Soluvit N

Package Leaflet: Information for the User

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

Soluvit N (Soluvit)

powder for solution for infusion
Soluvit N and Soluvit are different trade names for the same medicinal product.

Read the package leaflet carefully before using the medicinal product, as it contains important information for the patient.

• Keep this package leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 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 package and other information

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

Soluvit N is a medicinal product 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, together 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 you are allergic to the active substances or to any of the other ingredients of this medicinal product (listed in section 6).

Warnings and precautions

In patients treated with Soluvit N, the doctor may order regular blood tests to check the patient's health.
Soluvit N contains 60 μg of biotin per vial (i.e., after dilution, 6.0 μg in 1 ml). If the patient is to undergo laboratory tests, they should inform their doctor or laboratory personnel that they have recently taken Soluvit N, as biotin may interfere with the results of these 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 personnel.

Soluvit N and other medicinal products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, as well as any medicinal products you plan to use.

Tell your doctor:

• if you are taking phenytoin (a medicinal product used to treat epilepsy);
• if you are taking levodopa (a medicinal product used to treat Parkinson's disease);
• if you are taking hydroxocobalamin intravenously (a medicinal product used to treat vitamin B12 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, ask your doctor for advice before using this medicinal product.
The doctor will decide whether to use Soluvit N in women during pregnancy 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

Medicinal products 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 reconstituted 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 solution per kilogram of body weight per day.

Use of 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.
If you have any further questions about the use of this medicinal product, ask your doctor or nurse.

4. Possible side effects

Like all medicinal products, Soluvit N can cause side effects, although not everybody gets them.
Allergic reactions may occur, including severe anaphylactic reactions in patients 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 not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store Soluvit N

Keep the medicinal product out of the 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 outer packaging to protect from light.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Any unused solution should not be used.
Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Soluvit N contains

• The active substances of Soluvit N are: thiamine nitrate (equivalent to 2.5 mg of vitamin B1), riboflavin sodium phosphate (equivalent to 3.6 mg of vitamin B2), 3.1 mg, 4.9 mg

nicotinamide
40 mg
pyridoxine hydrochloride
(equivalent to 4.0 mg of vitamin B6)
4.9 mg
sodium pantothenate
(equivalent to 15.0 mg of pantothenic acid)
16.5 mg
sodium ascorbate
(equivalent to 100 mg of vitamin C)
113 mg
biotin
60 μg
folic acid
cyano-cobalamin
0.40 mg
5.0 μg

• The other ingredients (excipients) are: glycine, sodium 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 the contents of the package

Soluvit N is a powder for solution for infusion.
After reconstitution, each vial contains 10 ml of solution.
Soluvit N is available in glass vials, packaged in cartons of 10, in a cardboard box.
For more detailed information, contact the marketing authorization holder or the parallel importer:

Marketing authorization holder in France, the country of export:

Fresenius Kabi France
5, place du Marivel
92316 Sèvres Cedex
France

Manufacturer:

FRESENIUS KABI AB
Rapsgatan 7, SE-751 74 UPPSALA, Sweden

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in France, the country of export: 34009 367 669 5 2
367 669-5
356 521-1
34009 356 521 1 9

Parallel import authorization number: 241/15

Date of approval of the package leaflet: 12.05.2025

[Information on the trademark]

Information intended for healthcare professionals only:

Warnings and precautions for use

Soluvit N must not be administered in its undissolved form.
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/kg of body weight per day.
Administration
Instructions for reconstitution of the medicinal product before administration, see section: Preparation of the medicinal product 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 medicinal products used as a supplement to the requirement for water-soluble vitamins during parenteral nutrition.
No specific treatment is necessary.

Preparation of the medicinal product for use

During mixing with other medicinal products, 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 medicinal products:

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

Soluvit N can be added to medicinal products 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 medicinal products:

• 1. Vitalipid N Infant (children with a body weight over 10 kg)
• 2. Intralipid 10% or Intralipid 20%
• 3. water for injections
• 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 medicinal product per day.
The mixture resulting from the dissolution of 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 medicinal products 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 medicinal product with other medicinal products, except those mentioned in the section: Preparation of the medicinal product for use.

Storage conditions

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

Disposal of unused medicinal product

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