FrancophonIA/ELRC3.0 huggingface dataset:
English: • The Committee considered that the available data gave rise to serious doubts as to the evidence of the bioequivalence of Leflunomide Apotex and associated names with the EU reference product in view of concerns on the reliability of the data, due to the findings of the inspection of the Cetero Research facilities.
Slovenian: • Odbor je menil, da so razpoložljivi podatki povzročili resne dvome glede dokazov o biološki enakovrednosti zdravila Leflunomide Apotex in povezanih imen ter referenčnega zdravila v EU zaradi pomislekov glede zanesljivosti podatkov, ki so bili izpostavljeni v ugotovitvah inšpekcijskega pregleda ustanove Cetero Research.
English: Regarding the comparative dissolution testing, the CHMP was of the view that bioequivalence studies are pivotal to demonstrate bioequivalence for oral tablets.
Slovenian: Glede primerjalnega testiranja raztapljanja je odbor CHMP menil, da so študije biološke enakovrednosti ključne za dokazovanje biološke enakovrednosti peroralnih tablet.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study B050309, submitted in support of the marketing authorisation, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Leflunomide Apotex to its EU reference product, the CHMP was unable to conclude on the bioequivalence of Leflunomide Apotex.
Slovenian: Zaradi resnih pomislekov glede zanesljivosti in pravilnosti podatkov iz kritične, ključne študije biološke enakovrednosti B050309, predložene kot podpora za dovoljenje za promet z zdravilom, ter zaradi odsotnosti zanesljive študije biološke enakovrednosti, posebej zasnovane za ugotavljanje biološke enakovrednosti zdravila Leflunomide Apotex in referenčnega zdravila v EU, odbor CHMP ni mogel sklepati o biološki enakovrednosti zdravila Leflunomide Apotex.
English: As further evidence of the bioequivalence of Leflunomide Apotex with the reference product, the MAH provided an overview of the qualitative and quantitative composition of its 10 and 20 mg tablets intended for the US, Canadian and European market, considering them to be identical.
Slovenian: Kot dodatne dokaze za biološko enakovrednost zdravila Leflunomide Apotex in referenčnega zdravila je imetnik dovoljenja za promet z zdravilom predložil pregled kakovostne in količinske sestave za svoje 10- in 20-miligramske tablete, namenjene za trg v ZDA, Kanadi in Evropi, pri čemer je predpostavil, da je identična.
English: The results of the pivotal bioequivalence study showed that the 90% confidence intervals were within the 80% to 125% limits for AUC0-72 and Cmax and the pharmacokinetic data was therefore considered to demonstrate that the Leflunomide Apotex 20 mg tablets and the reference product 20 mg tablets were bioequivalent under fasting conditions.
Slovenian: Rezultati ključne študije biološke enakovrednosti so pokazali, da so bili 90-odstotni intervali zaupanja znotraj 80- do 125odstotnih omejitev za AUC0-72 in Cmax, zato se je sklepalo, da so farmakokinetični podatki dokazali, da sta zdravilo Leflunomide Apotex 20 mg tablete in referenčno zdravilo z 20-miligramskimi tabletami biološko enakovredni pri pogojih na tešče.
English: The MAH therefore concluded that the deficiencies identified at the Cetero Research Houston facility do not impact the benefit-risk balance of Leflunomide Apotex.
Slovenian: Zato je sklepal, da pomanjkljivosti, ki so jih odkrili v ustanovi Cetero Research v Houstonu, ne vplivajo na razmerje med tveganji in koristmi pri zdravilu Leflunomide Apotex.
English: Finally, the CHMP noted that the MAH did not plan to perform a new bioequivalence study, as it considered the provided additional data sufficient to confirm the validity of the studies for the EU applications in which Cetero Research was involved.
Slovenian: Odbor CHMP je ugotovil, da imetnik dovoljenja za promet z zdravilom ni načrtoval nove študije biološke enakovrednosti, saj je menil, da so predloženi dodatni podatki zadostni za potrditev veljavnosti študij za vloge v EU, pri katerih je bila vključena ustanova Cetero Research.
English: In conclusion, the MAH was of the opinion that the results from the pivotal bioequivalence study supporting the marketing authorisation application are confirmed by the other studies not conducted at, or analysed by, Cetero Research, which all showed a high degree of similarity between Leflunomide Apotex and the US and Canadian reference product.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da rezultate ključne študije biološke enakovrednosti, ki podpira vlogo za pridobitev dovoljenja za promet z zdravilom, potrjujejo druge študije, ki niso bile izvedene ali analizirane v ustanovi Cetero Research ter so vse pokazale veliko stopnjo podobnosti med zdravilom Leflunomide Apotex in referenčnim zdravilom iz ZDA in Kanade.
