powder for infusion, solution
What Viant is and what it is used for
Viant is a powder for infusion solution that is given via a drip. It contains 13 vitamins (see section 6). Viant is given directly into your blood to cover your daily need for vitamins. Viant thus maintains normal body functions in situations where you cannot get the vitamins through normal food intake.
Viant can be given to adults and children from 11 years of age.
The vitamins found in Viant may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you get Viant
You should not be given Viant:
- if you are allergic to any of the active substances in this medicine, to peanuts or soybeans, or any other ingredient in this medicine (listed in section 6)
- if you already have high levels of the vitamins contained in this medicine
- if you have too much calcium in your blood (hypercalcemia)
- if too much calcium is excreted in your urine ( hypercalciuria )
- if you receive vitamin A (retinol) from other sources or medicines containing substances similar to vitamin A ( retinoids )
- to newborns, infants, or children under 11 years of age.
Warnings and precautions
Talk to your doctor before receiving Viant.
The doctor will take special care
- if you get your vitamins from other sources
- if you have digestive disorders
- if you have liver or kidney problems
- if you already have diseases and/or disorders that can lead to hypercalcemia and/or hypercalciuria
- if you are at risk of a deficiency of B 12 – vitamin (cyanocobalamin), e.g. if you:
- have short bowel syndrome (lack of nutrient absorption as a result of bowel surgery), inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis ),
- using metformin (medicine to treat diabetes ) for more than four months,
- are using proton pump inhibitors or histamine-2 receptor blockers (medicines used to treat ulcers in the gastrointestinal tract or to reduce the acidity of gastric juice, eg omeprazole, pantoprazole, ranitidine, and famotidine) for more than 12 months,
- are vegan or strictly vegetarian,
- are older than 75 years
- if you use vitamin er for a long time
- if you receive this medicine immediately after a long period of severe starvation or malnutrition
- if you regularly drink alcohol (more than three standard glasses per day or seven standard glasses per week).
Contact a doctor or nurse immediately if you get signs of an allergic reaction such as sweating, skin redness, hives, or difficulty breathing. Infusion one will then be stopped immediately and appropriate treatment given.
Additional monitoring and tests such as various blood tests and liver function tests may be performed to check that your body is handling the vitamins you are receiving properly.
Healthcare professionals can also take steps to ensure that your vitamin needs are met. In addition to Viant, you can also get other vitamins to completely cover your needs.
Children
This solution must not be given to newborns, infants, or children under 11 years of age.
Other medicines and Viant
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Medicines containing vitamin A or substances similar to vitamin A ( retinoids ) must not be taken during treatment with Viant due to the risk of hypervitaminosis A (see section 3).
Viant can affect or be affected by certain other medicines. Tell your doctor, pharmacist, or nurse if you are using any of the following:
- medicines for the treatment of acne or psoriasis ( retinoids ), e.g. bexarotene or acitretin
- medicines for the treatment of epilepsy, eg phenobarbital, phenytoin, carbamazepine, fosphenytoin, and primidone
- medicines to treat HIV (antiretroviral medicines, tipranavir)
- antibiotics
- anti- inflammatory drugs
- medicines for the treatment of fungal infection, e.g. ketoconazole
- medicines to treat seizures or bipolar disorder (anticonvulsant medicines), e.g. cycloserine, hydralazine, isoniazid, penicillamine, phenelzine, theophylline, phenytoin, carbamazepine, phenobarbital
- ethionamide ( antibiotic for treating tuberculosis )
- medicines that block folic acid (folic acid antagonists), e.g. methotrexate, pyrimethamine
- deferoxamine (for treating iron poisoning)
- medicines that can increase the pressure around the brain (certain tetracyclines )
- medicines that inhibit blood coagulation (acenocoumarol, warfarin, phenprocoumon)
- fluoropyrimidine (medicine to treat cancer).
Viant and sampling
Viant should not be given to you immediately before a blood glucose or urine test, as it contains vitamin C which can lead to false test results.
Viant contains 0.06 mg of biotin per vial. If you are going to have laboratory tests, you must tell your doctor or the laboratory staff that you are taking or have recently taken Viant, because biotin can affect the results of these tests. Depending on the test used, results may be falsely elevated or falsely decreased due to biotin. The doctor may ask you to stop taking Viant before the laboratory tests. You should also be aware that other products you may be taking, such as multivitamins 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 such products.
Pregnancy, breastfeeding, and fertility
Pregnancy
If it is deemed necessary, Viant can be given during pregnancy, provided that attention is paid to the purpose of use and dosage to avoid an overdose of vitamin er.
