FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Cymevene in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Cymevene v Evropski uniji (EU).
English: When prescribing Cymevene, consideration should be given to official guidance on the appropriate use of antiviral agents.
Slovenian: Pri predpisovanju zdravila Cymevene je treba upoštevati uradne smernice za ustrezno uporabo protivirusnih zdravil.
English: For this reason, the CHMP agreed that Cymevene should not be used in pregnant women unless the potential benefit to the mother outweighs the potential risk to the unborn child.
Slovenian: Odbor CHMP je zato soglašal, da se pri nosečnicah zdravilo Cymevene ne sme uporabljati, razen če je morebitna korist za mater večja od morebitnega tveganja za nerojenega otroka.
English: Having harmonised the indication, the CHMP also harmonised the recommendations on how to use Cymevene.
Slovenian: Po uskladitvi indikacij je odbor CHMP uskladil tudi priporočila o načinu uporabe zdravila Cymevene.
English: Since the use of highly active antiretroviral therapy (HAART) has reduced the risk of CMV disease in patients with HIV infection, preventive treatment with Cymevene is no longer considered necessary.
Slovenian: Ker je uporaba visokoaktivne protiretrovirusne terapije (HAART) pri bolnikih, okuženih z virusom HIV, zmanjšala tveganje za bolezni zaradi CMV, preventivno zdravljenje z zdravilom Cymevene ni več potrebno.
English: Cymevene must not be used in patients allergic to its active substance ganciclovir, to a related antiviral medicine, valganciclovir, or to any other ingredients of the medicine.
Slovenian: Zdravilo Cymevene se ne sme uporabljati pri bolnikih, ki so alergični na zdravilno učinkovino ganciklovir, na sorodno protivirusno zdravilo, valganciklovir, ali na katero koli drugo sestavino zdravila.
English: Women who could become pregnant must be advised to use effective contraception during treatment with Cymevene and for at least 30 days after treatment has stopped.
Slovenian: Ženskam, ki bi lahko zanosile, je treba pri zdravljenju z zdravilom Cymevene in še vsaj 30 dni po prenehanju zdravljenja svetovati učinkovito kontracepcijo.
English: Cymevene can also be used to prevent CMV disease in patients with drug-induced immunosuppression (for example after an organ transplant or chemotherapy).
Slovenian: Zdravilo Cymevene se lahko uporablja tudi za preprečevanje bolezni zaradi CMV pri bolnikih z zdravili inducirano imunosupresijo (npr. po presaditvi organov ali po kemoterapiji).
English: However, the virus can cause problems in people with a weakened immune system such as people with acquired immune deficiency syndrome (AIDS) or who are undergoing cancer treatment or taking medicines to prevent rejection of an organ transplant.
Slovenian: Virus lahko povzroči težave pri ljudeh z oslabljenim imunskim sistemom, kot so ljudje s sindromom pridobljene imunske pomanjkljivosti (aids), bolniki, ki prejemajo zdravila za zdravljenje raka ali zdravila za preprečitev zavrnitve presadka.
English: The CHMP also agreed that Cymevene should no longer be indicated for the prevention of CMV disease in patients with AIDS.
Slovenian: Odbor CHMP je soglašal tudi, da zdravilo Cymevene ne sme biti več indicirano za preprečevanje bolezni zaradi CMV pri bolnikih z aidsom.
English: Cymevene is an antiviral medicine that is used to treat or prevent infection with cytomegalovirus (CMV) in immunocompromised individuals (people with a weakened immune system).
Slovenian: Zdravilo Cymevene je protivirusno zdravilo, ki se uporablja za zdravljenje in preprečevanje okužb s citomegalovirusom (CMV) pri imunsko oslabelih osebah (ljudeh z oslabljenim imunskim sistemom).
English: Men whose female partner could become pregnant must be advised to use barrier contraception methods during treatment with Cymevene, and for at least 90 days afterwards.
