FrancophonIA/ELRC3.0 huggingface dataset:
English: CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: CoAprovel 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle s 14 tabletami v pretisnem omotu iz PVC/PVDC/aluminija.
English: While this is not documented with CoAprovel, a similar effect should be anticipated.
Slovenian: Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom CoAprovel, čeprav to pri zdravljenju z njim ni bilo dokazano.
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle z 90 filmsko obloženimi tabletami v pretisnih omotihv iz PVC/PVDC/aluminijai.
English: CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Slovenian: CoAprovel 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: EU/1/98/086/023 - 14 tablets EU/1/98/086/024 - 28 tablets EU/1/98/086/031 - 30 tablets EU/1/98/086/025 - 56 tablets EU/1/98/086/028 - 56 x 1 tablets EU/1/98/086/026 - 84 tablets EU/1/98/086/034 - 90 tablets EU/1/98/086/027 - 98 tablets
Slovenian: EU/1/98/086/023 - 14 tablet EU/1/98/086/024 - 28 tablet EU/1/98/086/031 - 30 tablet EU/1/98/086/025 - 56 tablet EU/1/98/086/028 - 56 x 1 tableta EU/1/98/086/026 - 84 tablet EU/1/98/086/034 - 90 tablet EU/1/98/086/027 - 98 tablet
English: EU/1/98/086/011 - 14 tablets EU/1/98/086/012 - 28 tablets EU/1/98/086/029 - 30 tablets EU/1/98/086/013 - 56 tablets EU/1/98/086/014 - 56 x 1 tablets EU/1/98/086/021 - 84 tablets EU/1/98/086/032 - 90 tablets EU/1/98/086/015 - 98 tablets
Slovenian: EU/1/98/086/011 - 14 tablet EU/1/98/086/012 - 28 tablet EU/1/98/086/029 - 30 tablet EU/1/98/086/013 - 56 tablet EU/1/98/086/014 - 56 x 1 tableta EU/1/98/086/021 - 84 tablet EU/1/98/086/032 - 90 tablet EU/1/98/086/015 - 98 tablet
English: Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle s 84 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
English: Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle z 98 tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
English: Cartons of 56 x 1 film-coated tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Slovenian: Škatle s 56 x 1 filmsko obloženo tableto v perforiranih enoodmernih pretisnih omotih iz PVC/PVDC/aluminija.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
English: CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: CoAprovel 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Each film-coated tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Slovenian: Ena CoAprovel 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Cartons of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle s 14 filmsko obloženimi tabletami v pretisnem omotu iz PVC/PVDC/aluminija.
English: EU/1/98/086/016 - 14 tablets EU/1/98/086/017 - 28 tablets EU/1/98/086/030 - 30 tablets EU/1/98/086/018 - 56 tablets EU/1/98/086/019 - 56 x 1 tablets EU/1/98/086/022 - 84 tablets EU/1/98/086/033 - 90 tablets EU/1/98/086/020 - 98 tablets
Slovenian: EU/1/98/086/016 - 14 tablet EU/1/98/086/017 - 28 tablet EU/1/98/086/030 - 30 tablet EU/1/98/086/018 - 56 tablet EU/1/98/086/019 - 56 x 1 tableta EU/1/98/086/022 - 84 tablet EU/1/98/086/033 - 90 tablet EU/1/98/086/020 - 98 tablet
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle z 28 tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
English: CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; CoAprovel 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by CoAprovel 150 mg/12.5 mg.
Slovenian: Kadar je klinično primerno, se lahko razmisli o prehodu iz monoterapije na kombinirano zdravljenje:  Zdravilo CoAprovel 150 mg/12,5 mg je namenjeno bolnikom, pri katerih se zvišan krvni tlak med zdravljenjem samo s hidroklorotiazidom ali samo s 150 mg irbesartana ni dovolj znižal.
English: Cartons of 28 film-coated tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle z 28 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
English: Thu
Slovenian: Tor
English: CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: CoAprovel 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena tableta vsebuje 300 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Sat
Slovenian: Sob
English: Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
Slovenian: Ena tableta vsebuje 300 mg irbesartana in 25 mg hidroklorotiazida.
English: Cartons of 56 x 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Slovenian: Škatle s 56 x 1 tableto v perforiranih enoodmernih pretisnih omotih iz PVC/PVDC/aluminija.
English: Cartons of 98 film-coated tablets in PVC/PVDC/Aluminium blisters.
Slovenian: Škatle z 98 filmsko obloženimi tabletami v pretisnih omotih iz PVC/PVDC/aluminija.
English: CoAprovel is for oral use.
Slovenian: Uporablja se peroralno.
