FrancophonIA/ELRC3.0 huggingface dataset:
English: Finally, the Committee was concerned about the way data from patients who withdrew from treatment were handled, which could have biased the results in favour of Alsitek.
Croatian: Konačno, Odbor je izrazio zabrinutost zbog načina na koji se rukovalo podatcima bolesnika koji su se povukli iz liječenja, što je moglo utjecati na rezultate u korist lijeka Alsitek.
English: Refusal of the marketing authorisation for Alsitek (masitinib)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Alsitek (masitinib)
English: EMA/207380/2018 Rev. 2 EMEA/H/C/004398
Croatian: EMA/207380/2018 Rev.
English: The applicant presented the results of one main study involving 394 patients with ALS, where Alsitek was compared with placebo (a dummy treatment), both taken together with riluzole.
Croatian: Podnositelj zahtjeva dostavio je podatke iz glavnog ispitivanja koje je obuhvaćalo 394 bolesnika oboljelih od ALS-a kod kojih je lijek Alsitek uspoređen s placebom (prividno liječenje), pri čemu su se oba uzimala s riluzolom.
English: Alsitek is a medicine that contains the active substance masitinib.
Croatian: Alsitek je lijek koji sadrži djelatnu tvar masitinib.
English: Microglia and mast cells may play a role in the inflammation and damage to nerves in patients with ALS.
Croatian: Stanice mikroglije i mastociti imaju ulogu u upalama i oštećenju živaca u bolesnika s ALS-om.
English: The CHMP concluded that the main study in patients with ALS did not show that Alsitek is effective at slowing down progression of the disease.
Croatian: CHMP je zaključio da glavnim ispitivanjem provedenim na bolesnicima oboljelima od ALS-a nije dokazano da je Alsitek djelotvoran u usporavanju progresije bolesti.
English: How does Alsitek work?
Croatian: Kako djeluje Alsitek?
English: What was Alsitek expected to be used for?
Croatian: Za što se Alsitek trebao primjenjivati?
English: Alsitek was to be used in combination with riluzole, another medicine for ALS.
Croatian: Alsitek se trebao primjenjivati u kombinaciji s riluzolom, koji je također lijek za ALS.
English: On 18 April 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Alsitek, intended for the treatment of amyotrophic lateral sclerosis (ALS).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Alsitek, koji je namijenjen liječenju amiotrofične lateralne skleroze (ALS).
English: Alsitek was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 August 2016 for the treatment of ALS.
Croatian: Alsitek je uvršten na popis lijekova za rijetke bolesti dana 29. kolovoza 2016. za liječenje ALS-a.
English: Therefore, the CHMP was of the opinion that the study did not provide reliable evidence on the benefits of Alsitek and recommended that it be refused marketing authorisation.
Croatian: Stoga je CHMP smatrao da ispitivanjem nisu izneseni pouzdani dokazi o koristima lijeka Alsitek te je preporučio odbijanje izdavanja odobrenja za stavljanje u promet.
English: Alsitek was expected to be used to treat amyotrophic lateral sclerosis (ALS).
Croatian: Lijek Alsitek trebao se primjenjivati u liječenju amiotrofične lateralne skleroze (ALS).
English: Further information on the orphan designation can be found here.
Croatian: Više informacija o statusu lijeka za liječenje rijetkih bolesti možete naći ovdje.
English: Karvezide should be taken at least one hour before or four hours after these medications;
Croatian: Karvezide se mora uzeti najmanje jedan sat prije ili 4 sata poslije tih lijekova;
English: See also information under the heading “Do not take Karvezide”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Karvezide“.
English: It is important that you continue to take Karvezide until your doctor tells you otherwise.
Croatian: Važno je da kontinuirano uzimate Karvezide sve dok Vam liječnik ne odredi drugačije.
English: What Karvezide is and what it is used for
Croatian: Što je Karvezide i za što se koristi
English: Children should not take Karvezide
Croatian: Djeca ne smiju uzimati Karvezide
English: Date of first authorisation: 16 October 1998 Date of latest renewal: 16 October 2008
Croatian: Datum posljednje obnove: 16. listopada 2008.
