FrancophonIA/ELRC3.0 huggingface dataset:
English: If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered.
Croatian: Ako se karbimazol primjenjuje tijekom trudnoće, potrebno je primijeniti najnižu učinkovitu dozu bez dodatne primjene hormona štitnjače.
English: Carbimazole must only be administered during pregnancy after a strict individual benefit/risk assessment and only at the lowest effective dose without additional administration of thyroid hormones.
Croatian: Karbimazol se smije primjenjivati tijekom trudnoće samo nakon stroge procjene omjera koristi i rizika za svaku trudnicu pojedinačno, te samo u najnižoj učinkovitoj dozi bez dodatne primjene hormona štitnjače.
English: Close maternal, foetal and neonatal monitoring is warranted (see section 4.6).
Croatian: Savjetuje se pažljivo praćenje majke, fetusa i novorođenčeta (vidjeti dio 4.6).
English: Tabulated list of adverse reactions Vascular disorders
Croatian: Tablični popis nuspojava Krvožilni poremećaji
English: Thiamazole must not be given to patients with a history of acute pancreatitis after administration of thiamazole or its prodrug carbimazole.
Croatian: Tiamazol se ne smije primjenjivati u bolesnika s poviješću bolesti akutnog pankreatitisa nakon primjene tiamazola ili njegova prolijeka karbimazola.
English: Patients with a history of acute pancreatitis after administration of carbimazole or its active metabolite thiamazole.
Croatian: Bolesnici s anamnezom akutnog pankreatitisa nakon primjene karbimazola ili njegova aktivnog metabolita tiamazola.
English: Carbimazole must not be given to patients with a history of acute pancreatitis after administration of carbimazole or its active metabolite thiamazole.
Croatian: Karbimazol se ne smije primjenjivati u bolesnika s anamnezom akutnog pankreatitisa nakon primjene karbimazola ili njegova aktivnog metabolita tiamazola.
English: Bydureon is not an insulin and should therefore not be used as a substitute for insulin.
Croatian: Lijek Bydureon nije inzulin te se stoga ne smije koristiti kao zamjena za inzulin.
English: There have been post-marketing reports of acute pancreatitis in patients receiving carbimazole or its active metabolite thiamazole.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi akutnog pankreatitisa u bolesnika koji su primali karbimazol ili njegov aktivni metabolit tiamazol.
English: Patients with a history of acute pancreatitis after administration of thiamazole or its prodrug carbimazole.
Croatian: Bolesnici s anamnezom akutnog pankreatitisa nakon primjene tiamazola ili njegova prolijeka karbimazola.
English: There have been post-marketing reports of acute pancreatitis in patients receiving thiamazole or its prodrug carbimazole.
Croatian: Nakon stavljanja lijeka u promet prijavljeni su slučajevi akutnog pankreatitisa u bolesnika koji su dobivali tiamazol ili njegov prolijek karbimazol.
English: However, blood glucose self-monitoring may become necessary to adjust the dose of sulphonylureas or the dose of basal insulin.
Croatian: Međutim, možda će biti nužna samokontrola razine glukoze u krvi radi prilagođavanja doze sulfonilureje ili bazalnog inzulina.
English: Women of childbearing potential and pregnancy
Croatian: Posebna upozorenja i mjere opreza pri uporabi Žene reproduktivne dobi i trudnoća
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Trulicity therapy is started and insulin is reduced.
Croatian: Samokontrola razine glukoze u krvi nužna je radi prilagođavanja doze sulfonilureje ili inzulina, posebice ako je započeta terapija lijekom Trulicity i inzulin je smanjen.
English: Blood glucose selfmonitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Byetta therapy is started and insulin is reduced.
Croatian: Samokontrola razine glukoze u krvi nužna je radi prilagođavanja doze sulfonilureje ili inzulina, posebice ako je započeta terapija lijekom Byetta i inzulin je smanjen.
