FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Voriconazole Accord is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Vfend.
Slovenian: Ker je zdravilo Voriconazole Accord generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Vfend.
English: What is Voriconazole Accord and what is it used for?
Slovenian: Kaj je zdravilo Voriconazole Accord in za kaj se uporablja?
English: The list of fungi against which Voriconazole Accord is active can be found in the summary of product characteristics (also part of the EPAR).
Slovenian: Za seznam glivic, proti katerim deluje zdravilo Voriconazole Accord, glejte povzetek glavnih značilnosti zdravila (ki je tudi del EPAR).
English: Other information about Voriconazole Accord
Slovenian: Druge informacije o zdravilu Voriconazole Accord
English: When used for treating fungal infections, Voriconazole Accord is intended mainly for patients with worsening, possibly life-threatening, fungal infections.
Slovenian: Kadar se zdravilo Voriconazole Accord uporablja za zdravljenje glivičnih okužb, je namenjeno zlasti bolnikom, pri katerih se okužba poslabšuje in je potencialno smrtno nevarna.
English: Voriconazole Accord is an antifungal medicine that contains the active substance voriconazole.
Slovenian: Voriconazole Accord je protiglivično zdravilo, ki vsebuje zdravilno učinkovino vorikonazol.
English: Why is Voriconazole Accord approved?
Slovenian: Zakaj je bilo zdravilo Voriconazole Accord odobreno?
English: The active substance in Voriconazole Accord, voriconazole, is an antifungal medicine that belongs to the ‘triazole' group.
Slovenian: Zdravilna učinkovina zdravila Voriconazole Accord, vorikonazol, je zdravilo proti glivičnim okužbam iz skupine triazolov.
English: It is not intended to provide practical advice on how to use Voriconazole Accord.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How has Voriconazole Accord been studied?
Slovenian: Kako je bilo zdravilo Voriconazole Accord raziskano?
English: How is Voriconazole Accord used?
Slovenian: Kako se zdravilo Voriconazole Accord uporablja?
English: How does Voriconazole Accord work?
Slovenian: Kako zdravilo Voriconazole Accord deluje?
English: 2nd injection: after 3 weeks.
Slovenian: 2. injekcija: po 3 tednih
English: These clinical signs have been reported very rarely from the field.
Slovenian: Zelo redko so o teh kliničnih znakih poročali iz terena.
English: The duration of immunity is at least 1 year after the primary vaccination course.
Slovenian: Trajanje imunosti je vsaj 1 leto po osnovnem programu cepljenja.
English: ATC vet code: QI04AA02
Slovenian: Oznaka ATC vet: QI04AA02
English: EU/2/09/104/001 EU/2/09/104/002
Slovenian: EU/2/09/104/002
English: Girona SPAIN
Slovenian: Girona ŠPANIJA
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15/01/2010
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 15/01/2010
English: Date of last renewal: 07/11/2014
Slovenian: Datum podaljšanja dovoljenja za promet: 07/11/2014
English: As the duration of immunity is not yet fully established, any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Slovenian: Ker trajanje imunosti še ni dokončno ugotovljeno, se je potrebno za vsak program ponovnega cepljenja dogovoriti s pristojnimi nacionalnimi organi ali odgovornim veterinarjem, upoštevajoč pri tem epidemiološko situacijo.
English: United Kingdom Zoetis UK Limited
Slovenian: Zoetis UK Limited
English: Magyarország Zoetis Hungary Kft.
Slovenian: Zoetis Hungary Kft.
English: Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site.
Slovenian: Po dajanju dvakrat prevelikega odmerka se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
English: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pri več kot 1 živali od 10 živali med enim ciklom zdravljenja) - pogosti (pri več kot 1 a manj kot 10 živali od 100 živali) - občasni (pri več kot 1 a manj kot 10 živali od 1.000 živali) - redki (pri več kot 1 a manj kot 10 živali od 10.000 živali) - zelo redki (pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and on the label after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in nalepki po EXP.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Slovenian: NAČIN IN POT(I) UPORABE Za subkutano uporabo.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 1 leto.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity: 25 days after administration of the second dose.
Slovenian: *(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT_PCR, kar kaže, da virusni genom ni prisoten) Začetek imunosti: 25 dni po drugem odmerku.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dodecahydrate Sodium chloride
Slovenian: Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dodekahidrat Natrijev klorid
English: Pharmacotherapeutic group: Inactivated viral vaccines - bluetongue virus vaccine.
Slovenian: Farmakoterapevtska skupina: Inaktivirana protivirusna cepiva - cepivo proti virusu modrega jezika.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against BTV.
