natgillin/translations-raw huggingface dataset:
What is Replagal? 
Što je Replagal?
How is Replagal used? 
Kako se Replagal koristi?
How does Replagal work? 
Kako djeluje Replagal?
How has Replagal been studied? 
Kako je Replagal ispitivan?
The volume of distribution is 53 - 93 litres. 
Volumen distribucije iznosi 53-93 litre.
Sabervel should not be given to children under 18 years of age. 
Sabervel se ne smije davati djeci mlađoj od 18 godina.
Risk Management Plan (RMP) Not applicable 
Plan upravljanja rizicima (RMP)
This medicine should not be used in children and adolescents (under 18 years) because the safety and efficacy have not yet been fully established. 
Ovaj lijek ne smiju uzimati djeca i adolescenti (mlađi od 18 godina), jer sigurnost i djelotvornost još nisu u potpunosti utvrđene.
Always take Sabervel exactly as your doctor has told you. 
Uvijek uzmite Sabervel točno onako kako Vam je rekao liječnik.
• This medicine has been prescribed for you. 
Ovaj je lijek propisan Vama.
• if you suffer from heart problems 
• Ako imate srčanih problema.
The terminal elimination half-life of irbesartan is 11 - 15 hours. 
Krajnje poluvrijeme eliminacije irbesartana iznosi 11-15 sati.
If you take more Sabervel than you should: 
Ako uzmete više Sabervela nego što se trebali
DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first Authorization: 13 April 2012 
Datum prvog odobrenja: 13. travnja, 2012.
Like all medicines, Sabervel can cause side effects, although not everybody gets them. 
Kao i svi drugi lijekovi, Sabervel može uzrokovati nuspojave, iako ih neće svi dobiti.
hepatitis, abnormal liver function 
Hepatitis, abnormalna funkcija jetre
It is important that you continue to take Sabervel until your doctor tells you otherwise. 
Važno je da kontinuirano uzimate Sabervel sve dok Vam liječnik ne kaže drukčije.
Other medicines and Sabervel 
Drugih lijekova i Sabervel
Important information about some of the ingredients of Sabervel Sabervel contains lactose. 
Važne informacije o nekim sastojcima Sabervela Sabervel sadrži laktozu.
Irbesartan did not affect survival, development, or reproduction of offspring. 
Irbesartan nije imao učinka na preživljenje, razvoj, ili reprodukcijsku sposobnost potomstva.
WHAT SABERVEL IS AND WHAT IT IS USED FOR 
ŠTO JE SABERVEL I ZA ŠTO SE KORISTI
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components. 
Vezivanje za proteine plazme iznosi oko 96%, s neznatnim vezanjem za krvne stanice.
The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation is in place and functioning before and whilst the medicinal product is on the market. 
Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav prikazan u Modulu 1.8.1. nositelja odobrenja, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
Such conditions should be corrected before the administration of Sabervel. 
Takva stanja treba korigirati prije primjene Sabervela.
No specific information is available on the treatment of overdose with Sabervel. 
Nema dostupnih specifičnih podataka o liječenju predoziranja Sabervelom.
• if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel 
• Ako ste alergični (preosjetljivi) na irbesartan ili neki drugi sastojak Sabervela.
Your doctor will normally advise you to stop taking Sabervel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sabervel. 
Vaš će Vam liječnik obično preporučiti da prestanete uzimati Sabervel prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto Sabervela.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/ 
Detaljne informacije o ovog lijeka dostupne su na web stranici Europske agencije za lijekove (EMAe): http://www.ema.europa.eu/.
Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made. 
Trenutno dostupni podaci opisani su u dijelu 4.8, 5.1 i 5.2, međutim nije moguće dati preporuku o doziranju.
(See section 5.3). 
(vidjeti dio 5.1.).
Warnings and precautions Tell your doctor if any of the following apply to you: 
Upozorenja i mjere opreza Obavijestite svog liječnika ako se nešto od dolje navedenog odnosi na Vas:
After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%. 
