FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 3 year core study the rate per 1,000 women-years for ischaemic strokes was similar between the 20 mg bazedoxifene (1.98) and placebo (2.2) groups and higher in the 40 mg bazedoxifene (2.72) group.
Croatian: U trogodišnjem osnovnom ispitivanju je stopa ishemijskog moždanog udara na 1000 žena-godina bila podjednaka u skupinama koje su primale bazedoksifen u dozi od 20 mg (1,98) odnosno placebo (2,2), a veći u skupini koja je primala bazedoksifen u dozi od 40 mg (2,72).
English: After 5 years of treatment the rate per 1,000 women-years for ischaemic strokes was similar between the 20 mg bazedoxifene (1.87) and the placebo (2.02) groups.
Croatian: Nakon 5 godina liječenja stopa ishemijskog moždanog udara na 1000 žena-godina bila je podjednaka u skupinama koje su primale bazedoksifen 20 mg (1,87) odnosno placebo (2,02).
English: Lactose monohydrate Microcrystalline cellulose Pregelatinised starch (maize) Sodium starch glycolate Sodium lauryl sulfate
Croatian: Jezgra tablete: laktoza hidrat celuloza, mikrokristalična škrob, prethodno geliran (kukuruzni) natrijev škroboglikolat natrijev laurilsulfat silicijev dioksid, koloidni, bezvodni magnezijev stearat askorbatna kiselina
English: After 7 years the rate per 1,000 women-years was 2.06 in the bazedoxifene 20 mg group and 1.36 in the placebo group (relative risk 1.51).
Croatian: Nakon 7 godina je stopa na 1000 žena-godina u skupini liječenoj bazedoksifenom 20 mg iznosila 2,06, a u skupini koja je primala placebo 1,36 (relativan rizik 1,51).
English: There was one case of ovarian cancer in the 40 mg treatment group up to 5 years.
Croatian: U skupini liječenoj bazedoksifenom 40 mg do 5 godina zabilježen je jedan slučaj raka jajnika.
English: The rate per 1,000 women years for transient ischaemic attacks (TIA) was similar between the 20 mg bazedoxifene (1.1) and placebo (0.88) groups and higher in the 40 mg bazedoxifene (1.59) group.
Croatian: Stopa prolaznih ishemijskih ataka (TIA) na 1000 žena-godina bila je podjednaka u skupinama koje su primale bazedoksifen u dozi od 20 mg (1,1) odnosno placebo (0,88), a veći u skupini koja je primala bazedoksifen u dozi od 40 mg
English: There were no cases on thyroid cancer in the 40 mg treatment group up to 5 years.
Croatian: U skupini liječenoj bazedoksifenom 40 mg do 5 godina nije zabilježen niti jedan slučaj raka štitnjače.
English: Subjects with no baseline fracture n=757
Croatian: a ispitanica s novim prijelomom kralješka Ispitanice bez prijeloma na početku ispitivanja n=757
English: A single 20 mg dose of bazedoxifene was administered to these subjects.
Croatian: Tim je ispitanicama primijenjena jedna doza bazedoksifena od 20 mg.
English: Subjects with 1 baseline fracture n=967
Croatian: a ispitanica s ≥ 1 novim prijelomom kralješka Ispitanice s ≥ 1 prijelomom na početku ispitivanja n=967
English: At 3 years, there were no cases of endometrial cancer and 1 case (0.1%) of endometrial hyperplasia in the bazedoxifene 20 mg-treated subjects.
Croatian: Nakon 3 godine u ispitanica liječenih bazedoksifenom u dozi od 20 mg nije bilo slučajeva raka endometrija, a zabilježen je jedan slučaj (0,1%) hiperplazije endometrija.
English: The highest rate of VTE per 1,000 women-years of follow up was observed during the first year: 4.64 in the bazedoxifene 20 mg group and 1.73 in the placebo group (relative risk 2.69).The rate per 1,000 women-years at 3 years was 2.86 in the bazedoxifene 20 mg group and 1.76 in the placebo group (relative risk 1.63).
