FrancophonIA/ELRC3.0 huggingface dataset:
English: It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see sections 4.3, 4.4, 4.5 and 5.1).
Croatian: Takoder je indiciran za liječenje bubrežne bolesti u bolesnika s hipertenzijom i šećernom bolesti tipa 2 u sklopu antihipertenzivne terapije (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
English: When irbesartan is administered concomitantly with a low dose of hydrochlorothiazide (e.g. 12.5 mg daily), the antihypertensive response in black patients approaches that of white patients.
Croatian: Kada je ibesartan primijenjen istodobno s niskom dozom hidroklorotiazida (npr. 12,5 mg jedanput na dan), antihipertenzivni odgovor u bolesnika crne rase se približio onome u bolesnika bijele rase.
English: hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of irbesartan on the progression of renal disease and all-cause mortality were examined.
Croatian: U 1715 hipertenzivnih bolesnika sa šećernom bolesti tipa 2, proteinurijom ≥900 mg/dan i serumskim kreatininom u rasponu od 1,0 do 3,0 mg/dl ispitivan je dugotrajan učinak irbesartana (prosječno 2,6 godina) na progresiju bubrežne bolesti i svih uzroka mortaliteta.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: C OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE GOTOVOG LIJEKA U PROMET
English: Sixty per cent (60%) of patients in the placebo group reached this target blood pressure whereas this figure was 76% and 78% in the irbesartan and amlodipine groups respectively.
Croatian: skupini koja je primala placebo 60% bolesnika postiglo je ciljni krvni tlak dok je ta vrijednost bila 76% u skupini koja je primala irbesartan, odnosno 78% u skupini koja je primala amlodipin.
English: Marketing Authorisation Holder: Pharmathen S.A,
Croatian: Nositelj odobrenja za stavljanje u promet gotovog lijeka: Pharmathen S.A,
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure.
Croatian: Općenito: u bolesnika u kojih vaskularni tonus i funkcija bubrega ovise najviše o aktivnosti reninangiotenzin-aldosteronskog sustava (npr. bolesnici s teškim kongestivnim zatajenjem srca ili postojećom bolesti bubrega, uključujući stenozu bubrežne arterije), liječenje inhibitorima angiotenzin konvertirajućeg enzima ili antagonistima receptora angiotenzina II, koji utječu na taj sustav, povezano je s pojavom akutne hipotenzije, azotemije, oligurije i rijetko, akutnim zatajenjem bubrega.
English: ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Croatian: Dodatni antihipertenzivi (isključujući ACE inhibitore, antagoniste receptora angiotenzina II i dihidropiridinske blokatore kalcijevih kanala) dodavani su prema potrebi kako bi se postigao ciljni krvni tlak.
English: Hypertensive patients with type 2 diabetes and renal disease: the effects of irbesartan both on renal and cardiovascular events were not uniform across all subgroups, in an analysis carried out in the study with patients with advanced renal disease.
Croatian: Hipertenzivni bolesnici sa šećernom bolesti tipa 2 i bubrežnom bolesti: učinak irbesartana na događaje povezane s bubrezima i kardiovaskularnim sustavom nije bio ujednačen u svim podskupinama u analizi rezultata kliničkih ispitivanja bolesnika s uznapredovalom bubrežnom bolesti.
English: Do not use Sabervel after the expiry date which is stated on the carton and on the blister after EXP.
Croatian: Sabervel se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili blisteru.
English: However, initiation of therapy with 75 mg could be considered, particularly in haemodialysed patients and in the elderly over 75 years.
Croatian: 75 mg, posebice u hemodijaliziranih bolesnika i u bolesnika starijih od 75 godina.
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
Croatian: U bolesnika koji boluju od hipertenzije i šećerne bolesti s mikroalbuminurijom, uz normalnu bubrežnu funkciju, prijavljene su ortostatska omaglica i ortostatska hipotenzija kod njih 0,5%, dakle manje često, ali s većom učestalošću nego kod placeba.
English: Sabervel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Croatian: Ne smijete ga uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu ako ga uzimate u tom stadiju (vidjeti dio o trudnoći).
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Croatian: vrlo često: pojavljuje se u najmanje 1 na 10 bolesnika ili više od toga često: najmanje 1 na 100, a manje od 1 na 10 bolesnika manje često: najmanje 1 na 1000, a manje od 1 na 100 bolesnika.
