FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains 1 mg or 4 mg of topotecan (as hydrochloride).
Croatian: Jedna bočica sadržava 1 mg ili 4 mg topotekana (u obliku topotekanklorida).
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count <0.5 x 10
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila  0,5 x 10
English: Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3%.
Croatian: Incidencija pojave teškog (stupanj 3 ili 4) umora i astenije iznosila je 3%.
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Croatian: U kliničkim ispitivanjima topotekana prijavljeni su slučajevi neutropenijskog kolitisa sa smrtnim ishodom.
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Croatian: U urinu su pronađeni O-glukuronid topotekana i N-desmetiltopotekana.
English: Median survivals for the two groups were 25.0 and 24.7 weeks, respectively.
Croatian: Medijan vremena preživljenja iznosio je 25,0 za topotekan, odnosno 24,7 tjedana za CAV protokol.
English: HYCAMTIN 0.25 mg hard capsules
Croatian: HYCAMTIN 0,25 mg tvrde kapsule
English: In those patients (n = 102) with recurrence after 180 days, median survival in the topotecan plus cisplatin arm was 9.9 months (95% CI: 7, 12.6) versus 6.3 months (95% CI: 4.9, 9.5) for the cisplatin arm, with a hazard ratio of 0.75 (0.49, 1.16).
Croatian: U bolesnica (n = 102) s recidivom nakon 180 dana, medijan preživljenja u skupini liječenoj kombinacijom topotekana i cisplatina iznosio je 9,9 mjeseci (95% CI: 7; 12,6), naspram 6,3 mjeseca (95% CI: 4,9; 9,5) u skupini liječenoj cisplatinom, uz omjer hazarda od 0,75 (0,49; 1,16).
English: Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Croatian: Smrtni ishodi zbog sepse prijavljeni su u bolesnika koji su liječeni topotekanom (vidjeti dio 4.4).
English: How Hycamtin is used
Croatian: Kako se primjenjuje Hycamtin
English: Gastrointestinal perforation Hepatobiliary disorders Common
Croatian: Nepoznato gastrointestinalna perforacija Poremećaji jetre i žuči
English: Median time to onset of moderate to severe anaemia was day 12 with a median duration of 7 days.
Croatian: Medijan vremena do pojave teške anemije bio je 12. dan s medijanom vremena trajanja od 7 dana.
English: However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.2).
Croatian: Međutim, nema dovoljno dostupnih podataka na temelju kojih bi se moglo preporučiti doziranje u ovoj skupini bolesnika (vidjeti dio 4.2).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: • The other ingredients are: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507) and sodium hydroxide.
Croatian: • Drugi sastojci su: tartaratna kiselina (E334), manitol (E421), kloridna kiselina (E507) i natrijev hidroksid.
English: 1 x 1 mg 5 x 1 mg
Croatian: 5 x 1 mg
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma and faeces.
Croatian: U urinu, plazmi i fecesu pronađen je jedan N-desmetil metabolit koji je pokazao sličnu ili manju aktivnost od roditeljskog spoja u staničnoj kulturi.
English: What you need to know before you are given Hycamtin
Croatian: Što morate znati prije nego počnete primati Hycamtin
English: Use of topotecan in these patients is not recommended (see section 4.2).
Croatian: Primjena topotekana u ovih bolesnika se ne preporučuje (vidjeti dio 4.2).
English: HYCAMTIN 1 mg hard capsules topotecan
Croatian: HYCAMTIN 1 mg tvrde kapsule topotekan
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min) or severely impaired hepatic function (serum bilirubin 10 mg/dl) due to cirrhosis.
Croatian: Nema dovoljno iskustva s primjenom topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu 10 mg/dl ili više).
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Croatian: Prijavljeni su slučajevi intersticijske bolesti pluća (IBP) vezani uz primjenu topotekana, koji su u nekih bolesnika bili fatalni (vidjeti dio 4.8).
English: Each capsule contains 0.25 mg or 1 mg of topotecan (as hydrochloride).
Croatian: Jedna kapsula sadrži 0,25 ili 1 mg topotekana (u obliku topotekanklorida).
English: Hycamtin 1 mg powder for concentrate for solution for infusion should be reconstituted with 1.1 ml of water for injections to provide 1 mg per ml of topotecan.
Croatian: Hycamtin 1 mg prašak za otopinu za infuziju potrebno je rekonstituirati primjenom 1,1 ml vode za injekcije kako biste dobili 1 mg topotekana u 1 ml otopine.
English: 9/l) occurred in 6% of patients in 2% of courses.
