FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3350, red, yellow and black ferric oxides, pregelatinised starch, carnauba wax.
Croatian: Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, hipromeloza, silicijev dioksid, magnezijev stearat, titanijev dioksid, makrogol 3350, crveni, žuti i crni željezov oksid, prethodno gelirani škrob, karnauba vosak.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, red and yellow ferric oxides, carnauba wax.
Croatian: Ostali sastojci su laktoza hidrat, mikrokristalična celuloza, umrežena karmelozanatrij, hipromeloza, silicijev dioksid, magnezijev stearat, titanijev dioksid, makrogol 3000, crveni i žuti željezov oksid, karnauba vosak.
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets.
Croatian: NAZIV LIJEKA CoAprovel 150 mg/12,5 mg tablete
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mm Hg in patients with mild-to-moderate hypertension.
Croatian: U bolesnika s blagom do srednje teškom hipertenzijom doza od 150 mg irbesartana i 12,5 mg hidroklorotiazida jedanput na dan dovela je do srednje vrijednosti sniženja sistoličkog/dijastoličkog krvnog tlaka za 12,9/6,9 mm Hg (prilagođeno za placebo) u vrijeme najniže koncentracije u krvi (24 sata nakon uzimanja doze).
English: Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients; Pressor amines (e.g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Croatian: Nesteroidni protuupalni lijekovi: u nekih bolesnika primjena nesteroidnih protuupalnih lijekova može smanjiti diuretski, natriuretski i antihipertenzivni učinak tiazida;
English: Side effects reported since the launch of CoAprovel Some undesirable effects have been reported since marketing of CoAprovel.
Croatian: Neke su nuspojave prijavljene nakon stavljanja lijeka CoAprovel na tržište.
English: Tablet core:
Croatian: Tablica 1.
English: CoAprovel 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: CoAprovel 150 mg/12,5 mg tablete dostupne su u blister pakiranjima od 14, 28, 56 ili 98 tableta.
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg tablets.
Croatian: NAZIV LIJEKA CoAprovel 300 mg/12,5 mg tablete
English: Each film-coated tablet of CoAprovel 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Croatian: Jedna CoAprovel 300 mg/25 mg filmom obložena tableta sadrži 300 mg irbesartana i 25 mg hidroklorotiazida.
English: CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: CoAprovel 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: Cartons of 56 x 1 tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Croatian: Kutija s 56 x 1 tabletom u perforiranom PVC/PVDC/aluminij blisterima djeljivima na jedinične doze.
English: CoAprovel 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: CoAprovel 300 mg/12,5 mg tablete dostupne su u blister pakiranjima od 14, 28, 56 ili 98 tableta.
English: France sanofi-aventis France Tél: 0 800 222 555
Croatian: Tél: 0 800 222 555
English: However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but < 60 ml/min) this fixed dose combination should be administered with caution.
Croatian: Međutim, kombinaciju fiksne doze treba oprezno primjenjivati u bolesnika koji imaju blago do umjereno oštećenu funkciju bubrega (klirens kreatinina ≥ 30 ml/min, ali < 60 ml/min).
English: No dosage adjustment of CoAprovel is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Croatian: Za bolesnike s blagim ili umjerenim oštećenjem funkcije nije potrebna prilagodba doze lijeka CoAprovel (vidjeti dio 4.3).
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg film-coated tablets.
Croatian: NAZIV LIJEKA CoAprovel 300 mg/12,5 mg filmom obložene tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 300 mg irbesartana i 25 mg hidroklorotiazida.
English: Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 25 mg
Croatian: Jedna tableta sadrži 300 mg irbesartana i 25 mg hidroklorotiazida
English: EU/1/98/086/008 - 14 tablets EU/1/98/086/004 - 28 tablets EU/1/98/086/005 - 56 tablets EU/1/98/086/010 - 56 x 1 tablets EU/1/98/086/006 - 98 tablets
Croatian: EU/1/98/086/008 - 14 tableta EU/1/98/086/004 - 28 tableta EU/1/98/086/005 - 56 tableta EU/1/98/086/010 - 56 x 1 tableta EU/1/98/086/006 - 98 tableta
English: CoAprovel 300 mg/25 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Croatian: CoAprovel 300 mg/25 mg filmom obložene tablete dostupne su u blister pakiranjima od 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tabletatableta.
