FrancophonIA/ELRC3.0 huggingface dataset:
English: or ergot alkaloids (ergotamine, dihydroergotamine) should be administered with caution in patients receiving idebenone.
Croatian: terfenadin, cisaprid, ciklosporin, fentanil, pimozid, kinidin, sirolimus, takrolimus ili ergot alkaloidi (ergotamin, dihidroergotamin) potrebno primjenjivati uz oprez u bolesnika koji primaju idebenon.
English: How to store Raxone
Croatian: Moguće nuspojave Kako čuvati Raxone
English: Responders (N, %) 19 (30.6 %)
Croatian: Bolesnici koji su odgovorili na liječenje (N, %)
English: Hepatic or renal impairment
Croatian: Poremećaji jetre i žuči
English: These reactions are usually short lived and go away within 5 to 15 days but could last up to 49 days.
Croatian: Te su reakcije uglavnom kratkotrajne i prolaze nakon 5 do 15 dana, ali mogu trajati do 49 dana.
English: The full EPAR for Zeleris can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za VMP Zeleris nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: During injection of this product animals may show signs of moderate pain, such as movement of the head or neck.
Croatian: Za vrijeme injektiranja ovog proizvoda životinje mogu pokazati znakove umjerene boli, kao što je pokretanje glave ili vrata.
English: The dose depends on the animal's weight and is given by injection under the skin in the neck area.
Croatian: Doza ovisi o težini životinje i primjenjuje se injekcijom pod kožu u području vrata.
English: In case of eye contact the affected area should be rinsed immediately with water.
Croatian: U slučaju kontakta s očima, zahvaćeno je područje potrebno smjesta isprati vodom.
English: A success rate of 67% was achieved with Zeleris compared to 65% for florfenciol.
Croatian: Ostvarena je stopa uspješnosti od 67 % s VMP-om Zeleris, u usporedbi sa 65 % s florfenikolom.
English: What is Zeleris and what is it used for?
Croatian: Što je Zeleris i za što se koristi?
English: In addition, in the first 48 hours after the injection, Zeleris was more effective than florfenicol alone in reducing the body temperature to below 39.5˚C.
Croatian: Osim toga, tijekom prvih 48 sati nakon injekcije VMP Zeleris pokazao se djelotvornijim od monoterapije florfenikolom u snižavanju tjelesne temperature ispod 39,5 ˚C.
English: Zeleris florfenicol / meloxicam
Croatian: Zeleris florfenikol/meloksikam
English: Why is Zeleris approved?
Croatian: Zašto je Zeleris odobren?
English: Cattle weighing more than 150 kg will need to have the dose divided and injected at more than one site.
Croatian: Dozu lijeka za goveda koja teže iznad 150 kg bit će potrebno podijeliti i injektirati na više mjesta.
English: It should also not be used in pregnant cows which are intended to produce milk for human consumption within two months of calving.
Croatian: Također se ne smije koristiti u gravidnih krava koje su namijenjene za proizvodnju mlijeka za prehranu ljudi u roku od dva mjeseca nakon teljenja.
English: The withdrawal period for meat from cattle treated with Zeleris is 56 days.
Croatian: Razdoblje karencije za meso stoke liječene VMP-om Zeleris iznosi 56 dana.
English: It is not intended to provide practical advice on how to use Zeleris.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju VMP-a Zeleris.
English: The European Commission granted a marketing authorisation valid throughout the EU for Zeleris on 15 May 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za VMP Zeleris na snazi u Europskoj uniji od 15/05/2017.
English: Meloxicam belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Croatian: Meloksikam pripada skupini lijekova zvanih nesteroidni protuupalni lijekovi (NSAID).
English: Zeleris is a veterinary medicine used to treat cattle with bovine respiratory disease (BRD, a condition affecting the lungs) associated with a high temperature, which is due to the bacteria Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Croatian: Zeleris je veterinarsko-medicinski proizvod koji se koristi za liječenje respiratorne bolesti goveda (BRD, bolest koja utječe na pluća) povezane s visokom temperaturom, koju uzrokuju bakterije Mannheimia haemolytica, Pasteurella multocida i Histophilus somni.
