FrancophonIA/ELRC3.0 huggingface dataset:
English: 7 × 30 mg tablets and 7 × 90 mg tablets in card packaging 14 × 30 mg tablets and 14 × 90 mg tablets in card packaging 28 × 30 mg tablets and 28 × 90 mg tablets in card packaging
Croatian: 7 × 30 mg tableta i 7 × 90 mg tableta u kartonskom pakiranju 14 × 30 mg tableta i 14 × 90 mg tableta u kartonskom pakiranju 28 × 30 mg tableta i 28 × 90 mg tableta u kartonskom pakiranju
English: 7 × 30 mg tablets and 7 × 60 mg tablets in card packaging 14 × 30 mg tablets and 14 × 60 mg tablets in card packaging 28 × 30 mg tablets and 28 × 60 mg tablets in card packaging
Croatian: 7 × 30 mg tableta i 7 × 60 mg tableta u kartonskom pakiranju 14 × 30 mg tableta i 14 × 60 mg tableta u kartonskom pakiranju 28 × 30 mg tableta i 28 × 60 mg tableta u kartonskom pakiranju
English: EU/1/15/1000/005 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablets (28 × 15 mg + 28 × 45 mg)
Croatian: EU/1/15/1000/005 14 tableta (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tableta (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tableta (28 × 15 mg + 28 × 45 mg)
English: Jinarc 15 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Croatian: 7 ili 28 tableta u blisteru (PVC/aluminijska folija)
English: Each Jinarc 45 mg tablet contains 45 mg tolvaptan.
Croatian: Svaka tableta Jinarca od 45 mg sadrži 45 mg tolvaptana.
English: EU/1/15/1000/014 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablets (28 × 15 mg + 28 × 45 mg)
Croatian: EU/1/15/1000/014 14 tableta (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tableta (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tableta (28 × 15 mg + 28 × 45 mg)
English: Mon. Tue.
Croatian: • umor.
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets
Croatian: 14 tableta u 1 blisteru (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 15 mg i 7 × 45 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 15 mg i 7 × 45 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 15 mg i 7 × 45 mg tableta
English: 30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Croatian: Tableta od 30 mg: plava, okrugla (promjer: 8 mm), blago konveksna, s utisnutim „OTSUKA“ i „30“ na jednoj strani.
English: • fatigue
Croatian: • svrbež
English: EU/1/15/1000/008 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablets (28 × 30 mg + 28 × 60 mg)
Croatian: EU/1/15/1000/008 14 tableta (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tableta (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tableta (28 × 30 mg + 28 × 60 mg)
English: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
Croatian: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V.
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Croatian: Tél/Tel: +31 (0) 20 85 46 555
English: reduction in reciprocal serum creatinine during treatment [from end of titration to last on medicinal product visit])
Croatian: smanjenje recipročne vrijednosti serumskog kreatinina za 25 % tijekom liječenja [od završetka titracije do posljednjeg posjeta za vrijeme liječenja]) 2) medicinski značajna bubrežna bol (definirana kao traženje bolovanja, primjena analgetika posljednje linije, narkotika te antinociceptivnih, radioloških ili kirurških intervencija) 3) pogoršanje hipertenzije
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets
Croatian: 14 tableta u 1 blisteru (PVC/aluminijska folija) sa 7 × 15 mg i 7 × 45 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) sa 7 × 15 mg i 7 × 45 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) sa 7 × 15 mg i 7 × 45 mg tableta
English: Jinarc 45 mg tablets + Jinarc 15 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Croatian: + Jinarc 15 mg tablete: blisteri s kartonskim ovitkom ili bez njega sa 14 (7 jačih tableta + 7 slabijih tableta),
English: Otsuka Pharmaceutical Netherlands B.V. Teл: +31 (0) 20 85 46 555
Croatian: Teл: +31 (0) 20 85 46 555
English: Jinarc 90 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Croatian: + Jinarc 30 mg tablete: blisteri s kartonskim ovitkom ili bez njega sa 14 (7 jačih tableta + 7 slabijih tableta),
English: EU/1/15/1000/020 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablets (28 × 30 mg + 28 × 90 mg)
Croatian: EU/1/15/1000/020 14 tableta (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tableta (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tableta (28 × 30 mg + 28 × 90 mg)
English: EU/1/15/1000/011 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablets (28 × 30 mg + 28 × 90 mg)
Croatian: EU/1/15/1000/011 14 tableta (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tableta (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tableta (28 × 30 mg + 28 × 90 mg)
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets
Croatian: 14 tableta u 1 blisteru (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 60 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 60 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 60 mg tableta
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets
Croatian: 14 tableta u 1 blisteru (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 90 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 90 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) u kartonskom ovitku sa 7 × 30 mg i 7 × 90 mg tableta
English: EU/1/15/1000/017 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablets (28 × 30 mg + 28 × 60 mg)
Croatian: EU/1/15/1000/017 14 tableta (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tableta (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tableta (28 × 30 mg + 28 × 60 mg)
English: Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Svaka tableta od 15 mg sadrži približno 35 mg laktoze (u obliku hidrata).