English: Finally, the MAH provided comparative dissolution profiles between Leflunomide Apotex 10 and 20 mg, tablets and reference product 10 and 20 mg tablets from various markets, supporting the MAH view that the dissolution profiles of Leflunomide Apotex and the reference product are similar.
Slovenian: Na koncu je imetnik dovoljenja za promet z zdravilom predložil primerjalne profile raztapljanja za zdravilo Leflunomide Apotex 10 in 20 mg tablete ter referenčno zdravilo 10 in 20 mg tablete z različnih trgov, ki podpirajo mnenje imetnika dovoljenja za promet z zdravilom, da so profili raztapljanja zdravila Leflunomide Apotex in referenčnega zdravila podobni.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Leflunomide Apotex to its EU reference product, the benefit-risk balance of Leflunomide Apotex cannot be considered to be favourable.
Slovenian: Zaradi odsotnosti zanesljive študije biološke enakovrednosti, posebej zasnovane za ugotavljanje biološke enakovrednosti zdravila Leflunomide Apotex in referenčnega zdravila v EU, razmerja med tveganji in koristmi pri zdravilu Leflunomide Apotex ni mogoče obravnavati kot pozitivnega.
English: For six of the reports, quality assurance investigations were conducted by the MAH and no problems were identified with Leflunomide Apotex.
Slovenian: Pri šestih poročilih je imetnik dovoljenja za promet z zdravilom opravil preiskave zagotavljanja kakovosti, pri katerih niso bile odkrite nobene težave, povezane z zdravilom Leflunomide Apotex.
English: Therefore, the CHMP did not consider the available data to be sufficient to support the bioequivalence of the EU formulation of Leflunomide Apotex to the EU reference product.
Slovenian: Zato je odbor CHMP menil, da razpoložljivi podatki niso zadostni za podporo biološke enakovrednosti formulacije zdravila Leflunomide Apotex v EU in referenčnega zdravila v EU.
English: • The Committee is of the opinion that considering the serious doubts in respect of the evidence of bioequivalence, the benefit-risk of Leflunomide Apotex and associated names cannot be confirmed.
Slovenian: • Odbor je mnenja, da zaradi resnih dvomov glede dokazov o biološki enakovrednosti ni mogoče potrditi razmerja med tveganji in koristmi zdravila Leflunomide Apotex in povezanih imen.
English: However, the CHMP stated that bioequivalence studies performed with a non-EU reference products cannot be accepted as evidence of bioequivalence and that any evidence of product similarity between EU and non-EU products can only be considered as supportive.
Slovenian: Odbor CHMP je navedel, da študij biološke enakovrednosti, opravljenih z referenčnimi zdravili zunaj EU, ni mogoče sprejeti kot dokaz za biološko enakovrednost ter da se lahko dokazi o podobnosti zdravil znotraj EU in zunaj nje obravnavajo samo kot podporni.
English: The single pivotal bioequivalence study B050309 conducted to support the marketing authorization application was a comparative, parallel, three arm study to compare the relative bioavailability of Leflunomide Apotex 20 mg tablets with that of the EU reference product Arava 20 mg tablets in healthy, adult volunteers under fasting conditions.
Slovenian: Ena ključna študija biološke enakovrednosti B050309, opravljena za podporo vlogi za pridobitev dovoljenja za promet z zdravilom, je bila primerjalna študija s tremi vzporednimi skupinami, v kateri so primerjali relativno biološko uporabnost zdravila Leflunomide Apotex 20 mg tablete in referenčnega zdravila Arava 20 mg tablete za EU pri zdravih odraslih prostovoljcih na tešče.
English: In response to the CHMP list of questions, the MAH submitted a review of the benefit-risk balance of Leflunomide Apotex.
Slovenian: Kot odgovor na seznam vprašanj odbora CHMP je imetnik dovoljenja za promet z zdravilom predložil pregled razmerja med tveganji in koristmi pri zdravilu Leflunomide Apotex.
English: One case report reported lack of efficacy, where the product was used for lupus mixed connective tissue disease, which is not an approved indication.
Slovenian: V tem primeru se je zdravilo uporabljalo zaradi mešane bolezni vezivnega tkiva z lupusom, ki ni odobrena indikacija.
