FrancophonIA/ELRC3.0 huggingface dataset:
English: There are no data on the effects of ibandronic acid from humans.
Croatian: Nema saznanja o djelovanju ibandronatne kiseline kod ljudi.
English: Ibandronic acid 2.5 mg daily (N=294)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=294)
English: Posology The recommended dose is one 50 mg film-coated tablet daily.
Croatian: Preporučena je doza jedna 50 mg filmom obložena tableta dnevno.
English: EU/1/10/642/001 28 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes EU/1/10/642/002 84 film-coated tablets in PVC/Aclar/PVC - Aluminium blisters in cardboard boxes
Croatian: EU/1/10/642/001 28 filmom obloženih tableta u PVC/Aclar/PVC //aluminij blisteru, u kutiji.
English: Ocular inflammation
Croatian: Bubrežna funkcija
English: Ibandronic acid 2.5 mg daily (N=575)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=575)
English: Adverse experiences such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalization, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates.
Croatian: U bolesnika koji peroralno uzimaju bisfosfonate prijavljeni su štetni događaji kao što su ezofagitis, ulkusi jednjaka i erozije jednjaka, koji su u nekim slučajevima bili teški i zahtijevali su bolničko liječenje, rijetko s krvarenjem ili praćeni strikturom jednjaka ili perforacijom.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 mL/min) a dosage adjustment to one
Croatian: Bolesnicima s blagim oštećenjem bubrega (CLcr ≥50 i <80 ml/min) nije potrebna prilagodba doze.
English: Tel: +386 1 58 90 390
Croatian: Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis.
Croatian: U bolesnika koji su primali lijek Ibandronatna kiselina Teva za liječenje osteoporoze nakon njegova stavljanja na tržište, vrlo je rijetko prijavljena nuspojava koja se zove osteonekroza čeljusti (oštećenje kosti u čeljusti).
English: Arthralgia, Myalgia, Musculoskele tal pain, Muscle cramp,
Croatian: Bol u zglobovima, bol u mišićima, bol u mišićima i kostima, grčevi u mišićima, muskuloskeletalna ukočenost
English: Ibandronic acid 2.5 mg daily (N=977)
Croatian: Ibandronatna kiselina 2,5 mg jedanput dnevno (n=977)
English: 1 film-coated tablet
Croatian: Filmom obložena tableta
English: (see sections 5.1 and 5.2).
Croatian: Nema dostupnih podataka (vidjeti dijelove 5.1.i 5.2).
English: A statistically significant improvement in bone pain score was shown for ibandronic acid 50 mg compared to placebo.
Croatian: Ibandronatna kiselina 50 mg je u usporedbi s placebom pokazala statistički značajno poboljšanje rezultata kod boli u kostima.
English: At two years, 93.5 % (p=0.004) and 86.4 % of patients receiving ibandronic acid 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders.
Croatian: Nakon dvije godine, odgovorilo je 93,5% (p=0,004) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno, odnosno 86,4% onih koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: • The active substance is ibandronic acid.
Croatian: Djelatna tvar je ibandronatna kiselina.
English: Ibandronic Acid Teva should not be used during pregnancy.
Croatian: Ibandronatna kiselina Teva ne smije se koristiti u trudnoći.
English: At two years the median relative change was -68 % and -62 %, in the 150 mg monthly and 2.5 mg daily arms respectively.
Croatian: Nakon dvije godine medijan relativne vrijednosti promjene iznosio je -68% za ibandronatnu kiselinu 150 mg jedanput mjesečno, odnosno -62% za ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved “I150” on one side and plain on the other.
Croatian: Kako izgleda Ibandronatna kiselina Teva i sadržaj pakovanja Ibandronatna kiselina Teva filmom obložene tablete su bijele, bikonveksne tablete u obliku kapsula s utisnutom oznakom „1150“ na jednoj strani i bez oznake na drugoj strani.
