FrancophonIA/ELRC3.0 huggingface dataset:
English: Special warnings for each target species: Vaccinate healthy animals only.
Slovenian: Posebna opozorila za vsako živalsko vrsto: Cepite smo zdrave živali.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (pojavijo se pri več kot 1 od 10 zdravljenih živali) - pogosti (pojavijo se pri več kot 1 toda pri manj kot 10 živalih od 100 zdravljenih živali) - občasni (pojavijo se pri več kot 1 živali toda pri manj kot 10 živalih od 1000 zdravljenih živali) - redki (pojavijo se pri več kot 1 toda pri manj kot 10 živalih od 10.000 zdravljenih živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 zdravljenih živali, vključujoč posamezne primere)
English: After reconstitution the suspension looks clear.
Slovenian: Po rekonstituciji je suspenzija bistra.
English: Shelf life of the lyophilisate as packaged for sale: 24 months.
Slovenian: Rok uporabnosti liofilizata v pakiranju za prodajo: 24 mesecev.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Nobilis IB Ma5 for spray or oculonasal application.
Slovenian: Na voljo so podatki o varnosti in učinkovitosti, ki kažejo, da se to cepivo lahko meša in daje s cepivom Nobilis IB Ma5 za pršenje ali okulonazalno dajanje.
English: The safety and efficacy of the veterinary medicinal product has not been established during lay.
Slovenian: Varnost in učinkovitost zdravila za uporabo v veterinarski medicini ni bila ugotovljena v obdobju nesnosti.
English: STORAGE CONDITIONS
Slovenian: POGOJI SHRANJEVANJA
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov proizvajalcev biološke učinkovine
English: Vaccinated chickens may excrete the vaccine strain up to 20 days following vaccination.
Slovenian: Cepljeni piščanci lahko izločajo cepni sev do 20 dni po cepljenju.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the product mentioned above.
Slovenian: Ni podatkov o varnosti in učinkovitosti tega cepiva , kadar se uporabi s katerimkoli drugim zdravilom za uporabo v veterinarski medicini razen z omenjenim zgoraj.
English: Shelf life after reconstitution according to directions: 2 hours.
Slovenian: Rok uporabnosti po rekonstituciji v skladu z navodili: 2 uri.
English: Duration of immunity: 8 weeks.
Slovenian: Trajanje imunosti: 8 tednov.
English: The vaccine has been demonstrated to provide protection against QX-like variant.
Slovenian: Pokazalo se je, da cepivo zagotavlja zaščito proti različici podobni QX .
English: Store in a refrigerator (2 C - 8 C).
Slovenian: Shranjujte v hladilniku (2 C - 8 C).
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
English: Lyophilisate: Store in a refrigerator (2 C - 8 C).
Slovenian: Liofilizat: Shranjujte v hladilniku (2C - 8C).
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v tem navodilu za uporabo, obvestite svojega veterinarja.
English: Sealed aluminium laminate cup with a polypropylene (cup) and polypropylene/polyethylene (lid) contact layer containing 1,000; 2,500; 5,000 or 10,000 doses.
Slovenian: Zavarjena merica iz aluminijevega laminata s polipropilenskim (merica) in polipropilensko polietilenskim (pokrovček) stičnim slojem, ki vsebuje 1.000, 2.500, 5.000 ali 10.000 odmerkov.
English: Ensure that the nasal drop is inhaled before freeing the bird.
Slovenian: Prepričajte se, da je piščanec kapljico vdihnil, preden ga izpustite.
English: Do not freeze.
Slovenian: Cepivo ne sme zmrzniti.
English: INDICATION
Slovenian: INDIKACIJE
English: 1) The contents of a cup (1,000 doses only) can be added to Solvent Oculo/Nasal using the included adapter and administered after connecting the included dropper.
Slovenian: 1) Vsebino merice (samo 1.000 odmerkov) lahko dodate vehiklu Oculo/Nasal s pomočjo priloženega adapterja in jo daste živalim, ko ste namestili priloženo kapalko.