The recommended daily dose should not be exceeded because high doses of vitamin A during pregnancy can cause malformations in the fetus.
Breast-feeding
Use of Viant is not recommended during breastfeeding. If you breastfeed during treatment with Viant, there is a risk of an overdose of vitamin A in the child.
Fertility
There are no data on the effect of Viant on male or female fertility.
Driving ability and use of machinery
Viant has no or negligible effect on the ability to drive and use machines.
Viant contains sodium
This medicine contains up to 46 mg of sodium (the main ingredient in common/table salt) per vial. This corresponds to 2.3% of the maximum recommended daily intake of sodium for adults.
How Viant is given
The Viant powder is first dissolved in a liquid. It is then mixed with a larger amount of fluid ( parenteral nutrition solution, glucose, or electrolyte solution) before it is given to you. Viant will be given as a drip into a vein.
The recommended dose for adults and children from 11 years of age is 1 vial per day.
If you have been given too much Viant
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
The risk of vitamin overdose is greater if you receive other vitamin supplements or if the total supplement does not match your needs or if you already have an increased tendency to high vitamin levels (hypervitaminosis).
The most common symptoms of overdose are nausea, vomiting, and diarrhea. Symptoms of prolonged or acute vitamin E overdose may also include:
- dry, scaly skin
- headache, vomiting, and weakness
- jaundice
- increased pressure around the brain with symptoms such as headache, vomiting, confusion about time, and double vision
- coagulation disorders
- abdominal pain
- signs of kidney disease such as pain when you urinate or difficulty urinating
- high blood calcium levels
- numbness, tingling, or tingling in the hands or feet
- lack of coordination/fall
- yellow sweat production
- darker urine
Tell your doctor if you notice any of these symptoms after receiving Viant.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects can be serious. Contact a doctor immediately if you experience any of the following side effects, and the doctor will stop the treatment:
Has been reported (occurring in an unknown number of users)
Severe allergic (anaphylactoid) reactions, nausea, vomiting, diarrhea, and burning sensation or rash at the injection site. Elevated liver values (seen in blood tests).
How Viant should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label. The expiration date is the last day of the specified month.
Storage instructions
Store in a refrigerator (2 °C–8 °C). When stored at room temperature (maximum 25 °C), the medicine is only stable for 3 months.
Viant should only be used if the prepared solution is clear and yellow-orange and if the vial is undamaged. The prepared solution should be used immediately.
Contents of the packaging and other information
Contents declaration
1 vial with 932 mg dry substance (powder) contains:
| 1. | retinol ( vitamin A )(as retinol palmitate) | 0.99 mg1.82 mg | corresponding to retinol ( vitamin A ) | 3300 IU |
| 2. | cholecalciferol | 0.005 mg | corresponding to D 3 ‑ vitamin | 200 IU |
| 3. | all-rac-α-tocopherol ( vitamin E ) | 9.11 mg | ||
| 4. | all-rac phytomenadione( Vitamin K 1 ) | 0.15 mg | ||
| 5. | ascorbic acid ( vitamin C ) | 200 mg | ||
| 6. | thiamine (B 1 – vitamin )(as thiamine hydrochloride) | 6.00 mg7.63 mg | ||
| 7. | riboflavin(B 2 – vitamin )(as riboflavin sodium phosphate) | 3.60 mg 4.58 mg | ||
| 8. | pyridoxine( Vitamin B 6 )(as pyridoxine hydrochloride) | 6.00 mg 7.30 mg | ||
| 9. | cyanocobalamin(B 12 – vitamin ) | 0.005 mg | ||
| 10. | folic acid ( vitamin B 9 ) (as folic acid hydrate) | 0.60 mg | ||
| 11. | pantothenic acid( Vitamin B 5 )(as dexpanthenol) | 15.0 mg 14.0 mg | ||
| 12. | biotin ( vitamin B 7 ) | 0.06 mg | ||
| 13. | nicotinamide(B 3 – vitamin ) | 40.0 mg |
IU = IE (International Units)
Other ingredients are glycine, hydrochloric acid (for pH adjustment), sodium glycocholate, soybean phosphatidylcholine, and sodium hydroxide (for pH adjustment).
Appearance and package sizes of the medicine
Viant is a powder for infusion solution. It is a yellow-orange cake or powder supplied in brown glass vials.
It is packaged in boxes of 5 or 10 vials. Not all pack sizes may be marketed.
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
Local representative
B. Braun Medical AB
Box 110
182 12 Danderyd