FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Pri kuncih, ki so bili predhodno cepljeni 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: 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.
Slovenian: Za aktivno imunizacijo kuncev za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev, ki jo povzroča klasični RHD sev virusa.
English: TARGET SPECIES Rabbits
Slovenian: CILJNE ŽIVALSKE VRSTE
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.
Slovenian: Viala z 1 ml ali 10 ml, ali plastenka iz polietilen tereftalata (PET) s 50 ml z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SESTAVIN
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.
Slovenian: Dodajte 1-2 ml Nobivac Myxo-RHD vehikla v plastenko/e s 50 odmerki cepiva in poskrbite, da se liofilizat popolnoma raztopi.
English: Vaccine: Store in a refrigerator (2 °C - 8 °C).
Slovenian: Cepivo: shranjujte v hladilniku (2 °C - 8 °C).
English: Reconstitute a single dose vial of vaccine with 1 ml of Nobivac Myxo-RHD solvent and inject the total contents of the vial.
Slovenian: Rekonstituirajte vialo z enkratnim odmerkom cepiva z 1 ml Nobivac Myxo-RHD vehikla in injicirajte vso vsebino viale.
English: - PET vial (50 ml): Store in a refrigerator (2 °C - 8 °C).
Slovenian: Vehikel (50 ml plastenak iz PET): Shranjujte v hladilniku (2 °C - 8 °C).
English: PACKAGE LEAFLET Nobivac Myxo-RHD lyophilisate and solvent for suspension for injection for rabbits
Slovenian: Nobivac Myxo-RHD liofilizat in vehikel za suspenzijo za injiciranje za kunce
English: The vaccine strain is a myxoma virus expressing the capsid protein gene of rabbit haemorrhagic disease virus.
Slovenian: Sev cepiva je miksoma virus, ki ima v kapsidi proteinski gen virusa hemoragične bolezni kuncev.
English: No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Slovenian: Na samcih ni bila opravljena nobena študija v zvezi z reprodukcijo.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Slovenian: • Pogoji ali omejitve glede varne in učinkovite uporabe zdravila za uporabo v veterinarski medicini
English: Lyophilisate: Glass vial of 1 or 50 doses closed with a halogenobutyl rubber stopper and aluminium cap.
Slovenian: Viala z 1 ali 50 odmerki z zamaškom iz halogenbutilne gume in aluminijasto zaporko.
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection
Slovenian: Liofilizat in vehikel za suspenzijo za injiciranje
English: Withdraw the reconstituted vaccine concentrate from the vial(s) and inject it back into the Nobivac Myxo-RHD solvent vial.
Slovenian: Izvlecite rekonstituirani koncentrat cepiva iz vial/e in ga injicirajte nazaj v vialo z Nobivac MyxoRHD vehiklom.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Live myxoma vectored RHD virus strain 009: ≥103.0 FFU/dose.
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Miksoma virus, živi vektorski RHD sev 009: ≥10
English: NAME OF THE SOLVENT Nobivac Myxo-RHD Solvent
Slovenian: Nobivac Myxo-RHD
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi hidrolizirana želatina pankreasni presnovek kazeina sorbitol dinatrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: − very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: - občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Myxo-RHD
Slovenian: IME VEHIKLA Nobivac Myxo-RHD vehikel
English: - 1 ml and 10 ml glass vials: 4 years.
Slovenian: • 1 ml in 10 ml steklene viale: 4 leta • 50 ml plastenke iz PET: 2 leti
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Live myxoma vectored RHD virus.
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE Miksoma virus, živi, vektorski RHD
English: For proper reconstitution of the multi-dose vial, use the following procedure:
Slovenian: Za pravilno rekonstitucijo večodmerne plastenke ravnajte, kot sledi: 1.
English: A small, non-painful swelling (max. 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Slovenian: Lahko pride do prehodnega povišanja temperature za 1-2° C. V prvih dveh tednih po cepljenju običajno opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
English: To stimulate immunity against myxoma virus and rabbit haemorrhagic disease virus.