English: CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Slovenian: CoAprovel 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Ear and labyrinth disorders:
Slovenian: Ušesne bolezni, vključno z motnjami labirinta:
English: CoAprovel 150 mg/12.5 mg film-coated tablets.
Slovenian: IME ZDRAVILA CoAprovel 150 mg/12,5 mg filmsko obložene tablete
English: Nervous system disorders:
Slovenian: Bolezni živčevja:
English: Package leaflet: Information for the patient CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo CoAprovel 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Slovenian: Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 300 mg/25 mg filmsko obložene tablete so rožnate barve, bikonveksne in ovalne oblike.
English: EU/1/98/086/011-015 EU/1/98/086/021 EU/1/98/086/029 EU/1/98/086/032
Slovenian: EU/1/98/086/011-015 EU/1/98/086/021
English: Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Slovenian: Ena tableta vsebuje 150 mg irbesartana in 12,5 mg hidroklorotiazida.
English: Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo CoAprovel 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Slovenian: Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 150 mg/12,5 mg filmsko obložene tablete so breskove barve, bikonveksne in ovalne oblike.
English: Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo CoAprovel 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Film-coating:
Slovenian: Bolezni prebavil:
English: What CoAprovel looks like and contents of the pack CoAprovel 150 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Slovenian: Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 150 mg/12,5 mg tablete so breskove barve, bikonveksne in ovalne oblike.
English: Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo CoAprovel 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Slovenian: Navodilo za uporabo CoAprovel 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Lot
Slovenian: Čet
English: dizziness
Slovenian: zardevanje
English: Tablet core:
Slovenian: Žilne bolezni:
English: Hypromellose Titanium dioxide Macrogol 3350
Slovenian: Filmska obloga: laktoza monohidrat hipromeloza titanov dioksid makrogol 3350 rdeči in črni železov oksid karnauba vosek
English: (It is also better to avoid CoAprovel in early pregnancy - see pregnancy section) if you have severe liver or kidney problems if you have difficulty in producing urine if your doctor determines that you have persistently high calcium or low potassium levels in your blood if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Slovenian: Ne jemljite zdravila CoAprovel če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6) če ste alergični na hidroklorotiazid ali druga zdravila, ki vsebujejo derivate sulfonamida če ste noseči dlje kot tri mesece (Jemanju zdravila CoAprovel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate hudo okvaro jeter ali ledvic če imate težave z odvajanjem seča če je zdravnik ugotovil, da imate stalno zvečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg film-coated tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Slovenian: Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 300 mg/12,5 mg filmsko obložene tablete so breskove barve, bikonveksne in ovalne oblike.
English: Excipient with known effect: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Slovenian: Ena filmsko obložena tableta vsebuje 38,5 mg laktoze (v obliki laktoze monohidrata).
English: 37100 Tours - France
Slovenian: F-75008 Paris - Francija
English: flushing
Slovenian: omotica
English: Do not take CoAprovel if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines if you are more than 3 months pregnant.
Slovenian: Ne jemljite zdravila CoAprovel če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6) če ste alergični na hidroklorotiazid ali druga zdravila, ki vsebujejo derivate sulfonamida če ste noseči dlje kot tri mesece (Jemanju zdravila CoAprovel se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti) če imate hudo okvaro jeter ali ledvic če imate težave z odvajanjem seča če je zdravnik ugotovil, da imate stalno zvečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/12.5 mg tablets are peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Slovenian: Izgled zdravila CoAprovel in vsebina pakiranja CoAprovel 300 mg/12,5 mg tablete so breskove barve, bikonveksne in ovalne oblike.
English: if you are taking any of the following medicines used to treat high blood pressure: o an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Slovenian:  če imate težave s srcem  če imate težave z jetri  če imate sladkorno bolezen  če imate eritematozni lupus (znan tudi kot lupus ali sistemski eritematozni lupus) če imate primarni aldosteronizem (stanje, povezano s čezmernim izločanjem hormona aldosterona, kar povzroči zastajanje natrija in posledično zvišanje krvnega tlaka) če jemljete katero od naslednjih zdravil, ki se uporabljajo za zdravljenje visokega krvnega tlaka: o zaviralec ACE (na primer enalapril, lizinopril ali ramipril), zlasti če imate kakšne težave z ledvicami, ki so povezane s sladkorno boleznijo.
English: fever
Slovenian: Plodnost
English: Treatment is given for 5 to 14 days.
Slovenian: Zdravljenje traja pet do 14 dni.
English: The main measure of effectiveness in both studies was whether the infection was cured.
Slovenian: Glavno merilo učinkovitosti v obeh študijah je bilo, ali je bila okužba ozdravljena.
English: Further information on Quofenix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/quofenix.
