Vitalipid

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VITALIPID (VITALIPID)

Composition:

Active substances:

1 ml contains:

dl-α-tocopherol 0.91 mg;

retinol palmitate 194.1 µg;

(corresponds to retinol) 99 µg;

phylloquinone 15 µg;

ergocalciferol 0.5 µg;

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

pH 8

Osmolality 300 mOsm/kg water

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 is a mixture of fat-soluble vitamins which are absorbed following oral administration and exhibit no other pharmacodynamic effects except for supporting or supplementing the dietary intake.

Pharmacokinetics.

Following intravenous infusion, the fat-soluble vitamins in Vitalipid are metabolized in the same manner as fat-soluble vitamins administered orally.

Clinical characteristics.

Indications.

To be used as a supplement to intravenous parenteral nutrition 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 to any excipient of the medicinal product.

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

During pregnancy, vitamin A doses exceeding 8000 IU/day (equivalent to 2400 μg) are contraindicated.

Vitalipid is also contraindicated in newborns and children under 11 years of age.

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, granulomatosis).

Concomitant use with vitamin A or retinoids.

Interaction with other medicinal products and other forms of interaction.

Interactions between the individual vitamins contained in Vitalipid 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 systems of parenteral nutrition delivery have rarely been reported.

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

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

Special precautions for use

Infusion must be stopped 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 without additional vitamin A administration), impaired liver function, in pediatric patients with low body weight, and in patients receiving long-term vitamin therapy.

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

Hypervitaminosis D

Excess vitamin D may cause hypercalcaemia and hypercalciuria.

The risk of vitamin D toxicity is increased in patients with diseases and/or conditions leading to hypercalcaemia and/or hypercalciuria, as well as in patients receiving long-term 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 hepatic insufficiency, coagulation disorders, or concomitant use of oral anticoagulants, as well as in patients receiving long-term 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 above "Hypervitaminosis A").

General monitoring

The total amount of vitamins administered from all sources, such as 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 are not achieved.

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

Elderly patients

Dose adjustment (reduced dose and/or prolonged dosing intervals) should generally be considered in elderly patients due to the higher prevalence of decreased hepatic, renal, or cardiac function, concomitant diseases, or use of other medications.

Reconstitution

Vitalipid must be used only after dilution.

All mixing procedures must be performed under aseptic conditions.

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

Vitalipid, 10 mL (1 ampoule) (see dosing recommendations in section "Method of administration and dosage"), may be added to the following medicinal products:

" Intralipid 20 %", emulsion for infusion;

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

"SmofKabiven Central" and "SmofKabiven Peripheral", emulsion for infusion, regardless of package size;

"SMOFlipid 20 %", emulsion for infusion;

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

"Sodium chloride 9 mg/mL", solution for infusion.

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

Use during pregnancy or breastfeeding

Reproduction studies in animals and clinical trials during pregnancy have not been conducted. Studies involving pregnant or breastfeeding women have not been performed.

Administration of more than 8000 IU/day of vitamin A during pregnancy is not recommended due to the potential risk of congenital malformations.

Ability to influence reaction rate when driving or operating machinery

No effect on reaction speed when driving or operating machinery has been observed.

Method of Administration and Dosage

Do not use undiluted!

Dilution method

Vitalipid is administered intravenously after aseptic dilution.

The volume of diluent used for dilution should be determined according to the instructions for medical use (recommended diluents are specified in the section "Special precautions").

Dosage

Adult patients and children aged 11 years and older

1 ampoule (10 mL) per day.

Elderly patients

Dose adjustment based solely on age is not required; however, physicians should consider the increased risk of conditions that may affect dosing in elderly patients, such as multiple comorbidities, polypharmacy, malnutrition, metabolic disorders, and particularly impaired liver, kidney, or cardiac function (see section "Special precautions"), which may necessitate dose reduction or decreased frequency of administration.

Hepatic impairment

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

Children

Recommended for use in children aged 11 years and older.

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, seizures, or delayed generalized skin desquamation.

Chronic vitamin A poisoning (prolonged intake of vitamin A preparations in doses exceeding physiological requirements by patients who do not require such treatment) may result in elevated intracranial pressure, cortical hyperostosis in long bones, and premature closure of epiphyses. Diagnosis is typically established in the presence of tender or painful subperiosteal 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.

Hypersensitivity reactions are possible from the immune system.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continuous 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 via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

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

Incompatibility.

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

Manufacturer's address.

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 the Marketing Authorization Holder.

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