English: For active immunisation of chickens in order to reduce respiratory signs of avian infectious bronchitis caused by QX-like variants of infectious bronchitis virus (IBV).
Slovenian: Za aktivno imunizacijo piščancev z namenom zmanjšanja respiratornih znakov kužnega bronhitisa perutnine, ki ga povzročajo variantni sevi podobni QX virusa kužnega bronhitisa (IBV).
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO Vprašajte svojega veterinarja, kako odstraniti zdravila, ki jih več ne potrebujete.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Chickens should be vaccinated against other prevalent IBV serotypes (e.g. Massachusetts) according to the local IB vaccination programme.
Slovenian: Piščance je treba cepiti proti drugim razširjenim serotipom virusa infekcioznega bronhitisa (npr. Massachusetts) v skladu z lokalnim programom cepljenja proti infekcioznemu bronhitisu.
English: Lyophilisate for oculonasal suspension
Slovenian: Liofilizat za okulonazalno suspenzijo
English: Apply coarse spray ≥250 microns.
Slovenian: Uporabite razpršilnik z večjimi kapljicami ≥250 mikronov.
English: The vaccine virus is capable of spreading to in contact birds for a minimum of 20 days after vaccination and appropriate care should be taken to separate vaccinated from non-vaccinated chickens.
Slovenian: Cepni virus se lahko razširi na živali v stiku najmanj 20 dni po cepljenju in treba je ustrezno poskrbeti, da so cepljeni piščanci ločeni od necepljenih.
English: Shelf life of the solvent as packaged for sale: 4 years.
Slovenian: Rok uporabnosti vehikla v pakiranju za prodajo: 4 leta.
English: For the mixed products the onset of immunity is 3 weeks and the duration of immunity is 8 weeks for the claimed protection against Massachusetts and QX-like strains of IBV.
Slovenian: Za mešana zdravila je začetek imunosti 3 tedne, trajanje imunosti pa 8 tednov za zagotovljeno zaščito proti sevu Masachussets in sevu podobnemu QX virusa kužnega bronhitisa.
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Slovenian: Zato se za uporabo tega cepiva pred uporabo katerega koli drugega zdravila za uporabo v veterinarski medicini ali po njej odločamo od primera od primera.
English: Store below 25 °C.
Slovenian: Shranjujte pri temperaturi do 25 C.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ V EGP, ČE STA RAZLIČNA
English: Date of first authorisation: 04/09/2014.
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 04/09/2014.
English: CARDBOARD BOX with 10 cups of lyophilisate
Slovenian: KARTONSKA ŠKATLA z 10 odmerki liofilizata
English: This vaccine should only be used after it has been established that the QX-like IBV variant strain is epidemiologically relevant.
Slovenian: To cepivo smemo uporabiti le, ko je ugotovljeno, da je variantni sev QX podobnega virusa kužnega bronhitisa epidemiološko pomemben.
English: Precautionary measures should be taken to prevent spreading to wildlife.
Slovenian: Paziti je treba, da se prepreči razširjanje na prostoživeče živali.
English: Oculonasal use.
Slovenian: Okulonazalna aplikacija.
English: Nobilis IB Primo QX is intended to protect chickens against clinical signs of disease caused by IBV variant strain D388 only and should not be used as a replacement for other IBV vaccines.
Slovenian: Nobilis IB Primo QX je namenjen za zaščito piščancev pred kliničnimi znaki bolezni, ki jo povzroča samo variantni sev D388 virusa infekcioznega bronhitisa in se ne sme uporabljati kot nadomestilo za druga cepiva proti virusom infekcioznega bronhitisa.
English: Read the package leaflet of Nobilis IB Ma5 before use.
Slovenian: Pred uporabo preberite navodilo za uporabo za Nobilis IB Ma5.
English: Onset of immunity: 3 weeks.
Slovenian: Začetek imunosti: 3 tedni.