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for CoAprovel 150 mg/12.5 mg and CoAprovel 300 mg/12.5 mg, respectively.
Croatian: Učinci najniže i najviše koncentracije na sniženje krvnog tlaka nakon primjene lijeka CoAprovel 150 mg/12,5 mg odnosno CoAprovel 300 mg/12,5 mg, prema mjerenjima manžetom za vrijeme kontrolnog pregleda, iznosili su 68% odnosno 76%.
English: Each tablet of CoAprovel 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna CoAprovel 150 mg/12,5 mg tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
English: Cartons of 56 x 1 film-coated tablets in PVC/PVDC/Aluminium perforated unit dose blisters.
Croatian: Kutija s 56 x 1 filmom obložena tableta u perforiranom PVC/PVDC/aluminij blisterima djeljivima na jedinične doze.
English: flushing
Croatian: omaglica
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA CoAprovel 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe ROK VALJANOSTI
English: Respiratory, thoracic and mediastinal disorders:
Croatian: anafilaktičke reakcije, toksična epidermalna tkiva:
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.
Croatian: Nemojte uzimati CoAprovel ako ste alergični na irbesartan ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6.) ako ste alergični na hidroklorotiazid ili neki drugi lijek koji je derivat sulfonamida ako ste trudni više od 3 mjeseca (preporučuje se također izbjegavati CoAprovel i u ranoj trudnoći - vidjeti dio o trudnoći) ako imate teških problema s jetrom ili bubrezima ako imate poteškoća sa stvaranjem urina ako liječnik utvrdi da imate stalno povišenu razinu kalcija ili nisku razinu kalija u krvi ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren
English: CoAprovel 150 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Croatian: CoAprovel 150 mg/12,5 mg filmom obložene tablete dostupne su u blister pakiranjima od 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tableta.
English: Cartons of 14 tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 14 tableta u PVC/PVDC/aluminij blisterima.
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/25 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA CoAprovel 300 mg/25 mg tablete irbesartan/hidroklorotiazid NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe ROK VALJANOSTI
English: EU/1/98/086/007 - 14 tablets EU/1/98/086/001 - 28 tablets EU/1/98/086/002 - 56 tablets EU/1/98/086/009 - 56 x 1 tablets EU/1/98/086/003 - 98 tablets
Croatian: EU/1/98/086/007 - 14 tableta EU/1/98/086/001 - 28 tableta EU/1/98/086/002 - 56 tableta EU/1/98/086/009 - 56 x 1 tableta EU/1/98/086/003 - 98 tableta
English: However, another angiotensin-II antagonist affected fertility parameters in animal studies when given alone.
Croatian: Rezultati istraživanja na životinjskim modelima pokazali su, međutim, da je jedan drugi antagonist receptora angiotenzina II primijenjen sam utjecao na parametre plodnosti.
English: Each tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna CoAprovel 300 mg/12,5 mg tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
English: Cartons of 56 tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 56 tableta u PVC/PVDC/aluminij blisterima.
English: CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Croatian: CoAprovel 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Cartons of 98 tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 98 tableta u PVC/PVDC/aluminij blisterima.
English: Sanofi Bulgaria EOOD Тел.
Croatian: Sanofi Malta Ltd.
English: Package leaflet: Information for the patient CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika CoAprovel 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
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.
Croatian: CoAprovel 300 mg/25 mg filmom obložene tablete su bikonveksne, ovalne tablete boje breskve s utisnutom oznakom srca na jednoj i brojem 2788 na drugoj strani.
English: NAME OF THE MEDICINAL PRODUCT CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER sanofi-aventis groupe EXPIRY DATE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA CoAprovel 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET sanofi-aventis groupe ROK VALJANOSTI
English: CoAprovel 300 mg/12.5 mg film-coated tablets are supplied in blister packs of 14, 28, 30, 56, 84, 90 or 98 film-coated tablets.
Croatian: CoAprovel 300 mg/12,5 mg filmom obložene tablete dostupne su u blister pakiranjima od 14, 28, 30, 56, 84, 90 ili 98 filmom obloženih tableta.
English: Ireland sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00
Croatian: T/A SANOFI Tel: +353 (0) 1 403 56 00
English: dizziness
Croatian: Doziranje
English: Cartons of 28 tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 28 tableta u PVC/PVDC/aluminij blisterima.
