FrancophonIA/ELRC3.0 huggingface dataset:
English: • Conditions or restrictions with regard to the safe and effective use of the medicinal product
Croatian: • Uvjeti i ograničenja s obzirom na neškodljivu i djelotvornu primjenu
English: MRLs Target tissues
Croatian: MRL Ciljna tkiva Ostale odredbe
English: Active substance: Meloxicam20 mg
Croatian: Djelatna tvar: Meloksikam 20 mg
English: Horses: IV
Croatian: Konji: i.v.
English: • Conditions or restrictions regarding supply and use imposed on the marketing authorisation holder
Croatian: • Uvjeti ili ograničenja odobrenja za stavljanje u promet u pogledu opskrbe i primjene Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Goveda Jedna subkutana ili intravenska injekcija u dozi od 0,5 mg meloksikama/kg tjelesne težine (tj. 2,5 ml/100 kg tjelesne težine) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
English: Single intramuscular injection at a dose of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Croatian: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne težine (tj. 2,0 ml/100 kg tjelesne težine) u kombinaciji s antibiotskom terapijom, kako je odgovarajuće.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) Water for injections
Croatian: - etanol 99,9 % - Anhidrirana limunska kiselina - poloksamer 188 - makrogol 300 - glicin - natrijev hidroksid (za regulaciju pH) - hidroklorna kiselina (za regulaciju pH) - meglumin - voda za injekcije
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs: meat and offal: 5 days
Croatian: Goveda: Meso i jestive iznutrice: 15 dana; mlijeko: 5 dana Svinje: Meso i jestive iznutrice: 5 dana Konji:
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals Accidental self-injection may give rise to pain.
Croatian: Posebne mjere opreza koje mora poduzeti osoba koja primjenjuje veterinarsko-medicinski proizvod na životinjama
English: Horses: meat and offal: 5 days.
Croatian: Konji: meso i jestive iznutrice 5 dana.
English: Pregnancy and lactation:
Croatian: Graviditet i laktacija: Goveda i svinje:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Glass vial label for 10 ml
Croatian: OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Recocam 20 mg/ml otopina za injekciju za goveda, svinje i konje
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Recocam 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Recocam 20 mg/ml otopina za injekciju za goveda, svinje i konje meloksikam
English: PACKAGE LEAFLET Recocam 20 mg/ml solution for injection for cattle, pigs and horses
Croatian: UPUTA O VMP: Recocam 20 mg/ml otopina za injekciju za goveda, svinje i konje
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Farmakološk i djelatna(e) tvar(i)
English: Cattle: meat and offal: 15 days; milk: 5 days
Croatian: Goveda: meso i jestive iznutrice 15 dana; mlijeko: 5 dana Svinje: meso i jestive iznutrice 5 dana
English: Withdrawal period(s):
Croatian: KARENCIJA(E) Karencija:
English: vial (glass)
Croatian: bočica (staklena)
English: Immediate Packaging Pack size pre-filled syringe (glass)
Croatian: Veličina pakovanja štrcaljka s uloškom (staklena) 1
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Croatian: EMA broj postupka (Zaštićeno) ime Doza
English: 90 sachets (with a dosing spoon)
Croatian: 90 vrećica (sa dozirnom žličicom)
English: 3 vials + 3 ampoules
Croatian: 3 bočice + 3 ampule
English: • are over 75 years old
Croatian: • ste stariji od 75 godina
English: 18 September 2019
Croatian: 18. rujna 2019.
English: • Take the capsules at about the same time each day.
Croatian: • Kapsule uzimajte svakog dana u približno isto vrijeme.
English: If you take more Kisplyx than you should
Croatian: Ako uzmete više Kisplyxa nego što ste trebali
English: Kisplyx is not recommended for use in children and adolescents.
Croatian: Kisplyx se ne preporučuje za primjenu u djece i adolescenata.
English: Medical Dictionary for Regulatory Activities (MedDRA) version 17.1.
Croatian: Medicinski rječnik za regulatorne poslove (MedDRA), verzija 17.1.
English: The effects of Kisplyx in people younger than 18 years old are not known.
Croatian: Učinci Kisplyxa u osoba mlađih od 18 godina nisu poznati.
English: The time to onset was 69.6 weeks.
Croatian: Vrijeme do nastupa događaja bilo je 69,6 tjedana.
English: Date of first authorisation: 25 August 2016
Croatian: Datum prvog odobrenja: 25. kolovoza 2016.
English: Includes cases with a fatal outcome.
