Viant powder for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Viant® powder for solution for infusion

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What Viant is and what it is used for

Viant is a powder for solution for infusion administered by drip. It contains 13 vitamins (see section 6). Viant is used to supply directly into the bloodstream the vitamins your body needs each day to maintain normal bodily functions, when you are unable to obtain them through normal food intake.

Viant can be administered to adults and children aged 11 years and older.

2. What you need to know before using Viant

Do not use Viant:

• if you are allergic to any of the components of this medicine, to peanut or soya, or to any of the other components of this medicine (listed in section 6)
• if you already have high levels of these vitamins
• if you have too much calcium in your blood (hypercalcemia)
• if you have excessive excretion of calcium in the urine (hypercalciuria)
• if you are receiving vitamin A (retinol) from other sources or derivatives of vitamin A (retinoids)
• in newborns, infants, and children under 11 years of age

Warnings and precautions

Talk to your doctor before starting to use Viant.

Your doctor will be particularly cautious 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 vitamin B12 (cyanocobalamin) deficiency, e.g., if you have short bowel syndrome or inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), if you are taking metformin (a medicine used to treat diabetes) for more than four months, if you are taking proton pump inhibitors or histamine H2-receptor antagonists (medicines used to treat gastroduodenal ulcers or to reduce the acidity of gastric juices, e.g., omeprazole, pantoprazol, 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 of age
• you are planning to take the vitamins for a prolonged period
• you are planning to take this medicine immediately after a long period of starvation or severe malnutrition
• you regularly consume alcohol (more than three drinks per day or more than seven drinks per week)

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

Monitoring procedures and additional tests, such as various blood samples and liver function tests, may be performed to ensure your body is properly handling the administered vitamins.

The nursing staff may also take measures to ensure your body's vitamin requirements are met. In addition to Viant, you may receive additional vitamins to fully meet your needs.

Children

This solution must not be administered to newborns, infants, and children under 11 years of age.

Use of Viant with other medicines

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

Do not take any medicine containing vitamin A or derivatives of vitamin A (retinoids) during treatment with Viant due to the risk of hypervitaminosis A (see section 3).

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

• Medicines for acne or psoriasis (retinoids), such as, e.g., bexarotene or acitretin

• Medicines used to treat epilepsy, such as, e.g., phenobarbital, phenytoin, carbamazepine, fosphenytoin, and primidone

• Medicines used to treat HIV (antiretrovirals, tipranavir)

• Antibiotics

• Anti-inflammatory drugs

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

• Medicines 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)

• Medicines that block folic acid (antifolates), such as, e.g., methotrexate, pyrimethamine

• Deferoxamine (a medicine used to treat iron poisoning)

• Medicines that may cause increased intracranial pressure (some tetracyclines)

• Medicines to prevent blood clotting (acenocoumarol, warfarin, phenprocoumon)

• Fluoropyrimidines (medicines used to treat cancer)

Viant and laboratory tests

Viant must not be administered directly before a blood or urine glucose test, as it contains vitamin C, which may lead to inaccurate results.

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

Pregnancy, breastfeeding, and fertility

Pregnancy

You may receive Viant during pregnancy if necessary, provided the indication and dosage are observed to avoid vitamin overdose.

The recommended daily dose must not be exceeded, as high doses of vitamin A during pregnancy may cause fetal malformations.

Breastfeeding

The use of Viant is not recommended during breastfeeding. If you breastfeed while receiving Viant, there is a risk that your baby may receive an overdose of vitamin A.

Fertility

There are no data available on the effect of Viant on male or female fertility.

Driving and use of machines

The influence of Viant on the ability to drive and use machines is none or negligible.

Viant contains sodium

This medicine contains up to 46 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 2.3% of the maximum daily recommended intake of sodium for an adult.

3. How to use Viant

The Viant powder must first be dissolved in a liquid solution. It will then be mixed with a larger volume of fluid (parenteral nutrition regimen, glucose or electrolyte solution) before administration. Viant will be administered into a vein via an intravenous infusion.

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

If you have received more Viant than you should

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

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

• dryness and peeling of the skin
• headache, vomiting and weakness
• jaundice
• increased pressure in the brain with symptoms such as headache, vomiting, confusion regarding time and double vision
• coagulation disorders
• stomach pain
• signs of kidney disease, such as pain or difficulty urinating
• high levels of calcium in the blood
• numbness, pricking or tingling sensations in the feet or hands
• lack of coordination/falls
• yellow sweat
• darker urine

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

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Frequency not known (cannot be estimated from available data)

Severe allergic reactions (anaphylactoid), nausea, vomiting, diarrhoea, and stinging or rash at the injection site. Liver function blood tests may be increased.

Reporting of adverse effects

If you experience any adverse effects, consult your healthcare professional, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Viant

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

Do not use this medicine after the expiry date stated on the label. The expiry date is the last day of the month indicated.

Storage conditions

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

Viant must not be used if the reconstituted solution is not clear and yellow-orange in colour, or if the vial is damaged. The reconstituted solution should be used immediately.

6. Contents of the package and other information

Composition of Viant

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

The other components are glycine, hydrochloric acid (for pH adjustment), sodium glycocholate, soybean 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 powder supplied in brown glass vials.

It is packaged in boxes of 5 or 10 vials. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

• Braun Melsungen AG

Carl-Braun-Straße 1

34212 Melsungen, Germany

Manufacturer:

• Braun Melsungen AG

Am Schwerzelshof 1

34212 Melsungen, Germany

Postal address:

34209 Melsungen, Germany

Tel.: +49-5661-71-0

Fax: +49-5661-71-4567

Further information on this medicinal product is available upon request to 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 European Economic Area member states 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 powder for solution for infusion

United Kingdom (Northern Ireland): Nutratain

Date of the most recent review of this leaflet: December 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

This information is intended for healthcare professionals only:

Handling instructions

Strict aseptic precautions must be observed during reconstitution and dilution of the product in a suitable solution/emulsion for infusion.

Viant must be administered slowly.

The contents of one vial should be dissolved by adding 5 ml of a suitable solvent (water for injections, 50 mg/ml glucose solution, or 9 mg/ml sodium chloride solution) and gently shaking to dissolve the lyophilized powder. Do not use unless the reconstituted solution is clear and yellow-orange in color. The reconstituted solution should be used immediately.

The powder must be completely dissolved before transferring it to:

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

Mix the final solution thoroughly.

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

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

Use only if the original seal is intact and the container is undamaged.

For single use only. The container and any unused residues must be discarded after use. Disposal of unused medicine and all materials that have been in contact with it must comply with local regulations.

Incompatibilities

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

If co-administration of drugs incompatible with Viant is required, administration should be performed via separate IV lines.

Additives may be incompatible with parenteral nutrition containing Viant.

Vitamin A and thiamine in Viant may react with bisulfites present in parenteral nutrition solutions (e.g., as a result of mixture additions), leading to degradation of vitamin A and thiamine.

An increase in the pH of a solution may increase the degradation of certain vitamins. This should be considered when alkaline solutions are added to mixtures containing Viant.

Folic acid stability may be compromised when added to mixtures with high calcium concentrations.