FrancophonIA/ELRC3.0 huggingface dataset:
English: Infections and infestations Very common Infectionsb Blood and lymphatic system disorders Very common Neutropeniac Leukopeniad Anaemiae Thrombocytopeniaf Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea
Croatian: Poremećaji krvi i limfnog sustava Vrlo često neutropenijac leukopenijad anemijae trombocitopenijaf Manje često febrilna neutropenija Poremećaji metabolizma i prehrane Vrlo često smanjen tek Poremećaji živčanog sustava Često disgeuzija Poremećaji oka Često pojačano suzenje zamagljen vid suhoća oka Poremećaji dišnog sustava, prsišta i sredoprsja Često epistaksa
English: Fulvestrant should be used with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min).
Croatian: Fulvestrant treba primjenjivati uz oprez u bolesnica s teškim oštećenjem bubrežne funkcije (klirens kreatinina manji od 30 ml/min).
English: The geometric mean (standard deviation) steady state trough concentration (Cmin,ss) and AUCss was 4.2 (0.9) ng/mL and 3680 (1020) ng*hr/mL, respectively.
Croatian: Geometrijska srednja vrijednost (standardna devijacija) najniže koncentracije lijeka u stanju dinamičke ravnoteže (Cmin,ss) iznosila je 4,2 (0,9) ng/ml, a AUC u stanju dinamičke ravnotežes bio je 3680 (1020) ng*hr/ml.
English: This should be taken into consideration when prescribing fulvestrant to patients at risk.
Croatian: Ovo treba uzeti u obzir kada se fulvestrant propisuje bolesnicama s tom vrstom rizika.
English: N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; DOR=duration of response
Croatian: N=broj bolesnica; CI=interval pouzdanosti; NP=ne može se procijeniti; OR=objektivni odgovor; CBR=stopa kliničke dobrobiti
English: • as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
Croatian: • kao monoterapija za liječenje lokalno uznapredovalog ili metastatskog raka dojke pozitivnog na estrogenske receptore u postmenopauzalnih žena: - koje prethodno nisu bile liječene endokrinom terapijom, ili - koje su doživjele relaps bolesti tijekom ili nakon adjuvantnog antiestrogenskog liječenja ili progresiju bolesti tijekom antiestrogenskog liječenja.
English: A 2-week study in healthy postmenopausal volunteers treated with 20 μg per day ethinylestradiol showed that pre-treatment with fulvestrant 250 mg resulted in significantly reduced stimulation of the postmenopausal endometrium, compared to pre-treatment with placebo, as judged by ultrasound measurement of endometrium thickness.
Croatian: Dvotjedno ispitivanje u zdravih žena u postmenopauzi liječenih etinilestradiolom u dozi od 20 μg na dan pokazalo je da je prethodno liječenje fulvestrantom u dozi od 250 mg dovelo do značajno smanjene stimulacije postmenopauzalnog endometrija u odnosu na prethodno liječenje placebom, što je procijenjeno ultrazvučnim mjerenjem debljine endometrija.
English: treatment comparison
Croatian: Način primjene
English: -AI subgroup (n=313)a
Croatian: - AI podskupina (n=313)a
English: Caution should be taken while administering fulvestrant at the dorsogluteal injection site due to the proximity of the underlying sciatic nerve (see sections 4.2 and 4.8).
Croatian: Potreban je oprez pri primjeni lijeka fulvestrant u dorzoglutealno mjesto injekcije zbog blizine ishijadičnog živca (vidjeti dijelove 4.2 i 4.8).
English: Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, refined
Croatian: benzilbenzoat benzilni alkohol etanol, bezvodni ricinusovo ulje, rafinirano
English: Figure 1 Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment, Intent-To-Treat Population) ─ FALCON Study
Croatian: Slika 1 Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje) ─ ispitivanje FALCON
English: NOTE: Due to the proximity of the underlying sciatic nerve, caution should be taken if administering Fulvestrant Mylan at the dorsogluteal injection site (see section 4.4).
Croatian: Zbog blizine ishijadičnog živca, potreban je oprez ako se Fulvestrant Mylan primjenjuje na dorzoglutealnom mjestu injiciranja (vidjeti dio 4.4).
English: Exposure to temperatures below 2°C will not damage the product providing it is not stored below -20°C.
Croatian: Izlaganje temperaturama ispod 2°C neće naškoditi lijeku, pod uvjetom da se ne čuva na temperaturi ispod −20°C.