Slovenian: Nadaljnje informacije za zdravilo Quofenix so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/quofenix.
English: As a result, the bacteria cannot multiply and die.
Slovenian: Posledično se bakterije ne morejo razmnoževati in odmrejo.
English: Quofenix must not be used in children or adolescents under 18 years of age.
Slovenian: Zdravilo Quofenix se ne sme uporabljati pri otrocih ali mladostnikih, mlajših od 18 let.
English: It must not be used in women who are pregnant or breast feeding, or women who are able to have children who are not using contraception.
Slovenian: Ne sme se uporabljati pri ženskah, ki so noseče ali dojijo, ali pri ženskah, ki lahko zanosijo, a ne uporabljajo kontracepcije.
English: The European Medicines Agency decided that Quofenix's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Quofenix večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Quofenix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Quofenix?
English: Quofenix (delafloxacin) EMA/572803/2019
Slovenian: Quofenix (delafloksacin) EMA/572803/2019
English: Quofenix (delafloxacin)
Slovenian: Quofenix (delafloksacin)
English: As for all medicines, data on the use of Quofenix are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Quofenix stalno spremljajo.
English: After starting with a drip, the doctor may decide to switch to a tablet by mouth once every 12 hours.
Slovenian: Zdravljenje se začne s kapalno infuzijo, nato pa se zdravnik lahko odloči za prehod na jemanje tablet, in sicer ena tableta peroralno vsakih 12 ur.
English: Side effects reported with Quofenix are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Quofenix, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Quofenix is available as a powder to be made into a solution for infusion (300 mg) and as tablets (450 mg).
Slovenian: Zdravilo Quofenix je na voljo v obliki praška za pripravo raztopine za infundiranje (300 mg) in v obliki tablet (450 mg).
English: Since Quofenix's safety profile was similar to that of other fluoroquinolones, it was considered that, as for other fluoroquinolones, it should be authorised for use only when other antibiotics are not suitable.
Slovenian: Ker je varnostni profil zdravila Quofenix podoben varnostnemu profilu drugih fluorokinolonov, se šteje, da bi bilo treba, tako kot pri drugih fluorokinolonih, uporabo dovoliti samo, če drugi antibiotiki niso primerni.
English: Fluoroquinolones work by preventing bacteria involved in skin infections from making copies of their DNA (genetic material).
Slovenian: Fluorokinoloni delujejo tako, da bakterijam, ki sodelujejo pri okužbah kože, preprečujejo kopiranje njihove DNK (genetskega materiala).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Quofenix have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Quofenix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Quofenix
Slovenian: Druge informacije o zdravilu Quofenix
English: For more information about using Quofenix, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Quofenix glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: It contains the active substance delafloxacin.
Slovenian: Vsebuje učinkovino delafloksacin.
English: Quofenix has a different chemical structure to other fluoroquinolones, which means that it can enter bacterial cells more easily.
Slovenian: Zdravilo Quofenix ima drugačno kemijsko strukturo kot drugi fluorokinoloni, kar pomeni, da lažje vstopa v bakterijske celice.
English: Why is Quofenix authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Quofenix odobreno v EU?
English: The active substance in Quofenix, delafloxacin, belongs to a group of antibiotics called fluoroquinolones.
Slovenian: Učinkovina v zdravilu Quofenix, delafloksacin, spada v skupino antibiotikov, imenovanih fluorokinoloni.
English: An overview of Quofenix and why it is authorised in the EU
Slovenian: Pregled zdravila Quofenix in zakaj je odobreno v EU
English: Quofenix was shown to be as effective as alternative antibiotics in two main studies of adults with acute bacterial skin and skin structure infections.
Slovenian: Zdravilo Quofenix se je izkazalo za enako učinkovito kot alternativni antibiotiki v dveh glavnih študijah pri odraslih z akutno bakterijsko okužbo kože in kožnih struktur.
English: Quofenix must not be used in patients who are hypersensitive (allergic) to quinolone or fluoroquinolone antibiotics or in patients who have had tendon disorders related to treatment with a fluoroquinolone antibiotic.
Slovenian: Zdravilo Quofenix se ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) kinolonske ali fluorokinolonske antibiotike, ali pri bolnikih, ki so imeli težave s kitami, povezane z zdravljenjem s fluorokinolonskimi antibiotiki.
English: Quofenix is an antibiotic used in adults to treat bacterial infections of the skin and underlying tissues (acute bacterial skin and skin structure infections) when other medicines are not suitable.
Slovenian: Zdravilo Quofenix je antibiotik, ki se uporablja pri odraslih za zdravljenje bakterijskih okužb kože in podkožnih tkiv (akutnih bakterijskih okužbe kože in kožnih struktur), kadar druga zdravila niso primerna.
