FrancophonIA/ELRC3.0 huggingface dataset:
English: Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant or by appropriate channels approved for use by the competent authorities.
Slovenian: Odpadne snovi odstranite s prekuhavanjem, sežigom ali potopitvijo v ustreznem dezinfekcijskem sredstvu, katerega uporabo odobrijo pristojni organi.
English: In exceptional circumstances a hypersensitivity reaction may occur, which may require appropriate symptomatic treatment.
Slovenian: V izjemnih primerih se lahko pojavi preobčutljivostna reakcija, ki jo je treba ustrezno simptomatično zdraviti
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Water for injections.
Slovenian: Kalijev dihidrogen fosfat Natrijev dihidrogenfosfat dihidrat Magnezijev klorid heksahidrat Kalcijev klorid dihidrat Voda za injiciranje
English: first injection: from 8 weeks of age, second injection: 3 to 5 weeks later.
Slovenian: prvi odmerek: od osmega tedna starosti dalje, drugi odmerek: 3 do 5 tednov pozneje.
English: Use immediately after broaching.
Slovenian: Uporabite takoj po odprtju.
English: Do not mix with any other vaccine or immunological product except Merial non-adjuvanted vaccine range.
Slovenian: Ne mešajte z nobenim drugim cepivom ali imunološkim zdravilom, razen z Merialovimi neadjuviranimi cepivi.
English: Duration of immunity:1 year after the last vaccination.
Slovenian: Trajanje imunosti: eno leto po zadnjem cepljenju.
English: 10 x 1-ml suspension (10 doses) 20 x 1-ml suspension (20 doses) 50 x 1-ml suspension (50 doses)
Slovenian: 10 x 1 ml suspenzije (10 odmerkov) 20 x 1 ml suspenzije (20 odmerkov) 50 x 1 ml suspenzije (50 odmerkov)
English: Laboratoire Lyon Gerland 254, rue Marcel Mérieux F-69007 Lyon FRANCE
Slovenian: Laboratoire de Lyon Gerland 254, rue, Marcel Mérieux F-69007 LYON FRANCIJA
English: Plastic box containing 10, 20 or 50 type I glass bottle with a Butyl elastomer closure and sealed with an aluminium cap.
Slovenian: Plastična škatla z 10, 20 ali 50 stekleničkami iz stekla tipa I z butilelastomerno zaporko, zapečateno z aluminijastim pokrovčkom.
English: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCE
Slovenian: Laboratoire Porte des Alpes Rue de l'Aviation F-69800 SAINT PRIEST FRANCIJA
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years Use immediately after broaching.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 2 leti Uporabite takoj po odprtju.
English: Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C. After inoculation, the virus expresses the protective proteins, but does not replicate in the cat.
Slovenian: V naravi je infektivna le podskupina A. in imunizacija proti podskupini A zagotavlja tudi popolno zaščito proti A, B in C. Po inokulaciji virus izraža zaščitne proteine, vendar se v mački ne množi.
English: Active immunisation of cats of 8 weeks of age or older against feline leukaemia for the prevention of persistent viraemia and clinical signs of the related disease.
Slovenian: Aktivna imunizacija mačk, starih osem tednov ali več, proti mačji levkemiji za zaščito pred perzistentno viremijo in kliničnimi znaki bolezni.
English: Do not use in pregnant animals.
Slovenian: Ne uporabite pri brejih živalih.
English: FRANCE
Slovenian: NEMČIJA
English: Name and address of the manufacturer of the biological active substance(s)
Slovenian: Ime in naslov izdelovalca biološke zdravilne učinkovine (zdravilnih učinkovin).
English: Store and transport refrigerated (2°C - 8°C), Protect from light.
Slovenian: Shranjujte pri temperaturi 2 °C - 8 °C (v hladilniku), zaščiteno pred svetlobo.
English: No undesirable effect has been observed after the administration of several doses except those mentioned in the “Adverse reactions” section.
