FrancophonIA/ELRC3.0 huggingface dataset:
English: Citric acid monohydrate (E330) Diethylenetriaminepentaacetic acid Polysorbate 80 (E433)
Croatian: - Drugi sastojci su citratna kiselina hidrat (E330), dietilentriaminpentaacetatna kiselina, polisorbat
English: Nausea, diarrhoea
Croatian: Poremećaji probavnog sustava često mučnina, dijareja
English: Pyrexia
Croatian: Portsmouth
English: Placebo with SoC Percent (n/m) Difference (95% CI)
Croatian: Placebo sa standardnom terapijom Postotak (n/m)
English: ZINPLAVA with SoC Percent (n/N)
Croatian: ZINPLAVA sa standardnom terapijom Postotak (n/N)
English: 7 May 2015
Croatian: 7. svibnja 2015.
English: EMA/55773/2016 EMEA/V/C/003786
Croatian: EMEA/V/C/003786
English: This means that it blocks channels on the surface of cells through which calcium normally enters the cell.
Croatian: To znači da blokira kanale na površini stanica kroz koje kalcij normalno ulazi u stanice.
English: In addition, there were concerns that the safety of the medicine had not been fully demonstrated and one unresolved quality issue.
Croatian: Nadalje, postojale su zabrinutosti da sigurnost VMP-a nije bila u potpunosti dokazana, kao i jedno nerazriješeno pitanje kvalitete.
English: What is Lodipressin?
Croatian: Što je Lodipressin?
English: What were the CVMP's main concerns that led to the refusal?
Croatian: Koji su glavni razlozi za zabrinutost CVMP-a rezultirali odbijanjem?
English: After considering the grounds for this request, the CVMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 7 May 2015.
Croatian: Nakon razmatranja razloga za ovaj zahtjev CVMP je ponovno pregledao prvotno mišljenje i potvrdio je odbijanje izdavanja odobrenja za stavljanje u promet od 7. svibnja 2015.
English: Lodipressin was expected to be used to treat cats with systemic arterial hypertension (high blood pressure).
Croatian: Lodipressin se trebao koristiti za liječenje mačaka sa sistemskom arterijskom hipertenzijom (visok krvni tlak).
English: As part of its application the company presented the results of a field study involving cats with blood pressure of 160 mmHg or above.
Croatian: Tvrtka je u sklopu zahtjeva predstavila rezultate terenskog ispitivanja koje je uključivalo mačke s krvnim tlakom 160 mmHg ili višim.
English: In the second part, 23 cats received Lodipressin for 16 weeks with no placebo group.
Croatian: U drugom dijelu ispitivanja 23 su mačke tijekom 16 tjedana primale Lodipressin, a nije bilo skupine koja je primala placebo.
English: The CVMP therefore maintained its recommendation that the marketing authorisation be refused.
Croatian: CVMP je stoga zadržao preporuku da se odbije odobrenje za stavljanje u promet.
English: The study had two parts, an initial part with 19 cats, 11 of which were treated with Lodipressin and 8 of which received placebo (a dummy treatment) for two weeks.
Croatian: U početnom dijelu sudjelovalo je 19 mačaka, među kojima je njih 11 liječeno VMP-om Lodipressin, a osam ih je primalo placebo (prividno liječenje) dva tjedna.
English: This meant that whilst there is some evidence that Lodipressin is effective in lowering blood pressure, no firm conclusions could be drawn on its effectiveness for treatment of high blood pressure in cats.
Croatian: To znači da, iako postoje određeni dokazi da je Lodipressin djelotvoran u snižavanju krvnoga tlaka, nije bilo moguće donijeti nepobitne zaključke o njegovoj djelotvornosti za liječenje visokog krvnog tlaka u mačaka.
English: Lodipressin is a veterinary medicine that contains the active substance amlodipine besilate.
Croatian: Lodipressin je veterinarsko-medicinski proizvod koji sadrži djelatnu tvar amlodipin besilat.
English: By reducing the entry of calcium into these cells, amlodipine prevents the blood vessel from contracting, thus lowering the blood pressure.