Croatian: Najveća stopa VTE-a na 1000 žena-godina praćenja zabilježena je u prvoj godini: 4,64 u skupini liječenoj bazedoksifenom 20 mg te 1,73 u skupini koja je primala placebo (relativan rizik 2,69).
English: The rate per 1,000 women-years at 5 years was 2.34 in the bazedoxifene 20 mg group and 1.56 in the placebo group (relative risk 1.50).
Croatian: Stopa na 1000 žena-godina nakon pet godina je u skupini liječenoj bazedoksifenom 20 mg iznosila 2,34, a u skupini koja je primala placebo 1,56 (relativan rizik 1,50).
English: The mean LS and FN T-scores at baseline were -2.4 and -1.7, respectively.
Croatian: Srednja vrijednost početne T-vrijednosti na lumbalnom dijelu kralježnice bila je -2,4, a na vratu bedrene kosti -1,7.
English: After 7 years of treatment, the rate per 1,000 women-years for ischaemic strokes was the same for the 20 mg bazedoxifene (1.78) and the placebo (1.78) groups.
Croatian: Nakon 7 godina liječenja stopa ishemijskog moždanog udara na 1000 žena-godina bila je jednaka u skupinama koje su primale bazedoksifen 20 mg (1,78) odnosno placebo (1,78).
English: You may notice problems with your eyesight such as blurred vision while taking this medicine.
Croatian: Tijekom liječenja ovim lijekom možete imati tegoba s vidom, primjerice zamagljen vid.
English: if you have or have had a blood clot (for example, in the blood vessels in your legs, lungs, or eyes).
Croatian: ako ste alergični na bazedoksifen ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). ako imate ili ste imali krvni ugrušak (primjerice u krvnim žilama nogu, pluća ili očiju) ako ste trudni ili još uvijek možete zatrudnjeti.
English: Increase in blood triglycerides (fat found in your blood) Increase in liver enzymes
Croatian: alergijska reakcija (uključujući preosjetljivost i urtikariju) osip, svrbež suha usta povišenevrijednosti triglicerida (masnoća koje se nalaze u krvi) povišene vrijednosti jetrenih enzima omamljenost
English: Supplemental calcium and/or vitamin D should be added to the diet if daily intake is inadequate.
Croatian: U prehranu treba dodati nadomjeske kalcija i/ili vitamina
English: The rate per 1,000 women years for TIA was higher for the 20 mg bazedoxifene group (0.94) compared to placebo (0.62).
Croatian: Stopa TIA-a na 1000 žena-godina bila je veća u skupini liječenoj bazedoksifenom 20 mg (0,94) nego u skupini koja je primala placebo (0,62).
English: In the osteoporosis treatment study in 7,492 postmenopausal women (mean age, 66 years), among 1,886 subjects treated with bazedoxifene (20 mg), there were 5 cases of ovarian cancer (0.69 per 1,000) and among 1,885 subjects treated with placebo, there were 0 cases of ovarian cancer after 7 years of treatment.
Croatian: U ispitivanju liječenja osteoporoze sa 7492 žene u postmenopauzi (prosječne dobi 66 godina) nakon 7 godina je među 1886 žena liječenih bazedoksifenom (20 mg) zabilježeno 5 slučajeva raka jajnika (0,69 na 1000), dok među 1885 ispitanica koje su primale placebo nije zabilježen niti jedan slučaj raka jajnika.
English: In the osteoporosis treatment study in 7,492 postmenopausal women (mean age, 66 years), among 1,886 subjects treated with bazedoxifene (20 mg), there were 5 cases of thyroid cancer (0.69 per 1,000) and among 1,885 subjects treated with placebo, there was 1 case of thyroid cancer (0.14 per 1,000) after 7 years of treatment.
Croatian: U ispitivanju liječenja osteoporoze sa 7492 žene u postmenopauzi (prosječne dobi 66 godina) nakon 7 godina je među 1886 žena liječenih bazedoksifenom (20 mg) zabilježeno 5 slučajeva raka štitnjače (0,69 na 1000), dok je među 1885 ispitanica koje su primale placebo zabilježen 1 slučaj raka štitnjače (0,14 na 1000).