Croatian: Uključuje slučajeve sa smrtnim ishodom.
English: The capsules can be swallowed whole with water.
Croatian: Kapsule se mogu progutati cijele s vodom.
English: • Do not take Kisplyx if you are planning to become pregnant during your treatment.
Croatian: • Nemojte uzeti Kisplyx ako planirate zatrudnjeti tijekom liječenja.
English: ≥ 2 gm / 24 hours
Croatian: ≥2 g/24 h
English: Symptoms would depend on where the fistula is located.
Croatian: Simptomi ovise o mjestu na kojem se fistula nalazi.
English: Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggests that it is in the order of 85%.
Croatian: Apsolutna bioraspoloživost nije utvrđena u ljudi; međutim, podaci iz ispitivanja masene bilance ukazuju na to da se nalazi u redu veličine od 85%.
English: This is because the medicine passes into breast milk and may seriously harm your breastfed baby.
Croatian: Tako je zbog toga što lijek prelazi u mlijeko i može ozbiljno naštetiti Vašem dojenčetu.
English: Your doctor will help you decide whether the treatment should be continued.
Croatian: Liječnik će Vam pomoći odlučiti trebate li nastaviti s liječenjem.
English: How long to takeKisplyx You will usually carry on taking this medicine as long as you are getting benefit.
Croatian: Koliko dugo uzimati Kisplyx Obično ćete uzimati ovaj lijek sve dok od toga imate kliničku korist.
English: If you forget to take Kisplyx Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
Croatian: Ako ste zaboravili uzeti Kisplyx Nemojte uzeti dvostruku dozu (dvije doze odjednom) kako biste nadoknadili zaboravljenu dozu.
English: Other medicines and Kisplyx
Croatian: Drugi lijekovi i Kisplyx
English: • If you become pregnant while being treated with Kisplyx, tell your doctor immediately.
Croatian: • Ako zatrudnite dok se liječite Kisplyxom, odmah obavijestite svog liječnika.
English: When necessary, manage hypertension as recommended in Table 3.
Croatian: Kad je potrebno, liječite hipertenziju prema preporukama u tablici 3.
English: What Kisplyx is and what it is used for What you need to know before you take Kisplyx How to take Kisplyx
Croatian: Što je Kisplyx i za što se koristi Što morate znati prije nego počnete uzimati Kisplyx Kako uzimati Kisplyx
English: Frequencies are defined as:
Croatian: Učestalosti su definirane kao:
English: Do not take Kisplyx if:
Croatian: Nemojte uzimati Kisplyx:
English: Manufacturer Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Croatian: Proizvođač Eisai Manufacturing Ltd, Mosquito Way, Hatfield, Herts AL10 9SN, Ujedinjeno Kraljevstvo
English: This includes herbal preparations and medicines without a prescription.
Croatian: To uključuje biljne pripravke i lijekove koji se nabavljaju bez recepta.
English: Treatment should continue as long as there is clinical benefit or until unacceptable toxicity occurs.
Croatian: Liječenje treba nastaviti sve dok se opaža klinička korist ili do pojave neprihvatljive toksičnosti.
English: • you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na lenvatinib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
Croatian: Ako bolesnik propusti dozu i ne može je uzeti u roku od 12 sati, tu dozu treba preskočiti i uzeti sljedeću u uobičajeno vrijeme primjene.
English: Talk to your doctor before taking Kisplyx if you:
Croatian: Obratite se svom liječniku prije nego uzmete Kisplyx ako:
English: Diarrhoea was the most frequent cause of dose interruption/reduction and recurred despite dose reduction.
Croatian: Proljev je bio najčešći uzrok privremenog prekida/smanjenja doze i ponavljao se unatoč smanjenju doze.
English: Stable disease
Croatian: Stabilna bolest
English: What Kisplyx is and what it is used for
Croatian: Što je Kisplyx i za što se koristi
English: Therefore mortality may be attributed to complications related to primary duodenal lesions with possible contribution from additional toxicities in immature target organs.
Croatian: Stoga se mortalitet može pripisati komplikacijama povezanima s primarnim duodenalnim lezijama uz mogući doprinos dodatnih toksičnih učinaka na nezrele ciljne organe.
English: • Use highly effective contraception while taking this medicine, and for at least one month after you finish treatment.
Croatian: • Koristite visokoučinkovitu kontracepciju tijekom uzimanja ovog lijeka i još najmanje mjesec dana nakon što završite liječenje.
English: See detailed guidance in Table 3 in section 4.4.