Nakon peroralne primjene irbesartan se dobro apsorbirao: ispitivanja apsolutne bioraspoloživosti pokazala su vrijednosti oko 60-80%.
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. 
Epidemiološki dokazi koji se odnose na rizik od teratogenog učinka nakon uporabe ACE inhibitora tijekom prvog tromjesečja nisu bili dostatni za donošenje zaključaka; manji porast rizika, međutim, ne može se isključiti.
Sabervel is unlikely to affect your ability to drive or use machines. 
Sabervel ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
• The active substance is irbesartan. 
Djelatna tvar je irbesartan.
Less than 2% of the dose is excreted in the urine as unchanged irbesartan. 
Manje od 2% doze izlučuje se u obliku nepromijenjenog irbesartana.
Lactose: this medicinal product contains lactose. 
Laktoza: ovaj lijek sadrži laktozu.
• potassium-sparing medicines (such as certain diuretics) 
• lijekove koji čuvaju kalij (kao što su neki diuretici)
Tell your doctor if any of the following apply to you: 
Obavijestite svog liječnika ako se nešto od dolje navedenog odnosi na Vas:
Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40 
Vrijednosti AUC i Cmax irbesartana također su bile nešto veće u starijih ispitanika (≥ 65 godina) u usporedbi s mlađima (18-40 godina).
Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly. 
Stariji: iako za bolesnike starije od 75 godina treba razmotriti započinjanje terapije dozom od 75 mg, prilagodba doze obično nije potrebna.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/ 
Podrobnije informacije o ovom lijeku dostupne su na web stranicama Europske agencije za lijekove (EMA) http://www.ema.europa.eu/
Use in Children 
Primjena kod djece
orthostatic hypotension* 
ortostatska hipotenzija*
Read all of this leaflet carefully before you start taking this medicine . 
Pažljivo pročitajte cijelu uputu prije nego počnete uzimati lijek.
Therefore, the use of Sabervel is not recommended. 
Stoga se ne preporučuje primjena Sabervela.
The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product. 
Plan predavanja PSUR-a treba slijediti raspored prijave PSUR-a za referentni lijek.
arthralgia, myalgia (in some cases associated with increased plasma creatine kinase 
Artralgija, mijalgija (u nekim slučajevima povezana s povećanom koncentracijom kreatin kinaze u plazmi), grčevi mišića
The frequency of adverse reactions listed below is defined using the following convention: 
Učestalost dolje navedenih nuspojava definirana je na sljedeći način:
Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e.g., 
Bolesnici u svim liječenim skupinama obično su uzimali između 2 i 4 antihipertenzivna lijeka (npr.
Rodopi Prefecture, Block No 5, Rodopi 69300, Greece 
Rodopi Prefecture, Block No 5, Rodopi 69300, Grčka
Cartons of 28, 56, 90 or 98 film-coated tablets in PVC/PVDC-aluminium/PVDC blisters. 
Kutije s 28, 56, 90 ili 98 filmom obloženih tableta u PVC/PVDC-aluminij/PVDC blisterima.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system. 
Primarni aldosteronizam: bolesnici s primarnim hiperaldosteronizmom općenito ne reagiraju na antihipertenzivne lijekove koji djeluju putem inhibicije renin-angiotenzinskog sustava.
No significant effects on the number of corpora lutea, implants, or live fetuses were observed. 
Nisu zabilježeni značajni učinci na broj žutih tijela, implantate, ili žive fetuse.
See also information under the heading “Do not take Sabervel”. 
Vidjeti također informacije pod naslovom “Nemojte <uzimati> <primjenjivati> Saberver”
C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan. 
C irbesartana, 80-85% cirkulirajuće radioaktivnosti u plazmi odnosi se na nepromijenjeni irbesartan.
Pharmathen International S.A. Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, 
Pharmathen International S.A. Industrijski Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
Mechanism of action: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. 
