natgillin/translations-raw huggingface dataset:
Patients with known or suspected mitochondrial disease 
Bolesnici s poznatom mitohondrijskom bolesti ili sumnjom na mitohondrijsku bolest
Valproate and related substances - Mitochondrial toxicity (EPITT no 17956) 
- Mitohondrijska toksičnost (EPITT br. 17956)
• in patients who have had liver transplantation or 
• u bolesnika koji su se podvrgnuli transplantaciji jetre ili
POLG-related disorders should be suspected in patients with a family history or suggestive symptoms of a POLG-related disorder, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy, cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura. 
Na poremećaje povezane s POLG-om treba posumnjati u bolesnika s obiteljskom anamnezom ili sugestivnim simptomima poremećaja povezanog s POLG-om, koji obuhvaćaju, ali nisu ograničeni na neobjašnjenu encefalopatiju, refraktornu epilepsiju (fokalnu, miokloničnu), kliničku sliku epileptičkog statusa, zaostajanje u razvoju, psihomotoričku regresiju, aksonalnu senzorimotornu neuropatiju, miopatiju, cerebelarnu ataksiju, oftalmoplegiju ili kompliciranu migrenu s okcipitalnom aurom.
• in patients in the perioperative liver transplantation period and 
• u bolesnika u perioperativnom razdoblju kod transplantacije jetre i
Optimark is contraindicated in these patients (see section 4.3). 
Optimark je kontraindiciran u ovih bolesnika (vidjeti dio 4.3).
Patients who have had or are undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. 
Bolesnici koji su imali ili se podvrgavaju transplantaciji jetre pod posebnim su rizikom s obzirom na to da je incidencija akutnog zatajenja bubrega u ovoj skupini bolesnika visoka.
Possible side effects: 
Moguće nuspojave:
If you have a genetic problem causing a mitochondrial disorder (e.g. Alpers-Huttenlocher syndrome) Warnings and precautions 
Ako imate genetski problem koji uzrokuje mitohondrijski poremećaj (primjerice Alpers-Huttenlocherov sindrom)
In light of the data submitted by the marketing authorisation holders and the advice provided by the Pharmacogenomics Working Party, the PRAC concluded that the evidence is sufficient to support a causal association between valproate and aggravation of underlying mitochondrial diseases, including risk of hepatotoxicity occurring mainly in patients suffering from POLG (polymerase gamma) mutations. 
U svjetlu podataka dostavljenih od strane nositelja odobrenja za stavljanje lijeka u promet i savjeta od strane Radne grupe za farmakogenomiku, PRAC je zaključio da su dokazi dostatni kako bi podržali uzročno-posljedičnu povezanost između valproata i pogoršanja podležećih mitohondijskih bolesti, uključujući rizik od hepatotoksičnosti koji se pojavljuje uglavnom u bolesnika koji pate od mutacija POLG-a (polimeraze gama).
Gadodiamide; gadopentetic acid; gadoversetamideNephrogenic systemic fibrosis in patients with acute kidney injury (EPITT no 408) 
Gadodiamid; gadopentetatna kiselina; gadoversetamidnefrogena sistemska fibroza u bolesnika s akutnom ozljedom bubrega (EPITT br. 408)
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3). 
Stoga se Optimark ne smije koristiti u bolesnika koji su imali ili se podvrgavaju transplantaciji jetre i u novorođenčadi (vidjeti dio 4.3).
Homeopathic products containing lithium are not affected by this PRAC recommendation. 
Ova preporuka PRAC-a ne odnosi se na homeopatske lijekove koji sadrže litij.
Patients undergoing liver transplantation are at particular risk since the incidence of acute renal failure is high in this group. 
Bolesnici koji se podvrgavaju transplantaciji jetre pod posebnim su rizikom s obzirom na to da je incidencija akutnog zatajenja bubrega u toj skupini bolesnika visoka.
Section 4 Possible side effects: 
Dio 4. Moguće nuspojave:
SmPC changes for Omniscan (gadodiamide) and Magnevist (gadopentetic acid) 
Izmjene u Sažetku opisa svojstava lijeka za Omniscan (gadodiamid) i Magnevist (gadopentetatna kiselina)
Musculoskeletal disorders: 
Poremećaji mišićno-koštanog sustava:
Valproate may trigger or worsen clinical signs of underlying mitochondrial diseases caused by mutations of mitochondrial DNA as well as the nuclear encoded POLG gene. 