English: The rate per 1,000 women years for TIA was higher for the bazedoxifene 20 mg group (0.96) compared to placebo (0.55).
Croatian: Stopa TIA-a na 1000 žena-godina bila je veća u skupini liječenoj bazedoksifenom 20 mg (0,96) nego u skupini koja je primala placebo (0,55).
English: CONBRIZA is for use only by postmenopausal women.
Croatian: Lijek CONBRIZA smiju koristiti samo žene u postmenopauzi.
English: In rabbit studies, abortion and an increased incidence of heart (ventricular septal defect) and skeletal system (ossification delays, misshapen or misaligned bones, primarily of the spine and skull) anomalies in the foetuses were present at maternally toxic doses of 0.5 mg/kg/day (1.5 times the human exposure).
Croatian: U istraživanjima na kunićima su pri dozama toksičnima za majku od 0,5 mg/kg na dan (1,5 puta veća izloženost nego u ljudi) zabilježeni su pobačaji i povećana incidencija anomalija srca (defekt ventrikularnog septuma) i koštanog sustava ploda (odgođeno okoštavanje, deformacija ili krivi raspored kostiju, prvenstveno kralježnice i lubanje).
English: Bazedoxifene acts as both an oestrogen-receptor agonist and/or antagonist, depending upon the cell and tissue type and target genes.
Croatian: Ovisno o vrsti stanica i tkiva te ciljnim genima, bazedoksifen djeluje kao agonist i/ili antagonist estrogenskih receptora.
English: if you are suffering from breast cancer, as there is insufficient experience with this medicine use in women with this disease.
Croatian: ako ste u prošlosti imali povišene razine triglicerida (vrsta masnoće u tijelu) ako imate tegoba s jetrom ili teških tegoba s bubrezima. ako tijekom liječenja lijekom CONBRIZA imate bilo kakvo krvarenje iz rodnice, morate porazgovarati s liječnikom. ako imate rak dojke, jer nema dovoljno iskustva s primjenom ovog lijeka u žena koje boluju od te bolesti.
English: Effects on the uterus
Croatian: Učinci na dojke
English: Pulmonary embolism*
Croatian: palpitacije (osjećajlupanjasrca)
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja plućna embolija*
English: Retinal vein thrombosis*
Croatian: Poremećaji oka tromboza mrežnične vene*
English: Dry mouth
Croatian: Poremećaji probavnog sustava suha usta
English: Drowsiness
Croatian: Dojenje
English: CARTON TEXT
Croatian: TEKST NA KUTIJI
English: Cerebrovascular effects
Croatian: Utjecaj na moždano krvožilje
English: Four field studies were conducted.
Croatian: Provedena su četiri terenska ispitivanja.
English: The appropriate tablet strength should be used according to the dog's weight.
Croatian: Tabletu odgovarajuće jačine treba koristiti u skladu s tjelesnom težinom psa.
English: The tablets should be kept in the original packaging until use in order to prevent children directly accessing the medicine.
Croatian: Tablete treba čuvati u originalnom pakiranju sve do uporabe kako bi se djeci spriječio izravan pristup VMP-u.
English: Further information on Simparica Trio can be found on the Agency's website: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio.
Croatian: Više informacija o VMP-u Simparica Trio dostupno je na internetskim stranicama Agencije: ema.europa.eu/Find medicines/veterinary/EPAR/simparica-trio.
English: Sarolaner acts as an ‘ectoparasiticide'.
Croatian: Sarolaner djeluje kao „ektoparaziticid”.
English: In order to be exposed to the active substance, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Croatian: Kako bi ih se izložilo djelatnoj tvari, buhe i krpelji moraju se primiti za kožu i započeti hranjenje krvlju psa.
English: This overview was last updated in July 2019.
Croatian: Pregled informacija posljednji je put ažuriran u 7. 2019.
English: Two studies conducted in Australia and one in Japan that followed a similar design to the US study also showed 100% effectiveness against naturally occurring heartworm infection.
Croatian: Dva ispitivanja provedena u Australiji i jedno u Japanu prema sličnom obrascu kao i ispitivanje u SAD-u također su pokazala 100 % učinkovitost protiv prirodne infestacije srčanim crvima.
