Vitalipid for children

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITALIPID FOR CHILDREN

Composition:

Active substances:

1 ml contains:

dl-α-tocopherol 0.64 mg

Retinol palmitate 135.3 mcg
(corresponds to retinol) 69 mcg

Phytomenadione 20.0 mcg

Ergocalciferol 1.0 mcg

pH 8

Osmolality 300 mOsm/kg water

Excipients: refined soybean oil, glycerol, purified egg yolk phospholipids, sodium hydroxide, water for injections, nitrogen.

Pharmaceutical form. Concentrate for solution for infusion.

Main physicochemical properties: white homogeneous emulsion.

Pharmacotherapeutic group. Solutions for intravenous administration. Vitamins.

ATC Code B05X C.

Pharmacological properties.

Pharmacodynamics.

"Vitalipid for children" is a balanced mixture of fat-soluble vitamins that meets daily requirements during parenteral nutrition.

The biochemical and physiological properties of "Vitalipid for children" are determined by the properties of the 4 individual vitamins contained in the formulation, the main of which are as follows:

• Vitamin A participates in cell growth and differentiation, as well as in the physiological mechanisms of vision.
• Vitamin D regulates calcium and phosphorus metabolism in bones and kidneys.
• Vitamin E has antioxidant properties, prevents the formation of toxic oxidation products, and protects cellular components.
• Vitamin K participates in the activation of clotting factors II (prothrombin), VII, IX, and X, as well as proteins C and S, which are essential for the normal blood coagulation process. Vitamin K is required for the synthesis of other proteins in blood plasma, bones, and kidneys.

Pharmacokinetics.

The fat-soluble vitamins in "Vitalipid for children" are metabolized via the same pathways as dietary fat-soluble vitamins.

The pharmacokinetic properties of "Vitalipid for children" are determined by the properties of the 4 individual vitamins, the main of which are as follows:

• Vitamin A: normal serum levels range from 80–300 IU/mL; it is bound to a carrier protein and is excreted predominantly in bile and urine.
• Vitamin D: activated following hydroxylation in the liver and kidneys; it binds to a carrier protein and is excreted primarily in bile and urine.
• Vitamin E: transported in the blood by lipoproteins, metabolized in the liver, and excreted mainly in urine.
• Vitamin K: interacts with bile for absorption from the gastrointestinal tract, accumulates primarily in the liver, but is stored in the body only for a short period, is rapidly metabolized, and excreted in bile and urine.

Clinical characteristics.

Indications.

To be used as an adjunct to intravenous parenteral nutrition in neonates and children up to 11 years of age to meet the daily requirement for fat-soluble vitamins A, E, D2, and K1.

Contraindications.

Hypersensitivity to any of the active substances, egg, soy, peanut proteins, or any excipient of the medicinal product.

Purified soybean oil may contain peanut protein. Cross-allergic reactions have been observed with soybean oil and peanuts.

Hypervitaminosis of any vitamin contained in the medicinal product.

Severe hypercalcaemia, hypercalciuria, or any treatment, disease, and/or pathology leading to severe hypercalcaemia and/or hypercalciuria (e.g., neoplasms, bone metastases, primary hyperparathyroidism, granulomatous diseases).

Concomitant use with vitamin A or retinoids.

Interaction with other medicinal products and other types of interactions.

Interactions between the individual vitamins contained in "Vitalipid for children" and other drugs should be appropriately monitored.

Such interactions include:

• Retinoids, including bexarotene: increased risk of toxicity when used concomitantly with vitamin A.
• Tipranavir oral solution: contains vitamin E in amounts exceeding the recommended daily intake.
• Vitamin K antagonists (e.g., warfarin): enhanced anticoagulant effect of vitamin E.

Interactions between fat-soluble vitamins and other components or parenteral nutrition delivery systems have been rarely reported.

The presence of trace elements may cause slight degradation of vitamin A. Vitamin A is degraded under ultraviolet radiation.

Combination with warfarin should be avoided, as vitamin K1 interacts with coumarin anticoagulants.

