FrancophonIA/ELRC3.0 huggingface dataset:
English: • sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality
Croatian: • iznenadno nevoljno treperenje ili trzaji mišića, osjećaj nemira ili nemogućnost mirnog sjedenja ili stajanja, osjećaj nervoze, teškoće s koncentracijom, promjene osjeta okusa, teškoće pri kontroliranju pokreta npr. nedostatak koordinacije ili nevoljni pokreti mišića, sindrom nemirnih nogu, loša kvaliteta sna
English: Compared with healthy subjects, the apparent plasma clearance of duloxetine was 79% lower, the apparent terminal half-life was 2.3 times longer, and the AUC was 3.7 times higher in patients with moderate liver disease.
Croatian: U usporedbi sa zdravim ispitanicima, u bolesnika s umjereno teškom bolešću jetre je prividni klirens duloksetina iz plazme bio je 79% niži, prividan terminalni poluvijek bio je 2,3 puta dulji, a AUC je bio 3,7 puta veći.
English: Duloxetine has been associated with an increase in blood pressure and clinically significant hypertension in some patients.
Croatian: U nekih je bolesnika duloksetin povezan s povišenjem krvnog tlaka i klinički značajnom hipertenzijom.
English: There was also a small increase in fasting blood glucose and in total cholesterol in duloxetine-treated patients while those laboratory tests showed a slight decrease in the routine care group.
Croatian: Glukoza u krvi natašte i ukupni kolesterol bili su malo povećani u bolesnika liječenih duloksetinom, dok su laboratorijske pretrage pokazale malo sniženje tih parametara u skupini bolesnika na standardnom liječenju.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008 (7 hard gastro-resistant capsules) EU/1/04/283/009 (28 hard gastro-resistant capsules) EU/1/04/283/010 (98 hard gastro-resistant capsules)
Croatian: 12. BROJEVI ODOBRENJA ZA STAVLJANJE GOTOVOG LIJEKA U PROMET EU/1/04/283/008 (7 tvrdih želučanootpornih kapsula) EU/1/04/283/009 (28 tvrdih želučanootpornih kapsula) EU/1/04/283/010 (98 tvrdih želučanootpornih kapsula)
English: The pharmacokinetics of duloxetine in patients who are poor metabolisers with respect to CYP2D6 has not been specifically investigated.
Croatian: Farmakokinetika duloksetina u bolesnika koji su slabi metabolizatori s obzirom na CYP2D6 nije posebno ispitivana.
English: Based on the half-life of duloxetine, at least 5 days should be allowed after stopping ARICLAIM before starting an MAOI (see section
Croatian: S obzirom na poluvijek duloksetina, mora proći najmanje 5 dana nakon prestanka primjene lijeka ARICLAIM prije početka liječenja MAOI-ma (vidjeti dio 4.3).
English: • suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack
Croatian: • samoubilačke misli, tegobe sa spavanjem, škripanje ili stiskanje zubima, osjećaj dezorijentiranosti, nedostatak motivacije
English: You must wait at least 14 days after you have stopped taking an MAOI before you can take ARICLAIM.
Croatian: Nakon što ste prekinuli uzimati MAOI, morate pričekati najmanje 14 dana prije nego možete uzeti ARICLAIM.
English: However, concomitant administration of duloxetine with warfarin under steady state conditions, in healthy volunteers, as part of a clinical pharmacology study, did not result in a clinically significant change in INR from baseline or in the pharmacokinetics of R- or S-warfarin.
Croatian: Međutim, istodobna primjena duloksetina s varfarinom u stanju dinamičke ravnoteže u zdravih dobrovoljaca, kao dio kliničkog farmakološkog ispitivanja, nije rezultirala klinički značajnom promjenom INR-a u odnosu na početne vrijednosti, kao ni farmakokinetike
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS
Croatian: POSEBNE MJERE ZA UKLANJANJE NEISKORIŠTENOG LIJEKA ILI OTPADNIH
English: ARICLAIM may make you feel sleepy or dizzy.
Croatian: ARICLAIM može izazvati pospanost ili omaglicu.
English: Your doctor will tell you if you should be taking ARICLAIM.
Croatian: Liječnik će Vam reći smijete li uzimati lijek ARICLAIM.
English: In clinical trials adverse events seen on abrupt treatment discontinuation occurred in approximately 45% of patients treated with ARICLAIM and 23% of patients taking placebo.
Croatian: U kliničkom ispitivanju štetni događaji primijećeni nakon naglog prekida liječenja pojavili su se u približno 45% bolesnika liječenih lijekom ARICLAIM i u 23% bolesnika koji su uzimali placebo.