English: A mild transient respiratory reaction (including nasal exudates) may very rarely occur for at least 10 days after vaccination.
Slovenian: Zelo redke se lahko pojavi blaga respiratorna reakcija (z nazalnimi izločki) za najmanj 10 dni po cepljenju.
English: Reconstitute the lyophilisate immediately and entirely after opening of the cup.
Slovenian: Po odprtju vsebnika liofilizat takoj in popolnoma rekonstituirajte.
English: Administer 1 dose of reconstituted vaccine by coarse spray or by oculonasal route to chickens from 1 day of age or older.
Slovenian: Dajte 1 odmerek rekonstituiranega cepiva z razpršilnikom z večjimi kapljicami ali okulonazalno enodnevnim ali starejšim piščancem.
English: Packaging:
Slovenian: Pakiranje:
English: The protection against other circulating IB strains has not been investigated.
Slovenian: Zaščite proti drugim krožečim sevom kužnega bronhitisa niso raziskovali.
English: Solvent (Solvent Oculo/Nasal): blue-coloured solution.
Slovenian: Vehikel (vehikel Oculo/Nasal)): modro obarvana raztopina.
English: Read the vaccine package before use.
Slovenian: Pred uporabo preberite navodilo za uporabo.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM ZADNJE ODOBRITVE NAVODILA ZA UPORABO
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Slovenian: KOLIČINA GIH UČINKOVIN(E)
English: Solvent Oculo/Nasal for chickens
Slovenian: Vehikel Oculo/Nasal za piščance.
English: Solvent Oculo/Nasal should be used for oculonasal application.
Slovenian: Vehikel Oculo/Nasal se uporabi za okulonazalno dajanje.
English: CARDBOARD BOX with 10 vials of solvent
Slovenian: KARTONSKA ŠKATLA z 10 vialami vehikla
English: After reconstitution, administer 1 dose of vaccine by coarse spray or by the oculonasal route of administration to chickens from 1 day of age or older.
Slovenian: Po rekonstituciji dajte 1 odmerek cepiva z razprševanjem z velikimi kapljicami ali okulonazalno enodnevnim ali starejšim piščancem.
English: Lyophilisate: Off white, predominantly sphere shaped.
Slovenian: Liofilizat: belkast, večinoma v obliki kroglic.
English: Hydrolysed gelatine Pancreatic digest of casein Disodium phosphate dihydrate
Slovenian: Liofilizat: sorbitol hidrolizirana želatina pankreasni presnovek kazeina natrijev hidrogenfosfat dihidrat
English: EU/2/14/174/002 (10 x 1,000 doses + 10 x 35 ml solvent) EU/2/14/174/003 (10 x 5,000 doses)
Slovenian: EU/2/14/174/002 (10 x 1.000 odmerkov + 10 x 35 ml vehikla) EU/2/14/174/003 (10 x 5.000 odmerkov)
English: 1,000 doses (3-100 spheres) 2,500 doses (3-100 spheres) 5,000 doses (3-100 spheres) 10,000 doses (3-400 spheres)
Slovenian: 1.000 odmerkov (3-100 kroglic) 2.500 odmerkov (3-100 kroglic) 5.000 odmerkov (3-100 kroglic) 10.000 pdmerkov (3-400 kroglic)
English: Low density polyethylene (LDPE) vial of 35 ml with a halogenobutyl rubber stopper and aluminium cap.
Slovenian: Vehikel (vehikel Oculo/Nasal): LDPE viala s 35 ml s halogenbutilnim gumijastim zamaškom in aluminijasto zaporko.
English: Solvent: Store below 25 °C.
Slovenian: Vehikel: Shranjujte pri temperaturi do 25 C.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
English: Lyophilisate and solvent for oculonasal suspension Lyophilisate for oculonasal suspension.
Slovenian: Liofilizat in vehikel za suspenzijo ali liofilizat za suspenzijo.
English: To stimulate active immunity against the D388/QX type of avian infectious bronchitis virus.
