FrancophonIA/ELRC3.0 huggingface dataset:
English: Equioxx can only be obtained with a prescription.
Croatian: Equioxx se izdaje samo na recept.
English: The solution for injection is given into a vein while the paste and tablets are given by mouth.
Croatian: Otopina za injekciju daje se u venu, a pasta i tablete kroz usta.
English: The medicine is not authorised for use in horses producing milk for human consumption.
Croatian: Ovaj VMP nije odobren za primjenu u konja od kojih se dobiva mlijeko za ljudsku prehranu.
English: If the medicine is accidentally swallowed or someone accidentally injects themselves, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: Ako neka osoba nehotično proguta ovaj proizvod ili si nehotično ubrizga injekciju, potrebno je smjesta potražiti savjet liječnika te mu pokazati uputu o VMP-u ili naljepnicu proizvoda.
English: What is Equioxx and what is it used for?
Croatian: Što je Equioxx i za što se koristi?
English: It is not intended to provide practical advice on how to use Equioxx.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni VMP-a Equioxx.
English: Equioxx must not be used in breeding, pregnant or lactating horses.
Croatian: Equioxx se ne smije davati konjima tijekom oplodnje, graviditeta ili laktacije.
English: Equioxx is a medicine used in horses to relieve pain and inflammation in the joints caused by osteoarthritis (a long-term disease causing damage and pain in the joints) and to reduce the lameness that is associated with the disease.
Croatian: Equioxx je veterinarsko-medicinski proizvod koji se primjenjuje u konja za ublažavanje boli i upale u zglobovima uzrokovanih osteoartrozom (dugotrajna bolest koja uzrokuje oštećenja i bol u zglobovima) te za smanjenje s time povezane hromosti konja.
English: Equioxx must not be used in horses suffering from stomach or gut disorders and bleeding, nor in case of reduced liver, heart or kidney function or bleeding disorders.
Croatian: Equioxx se ne smije primjenjivati u konja s poremećajem želuca ili crijeva ili krvarenjem u tim organima, ni u konja s oslabljenim radom jetre, srca ili bubrega te s poremećajima krvarenja.
English: For the full list of all side effects reported with Equioxx and the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni VMP-a Equioxx i potpuni popis ograničenja potražite u uputi o VMP-u.
English: One study in the USA compared Equioxx to another NSAID medicine, phenylbutazone, and the second study in Europe compared Equioxx to the NSAID
Croatian: U jednom ispitivanju provedenom u SAD-u VMP Equioxx uspoređen je s drugim lijekom iz skupine NSAID-a, fenilbutazonom, a u drugom provedenom u Europi s NSAID-om vedaprofenom.
English: Equioxx oral paste and Equioxx solution for injection have been studied in a laboratory and found to be bioequivalent.
Croatian: Peroralna pasta Equioxx i otopina za injekciju Equioxx ispitivane su u laboratoriju i utvrđena je njihova bioekvivalentnost.
English: What are the risks associated with Equioxx?
Croatian: Koji su rizici povezani s VMP-om Equioxx?
English: Two field studies investigated the effectiveness of Equioxx oral paste in treating horses with lameness of more than 4 weeks due to osteoarthritis.
Croatian: Učinkovitost peroralne paste Equioxx ispitana je u dvama terenskim ispitivanjima u okviru liječenja konja zbog hromosti uzrokovane osteoartrozom u trajanju duljem od 4 tjedna.
English: Equioxx is available as a solution for injection, an oral paste and chewable tablets.
Croatian: Equioxx je dostupan u obliku otopine za injekciju, peroralne paste i tableta za žvakanje.
English: How does Equioxx work?
Croatian: Kako djeluje Equioxx?
English: The most common side effects with Equioxx (which may affect more than 1 in 10 horses) are ulcers or sores of the lining of the mouth or the skin around the mouth.
Croatian: Najčešće su nuspojave VMP-a Equioxx (koje se mogu javiti u više od 1 na 10 konja) čirevi ili rane u usnoj šupljini ili na koži oko usta.
English: The most common side effects with Equioxx (which may affect up to 1 in 100 horses) are salivation and lip and tongue swelling associated with the mouth sores.
Croatian: Najčešće su nuspojave VMP-a Equioxx (koje se mogu javiti u više od 1 na 10 konja) slinjenje i oticanje usne i jezika povezano s ranama u ustima.
English: Women of child-bearing age should avoid contact with, or wear disposable gloves, when giving the product.
Croatian: Pri davanju ovog VMP-a žene u reproduktivnoj dobi trebaju izbjegavati dodir s lijekom ili nositi rukavice za jednokratnu uporabu.
