FrancophonIA/ELRC3.0 huggingface dataset:
English: It is normal for a single drop to remain on the tip of your needle after your injection is complete.
Slovenian: Zakaj po končanem injiciranju iz moje igle izteka zdravilo Byetta Po končanem injiciranju je običajno, da na konici vaše igle ostane ena kaplja.
English: • bloating
Slovenian: • bruhanje
English: Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika, farmacevta ali medicinske sestre iz diabetološke ambulante.
English: Continue turning the dose knob clockwise until is in the centre of the dose window.
Slovenian: Obračajte gumb za odmerjanje v smeri urnega kazalca, dokler ni v sredini okenca za odmerjanje .
English: • vomiting
Slovenian: • napihnjenost
English: Particles or discolouration may appear in the cartridge after an injection.
Slovenian: Po injiciranju se v vložku lahko pojavijo delci ali sprememba barve.
English: Patients in the immediate-release exenatide-treated group with anHbA1c 8.0% at the end of the BIO phase decreased their insulin glargine dose by at least 10%.
Slovenian: Po štirih tednih so jim odmerek povečali na 10 µg dvakrat na dan. Bolniki, ki so prejemali eksenatid v obliki s takojšnjim sproščanjem in so imeli ob koncu OBI HbA1c ≤ 8,0 %, so zmanjšali odmerek insulina glargina za vsaj 10 %.
English: PEN USER MANUAL Byetta 5 micrograms solution for injection in pre-filled pen (exenatide)
Slovenian: PRIROČNIK ZA UPORABO INJEKCIJSKEGA PERESNIKA Byetta 5 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (eksenatid)
English: PEN USER MANUAL Byetta 10 micrograms solution for injection in pre-filled pen (exenatide)
Slovenian: PRIROČNIK ZA UPORABO INJEKCIJSKEGA PERESNIKA Byetta 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku (eksenatid)
English: If you get any side effects, talk to your doctor, pharmacist or diabetes nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro iz diabetološke ambulante.
English: You do not have to measure any doses, the pen measures each dose for you.
Slovenian: Ni vam potrebno meriti odmerka, odmerek vam odmeri že injekcijski peresnik.
English: • Throw away needles in a puncture-resistant container or as recommended by your healthcare professional.
Slovenian: • Igle zavrzite v embalažo, odporno proti vbodom, ali po navodilih zdravstvenega delavca.
English: ready to pull dose knob out ready to turn to dose position ready to inject 5 micrograms (mcg)
Slovenian: Pripravljen za injiciranje 5 mikrogramov (µg)
English: • Do not store the Byettapen with the needle attached.
Slovenian: • Injekcijskega peresnika Byetta ne shranjujte s pritrjeno iglo.
English: - If you get any side effects talk to your doctor, pharmacist, or diabetes nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro iz diabetološke ambulante.
English: Each cartridge is assembled into a disposable pen-injector (pen).
Slovenian: En vložek je vstavljen v injekcijski peresnik (peresnik) za enkratno uporabo.
English: • Unscrew the needle.
Slovenian: • Iglo odvijte.
English: The clinical experience in patients with moderate renal impairment is very limited (see section 4.2).
Slovenian: Klinične izkušnje pri bolnikih z zmerno okvaro ledvic so zelo omejene.
English: • Push outer needle shield containing the needle straight onto the pen, then screw needle on until secure.
Slovenian: • Potisnite zunanjo zaščito igle skupaj z iglo naravnost na injekcijski peresnik in nato iglo tesno privijte.
English: Byetta 5 micrograms solution for injection in pre-filled pen
Slovenian: Byetta 5 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Byetta 10 mcg injection exenatide
Slovenian: Byetta 10 µg injekcija eksenatid za subkutano uporabo
English: Byetta 5 mcg injection exenatide
Slovenian: Byetta 5 µg injekcija eksenatid za subkutano uporabo
English: Byetta 5 micrograms solution for injection in pre-filled pen exenatide
Slovenian: Byetta 5 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku eksenatid
English: How to store Byetta
Slovenian: Shranjevanje zdravila Byetta
English: • Grip pen firmly.
Slovenian: • Injekcijski peresnik čvrsto primite.