English: Comparison between groups (Fulvestrant 500 mg/Fulvestrant 250 mg)
Croatian: Usporedba između skupina (Fulvestrant 500 mg/ Fulvestrant 250 mg)
English: A two-year oncogenicity study in rats (intramuscular administration of fulvestrant) showed increased incidence of ovarian benign granulosa cell tumours in female rats at the high dose, 10 mg/rat/15 days and an increased incidence of testicular Leydig cell tumours in males.
Croatian: Dvogodišnje istraživanje onkogenosti u štakora (uz intramuskularnu primjenu fulvestranta) pokazalo je povećanu incidenciju benignih tumora granuloza stanica jajnika u ženki štakora pri visokoj dozi od 10 mg po štakoru tijekom 15 dana, a u mužjaka povećanu incidenciju tumora Leydigovih stanica testisa.
English: c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
Croatian: c Pojam 'neutropenija' obuhvaća sljedeće preporučene pojmove: neutropeniju, snižen broj neutrofila.
English: Neoadjuvant treatment for up to 16 weeks in breast cancer patients with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in serum bone-turnover markers.
Croatian: Neoadjuvantno liječenje tijekom najdulje 16 tjedana u bolesnica s rakom dojke liječenih fulvestrantom u dozi od 500 mg ili u dozi od 250 mg nije dovelo do klinički značajnih promjena serumskih biljega koštane pregradnje.
English: When fulvestrant is given in combination with palbociclib, it is important that you also read the package leaflet for palbociclib.
Croatian: Kada se fulvestrant daje u kombinaciji s palbociklibom, važno je da također pročitate i uputu o lijeku za palbociklib.
English: Secondary end points* OR [% (95% CI)] OR (measurable disease) [% (95% CI)]
Croatian: Sekundarne mjere ishoda* OR [% (95% CI)] OR (mjerljiva bolest) [% (95% CI)]
English: - The other ingredients (excipients) are benzyl benzoate, benzyl alcohol, ethanol, anhydrous, castor oil, refined.
Croatian: - Drugi sastojci (pomoćne tvari) su benzilbenzoat, benzilni alkohol, bezvodni etanol i rafinirano ricinusovo ulje.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva vrlo često osipe
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadržava 250 mg fulvestranta u 5 ml otopine.
English: Fertility The effects of fulvestrant on fertility in humans has not been studied.
Croatian: Plodnost Nisu ispitivani učinci fulvestranta na plodnost ljudi.
English: Variable Type of estimate
Croatian: Varijabla Vrsta procjene, usporedba liječenja
English: Figure 2 Kaplan-Meier plot of progression-free survival (investigator assessment, intentto-treat population) - PALOMA3 study
Croatian: Slika 2. Kaplan-Meierova krivulja preživljenja bez progresije bolesti (ocjena ispitivača, populacija predviđena za liječenje) - ispitivanje PALOMA3
English: e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
Croatian: e Pojam 'anemija' obuhvaća sljedeće preporučene pojmove: anemiju, sniženu vrijednost hemoglobina, sniženu vrijednost hematokrita.
English: DOR (measurable disease) [months (95% CI)]
Croatian: Trajanje odgovora (mjerljiva bolest) [mjeseci (95% CI)]
English: What Fulvestrant Mylan contains - The active substance is fulvestrant.
Croatian: Što sadrži Fulvestrant Mylan - Djelatna tvar je fulvestrant.
English: Fulvestrant showed effects upon reproduction and embryo/foetal development consistent with its anti-estrogenic activity, at doses similar to the clinical dose.
Croatian: Fulvestrant je, u dozama sličnima kliničkoj dozi, pokazao učinke na reprodukciju i razvoj embrija i fetusa sukladan svom antiestrogenskom djelovanju.
English: A Phase 3, international, randomised, double-blind, parallel-group, multicentre study of fulvestrant 500 mg plus palbociclib 125 mg versus fulvestrant 500 mg plus placebo was conducted in women with HR-positive, HER2-negative locally advanced breast cancer not amenable to resection or radiation therapy with curative intent or metastatic breast cancer, regardless of their menopausal status, whose disease progressed after prior endocrine therapy in the (neo) adjuvant or metastatic setting.
Croatian: Provedeno je međunarodno, randomizirano, dvostruko slijepo, multicentrično ispitivanje faze 3 s paralelnim skupinama, u kojem se kombinacija lijeka Faslodex u dozi od 500 mg i palbocikliba u dozi od 125 mg uspoređivala s kombinacijom lijeka Faslodex u dozi od 500 mg i placeba u žena - neovisno o njihovu menopauzalnom statusu - s lokalno uznapredovalim HR-pozitivnim i HER2-negativnim rakom dojke koji se nije mogao kurativno liječiti resekcijom ni radioterapijom ili metastatskim rakom dojke, kojima je bolest uznapredovala nakon prethodne endokrine terapije u (neo)adjuvantnim ili metastatskim uvjetima.