Croatian: Smanjivanjem prodiranja kalcija u te stanice amlodipin sprječava kontrakciju stijenki krvnih žila te tako snižava krvni tlak.
English: On 15 January 2015, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Lodipressin, intended for the treatment of systemic arterial hypertension in cats.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) usvojio je negativno mišljenje, preporučujući odbijanje izdavanja odobrenja za stavljanje u promet veterinarskomedicinskog proizvoda (VMP) Lodipressin koji je namijenjen liječenju sistemske arterijske hipertenzije u mačaka.
English: During the re-examination, the CVMP considered advice from an expert group in feline medicine.
Croatian: Tijekom ponovnog pregleda CVMP je u obzir uzeo savjet stručne skupine u području liječenja mačaka.
English: At the time of the initial evaluation, the CVMP considered that there were deficiencies in the way the field study had been designed and conducted and the results had been presented.
Croatian: U vrijeme donošenja prvotne ocjene CVMP je smatrao da su prisutni nedostaci u odnosu na oblik i provedbu terenskog ispitivanja te predstavljanje rezultata.
English: What was Lodipressin expected to be used for?
Croatian: Za što se Lodipressin trebao koristiti?
English: How is Lodipressin expected to work?
Croatian: Kako je Lodipressin trebao djelovati?
English: The company that applied for authorisation is Le Vet Beheer B.V.
Croatian: Tvrtka CLe Vet Beheer B.V. podnijela je zahtjev za izdavanje odobrenja.
English: The expert group advised that although the field study showed some evidence of a reduction in blood pressure, the many shortcomings in the study did not allow to conclude that the benefits of Lodipressin in the treatment of high blood pressure in cats outweigh the risks.
Croatian: Stručna skupina savjetovala je da, unatoč određenim dokazima prikupljenima na temelju terenskog ispitivanja u odnosu na snižavanje krvnoga tlaka, brojni nedostaci u ispitivanju nisu omogućili donošenje zaključka da koristi VMP-a Lodipressin u liječenju visokog krvnog tlaka u mačaka nadilaze rizike.
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate)
Croatian: Odbijanje odobrenja za stavljanje u promet veterinarskomedicinskog proizvoda Lodipressin (amlodipin besilat)
English: When calcium enters the cells in the blood vessel walls this causes contraction.
Croatian: Ulazak kalcija u stanice uzrokuje kontrakciju u stijenkama krvnih žila.
English: Refusal of the marketing authorisation for Lodipressin (amlodipine besilate) EMA/55773/2016
Croatian: Odbijanje odobrenja za stavljanje u promet veterinarsko-medicinskog proizvoda Lodipressin (amlodipin besilat)
English: If you or your child forgets to take the third (last) dose at the right time, take it as soon as you remember.
Croatian: Ako Vi ili Vaše dijete zaboravite uzeti treću (posljednju) dozu u pravo vrijeme, uzmite je čim se sjetite.
English: These include (but are not limited to):
Croatian: Tu pripadaju (ali popis nije ograničen samo na njih):
English: It is not known whether these toxic effects are reversible.
Croatian: Nije poznato jesu li ovi toksični učinci reverzibilni.
English: All patients were clinically cured.
Croatian: Svi su bili klinički izliječeni.
English: Never take more than one dose on the same day to make up for a missed dose.
Croatian: Nikad nemojte uzeti više od jedne doze u istom danu kako biste nadoknadili propuštenu dozu.
English: The mixture should be used immediately after preparation.
Croatian: Mješavina se mora primijeniti odmah nakon pripreme.
English: * see section 5.1
Croatian: * vidjeti dio 5.1
English: Take one dose on each day.
Croatian: Svakog dana uzmite jednu dozu.
English: If this happens within:
Croatian: Ako se to dogodi u roku od:
English: Most of the side effects are not severe and normally disappear within a few days or weeks after treatment.
Croatian: Nuspojave većinom nisu teške i obično nestanu u roku od nekoliko dana ili tjedana nakon liječenja.
