FrancophonIA/ELRC3.0 huggingface dataset:
English: For proper reconstitution of the multidose vial, use the following procedure:
Bulgarian: Za pravilno rekonstitucijo večodmerne viale ravnajte, kot sledi:
English: Onset of immunity: 3 weeks.
Bulgarian: Začetek imunosti: 3 tedni
English: - 1 ml and 10 ml glass vials: 4 years.
Bulgarian: - 1 ml in 10 ml steklene viale: 4 leta
English: SPECIAL STORAGE CONDITIONS No special storage conditions.
Bulgarian: Ni posebnih pogojev shranjevanja.
English: CONTRAINDICATIONS
Bulgarian: KONTRAINDIKACIJE
English: Read the package leaflet before use.
Bulgarian: Pred uporabo preberite navodilo za uporabo.
English: Name and address of the manufacturer responsible for batch release Intervet International B.V.
Bulgarian: Ime in naslov izdelovalca, odgovornega za sprostitev serije Intervet International BV
English: Active substance:
Bulgarian: Pomožne snovi:
English: After infection with virulent myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Bulgarian: cepljenih živalih lahko pojavi nekaj zelo majhnih oteklin, posebno na neporaščenih delih telesa, ki se hitro
English: In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination.
Bulgarian: V zelo redkih primerih se v treh tednih po cepljenju lahko pojavijo blagi klinični znaki miksomatoze.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX (SOLVENT ONLY)
Bulgarian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (SAMO VEHIKEL)
English: Not all pack sizes may be marketed.
Bulgarian: Ni nujno, da so v prometu vsa navedena pakiranja.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Bulgarian: NAČIN IN POT(I) UPORABE
English: Special precautions for use in animals:
Bulgarian: POSEBNA OPOZORILA Posebna opozorila za uporabo pri živalih:
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Bulgarian: natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Bulgarian: Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: 4.1 Target species
Bulgarian: KLINIČNI PODATKI 4.1 Ciljne živalske vrste
English: None.
Bulgarian: Jih ni.
English: PACKAGE SIZE 1 x 50 ml
Bulgarian: VELIKOST PAKIRANJA 1 x 50 ml
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Bulgarian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
English: After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
Bulgarian: Po rekonstituciji dajte 1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Bulgarian: 4.8 Medsebojno delovanje z drugimi zdravili
English: Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.
Bulgarian: Poskrbite, da je nastala suspenzija cepiva v viali z Nobivac Myxo-RHD vehiklom dobro premešana.
English: Store in a refrigerator (2 °C - 8 °C).
Bulgarian: Shranjujte v hladilniku (2 °C - 8 °C).
English: 4.9 Amounts to be administered and administration route
Bulgarian: 4.9 Odmerjanje in pot uporabe
English: Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Bulgarian: Steklena viala z 1 ali 50 odmerki zaprta z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
English: Intervet International B.V., site Boxmeer Wim de Körverstraat 35
Bulgarian: Intervet International BV, site Boxmeer Wim de Körverstraat 35
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Bulgarian: ZA ODSTRANJEVANJE NEPORABLJENEGA ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: Incompatibilities:
Bulgarian: Inkompatibilnosti
English: PACKAGE SIZE 10 x 10 ml
Bulgarian: VELIKOST PAKIRANJA 10 x 10 ml
English: Solvent (50 ml PET vial):
Bulgarian: Vehikel (50 ml viala iz PET):
English: Shelf-life of the solvent as packaged for sale:
Bulgarian: Rok uporabnosti liofilizata v pakiranju za prodajo:
English: 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.
Bulgarian: Za aktivno imunizacijo kuncev za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev (RHD), ki jo povzroča klasični
English: 50 ml vial
Bulgarian: 50 ml viala
English: PACKAGE SIZE
Bulgarian: VELIKOST PAKIRANJA
English: Solvent: clear colourless solution.
Bulgarian: Vehikel: bistra brezbarvna raztopina.
English: 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.
Bulgarian: 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.
English: 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.
Bulgarian: 37/2010 navaja, da se MRL ne zahtevajo, ali pa velja, da niso zajete v Uredbo (ES) št.
English: 1 ml and 10 ml vial
Bulgarian: - 1 ml in 10 ml viale
English: The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
Bulgarian: Sev cepiva je miksoma virus, ki ima v kapsidi proteinski gen virusa hemoragične bolezni kuncev.
English: Lyophilisate:
Bulgarian: ATCvet:
English: - PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
Bulgarian: - viale iz PET: Shranjujte v hladilniku (2 °C - 8 °C).