Slovenian: Po vnosu večkratnih odmerkov cepiva niso opazili nobenih drugih učinkov razen tistih, navedenih v poglavju »Neželeni učinki«.
English: Purevax FeLV Suspension for injection
Slovenian: Purevax FeLV suspenzija za injiciranje
English: EU/2/00/019/005 10 doses: 1-ml suspension (10 bottles) EU/2/00/019/006 20 doses: 1-ml suspension (20 bottles) EU/2/00/019/007 50 doses: 1-ml suspension (50 bottles)
Slovenian: EU/2/00/019/006 20 odmerkov: 1 ml suspenzije (20 stekleničk) EU/2/00/019/007 50 odmerkov: 1 ml suspenzije (50 stekleničk)
English: Administer one dose of 1ml according to the following schedule: Basic vaccination:
Slovenian: Dajte en odmerek po1 ml po naslednjem razporedu: Osnovno cepljenje:
English: The vaccine strain is a recombinant canarypox virus expressing the env and gag genes of FeLV-A.
Slovenian: Cepni sev je rekombinantni poxvirus kanarčkov, ki izraža env in gag gene FeLV-A.
English: Each dose of 1ml contains:
Slovenian: Vsak odmerek (1ml) vsebuje:
English: Plastic box containing 10, 20 or 50 bottles Not all pack sizes may be marketed.
Slovenian: Plastična škatla z 10, 20 ali 50 stekleničkami.
English: Marketing authorisation holder Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Slovenian: Imetnik dovoljenja za promet z zdravilom: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: Purevax FeLV suspension for injection
Slovenian: Purevax FeLV Suspenzija za injiciranje.
English: As a consequence, the vaccine induces an immune status against feline leukaemia virus.
Slovenian: Posledica tega je, da cepivo spodbudi imunsko odpornost proti virusu mačje levkemije.
English: Transient lethargy and hyperthermia may occur for 1 day, exceptionally 2 days.
Slovenian: Lahko se pojavita prehodna letargičnost in povišana temperatura, ki trajata en dan in le izjemoma dva dni.
English: Onset of immunity:2 weeks after primary vaccination course.
Slovenian: Nastop imunosti: dva tedna po prvem cepljenju.
English: A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks
Slovenian: Na mestu injiciranja se lahko pojavi manjši vozlič (< 2cm), ki je prehoden in izgine v enem do štirih tednih
English: For animal treatment only - to be supplied only on veterinary prescription.
Slovenian: Samo za živali -na veterinarski recept.
English: Potassium chloride Sodium chloride
Slovenian: Kalijev klorid
English: It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Slovenian: Pred cepljenjem je priporočljivo opraviti test za ugotavljanje prisotnosti antigenov za FeLV.
English: Manufacturing authorisation holder responsible for batch release MERIAL
Slovenian: Izdelovalec, odgovoren za sprostitev serije: MERIAL
English: A temporary small (< 2 cm) nodule may appear at the site of injection which regresses within 1 to 4 weeks.
Slovenian: NEŽELENI UČINKI Na mestu injiciranja se lahko pojavi manjši vozlič (<2cm), ki je prehoden in izgine v enem do štirih tednih.
English: EXP (mm/yy) Use immediately after broaching
Slovenian: EXP {mm/ll} Uporabite takoj po rekonstituciji.
English: Subcutaneous use
Slovenian: Subkutano dajanje
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components) and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da je cepivo varno zmešati z Merialovimi neadjuviranimi cepivi za mačke (več kombinacij mačjih cepiv s komponentami proti virusnemu rinotraheitisu, calicivirozi, panleukopenji in klamidiozi) in/ali varno aplicirati isti dan, vendar ne zmešano z Merialovimi adjuviranimi cepivi proti steklini.
English: FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGIH SNOVI Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97) ….. ≥ 10 7,2 CCID50
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered the same day but not mixed with Merial adjuvanted vaccines (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and rabies components).