Croatian: 9/l) zabilježena je u 6% bolesnika, u
English: Each capsule contains 1 mg of topotecan (as hydrochloride).
Croatian: Jedna kapsula sadržava 1 mg topotekana (u obliku topotekanklorida).
English: If reconstitution and dilution is performed under strict aseptic conditions (e.g. an LAF bench) the product should be used (infusion completed) within 12 hours at room temperature or 24 hours if stored at 2-8
Croatian: Ako su rekonstitucija i razrjeđivanje provedeni pod strogim aseptičkim uvjetima (npr. klupa s laminarnim strujanjem zraka), lijek treba upotrijebiti (završiti s infuzijom) unutar 12 sati ako se čuva na sobnoj temperaturi ili unutar 24 sata ukoliko se, nakon prvog otvaranja bočice, čuva pri temperaturi od 2°C - 8°C.
English: Also contains: tartaric acid (E334), mannitol (E421), hydrochloric acid (E507), sodium hydroxide.
Croatian: Također sadrži: tartaratnu kiselinu (E334),manitol (E421), kloridnu kiselinu (E507), natrijev hidroksid.
English: 1 x 4 mg 5 x 4 mg
Croatian: 5 x 4 mg
English: Hycamtin 4 mg powder for concentrate for solution for infusion should be reconstituted with 4 ml of water for injections to provide 1 mg per ml of topotecan.
Croatian: Hycamtin 4 mg prašak za otopinu za infuziju potrebno je rekonstituirati primjenom 4 ml vode za injekcije kako biste dobili 1 mg topotekana u 1 ml otopine.
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1%, respectively.
Croatian: Incidencija teških oblika (stupanj 3 ili 4) mučnine bila je 4%, povraćanja 3%, proljeva 2% i mukozitisa 1%.
English: How to store Hycamtin
Croatian: Kako čuvati Hycamtin
English: Pruritus
Croatian: Doziranje
English: HYCAMTIN 0.25 mg hard capsules HYCAMTIN 1 mg hard capsules
Croatian: HYCAMTIN 0,25 mg tvrde kapsule HYCAMTIN 1 mg tvrde kapsule
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Croatian: HYCAMTIN 1 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadržava 1 mg topotekana (u obliku topotekanklorida).
English: ANNEX III
Croatian: PRILOG III.
English: Geometric mean topotecan lactone dose-normalised AUC(0-) values were 9.4, 11.1 and 12.0 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively.
Croatian: Geometrijska srednja vrijednost AUC(0-) topotekan laktona normalizirana prema dozi iznosila je 9,4 ng*h/ml u ispitanika s klirensom kreatinina većim od 80 ml/min, 11,1 ng*h/ml u ispitanika s klirensom kreatinina od
English: Use of topotecan in this group of patients is not recommended (see section 4.4).
Croatian: Primjena topotekana u toj skupini bolesnika se ne preporučuje (vidjeti dio 4.4).
English: Tartaric acid (E334) Mannitol (E421) Hydrochloric acid (E507) Sodium hydroxide
Croatian: 6.1 Popis pomoćnih tvari tartaratna kiselina (E334) manitol (E421) kloridna kiselina (E507) natrijev hidroksid
English: • Stomach pain, constipation, indigestion.
Croatian: • bolovi u trbuhu, zatvor (konstipacija), probavne tegobe
English: Each capsule contains 0.25 mg of topotecan (as hydrochloride).
Croatian: Jedna kapsula sadržava 0,25 mg topotekana (u obliku topotekanklorida).
English: HYCAMTIN 0.25 mg hard capsules topotecan
Croatian: HYCAMTIN 0,25 mg tvrde kapsule topotekan
English: Topotecan 0.75 mg/m on days 1-3, every 21 days
Croatian: 1.-3. dana, svakih 21 dan
English: The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy.
Croatian: U kliničkim ispitivanjima kombinacije topotekana i cisplatina u liječenju raka vrata maternice sigurnosni profil topotekana bio je isti kao i pri monoterapiji topotekanom.
English: 9/l) occurred in 29% of patients in 14% of courses.
Croatian: 9/l) zabilježena je u 29% bolesnika, u
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n = 9) and Cmax (23%, n = 11) was noted on day 5.
Croatian: 1. dana) u 13 bolesnica s karcinomom jajnika, 5. dan je zabilježen blagi porast vrijednosti AUC-a (12%, n = 9) i Cmax (23%, n = 11).
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Croatian: HYCAMTIN 4 mg prašak za koncentrat za otopinu za infuziju Jedna bočica sadržava 4 mg topotekana (u obliku topotekanklorida).
