Proviten JR N/A

INDICATIONS

This IV is indicated as a daily multivitamin maintenance dosage for infants and children aged up to 11 years receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures ... Read moreThis IV is indicated as a daily multivitamin maintenance dosage for infants and children aged up to 11 years receiving parenteral nutrition. It is also indicated in other situations where administration by the intravenous route is required. Such situations include surgery, extensive burns, fractures and other trauma, severe infectious diseases and comatose states, which may provoke a stress situation with profound alterations in the body's metabolic demands and consequent tissue depletion of nutrients.

PHARMACOLOGY

This IV is a sterile, lyophilized powder/cake for infusion which contains nine water-soluble and four fat soluble vitamins. Mixed micelles is used as a solubilizing agent. It is presented as a lyophilized, orange-yellow, sterile powder cake that is to be reconstituted with 5 ml of Water for injections or other parenteral fluids, (e.g. as 0.9% Sodium chloride or 5% Dextrose solution), prior to administration by parenteral route.

DOSAGE

Infants weighing less than 1 kg: The daily dose is 30% (1.5 ml) of a single full dose (5 ml). Do not exceed this daily dose.Infants weighing 1 to 3 kg: The daily dose is 65% (3.25 ml) of a single full dose (5 ml). A supplemental Vitamin A may be required for low birth weight infants.Infants and children weighing 3 kg or more up to 11 years of age: The daily dose is 5 ml.

INTERACTION

This IV is not physically compatible with alkaline solutions or moderately alkaline drugs such as Acetazolamide, Chlorothiazide sodium, Aminophylline, sodium bicarbonate, Tetracycline HCl. It has also been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate. Direct addition of This IV to intravenous fat emulsions is not recommended. Thiamine, riboflavin, pyridoxine, niacinamide, and ascorbic acid have been reported to decrease the antibiotic activity of erythromycin, doxycycline and lincomycin. Folic acid may lower the serum concentration of phenytoin resulting in increased seizure frequency. Folic acid may decrease the patient's response to methotrexate therapy.

SIDE EFFECTS

There have been rare reports of anaphylactic reactions following parenteral multivitamin administration. Rare reports of anaphylactic reactions have also been reported after large intravenous doses of thiamine. The risk is negligible if thiamine is co-administered with other vitamins in the B group. There have been rare reports of the following types of reactions:- rash, erythema, pruritus, headache, dizziness, agitation, anxiety, diplopia, urticaria, shortness of breath, wheezing, and angioedema.

PREGNANCY & LACTATION

Not recommended

PRECAUTIONS & WARNINGS

Caution should be exercised when administering this multivitamin formulation to patients on warfarin sodium-type anticoagulant therapy as it contains Vitamin K. Larger doses or supplementation with oral or parenteral vitamin E are not recommended because elevated blood levels of vitamin E may result. Additional vitamin A supplementation may be required, especially in low birth weight infants. Polysorbates have been associated with the E-Ferol syndrome (thrombocytopenia, renal dysfunction, hepatomegaly, cholestasis, ascites, hypotension, and metabolic acidosis) in low birth weight infants. This product contains aluminum. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature.

THERAPEUTIC CLASS

Multi-vitamin & Multi-mineral combined preparations

STORAGE CONDITIONS

Before reconstitution: Keep in a cool and dry place away from light. After reconstitution: The reconstituted product should be used immediately or it should be stored at 2°C to 8°C for no more than 24 hours. Discard any unused portion of the reconstituted solution.