FrancophonIA/ELRC3.0 huggingface dataset:
English: Adlumiz is a medicine that contains the active substance anamorelin hydrochloride.
Croatian: Adlumiz je lijek koji sadržava djelatnu tvar anamorelin hidroklorid.
English: What was Adlumiz expected to be used for?
Croatian: Za što se lijek Adlumiz trebao koristiti?
English: How does Adlumiz work?
Croatian: Kako djeluje Adlumiz?
English: Therefore the CHMP was of the opinion that the benefits of Adlumiz did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CHMP smatrao da koristi lijeka Adlumiz ne nadmašuju s njim povezane rizike te je preporučio odbijanje odobrenja za stavljanje lijeka u promet.
English: Patients were given either Adlumiz or placebo (a dummy treatment) and the main measures of effectiveness were changes in lean body mass (body weight excluding fat) and hand grip strength.
Croatian: Bolesnici su primili lijek Adlumiz ili placebo (prividno liječenje), a glavne mjere djelotvornosti bile su promjene bezmasne tjelesne mase (tjelesna težina bez masnog tkiva) i snage stiska šake.
English: The CHMP concluded that the studies show a marginal effect of Adlumiz on lean body mass and no proven effect on hand grip strength or patients' quality of life.
Croatian: CHMP je zaključio da su ispitivanja pokazala marginalan učinak lijeka Adlumiz na bezmasnu tjelesnu masu te da nije dokazan učinak na snagu stiska šake ni kvalitetu života bolesnika.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes in Europe with Adlumiz.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ili programa milosrdnog davanja lijeka Adlumiz koji su u tijeku u Europskoj uniji.
English: Refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride)
Croatian: Odbijanje odobrenja za stavljanje u promet lijeka Adlumiz (anamorelin hidroklorid)
English: Adlumiz was expected to be used to treat anorexia (loss of appetite), cachexia (a form of muscle wasting with significant weight loss) or unintended weight loss in patients with a type of lung cancer called non-small cell lung cancer.
Croatian: Lijek Adlumiz trebao se primjenjivati u liječenju anoreksije (gubitak apetita), kaheksije (oblik propadanja mišića popraćen znatnim gubitkom težine) ili neželjenog gubitka tjelesne težine u bolesnika oboljelih od vrste raka pluća naziva rak pluća nemalih stanica.
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Adlumiz, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Adlumiz, koji je namijenjen liječenju anoreksije, kaheksije ili neželjenog gubitka tjelesne težine u bolesnika s rakom pluća nemalih stanica.
English: Adlumiz attaches to and activates a target on cells called a ghrelin receptor.
Croatian: Lijek Adlumiz veže se na ciljne stanice i aktivira receptor za grelin.
English: EU/1/19/1376/001
Croatian: EU/1/19/1376/001 LIBTAYO
English: 7 ml (50 mg/ml) 1 vial
Croatian: 350 mg koncentrat za otopinu za infuziju intravenska primjena bočica (staklo) 7 ml (50 mg/ml) 1 bočica
English: The full EPAR for Valdoxan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Valdoxan nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose is one tablet once a day, taken at bedtime.
Croatian: Preporučena doza je jedna tableta jednom na dan, a uzima se neposredno prije spavanja.
English: Valdoxan might also help to normalise the patient's sleep patterns.
Croatian: Valdoxan može također pomoći pri normalizaciji režima spavanja bolesnika.
English: Valdoxan can only be obtained with a prescription and is available as tablets (25 mg).
Croatian: Valdoxan se izdaje samo na recept i dostupan je u obliku tableta (25 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Valdoxan on 19 February 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Valdoxan na snazi u Europskoj uniji od 19. veljače 2009.
English: Valdoxan agomelatine
Croatian: Valdoxan agomelatin
English: Valdoxan is a medicine used to treat major depression in adults.
Croatian: Valdoxan je lijek koji se koristi za liječenje teške depresije u odraslih osoba.
English: However, the second study showed that symptoms returned in 21% of the patients taking Valdoxan over 24 weeks (34 out of 165), compared with 41% of the patients taking placebo (72 out of 174).
