Інструкція із застосування ENVITAVIT
Зміст інструкції
- What Envita is and what it is used for
- What you need to know before using Envita
- How to use Envita
- Possible side effects
- How to store Envita
- Contents of the pack and other information
Envita powder for solution for infusion
Read this leaflet carefully before you start to use 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
- If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Envita is and what it is used for
- 2. What you need to know before you use Envita
- 3. How to use Envita
- 4. Possible side effects
- 5. How to store Envita
- 6. Contents of the pack and other information
1. What Envita is and what it is used for
Envita is a powder for solution for infusion that is administered via intravenous drip. It contains
13 vitamins (see section 6). Envita is used to provide the daily requirement of vitamins
directly into the blood, to preserve normal bodily functions in cases where you are unable to take
vitamins normally with food.
Envita can be administered to adults and children aged 11 years or older.
2. What you need to know before using Envita
Do not use Envita:
- if you are allergic to any of the ingredients of this medicine, to peanuts, to soy or to any of the ingredients 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 calcium excretion in your 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
Talk to your doctor before using Envita.
The doctor will pay particular attention if:
- you are taking vitamins from other sources
- you have digestive disorders
- you have problems with the liver or kidneys
- you have pre-existing diseases and/or disorders that can cause hypercalcemia and/or hypercalciuria
- you are at risk of vitamin B12 (cyanocobalamin) deficiency, for example if you suffer from short bowel syndrome, inflammatory bowel disease (Crohn's disease or ulcerative colitis), if you use metformin (a medicine to treat diabetes) for more than four months, proton pump inhibitors or histamine H2 receptor antagonists (medicines to treat gastroduodenal ulcers or to reduce stomach acid like 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 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 a day or more than 7 glasses a 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 is
immediately stopped and appropriate treatment is administered.
Further checks and tests may be performed, such as various blood tests and liver function tests, to verify that your body is using the administered vitamins correctly.
The nursing staff may also take appropriate measures to ensure adequate vitamin intake
to meet your needs. In addition to Envita, you may receive other vitamins to fully cover
your needs.
Children
This solution should not be administered to newborns, infants and children under
11 years of age.
Other medicines and Envita
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or
may take any other medicine.
Due to the risk of hypervitaminosis A, no medicine containing vitamin A or vitamin A derivatives (retinoids) (see section 3) should be taken during treatment with Envita.
Envita can interact with other medicines. Tell your doctor, pharmacist or nurse if you are
using 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
- Antifungals, e.g. ketoconazole
- Medicines used to treat seizures or bipolar disorder (anticonvulsants), e.g. cycloserine, hydralazine, isoniazid, penicillamine, phenelzine, theophylline, phenytoin, carbamazepine, phenobarbital
- Etionamide (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 can cause pressure around the brain (some tetracyclines)
- Medicines used to prevent blood clotting (acenocoumarol, warfarin, phenprocoumone)
- Fluoropyrimidine (a medicine used to treat cancer)
Envita and laboratory tests
Envita should not be administered immediately before undergoing a blood glucose or
urine test, because it contains vitamin C which can lead to inaccurate results.
Pregnancy, breastfeeding and fertility
Pregnancy
If necessary, you can receive Envita during pregnancy, provided that the instructions and
dosages prescribed are followed to avoid an overdose of vitamins.
Breastfeeding
The use of Envita is not recommended if you are breastfeeding. If you breastfeed while taking Envita, the baby
may risk receiving an overdose of vitamin A.
Fertility
No data are available on the effect of Envita on male or female fertility.
Driving and operating machinery
Envita does not or negligibly alters the ability to drive vehicles and operate machinery.
Envita contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is
essentially “sodium-free”.
3. How to use Envita
Envita powder will first be dissolved in a liquid solution. Subsequently, before
administration, it will be mixed with a large volume of liquid (parenteral nutrition regimen, glucose or electrolyte solution). Envita will be administered intravenously via infusion.
The recommended dose is 1 vial per day for adults and children aged 11 years or older.
If you have received more Envita than you should
The risk of vitamin overdose is greater if you receive other vitamin supplements, if
the overall supplementation does not correspond to your needs, or if you are already predisposed to having
high vitamin levels (hypervitaminosis).