English: Sarolaner kills these parasites that have ingested the dog's blood by acting on their nervous system.
Croatian: Sarolaner ubija parazite koji su popili krv psa djelovanjem na njihov živčani sustav.
English: It can also be used as part of a treatment for flea allergy dermatitis (an allergic reaction to flea bites).
Croatian: Može se primjenjivati i kao dio liječenja alergijskog dermatitisa uzrokovanog buhama (alergijske reakcije na ugrize buha).
English: What is Simparica Trio and what is it used for?
Croatian: Što je Simparica Trio i za što se koristi?
English: Other information about Simparica Trio
Croatian: Ostale informacije o VMP-u Simparica Trio
English: For flea or tick infestations, one treatment with Simparica Trio is effective for up to 5 weeks.
Croatian: Kod infestacije krpeljima ili buhama jedan tretman VMP-om Simparica Trio učinkovit je do pet tjedana.
English: This means that it kills parasites present on the skin or in the fur of animals, such as fleas and ticks.
Croatian: To znači da ubija parazite koji se nalaze na koži ili u krznu životinja, poput buha i krpelja.
English: It acts by blocking signals, normally associated with the neurotransmitter acetylcholine, from their nerves to their muscles, causing sudden contraction followed by paralysis and death.
Croatian: Djeluje blokiranjem signala koji su obično povezani s neurotransmiterom acetilkolinom od živaca do mišića, što uzrokuje iznenadan grč, nakon čega dolazi do paralize i smrti.
English: This results in uncontrolled activity of the nervous system and thus the paralysis and death of the parasites.
Croatian: To rezultira nekontroliranim djelovanjem živčanog sustava i paralizom te posljedično uginućem parazita.
English: Simparica Trio (sarolaner / moxidectin / pyrantel)
Croatian: Simparica Trio (sarolaner/moksidektin/pirantel)
English: The European Medicines Agency decided that Simparica Trio'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 VMP-a Simparica Trio nadmašuju s njim povezane rizike te da VMP može biti odobren za primjenu u EU-u.
English: Moxidectin causes paralysis and death of these parasites by interfering in a different way to sarolaner with the flow of chloride ions in nerve cells associated with GABA and glutamate.
Croatian: Moksidektin izaziva paralizu i smrt tih parazita ometajući drugačije od sarolanera protok kloridnih iona u živčanim stanicama povezanih s GABA-om i glutamatom.
English: For gut worms only a single treatment is required.
Croatian: Za crijevne crve dovoljan je jednokratan tretman.
English: Pyrantel also kills roundworms and hookworms present in the gut but acts differently to moxidectin.
Croatian: Pirantel također ubija obiliće i kukaste crve prisutne u crijevima, no djeluje drugačije od moksidektina.
English: What are the risks associated with Simparica Trio?
Croatian: Koji su rizici povezani s VMP-om Simparica Trio?
English: In areas where lungworm and heartworm are present, treatments are required at monthly intervals.
Croatian: U područjima u kojima su prisutni plućni vlasci i srčani crvi potreban je tretman jednom mjesečno.
English: An overview of Simparica Trio and why it is authorised in the EU
Croatian: Pregled informacija o VMP-u Simparica Trio i zašto je odobren u EU-u
English: Why is Simparica Trio authorised in the EU?
Croatian: Zašto je VMP Simparica Trio odobren u EU-u?
English: To prevent lungworm and heartworm disease for one month, a single treatment is required.
Croatian: Za suzbijanje infekcije plućnim vlascima ili srčanim crvima tijekom jednog mjeseca potreban je jednokratan tretman.
English: At the same time, Simparica Trio is used to prevent heartworm and lungworm disease (both caused by blood worms that infect the heart and blood vessels supplying the lungs).
Croatian: Trio istovremeno se primjenjuje za suzbijanje infekcije plućnim vlascima ili srčanim crvima (obje infekcije uzrokuju crvi u krvi koji napadaju srce i krvne žile koje vode u pluća).
English: Simparica Trio must only be used when there is a need to treat both fleas or ticks and worms in the gut.
