natgillin/translations-raw huggingface dataset:
Ear and labyrinth disorder: Not known: 
Poremećaji uha i labirinta: Nepoznato:
At the end of the three weeks the mean reduction from baseline in the primary efficacy variable, trough seated systolic blood pressure (SeSBP) was 11.7 mmHg (low dose), 9.3 mmHg (medium dose), 13.2 mmHg (high dose). 
Nakon tri tjedna srednja vrijednost smanjenja krvnog tlaka u odnosu na početne vrijednosti za primarnu varijablu djelotvornosti, sistolički krvni tlak u sjedećem položaju kod najniže koncentracije u krvi (engl. seated systolic blood pressure, SeSBP), iznosila je 11,7 mmHg (niska doza), 9,3 mmHg (srednja doza) i 13,2 mmHg (visoka doza).
The demonstration of renal benefit of Ifirmasta in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1). 
Dokaz koristi Ifirmaste na bubrežnu funkciju u hipertenzivnih bolesnika sa šećernom bolešću tipa 2 zasniva se na ispitivanjima u kojima se irbesartan prema potrebi uzimao kao dopuna ostaloj antihipertenzivnoj terapiji za postizanje ciljnog krvnog tlaka (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
Other antihypertensive agents may increase the hypotensive effects of irbesartan; however Ifirmasta has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. 
Ifirmasta se, međutim, pokazala sigurnom za primjenu s ostalim antihipertenzivnim lijekovima poput beta blokatora, dugodjelujućih blokatora kalcijevih kanala i tiazida.
In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group. 
U bolesnika sa šećernom bolešću i hipertenzijom s kroničnom bubrežnom insuficijencijom i manifestnom proteinurijom, hiperkalijemija (≥ 5,5 mEq/l) se razvila u 46,3% bolesnika koji su primali irbesartan te u 26,3% bolesnika u placebo skupini.
C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces. 
Nakon peroralne ili i.v. primjene C irbesartana, oko 20% radioaktivnosti pojavilo se u mokraći, a ostatak u stolici.
Ifirmasta 75 mg film-coated tablets Ifirmasta 150 mg film-coated tablets Ifirmasta 300 mg film-coated tablets 
Ifirmasta 75 mg filmom obložene tablete Ifirmasta 150 mg filmom obložene tablete Ifirmasta 300 mg filmom obložene tablete
The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria. 
Klinička studija «Ispitivanje irbesartana u bolesnika s dijabetičkom nefropatijom« (Irbesartan Diabetic Nephropathy Trial, IDNT) pokazuje da irbesartan smanjuje progresiju bubrežne bolesti u bolesnika s kroničnom bubrežnom insuficijencijom i manifestnom proteinurijom.
The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline). 
U studiji su ispitivani dugotrajni učinci (2 godine) irbesartana na progresiju klinički izražene proteinurije (brzina izlučivanja albumina u mokraću (engl. urinary albumin excretion rate, UAER)
Cardiac disorders: Uncommon: tachycardia 
Srčani poremećaji: Manje često: tahikardija
Ifirmasta is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. 
Ifirmasta se ne preporučuje u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće, jer može ozbiljno naškoditi Vašem djetetu, uzimate li ga u tom razdoblju.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. 
Ako je došlo do izloženosti antagonistima receptora angiotenzina II od drugog tromjesečja trudnoće nadalje, preporučuje se ultrazvučni pregled bubrežne funkcije i lubanje.
If you take more Ifirmasta than you should If you accidentally take too many tablets, contact your doctor immediately. 
Ako slučajno uzmete previše tableta, odmah se obratite svom liječniku.
When Ifirmasta is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended. 
Oštećena funkcija bubrega i transplantacija bubrega Kada Ifirmastu uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati serumske razine kalija i kreatinina.
Blood and lymphatic system disorders: Not known: 
Poremećaji krvi i limfnog sustava Nepoznato:
The blood pressure lowering effects of irbesartan and thiazide-type diuretics are additive. 