Slovenian: Moškim, katerih partnerka bi lahko zanosila, je treba pri zdravljenju z zdravilom Cymevene in še vsaj 90 dni po prenehanju zdravljenja svetovati uporabo pregradnih kontracepcijskih metod.
English: The CHMP agreed that Cymevene can be used for the treatment of diseases caused by CMV in immunocompromised patients.
Slovenian: Odbor CHMP je soglašal, da se zdravilo Cymevene lahko uporablja za zdravljenje bolezni, ki jih pri imunsko oslabljenih bolnikih povzroča CMV.
English: It is not known whether ganciclovir passes into breast milk; however this possibility cannot be excluded and therefore breastfeeding must be discontinued in women treated with Cymevene, to avoid potential serious side effects in breastfed infants.
Slovenian: Te možnosti ni mogoče izključiti, zato je treba pri ženskah, zdravljenih z zdravilom Cymevene, dojenje prekiniti, da bi se izognili morebitnim resnim neželenim učinkom pri dojenih otrocih.
English: On 15 September 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Cymevene in the EU.
Slovenian: Da bi uskladili dovoljenja za promet z zdravilom Cymevene v EU, je Evropska komisija 15. septembra 2014 napotila zadevo na odbor CHMP.
English: Ganciclovir has the potential to cause birth defects in humans.
Slovenian: Zdravilo Ganciklovir lahko pri človeku povzroči prirojene anomalije.
English: Cymevene contains the active substance ganciclovir and is available as a powder to be made into a solution for infusion (drip) into a vein.
Slovenian: Na voljo je v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Cymevene was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Cymevene potrebno usklajevanje.
English: ATCvet code: QI02AD04.
Slovenian: Oznaka ATC vet: QI02AD04.
English: It is recommended to use a new applicator for each animal.
Slovenian: Priporočamo, da za vsako žival uporabite nov aplikator.
English: <{DD/MM/YYYY}>
Slovenian: {DD/MM/LLLL}
English: The following doses and administration methods should be used:
Slovenian: Uporabiti je treba naslednje odmerke in metode odmerjanja:
English: Cattle from 9 days of age:
Slovenian: Govedo od 9 dni starosti:
English: Date of first authorisation: 29/07/2019
Slovenian: Datum pridobitve dovoljenja za promet: 29/07/2019
English: The 5 doses vial is now ready to use.
Slovenian: Viala s 5 odmerki je zdaj pripravljena za uporabo.
English: The excipients listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC so bodisi dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Cattle from 10 weeks of age:
Slovenian: Govedo od 10 tednov starosti:
English: Solvent: Store below 25 °C.
Slovenian: Vehikel: Shranjujte pri temperaturi pod 25 °C.
English: The reconstituted vaccine is a slightly yellowish homogeneous suspension.
Slovenian: Rekonstituirano cepivo je rahlo rumenkasta homogena suspenzija.
English: *Cell culture infectious dose 50%
Slovenian: * 50% infektivni odmerek v celični kulturi
English: Special precautions for use in animals: Vaccinate healthy animals only.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih: Cepite samo zdrave živali.
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Slovenian: Za vse nadaljnje informacije o tem zdravilu se obrnite na lokalno predstavništvo imetnika dovoljenja za promet z zdravilom.
English: Volume of solvent to be used
Slovenian: Volumen vehikla, ki ga je treba uporabiti
English: 6 months after intramuscular vaccination.
Slovenian: 6 mesecev po intramuskularnem cepljenju.
English: Calves may uncommonly display a peak in temperature of at least 1.7°C two days after vaccination that resolves the next day without treatment.
Slovenian: Pri teletih se občasno pojavi porast telesne temperature vsaj 1,7 °C dva dni po cepljenju, ki izzveni naslednji dan brez zdravljenja.
English: Do not use this veterinary medicinal product and the solvent after the expiry date which is stated on the carton and the label.
Slovenian: Tega zdravila in vehikla ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in nalepki.
English: For the 25 doses vial, once the freeze-dried powder is in suspension, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining solvent.