English: PVC/Aclar/PVC - Aluminium blisters in cardboard boxes of 1 or 3 tablets.
Croatian: 1 ili 3 filmom obložene tablete u PVC/Aclar/PVC//aluminij blisteru, u kutiji.
English: *See further information below †Identified in post-marketing experience.
Croatian: *Vidjeti dodatne informacije niže
English: Cases of ONJ have been reported in the post-marketing setting for ibandronic acid.
Croatian: Slučajevi osteonekroze čeljusti prijavljeni su kod primjene ibandronatne kiseline nakon njezina stavljanja u promet.
English: (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)
Croatian: To može biti znak krvarenja čira u početnom dijelu crijeva (dvanaesniku) ili upale želuca (gastritis)
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for cancer-related conditions.
Croatian: U bolesnika koji su primali Ibandronatnu kiselinu Teva za liječenje stanja povezanih s rakom nakon njezina stavljanja na tržište, vrlo je rijetko prijavljena nuspojava koja se zove osteonekroza čeljusti (oštećenje kosti u čeljusti).
English: General disorders and administratio n site conditions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Musculoskele tal stiffness
Croatian: Osteonekroza čeljusti
English: Asthma exacerbation
Croatian: Egzacerbacija astme
English: The overall proportion of patients who experienced an adverse reaction, was 22.7 % and 25.0 % for ibandronic acid 150 mg once monthly after one and two years, respectively.
Croatian: odnosno 25% za ibandronatu kiselinu 150 mg jedanput mjesečno nakon jedne odnosno dvije godine.
English: Oesophagitis, abdominal pain, dyspepsia, nausea
Croatian: Upala jednjaka, bol u abdomenu, dispepsija, mučnina
English: Osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for osteoporosis (see section 4.8).
Croatian: U bolesnika koji su nakon njegova stavljanja u promet primali lijek Ibandronatna kiselina Teva za liječenje osteoporoze, vrlo je rijetko prijavljena osteonekroza čeljusti (vidjeti dio 4.8).
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Croatian: OBLIK I SADRŽAJ Filmom obložena tableta 28 filmom obloženih tableta 84 filmom obložene tablete
English: PVC/Aclar/PVC - Aluminium blisters in cardboard boxes of 28 or 84 tablets.
Croatian: 28 ili 84 filmom obloženih tableta u PVC/Aclar/PVC //aluminij blisteru, u kutiji.
English: Rare (may affect up to 1 in 1000 people):
Croatian: Rijetko (mogu se javiti u manje od 1 na 1000 osoba):
English: It is important that you take Ibandronic Acid Teva at the right time and in the right way.
Croatian: Važno je da Ibandronatnu kiselinu Teva uzimate u pravo vrijeme i na pravi način jer može izazvati iritaciju, upalu ili vrijed jednjaka (ezofagusa).
English: Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid
Croatian: Ibandronatna kiselina Teva 50 mg filmom obložene tablete ibandronatna kiselina
English: Common (may affect up to 1 in 10 people):
Croatian: Često (mogu se javiti u manje od 1 na 10 osoba):
English: Before receiving treatment, tell your doctor/nurse (health care professional) if: - you have any problems with your mouth or teeth such as poor dental health, gum disease or a planned tooth extraction.
Croatian: Prije nego započnete liječenje obavijestite svog liječnika/medicinsku sestru (zdravstvenog radnika): - ako imate bilo kakvih tegoba s ustima ili zubima, poput lošeg zdravlja zubi ili bolesti desni, ili ako planirate vaditi zub - ako nemate osiguranu redovitu stomatološku skrb i već dugo niste bili na kontrolnom stomatološkom pregledu - ako ste pušač (to može povećati rizik od problema sa zubima) - ako ste se prethodno liječili bisfosfonatom (koji se koristi za liječenje ili sprječavanje koštanih poremećaja) - ako uzimate lijekove koji se zovu kortikosteroidi (poput prednizolona ili deksametazona) - ako bolujete od raka
English: At two years 78.7 % (p=0.002) and 65.6 % of patients were identified as responders in the 150 mg monthly and 2.5 mg daily arms respectively.