Učinci irbesartana i tiazidnih diuretika na sniženje krvnog tlaka su aditivni.
- Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. 
- Manje često (mogu se javiti u manje od 1 na 100 osoba): ubrzani otkucaji srca, crvenilo praćeno osjećajem vrućine, kašalj, proljev, probavni poremećaji/žgaravica, problemi sa seksualnom funkcijom, bol u prsima.
Hyperkalemia 
hiperkalijemija
Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria. 
Klinička studija «Učinak irbesartana na mikroalbuminuriju u hipertenzivnih bolesnika sa šećernom bolešću tipa 2 (IRMA 2)» pokazuje da 300 mg irbesartana odgađa progresiju izražene proteinurije u bolesnika s mikroalbuminurijom.
The decrease in blood pressure is dose-related for once a day doses with a tendency towards plateau at doses above 300 mg. Doses of 150-300 mg once daily lower supine or seated blood pressures at trough (i.e. 24 hours after dosing) by an average of 8-13/5-8 mm Hg (systolic/diastolic) greater than those associated with placebo. 
Doze od 150 do 300 mg jedanput na dan smanjuju krvni tlak u ležećem ili sjedećem položaju u vrijeme najniže koncentracije u krvi (to jest 24 sata nakon uzimanja doze) i to u prosjeku za 8-13/5-8 mmHg (sistolički/dijastolički) više od placeba.
Do not take Ifirmasta - if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6), - if you are more than 3 months pregnant. 
Nemojte uzimati Ifirmastu - ako ste alergični na irbesartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6), - ako ste trudni više od 3 mjeseca (preporučuje se, također, izbjegavati Ifirmastu u ranoj trudnoći - vidjeti dio o trudnoći), - ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren.
The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response. 
Doza se kasnije može povećati na 300 mg (četiri tablete na dan) jednom na dan, ovisno o vrijednostima krvnog tlaka.
The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might also occur from overdose. 
Najčešće očekivane manifestacije predoziranja su hipotenzija i tahikardija.
The dose may later be increased to 300 mg (two tablets a day) once daily depending on blood pressure response. 
Doza se kasnije može povećati na 300 mg (dvije tablete na dan) jednom na dan, ovisno o vrijednostima krvnog tlaka.
Ifirmasta 300 mg film-coated tablets 14 tablets: EU/1/08/480/013 
Ifirmasta 300 mg filmom obložene tablete 14 tableta: EU/1/08/480/013
Potassium supplements and potassium-sparing diuretics: 
Nadomjesci kalija i diuretici koji štede kalij:
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4). 
Primjena antagonista receptora angiotenzina II ne preporučuje se tijekom prvog tromjesečja trudnoće (vidjeti dio 4.4), a kontraindicirana je tijekom drugog i trećeg tromjesečja (vidjeti dijelove 4.3 i 4.4).
Ifirmasta 150 mg film-coated tablets 14 tablets: EU/1/08/480/007 
Ifirmasta 150 mg filmom obložene tablete 14 tableta: EU/1/08/480/007
In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen. 
Za sekundarni ishod fatalnih i nefatalnih kardiovaskularnih događaja, u sveukupnoj ispitivanoj populaciji nije bilo razlika između tri skupine, iako je zabilježena povećana incidencija nefatalnog infarkta miokarda u žena i smanjena incidencija nefatalnog infarkta miokarda u muškaraca u skupini koja je primala irbesartan u odnosu na onu koja je primala placebo.
Excipient with known effect Ifirmasta 75 mg film-coated tablets Each film-coated tablet contains 4 mg castor oil. 
Pomoćna tvar s poznatim učinkom Ifirmasta 75 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 4 mg ricinusovog ulja.
What Ifirmasta looks like and contents of the pack Ifirmasta 75 mg film-coated tablets are: white, oval film-coated tablets. 