English: People who are hypersensitive (allergic) to florfenicol, meloxicam or any of the other ingredients of the medicine should avoid contact with Zeleris.
Croatian: Osobe koje su preosjetljive (alergične) na florfenikol, meloksikam ili bilo koje druge sastojke VMP-a trebaju izbjegavati kontakt s VMP-om Zeleris.
English: Zeleris was as effective as florfenicol alone in improving signs of the disease (based on behaviour and breathing) on day 7.
Croatian: VMP Zeleris bio je jednako djelotvoran kao i monoterapija florfenikolom u poboljšavanju znakova bolesti (na temelju ponašanja i disanja) sedmog dana terapije.
English: The most common side effects with Zeleris (which may affect more than 1 in 10 animals) are reactions at the injection site (mostly swelling, hardness, heat and pain) after injection under the skin.
Croatian: Najčešće nuspojave VMP-a Zeleris (mogu se javiti u više od 1 na 10 životinja) jesu reakcije na mjestu injekcije (uglavnom oticanje, tvrdoća, toplina i bol) nakon supkutane injekcije.
English: This is a summary of the European public assessment report (EPAR) for Zeleris.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o veterinarskomedicinskom proizvodu Zeleris.
English: Florfenicol is a broad-spectrum antibiotic which stops bacteria from growing by blocking the activity of ribosomes, the part of the bacterial cells where proteins are produced.
Croatian: Florfenikol je antibiotik širokog spektra koji sprječava rast bakterija blokiranjem ribosoma, dijela bakterijskih stanica u kojima se proizvode proteini.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Zeleris'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 Zeleris nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja treba odmah potražiti liječnički savjet te pokazati uputu o proizvodu ili etiketu.
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Croatian: Meloksikam djeluje blokadom enzima ciklooksigenaza koji je uključen u proizvodnju prostaglandina.
English: Zeleris must not be given to bulls intended for breeding nor to animals with impaired liver, heart or kidney function, bleeding disorders or with gut ulceration.
Croatian: VMP Zeleris ne smije se primjenjivati u bikova namijenjenih rasplodu ni u životinja s oštećenom funkcijom jetre, srca ili bubrega, poremećajima krvarenja ili ulceracijom crijeva.
English: In a field study 329 calves with bovine respiratory disease and a body temperature of 40˚C or higher were treated either with Zeleris or florfenicol alone.
Croatian: U okviru terenskog ispitivanja, 329 teladi s respiratornom bolesti goveda i tjelesnom temperaturom od 40 ˚C ili višom primilo je terapiju VMP-om Zeleris ili monoterapiju florfenikolom.
English: As Zeleris contains an antibiotic it is essential to closely follow the instructions in the package leaflet to minimise the development of antibiotic resistance.
Croatian: Budući da VMP Zeleris sadržava antibiotik, važno je slijediti upute o VMP-u kako bi se razvoj otpornosti na antibiotik sveo na najmanju moguću mjeru.
English: What are the risks associated with Zeleris?
Croatian: Koji su rizici povezani s VMP-om Zeleris?
English: Zeleris contains the active substances florfenicol and meloxicam.
Croatian: VMP Zeleris sadrži djelatne tvari florfenikol i meloksikam.
English: Other information about Zeleris:
Croatian: Ostale informacije o VMP-u Zeleris
English: The medicine is not authorised for use in cows producing milk for human consumption.
Croatian: VMP nije odobren za primjenu u krava od kojih se dobiva mlijeko za prehranu ljudi.
English: How is Zeleris used?
Croatian: Kako se Zeleris koristi?
English: Zeleris should not be administered by pregnant women.
Croatian: Trudnice ne smiju primjenjivati VMP Zeleris.
English: What benefits of Zeleris have been shown in studies?
Croatian: Koje su koristi od VMP-a Zeleris utvrđene u ispitivanjima?
English: The medicine can only be obtained with a prescription and is available as a solution for injection.
Croatian: VMP Zeleris izdaje se samo na veterinarski recept i dostupan je u obliku otopine za injekciju.
English: How does Zeleris work?
Croatian: Kako djeluje Zeleris?