English: • 31-60 minutes, half the dose must be taken again.
Croatian: • 31-60 minuta, mora se ponovno uzeti polovica doze.
English: The daily dose depends on the patient's body weight.
Croatian: Dnevna doza ovisi o tjelesnoj težini bolesnika.
English: Then take the third (last) dose approximately 24 hours after the second dose.
Croatian: Zatim uzmite treću (posljednju) dozu približno 24 sata nakon druge doze.
English: Your doctor will advise you when these readings will be taken.
Croatian: Liječnik će Vas obavijestiti kad će se napraviti ova pretraga.
English: Concomitant treatment with such medicinal products is not recommended.
Croatian: Ne preporučuje se istovremeno liječenje takvim lijekovima.
English: If the tablets are difficult to swallow, you can crush and mix them with water; drink the mixture immediately.
Croatian: Ako je tablete teško progutati, možete ih zdrobiti i pomiješati s vodom; mješavinu popijte odmah.
English: Daily dose (mg)
Croatian: Dnevna doza (mg)
English: Eurartesim with food and drink
Croatian: Eurartesim s hranom i pićem
English: − This medicine has been prescribed for you only.
Croatian: - Ovaj je lijek propisan Vama.
English: Do not use this medicine if you notice the blister is open.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je blister otvoren.
English: The table in this section is for adult patients only.
Croatian: Tablica u ovom dijelu odnosi se samo na odrasle bolesnike.
English: • is taking certain other medicines which could cause possible metabolic interactions.
Croatian: • uzimate određene druge lijekove koji mogu prouzročiti moguće metaboličke interakcije.
English: You or your child can drink water at any time.
Croatian: Vi ili Vaše dijete smijete piti vodu cijelo vrijeme.
English: Always take Eurartesim exactly as your doctor has told you to.
Croatian: Uvijek uzmite Eurartesim točno onako kako Vam je rekao liječnik.
English: • knows that any member of your family (parents, grandparents, brothers or sisters) died suddenly due to a heart problem or was born with heart problems;
Croatian: • znate da je neki član Vaše obitelji (roditelji, bake, djedovi, braća ili sestre) iznenada umro zbog srčanih poremećaja ili je bio rođen sa srčanim poremećajem;
English: If a dose is missed, it should be taken as soon as realised and then the recommended regimen continued until the full course of treatment has been completed.
Croatian: Ako se propusti doza, potrebno ju je uzeti čim se to primijeti, a zatim nastaviti s preporučenim režimom sve dok se ne završi cijela kura liječenja.
English: Re-dosing with Eurartesim should not be attempted more than once.
Croatian: Ponovna primjena doze Eurartesima ne smije se pokušati više od jedanput.
English: Taking this medicine, if the malaria infection returns
Croatian: Uzimanje ovog lijeka ako se malarija vrati
English: Tell your doctor immediately, or go immediately to the emergency department of your nearest hospital, taking this leaflet with you.
Croatian: Odmah obavijestite liječnika ili odmah otiđite u hitnu službu najbliže bolnice i pritom ponesite sa sobom ovu Uputu.
English: • has recently (for example within about one month) been treated for malaria with certain medicines or has taken certain medicines to prevent malaria.
Croatian: • ako ste nedavno (na primjer, u prethodnih otprilike mjesec dana) bili liječeni zbog malarije određenim lijekovima ili ste uzimali određene lijekove za sprječavanje malarije.
English: Via Ragazzi del '99, n. 5 40133 Bologna Italy
Croatian: Via Ragazzi del '99, n. 5 40133 Bologna
English: Examples are listed in the section “Other medicines and Eurartesim”.
Croatian: Primjeri su navedeni u dijelu “Drugi lijekovi i Eurartesim”.
English: No data are available for these paediatric subsets.
Croatian: Nema dostupnih podataka za ove pedijatrijske podskupine.
English: • The ECG monitoring recommendations.
Croatian: • Preporuke za EKG nadzor.
