Soluvit n

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SOLUVIT N (SOLUVIT N) Composition: active substances: 1 vial contains:

Excipients: glycine, disodium edetate, methylparaben (methylparahydroxybenzoate) E 218.

Pharmaceutical form. Lyophilisate for solution for infusion.
Main physicochemical properties: yellow lyophilized powder. Osmolality in 10 ml of water is approximately 490 mOsm/kg. pH in 10 ml of water is 5.8.

Pharmacotherapeutic group. Additional intravenous solutions. Vitamins. ATC code: B05X C.

Pharmacological properties.
Pharmacodynamics. Soluvit N is a mixture of water-soluble vitamins in amounts corresponding to those absorbed with oral intake and has no pharmacodynamic effects other than supporting or supplementing the nutritional regimen.

Pharmacokinetics. When administered intravenously, the water-soluble vitamins in Soluvit N are metabolized in the same way as water-soluble vitamins taken orally.

Clinical characteristics.
Indications. To be used in adults and children as part of parenteral nutrition to meet daily requirements for water-soluble vitamins.

Contraindications. Hypersensitivity to the active substances or to any of the excipients of the medicinal product, e.g., thiamine or methylparahydroxybenzoate.

Special precautions.
Soluvit N must not be administered undiluted. Soluvid N should be added to an infusion solution under aseptic conditions no later than one hour before the start of infusion.

Soluvit N contains methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed), and in isolated cases, bronchospasm.

When Soluvit N is diluted with a lipid emulsion, the mixture does not need to be protected from light, as the lipid emulsion has a light-protective effect. However, when Soluvit N is diluted with an aqueous-based solution, the mixture must be protected from light.

Effect on results of clinical laboratory tests.
Biotin may interfere with laboratory tests based on biotin/streptavidin interaction, potentially leading to falsely low or falsely high test results depending on the assay. The risk of interference is higher in children and patients with renal insufficiency and increases with higher doses.

When interpreting laboratory test results, possible biotin interference should be considered, especially if there is inconsistency with the clinical picture (e.g., thyroid function test results mimicking Graves' disease in asymptomatic patients taking biotin, or falsely negative troponin test results in patients with myocardial infarction taking biotin).

When biotin interference is suspected, alternative tests insensitive to biotin should be used. When laboratory tests are ordered for patients taking biotin, consultation with a laboratory physician is recommended.

Interaction with other medicinal products and other forms of interaction.
Folic acid may reduce plasma concentrations of phenytoin. In addition, administration of folic acid in high doses may interfere with the diagnosis of pernicious anemia.

Pyridoxine (vitamin B6) reduces the therapeutic effect of levodopa.

Soluvit N may be added to parenteral nutrition mixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements, provided compatibility and stability have been confirmed.

Special instructions for use.
This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e., essentially "sodium-free."

Use during pregnancy or breastfeeding.
Reproductive function studies in animals and clinical trials during pregnancy have not been conducted. Studies involving women during pregnancy or breastfeeding have not been performed.

Ability to influence reaction rate when driving or operating machinery.
Soluvit N has no effect or negligible effect on the ability to drive or operate machinery.

Method of administration and dosage.
Soluvit N should be added to an infusion solution under aseptic conditions no later than one hour before the start of infusion.

Dosage
Adults: The recommended daily dose for adult patients and children with body weight ≥10 kg is the contents of 1 vial, diluted under aseptic conditions in 10 ml of diluent, as described below.

Children: Children with body weight <10 kg should receive 1 ml of solution (prepared as described below) per kg of body weight per day.

Method of administration
Adults and children aged 11 years and older: Prior to administration, the contents of 1 vial of Soluvit N should be dissolved under aseptic conditions by adding 10 ml of: "Vitalipid" or "Intralipid 20%", or water for injections, or glucose infusion solution (5–50%).

Children under 11 years of age: Prior to administration, the contents of 1 vial should be dissolved under aseptic conditions by adding 10 ml of: "Vitalipid for children" (for children with body weight >10 kg) or "Intralipid 20%", or water for injections, or glucose infusion solution (5–50%).

Children with body weight <10 kg should receive 1 ml of solution per kg of body weight per day.
Children with body weight >10 kg should receive 10 ml of solution (1 vial) per day.

Due to differences in dosing regimens between Soluvit N and "Vitalipid for children," the mixture with "Vitalipid for children" is not recommended for children with body weight <10 kg.

Soluvit N may be added to parenteral nutrition mixtures containing carbohydrates, lipids, amino acids, electrolytes, and trace elements, provided compatibility and stability have been confirmed.

Children. Used in pediatric practice (see section "Method of administration and dosage").

Overdose.
Symptoms of overdose with water-soluble vitamins have not been observed, except in cases where excessively high doses were administered parenterally. Overdose due to water-soluble vitamins in parenteral nutrition has not been observed. Therefore, specific treatment is not required.

Adverse reactions.
Allergic reactions, including anaphylactic reactions, may occur in patients sensitive to any component of the product, e.g., folic acid, thiamine, or methylparahydroxybenzoate (frequency unknown).

Reporting suspected adverse reactions.
Reporting suspected adverse reactions after medicinal product authorization is important. It allows continuous monitoring of the benefit-risk profile 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 Information System for Pharmacovigilance at: https://aisf.dec.gov.ua.

Shelf life. 18 months.

Due to the risk of microbial contamination associated with adding infusion solution in a hospital ward, the mixture should be used immediately after preparation. Any unused solution must be discarded and not stored for later use.

Storage conditions.
Store at temperatures not exceeding 25 °C in the original packaging, in a place protected from light. Keep out of reach of children.

Individual vitamins are light-sensitive. When Soluvit N is diluted with a lipid emulsion, the mixture does not need to be protected from light, as the lipid emulsion provides a light-protective effect. However, if Soluvit N is diluted with an aqueous-based solution, the mixture must be protected from light.

Chemical and physical stability after dilution has been demonstrated for 24 hours at 25 °C. From a microbiological standpoint, the product should be used immediately. If the solution is not used immediately, the in-use storage duration and conditions are the responsibility of the user and should generally not exceed 24 hours at 2–8 °C, provided mixing was performed under controlled and validated aseptic conditions.

Incompatibilities.
Do not mix in the same container with other medicinal products except those specified in the section "Method of administration and dosage."

Packaging.
Vial with 10 ml lyophilisate, with stopper and aluminum cap; 10 vials in a cardboard box.

Prescription category. Prescription only.

Manufacturer.
Fresenius Kabi AB
Rapsagatan 7, Uppsala, 754 50, Sweden

Marketing Authorization Holder.
Fresenius Kabi Deutschland GmbH
Elze-Kröner-Strasse 1, 61352 Bad Homburg, Germany