FrancophonIA/ELRC3.0 huggingface dataset:
English: CoAprovel in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Croatian: CoAprovel u kombinaciji s lijekovima koji sadrže aliskiren (koristi se za liječenje esencijalne hipertenzije) ne smije se koristiti kod bolesnika sa šećernom bolešću ili umjerenim ili teškim oštećenjem bubrega.
English: It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide).
Croatian: Dostupan je u obliku tableta (150 mg ili 300 mg irbesartana i 12,5 mg hidroklorotiazida; 300 mg irbesartana i 25 mg hidroklorotiazida).
English: The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Croatian: Najčešće nuspojave lijeka CoAprovel (koje se mogu javiti u 1 do 10 na 100 osoba) su vrtoglavica, mučnina (osjećaj slabosti) ili povraćanje, neuobičajeno mokrenje, umor (zamor) i povećanje koncentracije dušika iz ureje u krvi (eng.
English: CoAprovel is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Croatian: CoAprovel je lijek koji sadrži dvije djelatne tvari, irbesartan i hidroklorotiazid.
English: Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Croatian: Daljnja ispitivanja izvedena su s dozama od 300 mg irbesartana u kombinaciji s 25 mg hidroklorotiazida.
English: CoAprovel must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Croatian: CoAprovel se ne smije koristiti ni kod bolesnika s teškim jetrenim, bubrežnim ili žučnim problemima, s preniskom razinom kalija u krvi ili previsokom razinom kalcija u krvi.
English: Doses higher than 300 mg irbesartan and 25 mg hydrochlorothiazide once a day are not recommended.
Croatian: Ne preporučuju se doze veće od 300 mg irbesartana i 25 mg hidroklorotiazida jednom na dan.
English: What is CoAprovel used for?
Croatian: Za što se CoAprovel koristi?
English: For the full list of all side effects reported with CoAprovel, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom CoAprovel potražite u uputi o lijeku.
English: CoAprovel contains two active substances, irbesartan and hydrochlorothiazide.
Croatian: CoAprovel sadrži dvije djelatne tvari, irbesartan i hidroklorotiazid.
English: CoAprovel is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Croatian: CoAprovel se koristi kod odraslih bolesnika s esencijalnom hipertenzijom (visokim krvnim tlakom) koja se ne može na odgovarajući način kontrolirati samo irbesartanom ili samo hidroklorotiazidom. „Esencijalna” označava hipertenziju koja nema očitog uzroka.
English: How is CoAprovel used?
Croatian: Kako se CoAprovel koristi?
English: How does CoAprovel work?
Croatian: Kako CoAprovel djeluje?
English: How has CoAprovel been studied?
Croatian: Kako se CoAprovel ispitivao?
English: Your doctor will confirm whether you should change to another treatment.
Croatian: Vaš će vam liječnik potvrditi trebate li promijeniti terapiju.
English: • If you are unsure whether you are affected, or if you have any questions, speak with your doctor or pharmacist.
Croatian: • Ako niste sigurni imate li tih problema, odnosno ako imate bilo kakvih pitanja, razgovarajte s liječnikom ili ljekarnikom.
English: • The available efficacy data for the described indications were considered to be very limited.
Croatian: • Dostupni podaci o djelotvornosti za opisane indikacije smatrani su vrlo ograničenima.
English: The review of ergot derivatives was initiated on 18 January 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Croatian: Procjena derivata ergota započela je 18. siječnja 2012. godine na zahtjev Francuske u skladu s člankom 31. Direktive 2001/83/EZ.
English: The severity of such adverse effects and their possible fatal outcome was underlined.
Croatian: Istaknuta je ozbiljnost takvih štetnih događaja, kao i njihov mogući smrtonosni ishod.
English: Patients were young (mean age 41 years-old), with a short time to onset after starting dihydroergotamine (less than 2 months, mean: 2 days).
Croatian: Bolesnici su bili mladi (prosječna dob 41 godina) s kratkim vremenom do nastupa nakon početka liječenja dihidroergotaminom (manje od dva mjeseca, u prosjeku: 2 dana).
English: Fibrosis can be a serious, sometimes fatal disease, which is often difficult to diagnose because of delayed symptoms and may be irreversible.
Croatian: Fibroza može biti ozbiljna, ponekad i smrtonosna bolest koju je često teško dijagnosticirati zbog odgođenih simptoma, a može biti i nepovratna.
English: There were fewer reports of fibrotic reactions with the other ergot derivatives.
