FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Riarify used?
Croatian: Kako se Riarify primjenjuje?
English: The three active substances in Riarify work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.
Croatian: Tri djelatne tvari u lijeku Riarify različito djeluju na smanjenje upale i održavanje prohodnosti dišnih putova, čime se bolesniku omogućuje lakše disanje.
English: Riarify is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD.
Croatian: Lijek Riarify učinkovito smanjuje učestalost pogoršanja bolesti i poboljšava funkciju pluća u bolesnika s KOPB-om.
English: For the full list of side effects and restrictions with Riarify, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih prilikom primjene lijeka Riarify potražite u uputi o lijeku.
English: These usually disappear without any treatment.
Croatian: Obično nestaju bez ikakvog liječenja.
English: Contact with the skin, eyes or mouth should be avoided.
Croatian: Potrebno je izbjegavati kontakt s kožom, očima ili ustima.
English: This overview was last updated in September 2019.
Croatian: Pregled informacija posljednji je put ažuriran u rujnu 2019.
English: The need to re-treat cats and the time interval between treatments requires veterinary assessment.
Croatian: Potrebu za ponovnim tretmanom mačaka i vremenski razmak između tretmana treba procijeniti veterinar.
English: Vectra Felis must not be used in cats or kittens weighing less than 0.6 kg.
Croatian: Vectra Felis ne smije se koristiti u mačaka ili mačića koji teže manje od 0,6 kg.
English: Treated cats should not be permitted to sleep with their owners, especially children, on the day of treatment.
Croatian: Na dan tretmana tretiranim mačkama ne smije se dopustiti spavanje s vlasnicima, posebice s djecom.
English: Further information on Vectra Felis can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-felis.
Croatian: Više informacija o VMP-u Vectra Felis nalazi se na internetskim stranicama Agencijeema.europa.eu/medicines/veterinary/EPAR/vectra-felis.:
English: This means that it kills parasites that occur on the skin or in the fur of animals, such as fleas that feed on the animal's skin.
Croatian: To znači da ubija parazite koji se pojavljuju na koži ili u dlaci životinja, kao što su buhe koje se hrane kožom životinje.
English: People must not handle treated cats for at least eight hours after application of the veterinary medicine.
Croatian: Ljudi ne smiju dirati tretirane mačke najmanje osam sati nakon primjene proizvoda.
English: Hands should be thoroughly washed immediately after use.
Croatian: Odmah nakon upotrebe potrebno je temeljito oprati ruke.
English: Dinotefuran is an insecticide which kills insects by acting on receptors (targets) in their nervous system called nicotinic acetylcholine receptors.
Croatian: Dinotefuran je insekticid koji ubija insekte djelujući na receptore (ciljeve) u njihovu živčanom sustavu naziva nikotinski acetilkolinski receptori.
English: The effectiveness of Vectra Felis against fleas was investigated in a large number of laboratory studies and in one field study.
Croatian: Učinkovitost VMP-a Vectra Felis protiv buha istražena je u velikom broju laboratorijskih ispitivanja i u jednom terenskom ispitivanju.
English: Vectra Felis (dinotefuran / pyriproxyfen)
Croatian: Vectra Felis (dinotefuran/piriproksifen)
English: Other information about Vectra Felis
Croatian: Druge informacije o VMP-u Vectra Felis
English: Vectra Felis (dinotefuran / pyriproxyfen) EMA/206131/2014
Croatian: Vectra Felis (dinotefuran/piriproksifen) EMA/206131/2014
English: Vectra Felis acts as an ectoparasiticide.
Croatian: Vectra Felis djeluje kao ektoparaziticid.
English: Vectra Felis received a marketing authorisation valid throughout the EU on 6 June 2014.
Croatian: Za VMP Vectra Felis izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od 6. lipnja 2014.
English: Vectra Felis was as effective as the comparator product and reduced flea counts by 91% over the 84 day study period.
Croatian: VMP Vectra Felis pokazao se jednako učinkovitim kao i usporedni proizvod te je njegovom primjenom tijekom 84-dnevnog ispitivanja broj buha smanjen za 91 %.
