Proviten JR IV Injection or Infusion

This is a lyophilized, sterile powder for infusion which contains both water-soluble and fat-soluble vitamins. Each vial contains:

• Vitamin A 2300 IU
• Vitamin D3 400 IU
• Vitamin E 7 mg
• Vitamin C 80 mg
• Vitamin B1 1.2 mg
• Vitamin B2 1.4 mg
• Vitamin B6 1 mg
• Vitamin B12 0.001 mg
• Folic acid 0.14 mg
• Dexpanthenol 5 mg
• Biotin 0.02 mg
• Nicotinamide 17 mg
• Vitamin K1 0.2 mg

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.

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.

The single dose vial of This IV is reconstituted by adding 5 ml of sterile Water for injection or other intravenous fluids like 0.9% Sodium Chloride injection or 5% dextrose injection. 5 ml of diluent should be added by means of sterile syringe into the vial and gently mixed to dissolve the lyophilized powder/cake. The product will form a clear and yellow color solution after reconstitution. The reconstituted solution is ready within three minutes for immediate use. After This IV is reconstituted it should be immediately diluted into the intravenous solution. The resulting solution should be administered immediately. Some of the vitamins in this product, particularly vitamins A, D and riboflavin are light-sensitive and exposure to light should be minimized. The reconstituted This IV should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritation. For a single dose, 5 ml of reconstituted This IV should be added directly to not less than 100 ml of intravenous dextrose, saline or similar infusion solutions.

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.

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.

Not recommended

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. Proviten JR 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.

The possibility of hypervitaminosis A or D should be borne in mind. Clinical manifestations of hypervitaminosis A have been reported in patients with renal failure receiving 1.5 mg/day retinol.

Multi-vitamin & Multi-mineral combined preparations

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.