natgillin/translations-raw huggingface dataset:
In a study of 37 paediatric PTPs, the pharmacokinetic parameters of ReFacto AF observed after a 50 IU/kg dose are shown in the table below. 
Farmakokinetički parametri lijeka ReFacto AF, zabilježeni nakon doze od 50 IU/kg u ispitivanju provedenom na 37 prethodno liječenih pedijatrijskih bolesnika, prikazani su u tablici ispod.
s r.o. 
°C.
Number of subjects 
Broj ispitanika
After reconstitution, each mL of solution contains approximately 62.5 IU moroctocog alfa. 
Nakon rekonstitucije, jedan ml otopine sadrži približno 62,5 IU moroktokoga alfa.
1 vial: 250 IU moroctocog alfa (approx. 62.5 IU/ml after reconstitution). 
1 bočica: 250 IU moroktokoga alfa (približno 62,5 IU /ml nakon pripreme otopine).
PUPs <6 years 
Prethodno neliječeni bolesnici < 6 godina
- After reconstitution with the supplied solvent [sodium chloride 9 mg/ml (0.9%) solution], each vial contains 62.5, 125, 250, or 500 IU, respectively (based on the strength of moroctocog alfa, 
- Nakon pripreme s priloženim otapalom [otopinom natrijevog klorida 9 mg/ml (0,9%)], jedna bočica sadrži 62,5, 125, 250 odnosno 500 IU (ovisno o jačini moroktokoga alfa, tj., 250, 500, 1000 ili 2000 IU) moroktokoga alfa po 1 ml pripremljene otopine za injekciju.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING REFACTO AF OUTER CARTON 
NALJEPNICA NAPUNJENE ŠTRCALJKE S OTAPALOM ZA REFACTO AF
After reconstitution, each mL of solution contains approximately 125 IU moroctocog alfa. 
Nakon rekonstitucije, jedan ml otopine sadrži približno 125 IU moroktokoga alfa.
Treatment with ReFacto AF should be started by a doctor who is experienced in the care of patients with haemophilia A. Your doctor will decide the dose of ReFacto AF you will receive. 
Liječenje lijekom ReFacto AF treba započeti liječnik s iskustvom u liječenju bolesnika s hemofilijom A.
ReFacto AF 250 IU powder and solvent for solution for injection ReFacto AF 500 IU powder and solvent for solution for injection ReFacto AF 1000 IU powder and solvent for solution for injection ReFacto AF 2000 IU powder and solvent for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII) 
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju moroktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
A solvent [sodium chloride 9 mg/ml (0.9%) solution for injection] is also supplied for reconstitution. 
Priloženo je i otapalo [otopina za injekciju natrijevog klorida 9 mg/ml (0,9%)] za pripremu lijeka.
After reconstitution, each mL of solution contains approximately 750 IU moroctocog alfa. 
Nakon rekonstitucije, jedan ml otopine sadrži približno 750 IU moroktokoga alfa.
The solution should appear clear to slightly opalescent and colourless. 
Otopina treba izgledati bistra do blago opalescentna i bezbojna.
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU powder and solvent for solution for injection Powder and solvent for solution for injection 
ReFacto AF 250 IU, 500 IU, 1000 IU, 2000 IU prašak i otapalo za otopinu za injekciju.
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000 
Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421-2-3355 5500
ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe 
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki
ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 3000 IU* moroctocog alfa**. 
ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 3000 IU* moroktokoga alfa**.
ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe ReFacto AF 3000 IU powder and solvent for solution for injection in pre-filled syringe Moroctocog alfa (recombinant human coagulation factor VIII) 
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki moroktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
The data in the table below relates to PUP and PTP data from ReFacto AF studies in patients <12 years. 
Podaci u tablici ispod odnose se na podatke o prethodno neliječenim bolesnicima i prethodno liječenim bolesnicima obuhvaćenim ispitivanjima lijeka ReFacto AF na bolesnicima u dobi
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS REFACTO AF VIAL LABEL 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
• hives, rash, itching 
• koprivnjača, osip, svrbež
ReFacto AF 250 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 250 IU* moroctocog alfa**. 
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 250 IU* moroktokoga alfa**.
PTPs <6 years 
Prethodno liječeni bolesnici < 6 godina
ReFacto AF 500 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 500 IU* moroctocog alfa**. 
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 500 IU* moroktokoga alfa**.
Keep the vial in the original package in order to protect from light. 
Bočicu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
After reconstitution, each mL of solution contains approximately 500 IU moroctocog alfa. 
Nakon rekonstitucije, jedan ml otopine sadrži približno 500 IU moroktokoga alfa.
After reconstitution, each mL of solution contains approximately 250 IU moroctocog alfa. 
