FrancophonIA/ELRC3.0 huggingface dataset:
English: The PRAC, as a consequence, concluded that the benefit-risk balance of the medicinal products Evra, Ioa and Zoely in the indication of contraception remains favourable, subject to the agreed conditions, restrictions, warnings, other changes to the product information and additional risk minimisation
Slovenian: Posledično je PRAC zaključil, da je razmerje med tveganji in koristmi zdravil Evra, Ioa in Zoely za indikacijo kontracepcije še naprej ugodno pod pogojem, da se upoštevajo dogovorjeni pogoji, omejitve, opozorila in druge spremembe informacij o zdravilu ter dodatni ukrepi za zmanjšanje tveganja.
English: It is known that the risk of arterial thromboembolism (ATE) (myocardial infarction, cerebrovascular accident) is also increased with use of CHCs, however there was no evidence for differences between
Slovenian: Znano je, da se z uporabo kombiniranih hormonskih kontraceptivov poveča tudi tveganje za arterijsko trombembolijo (ATE, tj. srčni infarkt in cerebrovaskularni dogodki), vendar pa ni dokazov, da bi med kombiniranimi hormonskimi kontraceptivi obstajale razlike v relativnem tveganju za ATE.
English: EMEA/301122/2007-EN
Slovenian: EMEA/301122/2007-SL
English: The rapporteur was Dr. J. Schefferlie and the co-rapporteur was Prof. R. Kroker.
Slovenian: Poročevalec je bil dr. J. Schefferlie, soporočevalec pa prof. R. Kroker.
English: London, 24 July 2007 EMEA/301122/2007
Slovenian: London, 24. julij 2007 EMEA/301122/2007
English: The Reference Member State was France and the Concerned Member States were Belgium, the Czech Republic, Germany, Italy, Spain, and the United Kingdom.
Slovenian: Referenčna država članica je bila Francija, zadevne države članice pa Belgija, Češka republika, Nemčija, Italija, Španija in Velika Britanija.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II.
Slovenian: Seznam zadevnih imen izdelkov je podan v dodatku I. Znanstveni zaključki so podani v dodatku II.
English: The product was accepted by the Czech Republic, Italy and Spain.
Slovenian: Zdravilo so sprejele Češka republika, Italija in Španija.
English: The final opinion was converted into a Decision by the European Commission on 13 June 2007.
Slovenian: Končno mnenje je Evropska komisija v Odločbo spremenila dne 13. junija 2007.
English: The arbitration procedure started on 8 September 2005 with the adoption of list of questions.
Slovenian: Postopek arbitraže se je pričel 8. septembra 2005 s sprejemom seznama vprašanj.
English: Belgium referred the reason for disagreement to the EMEA on 28 July 2005.
Slovenian: Belgija je razloge za nesoglasje dne 28. julija 2005 poslala agenciji EMEA.
English: On 25 October 2006 the European Commission forwarded a draft decision to the Standing Committee on Veterinary Medicinal Products for adoption by written procedure.
Slovenian: 25. oktobra 2006 je Evropska komisija posredovala osnutek odločbe Stalnemu odboru za zdravila za uporabo v veterinarski medicini v sprejem po pisnem postopku.
English: The reasons for the suspension were the same as those identified in the May 2006 CVMP meeting.
Slovenian: Razlogi za začasni preklic so bili isti kot na zasedanju CVMP maja 2006.
English: • the currently authorised withdrawal periods are inadequate to ensure that foodstuffs obtained from the treated animal do not contain residues which might constitute a health hazard to the consumer.
Slovenian: • trenutno odobrene karence ne zagotavljajo, da živila, proizvedena iz zdravljenih živali, ne vsebujejo za potrošnikovo zdravje potencialno nevarnih ostankov.
English: During their June 2006 meeting, the CVMP appointed Dr. R. Breathnach as rapporteur for the assessment of the grounds for the request for re-examination of the opinion.
Slovenian: Med svojim zasedanjem junija 2006 je CVMP določil dr. R. Breathnacha za poročevalca pri ocenjevanju podlage prošnje za ponovno presojo mnenja.
English: Concerns were raised by Belgium, Germany and the United Kingdom regarding the inadequacy of the withdrawal periods and the applications were withdrawn from these countries.
Slovenian: Belgija, Nemčija in Velika Britanija so izrazile pomisleke v zvezi z (ne)ustreznostjo karenc in vloge so bile v teh državah umaknjene.
English: During the written procedure a request was received from the France for new studies made available by the Marketing Authorisation Holder to be scientifically assessed.
Slovenian: Med pisnim postopkom je Francija posredovala prošnjo za znanstveno oceno novih študij, ki jih je dal na razpolago imetnik dovoljenja za promet z zdravilom.