English: Decreased uric acid clearance by the kidney is a known effect of tolvaptan.
Croatian: Poznat učinak tolvaptana je smanjeni klirens mokraćne kiseline putem bubrega.
English: • nausea
Croatian: • umor
English: Asthenia
Croatian: Doziranje
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets
Croatian: 14 tableta u 1 blisteru (PVC/aluminijska folija) sa 7 × 30 mg i 7 × 90 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) sa 7 × 30 mg i 7 × 90 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) sa 7 × 30 mg i 7 × 90 mg tableta
English: Otsuka Pharmaceutical Netherlands B.V. Thλ: +31 (0) 20 85 46 555
Croatian: Thλ: +31 (0) 20 85 46 555
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets
Croatian: 14 tableta u 1 blisteru (PVC/aluminijska folija) sa 7 × 30 mg i 7 × 60 mg tableta 28 tableta u 2 blistera (PVC/aluminijska folija) sa 7 × 30 mg i 7 × 60 mg tableta 56 tableta u 4 blistera (PVC/aluminijska folija) sa 7 × 30 mg i 7 × 60 mg tableta
English: Tel: +39 02 00 63 27 10
Croatian: Otsuka Pharmaceutical Italy S.r.l. Tel: +39 02 00 63 27 10
English: • heartburn
Croatian: • proljev
English: • The Summary of product Characteristics
Croatian: • Sažetak opisa svojstava lijeka
English: WALLET CARD
Croatian: VANJSKA KUTIJA
English: Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Croatian: Pomoćna(e) tvar(i) s poznatim učinkom Svaka tableta od 30 mg sadrži približno 70 mg laktoze (u obliku hidrata).
English: Name
Croatian: (Zaštićeno) ime
English: Strength Pharmaceutical Form Route of Administration Packaging
Croatian: Farmaceutski oblik Put primjene
English: EMEA Number
Croatian: EMA broj postupka
English: Package size
Croatian: Unutarnje pakovanje Veličina pakovanja
English: This summary was last updated in 07-2017.
Croatian: Ovaj sažetak posljednji je put ažuriran u 07.2017.
English: The full EPAR for Clopidogrel TAD can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Clopidogrel TAD nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The standard dose is one 75-mg tablet once a day.
Croatian: Standardna je doza jedna tableta od 75 mg jedanput na dan.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Croatian: Nakon toga slijedi standardna doza od 75 mg jedanput na dan tijekom najmanje četiri tjedna (u slučaju infarkta miokarda s „elevacijom ST-segmenta”) ili do 12 mjeseci (u slučaju nestabilne angine ili „non-Q” infarkta miokarda).
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna ako proizvode jednake razine djelatne tvari u tijelu.
English: This means that Clopidogrel TAD is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Croatian: To znači da je Clopidogrel TAD sličan „referentnom lijeku” koji je već odobren u Europskoj uniji (EU) pod nazivom Plavix.
English: clopidogrel
Croatian: klopidogrel
English: • recently had a myocardial infarction (heart attack).
Croatian: • su nedavno pretrpjele infarkt miokarda (srčani udar).
English: This means that it helps to prevent blood clots from forming.
Croatian: To znači da pomaže u sprečavanju stvaranja krvnih ugrušaka.
English: In acute coronary syndrome and atrial fibrillation, Clopidogrel TAD is used together with aspirin, the dose of which should not be higher than 100 mg.
Croatian: U slučaju akutnog koronarnog sindroma i fibrilacije atrija, Clopidogrel TAD koristi se zajedno s aspirinom, čija doza ne smije biti viša od 100 mg.
English: In acute coronary syndrome, treatment generally starts with a loading dose of four tablets.
Croatian: U slučaju akutnog koronarnog sindroma, terapija načelno započinje početnom dozom od četiri tablete.
English: • atrial fibrillation (irregular rapid contractions of the upper chambers of the heart), when it should be given with aspirin.
Croatian: • imaju fibrilaciju atrija (nepravilne brze kontrakcije gornjih komora srca), pri čemu se treba davati s aspirinom.
English: Acute coronary syndrome is a group of heart problems that include heart attacks and unstable angina (a severe type of chest pain).
Croatian: Akutni koronarni sindrom je skupina srčanih problema koja uključuje srčane udare i nestabilnu anginu (snažna bol u prsima).