English: • is taking or has taken any other medicines for the treatment of malaria (other than those mentioned above);
Croatian: • uzimate ili ste uzeli bilo koje druge lijekove za liječenje malarije (pored onih navedenih gore);
English: The above mentioned interactions for adults and the warnings in section 4.4 should be taken into account for the paediatric population.
Croatian: Prethodno spomenute interakcije u odraslih te upozorenja u dijelu 4.4 treba uzeti u obzir i za pedijatrijsku populaciju.
English: Date of first authorisation: 27 October 2011 Date of latest renewal: 09 September 2016
Croatian: Datum posljednje obnove odobrenja: 09. rujna 2016.
English: The majority of paediatric experience is derived from African children aged 6 months to 5 years.
Croatian: Pedijatrijsko iskustvo većinom je stečeno kod afričke djece u dobi od 6 mjeseci do 5 godina.
English: • is female, elderly (over 65 years) or vomiting;
Croatian: • ženskog ste spola, starije dobi (stariji od 65 godina) ili povraćate;
English: The ADRs noted for Eurartesim were generally mild in severity, and the majority were non-serious.
Croatian: Nuspojave zabilježene za Eurartesim bile su uglavnom blage po težini, a većina ih nije bila ozbiljna.
English: There is no data on a second course of treatment.
Croatian: Nema podataka o drugoj kuri liječenja.
English: In each case the results confirmed that Eurartesim was not inferior to the comparator medicinal product.
Croatian: U svakom su slučaju rezultati potvrdili da Eurartesim nije bio inferioran usporednom lijeku.
English: This inhibitory effect was no longer evident one week after last administration of Eurartesim.
Croatian: Taj inhibicijski učinak više nije bio vidljiv tjedan dana nakon posljednje primjene Eurartesima.
English: If this happens, talk to your doctor.
Croatian: Ako se to dogodi, obratite se svom liječniku.
English: In both studies, the true treatment failure rate was below the 5% efficacy threshold set by WHO.
Croatian: U oba ispitivanja, stvarna stopa neuspješnog liječenja bila je ispod 5% praga djelotvornosti koji je odredio SZO.
English: Compared to adult males, female patients and elderly patients have longer QTc intervals.
Croatian: U usporedbi s odraslim muškarcima, žene i stariji bolesnici imaju dulje QTc intervale.
English: Special precaution is advised in young children when vomiting, as they are likely to develop electrolyte disturbances.
Croatian: Savjetuje se poseban oprez u mlađe djece kad povraćaju, jer će vjerojatno razviti poremećaj elektrolita.
English: The elimination half-life of artenimol is approximately 1 hour.
Croatian: Poluvijek eliminacije artenimola iznosi približno 1 sat.
English: What Eurartesim is and what it is used for
Croatian: Što je Eurartesim i za što se koristi
English: Your doctor should have prescribed a dose that is appropriate for your weight or your child's weight as follows:
Croatian: Liječnik Vam je trebao propisati odgovarajuću dozu za Vašu tjelesnu težinu ili tjelesnu težinu Vašeg djeteta na sljedeći način:
English: You should not take Eurartesim with grapefruit juice due to possible interactions.
Croatian: Ne smijete uzimati Eurartesim sa sokom od grejpa zbog mogućih interakcija.
English: Clinical studies of Eurartesim did not include patients aged 65 years and over, therefore no dosing recommendation can be made.
Croatian: Klinička ispitivanja Eurartesima nisu uključila bolesnike u dobi od 65 ili više godina, pa se stoga ne može dati preporuka za doziranje.
English: The efficacy and safety of Eurartesim have been assessed in two large randomised, open-label clinical trials:
Croatian: Djelotvornost i sigurnost Eurartesima procijenjene su u dva velika, randomizirana, otvorena klinička ispitivanja.
English: No carcinogenicity studies have been performed.
Croatian: Nisu provedena ispitivanja kancerogenosti.
English: The same comparison showed that piperaquine absorption rate constant and terminal half-life in children were predominantly similar to those seen in adults.