Slovenian: Za stimuliranje aktivne imunosti proti virusu kužnega bronhitisa perutnine tipa D388/ QX.
English: It is important to avoid introduction of the IB D388 vaccine virus into premises in which the wild type strain is not present.
Slovenian: Pomembno je, da se cepni virus kužnega bronhitisa D388 ne zanese v prostore, kjer sev divje vrste virusa ni prisoten.
English: To be supplied only on veterinary prescription.
Slovenian: Na veterinarski recept .
English: The IB D388 vaccine should only be applied in hatcheries to chickens from 1 day of age or older if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks.
Slovenian: Cepivo D388 za kužni bronhitis se sme uporabljati samo v valilnicah za enodnevne ali starejše piščance, če se izvajajo ustrezne kontrole, da ne pride do širjenja cepnega virusa na piščance, ki bodo preseljeni v jate, ki niso izpostavljene virusu infekcijskega bronhitisa QX.
English: Solvent for oculonasal suspension.
Slovenian: Liofilizat za okulonazalno suspenzijo.
English: The IB D388/QX vaccine should only be applied in hatcheries if adequate controls are in place to avoid the spread of the vaccine virus to birds that will be transported to non-IB QX exposed flocks.
Slovenian: Cepivo D388 za kužni bronhitis se sme uporabljati samo v valilnicah za enodnevne ali starejše piščance, če se izvajajo ustrezne kontrole, da ne pride do širjenja cepnega virusa na piščance, ki jih bodo preseljevali v jate, ki niso izpostavljene infekcijskemu bronhitisu, ki ga povzroča QX.
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)) + cardboard box with 10 x 35 ml vial of solvent supplemented with dropper and adapter.
Slovenian: Kartonska škatla z 10 vialami liofilizata (1.000 odmerkov na merico s premerom 42 mm (3-100 kroglic)) + kartonska škatla z 10 vialami s 35 ml vehikla s kapalko in adapterjem.
English: Do not use in birds in lay or within 4 weeks before the start of the laying period.
Slovenian: Ne uporabite pri živalih v nesnosti ali v 4 tednih pred začetkom nesnosti.
English: Very mild inflammatory changes have occasionally been found in the kidneys of specific pathogen free (SPF) chickens after administration of a 10-fold overdose.
Slovenian: Po aplikaciji desetkratnega odmerka so v ledvicah SPF piščancev občasno ugotovili zelo blage vnetne spremembe.
English: EU/2/14/174/005 (10 x 2,500 doses)
Slovenian: EU/2/14/174/005 (10 x 2.500 odmerkov)
English: Nobilis IB Primo QX lyophilisate and solvent for oculonasal suspension for chickens Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Slovenian: Nobilis IB Primo QX, liofilizat in vehikel za okulonazalno suspenzijo za piščance Nobilis IB Primo QX liofilizat za okulonazalno suspenzijo za piščance
English: Sodium hydroxide or hydrochloric acid (for pH adjustment) Water for injections
Slovenian: Vehikel: modro barvilo V (E131) kalijev dihidrogenfosfat natrijev hidrogenfosfat dihidrat dinatrijev edetat dihidrat natrijev klorid natrijev hidroksid ali klorovodikova kislina (za uravnavanje pH) voda za injekcije
English: EU/2/14/174/004 (10 x 10,000 doses)
Slovenian: EU/2/14/174/004 (10 x 10.000 odmerkov)
English: Nobilis IB Primo QX lyophilisate for oculonasal suspension for chickens
Slovenian: Nobilis IB Primo QX, liofilizat za okulonazalno suspenzijo za piščance.
English: Live IBV, D388
Slovenian: Živi virus infekcioznega bronhitisa, D388
English: EU/2/14/174/001 (10 x 1,000 doses)
Slovenian: EU/2/14/174/001 (10 x 1.000 odmerkov)
English: ROUTE OF ADMINISTRATION
Slovenian: NAVODILO ZA UPORABO
English: Active substance: Live attenuated avian infectious bronchitis virus, strain D388: 10
Slovenian: Zdravilna učinkovina: Živi oslabljeni sev virusa infekcioznega bronhitisa perutnine D388: 10
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Po aplikaciji desetkratnega odmerka so v ledvicah SPF piščancev občasno ugotovili zelo blage vnetne spremembe.