English: The field study involved 129 cats with flea infestations that were treated once a month for three consecutive months either with Vectra Felis or with another spot-on product containing two different substances, fipronil and (S)-methoprene, that control fleas.
Croatian: Terensko je ispitivanje obuhvatilo 129 mačaka zaraženih buhama koje su jednom mjesečno tijekom tri uzastopna mjeseca liječene VMP-om Vectra Felis ili drugim lijekom za nakapavanje koji sadrži dvije različite tvari koje kontroliraju buhe, tj. fipronil i (S)-metopren.
English: In case of accidental spillage onto skin, the area should be washed off immediately with soap and water.
Croatian: U slučaju nehotičnog izlijevanja na kožu, zahvaćeno područje treba odmah isprati sapunom i vodom.
English: People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.
Croatian: Osobe preosjetljive (alergične) na bilo koji sastojak lijeka trebaju izbjegavati kontakt s ovim veterinarsko-medicinskim proizvodom.
English: The most common side effects with Vectra Felis (which may affect up to 1 in 1000 cats) are a slight scaling of the skin, temporary redness and itching or temporary hair loss at the application site.
Croatian: Najčešće nuspojave VMP-a Vectra Felis (koje se mogu javiti u najviše 1 od 1000 mačaka) jesu lagano ljuskanje kože, prolazno crvenilo i svrbež ili privremeni gubitak dlake na mjestu primjene.
English: If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Croatian: Ako iritacija kože ili očiju potraje ili ako se lijek nehotice proguta, odmah potražite savjet liječnika i pokažite mu uputu o VMP-u ili naljepnicu.
English: What is Vectra Felis and what is it used for?
Croatian: Što je Vectra Felis i za što se koristi?
English: The European Medicines Agency decided that Vectra Felis' 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 VMP-a Vectra Felis nadmašuju s njim povezane rizike te da se može izdati odobrenje za njegovu primjenu u EU-u.
English: Used applicators should be disposed of immediately and not left within the sight or reach of children.
Croatian: Upotrijebljene aplikatore ne smije se ostaviti unutar vidokruga ili dohvata djece, već ih treba odmah baciti.
English: An overview of Vectra Felis and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Vectra Felis i zašto je odobren u EU-u
English: If accidental exposure to the eyes occurs, the eyes should be rinsed with water with the eyelids open and for a sufficient length of time.
Croatian: Ako dođe do slučajnog izlaganja očiju, treba ih dovoljno dugo ispirati vodom, pri čemu kapci trebaju biti otvoreni.
English: The content of one full Vectra Felis applicator is applied directly to the cat's skin, after parting its fur, at the base of the cat's head.
Croatian: Sadržaj jednog punog aplikatora s VMP-om Vectra Felis primjenjuje se izravno na kožu na bazi mačje glave nakon što se razmakne dlaka.
English: It also prevents fleas from hatching and developing in the cat's environment.
Croatian: Osim toga sprječava izlijeganje i razvoj buha u mačkinom okruženju.
English: Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as by blocking the development of immature flea stages into adults.
Croatian: Piriproksifen je regulator rasta insekata koji zaustavlja životni ciklus buha tako što uzrokuje stvaranje neplodnih jajašaca i inhibira razvoj nezrelih buha u odrasle jedinke.
English: Vectra Felis is a veterinary medicine used to treat and prevent flea infestations in cats.
Croatian: Vectra Felis je veterinarsko-medicinski proizvod koji se koristi u mačaka za liječenje i sprječavanje infestacija buhama.
English: What are the risks associated with Vectra Felis?
Croatian: Koji su rizici povezani s VMP-om Vectra Felis?
English: Vectra Felis is available as a spot-on solution in an applicator and can be obtained without a prescription.
Croatian: VMP Vectra Felis dostupan je kao otopina za nakapavanje u aplikatoru i izdaje se bez recepta.
English: For a full list of all side-effects reported with Vectra Felis, see the package leaflet.
Croatian: Potpuni popis svih prijavljenih nuspojava povezanih s VPM-om Vectra Felis pročitajte u uputi o VMP-u.
English: Why is Vectra Felis authorised in the EU?
Croatian: Zašto je VMP Vectra Felis odobren u EU-u?