Nakon rekonstitucije, jedan ml otopine sadrži približno 250 IU moroktokoga alfa.
Once reconstituted, ReFacto AF should be inspected for particulate matter and discolouration prior to administration. 
Nakon pripreme ReFacto AF treba pregledati prije primjene da ne sadrži čestice i da nije promijenio boju.
ReFacto AF 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU* moroctocog alfa**. 
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU* moroktokoga alfa**.
Meana ± SD 
Srednja vrijednost a  SD
The solution will be clear to slightly opalescent and colourless. 
Otopina će biti bistra do blago opalescentna i bezbojna.
See the package leaflet for further information Sucrose, calcium chloride dihydrate, L-histidine, polysorbate 80, sodium chloride 
Za dodatne informacije vidjeti uputu o lijeku. saharoza kalcijev klorid dihidrat L-histidin polisorbat 80 natrijev klorid
ReFacto AF 2000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 2000 IU* moroctocog alfa**. 
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 2000 IU* moroktokoga alfa**.
ReFacto AF 1000 IU powder and solvent for solution for injection in pre-filled syringe Each pre-filled syringe contains nominally 1000 IU* moroctocog alfa**. 
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u napunjenoj štrcaljki Jedna napunjena štrcaljka nominalno sadrži 1000 IU* moroktokoga alfa**.
Detach the syringe from the vial adapter by gently pulling and turning the syringe counterclockwise. 
Odvojite štrcaljku od nastavka za bočicu tako što ćete nježno povući i zakrenuti štrcaljku u smjeru suprotnom od smjera kazaljke na satu.
ReFacto AF 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU* moroctocog alfa**. 
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU* moroktokoga alfa**.
ReFacto AF 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU* moroctocog alfa**. 
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU* moroktokoga alfa**.
Diarrhoea; vomiting; abdominal pain; nausea 
Poremećaji probavnog sustava proljev; povraćanje; bol u abdomenu; mučnina emećaji kože i potkožnog tkiva urtikarija; osip; pruritus hiperhidroza
Keep the vial in the outer carton in order to protect from light. 
Čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
Break off the tamper-resistant plastic tip cap from the solvent syringe by snapping the perforation of the cap. 
Odlomite plastični zatvarač za zaštitu od nepažljivog rukovanja s vrška štrcaljke s otapalom tako što ćete ga prelomiti duž perforacije na zatvaraču.
ReFacto AF 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU* moroctocog alfa**. 
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU* moroktokoga alfa**.
Calcium chloride dihydrate L-Histidine 
Prašak saharoza kalcijev klorid dihidrat L-histidin polisorbat 80 natrijev klorid
Major surgery 
Veći kirurški postupak
EXP Do not use after expiry date. 
Ne smije se primijeniti nakon isteka roka valjanosti
i.e., 250, 500, 1000, or 2000 IU), of moroctocog alfa per 1 ml of the prepared solution for injection. 
- jedna bočica praška moroktokoga alfa od 250, 500, 1000 ili 2000 IU - jedna napunjena štrcaljka s otapalom, 4 ml sterilne otopine za injekciju natrijevog klorida od
ReFacto AF 250 IU powder for solution for injection ReFacto AF 500 IU powder for solution for injection ReFacto AF 1000 IU powder for solution for injection ReFacto AF 2000 IU powder for solution for injection Moroctocog alfa (recombinant human coagulation factor VIII) IV use 
ReFacto AF 2000 IU prašak za otopinu za injekciju moroktokog alfa (rekombinantni ljudski koagulacijski faktor VIII) i.v. primjena
However, no proper explanation for these findings in women has been identified. 
Međutim nije pronađeno odgovarajuće objašnjenje ovih nalaza u žena.
 This medicine has been prescribed for you only. 
Ovaj je lijek propisan samo Vama.
Aprovel should not be given to children under 18 years of age. 
Aprovel se ne smije davati djeci mlađoj od 18 godina.
It is important that you continue to take Aprovel until your doctor tells you otherwise. 
Važno je da nastavite uzimati Aprovel sve dok Vam liječnik ne kaže drukčije.
Patients with high blood pressure 
Bolesnici s visokim krvnim tlakom
The safety and efficacy of Aprovel in children aged 0 to 18 has not been established. 
Sigurnost i djelotvornost lijeka Aprovel u djece u dobi od 0 do 18 godina nisu ustanovljene.
The volume of distribution is 53-93 litres. 
Volumen distribucije iznosi 53-93 litre.
Ask your pharmacist how to throw away medicines you no longer use. 
Pitajte svog ljekarnika kako baciti lijekove koje više ne trebate.
Date of first authorisation: 27 August 1997 Date of latest renewal: 27 August 2007 
Datum posljednje obnove: 27. kolovoza 2007.