Croatian: Vidjeti detaljne smjernice u tablici 3, dio 4.4
English: Genotoxicity Lenvatinib was not genotoxic.
Croatian: Genotoksičnost Lenvatinib nije bio genotoksičan.
English: Lenvatinib is not a substrate for OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or the BSEP.
Croatian: Lenvatinib nije supstrat OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2 ili BSEP-a.
English: Your doctor will discuss the results of these tests with you and decide whether you can be given Kisplyx.
Croatian: Liječnik će Vam objasniti rezultate tih pretraga i odlučiti možete li uzimati Kisplyx.
English: The study consisted of a Phase 1b dose finding and a Phase 2 portion.
Croatian: Ispitivanje se sastojalo od faze 1b za određivanje doze i dijela faze 2.
English: Partial responses
Croatian: Broj djelomičnih odgovora
English: If you are not sure talk to your doctor before taking Kisplyx.
Croatian: Ako niste sigurni, obratite se liječniku prije nego uzmete Kisplyx.
English: What you need to know before you take Kisplyx
Croatian: Što morate znati prije nego počnete uzimati Kisplyx
English: The mean terminal exponential half-life of lenvatinib is approximately 28 hours.
Croatian: Srednja vrijednost terminalnog eksponencijalnog poluvijeka lenvatiniba je približno 28 sati.
English: Lenvatinib should not be used during pregnancy unless clearly necessary and after a careful consideration of the needs of the mother and the risk to the foetus.
Croatian: Lenvatinib se ne smije primjenjivati tijekom trudnoće, osim ako je to neupitno potrebno te nakon pažljive procjene potreba majke i rizika za fetus.
English: Kisplyx may cause side effects that can affect your ability to drive or use machines.
Croatian: Kisplyx može uzrokovati nuspojave koje mogu utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: Figure 2: Kaplan-Meier Plot of Overall Survival
Croatian: Slika 2: Kaplan-Meierova krivulja ukupnog preživljenja
English: Resolves to less than 2 gm / 24 hours.
Croatian: Povukla se na vrijednost manju od 2 g/24 h
English: • Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake ‘EXP'.
English: Alanine aminotransferase increased‡
Croatian: povišena alanin aminotransferaza‡
English: What Kisplyx looks like and contents of the pack
Croatian: Kako Kisplyx izgleda i sadržaj pakiranja
English: Patients with high ECOG performance status
Croatian: Bolesnici s visokim ECOG statusom
English: Duration of response, months, median (95% CI)
Croatian: Trajanje odgovora, mjeseci, medijan (95% CI)
English: Objective Response Rate
Croatian: Stopa objektivnog odgovora
English: Paediatric population See section 4.2 for information on paediatric use.
Croatian: Pedijatrijska populacija Vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: In human liver cytosol, lenvatinib did not inhibit aldehyde oxidase activity.
Croatian: U citosolu ljudske jetre lenvatinib nije inhibirao aktivnost aldehid oksidaze.
English: If you take more Kisplyx than you should, talk to a doctor or pharmacist straight away.
Croatian: Ako uzmete više Kisplyxa nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
English: • heart problems or blood clots in the lungs (difficulty breathing, chest pain) or other organs
Croatian: • srčane tegobe ili krvni ugrušci u plućima (otežano disanje, bol u prsnom košu) ili drugim organima
English: Reports of fistulae that involve areas of the body other than stomach or intestines were observed across various indications.
Croatian: Izvješća o fistulama koje zahvaćaju druga područja osim želuca ili crijeva zabilježena su za različite indikacije.
English: Metastases were present in 95% of the patients and unresectable advanced disease was present in 5%.
Croatian: Metastaze su bile prisutne u 95% bolesnika, a neoperabilna uznapredovala bolest postojala je u 5% bolesnika.
English: Reactions were reported at various time points during treatment ranging from two weeks to greater than 1 year from initiation of lenvatinib, with a median latency of about 3 months.
Croatian: Reakcije su zabilježene u različitim vremenskim točkama tijekom liječenja, u rasponu od dva tjedna do dulje od 1 godine od početka primjene lenvatiniba, s medijanom latencije od otprilike 3 mjeseca.
English: Not Known (the following side effects have been reported since the marketing of lenvatinib but the frequency for them to occur is not known)
Croatian: Nepoznato (sljedeće nuspojave zabilježene su otkako je lenvatinib stavljen u promet, ali njihova učestalost nije poznata)
English: The mechanism of action for the worsening of hypercholesterolemia with the combination has not been studied directly and is not fully elucidated.
