FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies of immediate-release exenatide with metformin, a thiazolidinedione or both as background therapy
Croatian: Ispitivanja eksenatida s trenutnim oslobađanjem s metforminom, tiazolidindionom ili kombinacijom ovih dvaju lijekova kao osnovnom terapijom
English: Blue Pen Cap
Croatian: Plavi zatvarač brizgalice
English: Check Byetta in the cartridge.
Croatian: Provjerite lijek Byetta u ulošku.
English: • Remove the needle immediately after each injection.
Croatian: • Nakon svakog injiciranja odmah skinite iglu.
English: • hypoglycaemia
Croatian: • hipoglikemija
English: Fasting lipids
Croatian: Razina lipida natašte
English: • Throw away used needles in a puncture-resistant container or as recommended by your healthcare professional.
Croatian: • Upotrijebljene igle odložite u spremnik otporan na probijanje ili onako kako preporučuju vaši zdravstveni radnici.
English: • Remove paper tab from outer needle shield.
Croatian: • Skinite papirnatu zaštitu s vanjskog štitnika igle.
English: • Once in use, your Byettapen should be kept below 25ºC.
Croatian: • Nakon što je počnete koristiti, čuvajte Byetta brizgalica na temperaturi ispod 25°C.
English: • Attach a new needle.
Croatian: • Pričvrstite novu iglu.
English: In patients with end-stage renal disease receiving dialysis, single doses of immediate-release exenatide 5 mcg increased frequency and severity of gastrointestinal adverse reactions.
Croatian: U bolesnika u terminalnom stadiju bubrežne bolesti koji se liječe dijalizom pojedinačne doze eksenatida s trenutnim oslobađanjem od 5 µg povećale su učestalost i težina nuspojava u probavnom sustavu.
English: Concomitant medicinal products
Croatian: Lijekovi u istodobnoj primjeni
English: • Pull off outer needle shield.
Croatian: • Skinite vanjski štitnik igle.
English: • Difficulty to swallow
Croatian: • otežano gutanje
English: Intestinal obstruction
Croatian: Oštećenje bubrega
English: Package leaflet: Information for the patient Byetta 5 micrograms solution for injection in pre-filled pen Byetta 10 micrograms solution for injection in pre-filled pen exenatide
Croatian: Byetta 5 mikrograma otopina za injekciju u napunjenoj brizgalici Byetta 10 mikrograma otopina za injekciju u napunjenoj brizgalici eksenatid
English: • Unscrew the needle.
Croatian: • Odvijte iglu.
English: Studies of immediate-release exenatide in combination with basal insulin In a 30-week study, either immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) or a placebo was added to insulin glargine (with or without metformin, pioglitazone or both).
Croatian: U 30-tjednom ispitivanju je terapiji inzulinom glarginom (sa ili bez metformina, pioglitazona ili oba lijeka) dodana ili eksenatid s trenutnim oslobađanjem (u dozi od 5 µg dvaput na dan tijekom 4 tjedna, a zatim 10 µg dvaput na dan) ili placebo.
English: • Pull dose knob out until it stops and the is in the dose window.
Croatian: • Izvucite gumb za doziranje dok se ne zaustavi i dok se u prozorčiću ne pojavi simbol
English: • Do not store the Byettapen with the needle attached.
Croatian: • Nemojte čuvati Byetta brizgalicu s pričvršćenom iglom.
English: A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava glavobolja omaglica disgeuzija somnolencija
English: Do not reuse needles.
Croatian: Ne smijete ponovno koristiti istu iglu.
English: Immediate-release exenatide 10 mcg BID
Croatian: Eksenatid s trenutnim oslobađanjem 10 µg dvaput na dan
English: Cartridge Byetta Liquid
Croatian: ČUVANJE BYETTA BRIZGALICE
English: One injection of your pre-filled pen will give you your dose.
Croatian: Svoju ćete dozu primiti jednom injekcijom iz napunjene brizgalice.
English: With continued therapy, the frequency and severity decreased in most patients who initially experienced nausea.