English: For practical information about using Zeleris, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Zeleris vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Zeleris, 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 Zeleris, nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: For more information about treatment with Zeleris, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Zeleris vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Take it as soon as you remember then carry on as before.
Croatian: Uzmite je čim se sjetite, a zatim nastavite kao i ranije.
English: Animal studies are insufficient.
Croatian: Studije na životinjama nisu dostatne.
English: • if you are more than 3 months pregnant.
Croatian: • ako ste trudni više od 3 mjeseca.
English: After a single dose of
Croatian: Nakon jedne doze
English: If you forget to take a dose, do not worry.
Croatian: Ako zaboravite uzeti jednu dozu, ne brinite.
English: In some cases you may have to stop taking one of the medicines.
Croatian: U nekim slučajevima možda ćete morati prekinuti uzimanje nekog od lijekova.
English: The binding is long-lasting.
Croatian: Vezivanje je dugotrajno.
English: Additional information on individual components
Croatian: Dodatne informacije o individualnim komponentama
English: The mean duration of follow up was 4 years and 8 months.
Croatian: Prosječno trajanje praćenja bilo je 4 godine i 8 mjeseci.
English: If you do not take your tablet on one day, take your normal dose on the next day.
Croatian: Ako ne uzmete tabletu jedan dan, uzmite normalnu dozu sljedeći dan.
English: Avoid taking alcohol until you have talked to your doctor.
Croatian: Izbjegavajte konzumiranje alkohola dok se ne posavjetujete s liječnikom.
English: An updated RMP shall be submitted every three years.
Croatian: Ažurirani RMP treba dostaviti svake tri godine.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITAVNI SASTAV
English: Therefore the combination should be administered with caution, especially in the elderly.
Croatian: Stoga, se ova kombinacija mora primjenjivati s oprezom, osobito kod starijih osoba.
English: Sepsis including fatal outcome
Croatian: Sepsa uključujući fatalan ishod
English: In addition, an updated RMP should be submitted:
Croatian: Nadalje, ažurirani RMP treba dostaviti:
English: However, it is not known whether telmisartan was the cause.
Croatian: Međutim, nije poznato je li telmisartan uzrok.
English: Some side effects can be serious and need immediate medical attention:
Croatian: Neke nuspojave mogu biti ozbiljne i zahtijevati trenutno medicinsko zbrinjavanje:
English: SN: {number} {serial number}
Croatian: SN: {broj} [serijalizacijski broj]
English: If these effects are not treated they could be fatal.
Croatian: Ako se ovi učinci ne liječe, mogu imati smrtni ishod.
English: Chloride deficit is generally mild and usually does not require treatment.
Croatian: Deficit klorida je općenito blag te obično ne zahtijeva liječenje.
English: This is not considered to be of clinical relevance.
Croatian: To se ne smatra klinički značajnim.
English: About 60 % of the oral dose is eliminated within 48 hours.
Croatian: Oko 60 % oralne doze se eliminira unutar 48 sati.
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Croatian: Tablete se moraju progutati s vodom ili drugim bezalkoholnim pićem.
English: It is important that you take Kinzalkomb every day until your doctor tells you otherwise.
Croatian: Važno je da uzimate Kinzalkomb svaki dan dok Vam liječnik ne propiše drugačije.
English: There are usually no symptoms of high blood pressure before damage occurs.
Croatian: Obično nema simptoma visokog krvnog tlaka prije nego dođe do oštećenja.
English: There is limited experience with hydrochlorothiazide during pregnancy, especially during the first trimester.
Croatian: Postoji ograničeno iskustvo uz hidroklorotiazid tijekom trudnoće, posebice tijekom prvog tromjesečja.
English: Elderly Pharmacokinetics of telmisartan do not differ between the elderly and those younger than 65 years.
Croatian: Starije osobe Farmakokinetika telmisartana ne razlikuje se između starijih osoba i osoba mlađih od 65 godina.
English: Only minute amounts were found in urine.
Croatian: Samo su minorne količine pronađene u urinu.
English: Terminal elimination half-life was >20 hours.
Croatian: Poluvrijeme eliminacije je >20 sati.
English: See also information under the heading “Do not take Kinzalkomb”.
Croatian: Vidjeti također informacije pod naslovom „Nemojte uzimati Kinzalkomb“.