You can take Aprovel with or without food. 
Aprovel se može uzimati s hranom ili bez nje.
Do not store above 30°C. 
Ne čuvati na temperaturi iznad 30ºC.
See also information under the heading “Do not take Aprovel”. 
Vidjeti također informacije pod naslovom „Nemojte uzimati Aprovel“.
Similar effects have been very rarely reported with irbesartan so far. 
Do sada su vrlo rijetko prijavljeni slični učinci s irbesartanom.
This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established. 
Ovaj lijek ne smiju uzimati djeca ni adolescenti jer sigurnost i djelotvornost lijeka nisu još u potpunosti utvrđene.
What Aprovel is and what it is used for 
Što je Aprovel i za što se koristi
No significant difference was apparent between these doses. 
Nije zapažena značajna razlika između doza.
ATC code: C09C A04. 
ATK oznaka: C09C A04
Irbesartan did not affect survival, development, or reproduction of offspring. 
Irbesartan nije utjecao na preživljenje, razvoj ni reprodukciju potomstva.
Other medicines and Aprovel 
Drugi lijekovi i Aprovel
The antihypertensive effects are maintained during long term therapy. 
Antihipertenzivni učinci održani su tijekom dugotrajnog liječenja.
Please see section 2 “Aprovel contains lactose”. 
Vidjeti dio 2., „Aprovel sadrži laktozu”
The slowing in the progression to clinical proteinuria was evident as early as three months and continued over the 2 year period. 
Smanjenje progresije kliničke proteinurije bilo je vidljivo nakon tri mjeseca i nastavilo se tijekom 2 godine.
What you need to know before you take Aprovel 
Što morate znati prije nego počnete uzimati Aprovel
The patient should be closely monitored, and the treatment should be symptomatic and supportive. 
Bolesnika je potrebno pomno nadzirati, a liječenje treba biti potporno i simptomatsko.
Your doctor will normally advise you to stop taking Aprovel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Aprovel. 
Vaš će Vam liječnik obično preporučiti da prestanete uzimati Aprovel prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto lijeka Aprovel.
Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). 
Tablete treba progutati s dovoljnom količinom tekućine (npr. jednom čašom vode).
Aprovel with food and drink Aprovel can be taken with or without food. 
Aprovel s hranom i pićem Aprovel se može uzeti s hranom ili bez nje.
If you accidentally miss a daily dose, just take the next dose as normal. 
Ako slučajno zaboravite uzeti dnevnu dozu, uzmite sljedeću dozu kao što to obično i činite.
Therefore, this combination is not recommended (see section 4.4). 
Ta se kombinacija, stoga, ne preporučuje (vidjeti dio 4.4).
Aprovel contains lactose. 
Aprovel sadrži laktozu.
The predefined blood pressure goal was ≤ 135/85 mmHg. 
Unaprijed definirani ciljni krvni tlak bio je ≤ 135/85 mmHg.
Plasma protein binding is approximately 96%, with negligible binding to cellular blood components. 
Vezivanje za proteine plazme iznosi približno 96%, s neznatnim vezanjem za krvne stanice.
The terminal elimination half-life of irbesartan is 11-15 hours. 
Terminalno poluvrijeme eliminacije irbesartana iznosi 11-15 sati.
56 x 1 tablets: 
56 x 1 tableta:
An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment. 
Pridruženo poboljšanje brzine glomerularne filtracije nije zabilježeno tijekom prva tri mjeseca liječenja.
If you forget to take Aprovel 
Ako ste zaboravili uzeti Aprovel
The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment. 
Incidencija štetnih događaja nije bila povezana s dozom (unutar preporučenog raspona doza), spolom, dobi, rasom ni trajanjem liječenja.
What Aprovel is and what it is used for What you need to know before you take Aprovel How to take Aprovel 
Što se nalazi u ovoj uputi Što je Aprovel i za što se koristi Što morate znati prije nego počnete uzimati Aprovel Kako uzimati Aprovel
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).
Biotransformatin 
Biotransformacija
There was no evidence of mutagenicity, clastogenicity or carcinogenicity. 
Nije bilo znakova mutagenosti, klastogenosti ni kancerogenosti.
The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.(c) stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years). 
Od 23 djece, rezultati farmakokinetike za 21 dijete mogli su se usporediti s farmakokinetikom u odraslih (12 djece u dobi iznad 12 godina i 9 djece u dobi od 6 do 12 godina).
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 dijelovima 4.8, 5.1 i 5.2, međutim, nije moguće dati preporuku o doziranju.
IDNT was a double blind, controlled, morbidity and mortality trial comparing Aprovel, amlodipine and placebo. 
