FrancophonIA/ELRC3.0 huggingface dataset:
English: Doses should be reduced according to creatinine clearance in patients with renal impairment.
Croatian: Doze se trebaju smanjiti u skladu s lučenjem kreatinina u bolesnika s oštećenjem funkcije bubrega.
English: A parallel review is currently underway, looking at the quality of the products and the way the potency of colistimethate sodium is measured and tested, and may result in further changes to the product information once complete.
Croatian: Paralelan pregled je trenutno u tijeku, kojim se istražuje kvaliteta proizvoda i način na koji se mjeri i testira potencija kolistimetat natrija, a može rezultirati u daljnjim promjenama u informacijama o lijeku po završetku pregleda.
English: • Colistin and colistimethate sodium are older antibiotics (belonging to the class called polymyxins) that are sometimes used for infections that have become resistant to newer treatments.
Croatian: • Kolistin i kolistimetat natrij su stari antibiotici (ubrajaju se u klasu naziva polimiksini) koji se ponekad koriste za infekcije na novija liječenja.
English: Colistimethate sodium is given by injection or inhaled, and becomes colistin inside the body.
Croatian: Kolistimetat natrij primjenjuje se injekcijom ili se inhalira, i postaje kolistin u tijelu.
English: • Injection or infusion (drip) of colistimethate sodium should only be used to treat serious infections in patients with few other treatment options, normally combined with another antibiotic.
Croatian: • Injekciju ili infuziju (drip) kolistimetat natrija treba koristiti za liječenje ozbiljnih infekcija u bolesnika s malim brojem mogućnosti za liječenje, te se normalno kombiniraju s drugim antibioticima.
English: • When given by inhalation, colistimethate sodium solutions may be used for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults and children with cystic fibrosis.
Croatian: • Ako se primjenjuju inhalacijom, otopine kolistimetat natrija mogu se koristiti za upravljanje kroničnim pulmonarnim infekcijama uzrokovanim Pseudomonas aeruginosa u odraslih i djece sa cističnom fibrozom.
English: The CHMP concluded that injection or infusion (drip) of colistimethate sodium should be reserved for the treatment of serious infections due to susceptible bacteria, in patients whose other treatment options are limited.
Croatian: CHMP je zaključio da se injekcija ili infuzija (drip) kolistimetat natrija treba rezervirati za liječenje ozbiljnih infekcija uzrokovanih bakterijama koje su osjetljive na ove lijekove, u bolesnika čije su opcije za liječenje ograničene.
English: The review considered products given by injection or inhaled as a liquid into the lungs (systemic use) containing colistimethate sodium, which is converted to the active substance colistin in the body.
Croatian: Pregledom su obuhvaćeni lijekovi koji se primjenjuju injekcijom ili se inhaliraju kao tekućina u pluća (sistemska primjena) koja sadrži kolistimetat natrij koji se u tijelu konvertira u djelatnu tvar kolistin.
English: • Use of intravenous colistimethate sodium together with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.
Croatian: • Potreban je poseban oprez prilikom primjene intravenoznog kolistimetat natrija zajedno s drugim lijekovima koji su potencijalno nefrotoksični ili neurotoksični.
English: Colistimethate sodium may also be inhaled as a liquid vapour to treat lung infection in patients with cystic fibrosis.
Croatian: Kolistimetat natrij može se inhalirati kao tekuća para za liječenje infekcije pluća u bolesnika s cističnom fibrozom.
English: Where appropriate, adult doses of 125,000 IU for intraventricular administration and no more than this for intrathecal administration are recommended.
Croatian: Ako je primjenjivo, doza za odrasle osobe za intraventrikularnu primjenu, te se ne preporuča veća doza za intratekalnu primjenu.
English: CHMP concluded that colistimethate sodium may also be given by inhalation or in a nebuliser to treat ongoing (chronic) infections with the bacterium Pseudomonas aeruginosa in patients with cystic fibrosis.
Croatian: CHMP je zaključio da se kolistimetat natrij može primjenjivati inhalacijom ili u nebulizatoru za potrebe liječenja aktualnih (kroničnih) infekcija bakterijom Pseudomonas aeruginosa u bolesnika s cističnom fibrozom. (Lijekovi za inhalaciju poput suhog praška imaju različito doziranje i distribuciju u tijelu te nisu obuhvaćeni zaključcima pregleda.)
