FrancophonIA/ELRC3.0 huggingface dataset:
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme treba proći nakon primjene veterinarsko-medicinskog proizvoda i klanja životinje te korištenja mesa za prehranu ljudi.
English: Suvaxyn PCV is used to vaccinate pigs over the age of 3 weeks to reduce viral load in blood and lymphoid tissues and protect the pigs against the lesions in lymphoid tissues caused by Porcine Circovirus Type 2 as well as the reduced weight gain and potentially even death that is associated with Post-Weaning Multisystemic Wasting Syndrome (PMWS).
Croatian: Suvaxyn PCV koristi se za cijepljenje svinja starijih od 3 tjedna kako bi se smanjilo virusno opterećenje u krvi i limfnim tkivima, te lezije u limfnim tkivima povezane cirkovirusom svinja tip 2, kao i povećanje tjelesne težine, a potencijalno čak i smrtnost povezana sa sindromom kržljavosti odbijene prasadi (SKOP).
English: Suvaxyn PCV is a vaccine.
Croatian: Suvaxyn PCV je cjepivo.
English: What is the risk associated with Suvaxyn PCV?
Croatian: Koji su rizici povezani s VMP-om Suvaxyn PCV?
English: Why has Suvaxyn PCV been approved?
Croatian: Zašto je Suvaxyn PCV odobren?
English: What is Suvaxyn PCV?
Croatian: Što je Suvaxyn PCV?
English: What benefit has Suvaxyn PCV shown during the studies?
Croatian: Koje su koristi VMP-a Suvaxyn PCV utvrđene tijekom ispitivanja?
English: What is Suvaxyn PCV used for?
Croatian: Za što se Suvaxyn PCV koristi?
English: How does Suvaxyn PCV work?
Croatian: Kako djeluje Suvaxyn PCV?
English: How has Suvaxyn PCV been studied?
Croatian: Kako se Suvaxyn PCV ispitivao?
English: The full EPAR for MicardisPlus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek MicardisPlus nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Its use during the first three months of pregnancy is not recommended.
Croatian: Ne preporuča se primjena u žena tijekom prva tri mjeseca trudnoće.
English: MicardisPlus must not be used in women who are more than three months pregnant.
Croatian: MicardisPlus ne smiju uzimati žene koje su trudne dulje od tri mjeseca.
English: In all studies, the main measure of effectiveness was the reduction in diastolic blood pressure (the blood pressure measured between two heartbeats).
Croatian: U svim ispitivanjima glavna mjera djelotvornosti bilo je smanjenje dijastoličkog krvnog tlaka (krvni tlak izmjeren između dva otkucaja srca).
English: MicardisPlus has been studied in five main studies involving a total of 2,985 patients with mild to moderate hypertension.
Croatian: MicardisPlus je ispitivan u pet glavnih ispitivanja kojima je obuhvaćeno ukupno 2985 bolesnika s umjerenom hipertenzijom.
English: MicardisPlus telmisartan / hydrochlorothiazide
Croatian: MicardisPlus telmisartan/hidroklorotiazid
English: In four of these studies, MicardisPlus was compared with placebo (a dummy treatment) and with telmisartan taken alone in a total of 2,272 patients.
Croatian: U četiri od tih ispitivanja MicardisPlus je uspoređen s placebom (prividnim liječenjem) i s telmisartanom koji je samostalno uzimalo ukupno 2272 bolesnika.
English: It works by increasing urine output, reducing the amount of fluid in the blood and reducing the blood pressure.
Croatian: Djeluje povećavajući količinu izbačenog urina, smanjujući količinu tekućine u krvi i snižavajući krvni tlak.
English: MicardisPlus is taken by mouth once a day with liquid.
Croatian: MicardisPlus se uzima kroz usta jednom na dan s tekućinom, uz ili bez obroka.
English: The most common side effect with MicardisPlus (seen in between 1 and 10 patients in 100) is dizziness.
Croatian: Najčešća nuspojava lijeka MicardisPlus (uočena kod više od 10 na 100 bolesnika) je vrtoglavica.
English: This is a summary of the European public assessment report (EPAR) for MicardisPlus.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku MicardisPlus.
English: For more information about treatment with MicardisPlus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom MicardisPlus pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: What measures are being taken to ensure the safe and effective use of MicardisPlus?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka MicardisPlus?