English: Byetta 10 micrograms solution for injection in pre-filled pen
Slovenian: Byetta 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: • constipation
Slovenian: • zaspanost
English: • sleepiness
Slovenian: • driska
English: STEP 5 Reset the Pen
Slovenian: KORAK 5 Ponovno nastavite injekcijski peresnik
English: Byetta 10 micrograms solution for injection in pre-filled pen exenatide
Slovenian: Byetta 10 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku eksenatid
English: • Replace blue pen cap on pen before storage.
Slovenian: • Pred shranjevanjem na injekcijski peresnik ponovno namestite modri pokrovček peresnika.
English: • If the pen is stored with a needle attached, air bubbles may form in the cartridge.
Slovenian: • Zračni mehurčki v vložku lahko nastanejo, če injekcijski peresnik shranjujete s pritrjeno iglo.
English: Nervous system disorders
Slovenian: Občutek živčnosti
English: Eructation
Slovenian: Imunogenost
English: Keep your pen and needles out of the sight and reach of children.
Slovenian: Injekcijski peresnik in igle shranjujte nedosegljivo otrokom.
English: Check with your doctor, pharmacist, or diabetes nurse if you are not sure.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro iz diabetološke ambulante.
English: Constipation
Slovenian: Napenjanje
English: • burping
Slovenian: • riganje
English: - Firmly push the injection button in all the way until it stops.
Slovenian: • Obračajte gumb za odmerjanje v smeri urnega kazalca, dokler se ne ustavi na .
English: The Mutual Recognition Procedure started on 15 September 2005.
Slovenian: Postopek za medsebojno priznavanje se je začel 15. septembra 2005.
English: The Reference Member State was Denmark and the Concerned Member States were: United Kingdom.
Slovenian: Referenčna država članica je bila Danska, zadevna država članica pa je bilo Združeno kraljestvo.
English: The arbitration procedure started on 23 March 2006.
Slovenian: Arbitražni postopek se je začel 23. marca 2006.
English: The Denmark referred the reasons for disagreement to the EMEA on 3 March 2006.
Slovenian: Danska je agenciji EMEA posredovala razloge za nesoglasje dne 3. marca 2006.
English: These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Omenjeni državi članici nista mogli doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxagamma 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxagamma 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
English: The scope of the referral was to agree whether Doxagamma 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Slovenian: Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxagamma 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
English: Doxagamma 4 mg prolonged release tablets and associated names (doxazosin) is a receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Slovenian: Doxagamma 4 mg tablete s podaljšanim sproščanjem in povezana imena (doxazosin) vsebujejo snov, ki blokira receptor alfa, in se uporabljajo za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
English: Generics Ltd. submitted applications for mutual recognition of Doxagamma 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Slovenian: Družba Generics Ltd. je podala vloge za medsebojno priznavanje zdravila Doxagamma 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Danska dne 30. septembra 2002.
English: The Marketing Authorisation Holder provided written explanations on 08 April 2006.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil pisna pojasnila dne 8. aprila 2006, ustna pojasnila pa je podal 27. junija 2006.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxagamma 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Slovenian: Doxagamma 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
English: • The Committee considered the referral under Article 29(4) of Directive 2001/83/EC,
Slovenian: • odbor je obravnaval napotitev v skladu s členom 29(4) Direktive 2001/83/ES;
English: Day 60 of the CMDh procedure was on 2 August 2018.
Slovenian: 60. dan postopka skupine CMDh je bil 2. avgust 2018.
English: ENG/EE ring is indicated for contraception and is intended for women of fertile age.
Slovenian: ENG/EE-obroček je indiciran za kontracepcijo in je namenjen za ženske v rodni dobi.
English: The contraceptive effect of the vaginal delivery system is based on various mechanisms, the most important of which is the inhibition of ovulation.
Slovenian: Kontracepcijski učinek vaginalnega dostavnega sistema temelji na različnih mehanizmih, od katerih je najpomembnejši zaviranje ovulacije.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as a potential serious risk to public health.
Slovenian: • odbor je obravnaval vse podatke, ki jih je v povezavi s pomisleki, izraženimi kot možno resno tveganje za javno zdravje, predložil predlagatelj.
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.