English: After a single treatment, Vectra Felis prevents fleas for one month and blocks the flea life cycle so preventing infestation in the cat's environment for three months.
Croatian: Jednom primjenom VMP-a Vectra Felis sprječava se pojava buha tijekom mjesec dana i prekida životni ciklus buha, čime se sprječava infestacija mačkinog okruženja tijekom tri mjeseca.
English: How does Vectra Felis work?
Croatian: Na koji način Vectra Felis djeluje?
English: What benefits of Vectra Felis have been shown in studies?
Croatian: Koje su koristi od VMP-a Vectra Felis utvrđene u ispitivanjima?
English: How is Vectra Felis used?
Croatian: Kako se Vectra Felis primjenjuje?
English: * adsorbed on aluminium phosphate
Croatian: * adsorbirani na aluminijev fosfat
English: 0.5 milligram Al3+
Croatian: 0,5 milligrama Al3+
English: Strength Pharmaceutical form
Croatian: Broj rješenja (EU) Ime lijeka Jačina Farmaceutski oblik
English: --1 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1* 1
Croatian: --1 1 doza (0,5 ml) sadrži: Pneumokokni polisaharid serotipa 1* 1
English: 3 conjugated to diphtheria toxoid carrier protein
Croatian: 3 konjugiran na difterijski toksoid proteinski nosač
English: Pneumococcal polysaccharide serotype 18C* 2
Croatian: Pneumokokni polisaharid serotipa 18C* 2
English: 1 vial
Croatian: Sadržaj
English: 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
Croatian: 1 konjugirani na protein D, proteinski nosač (dobiven iz netipiziranog Haemophilus influenzae) 9-16 mikrograma 2 konjugiran na tetanusni toksoid proteinski nosač
English: 10 pre-filled syringes + 10 needles
Croatian: 10 napunjenih štrcaljki + 10 igala
English: Pneumococcal polysaccharide serotype 9V* 1
Croatian: Pneumokokni polisaharid serotipa 9V* 1
English: Pneumococcal polysaccharide serotype 6B* 1
Croatian: Pneumokokni polisaharid serotipa 6B* 1
English: The full EPAR for Darunavir Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Darunavir Krka nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Darunavir Krka may be given to adults or children from 3 years of age and weighing at least 15 kg.
Croatian: Darunavir Krka može se dati odraslim osobama ili djeci starijoj od 3 godine čija je tjelesna težina najmanje 15 kg.
English: This means that Darunavir Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
Croatian: To znači da Darunavir Krka sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Prezista.
English: As for every medicine, the company provided studies on the quality of Darunavir Krka.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Darunavir Krka.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenoj primjeni već su provedena za referentni lijek, Prezista, te ih ne treba ponavljati za lijek Darunavir Krka.
English: What measures are being taken to ensure the safe and effective use of Darunavir Krka?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Darunavir Krka?
English: This is a summary of the European public assessment report (EPAR) for Darunavir Krka.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Darunavir Krka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka has been shown to have comparable quality and to be bioequivalent to Prezista.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, utvrđeno da lijek Darunavir Krka posjeduje usporedivu kakvoću i da je bioekvivalentan lijeku Prezista.
English: Darunavir Krka does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Darunavir Krka ne liječi infekciju HIV-om ni AIDS, no liječenje HIV-a može odgoditi oštećenje imunosnog sustava te razvoj infekcija i bolesti povezanih s AIDS-om.
English: What are the benefits and risks of Darunavir Krka?
Croatian: Koje su koristi i rizici od lijeka Darunavir Krka?
English: Because Darunavir Krka 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 Darunavir Krka generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: What is Darunavir Krka and what is it used for?
Croatian: Što je Darunavir Krka i za što se koristi?
English: The medicine is always taken with low-dose ritonavir and with other HIV medicines, and should be taken with food.
Croatian: Lijek se uvijek uzima s niskim dozama ritonavira i u kombinaciji s drugim lijekovima protiv virusa HIV-a, a uzima se uz obrok.
English: Darunavir Krka is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Lijek Darunavir Krka protuvirusni je lijek koji se primjenjuje u kombinaciji s drugim lijekovima protiv virusa HIV-a za liječenje osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Krka 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 Darunavir Krka nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The Agency recommended that Darunavir Krka be approved for use in the EU.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka Darunavir Krka u promet u EU-u.