Slovenian: Za stimulacijo imunosti proti virusu miksomatoze in proti virusu hemoragične bolezni kuncev.
English: As a consequence rabbits are immunised against both myxoma virus and rabbit haemorrhagic disease virus.
Slovenian: Tako so kunci imunizirani proti miksoma virusu in proti virusu hemoragične bolezni kuncev.
English: Solvent (50 ml PET vial):
Slovenian: Vehikel (1 ml and 10 ml viala):
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Multi-dose vial
Slovenian: Večodmerne plastenke Količina vehikla
English: − very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri 1 od 10 živali od 100 živali)
English: Solvent
Slovenian: Odmerek
English: Single dose vial
Slovenian: Viale z enkratnim odmerkom
English: Name and address of the manufacturers of the biological active substance Intervet International B.V., site De Bilt Ambachtstraat 4
Slovenian: Intervet International BV, site De Bilt
English: PHARMACEUTICAL PARTICULARS
Slovenian: Sistem farmakovigilance
English: Fertility:
Slovenian: Vehikel:
English: - Plastic box with 25 x 1 dose vial of vaccine and 25 x 1 ml vial of solvent.
Slovenian: Zloženka s 25 x vialo z 1 odmerkom cepiva in 25x vialo z 1 ml vehikla.
English: - Plastic box with 5 x 1 dose vial of vaccine and 5 x 1 ml vial of solvent.
Slovenian: Zloženka s 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 1 ml vehikla.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Injection volume
Slovenian: Več odmerkov
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
Slovenian: 5 x 1 odmerek cepiva z vehiklom 25 x 1 odmerek cepiva z vehiklom 10 x 50 odmerkov cepiva - 10 ml viale z vehiklom
English: Pregnancy:
Slovenian: Pakiranja:
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
Slovenian: Zloženka s 5 x vialo z 1 odmerkom cepiva in 5x vialo z 1 ml vehikla Zloženka s 25 x vialo z 1 odmerkom cepiva in 25x vialo z 1 ml vehikla
English: Live myxoma vectored RHD virus strain 009: ≥103.0 and ≤106.1 FFU* *Focus Forming Units
Slovenian: Miksoma virus, živi vektorski RHD sev 009: ≥10
English: PACKAGE SIZE 10 x 10 ml
Slovenian: Zloženka z 10 x vialo z 10 ml vehikla.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VACCINE VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI (OZNAKA)
English: ml vial of solvent.
Slovenian: RHD vehiklom.
English: Subcutaneous use.
Slovenian: NAVODILO ZA UPORABO
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri 1 od 10 živali od 100 živali) - občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: - Cardboard box with 10 x 50 doses vial of vaccine + 2 x cardboard boxes each containing 1 x 50
Slovenian: Zloženka z 10 x vialo s 50 odmerki cepiva 2 zloženki z 1 x vialo s 50 ml vehikla Zloženka z 10 x vialo z 10 ml vehikla
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Slovenian: Intervet International B.V.
English: PACKAGE SIZE 1 x 50 ml
Slovenian: 2 zloženki z 1 x vialo s 50 ml vehikla.
English: Date of first authorisation: 18 July 2014 Date of latest renewal:
Slovenian: Datum prve odobritve: 18. julij 2014 Datum zadnjega podaljšanja:
English: These effects are more frequent if you also drink alcohol.
Slovenian: Ti učinki so pogostejši, če skupaj pijete tudi alkohol.
English: The recommended initial doses presented below are intended to act solely as a guideline.
Slovenian: Spodaj navedeni priporočeni začetni odmerki so namenjeni le kot smernice.
English: Most patients completely recover after appropriate measures are taken.
Slovenian: Večina bolnikov po uvedbi ustreznih ukrepov povsem okreva.
English: However, cases of spontaneous abortion have been reported.