Slovenian: Za vialo s 25 odmerki, potem, ko je prašek posušen z zamrzovanjem v suspenziji, odstranite vso suspenzijo, dobljeno iz viale s cepivom, in jo vbrizgajte v vialo, v kateri je ostanek vehikla.
English: Each dose of 2 ml contains:
Slovenian: En 2 ml odmerek vsebuje:
English: Pharmacotherapeutic group: Immunological for Bovidae, Cattle, Live viral vaccines, bovine respiratory syncytial virus (BRSV).
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za votloroge, govedo, živa virusna cepiva, bovini respiratorni sincicijski virus (BRSV).
English: Overdose (symptoms, emergency procedures, antidotes): No adverse reactions occurred following the administration of an overdose.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Po prevelikem odmerjanju ni bilo neželenih učinkov.
English: To stimulate active immunity against bovine respiratory syncytial virus.
Slovenian: Za spodbujanje aktivne imunosti proti bovinemu respiratornemu sincicijskemu virusu.
English: Laboratorios Hipra, S.A. Carretera C-63 Km 48.300 Polígon Industrial El Rieral, 17170 Amer (Girona) Spain
Slovenian: Laboratorios Hipra, S.A. Carretera C-63 Km 48.300 Polígon Industrial El Rieral, 17170 Amer (Girona) Španija
English: For nasal use, spray the required volume of the vaccine into the animal's nostrils (1 ml in each nostril) using an intranasal applicator (droplet size: 25-220 µm).
Slovenian: Za nazalno uporabo razpršite potrebni volumen cepiva v nosnici živali (1 ml v vsako nosnico) z intranazalnim aplikatorjem (velikost kapljic: 25-220 µm).
English: Solvent for NASYM
Slovenian: Vehikel za NASYM
English: No adverse reactions other than those described in section 4.6 occurred following the administration of an overdose.
Slovenian: Po prevelikem odmerjanju ni bilo drugih neželenih učinkov, razen tistih, ki so opisani v poglavju 4.6.
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov proizvajalca biološke učinkovine
English: Shake until the freeze-dried powder is in suspension.
Slovenian: Stresajte, dokler ni liofilizirani prašek v obliki suspenzije.
English: Reconstitute the vaccine with the corresponding volume of solvent:
Slovenian: Cepivo rekonstituirajte z ustreznim volumnom vehikla:
English: Each dose of 2 ml contains: Lyophilisate:
Slovenian: En 2 ml odmerek vsebuje: Liofilizat:
English: Lyophilisate: Store and transport refrigerated (2 °C - 8 °C).
Slovenian: Liofilizat: Shranjujte in prevažajte v hladilniku (2 °C - 8 °C).
English: Active immunisation of cattle to reduce virus shedding and respiratory clinical signs caused by bovine respiratory syncytial virus infection.
Slovenian: Aktivna imunizacija goveda za zmanjšanje izločanja virusa in respiratornih kliničnih znakov, ki jih povzroča okužba z bovinim respiratornim sincicijskim virusom.
English: 5 doses 25 doses
Slovenian: 5 odmerkov 25 odmerkov
English: Nasal use or intramuscular use.
Slovenian: Nazalna uporaba ali intramuskularna uporaba.
English: Do not mix with any other veterinary medicinal product, except with the solvent supplied for use with the veterinary medicinal product .
Slovenian: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini, razen z vehiklom, ki je priložen za uporabo s tem zdravilom.
English: Primary vaccination (nasal use): Spray 1 ml into each nostril (so the total volume administered is 2 ml).
Slovenian: Primarno cepljenje (nazalna uporaba): V vsako nosnico razpršite 1 ml (tako da je celotni aplicirani volumen 2 ml).
English: Slight alteration of faecal consistency may be commonly observed post-vaccination.
Slovenian: Po cepljenju se pogosto opazi rahle spremembe v konsistenci iztrebkov.
English: Duration of immunity: 2 months after nasal vaccination.
