Inc

  

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  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.

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