English: Other medicines and Karvezide
Croatian: Drugi lijekovi i Karvezide
English: While this is not documented with Karvezide, a similar effect should be anticipated.
Croatian: Iako to nije dokumentirano za Karvezide, može se očekivati sličan učinak.
English: Children and adolescents Karvezide should not be given to children and adolescents (under 18 years).
Croatian: Djeca i adolescenti Karvezide se ne smije davati djeci i adolescentima (mlađima od 18 godina).
English: Your doctor will instruct you how to switch from the previous treatment to Karvezide.
Croatian: Liječnik će Vas uputiti kako prijeći s prethodnog liječenja na Karvezide.
English: Your doctor will normally advise you to stop taking Karvezide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvezide.
Croatian: Vaš će Vam liječnik obično preporučiti da prestanete koristiti Karvezide prije nego što zatrudnite ili čim saznate da ste trudni te će Vam savjetovati da uzmete neki drugi lijek umjesto lijeka Karvezide.
English: Such conditions should be corrected before initiating therapy with Karvezide.
Croatian: Takva stanja treba korigirati prije započinjanja terapije lijekom Karvezide.
English: Karvezide is not recommended for use in children and adolescents because the safety and efficacy have not been established.
Croatian: Ne preporučuje se primjena lijeka Karvezide u djece i adolescenata jer sigurnost i djelotvornost nisu utvrđene.
English: Since Karvezide contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Croatian: Budući da Karvezide sadrži hidroklorotiazid, ne preporučuje se tijekom prvog tromjesečja trudnoće.
English: Protect your skin from sun exposure and UV rays while taking Karvezide.
Croatian: Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja lijeka Karvezide
English: If you forget to take Karvezide
Croatian: Ako ste zaboravili uzeti Karvezide
English: Karvezide should not be given to children under 18 years of age.
Croatian: Karvezide ne smiju uzimati djeca mlađa od 18 godina.
English: What you need to know before you take Karvezide
Croatian: Što morate znati prije nego počnete uzimati Karvezide
English: What Karvezide is and what it is used for What you need to know before you take Karvezide How to take Karvezide
Croatian: Što je Karvezide i za što se koristi Što morate znati prije nego počnete uzimati Karvezide Kako uzimati Karvezide
English: If Karvezide is used during breast feeding, doses should be kept as low as possible.
Croatian: Ako se Karvezide primjenjuje tijekom dojenja, njegove doze trebaju biti što je moguće niže.
English: Karvezide can be taken once daily, with or without food.
Croatian: Karvezide se može uzimati jedanput na dan, s hranom ili bez nje.
English: When necessary, Karvezide may be administered with another antihypertensive medicinal product (see sections 4.3, 4.4, 4.5 and 5.1).
Croatian: Kada je potrebno, Karvezide se može primjenjivati s drugim antihipertenzivnim lijekom (vidjeti dijelove 4.3, 4.4, 4.5 i 5.1).
English: No specific information is available on the treatment of overdose with Karvezide.
Croatian: Nema dostupnih specifičnih podataka o liječenju predoziranja lijekom Karvezide.
English: You should discontinue Karvezide treatment and seek medical attention.
Croatian: Prestanite uzimati Karvezide i zatražite liječničku pomoć.
English: Please see section 2 “Karvezide contains lactose”.
Croatian: Vidjeti dio 2., „Karvezide sadrži laktozu“.
English: There is no difference in response to Karvezide, regardless of age or gender.
Croatian: Ne postoji razlika u terapijskom odgovoru bolesnika na Karvezide s obzirom na dob ili spol.
English: Karvezide with food and drink Karvezide can be taken with or without food.
Croatian: Karvezide s hranom i pićem Karvezide se može uzeti s hranom ili bez nje.
English: Food does not affect the bioavailability of Karvezide.
Croatian: Hrana ne utječe na bioraspoloživost lijeka Karvezide.
English: Karvezide contains lactose.
Croatian: Karvezide sadrži laktozu.
English: The recommended dose of Karvezide is one or two tablets a day.
