FrancophonIA/ELRC3.0 huggingface dataset:
English: Solvent (50 ml PET vial):
Croatian: Otapalo (50 ml PET bočice):
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Croatian: Čuvati izvan pogleda i dosega djece.
English: In very rare cases the appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination.
Croatian: U vrlo rijetkim slučajevima mogu se javiti blagi klinički znakovi miksomatoze 3 tjedna nakon cijepljenja.
English: In very rare cases serious hypersensitivity reactions, which may be fatal, may occur after vaccination.
Croatian: U vrlo rijetkim slučajevima nakon cijepljenja se mogu javiti ozbiljne hipersenzitivne reakcije koje mogu biti fatalne.
English: The swelling will resolve completely by 3 weeks after vaccination.
Croatian: Oteklina potpuno nestaje 3 tjedna nakon cijepljenja.
English: Hydrolysed gelatine Pancreatic digest of casein Sorbitol
Croatian: Hidrolizirana želatina Pankreasni digest kazeina Sorbitol
English: Any reconstituted vaccine remaining at the end of this time should be discarded.
Croatian: preostalo nakon tog vremena, treba odbaciti.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Croatian: SADRŽAJ, IZRAŽEN MASOM, VOLUMENOM ILI BROJEM DOZA
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the vaccine.
Croatian: Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim otapalom koje je priloženo za primjenu s proizvodom.
English: − very rare (less than 1 animal in 10,000 animals, including isolated reports).
Croatian: - vrlo rijetke (manje od 1 životinje na 10,000 životinja, uključujući izolirane slučajeve).
English: - 50 ml PET vials: 2 years.
Croatian: - 50 ml plastične PET boce: 2 godine.
English: − very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Croatian: - vrlo česte (više od 1 u 10 životinja pokazuju nuspojave za vrijeme trajanja jednog tretmana)
English: Number of vials of freeze-dried vaccine to be added
Croatian: Broj bočica liofiliziranog cjepiva, koji se mora dodati
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.
Croatian: Kunići koji su prethodno cijepljeni sa drugim mikosomatskim cjepivom ili su imali prirodnu mikosomatsku terensku infekciju ne mogu razviti odgovarajući imunološki odgovor protiv zečje hemoragijske bolesti nakon cijepljenja.
English: Solvent: - Glass vial (1 ml or 10 ml): No special precautions for storage.
Croatian: Otapalo: - Staklene bočice (1 ml ili 10 ml): Ne zahtijeva posebne temperaturne uvjete čuvanja.
English: Shelf-life after reconstitution according to directions: 4 hours
Croatian: Rok valjanosti poslije rekonstitucije prema uputi: 4 sata
English: SPECIAL STORAGE CONDITIONS No special storage conditions.
Croatian: Nema posebnih uvjeta čuvanja.
English: 50 doses
Croatian: 1 doza 50 doza
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 dose
Croatian: SADRŽAJ: TEŽINA, VOLUMEN IL BROJ DOZA
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Shelf-life of the solvent as packaged for sale:
Croatian: Rok valjanosti otapala kad je zapakirano za prodaju:
English: After reconstitution, administer 1 dose of vaccine by subcutaneous injection to rabbits from 5 weeks of age onwards.
Croatian: Nakon rekonstitucije, 1 dozu cjepiva dati subkutano kunićima od 5 tjedana starosti nadalje.
English: Intervet International B.V., site Boxmeer Wim de Körverstraat 35
Croatian: Intervet International BV Wim de Körverstraat 35
English: - PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
Croatian: - PET bočice (50 ml): Čuvati u hladnjaku (2°C - 8°C).
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.
Croatian: Pored znakova uočenih nakon cijepljenja s jednom dozom, blaga oteklina lokalnih limfnih čvorova može se pojaviti 3 dana nakon cijepljenja s prekomjernom dozom.
English: Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Croatian: Naziv i adresa proizvođača biološki djelatne tvari Intervet International BV, site De Bilt
English: Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Croatian: Živi miksoma virus, vektorski RHD soj 009: ≥103,0 i ≤106,1 FFU*
English: TARGET SPECIES Rabbits.
