FrancophonIA/ELRC3.0 huggingface dataset:
English: In Docetaxel Zentiva 80 mg /4 ml vial the concentration of docetaxel is 20 mg/ml.
Slovenian: V viali, ki vsebuje zdravilo Docetaxel Zentiva 80 mg/4 ml, je koncentracija docetaksela 20 mg/ml.
English: Epistaxis (G3/4: < 1%)
Slovenian: omotica, glavobol (S3/4: < 1 %),
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Slovenian: Docetaxel Zentiva 160 mg/8 ml koncentrat za raztopino za infundiranje docetaksel
English: Asthenia (G3/4:
Slovenian: Žilne bolezni bolezen ven (S3/4:
English: Asthenia (severe:
Slovenian: Bolezni živčevja:
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Slovenian: Bolezni krvi in limfatičnega sistema nevtropenija (S3/4:
English: Stomatitis (G3/4: 18%); Diarrhoea (G3/4: 14%); Nausea (G3/4: 6%);
Slovenian: Bolezni prebavil stomatitis (S3/4: 5,3 %), driska (S3/4: 4 %), navzea (S3/4: 4 %), bruhanje (S3/4: 3 %)
English: Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m2 single agent
Slovenian: Opis izbranih neželenih učinkov monoterapije z zdravilom Docetaxel Zentiva 100 mg/m2 pri raku dojke
English: G3/4 Blood bilirubin increased
Slovenian: Preiskave zvečanje bilirubina v krvi S3/4
English: Tabulated summary of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m2 single agent
Slovenian: Tabelarični prikaz neželenih učinkov monoterapije z zdravilom Docetaxel Zentiva 100 mg/m2 pri raku dojke
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 160 mg/8 ml
Slovenian: NALEPKA NA VIALI/ Docetaxel Zentiva 160 mg/8 ml
English: G3/4 Blood bilirubin increased (< 2.5%);
Slovenian: Preiskave zvečanje bilirubina v krvi S3/4 (< 2,5 %), zvečanje zvečanje alkalne fosfataze v krvi S3/4 (< 2,5 %)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Slovenian: Docetaxel Zentiva 20 mg/1 ml koncentrat za raztopino za infundiranje docetaksel
English: Thrombocytopenia (G3/4: 4.0%);
Slovenian: trombocitopenija (S4: 0,5 %)
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Slovenian: Docetaxel Zentiva 80 mg/4 ml koncentrat za raztopino za infundiranje docetaksel
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 80 mg/4 ml
Slovenian: NALEPKA NA VIALI / Docetaxel Zentiva 80 mg/4 ml
English: These scabs usually disappear within 2 weeks.
Slovenian: Kraste navadno izginejo v dveh tednih.
English: Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Slovenian: Vsak odmerek (0,2 ml ali 0,5 ml) rekonstituiranega cepiva vsebuje:
English: Revaccination: Revaccinate annually.
Slovenian: Revakcinacija: Cepljenje ponovimo vsako leto.
English: The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe(ES) št. 470/2009.
English: To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case.
Slovenian: Da bi zagotovili celotno trajanje imunosti, se v tem primeru svetuje cepljenje od 7.
English: Any unused veterinary medicinal product or waste materials derived from such medicinal product should be disposed of in accordance with local requirements.
Slovenian: Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi zahtevami.
English: High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product.
Slovenian: Visoka stopnja materinih protiteles proti virusu miksoma in/ali virusu RHD lahko potencialno zmanjša učinkovitost zdravila.
English: The scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
Slovenian: Te kraste opazimo samo pri živalih z aktivno imunostjo in ne vplivajo na splošno zdravje, apetit ali obnašanje kunca.
English: The vector technology used to develop the vaccine strains allows the RHD virus components to be produced in vitro instead of using live rabbits for cultivation.
Slovenian: Vektorska tehnologija, ki se uporablja za pripravo sevov cepiva, omogoča, da se RHD virusna komponenta proizvaja in vitro, namesto da bi uporabili žive kunce.
English: 1 dose 50 doses
Slovenian: 1 odmerek 50 odmerkov
English: EXP {month/year} Once reconstituted use within 4 hours.
