Soluvit N

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Soluvit N, powder for solution for infusion

You should carefully read the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Soluvit N and what is it used for
• 2. Important information before using Soluvit N
• 3. How to use Soluvit N
• 4. Possible side effects
• 5. How to store Soluvit N
• 6. Contents of the packaging and other information

1. What is Soluvit N and what is it used for

Soluvit N is a medicine containing water-soluble vitamins, administered intravenously when oral nutrition is not possible. Vitamins are organic substances necessary in small amounts for the proper functioning of the body.
Soluvit N is indicated for use as a component of clinical nutrition, along with proteins, fats, carbohydrates, salts, and other vitamins.

2. Important information before using Soluvit N

When not to use Soluvit N

Do not use Soluvit N:

• if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

In patients using Soluvit N, the doctor may order regular blood tests to check their health.
Soluvit N contains 60 μg of biotin per vial (i.e., 6.0 μg per 1 ml after dilution). If the patient is to undergo laboratory tests, they should inform their doctor or laboratory staff that they have recently taken Soluvit N, as biotin may interfere with the results of such tests.
Depending on the test, the results may be falsely elevated or falsely low due to the presence of biotin.
The doctor may recommend stopping the use of Soluvit N before performing laboratory tests. It should also be remembered that other products that may be taken, such as multivitamin preparations or dietary supplements used to improve the condition of hair, skin, and nails, may also contain biotin and affect the results of laboratory tests. If the patient is taking such products, they should inform their doctor or laboratory staff.

Soluvit N and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Tell your doctor:

• if you are taking phenytoin (a medicine used to treat epilepsy);
• if you are taking levodopa (a medicine used to treat Parkinson's disease);
• if you are taking hydroxocobalamin intravenously (a medicine used to treat vitamin B deficiency and certain eye diseases).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
Your doctor will decide whether to use Soluvit N in women who are pregnant or breastfeeding.

Driving and using machines

Soluvit N has no influence or negligible influence on the ability to drive and use machines.

Soluvit N contains methyl parahydroxybenzoate

Medicines containing methyl parahydroxybenzoate may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm (not observed with Soluvit N).

3. How to use Soluvit N

The dissolved and diluted Soluvit N is administered by intravenous infusion (drip infusion).
The dosage for each patient is determined by the doctor.

Dosage

Adult patients and children with a body weight of 10 kg or more

The usual daily dose for adult patients and children with a body weight of 10 kg or more is the contents of one vial (dissolved in 10 ml of solution).

Children with a body weight below 10 kg

Children with a body weight below 10 kg should receive 1 ml of the solution per kilogram of body weight per day.

Using a higher dose of Soluvit N than recommended

The doctor or nurse will monitor the patient's health during the infusion, so the likelihood of administering a higher dose than recommended is low. However, if the patient thinks they have received a higher dose of Soluvit N than recommended, they should immediately inform their doctor or nurse.
In case of any further doubts about the use of this medicine, consult a doctor or nurse.

4. Possible side effects

Like all medicines, Soluvit N can cause side effects, although not everybody gets them.
Allergic reactions, including severe anaphylactic reactions, may occur in patients who are hypersensitive to any component of Soluvit N, such as folic acid, thiamine, or methyl parahydroxybenzoate (frequency not known).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Soluvit N

The medicine should be stored out of sight and reach of children.

The doctor or nurse is responsible for ensuring the proper storage, use, and disposal of Soluvit N.
Store below 25°C. Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Any unused portion of the medicine is not suitable for further use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Soluvit N contains

• The active substances of Soluvit N are: thiamine nitrate 3.1 mg (corresponding to 2.5 mg of vitamin B1), riboflavin sodium phosphate 4.9 mg (corresponding to 3.6 mg of vitamin B2), nicotinamide 40 mg, pyridoxine hydrochloride 4.9 mg (corresponding to 4.0 mg of vitamin B6), sodium pantothenate 16.5 mg (corresponding to 15.0 mg of pantothenic acid), sodium ascorbate 113 mg (corresponding to 100 mg of vitamin C), biotin 60 μg, folic acid 0.40 mg, cyanocobalamin 5.0 μg
• The other ingredients (excipients) are: glycine, disodium edetate, methyl parahydroxybenzoate.

