FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Adynovi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Croatian: Tvrtka koja stavlja na tržište lijek Adynovi provest će ispitivanje u cilju istraživanja potencijalnih učinaka nakupljanja PEG-a u koroidnom spletu mozga i drugim organima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Adynovi have also 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 Adynovi nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Adynovi?
Croatian: Koji su rizici povezani s lijekom Adynovi?
English: Adynovi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Croatian: Adynovi se izdaje samo na liječnički recept, a liječenje mora biti pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: In the second study in 66 children aged below 12 years, all patients were given Adynovi as a twiceweekly preventive treatment for around 6 months.
Croatian: U drugom ispitivanju koje je uključivalo 66 djece mlađe od 12 godina, lijek Adynovi svim je bolesnicima davan dvaput tjedno kao preventivna terapija tijekom otprilike šest mjeseci.
English: The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Croatian: Doza i učestalost liječenja ovise o tome primjenjuje li se lijek za liječenje ili sprječavanje krvarenja, kao i o stupnju hemofilije, jačini i mjestu krvarenja te stanju i tjelesnoj težini bolesnika.
English: It replaces the missing factor VIII, thereby helping the blood to clot and giving temporary control of the bleeding disorder.
Croatian: On zamjenjuje faktor VIII koji nedostaje i time potpomaže zgrušavanje krvi te omogućuje privremenu kontrolu poremećaja krvarenja.
English: Following treatment with factor VIII products, including Adynovi, some patients may develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Croatian: Nakon liječenja lijekovima koji sadrže faktor VIII, uključujući Adynovi, u nekih bolesnika mogu se razviti inhibitori (protutijela) faktora VIII koji onemogućuju djelovanje lijeka i dovode do gubitka kontrole nad krvarenjem.
English: Adynovi must not be used in patients who are hypersensitive (allergic) to rurioctocog alfa pegol or the related substance octocog alfa or to any of the other ingredients of the medicine, nor in those with known allergy to mouse or hamster proteins.
Croatian: Adynovi se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na rurioktokog alfa pegol ili srodnu tvar oktokog alfa ili na bilo koji drugi sastojak lijeka, kao ni u bolesnika alergičnih na bjelančevine miša ili hrčka.
English: However, part of the active substance in Adynovi (called PEG) may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Croatian: Međutim, dio djelatne tvari u lijeku Adynovi (koji se naziva PEG) može se nakon dugotrajnog liječenja nakupljati u tijelu, uključujući u strukturi u mozgu koja se naziva koroidni splet.
English: In addition, when bleeding did occur, Adynovi was rated excellent or good at treating around 96% of bleeding episodes.
Croatian: Osim toga, u slučajevima pojave krvarenja, lijek Adynovi ocijenjen je izvrsnim ili dobrim pri liječenju otprilike 96 % epizoda krvarenja.
English: For more information about treatment with Adynovi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Adynovi pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: When bleeding occurred, Adynovi was rated excellent or good at treating around 90% of episodes.
Croatian: U slučajevima pojave krvarenja, lijek Adynovi ocijenjen je izvrsnim ili dobrim pri liječenju otprilike 90 % epizoda.
English: Patients or their carers may be able to inject Adynovi themselves at home once they have been trained appropriately.
Croatian: Nakon odgovarajuće obuke, bolesnici ili njihovi njegovatelji mogu samostalno ubrizgavati lijek Adynovi kod kuće.
English: Adynovi is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Croatian: Lijek Adynovi dostupan je u obliku praška i otapala koji se miješaju kako bi se pripremila otopina za intravensku injekciju.
English: How is Adynovi used?
Croatian: Kako se Adynovi koristi?
English: What benefits of Adynovi have been shown in studies?
Croatian: Koje su koristi od lijeka Adynovi utvrđene u ispitivanjima?
English: Adynovi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII.
Croatian: Adynovi je lijek koji se primjenjuje za liječenje i sprječavanje krvarenja u bolesnika s hemofilijom A, nasljednim poremećajem krvarenja koji je uzrokovan manjkom bjelančevine za zgrušavanje naziva faktor VIII.
English: For practical information about using Adynovi, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Adynovi bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: How does Adynovi work?
Croatian: Kako djeluje Adynovi?
English: Adynovi has been shown in two main studies to be effective at preventing and treating bleeding episodes in patients with severe haemophilia who were previously treated with other factor VIII products.
Croatian: U dvama glavnim ispitivanjima lijek Adynovi pokazao se djelotvornim u sprječavanju i liječenju epizoda krvarenja u bolesnika s teškom hemofilijom koji su prethodno liječeni drugim lijekovima koji sadrže faktor VIII.
English: Studies show that Adynovi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.
