FrancophonIA/ELRC3.0 huggingface dataset:
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: Drugi 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: 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: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets.
Croatian: NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmom obložene tablete
English: Thiazide diuretic-associated azotemia may occur in patients with impaired renal function.
Croatian: U bolesnika s oštećenom funkcijom bubrega može se pojaviti azotemija povezana s uzimanjem tiazidskih diuretika.
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg contains 300 mg irbesartan and 25 mg hydrochlorothiazide.
Croatian: Jedna Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmom obložena tableta sadrži 300 mg irbesartana i 25 mg hidroklorotiazida.
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablete dostupne su u blister pakiranjima od 14, 28, 56 ili 98 tableta.
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: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets.
Croatian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablete dostupne su u blister pakiranjima od 14, 28, 56 ili 98 tableta.
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force-titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Croatian: Nakon jednog tjedna doze su sustavno forsirano titrirane (prije procjene odgovora na nisku dozu) na irbesartan/hidroklorotiazid 300 mg/25 mg odnosno irbesartan 300 mg.
English: (It is also better to avoid Irbesartan Hydrochlorothiazide Zentiva 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 Irbesartan Hydrochlorothiazide Zentiva 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 Irbesartan Hydrochlorothiazide Zentiva 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: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg tablete irbesartan/hidroklorotiazid NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva k.s. ROK VALJANOSTI
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva k.s. ROK VALJANOSTI
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
English: Irbesartan Hydrochlorothiazide Zentiva 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: Irbesartan Hydrochlorothiazide Zentiva 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: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Zentiva k.s. ROK VALJANOSTI
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: No dosage adjustment of Irbesartan Hydrochlorothiazide Zentiva is necessary in patients with mild to moderate hepatic impairment (see section 4.3).
Croatian: Za bolesnike s s blagim ili umjerenim oštećenjem funkcijejetre nije potrebna prilagodba doze lijeka Irbesartan Hydrochlorothiazide Zentiva (vidjeti dio 4.3).
English: EU/1/06/377/001 - 14 tablets EU/1/06/377/002 - 28 tablets EU/1/06/377/003 - 56 tablets EU/1/06/377/004 - 56 x 1 tablets EU/1/06/377/005 - 98 tablets
Croatian: EU/1/06/377/001 - 14 tableta EU/1/06/377/002 - 28 tableta EU/1/06/377/003 - 56 tableta EU/1/06/377/004 - 56 x 1 tableta EU/1/06/377/005 - 98 tableta
English: EU/1/06/377/006 - 14 tablets EU/1/06/377/007 - 28 tablets EU/1/06/377/008 - 56 tablets EU/1/06/377/009 - 56 x 1 tablets EU/1/06/377/010 - 98 tablets
Croatian: EU/1/06/377/006 - 14 tableta EU/1/06/377/007 - 28 tableta EU/1/06/377/008 - 56 tableta EU/1/06/377/009 - 56 x 1 tableta EU/1/06/377/010 - 98 tableta
English: • Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;
Croatian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati lijekom Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg.
English: Irbesartan Hydrochlorothiazide Zentiva 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: Irbesartan Hydrochlorothiazide Zentiva 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: EU/1/06/377/017 - 14 tablets EU/1/06/377/018 - 28 tablets EU/1/06/377/031 - 30 tablets EU/1/06/377/019 - 56 tablets EU/1/06/377/020 - 56 x 1 tablets EU/1/06/377/021 - 84 tablets EU/1/06/377/032 - 90 tablets EU/1/06/377/022 - 98 tablets
Croatian: EU/1/06/377/017 - 14 tableta EU/1/06/377/018 - 28 tableta EU/1/06/377/031 - 30 tableta EU/1/06/377/019 - 56 tableta EU/1/06/377/020 - 56 x 1 tableta EU/1/06/377/021 - 84 tableta EU/1/06/377/032 - 90 tableta EU/1/06/377/022 - 98 tableta
English: Each tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
English: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Croatian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Croatian: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: EU/1/06/377/011 - 14 tablets EU/1/06/377/012 - 28 tablets EU/1/06/377/029 - 30 tablets EU/1/06/377/013 - 56 tablets EU/1/06/377/014 - 56 x 1 tablets EU/1/06/377/015 - 84 tablets EU/1/06/377/030 - 90 tablets EU/1/06/377/016 - 98 tablets
Croatian: EU/1/06/377/011 - 14 tableta EU/1/06/377/012 - 28 tableta EU/1/06/377/029 - 30 tableta EU/1/06/377/013 - 56 tableta EU/1/06/377/014 - 56 x 1 tableta EU/1/06/377/015 - 84 tableta EU/1/06/377/030 - 90 tableta EU/1/06/377/016 - 98 tableta
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg and Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg, respectively.