The most common symptoms of overdose are nausea, vomiting and diarrhea. Other symptoms of
prolonged or acute vitamin overdose include:
- dry and cracked skin
- headache, vomiting and weakness
- jaundice
- increased intracranial pressure, with symptoms such as headache, vomiting, temporal disorientation 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 pins and needles 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 Envita.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.
4. Possible side effects
Envita 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 everyone
will experience them.
The following side effects may be serious. If you experience any of the following
side effects, inform your doctor immediately, who will stop the administration of
this medicine:
Not known (frequency cannot be estimated based on available data)
Severe allergic (anaphylactoid) reactions, feeling unwell, vomiting, diarrhea and a feeling of
burning or rash at the injection site. Liver parameters in the blood may be
increased.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult your healthcare professional. You can also report side effects directly
through the national reporting system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Envita
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 refers to the last day of that month.
Storage conditions
Store and transport in a refrigerator (2 °C - 8 °C). If stored at room temperature (not
exceeding 25°C), this medicine can only be used for three months.
Envita must not be used if the reconstituted solution is not clear and yellow-orange
or if the vial is in any way damaged. The reconstituted solution must be used
immediately.
6. Contents of the pack and other information
What Envita contains
One vial with 932 mg of dry substance (powder) contains:
- 1. Retinol (Vitamin A) 1.01 mg 1.82 mg equivalent to Retinol (Vitamin A) 3300 IU (in the form of Retinol palmitate)
- 2. Cholecalciferol 0.005 mg equivalent to Vitamin D 200 IU
- 3. all-rac-α-tocopherol 9.11 mg (Vitamin E)
- 4. Phytomenadione 0.15 mg (Vitamin K)
- 5. Ascorbic acid 200 mg (Vitamin C)
- 6. Thiamine (Vitamin B₁) 6.00 mg (in the form of Thiamine 7.63 mg hydrochloride)
- 7. Riboflavin 3.60 mg (Vitamin B₂) 4.58 mg (in the form of Riboflavin sodium phosphate)
- 8. Pyridoxine 6.00 mg (Vitamin B₆) 7.30 mg (in the form of Pyridoxine hydrochloride)
- 9. Cyanocobalamin 0.005 mg (Vitamin B₁₂)
- 10. Folic acid 0.60 mg (Vitamin B₉)
- 11. Pantothenic acid 15.0 mg (Vitamin B₅) 14.0 mg (in the form of Despanthenol)
- 12. Biotin (Vitamin B₇) 0.06 mg
- 13. Nicotinamide 40.0 mg Vitamin B₃)
The other components are glycine, hydrochloric acid (to adjust the pH), sodium glycolate,
soy phosphatidylcholine and sodium hydroxide (to adjust the pH).
Description of the appearance of Envita and contents of the pack
Envita is a powder for solution for infusion. It is a yellow-orange mass or powder
contained in brown glass vials.
It is packaged in cartons 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 in the Member States of the European Economic Area under the
following denominations:
| I AT | Viant 932 mg Pulver zur Herstellung einer Infusionslösung |
| BE | Nutratain, Poeder voor oplossing voor infusie |
| a BG | Viant |
| i CZ | Viant |
| DE | Viant |
| z DK | Viant |
| n EE | Viant |
| ES | Viant |
| e FI | Viant |
| FR | Viant |
| g HR | Viant |
| IT | Envita |
| A LU | Viant |
| NL | Nutratain |
The following information is intended exclusively for healthcare professionals:
Instructions for handling
Strict aseptic precautions must be followed during the reconstitution and dilution of the
product in a solution/emulsion for infusion
Envita must be administered slowly.
Dissolve the contents of one vial by adding 5 mL of a suitable solvent (water for
injections or 50 mg/mL glucose solution or 9 mg/mL sodium chloride solution) and shake
gently 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 to
- 50 mg/mL glucose solution
- 9 mg/mL sodium chloride solution
- lipid emulsion
- binary mixture for parenteral nutrition containing glucose, electrolytes and amino acids
- or ternary mixture for parenteral nutrition containing glucose, electrolytes, amino acids and lipids
Carefully mix the final solution.
After adding Envita to the parenteral nutrition solution, check for any changes in color and/or precipitates, insoluble complexes or crystals.
This medicinal product must not be mixed with other medicinal products 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 remaining contents must be discarded after use.