Croatian: Ispitivanja pokazuju da je lijek Adynovi učinkovit u sprječavanju i liječenju epizoda krvarenja u bolesnika s hemofilijom A te da je njegova sigurnost usporediva sa sigurnošću drugih lijekova koji sadrže faktor VIII.
English: Adynovi contains the active substance rurioctocog alfa pegol.
Croatian: Lijek Adynovi sadrži djelatnu tvar rurioktokog alfa pegol.
English: For the full list of all side effects see the package leaflet.
Croatian: Potpuni popis svih nuspojava potražite u uputi o lijeku.
English: EU/1/18/1335/001 POTELIGEO 4 mg/ml
Croatian: EU/1/18/1335/001 POTELIGEO
English: 5 ml
Croatian: 4 mg/ml
English: Intravenous use Vial (glass)
Croatian: Intravensku primjenu
English: Invented Name Strength Pharmaceutical Form
Croatian: Farmaceutski oblik Put primjene
English: Pack size
Croatian: 84 tablete
English: 3 pre-filled syringes
Croatian: 3 napunjene brizgalice
English: 1 pre-filled syringe
Croatian: 1 napunjena brizgalica
English: Vaccination campaigns are conducted normally twice a year in spring and autumn for consecutive years, until at least 2 years after the last confirmed case of rabies in the area.
Croatian: Kampanje cijepljenja obično se provode dvaput godišnje, u proljeće i jesen, tijekom više uzastopnih godina, do najmanje dvije godine nakon zadnjeg potvrđenog slučaja bjesnoće u tom području.
English: There are no known side effects.
Croatian: Nema poznatih nuspojava.
English: The protection against the virus lasts at least 6 months.
Croatian: Zaštita od virusa traje najmanje šest mjeseci.
English: The full EPAR for Rabitec can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Rabitec nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The baits are distributed by land or air and the vaccination area should be larger than 5,000 km2.
Croatian: Mamci se distribuiraju kopnom ili zrakom, a područje cijepljenja mora biti veće od 5 000 km2.
English: The baits should be handled with care.
Croatian: Mamcima treba pažljivo rukovati.
English: This summary was last updated in October 2017.
Croatian: Sažetak je posljednji put ažuriran u 10.2017.
English: Why is Rabitec approved?
Croatian: Zašto je VMP Rabitec odobren?
English: Protection lasts at least 6 months after vaccination.
Croatian: Zaštita traje najmanje šest mjeseci nakon cijepljenja.
English: What is Rabitec and what is it used for?
Croatian: Što je Rabitec i za što se koristi?
English: It presents a risk for people since it can be transmitted by bites or saliva from an infected animal.
Croatian: Predstavlja rizik za ljude jer se može prenijeti ugrizom ili slinom zaražene životinje.
English: It is not intended to provide practical advice on how to use Rabitec.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Rabitec.
English: animals are exposed to the rabies virus, the immune system will be able to respond more quickly, which will help to protect against the disease.
Croatian: Ako životinje u budućnosti budu izložene virusu bjesnoće, imunosni sustav moći će brže reagirati, što pomaže u zaštiti od bolesti.
English: To protect rabies free areas, vaccination may also be carried out at the border of these areas (vaccination belts) or in the form of spot vaccinations.
Croatian: Kako bi se zaštitila područja u kojima nema bjesnoće, cijepljenje se također može provoditi na granicama tih područja (pojasevi cijepljenja) ili u obliku točaka cijepljenja.
English: What are the risks associated with Rabitec?
Croatian: Koji su rizici povezani s VMP-om Rabitec?
English: The European Commission granted a marketing authorisation valid throughout the EU for Rabitec on 1 December 2017.
Croatian: Europska komisija dala je odobrenje za stavljanje u promet koje je za VMP Rabitec na snazi u Europskoj uniji od 01/12/2017.
English: Laboratory studies showed that around 90% of foxes and raccoon dogs produce antibodies against the rabies virus within 15 days of eating the bait.
Croatian: Laboratorijska ispitivanja pokazala su da, nakon što pojedu mamac, otprilike 90 % lisica i kunopasa stvara protutijela na virus bjesnoće unutar 15 dana.
English: When a fox or raccoon dog chews a bait and the vaccine is released in the animal's mouth, the immune system recognises the virus as ‘foreign' and makes defences against it.
Croatian: Nakon što lisica ili kunopas prožvače mamac i cjepivo se otpusti u usta životinje, imunosni sustav prepoznaje virus kao „strano
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Rabitec's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) pri Agenciji odlučio je da koristi od VMP-a Rabitec nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Rabitec is available as a liquid (suspension) contained in a bait pellet scented with fish meal to be chewed.
