Soluvit N

Package Leaflet: Information for the User

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

Soluvit N

powder for solution for infusion

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any 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 pack 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 in 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 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 laboratory test results. 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 the patient is taking, has recently taken, or plans to take.
Tell your doctor:

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The doctor will decide whether to use Soluvit N in pregnant or breastfeeding women.

Driving and using machines

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

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 more than the recommended dose of Soluvit N

The doctor or nurse will monitor the patient's health during the infusion, so the likelihood of administering a higher dose than recommended is small. However, if the patient believes 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 your 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 hypersensitive to any component of Soluvit N, such as folic acid or thiamine (frequency not known).

Reporting side effects

If side effects occur, including any not listed in the leaflet, inform 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
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 gather more information on the safety of the medicine.

5. How to store Soluvit N

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

The doctor or nurse is responsible for ensuring proper storage, use, and disposal of Soluvit N.
Do not store above 25°C. Store the vials in the outer 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.
Unused medicine should not be used. 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 pack and other information

What Soluvit N contains

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

4.9 mg
nicotinamide
40 mg
pyridoxine hydrochloride
(corresponding to 4.0 mg of vitamin B6)
4.9 mg
sodium pantothenate
(corresponding to 15.0 mg of pantothenic acid)
16.5 mg
sodium ascorbate
(corresponding 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, disodium edetate.

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 contents of the pack

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

Marketing authorization holder in Austria, the country of export:

Fresenius Kabi Austria GmbH, Hafnerstraße 36, A-8055 Graz, Austria

Manufacturer:

Fresenius Kabi AB, Rapsgatan 7, 75174 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
Austrian marketing authorization number: 1-19573

Parallel import authorization number: 100/23

Date of leaflet approval: 01.06.2023

[Information about the trademark]

Information intended exclusively 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/kg body weight/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 associated with overdose of water-soluble vitamins, except for parenteral administration of very high doses.
There are no reports of overdose of medicines used as a supplement to the requirement for water-soluble vitamins during parenteral nutrition.
No specific treatment is necessary.

Preparation of the medicine for use

When mixing with other medicines, follow the rules of asepsis.
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/kg body weight/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

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

Disposal of unused medicine

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