Croatian: Bilo je manje izvješća o fibrotičkim reakcijama s drugim derivatima ergota.
English: These indications were not included in the CHMP review; therefore these products will remain authorised and may continue to be used in those indications.
Croatian: Te indikacije nisu bile uključene u procjenu CHMP-a; stoga ti lijekovi ostaju odobreni i mogu se nastaviti koristiti u tim indikacijama.
English: The review was initiated due to concerns identified by the French National Agency for the Safety of Medicine and Health Products (ANSM) in a national pharmacovigilance review in 2011.
Croatian: Procjena je pokrenuta zbog zabrinutosti Francuske državne agencije za sigurnost lijekova i zdravstvenih proizvoda (ANSM) u državnoj farmakovigilancijskoj procjeni u 2011. godini.
English: In addition, scientific advisory groups held in December 2012 and October 2013 did not consider there was evidence of a therapeutic need for ergot derivatives in the indications covered by the review.
Croatian: Pored toga, skupine za znanstveno savjetovanje održale su sastanke u prosincu 2012. godine i u listopadu 2013. godine na kojima se nije smatralo da postoji dokaz terapijske potrebe za derivatima ergota u indikacijama obuhvaćenim procjenom.
English: 25 October 2013 EMA/652753/2013
Croatian: 18. prosinca 2013. EMA/27446/2014
English: On 27 June 2013, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of medicines containing ergot derivatives.
Croatian: Dana 27.lipnja 2013. godine Povjerenstvo Europske agencije za lijekove (CHMP) preporučilo je ograničenje uporabe lijekova koji sadrže derivate ergota.
English: The re-examination concluded on 24 October 2013 with the Committee maintaining its previous recommendation, which will now be sent to the European Commission.
Croatian: Ponovna je procjena završila 24. listopada 2013., s tim da je Povjerenstvo zadržalo svoje prethodne preporuke.
English: The CHMP noted the difficulty of diagnosing fibrosis (due to delayed onset of symptoms) and the probability of under-reporting of fibrotic reactions.
Croatian: CHMP je zabilježio poteškoću u dijagnosticiranju fibroze (zbog odgođenih pojava simptoma) i vjerojatnost nedovoljnog prijavljivanja fibrotskih reakcija.
English: • Patients currently taking these medicines for any of the above indications should have their treatment reviewed at a routine (non-urgent) medical appointment.
Croatian: • Bolesnicima koji trenutačno uzimaju te lijekove, za bilo koju od naznačenih indikacija treba procijeniti terapiju pri rutinskoj (redovitoj) medicinskoj kontroli.
English: In the EU, medicines containing ergot derivatives have been authorised by national procedures and have been marketed under various trade names.
Croatian: U EU-u su lijekovi koji sadrže ergot derivate odobreni nacionalnim postupcima i stavljeni na tržište pod različitim trgovačkim imenima.
English: − Symptomatic treatment of veno-lymphatic insufficiency.
Croatian: − simptomatskog liječenja veno-limfatičke insuficijencije.
English: • Cases of ergotism or potentially related symptoms were most frequently reported with dihydroergotamine.
Croatian: • Slučajevi ergotizma ili potencijalno povezanih simptoma najčešće su prijavljivani s dihidrergotaminom.
English: − Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II);
Croatian: − pomoćnog liječenja intermitentne klaudikacije kod simptomatske okluzivne bolesti perifernih arterija (PAOD stadij II);
English: At the request of a manufacturer of medicines containing dihydroergotoxine, one of the ergot derivatives, the CHMP carried out a re-examination of its opinion on this medicine.
Croatian: Na zahtjev proizvođača lijekova koji sadrže dihidroergotoksin, jedan od derivata ergota, CHMP je proveo ponovnu procjenu svojeg mišljenja o ovom lijeku.
English: The French medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the European Union.
Croatian: Francuska agencija za lijekove zatražila je od CHMP provođenje pune procjene omjera koristi i rizika te mišljenje o tome je li potrebno održati, promijeniti, suspendirati ili povući odobrenje za stavljanje lijeka u promet diljem Europske unije.
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer's disease and other dementia);
Croatian: − simptomatskog liječenja kroničnog patološkog, kognitivnog i neurosenzorskog oštećenja u starijih osoba (isključujući Alzheimerovu bolest i druge demencije);
English: benefits in these indications was very limited, the CHMP concluded that the benefits in the concerned indications did not outweigh the risk of fibrosis and ergotism.
