Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Soluvit N, powder for solution for infusion
Please read this leaflet carefully before using this medicine, as it contains important information for the patient.

Keep this leaflet for possible future reference.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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

What Soluvit N is and what it is used for
Important information before using Soluvit N
How to use Soluvit N
Possible side effects
How to store Soluvit N
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, to be used together with proteins, fats, carbohydrates, electrolytes, 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
For patients receiving Soluvit N, the doctor may recommend regular blood tests to monitor health status.
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 the doctor or laboratory personnel that they have recently received Soluvit N, as biotin may interfere with test results.
Depending on the test, results may be falsely elevated or falsely decreased due to the presence of biotin.
The doctor may advise discontinuing Soluvit N before laboratory testing. It should also be remembered that other products the patient may be taking, such as multivitamins 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 the doctor or laboratory personnel.

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 they plan to use.
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 has a negligible effect on the ability to drive or operate machinery.

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

3. How to use Soluvit N

Reconstituted and diluted Soluvit N 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 (reconstituted 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 condition 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 medicinal product, consult the physician or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience 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 (frequency unknown).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, 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 provide more information on the safety of the medicine.

5. How to store Soluvit N

Keep Soluvit N out of the sight and reach of children.
Your 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 medicinal product after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
Any unused portion of the medicinal product must not be used.
Medicinal products must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the packaging and other information

What Soluvit N contains

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

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
Soluvit N is a yellow powder for solution for infusion.
After reconstitution, each vial contains 10 ml of solution.
Soluvit N is available in transparent glass vials closed with rubber stoppers,
packaged in cardboard boxes containing 10 vials.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Romania, the country of export:
Fresenius Kabi AB
Rapsgatan 7
SE-751 74 Uppsala
Sweden
Manufacturer:
Fresenius Kabi AB
Rapsgatan 7
SE-751 74 Uppsala
Sweden
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Marketing Authorisation Number in Romania, the country of export: 12057/2019/01
Parallel Import Authorisation Number: 383/19

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
For instructions on 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 as vitamin supplementation during parenteral nutrition.
Specific treatment is not required.

Preparation of the medicinal product for use
Aseptic techniques must be observed when mixing with other medicinal products.

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 products:

Vitalipid N Adult
Intralipid 10% or Intralipid 20%
Water for injections
Glucose infusion solution (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 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 products:

Vitalipid N Infant (for children with body weight above 10 kg)
Intralipid 10% or Intralipid 20%
Water for injections
Glucose infusion solution (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. Store in the original packaging to protect from light.

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