FrancophonIA/ELRC3.0 huggingface dataset:
English: Concurrent use of other substances that have a high degree of protein binding (e.g. furosemide, ketoconazole, or non-steroidal anti-inflammatory drugs (NSAIDs)) may compete with cefovecin binding and thus may cause adverse effects.
Croatian: ketokonazola ili nesteroidnih protu-upalnih lijekova) može utjecati na vezivanje cefovecina i tako može uzrokovati nuspojave.
English: For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci and/or Staphylococcus pseudintermedius.
Croatian: Bacteroides spp., Prevotellu oralis, β hemolitičke streptokoke i/ili Staphylococcus pseudintermedius.
English: 1.8 mg/ml methyl parahydroxybenzoate (E218) 0.2 mg/ml propyl parahydroxybenzoate (E216) 12.3 mg/ml benzyl alcohol
Croatian: 80,0 mg/ml cefovecina (kao natrijeve soli) 1,8 mg/ml metil-parahidroksibenzoata (E218) 0,2 mg/ml propil-parahidroksibenzoata (E216)
English: 10.8 ml water for injections
Croatian: 13 mg/ml benzilnog alkohola 10,8 ml vode za injekciju
English: s.c. Read the package leaflet
Croatian: s.c. Pročitati uputu o VMP prije primjene.
English: Animal Weight (Dogs and Cats) Volume to be Administered 2.5 kg
Croatian: Težina životinje (psi i mačke)
English: QUANTITY OF OTHER SUBSTANCES 13 mg/ml benzyl alcohol
Croatian: KOLIČINA DJELATNE(IH) TVARI 13 mg/ml benzilnog alkohola.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 15. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET Zoetis Belgium SA
English: (periodontal 2008)
Croatian: Prevotella spp. (periodontalno 2008.)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats cefovecin
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Convenia 80 mg/ml prašak i otapalo za otopinu za injekciju za pse i mačke cefovecin
English: SPECIAL WARNING(S)
Croatian: 12. POSEBNA UPOZORENJA
English: 7.67 mg methyl parahydroxybenzoate (E218) 0.85 mg propyl parahydroxybenzoate (E216)
Croatian: 7,67 mg metil-parahidroksibenzoata (E218) 0,85 mg propil-parahidroksibenzoata (E216) Svaka bočica otapala sadrži:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Convenia 80 mg/ml prašak i otapalo za otopinu za injekciju za pse i mačke
English: B. PACKAGE LEAFLET
Croatian: Otapalo za Conveniu
English: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Benzyl alcohol
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari Metil-parahidroksibenzoat (E218) Propil-parahidroksibenzoat (E216)
English: PACKAGE LEAFLET: Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
Croatian: UPUTA O VMP: Convenia 80 mg/ml prašak i otapalo za otopinu za injekciju za pse i mačke
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (5 ml LYOPHILISED POWDER VIAL)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU VANJSKA KARTONSKA KUTIJA (SADRŽI BOČICU LIOFILIZIRANOG PRAŠKA I BOČICU OTAPALA)
English: Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE U PROMET Zoetis Belgium SA
English: EXPIRY DATE
Croatian: PUTOVI PRIMJENE
English: 4.11 Withdrawal period(s)
Croatian: 4.11 Karencija(e) Nije primjenjivo.
English: Dog Cat β haemolytic Streptococcus spp.
Croatian: Streptococcus spp.
English: Each 19 ml vial of diluent contains:
Croatian: Svaka bočica liofiliziranog praška od 23 ml sadrži:
English: The full EPAR for Varuby can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Varuby nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Varuby
Croatian: Ostale informacije o lijeku Varuby
English: What is Varuby and what is it used for?
Croatian: Što je Varuby i za što se koristi?
English: Varuby can only be obtained with a prescription and is available as 90-mg tablets.
Croatian: Varuby se izdaje samo na recept i dostupan je u obliku tableta od 90 mg.
English: What measures are being taken to ensure the safe and effective use of Varuby?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Varuby?
English: By blocking the receptors, Varuby can prevent this effect.