English: What benefits of Equioxx have been shown in studies?
Croatian: Koje su koristi VMP-a Equioxx dokazane u ispitivanjima?
English: For more information about treatment with Equioxx, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Dodatne informacije o terapiji VMP-om Equioxx vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: For practical information about using Equioxx, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Croatian: Praktične informacije o primjeni VMP-a Equioxx vlasnici životinja ili uzgajivači trebaju pročitati u uputi o VMP-u, odnosno trebaju se obratiti svojem veterinaru ili ljekarniku.
English: Similarly Equioxx oral paste and Equioxx chewable tablets have been shown to be bioequivalent.
Croatian: Isto tako, utvrđena je bioekvivalentnost peroralne paste Equioxx i tableta za žvakanje Equioxx.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Equioxx, 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 Equioxx, nalaze se informacije o sigurnosti primjene, uključujući odgovarajuće mjere opreza kojih se veterinari te vlasnici životinja ili uzgajivači trebaju pridržavati.
English: How is Equioxx used?
Croatian: Kako se Equioxx koristi?
English: The full EPAR for Thorinane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Thorinane nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Thorinane is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Croatian: Drugim riječima, Thorinane je sličan biološkom lijeku (poznatom kao „referentni lijek“) koji je već odobren u Europskoj uniji (EU).
English: What measures are being taken to ensure the safe and effective use of Thorinane?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Thorinane?
English: In addition, a study in 20 healthy subjects has shown that the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.
Croatian: Nadalje, ispitivanje na 20 zdravih ispitanika pokazalo je da jednake doze tih dvaju proizvoda primijenjenih supkutanom injekcijom uzrokuju slične učinke na faktore zgrušavanja krvi, primjenom različitih mjerila koja odražavaju način na koji lijek djeluje u tijelu.
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Thorinane and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji stoga je zaključio da ne postoje klinički značajne razlike između lijekova Thorinane i Clexane u pogledu djelotvornosti i sigurnosti te smatra da, kao i za lijek Clexane, koristi nadmašuju identificirani rizik.
English: What is Thorinane and what is it used for?
Croatian: Što je Thorinane i za što se koristi?
English: Thorinane enoxaparin sodium
Croatian: Thorinane enoksaparin natrij
English: The Committee recommended that Thorinane be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Thorinane u promet.
English: The most common side effect with Thorinane (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Thorinane to prevent blood clots during surgery.
Croatian: Najčešća nuspojava lijeka Thorinane (koja se može javiti u više od 1 na 10 osoba) je krvarenje; do ozbiljnog krvarenja došlo je u oko 4 na 100 osoba koje su primile lijek Thorinane radi sprječavanja krvnih ugrušaka tijekom kirurškog zahvata.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Thorinane have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Thorinane nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Thorinane is a ‘biosimilar medicine'.
Croatian: Thorinane je „biosličan lijek”.
English: It is not intended to provide practical advice on how to use Thorinane.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Thorinane.
English: This is a summary of the European public assessment report (EPAR) for Thorinane.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Thorinane.
English: What are the risks associated with Thorinane?
Croatian: Koji su rizici povezani s lijekom Thorinane?
English: Why is Thorinane approved?
Croatian: Zašto je lijek Thorinane odobren?
English: The active substance in Thorinane, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Croatian: Djelatna tvar lijeka Thorinane, enoksaparin, pripada skupini antikoagulansa naziva „heparini niske molekularne težine”.
English: Other information about Thorinane
Croatian: Ostale informacije lijeku Thorinane
English: The reference medicine for Thorinane is Clexane.
Croatian: Referentni lijek za Thorinane je Clexane.
English: For more information about treatment with Thorinane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Thorinane pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Thorinane must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke.
Croatian: Lijek Thorinane ne smije se primjenjivati u bolesnika s postojećim većim krvarenjem, ozbiljnim poremećajima zgrušavanja krvi ili bolestima koje povećavaju rizik od krvarenja, kao što su čir na želucu ili moždani udar.
English: Extensive laboratory studies comparing Thorinane with Clexane have shown that Thorinane is highly similar to Clexane in terms of structure, purity and biological activity.
Croatian: Opsežna laboratorijska ispitivanja u kojima je lijek Thorinane uspoređen s lijekom Clexane pokazala su da postoji velika sličnost između njih u pogledu strukture, čistoće i biološke aktivnosti.
English: Thorinane is available as a solution for injection in pre-filled syringes.
Croatian: Lijek Thorinane dostupan je kao otopina za injekciju u napunjenim štrcaljkama.
English: Studies have shown that Thorinane has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors.
