Viant polvo para solucion para perfusion

Label: information for the user

Viant® powder for infusion solution

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1. What isViantand how it is used

2. What you need to know before starting to useViant

3. How to useViant

4. Possible adverse effects

5. Storage ofViant

6. Contents of the package and additional information

Viant is a powder for solution for infusion administered by drip. It contains 13vitamins (see section6). Viant is used to directly supply the blood with the vitamins needed each day to maintain normal bodily functions, if you cannot obtain them through normal food intake.

Viant may be administered to adults and childrenage 11years or older.

Do not use Viant:

• if you are allergic to any of the components of this medication, peanuts or soy or any other component of this medication (listed in section6)
• if you already have high levels of these vitamins
• if you have high levels of calcium in your blood (hypercalcemia)
• if you have excessive calcium excretion in your urine (hypercalciuria)
• if you are taking vitaminA (retinol) from other sources or derivatives of vitaminA (retinoids)
• in newborns, infants and children under 11years

Warnings and precautions

Consult your doctor before starting to use Viant.

Your doctor will take special care if:

• you are taking vitamins from other sources
• you have digestive disorders
• you have liver or kidney problems
• you have pre-existing diseases and/or disorders that may cause hypercalcemia and/or hypercalciuria
• you are at risk of vitaminB12 (cianocobalamina) deficiency, e.g., if you have short bowel syndrome or an inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), if you use metformin (a medication to help treat diabetes) for more than four months, if you use proton pump inhibitors or histamine H2 receptor antagonists (medications to treat stomach ulcers or to reduce stomach acid, e.g., omeprazole, pantoprazole, etc., or ranitidine, famotidine, etc.) for more than 12 months, if you are a strict vegan or vegetarian or if you are over 75 years old
• you will be taking the vitamins for a prolonged period
• you will be taking this medication just after a long period of severe malnutrition or starvation
• you regularly consume alcohol (more than three drinks a day or more than seven drinks a week)

Call your doctor or nurse immediately if you experience signs of an allergic reaction such as sweating, skin redness, urticaria or difficulty breathing so that the infusion can be stopped immediately and appropriate treatment can be initiated.

It may be necessary to perform monitoring and additional tests, such as various blood and liver function tests to verify that your body is handling the administered vitamins properly.

Your nursing staff may also take measures to ensure that your vitamin needs are met. In addition to Viant, you may receive additional vitamins to fully meet your needs.

Children

This solution should not be administered to newborns, infants and children under 11years.

Use of Viant with other medications

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may need to take any other medication.

You should not take any medication that contains vitaminA or derivatives of vitaminA (retinoids) during treatment with Viant due to the risk of hypervitaminosisA (see section3).

Viant may interact with some medications. Inform your doctor, pharmacist or nurse if you are using any of the following:

• Acne or psoriasis medications (retinoids) such as, e.g., bexarotene or acitretin
• Medications used to treat epilepsy such as, e.g., phenobarbital, phenytoin, carbamazepine, fosphenytoin and primidone
• Medications used to treat HIV (antiretrovirals, tipranavir)
• Antibiotics
• Anti-inflammatory medications

• Antifungal medications such as, e.g., ketoconazole

• Medications used to treat seizures or bipolar disorder (anticonvulsants) such as, e.g., cycloserine, hydralazine, isoniazid, penicillamine, phenelzine, theophylline, phenytoin, carbamazepine, phenobarbital

• Ethionamide (an antibiotic used to treat tuberculosis)
• Medications that block folic acid (antifolates) such as, e.g., methotrexate, pyrimethamine
• Deferoxamine (a medication to treat iron poisoning)
• Medications that may cause increased pressure in the brain (some tetracyclines)
• Medications to prevent blood clotting (acenocoumarol, warfarin, phenprocoumon)
• Fluoropyrimidines (medications used to treat cancer)

Viant and laboratory tests

Do not have Viant administered directly before a blood glucose test or urine test, as it contains vitaminC, which may make your results inaccurate.

Viant contains 0.06 mg of biotin per vial. If you are to undergo laboratory tests, inform your doctor or the laboratory staff that you are receiving or have recently received Viant, as biotin may affect the results of these tests. Depending on the test, the results may show false elevations or false reductions due to biotin. Your doctor will be able to advise you to stop receiving Viant before undergoing laboratory tests. You should also be aware that other products you may be taking, such as multivitamin preparations or hair, skin and nail supplements, may also contain biotin and affect the results of laboratory tests. Inform your doctor or the laboratory staff if you are taking these types of products.

Pregnancy, breastfeeding and fertility

Pregnancy

You may receive Viant during pregnancy if necessary, always following the recommended indication and dosage to avoid excessive vitamin intake.

Do not exceed the recommended daily dose, as high doses of vitaminA during pregnancy may cause fetal malformations.

Breastfeeding

It is not recommended to use Viant if you are breastfeeding. If you are breastfeeding during treatment with Viant, there is a risk that your baby may suffer from vitaminA overdose.

Fertility

No data are available on the effect of Viant on male and female fertility.

Viant and driving/operating machinery

The influence of Viant on the ability to drive and operate machinery is negligible or insignificant.