English: 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
Croatian: U bolesnika sa šećernom bolesti koji su imali povišeni krvni tlak, kroničnu bubrežnu insuficijenciju i manifestnu proteinuriju, hiperkalijemija (≥ 5,5 mEq/L) se razvila u 46,3% bolesnika koji su primali irbesartan te u 26,3% bolesnika u placebo skupini.
English: significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Croatian: zabilježen je značajan porast kreatin kinaze u plazmi u 1,7% bolesnika koji su uzimali irbesartan.
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Croatian: Irbesartan značajno snižava relativni rizik u primarnoj kombiniranoj mjeri ishoda udvostručenog serumskog kreatinina,
English: Metabolism and nutrition disorders: Not known:
Croatian: Poremećaji metabolizma i prehrane:
English: Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Croatian: Smanjenje intravaskularnog volumena: simptomatska hipotenzija, posebice nakon prve doze, može se pojaviti u bolesnika s hipovolemijom i/ili hiponatrijemijom zbog snažne diuretske terapije, restrikcijske dijete sa smanjenim unosom soli, proljeva ili povraćanja.
English: As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan.
Croatian: urtikarija), kao i lokalizirano oticanje lica, usnica i/ili jezika kod bolesnika koji su uzimali irbesartan.
English: Renal impairment: no dosage adjustment is necessary in patients with impaired renal function.
Croatian: Oštećenje funkcije bubrega: nije potrebna prilagodba doze u bolesnika s oštećenom funkcijom bubrega.
English: Renal impairment: in patients with renal impairment or those undergoing haemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Croatian: Oštećena funkcija bubrega: u bolesnika s oštećenom bubrežnom funkcijom ili u bolesnika na hemodijalizi, farmakokinetički parametri irbesartana nisu bitno promijenjeni.
English: Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
Croatian: Prilagođena srednja vrijednost dijastoličkog krvnog tlaka u sjedećem položaju (sjDKT) u «najnižoj točki djelovanja» bila je sljedeća: 3,8 mmHg (niska doza), 3,2 mmHg (srednja doza) i 5,6 mmHg (visoka doza).
English: Each tablet of Sabervel 75 mg contains 75 mg irbesartan.
Croatian: • Jedna Sabervel 75 mg tableta sadrži 75 mg irbesartana.
English: In patients not adequately controlled by irbesartan alone, the addition of a low dose of hydrochlorothiazide (12.5 mg) to irbesartan once daily results in a further placebo-adjusted blood pressure reduction at trough of 7-10/3-6 mm Hg (systolic/diastolic).
Croatian: U bolesnika koji nisu prikladno kontrolirani samo s irbesartanom, dodatak niske doze hidroklorotiazida (12,5 mg) irbesartanu jedanput na dan rezultira dodatnim placebo prilagođenim sniženjem krvnog tlaka za 7-10/3-6 mm Hg (sistolički/dijastolički).
English: Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Croatian: Za učinak liječenja ocjenjivane su podskupine prema spolu, rasi, dobi, trajanju šećerne bolesti, početnom krvnom tlaku, serumskom kreatininu i izlučivanju albumina.
English: While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Croatian: Dok je sličan krvni tlak postignut u svim ispitivanim skupinama, manje bolesnika u skupini koja je primala 300 mg irbesartana (5,2%) dostiglo je ishod manifestne proteinurije u odnosu na skupinu koja je primala placebo (14,9%) ili na skupinu koja je primala 150 mg irbesartana
English: Side effects reported in clinical studies for patients treated with Irbesartan were:
Croatian: U kliničkim ispitivanjima na bolesnicima liječenima irbesartanom prijavljene su sljedeće nuspojave:
English: Rebound hypertension has not been observed.
Croatian: (rebound) hipertenzije.
English: B e lgië/Belgique/Belgien Pharmathen S.A.
Croatian: B e lgië /B e lgique /B e lgie n Pharmathen S.A.
English: INFORMATION IN BRAILLE Sabervel 75 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Sabervel 75 mg
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Croatian: Učestalost nuspojava u nastavku teksta definira se na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1.000 do < 1/100); rijetko (≥ 1/10.000 do < 1/1.000); vrlo rijetko (<
English: Pharmacotherapeutic group: Angiotensin-II antagonists, plain.
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: antagonisti angiotenzina II, čisti.
English: • potassium supplements
Croatian: • nadomjeske kalija
English: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Croatian: • ako uzimate bilo koji od lijekova navedenih u nastavku, koji se koriste za liječenje visokog krvnog tlaka: - ACE inhibitor (primjerice enalapril, lisinopril, ramipril), osobito ako imate bubrežne tegobe povezane sa šećernom bolešću.
