natgillin/translations-raw huggingface dataset:
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 20 July 2015.
Tvrtka je dostavila dodatne zatražene informacije, tako da je dodano „u iznimnim okolnostima” dana 20. srpnja 2015
Replagal has also been evaluated in additional studies involving 38 children aged 7 years or above.
Replagal je također ocijenjen u daljnjim ispitivanjima koja su obuhvatila 38 djece u dobi od 7 godina ili starijih.
Replagal was originally authorised under ‘exceptional circumstances', because as the disease is rare, limited information was available at the time of approval.
Replagal je prvobitno odobren u „iznimnim okolnostima” zbog toga što su, iz znanstvenih razloga, u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije.
The European Commission granted a marketing authorisation valid throughout the European Union for Replagal on 3 August 2001.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Replagal na snazi u Europskoj uniji od 3. kolovoza 2001.
Children who received Replagal had no unexpected increase in heart mass, and the levels of Gb3 in their blood were reduced.
Djeca koja su primila lijek Replagal nisu imala neočekivanih povećanja u srčanoj masi, a koncentracije Gb3 u njihovoj krvi su se smanjile.
Replagal agalsidase alfa
Replagal agalzidaza alfa
The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
Djelatna tvar lijeka Replagal, agalzidaza alfa, jest kopija ljudskog enzima, proizvedena metodom poznatom pod nazivom "tehnologija rekombinantne DNK": proizvodi ga stanice koje su primile gen (DNK), koji im omogućuje stvaranje enzima.
For more information about treatment with Replagal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Replagal pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
After 6 months of treatment, Replagal significantly reduced pain in patients compared with placebo.
Nakon 6 mjeseci terapije, Replagal je značajno smanjio bol u bolesnika u usporedbi s placebom.
People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
Osobe s Fabryjevom bolesti mogu imati široko raspon znakova i simptoma, uključujući ozbiljna stanja poput zatajenja bubrega, srčanih problema i moždanog udara.
Why has Replagal been approved?
Zašto je Replagal odobren?
Other information about Replagal
Ostale informacije o lijeku Replagal
These include chills, headache, nausea, pyrexia (fever), pain and discomfort, flushing and fatigue (tiredness), and are rarely severe.
Ove nuspojave uključuju zimicu, mučninu, pireksiju (vrućicu), bol i nelagodu, znojenje o iscrpljenost (umor), te su rijetko ozbiljne.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Replagal.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Replagal.
It is available as a concentrate to be made into solution for infusion (drip) into a vein.
Postoji kao koncentrat za suspenziju za infuziju (drip u venu).
The first study measured the effects of Replagal on pain while the second study measured its effect on the mass of the left ventricle (heart muscle), a measure of the amount of Gb3 in the heart cells.
Prvo je ispitivanje izmjerilo djelovanje lijeka Replagal na bol dok je drugo ispitivanje izmjerilo njegovo djelovanje na masu lijevog ventrikula (srčanog mišića), mjera količine Gb3 u srčanim stanicama.
If the enzyme is not present, Gb3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Ako enzim nije prisutan, Gb3 se ne može razgrađivati i ugrađuje se u stanice tijela poput stanica bubrega.
The most common side effects with Replagal (seen in more than 1 patient in 10) are infusionassociated reactions.
Najčešće nuspojave lijeka Replagal (može se javiti u više od 1 na 10 osoba) su reakcije povezane s infuzijom..
This is a summary of the European public assessment report (EPAR) for Replagal.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Replagal.
Replagal has been compared with placebo (a dummy treatment) in two main studies involving a total of 40 male patients.
Replagal je uspoređen s placebom (prividnim terapijom) u dva glavna ispitivanja koja su obuhvatila ukupno 40 muških bolesnika.
The effect of giving doses weekly rather than every two weeks was also investigated.
Istraženo je i djelovanje primjene tjednih doza u odnosu na primjenu svaka dva tjedna.
The replacement enzyme helps to break down the Gb3 and stops it building up in the cells.
Zamjenski enzim pomaže pri razgradnji Gb3 i zaustavlja njegovu ugradnju u stanice.
Enzyme replacement therapy provides patients with the enzyme they are lacking.
Enzimska zamjenska terapija osigurava bolesniku enzime koji mu nedostaju.
Replagal is designed to replace the human enzyme alpha-galactosidase A, which is lacking in people with Fabry disease.
Replagal je dizajniran kako bi zamijenio ljudski enzim alfa-galaktozidaza A, koji nedostaje osobama s Fabryjevom bolesti.
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal.
Samo liječnici koji su iskusni u liječenju bolesnika s Fabryjevom bolesti ili drugom nasljednom metaboličkom bolesti smiju primjenjivati lijek Replagal.
The CHMP decided that Replagal's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi od lijeka Replagal nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
What is the risk associated with Replagal?
Koji su rizici povezani s lijekom Replagal?
Replagal is medicine that contains the active substance agalsidase alfa.
Replagal je lijek koji sadrži djelatnu tvar agalzidaza alfa.
The CHMP decided that for patients with Fabry disease treatment with Replagal might provide longterm clinical benefits.
CHMP je odlučio da bolesnici s Fabryevom bolesti mogu imati dugoročne koristi od terapije lijekom Replagal.
Replagal is used to treat patients who have Fabry disease, a rare inherited disorder.
Replagal se koristi uza liječenje bolesnika s Fabryjevom bolesti, rijetkim nasljednim poremećajem.
Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g. The effects in female patients were comparable to those in male patients and weekly dosing had no advantage over standard doses.
Replagal je smanjio masu lijevog ventrikula prosječno za 11,5 g dok su bolesnici koji su primali placebo imali povećanje u masi lijevog ventrikula od 21,8 g.
Replagal is an enzyme replacement therapy.
Replagal je enzimska zamjenska terapija.
Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3 or GL-3).
Ovaj enzim normalno razgrađuje masnu tvar naziva globotriaosilkeramid (Gb3 ili GL-3).
What benefit has Replagal shown during the studies?
Koje su koristi lijeka Replagal utvrđene u ispitivanjima?
What is Replagal used for?
Za što se Replagal koristi?
For the full list of all side effects and restrictions with Replagal, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Replagal potražite u uputi o lijeku.
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.