Croatian: Ista je usporedba pokazala da su konstanta brzine apsorpcije i terminalni poluvijek piperakina u djece pretežno bili slični onima opaženima u odraslih.
English: You or your child must not take more than two courses within one year.
Croatian: Vi ili Vaše dijete ne smijete uzeti više od dvije kure u roku od godinu dana.
English: You should take the Eurartesim tablets with water only.
Croatian: Tablete Eurartesim trebate uzimati samo s vodom.
English: • suffers from changes to the levels of salts in the body (electrolyte imbalances);
Croatian: • bolujete od promjena u razinama soli u tijelu (neravnoteža elektrolita);
English: Its clearance was found to be slightly lower in female than in male healthy volunteers.
Croatian: Otkriveno je da je njegov klirens nešto niži u ženskih nego u muških zdravih dobrovoljaca.
English: • 30 minutes of taking Eurartesim, the whole dose must be taken again.
Croatian: • 30 minuta nakon uzimanja Eurartesima, mora se ponovno uzeti cijela doza.
English: - Severe malaria according to WHO definition.
Croatian: - Teška malarija prema definiciji Svjetske zdravstvene organizacije (SZO).
English: You should not breast-feed your baby while taking this medicine because the medicine may pass through breast milk to your baby.
Croatian: Ne smijete dojiti dok uzimate ovaj lijek jer bi mlijekom mogao prijeći u Vaše dijete.
English: Some medicines can affect the way Eurartesim works and your doctor may decide that Eurartesim is not suitable or that extra checks are needed while you or your child is taking the medicines which could cause possible interactions.
Croatian: Neki lijekovi mogu utjecati na način na koji Eurartesim djeluje i Vaš liječnik može odlučiti da Eurartesim nije pogodan ili da su potrebni dodatni pregledi dok Vi ili Vaše dijete uzimate lijekove koji mogu uzrokovati moguće interakcije.
English: Contact your doctor urgently to obtain an alternative treatment for malaria.
Croatian: Odmah se obratite svom liječniku kako biste dobili drugo liječenje za malariju.
English: Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems including:
Croatian: Njegov endoperoksidni most smatra se ključnim za njegovo antimalarijsko djelovanje, uzrokujući oštećenje slobodnim radikalima membranskih sustava parazita uključujući:
English: What Eurartesim looks like and contents of the pack
Croatian: Kako Eurartesim izgleda i sadržaj pakiranja
English: Other medicines and Eurartesim
Croatian: Drugi lijekovi i Eurartesim
English: The extent of interactions in the paediatric population is not known.
Croatian: Opseg interakcija u pedijatrijskoj populaciji nije poznat.
English: Vomiting when taking this medicine
Croatian: Povraćanje nakon uzimanja ovog lijeka
English: Eurartesim kills the Plasmodium falciparum parasite.
Croatian: Eurartesim ubija parazit Plasmodium falciparum.
English: Dosing should be based on body weight as shown in the table below.
Croatian: Doziranje treba temeljiti na tjelesnoj težini kako je prikazano u sljedećoj tablici:
English: For patients unable to swallow the tablets, such as infants and young children, Eurartesim may be crushed and mixed with water.
Croatian: Za bolesnike koji ne mogu progutati tablete, kao što su dojenčad i mala djeca, Eurartesim se može zdrobiti i pomiješati s vodom.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Eurartesim are provided with a healthcare profession educational pack containing the following:
Croatian: Nositelj odobrenja osigurat će da svi liječnici za koje se očekuje da će propisivati ili primjenjivati Eurartesim dobiju edukacijski paket za zdravstvene radnike koji sadrži sljedeće:
English: Your doctor may suggest special monitoring for you or your child because doses higher than those recommended may have an unwanted, severe effect on the heart (see also section 4).
Croatian: Liječnik može predložiti poseban nadzor Vas ili Vašeg djeteta zato što doze više od preporučenih mogu imati neželjeni, teški učinak na srce (vidjeti također dio 4).
English: Eurartesim should be administered over three consecutive days for a total of three doses taken at the same time each day.