Mehanizam djelovanja: irbesartan je snažan, oralno djelotvoran, selektivni antagonist receptora angiotenzina II (tip AT1).
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. 
Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kutija
This leaflet was last approved in 
Uputa je zadnji puta odobrena u {MM/GGGG}.
Keep out of the sight and reach of children. 
Čuvati izvan dohvata i pogleda djece.
Sabervel 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. 
Sabervel 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.
In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function 
U tom će Vam slučaju Vaš liječnik možda raditi redovite pretrage krvi, posebno određivanje koncentracije kalija u krvi u slučaju oslabljene funkcije bubrega.
Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration. 
Vršne koncentracije u plazmi postižu se 1,5 do 2 sata nakon oralne primjene.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. 
• ako imate šećernu bolest ili oštećenu bubrežnu funkciju i liječite se lijekom za snižavanje krvnog tlaka koji sadrži aliskiren
Children should not take Sabervel 
Djeca ne smiju uzimati Sabervel
Paediatric population: the safety and efficacy of Sabervel in children aged 0 to 18 has not been established. 
Pedijatrijska populacija: sigurnost primjene i djelotvornost Sabervela u djece u dobi do 18 godina nisu još ustanovljene.
In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Sabervel (see section 4.5). 
Konkretno, dodatak diuretika poput hidroklorotiazida je pokazao da ima aditivni učinak sa Sabervelom (vidjeti dio 4.5.).
Sabervel belongs to a group of medicines known as angiotensin-II receptor antagonists. 
Sabervel pripada skupini lijekova koja se naziva antagonisti receptora angiotenzina II.
Do not take Sabervel 
Nemojte uzimati Sabervel
Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3). 
Dostupni farmakodinamski/toksikološki podaci u štakora pokazali su izlučivanje irbesartana ili njegovih metabolita u mlijeko (vidjeti dio 5.3).
Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%). 
Regresija do normoalbuminurije (< 30 mg/dan) bila je češća u skupini koja je primala irbesartan 300 mg (34%) nego u skupini koja je primala placebo (21%).
• if you receive Sabervel for diabetic kidney disease. 
• Ako uzimate Sabervel zbog dijabetičke bolesti bubrega.
08184 - Palau-solità i Plegamans, Barcelona, Spain 
08184 - Palau-solità i Plegamans, Barcelona, Španjolska
If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicine. 
Ako Vam je liječnik rekao da ne podnosite neke šećere (npr. laktozu), obratite se svom liječniku prije uzimanja ovog lijeka.
There is no experience regarding the administration of Sabervel in patients with a recent kidney transplantation. 
Nema iskustava s primjenom Sabervela u bolesnika kojima je nedavno transplantiran bubreg.
Sabervel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg. 
Doza od 150 mg Sabervela jedanput na dan općenito osigurava bolju kontrolu krvnog tlaka nego doza od 75 mg u razdoblju od 24 sata.
dysgeusia 
Disgeuzija
If you get any of these symptoms or get short of breath, stop taking Sabervel and contact your doctor imme diate ly. 
Ako dobijete bilo koji od ovih simptoma ili nedostatak zraka, prestanite uzimati Sabervel i odmah se javite liječniku.
Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. 
Manje često su prijavljeni i slučajevi žutice (žutilo kože i/ili bjeloočnica).
Taking Sabervel with food and drink Sabervel can be taken with or without food. 
Uzimanje hrane i pića sa Sabervelom Sabervel može se uzeti s hranom ili bez nje.
No dosage adjustment is necessary in elderly patients. 
Stoga, nije potrebna prilagodba doze za starije bolesnike.
Second and third trimesters of pregnancy (see sections 4.4 and 4.6). 
Drugo i treće tromjesečje trudnoće (vidjeti dijelove 4.4. i 4.6).
Renal impairment and kidney transplantation: when Sabervel 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 Sabervel uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati serumske razine kalija i kreatinina.
Based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability. 