Croatian: U većine bolesnika koji su na početku liječenja osjetili mučninu njezina se učestalost i težina smanjila s nastavkom terapije.
English: Particles or discolouration may appear in the cartridge after an injection.
Croatian: Nakon injekcije u ulošku se mogu pojaviti čestice ili promjena boje.
English: Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Croatian: Puh/Tel: +358 10 23 010
English: Read the package leaflet and pen user manual before use.
Croatian: Prije uporabe pročitajte uputu o lijeku i upute za uporabu brizgalice.
English: • Throw away needles in a puncture-resistant container or as recommended by your healthcare professional.
Croatian: • Igle odložite u spremnik otporan na probijanje ili onako kako Vam je preporučio zdravstveni radnik.
English: Immediate-release exenatide 5 mcg BID
Croatian: Eksenatid s trenutnim oslobađanjem 5 µg dvaput na dan
English: Section 1.
Croatian: PRILOG I.
English: What Byetta is and what it is used for What you need to know before you use Byetta How to use Byetta
Croatian: Što morate znati prije nego počnete primjenjivati lijek Byetta Kako primjenjivati lijek Byetta Moguće nuspojave
English: PEN USER MANUAL Byetta 5 micrograms solution for injection in pre-filled pen (exenatide)
Croatian: UPUTE ZA UPORABU BRIZGALICE Byetta 5 mikrograma otopina za injekciju u napunjenoj brizgalici (eksenatid)
English: PEN USER MANUAL Byetta 10 micrograms solution for injection in pre-filled pen (exenatide)
Croatian: UPUTE ZA UPORABU BRIZGALICE Byetta 10 mikrograma otopina za injekciju u napunjenoj brizgalici (eksenatid)
English: Byetta 5 micrograms solution for injection in pre-filled pen
Croatian: Byetta 5 mikrograma otopina za injekciju u napunjenoj brizgalici
English: • constipation
Croatian: • podrigivanje
English: Each dose should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm. Immediate-release exenatide and basal insulin must be administered as two separate injections.
Croatian: Svaka doza se mora primijeniti supkutanom injekcijom u bedro, abdomen ili nadlakticu.
English: • Turn dose knob clockwise until it stops and the is in the dose window.
Croatian: • Okrećite gumb za doziranje u smjeru kazaljke na satu dok se ne zaustavi i dok se simbol ne pojavi u prozorčiću za doziranje.
English: Flatulence
Croatian: Imunogenost
English: Do not store with needle attached.
Croatian: Nemojte čuvati brizgalicu s pričvršćenom iglom.
English: Recap pen to protect from light.
Croatian: Vratiti zatvarač na brizgalicu radi zaštite od svjetlosti.
English: • Pen preparation is complete when the is in the centre of the dose window AND you have seen a stream or several drops come from the needle tip.
Croatian: • Injiciranje je dovršeno kada se u sredini prozorčića za doziranje nalazi simbol • Sada je brizgalica spremna za ponovno namještanje.
English: Byetta 10 micrograms solution for injection in pre-filled pen
Croatian: Byetta 10 mikrograma otopina za injekciju u napunjenoj brizgalici
English: Byetta 5 micrograms solution for injection in pre-filled pen exenatide
Croatian: Byetta 5 mikrograma otopina za injekciju u napunjenoj brizgalici eksenatid
English: Frequency of occurrence
Croatian: Učestalost pojavljivanja
English: • The is in the centre of the dose window.
Croatian: • kada se u sredini prozorčića za doziranje nalazi simbol
English: • Store your Byettapen properly.
Croatian: • Spremite Byetta brizgalicu na propisan način.
English: Byettashould come from needle tip.
Croatian: Iz vrha igle trebala bi izlaziti Byetta.
English: Byetta 10 micrograms solution for injection in pre-filled pen exenatide
Croatian: Byetta 10 mikrograma otopina za injekciju u napunjenoj brizgalici eksenatid
English: NEW PEN SETUP - DO THISONE TIME ONLY
Croatian: PODEŠAVANJE NOVE BRIZGALICE - UČINITE OVO SAMO JEDAN PUT
English: • Replace the cap on the pen in order to protect from light.