Slovenian: Podatki o varnosti in učinkovitosti cepiva so pokazali, da je cepivo varno aplicirati isti dan vendar ne zmešano z Merialovimi adjuviranimi cepivi (različne kombinacije cepiv s komponentami proti virusnemu rinotraheitisu, calicivirozi, panleukopenji in steklini).
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE (ZDRAVILNIH UČINKOVIN) IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA,
English: 4.2 Indications for use,specifying the target species
Slovenian: 4.2 Indikacije za uporabo
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Merial non-adjuvanted vaccine range (various combinations of feline viral rhinotracheitis, calicivirosis, panleukopenia and chlamydiosis components)
Slovenian: Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in aplicira z Merialovimi neadjuviranimi cepivi (različne kombinacije komponent virusnega rinotraheitisa mačk, kaliciviroze,
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Slovenian: NAVEDBA ZDRAVILNE UČINKOVINE IN DRUGE(IH) SNOVI
English: annual
Slovenian: enkrat letno
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Slovenian: POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDEOSKRBE IN UPORABE
English: D. STATEMENT OF THE MRLs
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL)
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Slovenian: GLEDE VARNE IN UČINKOVITE UPORABE
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: NAVODILO ZA UPORABO ZA: Purevax FeLV Suspenzija za injiciranje IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNEGA ZA
English: Keep out of the reach and sight of children.
Slovenian: Zdravilo shranjujte nedosegljivo otrokom.
English: FeLV recombinant Canarypox virus (vCP97) ........ ≥ 10 7.2 CCID50 (cell culture infective dose 50%)
Slovenian: Rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije(vCP97)…..
English: The recommended starting dose is one capsule three times a day.
Slovenian: Priporočeni začetni odmerek je ena kapsula trikrat na dan.
English: The full EPAR for Yargesa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Yargesa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Yargesa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Yargesa.
English: What measures are being taken to ensure the safe and effective use of Yargesa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Yargesa?
English: As a result, glucosylceramide builds up in different parts of the body, such as the spleen, liver and bones.
Slovenian: Glukozilceramid se posledično kopiči v različnih delih telesa, npr. v vranici, jetrih in kosteh.
English: The Committee recommended that Yargesa be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Yargesa odobri za uporabo v EU.
English: As for every medicine, the company provided studies on the quality of Yargesa.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Yargesa.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Yargesa has been shown to have comparable quality and to be bioequivalent to Zavesca.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Yargesa primerljivo raven kakovosti kot zdravilo Zavesca ter da mu je biološko enakovredno.
English: Yargesa is used in patients who cannot receive enzyme-replacement therapy.
Slovenian: Zdravilo Yargesa se uporablja pri bolnikih, ki ne morejo prejemati encimskega nadomestnega zdravljenja.
English: Because Yargesa is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Yargesa generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Yargesa is a ‘generic medicine'.
Slovenian: Zdravilo Yargesa je „generično zdravilo“.
English: This means that it contains the same active substance (miglustat) and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Zavesca.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot referenčno zdravilo Zavesca, ki je že odobreno v Evropski uniji (EU).
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Zavesca, and do not need to be repeated for Yargesa.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Zavesca, zato jih ni treba ponoviti za zdravilo Yargesa.
English: Other information about Yargesa
Slovenian: Druge informacije o zdravilu Yargesa
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Yargesa have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Yargesa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: For more information about treatment with Yargesa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Yargesa preberite navodilo za uporabo (ki je tudi del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the benefits and risks of Yargesa?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Yargesa?
English: What is Yargesa and what is it used for?
Slovenian: Kaj je zdravilo Yargesa in za kaj se uporablja?
English: A lower dose should be used in patients with reduced kidney function and those who develop diarrhoea.
Slovenian: Pri bolnikih z zmanjšanim delovanjem ledvic in tistih, pri katerih se pojavi driska, je treba uporabiti nižji odmerek.
English: Yargesa is available as 100 mg capsules to be taken by mouth.