English: Blood cholesterol increased
Croatian: Pretrage povišen kolesterol u krvi
English: The initiation of treatment with ARICLAIM is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis (see sections 4.4 and
Croatian: Kontraindicirano je započeti liječenje lijekom ARICLAIM u bolesnika s nekontroliranom hipertenzijom koja bolesnika može izložiti potencijalnom riziku od hipertenzivne krize (vidjeti dijelove 4.4 i 4.8).
English: Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.
Croatian: Opis odabranih nuspojava Prekid primjene duloksetina (osobito nagli prekid) često dovodi do pojave simptoma prekida primjene lijeka.
English: ARICLAIM must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min; see section 4.3).
Croatian: ARICLAIM se ne smije primjenjivati u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina < 30 ml/min; vidjeti dio 4.3).
English: Consequently, caution is advised when ARICLAIM is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g. benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Croatian: Stoga se savjetuje oprez kada se ARICLAIM primjenjuje u kombinaciji s drugim lijekovima ili tvarima koje djeluju na SŽS, uključujući alkohol i sedative (npr. benzodiazepine, morfinomimetike, antipsihotike, fenobarbital, sedativne antihistaminike).
English: • chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
Croatian: • bol u prsima, osjećaj hladnoće, žeđ, drhtanje, osjećaj vrućine, poremećen hod
English: Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Croatian: Savjetuje se oprez ako se ARICLAIM primjenuje istodobno s lijekovima koji se metaboliziraju prvenstveno pomoću CYP2D6 (risperidon, triciklički antidepresivi poput nortriptilina, amitriptilina i imipramina), naročito ako imaju uzak terapijski indeks (poput flekainida, propafenona i metoprolola).
English: Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function (e.g. NSAIDs or acetylsalicylic acid (ASA)), and in patients with known bleeding tendencies.
Croatian: Savjetuje se oprez u bolesnika koji uzimaju antikoagulanse i/ili lijekove za koje se zna da utječu na funkciju trombocita (npr. NSAIL ili acetilsalicilatna kiselina (ASK)) te u bolesnika s poznatom sklonošću krvarenjima.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: Renal impairment: End stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
Croatian: Oštećenje bubrežne funkcije: bolesnici u završnom stadiju bubrežne bolesti koji su na dijalizi imali su 2 puta više vrijednosti Cmax i AUC duloksetina u usporedbi sa zdravim ispitanicima.
English: ARICLAIM should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Croatian: Manija i napadaji ARICLAIM se mora s oprezom primjenjivati kod bolesnika s manijom u anamnezi ili s dijagnozom bipolarnog poremećaja i/ili napadaja.
English: • inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the large intestine (leading to diarrhoea)
Croatian: • upala usta, svjetlocrvena krv u stolici, neugodan zadah iz usta, upala debelog crijeva (što dovodi do proljeva)
English: Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing ARICLAIM to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Croatian: Prijavljeni su slučajevi midrijaze povezani s duloksetinom te se stoga ARICLAIM mora s oprezom propisivati bolesnicima s povišenim intraokularnim tlakom i onima s rizikom od akutnog glaukoma uskog kuta.
English: ARICLAIM may be associated with sedation and dizziness.
Croatian: Lijek ARICLAIM može biti povezan s pojavom sedacije i omaglice.
English: Effects of other medicinal products on duloxetine Antacids and H2 antagonists: Co-administration of duloxetine with aluminium- and magnesiumcontaining antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Croatian: Učinci drugih lijekova na duloksetin Antacidi i antagonisti H2 receptora: istodobna primjena duloksetina i antacida koji sadrže aluminij ili magnezij ili duloksetina i famotidina nije značajno utjecala na brzinu ni opseg apsorpcije duloksetina nakon peroralne primjene doze od 40 mg.
English: These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ARICLAIM, you should see your doctor.
Croatian: Ako primijetite bilo koji neuobičajen simptom dok uzimate neki od tih lijekova zajedno s lijekom ARICLAIM, morate se javiti svom liječniku.
English: ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules.
Croatian: ARICLAIM 30 mg dostupan je u pakiranjima od 7, 28 i 98 kapsula.
English: Also, you need to wait at least 5 days after you stop taking ARICLAIM before you take a MAOI.
Croatian: Također, nakon što ste prekinuli uzimati lijek ARICLAIM, morate pričekati najmanje 5 dana prije nego uzmete MAOI.
English: Angio-neurotic oedema6
Croatian: angioneurotski edem6
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from moisture.
Croatian: POSEBNE MJERE ČUVANJA Čuvati u originalnom pakovanju radi zaštite od vlage.
English: Feeling abnormal Feeling cold Thirst
Croatian: bol u prsima neuobičajeno osjećanje osjećaj hladnoće žeđ zimica
English: In prenatal/postnatal toxicity studies in the rat, duloxetine induced adverse behavioural effects in the offspring at exposures below maximum clinical exposure (AUC).
Croatian: U ispitivanju pre/postnatalne toksičnosti u štakora duloksetin je izazvao štetne bihevioralne učinke u mladunčadi pri razinama manjima od maksimalne kliničke izloženosti (AUC).