Croatian: Nakon dvije godine odgovorilo je 78,7% (p=0,002) bolesnika koji su primali ibandronatnu kiselinu 150 mg jedanput mjesečno odnosno 65,6% bolesnika koji su primali ibandronatnu kiselinu 2,5 mg jedanput dnevno.
English: Ibandronic Acid Teva 150 mg film-coated tablets Ibandronic acid
Croatian: Ibandronatna kiselina Teva 150 mg filmom obložene tablete ibandronatna kiselina
English: Ibandronic acid 150 mg once monthly was shown to be at least as effective as ibandronic acid 2.5 mg daily at increasing BMD in a two year, double-blind, multicentre study (BM 16549) of postmenopausal women with osteoporosis (lumbar spine BMD T score below -2.5 SD at baseline).
Croatian: Dvogodišnje, dvostruko slijepo, multicentrično ispitivanje (BM 16549) u žena s postmenopauzalnom osteoporozom (početna T-vrijednost BMD lumbalne kralježnice manja od -2,5 SD) pokazala je da je Ibandronatna kiselina 150 mg jedanput mjesečno barem jednako djelotvorna u povećanju BMD kao ibandronatna kiselina 2,5 mg jedanput dnevno.
English: Rare (may affect up to 1 in 1,000 people):
Croatian: Rijetko (mogu se javiti u najviše 1 na 1 000 osoba)
English: 3 film-coated tablets pack Month 1
Croatian: 1 filmom obložena tableta 3 filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 50 mg film-coated tablets
Croatian: NAZIV GOTOVOG LIJEKA Ibandronatna kiselina Teva 50 mg filmom obložene tablete
English: NAME OF THE MEDICINAL PRODUCT Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid
Croatian: NAZIV GOTOVOG LIJEKA Ibandronatna kiselina Teva 50 mg filmom obložene tablete ibandronatna kiselina
English: Ibandronic Acid Teva should not be used during breast-feeding.
Croatian: Ibandronatna kiselina Teva se ne smije koristiti za vrijeme dojenja.
English: - If you are allergic to ibandronic acid or any of the other ingredients of this medicine listed in section 6.
Croatian: Nemojte uzimati Ibandronatnu kiselinu Teva - Ako ste alergični (preosjetljivi) na ibandronatnu kiselinu ili bilo koju pomoćnu tvar navedenu u dijelu 6.
English: Bone pain *
Croatian: Bol u kostima *
English: Your doctor may do regular blood tests while you are taking Ibandronic Acid Teva.
Croatian: Za vrijeme liječenja Ibandronatnom kiselinom Teva, liječnik će Vam vjerojatno provoditi redovite krvne pretrage kako bi provjerio da li primate odgovarajuću dozu lijeka.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day.
Croatian: Ako se ibandronatna kiselina uzima 60 minuta prije prvog obroka u danu, nema znatnijeg smanjenja bioraspoloživosti.
English: METHOD AND ROUTE OF ADMINISTRATION
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: Crospovidone (type A) Silica colloidal anhydrous Stearic acid
Croatian: celuloza, mikrokristalična povidon K-30 krospovidon (vrste A) silicijev dioksid, koloidni, bezvodni stearatna kiselina
English: BMD
Croatian: BMD trohantera
English: Asthenia
Croatian: LIJEKA
English: This is because NSAIDs and Ibandronic Acid Teva can both irritate your stomach and gut
Croatian: To je važno stoga što i NSAIL i Ibandronatna kiselina Teva mogu uzrokovati nadražaj želuca i crijeva - injekcije antibiotika iz skupine aminoglikozida, poput gentamicina.
English: There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before a meal.
