Prospect: information for the user

Soluvit lyophilized for perfusion solution

Water-soluble vitamins

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Soluvit is a lyophilized powder of water-soluble vitamins that belongs to the group of medications called additives for intravenous solutions.

Soluvit is indicated in adult and pediatric patients to cover daily needs of water-soluble vitamins in parenteral nutrition.

Do not administer Soluvit:

• If you are allergic to the vitamins it contains or to any of the other components of this medication (listed in section 6).
• If you have presented signs of intolerance to thiamine (vitamin B1).

Warnings and precautions

Consult your doctor or pharmacist before Soluvit is administered to you.

• Soluvit must be reconstituted before administration.
• Soluvit must be added or mixed only with other medicinal products whose compatibility has been confirmed.
• Caution is required if you have undiagnosed pernicious anemia or other anemia caused by vitamin B12 deficiency, as folic acid may mask it.
• If you are being treated with levodopa (Parkinson's disease medication), caution is required as vitamin B6 may reduce its effect (see "Other medications and Soluvit").
• If you suffer from epilepsy, caution is required as there have been cases of epilepsy intensification with folic acid.
• If you have a certain hereditary optic nerve disease, caution is required as it may be affected by the content of cyanocobalamin (vitamin B12).
• Interference with laboratory clinical tests:If you are to undergo any diagnostic test (including blood, urine, etc. …) inform your doctor that you are using this medication, as it may alter the results, due to the content of pyridoxine and biotin.
• Soluvit contains 60 micrograms of biotin per vial. If you are to undergo laboratory tests, inform your doctor or laboratory personnel that you are receiving or have recently received Soluvit, as biotin may influence the results of these tests. Depending on the test, results may show false elevations or false reductions due to biotin. Your doctor may instruct you to stop receiving Soluvit before undergoing laboratory tests. You should also know that other products you may be taking, such as multivitamin preparations or supplements for hair, skin, and nails, may also contain biotin and affect the results of laboratory tests. Inform your doctor or laboratory personnel if you are taking this type of product.

Children

In children, depending on their age and body weight, Soluvit will be administered as indicated in section 3.

Other medications and Soluvit

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The active principles of Soluvit may interact with the following medications:

Interactions described for pyridoxine(vitamin B6):

• Levodopa: reducing its effects, unless associated with carbidopa.

Interactions described for cyanocobalamin(vitamin B12):

• Folic acid: in high doses may reduce blood cyanocobalamin levels.
• Chloramphenicol (antibiotic): may reduce the effect of cyanocobalamin.

Interactions described for folic acid:

• Folic acid may interfere with the diagnosis of certain types of anemia.
• Some epilepsy medications (barbiturates, phenytoin, primidone): at very high doses of Soluvit, interaction may occur.
• Primidone: may reduce the effects of primidone and folic acid levels.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before this medication is administered to you.

Pregnancy

There is no clinical evidence of risk in this population group. In necessary cases, Soluvit may be considered for use during pregnancy.

Breastfeeding

It should be decided whether to interrupt breastfeeding or interrupt treatment, taking into account the benefit of breastfeeding for the child and treatment for the mother versus potential risks, as the active principles of Soluvit pass into breast milk.

Driving and operating machinery

Not applicable.

Soluvit contains parahydroxybenzoate methyl (E-218) and sodium

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking) due to the presence of parahydroxybenzoate methyl.

This medication contains less than 23 mg (1 mmol) of sodium per vial, making it essentially "sodium-free".

In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

- Inadult patients and children with a body weight of more than 10 kg, the contents of one reconstituted vial per day are recommended.

Use in children

-In children with a body weight of less than 10 kg, administer 1/10 of the contents of a reconstituted vial (approximately 1 ml) per kilogram of body weight and per day.

IV route.

The Soluvit vial must be reconstituted before administration.

Reconstitution instructions

The product reconstitution will be performed by adding, in an aseptic manner, a solution or a lipid emulsion for intravenous perfusion.

The reconstituted powder must not be injected directly into the vein, but rather added to a solution or emulsion for perfusion whose compatibility with Soluvit has been demonstrated.

To use, the Soluvit vial must be reconstituted in an aseptic manner as follows:

Adults and children over 11 years:

The contents of one Soluvit vial must be dissolved by adding 10 ml of one of the following solutions/emulsions:

1. Vitalipid adults
2. Intralipid 100 mg/ml or Intralipid 200 mg/ml or Intralipid 300 mg/ml Emulsions for perfusion
3. Water for injectable preparations
4. Glucose solution for infusion, without electrolytes (5% - 50%)

Children under 11 years:

The contents of one vial can be dissolved by adding 10 ml of one of the following solutions:

1. Vitalipid infantil (for children over 10 kg of body weight)*
2. Intralipid 100 mg/ml or Intralipid 200 mg/ml Emulsions for perfusion
3. Water for injectable preparations
4. Glucose solution for infusion, without electrolytes (5% - 50%)

* The mixture 1 is not recommended for children with a body weight of less than 10 kg due to differences in the administration regimen.

Soluvit may be part of parenteral nutrition mixtures in which glucose, lipids, amino acids, and electrolytes are associated after having previously checked compatibility and stability in each case.

Soluvit dissolved must be added to the infusion solution within a time not exceeding one hour before its start and it must be used within 24 hours after its preparation.

If you use more Soluvit than you should

No adverse effects have been observed as a result of an overdose of water-soluble vitamins, except in cases of extremely high injectable doses.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

They could include:

Allergic reactions with skin rash, itching, or more serious reactions that could affect the skin, respiratory system, gastrointestinal system, throat constriction, chest pain, etc. due to hypersensitivity to one of the components, such as folic acid, thiamine, or methylparahydroxybenzoate.This includes severe allergic reactions (anaphylactic).(Unknown frequency),

At the site of intravenous administration, reactions at the injection site, itching, redness could occur.

Rapid intravenous administration could cause dizziness.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Store in the outer packaging to protect it from light.

Soluvit must be dissolved before use. When Soluvit is dissolved in aqueous base solutions, the mixture must be protected from light. This will not be necessary if Soluvit is dissolved with lipid emulsions, due to the protective effects of the fatty emulsion.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Soluvit lyophilized for infusion solution

Each vial contains:

The other components (excipients) are: glycine (amino acid), edetate disodium and methylparaben (E-218).

Osmolality in 10 ml of water: 490 mosm/kg water

pH in 10 ml of water: 5.8

Appearance of the product and contents of the package

It is presented in the form of a lyophilized solution for infusion (administered through a vein). It is a sterile lyophilized powder, yellow in color, contained in glass vials of 10 ml.

Format: each package contains 10 vials of 10 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FRESENIUS KABI ESPAÑA S.A.U

Marina 16-18

08005-Barcelona

Responsible for manufacturing

Fresenius Kabi AB

Rapsgatan 7, Uppsala

Sweden

Last review date of this prospectus:May 2019

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/