Croatian: CILJNE VRSTE ŽIVOTINJA Kunići.
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.
Croatian: Za aktivnu imunizaciju kunića za smanjenje smrtnosti i kliničkih znakova miksomatoze i za sprječavanje smrtnosti zbog hemoragične bolesti kunića uzrokovana klasičnim sojem RHD virusa.
English: Solvent (1 ml and 10 ml glass vial): No special precautions for storage.
Croatian: Otapalo (1 ml i 10 ml staklene bočice): Ne zahtjeva posebne uvjete čuvanja.
English: Shelf-life after reconstitution according to directions: 4 hours.
Croatian: Rok valjanosti nakon rekonstitucije prema uputi: 4 sata.
English: TARGET SPECIES Rabbits
Croatian: CILJNE VRSTE ŽIVOTINJA Kunići
English: Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Croatian: Liofilizat: Staklena bočica od 1 ili 50 doza s halogenbutil gumenim čepom i aluminijskom kapicom.
English: Total number of rabbits that can be vaccinated
Croatian: Broj kunića koje možemo cijepiti
English: Ensure that the lyophilisate is completely reconstituted before use.
Croatian: Prije uporabe liofilizat se mora potpuno rekonstituirati.
English: Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
Croatian: Čini se da u tome do određene mjere ulogu imaju nedavne ili latentne infekcije terenskim m miksoma virusom.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Croatian: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer
English: Name and address of the manufacturer responsible for batch release Intervet International B.V.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije u promet Intervet International BV
English: Use the vaccine suspension within 4 hours of reconstitution.
Croatian: 4. Suspenziju cjepiva upotrijebiti u roku od 4 sata nakon rekonstitucije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX (SOLVENT ONLY)
Croatian: PODACI NA VANJSKOM PAKOVANJU KUTIJA ( OTAPALO)
English: PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Croatian: Nobivac Myxo-RHD liofilizat i otapalo za suspenziju za injekciju za kuniće
English: Vaccine: Store in a refrigerator (2 °C - 8 °C).
Croatian: Cjepivo: čuvati u hladnjaku (2°C - 8°C).
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection.
Croatian: Liofilizat i otapalo za suspenziju za injekciju.
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.
Croatian: Staklena bočica od 1 ml ili 10 ml, ili plastična bočica od polietilen tereftalata (PET) od 50 ml s halogenbutil gumenim čepom i aluminijskom kapicom.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
Croatian: Živi miksoma virus, vektorski RHD soj 009, ≥103,0 FFU*/doza.
English: Disodium phosphate dihydrate
Croatian: Dinatrijev fosfat dihidrat
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.
Croatian: Za aktivnu imunizaciju kunića u dobi od 5 tjedana i više, za smanjenje smrtnosti i kliničkih znakova miksomatoze i za sprječavanje smrtnosti zbog hemoragične bolesti kunića uzrokovane klasičnim sojem RHD virusa.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
Croatian: OSNOVNI PODACI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA
English: The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
Croatian: Cjepni soj je miksoma virus, koji sadrži gen za kapsidni protein virusa hemoragične bolesti kunića.
English: SC
Croatian: S.C.
English: A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Croatian: U prva dva tjedna nakon cijepljenja, na mjestu injiciranja često nastaje manja oteklina koja nije bolna (najvećeg promjera do 2 cm).
English: Lyophilisate: off-white or cream-coloured pellet.
Croatian: Liofilizat: bjelkasta do kremasta peleta.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use.
Croatian: PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA Pročitati uputu o VMP prije primjene.
English: Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Croatian: Rekonstituirani koncentrat cjepiva izvući iz bočice(a) i vratiti u bočicu s Nobivac Myxo RHD
English: No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Croatian: Plodnost: Ispitivanja neškodljivosti na reprodukciju mužjaka nisu provedena.
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Croatian: - rijetke (više od 1 ali manje od 10 životinja na 10,000 životinja)
English: Cardboard box with 10 x 10 ml solvent vials (glass)
Croatian: Kartonska kutija sa 10x10 ml (staklenih) bočica otapala
English: Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
Croatian: Rekonstituirati bočicu s jednom dozom cjepiva s 1 ml Nobivac Myxo RHD otapala i upotrijebiti sav sadržaj bočice.
