Label: SOLUVIT N- thiamine mononitrate, riboflavin 5-phosphate sodium anhydrous, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, sodium pantothenate, biotin, sodium ascorbate powder, for solution

Soluvit N is a lyophilized, sterile, yellow mixture of water soluble vitamins for intravenous infusion. Qualitative and Quantitative Composition

One vial of Soluvit N contains:

For the full list of excipients, see section list of excipients.

• Osmolality in 10 ml of water: approx. 490 mosm/kg water
• pH in 10 ml of water: 5.8

Therapeutic indications

Soluvit N is indicated in adult patients and children as a supplement in intravenous nutrition to meet the daily requirements of water soluble vitamins.

Posology

Adults:

For adult patients and children weighing 10 kg or more, the recommended daily dosage is the content of one vial.

Infants:

Children weighing less than 10 kg should be given 1/10 of the content of one vial per kg body weight per day.

Known hypersensitivity to any of the components, e.g. thiamine or methyl parahydroxybenzoate.

Soluvit N must not be given undiluted.

When Soluvit N is diluted with water based solutions, the admixture should be protected from light. This is not necessary if Soluvit N is diluted with Intralipid because of the protective effect of the fat emulsion.

Interference with clinical laboratory tests

Biotin may interfere with laboratory tests that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results, depending on the assay. The risk of interference is higher in children and patients with renal impairment and increases with higher doses. When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed (e.g. thyroid test results mimicking Graves' disease in asymptomatic patients taking biotin or false negative troponin test results in patients with myocardial infarction taking biotin). Alternative tests not susceptible to biotin interference should be used, if available, in cases where interference is suspected. The laboratory personnel should be consulted when ordering laboratory tests in patients taking biotin.

Folic acid may lower the serum concentration of phenytoin and obscure pernicious anaemia.

Vitamin B6 can reduce the effect of levodopa.

Animal reproduction studies or clinical investigations during pregnancy have not been carried out with Soluvit N. There are, however, published reports on safe administration of water soluble vitamins in this patient group.

Not relevant.

Allergic reactions including severe (anaphylactic) reactions may occur in patients hypersensitive to any component of the preparation, e.g. folic acid, thiamine or methyl parahydroxybensoate (frequency not known).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

No adverse effects of an overdose of water soluble vitamins have been reported, with exception of cases of extremly high parenteral doses. Overdoses caused by parenteral preparations for nutritional supplement of water soluble vitamins have not been reported.

No specific treatment is needed. See also section Contraindications.

Glycine (Aminoacetic acid)

Disodium edetate.

Methyl parahydroxybenzoate

Soluvit N may only be added to or mixed with other medicinal products for which compatibility has been documented.

18 months

Shelf-life after mixing

Chemical and physical in-use stability after dilution has been demonstrated for 24 hours at 25°C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless mixing has taken place in controlled and validated aseptic conditions.

Do not store above 25°C. Protect from light.

Adults and children age 11 years and above:

The contents of one vial of Soluvit N are dissolved by adding 10 ml of:

1. Vitalipid N Adult

or 2. Intralipid 10%, Intralipid 20%, Intralipid 30%, Structolipid

or 3. Water for Injections

or 4. Glucose solution for infusion (5%-50%)

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

Children below 11 years of age:

The contents of one vial are dissolved by adding 10 ml of:

1. Vitalipid N Infant (for children above 10 kg/bw)

or 2. Intralipid 10%, Intralipid 20%

or 3. Water for Injections

or 4. Glucose solution for infusion (5%-50%)

Children weighing less than 10 kg should be given 1 ml of the dissolved mixture per kg body weight per day. Children weighing 10 kg or more should be given 10 ml (one vial) per day.

Due to differences in the dosage regimes for Soluvit N and Vitalipid N Infant, the mixture 1 is not recommended for children weighing less than 10 kg.

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

Disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Manufacturer:

Fresenius Kabi AB, Uppsala, Sweden

March 2019

PACKAGE LABEL – PRINCIPAL DISPLAY – Soluvit N Vial Label

Soluvit N

Powder for solution for infusion

PACKAGE LABEL – PRINCIPAL DISPLAY – Soluvit N Carton

Soluvit™ N

Powder for solution for infusion

10 Vials