Croatian: • Vratite zatvarač na brizgalicu kako biste je zaštitili od svjetlosti.
English: Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients > 70 years.
Croatian: U bolesnika starijih od 70 godina eksenatid s trenutnim oslobađanjem se treba primjenjivati uz oprez, a ne treba žuriti s povećanjem doze s 5 µg na 10 µg.
English: • dizziness
Croatian: • žgaravica
English: In a 24-week study, where either insulin lispro protamine suspension or insulin glargine was added to existing therapy of immediate-release exenatide and metformin, metformin and sulphonylurea or metformin and pioglitazone, HbA1c was lowered by 1.2% (n=170) and by 1.4% (n=167) respectively from a baseline of 8.2%.
Croatian: U 24-tjednom ispitivanju je postojećoj terapiji eksenatidom s trenutnim oslobađanjem i metforminom, metforminom i sulfonilurejom, metforminom i pioglitazonom dodana suspenzija inzulina lispro s protaminom ili inzulin glargin.
English: - If you get any side effects talk to your doctor, pharmacist, or diabetes nurse.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru u dijabetološkoj ambulanti.
English: Please see the accompanying Byetta Package Leaflet.
Croatian: Pročitajte priloženu uputu o lijeku Byetta.
English: If you get any side effects, talk to your doctor, pharmacist or diabetes nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru u dijabetološkoj ambulanti.
English: Outer Needle Shield
Croatian: Vanjski štitnik igle
English: Please see the accompanying Package Leaflet.
Croatian: Pročitajte priloženu uputu o lijeku.
English: Inner Needle Shield
Croatian: Unutarnji štitnik igle
English: • Turn dose knob clockwise until it stops at
Croatian: • Okrećite gumb za doziranje u smjeru kazaljke na satu dok se ne zaustavi na simbolu
English: COMMONLY ASKED QUESTIONS
Croatian: Dio 4. ČESTA PITANJA
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Croatian: • Odbor je razmotrio arbitražni postupak u skladu s člankom 29. stavkom 4. Direktive 2001/83/EZ
English: The contraceptive effect of the vaginal delivery system is based on various mechanisms, the most important of which is the inhibition of ovulation.
Croatian: Kontraceptivni učinak sustava vaginalne isporuke temelji se na raznim mehanizmima, od kojih je najvažniji mehanizam inhibicije ovulacije.
English: The Pharmacokinetics Working Party (PKWP) and the Modelling and Simulation Working Party (MSWP) were also consulted during the CMDh procedure.
Croatian: Zatraženo je mišljenje od Radne skupine za farmakokinetiku (PKWP) i Radne skupine za modeliranje i simulaciju (MSWP) tijekom CMDh-ova postupka.
English: Day 60 of the CMDh procedure was on 2 August 2018.
Croatian: Dana 2. kolovoza bio je 60. dan CMDh-ova postupka.
English: Manual stress (in-process control) and tensile strength (finished product specification) are performed on the ring during manufacture and the ring is not expected to lose its integrity after 3 weeks of use.
Croatian: Ispitivanja na manualni stres (kontrola tijekom postupka) i rasteznu čvrstoću (specifikacije gotovog proizvoda) provedena su tijekom proizvodnje te se ne očekuje da će prsten izgubiti cjelovitost nakon tri tjedna upotrebe.
English: Ethinylestradiol (EE) is an estrogen widely used in contraceptive products.
Croatian: Etinilestradiol (EE) je estrogen koji se jako često upotrebljava u kontracepcijskim proizvodima.
English: Perlinring 0.12mg/0.015mg/day is a vaginal delivery system containing etonogestrel and ethinylestradiol.
Croatian: Perlinring 0,12mg/0,015mg/dan sustav je vaginalne isporuke koji sadržava etonogestrel i etinilestradiol.
English: Additionally, the stability of the formulation has been shown to be maintained under extreme storage conditions with in vitro performance maintained.
Croatian: Uz to se stabilnost formulacije pokazala održivom u iznimnim uvjetima čuvanja uz održanu in vitro izvedbu.