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9%) or 5% w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Croatian: Kako bismo dobili konačnu koncentraciju topotekana od 25 do 50 µg/ml, potrebno je dodatno razrijediti odgovarajući volumen rekonstituirane otopine ili pomoću fiziološke otopine (9 mg/ml, odnosno 0,9% otopina natrijevog klorida) ili pomoću 5% otopine glukoze.
English: Median survival (weeks) (95% CI) Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI) Hazard ratio (95% CI) N = total number of patients treated CI = confidence interval
Croatian: Omjer hazarda (95% CI) N = ukupan broj liječenih bolesnika CI = interval pouzdanosti
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: OUTER CARTON
Croatian: VANJSKA KUTIJA
English: General disorders and administration site conditions Very common Pyrexia, asthenia, fatigue Common
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često pireksija, astenija, umor
English: Hycamtin 0.25 mg hard capsules Hycamtin 1 mg hard capsules topotecan
Croatian: Hycamtin 0,25 mg tvrde kapsule Hycamtin 1 mg tvrde kapsule topotekan
English: 1 mg vial
Croatian: 1 mg bočica
English: There is insufficient experience of the use of topotecan in patients with severely impaired hepatic function (serum bilirubin 10 mg/dl).
Croatian: Nema dovoljno iskustva s primjenom topotekana u bolesnika s teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu  10 mg/dl).
English: • if you are breast-feeding.
Croatian: • ako planirate postati ocem.
English: Hypersensitivity reaction including rash
Croatian: Poremećaji imunološkog sustava Često reakcije preosjetljivosti, uključujući osip
English: Mucosal inflammation Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Croatian: Nepoznato upala sluznice Smrtni ishodi zbog sepse prijavljeni su u bolesnika koji su liječeni topotekanom (vidjeti dio 4.4).
English: Severe bleeding (associated with thrombocytopenia) Immune system disorders Common
Croatian: Nepoznato jako krvarenje (povezano s trombocitopenijom)
English: 4 mg vial
Croatian: 4 mg bočica
English: NAME OF MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Non-haematological
Croatian: Nehematološke nuspojave
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion HYCAMTIN 4 mg powder for concentrate for solution for infusion
Croatian: HYCAMTIN 1 mg prašak za koncentrat za otopinu za infuziju HYCAMTIN 4 mg prašak za koncentrat za otopinu za infuziju
English: The overall incidence of drug-related diarrhoea was 22%, including 4% with Grade 3 and 0.4% with Grade 4.
Croatian: Ukupna incidencija proljeva povezanog s uzimanjem lijeka bila je 22%, uključujući 4% sa stupnjem 3, i 0,4% sa stupnjem 4. Proljev povezan s uzimanjem lijeka bio je češći u bolesnika starosne dobi ≥ 65 godina (28%) u usporedbi s bolesnicima mlađim od 65 godina (19%).
English: Relapsed SCLC
Croatian: Recidiv karcinoma pluća malih stanica (SCLC)
English: There are no data from Asian patients with renal impairment other than Koreans.
Croatian: Podaci o oštećenju bubrežne funkcije u bolesnika azijskog podrijetla prikupljeni su samo u Korejaca.
English: The prescribing information for cisplatin should be consulted for a full list of adverse events associated with cisplatin use.
Croatian: Za cjeloviti popis nuspojava povezanih s liječenjem cisplatinom potrebno je proučiti Sažetak opisa svojstava tog lijeka.
English: Mucosal inflammation
Croatian: Hematološke nuspojave
English: However, caution should be observed when driving or operating machines if fatigue and asthenia persist.
Croatian: Međutim, ukoliko su trajno prisutni umor i astenija, preporučuje se oprez prilikom vožnje i rada sa strojevima.
English: Hycamtin 1 mg powder for concentrate for solution for infusion Hycamtin 4 mg powder for concentrate for solution for infusion topotecan
Croatian: Hycamtin 1 mg prašak za koncentrat za otopinu za infuziju Hycamtin 4 mg prašak za koncentrat za otopinu za infuziju topotekan
English: • If you get any side effects, talk to your doctor.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: These may affect up to 1 in 1,000 people treated with Hycamtin:
Croatian: Mogu se javiti u do 1 na 1000 osoba liječenih lijekom Hycamtin:
English: These may affect more than 1 in 10 people treated with Hycamtin:
Croatian: Mogu se javiti u više od 1 na 10 osoba koje se liječe lijekom Hycamtin:
English: • If you get any side effects, talk to your doctor or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Serious side effects: tell your doctor These very common side effects may affect more than 1 in 10 people treated with Hycamtin:
Croatian: Ove vrlo česte nuspojave mogu se javiti u više od 1 na 10 osoba liječenih lijekom Hycamtin:
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion
Croatian: HYCAMTIN 4 mg prašak za koncentrat za otopinu za infuziju
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9%) or 5% w/v glucose is required to a final concentration of between 25 and 50 microgram/ml.