Kako Ifirmasta izgleda i sadržaj pakiranja Ifirmasta 75 mg filmom obložene tablete su: bijele, ovalne, filmom obložene tablete.
Ifirmasta 300 mg film-coated tablets Each film-coated tablet contains 16 mg castor oil. 
Ifirmasta 300 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 16 mg ricinusovog ulja.
Low-substituted Hydroxypropyl Cellulose (LH-21) Low-substituted Hydroxypropyl Cellulose (LH-11) Talc 
Jezgra tablete: manitol hidroksipropilceluloza hidroksipropilceluloza, nisko supstituirana (LH-21) hidroksipropilceluloza, nisko supstituirana (LH-11) talk makrogol 6000 ricinusovo ulje, hidrogenirano
Rreversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors. 
Tijekom istodobne primjene litija i inhibitora angiotenzin konvertirajućeg enzima zabilježen je reverzibilan porast koncentracije serumskog litija i njegove toksičnosti.
What Ifirmasta looks like and contents of the pack Ifirmasta 300 mg film-coated tablets are: white, oval film-coated tablets. 
Kako Ifirmasta izgleda i sadržaj pakiranja Ifirmasta 300 mg filmom obložene tablete su: bijele, ovalne, filmom obložene tablete.
Ifirmasta 75 mg film-coated tablets Each film-coated tablet contains 75 mg irbesartan (as hydrochloride). 
Ifirmasta 75 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 75 mg irbesartana (u obliku irbesartanklorida).
Studies have not been performed in patients with severe hepatic impairment. 
Nisu provođena ispitivanja u bolesnika s teškim oštećenjem funkcije jetre.
Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 8 mg castor oil. 
Ifirmasta 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 8 mg ricinusovog ulja.
Ifirmasta 75 mg film-coated tablets Irbesartan 
Ifirmasta 75 mg filmom obložene tablete irbesartan
What Ifirmasta looks like and contents of the pack Ifirmasta 150 mg film-coated tablets are: white, oval film-coated tablets. 
Kako Ifirmasta izgleda i sadržaj pakiranja Ifirmasta 150 mg filmom obložene tablete su: bijele, ovalne, filmom obložene tablete.
Ifirmasta 300 mg film-coated tablets Irbesartan 
Ifirmasta 300 mg filmom obložene tablete irbesartan
orthostatic hypotension* Uncommon: flushing 
ortostatska hipotenzija* Manje često: crvenilo praćeno osjećajem vrućine
Respiratory, thoracic and mediastinal disorders: Uncommon: cough 
Poremećaji dišnog sustava, prsišta i sredoprsja: Manje često: kašalj
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses. 
Pri preporučenim dozama irbesartan ne utječe značajno na razine serumskog kalija.
Ifirmasta 150 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as hydrochloride). 
Ifirmasta 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida).
Uncommon: may affect up to 1 in 100 people 
Često: mogu se javiti u manje od 1 na 10 osoba Manje često: mogu se javiti u manje od 1 na 100 osoba
Ifirmasta 300 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as hydrochloride). 
Ifirmasta 300 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida).
Ifirmasta 150 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters. 
Ifirmasta 150 mg filmom obložene tablete: dostupne u kutijama s 14, 28, 30, 56, 84, 90 i 98 filmom obloženih tableta u blisterima i kutijama s 56 x 1 filmom obloženih tableta u perforiranim blisterima djeljivim na jedinične doze.
Ifirmasta 150 mg film-coated tablets Irbesartan 
Ifirmasta 150 mg filmom obložene tablete irbesartan
Ifirmasta 75 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters. 
Ifirmasta 75 mg filmom obložene tablete dostupne u kutijama s 14, 28, 30, 56, 84, 90 i 98 filmom obloženih tableta u blisterima i kutijama s 56 x 1 filmom obloženih tableta u perforiranim blisterima djeljivim na jedinične doze.
Each film-coated tablet contains 75 mg irbesartan (as hydrochloride). 