Croatian: No, drugo je ispitivanje pokazalo da su se simptomi vratili u 21 % bolesnika (34 od 165) koji su uzimali lijek Valdoxan tijekom 24 tjedna, u usporedbi s 41 % bolesnika (72 od 174) koji su uzimali placebo.
English: This is a summary of the European public assessment report (EPAR) for Valdoxan.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Valdoxan.
English: What is Valdoxan and what is it used for?
Croatian: Što je Valdoxan i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Valdoxan?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Valdoxan?
English: The company that markets Valdoxan will supply educational material for doctors prescribing Valdoxan.
Croatian: Tvrtka koja stavlja lijek Valdoxan u promet dostavit će edukacijski materijal liječnicima koji propisuju lijek Valdoxan.
English: Therefore, the CHMP decided that Valdoxan's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je CHMP odlučio da koristi od lijeka Valdoxan nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: However, since the medicine has a different mode of action, few side effects and a different safety profile to existing antidepressants, the Committee concluded that Valdoxan could be a valuable treatment for some patients as long as their liver function is tested frequently.
Croatian: No, s obzirom na to da lijek ima drugačiji način djelovanja, malobrojne nuspojave i drugačijeg je sigurnosnog profila u odnosu na postojeće antidepresive, Odbor je zaključio da lijek Valdoxan može biti vrijedna terapija za neke bolesnike sve dok se njihova funkcija jetre često kontrolira.
English: This material explains the safety of the medicine, its interactions with other medicines, and includes guidance on the monitoring of liver function and management of possible symptoms of liver problems.
Croatian: U tom se materijalu pojašnjava sigurnost lijeka, njegove interakcije s drugim lijekovima, a on obuhvaća i smjernice o praćenju funkcije jetre i kontroli eventualnih simptoma bolesti jetre.
English: In the first study, there was no difference between Valdoxan and placebo in preventing symptoms from returning during 26 weeks of treatment.
Croatian: U prvom ispitivanju nije bilo razlike između lijeka Valdoxan i placeba u sprječavanju vraćanja simptoma tijekom 26 tjedana liječenja.
English: Valdoxan has been compared with placebo (a dummy treatment) in five main short-term studies involving a total of 1,893 adults with major depression.
Croatian: Valdoxan je uspoređen s placebom (prividnim liječenjem) u pet glavnih kratkotrajnih ispitivanja kojima su bile obuhvaćene ukupno 1 893 odrasle osobe s teškom depresijom.
English: Other information about Valdoxan
Croatian: Ostale informacije o lijeku Valdoxan
English: In the two studies where no active comparator was used Valdoxan was seen to be more effective than placebo.
Croatian: U dvama ispitivanjima u kojima nije korišten aktivni komparator, Valdoxan se pokazao djelotvornijim od placeba.
English: It must also not be used in patients who are taking medicines that slow down the breakdown of Valdoxan in the body, such as fluvoxamine (another antidepressant) and ciprofloxacin (an antibiotic).
Croatian: Ne smije se koristiti niti u bolesnika koji uzimaju lijekove koji usporavaju razgradnju lijeka Valdoxan u tijelu, poput fluvoksamina (drugi antidepresiv) i ciprofloksacina (antibiotik).
English: In the other three studies, which did include an active comparator, there were no differences in scores between the patients taking Valdoxan and those taking placebo.
Croatian: U preostalim trima ispitivanjima, u kojima je korišten aktivni komparator, nije bilo razlika u rezultatima između bolesnika koji su uzimali Valdoxan i onih koji su uzimali placebo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that Valdoxan's benefits in terms of treating depression might be lower than seen with other antidepressants.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji napomenuo je kako koristi lijeka Valdoxan u kontekstu liječenja depresije mogu biti manje od koristi uočenih s drugim antidepresivima.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Valdoxan have also 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 Valdoxan nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The active substance in Valdoxan, agomelatine, is an antidepressant.
Croatian: Djelatna tvar u lijeku Valdoxan, agomelatin, je antidepresiv.
English: The company also presented the results of a further study comparing Valdoxan with sertraline (another antidepressant), which showed that Valdoxan was more effective than sertraline, with a reduction in HAM D scores after six weeks..