Croatian: Kako biste dobili konačnu koncentraciju topotekana od 25 do 50 mikrograma po ml, potrebno je dodatno razrijediti odgovarajući volumen rekonstituirane otopine ili pomoću fiziološke otopine (0,9% w/v otopina natrijevog klorida) ili pomoću 5% w/v otopine glukoze za intravensku infuziju.
English: Use of topotecan in these patient groups is not recommended (see section 4.2).
Croatian: Primjena topotekana u toj skupini bolesnika se ne preporučuje (vidjeti dio 4.2).
English: Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Croatian: Kao komplikacija neutropenije izazvane topotekanom prijavljen je neutropenijski kolitis, ponekad sa smrtnim ishodom (vidjeti dio 4.4).
English: Plasma clearance in patients with renal impairment (creatinine clearance 41-60 ml/min.)
Croatian: Klirens plazme u bolesnika s oštećenjem bubrega (klirens kreatinina 41-60 ml/min) smanjio se na približno 67% u usporedbi s kontrolnom skupinom bolesnika.
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion
Croatian: HYCAMTIN 1 mg prašak za koncentrat za otopinu za infuziju
English: HYCAMTIN 4 mg powder for concentrate for solution for infusion topotecan
Croatian: HYCAMTIN 4 mg prašak za koncentrat za otopinu za infuziju topotekan
English: 1 x 4 mg vial
Croatian: 1 x 4 mg bočica
English: Cervical carcinoma
Croatian: Karcinom vrata maternice
English: HYCAMTIN 1 mg powder for concentrate for solution for infusion topotecan
Croatian: HYCAMTIN 1 mg prašak za koncentrat za otopinu za infuziju topotekan
English: These may affect up to 1 in 100 people treated with Hycamtin:
Croatian: Mogu se javiti u do 1 na 100 osoba liječenih lijekom Hycamtin:
English: Side effects with frequency not known
Croatian: Nuspojave nepoznate učestalosti
English: 1 x 1 mg vial
Croatian: 1 x 1 mg bočica
English: Thrombocytopenia Severe thrombocytopenia (Grade 4 - platelets <10 x 10
Croatian: Teška trombocitopenija (Stupanj 4 - trombociti
English: 9/l and a haemoglobin level of ≥9 g/dl (after transfusion if necessary).
Croatian: broj trombocita ≥ 100 x 10 9/l i vrijednost hemoglobina  9 g/dl (nakon transfuzije, ukoliko je potrebna).
English: abdominal pain
Croatian: Često bolovi u abdomenu
English: 5 x 4 mg vials
Croatian: 5 x 4 mg bočica
English: These may affect up to 1 in 10 people treated with Hycamtin:
Croatian: Mogu se javiti u do 1 na 10 osoba liječenih lijekom Hycamtin:
English: 5 x 1 mg vials
Croatian: 5 x 1 mg bočica
English: Monotherapy (ovarian and small cell lung carcinoma):
Croatian: • bolesnika s recidivom karcinoma pluća malih stanica (SCLC, od engl. small cell lung cancer)
English: Do not breast-feed if you are being treated with Hycamtin.
Croatian: Ne dojite tijekom primjene lijeka Hycamtin.
English: General disorders and administration site conditions Very common Fatigue Common
Croatian: Opći poremećaji i reakcije na mjestu primjene Vrlo često umor
English: MARKETING AUTHORISATION HOLDER
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Thrombocytopenia Severe (platelets <25 x 10
Croatian: Teška trombocitopenija (broj trombocita  25,0 x 10
English: Magyarország Novartis Hungária Kft. Tel.: +36 1 457 65 00
Croatian: Slovenská republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5439
English: MARKETING AUTHORISATION NUMBERS
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Novartis Poland Sp. z o.o.
Croatian: Novartis Farma S.p.A.
English: • patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Croatian: koji nisu pogodni za ponovno uvođenje prve linije liječenja (vidjeti dio 5.1).
