natgillin/translations-raw huggingface dataset:
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi 
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Po rekonstituciji dajte 1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje. 
After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
4.8 Medsebojno delovanje z drugimi zdravili 
4.8 Interaction with other medicinal products and other forms of interaction
Poskrbite, da je nastala suspenzija cepiva v viali z Nobivac Myxo-RHD vehiklom dobro premešana. 
Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.
Shranjujte v hladilniku (2 °C - 8 °C). 
Store in a refrigerator (2 °C - 8 °C).
4.9 Odmerjanje in pot uporabe 
4.9 Amounts to be administered and administration route
Steklena viala z 1 ali 50 odmerki zaprta z zamaškom iz halogenbutilne gume in aluminijasto zaporko. 
Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Intervet International BV, site Boxmeer Wim de Körverstraat 35 
Intervet International B.V., site Boxmeer Wim de Körverstraat 35
ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO 
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Inkompatibilnosti 
Incompatibilities:
VELIKOST PAKIRANJA 10 x 10 ml 
PACKAGE SIZE 10 x 10 ml
Vehikel (50 ml viala iz PET): 
Solvent (50 ml PET vial):
Rok uporabnosti liofilizata v pakiranju za prodajo: 
Shelf-life of the solvent as packaged for sale:
Za aktivno imunizacijo kuncev za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev (RHD), ki jo povzroča klasični 
For active immunisation of rabbits to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
50 ml viala 
50 ml vial
VELIKOST PAKIRANJA 
PACKAGE SIZE
Vehikel: bistra brezbarvna raztopina. 
Solvent: clear colourless solution.
Za aktivno imunizacijo kuncev od 5 tednov starosti dalje za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev (RHD), ki jo povzroča klasični RHD sev virusa. 
4.2 Indications for use, specifying the target species For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and to prevent mortality due to rabbit haemorrhagic disease (RHD) caused by classical RHD virus strains.
37/2010 navaja, da se MRL ne zahtevajo, ali pa velja, da niso zajete v Uredbo (ES) št. 
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
- 1 ml in 10 ml viale 
1 ml and 10 ml vial
Sev cepiva je miksoma virus, ki ima v kapsidi proteinski gen virusa hemoragične bolezni kuncev. 
The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
ATCvet: 
Lyophilisate:
- viale iz PET: Shranjujte v hladilniku (2 °C - 8 °C). 
- PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE 
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
in ne vplivajo na splošno zdravje, tek ali obnašanje kunca. 
These scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
50 odmerkov 
50 doses
s kakšnim drugim cepivom proti miksomatozi ali ki so preboleli miksomatozo, po cepljenju ne bo prišlo do pravega imunskega odgovora na hemoragično bolezen kuncev. 
Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop a proper immune response against rabbit haemorrhagic disease following vaccination.
Rekonstituirajte vialo z enim odmerkom cepiva z 1 ml Nobivac Myxo-RHD vehikla in injicirajte vso vsebino viale. 
Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
CILJNE ŽIVALSKE VRSTE 
TARGET SPECIES Rabbits
Na veterinarski recept. 
To be supplied only on veterinary prescription.
Na samcih ni bila opravljena nobena študija v zvezi z reprodukcijo. 
No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Liofilizat in vehikel za suspenzijo za injiciranje 
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
- zelo pogosti (pri več kot 1 živali od 10 živali v teku enega zdravljenja) 
− very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
ŠTEVILKA(E) DOVOLJENJA 
MARKETING AUTHORISATION NUMBER(S)
Izvlecite rekonstituirani koncentrat cepiva iz vial/e in ga injicirajte nazaj v vialo z Nobivac Myxo-RHD vehiklom. 
Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati zdravilo Nobivac Mixo-RHD, se mora posvetovati 
Any person intending to manufacture, import, possess, sell, supply and/or use Nobivac Myxo-RHD must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Miksoma virus, živi vektorski RHD sev 009: ≥10 
STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
Tako so kunci imunizirani proti miksoma virusu in proti virusu hemoragične bolezni kuncev. 
As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.
shranjujte v hladilniku (2 °C - 8 °C). 
Vaccine: Store in a refrigerator (2 °C - 8 °C).
KOLIČINA ZDRAVILNE UČINKOVINE Miksoma virus, živi, vektorski RHD 
QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
2 leti Rok uporabnosti vehikla v pakiranju za prodajo: 
Shelf-life of the lyophilisate as packaged for sale: 2 years.