Croatian: VMP Rabitec dostupan je kao tekućina (suspenzija) sadržana u peletu mamca za žvakanje s mirisom ribe.
English: Rabies is a life threatening viral disease that causes inflammation in the brain.
Croatian: Bjesnoća je virusna bolest opasna po život koja uzrokuje upalu mozga.
English: In case of skin or eye contact with the vaccine fluid the affected area should be rinsed immediately with water.
Croatian: Ako tekućina s cjepivom dođe u doticaj s kožom ili očima, zahvaćeno područje treba odmah isprati vodom.
English: Rabitec is a vaccine.
Croatian: Rabitec je cjepivo.
English: Rabitec is a veterinary vaccine used to protect wild foxes and raccoon dogs against rabies.
Croatian: Rabitec je veterinarsko cjepivo koje se koristi za zaštitu divljih lisica i kunopasa od bjesnoće.
English: The number of baits distributed depends on the density of the fox and raccoon dog population and the nature of the vaccination area.
Croatian: Broj mamaca koji se distribuiraju ovisi o gustoći populacije lisica i kunopasa te o prirodi područja cijepljenja.
English: Rabitec rabies virus vaccine (live)
Croatian: Rabitec cjepivo protiv virusa bjesnoće (živo)
English: Medical advice should be sought immediately and the package leaflet or label shown to the doctor, who should follow WHO recommendations for rabies exposure.
Croatian: Potrebno je odmah potražiti liječnički savjet te pokazati uputu o proizvodu ili naljepnicu, a liječnik treba postupati sukladno preporukama Svjetske zdravstvene organizacije za izloženost virusu bjesnoće.
English: Rabitec contains a weakened rabies virus that does not cause the disease.
Croatian: Rabitec sadržava oslabljen virus bjesnoće koji ne uzrokuje bolest.
English: This is a summary of the European public assessment report (EPAR) for Rabitec.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) veterinarsko-medicinskog proizvoda Rabitec.
English: Other information about Rabitec?
Croatian: Ostale informacije o VMP-u Rabitec
English: What benefits of Rabitec have been shown in studies?
Croatian: Koje su koristi od VMP-a Rabitec utvrđene u ispitivanjima?
English: Rabitec contains a modified live rabies virus which has been weakened so that it does not cause disease.
Croatian: VMP Rabitec sadržava živi, modificirani virus bjesnoće koji je oslabljen tako da ne uzrokuje bolest.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Rabitec, including the appropriate precautions to be followed by healthcare professionals and people who handle the product or come into contact with it.
Croatian: U sažetku opisa svojstava VMP-a kao i u uputi o VMP-u Rabitec nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se trebaju pridržavati veterinari i osobe koje rukuju VMP-om ili dolaze u kontakt s njim.
English: How is Rabitec used?
Croatian: Kako se Rabitec koristi?
English: Appropriate measures should be taken to prevent contamination such as wearing protective clothes and disposable rubber gloves, since the vaccine has been prepared with modified live virus.
Croatian: Budući da je cjepivo pripremljeno sa živim, modificiranim virusom, potrebno je poduzeti odgovarajuće mjere kako bi se spriječila kontaminacija, kao što je nošenje zaštitne odjeće i gumenih rukavica za jednokratnu uporabu.
English: For more information about treatment with Rabitec, read the package leaflet.
Croatian: Dodatne informacije o terapiji VMP-om Rabitec pročitajte u uputi o VMP-u.
English: How does Rabitec work?
Croatian: Kako djeluje Rabitec?
English: Luxembourg
Croatian: Luxemburg
English: For adults, the recommended dose is 300 mg once a day.
Croatian: Preporučena je doza za odrasle osobe 300 mg jedanput na dan.
English: Atazanavir Mylan is available as capsules (150 mg, 200 mg and 300 mg).
Croatian: Lijek Atazanavir Mylan dostupan je u obliku kapsula (150 mg, 200 mg i 300 mg).
English: The full EPAR for Atazanavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Atazanavir Mylan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 08-2016.
Croatian: Sažetak je posljednji put ažuriran: MM.2016.
English: It can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection.
Croatian: Izdaje se samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju infekcija HIV-om.
English: Atazanavir Mylan does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Atazanavir Mylan ne liječi infekciju HIV-om ni AIDS, no može odgoditi oštećenje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: This means that Atazanavir Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Reyataz.
Croatian: To znači da je Atazanavir Mylan sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Reyataz.
English: Ritonavir slows down the break-down of atazanavir, increasing the levels of atazanavir in the blood.
Croatian: Ritonavir usporava razgradnju atazanavira i tako povećava razine atazanavira u krvi.
English: It blocks an enzyme called protease, which is needed for the virus to multiply.
