SOLUVIT LYOPHILIZED FOR PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Soluvit Lyophilized for Solution for Infusion

Water-soluble Vitamins

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Soluvit and what is it used for
2. What you need to know before you start using Soluvit
3. How to use Soluvit
4. Possible side effects
5. Storage of Soluvit
6. Contents of the pack and further information

1. What is Soluvit and what is it used for

Soluvit is a lyophilized powder of water-soluble vitamins belonging to the group of medicines called additives for intravenous solutions.

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

2. What you need to know before you start using Soluvit

Soluvit must not be administered to you if:

• You are allergic to the vitamins it contains or to any of the other components of this medicine (listed in section 6).
• You have shown 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 proven.
• 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 (a medicine for Parkinson's disease), caution is required as vitamin B6 may reduce its effect (see "Other medicines and Soluvit").
• If you suffer from epilepsy, caution is required because some cases of intensified epilepsy with folic acid have been reported.
• If you have a certain hereditary disease of the optic nerve, caution is required as it may be affected by the content of cyanocobalamin (Vitamin B12).
• Interference with clinical laboratory tests: If you are going to have any diagnostic tests (including blood, urine, etc.), inform your doctor that you are using this medicine, as it may alter the results due to the content of pyridoxine and biotin.
• Soluvit contains 60 micrograms of biotin per vial. If laboratory tests are going to be performed, you must inform your doctor or the laboratory staff that you are receiving or have recently received Soluvit, as biotin may influence the results of these tests. Depending on the test, the results may show false elevations or false reductions due to biotin. Your doctor may indicate that you should stop receiving Soluvit before performing the laboratory tests. You should also be aware that other products you may be taking, such as multivitamin preparations or supplements for hair, skin, and nails, may also contain biotin and influence the results of laboratory tests. Inform your doctor or the laboratory staff 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 medicines and Soluvit

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

The active substances of Soluvit may interact with the following medicines:

Interactions described for pyridoxine (Vitamin B6):

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

Interactions described for cyanocobalamin (Vitamin B12):

• Folic acid: at high doses, it may reduce the amounts of cyanocobalamin in the blood.
• Chloramphenicol (antibiotic): may decrease the effect of cyanocobalamin.

Interactions described for folic acid:

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

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

Clinical experience has not revealed any risk in this population. If necessary, the use of Soluvit during pregnancy may be considered.

Breast-feeding

A decision must be made whether to discontinue breast-feeding or to discontinue the treatment, taking into account the benefit of breast-feeding for the child and the treatment for the mother, as the active substances of Soluvit pass into breast milk.

Driving and using machines

Not applicable.

Soluvit contains methylparahydroxybenzoate (E-218) and sodium

It may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation) because it contains methylparahydroxybenzoate.

This medicine contains less than 23 mg (1 mmol) of sodium per vial, so it is considered essentially "sodium-free".

3. How to use Soluvit

In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

• In adult and child patients with a body weight over 10 kg, the content of one reconstituted vial per day is recommended.

Use in children

-In children with a body weight under 10 kg, it is recommended to administer 1/10 of the content of one reconstituted vial (approximately 1 ml) per kg of body weight and day.

Intravenous route.

The Soluvit vial must be reconstituted before administration.

Reconstitution instructions

Reconstitution of the product will be performed by adding aseptically a solution or lipid emulsion for intravenous infusion.

The reconstituted powder must not be injected directly into the vein, but should be added to an infusion solution or emulsion whose compatibility with Soluvit has been demonstrated.

For use, the Soluvit vial must be reconstituted aseptically as follows:

Adults and children over 11 years:

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

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

Children under 11 years:

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

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

• 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 carbohydrates, lipids, amino acids, and electrolytes are associated after previously checking compatibility and stability in each case.

Soluvit dissolved should be added to the infusion solution no later than one hour before the start of the infusion and it should be used within 24 hours of 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, with the exception of cases of extremely high injectable doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following may occur:

Allergic reactions with skin rash, itching, or more serious reactions that may affect the skin, respiratory, gastrointestinal, throat constriction, chest pain, etc. due to hypersensitivity to any of the components such as folic acid, thiamine, or methylparahydroxybenzoate. This includes severe allergic reactions (anaphylactic), (frequency not known),

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

Rapid intravenous administration may cause dizziness.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Soluvit

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

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

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date is the last day of the month shown.

6. Contents of the pack and further information

Composition of Soluvit Lyophilized for Solution for Infusion

Each vial contains:

The other ingredients (excipients) are: glycine (aminoacetic acid), disodium edetate, and methylparahydroxybenzoate (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 pack contents

It is presented as a lyophilized powder for solution for infusion (administered in a vein). It is a sterile, yellow lyophilized powder contained in 10 ml glass vials.

Format: each pack contains 10 vials of 10 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

FRESENIUS KABI ESPAÑA S.A.U

Marina 16-18

08005-Barcelona

Manufacturer

Fresenius Kabi AB

Rapsgatan 7, Uppsala

Sweden

Date of last revision of this leaflet:May 2019

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/