Soluvit N

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. 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 drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness 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 drug 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

Soluvit N should not be used:

• if the patient is allergic to the active substances or to any of the other ingredients of this drug (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 the results of laboratory tests. If the patient is taking such products, they should inform their doctor or laboratory staff.

Soluvit N and other drugs

The patient should inform their doctor or pharmacist about all drugs they are currently taking or have recently taken, as well as any drugs they plan to use.
The patient should inform their doctor:

• if they are taking phenytoin (a drug used to treat epilepsy);
• if they are taking levodopa (a drug used to treat Parkinson's disease);
• if they are taking hydroxocobalamin intravenously (a drug 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 drug.
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 vehicles and operate machines.

Soluvit N contains methyl parahydroxybenzoate

Drugs 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 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 small. 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 drug, the patient should consult their doctor or nurse.

4. Possible side effects

Like all drugs, Soluvit N can cause side effects, although not everyone will experience 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 unknown).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their 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 drug.

5. How to store Soluvit N

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

The doctor or nurse is responsible for ensuring proper storage, use, and disposal of Soluvit N.
Vial with powder: Do not store above 25°C, protect from light.
Prepared solution: Store for 24 hours at a temperature of 2-8°C.
Do not use this drug after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Unused leftovers of the drug are not suitable for further use.
Drugs should not be thrown into the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Contents of the packaging and other information

What Soluvit N contains

• The active substances of the drug 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 (E 218).

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 drug 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, the patient should contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Greece, the country of export:

Fresenius Kabi Hellas S.A.

• L. Mesogeion 354, 15341 Agia Paraskevi, Athens, Greece

Manufacturer:

Fresenius Kabi AB
Rapsgatan 7, S-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
Authorization number in Greece, the country of export: 392/29-07-2013

Parallel import authorization number: 909/12 Date of approval of the leaflet: 14.12.2022

[Information about the trademark]

Information intended only for healthcare professionals:

Warnings and precautions for use

Soluvit N should 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 of body weight per day.
Administration
Instructions for reconstituting the drug before administration, see section: Preparation of the drug 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 drugs used to supplement the need for water-soluble vitamins during parenteral nutrition.
No specific treatment is necessary.

Preparation of the drug for use

When mixing with other drugs, the principles of asepsis should be followed.
Adult patients and children over 11 years old:
The contents of one vial of Soluvit N should be dissolved by adding 10 ml of one of the following drugs:

• 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 drugs 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 under 11 years old:
The contents of one vial of Soluvit N should be dissolved by adding 10 ml of one of the following drugs:

• 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 drug 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 drugs 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 drug with other drugs, except those listed in the section: Preparation of the drug for use.

Storage conditions

Vial with powder: Do not store above 25°C, protect from light.
Prepared solution: Store for 24 hours at a temperature of 2-8°C.

Disposal of unused drug

Any unused leftovers of the drug or its waste should be disposed of in accordance with local regulations.