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. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, tell your 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 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 the patient's 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 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.

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).
Dosing is determined by the doctor for each patient.

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 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 using 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 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 side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 this 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 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.
Unused portions of the medicine are 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 pack 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, niacinamide, 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, cyanocobalamin, 0.40 mg, 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 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, packaged in 10 pieces in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer:

Marketing authorization holder in the Netherlands, the country of export:

Fresenius Kabi Nederland B.V.
Amersfoortseweg 10 E
3712 BC Huis ter Heide, Netherlands

Manufacturer:

Pfizer Puurs
2870 Puurs, Belgium
Fresenius Kabi
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
Netherlands marketing authorization number: RVG 09077

Parallel import authorization number: 349/22 Date of leaflet approval: 23.09.2022

[Information on the trademark]

Information intended for healthcare professionals only:

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 reconstitution of 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 as a supplement to meet the needs 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/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 in the packaging. Protect from light.

Disposal of unused medicine

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