English: Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 30 filmom obloženih tableta u PVC/PVDC/aluminij blisterima.
English: Polska sanofi-aventis Sp. z o.o.
Croatian: Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00
English: CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: CoAprovel 150 mg/12,5 mg filmom 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.
Croatian: CoAprovel 150 mg/12,5 mg filmom obložene tablete su bikonveksne, ovalne tablete boje breskve s utisnutom oznakom srca na jednoj i brojem 2875 na drugoj strani.
English: Each film-coated tablet of CoAprovel 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna CoAprovel 150 mg/12,5 mg filmom obložena tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
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
Croatian: EU/1/98/086/023 - 14 tableta EU/1/98/086/024 - 28 tableta EU/1/98/086/031 - 30 tableta EU/1/98/086/025 - 56 tableta EU/1/98/086/028 - 56 x 1 tableta EU/1/98/086/026 - 84 tableta EU/1/98/086/034 - 90 tableta EU/1/98/086/027 - 98 tableta
English: cough
Croatian: kašalj
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2776 engraved on the other side.
Croatian: Bikonveksna, ovalna tableta boje breskve s utisnutom oznakom srca na jednoj i brojem 2776 na drugoj strani.
English: diarrhoea
Croatian: Dojenje
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
Croatian: EU/1/98/086/011 - 14 tableta EU/1/98/086/012 - 28 tableta EU/1/98/086/029 - 30 tableta EU/1/98/086/013 - 56 tableta EU/1/98/086/014 - 56 x 1 tableta EU/1/98/086/021 - 84 tableta EU/1/98/086/032 - 90 tableta EU/1/98/086/015 - 98 tableta
English: Cartons of 56 film-coated tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 56 filmom obloženih tableta u PVC/PVDC/aluminij blisterima.
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 90 filmom obloženih tableta u PVC/PVDC/aluminij blisterima.
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Croatian: Bikonveksna, ovalna tableta boje breskve s utisnutom oznakom srca na jednoj i brojem 2876 na drugoj strani.
English: Thu
Croatian: U
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
Croatian: EU/1/98/086/016 - 14 tableta EU/1/98/086/017 - 28 tableta EU/1/98/086/030 - 30 tableta EU/1/98/086/018 - 56 tableta EU/1/98/086/019 - 56 x 1 tableta EU/1/98/086/022 - 84 tableta EU/1/98/086/033 - 90 tableta EU/1/98/086/020 - 98 tableta
English: Each film-coated tablet of CoAprovel 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna CoAprovel 300 mg/12,5 mg filmom obložena tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
English: Cartons of 84 film-coated tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 84 filmom obloženih tableta u PVC/PVDC/aluminij blisterima.
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.
Croatian: CoAprovel 300 mg/12,5 mg filmom obložene tablete su bikonveksne, ovalne tablete boje breskve s utisnutom oznakom srca na jednoj i brojem 2876 na drugoj strani.
English: Cartons of 14 film-coated tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 14 filmom obloženih tableta u PVC/PVDC/aluminij blisterima.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
English: CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: CoAprovel 300 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2775 engraved on the other side.
Croatian: Bikonveksna, ovalna tableta boje breskve s utisnutom oznakom srca na jednoj i brojem 2775 na drugoj strani.
English: Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Croatian: Bikonveksna, ovalna tableta boje breskve s utisnutom oznakom srca na jednoj i brojem 2788 na drugoj strani.
English: CoAprovel 150 mg/12.5 mg film-coated tablets.
Croatian: NAZIV LIJEKA CoAprovel 150 mg/12,5 mg filmom obložene tablete
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Pregelatinised starch Silicon dioxide Magnesium stearate Red and yellow ferric oxides
Croatian: Jezgra tablete: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena škrob, prethodno geliran silicijev dioksid magnezijev stearat željezov oksid, crveni i žuti
English: Cartons of 28 film-coated tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 28 filmom obloženih tableta u PVC/PVDC/aluminij blisterima.
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.
Croatian: CoAprovel 150 mg/12,5 mg tablete su bikonveksne, ovalne tablete boje breskve s utisnutom oznakom srca na jednoj i brojem 2775 na drugoj strani.