Croatian: Ispitivanja su pokazala da lijek Thorinane ima veoma sličnu strukturu i biološku aktivnost u usporedbi s lijekom Clexane te da ima jednak učinak na faktore zgrušavanja krvi.
English: For practical information about using Thorinane, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Thorinane bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: In the treatment of unstable angina and heart attack Thorinane is given with aspirin (acetylsalicylic acid).
Croatian: Lijek Thorinane se pri liječenju nestabilne angine pektoris i infarkta miokarda primjenjuje u kombinaciji s aspirinom (acetilsalicilnom kiselinom).
English: How is Thorinane used?
Croatian: Kako se Thorinane koristi?
English: How does Thorinane work?
Croatian: Kako djeluje Thorinane?
English: Thorinane is an anticoagulant medicine (a medicine to prevent blood clots).
Croatian: Thorinane je antikoagulans (lijek za sprječavanje nastanka krvnih ugrušaka).
English: What benefits of Thorinane have been shown in studies?
Croatian: Koje su koristi lijeka Thorinane utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Thorinane, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Thorinane potražite u uputi o lijeku.
English: The active substance in Thorinane is enoxaparin sodium.
Croatian: Djelatna tvar lijeka Thorinane je enoksaparin natrij.
English: The injection site should be changed for each injection.
Croatian: Mjesto injekcije treba se promijeniti sa svakom injekcijom.
English: It is usually given once or twice a day when a rapid initial effect together with a more long-lasting effect is needed.
Croatian: Obično se daje jednom ili dvaput na dan ako je potrebno brzo početno djelovanje, kao i dugotrajnije djelovanje.
English: This summary was last updated in 11-2013.
Croatian: Sažetak je posljednji put ažuriran: 11.2013.
English: The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
Croatian: Uobičajena doza iznosi između 0,3 i 1,0 internacionalnih jedinica (IU) po kilogramu tjelesne mase na dan.
English: Actraphane is given 30 minutes before a meal.
Croatian: Actraphane se daje 30 minuta prije obroka.
English: The full EPAR for Actraphane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Actraphane nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The patient's blood glucose (sugar) should be tested regularly to find the lowest effective dose.
Croatian: Razina glukoze (šećera) u krvi bolesnika treba se redovito testirati kako bi se utvrdila najniža djelotvorna doza.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actraphane on 7 October 2002.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Actraphane vrijedi na prostoru Europske unije od 7. listopada 2002.
English: By controlling the blood glucose, the symptoms and complications of diabetes are reduced.
Croatian: Kontrolirajući razinu glukoze u krvi, smanjuju se simptomi i komplikacije dijabetesa.
English: EPAR summary for the public human insulin
Croatian: EPAR, sažetak za javnost humani inzulin
English: What measures are being taken to ensure the safe and effective use of Actraphane?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Actraphane?
English: Other information about Actraphane
Croatian: Ostale informacije o lijeku Actraphane
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 Actraphane.
Croatian: Objašnjava kako je Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) ocijenilo lijek da bi donijelo svoje mišljenje u korist davanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Actraphane.
English: Actraphane contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an isophane form, which is absorbed much more slowly during the day.
Croatian: Actraphane sadrži inzulin u dva oblika: topljivi oblik, koji djeluje brzo (u roku od 30 minuta nakon injekcije), i izofan, oblik koji se apsorbira mnogo sporije tijekom dana.
English: Diabetes is a disease in which the body does not produce enough insulin to control the blood glucose or when the body is unable to use insulin effectively.
Croatian: Dijabetes je bolest kod koje tijelo ne proizvodi dovoljno inzulina kako bi kontroliralo glukozu u krvi ili kada tijelo ne može učinkovito iskoristiti inzulin.
English: Actraphane is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Croatian: Actraphane se primjenjuje injekcijom ispod kože u bedro, abdominalni zid (u prednjem dijelu kuka), područje gluteusa (stražnjica) ili deltoidno područje (rame).
English: For more information about treatment with Actraphane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Actraphane pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Actraphane, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za lijek Actraphane uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: It is available as vials, cartridges (Penfill) or prefilled pens (InnoLet or FlexPen).
Croatian: Dostupan je u bočicama, ulošcima (Penfill) ili napunjenim olovkama (InnoLet ili FlexPen).
English: The active substance in Actraphane, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Croatian: Djelatna tvar u lijeku Actraphane, humani inzulin, proizvodi se metodom poznatom pod nazivom „rekombinantna tehnologija“: inzulin proizvode stanice kvasca, u koje se ugradio gen (DNK), što im omogućuje proizvodnju inzulina.
English: A risk management plan has been developed to ensure that Actraphane is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Actraphane.
