Vidalin F IV Infusion

Each vial contains: Active ingredients-

• Vitamin B 1 (as Thiamine Nitrate) BP 2.5 mg
• Vitamin B 2 (as Riboflavin Sodium Phosphate) BP 3.6 mg
• Nicotinamide BP 40 mg
• Vitamin B 6 (as Pyridoxine Hydrochloride) BP 4 mg
• Pantothenic Acid (as Dexpanthenol) BP 15 mg
• Ascorbic Acid (as Sodium Ascorbate) BP 100 mg
• Biotin BP 0.06 mg
• Folic Acid BP 0.4 mg
• Vitamin B 12 (as Cyanocobalamin) BP 0.005 mg

250 ml Glass Bottle: Each 100 ml contains: Components-

• Refined Soyabean Oil BP 20 gm
• Purified Egg Lecithin Ph. Gr. 1.2 gm
• Glycerol BP 2.25 gm

Each combipack contains-

• 1 vial of water-soluble multivitamin powder for infusion
• 1 bottle of 250 ml Fat Emulsion
• 1 disposable syringe (10 ml)
• 1 infusion set
• 1 hanger
• 1 first aid bandage &
• 1 alcohol pad.

Vidalin F IV is a sterile, lyophilized powder of water-soluble vitamins for infusion. It contains balanced amount of all the important water-soluble vitamins which act as coenzymes of vital enzymes associated with crucial physiological processes, energy metabolism, cell growth and replenishment especially in brain and nerve cells. Vitamin C acts as an antioxidant and helps in collagen formation. Intravenous administration of this combination gives prompt action. Vidalin F IV is a preparation of 20% refined soyabean oil intended to be used as an intravenous nutrient. Vidalin F IV prevents Essential Fatty Acid Deficiency (EFAD) and corrects the clinical manifestations of EFAD.

Total Parenteral nutrition: As a part of TPN, administer IV via a peripheral vein or by central venous catheter.
Vidalin F IV should comprise no more than 60% of the patient's total caloric intake, with carbohydrates and amino acids comprising the remaining 40% or more of caloric intake.

Adult: Initial infusion rate is 1ml/min for the first 15 to 30 mins. If no adverse reactions occur, the infusion rate can be increased to 2 ml/min. Do not exceed a daily dosage of 2.5 g/kg.

Children: Initial infusion rate is 0.1ml/min for the first 10 to 15 mins. If no adverse reactions occur, the infusion rate can be increased to 1g/kg in 4 hours. Do not exceed a daily dosage of 3 g/kg.

Infants: Starts at 0.5g/kg/24 hours and may be increased in relation to the infant's ability to eliminate fat. The maximum recommended dosage is 3g/kg/24 hours. The left-over contents of opened bottles should be discarded & not saved for later use. Do not use any bottles in which there appears to be separation of the emulsion.

Instructions for Use-

1. Take 10 ml emulsion from 250 ml glass bottle by syringe
2. Open the cap of 10 ml vial and inject the syringe containing 10 ml emulsion into the vial. It will make a light yellowish colored emulsion inside the vial
3. Take the emulsion from vial into syringe
4. Inject the syringe containing emulsion into the 250 ml glass bottle
5. Now give intravenously at 10 drops/ minute for the first 15 minutes and the rest at 20 drops/minute

Some drugs, like insulin, may interfere with the body's lipase system. This kind of interaction seems, however, to be of only limited clinical importance. Heparin in clinical doses cause a transient increase in lipolysis in plasma, resulting in a transient decrease in triglyceride clearance due to depletion of lipoprotein lipase. Vitamin B6 can reduce the effect of Levodopa. Folic Acid may lower the serum concentration of Phenytoin.

Fat Emulsion and Water-soluble vitamin combination is contraindicated in conditions with severely disordered fat metabolism, such as in severe liver damage and acute shock. Hypersensitivity to egg-, soya- or peanut protein or to any of active substances or excipients.

Fat Emulsion and Water-soluble vitamin combination may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence <1%). Reports of other adverse events in conjunction with 20% fat emulsion infusion are extremely rare, less than one report of certain events per one million infusions. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (tachypnoea) and circulatory effects (hypertension, hypotension) have been described. Thrombosis, haemolysis, reticulocytosis, abdominal pain, tiredness, priapism and neurological adverse reactions including headaches, flushing, dyspnoea, slight pressure over the eyes and dizziness have been reported.

Absolute safety of the fetus and the nursing infant has not been established. Therefore, Fat Emulsion and Water-soluble vitamin combination should be administered with caution during pregnancy and lactation.

Fat Emulsion and Water-soluble vitamin combination contains soya oil and egg lecithin which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut. Fat metabolism may be disturbed in conditions such as renal insufficiency, uncompensated diabetes, pancreatitis, certain forms of liver insufficiency, metabolic disorders and sepsis. Fat Emulsion and Water-soluble vitamin combination should be administered with caution as a strong correlation exists between C-reactive protein and the agglutination of Fat Emulsion and Water-soluble vitamin combination in seriously ill patients. Fat Emulsion and Water-soluble vitamin combination should be given with caution to neonates and premature infants with hyperbilirubinemia and in cases with suspected pulmonary hypertension. In low birthweight infants, the risk of lipid infusions may outweigh potential benefits due to further diminution of defenses against infection. In infants, metabolism of lipids in peripheral tissues may be diminished by infection and heparin administration. In neonates receiving long term parenteral nutrition, particularly premature neonates, platelet count, liver function tests and serum triglyceride concentration should be monitored. When Lyophilized Powder for Infusion is diluted with water-based solutions, the admixture should be protected from light. This is not necessary if lyophilized powder for infusion is diluted with intralipid because of the protective effect of the fat emulsion.

Impaired capacity to eliminate Fat Emulsion and Water-soluble vitamin combination may lead to fat overload syndrome as a result of overdosage. It may also occur at recommended rates of infusion in association with a sudden change in the clinical condition such as renal function impairment or infection. Fat overload syndrome is characterized by bone marrow depression, anemia, thrombocytopenia, hepatosplenomegaly, splenomegaly, hyperlipemia, fever, fat infiltration, focal seizures and shock. All symptoms are usually reversible if the infusion of Fat Emulsion and Water-soluble vitamin combination is discontinued. No adverse effects of an overdose of water-soluble multivitamin have been reported, with exception of cases of extremely high parenteral doses. The possibility of hypervitaminosis A and D should be considered if lyophilized powder for infusion is dissolved in another multivitamin injection.

Before reconstitution: Store at below 25°C in a dry place, protected from light. Keep out of reach of children. After reconstitution: The reconstituted Vidalin F IV solution should be added to the infusion emulsion aseptically immediately before the start of the infusion.