Svaka filmom obložena tableta sadrži 75 mg irbesartana (u obliku irbesartanklorida).
Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect. 
Za učinak liječenja ocjenjivane su podskupine prema spolu, rasi, dobi, trajanju šećerne bolesti, početnom krvnom tlaku, serumskom kreatininu i izlučivanju albumina.U podskupinama žena i pripadnika crne rase, koji su činili 32% odnosno 26% ukupne populacije u studiji, nisu bili vidljivi povoljni učinci na bubrege, premda to intervali pouzdanosti nisu isključivali.
Ifirmasta 300 mg film-coated tablets are available in boxes of 14, 28, 30, 56, 84, 90 and 98 film-coated tablets in blisters and in boxes of 56 x 1 film-coated tablets in perforated unit dose blisters. 
Ifirmasta 300 mg filmom obložene tablete: dostupne u kutijama s 14, 28, 30, 56, 84, 90 i 98 filmom obloženih tableta u blisterima i kutijama s 56 x 1 filmom obloženih tableta u perforiranim blisterima djeljivim na jedinične doze.
Each film-coated tablet contains 300 mg irbesartan (as hydrochloride). 
Svaka filmom obložena tableta sadrži 300 mg irbesartana (u obliku irbesartanklorida).
14 tablets: EU/1/08/480/013 28 tablets: EU/1/08/480/014 30 tablets: EU/1/08/480/023 56 tablets: EU/1/08/480/015 56 x 1 tablets: EU/1/08/480/016 84 tablets: EU/1/08/480/017 90 tablets: EU/1/08/480/024 98 tablets: EU/1/08/480/018 
14 tableta: EU/1/08/480/013 28 tableta: EU/1/08/480/014 30 tableta: EU/1/08/480/023 56 tableta: EU/1/08/480/015 56 x 1 tableta: EU/1/08/480/016 84 tableta: EU/1/08/480/017 90 tableta: EU/1/08/480/024 98 tableta: EU/1/08/480/018
14 tablets: EU/1/08/480/007 28 tablets: EU/1/08/480/008 30 tablets: EU/1/08/480/021 56 tablets: EU/1/08/480/009 56 x 1 tablets: EU/1/08/480/010 84 tablets: EU/1/08/480/011 90 tablets: EU/1/08/480/022 98 tablets: EU/1/08/480/012 
14 tableta: EU/1/08/480/007 28 tableta: EU/1/08/480/008 30 tableta: EU/1/08/480/021 56 tableta: EU/1/08/480/009 56 x 1 tableta: EU/1/08/480/010 84 tablete: EU/1/08/480/011 90 tableta: EU/1/08/480/022 98 tableta: EU/1/08/480/012
14 tablets: EU/1/08/480/001 28 tablets: EU/1/08/480/002 30 tablets: EU/1/08/480/019 56 tablets: EU/1/08/480/003 56 x 1 tablets: EU/1/08/480/004 84 tablets: EU/1/08/480/005 90 tablets: EU/1/08/480/020 98 tablets: EU/1/08/480/006 
14 tableta: EU/1/08/480/001 28 tableta: EU/1/08/480/002 30 tableta: EU/1/08/480/019 56 tableta: EU/1/08/480/003 56 x 1 tableta: EU/1/08/480/004 84 tablete: EU/1/08/480/005 90 tableta: EU/1/08/480/020 98 tableta: EU/1/08/480/006
Each film-coated tablet contains 150 mg irbesartan (as hydrochloride). 
Svaka filmom obložena tableta sadrži 150 mg irbesartana (u obliku irbesartanklorida).
56 tablets: EU/1/08/480/015 
56 tableta: EU/1/08/480/015
56 tablets: EU/1/08/480/009 
56 tableta: EU/1/08/480/009
98 tablets: EU/1/08/480/012 
98 tableta: EU/1/08/480/012
Steady state plasma concentrations are attained within 3 days after initiation of a once-daily dosing regimen.Limited accumulation of irbesartan (< 20%) is observed in plasma upon repeated once-daily dosing. 