Slovenian: Ker v postopku skupine CMDh ni bilo mogoče doseči dogovora, je referenčna država članica, Združeno kraljestvo, 7. avgusta 2018 sprožila napotitev v skladu s členom 29(4) Direktive 2001/83/ES.
English: Perlinring 0.12mg/0.015mg/day is a vaginal delivery system containing etonogestrel and ethinylestradiol.
Slovenian: Zdravilo Perlinring 0,12 mg/0,015 mg/dan je vaginalni dostavni sistem, ki vsebuje etonogestrel in etinilestradiol.
English: Ethinylestradiol (EE) is an estrogen widely used in contraceptive products.
Slovenian: Etinilestradiol (EE) je estrogen, ki se uporablja v najrazličnejših kontracepcijskih zdravilih.
English: Additionally, the stability of the formulation has been shown to be maintained under extreme storage conditions with in vitro performance maintained.
Slovenian: Poleg tega sta se stabilnost formulacije ter učinkovitost in vitro dokazano ohranili tudi pri skrajnih pogojih skladiščenja.
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.
Slovenian: Bioekvivalenca predlaganega zdravila z referenčnim zdravilom je bila dokazana samo za obdobje 21 dni, ne pa za 28 dni.
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).
Slovenian: Kot omenjeno, je v testnem in referenčnem zdravilu na 21. dan precejšnja količina ostankov zdravila (pri testnem in referenčnem zdravilu je količina ostankov približno 87 % oziroma 86 % začetne preostale koncentracije EE in 78 % oziroma 75 % začetne preostale koncentracije ENG);
English: The Pharmacokinetics Working Party (PKWP) and the Modelling and Simulation Working Party (MSWP) were also consulted during the CMDh procedure.
Slovenian: V postopku skupine CMDh so bila opravljena tudi posvetovanja z delovno skupino za farmakokinetiko ter delovno skupino za modeliranje in simulacije (MSWP).
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.
Slovenian: Čeprav ni dvoma, da model ni nadomestek za dokaz bioekvivalence (saj podatki in vitro na splošno niso sprejemljiv dokaz bioekvivalence), obstajajo izjeme, kakršna je npr. opustitev bioekvivalenčne študije na podlagi zgradbe biofarmacevtske klasifikacije.
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.
Slovenian: Referenčna država članica, Združeno kraljestvo, je menila, da je na podlagi vseh dostopnih podatkov in zlasti primerljivih farmacevtskih podatkov o podobni količini ostankov EE in ENG mogoče dovolj zanesljivo zaključiti, da se bioekvivalenca testnega in referenčnega zdravila ohrani do konca 28-dnevnega obdobja.
English: This modelling, together with the following information below was considered to provide further reassurance for the extended use up to 28 days:
Slovenian: Za to modeliranje, skupaj z informacijami v nadaljevanju, je bilo ugotovljeno, da dodatno podpira podaljšanje uporabe do 28. dne:
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.
Slovenian: Nasprotujoče zadevne države članice (DE, NL in FR) pa so ugovarjale, da se vaginalni dostavni sistem Perlinring 0,12 mg/0,015 mg na 24 ur ne sme odobriti, saj so dokazi za njegovo uporabo med 21. in 28. dnem ekstrapolirani in se zato bioekvivalenca v tem obdobju šteje za nedokazano.
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.
Slovenian: prav tako ni tveganja, da se učinkovine ne bi sproščale 28 dni, saj je njihova količina v obročku presežna.
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).
Slovenian: Ker priporočeno 21-dnevno odmerjanje podpira bioekvivalenčna študija, se je vprašanje, ki se je pojavilo in obravnavalo v okviru odbora CHMP, nanašalo na dodatne podatke, predložene v podporo uporabi med 21. in 28. dnem, ter na to, ali se ti podatki štejejo kot sprejemljivi za podporo podaljšani uporabi do 28. dne (skladno z referenčnim zdravilom).
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.
Slovenian: Znanstveni dokazi torej podpirajo trditev, da se bosta generično in referenčno zdravilo od 21. do 28. dne obnašala podobno.
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.