Slovenian: Zdravilo Yargesa je na voljo v obliki 100-miligramskih kapsul, ki se jemljejo peroralno.
English: It is not intended to provide practical advice on how to use Yargesa.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Patients with this disease lack an enzyme that breaks down a type of fat called glucosylceramide.
Slovenian: Bolnikom s to boleznijo primanjkuje encim, ki razgrajuje vrsto maščobe, imenovane glukozilceramid.
English: By preventing the enzyme from working, miglustat can reduce the production of glucosylceramide in cells, thereby reducing the symptoms of type-1 Gaucher disease.
Slovenian: Miglustat lahko s preprečevanjem delovanja encima zmanjša tvorbo glukozilceramida v celicah in s tem zmanjša simptome Gaucherjeve bolezni tipa 1.
English: Yargesa is a medicine used to treat adults with mild to moderate type-1 Gaucher disease.
Slovenian: Zdravilo Yargesa se uporablja za zdravljenje odraslih z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
English: For practical information about using Yargesa, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Yargesa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Therefore, the CHMP's view was that, as for Zavesca, the benefit outweighs the identified risk.
Slovenian: Zato je odbor CHMP menil, da njegove koristi enako kot pri zdravilu Zavesca odtehtajo znana tveganja.
English: Why is Yargesa approved?
Slovenian: Zakaj je bilo zdravilo Yargesa odobreno?
English: The medicine can only be obtained with a prescription and treatment should be supervised by doctors who are experienced in the management of Gaucher disease.
Slovenian: Predpisovanje in izdaja zdravila Yargesa je le na recept, zdravljenje z njim pa mora uvesti zdravnik specialist, ki ima izkušnje z zdravljenjem Gaucherjeve bolezni.
English: The active substance in Yargesa, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Slovenian: Zdravilna učinkovina zdravila Yargesa, miglustat, preprečuje delovanje encima, imenovanega glukozilceramid sintaza.
English: How does Yargesa work?
Slovenian: Kako zdravilo Yargesa deluje?
English: How is Yargesa used?
Slovenian: Kako se zdravilo Yargesa uporablja?
English: How has Yargesa been studied?
Slovenian: Kako je bilo zdravilo Yargesa raziskano?
English: EU number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/02/235/001 Monotard
Slovenian: Vsebnost (koncentracija)
English: Tavanic is marketed in the following EU Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden and United Kingdom.
Slovenian: Zdravilo Tavanic se trži v naslednjih državah članicah EU: Avstriji, Belgiji, Bolgariji, Cipru, Češki republiki, Estoniji, Finski, Franciji, Nemčiji, Grčiji, Madžarski, Irski, Italiji, Litvi, Luksemburgu, Malti, Nizozemski, Poljski, Portugalski, Slovaški, Sloveniji, Španiji, Švedski in Združenem Kraljestvu.
English: The European Commission issued a decision on 31 July 2012.
Slovenian: Evropska komisija je odločbo izdala dne 31. julija 2012.
English: Tavanic is authorised in the EU via national procedures.
Slovenian: Zdravilo Tavanic so odobrili v EU z nacionalnimi postopki.
English: Why was Tavanic reviewed?
Slovenian: Zakaj je bilo zdravilo Tavanic pregledano?
English: Tavanic is an antibiotic that belongs to the group ‘fluoroquinolones'.
Slovenian: Zdravilo Tavanic je antibiotik, ki spada v skupino „fluorokinolonov“.
English: After reviewing the available data supporting the use of the medicine, the CHMP agreed that:
Slovenian: Po pregledu razpoložljivih podatkov, ki podpirajo uporabo zdravila, je odbor CHMP potrdil, da:
English: On 24 May 2012 the European Medicines Agency completed a review of Tavanic.
Slovenian: Evropska agencija za zdravila je 24. maja 2012 končala pregled zdravila Tavanic.
English: The company that markets these medicines is Sanofi.