English: Novartis Pharma Services Inc. Τηλ: +357 22 690 690
Croatian: Τηλ: +357 22 690 690
English: Very common Nausea, vomiting and diarrhoea (all of which may be severe), constipation,
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Rijetko intersticijska bolest pluća (neki slučajevi su bili fatalni) Poremećaji probavnog sustava Vrlo često mučnina, povraćanje i proljev (svi mogu biti teški), konstipacija, bolovi u abdomenu
English: There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Croatian: Monoterapija (karcinom jajnika i karcinom pluća malih stanica): Nema dovoljno iskustva s primjenom topotekana u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 20 ml/min).
English: Pancytopenia
Croatian: Trombocitopenija
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Croatian: U bolesnika liječenih topotekanom prijavljena je mijelosupresija koja je dovela do sepse i smrtnog ishoda uslijed sepse(vidjeti dio 4.8).
English: LABELLING AND PACKAGE LEAFLET
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: o Is not favourable in all other currently approved indications.
Croatian: o Nije povoljan u svim drugim trenutno odobrenim indikacijama.
English: However it is important that this be confirmed in an appropriate pharmacokinetic study.
Croatian: Međutim, važno je da se to potvrdi u odgovarajućoj farmakokinetičkoj studiji.
English: Therefore some of the high dose formulations can no longer be recommended.
Croatian: Stoga se neke od formulacija s visokim dozama ne mogu više preporučivati.
English: • radiotherapy or drug therapy
Croatian: • radioterapijom ili terapijom
English: The CMDh agreed to:
Croatian: CMDh je pristao na:
English: CMDh position
Croatian: Stajalište CMDh-a
English: • Nausea and vomiting of functional, organic, infectious or dietetic origin
Croatian: • Mučnina i povraćanje funkcionalnog, organskog, infektivnog ili dijetetskog podrijetla
English: Therefore, in accordance with Article 116 of Directive 2001/83/EC, the PRAC recommends:
Croatian: Direktive 2001/83/EZ, PRAC preporučuje:
English: As a consequence, the intravenous formulation was withdrawn worldwide.
Croatian: Kao posljedica toga intravenska formulacija povučena je s tržišta širom svijeta.
English: Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Croatian: Nakon što je pregledao preporuku PRAC-a, CMDh se složio s općim znanstvenim zaključcima i razlozima za preporuku.
English: However, it is not expected that the mechanism of action will differ between adults and children, and there is in some Member States long-lasting clinical experience with this product in children.
Croatian: Međutim, ne očekuje se da će se mehanizam djelovanja između odrasli i djece razlikovati te u nekim državama članicama postoji dugoročno kliničko iskustvo s primjenom ovog lijeka u djece.
English: Domperidone is commonly used across Europe since 1970s when it was first time authorized via national procedures.
Croatian: Domperidon se često koristi širom Europe od 1970. godine kada je po prvi puta odobren putem nacionalnih postupaka.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC for domperidonecontaining medicinal products.
Croatian: • Povjerenstvo je razmatralo postupak u skladu s člankom 31. Direktive 2001/83/EZ za lijekove koji sadrže domperidon.
English: The International Birth Date for domperidone has been designated as March 1978, based on the first approval of domperidone in Belgium.
Croatian: Međunarodni datum rođenja za domperidon određen je kao ožujak 1978., a na temelju prvog odobrenja domperidona u Belgiji.
English: • Nausea and vomiting induced by:
Croatian: • Mučnina i povraćanje uzrokovano:
English: However new cases of cardiotoxicity continued to be reported.
Croatian: Međutim, nastavljeno je s prijavljivanjem novih slučajeva kardiotoksičnosti.
English: Domperidone is not approved in all Member States for paediatric use in the subpopulation under 12 years of age and adolescents weighing <35 kg.
Croatian: Domperidon nije odobren u svim državama članicama za pedijatrijsku uporabu u podpopulaciji mlađoj od 12 godina i adolescenata čija je tjelesna težina < 35 kg.
English: Whenever available, paediatric patients should make use of other formulations that allow for more accurate dosing (e.g. oral solution) and these should be supplied with an appropriate measuring device.
Croatian: Kad god je moguće, pedijatrijski bolesnici trebaju koristiti druge formulacije koje omogućavaju točnije doziranje (primjerice, oralne otopine) koje treba isporučiti s odgovarajućim mjernim uređajem.
English: A formulation for intravenous (IV) administration was discontinued in 1985.
Croatian: Formulacija za intravensku (IV) primjenu povučena je s tržišta 1985. godine.
English: • dopamine agonists (such as L-dopa and bromocriptine) used in the treatment of Parkinson's disease
Croatian: • agonistima dopamina (poput L-dope i bromokriptina) koji se koriste u liječenju