Croatian: Uobičajena doza lijeka Karvezide je jedna ili dvije tablete na dan.
English: If you get any of the above symptoms or get short of breath, stop taking Karvezide and contact your doctor immediately.
Croatian: Ako dobijete neki od tih simptoma ili ako imate nedostatak zraka, prestanite uzimati Karvezide i odmah se obratite svome liječniku.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Karvezide se ne preporučuje uzimati u ranoj trudnoći, a ne smije se uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu primjenjujete li ga u tom razdoblju (vidjeti dio o trudnoći).
English: The recommended dose of Karvezide is one tablet a day.
Croatian: Uobičajena doza lijeka Karvezide je jedna tableta na dan.
English: Karvezide 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.
Croatian: Karvezide 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.
English: Karvezide 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.
Croatian: Karvezide se ne preporučuje uzimati u ranoj trudnoći te se ne smije uzimati nakon trećeg mjeseca trudnoće jer može ozbiljno naškoditi Vašem djetetu uzimate li ga nakon trećeg mjeseca trudnoće.
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Karvezide.
Croatian: Tablice 2. i 3. prikazuju nuspojave prijavljene za pojedinačne komponente lijeka Karvezide.
English: Hypotension - Volume-depleted patients: Karvezide has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Croatian: Hipotenzija - bolesnici s hipovolemijom: Karvezide je rijetko povezan sa simptomatskom hipotenzijom u hipertenzivnih bolesnika koji nemaju druge rizične faktore koji bi uzrokovali hipotenziju.
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Karvezide, minimal or no effects were reported.
Croatian: Povišenje razine kolesterola i triglicerida bilo je povezano s terapijom tiazidima; međutim, pri dozi od 12,5 mg koliko sadrži Karvezide, zabilježeni su minimalni učinci ili ih uopće nije bilo.
English: Due to the hydrochlorothiazide contained in Karvezide, if you drink alcohol while on treatment with this medicine, you may have an increased feeling of dizziness on standing up, specially when getting up from a sitting position.
Croatian: Ako pijete alkohol za vrijeme terapije ovim lijekom, zbog hidroklorotiazida u lijeku Karvezide možete imati pojačan osjećaj omaglice prilikom ustajanja, posebno kod ustajanja iz sjedećeg položaja.
English: Karvezide is used to treat high blood pressure, when treatment with irbesartan or hydrochlorothiazide alone did not provide adequate control of your blood pressure.
Croatian: Karvezide se primjenjuje za liječenje visokog krvnog tlaka kad liječenje samo irbesartanom ili samo hidroklorotiazidom ne osigurava odgovarajuću kontrolu krvnog tlaka.
English: Because no information is available regarding the use of Karvezide during breast-feeding, Karvezide is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Croatian: Budući da nema dostupnih podataka o upotrebi lijeka Karvezide tijekom dojenja, ne preporučuje se njegova primjena tijekom dojenja i prednost treba dati drugoj terapiji s bolje ustanovljenim profilom sigurnosti primjene, osobito kada se doji novorođenče ili nedonošče.
English: Diuretic agents such as the hydrochlorothiazide contained in Karvezide may have an effect on other medicines.
Croatian: Diuretičke tvari, kao što je hidroklorotiazid iz lijeka Karvezide, mogu imati učinke na druge lijekove.
English: Therefore, the use of Karvezide is not recommended.
Croatian: Primjena lijeka Karvezide se stoga ne preporučuje.
English: Side effects reported in clinical studies for patients treated with Karvezide were:
Croatian: Nuspojave prijavljene u kliničkih ispitivanjima kod bolesnika liječenih lijekom Karvezide:
English: The two active ingredients in Karvezide work together to lower blood pressure further than if either was given alone.
Croatian: Dvije djelatne tvari lijeka Karvezide zajedno snažnije djeluju na sniženje krvnog tlaka nego kad se daju pojedinačno.
English: Preparations containing lithium should not be taken with Karvezide without close supervision by your doctor.
Croatian: Pripravci koji sadrže litij ne smiju se uzimati s lijekom Karvezide bez pomnog liječničkog nadzora.
