Vidalin F is a nutritional source of calories, essential fatty acids, and water-soluble vitamins intended for patients who require prolonged parenteral nutrition, usually for more than five days. It is used as part of intravenous nutritional therapy in conditions including:

• Preoperative and postoperative nutritional deficiencies where improved nitrogen balance is necessary
• Nutritional disorders or nitrogen imbalance caused by inadequate or impaired intestinal absorption due to gastrointestinal tumors, acute or chronic intestinal diseases such as peritonitis, ulcerative colitis, and terminal ileitis
• Burns requiring replacement of excessive nitrogen loss; prolonged unconsciousness following cranial trauma or poisoning where enteral feeding is unsuitable or impossible
• Impaired renal function where a concentrated energy source is needed to minimize protein breakdown
• Cachexia and essential fatty acid deficiency in patients unable to maintain or restore a normal fatty acid balance through oral intake
• Use medicines according to the advice of a registered physician.

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

Each vial contains active ingredients:

• Vitamin B1 (as Thiamine Nitrate) BP 2.5 mg
• Vitamin B2 (as Riboflavin Sodium Phosphate) BP 3.6 mg
• Nicotinamide BP 40 mg
• Vitamin B6 (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 B12 (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

Vidalin F IV is a sterile lyophilized preparation of water-soluble vitamins intended for infusion. It contains balanced amounts of essential water-soluble vitamins that function as coenzymes for important enzymatic reactions associated with vital physiological functions, energy metabolism, cellular growth, and tissue replenishment, particularly in brain and nerve cells. Vitamin C acts as an antioxidant and supports collagen synthesis. Intravenous administration of this combination provides rapid therapeutic action. Vidalin F IV also contains a 20% refined soybean oil fat emulsion designed for intravenous nutritional support. It helps prevent Essential Fatty Acid Deficiency (EFAD) and corrects the clinical manifestations associated with 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.

Administration

Instructions for Use-

• Take 10 ml emulsion from 250 ml glass bottle by syringe
• 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
• Take the emulsion from vial into syringe
• Inject the syringe containing emulsion into the 250 ml glass bottle
• Now give intravenously at 10 drops/ minute for the first 15 minutes and the rest at 20 drops/minute

Certain medicines, such as insulin, may interfere with the body's lipase activity. However, these interactions are generally considered to have limited clinical significance. Clinical doses of heparin may temporarily increase plasma lipolysis, causing a short-term reduction in triglyceride clearance due to depletion of lipoprotein lipase. Vitamin B6 may reduce the therapeutic effect of levodopa. Folic acid may decrease the serum concentration of phenytoin.

Fat Emulsion and Water-soluble vitamin combination is contraindicated in patients with severely impaired fat metabolism, such as those with severe liver damage or acute shock. It is also contraindicated in individuals with hypersensitivity to egg, soyabean, peanut protein, or any active ingredient or excipient present in the preparation.

Fat Emulsion and Water-soluble vitamin combination may occasionally increase body temperature (incidence <3%) and, less commonly, may cause shivering, chills, nausea, or vomiting (incidence <1%). Other adverse reactions associated with 20% fat emulsion infusion are extremely uncommon, with reported rates below one event per million infusions. Reported hypersensitivity reactions include anaphylactic reactions, skin rash, urticaria, respiratory symptoms such as tachypnoea, and circulatory effects including hypertension or hypotension. Thrombosis, haemolysis, reticulocytosis, abdominal pain, fatigue, priapism, and neurological symptoms including headache, flushing, dyspnoea, mild pressure over the eyes, and dizziness have also been reported.

The absolute safety of this preparation for the fetus and nursing infant has not yet been established. Therefore, Fat Emulsion and Water-soluble vitamin combination should be used cautiously during pregnancy and lactation.

Fat Emulsion and Water-soluble vitamin combination contains soybean oil and egg lecithin, which may rarely trigger allergic reactions. Cross-reactivity between soybean and peanut has also been reported. Fat metabolism may be impaired in conditions such as renal insufficiency, uncontrolled diabetes, pancreatitis, certain liver disorders, metabolic disorders, and sepsis. This preparation should be administered cautiously when there is a strong correlation between elevated C-reactive protein levels and agglutination of the emulsion in critically ill patients. Fat Emulsion and Water-soluble vitamin combination should be administered carefully in neonates and premature infants with hyperbilirubinemia or suspected pulmonary hypertension. In low birth weight infants, the risks associated with lipid infusion may outweigh its benefits due to reduced resistance to infection. Infections and heparin administration may reduce lipid metabolism in peripheral tissues. In neonates receiving long-term parenteral nutrition, especially premature infants, platelet count, liver function tests, and serum triglyceride levels should be monitored regularly. When lyophilized powder for infusion is diluted with water-based solutions, the admixture should be protected from light. This precaution is unnecessary when diluted with intralipid because the fat emulsion provides protective effects.

Reduced ability to eliminate Fat Emulsion and Water-soluble vitamin combination may result in fat overload syndrome due to overdose. Overdose may also occur if the recommended infusion rate is exceeded in association with sudden changes in the patient’s condition, such as impaired renal function or infection. Fat overload syndrome may present with bone marrow suppression, anemia, thrombocytopenia, hepatosplenomegaly, splenomegaly, hyperlipemia, fat infiltration, focal seizures, and shock. These symptoms are generally reversible after discontinuation of the infusion. No adverse effects related to overdose of water-soluble multivitamins have been reported except in cases of extremely high parenteral doses. The possibility of hypervitaminosis A and D should be considered if lyophilized powder for infusion is mixed with another multivitamin injection.

Specific combined vitamin preparations

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