Active ingredients

• 0.4 mg folic acid
• 40 mg nicotinamide
• 0.06 mg biotin
• 0.01 mg cyanocobalamin
• 112.48 mg sodium ascorbate
• 4.9 mg riboflavin 5'-phosphate, monosodium salt-2-water
• 16.5 mg sodium pantothenate
• 4.9 mg pyridoxine hydrochloride
• 3.1 mg thiamine nitrate

Excipients

• 0.5 mg disodium edetate-2-water
• 300 mg glycine

• The medicine is a powder and is used to cover the daily requirement of the water-soluble vitamins B ₁ , B ₂ , B ₆ , B ₁₂ , C, pantothenic acid, biotin and folic acid in adults and children aged 11 years and over as part of parenteral nutrition.

• The medicine is administered by medical professionals.
• The recommended dose for adults and children 11 years and older is one vial per day.
• Use in children and adolescents
  • The product must not be used in children aged 11 years or younger.
• Use in special patient groups
  • Caution is advised in patients with liver or kidney dysfunction and in the elderly.

• If a larger amount has been used than intended
  • If you experience allergic reactions, inform your doctor or pharmacist.

Soluvit N, powder for concentrate for solution for infusion. Indications: To cover the daily requirement of the water-soluble vitamins B1, B2, B6, B12, C, pantothenic acid, biotin and folic acid in adults and children aged 11 and over as part of parenteral nutrition.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Soluvit N, powder for concentrate for solution for infusion

Read the entire package leaflet carefully before you start using this medicine because it contains important information.

• Keep this leaflet. You may want to read it again later.
• If you have any further questions, please ask your doctor or healthcare professional.
• This medicine has been prescribed for you personally. Do not share it with anyone else. It may harm others, even if they have the same symptoms as you.
• If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. WHAT IS SOLUVIT N AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SOLUVIT N?
3. HOW SHOULD SOLUVIT N BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD SOLUVIT N BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS SOLUVIT N AND WHAT IS IT USED FOR?

Soluvit N is a powder used to meet the daily requirements of the water-soluble vitamins B1, B2, B6, B12, C, pantothenic acid, biotin, and folic acid in adults and children 11 years and older as part of parenteral nutrition.

2. WHAT SHOULD YOU CONSIDER BEFORE USE SOLUVIT N?

Do not use Soluvit N if you are allergic to Soluvit N or any other ingredient of this medicine (see the list in section 6).

Warnings and precautions:
Talk to your doctor before using Soluvit N if:

• if you have liver disease.
• if your kidney function is impaired.
• if you are a dialysis patient.
• if you have cancer.
• if you get vitamins from other sources
• if you know that you have a vitamin B12 deficiency.
• if you are diabetic (Soluvit N may affect the measured blood sugar levels).

Your doctor will monitor you during the infusion to ensure you receive the correct amount of vitamins. Tell your doctor if you experience signs of allergy (such as itching, hives, rash, reddening of the skin, chest discomfort, shortness of breath, tightness in the throat, discomfort in the upper abdomen) or difficulty breathing.

Effect on clinical laboratory tests:
Soluvit N contains 60 mcg of biotin per vial. If you are having a laboratory test, you must tell your doctor or laboratory personnel that you are taking or 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 decreased due to the biotin. Your doctor may ask you to stop taking Soluvit N before performing laboratory tests. You should also be aware that other products you may be taking, such as multivitamins or supplements for hair, skin, and nails, may also contain biotin and may interfere with the results of laboratory tests. Please tell your doctor or laboratory staff if you are taking such products.

Children and adolescents:
Soluvit N should not be used in children 11 years of age or younger.

Using Soluvit N with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or intend to take any other medicines.