English: • Patients with high blood pressure and type 2 diabetes with kidney disease
Croatian: Bolesnici s visokim krvnim tlakom i šećernom bolešću tipa 2 te bolešću bubrega
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Croatian: Poznato je da u ljudi terapija antagonistima receptora angiotenzina II tijekom drugog i trećeg tromjesečja izaziva fetotoksičnost (smanjena bubrežna funkcija, oligohidramnion, usporavanje okoštavanja lubanje) i neonatalnu toksičnost (zatajenje bubrega, hipotenzija, hiperkalijemija) (vidjeti dio
English: Reproductive system and breast disorders: Uncommon:
Croatian: Poremećaji reproduktivnog sustava i dojki: Manje često:
English: Each tablet of Sabervel 150 mg contains 150 mg irbesartan.
Croatian: • Jedna Sabervel 150 mg tableta sadrži 150 mg irbesartana.
English: Hepatic impairment: in patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Croatian: Oštećena funkcija jetre: u bolesnika s blagom do umjerenom cirozom farmakokinetički parametri irbesartana nisu bitno promijenjeni.
English: Titanium dioxide (E171)
Croatian: Film-ovojnica: titanijev dioksid (E171) hipromeloza makrogol 400
English: Following oral or intravenous administration of
Croatian: Nakon oralne ili intravenske primjene 14
English: Each tablet of Sabervel 300 mg contains 300 mg irbesartan.
Croatian: • Jedna Sabervel 300 mg tableta sadrži 300 mg irbesartana.
English: INFORMATION IN BRAILLE Sabervel 300 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Sabervel 300 mg
English: Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Croatian: Litij: tijekom istodobne primjene litija i inhibitora angiotenzin konvertirajućeg enzima zabilježen je reverzibilan porast koncentracije serumskog litija i njegove toksičnosti.
English: The demonstration of renal benefit of Sabervel 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).
Croatian: Dokaz koristi Sabervela na bubrežnu funkciju u hipertenzivnih bolesnika sa šećernom bolesti tipa 2 zasniva se na ispitivanjima u kojima se irbesartan prema potrebi uzimao kao dopuna ostalim antihipertenzivnim lijekovima za postizanje ciljnog krvnog tlaka (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
English: A lower starting dose (75 mg) should be considered for patients undergoing haemodialysis (see section
Croatian: U bolesnika na hemodijalizi treba razmotriti započinjanje liječenja nižom početnom dozom (75 mg)
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Croatian: Klinička studija «Učinak irbesartana na mikroalbuminuriju u hipertenzivnih bolesnika sa šećernom bolesti tipa 2 (IRMA 2)» pokazuje da 300 mg irbesartana odgađa progresiju izražene proteinurije u bolesnika s mikroalbuminurijom.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).
Croatian: <primjenjivati> Sabervel” i “Upozorenja i mjere opreza”).
English: mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Croatian: se razvila kod 29,4% bolesnika koji su primali 300 mg irbesartana i kod 22% bolesnika u placebo skupini.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih nejasnoća ili pitanja u vezi s primjenom ovoga lijeka, obratite se svom liječniku ili ljekarniku.
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5
Croatian: mikroalbuminurijom i normalnom bubrežnom funkcijom, hiperkalijemija (≥ 5,5 mEq/L)
English: 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).
Croatian: Nakon tri tjedna srednja vrijednost smanjenja krvnog tlaka u odnosu na početne vrijednosti za primarnu varijablu djelotvornosti, sistolički krvni tlak u sjedećem položaju (sjSKT) kod najniže koncentracije u krvi, iznosila je 11,7 mmHg (niska doza), 9,3 mmHg (srednja doza) i 13,2 mmHg
English: Sabervel is for oral use.
Croatian: Način primjene Sabervel je namijenjen za primjenu kroz usta.
English: INFORMATION IN BRAILLE Sabervel 150 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Sabervel 150 mg
English: Hepatic impairment: no dosage adjustment is necessary in patients with mild to moderate hepatic impairment.
Croatian: Oštećenje funkcije jetre: nije potrebna prilagodba doze u bolesnika s blagim do umjerenim oštećenjem funkcije jetre.
English: What Sabervel looks like and contents of the pack Sabervel 300 mg film-coated tablets are white, concave, round, film-coated tablets with 11 mm diameter.
Croatian: Kako Sabervel izgleda i sadržaj pakovanja Sabervel 300 mg filmom obložene tablete su bijele, konkavne, okrugle filmom obložene tablete promjera 11 mm .