Slovenian: EXP { mesec/leto } Rekonstituirano zdravilo uporabite v 4 urah.
English: *Focus Forming Units For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Slovenian: Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: Administer the total contents of the vial.
Slovenian: Injicirajte celotno vsebino viale.
English: For proper reconstitution of the multidose vial, use the following procedure:
Slovenian: Za pravilno rekonstitucijo večodmerne viale upoštevajte naslednji postopek:
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na viali.
English: Multi-dose vial (50 doses)
Slovenian: Viala z več odmerki ( 50 odmerki)
English: Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.
Slovenian: Rok uporabnosti zdravila (liofilizata) v pakiranju za prodajo: 2 leti.
English: Shelf life after reconstitution according to directions: 4 hours.
Slovenian: Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VACCINE GLASS VIAL LABEL - 1 dose / 50 doses glass vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Cepivo nalepka steklo - 1 odmerek/50 odmerek vial steklo
English: Administer 0.2 ml per animal.
Slovenian: Dajte 0,2 ml na žival.
English: After infection with virulent field myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Slovenian: Po okužbi z virulentnim naravnim miksoma virusom, se pri nekaterih cepljenih živalih lahko pojavi nekaj zelo majhnih oteklin, posebno na neporaščenih delih telesa, ki se hitro spremenijo v kraste.
English: Withdraw the reconstituted vaccine concentrate from the vial and inject it back into the solvent vial.
Slovenian: Izvlecite rekonstituirani koncentrat cepiva iz viale in ga injicirajte nazaj v vialo z vehiklom.
English: For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).
Slovenian: Za aktivno imunizacijo kuncev od 5 tednov starosti dalje za zmanjšanje smrtnosti in kliničnih znakov miksomatoze in za preprečevanje smrtnosti zaradi hemoragične bolezni kuncev, ki jo povzroča klasični RHD sev ( RHDV1) virusa in RHD sec 2 virus ( RHDV2).
English: 0.5 ml and 10 ml glass vial
Slovenian: 0,5 ml in 10 ml viale steklo
English: Ensure that the resulting vaccine suspension in the solvent vial is properly mixed.
Slovenian: Poskrbite, da je nastala suspenzija cepiva v viali z vehiklom dobro premešana.
English: In pet rabbits, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur in very rare cases.
Slovenian: Pri hišnih kuncih v zelo redkih primerih lahko pride do lokalnih reakcij, kot so nekroza, kraste ali izpadanje dlake.
English: Do not mix with any other veterinary medicinal product, except 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 cepivom.
English: Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits
Slovenian: Nobivac Myxo-RHD PLUS liofilizat in vehikel za suspenzijo za injiciranje za kunce
English: The appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination in very rare cases.
Slovenian: V zelo redkih primerih se v treh tednih po cepljenju lahko pojavijo blagi klinični znaki miksomatoze.
English: Primary vaccination: Administer one dose to rabbits from 5 weeks of age onwards.
Slovenian: Primarno cepljenje: Po rekonstituciji injicirajte 1 odmerek cepiva subkutano kuncem od 5 tednov starosti dalje.
English: Lyophilisate: Type I clear glass vial of 1 or 50 doses closed with a chlorobutyl rubber stopper and aluminium cap.
Slovenian: Viala iz prozornega stekla tip I z 1 ali 50 odmerki, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
English: Disodium phosphate dihydrate Potassium dihydrogen phosphate
Slovenian: hidrolizirana želatina pankreasni presnovek kazeina sorbitol natrijev hidrogenfosfat dihidrat Vehikel: natrijev hidrogenfosfat dihidrat kalijev dihidrogenfosfat voda za injekcije
English: Add 1 -2 ml of solvent to the 50-dose vaccine vial and ensure that the lyophilisate is fully dissolved.
Slovenian: Dodajte 1-2 ml topila 50 odmerki cepiva in poskrbite, da se liofilizat popolnoma raztopi.
English: Serious hypersensitivity reactions, which may be fatal, may occur after vaccination in very rare cases.
Slovenian: V zelo redkih primerih se lahko po cepljenju pojavijo hude preobčutljivostne reakcije, ki so lahko smrtne.