Special precautions for use.

The total amount of "Vitalipid for children" administered must not exceed 10 ml/day.

Infusion should be discontinued immediately if signs or symptoms of hypersensitivity reactions occur.

For single use only.

Vitamin toxicity

The patient's clinical condition and blood vitamin concentrations should be monitored to avoid overdosage and toxic effects, particularly of vitamins A, D, and E, especially in patients receiving additional vitamins from other sources or those receiving other agents that may increase the risk of vitamin toxicity. Monitoring is particularly important in patients receiving long-term vitamin therapy.

Hypervitaminosis A

The risk of developing hypervitaminosis A and vitamin A toxicity (e.g., manifested by skin and bone adverse reactions, diplopia, hepatic cirrhosis) is increased, for example, in patients with protein deficiency, impaired renal function (even if vitamin A is not additionally administered), impaired liver function, pediatric patients with low body weight, and patients receiving continuous vitamin therapy.

Acute liver disease in patients with adequate hepatic vitamin A stores may lead to the manifestation of vitamin A toxicity.

Hypervitaminosis D

Excessive vitamin D may cause hypercalcemia and hypercalciuria.

The risk of vitamin D toxicity is increased in patients with diseases and/or conditions leading to hypercalcemia and/or hypercalciuria, as well as in patients receiving continuous vitamin therapy.

Hypervitaminosis E

Although extremely rare, excessive doses of vitamin E may impair wound healing due to platelet dysfunction and coagulation disorders.

The risk of vitamin E toxicity is increased in patients with impaired liver function, coagulation disorders, or concomitant use of oral anticoagulants, as well as in patients receiving continuous vitamin therapy.

Special warnings for use

Patients with impaired liver function

Patients with hepatic insufficiency may require individualized vitamin dosing. Particular attention should be paid to preventing vitamin A toxicity, as liver disease is associated with increased susceptibility to vitamin A toxicity, especially in combination with chronic excessive alcohol consumption (see also above "Hypervitaminosis A").

General monitoring

The total intake of vitamins from all sources, including diet, other vitamin supplements, or medications containing vitamins as excipients, should be taken into account (see section "Interaction with other medicinal products and other forms of interaction"). Vitamin levels and the patient's clinical status should be monitored to ensure adequate vitamin levels are maintained.

It should be noted that certain vitamins, particularly vitamin A, are sensitive to ultraviolet radiation (e.g., direct or indirect sunlight). In addition, a high oxygen concentration in solution may increase the degradation of vitamins A and E. These factors should be considered if adequate vitamin levels cannot be achieved.

Monitoring for adequate vitamin levels is necessary when parenteral multivitamins are the sole source of vitamins over a prolonged period. For example, vitamin A levels should be monitored in patients with pressure ulcers, wounds, burns, short bowel syndrome, or cystic fibrosis.

Reconstitution

"Vitalipid for children" must be added to the solution or emulsion no earlier than 1 hour before the start of infusion. To achieve homogeneity of the mixture, the container with the mixture should be inverted several times immediately before the start of infusion.

Compatibility

"Vitalipid for children" must not be mixed with other medicinal products except those listed below. The volume and dose of the diluent must be determined according to the instructions for medical use of the respective medicinal product.

"Vitalipid for children" (see dosing recommendations in section "Posology and method of administration") may be added to the following medicinal products:

" Intralipid 20%", emulsion for infusion;

"SMOFlipid 20%", emulsion for infusion;

"Glucose 50 mg/ml", "Glucose 100 mg/ml", solution for infusion;

"Sodium chloride 9 mg/ml", solution for infusion;

For patients aged 2 years and older:

"Kabiven Central" or "Kabiven Peripheral", emulsion for infusion, regardless of package size;

"SMOFKabiven Central" and "SMOFKabiven Peripheral", emulsion for infusion, regardless of package size.

