Soluvit

Package leaflet: Information for the user

SOLUVIT powder for solution for infusion

Water-soluble vitamins mixture
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What SOLUVIT is and what it is used for
2. What you need to know before you use SOLUVIT
3. How to use SOLUVIT
4. Possible side effects
5. How to store SOLUVIT
6. Contents of the pack and other information

1. What SOLUVIT is and what it is used for

SOLUVIT is a powder for solution for infusion administered by intravenous drip.
It contains a mixture of water-soluble (hydrophilic) vitamins.
This medicinal product is used to provide the daily requirement of vitamins in case you are unable to take vitamins normally through food. Soluvit is indicated for vitamin supplementation in parenteral nutrition in adults and children.

2. What you need to know before using SOLUVIT

Do not use SOLUVIT

• if you are allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6), especially if you have previously experienced intolerance reactions to thiamine (vitamin B_) or methyl p-hydroxybenzoate.

Warnings and precautions
Talk to your doctor or nurse before this medicine is administered to you.
Exercise particular caution and inform your doctor:

• if you suffer from certain nervous system disorders affecting the eye (optic neuropathies), because the cyanocobalamin (vitamin B_) content in this medicine may worsen your symptoms;
• if you have blood disorders such as pernicious anemia, because folic acid may mask its symptoms;
• if you are being treated with phenytoin, a medicine used for epilepsy, because the folic acid (vitamin B_) content in this medicine may reduce the effectiveness of phenytoin.

SOLUVIT must be diluted before administration.
Other medicines and SOLUVIT
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
The vitamin B_ contained in this medicine may reduce the effects of levodopa, a medicine used to treat Parkinson's disease, a disorder of the nervous system.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or nurse before this medicine is administered.
This medicine may be used during pregnancy under direct medical supervision.
Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.
SOLUVIT contains methyl p-hydroxybenzoate and sodium
This medicine contains methyl p-hydroxybenzoate which may cause allergic reactions (including delayed reactions) and, exceptionally, bronchospasm.
SOLUVIT contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is practically 'sodium-free'.

3. How to use SOLUVIT

This medicine will be administered to you by trained medical personnel. If you have any doubts, consult your doctor or nurse.
The contents of one vial of this medicine must be diluted with an appropriate solution to a volume of 10 ml and then added to the intravenous infusion solution. Dilution of SOLUVIT will be carried out by trained medical personnel in a sterile environment.
You will receive the contents of one vial of SOLUVIT (10 ml) per day, which constitutes the daily requirement of vitamins for adults.

Use in children
In children with a body weight above 10 kg, the contents of one vial per day (10 ml) will be administered.
In children with a body weight below 10 kg, 1 ml of the vial contents will be administered per kg of body weight.

If you use more SOLUVIT than you should
Since this medicine will be administered by trained medical personnel, overdose is unlikely. Nevertheless, no cases of overdose with water-soluble vitamins have been reported.
In case of overdose, no specific treatment is required.
In the event of accidental ingestion or administration of an excessive dose of SOLUVIT, inform your doctor immediately or contact the nearest poison control centre.

If you forget to use SOLUVIT
Since this medicine will be administered by trained medical personnel, it is unlikely that a dose will be missed.
If you have any doubts about the use of SOLUVIT, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
The following may occur:

• allergic reactions due to the presence of certain components (for example thiamine or methyl p-hydroxybenzoate)
• severe anaphylactic reaction, frequency not known, due to the presence of folic acid

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SOLUVIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Medical personnel are aware of the appropriate storage conditions for this medicine.
Store below 25°C, protected from light.
If SOLUVIT is dissolved in aqueous solutions, the resulting solution must be protected from light;
this precaution is not necessary if SOLUVIT is diluted with solutions that do not contain water.
The diluted SOLUVIT solution must be added to the infusion solution within one hour after the start
of the infusion and must be used within 24 hours of preparation.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SOLUVIT contains

• The active substance is a mixture of water-soluble vitamins. Each vial contains 3.1 mg of thiamine mononitrate (equivalent to 2.5 mg of thiamine), 4.9 mg of sodium riboflavin phosphate (equivalent to 3.6 mg of riboflavin), 40 mg of nicotinamide, 4.9 mg of pyridoxine hydrochloride (equivalent to 4.0 mg of pyridoxine), 16.5 mg of sodium pantothenate (equivalent to 15 mg of pantothenic acid), 113 mg of sodium ascorbate (equivalent to 100 mg of ascorbic acid), 60 mcg of biotin, 0.4 mg of folic acid, 5 mcg of cyanocobalamin.
• Other components are: glycine (aminoacetic acid), methyl p-hydroxybenzoate, sodium edetate.

Description of the appearance of SOLUVIT and package contents
Pack containing 10 vials of powder for solution for infusion.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
FreseniusKabi Italia S.r.l. – Via Camagre, 41 – 37063 Isola della Scala (VR)
Manufacturer
FreseniusKabi AB
Rapsgatan, 7
Uppsala
Sweden
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The following information is intended for healthcare professionals only:

Indications
SOLUVIT is indicated during parenteral nutrition in adult and pediatric patients as a supplement of
water-soluble vitamins.
Storage
Store below 25°C, protected from light.
Incompatibilities
SOLUVIT may be diluted or mixed only with products whose compatibility has been documented.
Instructions for use

SOLUVIT must be dissolved before use.

Compatibility and instructions for use
All dilutions must be carried out aseptically.
Adults and children aged 11 years and older
The contents of one vial of lyophilisate must be reconstituted aseptically by adding 10 ml of one of the following:

1. VITALIPID ADULTS
2. INTRALIPID 10%/INTRALIPID 20%
3. Water for injections
4. Electrolyte-free glucose solution (5%–60%)

The resulting solution must not be used alone, but must be further diluted.
If the product has been reconstituted with solutions 1 or 2, the resulting solution must be further diluted only in INTRALIPID.
If reconstitution was carried out with solutions 3 or 4, the resulting solution must be further diluted in INTRALIPID or in an electrolyte-free glucose solution (5%–60%).

Children under 11 years of age
The contents of one vial of lyophilisate must be reconstituted aseptically by adding 10 ml of one of the following:

1. VITALIPID PEDIATRIC
2. INTRALIPID 10%/INTRALIPID 20%
3. Water for injections
4. Electrolyte-free glucose solution (5%–60%)

For children weighing less than 10 kg, administer 1 ml of the solution prepared as described above per kg of body weight per day.
For children weighing 10 kg or more, administer 10 ml (1 vial) per day.
The resulting solution must not be used alone, but must be further diluted.
If the product has been reconstituted with solutions 1 or 2, the resulting solution must be further diluted only in INTRALIPID.
If reconstitution was carried out with solutions 3 or 4, the resulting solution must be further diluted in INTRALIPID or in an electrolyte-free glucose solution (5%–60%).

Stability
The SOLUVIT solution obtained after dissolution must be added to the infusion solution within one hour from the start of the infusion and must be used within 24 hours of preparation.