Croatian: Farmaceutska tvrtka također je dostavila rezultate još jednog ispitivanja u kojem je lijek Valdoxan uspoređen sa sertralinom (drugim antidepresivom), a koje je pokazalo da je Valdoxan djelotvorniji od sertralina, uz smanjenje vrijednosti na Hamiltonovoj ocjenskoj ljestvici za depresiju nakon šest tjedana.
English: Two other main studies compared the ability of Valdoxan and placebo to prevent symptoms returning in 706 patients whose depression had already been controlled with Valdoxan.
Croatian: U dvama drugim glavnim ispitivanjima uspoređena je sposobnost lijeka Valdoxan i placeba za sprječavanje vraćanja simptoma u 706 bolesnika u kojih je depresija već prethodno bila kontrolirana lijekom Valdoxan.
English: A patient booklet will also be distributed to all patients who are prescribed Valdoxan so that they are aware of the risk to the liver, the importance of monitoring liver function and the signs of liver problems to look out for.
Croatian: Svim bolesnicima kojima je propisan lijek Valdoxan bit će dostavljena i brošura za bolesnike kako bi bili upoznati s rizicima za jetru, važnosti praćenja funkcije jetre i znakovima problema s funkcijom jetre na koje trebaju obratiti pozornost.
English: Valdoxan must not be used in patients who have problems with their liver, such as cirrhosis (scarring of the liver) or active liver disease, nor in patients whose level of transaminases (liver enzymes) in the blood is more than three times the normal level.
Croatian: Valdoxan se ne smije primjenjivati u bolesnika koji imaju problema s jetrom, poput ciroze (ožiljkasta jetra) ili aktivne bolesti jetre, niti u bolesnika u kojih je razina transaminaze (enzima jetre) u krvi trostruko viša od normalne razine.
English: It is not intended to provide practical advice on how to use Valdoxan.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Valdoxan.
English: What are the risks associated with Valdoxan?
Croatian: Koji su rizici povezani s lijekom Valdoxan?
English: Treatment should not be started or should be stopped in patients with abnormal liver enzyme levels in the blood (more than three times the normal level).
Croatian: Terapija se ne smije započinjati, odnosno mora se prekinuti, u bolesnika s abnormalnom razinom enzima jetre u krvi (trostruko većom od normalne razine).
English: The most common side effects with Valdoxan (seen in more than 1 patients in 100) are headache, nausea (feeling sick) and dizziness.
Croatian: Najčešće su nuspojave lijeka Valdoxan (zabilježene u više od 1 na 100 osoba) glavobolja, mučnina i vrtoglavica.
English: Why is Valdoxan approved?
Croatian: Zašto je lijek Valdoxan odobren?
English: For more information about treatment with Valdoxan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Valdoxan pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku.
English: For practical information about using Valdoxan, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Valdoxan bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: How is Valdoxan used?
Croatian: Kako se Valdoxan koristi?
English: What benefits of Valdoxan have been shown in studies?
Croatian: Koje su koristi lijeka Valdoxan utvrđene u ispitivanjima?
English: Valdoxan contains the active substance agomelatine.
Croatian: Valdoxan sadrži djelatnu tvar agomelatin.
English: How does Valdoxan work?
Croatian: Kako djeluje lijek Valdoxan?
English: For the full list of all side effects reported with Valdoxan, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Valdoxan potražite u uputi o lijeku.
English: Therefore, it is recommended that:
Croatian: Stoga se preporučuje:
English: Cubicin is not usually given to pregnant women.
Croatian: Cubicin se obično ne daje trudnicama.
English: - If you have, or have previously had kidney problems.
Croatian: - Ako imate, ili ste ranije imali, probleme s bubrezima.
English: See sections 4.4, 4.8 and 5.3.
Croatian: Vidjeti dijelove 4.4, 4.8 i 5.3.
English: What Cubicin is and what it is used for
Croatian: Što je Cubicin i za što se koristi
English: Cubicin should not be used more frequently than once a day.
Croatian: Cubicin se ne smije primjenjivati češće od jedanput na dan.