English: Clopidogrel TAD is available as tablets containing 75 mg clopidogrel.
Croatian: Clopidogrel TAD dostupan je kao tablete koje sadrže 75 mg klopidogrela.
English: Clopidogrel TAD can be started between seven days and six months after the stroke;
Croatian: Terapija lijekom Clopidogrel TAD može započeti od sedam dana do šest mjeseci nakon udara;
English: What is Clopidogrel TAD and what is it used for?
Croatian: Što je Clopidogrel TAD i za što se koristi?
English: • peripheral arterial disease (problems with blood flow in the arteries);
Croatian: • boluju od bolesti perifernih arterija (problemi s protokom krvi u arterijama);
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel TAD.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Clopidogrel TAD.
English: What measures are being taken to ensure the safe and effective use of Clopidogrel TAD?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Clopidogrel TAD?
English: Clopidogrel TAD is a medicine used to prevent problems caused by blood clots in adults who have:
Croatian: Clopidogrel TAD koristi se za sprječavanje problema uzrokovanih stvaranjem krvnih ugrušaka u odraslih osoba koje:
English: • recently had an ischaemic stroke (stroke caused by failure of the blood supply to part of the brain).
Croatian: • su nedavno pretrpjele ishemijski moždani udar (moždani udar uzrokovan nedovoljnom opskrbom krvi u nekom dijelu mozga).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel TAD 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 Clopidogrel TAD nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is used in those patients who have at least one risk factor for vascular events such as a heart attack or stroke, cannot take vitamin K antagonists (other medicines that prevent blood clots) and are at low risk of bleeding.
Croatian: Koristi se u bolesnika s najmanje jednim faktorom rizika za krvožilne poremećaje, poput srčanog ili moždanog udara, koji ne mogu uzimati antagoniste vitamina K (drugi lijekovi koji sprečavaju krvne ugruške) i koji su izloženi niskom riziku od krvarenja.
English: Clopidogrel TAD can be started between a few days and 35 days after the attack;
Croatian: Terapija lijekom Clopidogrel HCS može se započeti od nekoliko dana do 35 dana nakon infarkta;
English: Clopidogrel stops the platelets aggregating by blocking a substance called ADP from attaching to a special receptor on their surface.
Croatian: Clopidogrel sprečava nakupljanje trombocita tako što onemogućuje da se tvar koja se naziva ADP veže za poseban receptor na njihovoj površini.
English: Clopidogrel TAD is a ‘generic medicine'.
Croatian: Clopidogrel TAD je „generički lijek”.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel TAD has been shown to have comparable quality and to be bioequivalent to Plavix.
Croatian: Europska agencija za lijekove zaključila je kako je, u skladu sa zahtjevima EU-a, potvrđeno da lijek Clopidogrel TAD posjeduje usporedivu razinu kvalitete i da je bioekvivalentan lijeku Plavix.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Clopidogrel TAD on 23 September 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Clopidogrel TAD u promet koje vrijedi na prostoru Europske unije od 23. rujna 2009.
English: Some of these patients may have had a stent (a short tube) placed in an artery to prevent it from closing up;
Croatian: Neki od tih bolesnika mogu imati ugrađen stent (kratka cijev) u arteriji kako bi se spriječilo njezino zatvaranje;
English: What are the benefits and risks of Clopidogrel TAD?
Croatian: Koje su koristi i rizici lijeka Clopidogrel TAD?
English: For more information about treatment with Clopidogrel TAD, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Clopidogrel TAD pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Because Clopidogrel TAD 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 Clopidogrel TAD generički lijek te da je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: This stops the platelets becoming ‘sticky', reducing the risk of a blood clot forming and helping to prevent another heart attack or stroke.
Croatian: Time se sprečava „lijepljenje” trombocita i smanjuje rizik od stvaranja krvnih ugrušaka te pomaže u sprečavanju srčanog ili moždanog udara.
English: • a condition known as ‘acute coronary syndrome', when it should be given with aspirin (another medicine that prevents blood clots).
Croatian: • boluju od poremećaja naziva „akutni koronarni sindrom”, pri čemu se treba davati s aspirinom (drugi lijek koji sprečava stvaranje krvnih ugrušaka).
English: For practical information about using Clopidogrel TAD, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Clopidogrel TAD bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: Why is Clopidogrel TAD approved?
Croatian: Zašto je lijek Clopidogrel TAD odobren?
English: It is not intended to provide practical advice on how to use Clopidogrel TAD.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka.
English: Other information about Clopidogrel TAD
Croatian: Ostale informacije o lijeku Clopidogrel TAD
English: Therefore, the Agency's view was that, as for Plavix, the benefit outweighs the identified risk.