English: 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.
Croatian: Za sekundarni studijski 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.
English: Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Greece
Croatian: Pharmathen S.A, 6 Dervenakion Str., 15351 Pallini, Attiki, Grčka
English: PSURs
Croatian: PSURevi
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Croatian: Ako se utvrdi trudnoća, mora se odmah prekinuti terapija antagonistima receptora angiotenzina II te treba, ako je to primjereno, uvesti drugu terapiju.
English: tinnitus
Croatian: Tinitus
English: The dose may later be increased to 300 mg once daily
Croatian: Doza se kasnije može povećati na 300 mg jednom na dan, ovisno o vrijednostima krvnog tlaka.
English: Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water).
Croatian: Tablete treba progutati s dovoljnom količinom tekućine
English: 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Croatian: hiperkalijemija (≥ 5,5 mEq/L) se razvila kod 29,4% bolesnika koji su primali 300 mg irbesartana i kod 22% bolesnika u placebo skupini.
English: • Uncommon : heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
Croatian: • Manje često: ubrzani srčani ritam, crvenilo praćeno osjećajem vrućine, kašalj, proljev, probavni poremećaji/žgaravica, problemi sa seksualnom funkcijom, bol u prsištu.
English: diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Croatian: Bolesnici u svim liječenim skupinama obično su uzimali između 2 i 4 antihipertenzivna lijeka (npr. diuretike, beta blokatore, alfa blokatore) kako bi postigli unaprijed definirani krvni tlak od ≤ 135/85 mmHg ili smanjenje sistoličkog tlaka za 10 mmHg ako je početna vrijednost bila > 160 mmHg.
English: vertigo, headache Ear and labyrinth disorder: Not known:
Croatian: Poremećaji uha i labirinta:
English: Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Croatian: Osim ako se nastavak terapije antagonistima receptora angiotenzina II ne smatra neophodnim, bolesnice koje planiraju trudnoću trebaju prijeći na drugu antihipertenzivnu terapiju s potvrđenom sigurnošću primjene u trudnoći.
English: Potassium supplements and potassium-sp aring diuretics: based on experience with the use of other medicinal products that affect the reninangiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Croatian: Nadomjesci kalija i diuretici koji štede kalij: na temelju iskustva s ostalim lijekovima koji utječu na reninangiotenzinski sustav, istodobno uzimanje diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koji sadrže kalij ili ostalih lijekova koji mogu povećati serumsku razinu kalija (npr. heparin) može izazvati porast serumskog kalija te se stoga ne preporučuje (vidjeti dio 4.4).
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Croatian: Smanjenje razine hemoglobina*, koje nije bilo klinički značajno, zabilježeno je u 1,7% hipertenzivnih bolesnika s uznapredovalom dijabetičkom bubrežnom bolesti koji su primali irbesartan.
English: hypersensitivity reactions such as angioedema, rash, urticaria Metabolism and nutrition disorders:
Croatian: Reakcije preosjetljivosti kao što su angioedem, osip i urtikarija
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate.
Croatian: Jezgra tablete: laktoza hidrat celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni bezvodni hipromeloza magnezijev stearat
English: Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Croatian: Nadomjestci kalija i diuretici koji štede kalij: na temelju iskustva s ostalim lijekovima koji utječu na renin angiotenzinski sustav, istodobno uzimanje diuretika koji štede kalij, nadomjestaka kalija, nadomjestaka soli koji sadrže kalij ili ostalih lijekova koji mogu povećati serumsku razinu kalija (npr. heparin) može izazvati porast serumskog kalija te se stoga ne preporučuje (vidjeti dio 4.4.).
English: When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Croatian: te treba, ako je to primjereno, započeti s drugom terapijom (vidjeti dijelove 4.3 i 4.6).
English: Sabervel 300mg film-coated tablets are supplied in blister packs of 28, 56, 90 or 98 film- coated tablets.
Croatian: Sabervel 300 mg filmom obložene tablete dostupne su u blister pakiranjima od 28, 56, 90 ili 98 filmom obloženih tableta.
English: White, concave, round, film-coated tablet with 7 mm diameter.
Croatian: Bijela, konkavna, okrugla, filmom obložena tableta promjera 7 mm
English: Musculoskeletal and connective tissue disorders: Common:
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva:
English: impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Croatian: Poremećaji bubrega i mokraćnog sustava: Oštećena funkcija bubrega, uključujući slučajeve zatajenja bubrega u rizičnoj skupini bolesnika (vidjeti dio 4.4).