English: The European Commission granted a marketing authorisation valid throughout the European Union for MicardisPlus on 19 April 2002
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek MicardisPlus na snazi u Europskoj uniji od 19. travnja 2002.
English: Other information about MicardisPlus
Croatian: Ostale informacije o lijeku MicardisPlus
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for MicardisPlus.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka MicardisPlus.
English: Hydrochlorothiazide is a diuretic, which is another type of treatment for hypertension.
Croatian: Hidroklorotiazid je diuretik, te predstavlja drugu vrstu liječenja hipertenzije.
English: In patients with type 2 diabetes or in patients with moderate or severe kidney impairment, MicardisPlus must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension).
Croatian: U bolesnika s tipom 2 dijabetesa ili u bolesnika s umjerenim ili ozbiljnim oštećenjem funkcije bubrega, MicardisPlus se ne smije koristiti u kombinaciji s lijekovima koji sadrže aliskiren (koji se također koristi za liječenje esencijalne hipertenzije).
English: By blocking the receptors to which angiotensin II normally attaches, telmisartan stops the hormone having an effect, allowing the blood vessels to widen.
Croatian: Blokiranjem receptora na koja se angiotenzin II inače veže, telmisartan sprječava djelovanje hormona i omogućuje širenje krvnih žila.
English: A risk management plan has been developed to ensure that MicardisPlus is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka MicardisPlus.
English: Care must be taken when using MicardisPlus with other medicines that have an effect on blood potassium levels.
Croatian: Potreban je oprez prilikom uzimanja lijeka MicardisPlus zajedno s drugim lijekovima koji utječu na razinu kalija u krvi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for MicardisPlus including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek MicardisPlus nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The dose of MicardisPlus to be used depends on the dose of telmisartan that the patient was taking before: patients who were receiving 40 mg telmisartan should take the 40/12.5 mg tablets, and patients who were receiving 80 mg telmisartan should take the 80/12.5 mg tablets.
Croatian: Doza lijeka MicardisPlus koja se primjenjuje ovisi o dozi telmisartana koju je bolesnik prethodno uzimao: bolesnici koji su primali 40 mg telmisartana trebaju uzimati tablete od 40/12,5 mg, a bolesnici koji su primali 80 mg telmisartana trebaju uzimati tablete od 80/12,5 mg.
English: The Committee recommended that MicardisPlus be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka MicardisPlus u promet.
English: MicardisPlus was more effective at reducing diastolic blood pressure than telmisartan taken alone and than placebo.
Croatian: MicardisPlus je bio djelotvorniji u snižavanju dijastoličkog krvnog tlaka u odnosu na monoterapiju telmisartanom i placebo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that MicardisPlus's benefits are greater than its risks for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on telmisartan alone.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka MicardisPlus nadmašuju s njim povezane rizike za liječenje esencijalne hipertenzije u bolesnika čiji se krvni tlak ne kontrolira primjereno monoterapijom telmisartana.
English: Why has MicardisPlus been approved?
Croatian: Zašto je MicardisPlus odobren?
English: The fifth study compared the effects of remaining on the 80/12.5 mg tablet with switching to the 80/25 mg tablet in 713 patients who had not responded to the 80/12.5 mg tablet.
Croatian: Peto je ispitivanje usporedilo djelovanje preostalih na tabletama jačine 80/12,5 mg s tabletom jačine 80/25 mg u 713 bolesnika koji nisu odgovorili na tablete jačine 80/12,5 mg.
English: What is the risk associated with MicardisPlus?
Croatian: Koji su rizici povezani s lijekom MicardisPlus?
English: The 80/25 mg tablets are used in patients whose blood pressure is not controlled using the 80/12.5 mg tablets or who have been stabilised using the two active substances taken separately before switching to MicardisPlus.
Croatian: Tablete od 80/25 mg se koriste u bolesnika čiji se krvni tlak ne može kontrolirati primjenom tableta jačine 80/12,5 mg ili koji su stabilizirani primjenom dvije djelatne tvari koje se uzimaju zasebno prije prelaska na MicardisPlus.
English: It is available as oval tablets (40 mg or 80 mg telmisartan and 12.5 mg hydrochlorothiazide; 80 mg telmisartan and 25 mg hydrochlorothiazide).
Croatian: Dostupan je u obliku tableta (40 mg ili 80 mg irbesartana i 12,5 mg hidroklorotiazida; 80 mg irbesartana i 25 mg hidroklorotiazida).
English: What is MicardisPlus?
Croatian: Što je MicardisPlus?
