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
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Soluvit N is and what it is 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 Soluvit N is and what it is 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 as a component of parenteral nutrition, together with proteins, fats, carbohydrates, electrolytes, and other vitamins.

2. Important information before using Soluvit N

When Soluvit N must not be used
Soluvit N must not be used:

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

Warnings and precautions
The doctor may order regular blood tests for patients receiving Soluvit N to monitor their health status.
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, he/she should inform the doctor or laboratory personnel that Soluvit N has recently been administered, as biotin may interfere with test results.
Depending on the test, results may be falsely elevated or falsely low due to the presence of biotin.
The doctor may advise discontinuing Soluvit N prior to laboratory testing. It should also be noted that other products the patient may be taking, 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, he/she should inform the doctor or laboratory personnel.

Interaction of Soluvit N with other medicines
Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor:

• if the patient is taking phenytoin (a medicine used in the treatment of epilepsy);
• if the patient is taking levodopa (a medicine used in the treatment of Parkinson's disease);
• if the patient is receiving intravenous hydroxocobalamin (a medicine used in the treatment of vitamin B12 deficiency and certain eye disorders).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
The doctor will decide whether Soluvit N should be used during pregnancy or breastfeeding.

Driving and operating machinery
Soluvit N has no effect or negligible effect on the ability to drive mechanical vehicles or operate machinery.

Soluvit N contains methyl parahydroxybenzoate (E 218)
Medicines containing methyl parahydroxybenzoate (E 218) may cause allergic reactions (including delayed-type reactions) and, exceptionally, bronchospasm (such reactions have not been observed with Soluvit N).

3. How to use Soluvit N

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

Dosage
Adult patients and children with body weight equal to or above 10 kg
The usual daily dose for adult patients and children with body weight equal to or above 10 kg is the contents of 1 vial (dissolved in 10 ml of solution).

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

Administration of a higher than recommended dose of Soluvit N
The physician or nurse will monitor the patient's health status during the infusion; therefore, the likelihood of administering a higher than recommended dose is low. However, if the patient believes they have received a higher than recommended dose of Soluvit N, they should immediately inform the physician or nurse.

If there are any further doubts regarding the use of this medication, consult the physician or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions, including severe anaphylactic reactions, may occur in patients hypersensitive
to any component of Soluvit N, such as folic acid, thiamine or methyl
parahydroxybenzoate (E 218) (frequency unknown).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Soluvit N

Keep this medicine out of sight and reach of children.
The doctor or nurse is responsible for ensuring appropriate 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 container. The expiry date refers to the last day of the stated month.
Any unused portion of the medicine must 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 helps protect the environment.

6. Contents of the packaging and other information

What Soluvit N contains

• The active substances are: thiamine nitrate 3.1 mg (equivalent to 2.5 mg vitamin B₁), riboflavin sodium phosphate 4.9 mg (equivalent to 3.6 mg vitamin B₂), nicotinamide 40 mg, pyridoxine hydrochloride 4.9 mg (equivalent to 4.0 mg vitamin B₆), sodium pantothenate 16.5 mg (equivalent to 15.0 mg pantothenic acid), sodium ascorbate 113 mg (equivalent to 100 mg vitamin C), biotin 60 μg, folic acid 0.40 mg, cyanocobalamin 5.0 μg.
• Other components (excipients) are: glycine, disodium edetate, methyl parahydroxybenzoate (E 218).

Osmolality in 10 ml of water: approximately 490 mOsm/kg water, pH in 10 ml of water: 5.8.
What Soluvit N looks like and contents of the pack
The medicinal product is a yellow powder for solution for infusion.
After reconstitution, each vial contains 10 ml of solution.
Soluvit N is available in glass vials with rubber stoppers, aluminium caps and blue plastic caps, packed in cartons of 10 vials.
For further information, contact the marketing authorisation holder or the parallel importer:
Marketing authorisation holder in the Czech Republic, country of export:
Fresenius Kabi AB, Rapsgatan 7, 75174 Uppsala, Sweden
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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 86/851/92-C
Parallel import authorisation number: 66/23

Information intended exclusively for medical professionals:

Warnings and precautions for use
Soluvit N must not be administered in an undissolved form.
If aqueous solutions are used for dissolution, the mixture must be protected from light.
This is not necessary when Soluvit N is dissolved in a fat emulsion, e.g. Intralipid 10% or
Intralipid 20%, due to the protective effect of the emulsion.

Dosage and method of administration
Dosage
Adult patients and children with body weight equal to or above 10 kg
The contents of one vial cover the daily requirement for adult patients and children with body weight
equal to or above 10 kg.

Children with body weight below 10 kg
Children with body weight below 10 kg should receive 1/10 of the vial contents per kg body weight/day.

Method of administration
Instructions for reconstitution prior to administration, see section: Preparation of the medicinal product for use.

Overdose
There are no reports of adverse effects related to overdose of water-soluble vitamins, except following parenteral administration of very high doses.
There are no reports of overdose with products used to supplement water-soluble vitamin requirements during parenteral nutrition.
Specific treatment is not required.

Preparation of the medicinal product for use
When mixing with other medicinal products, aseptic techniques must be observed.

Adult patients and children aged 11 years and above
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 may be added to parenteral nutrition solutions containing carbohydrates, fats, amino acids, electrolytes and trace elements, provided pharmaceutical compatibility and stability of the resulting mixture have been confirmed.

Children under 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 (for children with body weight above 10 kg)
2. Intralipid 10% or Intralipid 20%
3. Water for injections
4. Glucose solution for infusion (5% to 50%).

Children with body weight below 10 kg should receive 1 ml of the resulting mixture per kg body weight/day.
Children with body weight equal to or above 10 kg should receive 10 ml (one vial) of the product per day.
The mixture obtained by dissolving Soluvit N in Vitalipid N Infant is not recommended for use in children with body weight below 10 kg due to differences in dosing.

Soluvit N may be added to parenteral nutrition solutions containing carbohydrates, fats, amino acids, electrolytes and trace elements, provided pharmaceutical compatibility and stability of the resulting mixture have been confirmed.

Pharmaceutical incompatibilities
Do not mix Soluvit N with other medicinal products except those listed in the section: Preparation of the medicinal product for use.

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

Disposal of unused medicinal product or waste material
Any unused residues of the medicinal product or waste material should be disposed of in accordance with local regulations.