English: 4.1 Target species
Croatian: 4.2 Indikacije za primjenu, navesti ciljne vrste životinja
English: NAME OF THE SOLVENT Nobivac Myxo-RHD Solvent
Croatian: Nobivac Myxo-RHD
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
Croatian: Plastična kutija s 5 x 1 dozom cjepiva i 5x1 ml (staklenih) bočica otapala Plastična kutija s 25 x 1 dozom cjepiva i 25x1 ml (staklenih) bočica otapala
English: To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Croatian: Za poticanje imunosti protiv virusa miksomatoze i virusa hemoragične bolesti kunića.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Croatian: PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: Ensure that the resulting vaccine suspension in the Nobivac Myxo-RHD solvent vial is properly mixed.
Croatian: Paziti da se nastala suspenzija cjepiva u bočici s Nobivac Myxo RHD otapalom dobro promiješa.
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
Croatian: 25 x 1 doza cjepiva i otapala 10 x 50 doza cjepiva ; 10 ml staklena bočica s otapalom 10 x 50 doza cjepiva -;50 ml PET bočica s otapalom
English: 4.4 Special warnings for each target species
Croatian: 12. POSEBNO(A) UPOZORENJE(A) Posebna upozorenja za svaku od ciljnih vrsta životinja:
English: Cardboard box with 1 x 50 ml solvent vials (PET)
Croatian: Kartonska kutija sa 1x50 ml (PET) bočica otapala
English: Solvent
Croatian: KARENCIJA
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/001-004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/132/001-004
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals)
Croatian: - manje česte (više od 1 ali manje od 10 životinja na 1000 životinja)
English: As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.
Croatian: Tako su kunići imunizirani i protiv miksoma virusa i protiv virusa hemoragične bolesti kunića.
English: ADVICE ON CORRECT ADMINISTRATION Ensure that the lyophilisate is completely reconstituted before use.
Croatian: Prije primjene liofilizat se mora potpuno rekonstituirati.
English: WITHDRAWAL PERIOD Zero days.
Croatian: Karencija: nula dana
English: Single-dose vial
Croatian: Višedozna bočica
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
Croatian: Miksoma virus, živi, vektorski RHD
English: Injection volume
Croatian: Količina otapala
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.
Croatian: Za pravilnu rekonstituciju višedozne bočice, koristiti sljedeći postupak: 1. Dodati 1 - 2 ml Nobivac Myxo RHD otapala u bočicu(e) s 50 doza cjepiva i paziti da se liofilizat potpuno otopi.
English: Single dose vial
Croatian: Bočice s pojedinačnom dozom
English: PACKAGE SIZE 1 x 50 ml
Croatian: VELIČINA PAKOVANJA 1x 50 ml CILJNE VRSTE ŽIVOTINJA Kunići
English: EXPIRY DATE EXP {month/year} Once reconstituted use within 4 hours.
Croatian: Rekonstituirano cjepivo upotrijebiti unutar 4 sata.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/004
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U 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.
Croatian: Plastična kutija s bočicom od 25 x 1 dozom cjepiva i 25 x 1 ml otapala.
English: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Croatian: Plastična kutija s bočicom od 5 x 1 dozom cjepiva i 5 x 1 ml otapala.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/11/132/003
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/11/132/003
English: Fertility:
Croatian: Otapalo:
English: - Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50 ml vial of solvent.
Croatian: Kartonska kutija s bočicom od 10 x 50 doza cjepiva; 2 x kartonske kutije od koje svaka po 50 ml otapala.
English: - Cardboard box with 10 x 50 doses vial of vaccine + cardboard box with 10 x 10 ml vial of solvent.
Croatian: Kartonska kutija s bočicom od 10 x 50 doza cjepiva; kutija s 10 bočica x 10 ml otapala.