Croatian: Ako se ibandronatna kiselina uzme 60 minuta prije jela, nema znatnijeg smanjenja bioraspoloživosti.
English: Aminoglycosides
Croatian: Aminoglikozidi
English: STATEMENT OF ACTIVE SUBSTANCE Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate).
Croatian: Jedna filmom obložena tableta sadrži 50 mg ibandronatne kiseline (u obliku natrijevog hidrata).
English: Tel: +385 1 37 20 000
Croatian: Pliva Hrvatska d.o.o. Tel: +385 1 37 20 000
English: - If you get any side effects, talk to your doctor or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
English: Acetylsalicylic acid and NSAIDs
Croatian: egzacerb acija astme
English: - Patients should not lie down for 60 minutes after taking Ibandronic Acid Teva.
Croatian: Nakon uzimanja Ibandronatne kiseline Teva bolesnik ne smije leći sljedećih 60 minuta.
English: Tel.: +48 22 345 93 00
Croatian: Teva Pharmaceuticals Polska Sp. z o.o. Tel.: +48 22 345 93 00
English: Rash
Croatian: Osip
English: Whereas
Croatian: A;
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Croatian: • PRAC je razmatrao postupak u skladu s člankom 20. Uredbe (EZ) br. 726/2004 za lijekove navedene u Prilogu
English: Overall conclusion
Croatian: Opći zaključak
English: Having reviewed the PRAC recommendation, the CHMP agrees with the PRAC overall conclusions and grounds for recommendation.
Croatian: Nakon što je pregledao preporuku PRAC-a, CHMP je suglasan s općim znanstvenim zaključcima i razlozima za preporuku PRAC-a.
English: • The PRAC therefore considered that the risk may constitute a possible class effect;
Croatian: • PRAC je stoga smatrao da se spomenuti rizik može pripisati mogućem učinku razreda;
English: The CANVAS and CANVAS-R studies and the CREDENCE and DECLARE Studies are planned to be completed in 2017 and 2020, respectively.
Croatian: Predviđa se da će ispitivanja CANVAS i CANVAS-R te ispitivanja CREDENCE i DECLARE biti dovršena 2017., odnosno 2020. godine.
English: Hence, it is currently not possible to establish whether the increased amputation risk is a class effect or not.
Croatian: Stoga trenutačno nije moguće utvrditi može li se povećani rizik od amputacija pripisati učinku razreda.
English: All RMPs should be updated accordingly via an appropriate variation to be submitted no later than one month of the European Commission decision;
Croatian: Sve planove upravljanja rizikom trebalo bi na odgovarajući način ažurirati njihovom izmjenom koja se mora dostaviti najkasnije jedan mjesec nakon donošenja odluke Europske komisije.
English: Consequently, the EC requested on 6 July 2016 to extend the current procedure to include all of the authorised products of the class of SGLT2 inhibitors.
Croatian: Stoga je Europska komisija 6. srpnja 2016. uputila zahtjev da se postojeći postupak proširi kako bi se njime obuhvatili svi odobreni lijekovi u razredu SGLT2 inhibitora.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance and Synjardy.
Croatian: CHMP stoga preporučuje izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet za lijekove Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance i Synjardy.
English: Sodium-glucose co-transporter 2 (SGLT2) inhibitors are used together with diet and exercise in patients with type 2 diabetes, either alone or in combination with other diabetes medicines.
Croatian: Inhibitori natrij-glukoze kotransportera 2 (SGLT2) primjenjuju se uz dijetu i tjelovježbu u bolesnika s dijabetesom tipa 2, kao monoterapija ili u kombinaciji s drugim lijekovima za liječenje dijabetesa.
English: • The PRAC was also of the opinion that a mechanism of action, allowing to understand which patients are at risk, is still unclear;
Croatian: • PRAC je također smatrao da i dalje nije jasan mehanizam djelovanja s pomoću kojega bi se moglo utvrditi koji su bolesnici izloženi riziku;
English: Final analysis of these studies, after un-blinding, will provide further information on the benefit/risk of SGLT2 inhibitors particularly of the risk of lower limb amputations.