English: What benefits of Quofenix have been shown in studies?
Slovenian: Kakšne koristi zdravila Quofenix so se pokazale v študijah?
English: The most common side effects with Quofenix (which may affect up to 1 in 10 people) are diarrhoea and nausea (feeling sick), which are mild to moderate.
Slovenian: Najpogostejša neželena učinka zdravila Quofenix (ki se lahko pojavita pri največ 1 od 10 bolnikov) sta driska in navzeja (siljenje na bruhanje), ki pa sta blaga do zmerna.
English: What is Quofenix and what is it used for?
Slovenian: Kaj je zdravilo Quofenix in za kaj se uporablja?
English: Quofenix can only be obtained with a prescription and prescribers should take into account official guidance on the use of antibiotics.
Slovenian: Predpisovanje in izdaja zdravila Quofenix je le na recept, poleg tega morajo zdravniki, ki zdravilo predpisujejo, upoštevati uradne smernice za uporabo antibiotikov.
English: Quofenix is given by infusion (drip) into a vein over one hour every 12 hours.
Slovenian: Zdravilo Quofenix se daje kot enourna (kapalna) infuzija v veno vsakih 12 ur.
English: What are the risks associated with Quofenix?
Slovenian: Kakšna tveganja so povezana z zdravilom Quofenix?
English: In the first study involving 660 patients, Quofenix given into a vein was compared with vancomycin plus aztreonam (two other antibiotics) both given into a vein.
Slovenian: V prvi študiji, v katero je bilo vključenih 660 bolnikov, so zdravilo Quofenix v obliki infuzije v veno primerjali z vankomicinom in aztreonamom (drugima dvema antibiotikoma), prav tako dajanima v
English: For the full list of side effects and restrictions with Quofenix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Quofenix glejte navodilo za uporabo.
English: Quofenix is as effective as alternative antibiotics given into a vein in treating acute bacterial skin and skin structure infections and offers the possibility of switching to treatment by mouth, which may be more convenient for the patient and could reduce hospitalisation costs.
Slovenian: Zdravilo Quofenix se je izkazalo za enako učinkovito kot alternativni antibiotiki, dajani v veno, pri zdravljenju akutnih bakterijskih okužb kože in kožnih struktur, ponuja pa tudi možnost peroralnega jemanja, kar je morda bolj priročno za bolnika in lahko zmanjša stroške bolnišničnega zdravljenja.
English: After treatment for up to 14 days, 58% of patients who received Quofenix were cured of their infection compared with 60% of patients who received vancomycin and aztreonam.
Slovenian: Po zdravljenju do 14 dni je bilo ozdravljenih 58 % bolnikov, ki so prejemali zdravilo Quofenix, v primerjavi s 60 % bolnikov, ki so prejemali vankomicin in aztreonam.
English: Persistent and disabling side effects have occurred with fluoroquinolone antibiotics in some patients.
Slovenian: Pri nekaterih bolnikih so se pri uporabi fluorokinolonskih antibiotikov pojavili trdovratni in oslabljujoči neželeni učinki.
English: In the second study involving 850 patients, Quofenix given into a vein for 3 days and afterwards given as tablets by mouth was compared with vancomycin plus aztreonam given into a vein.
Slovenian: V drugi študiji, v katero je bilo vključenih 850 bolnikov, so zdravilo Quofenix v obliki infuzije, dajane v veno tri dni, in nato v obliki tablet, jemanih peroralno, primerjali z vankomicinom in aztreonamom, dajanima v veno.
English: How does Quofenix work?
Slovenian: Kako zdravilo Quofenix deluje?
English: How is Quofenix used?
Slovenian: Kako se zdravilo Quofenix uporablja?
English: patients treated with Quofenix were cured of their infection, compared with 51% of patients treated with vancomycin and aztreonam.
Slovenian: Po 14 dneh zdravljenja je bilo ozdravljenih 52 % bolnikov, ki so prejemali zdravilo Quofenix, v primerjavi z 51 % bolnikov, ki so prejemali vankomicin in aztreonam.
English: The
Slovenian: Študija
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC
Slovenian: Izid postopka v skladu s členom 29 Direktive 2001/83/ES
English: The European Commission issued a decision on 19 November 2012.
Slovenian: Evropska komisija je sklep izdala dne 19. novembra 2012.
English: However, the Member States were not able to reach an agreement and the Portuguese medicines agency referred the matter to the CHMP for arbitration on 31 May 2012.
Slovenian: Vendar pa države članice niso uspele doseči soglasja, zato je portugalska regulatorna agencija za zdravila 31. maja 2012 zadevo napotila na CHMP v arbitražo.