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Bulgarian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
English: These scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
Bulgarian: in ne vplivajo na splošno zdravje, tek ali obnašanje kunca.
English: 50 doses
Bulgarian: 50 odmerkov
English: 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.
Bulgarian: s kakšnim drugim cepivom proti miksomatozi ali ki so preboleli miksomatozo, po cepljenju ne bo prišlo do pravega imunskega odgovora na hemoragično bolezen kuncev.
English: Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
Bulgarian: Rekonstituirajte vialo z enim odmerkom cepiva z 1 ml Nobivac Myxo-RHD vehikla in injicirajte vso vsebino viale.
English: TARGET SPECIES Rabbits
Bulgarian: CILJNE ŽIVALSKE VRSTE
English: To be supplied only on veterinary prescription.
Bulgarian: Na veterinarski recept.
English: No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Bulgarian: Na samcih ni bila opravljena nobena študija v zvezi z reprodukcijo.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Bulgarian: Liofilizat in vehikel za suspenzijo za injiciranje
English: − very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Bulgarian: - zelo pogosti (pri več kot 1 živali od 10 živali v teku enega zdravljenja)
English: MARKETING AUTHORISATION NUMBER(S)
Bulgarian: ŠTEVILKA(E) DOVOLJENJA
English: Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Bulgarian: Izvlecite rekonstituirani koncentrat cepiva iz vial/e in ga injicirajte nazaj v vialo z Nobivac Myxo-RHD vehiklom.
English: 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.
Bulgarian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati zdravilo Nobivac Mixo-RHD, se mora posvetovati
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
Bulgarian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Miksoma virus, živi vektorski RHD sev 009: ≥10
English: As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.
Bulgarian: Tako so kunci imunizirani proti miksoma virusu in proti virusu hemoragične bolezni kuncev.
English: Vaccine: Store in a refrigerator (2 °C - 8 °C).
Bulgarian: shranjujte v hladilniku (2 °C - 8 °C).
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
Bulgarian: KOLIČINA ZDRAVILNE UČINKOVINE Miksoma virus, živi, vektorski RHD
English: Shelf-life of the lyophilisate as packaged for sale: 2 years.
Bulgarian: 2 leti Rok uporabnosti vehikla v pakiranju za prodajo:
English: Special precautions for use in animals
Bulgarian: Indikacije za uporabo pri ciljnih živalskih vrstah
English: To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Bulgarian: Za stimuliranje imunosti proti miksoma virusu in proti virusu hemoragične bolezni kuncev.
English: 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.
Bulgarian: Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju
English: 4.5 Special precautions for use
Bulgarian: 4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih
English: Hydrolysed gelatine Pancreatic digest of casein Sorbitol
Bulgarian: hidrolizirana želatina pankreasni presnovek kazeina sorbitol natrijev hidrogenfosfat dihidrat
English: Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Bulgarian: Intervet International BV, site De Bilt Ambachtstraat 4
English: Multi-dose vial
Bulgarian: Večodmerna viala
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Bulgarian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
English: Pregnancy:
Bulgarian: Cepivo:
English: 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.
Bulgarian: Poleg neželenih učinkov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju
English: 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
Bulgarian: 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
English: Studies involving the use of the vaccine during early pregnancy were inconclusive.
Bulgarian: Brejost Študije uporabe cepiva med zgodnjo brejostjo so bile pomanjkljive, zato cepljenje v prvih 14
English: Pharmacotherapeutic group: Immunologicals for leporidae, live viral vaccine, ATCvet code: QI08AD
Bulgarian: imunološka zdravila za leporide, živo virusno cepivo, oznaka
English: Solvent
Bulgarian: Brejost
English: 6.1 List of excipients
Bulgarian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD
Bulgarian: IME VEHIKLA Nobivac Myxo-RHD Vehikel
English: A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Bulgarian: V prvih dveh tednih po cepljenju običajno opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
English: 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.
Bulgarian: Steklena viala z 1 ml ali 10 ml, ali viala iz polietilen tereftalata (PET)
English: NAME OF THE SOLVENT Nobivac Myxo-RHD Solvent
Bulgarian: Nobivac Myxo-RHD
English: BATCH NUMBER Lot {number}
Bulgarian: Serija {številka}
English: Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage.
Bulgarian: - steklene viale (1 ml ali 10 ml):
English: Rabbits.
Bulgarian: Kunci.