English: The MAH therefore considered that the pharmacokinetic data demonstrate that the EU Leflunomide Apotex is bioequivalent to both the US and Canadian reference products under fasting and fed conditions.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zato sklepal, da farmakokinetični podatki kažejo, da je zdravilo Leflunomide Apotex v EU biološko enakovredno referenčnima zdraviloma v ZDA in Kanadi pri pogojih na prazen in poln želodec.
English: The MAH also provided details of 4 bio-equivalence studies, conducted to support the marketing authorisation application in the United States and Canada, comparing Leflunomide Apotex with their reference product, under fasting and fed conditions.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil tudi podrobnosti 4 študij biološke enakovrednosti, ki so bile opravljene za podporo vlogi za pridobitev dovoljenja za promet z zdravilom v ZDA in Kanadi ter v katerih so primerjali zdravilo Leflunomide Apotex z referenčnim zdravilom pri pogojih na prazen in poln želodec.
English: • The Committee considered that the responses of the MAH are not adequate to refute the serious doubts as to the evidence of the bioequivalence of Leflunomide Apotex and associated names with the EU reference product.
Slovenian: • Odbor je menil, da odgovori imetnika dovoljenja za promet z zdravilom niso zadostni, da bi zavrnili resne dvome glede dokazov o biološki enakovrednosti zdravila Leflunomide Apotex in povezanih imen ter referenčnega zdravila v EU.
English: The CHMP noted that although f2 calculations were not provided, the MAH conclusion was supported based on the studies in the two media.
Slovenian: Odbor CHMP je ugotovil, da sklep imetnika dovoljenja za promet z zdravilom podpirajo študije v dveh medijih, čeprav niso bili predloženi izračuni f2.
English: The MAH considered that the data described in this PSUR did not change the benefit-risk balance of Leflunomide Apotex.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da podatki v tem poročilu PSUR niso spremenili razmerja med tveganji in koristmi pri zdravilu Leflunomide Apotex.
English: Package Leaflet 1.
Slovenian: Navodilo za uporabo 1.
English: - Stopping breast milk production for medical reasons only, and when you and your doctor have decided that it is necessary.
Slovenian: Zaustavitev tvorjenja materinega mleka samo zaradi zdravstvenih razlogov in kadar se vi in vaš zdravnik odločite, da je to nujno potrebno.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko ustrezni organi države članice naknadno posodobijo v sodelovanju z referenčno državo članico, kot je primerno, v skladu s postopki, opisanimi v poglavju 4, naslovu III Direktive 2001/83/EC.
English: Bromocriptine should not routinely be used to stop breast milk production.
Slovenian: Bromokriptin naj se ne uporablja rutinsko za ustavitev tvorjenja materinega mleka.
English: Bromocriptine may be used for:
Slovenian: Bromokriptin se lahko uporablja za:
English: This Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Slovenian: Ta Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo je rezultat postopka napotitve.
English: What bromocriptine is and what it is used for:
Slovenian: Kaj je bromokriptin in za kaj ga uporabljamo
English: Blood pressure should be carefully monitored, especially during the first days of therapy.
Slovenian: Potrebno je pozorno spremljanje krvnega tlaka, najbolj v prvih dneh uporabe zdravila.
English: Therefore, your doctor will need to check your blood pressure regularly during the first days of treatment.
Slovenian: Da bi se temu izognili, mora vaš zdravnik v prvih dneh zdravljenja redno preverjati vaš krvni tlak.
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Slovenian: [Obstoječe informacije o zdravilu se spremenijo (vstavljanje, zamenjava ali izbris besedila,če je primerno) tako, da izražajo dogovorjeno besedilo, kot je predvideno v nadaljevanju.]
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Priloga III Spremembe posameznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo
English: 4.3 Contraindications [This section should be amended as appropriate to reflect the wording below for all products referred in Annex I]
Slovenian: 4.3 Kontraindikacije [To poglavje se spremeni tako, da odraža spodnje besedilo za vsa zdravila, navedena v Prilogi I.]
English: Prevention or suppression of post-partum physiological lactation only where medically indicated (such as in case of intrapartum loss, neonatal death, HIV infection of the mother…).
Slovenian: Preprečevanje ali zaviranje poporodnega fiziološkega dojenja samo takrat, kadar je klinično indicirano (kot na primer ob medporodni izgubi, neonatalni smrti, okužbi matere z virusom HIV...).
English: What you need to know before you take bromocriptine [The wording below should be inserted in this section under the following headings for all products referred to in Annex I]
Slovenian: Kaj morate vedeti pred uporabo bromokriptina [Spodnje besedilo se vstavi v to poglavje pod naslednje naslove, za vsa zdravila iz Priloge I.] Ne jemljite bromokriptina:
English: In some patients the development of seizures or stroke was preceded by severe headache and/or transient visual disturbances.