Slovenian: Trajanje imunosti: 2 meseca po nazalnem cepljenju.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA ODGOVOREN ZA SPROŠČANJE SERIJ
English: Inject the 10 ml of solvent into the vial containing the lyophilisate (freeze-dried powder).
Slovenian: Injicirajte 10 ml vehikla v vialo z liofilizatom (prašek posušen z zamrzovanjem).
English: Full immunity is established from 21 days after nasal vaccination.
Slovenian: Polna imunost je vzpostavljena po 21. dnevu po aplikaciji v nos.
English: Solvent: Homogeneous-clear solution.
Slovenian: Vehikel: Homogena, bistra raztopina.
English: Solvent: Polyethylene (PET) vials of 10 ml or 50 ml, sealed with a bromobutyl rubber stopper and aluminium cap.
Slovenian: Vehikel: polietilenske (PET) viale z 10 ml ali 50 ml, zaprte z zamaškom iz bromobutilne gume in aluminijasto zaporko.
English: Primary vaccination (intramuscular injection): One intramuscular injection of 2 ml should be given, followed by a second intramuscular injection of 2 ml given 4 weeks later.
Slovenian: Primarno cepljenje (intramuskularna injekcija): Aplicirajte eno intramuskularno injekcijo po 2 ml, ki ji 4 tedne pozneje sledi druga intramuskularna injekcija po 2 ml.
English: Reduction of respiratory clinical signs (but not a reduction of virus shedding) is observed 5 days after nasal vaccination.
Slovenian: 5 dnii po aplikaciji v nos je opazno zmanjšanje respiratornih kliničnih znakov (ne pa zmanjšanje izločanja virusa).
English: Use only sterile needles and syringes for administration.
Slovenian: Za injiciranje uporabljajte le sterilne igle in injekcijske brizge.
English: Number of doses in vial of lyophilisate
Slovenian: Število odmerkov v viali liofilizata
English: Revaccination: One intramuscular injection of 2 ml should be given 6 months after completion of the primary vaccination scheme and then every 6 months after the last revaccination.
Slovenian: Revakcinacija: Eno intramuskularno injekcijo po 2 ml aplicirajte 6 mesecev po zaključku sheme primarnega cepljenja in nato vsakih 6 mesecev po zadnjei revakcinaciji.
English: 21 days after the second dose of the two dose intramuscular vaccination schedule.
Slovenian: 21 dni po drugem odmerku pri intramuskularnem dajanju.
English: Lyophilisate (vaccine): 10 ml type I glass vials of 5 or 25 doses, sealed with a bromobutyl rubber stopper and aluminium cap.
Slovenian: Liofilizat (cepivo): 10 ml viale iz stekla tipa I s 5 odmerki ali 25 odmerki, zaprta z zamaškom iz bromobutilne gume in aluminijasto zaporko.
English: Shelf life of the solvent: 5 years
Slovenian: Rok uporabnosti vehikla: 5 let.
English: Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Sodium chloride
Slovenian: Vehikel: kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat natrijev klorid kalijev klorid voda za injekcije
English: 10 vials of lyophilisate (50 doses) 10 vials of lyophilisate (250 doses)
Slovenian: 10 vial liofilizata (50 odmerkov) 10 vial liofilizata (250 odmerkov)
English: 10 vials of solvent (100 ml) 10 vials of solvent (500 ml)
Slovenian: 10 vial vehikla (100 ml) 10 vial vehikla (500 ml)
English: Revaccination: One intramuscular injection of 2 ml should be given 2 months after the primary vaccination, and then every 6 months after the last revaccination.
Slovenian: Revakcinacija: Eno intramuskularno injekcijo po 2 ml aplicirajte 2 meseca po primarnemu cepljenju in nato vsakih 6 mesecev po zadnji revakcinaciji.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (1x5 doses and 1x25 doses)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (1x5 odmerkov in 1x25 odmerkov)
English: 25 doses
Slovenian: 25 odmerkov
English: Potassium dihydrogen phosphate Dipotassium phosphate
Slovenian: NZ amin sorbitol kalijev dihidrogenfosfat kalijev hidrogenfosfat
English: Avoid contamination during reconstitution and use.