Croatian: S obzirom na to da je dokaz koristi ovih lijekova u tim indikacijama bio vrlo ograničen, CHMP je zaključio da koristi u dotičnim indikacijama nisu nadmašile rizik od fibroze i ergotizma.
English: They have also been used for treating chronic pathological cognitive and neurosensorial impairment (problems with memory and sensation) and for preventing migraine headaches.
Croatian: Također su korišteni za liječenje kroničnog, patološkog, kognitivnog i neurosenzorskog oštećenja (problema s memorijom i osjetom) i za sprečavanje migrenskih glavobolja.
English: This is based on a review of data showing an increased risk of fibrosis (formation of excess connective tissue that can damage organs and body structures) and ergotism (symptoms of ergot poisoning, such as spasms and obstructed blood circulation) with these medicines.
Croatian: To se temelji na podacima koji pokazuju povećani rizik od fibroze (stvaranja prekomjernog vezivnog tkiva koje može oštetiti organe i tjelesne strukture) i ergotizma (simptoma trovanja ergotom poput grčeva i opstrukcije u krvotoku) s tim lijekovima.
English: The CHMP noted that there is a plausible mechanism by which ergot-derivatives could cause fibrosis and ergotism.
Croatian: CHMP je zabilježio postojanje vjerojatnog mehanizma kojim bi derivati ergota mogli uzrokovati fibrozu i ergotizam.
English: Medicines containing ergot derivatives have an effect on blood circulation and they have been used for decades to treat conditions involving circulatory problems.
Croatian: Lijekovi koji sadrže derivate ergota imaju učinak na krvotok i desetljećima se koriste za liječenje stanja koja uključuju probleme s krvotokom.
English: • Fibrosis was most frequently reported with dihydroergotamine, including retroperitoneal, cardiac, pulmonary and pleural fibrosis.
Croatian: • Fibroza je bila najčešće prijavljivana kod dihidrergotamina uključujući retroperitonealnu, srčanu, plućnu i pleuralnu fibrozu.
English: Several cases of ergotism or symptoms potentially related to ergotism (including severe cases of symptoms of constriction of peripheral blood vessels) were also identified with the other ergot derivatives.
Croatian: Nekoliko slučajeva ergotizma ili simptoma potencijalno povezanih s ergotizmom (uključujući nekoliko slučajeva simptoma suženja perifernih krvnih žila) također su identificirani kod drugih derivata ergota.
English: − Prophylaxis of migraine headache;
Croatian: − profilakse migrenske glavobolje;
English: • Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis, through serotoninergic receptor activation, which is extensively described in the literature.
Croatian: • Derivati ergota prepoznati su kao mogući uzročnici fibroze, posebice fibroze srčanog zaliska putem aktivacije serotoninergičnog receptora koja je detaljno opisana u literaturi.
English: The varying affinity for serotoninergic receptors of the different ergot derivatives, and the therapeutic doses used, may explain the differences observed in reporting frequencies for the fibrotic reactions.
Croatian: Promjenjivi afinitet za serotoninergične receptore s različitim derivatima ergota i korištenim terapijskim dozama može objasniti razlike uočene kod učestalosti prijavljivanja za fibrotičke reakcije.
English: − Orthostatic hypotension;
Croatian: − ortostatske hipotenzije;
English: Certain ergot derivatives have been used to treat conditions usually affecting elderly patients, such as peripheral arterial occlusive disease (PAOD, where the body's large arteries become obstructed) causing pain when walking, and Raynaud's syndrome (where the blood supply is blocked to the extremities, usually the fingers and toes), as well as eyesight disturbances due to blood circulation problems.
Croatian: Određeni derivati ergota korišteni su za liječenje stanja koja obično pogađaju starije bolesnike poput okluzivne bolesti perifernih arterija (PAOD, kod koje je blokirana najveća arterija u tijelu) uzrokujući bol kod hodanja i Raynaudov sindrom (gdje je opskrba krvlju blokirana prema ekstremitetima (obično prema prstima ruku i nogu) kao i poremećaji vida zbog problema s krvotokom.
English: − Ancillary treatment of Raynaud's syndrome;
Croatian: − pomoćnog liječenja Raynaudovog sindroma;
English: These medicines should no longer be used to treat several conditions involving blood circulation problems or problems with memory and sensation, or to prevent migraine headaches, since the risks are greater than the benefits in these indications.
Croatian: Ti se lijekovi više ne smiju koristiti za liječenje nekoliko stanja koja uključuju probleme s cirkulacijom ili pamćenjem i osjetom ili za sprječavanje migrena s obzirom da su rizici u ovim indikacijama veći od koristi.
