Envitavit

Package leaflet: Information for the user

Envitavit powder for solution for infusion

Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Envitavit is and what it is used for

Envitavit is a powder for solution for infusion administered by intravenous drip. It contains 13 vitamins (see section 6). Envitavit is used to provide the daily requirement of vitamins directly into the bloodstream, in order to maintain normal body functions when you are unable to take in vitamins normally through food.
Envitavit can be administered to adults and children aged 11 years and older.

2. What you need to know before using Envitavit

Do not use Envitavit:

• if you are allergic to any of the ingredients of this medicine, to peanuts, soy, or to any of the components 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 using Envitavit.
Your doctor will pay particular attention 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 conditions that may cause hypercalcemia and/or hypercalciuria
• you are at risk of vitamin B12 (cyanocobalamin) deficiency, for example if you have short bowel syndrome, inflammatory bowel disease (Crohn’s disease or ulcerative colitis), if you are taking

metformin (a medicine used to treat diabetes) for more than four months, proton pump
inhibitors or histamine H receptor antagonists (medicines used to treat gastroduodenal ulcers or
to reduce gastric acidity such as omeprazole, pantoprazole, etc., or ranitidine,
famotidine, etc.) for more than 12 months, if you are vegan or strictly vegetarian, or if you are over 75 years old

• you take vitamins for prolonged periods
• you take this medicine immediately after a long period of severe fasting or malnutrition
• you regularly consume alcohol (more than 3 glasses per day or more than 7 glasses per week)

Contact your doctor or nurse immediately if you experience signs of an allergic reaction such as
sweating, skin redness, hives, or difficulty breathing, so that the infusion can be stopped
immediately and appropriate treatment administered.
Additional monitoring and tests may be performed, for example various blood tests and liver function tests, to
ensure your body is properly utilizing the administered vitamins.
The nursing staff may also take appropriate measures to ensure an adequate vitamin supply according to your needs. In addition to Envitavit, you may receive other vitamins to fully meet your requirements.

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

Other medicines and Envitavit
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Due to the risk of hypervitaminosis A, no medicine containing vitamin A or vitamin A derivatives (retinoids) should be taken during treatment with Envitavit (see section 3).
Envitavit may interact with other medicines. Inform your doctor, pharmacist, or nurse if you are taking any of the following medicines:

• Medicines for 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, tipranavir)
• Antibiotics
• Anti-inflammatory drugs
• Antifungal medicines, e.g., ketoconazole
• Medicines used to treat seizures or bipolar disorders (anticonvulsants), e.g., cycloserine, hydralazine, isoniazid, penicillamine, phenelzine, theophylline, phenytoin, carbamazepine, phenobarbital
• Ethionamide (an antibiotic used to treat tuberculosis)
• Medicines that block folic acid (antifolates), e.g., methotrexate, pyrimethamine
• Deferoxamine (a medicine used to treat iron poisoning)
• Medicines that may cause increased pressure around the brain (some tetracyclines)
• Medicines used to prevent blood clotting (acenocoumarol, warfarin, phenprocoumon)
• Fluoropyrimidines (a medicine used to treat cancer)

Envitavit and laboratory tests
Envitavit must not be administered immediately before undergoing blood glucose or urine tests, as it contains vitamin C which may lead to inaccurate results.
Envitavit contains 0.06 mg of biotin per vial. If you are scheduled for laboratory tests, you must inform your doctor or laboratory personnel that you are taking or have recently taken Envitavit, because biotin can affect the results of such tests. Depending on the test used, results may be falsely elevated or falsely low due to biotin. Your doctor may ask you to stop taking Envitavit before undergoing laboratory tests. You should also be aware that other products you may be taking, such as multivitamin complexes or supplements for hair, skin, and nails, may contain biotin and affect laboratory test results. Inform your doctor or laboratory personnel if you are taking such products.

Pregnancy, breastfeeding, and fertility
Pregnancy
If necessary, you may receive Envitavit during pregnancy, provided that prescribed indications and dosages are followed 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 Envitavit is not recommended if you are breastfeeding. If you breastfeed while taking Envitavit, the infant may be exposed to an overdose of vitamin A.

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

Driving and using machines
Envitavit does not alter or alters negligibly the ability to drive vehicles and use machines.