English: This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent').
Croatian: Odobrenje se temeljilo na odobrenju koje je izdano za lijek Renvela 2009. godine („informirani pristanak”).
English: • adults and children from 6 years of age with chronic (long-term) kidney disease.
Croatian: • odraslih i djece starijih od 6 godina s kroničnom (dugoročnom) bolešću bubrega.
English: • adult patients on dialysis (a technique to remove unwanted substances from the blood);
Croatian: • odraslih bolesnika na dijalizi (postupku kojim se uklanjaju neželjene tvari iz krvi);
English: Further information on Sevelamer carbonate Winthrop can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
Croatian: Više informacija o lijeku Sevelamer carbonate Winthrop nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/sevelamer-carbonate-winthrop.
English: Sevelamer carbonate Winthrop is available as tablets (800 mg) and as powder (800 mg and 2.4 g) to be taken 3 times a day with meals.
Croatian: Sevelamer carbonate Winthrop dostupan je u obliku tableta (800 mg) i praška (800 mg i 2,4 g) te se uzima 3 puta dnevno uz obrok.
English: (sevelamer carbonate)
Croatian: (sevelamer karbonat)
English: Sevelamer carbonate Winthrop received a marketing authorisation valid throughout the EU on 15 January 2015.
Croatian: Sevelamer carbonate Winthrop dobio je odobrenje za stavljanje u promet koje je na snazi na prostoru EU-a od 15. siječnja 2015.
English: When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping to reduce phosphate levels in the blood.
Croatian: Kada se uzima uz jelo, veže se u crijevima za fosfat iz hrane, čime sprječava tijelo da apsorbira fosfat i time smanjuje razine fosfata u krvi.
English: In two main studies in 110 adults with kidney disease who were on dialysis, Sevelamer carbonate Winthrop brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.
Croatian: U dva glavna ispitivanja na 110 odraslih bolesnika koji su bili na dijalizi zbog bolesti bubrega, Sevelamer carbonate Winthrop smanjio je razinu fosfata na približno 1,5 - 1,6 mmol/l (što je u okviru ili blizu normalnog raspona) te je bio jednako učinkovit kao i drugi odobreni lijek Renagel.
English: Finally, a main study also showed that Sevelamer carbonate Winthrop was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Winthrop had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
Croatian: Konačno, u glavnom je ispitivanju također utvrđeno da je Sevelamer carbonate Winthrop bio učinkovit u smanjenju razina fosfata u stotinu djece: u djece koja su primala Sevelamer carbonate Winthrop zabilježeno je veće smanjenje razine fosfora (0,87 mg/dl) nego u djece koja su primala placebo (prividno liječenje) i čija se razina fosfora povećala za 0,04 mg/dl.
English: Sevelamer carbonate Winthrop should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.
Croatian: Sevelamer carbonate Winthrop treba se koristiti s drugim terapijama kao što su dodatci kalcija i vitamina D za sprječavanje razvoja bolesti kostiju.
English: 1 Previously known as Sevelamer carbonate Zentiva.
Croatian: 1 Prethodno registriran pod nazivom Sevelamer carbonate Zentiva.
English: The most common side effects with Sevelamer carbonate Winthrop (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation.
Croatian: Najčešće nuspojave lijeka Sevelamer carbonate Winthrop (mogu se javiti u više od 1 na 10 osoba) su mučnina (slabost), povraćanje, bol u gornjem dijelu abdomena (trbuha) i zatvor.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Winthrop 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 Sevelamer carbonate Winthrop nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The dose to take depends on the patient's level of blood phosphate and, for children, their height and weight.
Croatian: Doza koja se primjenjuje ovisi o razini fosfata u krvi bolesnika, a kod djece se u obzir uzimaju i visina te težina.
English: Sevelamer carbonate Winthrop must not be taken on an empty stomach and patients should keep to their prescribed diets.
Croatian: Sevelamer carbonate Winthrop ne smije se uzimati na prazan želudac, a bolesnici se trebaju pridržavati propisane dijete.