English: − Acute retinopathies of vascular origin;
Croatian: − akutne retinopatije vaskularnog podrijetla;
English: Ergot derivatives that are only indicated for these conditions will have their marketing authorisations suspended across the EU.
Croatian: Derivati ergota koji su indicirani samo za navedena stanja bit će povučeni s tržišta diljem EU-a.
English: • Medicines containing substances known as ergot derivatives can have serious side effects, called fibrosis and ergotism.
Croatian: • Lijekovi koji sadrže tvari poznate kao derivati ergota mogu imati ozbiljne nuspojave zvane fibroza i ergotizam.
English: As a result, they should no longer be used in the EU to treat a number of conditions involving blood circulation problems (that usually affect elderly patients) or problems with memory and sensation, or to prevent migraine headaches, as the risks outweigh the benefits.
Croatian: Kao rezultat toga, više se ne smiju koristiti u EU-u za liječenje brojnih stanja koja uključuju probleme s krvotokom (koji obično zahvaćaju starije bolesnike) ili probleme s memorijom i osjetom, odnosno za sprječavanje migrenskih glavobolja jer rizici nadmašuju koristi.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin;
Croatian: − pomoćnog liječenja smanjenja oštrine vida i poremećaja vidnog polja prvenstveno vaskularnog podrijetla;
English: In its review, the CHMP considered all available data on the benefits and risks of ergot derivatives, including data from clinical studies, post-marketing safety reports and the published literature.
Croatian: U svojoj je procjeni CHMP razmotrio sve dostupne podatke o koristima i rizicima derivata ergota uključujući i podatke iz kliničkih ispitivanja, izvješća iz ispitivanja nakon stavljanja lijeka u promet i objavljenu literaturu.
English: Ergot derivatives are substances derived from a group of fungi commonly known as ergot.
Croatian: Derivati ergota tvari su dobivene iz skupine gljivica koje su općenito poznate kao ergot.
English: The CHMP opinion follows a review of available safety and efficacy data on ergot derivatives in the above indications, including clinical studies, post-marketing data in Europe and the published literature:
Croatian: Mišljenje CHMP slijedilo je procjenu dostupnih podataka o sigurnosti i djelotvornosti derivata ergota u prethodno navedenim indikacijama uključujući klinička ispitivanja te podatke nakon stavljanja lijeka u promet i objavljenu literaturu:
English: They will remain authorised for use by patients in those indications.
Croatian: U tim se indikacijama bolesnicima odobrava njihova uporaba.
English: • Healthcare professionals should stop prescribing medicines containing dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine, for any of the following indications:
Croatian: • Zdravstveni djelatnici trebaju prestati propisivati lijekove koji sadrže dihidroergokristin, dihidroergotamin, dihidroergotoksin, nikergolin ili kombinaciju dihidroergokriptina s kofeinom kod bilo koje od sljedećih indikacija:
English: • You should make a non-urgent appointment with your doctor if you are taking a medicine containing any of these substances: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine.
Croatian: • Trebate zakazati redoviti pregled kod svog liječnika ako uzimate lijekove koji sadrže bilo koju od navedenih tvari: dihidroergokristin, dihidroergotamin, dihidroergotoksin, nikergolin ili kombinaciju dihidroergokriptina s kofeinom.
English: • Some ergot derivatives are approved in some EU Member States for use in other therapeutic indications, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
Croatian: • Neki su derivati ergota odobreni u pojedinim državama članicama za upotrebu u drugim terapijskim indikacijama uključujući druge cirkulatorne poremećaje, liječenje demencije (uključujući Alzheimerovu bolest) i liječenje akutne migrene.
English: Five ergot derivatives were considered in the CHMP review: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline and the combination of dihydroergocryptine with caffeine.
Croatian: Pet derivata ergota činilo je predmet procjene CHMP-a:dihidroergokristin, dihidroergotamin, dihidroergotoksin, nikergolin i kombinacija dihidrergokriptina i kofeina.
English: In some EU countries, certain ergot derivatives are also authorised for other indications not covered by the CHMP review, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
Croatian: U nekim su državama EU-a određeni derivati ergota također odobreni za druge indikacije koje nije obuhvatila procjena CHMP-a, uključujući i druge bolesti krvotoka, liječenje demencije (uključujući Alzheimerovu bolest) i liječenje akutne migrene.