Osmolality in 10 ml of water: approximately 490 mOsm/kg of water, pH in 10 ml of water: 5.8.

What Soluvit N looks like and what the packaging contains

The medicine is a yellow powder for solution for infusion.
After dissolution, each vial contains 10 ml of solution.
Soluvit N is available in transparent glass vials closed with rubber stoppers, packaged in cartons of 10.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Fresenius Kabi AB
Rapsgatan 7
SE-751 74 Uppsala
Sweden

Manufacturer:

Fresenius Kabi AB
Rapsgatan 7
SE-751 74 Uppsala
Sweden

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing authorization number in Romania, the country of export:12057/2019/01
Parallel import authorization number:383/19

Date of leaflet approval: 23.09.2024

[Information about the trademark]

Information intended only for healthcare professionals:

Warnings and precautions for use

Soluvit N must not be administered undissolved.
If water solutions are used for dissolution, the mixture should be protected from light.
This is not necessary if Soluvit N is dissolved in a fat emulsion, such as Intralipid 10% or Intralipid 20%, due to the protective effect of the emulsion.

Dosage and administration

Dosage
Adult patients and children with a body weight of 10 kg or more
The contents of one vial cover the daily needs of adult patients and children with a body weight of 10 kg or more.
Children with a body weight below 10 kg
Children with a body weight below 10 kg should receive 1/10 of the vial contents per kilogram of body weight per day.
Administration
Instructions for reconstituting the medicine before administration, see section: Preparation of the medicine for use.

Overdose

There are no reports of adverse reactions related to overdose of water-soluble vitamins, except for parenteral administration of very high doses.
There are no reports of overdose of medicines used to supplement the need for water-soluble vitamins during parenteral nutrition.
No specific treatment is necessary.

Preparation of the medicine for use

During mixing with other medicines, aseptic rules should be followed.
Adult patients and children from 11 years of age
The contents of one vial of Soluvit N should be dissolved by adding 10 ml of one of the following medicines:

• 1. Vitalipid N Adult
• 2. Intralipid 10% or Intralipid 20%
• 3. water for injection
• 4. glucose solution for infusion (5% to 50%).

Soluvit N can be added to medicines used for parenteral nutrition containing carbohydrates, fats, amino acids, electrolytes, and trace elements, provided that pharmaceutical compatibility and stability of the resulting mixture have been confirmed.
Children up to 11 years of age
The contents of one vial of Soluvit N should be dissolved by adding 10 ml of one of the following medicines:

• 1. Vitalipid N Infant (children with a body weight over 10 kg)
• 2. Intralipid 10% or Intralipid 20%
• 3. water for injection
• 4. glucose solution for infusion (5% to 50%).

Children with a body weight below 10 kg should receive 1 ml of the resulting mixture per kilogram of body weight per day.
Children with a body weight of 10 kg or more should receive 10 ml (one vial) of the medicine per day.
The mixture resulting from dissolving Soluvit N in Vitalipid N Infant is not recommended for use in children with a body weight below 10 kg due to differences in dosing.
Soluvit N can be added to medicines used for parenteral nutrition containing carbohydrates, fats, amino acids, electrolytes, and trace elements, provided that pharmaceutical compatibility and stability of the resulting mixture have been confirmed.

Incompatibilities

Do not mix the medicine with other medicines, except those listed in the section: Preparation of the medicine for use.

Storage conditions

Store below 25°C. Store in the original packaging to protect from light.

Disposal of unused medicine

Any unused medicine or waste should be disposed of in accordance with local regulations.