Croatian: Stoga je stav Agencije da korist nadmašuje identificirani rizik, kao i za lijek Plavix.
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Croatian: Krv se gruša zbog nakupljanja (povezivanja) posebnih stanica u krvi koje se nazivaju trombocitima.
English: The active substance in Clopidogrel TAD, clopidogrel, is an inhibitor of platelet aggregation.
Croatian: Djelatna tvar lijeka Clopidogrel TAD, klopidogrel, inhibitor je nakupljanja trombocita.
English: Because Clopidogrel TAD is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Croatian: Tad generički lijek, ispitivanja na ljudima bila su ograničena na utvrđivanje činjenice je li lijek bioekvivalentan referentnom lijeku Plavix.
English: Clopidogrel TAD contains the active substance clopidogrel.
Croatian: Clopidogrel TAD sadrži djelatnu tvar klopidogrel.
English: Clopidogrel TAD can only be obtained with a prescription.
Croatian: Clopidogrel TAD izdaje se samo na liječnički recept.
English: The Agency recommended that Clopidogrel TAD be approved for use in the EU.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka Clopidogrel TAD u promet.
English: How is Clopidogrel TAD used?
Croatian: Kako se Clopidogrel TAD koristi?
English: How does Clopidogrel TAD work?
Croatian: Kako djeluje Clopidogrel TAD?
English: How has Clopidogrel TAD been studied?
Croatian: Kako je lijek Clopidogrel TAD ispitivan?
English: The first dose should be followed by 3 more doses after 2, 4, and 9 weeks and then one dose every 4 months thereafter.
Croatian: Poslije prve doze trebaju slijediti još tri doze nakon dva tjedna, četiri tjedna i devet tjedana, a potom jedna doza svaka četiri mjeseca.
English: In its assessment, the European Medicines Agency recognised the serious nature of the disease and the urgent need for effective treatments.
Croatian: U svojoj procjeni Europska agencija za lijekove prepoznala je ozbiljnu narav ove bolesti i hitnu potrebu za učinkovitim liječenjem.
English: This summary was last updated in 11-2017.
Croatian: Sažetak je posljednji put ažuriran u 11. 2017.
English: This replaces the missing protein, thereby relieving the symptoms of the disease.
Croatian: Tako je zamijenjen protein koji nedostaje, a to ublažava simptome bolesti.
English: The disease is linked to a defect on chromosome 5q and symptoms usually start shortly after birth.
Croatian: Bolest je povezana s oštećenjem na kromosomu 5q, a simptomi obično počinju ubrzo nakon rođenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Spinraza on 30 May 2017.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Spinraza u promet koje vrijedi na prostoru Europske unije od 30. svibnja 2017.
English: The medicine is available as a solution for injection in 12 mg vials.
Croatian: Lijek je dostupan kao otopina za injekciju u bočicama od 12 mg.
English: What measures are being taken to ensure the safe and effective use of Spinraza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Spinraza?
English: What is Spinraza and what is it used for?
Croatian: Što je Spinraza i za što se koristi?
English: It is given by intrathecal injection (into the lower back, directly into the spine) by a doctor or nurse experienced in carrying out this procedure.
Croatian: Primjenjuje se intratekalnom injekcijom (u donji dio leđa, izravno u kralježnicu), a daje je liječnik ili medicinska sestra s iskustvom u izvođenju tog postupka.
English: The SMN protein is made from two genes, SMN1 and SMN2.
Croatian: Protein SMN sastavljen je od dva gena, SMN1 i SMN2.
English: In addition, most babies treated with Spinraza survived for longer and needed breathing support later than those given placebo.
Croatian: Nadalje, većina dojenčadi liječena lijekom Spinraza preživjela je dulje i potporu disanja trebala kasnije nego ona koja je primala placebo.
English: Although the medicine was not tested in patients with the most severe and the mildest forms of SMA, it is expected to provide similar benefits to these patients.
Croatian: Iako lijek nije ispitan u bolesnika s najtežim i najblažim oblicima SMA-e, očekuje se da će koristi koje on pruža biti slične i u tih bolesnika.
English: This is a summary of the European public assessment report (EPAR) for Spinraza.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Spinraza.
English: The most common side effects with Spinraza (which may affect more than 1 in 10 people) are headache, back pain and vomiting.
Croatian: Najčešće su nuspojave lijeka Spinraza (koje se mogu javiti u više od 1 na 10 osoba) glavobolja, bol u leđima i povraćanje.
English: Spinraza has been shown to lead to clinically meaningful improvements in young children with varying degrees of disease severity.
Croatian: Pokazalo se da se lijekom Spinraza postižu klinički značajna poboljšanja u male djece s različitim stupnjevima težine bolesti.