Croatian: Učinci najniže i najviše koncentracije na sniženje krvnog tlaka nakon primjene lijeka Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg odnosno Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg, prema mjerenjima manžetom za vrijeme kontrolnog pregleda, iznosili su 68% odnosno 76%.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets.
Croatian: NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmom obložene tablete
English: EU/1/06/377/023 - 14 tablets EU/1/06/377/024 - 28 tablets EU/1/06/377/033 - 30 tablets EU/1/06/377/025 - 56 tablets EU/1/06/377/026 - 56 x 1 tablets EU/1/06/377/027 - 84 tablets EU/1/06/377/034 - 90 tablets EU/1/06/377/028 - 98 tablets
Croatian: EU/1/06/377/023 - 14 tableta EU/1/06/377/024 - 28 tableta EU/1/06/377/033 - 30 tableta EU/1/06/377/025 - 56 tableta EU/1/06/377/026 - 56 x 1 tableta EU/1/06/377/027 - 84 tableta EU/1/06/377/034 - 90 tableta EU/1/06/377/028 - 98 tableta
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets.
Croatian: NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets.
Croatian: NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets.
Croatian: NAZIV LIJEKA Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmom obložene tablete
English: Irbesartan Hydrochlorothiazide Zentiva 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: Irbesartan Hydrochlorothiazide Zentiva 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: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/25 mg film-coated tablets are pink, biconvex, ovalshaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Croatian: Kako Irbesartan Hydrochlorothiazide Zentiva izgleda i sadržaj pakiranja Irbesartan Hydrochlorothiazide Zentiva 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: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg contains 150 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmom obložena tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida.
English: • stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Croatian: promjene funkcije bubrega, karakterizirane blagim porastom razine ureje i kreatinina u serumu kao i hiperplazija/hipertrofija jukstaglomerularnog aparata, što je izravna posljedica interakcije irbesartana s renin-angiotenzinskim sustavom; blago sniženje eritrocitnih parametara (eritrociti, hemoglobin, hematokrit); diskoloracija želuca, ulceracije i fokalna nekroza sluznice želuca primijećene su u nekoliko štakora tijekom šestomjesečnog istraživanja toksičnosti nakon doza od 90 mg/kg/dan irbesartana, 90 mg/kg/dan hidroklorotiazida te kombinacije irbesartana/hidroklorotiazida od 10/10 mg/kg/dan; te lezije nisu zabilježene kod makaki majmuna; smanjenje razine kalija u serumu koje izaziva hidroklorotiazid djelomično je smanjeno kad se hidroklorotiazid davao u kombinaciji s irbesartanom.
English: Each film-coated tablet of Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg contains 300 mg irbesartan and 12.5 mg hydrochlorothiazide.
Croatian: Jedna Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmom obložena tableta sadrži 300 mg irbesartana i 12,5 mg hidroklorotiazida.
English: Side effects reported since the launch of Irbesartan Hydrochlorothiazide Zentiva Some undesirable effects have been reported since marketing of Irbesartan Hydrochlorothiazide Zentiva.
Croatian: Neke su nuspojave prijavljene nakon stavljanja lijeka Irbesartan Hydrochlorothiazide Zentiva na tržište.
English: Lactose monohydrate Hypromellose Titanium dioxide Macrogol 3350
Croatian: Film ovojnica: laktoza hidrat hipromeloza titanijev dioksid makrogol 3350 željezov oksid, crveni i crni karnauba vosak
English: Dosage
Croatian: PSUR
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2875 engraved on the other side.
Croatian: Kako Irbesartan Hydrochlorothiazide Zentiva izgleda i sadržaj pakiranja Irbesartan Hydrochlorothiazide Zentiva 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: • Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Irbesartan Hydrochlorothiazide
Croatian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati irbesartanom u dozi od 300 mg ili lijekom Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg.
English: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets are peach, biconvex, ovalshaped, with a heart debossed on one side and the number 2876 engraved on the other side.
Croatian: Kako Irbesartan Hydrochlorothiazide Zentiva izgleda i sadržaj pakiranja Irbesartan Hydrochlorothiazide Zentiva 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: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 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: Kako Irbesartan Hydrochlorothiazide Zentiva izgleda i sadržaj pakiranja Irbesartan Hydrochlorothiazide Zentiva 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 Irbesartan Hydrochlorothiazide Zentiva 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika Irbesartan Hydrochlorothiazide Zentiva 150 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: If you take more Irbesartan Hydrochlorothiazide Zentiva than you should If you accidentally take too many tablets, contact your doctor immediately.
Croatian: Ako slučajno uzmete previše tableta, odmah se obratite svome liječniku.