English: Cubicin will usually be given to you by a doctor or a nurse.
Croatian: Cubicin će Vam obično davati liječnik ili medicinska sestra.
English: Date of first authorisation: 19 January 2006 Date of latest renewal: 29 November 2010
Croatian: Datum posljednje obnove odobrenja: 29. studenoga 2010.
English: The most common type of infection treated was wound infection (38% of patients), while 21% had major abscesses.
Croatian: Najčešća vrsta infekcije koja se liječila bila je infekcija rane (38% bolesnika), dok je 21% imalo velike apscese.
English: 1**, cough
Croatian: 1**, kašalj
English: This mode of administration was only studied in healthy subjects.
Croatian: Ovaj način primjene ispitan je samo u zdravih ispitanika.
English: Cubicin may interfere with laboratory tests that measure how well your blood is clotting.
Croatian: Cubicin može utjecati na laboratorijske pretrage koje određuju kako dobro se Vaša krv zgrušava.
English: Other medicines and Cubicin Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Cubicin Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Mitochondrial loss/damage was also observed; however the role and significance of this finding in the overall pathology are unknown.
Croatian: Također je uočen gubitak/oštećenje mitohondrija, ali uloga i važnost ovog nalaza u sveukupnoj patologiji nisu poznate.
English: AUC0-24hr (g×hr/ml) Cmax (g/ml) Apparent t1/2 (hr) CL/wt (ml/hr/kg)
Croatian: AUC0-24h (g×h/ml) Cmax (g/ml) Prividni t1/2 (h) CL/wt (ml/h/kg)
English: If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako ste alergični na daptomicin ili na natrijev hidroksid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Your doctor may need to change the dose of Cubicin (see section 3 of this leaflet).
Croatian: Vaš liječnik će možda morati promijeniti dozu lijeka Cubicin (vidjeti dio 3 ove upute).
English: While the exact incidence of eosinophilic pneumonia associated with daptomycin is unknown, to date the reporting rate of spontaneous reports is very low (< 1/10,000).
Croatian: Iako je točna incidencija eozinofilne pneumonije povezane s daptomicinom nepoznata, do sada je stopa prijavljivanja spontanih izvješća bila vrlo niska (<1/10 000).
English: If this happens, tell your doctor who will decide whether you should continue the treatment.
Croatian: Ako se to dogodi, obavijestite svog liječnika, koji će odlučiti trebate li nastaviti terapiju.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika)
English: What you need to know before you are given Cubicin
Croatian: Što morate znati prije nego primite Cubicin
English: If superinfection occurs during therapy, appropriate measures should be taken.
Croatian: Ako se tijekom terapije javi superinfekcija, potrebno je poduzeti odgovarajuće mjere.
English: Cubicin is indicated for the treatment of the following infections (see sections 4.4 and 5.1).
Croatian: Cubicin je indiciran za liječenje sljedećih infekcija (vidjeti dijelove 4.4 i 5.1).
English: If your kidneys do not work well, you may receive Cubicin less often, e.g. once every other day.
Croatian: Ako Vaši bubrezi ne rade dobro, možda ćete Cubicin primati rjeđe, npr. jedanput svaki drugi dan.
English: Tell your doctor straight away if you develop any of the following symptoms: - Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Cubicin.
Croatian: Odmah obavijestite svog liječnika ako dobijete bilo koji od sljedećih simptoma: - Ozbiljne, akutne alergijske reakcije zabilježene su u bolesnika koji su liječeni gotovo svim antibakterijskim lijekovima, uključujući i Cubicin.
English: For Reconstitution:
Croatian: Za rekonstituciju:
English: Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Cubicin.
Croatian: Ovisno o vrsti infekcije (infekcija) koju imate, Vaš liječnik može propisati i druge antibakterijske lijekove dok se liječite lijekom Cubicin.
English: Cubicin should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.
Croatian: Cubicin se ne smije primjenjivati u djece mlađe od jedne godine jer su ispitivanja na životinjama pokazala da u ovoj dobnoj skupini može doći do teških nuspojava.
English: Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could affect the baby.