Croatian: Mehanizam djelovanja kod pogoršanja hiperkolesterolemije uz primjenu kombinacije lijekova nije bio izravno ispitan i nije potpuno razjašnjen.
English: Please see distribution section.
Croatian: Vidjeti pod naslovom Distribucija.
English: These proteins can be present in high amounts in cancer cells, and by blocking their action Kisplyx may slow the rate at which the cancer cells multiply and the tumour grows and help to cut off the blood supply that the cancer needs.
Croatian: Ti proteini mogu biti prisutni u velikim količinama u stanicama raka, pa blokiranjem njihovog rada Kisplyx može usporiti brzinu umnažanja stanica raka i brzinu rasta tumora te pomoći da se prekine opskrba krvlju koja je raku potrebna.
English: Similarly, no induction of P-gp mRNA expression was observed.
Croatian: Slično tomu, nije opažena indukcija P-gp mRNA ekspresije.
English: • The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30, 60 or 90 hard capsules.
Croatian: • Kapsule dolaze u blisterima od poliamida/aluminija/PVC-a zatvorenima aluminijskom folijom kroz koju se protisnu kapsule, u kutijama s 30, 60 ili 90 tvrdih kapsula.
English: 7.5 (3.8, NE)
Croatian: 7,5 (3,8; NP)
English: Not all pack sizes may be marketed .
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: Hepatocellular damage/hepatitisi
Croatian: kolecistitis hepatocelularno oštećenje/hepatitisi
English: Systolic BP ≥140 mmHg up to <160 mmHg or diastolic BP ≥90 mmHg up to <100 mmHg
Croatian: Sistolički KT ≥140 mmHg do <160 mmHg ili dijastolički KT ≥90 mmHg do <100 mmHg
English: Before taking Kisplyx, your doctor may carry out some blood tests, for example to check your blood pressure and your liver or kidney function and to see if you have low levels of salt and high levels of thyroid stimulating hormone in your blood.
Croatian: Prije nego što počnete uzimati Kisplyx liječnik će možda provesti neke pretrage krvi kako bi, primjerice, provjerio Vaš krvni tlak te funkciju jetre i bubrega i ustanovio imate li u krvi niske razine soli i visoke razine hormona koji potiče rad štitnjače.
English: Percentages are based on the total number of subjects in the Full Analysis Set within relevant treatment group.
Croatian: Vrijednosti postotaka dobivene su na temelju ukupnog broja ispitanika u cijeloj analiziranoj skupini bolesnika unutar određene terapijske skupine.
English: • Do not breast-feed if you are taking Kisplyx.
Croatian: • Nemojte dojiti ako uzimate Kisplyx.
English: Kisplyx treatment should be initiated and supervised by a health care professional experienced in the use of anticancer therapies.
Croatian: Liječenje lijekom Kisplyx treba započeti i nadzirati zdravstveni radnik s iskustvom u primjeni terapija protiv raka.
English: The combination should be used in patients with severe hepatic impairment only if the anticipated benefit exceeds the risk.
Croatian: Ovu kombinaciju lijekova treba upotrijebiti u bolesnika s teškim oštećenjem funkcije jetre samo ako je očekivana korist veća od rizika.
English: It is currently unknown if lenvatinib increases the risk of thromboembolic events when combined with oral contraceptives.
Croatian: Trenutno nije poznato povećava li lenvatinib rizik od tromboembolijskih događaja kad se kombinira s oralnim kontraceptivima.
English: The treatment effect of the combination on PFS and ORR was also supported by a post-hoc retrospective independent blinded review of scans.
Croatian: Terapijski učinak kombinacije lijekova na PFS i ORR potkrijepljen je također neovisnim post hoc retrospektivnim maskiranim pregledom snimaka.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: Name and address of the manufacturer responsible for batch release Eisai Manufacturing Ltd.
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Eisai Manufacturing Ltd.
English: A total of 62 patients received the combination of lenvatinib and everolimus at the recommended dose.
Croatian: Ukupno 62 bolesnika primala su kombinaciju lenvatiniba i everolimusa u preporučenoj dozi.
English: There are no data on the use of lenvatinib immediately following sorafenib or other anticancer treatments and there may be a potential risk for additive toxicities unless there is an adequate washout period between treatments.
Croatian: Nema podataka o primjeni lenvatiniba neposredno nakon liječenja sorafenibom ili drugim lijekovima protiv raka i može postojati mogući rizik od aditivnih toksičnih učinaka, osim ako je između liječenja proteklo odgovarajuće razdoblje ispiranja lijeka iz organizma (engl. washout).
