FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that Rivastigmine Actavis is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Croatian: To znači da je Rivastigmin Actavis sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Exelon.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine Actavis on 16 June 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Rivastigmin Actavis na snazi u Europskoj uniji od 16. lipnja 2011.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rivastigmine Actavis.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke o uvjetima za primjenu lijeka Rivastigmin Actavis.
English: For more information about treatment with Rivastigmine Actavis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Rivastigmin Actavis pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Treatment should continue as long as the medicine has a benefit, but the dose can be reduced or treatment interrupted if the patient has side effects.
Croatian: Liječenje se treba nastaviti sve dok bolesnik ima koristi od lijeka, no doza se može smanjiti ili se liječenje može prekinuti ako dođe do nuspojava.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine Actavis.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Rivastigmin Actavis.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Croatian: U bolesnika s Alzheimerovom demencijom ili demencijom uzrokovanom Parkinsonovom bolešću, određene živčane stanice u mozgu odumiru, što ima za posljedicu nisku koncentraciju neurotransmitera acetilkolina (tvari koja omogućuje živčanim stanicama da međusobno komuniciraju).
English: Rivastigmine Actavis rivastigmine
Croatian: Rivastigmin Actavis rivastigmin
English: Treatment with Rivastigmine Actavis should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Croatian: Liječenje lijekom Rivastigmin Actavis treba započeti i nadzirati liječnik s iskustvom u dijagnosticiranju i liječenju Alzheimerove bolesti ili demencije kod osoba s Parkinsonovom bolešću.
English: It can also be used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Croatian: Također se može primjenjivati za liječenje blage do umjereno teške demencije u bolesnika s Parkinsonovom bolešću.
English: Rivastigmine Actavis is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Croatian: Rivastigmin Actavis koristi se za liječenje bolesnika s blagom do umjereno teškom Alzheimerovom demencijom, progresivnim poremećajem mozga koji postupno utječe na pamćenje, intelektualne sposobnosti i ponašanje.
English: The highest tolerated dose should be used to get the maximum benefit, but the dose should not exceed 6 mg twice a day.
Croatian: Da bi se postigla maksimalna korist, bolesnike treba održavati na najvišoj dozi koju dobro podnose, no doza ne smije premašiti 6 mg dva puta na dan.
English: Rivastigmine Actavis is a ‘generic medicine'.
Croatian: Rivastigmin Actavis je „generički lijek”.
English: In patients who tolerate this dose, it can be increased in 1.5 mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Croatian: U bolesnika koji dobro podnose ovu dozu, doza se može povećavati u povećanjima od 1,5 mg svaka 2 tjedna do redovne doze od 3 do 6 mg dva puta na dan.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine Actavis by the patient.
Croatian: Terapiju treba započeti samo ako je dostupan njegovatelj koji će redovito nadzirati bolesnikovo uzimanje lijeka Rivastigmin Actavis.
English: Because Rivastigmine Actavis is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je lijek Rivastigmin Actavis generički lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: By blocking these enzymes, Rivastigmine Actavis allows levels of acetylcholine to increase in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Croatian: Blokiranjem tih enzima, Rivastigmin Actavis omogućava povećavanje koncentracije acetilkolina u mozgu te tako pomaže u smanjivanju simptoma Alzheimerove demencije i demencije uzrokovane Parkinsonovom bolešću.
English: Other information about Rivastigmine Actavis
Croatian: Ostale informacije o lijeku Rivastigmin Actavis
English: The CHMP concluded that, in accordance with EU requirements, Rivastigmine Actavis has been shown to have comparable quality and to be bioequivalent to Exelon.
Croatian: CHMP je zaključio da je, u skladu sa zahtjevima EU-a, potvrđeno kako Rivastigmin Actavis posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Exelon.
English: The Committee recommended that Rivastigmine Actavis be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Rivastigmin Actavis.
English: What are the benefits and risks of Rivastigmine Actavis?
Croatian: Koje su koristi i rizici od lijeka Rivastigmina Actavis?
English: The active substance in Rivastigmine Actavis, rivastigmine, is a dementia medicine.
Croatian: Djelatna tvar Rivastigmina Actavis, rivastigmin, je lijek za demenciju.
English: Because Rivastigmine Actavis is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Croatian: Budući da je Rivastigmin Actavis generički lijek, ispitivanja na bolesnicima bila su ograničena na ispitivanja za utvrđivanje da je lijek bioekvivalentan referentnom lijeku Exelon.
English: Why has Rivastigmine Actavis been approved?
Croatian: Zašto je Rivastigmin Actavis odobren?
English: Rivastigmine Actavis is a medicine containing the active substance rivastigmine.
Croatian: Rivastigmin Actavis je lijek koji sadrži djelatnu tvar rivastigmin.
English: Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Exelon.
English: What is Rivastigmine Actavis used for?
Croatian: Za što se Rivastigmin Actavis koristi?
English: How is Rivastigmine Actavis used?
Croatian: Kako se koristi Rivastigmin Actavis?
English: What is Rivastigmine Actavis?
Croatian: Što je Rivastigmin Actavis?
English: How does Rivastigmine Actavis work?
Croatian: Kako djeluje Rivastigmin Actavis?
English: How has Rivastigmine Actavis been studied?
Croatian: Kako je Rivastigmin Actavis ispitivan?
English: Strength Pharmaceutical form
Croatian: Jačina Farmaceutski oblik Ciljna vrsta životinja
English: Withdrawal period
Croatian: 1bočica
English: The infusion should last around 4 hours.
Croatian: Infuzija treba trajati oko 4 sata.
English: The recommended dose is 2 mg per kilogram body weight, given once a week.
Croatian: Preporučena doza je 2 mg po kilogramu, jednom tjedno.
English: These are usually mild or moderate and more frequent in the first 12 weeks of treatment.
Croatian: Ove su nuspojave najčešće blage i češće se u prvih 12 tjedana liječenja.
English: This summary was last updated in 04-2014.
Croatian: Sažetak je posljednji put ažuriran: 04. 2014.
English: Patients may also be given a medicine to prevent fever.
Croatian: Bolesnici mogu također primiti lijek za sprečavanje groznice.
English: Why is Vimizim approved?
Croatian: Zašto je Vimizim odobren?
English: If the enzyme is not present, or only present in very small quantities, GAGs cannot be broken down and they build up in bones and organs.
Croatian: Ako enzimi nisu prisutni ili ako su prisutni u samo malim količinama, GAG-ovi se ne mogu razgraditi te se nakupljaju u kostima i organima.
English: What is Vimizim and what is it used for?
Croatian: Što je Vimizim i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vimizim on 28 April 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Vimizim vrijedi na prostoru Europske unije od 28. travnja 2014.
English: What measures are being taken to ensure the safe and effective use of Vimizim?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Vimizim?
English: This causes the signs of the disease, the most noticeable being short bones, difficulty moving and breathing, clouding of the eyes and hearing loss.
Croatian: Ovo uzrokuje znakove bolesti, a najočitiji znakovi su kratke kosti, poteškoće u kretanju i disanju, magljenje pred očima i gubitak sluha.
English: The company will also set up a registry to assess the long-term benefits and risks of Vimizim.
Croatian: Tvrtka je dužna također voditi registar za ocjenu dugoročnih koristi i rizika lijeka Vimizim.
English: The most common side effects with Vimizim (which may affect more than 1 in 10 people) are infusionrelated reactions, including headache, nausea (feeling sick), vomiting, fever, chills and abdominal pain (stomach ache).
Croatian: Najčešće nuspojave lijeka Vimizim (kod više od 1 na 10 osoba) su reakcije povezane s infuzijom, uključujući glavobolju, mučninu (osjećaj slabosti), povraćanje, groznicu, drhtavicu i abdominalnu bol (bol u trbuhu).