Valproat može potaknuti ili pogoršati kliničke znakove podležeće mitohondrijske bolesti uzrokovane mutacijama mitohondrijske DNK kao i nuklearnog gena koji kodira za POLG.
<invented name> is contraindicated in these patients (see section 4.3). 
<Zaštićeno ime> je kontraindiciran u ovih bolesnika (vidjeti dio 4.3).
IMNM is clinically characterized by persistent proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment. 
IMNM je klinički karakterizirana perzistentnom slabošću proksimalnih mišića te povišenim razinama kreatin kinaze u serumu koje se ne povlače unatoč prekidu liječenja statinom.
Section 2: 
Dio 2:
Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in the nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome, and in children under two years of age who are suspected of having a POLG-related disorder (see section 4.4). 
Valproat je kontraindiciran u bolesnika za koje je poznato da imaju mitohondrijske poremećaje uzrokovane mutacijama nuklearnog gena koji kodira za mitohondrijski enzim polimerazu γ (POLG), poput Alpers-Huttenlocherova sindroma, te u djece mlađe od dvije godine za koje se sumnja da boluju od poremećaja povezanog s POLG-om (vidjeti dio 4.4).
Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests. 
Prije primjene lijeka Optimark, za sve bolesnike treba provesti laboratorijske testove kako bi se otkrila bubrežna disfunkcija.
In light of the data available, the PRAC has agreed that the evidence is sufficient to conclude that longterm use of lithium may induce microcysts, oncocytomas and collecting duct renal carcinomas. 
U svjetlu dostupnih podataka PRAC je zaključio da postoje dostatni dokazi kako bi se zaključilo da dugotrajna primjena litija može uzrokovati mikrociste, onkocitome i karcinome sabirnih kanalića bubrega.
Frequency not known: Immune-mediated necrotizing myopathy (see section 4.4) Package Leaflet: 
Učestalost nepoznata: Imunološki posredovana nekrotizirajuća miopatija (vidjeti dio 4.4) Uputa o lijeku:
Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma). 
Tumori bubrega: Bolesnici s teškim oštećenjem bubrega koji su primali litij tijekom više od 10 godina mogu biti pod rizikom od razvoja benignih ili malignih tumora bubrega (mikrocisti, onkocitoma ili karcinoma sabirnih kanalića bubrega).
The package leaflets should be updated accordingly. 
Uputu o lijeku treba ažurirati u skladu s tim.
Having considered the available evidence from the literature, the PRAC has agreed that the MAHs for medicinal products containing atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin or lovastatin should submit a variation within 2 months to amend the product informations as described below (new text underlined): 
Razmotrivši dostupne dokaze iz literature, PRAC je zaključio da nositelji odobrenja za lijekove koji sadrže atorvastatin, simvastatin, pravastatin, fluvastatin, pitavastatin ili lovastatin trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan):
Summary of Product Characteristics (SmPC): 
Sažetak opisa svojstava lijeka (SmPC)
SmPC changes for Optimark (gadoversetamide) 4.2 Posology and method of administration 
Izmjene u Sažetku opisa svojstava lijeka za Optimark (gadoversetamid) 4.2. Doziranje i način primjene
Lithium - Solid renal tumours (EPITT no 18090) 
Litij - solidni tumori bubrega (EPITT br. 18090)
In particular, valproateinduced acute liver failure and liver-related deaths have been reported at a higher rate in patients with hereditary neurometabolic syndromes caused by mutations in the gene for the mitochondrial enzyme polymerase γ (POLG), e.g. Alpers-Huttenlocher Syndrome. 
Posebice, prijavljene su više stope akutnog zatajenja jetre induciranog valproatom i smrti povezane s jetrom u bolesnika s nasljednim neurometaboličkim sindromima uzrokovanima mutacijama u genu za mitohondrijski enzim polimerazu γ (POLG), poput Alpers-Huttenlocherova sindroma.
Prior to administration of <invented name>, all patients should be screened for renal dysfunction by obtaining laboratory tests. 
Prije primjene lijeka <zaštićeno ime>, za sve bolesnike treba provesti laboratorijske testove kako bi se otkrila bubrežna disfunkcija.