Slovenian: Vendar pa so poročali o primerih spontanega splava.
English: • Educational material for Healthcare Professionals
Slovenian: • Izobraževalno gradivo za zdravstvene delavce
English: Infection including opportunistic infections
Slovenian: Okužba vključno z oportunističnimi okužbami
English: The educational pack should contain the following:
Slovenian: Paket izobraževalnih gradiv bo vseboval naslednje:
English: Prevention and management should be in accordance with appropriate clinical guidance.
Slovenian: Preventiva in obvladovanje morajo biti v skladu z ustreznimi kliničnimi smernicami.
English: The course of pre-existing infections may be aggravated.
Slovenian: Potek obstoječih okužb se lahko poslabša.
English: - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Slovenian: - če imate spremembo električnega delovanja srca, imenovano »podaljšanje QT intervala«.
English: To date, no other relevant epidemiological data are available.
Slovenian: Drugi pomembni epidemiološki podatki za sedaj niso na voljo.
English: Gonzagagasse 16/16 1010 Wien Austria
Slovenian: Gonzagagasse 16/16 1010 Wien Avstrija
English: Other interactions leading to clinically detrimental effects
Slovenian: Druge interakcije, ki so povzročile klinično škodljive učinke
English: When treating rejection, the same doses may be used.
Slovenian: Pri zdravljenju zavrnitve se lahko uporabijo enaki odmerki.
English: Pure red cell aplasia
Slovenian: (PRCA, pure red cell aplasia).
English: You should keep in regular contact with your doctor.
Slovenian: Bodite v stalnem stiku z zdravnikom.
English: - if you are taking any medicines mentioned below under “Other medicines and Envarsus”.
Slovenian: - če jemljete katera koli zdravila, omenjena spodaj v »Druga zdravila in zdravilo Envarsus«,
English: Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Slovenian: Vaš odmerek je odvisen od vašega splošnega stanja in od tega, katera druga imunosupresivna zdravila jemljete.
English: The use of Envarsus is not recommended in children and adolescents under 18 years.
Slovenian: Uporaba zdravila Envarsus se ne priporoča pri otrocih in mladostnikih, starih manj kot 18 let.
English: Stevens Johnson syndrome
Slovenian: StevensJohnsonov sindrom
English: Hypersensitivity to other macrolides.
Slovenian: Preobčutljivost na druge makrolide.
English: This medicine should be taken once a day.
Slovenian: To zdravilo jemljite enkrat na dan.
English: If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Slovenian: Če pride do prevelikega odmerjanja, je treba uporabiti splošne podporne ukrepe in simptomatsko zdravljenje.
English: Dose adjustments should be made to ensure that similar systemic exposure is maintained after the switch.
Slovenian: Odmerek je treba prilagoditi, da se zagotovi vzdrževanje podobne sistemske izpostavljenosti po prehodu.
English: A forgotten dose should be taken as soon as possible on the same day.
Slovenian: Pozabljeni odmerek je treba nadomestiti še isti dan takoj, ko je možno.
English: Corresponding data based on whole blood averaged 47.6 L.
Slovenian: Ustrezni podatek na podlagi polne krvi je povprečno 47,6 l.
English: Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Slovenian: Nositi morate primerna zaščitna oblačila in uporabljati sredstva za sončenje z visokim zaščitnim faktorjem.
English: 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.
Slovenian: Če izgled tega zdravila ni tak, kot vedno, ali če so se navodila za odmerek spremenila, se posvetujte z zdravnikom ali farmacevtom takoj, ko je možno, in se prepričajte, ali imate pravo zdravilo.
English: In practice, tacrolimus-based therapy has been initiated 12 to 24 hours after discontinuation of ciclosporin.
Slovenian: V praksi so zdravljenje na osnovi takrolimusa začenjali od 12 do 24 ur po prekinitvi ciklosporina.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to
Slovenian: Pogostnost neželenih učinkov je opredeljena kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do
English: The tablets should be swallowed whole with a glass of water.