English: Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika CoAprovel 150 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Croatian: Bikonveksna, ovalna tableta boje breskve s utisnutom oznakom srca na jednoj i brojem 2875 na drugoj strani.
English: Package leaflet: Information for the patient CoAprovel 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika CoAprovel 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
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.
Croatian: CoAprovel 300 mg/12,5 mg tablete su bikonveksne, ovalne tablete boje breskve s utisnutom oznakom srca na jednoj i brojem 2776 na drugoj strani.
English: Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika CoAprovel 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Croatian: Jedna tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida
English: Cartons of 98 film-coated tablets in PVC/PVDC/Aluminium blisters.
Croatian: Kutija s 98 filmom obloženih tableta u PVC/PVDC/aluminij blisterima.
English: Package leaflet: Information for the patient CoAprovel 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika CoAprovel 300 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: Excipient with known effect: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 38,5 mg laktoze (u obliku laktoze hidrata).
English: Slovenija sanofi-aventis d.o.o.
Croatian: France sanofi-aventis France
English: Each tablet contains: irbesartan 300 mg and hydrochlorothiazide 12.5 mg
Croatian: Jedna tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida
English: Hypromellose Titanium dioxide Macrogol 3350
Croatian: Film ovojnica: laktoza hidrat hipromeloza titanijev dioksid makrogol 3350 željezov oksid, crveni i crni karnauba vosak
English: Microcrystalline cellulose Croscarmellose sodium Lactose monohydrate Magnesium stearate Colloidal hydrated silica Pregelatinised maize starch Red and yellow ferric oxides (E172)
Croatian: 6.1 Popis pomoćnih tvari celuloza, mikrokristalična karmelozanatrij, umrežena laktoza hidrat magnezijev stearat silicijev dioksid, koloidni, hidratizirani kukuruzni škrob, prethodno geliran željezov oksid, crveni i žuti (E172)
English: Treatment is given for 5 to 14 days.
Croatian: Terapija se daje od 5 do 14 dana.
English: Quofenix must not be used in children or adolescents under 18 years of age.
Croatian: Quofenix se ne smije primjenjivati u djece ili adolescenata mlađih od 18 godina.
English: Further information on Quofenix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/quofenix.
Croatian: Više informacija o lijeku Quofenix dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/quofenix.
English: As a result, the bacteria cannot multiply and die.
Croatian: Kao rezultat toga, bakterije se ne mogu umnožavati i odumiru.
English: After starting with a drip, the doctor may decide to switch to a tablet by mouth once every 12 hours.
Croatian: Nakon početne terapije ukapavanjem liječnik može odlučiti prijeći na peroralnu primjenu tableta svakih 12 sati.
English: Quofenix (delafloxacin) EMA/572803/2019
Croatian: Quofenix (delafloksacin) EMA/572803/2019
English: The main measure of effectiveness in both studies was whether the infection was cured.
Croatian: Glavno mjerilo učinkovitosti u obama ispitivanjima bila je uspješnost izlječenja infekcije.
English: Quofenix is given by infusion (drip) into a vein over one hour every 12 hours.
Croatian: Quofenix se primjenjuje intravenskom infuzijom (ukapavanjem) u trajanju od jednoga sata svakih 12 sati.
English: Quofenix (delafloxacin)
Croatian: Quofenix (delafloksacin)
English: Quofenix is available as a powder to be made into a solution for infusion (300 mg) and as tablets (450 mg).
Croatian: Quofenix je dostupan kao prašak od kojeg se priprema otopina za infuziju (300 mg) i kao tablete (450 mg).
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.
Croatian: Ne smije se primjenjivati u žena koje su trudne ili koje doje ili žena u reproduktivnoj dobi koje ne koriste kontracepciju.
English: What measures are being taken to ensure the safe and effective use of Quofenix?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Quofenix?
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.
Croatian: Budući da je sigurnosni profil lijeka Quofenix sličan onom kod drugih fluorokinolona, smatra se da kao i kod drugih fluorokinolona lijek treba biti odobren za primjenu samo kada drugi antibiotici nisu prikladni.
English: Quofenix has a different chemical structure to other fluoroquinolones, which means that it can enter bacterial cells more easily.
Croatian: Quofenix ima drukčiju kemijsku strukturu od ostalih fluorokinolona, što znači da lakše ulazi u stanice bakterije.