Frequency unknown: Benign/malignant kidney tumours (microcysts, oncocytoma, or collecting duct renal carcinoma) (in long-term therapy). 
Učestalost nepoznata: Benigni/maligni tumori bubrega (mikrociste, onkocitomi ili karcinom sabirnih kanalića bubrega) (kod dugotrajne terapije).
Frequency unknown: Microcysts, oncocytoma and collecting duct renal carcinoma (in long-term therapy) (see Section 4.4). 
Učestalost nepoznata: Mikrociste, onkocitomi i karcinom sabirnih kanalića bubrega (u dugotrajnoj terapiji) (vidjeti dio 4.4).
• in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury. 
• u bolesnika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73 m2) i/ili akutnom ozljedom bubrega.
Talk to your doctor <or> , <pharmacist> <or nurse> before <taking> <using> <product name>: You know that there is a genetic problem causing a mitochondrial disorder in your family. 
Obratite se svom liječniku <ili> , <ljekarniku> <ili medicinskoj sestri> prije <uzimanja>
Having considered the available evidence the PRAC has agreed that the MAH of Omniscan, Optimark and Magnevist should submit a variation within 2 months, to amend the product information as described below (new text underlined / text to be removed strikethrough). 
Razmotrivši dostupne dokaze, PRAC je zaključio da nositelji odobrenja za Omniscan, Optimark i Magnevist trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan / tekst koji će se ukloniti prekrižen).
Renal tumours: Cases of microcysts, oncocytomas and collecting duct renal carcinoma have been reported in patients with severe renal impairment who received lithium for more than 10 years (see Section 4.8). 
Posebna upozorenja i mjere opreza pri uporabi Tumori bubrega: Slučajevi mikrocisti, onkocitoma i karcinoma sabirnih kanalića bubrega prijavljeni su u bolesnika s teškim oštećenjem bubrega koji su primali litij više od 10 godina (vidjeti dio 4.8).
Therefore <invented name> must not be used in patients with severe renal impairment, in patients in the perioperative liver transplantation period and in neonates (see section 4.3). 
Stoga se <zaštićeno ime> ne smije primjenjivati u bolesnika s teškim oštećenjem funkcije bubrega, u bolesnika u perioperativnom razdoblju kod transplantacije jetre i u novorođenčadi (vidjeti dio 4.3).
4.4 Special warnings and precautions for use 
Posebna upozorenja i mjere opreza za uporabu
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR <30ml/min/1.73m²) and/or acute kidney injury. 
Prijavljeni su slučajevi nefrogene sistemske fibroze (NSF) povezane s primjenom lijeka Optimark i nekim kontrastnim sredstvima koja sadrže gadolinij u bolesnika s akutnim ili kroničnim teškim oštećenjem bubrega (GFR <30ml/min/1,73m²) i/ili akutnom ozljedom bubrega.
The marketing authorisation holders for valproate (and related substances) containing medicinal products should submit a variation within 2 months to amend the product information as described below (new text underlined). 
Nositelji odobrenja za lijekove koji sadrže valproat (i srodne tvari) trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan).
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of <invented name> and some other gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury. 
Prijavljeni su slučajevi nefrogene sistemske fibroze (NSF) povezane s primjenom lijeka <zaštićeni naziv> i nekim drugim kontrastnim sredstvima koja sadrže gadolinij u bolesnika s akutnim ili kroničnim teškim oštećenjem bubrega (GFR <30 ml/min/1,73m²) i/ili akutnom ozljedom bubrega.
Therefore, the Marketing Authorisation Holders of lithium containing medicinal products should submit a variation within 2 months, to amend the product information as described below (new text underlined). 
Stoga nositelji odobrenja za lijekove koji sadrže litij trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku kako je to opisano u nastavku (novi tekst podcrtan).
There have been very rare reports of an immune-mediated necrotizing myopathy (IMNM) during or after treatment with some statins. 
Tijekom ili nakon liječenja nekim statinima vrlo rijetko je prijavljena imunološki posredovana nekrotizirajuća miopatija (IMNM).
Patients with iImpaired renal function 
Bolesnici s oštećenjem funkcije bubrega
Package leaflet: 
- Nuspojave:
4.3 Contraindications <invented name> is contraindicated in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury, in patients in the perioperative liver transplantation period and in neonates up to 4 weeks of age (see section 4.4). 