Croatian: Blokiranjem dotičnih receptora Varuby može spriječiti taj učinak.
English: Why is Varuby approved?
Croatian: Zašto je lijek Varuby odobren?
English: The active substance in Varuby, rolapitant, works by blocking neurokinin-1 (NK1) receptors.
Croatian: Djelatna tvar u lijeku Varuby, rolapitant, djeluje blokirajući receptore neurokinin-1 (NK1).
English: This is a summary of the European public assessment report (EPAR) for Varuby.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Varuby.
English: Two tablets are swallowed on the first day of each cycle of chemotherapy, 2 hours or less before chemotherapy starts.
Croatian: Dvije tablete treba uzeti prvog dana svakog ciklusa kemoterapije, unutar dva sata prije početka kemoterapije.
English: What are the risks associated with Varuby?
Croatian: Koji su rizici povezani s lijekom Varuby?
English: It is not intended to provide practical advice on how to use Varuby.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Varuby.
English: Overall, therefore, Varuby's benefits are greater than its risks and it has been recommended for approval for use in the EU.
Croatian: Stoga su, ukupno gledajući, prednosti lijeka Varuby veće od njegovih rizika te je preporučen za korištenje u EU-u.
English: Varuby contains the active substance rolapitant.
Croatian: Varuby sadrži djelatnu tvar rolapitant.
English: In both studies, one involving 532 patients and the other involving 555 patients, participants also received dexamethasone and granisetron (a 5-HT3 receptor antagonist).
Croatian: U oba ispitivanja, pri čemu je u jednom sudjelovalo 532 bolesnika, a u drugom 555, sudionici su također primili deksametazon i granisetron (antagonist receptora 5-HT3).
English: The most common side effects with Varuby (which may affect between 1 and 2 people in 100) are tiredness and headache.
Croatian: Najčešće nuspojave lijeka Varuby (mogu se javiti u 1 do 2 na 100 bolesnika) su umor i glavobolja.
English: Chemotherapy can release a substance in the body (substance P) which attaches to these receptors and stimulates delayed nausea and vomiting.
Croatian: Kemoterapijom se u tijelo može izlučiti tvar (tvar P) koja se veže na te receptore i stimulira odgođenu mučninu i povraćanje.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Varuby have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Varuby nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: There was no delayed nausea and vomiting in 71% of patients given Varuby (475 of 666) compared with 62% of those given placebo (410 of 666).
Croatian: U 71 % bolesnika (475 od 666) koji su primili Varuby nije bilo odgođene mučnine i povraćanja u usporedbi s 62 % bolesnika koji su primili placebo (410 od 666).
English: Patients taking Varuby must not take St John's wort (a herbal medicine for mild depression) as this can reduce the effect of Varuby.
Croatian: Bolesnici koji uzimaju Varuby ne smiju uzimati gospinu travu (biljni lijek za blagu depresiju) jer on može smanjiti učinak lijeka Varuby.
English: Varuby acts against delayed nausea and vomiting (when the symptoms occur 24 hours or more after the cancer treatment) and is given with other medicines that help control more immediate nausea and vomiting.
Croatian: Varuby suzbija odgođenu mučninu i povraćanje (kad se simptomi jave 24 sata ili kasnije nakon terapije protiv raka) te se primjenjuje s drugim lijekovima koji pomažu u kontroli neposrednije pojave mučnine i povraćanja.
English: Adding the results from both studies together, there was no nausea and vomiting in the period from 24 to 120 hours after chemotherapy in 71% of patients (382 out of 535) given Varuby, while the figure with placebo was 60% (322 out of 535 patients).
Croatian: Zbroj rezultata iz obje studije pokazao je izostanak mučnine i povraćanja unutar 24 do 120 sati nakon kemoterapije u 71 % bolesnika (382 od 535) koji su primili Varuby, dok je u skupini koja je primila placebo taj rezultat bio 60 % (322 od 535 bolesnika).
English: Varuby is given with dexamethasone and a 5-HT3 receptor antagonist (two other types of medicine to prevent nausea and vomiting) but how these are given depends on the type of chemotherapy.