English: MicardisPlus must also not be used in people who have severe liver, kidney or bile problems, blood potassium levels that are too low, or blood calcium levels that are too high.
Croatian: MicardisPlus se ne smije koristiti ni kod bolesnika s teškim jetrenim, bubrežnim ili žučnim problemima, s preniskom razinom kalija u krvi niti s previsokom razinom kalcija u krvi.
English: In patients who were not controlled on the 80/12.5 mg tablet, switching to the 80/25 mg tablet was more effective in reducing diastolic blood pressure than remaining on the lower dose.
Croatian: U bolesnika koji nisu odgovarajuće kontrolirani tabletom jačine 80/12,5 mg, prelazak na tabletu jačine 80/25 mg bio je djelotvorniji u snižavanju dijastoličkog tlaka od ostanka na slabijoj dozi.
English: MicardisPlus is a medicine that contains two active substances, telmisartan and hydrochlorothiazide.
Croatian: MicardisPlus je lijek koji sadrži dvije djelatne tvari, telmisartan i amlodipin.
English: The full list of these medicines is given in the Package Leaflet.
Croatian: Potpuni popis tih lijekova potražite u uputi o lijeku.
English: MicardisPlus contains two active substances, telmisartan and hydrochlorothiazide.
Croatian: MicardisPlus sadrži dvije djelatne tvari, telmisartan i hidroklorotijazid.
English: MicardisPlus is used in adult patients who have essential hypertension (high blood pressure) that is not adequately controlled by telmisartan alone.
Croatian: MicardisPlus se koristi kod odraslih bolesnika s esencijalnom hipertenzijom (visokim krvnim tlakom) koja se ne može na odgovarajući način kontrolirati samo telmisartanom. „Esencijalno” znači da ne postoji očiti uzrok hipertenzije.
English: For the full list of all side effects reported with MicardisPlus, see the Package Leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka MicardisPlus potražite u uputi o lijeku.
English: What is MicardisPlus used for?
Croatian: Za što se MicardisPlus koristi?
English: How is MicardisPlus used?
Croatian: Kako se MicardisPlus koristi?
English: How does MicardisPlus work?
Croatian: Kako djeluje MicardisPlus?
English: What benefit has MicardisPlus shown during the studies?
Croatian: Koje su koristi lijeka MicardisPlus utvrđene u ispitivanjima?
English: How has MicardisPlus been studied?
Croatian: Kako je MicardisPlus ispitivan?
English: You may also feel your heart is beating irregularly and faster.
Croatian: Također možete osjetiti da Vam srce kuca brže i nepravilno.
English: The absolute bioavailability is about 75%.
Croatian: Apsolutna biodostupnost je oko 75%.
English: Preferably take one dose in the morning and one in the evening.
Croatian: Najbolje je uzimati jednu dozu ujutro a jednu uvečer.
English: If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose.
Croatian: Ukoliko zaboravite uzeti dozu, uzmite je čim se sjetite, osim ako je uskoro vrijeme za Vašu sljedeću dozu.
English: EXP: Use the strip within 30 days of opening.
Croatian: EXP Iskoristite strip unutar 30 dana od otvaranja.
English: Maximum plasma concentrations (Cmax) are reached after about 30- 60 minutes.
Croatian: Najveće plazmatske koncentracije (Cmax) postižu se nakon 30-60 minuta.
English: There are no special dose requirements for elderly patients, but as with all medicines, use of the lowest effective dose is recommended.
Croatian: Nema posebnih preporuka za doziranje u starijih bolesnika, ali kao i sa svim lijekovima, preporučuje se primijeniti najnižu djelotvornu dozu.
English: Monitoring of cardiac function and general supportive measures are recommended.
Croatian: Preporučuje se nadzor srčane funkcije i opće potporne mjere.
English: The patients should be advised not to take these tablets.
Croatian: Bolesnike treba savjetovati da ne uzmu te tablete.
English: <Invented name> with alcohol
Croatian: <Invented name> s alkoholom
English: • Very fast, uneven or forceful heart-beat (palpitations)
Croatian: • Vrlo brzi, nejednaki ili snažni otkucaji srca (palpitacije)
English: This may seriously affect your blood pressure.
Croatian: To može ozbiljno utjecati na Vaš tlak.
English: If you drink alcohol while you are treated with <Invented name>, your blood pressure may be decreased even further.