English: Aluminium/aluminium blisters (PA/Al/PVC/Al or PA/PA/Al/PVC/Al).
Croatian: Aluminij/aluminij blisteri (PA/Al/PVC/Al ili PA/PA/Al/PVC/Al).
English: One blister contains 7 or 10 tablets.
Croatian: Jedan blister sadržava 7 ili 10 tableta.
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Croatian: Bolesnik se mora pomno pratiti, a liječenje mora biti simptomatsko i suportivno.
English: If you take more Kinzalkomb than you should
Croatian: Ako uzmete više Kinzalkomba nego što ste trebali
English: Your doctor may need to change the dose of these other medications or take other precautions.
Croatian: Liječnik će Vam možda morati promijeniti dozu drugih lijekova i/ili poduzeti druge mjere opreza.
English: NN: {number} {national reimbursement number or other national number identifying the medicinal product}
Croatian: NN: {broj} [nacionalni broj s liste lijekova ili drugi nacionalni broj za identifikaciju lijeka]
English: • if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na telmisartan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Studije na životinjama pokazale su reproduktivnu toksičnost (vidjeti dio 5.3).
English: If a photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Croatian: Ako dođe do pojave reakcije fotoosjetljivosti tijekom liječenja, preporučuje se prekid liječenja.
English: Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
Croatian: Ozbiljni angioedem može se pojaviti rijetko (≥1/10 000 do <1/1000).
English: Both substances help to control high blood pressure.
Croatian: Obje tvari pomažu u kontroli visokog krvnog tlaka.
English: For more detailed information see above under the heading “Cardiovascular prevention”.
Croatian: Za detaljnije informacije, vidjeti prethodni tekst pod naslovom “Kardiovaskularna prevencija”.
English: Date of latest renewal: 23 April 2007
Croatian: Datum posljednje obnove odobrenja: 23. travnja 2007.
English: The event may be a chance finding or related to a mechanism currently not known (see section 5.1).
Croatian: Događaj može biti slučajno otkriće ili povezan s trenutno nepoznatim mehanizmom (također vidjeti dio 5.1).
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Croatian: Ne očekuje se da malo smanjenje u AUC uzrokuje smanjenje terapijske djelotvornosti lijeka.
English: * The event may have happened by chance or could be related to a mechanism currently not known.
Croatian: * Do događaja je moglo doći slučajno ili je mogao biti povezan s trenutno nepoznatim mehanizmom.
English: (It is also better to avoid Kinzalkomb in early pregnancy - see pregnancy section.)
Croatian: (Također je bolje izbjegavati Kinzalkomb u ranoj trudnoći pogledajte dio o trudnoći.)
English: Contact your doctor, pharmacist, or your nearest hospital emergency department immediately.
Croatian: Odmah obavijestite svog liječnika ili ljekarnika ili se javite u hitnu službu najbliže bolnice.
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Croatian: Stoga je važno redovito mjeriti krvni tlak kako bi se provjerilo je li unutar normalnih vrijednosti.
English: After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Croatian: Nakon prve doze telmisartana, antihipertenzivna aktivnost postupno postaje vidljiva unutar 3 sata.
English: If you feel dizzy or tired, do not drive or operate machinery.
Croatian: Ako osjećate omaglicu ili umor, nemojte upravljati vozilima ili strojevima.
English: This applies especially to the medicines listed below taken at the same time with Kinzalkomb:
Croatian: Ovo se osobito odnosi na lijekove navedene u nastavku koji se uzimaju istodobno uz Kinzalkomb:
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Croatian: Epidemiološki dokaz, s obzirom na rizik od teratogenosti nakon izloženosti ACE inhbitorima tijekom prvog tromjesečja trudnoće, nije konačan; međutim, ne može se isključiti malo povećanje rizika.
English: Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
Croatian: Preporučuje se titracija individualnih doza sa svakom od dvaju komponenata prije prelaska na kombinaciju fiksnih doza.
English: You should see your doctor immediately if you experience any of the following symptoms:
Croatian: Morate se trenutno javiti liječniku ako imate neki od sljedećih simptoma:
English: Protect your skin from sun exposure and UV rays while taking Kinzalkomb.