For children with body weight above 10 kg and aged up to 11 years:

"Vitalipid for children" may be used to reconstitute "Soluvit N", lyophilisate for infusion solution. One vial of "Soluvit N" is dissolved by adding 10 ml (one ampoule) of "Vitalipid for children". The resulting mixture is then added to any compatible medicinal product.

For children with body weight up to 10 kg:

"Vitalipid for children" is not recommended for reconstituting "Soluvit N" due to differences in dosing regimens between "Vitalipid for children" and "Soluvit N".

Exposure of intravenous parenteral nutrition solutions, especially those containing trace elements and/or vitamins, to light may have adverse effects on clinical outcomes in neonates due to the formation of peroxides and other degradation products. Prepared solutions containing "Vitalipid for children" administered to neonates and children under 2 years of age should be protected from light until the end of infusion.

Use during pregnancy or breastfeeding.

Not applicable.

Ability to affect reaction speed when driving vehicles or operating machinery.

For use in children.

Method of Administration and Dosage

Do not use undiluted!

Method of Dilution

"Vitalipid for children" is intended for intravenous use after aseptic dilution.

The volume of the preparation to be used for dilution is determined according to its instructions for medical use (recommended diluents and volume of "Soluvit N" are specified in the section "Special Instructions").

The dose of "Vitalipid for children", calculated according to the child's body weight or age, is administered after dilution in the specified volume of diluent.

Recommended dosage for premature newborns and newborns with low body weight – less than 2.5 kg:

4 mL/kg body weight/day.

For children with body weight above 2.5 kg and up to 11 years of age:

The recommended dose is 10 mL (1 ampoule) per day.

Liver Function Impairment

To maintain adequate vitamin levels and prevent vitamin toxicity, vitamin mixtures should be administered individually for each patient (see section "Special Instructions").

Children

For use in newborns and children up to 11 years of age.

Overdose

Repeated overdose of fat-soluble vitamins may lead to symptoms of toxicity. A single overdose of fat-soluble vitamins will not cause adverse effects.

Prolonged infusion of excessive doses of vitamin D may increase serum concentrations of vitamin metabolites, potentially leading to osteopenia.

Rapid infusion of vitamin K1 in a colloidal aqueous solution may provoke flushing, bronchospasm, tachycardia, and hypotension.

Acute overdose of vitamin A (doses exceeding 150,000 IU) may cause gastrointestinal disturbances, headache, increased intracranial pressure, optic disc edema, psychiatric disorders, irritability, convulsions, or delayed generalized skin desquamation.

Chronic vitamin A poisoning (prolonged intake of vitamin A preparations in doses exceeding physiological requirements in patients who do not require such treatment) may lead to increased intracranial pressure, cortical hyperostosis in long bones, and premature epiphyseal closure. Diagnosis is usually established in the presence of tender or painful subcutaneous swelling of the extremities.

Radiological examination reveals periosteal reaction in the ulna, fibula, clavicle, and ribs.

Treatment of acute or chronic overdose

Discontinue the drug, reduce calcium intake, increase diuresis (urine excretion), and restore fluid balance.

Adverse reactions.

Allergic reactions are possible from the immune system.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store in a place protected from light, in the original packaging at a temperature not exceeding 25°C. Keep out of reach of children. Do not freeze.

Incompatibilities.

This medicinal product must not be mixed with other medicinal products except those specified in the section "Special precautions for use".

Packaging.

10 ml of concentrate in a glass ampoule; 10 ampoules per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Fresenius Kabi AB, Sweden /
Fresenius Kabi AB, Sweden

Address of manufacturer's site of operation.

Rapsgatan 7, Uppsala, 754 50, Sweden /
Rapsgatan 7, Uppsala, 754 50, Sweden

Marketing Authorization Holder.

Fresenius Kabi Deutschland GmbH, Germany /
Fresenius Kabi Deutschland GmbH, Germany

Address of Marketing Authorization Holder.

Else-Kröner-Strasse, 1, 61352 Bad Homburg, Germany /
Else-Kröner-Strasse, 1, 61352 Bad Homburg, Germany