Croatian: Ako pijete alkohol dok se liječite <Invented name>, krvni tlak Vam se može još više sniziti.
English: • Headache - This especially occurs during the first few days of treatment.
Croatian: • Glavobolja - posebno često se javlja tijekom prvih nekoliko dana liječenja.
English: Study follow up for endpoint analysis was between 12 and 36 months with a mean of 1.6 years.
Croatian: Praćenje u ispitivanju do analize ishoda trajalo je između 12 i 36 mjeseci sa srednjom vrijednošću 1,6 godina.
English: Children • <Invented name> is not recommended in children.
Croatian: Djeca <Invented name> se ne preporučuje u djece.
English: The tablet of 10 mg can be divided into equal doses.
Croatian: Tableta od 10 mg se može razdijeliti na jednake doze.
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte upravljati vozilima ili raditi s bilo kakvim alatima ili strojevima.
English: The plasma concentration (and the area under the curve (AUC)) shows a linear proportionality to the dose.
Croatian: Plazmatska koncentracija (i površina ispod krivulje (AUC)) linearno je proporcionalna dozi.
English: You should avoid taking this medicine while you are pregnant.
Croatian: Trebate izbjegavati uzimanje ovog lijeka za vrijeme trudnoće.
English: The tablets are to be swallowed in the morning and in the evening as a whole with some liquid.
Croatian: Tablete ujutro i uvečer treba progutati cijele s nešto tekućine.
English: • Aching muscles not caused by exercise (myalgia).
Croatian: • Bol u mišićima koja nije uzrokovana vježbanjem (mijalgija).
English: Do not take out or separate tablet from the blister strip until intake.
Croatian: Nemojte vaditi ili odvajati tabletu od blister stripa prije uzimanja.
English: Do not take aspirin or any medicines for inflammation (corticosteroids).
Croatian: Nemojte uzeti aspirin ni bilo koji lijek protiv upale (kortikosteroid).
English: • Feeling of weakness.
Croatian: • Osjećaj slabosti.
English: You may have eye injuries, stop taking <Invented name> and contact your doctor immediately.
Croatian: Moguće je da imate oštećenja očiju, prestanite uzimati <Invented name> i odmah se obratite svom liječniku.
English: Do not swallow the drying agent which is the bigger tablet on one end of each blister strip.
Croatian: Nemojte progutati sredstvo za sušenje; to je veća tableta na jednom kraju svakog blister stripa.
English: • If your eyes become red, itchy or swollen.
Croatian: • Ako Vam oči postanu crvene, otečene ili Vas svrbe.
English: Paediatric population <Invented name> is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Croatian: <Invented name> se ne preporučuje u pedijatrijskih bolesnika jer sigurnost i djelotvornost u ovoj skupini bolesnika nisu još ustanovljene.
English: Detailed information on this medicine is available on the website of {MS/Agency}
Croatian: Drugi izvori informacija <Detaljne informacije o ovom lijeku dostupne su na internet stranici {naziv države članice/nadležnog tijela}>
English: Your doctor may progressively increase the dose to reduce the frequency of headaches.
Croatian: Vaš liječnik može postupno povećavati dozu kako bi se smanjila učestalost glavobolja.
English: Driving and using machines <Invented name> may cause dizziness or weakness.
Croatian: Upravljanje vozilima i strojevima <Invented name> može uzrokovati omaglicu ili slabost.
English: • Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing
Croatian: • Oticanje lica, usana, usta, jezika ili grla može uzrokovati otežano gutanje ili disanje
English: • If you have heart problems such as heart failure.
Croatian: • Ako imate problema sa srcem kao što je zatajenje srca.
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure to which this Commission decision relates.
Croatian: Ovaj sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ishod su arbitražnog postupka na koji se odnosi ova odluka Komisije.
English: Steady state is rapidly achieved (within 4 to 5 days) during repeated oral administration (bid regimen).
Croatian: Stanje dinamičke ravnoteže postiže se brzo (unutar 4-5 dana) tijekom ponovljene oralne primjene (pri režimu doziranja dva puta dnevno (bid)).
English: Distribution of the product throughout the body remains stable, irrespective of dose, within the therapeutic range.
Croatian: Distribucija lijeka u tijelu ostaje stabilna neovisno o dozi unutar terapijskog raspona.
English: Do not take this medicine and talk to your doctor if you are taking the following:
Croatian: Nemojte uzimati ovaj lijek i obratite se svome liječniku ako uzimate sljedeće:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenosti.