Croatian: Zaštitite svoju kožu od izlaganja suncu i UV zrakama za vrijeme uzimanja Kinzalkomba.
English: If you accidentally take too many tablets you may experience symptoms such as low blood pressure and rapid heartbeat.
Croatian: Ako slučajno uzmete previše tableta, može doći do pojave simptoma kao što su niski krvni tlak i ubrzani otkucaji srca.
English: The clinical relevance of this observation is not known.
Croatian: Klinički značaj spomenutog opažanja nije poznat.
English: The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Croatian: Primarno liječenje je prekid primjene hidroklorotiazida što je prije moguće.
English: The effect of pressor amines may be decreased.
Croatian: Učinak presornih amina može se smanjiti.
English: The terminal elimination half-life of hydrochlorothiazide is 10 - 15 hours.
Croatian: Poluvrijeme eliminacije hidroklorotiazida je 10-15 sati.
English: The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Croatian: Funkcionalna uloga ovih receptora nije poznata, niti učinak njihove moguće prekomjerne stimulacije putem angiotenzina II, čije vrijednosti se povećavaju telmisartanom.
English: Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled.
Croatian: Može doći do potrebe razmatranja promptnih medicinskih ili kirurških liječenja, ako se intraokularni tlak ne kontrolira.
English: These findings are considered to be due to the pharmacological activity of telmisartan.
Croatian: Ova otkrića smatraju se posljedicom farmakološke aktivnosti telmisartana.
English: Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body.
Croatian: Liječenje hidroklorotiazidom može izazvati neravnotežu elektrolita u Vašem tijelu.
English: The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of treatment and is sustained during long-term therapy.
Croatian: Maksimalno smanjenje krvnog tlaka se općenito postiže 4-8 tjedana nakon početka liječenja, te se održava tijekom dugotrajnog liječenja.
English: Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Croatian: Epidemiološke studije pokazale su da dugotrajno liječenje hidroklorotiazidom reducira rizik od kardiovaskularne smrtnosti i morbiditeta.
English: The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Croatian: Inhibitorski učinak se održava tijekom 24 sata i može se izmjeriti još uvijek do 48 sati.
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Croatian: Iako ne postoje kontrolirani epidemiološki podaci o riziku uz antagoniste receptora angiotenzina II, slični rizici mogu postojati za ovu skupinu lijekova.
English: Lithium containing medicines to treat some types of depression.
Croatian: - Lijekovi koji sadrže litij za liječenje određenih oblika depresije.
English: Hydrochlorothiazide should not be used for essential hypertension in pregnant women except in rare situations where no other treatment could be used.
Croatian: Hidroklorotiazid se ne smije primjenjivati u esencijalnoj hipertenziji kod trudnica, osim u rijetkim slučajevima u kojima se ne može primijeniti drugo liječenje.
English: Talk to your doctor before taking Kinzalkomb:
Croatian: Obratite se svom liječniku prije nego uzmete Kinzalkomb:
English: Talk to your doctor before taking Kinzalkomb if you are suffering or have ever suffered from any of the following conditions or illnesses:
Croatian: Obratite se svom liječniku prije nego uzmete Kinzalkomb ako bolujete ili ste bolovali od nekih od sljedećih stanja ili bolesti:
English: You can take Kinzalkomb with or without food.
Croatian: Možete uzimati Kinzalkomb sa ili bez hrane.
English: Electrolyte imbalance
Croatian: Neravnoteža elektrolita
English: The incidence of the primary endpoint was similar in the telmisartan (16.7 %) and ramipril (16.5 %) groups.
Croatian: Incidencija primarnog ishoda bila je slična u skupini na telmisartanu (16,7 %) i ramiprilu (16,5 %).
English: Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Croatian: Nakon naglog prekida liječenja telmisartanom, krvni tlak se postupno vraća na vrijednosti prije liječenja tijekom perioda od nekoliko dana, bez dokaza o rebound hipertenziji.
English: By 3 hours after administration plasma concentrations are similar whether telmisartan is taken fasting or with food.
Croatian: Tri sata nakon primjene koncentracije u plazmi su slične bez obzira je li telmisartan uzet s ili bez hrane.