English: The scope of the referral was to agree whether the proposed withdrawal periods of 58 days for cattle and 35 days for pigs were adequately established.
Slovenian: Namen napotitve je bila uskladitev mnenj, ali sta bili predlagani karenci 58 dni za govedo in 35 dni za prašiče pravilno določeni.
English: The detailed grounds for the request were submitted to the EMEA on 18 July 2006 and the evaluation procedure for the re-examination started on 19 July 2006.
Slovenian: Podrobna podlaga za to prošnjo je bila EMEA predložena dne 18. julija 2006, 19. julija 2006 pa se je pričel postopek vrednotenja v okviru ponovne presoje.
English: o in cattle, residue concentration at the injection site were still above the MRL at the last slaughter time point; o in pigs, residue concentrations at the injection site were still above the MRL at the last slaughter time point.
Slovenian: o pri govedu so bile koncentracije ostankov na mestu injiciranja še pri zadnji časovni točki zakola višje od MRL; o pri prašičih so bile koncentracije ostankov na mestu injiciranja še pri zadnji časovni točki zakola višje od MRL.
English: On 14 November 2006 the European Commission suspended the written procedure and on 16 November 2006, requested the CVMP, to consider the new residue studies in the assessment of the referral and to revise as appropriate the opinion of 13 September 2006.
Slovenian: Dne 14. novembra 2006 je Evropska komisija prekinila pisni postopek ter 16. novembra 2006 zaprosila CVMP, naj v oceni postopka napotitve upošteva nove študije ostankov in ustrezno popravi svoje mnenje z dne 13. septembra 2006.
English: In both species the product is administered intramuscularly at a dose rate of 15 mg amoxicillin/kg bw (equivalent to 1 ml of Suramox 15% LA / 10 kg bw) twice at 48 hours interval.
Slovenian: Pri obeh vrstah se zdravilo daje intramuskularno v odmerku 15 mg amoksicilina/1 kg tm (enakovredno 1 ml zdravila Suramox 15 % LA/10 kg tm) dvakrat v 48-urnem razmiku.
English: On 1 June 2006, the representative of the MAH notified the EMEA on his intention to request the reexamination of the CVMP opinion in accordance with Article 36(4)2.
Slovenian: Dne 1. junija 2006 je zastopnik imetnika dovoljenja za promet z zdravilom obvestil EMEA, da namerava zaprositi za ponovno preučitev mnenja CVMP v skladu s členom 36(4)2.
English: The Marketing Authorisation Holder (MAH) provided written explanations on 16 January 2006.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil pisna pojasnila 16. januarja 2006.
English: The Marketing Authorisation Holder submitted the new residue studies to the CVMP on 9 January 2007 and provided oral explanations to the Committee on 13 March 2007 including presentation of a new residue study in pigs and a new calculation and proposal for the withdrawal period for pigs.
Slovenian: Imetnik dovoljenja za promet je nove študije ostankov posredoval CVMP 9. januarja 2007 ter 13. marca 2007 podal ustno razlago Odboru, vključno s predstavitvijo nove študije ostankov pri prašičih in novim izračunom in predlogom karence za prašiče.
English: A Marketing Authorisation for Suramox 15% LA was previously granted to Virbac S.A. in France on 6 July 2004 based on an abridged application having Duphamox LA as reference medicinal product, with a withdrawal period of 58 days in cattle for meat and offal and 35 days in pigs for meat and offal.
Slovenian: Dovoljenje za promet za zdravilo Suramox 15 % LA je bilo prvotno podeljeno podjetju Virbac S.A. iz Francije dne 6. julija 2004, in sicer na podlagi skrajšane vloge za Duphamox LA kot referenčno zdravilo, s karenco 58 dni pri govedu za meso in drobovino ter 35 dni pri prašičih za meso in drobovino.
English: • the currently established withdrawal periods for cattle and pigs are inadequate to ensure that residues do not exceed the MRLs;
Slovenian: • trenutno določene karence za govedo in prašiče ne zagotavljajo, da ostanki ne presegajo
English: At the request of the MAH the evaluation procedure was suspended on 15 March 2006 in order to allow for the MAH to prepare for the provision of oral explanations.
Slovenian: Na prošnjo imetnika dovoljenja za promet z zdravilom je bil 15. marca 2006 postopek vrednotenja začasno ustavljen, da bi tako imetniku dovoljenja za promet z zdravilom omogočili pripravo na ustno pojasnjevanje.