4.3. Kontraindikacije <zaštićeno ime> je kontraindiciran u bolesnika s teškim oštećenjem bubrega (GFR < 30ml/min/1,73m2) i/ili akutnom ozljedom bubrega i u bolesnika u perioperativnom razdoblju kod transplantacije jetre te u novorođenčadi starosti do 4 tjedna (vidjeti dio 4.4).
Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3). 
Optimark je kontraindiciran u bolesnika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73m2) i/ili akutnom ozljedom bubrega te u bolesnika koji su se podvrgnuli transplantaciji jetre ili u bolesnika u perioperativnom razdoblju kod transplantacije jetre (vidjeti dio 4.3).
Package Leaflet 
Nuspojave
Renal impairment <invented name> is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute kidney injury and in patients in the perioperative liver transplantation period (see section 4.3). 
<zaštićeno ime> je kontraindiciran u bolesnika s teškim oštećenjem bubrega (GFR < 30 ml/min/1,73m2) i/ili akutnom ozljedom bubrega te u bolesnika u perioperativnom razdoblju kod transplantacije jetre (vidjeti dio 4.3).
Section 4.4 - Special warnings and precautions for use: 
- Posebna upozorenja i mjere opreza pri uporabi:
Taken into account all available data PRAC agreed that all MAHs for paroxetine containing products should submit a variation within 2 months to amend the product information (section 4.8 of the SmPC and package leaflet) as described below (new text underlined). 
Uzimajući u obzir sve dostupne podatke, PRAC je zaključio da nositelji odobrenja za lijekove koji sadrže paroksetin trebaju podnijeti izmjenu u roku od 2 mjeseca kako bi se nadopunile informacije o lijeku (dio 4.8.
Renal and hepatic impairment 
Valproat i srodne tvari
Renal and urinary disorders: 
Poremećaji bubrega i mokraćnog sustava:
It is important that you continue to take Irbesartan Zentiva until your doctor tells you otherwise. 
Važno je da nastavite uzimati Irbesartan Zentiva sve dok Vam liječnik ne kaže drukčije.
Date of latest renewal: 19 January 2012 
Datum posljednje obnove: 19. siječnja 2012.
Irbesartan Zentiva should not be given to children under 18 years of age. 
Irbesartan Zentiva se ne smije davati djeci mlađoj od 18 godina.
See also information under the heading “Do not take Irbesartan Zentiva”. 
Vidjeti također informacije pod naslovom „Nemojte uzimati Irbesartan Zentiva“.
The safety and efficacy of Irbesartan Zentiva in children aged 0 to 18 has not been established. 
Sigurnost i djelotvornost lijeka Irbesartan Zentiva u djece u dobi od 0 do 18 godina nisu ustanovljene.
If you get any of these symptoms or get short of breath, stop taking Irbesartan Zentiva and contact your doctor immediately. 
Ako primijetite bilo koji od ovih simptoma ili osjetite nedostatak zraka, prestanite uzimati Irbesartan Zentiva i odmah se javite liječniku.
Irbesartan Zentiva with food and drink Irbesartan Zentiva can be taken with or without food. 
Irbesartan Zentiva s hranom i pićem Irbesartan Zentiva se može uzeti s hranom ili bez nje.
What Irbesartan Zentiva is and what it is used for What you need to know before you take Irbesartan Zentiva How to take Irbesartan Zentiva Possible side effects 
Što je Irbesartan Zentiva i za što se koristi Što morate znati prije nego počnete uzimati Irbesartan Zentiva Kako uzimati Irbesartan Zentiva Moguće nuspojave
What Irbesartan Zentiva is and what it is used for 
Što je Irbesartan Zentiva i za što se koristi
Your doctor will normally advise you to stop taking Irbesartan Zentiva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Irbesartan Zentiva. 
Vaš će Vam liječnik obično preporučiti da prestanete uzimati Irbesartan Zentiva prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto lijeka Irbesartan Zentiva.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan Zentiva, amlodipine and placebo. 
IDNT je bilo dvostruko slijepo, kontrolirano ispitivanje morbiditeta i mortaliteta u kojem su uspoređivani Irbesartan Zentiva, amlodipin i placebo.