English: Solvent for Nobivac Myxo-RHD PLUS
Slovenian: Vehikel za Nobivac Myxo-RHD PLUS
English: As a consequence rabbits are immunised against myxoma virus and both classical and type 2 RHD virus.
Slovenian: Posledično so kunci imunizirani proti miksoma virusu in proti klasičnemu in tip 2 RHD virusu.
English: Reconstituted product: off-pink or pink coloured suspension.
Slovenian: Rekonstituirano zdravilo: suspenzija rahlo rožnate ali rožnate barve
English: Solvent: Type I clear glass vial of 0.5 ml or 10 ml closed with a bromobutyl rubber stopper and aluminium cap.
Slovenian: Viala iz prozornega stekla tip I z 0,5 ml ali 10 ml, zaprta z zamaškom iz bromobutilne gume in aluminijasto zaporko.
English: In addition to the signs observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after the administration of a ten-fold overdose.
Slovenian: Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju z desetkrat večjim odmerkom opazimo rahlo oteklino lokalnih limfnih vozlov.
English: For proper reconstitution of the multi-dose vial, use the following procedure:
Slovenian: Za pravilno rekonstitucijo večodmerne plastenke ravnajte, kot sledi:
English: Pharmacotherapeutic group: Immunologicals for Leporidae, live viral vaccine for rabbits ATC-vet code: QI08AD
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za zajce in kunce (leporidae), živo virusno cepivo za kunce
English: NL - 5831 AN Boxmeer
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer Nizozemska
English: Plastic box with 5 x 1 dose vials of vaccine and 5 x 0.5 ml solvent vials (glass) Plastic box with 25 x 1 dose vials of vaccine and 25 x 0.5 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Slovenian: Plastična škatla z 5 x 1 odmerek cepiva z 5 x 0,5 ml vehikel ( steklo) Plastična škatla z 25 x 1 odmerek cepiva z 25 x 0,5 ml vehikel ( steklo) Kartonska škatla s 10 x 50 odmerkov cepiva
English: The vaccine is intended to stimulate immunity against myxoma virus and rabbit haemorrhagic disease viruses in rabbits.
Slovenian: Za stimulacijo imunosti proti virusu miksomatoze in proti virusu hemoragične bolezni kuncev.
English: Name and address of the manufacturer of the biological active substances Intervet International B.V.
Slovenian: Ime in naslov proizvajalca biološke učinkovine
English: Special precautions for use in animals: Not applicable.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih:
English: Intervet International B.V. Wim de Körverstraat 35
Slovenian: Intervet International B.V.
English: The vaccine strains are myxoma viruses expressing the capsid protein gene of classical or type 2 RHD viruses.
Slovenian: Sev cepiva je miksoma virus, ki ima v kapsidi proteinski gen virusa hemoragične bolezni kuncev, klasični ali tip 2 RHD virus.
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: PACKAGE LEAFLET:
Slovenian: Pakiranja:
English: Reconstitute a multi-dose vial containing lyophilisate with 10 ml of the supplied solvent.
Slovenian: Rekonstituirajte večodmerno vialo, ki vsebuje liofilizat, z 10 ml priloženega topila.
English: Lyophilisate: off-white or cream-coloured pellet.
Slovenian: Liofilizat: sivobeli ali kremno obarvani peleti.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA STIČNI OVOJNINI Nalepka za vehikel
English: A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
Slovenian: Lahko pride do prehodnega povišanja temperature za 1-2° C. V prvih dveh tednih po cepljenju običajno opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
English: No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Slovenian: Plodnost: Na samcih ni bila opravljena nobena študija varnosti v zvezi z reprodukcijo.
English: 5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine
Slovenian: 5 x 1 odmerek cepiva z topilom 25 x 1 odmerek cepiva z topilom 10 x 50 odmerkov cepiva
English: Single dose vial
Slovenian: Viala z enkratnim odmerkom
English: Cardboard box with 10 x 10 ml solvent vials (glass)
Slovenian: ŠKATLA ( VEHIKEL) Kartonska škatla s 10 x 10 odmerkov vehikla ( steklo)
English: NAME OF THE SOLVENT
Slovenian: IME VEHIKLA
English: Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU* Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU*
Slovenian: Miksoma virus, živi vektorski RHD sev 009: 103.0 - 105.8 FFU* Miksoma virus, živi vektorski RHD sev MK1899: 103.0 - 105.8 FFU*
English: Solvent: No special precautions for storage.
