Multi-12/K₁ Pediatric Multiple Vitamins for Infusion

/ Teva

Multi-12/K1 Pediatric should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation. Multi-12/K1 Pediatric must be diluted prior to intravenous infusion.
For administration to infants and children weighing ≥ 3 kg up to 11 years of age: Add one daily dose [the entire contents of Vial 1 (4 mL) and of Vial 2 (1 mL)] to not less than 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
For administration to infants weighing ≥ 1500 g and < 3 kg: The daily dose is 65% of the contents of Vial 1 and Vial 2, added to not less than 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
For administration to infants weighing < 1500 g: The daily dose is 30% of the contents of Vial 1 and Vial 2, added to not less than 100 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
After Multi-12/K1 Pediatric is diluted in an intravenous infusion, the resulting solution should be refrigerated unless it is to be administered immediately, and in any event should be administered within 24 hours. Discard any unused portions.
Some of the vitamins in this product, particularly vitamins A, D, and riboflavin, are light-sensitive. Exposure to light should be minimized.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.

Multi-12/K1 Pediatric is indicated for use as a multiple vitamin supplement for infants and children up to 11 years of age.
Its administration helps to maintain plasma vitamin levels and helps to prevent depletion of endogenous stores of the vitamins and development of subsequent deficiency symptoms.
It is also indicated in other situations where there are increased requirements for vitamins due to stress situations such as surgery, extensive burns, fractures and other trauma, severe infectious diseases, and comatose states.
The physician should not await the development of clinical signs of vitamin deficiency before initiating vitamin therapy. The use of a multivitamin product obviates the need to speculate on the status of individual vitamin nutriture.
Multi-12/K1 Pediatric, through the intake of these necessary vitamins, contributes towards the maintenance of the body’s normal resistance and repair processes.

Known hypersensitivity to any of the vitamins in this product or a pre-existing hypervitaminosis.

Unlike the adult formulation, this product contains Vitamin K1. Caution should be used when administering Multi-12/K1 Pediatric to neonates undergoing concomitant parenteral therapy with drugs containing polysorbate 80. If deemed necessary, to limit the concomitant administration of polysorbate 80, discontinue Multi-12/K1 Pediatric therapy for a few days and resume it when the other drug therapy has been ceased.

There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine. The risk, however, is negligible if thiamine is co-administered with other B vitamins. There have been no reports of fatal anaphylactoid reactions associated with pediatric multivitamin preparations.
There have been rare reports of the following types of reactions:
Dermatologic: rash, erythema, pruritus.
CNS: headache, dizziness, agitation, anxiety.
Ophthalmic: diplopia.
Allergic: urticaria, periorbital and digital edema.

Multi-12/K1 Pediatric is not physically compatible with acetazolamide, aminophylline, ampicillin, or moderately alkaline solutions. It has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate.