FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of Abilify Maintena in the treatment of schizophrenia in patients 65 years of age or older has not been established (see section 4.4).
Croatian: 65 godina ili starijih nisu ustanovljene (vidjeti dio 4.4).
English: Gait disturbance Chest discomfort Injection site reaction Injection site erythema Injection site swelling Injection site discomfort Injection site pruritus Thirst
Croatian: otvrdnuće na mjestu injekcije, umor pireksija, astenija, smetnje u hodu, nelagoda u prsištu, reakcija na mjestu injekcije, eritem na mjestu injekcije, oticanje na mjestu injekcije, nelagoda na mjestu injekcije, svrbež na mjestu injekcije,
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole
Croatian: Abilify Maintena 300 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem u napunjenoj štrcaljki. aripiprazol
English: Hepatic impairment
Croatian: psihotični poremećaj,
English: In the Double-blind Placebo-controlled Phase of the 52-week trial, from baseline to last visit there was a mean decrease in prolactin levels in Abilify Maintena (−0.38 ng/ml) compared with a mean increase in placebo (1.67 ng/ml).
Croatian: (−0,38 ng/ml) za razliku od skupine koja je primala placebo u kojoj se u prosjeku povisila (1,67 ng/ml).
English: Immune system disorders
Croatian: poremećaji kontrole nagona,
English: Suicidal ideation Psychotic disorder Hallucination Delusion
Croatian: halucinacija, deluzije, hiperseksualnost,
English: Thrombocytopenia Neutrophil count decreased White blood cell count decreased
Croatian: Poremećaji krvi i limfnog sustava neutropenija, anemija, trombocitopenija, smanjen broj neutrofila, smanjen broj bijelih krvnih stanica leukopenija
English: Ventricular extrasystoles Bradycardia
Croatian: hipersekrecija sline pankreatitis, disfagija
English: Tardive dyskinesia Parkinsonism Movement disorder Psychomotor hyperactivity Restless legs syndrome Cogwheel rigidity Hypertonia
Croatian: psihomotorna hiperaktivnost, sindrom nemirnih nogu,
English: It is used for the treatment of:
Croatian: Upotrebljava se za liječenje sljedećeg:
English: Further information on Mekinist can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Mekinist možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Mekinist is available as tablets (0.5 and 2 mg).
Croatian: Lijek Mekinist dostupan je u obliku tableta (0,5 mg i 2 mg).
English: The dose of Mekinist is 2 mg once a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal) and at around the same time every day.
Croatian: Doza lijeka Mekinist je 2 mg jednom dnevno na prazan želudac (barem 1 sat prije ili 2 sata nakon obroka), otprilike u isto doba dana svaki dan.
English: Other information about Mekinist
Croatian: Ostale informacije o lijeku Mekinist
English: What measures are being taken to ensure the safe and effective use of Mekinist?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Mekinist?
English: Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo.
Croatian: Približno 40 % bolesnika koji su liječeni kombinacijom lijekova umrlo je ili im se bolest vratila nakon otprilike 3,5 godine u odnosu na 59 % bolesnika koji su primali placebo.
English: This leads cancers to develop by allowing uncontrolled division of cells.
Croatian: To potiče razvoj raka time što dopušta nekontroliranu diobu stanica.
English: • melanoma (a skin cancer) that has spread or cannot be removed surgically.
Croatian: • melanoma (raka kože) koji se proširio ili se ne može kirurški odstraniti.
English: For more information about using Mekinist, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Mekinist, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mekinist have 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 Mekinist nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: What is Mekinist and what is it used for?
Croatian: Što je Mekinist i za što se primjenjuje?
English: The Agency also found it to be of benefit in patients with advanced melanoma that had been removed surgically.
Croatian: Agencija također smatra da je koristan za bolesnike s uznapredovalim melanomom koji je kirurški odstranjen.
English: An overview of Mekinist and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Mekinist i zašto je odobren u EU-u
English: Treatment with Mekinist must be started and supervised by a doctor experienced in the use of cancer medicines.
Croatian: Liječenje lijekom Mekinist mora započeti i nadzirati liječnik s iskustvom u primjeni lijekova protiv raka.
English: Side effects reported with Mekinist are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Mekinist pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: It is used in combination with dabrafenib.
Croatian: Primjenjuje se u kombinaciji s dabrafenibom.
English: As for all medicines, data on the use of Mekinist are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Mekinist kontinuirano se prate.
English: What are the risks associated with Mekinist?
Croatian: Koji su rizici povezani s lijekom Mekinist?
English: In an additional study Mekinist did not show any benefit when given to patients who did not respond to previous treatment with another cancer medicine that blocked BRAF.
Croatian: U dodatnom ispitivanju lijek Mekinist nije pokazao nikakve koristi prilikom primjene u bolesnika koji nisu odgovorili na prethodno liječenje nekim drugim lijekom protiv raka koji inhibira BRAF.
English: When Mekinist is taken in combination with dabrafenib the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.
Croatian: Kada se Mekinist uzima u kombinaciji s dabrafenibom, najčešće nuspojave (mogu se pojaviti u više od 1 na 5 osoba) su vrućica, umor, mučnina, zimica, glavobolja, proljev, povraćanje, bol u zglobovima i osip.
English: Why is Mekinist authorised in the EU?
Croatian: Zašto je lijek Mekinist odobren u EU-u?
English: Mekinist received a marketing authorisation valid throughout the EU on 30 June 2014.
Croatian: Lijek Mekinist dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 30. lipnja
English: This was based on a main study involving 322 patients who received either Mekinist or the comparator medicine and which measured how long patients lived until their disease got worse.
Croatian: Zaključak se temelji na glavnom ispitivanju kojim je bilo obuhvaćeno 322 bolesnika koji su primali ili Mekinist ili usporedni lijek, a mjereno je vrijeme koje su bolesnici preživjeli bez pogoršanja bolesti.
English: In melanoma and non-small cell lung cancer with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Croatian: U slučaju melanoma i raka pluća nemalih stanica s mutacijom BRAF V600 prisutan je abnormalan oblik proteina BRAF, koji aktivira drugi protein naziva MEK uključen u stimulaciju diobe stanica.
English: The most common side effects with Mekinist (which may affect more than 1 in 5 people) are rash, diarrhoea, tiredness, peripheral oedema (swelling, especially of ankles and feet), nausea and acneiform dermatitis (acne-like inflammation of the skin).
Croatian: Najčešće nuspojave lijeka Mekinist (koje se mogu pojaviti kod više od 1 na 5 osoba) su osip, proljev, umor, periferni edem (oticanje, posebice gležnjeva i stopala), mučnina i akneiformni dermatitis (upala kože u obliku akni).
English: Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called 'BRAF V600'.
Croatian: Mekinist je lijek protiv raka namijenjen odraslim bolesnicima čije stanice raka imaju specifičnu genetsku mutaciju (promjenu) koja se naziva „BRAF V600”.
English: Mekinist can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back.
Croatian: Nakon operacije uznapredovalog melanoma liječenje se normalno nastavlja sljedećih 12 mjeseci, osim ako se bolest ne vrati.
English: Two additional studies on melanoma that had spread to other parts of the body or could not be removed surgically looked at using the combination of Mekinist and dabrafenib.
Croatian: U dva dodatna ispitivanja melanoma koji se proširio na druge dijelove tijela ili se nije mogao kirurški odstraniti ispitivala se kombinacija lijekova Mekinist i dabrafenib.
English: Mekinist contains the active substance trametinib.
Croatian: Mekinist sadrži djelatnu tvar trametinib.
English: Patients given the combination lived for 11 months without their disease worsening compared with 8.8 months for those given dabrafenib alone.
Croatian: Bolesnici liječeni kombinacijom lijekova živjeli su 11 mjeseci bez pogoršanja bolesti, u usporedbi s 8,8 mjeseca u bolesnika koji su primali samo dabrafenib.
English: How does Mekinist work?
Croatian: Kako djeluje Mekinist?
English: Mekinist was more effective than the cancer medicines dacarbazine or paclitaxel at controlling melanoma that had spread to other parts of the body or could not be removed surgically.
Croatian: Lijek Mekinist učinkovitiji je od drugih lijekova protiv raka, tj. dakarbazina ili paklitaksela, u kontroli melanoma koji su se proširili na ostale dijelove tijela ili ih nije moguće kirurški odstraniti.
English: The Agency considered that Mekinist when used alone or in combination with dabrafenib had shown a clinically relevant benefit in patients with non-small cell lung cancer or with melanoma that had spread or could not be removed surgically.
Croatian: Agencija je smatrala da je Mekinist primijenjen kao monoterapija ili u kombinaciji s dabrafenibom pokazao klinički relevantnu korist u bolesnika oboljelih od raka pluća nemalih stanica ili melanoma koji se proširio ili se nije mogao kirurški odstraniti.
English: Mekinist's side effects were considered acceptable and manageable with appropriate measures.
Croatian: Smatralo se da su nuspojave lijeka Mekinist prihvatljive i da ih je moguće liječiti odgovarajućim mjerama.
English: In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Mekinist and dabrafenib given for 1 year was compared with placebo (a dummy treatment).
Croatian: U ispitivanju u kojem je sudjelovalo 870 bolesnika s melanomom faze III. koji je kirurški odstranjen, uspoređen je učinak kombinacije lijekova Mekinist i dabrafenib davan tijekom 1 godine u odnosu na placebo (prividno liječenje).
English: The use of Mekinist and dabrafenib led to a response in over 60% of the patients, compared with 23% of patients using dabrafenib alone.
Croatian: Kombinirana primjena lijeka Mekinist i dabrafeniba dovela je do odgovora u više od 60 % bolesnika, a monoterapija dabrafenibom u 23 % bolesnika.
English: The European Medicines Agency decided that Mekinist's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Mekinist nadmašuju s njim povezane rizike za rak s mutacijom BRAF V600 te da može biti odobren za primjenu u Europskoj uniji.
English: In one study, 423 patients were given either the combination or dabrafenib alone.
Croatian: U jednom ispitivanju, 423 bolesnika primilo je ili kombinaciju lijekova ili samo dabrafenib.
English: In a second study involving 704 patients, Mekinist with dabrafenib was compared with another medicine for melanoma, vemurafenib.
Croatian: U drugom ispitivanju, kojim je bilo obuhvaćeno 704 bolesnika, kombinacija lijeka Mekinist i dabrafeniba uspoređena je s drugim lijekom za liječenje melanoma, vemurafenibom.
English: Mekinist has been studied in patients whose cancer had the BRAF V600 mutation.
Croatian: Mekinist je ispitivan u bolesnika koji boluju od raka s mutacijom BRAF V600.
English: What benefits of Mekinist have been shown in studies?
Croatian: Koje su koristi od lijeka Mekinist utvrđene u ispitivanjima?
English: Patients given the combination lived on average 25.6 months versus 18 months with vemurafenib.
Croatian: Bolesnici koji su primali kombinaciju lijekova živjeli su u prosjeku 25,6 mjeseci naspram 18 mjeseci koliko su živjeli bolesnici kojima je davan vemurafenib.
English: In one main study, 171 patients with non-small cell lung cancer received either dabrafenib combined with Mekinist or dabrafenib alone.
Croatian: U jednom glavnom ispitivanju 171 osoba oboljela od raka pluća nemalih stanica primala je ili dabrafenib u kombinaciji s lijekom Mekinist ili samo dabrafenib.
English: Patients taking Mekinist lived on average for 4.8 months before their disease getting worse, compared with 1.5 months for patients given dacarbazine or paclitaxel.
Croatian: Bolesnici koji su primali lijek Mekinist živjeli su u prosjeku 4,8 mjeseci bez pogoršanja bolesti, a oni koji su primali dakarbazin ili paklitaksel 1,5 mjeseci.
English: Mekinist is used on its own or in combination with another cancer medicine, dabrafenib;
Croatian: Mekinist se primjenjuje kao monoterapija ili u kombinaciji s dabrafenibom, drugim lijekom za liječenje raka;
English: For the full list of side effects and restrictions of Mekinist, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja za lijek Mekinist potražite u uputi o lijeku.
English: The active substance in Mekinist, trametinib, works by blocking MEK and by preventing its activation by BRAF, thereby slowing down the growth and spread of the cancer.
Croatian: Djelatna tvar u lijeku Mekinist je trametinib, a djeluje tako da inhibira protein MEK i sprječava da ga BRAF aktivira.
English: How is Mekinist used?
Croatian: Kako se Mekinist primjenjuje?
English: • advanced (stage III) melanoma after surgery for it. Mekinist is used in combination with dabrafenib;
Croatian: • uznapredovalog melanoma (faza III.) nakon kirurškog zahvata.
English: 12 hours before your operation.
Croatian: 12 sati prije operacije.
English: Stop taking the vitamin-K antagonist.
Croatian: Prestanite uzimati antagonist vitamina K.
English: Treatment continued for 6 to 14 days (median duration 7 days).
Croatian: 6 do 14 dana (medijan trajanja: 7 dana).
English: - At doses used for treatment
Croatian: Pri dozama koje se koriste za liječenje
English: Do not use this medicine if you notice {description of the visible signs of deterioration}.
Croatian: Nemojte primijeniti ovaj lijek ako primijetite {opis vidljivih znakova odstupanja u kakvoći}.
English: • Benzyl alcohol
Croatian: • Benzilni alkohol
English: Operations and Anaesthetics
Croatian: Operacije i anestetici
English: (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); and very rare (< 1/10,000) or not known (cannot be estimated from available data).
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: As benzyl alcohol may cross the placenta, it is recommended to use a formulation that does not contain benzyl alcohol.
Croatian: Budući da benzilni alkohol može proći kroz placentu, preporučuje se primjena formulacije koja ne sadrži benzilni alkohol.
English: some medicines for heart problems.
Croatian: (diuretici) i neki lijekovi za srčane tegobe
English: These medicinal products differ in their manufacturing process, molecular weights, specific anti-Xa and antiIIa activities, units, dosage and clinical efficacy and safety.
Croatian: Ti se lijekovi razlikuju prema načinu proizvodnje, molekulskoj masi, specifičnoj anti-Xa i anti-IIa aktivnosti, jedinicama, dozama te kliničkoj djelotvornosti i sigurnosti.
English: DATE OF REVISION OF THE TEXT {MM/YYYY} {DD/MM/YYYY} {DD month YYYY}
Croatian: DATUM REVIZIJE TEKSTA {MM/GGGG} {DD/MM/GGGG} {DD mjesec GGGG}
English: This reduction in the combined incidence was maintained after 30 days (from 23.3 to 19.8%; relative risk reduction of
Croatian: To sniženje kombinirane incidencije bilo je održano nakon 30 dana (s 23,3 na 19,8%; smanjenje relativnog rizika: 15%).
English: • Haemorrhage As with other anticoagulants, bleeding may occur at any site.
Croatian: • Krvarenje Kao i kod drugih antikoagulansa, krvarenje se može javiti na bilo kojem mjestu.
English: Withdraw 30 mL from the infusion bag with a syringe and discard the liquid.
Croatian: Štrcaljkom izvucite 30 ml iz infuzijske vrećice i bacite tekućinu.
English: A total of 1,102 patients were enrolled in the study, and 1073 patients were treated.
Croatian: U ispitivanje su bila uključena ukupno 1102 bolesnika, a liječeno je njih 1073.
English: Operation or periods of limited mobility due to an illness
Croatian: Kod operacije ili tijekom razdoblja smanjene pokretljivosti zbog bolesti
English: - At doses used for prophylaxis
Croatian: - Pri dozama koje se koriste za profilaksu
English: This difference persisted at three months [13.8% vs 5.5% (n=23 vs 9), p=0.01].
Croatian: Ta je razlika bila prisutna i nakon tri mjeseca (13,8% naspram 5,5% [n=23 naspram 9], p=0,01).
English: These anticoagulant activities are mediated through anti-thrombin III (ATIII) resulting in antithrombotic activities in humans.
Croatian: U tim antikoagulacijskim aktivnostima posreduje antitrombin III (ATIII), što u ljudi dovodi do antitrombotske aktivnosti.
English: It is important for you to keep having LOVENOX (and associated names) injections until your doctor decides to stop them.
Croatian: Važno je da nastavite primjenjivati injekcije lijeka LOVENOX (i pridružena imena) sve dok Vaš liječnik ne odluči da je vrijeme da prestanete.
English: The amount of LOVENOX (and associated names) given to you will depend on your age and the kind of heart attack you have had.
Croatian: Količina lijeka LOVENOX (i pridružena imena) koju ćete primiti ovisit će o Vašoj dobi i vrsti srčanog udara koji ste pretrpjeli.
English: • The maximum amount of LOVENOX (and associated names) given for the first two injections is 7,500 IU (75 mg).
Croatian: • Maksimalna doza lijeka LOVENOX (i pridružena imena) koju ćete primiti u prve dvije injekcije je 7500 IU (75 mg).
English: Do not start treatment with LOVENOX (and associated names) until 12 hours after the final dose of direct oral anticoagulant.
Croatian: Nemojte početi primjenjivati LOVENOX (i pridružena imena) dok ne prođe najmanje 12 sati od posljednje doze direktnog oralnog antikoagulansa.
English: Like other similar medicines (medicines to reduce blood clotting), LOVENOX (and associated names) may cause bleeding which may potentially be life-threatening.
