Soluvit lyophilisate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Soluvit lyophilisate for solution for infusion

Water-soluble vitamins

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

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

Contents of this leaflet

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

1. What Soluvit is and what it is used for

Soluvit is a lyophilized powder of water-soluble vitamins belonging to the group of drugs known as additives for intravenous solutions.

Soluvit is indicated in adult and pediatric patients to meet daily requirements of water-soluble vitamins during parenteral nutrition.

2. What you need to know before 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 (vitamina B1).

Warnings and precautions

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

• Soluvit must be reconstituted before administration.
• Soluvit must only be added or mixed 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 its symptoms.
• Caution is required if you are being treated with levodopa (a medication for Parkinson's disease), since vitamin B6 may reduce its effect (see "Other medicines and Soluvit").
• If you suffer from epilepsy, caution is advised because there have been some cases of increased seizure activity with folic acid.
• Caution is required if you have a certain hereditary optic nerve disease, as it could be affected by the cyanocobalamin (vitamin B12) content.
• Interferences with clinical laboratory tests: If you are scheduled for any diagnostic tests (including blood, urine, etc.), inform your doctor that you are using this medicine, as it may alter test results due to its content of pyridoxine and biotin.
• Soluvit contains 60 micrograms of biotin per vial. If laboratory tests are to be performed, you must inform your doctor or laboratory personnel that you are receiving or have recently received Soluvit, as biotin may influence test results. 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 laboratory tests are performed. 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 affect laboratory test results. Inform your doctor or laboratory personnel if you are taking such products.

Children

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

Other medicines and Soluvit

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Interactions described for pyridoxine (vitamin B6):

• Levodopa: may reduce its effects, unless administered together with carbidopa

Interactions described for cyanocobalamin (vitamin B12):

• Folic acid: at high doses, may reduce blood levels of cyanocobalamin
• Chloramphenicol (an 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 antiepileptic medicines (barbiturates, phenytoin, primidone): interaction may occur at very high doses of Soluvit.
• Primidone: the effects of primidone and levels of folic acid may be reduced.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before receiving this medicine.

Pregnancy

Clinical experience has not shown any risk in this population group. When necessary, Soluvit may be considered for use during pregnancy.

Breastfeeding

A decision must be made whether to discontinue breastfeeding or discontinue treatment, taking into account the benefit of breastfeeding for the child and the treatment for the mother versus the potential risks, as the active substances in Soluvit are excreted in breast milk.

Driving and use of machines

Not applicable.

Soluvit contains methylparaben (E-218) and sodium

May cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of suffocation), because it contains methylparaben.

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

3. How to use Soluvit

If in doubt, consult your doctor or pharmacist.

The recommended dose is:

• In adult patients and children weighing more than 10 kg, the contents of one reconstituted vial per day is recommended.

Use in children

• In children weighing less than 10 kg, it is recommended to administer 1/10 of the contents of one reconstituted vial (approximately 1 ml) per kg of body weight per day.

Intravenous use.

The Soluvit vial must be reconstituted before administration.

Reconstitution instructions

Reconstitution of the product must be performed aseptically by adding an intravenous perfusion solution or lipid emulsion.

The reconstituted powder must not be injected directly into the vein, but should be added to a perfusion 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 of age:

The contents of one Soluvit vial should 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 infusion
3. Water for injections
4. Glucose infusion solution, without electrolytes (5% – 50%)

Children under 11 years of age:

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

1. Vitalipid infantil (for children weighing more than 10 kg)*
2. Intralipid 100 mg/ml or Intralipid 200 mg/ml emulsions for infusion
3. Water for injections
4. Glucose infusion solution, without electrolytes (5% – 50%)

* Mixture 1 is not recommended for children weighing less than 10 kg due to differences in the administration regimen.

Soluvit may be part of parenteral nutrition mixtures containing carbohydrates, lipids, amino acids, and electrolytes, provided compatibility and stability have been verified in each case.

Reconstituted Soluvit should be added to the infusion solution no more than one hour before the start of infusion, and the solution 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 overdosage with water-soluble vitamins, except in cases of extremely high injectable doses.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following may occur:

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

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

Rapid intravenous administration could cause dizziness.

Reporting of adverse effects

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

By reporting adverse 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 must be dissolved before use. When Soluvit is diluted in aqueous-based solutions, the mixture should be protected from light. This is not necessary if Soluvit is diluted with lipid emulsions, due to the protective effect of the fatty emulsion.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

6. Contents of the package and other information

Composition of Soluvit, lyophilisate for solution for infusion

Each vial contains:

The other components (excipients) are: glycine (aminoacetic acid), disodium edetate, and methyl parahydroxybenzoate (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 container

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

Pack size: each package 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 the most recent review of this leaflet: May 2019

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