English: Kisplyx blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow.
Croatian: Kisplyx blokira djelovanje proteina koji se zovu receptori tirozin kinaze i uključeni su u razvoj novih krvnih žila koje stanice opskrbljuju kisikom i hranjivim tvarima i pomažu njihov rast.
English: Of the 153 patients randomly allocated, 73% were male, the median age was 61 years, 37% were 65 years or older, 7% were 75 years or older, and 97% were Caucasian.
Croatian: Od 153 randomizirana bolesnika, 73% bili su muškarci s medijanom dobi od 61 godine, 37% bolesnika bilo je u dobi od 65 godina ili stariji, 7% je imalo 75 ili više godina, a 97% bolesnika bili su bijelci.
English: Figure 1: Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment)
Croatian: Slika 1: Kaplan-Meierova krivulja preživljenja bez progresije bolesti (procjena ispitivača)
English: 13.0 (3.7, NE)
Croatian: 13,0 (3,7; NP)
English: No events of hypocalcaemia required dose reduction or interruption, and no patients discontinued treatment due to hypocalcaemia.
Croatian: Nijedan događaj hipokalcemije nije zahtijevao sniženje doze ili privremeni prekid primjene i niti jedan bolesnik nije zbog hipokalcemije trajno prestao s liječenjem.
English: Refer also to section 4.8, Other special populations.
Croatian: Pogledati i dio 4.8 pod naslovom Druge posebne populacije.
English: See section 4.8 Description of selected adverse reactions for further characterisation.
Croatian: Vidjeti dio 4.8, Opis odabranih nuspojava za dodatno objašnjenje.
English: Hypothyroidism should be treated according to standard medical practice to maintain euthyroid state.
Croatian: Hipotireozu treba liječiti prema standardima medicinske prakse kako bi se održalo eutiroidno stanje.
English: In vitro transporter studies
Croatian: Ispitivanje transportera in vitro
English: All patients had a baseline ECOG PS of either 0 (55%) or 1 (45%) with similar distribution across the 3 treatment arms.
Croatian: Svi bolesnici imali su na početku ispitivanja ECOG PS od 0 (55%) ili 1 (45%) uz sličnu raspodijeljenost u sve 3 terapijske skupine.
English: Hypertension includes: hypertension, hypertensive crisis, increased blood pressure diastolic, and increased blood pressure.
Croatian: Hipertenzija uključuje: hipertenziju, hipertenzivnu krizu, povišen dijastolički krvni tlak i povišen krvni tlak.
English: Kisplyx is a medicine that contains the active substance lenvatinib.
Croatian: Kisplyx je lijek koji sadrži djelatnu tvar lenvatinib.
English: Contraception, pregnancy and breast-feeding
Croatian: Kontracepcija, trudnoća i dojenje
English: • bleeding (most commonly nose bleeds, but also other types of bleeding such as blood in the urine,
Croatian: • krvarenja (najčešće iz nosa, ali i druge vrste krvarenja, kao što su krv u mokraći, modrice,
English: In case of suspected overdose, lenvatinib should be withheld and appropriate supportive care given as required.
Croatian: U slučaju sumnje na predoziranje, potrebno je obustaviti primjenu lenvatiniba i po potrebi primijeniti odgovarajuću potpornu njegu.
English: In 1.1% of patients, hypertension led to permanent treatment discontinuation.
Croatian: U 1,1% bolesnika hipertenzija je dovela do trajnog prekida liječenja.
English: The additional liquid must be swallowed.
Croatian: Tu naknadno dodanu tekućinu također treba popiti.
English: You may need to have additional treatment with other medicines, to take a lower dose of Kisplyx, or to take extra care due to an increased risk of side effects.
Croatian: Možda ćete trebati dodatno liječenje drugim lijekovima, uzimati nižu dozu Kisplyxa ili biti posebno oprezni zbog povećanog rizika od nuspojava.
English: • Your doctor may reduce your dose if you experience side effects.
Croatian: • Liječnik Vam može sniziti dozu ako imate nuspojave.
English: For those patients already on antihypertensive medication, the dose of the current agent may be increased, if appropriate, or one or more agents of a different class of antihypertensive should be added.
Croatian: U onih bolesnika koji već uzimaju antihipertenzivnu terapiju, doza lijeka koji trenutno uzimaju može se povisiti ako je to primjereno, ili treba dodati jedan ili više lijekova iz druge skupine antihipertenziva.