IDNT je bilo dvostruko slijepo, kontrolirano ispitivanje morbiditeta i mortaliteta u kojem su uspoređivani Aprovel, amlodipin i placebo.
SPECIAL STORAGE CONDITIONS Do not store above 30°C. 
POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 30ºC.
However, there was no difference in the half-life and accumulation of irbesartan. 
Međutim, nije bilo razlika što se tiče poluvijeka i nakupljanja irbesartana.
No specific information is available on the treatment of overdose with Aprovel. 
Nema dostupnih specifičnih podataka o liječenju predoziranja lijekom Aprovel.
F-75008 Paris - France 
F-75008 Paris - Francuska
At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses. 
U 24 sata snižavanje krvnog tlaka bilo je 60-70% vršnog dijastoličkog i sistoličkog odgovora pri preporučenim dozama.
There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses. 
Nije bilo znakova abnormalne sistemske toksičnosti niti toksičnosti za ciljni organ pri klinički relevantnim dozama.
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 u pedijatrijskoj populaciji u dobi od 6 do 16 godina, ali trenutni podaci nisu dostatni da bi podržali proširenje primjene na djecu, sve dok ne budu dostupni dodatni podaci (vidjeti dio 4.8, 5.1 i 5.2).
When the individual components of the primary endpoint were analysed, no effect in all cause mortality was observed, while a positive trend in the reduction in ESRD and a significant reduction in doubling of serum creatinine were observed. 
Kad su se analizirale individualne komponente primarne mjere ishoda, nisu zabilježeni učinci na sve uzroke smrtnosti, dok je zabilježen pozitivan trend u smanjenju terminalne faze bubrežne bolesti i značajno smanjenje u udvostručavanju serumskog kreatinina.
 Keep this leaflet. 
Sačuvajte ovu uputu.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended. 
Ako je kombinacija neophodna, preporučuje se pažljiva kontrola serumske razine litija.
Results showed that Cmax, AUC and clearance rates were comparable to those observed in adult patients receiving 150 mg irbesartan daily. 
Rezultati su pokazali da su Cmax, AUC i brzine klirensa usporedivi s onima uočenim u odraslih bolesnika koji su uzimali 150 mg irbesartana na dan.
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. 
Liječnik može preporučiti nižu dozu, posebice na početku liječenja određene skupine bolesnika kao što su bolesnici na hemodijalizi ili stariji od 75 godina.
If you get any of these symptoms or get short of breath, stop taking Aprovel and contact your doctor immediately. 
Ako primijetite bilo koji od ovih simptoma ili osjetite nedostatak zraka, prestanite uzimati Aprovel i odmah se javite liječniku.
Reproductive system and breast disorders Uncommon: sexual dysfunction 
Poremećaji reproduktivnog sustava i dojki Manje često: seksualna disfunkcija
In particular, they appeared less favourable in women and non-white subjects (see section 5.1). 
Posebice je bio slabije izražen u žena i bolesnika koji nisu bijele rase (vidjeti dio 5.1).
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 older people. 
Iako za bolesnike starije od 75 godina treba razmotriti započinjanje terapije dozom od 75 mg, dozu obično nije potrebno prilagoditi u starijih osoba.
Therefore, the use of Aprovel is not recommended. 
Stoga se ne preporučuje primjena lijeka Aprovel.
The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. 
Uobičajena preporučena početna doza i doza održavanja iznosi 150 mg jedanput na dan, s hranom ili bez nje.
It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II. 
Očekuje se da blokira sve aktivnosti angiotenzina II posredovane AT1 receptorom, bez obzira na izvor ili put sinteze angiotenzina II.
The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000). 
Učestalost nuspojava u nastavku teksta definira se na sljedeći način: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000).
dysgeusia 
disgeuzija
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 ovoga ispitivanja, u trajanju od 26 tjedana, najčešće opažene laboratorijske abnormalnosti bile su povećana koncentracija kreatinina (6,5%) i povišene vrijednosti CK u 2% djece koja su primila lijek.
Aprovel is indicated in adults for the treatment of essential hypertension. 
Aprovel je indiciran za liječenje esencijalne hipertenzije u odraslih.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. 
Irbesartan je snažan, oralno aktivan, selektivni antagonist receptora angiotenzina II (tip AT1).
Irbesartan lowers blood pressure with minimal change in heart rate. 
Irbesartan snižava krvni tlak uz minimalne promjene srčanog ritma.
Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or allcause mortality. 
Irbesartan značajno snižava relativni rizik u primarnoj kombiniranoj mjeri ishoda udvostručavanja serumskog kreatinina, terminalne faze bubrežne bolesti ili svih uzroka mortaliteta.
Aprovel 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. 
Aprovel 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.
2112 Veresegyház - Hungary 
2112 Veresegyhaz - Mađarska