FrancophonIA/ELRC3.0 huggingface dataset:
English: Nicorandil is a vasodilator agent with a dual mechanism of action, which leads to relaxation of smooth tonic vascular muscles in both venous and arterial part of vessels.
Croatian: Nikorandil je vazodilatatorsko sredstvo s dualnim mehanizmom djelovanja, koje rezultira opuštanjem glatkih toničnih vaskularnih mišića u venskom i arterijskom dijelu krvnih žila.
English: The final PL wording was agreed by the CHMP.
Croatian: To je potvrdio CHMP.
English: In the meantime, it is acknowledged by the CHMP that in the context of ulceration, early diagnosis of ulcerations and nicorandil withdrawal appear to be the most adequate measure leading to healing and prompt recovering.
Croatian: U međuvremenu, CHMP je potvrdio da se u kontekstu ulceracije, rana dijagnoza ulceracija i prestanak primjene nikorandila čine najprimjerenijim mjerama koje dovode do ozdravljenja i brzog oporavka.
English: Taking the above into account the CHMP was of the view that for the treatment of symptomatic stable angina, nicorandil should be considered in second line.
Croatian: Uzimajući u obzir prethodno navedeno, CHMP je bio mišljenja da se liječenje simptomatične stabilne angine nikorandilom treba razmotriti kao druga linija: Predloženu indikaciju treba revidirati kako slijedi:
English: One study performed by Meany and colleagues8 (1989) on 46 patients, compared nicorandil 10 mg b.i.d.
Croatian: U jednom ispitivanju koje su proveli Meany i suradnici8 (1989.) na 46 bolesnika nikorandil u dozi od 10 mg b.i.d. i 20 mg b.i.d. uspoređen je s placebom.
English: Overall summary of the scientific evaluation of Ikorel and associated names, and Dancor and associated names (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene lijeka Ikorel i povezanih naziva, te lijeka Dancor i povezanih naziva
English: Ulvenstam G, Diderholm E, Frithz G, et al. Antianginal and anti-ischemic efficacy of nicorandil compared with nifedipine in patients with angina pectoris and coronary heart disease: a double-blind, randomized, multicenter study.
Croatian: Antianginal and anti-ischemic efficacy of nicorandil compared with nifedipine in patients with angina pectoris and coronary heart disease: a double-blind, randomized, multicenter study.
English: Meeter K, Kelder JC, Tijssen JG, et al. Efficacy of nicorandil versus propranolol in mild stable angina pectoris of effort: a long-term, double-blind, randomized study.
Croatian: Efficacy of nicorandil versus propranolol in mild stable angina pectoris of effort: a long-term, double-blind, randomized study.
English: Section 4.4 - Special warnings and precautions for use Initially lack of glucose-6-phosphate-dehydrogenase was added as contraindication.
Croatian: Početni manjak glukoze-6-fosfata-dehidrogenaze dodan je kao kontraindikacija.
English: the CHMP was of the opinion that the benefit/risk ratio of Ikorel and associated names and Dancor and associated names is considered to be favourable.
Croatian: CHMP je smatrao da se omjer koristi i rizika lijeka Ikorel i povezanih naziva te lijeka Dankor i povezanih naziva može smatrati pozitivnim.
English: increases the risk of ulceration, and does not guarantee a safe use for a symptomatic treatment.
Croatian: Zaključno, čini se da doza od 20 mg b.i.d. povećava rizik od ulceracije, a ne jamči sigurnu primjenu za simptomatično liječenje.
English: failed to show any objective improvement in exercise performance as compared to placebo.
Croatian: Pet (5) mg nikorandila b.i.d. nije pokazalo nikakvo objektivno poboljšanje u performansama djelovanja u usporedbi s placebom.
English: This results in an increased pooling in capacitance vessels with a decrease in preload.
Croatian: To rezultira povišenim povlačenjem u vene uz smanjenje preopterećenja.
English: In the context of ulceration, early diagnosis of ulcerations and nicorandil withdrawal appear to be the most adequate measure leading to healing and prompt recovering.
Croatian: U kontekstu ulceracije, čini se da je rana dijagnoza ulceracija i prekid primjene nikorandila najčešća mjera koja rezultira zacjeljivanjem i brzim oporavkom.
English: Thus, the endpoints were analysed for the 20 mg b.i.d.
Croatian: Većina ispitivanja provedena je primjenom 10 mg b.i.d. te zatim 20 mg b.i.d. Stoga, analizirane su završne točke za doziranje 20 mg b.i.d.
English: 3 Guermonprez JL, Blin P, Peterlongo F. A double-blind comparison of the long-term efficacy of a potassium channel opener and a calcium antagonist in stable angina pectoris.
Croatian: A double-blind comparison of the long-term efficacy of a potassium channel opener and a calcium antagonist in stable angina pectoris.
English: Nicorandil is a vasodilator agent used to treat angina.
Croatian: Nikorandil je vazodilatacijsko sredstvo koje se koristi za liječenje angine.
English: Lancet 2002;359: 1269-1275
Croatian: Lancet 2002;359: 1269-1275 Nishimura M, Tokoro T, Nishida M, et al.
English: Section 4.1 - Therapeutic indications i. Angina pectoris
Croatian: Odjeljak 4.1 - Terapijske indikacije i.
English: Five (5) mg nicorandil b.i.d.
Croatian: 3 Guermonprez JL, Blin P, Peterlongo F.
English: Package Leaflet
Croatian: Označivanje
English: Nishimura M, Tokoro T, Nishida M, et al.
Croatian: Ulvenstam G, Diderholm E, Frithz G, et al.
English: in increasing time to onset of angina and in reducing time to 1-mm ST depression.
Croatian: U tom ispitivanju nikorandil 10 mg b.i.d. bio je podjednako djelotvoran kao i 20 mg b.i.d. u povećavanju vremena do nastupanja angine te u smanjivanju vremena do depresije 1-mm ST.
English: dose was
Croatian: Case Rep.
English: class III and IV).
Croatian: (vidi Prilog I.)
English: Further information on Neulasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Neulasta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Pain in muscles is also common.
Croatian: Bol u mišićima također je česta.
English: This overview was last updated in 08-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u 08. 2018.
English: This compares with around five to seven days when no stimulating factor is used.
Croatian: Ovo se uspoređuje s pet do sedam dana bez primjene faktora rasta.
English: What measures are being taken to ensure the safe and effective use of Neulasta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Neulasta?
English: What is Neulasta and what is it used for?
Croatian: Što je Neulasta i za što se primjenjuje?
English: Neulasta received a marketing authorisation valid throughout the EU on 22 August 2002.
Croatian: Lijek Neulasta dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 22. kolovoza 2002.
English: Other information about Neulasta
Croatian: Ostale informacije o lijeku Neulasta
English: The most common side effect with Neulasta (which may affect more than 1 in 10 people) is pain in the bones.
Croatian: Najčešća nuspojava lijeka Neulasta (koja se može javiti u više od 1 na 10 osoba) jest bol u kostima.
English: An overview of Neulasta and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Neulasta i zašto je odobren u EU-u
English: In both studies, the patients had severe neutropenia for around 1.7 days during their first chemotherapy cycle.
Croatian: U oba ispitivanja, pacijenti su imali tešku neutropeniju tijekom otprilike 1,7 dana tijekom njihova prvog kemoterapijskog ciklusa.
English: Side effects reported with Neulasta are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Neulasta pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Neulasta?
Croatian: Koji su rizici povezani s lijekom Neulasta?
English: Why has Neulasta been approved?
Croatian: Zašto je lijek Neulasta odobren?
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (neutropenia accompanied by fever).
Croatian: Posebno se daje za skraćivanje trajanja neutropenije i sprječavanje febrilne neutropenije (neutropenije popraćene vrućicom).
English: As for all medicines, data on the use of Neulasta are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Neulasta kontinuirano se prate.
English: Neulasta has been studied in two main studies involving 467 patients with breast cancer who were being treated with chemotherapy.
Croatian: Lijek Neulasta ispitivan je u dvama glavnim ispitivanjima u kojima je sudjelovalo 467 bolesnika s rakom dojke koji su bili liječeni kemoterapijom.
English: Neulasta is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Croatian: Neulasta se daje kao pojedinačna doza od 6 mg koja se ubrizgava ispod kože najmanje 24 sata nakon kraja svakog ciklusa kemoterapije (terapije protiv raka).
English: The company that markets Neulasta will ensure that patients or carers using the medicine are provided with an alert card explaining how to use the injection device that delivers the medicine.
Croatian: Tvrtka koja stavlja lijek Neulasta u promet osigurat će da bolesnici ili njegovatelji koji primjenjuju lijek dobiju karticu sa upozorenjima na kojoj je objašnjeno kako se koristi pribor za primjenu lijeka injekcijom.
English: The European Medicines Agency decided that Neulasta's benefits 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 Neulasta nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Neulasta can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Croatian: Lijek Neulasta izdaje se samo na liječnički recept, a terapiju mora započeti i pratiti liječnik s iskustvom u liječenju raka ili poremećaja krvi.
English: Neulasta was as effective as filgrastim in reducing the duration of severe neutropenia.
Croatian: Lijek Neulasta bio je jednako učinkovit kao i filgrastim kod smanjenja trajanja teške neutropenije.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Neulasta 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 Neulasta nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: In both studies, the effectiveness of a single injection of Neulasta was compared with multiple daily injections of filgrastim during each of four chemotherapy cycles.
Croatian: U oba ispitivanja, učinkovitost jedne injekcije lijeka Neulasta uspoređena je s višekratnim dnevnim injekcijama filgrastima tijekom svakog kemoterapijskog ciklusa.
English: The main measure of effectiveness was the duration of severe neutropenia during the first cycle of chemotherapy.
Croatian: Glavna mjera djelotvornosti bilo je trajanje teške neutropenije tijekom prvog kemoterapijskog ciklusa.
English: For more information about using Neulasta, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Neulasta pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Neulasta is effective at reducing the duration of severe neutropenia during chemotherapy and its side effects were considered manageable.
Croatian: Lijek Neulasta učinkovit je kod smanjenja trajanja teške neutropenije tijekom kemoterapije, a njegove nuspojave smatrale su se upravljivima.
English: Neulasta is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Croatian: Lijek Neulasta nije namijenjen za korištenje u bolesnika s rakom krvi, kroničnom mijeloidnom leukemijom i mijelodisplastičnim sindromima (stanjima kod kojih se stvara veliki broj abnormalnih krvnih stanica, koja se mogu razviti u leukemiju).
English: What benefits of Neulasta have been shown in studies?
Croatian: Koje su koristi od lijeka Neulasta utvrđene u ispitivanjima?
English: The active substance in Neulasta, pegfilgrastim, consists of filgrastim, which is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Croatian: Djelatna tvar u lijeku Neulasta, pegfilgrastim, sastoji se od filgrastima, koji je vrlo sličan ljudskoj bjelančevini naziva faktor stimulacije rasta granulocita (G-CSF).
English: In Neulasta, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Croatian: U lijeku Neulasta filgrastim je „pegiliran” (konjugiran s kemijskom tvari koja se naziva polietilenglikol).
English: How does Neulasta work?
Croatian: Kako djeluje Neulasta?
English: Neulasta is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Croatian: Neulasta je lijek koji se primjenjuje u bolesnika oboljelih od raka radi ublaživanja neutropenije (niskih razina neutrofila, vrste bijelih krvnih stanica), koja je česta nuspojava liječenja raka i koja može dovesti do osjetljivosti bolesnika na infekcije.
English: For the full list of side effects and restrictions with Neulasta, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka
English: How is Neulasta used?
Croatian: Kako se Neulasta primjenjuje?
English: • Difficulty in sleeping
Croatian: • Teškoće sa spavanjem
English: If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
Croatian: Ako osjećate omaglicu ili pospanost, nemojte upravljati vozilima i strojevima niti izvoditi bilo kakve zadatke koji zahtijevaju pozornost.
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su prema sljedećim pravilima: vrlo često (≥1/10); često (≥1/100 do <1/10); manje često (≥1/1000 do <1/100); rijetko (≥1/10 000 do <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Date of latest renewal: 15 February 2016
Croatian: Datum posljednje obnove odobrenja: 15. veljače 2016.
English: • if you have a low body weight.
Croatian: • ako imate malu tjelesnu težinu.
English: If you have not taken Rivastigmine Actavis for more than three days, do not take the next dose until you have talked to your doctor.
Croatian: Ako niste uzeli Rivastigmin Actavis više od tri dana, nemojte uzimati sljedeću dozu dok se niste posavjetovali sa svojim liječnikom.
English: • if you are allergic to rivastigmine or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na rivastigmin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: If you find you have forgotten to take your dose of Rivastigmine Actavis, wait and take the next dose at the usual time.
Croatian: Ako primijetite da ste zaboravili uzeti svoju dozu Rivastigmina Actavis, pričekajte i uzmite iduću dozu u uobičajeno vrijeme.
English: 4879 AC Etten-Leur The Netherlands
Croatian: 4879 AC Etten-Leur Nizozemska
English: Your doctor will tell you what dose of Rivastigmine Actavis to take.
Croatian: Liječnik će Vam reći koju dozu Rivastigmina Actavis trebate uzimati.
English: In vitro, this metabolite shows minimal inhibition of acetylcholinesterase (<10 %).
Croatian: In vitro, taj metabolit pokazuje minimalnu inhibiciju acetilkolinesteraze (<10 %).
English: What Rivastigmine Actavis is and what it is used for
Croatian: Što je Rivastigmin Actavis i za što se koristi
English: How to store Rivastigmine Actavis Contents of the pack and other information
Croatian: Kako čuvati Rivastigmin Actavis Sadržaj pakiranja i druge informacije
English: Absolute bioavailability after a 3 mg dose is about 36 %±13 %.
Croatian: Apsolutna bioraspoloživost nakon doze od 3 mg iznosi oko 36 %±13 %.
English: Talk to your doctor before taking Rivastigmine Actavis:
Croatian: Obratite se svom liječniku prije nego uzmete Rivastigmin Actavis:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičnih izvješća o neškodljivosti za ovaj lijek navedeni su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107c stavkom 7 Direktive 2001/83 / EZ i svaka naknadna izmjena objavljuje se na europskom internetskom portalu za lijekove.
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Croatian: Rivastigmin se ne smije koristiti za vrijeme trudnoće, osim u slučaju jasne potrebe.
English: C-rivastigmine, renal elimination was rapid and essentially complete (>90 %) within 24 hours.
Croatian: C, eliminacija putem bubrega bila je brza i u osnovi potpuna (>90 %) unutar 24 sata.
English: If this applies to you, tell your doctor and do not take Rivastigmine Actavis.
Croatian: Ako se ovo odnosi na Vas, obratite se svom liječniku i nemojte uzimati Rivastigmin Actavis.
English: Less than 1 % of the administered dose is excreted in the faeces.
Croatian: Manje od 1 % primijenjene doze izlučuje se u stolici.
English: The capsules are packed in blisters available in three different pack sizes (28, 56 and 112 capsules) and capsule containers of 250 capsules, but these may not all be available in your country.
Croatian: Kapsule su pakirane u blistere dostupne u tri različite veličine pakiranja (28, 56 i 112 kapsula) i spremnike s kapsulama koji sadrže 250 kapsula, no moguće je da sva pakiranja nisu dostupna na tržištu.
English: However, rivastigmine may be used in this patient population and close monitoring is necessary.
Croatian: Međutim, rivastigmin se može koristiti u ovoj populaciji bolesnika te je nužno pažljivo praćenje.
English: Hard capsule (Capsule).
Croatian: Tvrda kapsula (kapsula).
English: Patients with mild dementia dementia (MMSE 10-17)
Croatian: Bolesnici s umjerenom demencijom (MMSE 10-17)
English: The most commonly reported adverse reactions (ADRs) are gastrointestinal, including nausea (38 %) and vomiting (23 %), especially during titration.
Croatian: Najčešće zabilježene nuspojave su one gastrointestinalne, uključujući mučninu (38 %) i povraćanje (23 %), osobito tijekom titracije.
English: As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Croatian: Posljedično tome, rivastigmin ima mali ili umjereni utjecaj na sposobnost vožnje i rada sa strojevima.
English: Administration of rivastigmine with food delays absorption (tmax) by 90 min and lowers Cmax and increases AUC by approximately 30 %.
Croatian: Primjena rivastigmina s hranom odgađa apsorpciju (tmax) za 90 minuta te snižava Cmax i povećava AUC za otprilike 30 %.
English: Hypersensitivity to the active substance, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, druge derivate karbamata ili na neku od pomoćnih tvari navedenih u dijelu 6.1.
English: What you need to know before you take Rivastigmine Actavis
Croatian: Što morate znati prije nego počnete uzimati Rivastigmin Actavis
English: Protein binding of rivastigmine is approximately 40 %.
Croatian: Rivastigmin se veže na proteine plazme približno 40 %.
English: In healthy young men, an oral 3 mg dose decreases acetylcholinesterase (AChE) activity in CSF by approximately 40 % within the first 1.5 hours after administration.
Croatian: U zdravih, mladih muškaraca, oralna doza od 3 mg smanjuje aktivnost acetilkolinesteraze (AChE) u cerebrospinalnoj tekućini za približno 40 % unutar prvih 1,5 sati nakon primjene.
English: Uncommon (may affect up to 1 in 100 people) • Uneven heartbeat and poor control of movements
Croatian: Manje često (mogu se javiti u do 1 na 100 ljudi) • Nepravilni otkucaji srca i slaba kontrola pokreta
English: An initial dose of 0.03 mg/kg intravenous atropine sulfate is recommended, with subsequent doses based on clinical response.
Croatian: Preporučuje se početna doza od 0,03 mg/kg atropin sulfata intravenski, a ostale doze ovise o kliničkom odgovoru.
English: Other medicines and Rivastigmine Actavis
Croatian: Drugi lijekovi i Rivastigmin Actavis
English: Allergic dermatitis (disseminated)
Croatian: Alergijski dermatitis (diseminirani)
English: • if you suffer from trembling.
Croatian: • ako imate drhtavicu.
English: Restlessness Hallucination, visual Depression
Croatian: Halucinacije, vidne Depresija
English: If adverse reactions persist, the daily dose should be temporarily reduced to the previous welltolerated dose or the treatment may be discontinued.
Croatian: Ako nuspojave i dalje traju, dnevnu dozu treba privremeno smanjiti na prethodnu dozu koju je bolesnik dobro podnosio ili se liječenje može prekinuti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with rivastigmine in all subsets of the paediatric population in the treatment of Alzheimer's dementia and in the treatment of dementia in patients with idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja rivastigmina u svim podskupinama pedijatrijske populacije u liječenju Alzheimerove demencije te u liječenju demencije u bolesnika s idiopatskom Parkinsonovom bolešću (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: - Capsule containers (HDPE) with LDPE caps: 250 hard capsules.
Croatian: - Spremnici (HDPE) s kapsulama s LDPE zatvaračima: 250 tvrdih kapsula.
English: • Bleeding in the gut - shows as blood in stools or when being sick
Croatian: • Krvarenje u crijevima - prikazuje se kao krv u stolici ili kada povraćate
English: Alzheimer's disease may cause gradual impairment of driving performance or compromise the ability to use machinery.
Croatian: Alzheimerova bolest može postupno smanjiti sposobnost upravljanja vozilima ili narušiti sposobnost rada sa strojevima.
English: What Rivastigmine Actavis is and what it is used for What you need to know before you take Rivastigmine Actavis How to take Rivastigmine Actavis Possible side effects
Croatian: Što je Rivastigmin Actavis i za što se koristi Što morate znati prije nego počnete uzimati Rivastigmin Actavis Kako uzimati Rivastigmin Actavis Moguće nuspojave
English: If you get any of these side effects, contact your doctor as you may need medical assistance.
Croatian: Ako se pojavi bilo koja od ovih nuspojava, obratite se svom liječniku jer možda trebate medicinsku pomoć.
English: Keep out of sight and reach of children.
Croatian: Čuvati izvan pogleda i dohvata djece.
English: Patients with severe hepatic impairment have not been studied, however, Rivastigmine Actavis capsules may be used in this patient population provided close monitoring is exercised (see section 4.4 and 5.2).
Croatian: Nisu proučavani bolesnici s teškim oštećenjem jetre, međutim, Rivastigmin Actavis kapsule mogu se primjenjivati u ovoj bolesničkoj populaciji pod uvjetom da se provodi pažljivo praćenje (vidjeti dijelove 4.4 i 5.2).
English: If you forget to take Rivastigmine Actavis
Croatian: Ako ste zaboravili uzeti Rivastigmin Actavis