English: What Irbesartan Hydrochlorothiazide Zentiva looks like and contents of the pack Irbesartan Hydrochlorothiazide Zentiva 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: Kako Irbesartan Hydrochlorothiazide Zentiva izgleda i sadržaj pakiranja Irbesartan Hydrochlorothiazide Zentiva 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: PV-Italy@zentiva.com
Croatian: PV-Lithuania@zentiva.com
English: Package leaflet: Information for the patient Irbesartan Hydrochlorothiazide Zentiva 300 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Croatian: Uputa o lijeku: Informacija za bolesnika Irbesartan Hydrochlorothiazide Zentiva 300 mg/12,5 mg filmom obložene tablete irbesartan/hidroklorotiazid
English: Each tablet contains: irbesartan 150 mg and hydrochlorothiazide 12.5 mg
Croatian: Jedna tableta sadrži 150 mg irbesartana i 12,5 mg hidroklorotiazida
English: Posology
Croatian: publika
English: 120 (60 x 2) capsules (multipack)
Croatian: 120 (60 x 2) kapsula (višestruko pakiranje)
English: 4866 Unterach am Attersee Austria
Croatian: 4866 Unterach am Attersee Austrija
English: There is no known reason for this.
Croatian: Razlog tome nije poznat.
English: In some cases you may need a blood transfusion.
Croatian: U nekim slučajevima može biti potrebna transfuzija krvi.
English: A risk to the newborn/infant cannot be excluded.
Croatian: Rizik za novorođenče/dojenče ne može biti isključen.
English: Blood tests during treatment
Croatian: Krvne pretrage tijekom liječenja
English: If this does occur, it is most likely to occur at the first dose.
Croatian: Dođe li do navedenoga, najvjerojatnije će to biti pri primjeni prve doze lijeka.
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Croatian: To može dovesti do obilnoga krvarenja iz relativno malih rana, poput male porezotine.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali ili biste mogli uzimati bilo koje druge lijekove.
English: If you feel tired or weak, do not drive, and do not use any tools or machines.
Croatian: Osjećate li se umorno ili slabo, nemojte voziti, niti rukovati alatima ili strojevima.
English: These patients should be treated with caution.
Croatian: Ove bolesnike valja liječiti s oprezom.
English: This includes spontaneous case reports as well as serious adverse events from ongoing studies.
Croatian: Uključeni su spontano prijavljeni slučajevi kao i ozbiljne nuspojave iz studija koje su u tijeku.
English: This can even be life threatening.
Croatian: Ovakvo stanje može biti opasno po život.
English: If you are an elderly person, you could be more sensitive to nervous system side effects (see the list above under “Warnings and precautions”).
Croatian: Ako ste starija osoba, mogli biste biti osjetljiviji na nuspojave živčanog sustava (pogledajte popis iznad pod naslovom „Upozorenja i mjere opreza“).
English: Infection and infestations
Croatian: Infekcije i infestacije
English: Your dose of Atriance may need to be adjusted.
Croatian: Vaša doza lijeka Atriance će možda morati bit prilagođena.
English: Efficacy and safety were similar for both regimens.
Croatian: Djelotvornost i sigurnost primjene u oba slučaja bile su podjednake.
English: The abnormal high number of white blood cells can appear in the blood and other parts of the body.
Croatian: Abnormalno visok broj bijelih krvnih stanica se može pojaviti u krvi i drugim dijelovima tijela.
English: No case of overdose has been reported.
Croatian: Do sada nije prijavljen niti jedan slučaj predoziranja.
English: • Signs of infection.
Croatian: • Znakovi infekcije.
English: The following convention has been utilised for the classification of frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Croatian: Pri klasifikaciji učestalosti nuspojava korištena je sljedeća kategorizacija: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko (<1/10 000), i nepoznato (ne može se procijeniti iz raspoloživih podataka).
English: Date of first authorisation: 22 August 2007 Date of latest renewal: 16 June 2017
Croatian: Datum posljednje obnove odobrenja: 16. lipnja 2017.
English: Atriance may reduce the number of white blood cells and lower your resistance to infection (including pneumonia).
Croatian: Atriance može smanjiti broj bijelih krvnih stanica i umanjiti Vašu otpornost na infekciju (uključujući upalu pluća).
English: Ask your doctor for advice before taking any medicine.
Croatian: Obratite se svom liječniku za savjet prije nego uzmete bilo koji lijek.
English: Atriance is used to treat patients with:
Croatian: Atriance se koristi za liječenje oboljelih od:
English: The following additional adverse reactions were seen:
Croatian: Uočene su sljedeće nuspojave:
English: 38.0 µM.h (39 %), respectively.
Croatian: 38,0 µM.h (39%).
English: The potential risk in humans is unknown, however, exposure during pregnancy will likely lead to anomalies and malformations of the foetus.
Croatian: Mogući rizik u ljudi nije poznat, no primjena ovoga lijeka tijekom trudnoće vjerojatno bi rezultirala anomalijama i malformacijama ploda.