Viantan

Patient Information Leaflet

Viantan, powder for solution for infusion
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

1. What Viantan is and what it is used for

Viantan is a powder for solution for infusion administered intravenously via an infusion. It contains 13 vitamins (see section 6). Viantan is used to meet the daily requirement of vitamins by delivering them directly into the bloodstream, thereby maintaining normal body function in patients who are unable to take vitamins orally through food.
Viantan can be administered to adults and children aged 11 years and older.

2. Important information before using Viantan

When not to use Viantan:

• if the patient is allergic to any of the ingredients of this medicine, peanuts or soy, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient already has high levels of these vitamins;
• if the patient has too much calcium in the blood (hypercalcemia);
• if the patient excretes excessive amounts of calcium in the urine (hypercalciuria);
• if the patient is 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
Before starting treatment with Viantan, discuss this with your doctor.
Your doctor will take special precautions if the patient:

• is taking vitamins from other sources;

• has digestive disorders;

• has liver or kidney disorders;

• has a previously diagnosed disease and (or) disorder that may cause hypercalcemia and (or) hypercalciuria;

• is at risk of vitamin B12 (cyanocobalamin) deficiency, e.g. if the patient has short bowel syndrome, inflammatory bowel disease (e.g. Crohn's disease or ulcerative colitis), if the patient has been taking metformin (a medicine used to treat diabetes) for longer than four months, proton pump inhibitors or histamine H2-receptor blockers (medicines used to treat peptic ulcer disease of the stomach and duodenum or to reduce gastric acidity, e.g. omeprazole, pantoprazole, etc., or ranitidine, famotidine, etc.) for longer than 12 months, if the patient is a vegan or strict vegetarian, or if the patient is over 75 years of age;

• is taking vitamins for a prolonged period;

• is taking the medicine after a prolonged period of fasting or malnutrition;

• regularly consumes alcohol (more than 3 alcoholic drinks per day or more than 7 alcoholic drinks per week).

If symptoms of an allergic reaction occur, such as sweating, skin redness, urticaria (hives), or difficulty breathing, the doctor or nurse should be notified immediately so that the infusion can be stopped immediately and appropriate treatment initiated.
Additional monitoring and tests, including various blood tests and liver function tests, may be performed to ensure that the patient's body is properly handling the administered vitamins.
The nursing staff may also take steps to ensure that the patient receives an amount of vitamins appropriate to the body's needs. The patient may receive additional vitamins alongside Viantan to fully meet the body's requirements.

Children
The solution must not be administered to newborns, infants or children under 11 years of age.

Viantan and other medicines
Tell your doctor, pharmacist or nurse about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
During treatment with Viantan, do not take medicines containing vitamin A or vitamin A derivatives (retinoids) due to the risk of developing hypervitaminosis A (see section 3).
Viantan may interact with other medicines. The patient should inform the doctor, pharmacist or nurse if they are taking any of the following:

• medicines used to treat acne or psoriasis (retinoids), e.g. bexarotene or acitretin;
• medicines used to treat epilepsy, e.g. phenobarbital, phenytoin, carbamazepine, fosphenytoin and primidone;
• medicines used to treat HIV (antiretrovirals), e.g. tipranavir;
• antibiotics;
• anti-inflammatory medicines;
• antifungal medicines, e.g. ketoconazole;
• medicines used to treat seizures or bipolar disorder (anticonvulsants), e.g. cycloserine, hydralazine, isoniazid, penicillamine, phenelzine, theophylline, phenytoin, carbamazepine, phenobarbital;
• ethionamide (an antibiotic used to treat tuberculosis);
• medicines that block the action of folic acid (folic acid antagonists), e.g. methotrexate, pyrimethamine;
• deferoxamine (a medicine used to treat iron poisoning);
• medicines that may increase intracranial pressure (some tetracyclines);
• medicines used to prevent blood clots (acenocoumarol, warfarin, phenprocoumon);
• fluoropyrimidines (medicines used to treat cancer).

Viantan and laboratory tests
Do not administer Viantan to the patient immediately before a blood glucose test or urine test, as this medicine contains vitamin C, which may cause inaccurate test results.
One vial of Viantan contains 0.06 mg of biotin. If the patient is to undergo laboratory tests, they must inform the doctor or laboratory staff that they have recently taken Viantan, as biotin may interfere with test results. Depending on the test, results may be falsely elevated or falsely low due to biotin. The doctor may instruct the patient to stop taking Viantan before laboratory tests are performed. It should also be remembered that other products the patient may be taking, such as multivitamin preparations or dietary supplements used to improve hair, skin and nails, may also contain biotin and affect laboratory test results. If the patient is taking such products, they should inform the doctor or laboratory staff.

Pregnancy, breastfeeding and effects on fertility
Pregnancy
If necessary, a pregnant woman may receive Viantan, provided that the indications and dosage are strictly observed to avoid vitamin overdose.
The recommended daily dose should not be exceeded, as high doses of vitamin A during pregnancy may cause congenital malformations in the fetus.
Breastfeeding
Use of Viantan is not recommended during breastfeeding. If a patient is breastfeeding while taking Viantan, there is a risk of vitamin A overdose in the infant.
Effects on fertility
There are no available data on the effects of Viantan on fertility in men or women.

Driving and operating machinery
Viantan has no effect or has a negligible effect on the ability to drive and operate machinery.

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

3. How to use Viantan

Viantan in powder form must first be dissolved in a liquid solution. Then, before administration to the patient, it should be mixed with a larger volume of fluid (parenteral nutrition solution, glucose, or electrolytes). Viantan is administered intravenously by infusion.