English: The frequency of adverse reactions is defined using the following convention:
Croatian: Učestalost nuspojava je određena prema slijedećim pravilima:
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Croatian: Otapalo: Dinatrijev fosfat dihidrat
English: 6.2 Incompatibilities
Croatian: Voda za injekcije 6.2 Inkompatibilnosti
English: - Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50
Croatian: Kartonska kutija s bočicom od 10 x 50 doza cjepiva; 2 kutije, svaka po 50 ml otapala
English: PACKAGE SIZE 10 x 10 ml
Croatian: VELIČINA PAKOVANJA 10x 10 ml CILJNE VRSTE ŽIVOTINJA Kunići
English: − common (more than 1 but less than 10 animals in 100 animals)
Croatian: - česte (više od jedne ali manje od 10 životinja od 100 životinja) - manje česte (više od 1 ali manje od 10 životinja na 1000 životinja)
English: 1 ml and 10 ml vial
Croatian: bočica sa 1 ml ili 10 ml
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN” Keep out of the sight and reach of children.
Croatian: 14. RIJEČI “ČUVATI IZVAN DOSEGA
English: Most patients completely recover after appropriate measures are taken.
Croatian: Većina se bolesnika potpuno oporavi nakon što se poduzmu odgovarajuće mjere.
English: To date, no other relevant epidemiological data are available.
Croatian: Do danas, nisu dostupni drugi relevanti epidemiološki podaci.
English: This medicine should be taken once a day.
Croatian: Ovaj lijek morate uzimati jedanput na dan.
English: • Educational material for Healthcare Professionals
Croatian: • Edukacijski materijal za zdravstvene djelatnike
English: These effects are more frequent if you also drink alcohol.
Croatian: Takvi se učinci češće javljaju ako se konzumira i alkohol.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Croatian: Približno 2% radioaktivnosti eliminirano je mokraćom.
English: There are several metabolites identified.
Croatian: Identificirano je nekoliko metabolita.
English: A double dose should not be taken on the next day.
Croatian: Ne smije se uzeti dvostruka doza sljedećeg dana.
English: Stevens Johnson syndrome
Croatian: Stevens Johnsonov sindrom
English: Envarsus with food and drink
Croatian: Envarsus s hranom i pićem
English: Gonzagagasse 16/16 1010 Wien Austria
Croatian: Gonzagagasse 16/16 1010 Wien Austrija
English: The educational pack should contain the following:
Croatian: Edukacijski paket bi trebao sadržavati sljedeće:
English: Take the tablet as soon as possible on the same day.
Croatian: Uzmite tabletu čim je moguće prije isti dan.
English: The tablets should be swallowed whole with a glass of water.
Croatian: Tablete morate progutati cijele uz čašu vode.
English: Please contact your doctor immediately, should you experience severe effects.
Croatian: Molimo, odmah se obratite Vašem liječniku ako iskusite teške nuspojave.
English: Prevention and management should be in accordance with appropriate clinical guidance.
Croatian: Prevencija i liječenje trebaju biti u skladu s odgovarajućim kliničkim smjernicama.
English: The recommended initial doses presented below are intended to act solely as a guideline.
Croatian: Niže navedene preporučene početne doze služe isključivo kao smjernice.
English: Hypersensitivity to other macrolides.
Croatian: Preosjetljivost na druge makrolide.
English: What Envarsus is and what it is used for
Croatian: Što je Envarsus i za što se koristi
English: Once daily.
Croatian: Jedanput na dan.
English: Injury, poisoning and procedural complications primary graft dysfunction
Croatian: Ozljede, trovanja i proceduralne komplikacije primarna disfunkcija presatka
English: <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If you have accidentally taken too much Envarsus, contact your doctor or nearest hospital emergency department immediately.
Croatian: Ako ste slučajno uzeli previše Envarsusa, odmah se javite liječniku ili odmah otiđite u hitnu službu najbliže bolnice.
English: Do not stop your treatment unless your doctor tells you to do so.
Croatian: Nemojte prestati s liječenjem osim ako Vam tako nije savjetovao Vaš liječnik.
English: The half-life of tacrolimus is long and variable.
Croatian: Poluvijek takrolimusa je dug i varijabilan.
English: Contents of the pack and other information What Envarsus contains
Croatian: Sadržaj pakiranja i druge informacije Što Envarsus sadrži
English: Experience with overdose is limited.