Ograničena akumulacija irbesartana (< 20%) zabilježena je u plazmi nakon primjene opetovanih doza jedanput na dan.
28 tablets: EU/1/08/480/014 
28 tableta: EU/1/08/480/014
28 tablets: EU/1/08/480/008 
28 tableta: EU/1/08/480/008
- Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (two tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease. 
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg jednom na dan (dvije tablete na dan).
30 tablets: EU/1/08/480/023 
30 tableta: EU/1/08/480/023
- Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease. 
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg jednom na dan (četiri tablete na dan).
98 tablets: EU/1/08/480/018 
98 tableta: EU/1/08/480/018
30 tablets: EU/1/08/480/021 
30 tableta: EU/1/08/480/021
- Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg once daily is the preferred maintenance dose for the treatment of associated kidney disease. 
U bolesnika koji imaju visoki krvni tlak i boluju od šećerne bolesti tipa 2 preporučena doza održavanja za liječenje pridružene bolesti bubrega iznosi 300 mg jednom na dan.
fatigue Uncommon: chest pain 
umor Manje često: bol u prsištu
90 tablets: EU/1/08/480/024 
90 tableta: EU/1/08/480/024
90 tablets: EU/1/08/480/022 
90 tableta: EU/1/08/480/022
Irbesartan 
Doziranje
56 x 1 tablets: EU/1/08/480/010 84 tablets: EU/1/08/480/011 
56 x 1 tableta: EU/1/08/480/010
56 x 1 tablets: EU/1/08/480/016 84 tablets: EU/1/08/480/017 
56 x 1 tableta: EU/1/08/480/016
Granules And Solvent For Oral Suspension 
Granule i otapalo za oralnu suspenziju
Member State in EEA 
Država članica EGP-a
INN/Active substance + Strength 
INN / Djelatna tvar + jačina
Pharmaceutical form Route of Administration 
Farmaceutski oblik Put primjene
Modified-Release Tablet 
Tableta s prilagođenim oslobađanjem
Docpharm Arzneimittelvertrieb GmbH & Co. 
Arzneimittelvertrieb GmbH & Co.
Flumequine 0.4g Tablet 
Flumekin 0,4 g tableta
Elpen Pharmaceutical Co. Inc. 
Elpen Pharmaceutical Co.
B. Braun Medical, Lda. 
Braun Medical, Lda.
Costakis Tsisios & Co. Ltd 
Costakis Tsisios & Co.
Enoxacin Sesquihydrate 217mg Tablet 
Enoksacin seskvihidrat 217 mg tableta
Benedetti & Co. S.P.A. 
Benedetti & Co.
Levofloxacino Efg Teva Levofloxacin Hemihydrate 500mg Tablet 
Levofloxacino Efg Teva Levofloksacin hemihidrat 500 mg tableta
Norfloxacin 400mg 
Norfloksacin 400 mg
Fresenius Kabi Bulgaria Eood левофлоксацин каби Levofloxacin 5mg/Ml 
Fresenius Kabi Bulgaria Eood левофлоксацин каби Levofloksacin 5 mg/ml
Pipemidic Acid Trihydrate 235.63mg Capsule 
Pipemidinska kiselina trihidrat 235,63 mg kapsula
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloxacin 5mg/Ml 
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloksacin 5 mg/ml
Pefloxacin Mesilate Dihydrate 515.3mg/5 Ml 
Pefloksacin mesilat dihidrat 515,3 mg/5 ml
Prulifloxacin 600mg 
Prulifloksacin 600 mg
Nalidixic Acid Remedica Nalidixic Acid 500mg Tablet 
Nalidixic Acid Remedica Nalidiksična kiselina 500 mg tableta