English: How to take Karvezide
Croatian: Kako uzimati Karvezide
English: Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvezide” and “Warnings and precautions”).
Croatian: Liječnik će Vam možda morati promijeniti dozu i/ili poduzeti druge mjere opreza: Ako uzimate ACE inhibitor ili aliskiren (vidjeti također informacije pod naslovima
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: No dosage adjustment of Karvezide is necessary in older people.
Croatian: Nije potrebno prilagođavati dozu lijeka Karvezide za starije osobe.
English: Non-melanoma skin cancer: based on available data from epidemiological studies, cumulative dose dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Croatian: Nemelanomski rak kože: Na temelju dostupnih podataka iz epidemioloških ispitivanja, između hidroklorotiazida i NMSC-a primijećena je povezanost ovisna o kumulativnoj dozi (vidjeti također dijelove 4.4 i 5.1).
English: You can take Karvezide with or without food.
Croatian: Karvezide se može uzimati s hranom ili bez nje.
English: Other antihypertensive agents: the antihypertensive effect of Karvezide may be increased with the concomitant use of other antihypertensive agents.
Croatian: Ostali antihipertenzivni lijekovi: antihipertenzivni učinak lijeka Karvezide može se pojačati istodobnim uzimanjem drugih antihipertenziva.
English: In addition to the side effects listed above, chest pain, severe allergic reactions (anaphylactic shock) and decrease in the number of platelets (a blood cell essential for the clotting of the blood) have also been reported.
Croatian: Uz gore navedene nuspojave zabilježene su i bol u prsnom košu, teške alergijske reakcije (anafilaktički šok) i smanjenje broja krvnih pločica (krvna stanica nužna za zgrušavanje krvi).
English: There is no experience regarding the administration of Karvezide in patients with a recent kidney transplantation.
Croatian: Nema iskustava s primjenom lijeka Karvezide u bolesnika kojima je nedavno transplantiran bubreg.
English: Therefore, the combination of lithium and Karvezide is not recommended (see section 4.4).
Croatian: Stoga se kombinacija litija i lijeka Karvezide ne preporučuje (vidjeti dio 4.4).
English: Renal impairment and kidney transplantation: when Karvezide is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Croatian: Oštećena funkcija bubrega i transplantacija bubrega: kad Karvezide uzimaju bolesnici s oštećenom funkcijom bubrega, preporučuje se periodički kontrolirati razine kalija, kreatinina i mokraćne kiseline u serumu.
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Karvezide.
Croatian: Dodatne informacije o pojedinačnim komponentama lijeka: uz navedene nuspojave kombiniranog lijeka, moguće nuspojave lijeka Karvezide mogu biti i one prethodno prijavljene za pojedinačne komponente lijeka.
English: How to store Karvezide
Croatian: Kako čuvati Karvezide
English: Due to the hydrochlorothiazide component, Karvezide is not recommended for patients with severe renal dysfunction (creatinine clearance < 30 ml/min).
Croatian: Zbog hidroklorotiazida u sastavu lijeka, Karvezide se ne preporučuje bolesnicima s teško oštećenom funkcijom bubrega (klirens kreatinina < 30 ml/min.).
English: Angiotensin II Receptor Antagonists (AIIRAs):
Croatian: Antagonisti receptora angiotenzina II:
English: Although not specifically studied with the Karvezide, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Croatian: Iako nisu provedena posebna ispitivanja s lijekom Karvezide, ni s irbesartanom niti s hidroklorotiazidom nije primijećen povratak hipertenzije (tzv. rebound hipertenzija).
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with Karvezide (see section 4.5).
Croatian: Diuretici koji štede kalij, nadomjesci kalija ili nadomjesci soli koji sadrže kalij moraju se s oprezom istodobno primjenjivati s lijekom Karvezide (vidjeti dio 4.5).
English: Karvezide is a combination of two active substances, irbesartan and hydrochlorothiazide.
Croatian: Karvezide je kombinacija dvije djelatne tvari, irbesartana i hidroklorotiazida.
English: Conversely, due to the irbesartan component of Karvezide hyperkalaemia might occur, especially in the presence of renal impairment and/or heart failure, and diabetes mellitus.
Croatian: Nasuprot tomu, zbog irbesartana u sastavu lijeka Karvezide može se pojaviti hiperkalijemija, posebice ako istodobno postoji narušena funkcija bubrega i/ili srčano zatajenje i šećerna bolest.
English: When clinically appropriate direct change from monotherapy to the fixed combinations may be considered:  Karvezide 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone;  Karvezide 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Karvezide 150 mg/12.5 mg.  Karvezide 300 mg/25 mg may be administered in patients insufficiently controlled by Karvezide 300 mg/12.5 mg.
Croatian: Kad je klinički primjereno, može se razmotriti izravni prijelaz s monoterapije na fiksnu kombinaciju: Karvezide 150 mg/12,5 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati samo hidroklorotiazidom ili irbesartanom u dozi od 150 mg; Karvezide 300 mg/12,5 mg može se propisati bolesnicima čiji se krvni tlak ne može na odgovarajući način kontrolirati irbesartanom u dozi od 300 mg ili lijekom Karvezide 150 mg/12,5 mg.
English: Karvezide will usually be prescribed by your doctor when your previous treatment did not reduce your blood pressure enough.
Croatian: Liječnik će Vam obično propisati Karvezide ako Vam dosadašnje liječenje povišenog krvnog tlaka nije osiguralo odgovarajući učinak.
English: Following oral administration of Karvezide, the absolute oral bioavailability is 60-80% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Croatian: Nakon peroralne primjene lijeka Karvezide apsolutna oralna bioraspoloživost je 60-80% za irbesartan, odnosno 50-80% za hidroklorotiazid.
English: Karvezide is unlikely to affect your ability to drive or use machines.
Croatian: Karvezide ne bi trebao utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: The use of Karvezide during breast feeding is not recommended.
Croatian: Ne preporučuje se upotreba lijeka Karvezide tijekom dojenja.
English: Based on its pharmacodynamic properties, Karvezide is unlikely to affect the ability to drive and use machines.
Croatian: Na temelju farmakodinamičkih svojstava, Karvezide ne bi trebao utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Karvezide should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Croatian: Karvezide ne smiju uzimati bolesnici s teško oštećenom funkcijom bubrega (klirens kreatinina <30 ml/min) (vidjeti dio 4.3).
English: Severe hepatic impairment, biliary cirrhosis and cholestasis The concomitant use of Karvezide with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (glomerular filtration rate (GFR) <60 ml/min/1.73 m²) (see sections 4.5 and 5.1).
Croatian: Teško oštećenje funkcije jetre, bilijarna ciroza i kolestaza Istodobna primjena lijeka Karvezide s lijekovima koji sadrže aliskiren kontraindicirana je u bolesnika sa šećernom bolešću ili oštećenjem bubrega (GFR < 60 ml/min/1,73 m2) (vidjeti dijelove 4.5 i 5.1).
English: Efficacy and safety of Karvezide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Croatian: Djelotvornost i sigurnost lijeka Karvezide kao inicijalne terapije za tešku hipertenziju (dijastolički tlak u sjedećem položaju ≥ 110 mmHg) ocijenjena je u multicentričnom, randomiziranom, dvostruko-slijepom ispitivanju s aktivnom kontrolom, u trajanju od 8 tjedana, s paralelnom skupinom.
English: Karvezide is not indicated in patients with severe hepatic impairment.
Croatian: Karvezide nije indiciran u bolesnika s teško oštećenom funkcijom jetre.
English: Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with Karvezide.
Croatian: Nadalje, tiazidi smanjuju renalni klirens litija pa uzimanje lijeka Karvezide može povećati rizik od toksičnosti litija.
English: There is no clinical experience with Karvezide in patients with hepatic impairment.
Croatian: Nema kliničkog iskustva s primjenom lijeka Karvezide u bolesnika s oštećenom funkcijom jetre.
English: Lithium: the combination of lithium and Karvezide is not recommended (see section 4.5).
Croatian: Litij: ne preporučuje se kombinacija litija i lijeka Karvezide (vidjeti dio 4.5).