Slovenian: Med rekonstitucijo in uporabo pazite, da ne pride do kontaminacije.
English: 1 vial of lyophilisate and 1 vial of solvent (5 doses) 1 vial of lyophilisate and 1 vial of solvent (25 doses)
Slovenian: 1 viala liofilizata in 1 viala vehikla (5 odmerkov) 1 viala liofilizata in 1 viala vehikla (25 odmerkov)
English: la Selva, 135 17170 Amer (Girona) SPAIN
Slovenian: la Selva, 135 17170 Amer (Girona) ŠPANIJA
English: la Selva 135, 17170 Amer (Girona) Spain
Slovenian: la Selva 135, 17170 Amer (Girona) Španija
English: Phosphate buffer solution Lyophilisate: Whitish freeze-dried lyophilisate.
Slovenian: raztopina s fosfatnim pufrom Liofilizat: Belkast liofilizat posušen z zamrzovanjem.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for solvent (10 x 10 ml and 10 x 50 ml)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla za vehikel (10x10 ml merkov in 10x50 ml)
English: 5 doses
Slovenian: 5 odmerkov
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box for lyophilisate (10 x 5 doses and 10 x 25 doses)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla za liofilizat (10x5 odmerkov in 10x25 odmerkov)
English: Cardboard box with 1 lyophilisate vial of 25 doses and 1 vial of 50 ml of solvent.
Slovenian: Kartonska škatla z 1 vialo liofilizata s 25 odmerki in 1 vialo s 50 ml vehikla.
English: Cardboard box with 10 lyophilisate vials of 25 doses.
Slovenian: Kartonska škatla z 10 vialami liofilizata s 25 odmerki.
English: Cardboard box with 1 lyophilisate vial of 5 doses and 1 vial of 10 ml of solvent.
Slovenian: Kartonska škatla z 1 vialo liofilizata s 5 odmerki in 1 vialo z 10 ml vehikla.
English: Peel the top off the aluminium cap on the vial containing the solvent, and withdraw 10 ml.
Slovenian: Odlepite vrh z aluminijaste zaporke na viali z vehiklom in v injekcijsko brizgo povlecite 10 ml. 2.
English: Shelf life of the veterinary medicinal product as packaged for sale: 15 months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 15 mesecev Rok uporabnosti po rekonstituciji v skladu z navodili: uporabite takoj.
English: Cardboard box with 10 lyophilisate vials of 5 doses.
Slovenian: Kartonska škatla z 10 vialami liofilizata s 5 odmerki.
English: Each dose of 2 ml contains: Live attenuated bovine respiratory syncytial virus, strain Lym-56 ................... 104.7 - 6.5 CCID50
Slovenian: En 2 ml odmerek vsebuje: živ oslabljen bovini respiratorni sincicijski virus, sev Lym-56 ........................ 104,7-6,5 CCID50
English: 21 days after administration of one dose by the nasal route.
Slovenian: Nastop imunosti: 21 dni po dajanju enega odmerka prek nosu.
English: Cardboard box with 10 vials of 10 ml of solvent.
Slovenian: Kartonska škatla z 10 vialami z 10 ml vehikla.
English: Each dose of 2 ml contains: Live attenuated bovine respiratory syncytial virus, strain Lym-56 ................... 104.7 - 6.5 CCID50*
Slovenian: En 2 ml odmerek vsebuje: živ oslabljen bovini respiratorni sincicijski virus, sev Lym-56 ........................ 104,7-6,5 CCID50*
English: Phosphate buffer solution
Slovenian: Vehikel: raztopina s fosfatnim pufrom
English: Lyophilisate for suspension for injection or nasal spray
Slovenian: liofilizat za suspenzijo za injiciranje ali pršilo za nos
English: Cardboard box with 10 vials of 50 ml of solvent.
Slovenian: Kartonska škatla z 10 vialami s 50 ml vehikla.