Slovenian: Pri tej kategoriji živali cepivo uporabite le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja in/ali v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrega jezika
English: Shelf-life after first opening the immediate packaging: use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: porabite takoj.
English: Portugal Zoetis Portugal, Lda.
Slovenian: Zoetis Portugal, Lda.
English: D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION The periodic safety update report (PSUR) cycle should be restarted for submission of 6 monthly reports (covering all authorised presentations of the product) for the next two years, followed by yearly reports for the subsequent two years and thereafter at 3 yearly intervals, unless otherwise required.
Slovenian: Cikel rednih posodobljenih poročil o varnosti zdravila (PSUR) se ponovno začne z oddajo šestmesečnih poročil (vključene so vse odobrene oblike zdravila) v obdobju naslednjih dveh let, ki mu sledi oddaja dveh letnih poročil za naslednji dve leti, po tem obdobju pa se poročila oddajajo v triletnih obdobjih , razen če je zahtevano drugače.
English: Aluminium hydroxide (Al3+)
Slovenian: Dodatek: Aluminijev hidroksid (Al3+)
English: Any person intending to manufacture, import, possess, sell, supply and use ZULVAC 8 Ovis 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.
Slovenian: Vsakdo, ki namerava izdelovati,uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati ZULVAC 8 Ovis, se mora posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja še pred izdelavo, uvozom oziroma vnosom, posedovanjem, prodajo,
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02
Slovenian: Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
English: Special precautions for use in animals: Only use in healthy animals.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave živali.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Slovenian: Da se izognete naključni kontaminaciji cepiva med uporabo, je pri večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
English: To stimulate active immunity against bluetongue virus, serotype 8 in sheep.
Slovenian: Za stimulacijo aktivne imunosti proti virusu modrega jezika, serotip 8, pri ovcah.
English: Special precautions for use in animals Only use in healthy animals.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepite samo zdrave živali.
English: PACKAGE LEAFLET FOR: ZULVAC 8 Ovis suspension for injection for sheep
Slovenian: ZULVAC 8 Ovis suspenzija za injiciranje za ovce
English: PHARMACEUTICAL FORM Off-white or pink suspension for injection
Slovenian: Belkasta ali rožnata suspenzija za injiciranje
English: Luxembourg/Luxemburg Zoetis Belgium SA
Slovenian: Luxembourg/Luxemburg
English: The manufacture, import, possession, sale, supply and/or use of ZULVAC 8 Ovis may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Izdelava,uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba ZULVAC 8 Ovis je lahko v državi članici prepovedana na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: In one laboratory safety study, transient increase in rectal temperature during the 24 hours following vaccination not exceeding 1.2°C and local reaction at the injection site, in most cases in the form of a general swelling (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days) were observed very commonly.
Slovenian: V eni laboratorijski študiji o varnosti so zelo pogosto opazili prehodno povečanje rektalne temperature do24 ur po cepljenju, ki pa ni presegla1,2 °C in lokalno reakcijo na mestu injiciranja, v večini primerov v obliki splošne otekline (ki ne traja več kot 7 dni) ali kot otipljive nodule (subkutani granulomi, ki lahko trajajo tudi več kot 48 dni).
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Slovenian: Varnost in učinkovitost cepiva pri plemenskih samcih nista bili ugotovljenia.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box 1 x 100ml / Carton box 1 x 240 ml
Slovenian: Kartonska škatla 1 x 100ml / Kartonska škatla 1 x 240 ml
English: 6.5 Nature and composition of immediate packaging Type II glass bottle with butyl elastomer closure.
Slovenian: Viala iz stekla tipa II z zamaškom iz butilnega elastomera
English: România Zoetis România S.R.L
Slovenian: Zoetis România S.R.L
English: 17813 Vall de Bianya
Slovenian: Camprodón s/n "la Riba" 17813 Vall de Bianya
English: 100 ml (50 doses) 240 ml (120 doses)
Slovenian: VELIKOST PAKIRANJA 100 ml (50 odmerkov) 240 ml (120 odmerkov)
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 2 ml contains:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI En 2 ml odmerek vsebuje:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable.
Slovenian: Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
English: Active immunisation of sheep from 1.5 months of age for the prevention* of viraemia caused by bluetongue virus, serotype 8.