Croatian: Konačnom analizom tih ispitivanja, nakon njihova otkrivanja, pružit će se daljnje informacije o omjeru koristi i rizika SGLT2 inhibitora, osobito rizika od amputacija donjih udova.
English: • The PRAC was therefore of the view that the risk of lower limb amputation should be included in the product information for all products listed in Annex A, with a warning highlighting to healthcare professional and patients the importance of routine preventative foot care.
Croatian: • PRAC je stoga smatrao da bi se rizik od amputacija donjih udova trebalo navesti u informacijama o lijeku za sve lijekove navedene u Prilogu A, zajedno s upozorenjem zdravstvenim radnicima i bolesnicima o važnosti redovite preventivne njege stopala.
English: The European Commission (EC) triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 15 April 2016; the PRAC was requested to assess the impact on the benefit-risk balance of canagliflozin containing medicinal products, to assess whether this is a class issue and to issue a recommendation by 31 March 2017 on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked and whether provisional measures are necessary to ensure the safe and effective use of these medicinal products.
Croatian: Uredbe (EZ) br. 726/2004 te je zatražila od Odbora za procjenu rizika u području farmakovigilancije (PRAC) da procijeni utjecaj na omjer koristi i rizika lijekova koji sadržavaju kanagliflozin, da procijeni je li riječ o problemu na razini razreda te da donese preporuku do 31. ožujka 2017. o tome hoće li predmetna odobrenja za stavljanje lijeka u promet i dalje ostati na snazi ili će ih trebati izmijeniti, obustaviti ili opozvati te je li potrebno uvesti privremene mjere kako bi se zajamčila sigurna i učinkovita uporaba tih lijekova.
English: • Because no specific risk factors could be identified apart from general amputation risk factors potentially contributing to the events, the PRAC recommended that patients should be advised on routine preventative foot care and maintaining adequate hydration as a general advice to prevent amputation;
Croatian: • s obzirom na to da osim općih čimbenika rizika od amputacija nisu utvrđeni nikakvi posebni čimbenici rizika koji mogu pridonijeti slučajevima amputacija, PRAC je preporučio da se bolesnike savjetuje o redovitoj preventivnoj njezi stopala te pravilnoj hidrataciji organizma kao dio općeg savjeta za prevenciju amputacija;
English: Furthermore, the PRAC considered that a class effect could not be excluded, as all SGLT2 inhibitors share the same mechanism of action, as the potential mechanism leading to an increased amputation risk is not known, and as an underlying cause specific to canagliflozin containing medicines only cannot be identified at the moment.
Croatian: Nadalje, PRAC je također smatrao da se ne može isključiti učinak razreda s obzirom na to da svi SGLT2 inhibitori imaju isti mehanizam djelovanja, da nije poznat mogući mehanizam koji uzrokuje povećan rizik od amputacija i da se trenutačno ne može utvrditi glavni uzrok tom riziku koji je svojstven samo lijekovima koji sadržavaju kanagliflozin.
English: The mechanism of action that would allow understanding which patients are at risk is therefore still unclear.
Croatian: Još nije jasan mehanizam djelovanja s pomoću kojega bi bilo moguće utvrditi koji su bolesnici izloženi riziku.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance and Synjardy remain favourable subject to the amendments to the product information described above.
Croatian: CHMP slijedom toga zaključuje da je omjer koristi i rizika lijekova Invokana, Vokanamet, Forxige, Edistride, Xigduo, Ebymect, Jardiance i Synjardy i dalje povoljan, pod uvjetom da se u informacije o lijeku unesu prethodno opisane izmjene.