Indikacije za uporabo pri ciljnih živalskih vrstah 
Special precautions for use in animals
Za stimuliranje imunosti proti miksoma virusu in proti virusu hemoragične bolezni kuncev. 
To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju 
In addition to the signs observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih 
4.5 Special precautions for use
hidrolizirana želatina pankreasni presnovek kazeina sorbitol natrijev hidrogenfosfat dihidrat 
Hydrolysed gelatine Pancreatic digest of casein Sorbitol
Intervet International BV, site De Bilt Ambachtstraat 4 
Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Večodmerna viala 
Multi-dose vial
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO 
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Cepivo: 
Pregnancy:
Poleg neželenih učinkov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju 
In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after overdose vaccination.
10 x 50 odmerkov cepiva + 10 x 10 ml steklene viale z vehiklom 10 x 50 odmerkov cepiva + 2 x 50 ml viale iz PET z vehiklom 
5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine + 10 x 10 ml glass solvent vials 10 x 50 doses of vaccine + 2 x 50 ml PET solvent vials
Brejost Študije uporabe cepiva med zgodnjo brejostjo so bile pomanjkljive, zato cepljenje v prvih 14 
Studies involving the use of the vaccine during early pregnancy were inconclusive.
imunološka zdravila za leporide, živo virusno cepivo, oznaka 
Pharmacotherapeutic group: Immunologicals for leporidae, live viral vaccine, ATCvet code: QI08AD
Brejost 
Solvent
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi 
6.1 List of excipients
IME VEHIKLA Nobivac Myxo-RHD Vehikel 
NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD
V prvih dveh tednih po cepljenju običajno opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera). 
A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Steklena viala z 1 ml ali 10 ml, ali viala iz polietilen tereftalata (PET) 
Glass vial of 1 ml or 10 ml, or polyethylene terephthalate (PET) vial of 50 ml closed with a halogenobutyl rubber stopper and aluminium cap.
Nobivac Myxo-RHD 
NAME OF THE SOLVENT Nobivac Myxo-RHD Solvent
Serija {številka} 
BATCH NUMBER Lot {number}
- steklene viale (1 ml ali 10 ml): 
Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage.
Kunci. 
Rabbits.
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) 
C. STATEMENT OF THE MRLs
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/09/2011
Vehikel: 
Fertility:
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MALIH STIČNIH 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
(kartonska škatla z 10 x 10 ml vialami (stelenimi) z vehiklom 
Cardboard box with 10 x 10 ml solvent vials (glass)
toda manj kot 10 živalih od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere) 
− very rare (less than 1 animal in 10,000 animals, including isolated reports).
(kartonska škatla z 1 x 50 ml vialo (PET) z vehiklom 
Cardboard box with 1 x 50 ml solvent vials (PET)
Kraste navadno izginejo v dveh 
The scabs usually disappear within 2 weeks after the small swellings have been observed.
cepiva + kartonska škatla z 10 x vialo z 10 ml vehikla. 
- Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Zdravilo shranjujte nedosegljivo otrokom. 
SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
s 25 x 1 odmerek cepiva in 25 x 1 vialo (stekleno) z vehiklom Kartonska škatla z 10 x 50 odmerki cepiva 
Plastic box with 5 x 1 dose of vaccine including 5 x 1 ml solvent vials (glass) Plastic box with 25 x 1 dose of vaccine including 25 x 1 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Vehikel ne 
Single-dose vial
ZA PROMET EU/2/11/132/004 
MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/004
s 25 x vialo z 1 odmerkom cepiva in 25 x vialo z 1 ml vehikla. 
- Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL) 
STATEMENT OF THE MRLs
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM” 
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
ZA PROMET EU/2/11/132/003 
MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/003
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla. 
- Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: belkasta ali krem peleta. 
Lyophilisate: off-white or cream-coloured pellet.
Število vial 
Volume
Miksoma virus, živi vektorski RHD sev 009: ≥10 
Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Po rekonstituciji dajte1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje. 
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
toda manj kot 10 živalih od 1000 živali) - redki (pri več kot 1 
− rare (more than 1 but less than 10 animals in 10,000 animals)
- 50 ml viale iz PET: 2 leti Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure 
- 50 ml PET vials: 2 years.
cepiva + 2 x kartonski škatli, vsaka z vialo 
- Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50
toda manj kot 10 živalih od 100 živali) - občasni (pri več kot 1 
− common (more than 1 but less than 10 animals in 100 animals)
Dodajte 1-2 ml Nobivac Myxo-RHD vehikla v vialo/e 
Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
Nobivac Myxo-RHD liofilizat 
PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Večodmerna viala Količina 
Injection volume
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA 
WITHDRAWAL PERIOD
s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla - Plastična škatla 
Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
OVOJNINI NALEPKA ZA VEHIKEL 
MANUFACTURER'S BATCH NUMBER Lot {number}
Datum zadnjega podaljšanja: 
WITHDRAWAL PERIOD Withdrawal period: Zero days.