Na temelju farmakodinamičkih svojstava, irbesartan ne bi trebao utjecati na te sposobnosti.
Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3). 
Irbesartan nije imao nikakvog utjecaja na plodnost tretiranih štakora i njihovih potomaka do doza koje induciraju prve znakove roditeljske toksičnosti (vidjeti dio 5.3).
Paediatric population: irbesartan has been studied in paediatric populations aged 6 to 16 years old but the current data are insufficient to support an extension of the use in children until further data become available (see sections 4.8, 5.1 and 5.2). 
Pedijatrijska populacija: irbesartan je ispitivan na pedijatrijskoj populaciji u dobi od 6 do 16 godina, ali trenutni podaci nisu dostatni da bi podržali proširenje primjene na djecu dok ne budu i daljnji podaci dostupni (vidjeti dijelove 4.8., 5.1. i 5.2.).
Therefore, this combination is not recommended (see section 4.4). 
Ta se kombinacija stoga ne preporučuje (vidjeti dio 4.4).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Molimo Vas da obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali neke druge lijekove, uključujući lijekove nabavljene bez recepta.
In the 26-week open-label period of this trial the most frequent laboratory abnormalities observed were creatinine increases (6.5%) and elevated CK values in 2% of child recipients. 
U otvorenom razdoblju ove studije, u trajanju od 26 tjedana, najčešće opažene laboratorijske abnormalnosti bile su povećana koncentracija kreatinina (6,5%) i povišene vrijednosti CK u 2% djece.
You can take Sabervel with or without food. 
Sabervel se može uzimati s hranom ili bez nje.
Sabervel is indicated in adults for the treatment of essential hypertension. 
4.1 Terapijske indikacije Sabervel je indiciran u odraslih za liječenje esencijalne hipertenzije.
• if you are going to have an operation (surgery) or be given anaesthetics. 
• Ako trebate ići na bilo kakav kirurški zahvat ili trebate primiti anestetike.
Approximately 33% of patients in the irbesartan group reached the primary renal composite endpoint compared to 39% and 41% in the placebo and amlodipine groups [20% relative risk reduction versus placebo (p = 0.024) and 23% relative risk reduction compared to amlodipine (p = 0.006)]. 
Oko 33% bolesnika u irbesartan skupini dostiglo je primarni složeni studijski ishod za bubrežnu bolest, u usporedbi sa 39% u placebo i 41% u amlodipin skupini [20% smanjenje relativnog rizika u odnosu na placebo (p=0,024) i 23% smanjenje relativnog rizika u usporedbi s amplodipinom (p=0,006)].
Studies in animals indicate that the radiolabeled irbesartan is detected in rat and rabbit fetuses. 
Ispitivanja na životinjama pokazuju da je radioaktivno označeni ibesartan otkriven u štakora i fetusa kunića.
In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. 
U bolesnika s povišenim krvnim tlakom, šećernom bolesti tipa 2 i bubrežnom bolešću također su prijavljeni omaglica i nizak krvni tlak nakon podizanja iz sjedećeg ili ležećeg položaja, bol u zglobovima i mišićima i smanjene razine proteina u crvenim krvnim stanicama (hemoglobina).
Because no information is available regarding the use of Sabervel during breast-feeding, Sabervel is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant. 
Budući da nema dostupnih podataka o upotrebi Sabervela tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s boljim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
No studies on the effects on the ability to drive and use machines have been performed. 
Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i rada na strojevima.
• if you get excessive vomiting or diarrhoea 
• Ako Vas muči prekomjerno povraćanje ili proljev.
In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%). 
U placebom kontroliranim ispitivanjima, koja su provedena na bolesnicima s hipertenzijom, ukupna incidencija štetnih događaja nije se razlikovala između skupine koja je uzimala irbesartan (56,2%) i placebo skupine (56,5%).
Sabervel prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. 