English: There is also no risk of the active substances not being released over 28 days as there is an excess of active substances present in the ring.
Croatian: Također, ne postoji rizik od neotpuštanja djelatne tvari tijekom 28 dana jer ne postoji višak djelatnih tvari u prstenu.
English: As no agreement could be reached during the CMDh procedure, a referral under Article 29(4) of Directive 2001/83/EC was triggered by the reference Member State United Kingdom (UK) on 7 August 2018.
Croatian: Budući da nije postignut dogovor tijekom postupka CMDh-a, Ujedinjena Kraljevina, kao država članica, pokrenula je arbitražni postupak 7. kolovoza 2018. na temelju članka 29. stavka 4. Direktive 2001/83/EZ.
English: Although it is recognised that the model is not a surrogate for demonstrating bioequivalence (as in vitro data are generally not accepted to demonstrate bioequivalence), exceptions do exist such as in the case of BCSbased biowaiver.
Croatian: Iako je potvrđeno da model nije zamjena za dokaz o bioekvivalentnosti (jer in vitro podatci općenito nisu prihvaćeni kao dokaz bioekvivalentnosti), postoje izuzetci kao u slučaju izostavljanja ispitivanja bioekvivalencije na temelju biofarmaceutskog sustava klasifikacije.
English: Bioequivalence of the proposed product to the reference medicinal product was demonstrated only for the period of 21 days, but not for 28 days.
Croatian: Bioekvivalentnost predloženog lijeka u odnosu na referentni lijek dokazana je samo za razdoblje od 21 dana, no ne i za razdoblje od 28 dana.
English: The tolerability of the ring after 28 days is also not expected to raise concerns given that the test and reference medicinal products have a similar polymer, active amounts and ring dimensions.
Croatian: Ne očekuje se utjecaj na podnošljivost prstena nakon 28 dana budući da ispitivani i referentni lijek imaju sličan polimer, djelatne količine i dimenzije prstena.
English: Furthermore, the vaginal ring integrity is not expected to be affected if retained over the period of 28 days.
Croatian: Nadalje, ne očekuje se utjecaj na cjelovitost vaginalnog prstena tijekom primjene od 28 dana.
English: Etonogestrel (ENG) is a 19-nortestosterone-derived progestagen and binds with high affinity to progesterone receptors in the target organs.
Croatian: Etonogestrel (ENG) je progestagen izveden iz 19-nortestosterona te se jako veže na receptore progesterona u ciljnim organima.
English: This modelling, together with the following information below was considered to provide further reassurance for the extended use up to 28 days:
Croatian: Smatralo se da to modeliranje, uz informacije navedene u nastavku, omogućuje dodatno osiguranje u pogledu produljene upotrebe do 28 dana:
English: • The Committee was of the view that the totality of data submitted justified the maintenance of the contraceptive efficacy up to 28 days for Perlinring, in line with the reference medicinal product NuvaRing.
Croatian: • Odbor je smatrao da ukupni dostavljeni podatci opravdavaju održavanje kontracepcijske djelotvornosti do 28 dana za Perlinring, u skladu s referentnim lijekom NuvaRing.
English: In summary, scientific evidence supports that the generic product and reference medicinal product would behave similarly after Day 21 up to Day 28 of use.
Croatian: Ukratko, znanstveni dokazi potkrjepljuju pretpostavku da će se generički lijek i referentni lijek slično ponašati nakon 21. dana sve do 28. dana upotrebe.
English: As mentioned above there is a significant residual amount of drug in both the test and the reference medicinal product at 21 days (residual content for test and reference products is approximately 87% vs. 86% for EE and for ENG 78% vs. 75% of the initial concentration remaining).
Croatian: Kako je prethodno navedeno, postoji znatna ostatna količina lijeka u ispitivanom i u referentnom lijeku 21. dana (ostatni sadržaj za ispitivani i referentni lijek iznosi 87 % u usporedbi s 86 % za etinilestradiol te za etonogestrel 78 % u usporedbi sa 75 % početne ostatne koncentracije).