Croatian: Iskustvo s predoziranjem je ograničeno.
English: Both generalised and localised infections can occur.
Croatian: Mogu nastati generalizirane i lokalizirane infekcije.
English: Date of first authorisation: 18 July 2014 Date of latest renewal:
Croatian: Datum prvog odobrenja: 18. srpnja 2014.
English: Corresponding data based on whole blood averaged 47.6 L.
Croatian: Odgovarajući podatak iz pune krvi prosječno iznosi 47,6 l.
English: The course of pre-existing infections may be aggravated.
Croatian: Tijek postojećih infekcija može se pogoršati.
English: How long should I take the Envarsus tablets
Croatian: Koliko dugo moram uzimati tablete Envarsus
English: This is because immunosuppressants could increase the risk of skin cancer.
Croatian: Razlog tome je taj što imunosupresivi mogu povećati rizik od raka kože.
English: The use of Envarsus is not recommended in children and adolescents under 18 years.
Croatian: Ne preporučuje se primjena Envarsusa u djece i adolescenata mlađih od 18 godina.
English: In addition, synergistic/additive nephrotoxic effects can occur.
Croatian: mogu se pojaviti i sinergistički/aditivni nefrotoksični učinci.
English: Envarsus is used in adults.
Croatian: Envarsus se primjenjuje u odraslih.
English: Administration should commence within 24 hours after the completion of surgery.
Croatian: S primjenom treba započeti u roku od 24 sata nakon završetka operacije.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription and herbal preparations.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste nabavili bez liječničkog recepta i biljne pripravke.
English: The safety and efficacy of Envarsus in children below 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost Envarsusa u djece mlađe od 18 godina nije još ustanovljena.
English: How to store Envarsus 6.
Croatian: Kako čuvati Envarsus 6.
English: Clinically significant interactions have also been observed with phenobarbital.
Croatian: Klinički značajne interakcije primijećene su i s fenobarbitalom.
English: What Envarsus looks like and contents of the pack
Croatian: Kako Envarsus izgleda i sadržaj pakiranja
English: The dose may vary depending upon the immunosuppressive regimen chosen.
Croatian: Doza može varirati ovisno o odabranom imunosupresivnom režimu.
English: Envarsus is used to control your body's immune response, enabling your body to accept the transplanted organ.
Croatian: Envarsus se primjenjuje za kontrolu imunološkog odgovora Vašeg tijela, čime se Vašem tijelu omogućuje da prihvati presađeni organ.
English: Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Croatian: Nosite odgovarajuću zaštitnu odjeću i koristite sredstva za zaštitu od sunca sa visokim faktorom zaštite.
English: 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.
Croatian: Prije puštanja lijeka u promet u svakoj zemlji članici, nositelj odobrenja za stavljanje lijeka u promet dogovorit će sadržaj i oblik edukacijskog programa s nadležnim nacionalnim tijelom.
English: 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.
Croatian: Primjena takrolimusa u trudnica može se uzeti u obzir ako nema sigurnije alternative te ukoliko očekivana korist opravdava mogući rizik za fetus.
English: Dose adjustments should be made to ensure that similar systemic exposure is maintained after the switch.
Croatian: Potrebno je napraviti prilagodbe doze kako bi se osiguralo da se slična sustavna izloženost održi nakon zamjene.
English: Other medicines and Envarsus
Croatian: Drugi lijekovi i Envarsus
English: How much Envarsus do I have to take
Croatian: Koliko Envarsusa moram uzeti
English: How should I take the Envarsus tablets Envarsus is taken orally once daily, generally on an empty stomach.
Croatian: Kako trebam uzimati tablete Envarsus Envarsus se uzima kroz usta jedanput na dan, obično na prazan želudac.
English: It is not recommended that Envarsus is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Croatian: Ne preporučuje se uzimanje Envarsusa zajedno s ciklosporinom (drugi lijek koji se koristi za sprječavanje odbacivanja organa nakon presađivanja).
English: In the de novo liver transplant study, 29 subjects were treated with Envarsus.
Croatian: U ispitivanju de novo transplantacije jetre, 29 ispitanika liječeno je Envarsusom.