Soluvit N

Package Leaflet: Information for the User

SOLUVIT N, Powder for Solution for Infusion

Read the Package Leaflet Carefully Before Using the Medicinal Product, as it Contains Important Information for You.

Important Information for the Patient.

• You should keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this package leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Package Leaflet Contents

• 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. Package Contents and Other Information

1. What SOLUVIT N is and What it is Used For

SOLUVIT N is a medicinal product containing water-soluble vitamins, administered intravenously when oral nutrition is impossible. 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 parenteral nutrition, together 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 you are allergic to the active substances or to any of the other ingredients of this medicinal product (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 the 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 the doctor or laboratory staff.

SOLUVIT N and Other Medicinal Products

Tell your doctor or pharmacist about all the medicinal products you are taking or have recently taken, as well as any you plan to take. Inform your doctor:

• if you are taking phenytoin (a medicinal product used to treat epilepsy);
• if you are taking levodopa (a medicinal product used to treat Parkinson's disease);
• if you are taking hydroxocobalamin intravenously (a medicinal product used to treat vitamin B deficiency and certain eye diseases).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicinal product. The doctor will decide whether to use SOLUVIT N in women during pregnancy or breastfeeding.

Driving and Using Machines

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

SOLUVIT N Contains Methyl Parahydroxybenzoate

Medicinal products containing methyl parahydroxybenzoate may cause allergic reactions (possible late reactions) and, exceptionally, bronchospasm (not observed with SOLUVIT N).

3. How to Use SOLUVIT N

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.

Use of a Higher Than 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 the doctor or nurse. If you have any further questions about the use of this medicinal product, ask your doctor or nurse.

4. Possible Side Effects

Like all medicinal products, SOLUVIT N can cause side effects, although not everybody gets them. Allergic reactions, including severe anaphylactic reactions, may occur in patients who are hypersensitive to any component of SOLUVIT N, such as folic acid, thiamine, or methyl parahydroxybenzoate (frequency not known).

Reporting Side Effects

If you experience any side effects, including any not listed in this package leaflet, please inform 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, e-mail: ndl@urpl.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store SOLUVIT N

Keep the Medicinal Product Out of the Sight and Reach of Children.

The doctor or nurse is responsible for ensuring the proper storage, use, and disposal of SOLUVIT N. Store in a temperature below 25°C. Store in the original package to protect from light. Do not use this medicinal product after the expiry date stated on the package. The expiry date refers to the last day of the month stated. Unused portions of the medicinal product are not suitable for further use. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What SOLUVIT N Contains

• The active substances of the medicinal product are: thiamine nitrate (equivalent to 2.5 mg of vitamin B1) 3.1 mg, riboflavin sodium phosphate (equivalent to 3.6 mg of vitamin B2) 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, cyanocobalamin 0.40 mg, 5.0 μg.

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 Package Contents

The medicinal product 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, packaged in 10 pieces in a cardboard box.

Marketing Authorization Holder and Manufacturer

Fresenius Kabi AB, S-751 74 Uppsala, Sweden. For further information, please contact the representative of the marketing authorization holder: Fresenius Kabi Polska Sp. z o.o., Al. Jerozolimskie 134, 02-305 Warsaw, tel.: +48 22 345 67 89.

Date of Last Revision of the Package Leaflet:

Information Intended for Healthcare Professionals Only:

Warnings and Precautions for Administration

SOLUVIT N must not be administered in its undissolved form. 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: The contents of one vial cover the daily needs of adult patients and children with a body weight of 10 kg or more. Administration: Instructions for reconstitution of the medicinal product before administration, see section: Preparation of the Medicinal Product for Administration.

Overdose

There are no reports of adverse reactions associated with overdose of water-soluble vitamins, except for very high doses administered parenterally. There are no reports of overdose of medicinal products used to supplement the need for water-soluble vitamins during parenteral nutrition. No specific treatment is necessary.

Preparation of the Medicinal Product for Administration

During mixing with other medicinal products, 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 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 can be added to medicinal products 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 medicinal products:

• 1. Vitalipid N Infant (children with a body weight over 10 kg)
• 2. Intralipid 10% or Intralipid 20%
• 3. Water for Injections
• 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 medicinal product per day. The mixture resulting from the dissolution of 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 medicinal products 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 medicinal product with other medicinal products, except those listed in the section: Preparation of the Medicinal Product for Administration.

Storage Conditions

Store in a temperature below 25°C. Store in the original package to protect from light.

Disposal of Unused Medicinal Product

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.