English: What are the risks associated with Vimizim?
Croatian: Koji su rizici povezani s lijekom Vimizim?
English: Serious but uncommon infusion-related reactions include anaphylaxis (severe allergic reaction).
Croatian: Ozbiljne, ali manje česte reakcije, povezane s infuzijom uključuju anafilaksu (ozbiljnu alergijsku reakciju).
English: Before treatment, the patients could walk on average just over 200 metres in six minutes.
Croatian: Prije liječenja, bolesnici su mogli hodati prosječno nešto više od 200 metara u šest minuta.
English: Enzyme replacement therapy provides patients with the enzyme they are lacking.
Croatian: Enzimska zamjenska terapija pruža bolesnicima enzim koji im nedostaje.
English: Elosulfase alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce the enzyme.
Croatian: Elosulfaza alfa proizvodi se metodom poznatom pod nazivom „tehnologija rekombinantne DNK”: proizvode ga stanice u koje je umetnut gen (DNK), što omogućuje proizvodnju enzima.
English: The replacement enzyme helps to break down GAGs and stop them building up in cells, thereby improving the symptoms of MPS IVA.
Croatian: Zamjenski enzim pomaže pri razgradnji GAG-ova i zaustavlja nakupljanje u stanicama, te stoga poboljšava simptome MPS IVA.
English: This is a summary of the European public assessment report (EPAR) for Vimizim.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Vimizim.
English: It is not intended to provide practical advice on how to use Vimizim.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Vimizim.
English: In addition, the company that makes Vimizim must ensure that all healthcare professionals expected to prescribe or use the medicine are provided with educational material, informing them of how the medicine should be used and the risk of severe allergic reactions.
Croatian: Nadalje, proizvođač lijeka Vimizim mora osigurati da svi liječnici za koje se očekuje da će propisivati ili koristiti lijek prime edukacijski materijal u kojem ih se obavještava o načinu primjene lijeka kao i riziku od teških alergijskih reakcija.
English: The CHMP concluded that, following 6 months of treatment, Vimizim was shown to be effective at improving the distance patients could walk in six minutes, and this was accompanied by other beneficial effects, including improved ability to carry out daily activities.
Croatian: CHMP je zaključio da se 6 mjeseci nakon liječenja Vimizim pokazao djelotvornim u povećanju udaljenosti koju su bolesnici mogli prehodati u šest minuta, a to je popraćeno drugim koristima, uključujući i poboljšavanje sposobnosti obavljanja svakodnevnih aktivnosti.
English: Vimizim elosulfase alfa
Croatian: Vimizim elosulfaza alfa
English: Other information about Vimizim
Croatian: Ostale informacije o lijeku Vimizim
English: Because the number of patients with MPS IVA is low, the disease is considered ‘rare', and Vimizim was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 July 2009.
Croatian: Budući da je broj bolesnika sa sindromom MPS IVA nizak, dotična se bolest smatra „rijetkom” te se Vimizim označava kao lijek za liječenje rijetkih bolesti od 24. srpnja 2009.
English: Vimizim has been investigated in one main study involving 176 patients with MPS IVA, which compared Vimizim with placebo (a dummy treatment).
Croatian: Vimizim je ispitan u jednom glavnom ispitivanju koje je obuhvatilo 176 bolesnika oboljelih od MPS IVA, u kojem je lijek Vimizim uspoređen s placebom (lažnim liječenjem).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vimizim's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučilo je da koristi od lijeka Vimizim nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: The main measure of effectiveness was the change in the distance patients could walk in six minutes after 6 months of treatment.
Croatian: Glavna mjera djelotvornosti bila je promjena u udaljenosti koju su bolesnici mogli prijeći nakon 6 mjeseci liječenja.
English: The Committee also considered that the safety profile of Vimizim appears manageable and serious side effects are uncommon, but further long-term safety data are to be collected.
Croatian: Povjerenstvo je također zaključilo da se sigurnosni profil lijeka Vimizim čini upravljivim te da su ozbiljne nuspojave neuobičajene, no treba prikupiti daljnje dugoročne podatke o sigurnoj primjeni.
English: After 6 months, patients treated with the recommended dose of Vimizim could walk an extra 37 metres on average in six minutes, compared with an increase of 14 metres in patients receiving placebo.
Croatian: Nakon 6 mjeseci, bolesnici liječeni preporučenom dozom lijeka Vimizim mogli su prijeći dodatnih 37 metara prosječno u šest minuta u usporedbi s 14 metara u bolesnika koji su primali placebo.
English: This disease is caused by the lack of an enzyme called N-acetylgalactosamine-6-sulfatase, which is needed to break down substances in the body called glycosaminoglycans (GAGs).
Croatian: Ovu bolest uzrokuje manjak enzima naziva N-acetilgalaktozamin-6-sulfataza, koji je potreban za razgradnju tvari u tijelu naziva glikozaminoglikani (GAG-ovi).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Vimizim možete naći na internetskim stranicama Agencije: : ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It is used to treat patients with mucopolysaccharidosis type IVA (MPS IVA, also known as Morquio A syndrome).
Croatian: Koristi se za liječenje bolesnika oboljelih od mukopolisaharidoze tip IV A (MPS IVA, poznat također pod nazivom Morquiov A sindrom).
English: A risk management plan has been developed to ensure that Vimizim is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Vimizim.
English: Before receiving Vimizim, the patient should be given a medicine to prevent an allergic reaction to Vimizim.
Croatian: Prije primanja lijeka Vimizim, bolesnik mora primiti lijek radi sprečavanja alergijske reakcije na Vimizim.
English: Study results also suggested that the medicine could improve how well patients breathe or climb stairs, and in children, how well they grew.
Croatian: Rezultati ispitivanja također ukazuju da bi lijek mogao poboljšati disanje u bolesnika ili sposobnost uspinjanja stepenicama, te kvalitetu razvoja u djece.
English: Vimizim is available as a concentrate to be made into a solution for infusion (drip) into a vein.
Croatian: Vimizim je dostupan kao koncentrat za pripremu otopine za infuziju (drip) u venu.
English: The full EPAR and risk management plan summary for Vimizim can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Vimizim nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What benefits of Vimizim have been shown in studies?
Croatian: Koje su koristi lijeka Vimizim dokazane u ispitivanjima?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vimizim, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Vimizim uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: The active substance in Vimizim, elosulfase alfa, is a copy of the human enzyme N-acetylgalactosamine-6-sulfatase.
Croatian: Djelatna tvar u lijeku Vimizim, elosulfaza alfa, kopija je ljudskog enzima N-acetilgalaktozamina-6-sulfataze.
English: Vimizim must not be used in patients who have experienced life-threatening allergic reactions to elosulfase alfa or any of the other ingredients in Vimizim.
Croatian: Vimizim se ne smije koristiti u bolesnika kod kojih su se manifestirale po život opasne alergijske reakcije na elosulfazu alfa ili na bilo koju drugu pomoćnu tvar lijeka Vimizim.
English: Treatment with Vimizim should be supervised by a doctor experienced in MPS IVA or similar diseases.
Croatian: Liječenje lijekom Vimizim mora nadzirati liječnik iskusan u liječenju bolesnika sa sindromom MPS IVA ili drugim sličnim bolestima.
English: For more information about treatment with Vimizim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Vimizim pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: How does Vimizim work?
Croatian: Kako djeluje Vimizim?
English: Vimizim is a medicine that contains the active substance elosulfase alfa.
Croatian: Vimizim je lijek koji sadrži djelatnu tvar elosulfaza alfa.
English: The medicine can only be obtained with a prescription and should be given by an appropriately trained healthcare professional.
Croatian: Ovaj se lijek izdaje samo na liječnički recept te ga mora davati zdravstveni djelatnik odgovarajuće educiran za zbrinjavanje hitnih stanja.
English: Vimizim is an enzyme replacement therapy.
Croatian: Vimizim je enzimska zamjenska terapija.
English: For practical information about using Vimizim, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Vimizim pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: For the full list of all side effects reported with Vimizim, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vimizim potražite u uputi o lijeku.
English: ATCvet code: QP53BX03.
Croatian: ATCvet kod: QP53BX03.
English: There is no antidote available.
Croatian: Nema dostupnog protuotrova.
English: Plasma protein binding is high (~99%).
Croatian: Vezanje proteina plazme je visoko (~99%).
English: Bioavailability was shown to be approximately 70%.
Croatian: Dokazana bioraspoloživost je oko 70%.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11/02/2011.
Croatian: Datum prvog odobrenja: 11/02/2011.
English: The recommended dosage regimen should be followed (see section 4.10 for information regarding overdose).
Croatian: Potrebno je slijediti preporučeni režim doziranja (vidi u odjeljku 4.10 za informacije u vezi predoziranja).
English: Administer with food.
Croatian: Primijeniti uz hranu.
English: Seek veterinary advice regarding information on the optimal time to start treatment with this product.
Croatian: Potražite savjet veterinara u vezi s informacijama o optimalnom vremenu za početak liječenja ovim proizvodom.
English: Do not use in dogs or cats under 14 weeks of age.
Croatian: Ne primjenjivati na psima i mačkama ispod 14 tjedana starosti.
English: Children should not come into contact with the veterinary medicinal product.
Croatian: Djeca ne smiju doći u kontakt s veterinarsko-medicinskim proizvodom.
English: Use with caution in dogs and cats with pre-existing epilepsy.
Croatian: Primjenjujte s oprezom na psima i mačkama s postojećom epilepsijom.
English: The recommended dosage regimen should be followed.
Croatian: Potrebno je slijediti preporučeni režim doziranja.
English: However there was no evidence in the clinical observations and clinical chemistry parameters that indicated any loss in organ function.
Croatian: Međutim nema dokaza u kliničkim promatranjima i kliničkim kemijskim parametrima koji bi ukazivali na bilo kakav gubitak funkcije organa.
English: All dogs and cats within the household should be treated.
Croatian: Svi psi i mačke u kućanstvu moraju biti tretirani.
English: The veterinary medicinal product should be administered with food or immediately after feeding.
Croatian: Veterinarsko-medicinski proizvod mora se primijeniti s hranom ili neposredno nakon hranjenja.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH
English: Furthermore, a reduction of food intake was observed in females, however a significant reduction in their bodyweight was not observed.
Croatian: Nadalje, smanjenje uzimanja hrane primijećeno je kod ženki, međutim nije primijećeno značajno smanjenje njihove tjelesne težine.
English: Regular monthly treatments with Comfortis break the fleas' life cycle and may be needed to control the flea population in contaminated households.
Croatian: Redovno mjesečno tretiranje Comfortisom prekida životni ciklus buha i može biti potrebno radi kontrole populacije buha u kontaminiranim kućanstvima.
English: Spinosad has been shown to be a substrate for P-glycoprotein (PgP).
Croatian: Spinosad se pokazao kao supstrat za P-glikoprotein (PgP).
English: In pregnant dogs (bitches), the safety of spinosad has not been sufficiently established.
Croatian: Kod gravidnih pasa (kuja), neškodljivost spinosada nije dovoljno ustanovljena.
English: If fleas reappear in the fourth week, the treatment interval can be shortened by up to 3 days in dogs.
Croatian: Ako se buhe pojave u četvrtom tjednu, interval liječenja može se skratiti do 3 dana kod pasa.
English: In very rare cases, blindness, impaired vision and other eye disorders were observed.
Croatian: Vrlo rijetko zabilježeni su slučajevi sljepoće, slabijeg vida i ostali poremećaja oka.