Slovenian: Pri nekaterih bolnikih se je po hudih glavobolih in/ali prehodnih motnjah vida pojavil epileptični napad ali kap.
English: Bromocriptine is contraindicated for use in the suppression of lactation or other non-life threatening indications in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders.
Slovenian: Bromokriptin je kontraindiciran za uporabo pri zaviranju dojenja ali drugih indikacijah, ki niso smrtno nevarne pri bolnikih z anamnezo koronarne arterijske bolezni ali drugih resnih bolezni srca in ožilja ali simptomi/anamnezo hudih duševnih motenj.
English: In rare cases serious adverse events, including hypertension, myocardial infarction, seizures, stroke, or psychiatric disorders have been reported in post-partum women treated with bromocriptine for the inhibition of lactation.
Slovenian: V redkih primerih so poročali o resnih neželenih učinkih, vključno s hipertenzijo, srčnim infarktom, epileptičnim napadom, s kapjo ali psihiatričnimi motnjami, ki so se pojavili pri ženskah, zdravljenih z bromokriptinom za zaviranje dojenja v poporodnem obdobju.
English: - You have high blood pressure, - You have ever had blood pressure problems during pregnancy or after giving birth, such as eclampsia, pre-eclampsia, pregnancy-induced high blood pressure, high blood pressure after giving birth.
Slovenian: − če ste imeli kadar koli težave s krvnim tlakom med nosečnostjo ali po porodu, kot na primer eklampsijo, preeklampsijo, zvišan krvni tlak, kot posledica nosečnosti, zvišan krvni tlak po porodu;
English: Bromocriptine is contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and in the puerperium.
Slovenian: Bromokriptin je kontraindiciran pri bolnikih z nenadzorovano hipertenzijo, motnjo krvnega tlaka v nosečnosti (vključno z eklampsijo, preeklampsijo ali z nosečnostjo inducirano hipertenzijo), s hipertenzijo v poporodnem obdobju.
English: Bromocriptine is not recommended for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with nonpharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
Slovenian: Bromokriptin se ne priporoča za rutinsko zaviranje dojenja ali lajšanje simptomov poporodne bolečine in nabreklosti, ki se lahko enakovredno obravnavajo brez farmakološkega zdravljenja (kot na primer s trdno podporo prsi ali uporabo ledu) in/ali z enostavnimi analgetiki.
English: 4.4 Special warnings and precautions for use [For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Slovenian: 4.4 Posebna opozorila in previdnost pri uporabi izdelka [Samo za zdravila jakosti 1 mg in 2,5 mg naj se poglavje spremeni tako, da kar najbolje odraža spodnje besedilo.]
English: or unremitting headache (with or without visual disturbances), or evidence of central nervous system toxicity develop, the administration of bromocriptine should be discontinued and the patient should be evaluated promptly.
Slovenian: nakazujoča bolečina v prsih, hud, napredujoč ali vztrajen glavobol (z motnjo vida ali brez nje), dokazi toksičnosti za osrednji živčni sistem, naj se uporaba bromokriptina prekine, bolnika pa je treba takoj pregledati.
English: It should also not be used to relieve symptoms of painful breast engorgement after giving birth if these can be adequately treated with non-medical means (such as firm breast support, ice application…) and/ or a painkiller.
Slovenian: Prav tako naj se ne uporablja za zmanjšanje simptomov nabreklih prsi po porodu, če se lahko to izboljša z ukrepi, ki ne vključujejo zdravil (kot na primer s trdno podporo prsi ali uporabo ledu) in/ali z zdravili za zmanjšanje bolečine.
English: - You have, or have ever had, heart disease, or other severe blood vessel disease - You have, or have ever had, serious mental health problems
Slovenian: − če imate ali ste kadar koli imeli bolezni srca ali druge resne bolezni ožilja;
English: [For products of 1 mg and 2.5 mg strengths only, this section should be amended as appropriate to reflect the wording below]
Slovenian: [Samo za zdravila jakosti 1 mg in 2,5 mg naj se poglavje spremeni tako, da kar najbolje odraža spodnje besedilo.]
English: Speak immediately to your doctor if you experience high blood pressure, chest pain or unusually severe or persistent headache (with or without vision problems).
Slovenian: Če občutite zvišan krvni tlak, bolečino v prsih ali hud in vztrajen glavobol (z motnjo vida ali brez nje) se takoj posvetujte s svojim zdravnikom.