Croatian: Djeluje tako da onemogućuje djelovanje enzima koji se naziva proteaza, a koji je potreban za umnožavanje virusa.
English: Atazanavir Mylan is an HIV medicine used to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immunodeficiency syndrome (AIDS).
Croatian: Atazanavir Mylan je lijek protiv HIV-a koji se upotrebljava za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Atazanavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Atazanavir Mylan, kada se uzima u kombinaciji s drugim protuvirusnim lijekovima, smanjuje količinu HIV-a u krvi i održava je na niskoj razini.
English: Blocking the enzyme prevents the virus from multiplying, slowing down the spread of infection.
Croatian: Onemogućavanjem djelovanja enzima sprečava se umnožavanje virusa, što usporava širenje infekcije.
English: This is a summary of the European public assessment report (EPAR) for Atazanavir Mylan.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Atazanavir Mylan.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Mylan (protease inhibitors) do not work.
Croatian: Ne očekuje se da će lijek djelovati u bolesnika u kojih ne djeluju brojni lijekovi koji pripadaju istom razredu kojem pripada i Atazanavir Mylan (inhibitori proteaze).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Atazanavir Mylan has been shown to have comparable quality and to be bioequivalent to Reyataz.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je, u skladu sa zahtjevima EU-a, potvrđeno da Atazanavir Mylan posjeduje usporedivu razinu kvalitete te da je bioekvivalentan lijeku Reyataz.
English: The Committee recommended that Atazanavir Mylan be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za lijek Atazanavir Mylan za uporabu u EU-u.
English: A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster'.
Croatian: Istodobno se obično daje mala doza drugog lijeka, ritonavira, kao „pojačivača” djelovanja.
English: Doctors should prescribe Atazanavir Mylan only after they have looked at which medicines the patient has taken and carried out tests to establish that the virus is likely to respond to Atazanavir Mylan.
Croatian: Liječnici trebaju propisati lijek Atazanavir Mylan tek nakon što provjere koje je lijekove bolesnik uzimao i provedu pretrage kako bi utvrdili da je vjerojatno da će virus reagirati na lijek.
English: Atazanavir Mylan is a ‘generic medicine'.
Croatian: Atazanavir Mylan je „generički lijek”.
English: Atazanavir Mylan is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Croatian: Atazanavir Mylan obično se daje s ritonavirom radi njegova boljeg djelovanja, ali u određenim situacijama liječnici mogu razmotriti mogućnost prestanka davanja ritonavira odraslim bolesnicima.
English: Because Atazanavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Atazanavir Mylan generički lijek i da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atazanavir Mylan 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 Atazanavir Mylan nalaze se u sažetku opisa svojstava lijeka i uputi o lijeku.
English: What measures are being taken to ensure the safe and effective use of Atazanavir Mylan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Atazanavir Mylan?
English: For more information about treatment with Atazanavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Atazanavir Mylan pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: It is not intended to provide practical advice on how to use Atazanavir Mylan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Atazanavir Mylan.
English: What is Atazanavir Mylan and what is it used for?
Croatian: Što je Atazanavir Mylan i za što se koristi?
English: The active substance in Atazanavir Mylan, atazanavir, is a protease inhibitor.
Croatian: Djelatna tvar u lijeku Atazanavir Mylan, atazanavir, inhibitor je proteaze.
English: What are the benefits and risks of Atazanavir Mylan?
Croatian: Koje su koristi i rizici od lijeka Atazanavir Mylan?
English: Other information about Atazanavir Mylan
Croatian: Ostale informacije o lijeku Atazanavir Mylan
English: Therefore, the CHMP's view was that, as for Reyataz, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a da koristi nadmašuju utvrđeni rizik, kao i za lijek Reyataz.
English: For practical information about using Atazanavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Atazanavir Mylan bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.
Croatian: Primjenjuje se za liječenje bolesnika u dobi od 6 godina i starijih, u kombinaciji s malom dozom ritonavira i drugim protuvirusnim lijekovima.
English: Why is Atazanavir Mylan approved?
Croatian: Zašto je Atazanavir Mylan odobren?
English: In younger patients, the dose of Atazanavir Mylan depends on body weight.
Croatian: Doza lijeka Atazanavir Mylan za mlađe bolesnike ovisi o njihovoj tjelesnoj težini.
English: Because Atazanavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Reyataz.
Croatian: Budući da je lijek Atazanavir Mylan generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje njegove bioekvivalentnosti s referentnim lijekom Reyataz.
English: How does Atazanavir Mylan work?
Croatian: Kako djeluje Atazanavir Mylan?
English: How is Atazanavir Mylan used?
Croatian: Kako se koristi Atazanavir Mylan?