English: The reference Member State (RMS) United Kingdom, considered that, based on the totality of available data and in particular owing to the comparable pharmaceutical data, the similar residual content of EE and ENG, it is possible to conclude with a sufficient degree of certainty that bioequivalence of test and reference medicinal product is maintained over the period of 28 days.
Croatian: Referentna država članica, Ujedinjena Kraljevina, smatrala je da je, na temelju ukupnih dostupnih podataka, a posebice zbog usporedivih farmaceutskih podataka, sličnog ostatnog sadržaja etonogestrela i etinilestradiola, moguće s dovoljnom sigurnošću zaključiti da se bioekvivalentnost ispitivanog i referentnog lijeka održava tijekom razdoblja od 28 dana.
English: The etonogestrel/ethinylestradiol combined contraceptive vaginal ring provides continuous delivery of contraceptive steroids through the vagina, avoiding the need for daily drug administration.
Croatian: Kombinacija etonogestrela i etinilestradiola u vaginalnom kontracepcijskom prstenu omogućuje neprekidnu isporuku kontraceptivnih steroida kroz vaginu pa tako nema potrebe za svakodnevnom primjenom lijeka.
English: The Committee, as a consequence, considers that the benefit-risk balance of Perlinring and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Croatian: Odbor, posljedično, smatra da je omjer koristi i rizika Perlinring i pridruženih imena povoljan te stoga preporučuje izdavanje odobrenja za stavljanje u promet lijeka navedenog u Prilogu I. mišljenja CHMPa.
English: However, the objecting CMSs (DE, NL and FR) contended that Perlinring 0.12mg/0.015mg per 24 hours vaginal delivery system is not approvable since the evidence for its use between day 21 and day 28 is built only on extrapolation, and bioequivalence in this period is considered not proven.
Croatian: Međutim, države članice koje su imale primjedbe (Njemačka, Nizozemska i Francuska) navele su da Perlinring 0,12mg/0,015mg na 24 sata, vaginalni sustav isporuke, nije moguće odobriti jer se dokazi o njegovoj primjeni između 21. i 28. dana temelje samo na ekstrapolaciji, dok se smatra da bioekvivalentnost za to razdoblje nije dokazana.
English: The sampling period of 21 days in the conducted bioequivalence study is in line with the recommended use of the product, and it is undisputed that the evidence for bioequivalence of the test product Perlinring and the reference medicinal product NuvaRing has been adequately demonstrated for the recommended duration of use.
Croatian: Razdoblje uzorkovanja od 21 dana u provedenom ispitivanju bioekvivalentnosti u skladu je s preporučenom upotrebom lijeka te nema sumnje da je dokaz bioekvivalentnosti ispitivanog lijeka Perlinring i referentnog lijeka NuvaRing jasno dokazan za preporučeno trajanje upotrebe.
English: The lack of in vivo data supporting the extended ring use (of up to 28 days), which is stated as a deviation from the recommended regimen (21 days) in line with information included in the product information of the reference medicinal product NuvaRing, was considered to be a potential serious risk to public health (PSRPH).
Croatian: Nedostatak in vivo podataka koji bi potkrijepili produljenu upotrebu prstena (do 28 dana), što je navedeno kao odstupanje od preporučenog režima (21 dan) u skladu s informacijama uključenim u informacije o lijeku referentnog lijeka NuvaRing, smatra se potencijalnim ozbiljnim rizikom po javno zdravlje (PSRPH).
English: Therefore the CHMP agreed by majority, that the extended use of up to 28 days is supported by the totality of the data submitted by the applicant.
Croatian: Stoga je CHMP većinom glasova donio odluku da je produljena upotreba do 28 dana potkrijepljena ukupnim podatcima koje je podnositelj zahtjeva dostavio.
English: The Committee considered the available data submitted in support of the use of Perlinring during an extended week up to 28 days, which included in vivo-in vitro correlation, pharmaceutical data such as in vitro dissolution and residual content, and ring integrity and tolerability.