Slovenian: Tablete zaužijte cele s kozarcem vode.
English: Administration should commence within 24 hours after the completion of surgery.
Slovenian: Dajanje se mora začeti v roku 24 ur po koncu operacije.
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Slovenian: Pozitiven EBV-PCR lahko traja mesece in sam po sebi ni kazalec limfoproliferativne bolezni ali limfoma.
English: Envarsus with food and drink
Slovenian: Zdravilo Envarsus skupaj s hrano in pijačo
English: In healthy subjects, the mean half-life in whole blood is approximately 30 hours.
Slovenian: Pri zdravih prostovoljcih je povprečni razpolovni čas v polni krvi približno 30 ur.
English: Following your kidney or liver transplant, your body's immune system will try to reject the new organ.
Slovenian: Po presaditvi ledvice ali jeter bo imunski sistem telesa poskusil zavrniti novi organ.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Slovenian: Spremljanje najnižjih ravni v polni krvi je zato dobra ocena sistemske izpostavljenosti.
English: Envarsus is used in adults.
Slovenian: Zdravilo Envarsus se uporablja pri odraslih.
English: This medicine should only be prescribed for you by a doctor with experience in the treatment of transplant patients.
Slovenian: To zdravilo vam lahko predpiše le zdravnik, izkušen z zdravljenjem bolnikov po presaditvi.
English: Envarsus doses are usually reduced in the post-transplant period.
Slovenian: Odmerki zdravila Envarsus se med obdobjem po presaditvi običajno zmanjšajo.
English: Effect on hepatic clearance is less pronounced.
Slovenian: Učinek na jetrni očistek je manj izrazit.
English: - if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na takrolimus ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: - The clinical risks associated with over- and under-dosing.
Slovenian: - Klinična tveganja, povezana s premajhnim in prevelikim odmerjanjem.
English: Ostenfelder Strasse 51-61 D-59320 Ennigerloh Germany
Slovenian: Ostenfelder Strasse 51-61 D-59320 Ennigerloh
English: No specific antidote to tacrolimus therapy is available.
Slovenian: Specifičnega antidota za takrolimus ni na voljo.
English: A double dose should not be taken on the next day.
Slovenian: Naslednji dan bolnik ne sme vzeti dvojnega odmerka.
English: Therapeutic drug monitoring
Slovenian: Terapevtsko nadziranje zdravila
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.
Slovenian: Zdravljenje s takrolimusom pride v poštev tudi pri nosečnicah, če ni varnejše alternative in če pričakovana korist opravičuje možno tveganje za plod.
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.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z zdravili brez recepta ali zdravili rastlinskega izvora.
English: Available tacrolimus is generally rapidly absorbed.
Slovenian: Absorpcija razpoložljivega takrolimusa je običajno hitra.
English: It should be noted however, that there has been no direct experience with Envarsus in overdose.
Slovenian: Vendar je treba opozoriti, da ni neposrednih izkušenj s prevelikim odmerjanjem zdravila Envarsus.
English: Severe effects may occur, including allergic and anaphylactic reactions.
Slovenian: Pojavijo se lahko hudi neželeni učinki, vključno z alergijskimi in anafilaktičnimi reakcijami.
English: There is no evidence that male and female patients require different doses to achieve similar trough levels.
Slovenian: Ni dokazov, da bi bili pri bolnikih moškega in ženskega spola potrebni različni odmerki za dosego enakih najnižjih koncentracij.
English: During treatment, careful monitoring with EBV-PCR (Polymerase-Chain-Reaction) is recommended.
Slovenian: Med zdravljenjem je priporočljivo skrbno nadziranje z EBV-PCR (verižna reakcija s polimerazo).
English: Envarsus may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Envarsus ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Posterior reversible encephalopathy syndrome (PRES)
Slovenian: Sindrom posteriorne reverzibilne encefalopatije (PRES)
English: The combined administration of ciclosporin and tacrolimus is not recommended.