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and of insulin particularly when prolonged-release exenatide therapy is started and insulin is reduced.
Croatian: Samokontrola razine glukoze u krvi nužna je radi prilagođavanja doze sulfonilureje ili inzulina, posebice ako je započeta terapija eksenatidom s produljenim oslobađanjem, a inzulin je smanjen.
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and insulin, particularly when Victoza therapy is started and insulin is reduced.
Croatian: Samopraćenje razine glukoze u krvi nužno je radi prilagođavanja doze sulfonilureje i inzulina, posebice ako je započeta terapija lijekom Victoza i inzulin je smanjen.
English: Posology and method of administration Add-on therapy
Croatian: Sažetak opisa svojstava lijeka 4.2. Doziranje i način primjene Dodatna terapija
English: Immediate Packaging Pack size
Croatian: EMA broj postupka (Zaštićeno) ime Doza Farmaceutski oblik Put primjene Unutarnje Pakovanje Veličina pakovanja bočica (HDPE)
English: EMA Number
Croatian: DODATAK
English: Celsentri maraviroc
Croatian: Celsentri maravirok
English: The full EPAR for Celsentri can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Celsentri nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients who have reduced kidney function may need to take Celsentri less frequently.
Croatian: Bolesnici sa smanjenom funkcijom bubrega možda trebaju uzimati Celsentri manje često.
English: Based on these data, effectiveness is expected to be similar in children and adults.
Croatian: Na temelju tih podataka, očekuje se da će učinkovitost u djece i odraslih biti slična.
English: In adults, the recommended dose is 150, 300 or 600 mg twice a day, depending on the other medicines that the patient is taking.
Croatian: U odraslih, preporučena doza je 150, 300 ili 600 mg dva puta na dan, ovisno o drugim lijekovima koje bolesnik uzima.
English: What is Celsentri and what is it used for?
Croatian: Što je Celsentri i za što se koristi?
English: The safety profile of Celsentri is considered acceptable and no major concerns have been identified.
Croatian: Sigurnosni profil lijeka Celsentri smatra se prihvatljivim i nisu ustanovljeni razlozi za ozbiljnu zabrinutost.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Celsentri on 18 September 2007.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Celsentri u promet koje vrijedi na prostoru Europske unije od 18. rujna 2007.
English: This summary was last updated in 05-2017.
Croatian: Sažetak je posljednji put ažuriran: 05. 2017.
English: Celsentri is available as tablets (25, 75, 150 and 300 mg) and as a liquid (20 mg/ml) to be taken by mouth.
Croatian: Celsentri je dostupan u obliku tableta (od 25, 75, 150 i 300 mg) i tekućine (20 mg/ml) i uzima se na usta.
English: In children, the dose is based on body weight.
Croatian: U djece doza ovisi o djetetovoj tjelesnoj težini.
English: Other information about Celsentri
Croatian: Ostale informacije o lijeku Celsentri
English: What measures are being taken to ensure the safe and effective use of Celsentri?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Celsentri?
English: Celsentri does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Celsentri neće izliječiti infekciju HIV-om niti AIDS, ali može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: The patients had previously taken other treatments for HIV for at least six months, but these had stopped working.
Croatian: Bolesnici su bili prethodno liječeni drugim terapijama protiv HIV-a najmanje šest mjeseci, ali one su prestale djelovati.
English: Similar results were also seen when looking at the patients who continued treatment with Celsentri 300 mg twice a day for 48 weeks.
Croatian: Slični rezultati opaženi su i u bolesnika koji su nastavili liječenje lijekom Celsentri 300 mg dva puta na dan tijekom 48 tjedana.
English: Celsentri tablets must not be used in patients who are hypersensitive (allergic) to peanut and soya.
Croatian: Celsentri u obliku tableta ne smiju uzimati bolesnici koji su preosjetljivi (alergični) na kikiriki ili soju.
English: This is a summary of the European public assessment report (EPAR) for Celsentri.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Celsentri.