English: For more information about treatment with Darunavir Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Darunavir Krka pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: It is not intended to provide practical advice on how to use Darunavir Krka.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Darunavir Krka.
English: Darunavir Krka is a ‘generic medicine'.
Croatian: Darunavir Krka je „generički lijek”.
English: For practical information about using Darunavir Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Darunavir Krka bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Darunavir Krka can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV.
Croatian: Darunavir Krka izdaje se samo na liječnički recept, a liječenje mora započeti zdravstveni radnik s iskustvom u liječenju HIV-a.
English: The active substance in Darunavir Krka, darunavir, is a protease inhibitor.
Croatian: Djelatna tvar u lijeku Darunavir Krka, darunavir, inhibitor je proteaze.
English: Other information about Darunavir Krka
Croatian: Ostale informacije o lijeku Darunavir Krka
English: Darunavir Krka is always given with ritonavir.
Croatian: Darunavir Krka uvijek se daje uz ritonavir.
English: Darunavir Krka contains the active substance darunavir.
Croatian: Darunavir Krka sadržava djelatnu tvar darunavir.
English: Darunavir Krka, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Croatian: Kad se uzima u kombinaciji s drugim lijekovima protiv HIV-a, Darunavir Krka smanjuje koncentraciju HIV-a u krvi i održava je na niskoj razini.
English: Darunavir Krka is available as tablets.
Croatian: Darunavir Krka dostupan je u obliku tableta.
English: Why is Darunavir Krka approved?
Croatian: Zašto je lijek Darunavir Krka odobren?
English: How is Darunavir Krka used?
Croatian: Kako se Darunavir Krka koristi?
English: How has Darunavir Krka been studied?
Croatian: Kako je Darunavir Krka ispitivan?
English: How does Darunavir Krka work?
Croatian: Kako djeluje Darunavir Krka?
English: Many may feel quite normal.
Croatian: Mnogi se mogu osjećati sasvim normalno.
English: Elderly people (over 65 years)
Croatian: Starije osobe (više od 65 godina)
English: In other patients, one or the other effect may be dominant.
Croatian: U ostalih bolesnika bi jedan ili drugi učinak mogao biti dominantan.
English: - if you are more than 3 months pregnant.
Croatian: - ako ste trudni dulje od 3 mjeseca.
English: You may require medical attention.
Croatian: Možda će Vam trebati liječnička pomoć.
English: Date of latest renewal: 27 August 2018
Croatian: Datum posljednje obnove odobrenja: 27. kolovoza 2018.
English: This is because the safety and benefits of this medicine are not known in this population.
Croatian: To je zato što sigurnost i koristi ovog lijeka nisu poznati u ovoj populaciji.
English: Mean duration of follow-up was 3.5 years.
Croatian: Srednja vrijednost trajanja praćenja bila je 3,5 godina.
English: Animal studies are insufficient.
Croatian: Ispitivanja na životinjama su nedostatna.
English: Additional information on individual components
Croatian: Dodatne informacije o pojedinačnim komponentama
English: CYP450 interactions
Croatian: CYP450 interakcije
English: The mean half-life is about 40 hours (range 34-41 hours).
Croatian: Srednja vrijednost poluvijeka je oko 40 sati (raspon 34-41 sat).
English: The mechanism of this effect has not been established.
Croatian: Nije utvrđen mehanizam ovog učinka.
English: - if the patient is less than 2 years of age.
Croatian: - ako je bolesnik mlađi od 2 godine.
English: These combinations were efficacious and well tolerated.
Croatian: Te su kombinacije bile učinkovite te su se dobro podnosile.
English: The antihypertensive effect is largely manifested within 1 week and the maximum effect is generally seen within 4 weeks.
Croatian: Antihipertenzivni učinak se uglavnom očituje unutar 1 tjedna, a maksimalni učinak se općenito vidi unutar 4 tjedna.
English: It is very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects.
Croatian: Vrlo je važno da uzimate ovaj lijek točno onako kako Vam je rekao liječnik kako biste postigli najbolje rezultate i smanjili rizik od nuspojava.