Slovenian: INDIKACIJA(E) Aktivna imunizacija ovac, starejših od 1,5 meseca, za preprečitev* viremije, ki jo povzroča virus modrega jezika, serotip 8.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
English: Aluminium hydroxide
Slovenian: Aluminijev hidroksid Saponin
English: Rue Laid Burniat 1 1348 Louvain-la-Neuve
Slovenian: 1348 Louvain-la-Neuve BELGIJA
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) One dose of 2 ml of vaccine contains:
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN Vsak odmerek cepiva (2 ml) vsebuje:
English: Pack of 1 bottle of 120 doses (240 ml).
Slovenian: 1 viala s 120 odmerki (240 ml).
English: Pack of 1 bottle of 50 doses (100 ml).
Slovenian: 1 viala s 50 odmerki (100 ml).
English: Active substance(s):
Slovenian: Zdravilna(e) učinkovina(e):
English: A transient increase in rectal temperature, not exceeding 0.6°C, may occur during the 24 hours following administration of a two-fold overdose.
Slovenian: Do 24 ur po dajanju dvakrat prevelikega odmerka se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 0,6 °C.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: Name and address of the manufacturer(s) responsible for batch release Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Ime in naslov izdelovalca(izdelovalcev) zdravila, odgovornega(odgovornih) za sprostitev serije: Zoetis Manufacturing & Research Spain, S.L.
English: a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če ugotovi da:
English: 1st injection: from 1.5 months of age.
Slovenian: Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja: 1. injekcija: od 1,5 meseca starosti.
English: Once broached use immediately.
Slovenian: Načeto zdravilo uporabite takoj.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani
English: Use in other domestic and wild ruminant species that are considered at risk of infection should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Slovenian: Ob uporabi pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost.
English: The import, possession, sale, supply and/or use of this veterinary medicinal product may be prohibited in Member States on the Whole or part of its territory.
Slovenian: Izdelava, uvoz/vnos, posedovanje, prodaja, oskrba in/ali uporaba tega zdravila je lahko državi članici prepovedana v na njenem celotnem ozemlju ali delu ozemlja; za nadaljnje informacije glej navodilo za uporabo.
English: Adjuvant(s):
Slovenian: Pomožna(Pomožne) snov(i):
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Slovenian: Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02 RP* ≥ 1
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml / Vial label 240 ml
Slovenian: PODATKI NA STIČNI OZ. PRIMARNI OVOJNINI Nalepka na viali 100 ml/Nalepka na viali 200 ml
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose of 2 ml of vaccine contains:
Slovenian: Vsak odmerek (2 ml) cepiva vsebuje:
English: ANNEX II A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: IZDELOVALEC(IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK(I) DOVOLJENJ(A) ZA IZDELAVO ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJE
English: Overdose:
Slovenian: Osnovno cepljenje:
English: BELGIUM
Slovenian: Sverige
English: Excipient(s): Thiomersal
Slovenian: Dodatek(Dodatki): Aluminijev hidroksid (Al3+)
English: Norge Zoetis Finland Oy
Slovenian: Zoetis Finland Oy
English: Pack sizes
Slovenian: Lot { številka }
English: OTHER INFORMATION Pack sizes
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: See package leaflet for further information
Slovenian: DRUGE INFORMACIJE
English: Polska
Slovenian: Magyarország
English: Date of first authorisation: 17 February 2017 Date of latest renewal:
Slovenian: Datum prve odobritve: 17. februar 2017 Datum zadnjega podaljšanja:
English: Do not have Truxima if you have an active infection or a serious problem with your immune system.
Slovenian: Zdravila Truxima ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim imunskim sistemom.
English: Your doctor may decide to stop your Truxima treatment if these reactions are serious.
Slovenian: Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Truxima, če so te reakcije resne.
English: If you can get pregnant, you and your partner must use an effective method of contraception while using Truxima.
Slovenian: Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila Truxima uporabljati učinkovito kontracepcijsko zaščito.
English: Patients should receive Truxima for at least 24 months after achievement of remission (absence of clinical signs and symptoms).
Slovenian: Bolniki morajo zdravilo Truxima prejemati vsaj 24 mesecev po doseženi remisiji (odsotnost kliničnih znakov in simptomov).
English: • Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Truxima.
Slovenian: • Pokažite jo vsem zdravnikom, medicinskim sestram in zobozdravnikom, ki jih obiščete - ne samo specialistu, ki vam predpiše zdravilo Truxima.
English: Truxima will be given to you by a doctor or nurse who is experienced in the use of this treatment.
Slovenian: Zdravilo Truxima vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
English: Depending on the signs and symptoms of your disease, your doctor will decide when you should receive more Truxima.
Slovenian: Glede na znake in simptome vaše bolezni se bo zdravnik odločil, kdaj boste ponovno zdravljeni z zdravilom Truxima.