English: Pharmacotherapeutic group: Other vasodilators used in cardiac diseases, ATC code: C01DX16
Croatian: Farmakoterapijska skupina: Ostali vazodilatatori za liječenje bolesti srca, ATK oznaka: C01DX16 Mehanizam djelovanja
English: Fertility There are insufficient data on fertility to estimate the risk for humans (see section 5.3).
Croatian: Plodnost Nema dovoljno podataka o plodnosti za procjenu rizika u ljudi (vidjeti dio 5.3).
English: The usual therapeutic range is 10 to 20 mg twice daily.
Croatian: Uobičajen terapijski raspon je 10 do 20 mg dva puta dnevno.
English: These metabolites represented the major route of transformation of nicorandil.
Croatian: Ovi metaboliti predstavljaju glavni put transformacije nikorandila.
English: • Dapoxetine, a medicine used to treat premature ejaculation.
Croatian: • Dapoksetin, lijek koji se koristi za liječenje prijevremene ejakulacije.
English: Progressive dose titration may reduce the frequency of these headaches (see section 4.2).
Croatian: Postupno povećavanje doze može smanjiti učestalost ovih glavobolja (vidjeti dio 4.2).
English: For the tablet of 20 mg, the score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Croatian: Razdjelna crta na tableti od 20 mg služi samo da Vam pomogne prelomiti tabletu ako je ne možete progutati cijelu.
English: Upon cessation of treatment, recovery from nicorandil-induced testicular toxicity was observed after 4 weeks; which indicates that the observed changes are reversible.
Croatian: Nakon ukidanja liječenja, oporavak od toksičnog djelovanja nikorandila na testise uočen je nakon 4 tjedna; što upućuje na zaključak da su uočene promjene reverzibilne.
English: The tablets are sensitive to moisture; hence the patients should be advised to keep the tablets in their blister until intake.
Croatian: Tablete su osjetljive na vlagu; stoga bolesnike treba savjetovati da do uzimanja tablete čuvaju u blisteru.
English: If not successful, increase in circulating plasma volume by substitution of fluid is recommended.
Croatian: Ako to nije dovoljno, preporučuje se povećati cirkulirajući volumen plazme nadoknadom tekućine.
English: Hyperkalaemi a (see section 4.4 and 4.5)
Croatian: Hiperkalijemija (vidjeti dio 4.4 i 4.5)
English: • Medicines for depression.
Croatian: • Lijekove za liječenje depresije.
English: In life-threatening situations, administration of vasopressors must be considered.
Croatian: U životno ugrožavajućim situacijama potrebno je razmotriti primjenu vazopresora.
English: Also some medicines may affect the way <Invented name> works.
Croatian: Također, neki lijekovi mogu utjecati na djelovanje <Invented name>.
English: If you do accidentally take any of these drying agent tablets, they should not harm you but you should straight away talk to your doctor.
Croatian: Ako slučajno progutate neku od tableta sredstva za sušenje, ne bi Vam trebale naškoditi, ali se odmah javite svome liječniku.
English: • if you have low blood pressure (hypotension).
Croatian: • ako imate nizak krvni tlak (hipotenziju).
English: On the blister, it is clearly indicated which tablet is the drying agent.
Croatian: Na blisteru je jasno označeno koja tableta je sredstvo za sušenje.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contains a drying agent in each blister strip.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Svaki blister strip sadrži sredstvo za sušenje.
English: There is no significant hepatic first pass effect.
Croatian: Nema značajnog učinka prvog prolaska kroz jetru.
English: Feeling of weakness
Croatian: Osjećaj slabosti
English: • Yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine - This may be signs of liver problems.
Croatian: • Žutilo kože i očiju, svijetla boja stolice, tamna boja mokraće - to mogu biti znakovi problema s jetrom
English: • Medicines to treat high blood pressure.
Croatian: • Lijekove za liječenje visokog krvnog tlaka.
English: Nicorandil does not affect the pharmacodynamics of acenocoumarol.
Croatian: Nikorandil ne utječe na farmakodinamiku acenokumarola.
English: It works by increasing the blood flow through the blood vessels of the heart.
Croatian: Djeluje tako što povećava protok krvi kroz krvne žile srca.
English: Patients should be advised of the signs and symptoms and monitored closely for corneal ulcerations.
Croatian: Bolesnike treba savjetovati o znakovima i simptomima kornealnih ulceracija te ih pažljivo nadzirati.