English: Before treatment, the doctor must check that the patient's blood only shows infection with CCR5-tropic virus.
Croatian: Prije liječenja liječnik mora provjeriti da krv bolesnika pokazuje samo infekciju CCR5tropnim virusom.
English: In the studies Celsentri was compared with placebo (a dummy treatment).
Croatian: U ispitivanjima je Celsentri uspoređen s placebom (prividnim liječenjem).
English: What are the risks associated with Celsentri?
Croatian: Koji su rizici povezani s lijekom Celsentri?
English: Celsentri cannot work against viruses that attach to another protein called CXCR4, or when it can attach to both CCR5 and CXCR4.
Croatian: Celsentri ne može djelovati protiv virusa koji se pričvrste na drugi protein naziva CXCR4 ili kada se može pričvrstiti i na CCR5 i CXCR4.
English: All of the patients also took ‘optimised background therapy' (a combination of other HIV medicines chosen for each patient to increase the chances of reducing the levels of HIV in the blood).
Croatian: Svi bolesnici uzimali su i „optimiziranu osnovnu terapiju” (kombinacija drugih lijekova protiv HIV-a određena za svakog bolesnika kako bi se povećala vjerojatnost smanjenja razina HIV-a u krvi).
English: It is not intended to provide practical advice on how to use Celsentri.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Celsentri.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Celsentri's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka Celsentri nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Celsentri have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Celsentri nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The most common side effects with Celsentri (which may affect up to 1 in 10 people) are nausea (feeling sick), diarrhoea, fatigue (tiredness) and headache.
Croatian: Najčešće nuspojave lijeka Celsentri (koje se mogu javiti u do 1 na 10 osoba) jesu mučnina, proljev, umor i glavobolja.
English: Why is Celsentri approved?
Croatian: Zašto je lijek Celsentri odobren?
English: It blocks the CCR5 protein on the surface of the cells in the body that HIV infects.
Croatian: On blokira protein CCR5 na površini stanica u tijelu koje je inficirano HIV-om.
English: For more information about treatment with Celsentri, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Celsentri pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Celsentri is an HIV medicine used to treat patients from 2 years of age and weighing at least 10 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Celsentri je lijek protiv HIV-a namijenjen za liječenje bolesnika u dobi od 2 godine nadalje, tjelesne težine od najmanje 10 kg, koji su zaraženi virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji je uzrok sindroma stečene imunološke deficijencije (AIDS).
English: Celsentri has been shown to be effective at reducing the levels of HIV in the blood in two main studies involving a total of 1,076 mostly adult patients with CCR5-tropic HIV infection.
Croatian: Pokazalo se da je Celsentri učinkovito smanjio razine HIV-a u krvi u dva glavna ispitivanja koja su uključila ukupno 1076 uglavnom odraslih bolesnika s infekcijom CCR5-tropnim HIV-om.
English: Celsentri used in combination with other HIV medicines has been shown to be effective at reducing the levels of HIV in the blood in adults, and similar effects are expected in children.
Croatian: Pokazalo se da je Celsentri u kombinaciji s drugim lijekovima protiv HIV-a učinkovit za smanjenje razina HIV-a u krvi u odraslih, a slični učinci očekuju se i u djece.
English: As HIV can only reproduce itself within cells, Celsentri, taken in combination with other HIV medicines, reduces the level of CCR5-tropic HIV, and keeps it at a low level.
Croatian: Budući da se HIV može reproducirati samo unutar stanica, Celsentri u kombinaciji s drugim lijekovima protiv HIV-a smanjuje razinu CCR5-tropnog HIV-a i zadržava ga na niskoj razini.
English: Celsentri can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Croatian: Celsentri se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: By attaching itself to the protein, Celsentri prevents the virus from entering the cells.
Croatian: Time što se pričvrsti na protein, Celsentri sprječava ulazak virusa u stanicu.
English: The active substance in Celsentri, maraviroc, is a ‘CCR5 antagonist'.