Slovenian: Vehikel: Za shranjevanje ni posebnih navodil.
English: Live myxoma vectored RHD viruses
Slovenian: KOLIČINA UČINKOVINE Miksoma virus, živi, vektorski RHD
English: Reconstitute a single dose vial containing lyophilisate with 0.5 ml of the supplied solvent.
Slovenian: Rekonstituirajte vialo za enkratni odmerek, ki vsebuje liofilizat, z 0,5 ml vehikla.
English: − 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 živali od 10 živali v teku enega zdravljenja) - pogosti (pojavijo se pri 1 od 10 živali od 100 živali) - občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: Rabbits.
Slovenian: Kunci.
English: No special precautions for storage.
Slovenian: Za shranjevanje ni posebnih navodil.
English: - Cardboard box with 10 x 50 doses vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
Slovenian: Kartonska škatla z 10 x vialo s 50 odmerki cepiva, in kartonska škatla z 10 x 10 ml odmerki topila.
English: Water for injections
Slovenian: Subkutana injekcija.
English: Read package leaflet before use.
Slovenian: Subkutana injekcija Pred uporabo preberite navodilo za uporabo.
English: In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after administration of a ten-fold overdose.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Poleg znakov, ki jih opazimo po cepljenju z enkratnim odmerkom, lahko v prvih 3 dneh po cepljenju s desetkrat večjim odmerkom opazimo rahlo oteklino lokalnih limfnih vozlov.
English: Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU/dose.
Slovenian: Miksoma virus, živi vektorski RHD sev 009: 103.0 - 105.8 FFU/odmerek Miksoma virus, živi vektorski RHD sev MK1899: 103.0 - 105.8 FFU/odmerek
English: - Cardboard box with 10 x 50 dose vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
Slovenian: Kartonska škatla z 10 vialami s 50 odmerki cepiva, in kartonska škatla z 10 vialami z 10 ml vehikla.
English: - Plastic box with 25 x 1 dose vials of vaccine and 25 vials containing 0.5 ml of solvent.
Slovenian: Plastična škatla s 25 vialami z 1 odmerkom cepiva in 25 vialami z 0,5 ml vehikla.
English: - Plastic box with 5 x 1 dose vials of vaccine and 5 vials containing 0.5 ml of solvent.
Slovenian: Plastična škatla z 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 0,5 ml topila.
English: A transient temperature increase of 1 - 2 °C can commonly occur.
Slovenian: Pogosto lahko pride do prehodnega povišanja temperature za 1-2° C. V prvih dveh tednih po cepljenju lahko pogosto opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
English: Rabbits
Slovenian: Kunci
English: Special warnings for each target species: Vaccinate healthy animals only.
Slovenian: Posebna opozorila za vsako ciljno vrsto:
English: Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 vials containing 0.5 ml of solvent.
Slovenian: Plastična škatla s 5 vialami z 1 odmerkom cepiva in 5 vialami z 0,5 ml vehikla.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Slovenian: NAVEDBA UČINKOVIN(E)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: 1 Previously known as Zevtera.
Slovenian: Prvotno znano kot Zevtera.
English: What did the company present to support its application?
Slovenian: Kaj je podjetje predložilo v podporo svoji vlogi?
English: 18 February 2010 EMA/83783/2010 EMEA/H/C/883
Slovenian: EMA/476144/2010 EMEA/H/C/000883
English: What were the CHMP's main concerns that led to the refusal
Slovenian: Kateri so bili glavni zadržki CHMP, ki so privedli do zavrnitve?
English: The company that applied for the authorisation is Janssen-Cilag International N.V.
Slovenian: Vlogo za dovoljenje je podala družba Janssen-Cilag International N.V.
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has t might affect the response to treatment.
Slovenian: „Zapleteno“ pomeni, da je okužbo težko zdraviti, ker se je razširila na tkiva globoko pod kožo, morda bo potrebno operativno zdravljenje ali pa se pri bolniku pojavljajo druga stanja, ki lahko vplivajo na odziv na zdravljenje.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Slovenian: Kakšne so posledice te zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
English: What is Zeftera?