Viant contains sodium

This medication contains up to 46 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 2.3% of the maximum recommended daily sodium intake for an adult.

Viant powder must be dissolved first in a liquid solution. It will then be mixed with a larger volume of fluid (parenteral nutrition regimen, glucose solution, or electrolytes) before administration.Viant will be administered through a vein using an infusion set.

The recommended dose is 1vial per day for adults and children 11years of age or older.

If you received more Viant than you should have

The risk of vitamin overdose is higher if you are taking other vitamin supplements or if the total supplemented amount does not match your needs or if you are prone to high vitamin levels (hypervitaminosis).

The most common symptoms of an overdose are nausea, vomiting, and diarrhea. Other symptoms of acute or long-term vitamin overdose are:

• dryness and flaking of the skin
• headache, vomiting, and weakness
• jaundice
• increased intracranial pressure with symptoms such as headache, vomiting, confusion regarding time, and double vision
• coagulation disorders
• abdominal pain
• signs of kidney disease, such as pain or difficulty urinating
• high levels of calcium in the blood
• numbness, tingling, or pins and needles in the feet or hands
• lack of coordination/falls
• yellow sweat
• dark urine

Inform your doctor if you notice any of these symptoms after using Viant.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at 915620420, indicating the medication and amount ingested.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may be serious. If you experience any of the following adverse effects, inform your doctor immediately, who will stop administering this medication:

Unknown frequency (cannot be estimated from available data)

Severe allergic reactions (anaphylactoid), nausea, vomiting, diarrhea, and itching or rash at the injection site. Blood tests for liver function may be elevated.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your healthcare professional, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the label. The expiration date is the last day of the month indicated.

Storage Conditions

Storein refrigerator(between 2°C and 8°C). If stored at room temperature (not above 25°C), this medication can only be used within three months.

Viantshould not be used if the reconstituted solution is not transparent and yellow-orange in color, or if the vial shows any damage.The reconstituted solution must be used immediately.

Composition of Viant

A vial of 932mg of dry substance (powder) contains:

The other components are glycine, hydrochloric acid (for pH adjustment), sodium glycinate, soy phosphatidylcholine, and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the container

Viant is a powder for solution for infusion.It is a yellow‑orange mass or powder supplied in brown glass vials.

It is presented in packs of 5 or 10vials. Only some sizes of packaging may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

B.Braun Melsungen AG

Carl‑Braun‑Straße 1

34212 Melsungen, Germany

Manufacturer responsible:

B.Braun Melsungen AG

Am Schwerzelshof 1

34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

Phone:+49‑5661‑71‑0

Fax:+49‑5661‑71‑4567

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

B.Braun Medical SA

Ctra. Terrasa, 121

08191 Rubí (Spain)

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria, Germany, Luxembourg:Viant Pulver zur Herstellung einer Infusionslösung

Bulgaria:Viant powder for solution for infusion

Croatia:Viant prašak za otopinu za infuziju

Czech Republic, Denmark,

Estonia, Finland, Norway, Portugal,

Slovakia, Sweden:Viant

Italy:Envitavit

Poland:Viantan

Slovenia:Viant, prašek za raztopino za infundiranje

Spain:Viant polvo para solución para perfusión

United Kingdom (Northern Ireland):Nutratain

Last update of this leaflet: December 2022

For detailed information about this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Handling instructions

Strict asepsis precautions must be taken during the reconstitution and dilution of the product in an appropriate infusion solution/emulsion.

Viant must be administered slowly.

The contents of one vial must be dissolved by adding 5ml of an appropriate solvent (sterile water for injection or a 50mg/ml glucose solution or a 9mg/ml sodium chloride solution) and gently agitating to dissolve the lyophilized powder. Do not use unless the reconstituted solution is transparent and yellow‑orange in color. The reconstituted solution must be used immediately.

The powder must be completely dissolved before transferring it to:

• a 50mg/ml glucose solution
• a 9mg/ml sodium chloride solution
• a lipid emulsion
• a binary mixture for parenteral nutrition that combines glucose, electrolytes, and amino acids
• or a ternary mixture for parenteral nutrition that combines glucose, electrolytes, and solutions of amino acids and lipids

Mix the final solution well.

After adding Viant to a parenteral nutrition solution, check that no abnormal color change or precipitation, insoluble complexes, or crystals have occurred.

This medicinal product must not be mixed with other products, except those mentioned above, unless their compatibility and stability have been demonstrated.

Use only when the original packaging is intact and the container is not damaged.

For single use only. The container and unused residues must be disposed of after use. The disposal of unused medicinal product and all materials that have been in contact with it must be carried out in accordance with local regulations.

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other products.

If the co-administration of incompatible products with Viant is necessary, administration must be carried out via separate IV routes.

Adjuvants may be incompatible with parenteral nutrition solutions containing Viant.

The vitaminA and thiamine in Viant may react with bisulfites in parenteral nutrition solutions (e.g., as a result of the aggregation of mixtures), resulting in the degradation of vitaminA and thiamine.

An increase in the pH of a solution may increase the degradation of some vitamins. This must be taken into account when adding alkaline solutions to mixtures containing Viant.

The stability of folic acid may be altered when added to mixtures with high calcium concentrations.