English: Each dose of reconstituted vaccine contains: Live attenuated avian infectious bronchitis virus, strain D388: 104.0 - 105.5 EID50
Slovenian: Vsak odmerek rekonstituiranega cepiva vsebuje: Živi oslabljeni sev virusa infekcioznega bronhitisa perutnine D388: 10
English: Spray or oculonasal administration.
Slovenian: Pršilo ali okulonazalno dajanje.
English: Administration routes:
Slovenian: Načini uporabe:
English: Live attenuated avian infectious bronchitis virus, strain D388: 10
Slovenian: Živi oslabljeni sev virusa infekcioznega bronhitisa perutnine D388: 10
English: Measure the correct volume of water for the number of birds to be vaccinated
Slovenian: Odmerite pravilno količino vode za število piščancev, ki jih je treba cepiti (odvisno od uporabljene naprave) 2) Med mešanjem dodajte vsebino pravilnega števila meric.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
English: Cardboard box with 10 cups of lyophilisate (10,000 doses per 61 mm diameter cup (3-400 spheres)).
Slovenian: Kartonska škatla z 10 mericami liofilizata (10.000 odmerkov na merico s premerom 61 mm (3-400 kroglic)).
English: 2) Shake the vaccine suspension.
Slovenian: 2) Cepno suspenzijo pretresite.
English: Solvent:
Slovenian: Vehikel:
English: Cardboard box with 10 cups of lyophilisate (1,000 doses per 42 mm diameter cup (3-100 spheres)).
Slovenian: Kartonska škatla z 10 mericami liofilizata (1.000 odmerkov na merico s premerom 42 mm (3-100 kroglic)).
English: Cardboard box with 10 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3-100 spheres))
Slovenian: Kartonska škatla z 10 mericami liofilizata (2.500 odmerkov na merico s premerom 42 mm (3-100 kroglic))
English: Cardboard box with 10 cups of lyophilisate (5,000 doses per 42 mm diameter cup (3-100 spheres)).
Slovenian: Kartonska škatla z 10 mericami liofilizata (5.000 odmerkov na merico s premerom 42 mm (3-100 kroglic)).
English: Cardboard box with 10 cups of lyophilisate (2,500 doses per 42 mm diameter cup (3-100 spheres)).
Slovenian: Kartonska škatla z 10 mericami liofilizata (2.500 odmerkov na merico s premerom 42 mm (3-100 kroglic)).
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila
English: --1 ≥ 3.2 x 10
Slovenian: --1 ≥ 3,2 x 106 enot ELISA
English: EU number
Slovenian: EU številka
English: ELISA Units
Slovenian: Karenca
English: It can be found here (in English only).
Slovenian: Dokument je na voljo tukaj (samo v angleščini).
English: Current text to be deleted is struck through.
Slovenian: Trenutno besedilo, ki ga je treba izbrisati, je prečrtano.
English: Uncommon Rare Not known
Slovenian: Redki Neznana pogostnost
English: Adopted at the 9-12 January 2017 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 9. in 12. januarjem 2017
English: The product information wording in this document is extracted from the document entitled ‘PRAC recommendations on signals' which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals.
Slovenian: Besedilo informacij o zdravilu v tem dokumentu izvira iz dokumenta z naslovom „Priporočila odbora PRAC o signalih“, ki vsebuje celotno besedilo priporočil odbora PRAC za posodobitev informacij o zdravilu in nekatere splošne napotke za obdelavo signalov.
English: Interaction with other medicinal products and other forms of interaction A need for lower propofol doses has been observed in patients taking valproate.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Pri bolnikih, ki jemljejo valproat, je bila opažena potreba po nižjih odmerkih propofola.