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

3. How to use Envitavit

The Envitavit powder will first be dissolved in a liquid solution. Subsequently, prior to administration, it will be mixed with a large volume of fluid (parenteral nutrition regimen, glucose solution, or electrolyte solution). Envitavit will be administered intravenously by infusion.
The recommended dose is 1 vial per day for adults and children aged 11 years and older.
If you have received more Envitavit than you should have
The risk of vitamin overdose is higher if you are also receiving other vitamin supplements, if the total vitamin intake does not match your requirements, or if you are already predisposed to high vitamin levels (hypervitaminosis).
The most common symptoms of overdose are nausea, vomiting, and diarrhoea. Other symptoms of acute or prolonged vitamin overdose include:

• dry, cracked skin
• headache, vomiting, and weakness
• jaundice
• increased intracranial pressure, with symptoms such as headache, vomiting, temporary disorientation, and double vision
• coagulation disorders
• stomach ache
• signs of kidney disease such as pain or difficulty urinating
• elevated calcium levels in the blood
• numbness, tingling, or prickling sensations in the feet or hands
• loss of coordination/falls
• yellow sweat
• darker urine

Inform your doctor if you experience any of these symptoms after taking Envitavit.

If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Envitavit may contain traces of soy proteins. If you are allergic to peanuts or soy, do not use this medicine.
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects can be serious. If you experience any of the following side effects, inform your doctor immediately; the doctor will discontinue administration of this medicine:
Not known (frequency cannot be established from the available data)
Severe allergic (anaphylactoid) reactions, feeling unwell, vomiting, diarrhoea, and a burning sensation or skin rash at the injection site. Liver function parameters in the blood may be increased.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your healthcare professional. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Envitavit

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 refers to the last day of that month.
Storage conditions
Store in a refrigerator (2 °C - 8 °C). If stored at room temperature (not exceeding 25°C), this medicine may be used for up to three months only.
Envitavit must not be used if the reconstituted solution is not clear and yellow-orange in colour, or if the vial is in any way damaged. The reconstituted solution must be used immediately.

6. Package contents and other information

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

1. Retinol (Vitamin A) 0.99 mg equivalent to Retinol 3300 IU (as Retinol palmitate 1.82 mg (Vitamin A))
2. Colecalciferol 0.005 mg equivalent to Vitamin D 200 IU
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 Thiamine hydrochloride 7.63 mg)
7. Riboflavin 3.60 mg (Vitamin B(_2)) (as Riboflavin sodium phosphate hydrate 4.58 mg)
8. Pyridoxine (Vitamin B(_6)) 6.00 mg (as Pyridoxine hydrochloride 7.30 mg)
9. Cyanocobalamin 0.005 mg (Vitamin B(_{12}))
10. Folic acid 0.60 mg (Vitamin B(_9)) (as Folic acid hydrate)
11. Pantothenic acid 15.0 mg (Vitamin B(_5)) (as Dexpanthenol 14.0 mg)
12. Biotin (Vitamin B(_7)) 0.06 mg
13. Nicotinamide 40.0 mg (Vitamin B(_3))

The other components are glycine, hydrochloric acid (to adjust pH), sodium glycocolate, soybean phosphatidylcholine, and sodium hydroxide (to adjust pH).

Description of the appearance of Envitavit and package contents
Envitavit is a powder for solution for infusion. It is a yellow-orange powder or mass contained in brown glass vials.
It is packaged in boxes containing 5 or 10 vials. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 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, Slovak Republic, 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

The following information is intended for healthcare professionals only:
Instructions for handling
Strict aseptic precautions must be followed during reconstitution and dilution of the product into an infusion solution/emulsion.
Envitavit must be administered slowly.

Dissolve the contents of one vial 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 shake to dissolve the lyophilized powder. Use only if the reconstituted solution is clear and yellow-orange in color. The reconstituted solution must be used immediately.

The powder must be completely dissolved before transferring it into:

• 50 mg/mL glucose solution
• 9 mg/mL sodium chloride solution
• lipid emulsion
• binary parenteral nutrition mixture containing glucose, electrolytes, and amino acids
• or ternary parenteral nutrition mixture containing glucose solutions, electrolytes, amino acids, and lipids

Mix the final solution thoroughly.
After adding Envitavit to the parenteral nutrition solution, check for any color changes and/or precipitates, insoluble complexes, or crystals.

This medicinal product must not be mixed with other medicinal products except those listed 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 residual contents must be disposed of after use.

Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
If it is necessary to co-administer drugs incompatible with Envitavit, administer them via separate intravenous lines.

Additives may be incompatible with parenteral nutrition mixtures containing Envitavit.
The vitamin A and thiamine contained in Envitavit may react with bisulfites present in parenteral nutrition solutions (e.g., in mixtures), resulting in degradation of vitamin A and thiamine.
An increase in the pH of a solution may increase the degradation of certain vitamins. This should be taken into account when adding alkaline solutions to mixtures containing Envitavit.
The stability of folic acid may be compromised by an increased calcium concentration in the mixture.