powder for infusion liquid, solution
water-soluble vitamins er
What Soluvit is and what it is used for
Solution is a sterile freeze-dried mixture of water-soluble vitamins.
Solution is used as a supplement to meet the daily need for water-soluble vitamins during intravenous nutrition.
Soluvit may also be approved to treat other conditions not mentioned in this product information. Ask a doctor or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before using Soluvit
Do not use Soluvit
- if you are allergic to active substances (e.g. thiamine ) or any other ingredient of this medicine (listed in section 6, e.g. methyl parahydroxybenzoate).
Warnings and precautions
Talk to a doctor or nurse before using Soluvit.
The folic acid supply can mask signs of pernicious anemia.
Solution contains 60 micrograms of biotin per vial. If you are going to have laboratory tests, you must tell your doctor or the laboratory staff that you are taking or have recently taken Soluvit, as biotin can affect the results of these tests. Depending on the test used, results may be falsely elevated or falsely decreased due to biotin. The doctor may ask you to stop taking Soluvit before the 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 affect the results of laboratory tests. Inform your doctor or laboratory staff if you are taking such products.
Other medicines and Soluvit
Tell the doctor or nurse if you are taking, have recently taken, or might take other medicines.
Pyridoxine ( vitamin B6 ) can reduce the effect of levodopa.
Folic acid is suspected of lowering the serum concentration of phenytoin.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.
Clinical studies for the use of Soluvit during pregnancy have not been conducted. However, there are literature publications on the safe use of water-soluble vitamins during pregnancy.
Driving ability and use of machinery
The product is not expected to affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or nurse if you are unsure.
Solution contains methyl parahydroxybenzoate
Can cause an allergic reaction (possibly delayed) and exceptionally spasm in the trachea.
How to use Soluvit
Solution should not be given undiluted. The dissolved Soluvit mixture is added to parenteral nutrition solutions. Detailed instructions for use and handling are given in the section “The following information is intended for healthcare professionals only”.
Dosage :
Adults: 1 vial per day.
Use for children and adolescents
Children over 10 kg: 1 vial per day.
Children under 10 kg: 1/10 of the contents of the bottle (1 ml) per kg of body weight per day.
If you have received too much Soluvit
Overdosage of water-soluble vitamins has not been found to cause side effects except in some rare cases, where very large amounts of the drug have been administered intravenously.
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you have any further questions about this medicine, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions including severe (anaphylactic) may occur in patients who are hypersensitive to any ingredient, e.g. folic acid, thiamine, or methyl parahydroxybenzoate (has been reported (occurring in an unknown number of users)).
How Soluvit should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25 °C. Store the bottle in the outer carton. Light sensitive.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Do not use this medicine if the packaging is damaged.
Contents of the packaging and other information
Contents declaration
| The active substances in 1 bottle are: | Corresponding: | ||
| Thiamine nitrate | 3.1 mg | Thiamine ( vitamin B1 ) _ | 2.5 mg |
| Riboflavin sodium phosphate | 4.9 mg | Riboflavin ( vitamin B 2 ) | 3.6 mg |
| Nicotinamide | 40 mg | ||
| Pyridoxine hydrochloride | 4.9 mg | Pyridoxine ( vitamin B 6 ) | 4 mg |
| Nartium pantothenate | 16.5 mg | Pantothenic acid | 15 mg |
| Sodium ascorbate | 113 mg | Ascorbic acid ( vitamin C ) | 100 mg |
| Biotin | 60 μg | ||
| Folic acid | 0.4 mg | ||
| Cyanocobalamin | 5.0 μg |
Other ingredients are glycine, disodium edetate, and methyl parahydroxybenzoate (E 218).
Appearance and package sizes of the medicine
Yellow powder.