English: Two phase-3 clinical studies were completed in a total of 851 postmenopausal women with advanced breast cancer who had disease recurrence on or after adjuvant endocrine therapy or progression following endocrine therapy for advanced disease.
Croatian: Završena su dva klinička ispitivanja faze 3 s ukupno 851 ženom u postmenopauzi s uznapredovalim rakom dojke u kojih se bolest ponovno javila tijekom ili nakon adjuvantnog endokrinog liječenja ili je došlo do progresije nakon endokrinog liječenja uznapredovale bolesti.
English: Patients were well matched for baseline demographics and prognostic characteristics between the fulvestrant plus palbociclib arm and the fulvestrant plus placebo arm.
Croatian: Početne demografske i prognostičke značajke bile su dobro ujednačene između skupine liječene lijekom Faslodex plus palbociklibom i one koja je primala Faslodex plus placebo.
English: A Phase 3, randomised, double-blind, double-dummy, multicentre study of fulvestrant 500 mg versus anastrozole 1 mg was conducted in postmenopausal women with ER-positive and/or PgR-positive locally advanced or metastatic breast cancer who had not previously been treated with any hormonal therapy.
Croatian: Provedeno je randomizirano, dvostruko slijepo, multicentrično ispitivanje faze 3 s dvostrukim placebom u kojem se fulvestrant u dozi od 500 mg uspoređivao s anastrozolom u dozi od 1 mg u postmenopauzalnih žena s ER-pozitivnim i/ili PgR-pozitivnim lokalno uznapredovalim ili metastatskim rakom dojke koje prethodno nisu primile nikakvu hormonsku terapiju.
English: For user convenience, the needle bevel- up position is oriented to the lever arm (see Figure 4).
Croatian: Radi lakše primjene kosi otvor vrha igle okrenut je prema ručici poluge (vidjeti Sliku 4).
English: • Administer intramuscularly slowly (1-2 minutes/injection) into the buttock (gluteal area).
Croatian: • Primijenite sporom intramuskularnom injekcijom (12 minute po injekciji) u mišić stražnjice (područje gluteusa).
English: Fulvestrant + Palbociclib (N=345)
Croatian: Faslodex + palbociklib (N=345)
English: Mylan Teoranta Coill Rua Inverin
Croatian: Proizvođač MYLAN TEORANTA Inverin
English: In patients administered fulvestrant, an increase in exposure of this magnitude is expected to be well tolerated.
Croatian: Očekuje se da će bolesnice koje su primile fulvestrant dobro podnijeti ovu razinu izloženosti.
English: Neoadjuvant treatment for up to 16 weeks in breast cancer patients treated with either fulvestrant 500 mg or fulvestrant 250 mg did not result in clinically significant changes in endometrial thickness, indicating a lack of agonist effect.
Croatian: Neoadjuvantno liječenje tijekom najdulje 16 tjedana nije u bolesnica s rakom dojke liječenima fulvestrantom u dozi od 500 mg ili fulvestrantom u dozi od 250 mg dovelo do klinički značajnih promjena u debljini endometrija, što ukazuje da lijek nema agonistički učinak.
English: Fulvestrant plus palbociclib (N=206)
Croatian: Faslodex plus palbociklib (N=206)
English: -AE subgroup (n=423) -AI subgroup (n=313)a a
Croatian: - AE podskupina (n=423) - AI podskupina (n=313)a
English: Two clear type 1 glass pre-filled syringes with polypropylene plunger rod, fitted with a tamper-evident closure, each containing 5 ml Fulvestrant Mylan solution for injection.
Croatian: Dvije napunjene štrcaljke od prozirnog stakla tipa 1 s potisnim klipom od polipropilena i sigurnosnim zatvaračem, od kojih svaka sadrži 5 ml Fulvestrant Mylan otopine za injekciju.
English: Very common Hypersensitivity reactionse Uncommon
Croatian: Poremećaji imunološkog sustava vrlo često reakcije preosjetljivostie manje često anafilaktičke reakcije
English: A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to fulvestrant plus palbociclib or fulvestrant plus placebo and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Croatian: Ukupno je 521 žena u predmenopauzi/perimenopauzi i postmenopauzi kojoj je bolest progredirala tijekom ili unutar 12 mjeseci od završetka adjuvantne endokrine terapije odnosno tijekom ili unutar mjesec dana od završetka endokrine terapije za uznapredovalu bolest randomiziranu u omjeru 2:1 za liječenje kombinacijom lijeka Faslodex i palbocikliba ili kombinacijom lijeka Faslodex i placeba.