Croatian: Varuby se primjenjuje s deksametazonom i antagonistom receptora 5-HT3 (dva druga lijeka za suzbijanje mučnine i povraćanja), no način njihove primjene ovisi o vrsti kemoterapije.
English: Varuby produced an improvement in the control of delayed nausea and vomiting when added to other standard treatments.
Croatian: Lijek Varuby poboljšava kontrolu odgođene mučnine i povraćanja kad se primjenjuje s drugim standardnim terapijama.
English: In addition, any side effects were manageable and were similar to those usually observed with medicines for nausea and vomiting.
Croatian: Osim toga, sve se nuspojave moglo kontrolirati te su bile slične onima zabilježenima kod drugih lijekova za mučninu i povraćanje.
English: For practical information about using Varuby, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Varuby bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: What benefits of Varuby have been shown in studies?
Croatian: Koje su koristi od lijeka Varuby utvrđene u ispitivanjima?
English: Varuby was also more effective than placebo in a third main study when used with dexamethasone and granisetron in patients given moderately emetogenic chemotherapy.
Croatian: Varuby se također pokazao djelotvornijim od placeba u trećem glavnom ispitivanju kad ga se primjenjivalo s deksametazonom i granisetronom u bolesnika koji su primili umjereno emetogenu kemoterapiju.
English: In two main studies, Varuby was more effective than placebo (a dummy treatment) in preventing delayed nausea and vomiting after highly emetogenic chemotherapy.
Croatian: U dva glavna ispitivanja Varuby je bio djelotvorniji od placeba (prividnog liječenja) u suzbijanju odgođene mučnine i povraćanja nakon visoko emetogene kemoterapije.
English: For more information about treatment with Varuby, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Varuby pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: When given with medicines that work by other mechanisms to prevent immediate nausea and vomiting, Varuby can help provide prolonged control against these symptoms after chemotherapy.
Croatian: Kad se primjenjuje s lijekovima koji na drugi način suzbijaju neposrednu mučninu i povraćanje, Varuby može duže kontrolirati suzbijanje tih simptoma nakon kemoterapije.
English: Different chemotherapy medicines produce different degrees of nausea and vomiting, and Varuby is used in patients receiving highly or moderately emetogenic (vomit-inducing) chemotherapy.
Croatian: Različiti lijekovi koji se koriste u kemoterapiji uzrokuju različit intenzitet mučnine i povraćanja te se Varuby koristi u bolesnika koji primaju visoko ili umjereno emetogenu kemoterapiju (koja izaziva povraćanje).
English: Varuby is a medicine used to prevent nausea (feeling sick) and vomiting in adult cancer patients who are receiving chemotherapy (medicines to treat cancer).
Croatian: Varuby je lijek koji se koristi za sprječavanje mučnine (slabosti) i povraćanja u odraslih bolesnika koji boluju od raka, koji primaju kemoterapiju (lijekovi za liječenje raka).
English: How is Varuby used?
Croatian: Kako se Varuby koristi?
English: Although a number of medicines are approved in the EU for management of chemotherapy-associated nausea and vomiting significant numbers of patients still experience it, and management of nausea in particular remains a challenge.
Croatian: Iako je u EU-u odobren niz lijekova za kontroliranje simptoma mučnine i povraćanja uzrokovanih kemoterapijom, veliki ih broj bolesnika i dalje ima, te kontrola mučnine i dalje predstavlja velik izazov.
English: How does Varuby work?
Croatian: Kako djeluje Varuby?
English: For further information, see the summary of product characteristics (also part of the EPAR).
Croatian: Dodatne informacije pročitajte u sažetku opisa svojstava lijeka (također dio EPAR-a).
English: For the full list of all side effects and restrictions with Varuby, see the package leaflet.
Croatian: Potpuni popis svih nuspojava i ograničenja zabilježenih pri primjeni lijeka Varuby potražite u uputi o lijeku.