Croatian: Simparica Trio smije se koristiti samo kad postoji potreba za tretiranjem i buha ili krpelja i crva u crijevima.
English: In a US study of 410 dogs in an area affected by heartworm disease, dogs treated with Simparica Trio every 30 days until day 300 showed 100% effectiveness based on blood tests at days 120, 240 and 330 after first treatment.
Croatian: U ispitivanje na 410 pasa u SAD-u infestiranih srčanim crvima, kod pasa liječenih VMP-om Simparica Trio svakih 30 dana do 300. dana VMP je pokazao 100 % učinkovitost na temelju pretraga krvi 120., 240. i 330. dana nakon prvog tretmana.
English: Further flea or tick treatment should be continued using a different veterinary medicine with a narrower range of action.
Croatian: Daljnji tretmani protiv buha ili krpelja trebaju se nastaviti drugim VMP-om s užim rasponom djelovanja.
English: Simparica Trio is available as chewable tablets and can only be obtained with a prescription.
Croatian: VMP Simparica Trio dostupan je u obliku tableta za žvakanje i izdaje se samo na veterinarski recept.
English: The study showed Simparica Trio to be comparable to the comparator medicine as measured by the percentage reduction in live tick counts on day 7, 14, 21 and 30 after treatment.
Croatian: Ispitivanje je pokazalo da je VMP Simparica Trio usporediv s usporednim lijekom na temelju mjerenja postotka smanjenja broja živih krpelja 7., 14., 21. i 30. dana nakon tretmana.
English: In a field study involving 622 dogs in an area of Denmark and Italy known to be affected by lungworm disease, dogs treated with Simparica Trio every 30 days until day 270 did not test positive for lungworm until day 300 after first treatment and therefore the effectiveness was 100% with some dogs testing positive in the control group which was given a dummy treatment.
Croatian: U terenskom ispitivanju koje je uključivalo 622 psa u Danskoj i Italiji infestiranih plućnim vlascima, psi tretirani VMP-om Simparica Trio svakih 30 dana do 270. dana nisu bili pozitivni na testu za plućne vlasce do 300. dana nakon prvog tretmana.
English: Effectiveness, based on faecal egg counts on day 7 after treatment, for dogs treated with Simparica Trio was comparable to the comparator medicine.
Croatian: Učinkovitost je na temelju broja jajašaca u stolici 7. dana nakon tretmana pasa VMP-om Simparica Trio bila usporediva s usporednim lijekom.
English: How is Simparica Trio used?
Croatian: Kako se Simparica Trio koristi?
English: Simparica Trio is a veterinary medicine used to treat dogs with flea or tick infestations and roundworm or hookworm infections in the gut.
Croatian: Trio je veterinarsko-medicinski proizvod koji se primjenjuje za tretiranje pasa s infestacijom buha ili krpelja, odnosno s crijevnim infestacijama oblićima i kukastim crvima.
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey signals between nerves (neurotransmitters).
Croatian: posebno onih povezanih s gama-aminobutričnom kiselinom (GABA) i glutamatom, dvjema tvarima koje prenose signale između živaca (neurotransmiteri).
English: Safety information has been included in the summary of product characteristics and the package leaflet for Simparica Trio, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Croatian: U sažetku opisa svojstava VMP-a, kao i u uputi o VMP-u Simparica Trio nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: The study showed Simparica Trio to be comparable to the comparator medicine as measured by flea counts on day 14 and 30 after treatment.
Croatian: Ispitivanje je pokazalo da je VMP Simparica Trio usporediv s usporednim lijekom na temelju mjerenja broja buha 14. i 30. dana nakon tretmana.
English: In a field study in dogs infested with at least 5 live fleas, 297 dogs were treated with Simparica Trio and 164 dogs with afoxolaner and milbemycin oxime (an authorised treatment for fleas and ticks).
Croatian: U terenskom ispitivanju pasa infestiranih s najmanje pet živih buha, 297 pasa tretirano je VMP-om Simparica Trio, a 164 psa afoksolanerom i milbemicin oksimom (odobrenom terapijom za krpelje i buhe).