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

Receiving a higher than recommended dose of Viantan
The risk of vitamin overdose is greater if the patient is receiving other vitamin supplements, if the total dose of supplements is not appropriate for the patient's needs, or if the patient already has a tendency towards elevated vitamin levels (hypervitaminosis).

The most common symptoms of overdose include nausea, vomiting, and diarrhoea. Other symptoms of chronic or acute vitamin overdose include:

• dry, peeling skin;
• headache, vomiting, and weakness;
• jaundice;
• increased intracranial pressure with symptoms such as headache, vomiting, confusion regarding time, and double vision;
• blood clotting disorders;
• abdominal pain;
• signs of kidney disease, such as pain during urination or difficulty urinating;
• high calcium levels in the blood;
• numbness, tingling, or prickling sensations in the feet or hands;
• lack of coordination and (or) falling;
• yellow sweat;
• darker urine.

If any of the above symptoms occur in a patient after taking Viantan, they should inform their doctor.

If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Viantan may contain traces of soy protein. Do not use this medicine if you are allergic to peanuts or soy.

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

The following adverse reactions may be serious. If any of the following adverse reactions occur, inform your doctor immediately, who will discontinue the medicine:

Unknown (frequency cannot be estimated from the available data) Severe allergic reactions (anaphylactoid reactions), nausea, vomiting, diarrhoea, and burning sensation or rash at the injection site. Increased liver function test parameters.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your healthcare professional. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Viantan

Keep the 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 refers to the last day of the stated month.
Storage conditions
Store in a refrigerator (2°C–8°C). If stored at room temperature (below 25°C), the medicine must be used within three months.
Do not use Viantan 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 pack and other information

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

1. Retinol (vitamin A) 0.99 mg, equivalent to 3300 IU of retinol (as 1.82 mg of retinyl palmitate (vitamin A))
2. Cholecalciferol 0.005 mg, equivalent to 200 IU of vitamin D
3. all-rac-α-Tocopherol 9.11 mg (vitamin E)
4. all-rac-Phytomenadione 0.15 mg (vitamin K)
5. Ascorbic acid 200 mg (vitamin C)
6. Thiamine (vitamin B(_1)) 6.00 mg (as 7.63 mg thiamine hydrochloride)
7. Riboflavin (vitamin B(_2)) 3.60 mg (as 4.58 mg riboflavin sodium phosphate hydrate)
8. Pyridoxine (vitamin B(_6)) 6.00 mg (as 7.30 mg pyridoxine hydrochloride)
9. Cyanocobalamin 0.005 mg (vitamin B(_{12}))
10. Folic acid (vitamin B(_{9})) 0.60 mg (as hydrated folic acid)
11. Pantothenic acid 15.0 mg (vitamin B(_{5})) (as 14.0 mg dexpanthenol)
12. Biotin (vitamin B(_{7})) 0.06 mg
13. Nicotinamide (vitamin B(_{3})) 40.0 mg

Other ingredients: glycine, concentrated hydrochloric acid (for pH adjustment), sodium glycocholate, phosphatidylcholine
soybean (Lipoid S 100), and sodium hydroxide (for pH adjustment).

What Viantan looks like and contents of the pack
Viantan is a powder for solution for infusion. It is an orange-yellow solid or powder supplied in vials made of amber glass.
The medicine is packaged in cardboard boxes containing 5 or 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
B. Braun Melsungen AG
Carl-Braun-Straße 1
34212 Melsungen, Germany

Manufacturer:
B. Braun Melsungen AG
Am Schwerzelshof 1
34212 Melsungen, Germany

Postal address:
34209 Melsungen, Germany
Tel.: +49-5661-71-0
Fax: +49-5661-71-4567

This medicinal product is authorised for marketing in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:

Information intended exclusively for medical professionals:
Instructions for preparing the medicinal product for administration
During reconstitution and dilution of the product in a suitable solution and (or) infusion emulsion, strict adherence to aseptic technique principles is required.
The medicinal product Viantan must be administered slowly.
The contents of the 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 if the reconstituted solution is not clear and yellow-orange in color. The reconstituted solution must be used immediately.
The powder must be completely dissolved before adding to any of the following medicinal products:

• 50 mg/ml glucose solution,
• 9 mg/ml sodium chloride solution,
• fat emulsion,
• two-component parenteral nutrition mixture containing glucose, electrolytes, and amino acids,
• or three-component parenteral nutrition mixture containing glucose, electrolytes, amino acid solutions, and lipids.

The final solution must be thoroughly mixed.
After adding the medicinal product Viantan to the parenteral nutrition solution, check for any abnormal change in color and (or) for the presence of precipitate, insoluble complexes, or crystals.
Do not mix the medicinal product with other medicinal products except those listed above, unless compatibility and stability have been demonstrated.
Use only if the original closure is intact and the container is undamaged.
For single use only. After use, the container and any unused remnants must be discarded.
Any unused remnants of the medicinal product or waste material must be disposed of in accordance with local regulations.
Pharmaceutical incompatibilities
Do not mix the medicinal product with other medicinal products, as compatibility studies have not been performed.
If simultaneous administration of drugs incompatible with the medicinal product Viantan is necessary, they should be administered through separate intravenous lines.
Additives may be incompatible with parenteral nutrition mixtures containing the medicinal product Viantan.
Vitamin A and thiamine contained in the medicinal product Viantan may react with sulfites present in parenteral nutrition solutions (e.g., originating from additives), which may lead to degradation of vitamin A and thiamine.
Elevated pH of the solution may enhance degradation of certain vitamins. This should be taken into account when adding alkaline solutions to a mixture containing Viantan.
Folic acid stability may be reduced due to increased calcium concentration in the added preparation.