English: Propofol; valproate - Pharmacokinetic drug interaction leading to an increased propofol exposure (EPITT no 18696)
Slovenian: Propofol; valproat - farmakokinetično medsebojno delovanje zdravil, katerega posledica je povečana izpostavljenost propofolu (EPITT št. 18696)
English: Summary of product characteristics (propofol) 4.5.
Slovenian: Povzetek glavnih značilnosti zdravila (propofol) 4.5.
English: Summary of product characteristics 4.8.
Slovenian: Povzetek glavnih značilnosti zdravila 4.8.
English: New text to be added to the product information is underlined.
Slovenian: Novo besedilo, ki ga je treba dodati v informacije o zdravilu, je podčrtano.
English: Common side effects (may affect up to 1 in 10 people) - Collection of fluid around the heart (pericardial effusion)
Slovenian: Pogosti neželeni učinki (prizadenejo lahko največ 1 osebo od 10) - Nabiranje tekočine okoli srca (perikardialni izliv)
English: When used concomitantly, a dose reduction of propofol may be considered.
Slovenian: Ob sočasnem jemanju obeh učinkovin je treba razmisliti o zmanjšanju odmerka propofola.
English: Undesirable effects Tabulated list of adverse reactions System Organ
Slovenian: Preglednica z neželenimi učinki Organski sistem Zelo
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/5725/2017
Slovenian: Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih EMA/PRAC/38529/2017
English: New product information wording - Extracts from PRAC recommendations on signals
Slovenian: Novo besedilo informacij o zdravilu - izvlečki iz priporočil odbora PRAC o signalih
English: Azacitidine - Pericarditis and pericardial effusion (EPITT no 18733)
Slovenian: Azacitidin - perikarditis in perikardialni izliv (EPITT št. 18733)
English: Pericardial effusion
Slovenian: Perikardialni izliv
English: Common
Slovenian: Občasni
English: Quinta da Fonte - Edifício D. José - Piso 1, 2780-730 Paço d' Arcos
Slovenian: Quinta da FonteEdifício D. José - Piso 1, 2780-730 Paço d' Arcos
English: D-55127 Mainz
Slovenian: D-55127 Mainz Nemčija
English: Flemingweg 18, 2408 AV ALPHEN A/D RIJN The Netherlands
Slovenian: Flemingweg 18, 2408 AV ALPHEN A/D RIJN
English: Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT United Kingdom
Slovenian: Novo Nordisk Limited, Broadfield Park, Brighton Road, Crawley, West Sussex RH11 9RT
English: 1010 Wien Austria
Slovenian: 1010 Dunaj Avstrija
English: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle - 92400 Courbevoie
Slovenian: Novo Nordisk, Coeur Défense - 100, avenue du Général de Gaulle - 92400
English: Boulevard international 55 1070 Brussels
Slovenian: NOVO NORDISK PHARMA SA Boulevard international 55 1070 Bruselj Belgija
English: Farmacêuticos, Lda.
Slovenian: Novo NordiskComércio de Produtos Farmacêuticos, Lda.
English: Novo Nordisk Hellas Ltd. A. Panagouli 80 & Aghias Triados 65.
Slovenian: A. Panagouli 80 & Aghias Triados 65. 153 43 Aghia Paraskevi, Atene Grčija
English: Luxembourg Novo Nordisk Pharma Riverside Business Park B-1070 Bruxelles
Slovenian: Novo Nordisk Pharma Riverside Business Park
English: Somatropin Novo Nordisk solution for injection, pre-filled pen
Slovenian: Somatropin Novo Nordisk raztopina za injiciranje, napolnjen injekcijski peresnik
English: solution for injection in pre-filled syringe
Slovenian: raztopina za injiciranje v napolnjeni injekciji
English: 10 mg/1.5 mL solution for injeciton subcutaneous use
Slovenian: 10 mg/1.5 ml solución inyectable