Croatian: Kao i drugi slični lijekovi (lijekovi koji smanjuju nastanak krvnih ugrušaka), LOVENOX (i pridružena imena) može uzrokovati krvarenje koje može biti opasno po život.
English: If a child accidentally injects or swallows LOVENOX (and associated names), take them to a hospital causualty department straight away.
Croatian: Ako dijete slučajno injicira ili proguta LOVENOX (i pridružena imena), odmah ga odvedite na bolnički odjel hitne pomoći.
English: Other medicines and LOVENOX (and associated names) Tell your doctor or pharmacist if you are taking or might take/use any other medicines.
Croatian: Drugi lijekovi i LOVENOX (i pridružena imena) Obavijestite svog liječnika ili ljekarnika ako uzimate ili biste mogli uzeti bilo koje druge lijekove.
English: Excipient(s) with known effect: benzyl alcohol.
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom: benzilni alkohol.
English: The absolute bioavailability of enoxaparin sodium after SC injection, based on anti-Xa activity, is close to 100%.
Croatian: Apsolutna bioraspoloživost enoksaparinnatrija nakon supkutane injekcije, na temelju anti-Xa aktivnosti, iznosi gotovo 100%.
English: Other sources of information Detailed information on this medicine is available on the website of {name of MS Agency (link)}
Croatian: Ostali izvori informacija Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici {naziv nadležnog tijela države članice (poveznica)}
English: The safety and efficacy of LOVENOX (and associated names) has not been evaluated in children or adolescents.
Croatian: Sigurnost i djelotvornost lijeka LOVENOX (i pridružena imena) nije se ispitivala u djece i adolescenata.
English: It should not be mixed or coadministered with other medications.
Croatian: Ne smije se miješati ni primjenjivati istodobno s drugim lijekovima.
English: There were no significant differences in major haemorrhages, although a haemorrhage at the site of the SC injection was more frequent.
Croatian: Nije bilo značajnih razlika u velikim krvarenjima, iako je krvarenje na mjestu s.c injiciranja bilo češće.
English: Talk to your doctor or pharmacist before using LOVENOX (and associated names) if:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što primijenite LOVENOX (i pridružena imena):
English: Benzyl alcohol may also cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old (see section 4.4).
Croatian: Benzilni alkohol također može izazvati toksične reakcije i anafilaktoidne reakcije u dojenčadi i djece u dobi do 3 godine (vidjeti dio 4.4).
English: It is recommended to use the LOVENOX formulation without benzyl alcohol in pregnant women.
Croatian: U trudnica se preporučuje koristiti formulaciju lijeka LOVENOX bez benzilnog alkohola.
English: LOVENOX (and associated names) contains benzyl alcohol and must not be used in newborn and premature neonates (see section 4.3).
Croatian: LOVENOX (i pridružena imena) sadrži benzilni alkohol i ne smije se primjenjivati u novorođenčadi i nedonoščadi (vidjeti dio 4.3).
English: (numbness or weakness in lower limbs), bowel and/or bladder dysfunction.
Croatian: (utrnulost ili slabost u donjim ekstremitetima) te disfunkcija crijeva i/ili mokraćnog mjehura.
English: • If the patient is a premature or newborn baby up to 1 month because of the risk of severe toxicity including abnormal respiration (“gasping syndrome”).
Croatian: • ako je bolesnik nedonošče ili novorođenče u dobi do 1 mjeseca, jer postoji rizik od jake toksičnosti, uključujući poremećaj disanja ("sindrom dahtanja")
English: The safety and efficacy of enoxaparin sodium in paediatric population have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost enoksaparinnatrija u pedijatrijskih bolesnika nisu ustanovljene.
English: At higher doses, increases in activated partial thromboplastin time (aPTT), and activated clotting time (ACT) may occur.
Croatian: Kad se primjenjuje u većim dozama, može doći do produljenja aktiviranog parcijalnog tromboplastinskog vremena (aPTV) i aktiviranog vremena zgrušavanja (engl. activated clotting time,
English: • If you are using LOVENOX (and associated names) to treat blood clots in your body and going to receive spinal or epidural anaesthesia or lumbar puncture within 24 hours.
Croatian: • ako primjenjujete LOVENOX (i pridružena imena) za liječenje krvnih ugrušaka u tijelu, a primit ćete spinalnu ili epiduralnu anesteziju ili ići na lumbalnu punkciju unutar sljedeća 24 sata