English: Basis for the recommendations
Croatian: Temelji za preporuke
English: These include:
Croatian: Ti uvjeti obuhvaćaju:
English: Information for patients and healthcare professionals
Croatian: Informacije za bolesnike i zdravstvene radnike
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: Odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima diljem EU-a.
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek.
Croatian: Na tržište se stavljaju pod nazivima nekoliko trgovačkih marki uključujući: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro i Valprolek.
English: The review of valproate medicines was initiated on 9 March 2017 at the request of the French medicines regulator ANSM, under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje lijekova koji sadržavaju valproat započeto je 9. ožujka 2017. na zahtjev Francuske agencije za lijekove i medicinske proizvode (ANSM) u skladu s člankom 31. Direktive 2001/83/EZ.
English: It is known that if taken in pregnancy they can cause malformations in the baby and developmental disorders after birth.
Croatian: Poznato da je primjena u trudnoći može prouzročiti malformacije u djeteta i razvojne poremećaje nakon rođenja.
English: Member State representatives agree new restrictions and pregnancy prevention programme
Croatian: Predstavnici država članica usvojili su nova ograničenja i program za sprječavanje začeća
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/145600/2018
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which has adopted a position.
Croatian: Preporuke PRAC-a poslane su Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je donijela odluku.
English: The medicines authorities in the individual countries will approve appropriate details of the visual warning for their national situation.
Croatian: Nadležna tijela za lijekove u pojedinačnim državama odobrit će odgovarajuće pojedinosti vizualnog upozorenja za situacije u svojim državama.
English: • It is important that patients discuss any concerns about their medication with an appropriate healthcare professional.
Croatian: • Važno je da bolesnici razgovaraju o svim pitanjima koja imaju u vezi s lijekom s odgovarajućim zdravstvenim radnikom.
English: In addition, all companies marketing such medicines will need to have in place a risk management plan which details the measures taken to ensure that a medicine is used as safely as possible.
Croatian: Uz to će sve tvrtke koje takve lijekove stavljaju na tržište morati imati utvrđen plan upravljanja rizikom u kojem su detaljno navedene mjere poduzete kako bi se osiguralo da se lijek primjenjuje što je moguće sigurnije.
English: In some EU Member States they are also authorised to prevent migraine headaches.
Croatian: U nekim državama članicama EU-a također su odobreni za sprječavanje migrene.
English: The new measures endorsed by CMDh therefore strengthen previous restrictions on valproate use and requirements to inform women of the risk.
Croatian: Stoga nove mjere koje je odobrio CMDh pooštravaju prethodna ograničenja za primjenu valproata i zahtjeve za informiranje žena o rizicima.
English: The programme is designed to ensure that patients are made fully aware of the risks and the need to avoid becoming pregnant.
Croatian: Program je osmišljen kako bi se osiguralo da su bolesnice potpuno upoznate s rizicima i potrebom izbjegavanja začeća.
English: The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide.
Croatian: Djelatna tvar u tim lijekovima može biti valproična kiselina, magnezijev valproat, natrijev valproat, valproat seminatrij ili valpromid.
English: During the review, the PRAC also consulted very widely with healthcare professionals and with patients, including women and their children who have been affected by valproate use during pregnancy, through written submissions, expert meetings, meetings with stakeholders (including healthcare professionals, patients organisations, patients and their families), and via a public hearing.
Croatian: PRAC se, tijekom pregleda, također iscrpno savjetovao sa zdravstvenim radnicima i bolesnicima, uključujući žene i njihovu djecu koja su tijekom trudnoće bila izložena valproatu, kroz pisane podneske, sastanke sa stručnjacima, sastanke s interesnim skupinama (uključujući zdravstvene radnike, organizacije bolesnika, bolesnike i njihove obitelji) te na javnoj raspravi.
English: • As before, valproate treatment should never be started unless alternative treatments are not suitable, including in young girls below the age of puberty.
Croatian: • Kao i ranije, liječenje valproatom nikada se ne smije započeti osim ako alternativno liječenje nije prikladno, uključujući mlade djevojke koje još nisu ušle u pubertet.