Croatian: Ako primate Cubicin ne smijete dojiti, jer on može ući u majčino mlijeko i utjecati na dojenče.
English: The fully reconstituted product will appear clear and may have a few small bubbles or foam around the edge of the vial.
Croatian: Potpuno rekonstituiran lijek će izgledati bistro te može imati nekoliko malenih mjehurića ili pjenu oko ruba bočice.
English: Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.
Croatian: Vaš liječnik može odlučiti da neko vrijeme ne primate Cubicin, ili na neko vrijeme prekinuti liječenje drugim lijekom.
English: - The other ingredient is sodium hydroxide.
Croatian: - Drugi sastojak je natrijev hidroksid.
English: The highest measured concentration of daptomycin in the breast milk was 0.045 mcg/ml, which is a low concentration.
Croatian: Najviša izmjerena koncentracija daptomicina u majčinom mlijeku iznosila je 0,045 mcg/ml, što predstavlja nisku koncentraciju.
English: Regular monitoring of renal function is advised (see also section 5.2).
Croatian: Savjetuje se redovito praćenje bubrežne funkcije (vidjeti također dio 5.2).
English: Steady-state concentrations are achieved by the third daily dose.
Croatian: Ravnotežne su koncentracije postignute s trećom dnevnom dozom.
English: Since these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorised as not known.
Croatian: Budući da se radi o spontano prijavljenim nuspojavama unutar populacije neodređene veličine, nije moguće pouzdano procijeniti učestalost te se ona stoga definira kao nepoznata.
English: It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice.
Croatian: Pri donošenju odluke o korištenju daptomicina preporučuje se uzeti u obzir antibakterijsku osjetljivost mikroorganizma, a odluka se mora temeljiti na savjetu stručnjaka.
English: In some cases of myopathy involving raised CPK and muscle symptoms, the patients also presented with elevated transaminases.
Croatian: U nekim slučajevima miopatije koje su uključivale povišenje CPK i mišićne simptome, bolesnici su također imali i povišene transaminaze.
English: • Patients should be reviewed regularly while on therapy for any signs or symptoms that might represent myopathy.
Croatian: • Bolesnike treba tijekom terapije redovito provjeravati radi pojave bilo kojeg znaka ili simptoma koji može ukazivati na miopatiju.
English: - Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting.
Croatian: - Oralne antikoagulanse (npr. varfarin), to su lijekovi koji sprječavaju zgrušavanje krvi.
English: You should not be given Cubicin
Croatian: Ne smijete primiti Cubicin
English: The symptoms generally go away within a few days of stopping Cubicin.
Croatian: Simptomi obično prolaze unutar nekoliko dana nakon prekida primjene lijeka Cubicin.
English: If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.
Croatian: Ukoliko Vam se pojave uzdignute ili tekućinom ispunjene kožne pjege na velikom dijelu tijela, odmah obavijestite svog liječnika ili medicinsku sestru.
English: What Cubicin contains - The active substance is daptomycin.
Croatian: Što Cubicin sadrži - Djelatna tvar je daptomicin.
English: Cubicin is not physically or chemically compatible with glucose-containing solutions.
Croatian: Cubicin nije fizikalno ni kemijski kompatibilan s otopinama koje sadrže glukozu.
English: The most frequently reported adverse reactions (frequency common (≥ 1/100 to < 1/10)) are:
Croatian: Najčešće prijavljene nuspojave (česta učestalost (≥1/100 do <1/10)) su:
English: Serious side effects with frequency not known (frequency cannot be estimated from the available data)
Croatian: Ozbiljne nuspojave s nepoznatom učestalošću (učestalost se ne može procijeniti iz dostupnih podataka)
English: Cubicin should be discontinued in the presence of unexplained muscle symptoms if the CPK level reaches greater than 5 times upper limit of normal.
Croatian: Cubicin treba ukinuti ako postoje neobjašnjivi mišićni simptomi, a razina CPK poraste više od 5 puta od gornje granice normale.
English: Therefore it is important that your doctor takes into account that you are receiving Cubicin.
Croatian: Stoga je važno da liječnik zna da primate Cubicin.