Slovenian: Ta zdravila trži družba Sanofi.
English: It works by blocking an enzyme that bacteria use to make copies of their DNA.
Slovenian: Deluje tako, da zavira encim, ki ga bakterije uporabljajo za kopiranje svoje DNK.
English: On 11 October 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Tavanic in the EU.
Slovenian: Evropska komisija je 11. oktobra 2010 zadevo napotila k odboru CHMP z namenom uskladitve dovoljenj za promet z zdravilom Tavanic v EU.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: To je povzročilo razlike med državami članicami glede tega, kako se zdravilo lahko uporablja, kar se izraža v razlikah med povzetki glavnih značilnosti zdravila, označevanji in navodili za uporabo v državah, v katerih se zdravilo trži.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the product information for Tavanic in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je treba uskladiti informacije o zdravilu Tavanic v Evropski uniji (EU).
English: The amended information to doctors and patients is available here for solution for infusion and tablets.
Slovenian: Spremenjene informacije za zdravnike in bolnike so na voljo na povezavah raztopina za infundiranje in tablete.
English: The CHMP also harmonised other sections of the SmPC including the addition of a new warning in section 4.4 recommending that an eye specialist should be consulted if vision becomes impaired or any effects on the eyes are experienced.
Slovenian: Odbor CHMP je uskladil tudi druga poglavja povzetka glavnih značilnosti zdravila, vključno z dodatkom novega opozorila v poglavju 4.4, ki priporoča, da se je treba posvetovati z okulistom, če pride do poslabšanja vida ali kakršnih koli učinkov na oči.
English: Tavanic is currently used to treat various infections and is available as tablets or solution for infusion.
Slovenian: Zdravilo Tavanic se trenutno uporablja za zdravljenje različnih okužb in je na voljo v obliki tablet ali raztopine za infundiranje.
English: In addition, the Committee added new side effects in section 4.8 including ligament rupture, hypoglycaemic coma, benign intracranial hypertension, as well as palpitations and ventricular tachycardia, which may result in cardiac arrest.
Slovenian: Poleg tega je poglavju 4.8 dodal nove neželene učinke, vključno z rupturo ligamenta, hipoglikemično komo, benigno intrakranialno hipertenzijo ter palpitacijami in ventrikularno tahikardijo, ki lahko povzročita srčni zastoj.
English: Based on the data reviewed, the CHMP decided a harmonisation of the contraindications of Tavanic in patients hypersensitive (allergic) to levofloxacin, any other quinolone or any of the excipients, in patients with epilepsy, in patients with history of tendon disorders related to fluoroquinolone administration, in children or growing adolescents, during pregnancy and in breast-feeding women.
Slovenian: Na podlagi pregledanih podatkov se je odbor CHMP odločil za uskladitev kontraindikacij pri zdravilu Tavanic pri bolnikih s preobčutljivostjo za (alergijo na)levofloksacin, katere koli druge kinolone ali katero koli pomožno snov, pri bolnikih z epilepsijo, bolnikih z anamnezo težav s kitami, povezanih z uporabo fluorokinolona, pri otrocih ali mladostnikih, ki še rastejo, med nosečnostjo in pri doječih materah.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je ob upoštevanju predloženih podatkov in interne znanstvene razprave odločil, da je treba uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo v vsej EU.
English: By doing this, it stops the bacteria that are causing an infection from growing and multiplying.
Slovenian: Tako ustavi rast in razmnoževanje bakterij, ki povzročajo okužbo.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the posology and frequency of administration of Tavanic, including the posology for acute exacerbations of chronic bronchitis and pyelonephritis.
Slovenian: Ker je odbor CHMP uskladil indikacije, je uskladil tudi priporočila za odmerjanje in pogostnost uporabe zdravila Tavanic, vključno z odmerjanjem pri akutnih eksacerbacijah kroničnega bronhitisa in pri pielonefritisu.
English: What is Tavanic?
Slovenian: Kaj je zdravilo Tavanic?