English: • it was not possible to establish a withdrawal period for cattle and pigs based on the data available;
Slovenian: • na podlagi predloženih podatkov karence za govedo in prašiče ni bilo mogoče določiti;
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR Suramox 15 % LA and its associated name Stabox 15 % LA International Non-Proprietary Name (INN): Amoxicillin
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA zdravilo Suramox 15 % LA in z njim povezano ime Stabox 15 % LA Mednarodno nelastniško ime (INN): amoksicilin
English: During its March 2007 meeting, the CVMP, considered the new residue studies submitted with regard to Suramox 15% LA and concluded that the new data did not allow establishment of withdrawal periods for edible tissues in cattle and pigs.
Slovenian: Med svojim zasedanjem marca 2007 je CVMP preučil nove študije ostankov za zdravilo Suramox 15 % LA ter zaključil, da novi podatki ne omogočajo določitve karence za užitna tkiva goveda in prašičev.
English: Therefore the Committee adopted by consensus a revised opinion confirming its previous recommendation for the suspension of the marketing authorizations for Suramox 15% LA and the associated invented name, Stabox 15% LA.
Slovenian: Posledično je Odbor soglasno sprejel revidirano mnenje, potrjujoče njegovo predhodno priporočilo za začasni preklic dovoljenja za promet z zdravilom Suramox 15 % LA in z njim povezanim izmišljenim imenom Stabox 15 % LA.
English: On 13 September 2006 the CVMP, considered the detailed grounds the re-examination of the opinion and confirmed its previous opinion concluding that the marketing authorisations for Suramox 15% LA should be suspended.
Slovenian: 13. septembra 2006 je CVMP obravnaval podrobno podlago za ponovno presojo mnenja in potrdil svoje prvotno mnenje, s katerim priporoča začasni preklic dovoljenja za promet za zdravilo Suramox 15 % LA.
English: The oral explanations were presented on 17 May 2006 by the MAH to the Committee.
Slovenian: Imetnik dovoljenja za promet je dal ustna pojasnila Odboru 17. maja 2006.
English: Suramox 15% LA is an injectable suspension containing amoxicillin, which is a beta-lactam antibiotic, belonging to the group of penicillins.
Slovenian: Zdravilo Suramox 15 % LA je suspenzija za injiciranje, ki vsebuje amoksicilin, t.j.
English: During its May 2006 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion recommending the suspension of the
Slovenian: Med svojim zasedanjem maja 2006 je CVMP, z ozirom na vse posredovane podatke in znanstveno razpravo v okviru Odbora, soglasno sprejel mnenje in z njim priporočil začasni preklic dovoljenja za promet z zdravilom Suramox 15 % LA in z njim povezanim izmišljenim imenom Stabox 15 % LA, namenjenim za govedo in prašiče.
English: Frequency of this reactin cannot be estimated from the available data.
Slovenian: Pogostnosti te reakcije ni mogoče oceniti na podlagi podatkov, ki so na voljo.
English: • Risk Management Plan (RMP)
Slovenian: • • Načrt za obvladovanje tveganja (RMP)
English: Medical attention may be needed.
Slovenian: Morda boste potrebovali zdravniško pomoč.
English: This reaction may rarely occur (may affect up to 1 in 1,000 people).
Slovenian: Ta reakcija se lahko pojavi redko (pojavi se lahko pri največ 1 od 1.000 bolnikov).
English: To be used within 60 days of opening the bag.
Slovenian: Uporabite v 60 dneh od odprtja vrečke.
English: Both belong to a group of medicines called bronchodilators.
Slovenian: Obe spadata v skupino zdravil, imenovanih bronhodilatatorji.
English: A behavioural intervention program was added to both treatment groups for an additional 4 weeks.
Slovenian: Obema terapevtskima skupinama so za dodatne 4 tedne dodali vedenjski intervencijski program.
English: Hypokalaemia is usually transient, not requiring supplementation.
Slovenian: Hipokaliemija je po navadi prehodna, zato ne zahteva dodatnega zdravljenja.
English: When you press the button all the way down, the control window changes from red to green.
Slovenian: Ko pritisnete gumb do konca, se kontrolno okence spremeni iz rdečega v zelenega.
English: The medicine must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.
Slovenian: Zdravilo je treba uporabljati vsak dan dvakrat na dan, in ne samo takrat, ko se pojavijo težave z dihanjem ali drugi simptomi KOPB.
English: Breathlessness and other symptomatic outcomes:
Slovenian: Zadihanost in drugi simptomatski izidi:
English: Make sure the orange button is on top.
Slovenian: Prepričajte se, da je oranžni gumb na vrhu.
English: Use of rescue medication
Slovenian: Uporaba reševalnega zdravila
English: The recommended dose is one inhalation twice daily.