English: C. STATEMENT OF THE MRLs
Bulgarian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/09/2011
Bulgarian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA
English: Fertility:
Bulgarian: Vehikel:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
Bulgarian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MALIH STIČNIH
English: Cardboard box with 10 x 10 ml solvent vials (glass)
Bulgarian: (kartonska škatla z 10 x 10 ml vialami (stelenimi) z vehiklom
English: − very rare (less than 1 animal in 10,000 animals, including isolated reports).
Bulgarian: toda manj kot 10 živalih od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere)
English: Cardboard box with 1 x 50 ml solvent vials (PET)
Bulgarian: (kartonska škatla z 1 x 50 ml vialo (PET) z vehiklom
English: The scabs usually disappear within 2 weeks after the small swellings have been observed.
Bulgarian: Kraste navadno izginejo v dveh
English: - Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Bulgarian: cepiva + kartonska škatla z 10 x vialo z 10 ml vehikla.
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Bulgarian: Zdravilo shranjujte nedosegljivo otrokom.
English: 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
Bulgarian: s 25 x 1 odmerek cepiva in 25 x 1 vialo (stekleno) z vehiklom Kartonska škatla z 10 x 50 odmerki cepiva
English: Single-dose vial
Bulgarian: Vehikel ne
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/004
Bulgarian: ZA PROMET EU/2/11/132/004
English: - Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Bulgarian: s 25 x vialo z 1 odmerkom cepiva in 25 x vialo z 1 ml vehikla.
English: STATEMENT OF THE MRLs
Bulgarian: NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA ( MRL)
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Bulgarian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/003
Bulgarian: ZA PROMET EU/2/11/132/003
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Bulgarian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Bulgarian: s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla.
English: Lyophilisate: off-white or cream-coloured pellet.
Bulgarian: Liofilizat in vehikel za suspenzijo za injiciranje Liofilizat: belkasta ali krem peleta.
English: Volume
Bulgarian: Število vial
English: Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Bulgarian: Miksoma virus, živi vektorski RHD sev 009: ≥10
English: 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.
Bulgarian: Po rekonstituciji dajte1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje.
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Bulgarian: toda manj kot 10 živalih od 1000 živali) - redki (pri več kot 1
English: - 50 ml PET vials: 2 years.
Bulgarian: - 50 ml viale iz PET: 2 leti Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure
English: - Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50
Bulgarian: cepiva + 2 x kartonski škatli, vsaka z vialo
English: − common (more than 1 but less than 10 animals in 100 animals)
Bulgarian: toda manj kot 10 živalih od 100 živali) - občasni (pri več kot 1
English: Add 1 - 2 ml of Nobivac Myxo-RHD solvent to the 50-dose vaccine vial(s) and ensure that the lyophilisate is fully dissolved.
Bulgarian: Dodajte 1-2 ml Nobivac Myxo-RHD vehikla v vialo/e
English: PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Bulgarian: Nobivac Myxo-RHD liofilizat
English: Injection volume
Bulgarian: Večodmerna viala Količina
English: WITHDRAWAL PERIOD
Bulgarian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Bulgarian: s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla - Plastična škatla
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Bulgarian: OVOJNINI NALEPKA ZA VEHIKEL
English: WITHDRAWAL PERIOD Withdrawal period: Zero days.
Bulgarian: Datum zadnjega podaljšanja:
English: PHARMACEUTICAL PARTICULARS
Bulgarian: ZA PROMET Z ZDRAVILOM
English: ADVERSE REACTIONS
Bulgarian: NEŽELENI UČINKI
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Bulgarian: POSEBNO(A) OPOZORILO(A), ČE JE(SO) POTREBNO(A)
English: Single dose vial
Bulgarian: Viala z enkratnim odmerkom
English: 6.5 Nature and composition of immediate packaging
Bulgarian: Vrsta ovojnine in vsebina
English: Solvent (1 ml and 10 ml glass vial): No special precautions for storage.
Bulgarian: Vehikel (1 ml in 10 ml steklena viala):
English: - Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Bulgarian: cepiva + kartonska škatla z 10 x vialo z 10 ml vehikla - Kartonska škatla z 10 x vialo
English: Most patients completely recover after appropriate measures are taken.
Bulgarian: Повечето пациенти се възстановяват напълно след вземането на подходящи мерки.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Bulgarian: Приблизително 2% от радиоактивността е елиминирана в урината.
English: This medicine should be taken once a day.
Bulgarian: Това лекарство трябва да се приема веднъж дневно.
English: You should keep in regular contact with your doctor.
Bulgarian: Трябва да поддържате редовна връзка с Вашия лекар.