Slovenian: Kaj je zdravilo Zeftera?
English: On 18 February 2010, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product for the treatment of adults with complicated skin and soft-tissue infections.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 18. februarja 2010 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Zeftera, namenjenim zdravljenju zapletenih okužb kože in mehkih tkiv pri odraslih.
English: This prevents the bacteria from building the walls that surround their cells, which kills the bacteria.
Slovenian: S tem bakterijam preprečuje gradnjo zidu, s katerim ogradijo svoje celice, in jih tako uniči.
English: What was Zeftera expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Zeftera uporabljalo?
English: The active substance in Zeftera, ceftobiprole, is an antibiotic that belongs to the group ‘cephalosporins'.
Slovenian: Zdravilna učinkovina zdravila Zeftera, ceftobiprol, je antibiotik, ki sodi v skupino „cefalosporinov“.
English: The Commi therefore recommended that, in light of the uncertainty surrounding the results, th not be granted marketing authorisation.
Slovenian: Odbor je tako priporočil, da se zaradi negotovosti glede zanesljivosti rezultatov zdravilu dovoljenje za promet ne odobri.
English: How is Zeftera expected to work?
Slovenian: Kako naj bi zdravilo Zeftera delovalo?
English: The company informed the CHMP that that there are no consequences for patients in clinical trials with Zeftera and that there are no compassionate use programmes in progress with Zeftera.
Slovenian: Družba je obvestila CHMP, da zavrnitev nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Zeftera, programi sočutne uporabe zdravila Zeftera pa se ne izvajajo.
English: In bo effectiveness was the number of patients whose infection had been cured at the
Slovenian: Glavno merilo učinkovitosti pri obeh študijah je bilo število bolnikov, pri katerih je bila okužba ob koncu zdravljenja ozdravljena.
English: is active against several types of bacteria, including methicillin-resistant Staphylococcus d in humans.
Slovenian: Ceftobiprol učinkuje proti več vrstam bakterij, vključno proti bakteriji Staphylococcus aureus (MRSA), odporni na meticilin.
English: The first study compared Zeftera with vancomycin (another an ceftazidime (another cephalosporin antibiotic) in 828 patients.
Slovenian: V prvi študiji so primerjali rezultate zdravljenja z zdravilom Zeftera v primerjavi z vankomicinom (drug antibiotik, učinkovit proti MRSA) pri 784 bolnikih, v drugi študiji pa zdravljenje z zdravilom Zeftera v primerjavi s kombinacijo vankomicina in ceftazidima (drug cefalosporinski antibiotik) pri 828 bolnikih.
English: Refusal of the marketing authorisation for Zeftera
Slovenian: Zavrnitev dovoljenja za promet z zdravilom Zeftera (ceftobiprol)
English: The effects of Zeftera were first tested in experimental models before being studie The company presented results of two main studies involving adults with complicated ski tissue infections.
Slovenian: Podjetje je predstavilo rezultate dveh glavnih študij z odraslimi bolniki z zapletenimi okužbami kože in mehkih tkiv.
English: These subsequent inspections showed that the studies had not been conducted in ‘good clinical practice' (GCP) in some beneficial to patients, the CHMP was concerned about how reliable the results were.
Slovenian: Čeprav so rezultati študije kazali, da je zdravilo za bolnike učinkovito, pa je CHMP izrazil zadržke glede zanesljivosti rezultatov.
English: In November 2008, the CHMP gave a positive opinion on Zeftera, recomm marketing authorisatio study sites by the Food and Drug Administration (FDA) in the United States of A concerns over the way the main clinical studies were conducted.
Slovenian: CHMP je novembra 2008 izdal pozitivno mnenje o zdravilu Zeftera in priporočil, da se za zdravilo odobri dovoljenje za promet.
English: Zeftera was expected to be used to treat adults with complicated infections of th other conditions tha
Slovenian: Zdravilo Zeftera naj bi se uporabljalo za zdravljenje odraslih bolnikov z zapletenimi okužbami kože in „mehkih tkiv“ pod kožo.