English: Adverse reactions listed below are classified according to frequency and System Organ Class (SOC).
Croatian: Navedene nuspojave klasificirane su prema učestalosti i organskim sustavima.
English: How to use Fulvestrant Mylan
Croatian: Kako primjenjivati Fulvestrant Mylan
English: Progression-Free Survival Number of PFS Events (%) PFS Hazard Ratio (95% CI) and pvalue
Croatian: Preživljenje bez progresije bolesti Broj događaja PFS-a (%) Omjer hazarda (95% CI) i p-vrijednost za PFS
English: Fulvestrant plus palbociclib (N=141)
Croatian: Faslodex plus palbociklib (N=141)
English: • Pull shield straight off needle to avoid damaging needle point.
Croatian: • Povucite zaštitni zatvarač sa igle ravno kako ne biste oštetili vrh igle.
English: Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Croatian: ulceracije u ustima, upalu sluznice, bol u usnoj šupljini, nelagodu u usnoj šupljini i ždrijelu, bol u usnoj šupljini i ždrijelu, stomatitis.
English: Nominal p-value with no adjustments made for multiplicity between the initial overall survival analyses at 50% maturity and the updated survival analyses at 75% maturity.
Croatian: c Nominalna p-vrijednost bez korekcije za multiplicitet između inicijalnih analiza ukupnog preživljenja pri
English: Table 4 Summary of results of the primary efficacy endpoint (PFS) and key secondary efficacy endpoints (Investigator Assessment, Intent-To-Treat Population) ─ FALCON study
Croatian: Tablica 4 Sažetak rezultata za primarnu mjeru ishoda za djelotvornost (PFS) i ključne sekundarne mjere ishoda za djelotvornost (ocjena ispitivača, populacija predviđena za liječenje)
English: Comparison between groups (Fulvestrant 500 mg/ Fulvestrant 250 mg) Hazard ratio
Croatian: Usporedba između skupina (Fulvestrant 500 mg/Fulvestrant 250 mg) Apsolutna razlika u %
English: One clear type 1 glass pre-filled syringe with polypropylene plunger rod, fitted with a tamper-evident closure, containing 5 ml Fulvestrant Mylan solution for injection.
Croatian: Jedne napunjene štrcaljke od prozirnog stakla tipa 1 s potisnim klipom od polipropilena i sigurnosnim zatvaračem, koja sadrži 5 ml Fulvestrant Mylan otopine za injekciju.
English: Injection site related events including sciatica, neuralgia, neuropathic pain, and peripheral neuropathy have been reported with fulvestrant injection.
Croatian: Kod primjene injekcije fulvestranta zabilježeni su događaji povezani s mjestom injiciranja uključujući išijas, neuralgiju, neuropatsku bol i perifernu neuropatiju.
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane često anoreksijaa
English: 4.4 Special warnings and precautions for use Fulvestrant should be used with caution in patients with mild to moderate hepatic impairment (see sections 4.2, 4.3 and 5.2).
Croatian: Fulvestrant treba primjenjivati uz oprez u bolesnica s blagim do umjerenim oštećenjem jetrene funkcije (vidjeti dijelove 4.2, 4.3 i 5.2).
English: Fulvestrant + placebo (N=172)
Croatian: Faslodex + placebo (N=172)
English: Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Croatian: Fulvestrant Mylan 250 mg otopina za injekciju u napunjenoj štrcaljki fulvestrant
English: Fulvestrant plus placebo (N=105)
Croatian: Faslodex plus placebo (N=105)
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava često smanjen broj trombocitae
English: Fulvestrant plus placebo (N=69)
Croatian: Faslodex plus placebo (N=69)
English: For the subgroup of patients with disease limited to non-visceral metastasis (n=208), the HR was 0.592 (95% CI: 0.419, 0.837) for the fulvestrant arm compared to the anastrozole arm. For the subgroup of patients with visceral metastasis (n=254), the HR was 0.993 (95% CI: 0.740, 1.331) for the fulvestrant arm compared to the anastrozole arm.
Croatian: U podskupini bolesnica s bolešću ograničenom na nevisceralne metastaze (n=208) HR za skupinu liječenu fulvestrantom u odnosu na onu koja je primala anastrozol iznosio je 0,592 (95% CI: 0,419; 0,837).