English: In some EU Member States, ergot derivatives are also authorised for other indications such as treatment of dementia, including Alzheimer's disease, and treatment (as opposed to prevention) of acute migraine headache.
Croatian: U nekim su državama članicama EU-a derivati ergota također odobreni za druge indikacije poput liječenja demencije uključujući i Alzheimerovu bolest te liječenje (naspram prevencije) akutne migrene.
English: The European Commission has already endorsed the CHMP opinion for 4 other ergot derivatives (dihydroergocristine, dihydroergotamine, nicergoline dihydroergocryptine), adopting a final legally binding decision on 27 September 2013.
Croatian: Europska komisija potvrdila je mišljenje CHMP za dihidroergokristin, dihidroergotamin, nikergolin i dihidroergokriptin 27. rujna 2013., a mišljenje CHMP-a za dihidroergotoksin 18. prosinca 2013.
English: The CHMP opinion on dihydroergotoxine will now be forwarded to the European Commission, which will issue a final decision in due course.
Croatian: Preporuke CHMP-a poslane su Europskoj komisiji koja ih je potvrdila i izdala konačne, pravno obvezujuće odluke koje vrijede širom EU-a.
English: 7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs
Croatian: 7 napunjenih štrcaljki + 14 igala za injekciju + 14 blazinica natopljene alkoholom
English: 1 vial + 1 pre-filled syringe + 2 injection needles + 2 alcohol swabs
Croatian: 1 napunjena štrcaljka + 2 igle za injekciju + 2 blazinice natopljene alkoholom
English: Invented Name
Croatian: (Zaštićeno) ime
English: Strength Pharmaceutical form Route of administration
Croatian: Farmaceutski oblik Put primjene Unutarnje pakovanje Sastav (koncentracija)
English: Additional information:
Croatian: Dodatne informacije:
English: If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
Croatian: Ako to učinite, već unutar nekoliko sati Vaš krvni tlak može pasti opasno nisko, što može uzrokovati smrt.
English: Week 0 (After ≥36 Weeks on Treatment)
Croatian: 0. tjedan (nakon ≥ 36 tjedana liječenja)
English: Do not drive or operate machines unless you are feeling well.
Croatian: Ne upravljajte vozilima ili strojevima ako se ne osjećate dobro.
English: Hold the bottle firmly.
Croatian: Držite bocu čvrsto.
English: Stay in regular contact with your doctor
Croatian: Ostanite u redovitom kontaktu sa svojim liječnikom
English: “Pull here” (with Alert card attached)
Croatian: ''Povucite ovdje'' (s priloženom Karticom s upozorenjem)
English: This is consistent with the known activity of other nucleoside analogues.
Croatian: To je u skladu s poznatom aktivnošću drugih analoga nukleozida.
English: Let it dry completely before you use it again
Croatian: Neka se potpuno osuši prije nego je koristite ponovno.
English: It is a potent selective inhibitor of HIV-1 and HIV-2.
Croatian: On je snažni selektivni inhibitor HIV-1 i HIV-2.
English: It also increases the CD4 cell count in your blood.
Croatian: Također povećava broj CD4 stanica u krvi.
English: How to measure the dose and take the medicine
Croatian: Kako odrediti dozu i uzeti lijek
English: The duration of double-blind treatment was at least 48 weeks.
Croatian: Dvostruko slijepo liječenje trajalo je najmanje 48 tjedana.
English: Look out for important symptoms
Croatian: Obratite pozornost na važne znakove
English: Write your doctor's details below:
Croatian: Ispod upišite podatke svog liječnika:
English: If your child gets the symptoms described below it is essential that you follow the instructions given.
Croatian: Ako Vaše dijete dobije simptome opisane dolje važno je da slijedite dane upute.
English: From these results, it can be concluded with 95% confidence that the true difference is no greater than 8.4% in favour of the twice daily regimen.
Croatian: Iz tih rezultata može se zaključiti s 95% pouzdanošću da stvarna razlika nije veća od 8,4% u korist doziranja dvaput na dan.
English: No safety concerns were observed in these subjects.
Croatian: U tih ispitanika nisu primijećeni nikakvi sigurnosni problemi.
English: It should be taken into account that data for the once daily regimen are very limited in this population (see sections 5.1 and 5.2).
Croatian: Treba uzeti u obzir činjenicu da su podaci o režimu primjene jedanput na dan u ovoj populaciji vrlo ograničeni (vidjeti dijelove 5.1 i 5.2).
English: The dose depends on the child's body weight.
Croatian: Doza ovisi o tjelesnoj težini djeteta.