Croatian: Djelatna tvar lijeka Celsentri, maravirok, antagonist je receptora CCR5.
English: Celsentri contains the active substance maraviroc.
Croatian: Celsentri sadrži djelatnu tvar maravirok.
English: Additional data indicate that Celsentri given at a suitable dose to children is handled by their body in the same way as in adults.
Croatian: Dodatni podaci pokazuju da djeca, kada im se Celsentri daje u prikladnoj dozi, reagiraju jednako kao i odrasli.
English: This means that the virus, when infecting a cell, attaches to a specific protein called CCR5 on the surface of the cell.
Croatian: To znači da se virus, kada zarazi stanicu, pričvrsti na protein naziva CCR5 na površini stanice.
English: Celsentri is used in combination with other HIV medicines, and only in patients who have been treated for HIV infection before and only when the HIV-1 they are infected with is ‘CCR5-tropic', which is determined by a blood test.
Croatian: Celsentri se primjenjuje u kombinaciji s drugim lijekovima protiv HIV-a, i to samo u onih bolesnika koji su već bili liječeni zbog infekcije HIV-om te samo onda kada je HIV-1 kojim su zaraženi „CCR5-tropni”, što se određuje pretragom krvi.
English: Looking at the results of the two studies taken together, the levels of HIV in the blood had fallen by an average of 99% after 24 weeks in the patients adding Celsentri to optimised background therapy, compared with 90% in those adding placebo.
Croatian: Pregledom rezultata dvaju ispitivanja zajedno pokazalo se da su se nakon 24 tjedna razine HIV-a u krvi smanjile za prosječno 99 % u bolesnika u kojih je optimiziranoj osnovnoj terapiji dodan Celsentri, u usporedbi s 90 % u onih kojima je dodan placebo.
English: How does Celsentri work?
Croatian: Kako djeluje Celsentri?
English: The proportion of patients who had undetectable levels of HIV in their blood after 24 weeks was about 45% with Celsentri compared to 23% with placebo.
Croatian: Udio bolesnika kojima se razine HIV-a u krvi nisu mogle detektirati nakon 24 tjedna, iznosio je oko 45 % kada su primali Celsentri u usporedbi s 23 % onih koji su primali placebo.
English: What benefits of Celsentri have been shown in studies?
Croatian: Koje su koristi lijeka Celsentri dokazane u ispitivanjima?
English: For practical information about using Celsentri, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Celsentri bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: For the full list of all side effects reported with Celsentri, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Celsentri potražite u uputi o lijeku.
English: CCR5-tropic HIV uses this protein to enter the cells.
Croatian: Taj protein služi CCR5-tropnom HIV-u za ulazak u stanicu.
English: How is Celsentri used?
Croatian: Kako se Celsentri koristi?
English: Aprovel was used for two years or more.
Croatian: Aprovel se primjenjivao tijekom dvije godine ili duže.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aprovel on 27 August 1997.
Croatian: Europska komisija izdaje odobrenje za stavljanje u promet koje za Aprovel vrijedi na prostoru Europske unije od 27. kolovoza 1997.
English: The full EPAR for Aprovel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za Aprovel može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Aprovel
Croatian: Druge informacije o lijeku Aprovel
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Croatian: Ako se krvi tlak ne može dostatno kontrolirati, doza se može povećati na 300 mg jedanput na dan ili se mogu dodati drugi antihipertenzivi, poput hidroklorotiazida.
English: The usual recommended dose of Aprovel is 150 mg once a day.
Croatian: Uobičajena preporučena doza lijeka Aprovel je 150 mg jedanput na dan.
English: For more information about treatment with Aprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Aprovel pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Aprovel was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Croatian: Aprovel je uspoređen s placebom (lažnim liječenjem) u 712 bolesnika s drugim antihipertenzivima (atenololom, enalaprilom ili amlodipinom) u 823 bolesnika.
English: Why has Aprovel been approved?