English: • Inability to achieve or maintain erection
Croatian: • nemogućnost postizanja ili održavanja erekcije
English: − Second and third trimesters of pregnancy (see section 4.6).
Croatian: Drugo i treće tromjesečje trudnoće (vidjeti dio 4.6).
English: No interactions have been identified.
Croatian: Nisu otkrivene interakcije.
English: All three doses were well tolerated in both elderly and very elderly patients.
Croatian: Sve tri doze dobro su se podnosile među starim tako i među vrlo starim bolesnicima.
English: • Increased sensitivity of skin to the sun
Croatian: • povećana osjetljivost kože na sunce
English: • Sad mood (depression)
Croatian: • tužno raspoloženje (depresija)
English: The tablets should be swallowed whole with some water.
Croatian: Tablete trebaju biti progutane cijele uz malo vode.
English: In some cases this occurred as part of a hypersensitivity reaction.
Croatian: U nekim slučajevima pojavila se kao dio reakcije preosjetljivosti.
English: The age at which the transporter system is mature cannot be determined.
Croatian: Dob u kojoj je sustav prijenosa zreo ne može se utvrditi.
English: Additional information on aliskiren interactions
Croatian: Dodatne informacije o interakcijama aliskirena
English: Lowering the blood pressure to a normal level reduces the risk of developing these disorders.
Croatian: Snižavanjem krvnoga tlaka na normalnu razinu smanjuje se rizik od razvoja tih poremećaja.
English: • Reduced appetite
Croatian: • smanjen apetit
English: - if you suffer from heart problems.
Croatian: - ako patite od srčanih problema.
English: Treatment of essential hypertension in adults.
Croatian: Liječenje esencijalne hipertenzije u odraslih.
English: - if you have serious congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).
Croatian: - ako imate ozbiljno kongestivno zatajenje srca (vrsta bolesti srca u kojoj srce ne može pumpati dovoljno krvi za opskrbu cijelog tijela).
English: Some side effects can be serious: A few patients have experienced these serious side effects.
Croatian: Pojedine nuspojave mogu biti ozbiljne: Nekoliko je bolesnika imalo ove ozbiljne nuspojave.
English: Results of the neurocognitive assessments showed some improvements in most of the test scores, with no meaningful difference between the treatment groups.
Croatian: Rezultati neurokognitivnih ocjena pokazali su nešto poboljšanja u većini rezultata testova, bez značajne razlike između liječenih skupina.
English: Mechanisms responsible for the deviation from dose proportionality have not been identified.
Croatian: Nisu utvrđeni mehanizmi koji su odgovorni za odstupanje od proporcionalnosti doza.
English: Do not take this medicine if you are pregnant (see section ‘Do not take Rasilez HCT').
Croatian: Nemojte uzimati ovaj lijek ako ste trudni (pogledajte dio „Nemojte uzimati Rasilez HCT“).
English: Chloride deficit is generally mild and usually does not require treatment.
Croatian: Nedostatak klorida je općenito blag i obično ne zahtjeva liječenje.
English: Therefore, caution should be exercised in these patients.
Croatian: Stoga je nužan oprez u tih bolesnika.
English: The blood pressure lowering effect is present within one week after beginning treatment.
Croatian: Učinak snižavanja krvnog tlaka prisutan je u unutar tjedan dana nakon početka liječenja.
English: It reduces the amount of angiotensin II the body can make.
Croatian: Smanjuje količinu angiotenzina II koji tijelo može stvarati.
English: The antihypertensive effect of a single dose of the combination persisted for 24 hours.
Croatian: Antihipertenzivni učinak jednokratne doze kombinacije održao se 24 sata.
English: One dosage unit contains no more than 100 micrograms of gluten.
Croatian: Jedna dozna jedinica ne sadrži više od 100 mikrograma glutena.
English: If you experience this symptom, do not drive or use tools or machines.
Croatian: Ako osjetite taj simptom, nemojte upravljati vozilima niti rukovati alatima ili strojevima.
English: Currently available data are described in sections 4.8, 5.1, and 5.2.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8, 5.1 i 5.2.
English: Not recommended (see section 4.2)
Croatian: Ne preporučuje se (vidjeti dio 4.2)