Slovenian: Kombinirana uporaba ciklosporina in takrolimusa se ne priporoča.
English: 59320 Ennigerloh Germany or
Slovenian: 59320 Ennigerloh
English: Certain combinations of tacrolimus with substances known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Slovenian: Nekatere kombinacije takrolimusa z učinkovinami z znanimi nefrotoksičnimi ali nevrotoksičnimi učinki povečajo tveganje za te učinke (glejte poglavje 4.5).
English: The Marketing Authorisation Holder should ensure that, at launch, all Healthcare Professionals who are expected to prescribe or dispense Envarsus are provided with an Educational pack.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo ob začetku trženja zdravila vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali ali izdajali zdravilo Envarsus, prejeli paket izobraževalnih gradiv.
English: The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Slovenian: Ledvice in pankreas sta bila primarna organa, prizadeta v študijah toksičnosti pri podganah in pavijanih.
English: Take the tablets immediately following removal from the blister.
Slovenian: Tablete vzemite takoj, ko jih odstranite iz pretisnega omota.
English: The dose may vary depending upon the immunosuppressive regimen chosen.
Slovenian: Odmerek zdravila lahko variira, odvisno od izbranega režima imunosupresivnega zdravljenja.
English: What you need to know before you take Envarsus 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Envarsus 3.
English: However, owing to the nephrotoxic potential of tacrolimus, careful monitoring of renal function is recommended (including serial serum creatinine concentrations, calculation of creatinine clearance, and monitoring of urine output).
Slovenian: Toda zaradi nefrotoksičnega potenciala takrolimusa je priporočljivo skrbno nadzirati delovanje ledvic (vključno z rednim določanjem koncentracije kreatinina v serumu, izračunavanjem očistka kreatinina in nadziranjem izločanja urina).
English: How much Envarsus do I have to take
Slovenian: Koliko zdravila Envarsus moram vzeti
English: Take the tablet as soon as possible on the same day.
Slovenian: Tableto vzemite še isti dan takoj,
English: Your doctor may need to adjust your dose of Envarsus or will decide to stop treatment with tacrolimus.
Slovenian: Morda bo zdravnik moral vaš odmerek zdravila Envarsus prilagoditi ali pa se bo odločil za ukinitev zdravljenja s takrolimusom.
English: After opening the aluminium foil wrapper: 45 days.
Slovenian: 30 mesecev Po odprtju ovitka iz aluminijaste folije: 45 dni.
English: This effect may be enhanced if Envarsus is administered in association with alcohol.
Slovenian: Ta učinek se lahko stopnjuje, če se zdravilo Envarsus uporablja skupaj z alkoholom.
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).
Slovenian: < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000);
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Envarsus.
Slovenian: Pri tej skupini bolnikov je pred začetkom zdravljenja z zdravilom Envarsus treba izvesti serološko testiranje na EBV-VCA.
English: Accordingly, high-risk patients receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9-12 months).
Slovenian: Glede na to je treba zelo ogrožene bolnike, ki se zdravijo z intenzivno imunosupresijo, nadzorovati s preiskavami, kot sta ehokardiografija ali EKG, in sicer pred presaditvijo in po njej (npr. uvodoma po 3 mesecih in potem pri 9 - 12 mesecih).
English: Do not use this medicine after the expiry date which is stated on the carton, blister and wrapper after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, pretisnem omotu in ovitku poleg oznake "EXP".
English: Store in the original aluminium foil wrapper in order to protect from light.
Slovenian: Shranjujte v originalnem ovitku iz aluminijaste folije za zagotovitev zaščite pred svetlobo.
English: Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Slovenian: Prepričajte se, da vsakič prejmete enako zdravilo s takrolimusom, razen če ste se z zdravnikom specialistom za presaditve dogovorili, da boste prešli na drugo zdravilo s takrolimusom.