VIANT powder for infusion solution

2. What you need to know before you use Viant

Do not use Viant:

• if you are allergic to any of the components of this medicine, peanuts, or soy, or 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 the blood (hypercalcemia)
• if you have excessive calcium excretion in the urine (hypercalciuria)
• if you are receiving vitamin A (retinol) from other sources or vitamin A derivatives (retinoids)
• in newborns, infants, and children under 11 years of age

Warnings and precautions

Consult your doctor before starting to use Viant.

Your doctor will be particularly careful if:

• you are taking vitamins from other sources
• you have digestive disorders
• you have liver or kidney problems
• you have pre-existing diseases/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 use metformin (a medicine to help treat diabetes) for more than four months, if you use proton pump inhibitors or histamine H2 receptor antagonists (medicines to treat gastroduodenal ulcers or to reduce gastric 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 of age
• you are going to take the vitamins for a prolonged period
• you are going 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 appear, such as sweating, skin redness, hives, or difficulty breathing, so that the infusion can be interrupted immediately and appropriate treatment can be initiated.

It is possible that surveillance measures and additional tests, such as various blood tests and liver function tests, will be performed to verify that your body is handling the administered vitamins properly.

The nursing staff may also take measures to ensure that your body's 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 11 years of age.

Using Viant with other medicines

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

You should not take any medicine that contains vitamin A or vitamin A derivatives (retinoids) during treatment with Viant due to the risk of vitamin A overdose (see section 3).

Viant may interact with some medicines. Tell 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 drugs 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)
• Drugs that block folic acid (antifolates), such as, e.g., methotrexate, pyrimethamine
• Deferoxamine (a drug used to treat iron poisoning)
• Drugs that can cause pressure in the brain (some tetracyclines)
• Drugs to prevent blood clotting (acenocoumarol, warfarin, phenprocoumon)
• Fluoropyrimidines (drugs used to treat cancer)

Viant and tests

Viant should not be administered directly before a blood glucose test or urine test, as it contains vitamin C, which can make your results inaccurate.

Viant contains 0.06 mg of biotin per vial. If you are going to have laboratory tests, you must inform your doctor or laboratory staff that you are receiving or have recently received Viant, as biotin can affect the results of these tests. Depending on the test, the results may show false elevations or false reductions due to biotin. Your doctor may indicate that you should stop receiving Viant before having laboratory tests. 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 the results of laboratory tests. Inform your doctor or laboratory staff if you are taking this type of product.

Pregnancy, breastfeeding, and fertility

Pregnancy

You can receive Viant during pregnancy if necessary, provided that the indication and dosage are observed to avoid an overdose of vitamins.

Do not exceed the recommended daily dose, as high doses of vitamin A during pregnancy can cause fetal malformations.

Breastfeeding

The use of Viant is not recommended if you are breastfeeding. If you breastfeed during treatment with Viant, there is a risk that your baby may suffer from a vitamin A overdose.

Fertility

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

Driving and using machines

Viant has no or negligible influence on the ability to drive and use machines.

Viant contains sodium

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

3. How to use Viant

The Viant powder must be dissolved first in a liquid solution. Then, before administering it, it will be mixed with a larger volume of fluid (parenteral nutrition regimen, glucose solution, or electrolytes). Viant will be administered into a vein through a drip.

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

If you received more Viant than you should

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

The most common symptoms of 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 pressure in the brain with symptoms such as headache, vomiting, confusion about 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, tingling, or burning sensation in the feet or hands
• lack of coordination/falls
• yellow sweat
• darker urine

Tell 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, phone: 915620420, indicating the medicine and the amount ingested.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may be serious. If you experience any of the following side effects, tell your doctor immediately, who will stop administering this medicine:

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effect, talk to your healthcare professional, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es.

By reporting side 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 which is stated on the label. The expiry date is the last day of the month stated.

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 for a period of three months.

Viant should not be used if the reconstituted solution is not transparent and yellow-orange in color, or if the vial is damaged in any way. The reconstituted solution should be used immediately.

6. Contents of the pack and other information

Composition of Viant

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

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

Appearance of the product and pack contents

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

It is packed 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

Mailing address

34209 Melsungen, Germany

Phone: +49-5661-71-0

Fax: +49-5661-71-4567

You can request more information about this medicine from the local representative of the marketing authorization holder

B.Braun Medical SA

Ctra. Terrasa, 121

08191 Rubí (Spain)

This medicine 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

Date of last revision of this leaflet: December 2022

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

This information is intended only for healthcare professionals:

Handling instructions

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

Viant should be administered slowly.

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

The powder must be completely dissolved before transferring it to

• a glucose solution 50 mg/ml
• a sodium chloride solution 9 mg/ml
• 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 there has been no abnormal color change and/or that precipitates, insoluble complexes, or crystals have not appeared.

This medicine should not be mixed with other medicines, except those mentioned above, unless compatibility and stability have been demonstrated.

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

For single use. The container and unused contents should be discarded after use. The disposal of unused medicine and all materials that have come into contact with it should be carried out in accordance with local regulations.

Incompatibilities

In the absence of compatibility studies, this medicine should not be mixed with other medicines.

If co-administration of incompatible medicines with Viant is necessary, administration will be carried out through separate IV routes.

Additives may be incompatible with parenteral nutrition containing Viant.

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

An increase in the pH of a solution may increase the degradation of some vitamins. This should 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.