Hameln Pharma Plus Gmbh Levofloxacin Hameln Levofloxacin Hemihydrate 256.5mg/50 Ml 
Hameln Pharma Plus Gmbh Levofloxacin Hameln Levofloksacin hemihidrat 256,5 mg/50 ml
Pipemidic Acid Trihydrate 471.25mg Capsule 
Pipemidinska kiselina trihidrat 471,25 mg kapsula
Pipemidic Acid Trihydrate 471.22mg Capsule 
Pipemidinska kiselina trihidrat 471,22mg kapsula
Ciprofloxacin Hydrochloride 669.4mg Tablet, Ciprofloxacin Hydrated 506mg Tablet 
Ciprofloksacin hidroklorid 669,4 mg tableta, Ciprofloksacin hidriran 506 mg tableta
Ibi G. Lorenzini Spa 
Lorenzini Spa
Ciprofloxacin Hydrochloride 669.4mg Tablet 
Ciprofloksacin hidroklorid 669,4 mg tableta
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloxacin Hemihydrate 512.46mg Tablet 
Teva Pharmaceuticals Bulgaria Eood левофлоксацин тева Levofloksacin hemihidrat 512,46 mg tableta
Gastroenteral Use | Oral Use 
Gastroenteralna primjena
Norfloxacin 400mg Capsule Capsule 
Norfloksacin 400 mg kapsula Kapsula
Lomefloxacin Hydrochloride 441.6mg Tablet 
Lomefloksacin hidroklorid 441,6 mg tableta
Generics Pharma Hellas Ltd Ciprofloxacin Generics Ciprofloxacin 2mg/Ml 
Generics Pharma Hellas Ltd Ciprofloxacin Generics Ciprofloksacin 2 mg/ml
Ciprofloxacin 500mg Sachet Oral Suspension In Sachet 
Ciprofloksacin 500 mg vrećica Oralna suspenzija u vrećici
Ciprofloxacin Hydrochloride Monohydrate 443mg/200 Ml 
Ciprofloksacin hidroklorid monohidrat 443 mg/200 ml
Norfloxacin 400mg Capsule Capsule, Hard 
Norfloksacin 400 mg kapsula Kapsula, tvrda
Pefloxacin Mesilate 80mg/Ml 
Pefloksacin mesilat 80 mg/ml
Pefloxacin Laropharm Pefloxacin 400mg Tablet 
Pefloxacin Laropharm Pefloksacin 400 mg tableta
Moxifloxacin Hydrochloride 454,27mg Tablet 
Moksifloksacin hidroklorid 454,27 mg tableta
Ofloxacin 200mg/40 Ml 
Ofloksacin 200 mg/40 ml
Pefloxacin Mesilate 3.2mg/Ml 
Pefloksacin mesilat 3,2 mg/ml
Coated Tablet 
Filmom obložene tablete
Annex IA List of nationally authorised medicinal products recommended for suspension 
Popis nacionalno odobrenih lijekova preporučenih za suspenziju
Ciprofloxacină Arena Ciprofloxacin Hydrochloride 116.4mg Tablet 
Ciprofloxacină Arena Ciprofloksacin hidroklorid 116,4 mg tableta
A. List of nationally authorised medicinal products recommended for suspension Member 
Popis nacionalno odobrenih lijekova preporučenih za suspenziju Država članica
Ciprofloxacin Hikma Ciprofloxacin 400mg Bag Solution For Infusion Intravenous Use 
Ciprofloxacin Hikma Ciprofloksacin 400 mg vrećica Otopina za infuziju Intravenska primjena
Ciprofloxacin 100mg/50 Ml | Ciprofloxacin 200mg/100 Ml | Ciprofloxacin 400mg/200 Ml 
Ciprofloksacin 100 mg/50 ml | Ciprofloksacin 200 mg/100 ml | Ciprofloksacin 400 mg/200 ml
B. List of nationally authorised medicinal products recommended for variation Member 
Popis nacionalno odobrenih lijekova preporučenih za izmjenu Država članica
Nalidixic Acid 500mg Capsule Capsule, Hard 
Cinoksacin 500 mg kapsula Kapsula, tvrda
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