Slovenian: Odbor je obravnaval razpoložljive podatke, predložene v podporo uporabi zdravila Perlinring v dodatnem tednu do 28. dne, ki so vključevali korelacijo in vivo-in vitro, farmacevtske podatke, kot so podatki o in vitro raztapljanju in količini ostankov, ter celovitost in prenašanje obročka,
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.
Slovenian: Vzorčno obdobje 21 dni v opravljeni bioekvivalenčni študiji se sklada s priporočeno uporabo zdravila, pri čemer je bila bioekvivalenca testnega zdravila Perlinring in referenčnega zdravila NuvaRing za priporočeno trajanje uporabe nesporno zadovoljivo dokazana.
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
Slovenian: farmacevtska ekvivalenca testnega in referenčnega zdravila je bila dokazana, poleg tega so bili podani primerljivi podatki o raztapljanju in vitro, s katerimi je bilo ocenjeno sproščanje obeh zdravil v času 28 dni;
English: Furthermore, the vaginal ring integrity is not expected to be affected if retained over the period of 28 days.
Slovenian: poleg tega v 28-dnevnem obdobju ni pričakovati zmanjšanja celovitosti vaginalnega obročka.
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).
Slovenian: Zaradi pomanjkanja podatkov in vivo, ki bi podpirali podaljšano uporabo obročka (do 28. dne), navedeno kot odmik od priporočene sheme (21 dni) skladno z informacijami, vključenimi v informacije o zdravilu za referenčno zdravilo NuvaRing, je bilo ocenjeno, da obstaja možno resno tveganje za javno zdravje (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.
Slovenian: Odbor CHMP je zato večinsko soglašal, da podatki, ki jih je predložil predlagatelj, kot celota podpirajo podaljšano uporabo do 28. dne.
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.
Slovenian: Da bi odgovorili na pomislek o podaljšanju uporabe (podaljšana uporaba obročka) do 28. dne, kar je odmik od priporočene uporabe, vključene v povzetek glavnih značilnosti zdravila NuvaRing, je predlagatelj predložil dodatne informacije, in sicer podatke o farmacevtski kakovosti za testno in referenčno zdravilo ter podatke o raztapljanju in vitro, v katerih so bili ocenjeni hitrost sproščanja testnega in referenčnega zdravila v času 28 dni, korelaciji in vitro-in vivo (IVIVC) za referenčno formulacijo za 28 dni, korelaciji in vitro-in vivo (IVIVC) za testno formulacijo za 21 dni ter količinah ostankov v obročkih z etonogestrelom in etinilestradiolom v testnem in referenčnem zdravilu na 21. dan.
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.
Slovenian: Prav tako ni pričakovati pomislekov o prenašanju obročka po 28 dneh, saj so polimer, količine učinkovin in mere obročka pri testnem in referenčnem zdravilu podobni.
English: The recommended period of use of this product is 21 days; however, according to the summary of product characteristics (SmPC) of the reference medicinal product, even though not the recommended regimen, the contraceptive efficacy of the reference product is maintained for up to 28 days.
Slovenian: Priporočeni čas uporabe tega zdravila je 21 dni, vendar se skladno s povzetkom glavnih značilnosti zdravila referenčnega zdravila kontracepcijska učinkovitost referenčnega zdravila ohrani do 28 dni, čeprav to ni priporočena shema.
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.
Slovenian: Da bi obravnavali vidik podaljšanja uporabe do 28. dne, vključen v povzetek glavnih značilnosti zdravila NuvaRing kot odmik od priporočene uporabe, je predlagatelj dodatno opravil modeliranje IVIVC, da bi na podlagi podatkov o testnem zdravilu za 21 dni in objavljenih podatkov o referenčnem zdravilu za 28 dni dokazal, da se obnašanje obročka med 21. in 28. dnem ne spremeni.
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.
Slovenian: • odbor je presodil, da predloženi podatki kot celota utemeljujejo ohranitev kontracepcijske učinkovitosti obročka do 28 dni za zdravilo Perlinring, skladno z referenčnim zdravilom NuvaRing odbor zato ocenjuje, da je razmerje med tveganji in koristmi zdravila Perlinring in povezanih imen ugodno, in priporoča izdajo dovoljenja (dovoljenj) za promet z zdravili, navedenimi v Prilogi I k mnenju odbora CHMP.