Each vial contains: Retinol palmitate equivalent to Retinol 3500 IU, Cholecalciferol 220 IU, DL-α-tocopherol (equivalent to α-tocopherol 11.2 IU) 10.2 mg, Ascorbic acid 125 mg, Cocarboxylase tetrahydrate 5.8 mg (equivalent to Thiamine 3.51 mg), Riboflavin sodium phosphate dihydrate 5.67 mg (equivalent to Riboflavin 4.14 mg), Pyridoxine hydrochloride 5.5 mg (equivalent to Pyridoxine 4.53 mg), Cyanocobalamin 6 μg, Folic acid 414 μg, Dexpanthenol 16.15 mg (equivalent to Pantothenic acid 17.25 mg), Biotin 69 μg, Nicotinamide 46 mg.
Pharmacology: LYOVEN is a multivitamin preparation of both water soluble and fat soluble vitamins (except vitamin K). Redresses the body's vitamin requirements which may be diminished due to various stress situations (trauma, surgery, burns, infections) which are likely to slow the healing process.
LYOVEN is indicated when the daily requirements of vitamins are required to be given to the patient by the parenteral route because oral administration is either contraindicated, impossible or insufficient (e.g., due to malnutrition, gastrointestinal malabsorption, etc.).
Adults and children over 11 years of age should receive the contents of one vial per day. First, 5 ml of water for injections, 0.9% NaCl infusion solution, or 5% dextrose infusion solution should first be added by syringe into the vial and gently mixed to dissolve the lyophilized powder. The resultant solution should then be administered by slow intravenous injection (at least 10 minutes) or by infusion in either 0.9% NaCl infusion solution or 5% dextrose infusion solution.
LYOVEN may be included in the composition of parenteral nutrition mixtures combining carbohydrates, lipids, amino acids, electrolytes and trace elements, provided that compatibility and stability have been confirmed.
Manifestation of vitamin A and vitamin D hypervitaminosis (symptomatology related to hypercalcemia) are possible in the case of prolonged administration of significant doses of these vitamins.
In patients with pre-existing hypervitaminosis or known hypersensitivity to any of the active constituent in particular patients with hypersensitivity to thiamine (vitamin B1).
Anaphylactic reactions may occur in allergic patients because of the presence of vitamin B1. Mild allergic reactions such as sneezing or mild asthma are warning signs that a further injection may give rise to anaphylactic shock.
Caution should be exercised when administering LYOVEN to patients who may be receiving vitamin A from other sources.
Following intravenous bolus injection, a moderate rise only in SGPT transaminases has been noted in some patients with active inflammatory enterocolitis. Increased levels are rapidly reversible following the interruption of administration. It is advisable to monitor transaminase levels in patient of this type. Also in the case of impaired kidney function, lipid soluble vitamin levels should be carefully monitored.
LYOVEN does not contain vitamin K. If this vitamin is required by the patient, it must be administered separately.
LYOVEN should not be given as a direct, undiluted intravenous injection as it may give rise to dizziness, faintness and possible tissue irritations.
Daily vitamin requirements must be calculated to avoid overdose and toxic effects, especially with regard to vitamins A and D in pediatric patients.
In patients for whom total parenteral will be continued for long periods of time, vitamins A, C, D and folic acid blood levels should be monitored.
Pregnancy and lactation.
It is recommended that this product should not be used in pregnancy. Since vitamins are known to be excreted in breast milk, this product should also not be used in women who are breastfeeding.
Allergic reactions have been known to occur following intravenous administration of thiamine and to other members of the B-complex present in the solution. There have been rare reports of anaphylactoid reactions following large intravenous doses of thiamine. The risk, however, is negligible if thiamine is co-administered with other B-groups vitamins. There have been rare reports of the following types of reactions:
Dermatological: rash, erythema, pruritus.
Central nervous system: headache, dizziness, agitation, anxiety.
Ophthalmic: diplopia.
Allergic: urticaria, periorbital and digital edema.
Person susceptible to the effects of nicotinamide may experience flushing, itching or burning of the skin after infusion.
The dosage of drugs known to be influenced by folic acid, for example phenytoin must be carefully monitored.
Folic acid may obscure pernicious anemia.
Pyridoxine can reduce the effect of levodopa.
It has been reported that folic acid is unstable in the presence of calcium salts such as calcium gluconate.
Some of the vitamins in LYOVEN may react with vitamin K bisulfite.
Direct addition of LYOVEN to intravenous fat emulsions is not recommended.
Incompatibilities: The efficiency of some antibiotics may be negatively influenced by multivitamin preparations. Careful aseptic addition and thorough mixing of any additives is mandatory.
Store at temperature below 25°C, protect from light.
Shelf life after reconstitution: The injection solution after reconstituted using 5 ml of water for injections, 0.9% NaCl infusion solution, or 5% dextrose infusion solution stable within 24 hours at temperature 5°C±3°C, protect from light.
The infusion solution after diluted using 500 ml of 0.9% NaCl infusion solution or 5% dextrose infusion solution stable within 24 hours at temperature 30°C±2°C, protect from light.
A11EX - Vitamin B-complex, other combinations ; Used as dietary supplements.
Lyoven powd for inj (lyo)
217 mg x 1's
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