Take special care if you are taking any of the following types of medicines:

• L&ndash%%%Dopa (for the treatment of Parkinson&ndash%%%disease),
• Phenobarbital, phenytoin, primidone, carbamazepine, phenobarbital, valproate (for the treatment of epilepsy),
• Aspirin (to treat pain and inflammation),
• Chloramphenicol, trimethoprim (for the treatment of bacterial infections),
• Deferoxamine (for the treatment of iron poisoning or excessive concentrations of iron in the body),
• Ethionamide, Cycloserine, Isoniazid (for the treatment of tuberculosis),
• Fluoropyrimidines, Raltitrexed (for the treatment of cancer),
• Methotrexate, sulfasalazine, penicillamine (for the treatment of rheumatoid arthritis),
• Pyrimethamine (for the treatment of malaria),
• Triamterene, hydralazine (for the treatment of heart disease),
• Phenelzine (for the treatment of depression),
• Theophylline (for the treatment of respiratory diseases and asthma).

Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If necessary, you can receive Soluvit N during pregnancy, provided the indication and dosage are observed to avoid vitamin overdose.

Driving and using machines:
There is no information on the effects of Soluvit N on the ability to drive and use machines.

Soluvit N contains sodium:
Soluvit N contains less than 1 mmol (23 mg) sodium/vial, which means the medicine is essentially sodium-free.

3. HOW TO USE SOLUVIT N

Soluvit N is administered by a healthcare professional. You will normally receive Soluvit N as an infusion into a vein. The recommended dose of Soluvit N for adults and children 11 years and older is one vial per day. Soluvit N is intended for intravenous use after reconstitution and addition to an infusion solution. The infusion should be administered slowly over at least 1 to 2 hours.

Use in children and adolescents:
Soluvit N must not be used in children aged 11 years or younger.

Use in special patient groups:
Caution is advised in patients with impaired liver or kidney function and in the elderly.

If a larger amount of Soluvit N is used than intended:
If you experience allergic reactions, inform your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Overdose is not expected within the stated dose range. Signs of overdose may be allergic reactions. If you notice any of these signs of overdose, consult your doctor. The following side effects have been reported with medicinal products of a similar composition. The frequency is not known (cannot be estimated from the available data).

• Allergic reactions such as hives, difficulty breathing, tightness in the throat, stomach upset, itching, rash, redness of the skin, chest discomfort
• Taste disorders or loss of taste,
• fatal heart attack,
• Rapid heartbeat,
• Rapid breathing,
• Diarrhea,
• Vomit,
• Nausea,
• Fever,
• Pains,
• Reactions, pain or rash at the infusion or injection site,
• Burning sensation during administration,
• Increased levels of diagnostic markers in the body.

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD SOLUVIT N BE STORE?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label after ###EXP###. The expiry date refers to the last day of that month. Keep the vial in the outer carton to protect from light. Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Soluvit N contains:
The active ingredients are: Thiamine nitrate 3.1 mg, Riboflavin-5'-phosphate sodium 2 H2O 4.9 mg (equivalent to 3.6 mg riboflavin), Nicotinamide 40 mg, Pyridoxine hydrochloride 4.9 mg (equivalent to 4.0 mg pyridoxine), Sodium pantothenate 16.5 mg (equivalent to 15.0 mg D-pantothenic acid), Sodium ascorbate 113 mg (equivalent to 100 mg ascorbic acid), Biotin 0.06 mg, Folic acid 0.4 mg, Cyanocobalamin 0.005 mg. The other ingredients are: Glycine 300 mg, Disodium edetate 0.5 mg.

What Soluvit N looks like and contents of the pack:
Pack containing 10 vials of powder concentrate for solution for infusion.

Marketing
Authorisation Holder and Manufacturer:
Baxter Deutschland GmbH
Edisonstraße 4
85716 Unterschleißheim
Germany

Manufacturer:
Baxter Deutschland GmbH
Dr.-Wandinger-Straße 1
94447 Plattling Germany

Or

Bieffe medical SpA
Via Nuova Provinciale
I-23034 Grosotto
Italy

This leaflet was last revised in March 2025.

Source: Information from the package leaflet,
as of: 10/2024

Indications: to cover the daily requirement of water-soluble vitamins B1, B2, B6, B12, C, pantothenic acid, biotin and folic acid in adults and children from 11 years of age as part of parenteral nutrition.