English: Lyophilisate: Whitish freeze-dried lyophilisate.
Slovenian: Liofilizat: dekstran saharoza želatina
English: NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle.
Slovenian: NAVODILO ZA UPORABO NASYM liofilizat in vehikel za suspenzijo za injiciranje ali pršilo za nos za govedo
English: NASYM lyophilisate for suspension for injection or nasal spray for cattle
Slovenian: NASYM liofilizat za suspenzijo za injiciranje ali pršilo za nos za govedo
English: Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56 ..... 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
Slovenian: živ oslabljen bovini respiratorni sincicijski virus (BRSV), sev Lym-56 .......... 104,7-6,5 CCID50*
English: Lyophilisate and solvent for suspension for injection or nasal spray
Slovenian: liofilizat in vehikel za suspenzijo za injiciranje ali pršilo za nos
English: Live attenuated bovine respiratory syncytial virus, strain Lym-56 ................... 104.7 - 6.5 CCID50* *Cell culture infectious dose 50%
Slovenian: živ oslabljen bovini respiratorni sincicijski virus, sev Lym-56 ........................ 104,7-6,5 CCID50*
English: Live attenuated bovine respiratory syncytial virus, strain Lym-56.
Slovenian: NASYM liofilizat in vehikel za suspenzijo za injiciranje ali pršilo za nos za govedo živ oslabljen bovini respiratorni sincicijski virus, sev Lym-56.
English: Solvent vials (10 ml and 50 ml) NAME OF THE VETERINARY MEDICINAL PRODUCT
Slovenian: OVOJNINAH Viale z vehiklom (10 ml in 50 ml)
English: Marketing authorisation holder and manufacturer responsible for batch release: Laboratorios Hipra, S.A.
Slovenian: Imetnik dovoljenja za promet z zdravilom in proizvajalec odgovoren za sproščanje serij:
English: Vial of lyophilisate (5 doses and 25 doses) NAME OF THE VETERINARY MEDICINAL PRODUCT
Slovenian: OVOJNINAH Viala z liofilizatom (5 odmerkov in 25 odmerkov)
English: Avda.
Slovenian: Rp-Vet.
English: Packaging Content Package size Withdrawal Period
Slovenian: Poti dajanja Pakiranje Vsebina Velikost pakiranja
English: Pharmaceut ical Form
Slovenian: Farmacevtska oblika
English: Invented Name
Slovenian: Številka EU Izmišljeno ime Jakost
English: EU/1/19/1388/001 Polivy
Slovenian: EU/1/19/1388/001
English: Intravenous use vial (glass)
Slovenian: Intravensko Viala (steklo)
English: Powder for concentrate for solution for infusion
Slovenian: 140 mg Prašek za koncentrat za raztopino za infundiranje
English: Pack size
Slovenian: Polivy
English: EMA/808930/2011 corr. EMEA/H/C/001225
Slovenian: EMA/990694/2011 EMEA/H/C/001225
English: Treatment may continue for as long as the doctor considers that the patient is benefiting from it.
Slovenian: Zdravljenje lahko traja toliko časa, dokler zdravnik meni, da bolniku koristi.
English: The very first dose at the start of the treatment should be taken under medical supervision.
Slovenian: Prvi odmerek na začetku zdravljenja je treba uporabiti pod zdravniškim nadzorom.
English: The recommended dose is one capsule twice daily, taken as close as possible to 12 hours apart.
Slovenian: Priporočeni odmerek je ena kapsula dvakrat na dan in jo je treba uporabiti v čim bolj točnem razmiku 12 ur.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Colobreathe on 13 February 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Colobreathe, veljavno po vsej Evropski uniji, odobrila dne 13. februarja 2012.
English: They are not to be inhaled using any other device.
Slovenian: Vdihniti se ne smejo z nobenim drugim pripomočkom.
English: FEV1 is the most air a person can breathe out in one second.
Slovenian: FEV1 je največja prostornina zraka, ki jo lahko bolnik izpihne v eni sekundi.