English: Side effects reported with Sevelamer carbonate Winthrop are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Sevelamer carbonate Winthrop pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Winthrop reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Croatian: U trećem glavnom ispitivanju na 49 odraslih bolesnika koji nisu bili na dijalizi, Sevelamer carbonate Winthrop smanjio je razine fosfata s 2,0 mmol/l na 1,6 mmol/l.
English: The European Medicines Agency therefore decided that Sevelamer carbonate Winthrop's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Sevelamer carbonate Winthrop nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: An overview of Sevelamer carbonate Winthrop and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Sevelamer carbonate Winthrop i zašto je odobren u EU-u
English: For more information about using Sevelamer carbonate Winthrop, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Sevelamer carbonate Winthrop pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The active substance in Sevelamer carbonate Winthrop, sevelamer carbonate, is a phosphate binder.
Croatian: Djelatna tvar u lijeku Sevelamer carbonate Winthrop, sevelamer karbonat, tvar je za vezanje fosfata.
English: What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Winthrop?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Sevelamer carbonate Winthrop?
English: As for all medicines, data on the use of Sevelamer carbonate Winthrop are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Sevelamer carbonate Winthrop kontinuirano se prate.
English: Why is Sevelamer carbonate Winthrop approved?
Croatian: Zašto je Sevelamer carbonate Winthrop odobren?
English: Sevelamer carbonate Winthrop is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
Croatian: Sevelamer carbonate Winthrop lijek je za održavanje hiperfosfatemije pod kontrolom (visoke razine fosfata u krvi) u sljedećih bolesnika:
English: What is Sevelamer carbonate Winthrop and what is it used for?
Croatian: Što je Sevelamer carbonate Winthrop i za što se koristi?
English: Studies show that Sevelamer carbonate Winthrop is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable.
Croatian: Ispitivanja pokazuju da je lijek Sevelamer carbonate Winthrop učinkovit u smanjenju razine fosfata u krvi u bolesnika s hiperfosfatemijom, te se smatra da se njegove nuspojave može kontrolirati.
English: Other information about Sevelamer carbonate Winthrop
Croatian: Ostale informacije o lijeku Sevelamer carbonate Winthrop
English: Sevelamer carbonate Winthrop must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut).
Croatian: Sevelamer carbonate Winthrop ne smiju uzimati osobe s niskom razinom fosfata u krvi ili opstrukcijom (začepljenjem) crijeva.
English: What are the risks associated with Sevelamer carbonate Winthrop?
Croatian: Koji su rizici povezani s lijekom Sevelamer carbonate Winthrop?
English: Sevelamer carbonate Winthrop has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
Croatian: U ispitivanjima je utvrđeno da je Sevelamer carbonate Winthrop učinkovit u smanjenju razine fosfata u krvi u bolesnika s hiperfosfatemijom.
English: For the full list of side effects of Sevelamer carbonate Winthrop, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Sevelamer carbonate Winthrop potražite u uputi o lijeku.
English: How does Sevelamer carbonate Winthrop work?
Croatian: Kako djeluje Sevelamer carbonate Winthrop?
English: What benefits of Sevelamer carbonate Winthrop have been shown in studies?
Croatian: Koje su koristi od lijeka Sevelamer carbonate Winthrop utvrđene u ispitivanjima?
English: It contains the active substance sevelamer carbonate.
Croatian: Sadrži djelatnu tvar sevelamer karbonat.
English: Effect is unknown.
Croatian: Učinak nije poznat.
English: Keep the tablet bottle with you so that you can show what you have taken.
Croatian: Imajte bocu s tabletama sa sobom, tako da možete pokazati što ste uzeli.
English: < 50 years ≥ 50 years
Croatian: < 50 godina ≥ 50 godina
English: ATC code: J05AR17.
Croatian: ATK oznaka: J05AR17.
English: Date of first authorisation: 21 April 2016
Croatian: Datum prvog odobrenja: 21. travnja 2016.
English: None of the changes was considered clinically relevant.
Croatian: Nijedna promjena nije se smatrala klinički važnom.
English: Descovy contains two active substances:
Croatian: Descovy sadrži dvije djelatne tvari:
English: Adults: one tablet each day, with or without food
Croatian: Odrasli: jedna tableta svaki dan, s hranom ili bez nje.
English: As a result, the amounts of Descovy or other medicines in your blood may change.
