Proviten IV(Vitamin A, Vitamin-B complex, Vitamin-C , Vitamin-D and Vitamin E)

Therapeutic Group: Vitamins and Minerals

Presentation

Proviten IV for injection/infusion: Proviten IV is a lyophilized, sterile powder for injection/infusion which contains both water soluble and fat soluble vitamins.

Each vial of Proviten IV contains:

Vitamin A 3500 IU

Vitamin D3 220 IU

Vitamin E 11.20 mg

Vitamin C 125 mg

Vitamin B1 3.51 mg

Vitamin B2 4.14 mg

Vitamin B6 4.53 mg

Vitamin B12 0.006 mg

Folic acid 0.414 mg

Pantothenic acid 17.25 mg

Biotin 0.069 mg

Nicotinamide 46 mg

Description

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

Indications

Proviten IV is indicated as a daily multivitamin maintenance dosage for adults and children aged 11 years and above 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.

Dosage & Administration

Adults and children aged 11 years and above: 1 vial/day

Administration procedure:
The single dose vial of Proviten IV is reconstituted by adding 5ml of sterile Water for injection or other intravenous fluids like 0.9% Sodium Chloride injection or 5% Glucose injection. 5 ml of diluent should be added by means of sterile syringe into the vial and gently mixed to dissolve the lyophilized powder. The entire volume of the resultant solution should then be administered by slow Intravenous injection (at least over 10 minutes) or further diluted for intravenous infusion. To minimize vitamin losses in parenteral nutrition admixtures, add the vitamins immediately prior to administration and complete administration within 24 hours.

Side Effects

Anaphylactic reactions have been reported following large intravenous doses of Thiamine. Urticaria and rash have also been associated with this preparation. There have been very rare reports of anaphylactic reactions following IV injection/infusion with this preparation over 1-4 minutes.

Precautions

Anaphylactic reactions may occur in allergic subjects who are susceptible to Thiamine (Vitamin B1) and nicotinamide components of this product. Mild allergic reactions such as sneezing or mild asthma are warning signs that further injection/infusion may give rise to anaphylactic shock. Due to glychocolic acid content, repeated and prolonged administration in patients with jaundice of hepatic origin or severe biochemical evidence of cholestatis requires careful monitoring of liver function. Also in the case of impaired kidney function, fat-soluble vitamin levels should be carefully monitored.

Use in Pregnancy & Lactation

The use of this preparation has not been studied in human during pregnancy. Proviten IV should be given to a pregnant woman only if clearly needed. The use of this product in lactating women is not recommended.

Drug Interaction

Patients receiving drugs that bind to a1-acid glycoprotein should be closely monitored for increases in response to these drugs, e.g. propranolol, prazosin and quinidine. Folic acid may increase the metabolism of some antiepileptics, such as phenobartbitol, phenytoin and primidone. Pyridoxine can reduce the effect of levo-dopa. Bleomycin can be inactivated by ascorbic acid and riboflavin.

Over Dose

Accumulation of Vitamin A and Vitamin D may be occured with prolonged administration of high doses.

Storage

Before reconstitution: Store below 25°C. Protect from light and do not freeze.
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.

Commercial Pack

Proviten IV for injection/infusion: Each box contains one vial of multivitamin, one 5 ml sterile disposable syringe, one bottle of 100 ml normal saline, one infusion set, Hanger, First aid band and Alcohol pad.