English: This gives Actraphane a longer duration of action.
Croatian: To daje lijeku Actraphane dulje trajanje djelovanja.
English: This is a summary of the European public assessment report (EPAR) for Actraphane.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Actraphane.
English: Actraphane is used to treat diabetes.
Croatian: Actraphane se koristi za liječenje dijabetesa.
English: Actraphane has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Croatian: Actraphane se ispitivao u ukupno 294 bolesnika oboljelih od dijabetesa tipa 1, u slučaju kada gušterača ne može proizvoditi inzulin, i dijabetesa tipa 2, u slučaju kada tijelo ne može učinkovito iskoristiti inzulin.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Croatian: Zamjenski inzulin djeluje na isti način kao prirodno proizveden inzulin i pomaže glukozi da uđe u stanice iz krvi.
English: HbA1c gives an indication of how well the blood glucose is controlled.
Croatian: HbA1c indicira koliko se dobro kontrolira razina glukoze u krvi.
English: Actraphane was effective for both type 1 and type 2 diabetes.
Croatian: Actraphane se pokazao učinkovitim i za dijabetes tipa 1 i za dijabetes tipa 2.
English: About onethird of the patients had type 1 diabetes and the remainder had type 2 diabetes.
Croatian: Oko trećine bolesnika imalo je dijabetes tipa 1, dok su preostali imali dijabetes tipa
English: The most common side effect with Actraphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Croatian: Najčešća nuspojava lijeka Actraphane (primijećena kod više od 1 na 10 osoba) je hipoglikemija (niske razine glukoze u krvi).
English: The CHMP decided that Actraphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Actraphane nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: What is the risk associated with Actraphane?
Croatian: Koji su rizici povezani s lijekom Actraphane?
English: The study compared Actraphane 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Croatian: Ispitivanje je usporedilo Actraphane 30 sa sličnom mješavinom koja je, međutim, sadržavala analogni inzulin (inzulin aspart).
English: The study measured the level of glycosylated haemoglobin (HbA1c) after 12 weeks, which is the percentage of haemoglobin in the blood that has glucose attached.
Croatian: Ispitivanje je mjerilo razinu glikoziliranog hemoglobina (HbA1c), koji predstavlja postotak hemoglobina u krvi na koji se vezala glukoza, nakon 12 tjedana.
English: Why has Actraphane been approved?
Croatian: Zašto je Actraphane odobren?
English: Actraphane led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Croatian: Actraphane je smanjio razinu glikoziliranog hemoglobina (HbA1c), što pokazuje da je kontrolirao razinu glukoze u krvi u sličnoj mjeri kako i drugi humani inzulini.
English: Actraphane is a suspension for injection that contains the active substance human insulin.
Croatian: Actraphane je otopina za injekciju koja sadrži djelatnu tvar humani inzulin.
English: Actraphane contains both fast-acting (soluble) and long-acting (isophane) insulin:
Croatian: Actraphane sadrži brzodjelujući (topljivi) inzulin i dugodjelujući (izofan) inzulin:
English: What is Actraphane?
Croatian: Što je Actraphane?
English: Actraphane is a replacement insulin which is very similar to the insulin made by the pancreas.
Croatian: Actraphane je zamjenski inzulin koji je vrlo sličan inzulinu koji proizvodi gušterača.
English: What benefit has Actraphane shown during the studies?
Croatian: Koje su koristi lijeka Actraphane dokazane u ispitivanjima?
English: What is Actraphane used for?
Croatian: Za što se Actraphane koristi?
English: How is Actraphane used?
Croatian: Kako se Actraphane koristi?
English: How has Actraphane been studied?
Croatian: Kako je Actraphane ispitivan?
English: How does Actraphane work?
Croatian: Kako djeluje Actraphane?
English: ATCvet code: QI09AE03.
Croatian: ATCvet kod: QI09AE03.
English: Provide enough space so that all pigs can drink the required amount.
Croatian: Osigurajte dovoljno prostora tako da sve svinje mogu popiti potrebnu količinu.
English: The expiry date refers to the last day of that month.
Croatian: Rok valjanosti se odnosi na zadnji dan tog mjeseca.
English: Shake well and use immediately.
Croatian: Dobro protresite i odmah primijenite.
English: Alternatively, refer to the following table:
Croatian: Alternativno, pogledajte sljedeću tablicu:
English: The actual amount of water consumed may however vary considerably depending on several factors.
Croatian: Stvarna količina konzumirane vode može značajno varirati ovisno o nekoliko čimbenika.
English: Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required.
Croatian: Pitajte vašeg veterinara ili farmaceuta kako odlagati lijekove koji vam više nisu potrebni.