Slovenian: Priporočen odmerek je en vdih dvakrat na dan.
English: Further information regarding these two substances is provided below.
Slovenian: Več informacij o teh dveh učinkovinah je na voljo v nadaljevanju.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, in objavljenem na evropskem spletnem portalu o zdravilih.
English: If the control window still does not change to red, you may have forgotten to release the orange button before inhaling, or you may not have inhaled strongly enough.
Slovenian: Če se kontrolno okence še vedno ne obarva rdeče, ste morda pred inhaliranjem pozabili sprostiti oranžni gumb, ali pa morda niste dovolj močno inhalirali.
English: *As the primary endpoint did not achieve statistical significance, all p-values for secondary endpoints are tested at a nominal significance level of 0.05, and no formal statistical inference can be drawn.
Slovenian: *Ker primarni opazovani dogodek ni dosegel statistične značilnosti, so bile vse vrednosti p za sekundarne opazovane dogodke testirane z nominalno ravnjo značilnosti 0,05 in formalno statistično sklepanje ni mogoče.
English: • Medicines that lower the amount of potassium in your blood.
Slovenian: • zdravila, ki znižujejo raven kalija v krvi.
English: • Each time you load a dose by pressing the orange button, the dose indicator moves by a small amount towards the next number (50, 40, 30, 20, 10, or 0).
Slovenian: • Vsakič, ko s pritiskom na oranžni gumb naložite odmerek, se indikator odmerka za malenkost premakne proti naslednji številki (50, 40, 30, 20, 10, ali 0).
English: Some side effects may be serious: if you get any of these side effects, tell your doctor immediately.
Slovenian: Nekateri neželeni učinki so lahko resni: Če pride do katerega od navedenih neželenih učinkov, takoj obvestite zdravnika.
English: - You can use Brimica Genuair anytime before or after food or drink.
Slovenian: - Zdravilo Brimica Genuair lahko uporabite kadar koli pred uživanjem hrane ali pijače ali po tem.
English: Hypokalaemia increases susceptibility to cardiac arrhythmias.
Slovenian: Hipokaliemija povečuje dovzetnost za srčne aritmije.
English: It is important to instruct the patients to read the Instructions for Use in the Package Leaflet.
Slovenian: Pomembno je bolnike poučiti, da natančno preberejo navodila za uporabo v Navodilu za uporabo.
English: - The recommended dose is one inhalation in the morning and one inhalation in the evening.
Slovenian: - Priporočeni odmerek je en vdih zjutraj in en vdih zvečer.
English: Orange button
Slovenian: Oranžni gumb
English: Moreover, post-marketing reports of ‘peripheral oedema' did not show positive re-challenge.
Slovenian: Poleg tega v poročilih po prihodu zdravila na trg pri "perifernih edemih" niso ugotovili pozitivne ponovne provokacije.
English: If this occurs, medicinal product should be stopped and other treatment will be considered.
Slovenian: Če pride do tega, je treba zdravljenje z zdravilom prekiniti in razmisliti o drugačnem zdravljenju.
English: The plasma protein binding of formoterol is 61% to 64% (34% primarily to albumin).
Slovenian: Vezava formoterola na plazemske proteine je znašala med 61 % in 64 % (na albumin v osnovi znaša 34 %).
English: Name and address of the manufacturer responsible for batch release Industrias Farmacéuticas Almirall, S.A.
Slovenian: Ime in naslov izdelovalca, odgovornega za sproščanje serij Industrias Farmacéuticas Almirall, S.A.
English: • Medicines which can cause a type of change in the electrical activity of the heart known as QT interval prolongation (observed in an electrocardiogram).
Slovenian: • zdravila, ki lahko povzročijo vrsto spremembe električne dejavnosti srca, poznano kot podaljšanje intervala QT (opazi se na elektrokardiogramu).
English: If a dose is missed, it should be taken as soon as possible and the next dose should be taken at the usual time.
Slovenian: Če se odmerek izpusti, ga je treba uporabiti čim prej, naslednji odmerek pa ob običajnem času.
English: If you are affected by either of these side effects, do not drive or use machines until the dizziness has cleared or your vision has returned to normal.
Slovenian: Če imate katerega koli od teh neželenih učinkov, ne vozite in ne upravljajte strojev, dokler omotica ne mine in se povrne normalen vid.
English: Do not hold the orange button down while inhaling.
Slovenian: Ne držite oranžnega gumba navzdol, medtem ko inhalirate.
English: If you use Brimica Genuair with some other medicines, the effect of Brimica Genuair or the other medicines may be altered.