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
Croatian: Ako se donese odluka o uvođenju antidepresivne farmakološke terapije, preporučuje se postupan prekid liječenja lijekom ARICLAIM
English: • fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
Croatian: • nesvjestica, omaglica, ošamućenost ili nesvjestica pri ustajanju, hladni prsti na rukama i/ili nogama • stezanje u grlu, krvarenja iz nosa
English: ARICLAIM 60 mg is available in packs of 28 and 98 capsules.
Croatian: ARICLAIM 60 mg dostupan je u pakiranjima od 28 i 98 kapsula.
English: Concomitant use of ARICLAIM with nonselective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.5).
Croatian: Kontraindicirana je istodobna primjena lijeka ARICLAIM s neselektivnim, ireverzibilnim inhibitorima monoamino-oksidaze (MAO) (vidjeti dio 4.5).
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of ARICLAIM 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Croatian: 8-tjedno akutno liječenje lijekom ARICLAIM u dozi od 60 mg jednom dnevno održalo se tijekom sljedećih 6 mjeseci, mjereno promjenom 24-satnih podataka o prosječnoj boli u kratkom upitniku o boli (eng.
English: Infections and infestations Immune system disorders
Croatian: Infekcije i infestacije
English: Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of ARICLAIM in this age group have not yet been demonstrated.
Croatian: ARICLAIM na rast, sazrijevanje te intelektualni razvoj i razvoj ponašanja nisu još dokazani u ovoj dobnoj skupini.
English: The 60 mg capsules are blue and green and are printed with ‘60 mg' and the code ‘9542'.
Croatian: Kapsule od 60 mg su plave i zelene boje s otisnutim oznakom ‘60 mg' i oznakom ‘9542'.
English: Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John's Wort and MAOIs (such as moclobemide and linezolid).
Croatian: Lijekovi koji povećavaju razinu serotonina: triptani, tramadol, triptofan, SSRI (poput paroksetina i fluoksetina), inhibitori ponovne pohrane serotonina i noradrenalina (poput venlafaksina), triciklički antidepresivi (poput klomipramina, amitriptilina), petidin, gospina trava i inhibitori MAO (poput moklobemida i linezolida).
English: Read the leaflet before use.
Croatian: Prije uporabe pročitati uputu o lijeku.
English: ARICLAIM hard gastro-resistant capsules contain sucrose.
Croatian: ARICLAIM tvrde želučanootporne kapsule sadrže saharozu.
English: ARICLAIM must not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Croatian: Oštećenje jetrene funkcije ARICLAIM se ne smije primjenjivati u bolesnika s bolešću jetre čija je posljedica oštećenje jetrene funkcije (vidjeti dijelove 4.3 i 5.2).
English: The 30 mg capsules are blue and white and are printed with ‘30 mg' and the code ‘9543'.
Croatian: Kapsule od 30 mg su plave i bijele boje s otisnutim oznakom ‘30 mg' i oznakom ‘9543'.
English: No dosage adjustment is necessary for patients with mild or moderate renal dysfunction (creatinine clearance 30 to 80 ml/min).
Croatian: U bolesnika s blagom ili umjerenom disfunkcijom bubrežne funkcije (klirens kreatinina 30 do 80 ml/min) nije potrebna prilagodba doze.
English: 7 hard gastro-resistant capsules 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
Croatian: 7 tvrdih želučanootpornih kapsula 28 tvrdih želučanootpornih kapsula 98 tvrdih želučanootpornih kapsula
English: The use of ARICLAIM while breastfeeding is not recommended.
Croatian: Ne preporučuje se uzimanje lijeka ARICLAIM za vrijeme dojenja.
English: Stomatitis Haematochezia Breath odour Microscopic colitis
Croatian: Poremećaji probavnog sustava mučnina suha usta stomatitis hematohezija zadah iz usta mikroskopski kolitis9
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
English: Dehydration Hyponatraemia SIADH6
Croatian: Poremećaji metabolizma i prehrane dehidracija hiponatrijemija SIADH6
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet i proizvođač Nositelj odobrenja za stavljanje gotovog lijeka u promet: Eli Lilly Nederland BV, Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: Syncope2 Hypertension3,7
Croatian: crvenilo uz osjećaj vrućine sinkopa2 hipertenzija3,7
English: Edible white ink: titanium dioxide (E171), propylene glycol, shellac, povidone.
Croatian: Jestiva bijela tinta: titanijev dioksid (E171), propilenglikol, šelak, povidon
English: − have severe kidney disease
Croatian: − imate tešku bolest bubrega
English: • difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow
Croatian: • otežano ili nemogućnost mokrenja, otežan početak mokrenja, potreba za mokrenjem tijekom noći, pojačana potreba za mokrenjem, smanjen protok mokraće