Unused medicinal product and waste materials derived from such medicinal product must be disposed of in
accordance with local regulations.
| NO | c Viant |
| PL | Viantan |
| PT | a Viant |
| SE | Viant |
| SI | m Viant, prašek za raztopino za infundiranje |
| SK | Viant |
| UK | r Nutratain |
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 that are incompatible with Envita, administer them
via separate i.v. lines.
Additives may be incompatible with parenteral nutrition containing Envita.
The vitamin A and thiamine contained in Envita may react with bisulfites in parenteral nutrition solutions (e.g. in the case of mixtures), resulting in degradation of vitamin A
and thiamine.
Increasing the pH of a solution may increase the degradation of some vitamins. This
aspect should be taken into consideration when adding alkaline solutions to the mixture
containing Envita.
The stability of folic acid may be compromised by an increase in calcium concentration
in the mixture.
- Країна реєстрації
- Лікарська формаPowder for intravenous infusion solution, 932 MG
- Потрібен рецептТак
- Виробник
- Ця інформація надана лише для ознайомлення і не є медичною порадою. Рішення щодо лікування завжди приймає лікар.
- Альтернативи до ENVITAVITЛікарська форма: Concentrate for infusion solution, 1 G/10 MLДіюча речовина: Хлорид кальцияПотрібен рецептЛікарська форма: Concentrate for injectable/infusion solution, 500 MG/10 MLДіюча речовина: Хлорид кальцияПотрібен рецептЛікарська форма: Concentrate for infusion solution, 1 G/10 MLДіюча речовина: Хлорид кальцияВиробник: S.A.L.F. SPA LABORATORIO FARMACOLOGICOПотрібен рецепт
Аналоги ENVITAVIT в інших країнах
Препарати з тією самою діючою речовиною, доступні в інших країнах.
Аналог ENVITAVIT у Польща
Аналог ENVITAVIT у Україна
Аналог ENVITAVIT у Іспанія
Лікарі онлайн щодо ENVITAVIT
Застосування, безпека та можливість призначення рецепта — за результатами медичної оцінки.
Отримайте рецепт на ENVITAVIT онлайн
Заповніть форму за 2 хвилини
Розкажіть про симптоми, історію хвороби та потрібний препарат.
Оберіть лікаря або ми призначимо
Оберіть спеціаліста або ми підберемо найближчого доступного лікаря.
Лікар розглядає ваш випадок
Зазвичай протягом 30 хвилин. Може ставити уточнювальні запитання в чаті.
Отримайте в будь-якій аптеці
Електронний рецепт надсилається на вашу пошту — дійсний по всій Польщі.
Часті запитання
ENVITAVIT потребує рецепта в Італія. Ви можете обговорити з лікарем онлайн, чи підходить цей лікарський засіб для вашої ситуації.
ENVITAVIT виробляється компанією B. BRAUN MELSUNGEN AG. Назва бренду та упаковка можуть відрізнятися залежно від дистрибʼютора.
Лікарі, зокрема Сімейні лікарі, Психіатри, Дерматологи, Кардіологи, Ендокринологи, Гастроентерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Інфекціоністи, Алергологи, Геріатри, Педіатри, Онкологи, можуть оцінити доцільність застосування ENVITAVIT з урахуванням вашого стану та місцевих правил. Ви можете записатися на онлайн-консультацію, щоб обговорити симптоми та можливі подальші кроки.
Польща має добре розвинену систему охорони здоров'я у великих містах, таких як Варшава, Краків, Вроцлав і Гданськ. Аптеки широко доступні та працюють відповідно до чинного законодавства, забезпечуючи доступ до рецептурних препаратів.
Ви можете придбати ENVITAVIT у Варшаві, Кракові, Вроцлаві або Гданську в будь-якій аптеці за наявності дійсного рецепта.
Щоб отримати рецепт, ви можете скористатися Oladoctor:
Інші препарати з тією самою діючою речовиною () включають KALKIO KLORURO BIOINDUSTRIA L.I.M., KALKIO KLORURO GALENIKA SENESE, KALKIO KLORURO S.A.L.F.. Вони можуть відрізнятися торговою назвою або формою випуску, але містять той самий терапевтичний компонент. Перед зміною або початком прийому нового препарату варто проконсультуватися з лікарем.
