English: Women and girls who have been prescribed valproate should not stop taking their medicine without consulting their doctor as doing so could result in harm to themselves or to an unborn child.
Croatian: Žene i djevojke kojima je propisan valproat ne trebaju prestati uzimati lijek bez savjetovanja s liječnikom jer time mogu naštetiti sebi ili nerođenom djetetu.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.
Croatian: Ocjenjivanje je prvotno proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosnih pitanja koja se odnose na lijekove za liječenje ljudi, koji je donio niz preporuka.
English: The new measures include a ban on the use of such medicines for migraine or bipolar disorder during pregnancy, and a ban on treating epilepsy during pregnancy unless there is no other effective treatment available.
Croatian: Nove mjere uključuju zabranu upotrebe takvih lijekova protiv migrene ili bipolarnog poremećaja tijekom trudnoće te zabranu liječenja epilepsije tijekom trudnoće osim ako drugo djelotvorno liječenje nije dostupno.
English: • Healthcare professionals will receive further information at national level in due course as the recommendations are implemented.
Croatian: • Zdravstveni će radnici pravodobno primiti dodatne informacije na nacionalnoj razini u postupku provedbe preporuka.
English: New measures to avoid valproate exposure in pregnancy endorsed
Croatian: Odobrene nove mjere izbjegavanja izlaganja valproatu u trudnoći
English: The measures are based on a review of available scientific evidence, including drug utilisation studies and clinical and laboratory evidence of the effects of the medicine.
Croatian: Mjere se temelje na pregledu dostupnih znanstvenih dokaza, uključujući ispitivanja potrošnje lijeka te kliničke i znanstvene dokaze učinaka lijeka.
English: • Educational materials in the form of guides for patients and doctors will also be updated to reflect the current situation and provide age-appropriate advice.
Croatian: • Edukativni materijali u obliku vodiča za bolesnike i liječnike također će se ažurirati kako bi prikazali trenutačnu situaciju i omogućili savjete primjerene za određenu dob.
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Croatian: Lijekovi koji sadržavaju valproat odobreni su u nacionalnim postupcima u svim državama članicama EU-a te u Norveškoj i Islandu.
English: A visual warning of the pregnancy risks (in the form of boxed text with other possible elements such as a warning symbol) must also be placed on the packaging of the medicines and warnings be included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
Croatian: Vizualno upozorenje o rizicima u trudnoći (u obliku uokvirenog teksta s drugim mogućim elementima, kao što je znak upozorenja) također se mora nalaziti na pakiranju lijekova, a upozorenja moraju biti uključena na kartice za bolesnike koje su priložene u kutijama i koje se isporučuju s lijekom svaki put kad se isporučuje i lijek.
English: Further, the medicines must not be used in any woman or girl able to have children unless the conditions of a new pregnancy prevention programme are met.
Croatian: Nadalje, lijekovi se ne smiju primjenjivati ni u jedne žene ni djevojke koja može imati djecu, osim ako su zadovoljeni uvjeti novog programa sprječavanja začeća.
English: The CMDh agreed with EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which carried out a review and recommended the new measures, that despite previous recommendations aimed at better informing patients of the risks with these medicines, women were still not always receiving the right information in a timely manner.
Croatian: CMDh se složio s Odborom za procjenu rizika u području farmakovigilancije (PRAC) Europske agencije za lijekove, koji je pregledao i preporučio nove mjere, da žene i dalje, unatoč prethodnim preporukama koje su za cilj imale bolju informiranost bolesnica o rizicima povezanima s ovim lijekovima, ne primaju uvijek točne i pravodobne informacije.
English: • Although steps had been taken previously to better inform women about these risks and discourage use of valproate in girls and women unless there was no alternative, the evidence shows that this information is still not getting to patients.
Croatian: • Iako su i ranije poduzete mjere s ciljem bolje informiranosti žena o ovim rizicima te se primjena valproata u djevojaka i žena nije preporučivala osim u slučajevima u kojima nije bilo zamjenskog liječenja, dokazi pokazuju da ove informacije i dalje ne dolaze do bolesnica.