ZA PROMET Z ZDRAVILOM 
PHARMACEUTICAL PARTICULARS
NEŽELENI UČINKI 
ADVERSE REACTIONS
POSEBNO(A) OPOZORILO(A), ČE JE(SO) POTREBNO(A) 
SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Viala z enkratnim odmerkom 
Single dose vial
Vrsta ovojnine in vsebina 
6.5 Nature and composition of immediate packaging
Vehikel (1 ml in 10 ml steklena viala): 
Solvent (1 ml and 10 ml glass vial): No special precautions for storage.
cepiva + kartonska škatla z 10 x vialo z 10 ml vehikla - Kartonska škatla z 10 x vialo 
- Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Повечето пациенти се възстановяват напълно след вземането на подходящи мерки. 
Most patients completely recover after appropriate measures are taken.
Приблизително 2% от радиоактивността е елиминирана в урината. 
Approximately 2% of the radioactivity was eliminated in the urine.
Това лекарство трябва да се приема веднъж дневно. 
This medicine should be taken once a day.
Трябва да поддържате редовна връзка с Вашия лекар. 
You should keep in regular contact with your doctor.
Когато се лекува отхвърляне, могат да се използват същите дози. 
When treating rejection, the same doses may be used.
Към момента няма налични други релевантни епидемиологични данни. 
To date, no other relevant epidemiological data are available.
Тези ефекти са по-чести, ако употребявате и алкохол. 
These effects are more frequent if you also drink alcohol.
- ако имате промяна в електрическата активност на сърцето, наречена “удължаване на QT 
- if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Ходът на предварително съществуващи инфекции може да се влоши. 
The course of pre-existing infections may be aggravated.
Вземете таблетката възможно най-скоро в същия ден. 
Take the tablet as soon as possible on the same day.
Въпреки това, има съобщения за случаи на спонтанен аборт. 
However, cases of spontaneous abortion have been reported.
Envarsus с храна и напитки 
Envarsus with food and drink
Не трябва да се приема двойна доза на следващия ден. 
A double dose should not be taken on the next day.
Други взаимодействия, водещи до клинично вредни ефекти 
Other interactions leading to clinically detrimental effects
Други лекарства и Envarsus 
Other medicines and Envarsus
Има няколко идентифицирани метаболита. 
There are several metabolites identified.
Свръхчувствителност към други макролиди. 
Hypersensitivity to other macrolides.
В системната циркулация само един от неактивните метаболити е наличен в ниски концентрации. 
In systemic circulation only one of the inactive metabolites is present at low concentrations.
Envarsus се използва при възрастни. 
Envarsus is used in adults.
Вашата доза зависи от общото Ви състояние и от това какви други имуносупресивни лекарства приемате. 
Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Карти на пациентите, които да се предоставят на пациентите с продукта 
• Patient cards to be given to patients with the product
Не шофирайте и не използвайте инструменти и машини, ако се чувствате замаяни или сънливи, или имате затруднения да виждате ясно след приемане на Envarsus. 
Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Envarsus.
Gonzagagasse 16/16 1010 Wien 
Gonzagagasse 16/16 1010 Wien Austria
Трябва да ограничите излагането си на слънце и на UV (ултравиолетова) светлина, докато приемате Envarsus. 
You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Envarsus.
Терапията с такролимус налага внимателно мониториране от адекватно квалифициран и екипиран персонал. 
Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel.
Образователният пакет трябва да съдържа: 
The educational pack should contain the following:
Честотата на мониториране на кръвното ниво трябва да се базира на клиничните нужди. 
The frequency of blood level monitoring should be based on clinical needs.
Трябва да се избягва използването на живи атенюирани ваксини. 
The use of live attenuated vaccines should be avoided.
Представените по-долу препоръчителни начални дози са предвидени само за насока. 
The recommended initial doses presented below are intended to act solely as a guideline.
Опитът с предозиране е ограничен. 
Experience with overdose is limited.
На пациентите трябва да се казва да не поглъщат десиканта. 
Patients should be advised not to swallow the desiccant.
Той е имуносупресор. 
It is an immunosuppressant.