Other medicines and Irbesartan Zentiva 
Drugi lijekovi i Irbesartan Zentiva
Lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
Laktoza: bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality. 
Irbesartan značajno snižava relativni rizik u primarnoj kombiniranoj mjeri ishoda udvostručavanja serumskog kreatinina, terminalne faze bubrežne bolesti ili svih uzroka mortaliteta.
Please see section 2 “Irbesartan Zentiva contains lactose”. 
Vidjeti dio 2., „Irbesartan Zentiva sadrži laktozu“
What you need to know before you take Irbesartan Zentiva 
Što morate znati prije nego počnete uzimati Irbesartan Zentiva
No specific information is available on the treatment of overdose with Irbesartan Zentiva. 
Nema dostupnih specifičnih podataka o liječenju predoziranja lijekom Irbesartan Zentiva.
You can take Irbesartan Zentiva with or without food. 
Irbesartan Zentiva se može uzimati s hranom ili bez nje.
Irbesartan Zentiva is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely. 
Irbesartan Zentiva se ne preporučuje majkama koje doje, a Vaš liječnik može izabrati drugu terapiju ako želite dojiti, osobito ako se radi o dojenju novorođenčeta ili nedonoščeta.
While this is not documented with Irbesartan Zentiva, a similar effect should be anticipated with angiotensin-II receptor antagonists. 
Iako to još nije potvrđeno za Irbesartan Zentiva, sličan učinak može se očekivati s antagonistima receptora angiotenzina II.
Irbesartan Zentiva is unlikely to affect your ability to drive or use machines. 
Irbesartan Zentiva ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
There is no experience regarding the administration of Irbesartan Zentiva in patients with a recent kidney transplantation. 
Nema iskustava s primjenom lijeka Irbesartan Zentiva u bolesnika kojima je nedavno transplantiran bubreg.
Irbesartan Zentiva is indicated in adults for the treatment of essential hypertension. 
Irbesartan Zentiva je indiciran za liječenje esencijalne hipertenzije u odraslih.
Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan Zentiva 300 mg group (34%) than in the placebo group (21%). 
Regresija do normoalbuminurije (< 30 mg/dan) bila je češća u skupini koja je primala lijek Irbesartan Zentiva u dozi od 300 mg (34%) nego u skupini koja je primala placebo (21%).
The blood pressure lowering effect of Irbesartan Zentiva is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy. 
Učinak lijeka Irbesartan Zentiva na snižavanje krvnog tlaka vidljiv je unutar 1-2 tjedna, s maksimalnim učinkom nakon 4-6 tjedana od početka terapije.
Because no information is available regarding the use of Irbesartan Zentiva during breast-feeding, Irbesartan Zentiva is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant. 
Budući da nema dostupnih podataka o upotrebi lijeka Irbesartan Zentiva tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s ustanovljenim boljim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Irbesartan Zentiva (see section 4.4). 
Prethodno liječenje visokim dozama diuretika može dovesti do smanjenja volumena i rizika od pojave hipotenzije prilikom uvođenja terapije lijekom Irbesartan Zentiva (vidjeti dio 4.4).
Irbesartan Zentiva belongs to a group of medicines known as angiotensin-II receptor antagonists. 
Irbesartan Zentiva pripada skupini lijekova koja se naziva antagonisti receptora angiotenzina II.
Irbesartan Zentiva 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. 
Irbesartan Zentiva se ne preporučuje u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu ako ga uzimate u tom razdoblju.
Such conditions should be corrected before the administration of Irbesartan Zentiva. 
Takva stanja treba korigirati prije primjene lijeka Irbesartan Zentiva.
Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan Zentiva, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated. 
Bolesnici su titrirani od 75 mg do doze održavanja od 300 mg lijeka Irbesartan Zentiva, od 2,5 mg do 10 mg amlodipina ili placeba do granice podnošljivosti.
Irbesartan Zentiva at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. 
Doza od 150 mg lijeka Irbesartan Zentiva jedanput na dan općenito osigurava bolju kontrolu krvnog tlaka u razdoblju od 24 sata nego doza od 75 mg.
Renal impairment and kidney transplantation: when Irbesartan Zentiva 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: kad Irbesartan Zentiva uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati serumske razine kalija i kreatinina.