Slovenian: Če zdravilo Brimica Genuair uporabljate z drugimi zdravili, se lahko učinek zdravila Brimica Genuair ali drugih zdravil spremeni.
English: Each delivered dose contains approximately 11 mg lactose (as monohydrate).
Slovenian: En dostavljen odmerek vsebuje približno 11 mg laktoze (v obliki monohidrata).
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Slovenian: Pogostnost neželenih učinkov je opredeljena po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The most frequently reported adverse reactions with Brimica Genuair were nasopharyngitis (7.9%) and headache (6.8%).
Slovenian: Najpogosteje poročana neželena učinka zdravila Brimica Genuair sta bila nazofaringitis (7,9 %) in glavobol (6,8 %).
English: Brimica Genuair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Slovenian: Zdravilo Brimica Genuair se lahko uporablja med nosečnostjo samo, če se pričakuje, da koristi odtehtajo morebitna tveganja.
English: Even though the orange button is locked, your last dose may still be inhaled.
Slovenian: Tudi če je oranžni gumb zaklenjen, lahko še vedno vdihnete zadnji odmerek.
English: The combination of these substances with different mechanisms of action results in additive efficacy compared to that achieved with either component alone.
Slovenian: Kombinacija teh učinkovin z različnima mehanizmoma delovanja je dodatno prispevala k učinkovitosti v primerjavi z učinkovitostjo posamezne učinkovine.
English: It is unknown whether aclidinium (and/or its metabolites) or formoterol are excreted in human milk.
Slovenian: Ni znano, ali se aklidinij (in/ali njegovi presnovki) ali formoterol izločata v materino mleko.
English: Cytochrome P450 isoenzymes CYP2D6, CYP2C19, CYP2C9 and CYP2A6 are involved in the O-demethylation of formoterol.
Slovenian: Izoencimi citokroma P450 (CYP2D6, CYP2C19, CYP2C9 in CYP2A6) so vpleteni v proces O-demetilacije formoterola.
English: These effects are known exaggerated pharmacological responses observed with β2-agonists.
Slovenian: Ti učinki so znani pretirani farmakološki odzivi, opaženi pri agonistih β2.
English: Aclidinium is rapidly and extensively hydrolysed to its pharmacologically inactive alcohol- and carboxylic acid-derivatives.
Slovenian: Aklidinij se hitro in obširno hidrolizira v farmakološko neaktivne derivate alkohola in karboksilne kisline.
English: Aclidinium/formoterol did not statistically significantly reduce the average number of night-time awakenings due to COPD compared with placebo or formoterol.
Slovenian: Aklidinij/formoterol ni statistično pomembno zmanjšal povprečnega števila zbujanj ponoči zaradi KOPB v primerjavi s placebom ali formoterolom.
English: It is important that you read this information as the Genuair may work differently from inhalers you have used previously.
Slovenian: Pomembno je, da preberete te informacije, ker lahko inhalator Genuair deluje drugače od inhalatorjev, ki ste jih že prej uporabljali.
English: Hypokalaemic treatment
Slovenian: Hipokaliemično zdravljenje
English: Keep breathing in for as long as possible.
Slovenian: Nadaljujte z vdihavanjem kolikor dolgo je mogoče.
English: Make sure you have released the orange button, and you have breathed out completely.
Slovenian: Preverite, da ste sprostili oranžni gumb in da ste v celoti izdihnili.
English: Since aclidinium bromide is quickly broken down in plasma, the level of systemic anticholinergic undesirable effects is low.
Slovenian: Aklidinijev bromid se hitro razgrajuje v plazmi, zato je raven sistemskih antiholinergičnih neželenih učinkov nizka.
English: No dose adjustments are necessary in these patients.
Slovenian: Prilagajanje odmerka pri teh bolnikih ni potrebno.
English: Squeeze here and pull
Slovenian: Tukaj stisnite in povlecite
English: Do not use Brimica Genuair: - if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in Section 6).
Slovenian: Ne uporabljajte zdravila Brimica Genuair: - če ste alergični na aklidinij, formoterolijev fumarat dihidrat ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics, ATC code: R03AL05
Slovenian: Farmakoterapevtska skupina: zdravila za obstruktivne pljučne bolezni, adrenergiki v kombinaciji z antiholinergiki, oznaka ATC: R03AL05
English: Stop and Check:
Slovenian: Preden nadaljujete, preverite:
English: The low absolute bioavailability of inhaled aclidinium (<5%) is because aclidinium undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Slovenian: Nizka absolutna biološka razpoložljivost inhaliranega aklidinija (< 5 %) je posledica obširne sistemske in predsistemske hidrolize aklidinija, odloženega v pljuča ali zaužitega.