English: These are very rare, but may include high blood pressure, heart attack, convulsion, stroke or mental problems.
Slovenian: Po porodu ste lahko bolj izpostavljeni določenim stanjem, ki pa so redka: zvišan krvni tlak, srčni infarkt, epileptični napad, kap ali duševne motnje.
English: 4.1 Therapeutic indications [A. For products of 1 mg and 2.5 mg strengths, the current indication related to lactation inhibition in post-partum, including the examples of mastitis and painful breast engorgement, should be deleted and the below wording should be included in its place]
Slovenian: 4.1 Terapevtske indikacije [A. Za zdravila jakosti 1 mg in 2,5 mg naj se izbriše indikacija, ki se nanaša na zaviranje poporodnega dojenja, vključno v primerih mastitisa in boleče nabreklosti prsi, ter se namesto tega zapiše spodnje besedilo.]
English: [A. For products of 1 mg and 2.5 mg strengths, the current indication related to lactation inhibition in post-partum, including the examples of mastitis and painful breast engorgement, should be deleted and the below wording should be included in its place]
Slovenian: [A. Za zdravila jakosti 1 mg in 2,5 mg naj se izbriše indikacija, ki se nanaša na zaviranje poporodnega dojenja, vključno v primerih mastitisa in boleče nabreklosti prsi, ter se namesto tega zapiše spodnje besedilo.]
English: [B. For product of higher strengths (5 mg and 10 mg) the indication related to inhibition of lactation in post-partum, including the examples of mastitis and painful breast engorgement, should be removed and the complete SmPC should be revised to remove wording related to the deleted indication]
Slovenian: [B. Za zdravila višje jakosti (5 mg in 10 mg) naj se umakne indikacija, ki se nanaša na zaviranje poporodnega dojenja, vključno v primerih mastitisa in boleče nabreklosti prsi.
English: If hypertension, suggestive chest pain, severe, progressive,
Slovenian: Če se pojavijo hipertenzija,
English: A total of 104 subjects were enrolled.
Slovenian: Skupaj so bili vključeni 104 preiskovanci.
English: 30 January 2019
Slovenian: 30. januar 2019
English: The MAH should submit the protocol for the above mentioned study.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora predložiti protokol za zgoraj omenjeno študijo.
English: (Annex V of the CMDh position).
Slovenian: (Priloga V stališča skupine CMDh).
English: The levels of magnesium in these cases are not considered to represent clinically relevant hypermagnesemia.
Slovenian: Šteje se, da ravni magnezija v teh primerih ne predstavljajo klinično pomembne hipermagneziemije.
English: Overall, data suggest that neonates can tolerate during a short time a relatively wide range of serum magnesium concentrations without increased risk of adverse outcomes.
Slovenian: Na splošno podatki kažejo, da novorojenčki v krajšem obdobju lahko prenašajo sorazmerno širok razpon koncentracij magnezija v serumu brez povečanega tveganja za neželene izide.
English: Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorisation were warranted.
Slovenian: Odbor PRAC je zato na podlagi razpoložljivih podatkov o končnem poročilu študije PASS menil, da so potrebne spremembe pogojev dovoljenja za promet z zdravilom.
English: Hypermagnesaemia was reported in 4 cases, 3 of which were mild and one moderate in severity.
Slovenian: Poročali so o 4 primerih hipermagneziemije, od katerih so bili 3 blagi in eden zmeren.
English: No pattern of accumulation or continued increase in serum magnesium levels that would raise any safety concern was observed.
Slovenian: Opazili niso nobenega vzorca kopičenja ali stalnega zviševanja ravni magnezija v serumu, ki bi vzbujala zaskrbljenost glede varnosti.
English: The MAH should conduct a prospective non-interventional post-authorisation safety study to further evaluate magnesium levels observed in term newborn infants and children up to two years of age treated with Numeta G16%E in routine clinical practice.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora opraviti prospektivno, neintervencijsko študijo varnosti po pridobitvi dovoljenja za promet z zdravilom, s katero bo nadalje ocenil ravni magnezija, opažene pri donošenčkih in otrocih, starih do dveh let, ki se zdravijo z zdravilom Numeta G16%E v rutinski klinični praksi.
English: No potential risk factors for notable increase in serum magnesium were identified.
Slovenian: Potencialnih dejavnikov tveganja za opazno zvišanje ravni magnezija v serumu niso identificirali.
English: October 2018 CMDh meeting
Slovenian: Zasedanje skupine CMDh oktobra 2018