Croatian: Kao rezultat, količine lijeka Descovy ili drugih lijekova u Vašoj krvi mogu biti promijenjene.
English: What Descovy is and what it is used for
Croatian: Što je Descovy i za što se koristi
English: If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Croatian: Ako ste zaraženi virusom hepatitisa B, Vaš će liječnik pažljivo razmotriti najbolji režim liječenja za Vas.
English: • Use effective contraception while taking Descovy.
Croatian: • Koristite učinkovitu kontracepciju dok uzimate lijek Descovy.
English: Descovy should be taken orally, once daily with or without food (see section 5.2).
Croatian: Descovy se mora uzimati peroralno, jedanput na dan, s hranom ili bez nje (vidjeti dio 5.2).
English: Therefore, the same problems may be seen if Descovy is administered with a third nucleoside analogue.
Croatian: Stoga bi se isti problemi mogli vidjeti ako se Descovy primijeni s trećim analogom nukleozida.
English: • antibiotics, used to treat bacterial infections including tuberculosis, containing:
Croatian: • antibiotike, primjenjuju se za liječenje bakterijskih infekcija, uključujući i tuberkulozu, a koji sadržavaju:
English: Other types of medicine:
Croatian: Druge vrste lijekova:
English: If you take more Descovy than you should
Croatian: Ako uzmete više lijeka Descovy nego što ste trebali
English: Descovy therefore reduces the amount of HIV in your body.
Croatian: Zato Descovy smanjuje količinu HIV-a u Vašem tijelu.
English: • Your doctor may not prescribe Descovy to you if the virus has a K65R mutation.
Croatian: Vaš Vam liječnik možda neće propisati Descovy, ako virus nosi mutaciju K65R.
English: Descovy should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Croatian: Descovy se smije primjenjivati tijekom trudnoće samo ako moguća korist opravdava mogući rizik za fetus.
English: Other protease inhibitors
Croatian: Drugi inhibitori proteaze
English: Descovy may interact with other medicines.
Croatian: Descovy može biti u interakciji s drugim lijekovima.
English: If you have taken Descovy during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: Ako ste Descovy uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: Descovy can cause dizziness.
Croatian: Descovy može uzrokovati omaglicu.
English: b Week 96 window was between Day 630 and 713 (inclusive).
Croatian: b Okvir 96. tjedna bio je između 630. i 713. dana (uključivo).
English: The film-coated tablet should not be chewed, crushed, or split.
Croatian: Filmom obložena tableta ne smije se žvakati, drobiti ili lomiti.
English: Emtricitabine has demonstrated low carcinogenic potential in mice and rats.
Croatian: Emtricitabin je pokazao nisku razinu kancerogenosti u miševa i štakora.
English: What Descovy looks like and contents of the pack
Croatian: Kako Descovy izgleda i sadržaj pakiranja
English: For lipids, there is in some cases evidence for a treatment effect, while for weight gain there is no strong evidence relating this to any particular treatment.
Croatian: Za lipide, u nekim slučajevima postoji dokaz o učinku liječenja, dok za porast tjelesne težine nema čvrstog dokaza povezanosti s bilo kojim posebnim liječenjem.
English: Once you start taking Descovy, look out for:
Croatian: Kad jednom počnete uzimati lijek Descovy, pazite na:
English: There are no adequate and well-controlled studies of Descovy or its components in pregnant women.
Croatian: Nisu provedena odgovarajuća i dobro kontrolirana ispitivanja lijeka Descovy ili njegovih komponenti u trudnica.
English: Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg.
Croatian: Nemojte davati ovaj lijek djeci u dobi od 11 godina i mlađoj ili ako imaju težinu manju od 35 kg.
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations.
Croatian: Farmakoterapijska skupina: Antivirusni lijek za sistemsku primjenu; antivirusni lijekovi za liječenje HIV infekcija, kombinacije.
English: While taking Descovy you may still develop infections or other illnesses associated with HIV infection.
Croatian: Dok uzimate lijek Descovy i dalje možete razvijati infekcije ili druge bolesti povezane s HIV-infekcijom.
English: 5 Study conducted with Descovy.
Croatian: 5 Ispitivanje provedeno s lijekom Descovy.