English: Further to the information received by the EMA, the Independent Data Monitoring Committee (IDMC) for the CANVAS and CANVAS-R studies, which has access to all un-blinded CV outcome and safety data, recommended that the study should continue, that action to minimize this potential risk should be taken and that participants should be informed adequately about this risk.
Croatian: Uz informacije koje je primila Europska agencija za lijekove (EMA), Neovisno povjerenstvo za praćenje podataka za klinička ispitivanja CANVAS i CANVAS-R, koje ima pristup svim podacima o kardiovaskularnim ishodima u otvorenim ispitivanjima i sigurnosnim pojedinostima, preporučilo je nastavak provođenja ispitivanja, poduzimanje koraka kako bi se taj potencijalni rizik sveo na najmanju moguću mjeru te obavještavanje sudionika o tom riziku na odgovarajući način.
English: All members of the class share the same mode of action and there is no confirmed underlying mechanism that is canagliflozin-specific.
Croatian: Svi lijekovi u tom razredu imaju isti način djelovanja i nije utvrđen temeljni mehanizam koji je svojstven samo kanagliflozinu.
English: • The PRAC reviewed the totality of the data submitted by the marketing authorisation holders in relation to the risk of lower limb amputation in patients treated with Sodium-glucose cotransporter 2 (SGLT2) inhibitors for type 2 diabetes mellitus;
Croatian: • PRAC je pregledao sve podatke koje su podnijeli nositelji odobrenja u vezi s rizikom amputacija donjih udova u bolesnika s dijabetesom melitus tipa 2 i koji su liječeni inhibitorima natrijglukoze kotransportera 2 (SGLT2).
English: • The PRAC considered that the available data on amputation in the CANVAS and CANVAS-R trials confirm that treatment with canagliflozin may contribute to an increased risk of amputation of the lower limb, mainly of the toe;
Croatian: • PRAC je smatrao da dostupni podaci o amputacijama u ispitivanjima CANVAS i CANVAS-R potvrđuju da liječenje kanagliflozinom može prouzročiti povećan rizik od amputacija donjih udova, ponajprije nožnih prstiju;
English: The PRAC therefore recommended that the variation to the terms of the marketing authorisation for the above listed products referred to in Annex A, for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation, was warranted.
Croatian: PRAC je stoga preporučio izmjene uvjeta za izdavanje odobrenja za stavljanje lijeka u promet za prethodno navedene lijekove iz Priloga A, a relevantni dijelovi sažetka opisa svojstava lijeka i upute o lijeku za predmetne lijekove navedeni su u Prilogu III. preporuke PRAC-a.
English: PRAC noted that an increased amputation risk has only become apparent with canagliflozin so far, but one large cardiovascular outcome study (DECLARE) is still on-going for dapagliflozin and amputation events were not been systematically captured within the completed large cardiovascular outcome study conducted with empagliflozin (EMPA-REG).
Croatian: PRAC je napomenuo da je povećani rizik od amputacija dosad ustanovljen samo u bolesnika koji primjenjuju kanagliflozin, ali da je trenutačno u tijeku veliko ispitivanje o utjecaju dapagliflozina na kardiovaskularne ishode (DECLARE) te da slučajevi amputacija nisu sustavno praćeni u okviru zaključenog velikog ispitivanja o utjecaju na kardiovaskularne ishode primjenom empagliflozina (EMPAREG).
English: • The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for post-marketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Croatian: • PRAC je također smatrao da bi dodatne informacije o slučajevima amputacija trebalo prikupiti s pomoću odgovarajućih obrazaca prikaza slučaja ispitanika (CRF-ova) za klinička ispitivanja i popratnih upitnika za lijekove koji su već stavljeni na tržište, uporabom popisa općih pojmova iz Medicinskog rječnika za regulatorne poslove (MedDRA) kojima se daje prednost za simptome koji prethode amputaciji te odgovarajućim metaanalizama velikih ispitivanja, uključujući ispitivanja o utjecaju na kardiovaskularne ishode.