Croatian: Odbor je razmotrio dostupne podatke dostavljene kako bi potkrijepili produljenu upotrebu Perlinringa tijekom jednog produljenog tjedna do 28 dana, koji su uključivali in vivo-in vitro korelaciju, farmaceutske podatke kao što su in vitro otpuštanje i ostatni sadržaj te cjelovitost prstena i podnošljivost.
English: In order to address the concern of the extended (lengthened ring use) of up to 28 days, which is a deviation from the recommended use that is included in the SmPC of NuvaRing, the applicant provided further information on pharmaceutical quality data between the test and reference medicinal product, in vitro dissolution data which evaluated the rate of release of the test and reference product over 28 days, In Vitro-In Vivo Correlation (IVIVC) for the reference formulation for 28 days and an In Vitro-In Vivo Correlation (IVIVC) for the test formulation for 21 days, and the residual contents in the rings of etonogestrel and ethinyelstradiol at 21 days for test and reference medicinal product.
Croatian: Kako bi otklonio zabrinutost radi produljene (dulje) upotrebe prstena u trajanju do 28 dana, što je odstupanje od preporučene upotrebe navedene u sažetku opisa svojstava lijeka NuvaRing, podnositelj zahtjeva dostavio je dodatne informacije o farmaceutskoj kvaliteti podataka između ispitanog i referentnog lijeka, podatke o in vitro otpuštanju, odnosno ocjenu brzine otpuštanja ispitivanog i referentnog lijeka tijekom 28 dana, podatke o In Vitro-In Vivo korelaciji (IVIVC) za referentnu formulaciju za 28 dana te o In Vitro-In Vivo korelaciji (IVIVC) za ispitivanu formulaciju za 21 dan, kao i podatke o ostatnom sadržaju u prstenovima koji sadržavaju etonogestrel i etinielstradiol nakon 21 dana za ispitivani i referentni lijek.
English: Pharmaceutical equivalence of test and reference medicinal product, and comparable in vitro dissolution data evaluating the rate of release of both over 28 days has been demonstrated
Croatian: Dokazane su farmaceutska ekvivalentnost ispitivanog i referentnog lijeka te usporedivi podatci o in vitro otpuštanju za ocjenu brzine otpuštanja oba lijeka tijekom 28 dana
English: Considering that the recommended posology of 21 days is supported by a bioequivalence study, the issue raised and discussed at the CHMP concerned the additional data submitted to support the use between day 21 and day 28 and whether these data were considered acceptable to support the extended use of up to 28 days (in line with the reference medicinal product).
Croatian: Uzimajući u obzir da je preporučeno doziranje od 21 dana potkrijepljeno ispitivanjem bioekvivalentnosti, problem koji je iznesen i o kojem se raspravljalo u Odboru za lijekove za humanu uporabu (CHMP) odnosio se na dodatne dostavljene podatke koji su trebali potkrijepiti upotrebu između 21. i 28. dana te na pitanje jesu li ti podatci prihvatljivi kako bi potkrijepili produljenu upotrebu do 28 dana (u skladu s referentnim lijekom).
English: To address the issue of extended use up to 28 days, which is included in the SmPC of NuvaRing as a deviation to the recommended use, the applicant has additionally conducted IVIVC modelling to demonstrate that the behaviour of the ring does not change between 21 and 28 days, based on data from the test product for 21 days and from published data on reference product for 28 days.
Croatian: Kako bi se riješilo sporno pitanje produljene upotrebe do 28 dana, što je u sažetku opisa svojstava lijeka NuvaRing navedeno kao odstupanje od preporučene upotrebe, podnositelj zahtjeva dodatno je proveo IVIVC modeliranje kako bi dokazao da se ponašanje prstena ne mijenja između 21. i 28. dana, na temelju podataka ispitivanog lijeka za 21 dan te objavljenih podataka o referentnom lijeku za 28 dana.
English: ENG/EE ring is indicated for contraception and is intended for women of fertile age.
Croatian: Prsten s etonogestrelom i etinilestradiolom indiciran je za kontracepciju te namijenjen ženama reproduktivne dobi.