Croatian: Zašto je Aprovel odobren?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aprovel.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te svoje preporuke o uvjetima za primjenu lijeka Aprovel.
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Croatian: Također je ispitana primjena lijeka Aprovel u kombinaciji s hidroklorotiazidom u 1.736 bolesnika.
English: In this study, Aprovel was compared with placebo and with amlodipine.
Croatian: U ovom ispitivanju, Aprovel je uspoređen s placebom i s amlodipinom.
English: Aprovel is a medicine that contains the active substance irbesartan.
Croatian: Aprovel je lijek koji sadrži djelatnu tvar irbesartan.
English: In patients with hypertension and type 2 diabetes, Aprovel is added to some other treatments for hypertension.
Croatian: U bolesnika s hipertenzijom i šećernom bolešću tipa 2, Aprovel se dodaje drugim terapijama za hipertenziju.
English: For the treatment of kidney disease, Aprovel was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Croatian: Za liječenje bolesti bubrega, Aprovel je ispitan u dva velika ispitivanja koja su obuhvatila ukupno 2.326 bolesnika sa šećernom bolešću tipa
English: What is the risk associated with Aprovel?
Croatian: Koji su rizici povezani s lijekom Aprovel?
English: Aprovel must not be used in people who are hypersensitive (allergic) to irbesartan or any of the other ingredients.
Croatian: Aprovel se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na irbesartan ili na bilo koju drugu pomoćnu tvar.
English: The active substance in Aprovel, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Croatian: Irbesartan, djelatna tvar u lijeku Aprovel je „antagonist receptora angiotenzina II”, što znači da ova tvar blokira djelovanje hormona u tijelu naziva angiotenzin II.
English: What is Aprovel?
Croatian: Što je Aprovel?
English: This is a summary of the European public assessment report (EPAR) for Aprovel.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Aprovel.
English: The most common side effect with Aprovel (seen in more than 1 patient in 10) is hyperkalaemia (high blood potassium levels).
Croatian: Najčešća nuspojava s lijekom Aprovel (koja se može javiti u više od 1 na 10 osoba) je hiperkalemija (visoka razina kalija u krvi).
English: The second study looked at whether Aprovel increased the time taken until the patients' blood creatinine levels had doubled (a marker of kidney disease), until they needed a kidney transplant or dialysis, or until they died.
Croatian: Drugo je ispitivanje istražilo je li Aprovel povećao vrijeme potrebno da se razine kreatinina u krvi bolesnika udvostruče (marker bolesti bubrega), dok im je bila potrebna transplantacija bubrega ili dijaliza, ili do njihove smrti.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Croatian: Ako se koristio s hidroklorotiazidom, dva lijeka ostvaruju kombinirani učinak.
English: Aprovel in combination with aliskirencontaining medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Croatian: U kombinaciji s lijekovima koji sadrže aliskiren (koristi se za liječenje esencijalne hipertenzije), Aprovel se ne smije koristiti u bolesnika s dijabetesom, ili umjerenim do ozbiljnim oštećenjem funkcije bubrega.
English: Aprovel is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Croatian: Aprovel se također koristi za liječenje bolesti bubrega u odraslih s hipertenzijom i šećernom bolešću tipa
English: The CHMP decided that Aprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) odlučilo je da koristi od lijeka Aprovel nadmašuju s njim povezane rizike te je preporučilo izdavanje odobrenja za stavljanje lijeka u promet.
English: In the second kidney disease study, Aprovel reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Croatian: U drugom ispitivanju bolesti bubrega Aprovel je tijekom ispitivanja smanjio relativan rizik od udvostručavanja razina kreatinina u krvi, koje zahtjeva transplantaciju bubrega ili dijalizu odnosno uzrokuju smrt, za 20% u usporedbi s placebom.
English: What benefit has Aprovel shown during the studies?
Croatian: Koje koristi lijeka Aprovel su dokazane u ispitivanjima?