English: Before you are given Truxima, you will be given other medicines (pre-medication) to prevent or reduce possible side effects.
Slovenian: Preden boste dobili zdravilo Truxima, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
English: EFS - Event Free Survival
Slovenian: EFS: preživetje brez dogodka (Event Free Survival)
English: Your doctor may decide to treat you longer with Truxima (up to 5 years), depending on how you respond to the medicine.
Slovenian: Zdravnik se lahko odloči, da vas bo z zdravilom Truxima zdravil dlje (do 5 let), odvisno od tega, kako se odzovete na zdravilo.
English: Your doctor will check if you should have any vaccines before you receive Truxima.
Slovenian: Vaš zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili zdravilo Truxima.
English: • you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis,
Slovenian: • imate hudo srčno popuščanje ali hudo, neurejeno srčno bolezen in imate tudi revmatoidni artritis,
English: Kaplan-Meier Estimate of Median Time to Event (months)
Slovenian: Kaplan-Meierjeva ocena mediane časa do dogodka (meseci)
English: EULAR Response (Good/Moderate)
Slovenian: Odziv po EULAR (dober/zmeren)
English: • changes in laboratory tests carried out by your doctor.
Slovenian: spremembe rezultatov laboratorijskih preiskav, ki jih naroči vaš zdravnik.
English: The pre-specified non-inferiority margin for the treatment difference was 20%.
Slovenian: Vnaprej opredeljena meja neinferiornosti za razliko zdravljenj je bila 20 %.
English: You may be asked not to take these other medicines 12 hours before you are given Truxima.
Slovenian: Morda vam bo naročil, da ne jemljite teh drugih zdravil 12 ur, preden boste dobili zdravilo Truxima.
English: Truxima may also cause changes in laboratory tests carried out by your doctor.
Slovenian: Zdravilo Truxima lahko vpliva tudi na spremembe laboratorijskih preiskav, ki jih naroči vaš zdravnik.
English: Truxima is indicated in adults for the following indications:
Slovenian: Zdravilo Truxima je pri odraslih indicirano za naslednje indikacije:
English: If you respond well to treatment, you may be given Truxima as a maintenance treatment.
Slovenian: Če se boste na zdravilo dobro odzvali, boste lahko zdravilo Truxima prejemali kot vzdrževalno zdravljenje.
English: Frequencies are defined as very common (≥ 1/10), common
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10),
English: The safety and efficacy of Truxima in children below 18 years has not been established.
Slovenian: Varnost in učinkovitost zdravila Truxima pri otrocih do 18 leta starosti nista dokazani.
English: This is because Truxima may pass into breast milk.
Slovenian: Zdravilo Truxima namreč lahko prehaja v materino mleko.
English: This may be months from now.
Slovenian: To je lahko šele čez nekaj.
English: In patients where the treatment is working, Truxima may be continued for 2 years after completing the initial treatment.
Slovenian: Pri bolnikih, pri katerih takšno zdravljenje deluje, je mogoče zdravila Truxima nadaljevati še dve leti po dokončanju začetnega zdravljenja.
English: When should I not have Truxima?
Slovenian: Kdaj ne smete prejeti zdravila Truxima?
English: No dose reductions of Truxima are recommended.
Slovenian: Odmerka zdravila Truxima ni priporočljivo zmanjšati.
English: The cells that are affected by Truxima help to fight infection and you should wait until the infection has passed before you are given Truxima.
Slovenian: Celice, ki jih zdravilo Truxima uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Truxima.
English: Other medicines and Truxima
Slovenian: Druga zdravila in zdravilo Truxima
English: Truxima should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available (see section 4.4).
Slovenian: Zdravilo Truxima je treba dajati pod nadzorom izkušenega zdravnika in v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo (glejte poglavje 4.4).
English: Contents of the pack and other information What Truxima contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Truxima
English: Some vaccines should not be given at the same time as Truxima or in the months after you receive Truxima.
Slovenian: Nekatera cepiva se ne smejo dajati sočasno z zdravilom Truxima ali nekaj mesecev po prejetju tega zdravila.
English: • ringing sound in the ears, ear pain
Slovenian: zvonjenje v ušesih, bolečine v ušesu,
English: Rarely Truxima can cause a serious brain infection, called “Progressive Multifocal Leukoencephalopathy” or PML.
Slovenian: Redko lahko zdravilo Truxima povzroči resno možgansko okužbo, imenovano progresivna multifokalna levkoencefalopatija ali PML.