Sabervel sprječava vezanje angiotenzina II na te receptore, uzrokujući opuštanje krvnih žila i sniženje krvnog tlaka.
The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/min, respectively. 
Ukupni tjelesni klirens iznosi 157-176, a bubrežni klirens 3-3,5 ml/min.
Fertility and reproductive performance were not affected in studies of male and female rats even at oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including mortality at the highest dose. 
Nije bilo utjecaja na plodnost i reprodukcijsku sposobnost u ispitivanjima na mužjacima i ženkama štakora, čak i pri oralnim dozama irbesartana koje katkad uzrokuju roditeljsku toksičnost (od 50 do 650 mg/kg/dan), uključujući i smrtnost pri najvišoj dozi.
Hypersensitivity to the active substance, or to any of the excipients (see section 6.1). 
Preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari (vidjeti dio 6.1).
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur. 
Nesteroidni protuupalni lijekovi: kad se antagonisti angiotenzina II primjenjuju istodobno s nesteroidnim protuupalnim lijekovima (tj. selektivnim inhibitorima COX2, acetilsalicilnom kiselinom (> 3 g/dan) i neselektivnim NSAIL) moguć je oslabljeni antihipertenzivni učinak.
Irbesartan is excreted in the milk of lactating rats. 
Irbesartan se izlučuje u mlijeku kod štakorica.
In patients insufficiently controlled with 150 mg once daily, the dose of Sabervel can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1). 
U bolesnika u kojih se bolest ne može dostatno kontrolirati dozom od 150 mg jedanput na dan, doza Sabervela može se povećati na 300 mg ili se mogu dodati drugi antihipertenzivi (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
UVJETI ILI OGRANIČENJA VEZANA UZ SIGURNU I UČINKOVITU PRIMJENU
28 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets 
28 filmom obloženih tableta 56 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta
• medicines containing lithium 
• lijekove koji sadrže litij
Sabervel 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. 
Sabervel se ne preporučuje u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi
Over a subsequent two week period where patients were re-randomized to either active medicinal product or placebo, patients on placebo had increases of 2.4 and 2.0 mmHg in SeSBP and SeDBP compared to +0.1 and -0.3 mmHg changes respectively in those on all doses of irbesartan (see section 4.2). 
Tijekom sljedeća dva tjedna kada su bolesnici ponovo randomizirani ili na lijek ili na placebo, bolesnici na placebu imali su porast od 2,4 i 2,0 mmHg za sjSKT i sjDKT, u usporedbi s promjenom od +0,1 i -0,3 mmHg za bolesnike na svim dozama irbesartana (vidjeti dio 4.2.).
Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however irbesartan has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. 
Diuretici i drugi antihipertenzivni lijekovi: drugi antihipertenzivi mogu pojačati hipotenzivni učinak irbesartana; irbesartan se, međutim, pokazao sigurnim za primjenu s ostalim antihipertenzivnim lijekovima poput beta blokatora, dugodjelujućih blokatora kalcijevih kanala i tiazida.
• salt substitutes containing potassium 
• nadomjeske soli koji sadrže kalij
Lithium: the combination of lithium and Sabervel is not recommended (see section 4.5). 
Litij: ne preporučuje se kombinacija litija i Sabervela (vidjeti dio 4.5).
6, Dervenakion str., 15351 Pallini Attiki, Greece Tel.: +30 210 66 65 067 
6, Dervenakion str., 15351 Pallini Attiki, Grčka Tel.: +30 210 66 65 067
hypersensitivity reactions such as angioedema, rash, urticaria 
Reakcije preosjetljivosti kao što su angioedem, osip, urtikarija
While this is not documented with Sabervel, a similar effect should be anticipated with angiotensin-II receptor antagonists. 
Iako to još nije potvrđeno za Sabervel, sličan učinak može se očekivati s antagonistima receptora angiotenzina II.
C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces. 
irbesartana, oko 20% radioaktivnosti pojavilo se u mokraći, a ostatak u stolici.