English: Treatment of overdose with Descovy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Croatian: Liječenje predoziranja lijekom Descovy obuhvaća opće potporne mjere uključujući nadzor vitalnih znakova i praćenje kliničkog stanja bolesnika.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Croatian: U slučaju predoziranja bolesnik mora biti pod nadzorom kako bi se uočili znakovi toksičnosti (vidjeti dio 4.8).
English: Interaction not studied with either of the components of Descovy.
Croatian: Interakcija nije ispitana ni s jednom komponentom lijeka Descovy.
English: You should not take Descovy with medicines containing:
Croatian: • Ne smijete uzimati lijek Descovy s lijekovima koji sadrže:
English: Do not stop taking Descovy without talking to your doctor: see section 3, Do not stop taking Descovy.
Croatian: Nemojte prestati uzimati lijek Descovy bez prethodnog razgovora sa svojim liječnikom: pogledajte dio 3, Nemojte prestati uzimati lijek Descovy.
English: Interactions between the components of Descovy and potential co-administered medicinal products are listed in Table 2 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Croatian: Interakcije između komponenti lijeka Descovy i potencijalno istodobno primijenjenih lijekova navedene su u Tablici 2 (povećanje je označeno kao “↑”, smanjenje kao “↓”, bez promjene kao “↔”).
English: The safety and efficacy of Descovy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Descovy u djece mlađe od 12 godina ili težine < 35 kg nisu još ustanovljene.
English: In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
Croatian: Kako bi se izbjegao prijenos HIV-a na dojenče, preporučuje se da žene zaražene HIV-om ne doje svoju dojenčad ni u kojem slučaju.
English: It is not an inhibitor or inducer of CYP3A in vivo.
Croatian: Nije inhibitor ni induktor CYP3A in vivo.
English: If you have both HIV infection and hepatitis B, it is very important not to stop taking Descovy without talking to your doctor first.
Croatian: Ako imate i HIV-infekciju i hepatitis B, jako je važno da ne prestanete uzimati lijek Descovy, a da prije toga niste razgovarali s liječnikom.
English: This is because one of the active substances in this medicine passes into breast milk.
Croatian: Jedna od djelatnih tvari iz ovoga lijeka prelazi u majčino mlijeko.
English: Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease.
Croatian: Uzimanje ove vrste lijeka tijekom dugog razdoblja, uzimanje kortikosteroida, pijenje alkohola, jako oslabljen imunološki sustav i prekomjerna tjelesna težina mogu biti neki od mnogih čimbenika rizika za razvoj ove bolesti.
English: The interactions described are based on studies conducted with Descovy, or the components of Descovy as individual agents and/or in combination, or are potential drug-drug interactions that may occur with Descovy.
Croatian: Opisane interakcije temelje se na ispitivanjima koja su provedena s lijekom Descovy ili komponentama lijeka Descovy kao pojedinačnim tvarima i/ili u kombinaciji, ili su potencijalne interakcije lijekova koje se mogu pojaviti s lijekom Descovy.
English: What Descovy is and what it is used for What you need to know before you take Descovy How to take Descovy
Croatian: Što je Descovy i za što se koristi Što morate znati prije nego počnete uzimati lijek Descovy Kako uzimati lijek Descovy
English: If you are on dialysis, take your daily dose of Descovy following completion of dialysis.
Croatian: Ako ste na dijalizi, uzmite svoju dnevnu dozu lijeka Descovy nakon završetka postupka dijalize.
English: No data are available to make dose recommendations in children less than 18 years with end stage renal disease.
Croatian: Nema dostupnih podataka na temelju kojih bi se mogla preporučiti doza u djece mlađe od 18 godina sa završnim stadijem bolesti bubrega.
English: If you have hepatitis B liver problems may become worse after you stop taking Descovy.
Croatian: Ako imate hepatitis B, tegobe s jetrom mogu se pogoršati nakon što prestanete uzimati lijek Descovy.
English: 2 When data are available from drug-drug interaction studies.
Croatian: 2 Kada su podaci dostupni iz ispitivanja interakcija lijekova.
English: The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 μM.
Croatian: Vrijednosti 50% učinkovite koncentracije (EC50) za emtricitabin bile su u rasponu od 0,0013 do 0,64 µM.