Croatian: Eurartesim treba primijeniti tijekom tri uzastopna dana u ukupno tri doze koje se uzimaju svakog dana u isto vrijeme.
English: The results for the primary endpoint in the modified intent to treat (m-ITT) populations (defined as all randomised patients who received at least one dose of the study treatment, with the exclusion of those patients lost to follow up for unknown reasons) were as follows:
Croatian: Rezultati za primarni ishod u modificiranim populacijama s namjerom liječenja (engl. modified intent to treat, m-ITT) (definiranima kao svi randomizirani bolesnici koji su primili najmanje jednu dozu ispitivane terapije, uz isključenje onih bolesnika koji su izgubljeni iz praćenja zbog nepoznatih razloga) bili su sljedeći:
English: Eurartesim should be taken orally with water and without food.
Croatian: Eurartesim treba uzimati peroralno s vodom i bez hrane.
English: The main consequence of this interaction could be a reduction of efficacy of the co-administered medicinal products.
Croatian: Glavna posljedica ove interakcije mogla bi biti smanjenje djelotvornosti istovremeno primijenjenih lijekova.
English: • That piperaquine absorption is increased in the presence of food, therefore to reduce this risk of QTc interval prolongation, the patients should be advised to take the tablets with water, without food, no less than three hours after the last food intake.
Croatian: • Da je apsorpcija piperakina povećana u prisutnosti hrane pa stoga, da se smanji rizik od produljenja QTc intervala, bolesnicima treba savjetovati da uzimaju tablete s vodom, bez hrane, najmanje 3 sata nakon zadnjeg uzimanja hrane.
English: The exposure of pregnant women during the 2nd and 3rd trimester was not associated with any harm of the unborn child.
Croatian: Izloženost lijeku u drugom i trećem tromjesečju trudnoće nije bila povezana ni s kakvim štetnim učincima za nerođeno dijete.
English: If you are taking folate supplements to prevent possible neural tube birth defects, you can continue taking them at the same time as Eurartesim.
Croatian: Ako uzimate nadomjeske folata za sprječavanje mogućih urođenih defekata neuralne cijevi, možete ih nastaviti uzimati u isto vrijeme kad i Eurartesim.
English: Risk factors may include young age (children under 5 years old) and previous treatment with IV artesunate.
Croatian: Čimbenici rizika mogu uključivati mlađu dječju dob (djeca mlađa od 5 godina) i prethodnu i.v. terapiju artesunatom.
English: In females delivering normally the development, behaviour and growth of the surviving progeny was normal following exposure in utero or via milk.
Croatian: U ženki koje su imale normalan okot, razvoj, ponašanje i rast preživjelog potomstva bili su normalni nakon izloženosti in utero ili putem mlijeka.
English: Италия, Olaszország, Itàlie, Italja, Italien, Italia, Itaalia, Włochy, Italija, Ítalía, taliansko, Itālija Teл/Tel/Tlf/Sími/Puh: +39 051 6489602
Croatian: Италия, Olaszország, Itàlie, Italja, Italien, Italia, Itaalia, Włochy, Italija, Ítalía, taliansko, Itālija Teл/Tel/Tlf/ Sími/Puh: +39 051 6489602 alfasigmaspa@legalmail.it
English: The elimination half-life of piperaquine is around 22 days for adult patients and around 20 days for paediatric patients.
Croatian: Poluvijek eliminacije piperakina iznosi oko 22 dana kod odraslih bolesnika i oko 20 dana kod pedijatrijskih bolesnika.
English: You should try to take the dose at about the same time on each of the three days.
Croatian: Nastojte uzeti dozu u približno isto vrijeme svakog dana tijekom ta tri dana.
English: There are no specific data relating to the effects of piperaquine on fertility, however, to date no adverse events have been reported during clinical use.
Croatian: Nema posebnih podataka koji se odnose na učinke piperakina na plodnost; međutim, do danas nisu zabilježeni štetni događaji tijekom kliničke primjene.
English: Tell your doctor or pharmacist if you or your child is taking, has recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako Vi ili Vaše dijete uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.