English: For more information about using Simparica Trio, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Više informacija o primjeni VMP-a Simparica Trio pročitajte u uputi o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: Moxidectin kills parasites present inside the body of animals, such as roundworms, hookworms, lungworm and heartworm.
Croatian: Moksidektin ubija parazite u tijelu životinje poput obilića, kukastih crva, plućnih vlasaca i srčanih crva.
English: Roundworms and hookworms
Croatian: Obilići i kukasti crvi
English: What benefits of Simparica Trio have been shown in studies?
Croatian: Koje su koristi od VMP-a Simparica Trio utvrđene u ispitivanjima?
English: In a further field study in dogs infested with at least 3 live ticks, 189 dogs were treated with Simparica Trio and 91 dogs with afoxolaner and milbemycin oxime.
Croatian: U dodatnom terenskom ispitivanju pasa infestiranih s barem tri živa krpelja, 189 pasa tretirano je VMP-om Simparica Trio, a 91 pas afoksolanerom i milbemicin oksimom.
English: Simparica Trio contains the active substances sarolaner, moxidectin and pyrantel.
Croatian: Simparica Trio sadrži djelatne tvari sarolaner, moksidektin i pirantel.
English: Heartworms
Croatian: Krpelji
English: In a field study involving dogs infected with roundworms or hookworms, 194 dogs were treated with Simparica Trio and 97 dogs with afoxolaner and milbemycin oxime.
Croatian: U terenskom ispitivanju pasa infestiranih obilićima i kukastim crvima, 194 pasa tretirano je VMP-om Simparica Trio, a 97 pasa afoksolanerom i milbemicin oksimom.
English: How does Simparica Trio work?
Croatian: Kako djeluje Simparica Trio?
English: Simparica contains three active substances: sarolaner, moxidectin and pyrantel.
Croatian: Trio sadrži djelatne tvari sarolaner, moksidektin i pirantel.
English: Simparica Trio received a marketing authorisation valid throughout the EU on 17 September 2019.
Croatian: Trio izdano je odobrenje za stavljanje u promet koje je na snazi u EU-u od
English: This summary was last updated in 07-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran u 07. 2017.
English: The usual dose is 60 mg once a day for 12 or 24 weeks.
Croatian: Uobičajena doza iznosi 60 mg jednom na dan tijekom 12 tjedana ili 24 tjedna.
English: What is Daklinza and what is it used for?
Croatian: Što je Daklinza i za što se koristi?
English: The full EPAR and risk management plan summary for Daklinza can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Daklinza nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Around 99% of patients with genotype 1 infection (125 out of 126), 96% of patients with genotype 2 infection (25 out of 26) and 89% of patients with genotype 3 infection (16 out of 18) did not show any sign of the virus in their blood 12 weeks after the end of their planned treatment.
Croatian: Otprilike 99 % bolesnika zaraženih genotipom 1 (125 od 126), 96 % bolesnika zaraženih genotipom 2 (25 od 26) i 89 % bolesnika zaraženih genotipom 3 (16 od 18) nije pokazalo nikakve znakove virusa u krvi 12 tjedana nakon završetka planiranog liječenja.
English: Almost all the patients in the main study had the virus cleared from their blood.
Croatian: Gotovo svim bolesnicima u glavnom ispitivanju uklonjen je virus iz krvi.
English: It contains the active substance daclatasvir.
Croatian: Sadrži djelatnu tvar daklatasvir.
English: Daklinza is available as 30, 60, and 90 mg tablets.
Croatian: Lijek Daklinza dostupan u obliku tableta od 30, 60 i 90 mg.
English: This is a summary of the European public assessment report (EPAR) for Daklinza.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Daklinza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Daklinza on 22 August 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Daklinza na snazi u Europskoj uniji od 22. kolovoza 2014.
English: The dose may have to be raised or lowered if the patient is taking other medicines that decrease or increase Daklinza's effects.
Croatian: Doza se može povećati ili smanjiti ako bolesnik uzima druge lijekove koji umanjuju ili povećavaju učinak lijeka Daklinza.
English: Other information about Daklinza
Croatian: Ostale informacije o lijeku Daklinza