Това е нужно, защото имуносупресорите биха могли да повишат риска от рак на кожата. 
This is because immunosuppressants could increase the risk of skin cancer.
Дозата може да е различна в зависимост от избраната имуносупресивна схема. 
The dose may vary depending upon the immunosuppressive regimen chosen.
Приложението трябва да започне в рамките на 24 часа след завършване на хирургичната намеса. 
Administration should commence within 24 hours after the completion of surgery.
Началната доза за предотвратяване на отхвърляне на Вашия трансплантиран орган ще се определи от Вашия лекар, изчислена според телесното Ви тегло. 
The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Съответните данни, базирани на цяла кръв, са били средно 47,6 l. 
Corresponding data based on whole blood averaged 47.6 L.
Таблетките трябва да се поглъщат цели с чаша вода. 
The tablets should be swallowed whole with a glass of water.
Преди пускането на пазара във всяка държава членка притежателят на разрешението за употреба (ПРУ) трябва да съгласува съдържанието и формата на програмата за обучение с националния компетентен орган. 
Prior to launch in each Member State, the Marketing Authorisation Holder MAH shall agree the content and format of the educational programme with the national competent authority.
Образователни материали за медицински специалисти 
• Educational material for Healthcare Professionals
Употребата на Envarsus не се препоръчва при деца и юноши под 18-годишна възраст. 
The use of Envarsus is not recommended in children and adolescents under 18 years.
При здрави участници средният полуживот в цяла кръв е приблизително 30 часа. 
In healthy subjects, the mean half-life in whole blood is approximately 30 hours.
Както при други мощни имуносупресивни вещества, рискът от вторичен рак е неизвестен (вж. точка 4.8). 
As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Безопасността и ефикасността на Envarsus при деца на възраст под 18 години все още не са установени. 
The safety and efficacy of Envarsus in children below 18 years of age have not yet been established.
Полуживотът на такролимус е дълъг и вариабилен. 
The half-life of tacrolimus is long and variable.
Сравненията на концентрациите от публикациите в литературата с индивидуалните стойности в клиничната практика трябва да се оценят с внимание и знание за използваните тестови методи. 
Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Трябва да се правят корекции на дозата, за да се гарантира поддържане на подобна системна експозиция след преминаването. 
Dose adjustments should be made to ensure that similar systemic exposure is maintained after the switch.
Поради това, Вие може да бъдете попредразположени към инфекции, докато приемате Envarsus. 
Therefore, you may be more prone to infections while you are taking Envarsus.
Другите метаболити имат само слаба имуносупресивна активност или нямат такава. 
The other metabolites have only weak or no immunosuppressive activity.
Ако външният вид на това лекарство не е както обикновено или ако инструкциите за дозата са се променили, веднага кажете на Вашия лекар или фармацевт, за да се уверите, че имате правилното лекарство. 
If the appearance of this medicine is not the same as usual, or if doe instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Ако се получи предозиране, трябва да се проведат общи поддържащи мерки и симптоматично лечение. 
If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Както при други имуносупресивни средства, поради потенциалния риск от злокачествени кожни промени, излагането на слънчева светлина и UV светлина трябва да се ограничи чрез носене на предпазно облекло и използване на слънцезащитен крем с висок фактор на защита. 
As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Лечението с такролимус може да се обмисли при бременни жени, когато няма по-безопасна алтернатива и когато предвижданата полза оправдава потенциалния риск за плода. 
Tacrolimus treatment can be considered in pregnant women when there is no safer alternative, and when the perceived benefit justifies the potential risk to the foetus.
Такролимус понижава защитните механизми на организъм Ви (имунната система), която няма да е толкова силна при борбата с инфекции. 
Tacrolimus reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Тъй като не могат да се изключат вредни ефекти върху новороденото, жените не трябва да кърмят, докато приемат 
As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Envarsus.
Носете подходящо предпазно облекло и използвайте слънцезащитен крем с висок защитен фактор. 
Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
След трансплантирането на бъбрек или черен дроб, имунната система на организъм Ви ще се опита да отхвърли новия орган. 
Following your kidney or liver transplant, your body's immune system will try to reject the new organ.
Освен това, могат да се получат синергични/адитивни нефротоксични ефекти. 
In addition, synergistic/additive nephrotoxic effects can occur.
Това лекарство трябва да Ви бъде предписано само от лекар с опит в лечението на пациенти с трансплантати. 
This medicine should only be prescribed for you by a doctor with experience in the treatment of transplant patients.
Колко Envarsus трябва да приемам 
How much Envarsus do I have to take