English: When treating rejection, the same doses may be used.
Bulgarian: Когато се лекува отхвърляне, могат да се използват същите дози.
English: To date, no other relevant epidemiological data are available.
Bulgarian: Към момента няма налични други релевантни епидемиологични данни.
English: These effects are more frequent if you also drink alcohol.
Bulgarian: Тези ефекти са по-чести, ако употребявате и алкохол.
English: - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Bulgarian: - ако имате промяна в електрическата активност на сърцето, наречена “удължаване на QT
English: The course of pre-existing infections may be aggravated.
Bulgarian: Ходът на предварително съществуващи инфекции може да се влоши.
English: Take the tablet as soon as possible on the same day.
Bulgarian: Вземете таблетката възможно най-скоро в същия ден.
English: However, cases of spontaneous abortion have been reported.
Bulgarian: Въпреки това, има съобщения за случаи на спонтанен аборт.
English: Envarsus with food and drink
Bulgarian: Envarsus с храна и напитки
English: A double dose should not be taken on the next day.
Bulgarian: Не трябва да се приема двойна доза на следващия ден.
English: Other interactions leading to clinically detrimental effects
Bulgarian: Други взаимодействия, водещи до клинично вредни ефекти
English: Other medicines and Envarsus
Bulgarian: Други лекарства и Envarsus
English: There are several metabolites identified.
Bulgarian: Има няколко идентифицирани метаболита.
English: Hypersensitivity to other macrolides.
Bulgarian: Свръхчувствителност към други макролиди.
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Bulgarian: В системната циркулация само един от неактивните метаболити е наличен в ниски концентрации.
English: Envarsus is used in adults.
Bulgarian: Envarsus се използва при възрастни.
English: Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Bulgarian: Вашата доза зависи от общото Ви състояние и от това какви други имуносупресивни лекарства приемате.
English: • Patient cards to be given to patients with the product
Bulgarian: Карти на пациентите, които да се предоставят на пациентите с продукта
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Envarsus.
Bulgarian: Не шофирайте и не използвайте инструменти и машини, ако се чувствате замаяни или сънливи, или имате затруднения да виждате ясно след приемане на Envarsus.
English: Gonzagagasse 16/16 1010 Wien Austria
Bulgarian: Gonzagagasse 16/16 1010 Wien
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Envarsus.
Bulgarian: Трябва да ограничите излагането си на слънце и на UV (ултравиолетова) светлина, докато приемате Envarsus.
English: Tacrolimus therapy requires careful monitoring by adequately qualified and equipped personnel.
Bulgarian: Терапията с такролимус налага внимателно мониториране от адекватно квалифициран и екипиран персонал.
English: The educational pack should contain the following:
Bulgarian: Образователният пакет трябва да съдържа:
English: The frequency of blood level monitoring should be based on clinical needs.
Bulgarian: Честотата на мониториране на кръвното ниво трябва да се базира на клиничните нужди.
English: The use of live attenuated vaccines should be avoided.
Bulgarian: Трябва да се избягва използването на живи атенюирани ваксини.
English: The recommended initial doses presented below are intended to act solely as a guideline.
Bulgarian: Представените по-долу препоръчителни начални дози са предвидени само за насока.
English: Experience with overdose is limited.
Bulgarian: Опитът с предозиране е ограничен.
English: Patients should be advised not to swallow the desiccant.
Bulgarian: На пациентите трябва да се казва да не поглъщат десиканта.
English: It is an immunosuppressant.
Bulgarian: Той е имуносупресор.
English: This is because immunosuppressants could increase the risk of skin cancer.
Bulgarian: Това е нужно, защото имуносупресорите биха могли да повишат риска от рак на кожата.
English: The dose may vary depending upon the immunosuppressive regimen chosen.
Bulgarian: Дозата може да е различна в зависимост от избраната имуносупресивна схема.
English: Administration should commence within 24 hours after the completion of surgery.
Bulgarian: Приложението трябва да започне в рамките на 24 часа след завършване на хирургичната намеса.
English: The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Bulgarian: Началната доза за предотвратяване на отхвърляне на Вашия трансплантиран орган ще се определи от Вашия лекар, изчислена според телесното Ви тегло.
English: Corresponding data based on whole blood averaged 47.6 L.
Bulgarian: Съответните данни, базирани на цяла кръв, са били средно 47,6 l.
English: The tablets should be swallowed whole with a glass of water.
Bulgarian: Таблетките трябва да се поглъщат цели с чаша вода.