English: Fulvestrant plus placebo (N=174)
Croatian: Faslodex plus placebo (N=174)
English: All Patients -AE subgroup (n=423) -AI subgroup (n=313) a
Croatian: Svi bolesnici - AE podskupina (n=423)
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe contains 250 mg fulvestrant in 5 ml solution
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadržava 250 mg fulvestranta u 5 ml otopine.
English: Stomatitisg Diarrhoea Vomiting Skin and subcutaneous tissue disorders Very common Alopecia Rashh Common Dry skin General disorders and administration site conditions Very common Fatigue Pyrexia Common Asthenia Investigations Common AST increased ALT increased
Croatian: Poremećaji probavnog sustava Vrlo često mučnina stomatitisg proljev povraćanje Poremećaji kože i potkožnog tkiva Vrlo često alopecija osiph Često suha koža Opći poremećaji i reakcije na mjestu primjene Vrlo često umor pireksija Često astenija Pretrage
English: Reproductive system and breast disorders Common
Croatian: Klasifikacija organskih sustava Učestalost
English: When fulvestrant is combined with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Croatian: Kada se fulvestrant kombinira s palbociklibom, vidjeti i sažetak opisa svojstava lijeka za palbociklib.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Fulvestrant Mylan 250 mg solution for injection in prefilled syringe fulvestrant
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Fulvestrant Mylan 250 mg otopina za injekciju u napunjenoj štrcaljki fulvestrant i.m. primjena
English: Adverse reactions by system organ class and frequency Infections and infestations
Croatian: Infekcije i infestacije Vrlo često infekcijeb
English: When fulvestrant is used in combination with palbociclib, please also refer to the Summary of Product Characteristics of palbociclib.
Croatian: Kada se fulvestrant primjenjuje u kombinaciji s palbociklibom, vidjeti i sažetak opisa svojstava lijeka za palbociklib.
English: f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
Croatian: f Pojam 'trombocitopenija' obuhvaća sljedeće preporučene pojmove: trombocitopeniju, snižen broj trombocita.
English: NAME OF THE MEDICINAL PRODUCT Fulvestrant Mylan 250 mg solution for injection in prefilled syringe
Croatian: NAZIV LIJEKA Fulvestrant Mylan 250 mg otopina za injekciju u napunjenoj štrcaljki
English: You must not breast-feed while on treatment with Fulvestrant Mylan.
Croatian: Tijekom liječenja lijekom Fulvestrant Mylan ne smijete dojiti.
English: What you need to know before you use Fulvestrant Mylan 3.
Croatian: Što je Fulvestrant Mylan i za što se koristi Što morate znati prije nego počnete primjenjivati Fulvestrant Mylan Kako primjenjivati Fulvestrant Mylan Moguće nuspojave
English: OSb
Croatian: CBR
English: PFS Median [months (95% CI)] Number of OS Events* OS Hazard Ratio (95% CI) and p-value
Croatian: Broj događaja OS-a* Omjer hazarda (95% CI) i p-vrijednost za OS
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
English: Combined analysis of both studies showed the hazard ratio of fulvestrant 250 mg to anastrozole for progression-free survival was
Croatian: Kombinirana analiza obaju ispitivanja pokazala je da je omjer hazarda lijeka fulvestrant 250 mg u odnosu na anastrozol za preživljenje bez progresije bolesti bio 0,95 (95% CI 0,82 do 1,10).
English: Very common Elevated hepatic enzymes (ALT, AST, ALP) a
Croatian: Često povišene vrijednosti AST-a povišene vrijednosti ALT-a
English: h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular,
Croatian: h Pojam 'osip' obuhvaća sljedeće preporučene pojmove: osip, makulopapularni osip, pruritički osip, eritemski osip, papularni osip, dermatitis, akneiformni dermatitis, izbijanje kožnih promjena uzrokovanih toksičnim učinkom lijeka.
English: For the full list of all side effects reported with Copalia HCT, see the package leaflet.
Croatian: For the full list of all side effects reported with Copalia HCT, see the pPackage lLeaflet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT on 4 November 2009.
Croatian: The European Commission granted a marketing authorisation valid throughout the European Union for Copalia HCT to Novartis Europharm Limited on 16 4 October November 2009.
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Copalia HCT which combines the three substances in a single tablet.
Croatian: The Committee for Medicinal Products for Human Use (CHMP) noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Copalia HCT which combines the three substances in a single tablet.
English: Copalia HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Copalia HCT.
Croatian: Copalia HCT should must not be used in people who may beare hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Copalia HCT.
English: It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique).
Croatian: anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique).