FrancophonIA/ELRC3.0 huggingface dataset:
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Comb 50").
Slovenian: Primeri: - injicirate preveč insulina, - izpustite obroke ali jih imate prepozno, - ne jeste dovolj ali uživate hrano, ki vsebuje manj ogljikovih hidratov kot normalno (sladkor in sladkorju podobne snovi imenujemo ogljikovi hidrati; toda umetna sladila NISO ogljikovi hidrati), - izgubljate ogljikove hidrate zaradi bruhanja ali driske, - pijete alkohol (zlasti če ne jeste dosti), - ste bolj dejavni kot navadno ali je telesna dejavnost drugačna kot ponavadi, - okrevate po poškodbi, operaciji ali drugem stresu, - okrevate po bolezni ali po vročini, - uporabljate ali ste nehali uporabljatidoločena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo Insuman Comb 50").
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Comb 15").
Slovenian: Primeri: - injicirate preveč insulina, - izpustite obroke ali jih imate prepozno, - ne jeste dovolj ali uživate hrano, ki vsebuje manj ogljikovih hidratov kot normalno (sladkor in sladkorju podobne snovi imenujemo ogljikovi hidrati; toda umetna sladila NISO ogljikovi hidrati), - izgubljate ogljikove hidrate zaradi bruhanja ali driske, - pijete alkohol (zlasti če ne jeste dosti), - ste bolj dejavni kot navadno ali je telesna dejavnost drugačna kot ponavadi, - okrevate po poškodbi, operaciji ali drugem stresu, - okrevate po bolezni ali po vročini, - uporabljate ali ste nehali uporabljatidoločena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo Insuman Comb 15").
English: Examples include: you inject too much insulin, you miss meals or delay them, you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates), you lose carbohydrates due to vomiting or diarrhoea, you drink alcohol, particularly if you are not eating much, you are doing more exercise than usual or a different type of physical activity, you are recovering from an injury or operation or other stress, you are recovering from an illness or from fever, you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Insuman Basal").
Slovenian: Primeri: - injicirate preveč insulina, - izpustite obroke ali jih imate prepozno, - ne jeste dovolj ali uživate hrano, ki vsebuje manj ogljikovih hidratov kot normalno (sladkor in sladkorju podobne snovi imenujemo ogljikovi hidrati; toda umetna sladila NISO ogljikovi hidrati), - izgubljate ogljikove hidrate zaradi bruhanja ali driske, - pijete alkohol (zlasti če ne jeste dosti), - ste bolj dejavni kot navadno ali je telesna dejavnost drugačna kot ponavadi, - okrevate po poškodbi, operaciji ali drugem stresu, - okrevate po bolezni ali po vročini, - uporabljate ali ste nehali uporabljatidoločena druga zdravila (glejte poglavje 2, "Druga zdravila in zdravilo Insuman Basal ").
English: Insuman Comb 50 100
Slovenian: Insuman Comb 50 100 i.e./ml
English: Patients hypersensitive to Insuman Basal for whom no better tolerated preparation is available must only continue treatment under close medical supervision and - where necessary - in conjunction with anti-allergic treatment.
Slovenian: Bolniki, ki so preobčutljivi za Insuman Basal, a tudi nobenega drugega pripravka ne prenašajo bolje, smejo zdravljenje nadaljevati le pod skrbnim zdravniškim nadzorom in - če je potrebno - ob hkratnem antialergijskem zdravljenju.
English: Insuman Basal in pre-filled pen is only suitable for injecting just under the skin.
Slovenian: Zdravilo Insuman Basal v napolnjenem injekcijskem peresniku je primerno samo za injiciranje tik pod kožo.
English: Pack size
Slovenian: shranite zavrzite
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), - sulfonamide antibiotics.
Slovenian: Med zdravili, ki lahko povzročijo znižanje koncentracije krvnega sladkorja (hipoglikemija) so: - vsa druga zdravila za zdravljenje sladkorne bolezni, - zaviralci angiotenzinske konvertaze (ACE - angiotensin converting enzyme) (uporabljajo se za zdravljenje določenih bolezenskih stanj srca ali visokega krvnega tlaka), - dizopiramid (uporablja se za zdravljenje določenih bolezenskih stanj srca), - fluoksetin (uporablja se za zdravljenje depresije), - fibrati (uporabljajo se za zniževanje visokih koncentracij krvnih lipidov), - zaviralci monoaminooksidaze (MAO) (uporabljajo se za zdravljenje depresije), - pentoksifilin, propoksifen, salicilati (na primer acetilsalicilna kislina, uporabljajo se za lajšanje bolečine in znižanje zvišane telesne temperature), - sulfonamidni antibiotiki.
English: Dose adjustment may also be required, for example, if
Slovenian: Hipoglikemija je verjetnejša tudi, če
English: - you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you have recently changed from an animal insulin to a human insulin such as Insuman, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Slovenian: (diabetična avtonomna nevropatija), - ste nedavno (na primer prejšnji dan) doživeli hipoglikemijo ali če se hipoglikemija pojavi počasi, - imate skoraj normalno ali vsaj močno izboljšano koncentracijo krvnega sladkorja, - ste namesto živalskega insulina pred kratkim začeli uporabljati humani insulin, kakršen je
English: Do not put Insuman Basal next to the freezer compartment or a freezer pack.
Slovenian: Zdravila Insuman Basal ne shranjujte v bližini zamrzovalnega razdelka ali zamrzovalnega vložka.
English: Insuman Implantable is an insulin solution with a rapid onset and short duration of action.
Slovenian: Zdravilo Insuman Implantable je raztopina insulina s hitrim začetkom in kratkim trajanjem delovanja.
English: Insuman Rapid 100 IU/ml solution for injection in a cartridge
Slovenian: Insuman Rapid SoloStar 100 i.e./ml v napolnjenem injekcijskem peresniku Ravnanje z injekcijskim peresnikom
English: Article 35 of Directive 2001/82/EC, as amended
Slovenian: Člen 35 Direktive 2001/82/ES, kakor je bil spremenjena.
English: The Rapporteur and Co-Rapporteur appointed were Mrs R. Kearsley and Mr G. J. Schefferlie respectively.
Slovenian: Poročevalka je bila ga. R. Kearsley, soporočevalec pa g. G. J. Schefferlie.
English: EMEA/402698/2008-EN
Slovenian: EMEA/402698/2008-SL
English: Marketing Authorisations for veterinary medicinal products containing toltrazuril and intended for use in poultry species were previously granted to Bayer HealthCare and/or Ceva Santé Animale in Austria, Belgium, Bulgaria, Cyprus, Czech republic, France, Germany, Greece, Hungary, Ireland, Italy, Poland, Portugal, Romania, Slovakia, Slovenia, the Netherlands and the United Kingdom following national marketing authorisation procedures.
Slovenian: Dovoljenja za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena za uporabo pri perutnini, so bila pred tem odobrena družbi Bayer HealthCare in/ali Ceva Santé Animale v Avstriji, Belgiji, Bolgariji, na Cipru, v Češki republiki, Franciji, Nemčiji, Grčiji, na Madžarskem, Irskem, v Italiji, na Poljskem, Portugalskem, v Romuniji, na Slovaškem, v Sloveniji, na Nizozemskem in v Združenem kraljestvu po nacionalnih postopkih za odobritev dovoljenja za promet z zdravilom.
English: London, 26 September 2008 EMEA/402698/2008
Slovenian: London, 26. septembra 2008 EMEA/402698/2008
English: In practice this means that in intensive systems all the birds in one house will be treated even if not all exhibit signs of disease.
Slovenian: To v praksi pomeni, da se pri sistemih intenzivne reje zdravi vsa perutnina v eni hiši, čeprav vsa ne kažejo znakov bolezni.
English: The recommended dose and duration of treatment for chickens and turkeys is 7 mg/kg bodyweight per day for two consecutive days.
Slovenian: Priporočeni odmerek in trajanje zdravljenja za piščance in purane je 7 mg/kg telesne mase na dan, in sicer dva zaporedna dneva.
English: Germany referred the issue to CVMP due to concerns that toltrazuril may present a potential serious risk to the environment on the following grounds:
Slovenian: Nemčija je zadevo napotila na CVMP zaradi skrbi, da lahko toltrazuril pomeni morebitno resno tveganje za okolje in to iz naslednjih razlogov:
English: The final opinion was converted into a Decision by the European Commission on 26 September 2008.
Slovenian: Evropska komisija je odločbo izdala dne 26. septembra 2008.
English: The arbitration procedure started on 11 October 2007 with the adoption of a list of questions to be put to the Marketing Authorisation Holders.
Slovenian: Arbitražni postopek se je začel 11. oktobra 2007 s sprejetjem seznama vprašanj, na katera morajo odgovoriti imetniki dovoljenja za promet.
English: On 31 August 2007 a Community referral under Article 35 of Directive 2001/82/EC, as amended, was initiated by Germany for the nationally authorised product Baycox 2.5 % (solution for poultry).
Slovenian: Dne 31. avgusta 2007 je Nemčija sprožila skupno napotitev po členu 35 Direktive 2001/82/ES, kakor je bila spremenjena, za nacionalno odobreno zdravilo Baycox 2,5 % (raztopina za perutnino).
English: During its 11-13 December 2007 meeting, the CVMP agreed on a two month extension to the date for submission of responses to the list of questions following a request from Bayer HealthCare.
Slovenian: CVMP se je na zasedanju od 11. do 13. decembra 2007 strinjal z dvomesečnim podaljšanjem roka za predložitev odgovorov na seznam vprašanj, ki ga je zahtevala družba Bayer HealthCare.
English: The date set for submission of written responses by the Marketing Authorisation Holders was 14 January 2008.
Slovenian: Datum za predložitev odgovorov imetnikov dovoljenja za promet v pisni obliki je bil 14. januar 2008.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amendments to the relevant sections of the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Dodatku I. Znanstveni zaključki so na voljo v Dodatku II, spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila pa v Dodatku III.
English: • An extended risk assessment on the basis of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines fully and clearly demonstrated that veterinary medicinal products containing toltrazuril and intended for use in poultry species must be expected to have impact on the environment.
Slovenian: • razširjena ocena tveganja na osnovi smernic Mednarodnega sodelovanja o uskladitvi tehničnih zahtev za registracijo zdravil za uporabo v veterinarski medicini (VICH) je jasno pokazala, da je treba pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena za uporabo pri perutninskih živalskih vrstah, pričakovati, da bodo vplivala na okolje.
English: During its July 2008 meeting, the CVMP, in light of the overall data submitted and the scientific discussion within the Committee, adopted by consensus an opinion concluding that the assessment of the risk presented by toltrazuril and its major metabolite, toltrazuril sulfone, to terrestrial plants and to groundwater demonstrated that use of products containing toltrazuril is acceptable.
Slovenian: CVMP je na svojem zasedanju julija 2008 ob upoštevanju vseh predloženih podatkov in znanstvene razprave soglasno sprejel mnenje, da je ovrednotenje tveganja, ki ga predstavljata toltrazuril in njegovi glavni presnovek, toltrazuril sulfon, za kopenske rastline in talno vodo, pokazalo, da je uporaba zdravil s toltrazurilom sprejemljiva.
English: The CVMP concluded that the marketing authorisations can be maintained without special warnings in point 5.3 (Environmental properties) of the SPC provided that the product is used under the conditions agreed, i.e. a dose of 7 mg/kg bw on two consecutive days for the treatment of coccidiosis in chickens and turkeys.
Slovenian: CVMP je zaključil, da lahko imetniki ohranijo dovoljenja za promet brez potrebe po posebnih opozorilih v točki 5.3 (Okoljski podatki) povzetka glavnih značilnosti zdravila (SPC), če se bo zdravilo uporabljalo pod dogovorjenimi pogoji, tj. odmerek 7 mg/kg telesne mase dva dni zapored za zdravljenje kokcidioze pri piščancih in puranih.
English: The Committee further recommended that relevant Marketing Authorisations should be varied in order to harmonise the indications and dosing regimens to bring these in line with those used in the environmental risk assessment.
Slovenian: Odbor je tudi predlagal da je treba ustrezna dovoljenja za promet z zdravilom spremeniti, da bi uskladili indikacije in režime odmerjanja s tistimi, ki so bili uporabljeni v oceni tveganja za okolje.
English: The Marketing Authorisation Holders presented oral explanations to the CVMP on 18 June 2008.
Slovenian: Imetniki dovoljenj za promet so dne 18. marca 2008 predložili pisna, dne 18. junija 2008 pa na CVMP-ju še ustna pojasnila
English: On 10 October 2007 the European Commission decided that the scope of the referral should include all authorised veterinary medicinal products containing toltrazuril (i.e. reference product and generics thereof) and intended for use in poultry species.
Slovenian: Dne 10. oktobra 2007 je Evropska komisija odločila, da mora obseg napotitve vključevati vsa odobrena zdravila za uporabo v veterinarski medicini, ki vsebujejo toltrazuril (tj. referenčno zdravilo in generična zdravila, ki izvirajo iz tega) in so namenjena za uporabo pri perutninskih živalskih vrstah.
English: Toltrazuril is a triazinetrione derivative administered orally in the drinking water for the treatment of coccidiosis in chickens and turkeys.
Slovenian: Toltrazuril je derivat triazintriona, ki se daje peroralno v vodi za pitje pri zdravljenju kokcidioze pri piščancih in puranih.
English: However, it was noted that the indications, species and posology in SPCs of some of the authorised products were different and these therefore needed to be amended to bring them in line with the indications and dosing regimens used in the environmental risk assessment.
Slovenian: Hkrati je bilo ugotovljeno, da se indikacije, živalske vrste in odmerjanje v povzetkih glavnih značilnosti za nekatera odobrena zdravila razlikujejo in jih je zato potrebno spremeniti, da bodo skladni s tisto indikacijo in režimom odmerjanja, ki sta bila uporabljena v oceni tveganja za okolje.
English: OPINION FOLLOWING AN ARTICLE 351 REFERRAL FOR ALL AUTHORISED VETERINARY MEDICINAL PRODUCTS CONTAINING TOLTRAZURIL INTENDED FOR USE IN POULTRY SPECIES International Non-Proprietary Name (INN): Toltrazuril
Slovenian: MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 351 ZA VSA ODOBRENA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, KI VSEBUJEJO TOLTRAZURIL, NAMENJEN ZA UPORABO PRI PERUTNINI Mednarodno nelastniško ime (INN): Toltrazuril
English: Therefore the Committee recommended maintaining the Marketing Authorisations for all veterinary medicinal products containing toltrazuril intended for use in chickens and turkeys.
Slovenian: CVMP je predlagal ohranitev dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini, ki vsebujejo toltrazuril in so namenjena za uporabo pri piščancih in puranih.
English: 05 June 2015
Slovenian: 5. junij 2015
English: The areas harmonised include:
Slovenian: Področja, ki jih je treba uskladiti, so naslednja:
English: The European Commission issued an EU-wide legally binding decision to implement these changes on 05 June 2015.
Slovenian: Evropska komisija je za uveljavitev teh sprememb 5. junija 2015 izdala pravno zavezujoči sklep, veljaven po vsej Evropski uniji.
English: The usual starting dose is 10 mg taken twice a day, preferably in the morning and in the evening.
Slovenian: Običajni začetni odmerek je 10 mg dvakrat na dan, po možnosti zjutraj in zvečer.
English: Ikorel and Dancor are marketed in the following EU Member States: Austria, Denmark, France, Ireland, the Netherlands, Portugal, and the United Kingdom.
Slovenian: Zdravili Ikorel in Dancor se tržita v naslednjih državah članicah EU: v Avstriji, na Danskem, v Franciji, na Irskem, Nizozemskem, Portugalskem in v Združenem kraljestvu.
English: The companies that market these medicines are Sanofi-Aventis and Merck KGaA.
Slovenian: Družbi, ki tržita ti zdravili, sta Sanofi-Aventis in Merck KGaA.
English: 4.1 Therapeutic indication
Slovenian: Terapevtske indikacije
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for these medicines in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je sklenil, da je treba uskladiti podatke o predpisovanju teh zdravil v Evropski uniji (EU).
English: Ikorel and Dancor have been authorised in the EU via national procedures.
Slovenian: Zdravili Ikorel in Dancor sta bili v EU odobreni po nacionalnih postopkih.
English: On 26 March 2015, the European Medicines Agency completed a review of Ikorel and Dancor.
Slovenian: Evropska agencija za zdravila je 26. marca 2015 zaključila pregled zdravil Ikorel in Dancor.
English: The CHMP also harmonised other sections of the SmPC including sections 4.5 (interactions with other medicinal products), 4.8 (undesirable effects) and 5.1 (pharmacodynamic properties).
Slovenian: CHMP je prav tako uskladil druga poglavja povzetka glavnih značilnosti zdravila, vključno s poglavjem 4.5 (Medsebojno delovanje z drugimi zdravili in druge oblike interakcij), 4.8 (Neželeni učinki) in 5.1 (Farmakodinamične lastnosti).
English: This has led to divergences across Member States in the way the medicines can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicines are marketed.
Slovenian: Zato je med državami članicami prišlo do razlik v načinu, kako naj se zdravili uporabljata, kar je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, v katerih se zdravili tržita.
English: • Medicines that could increase the levels of potassium in the blood, especially in patients with reduced kidney function;
Slovenian: • zdravila, ki lahko povečajo ravni kalija v krvi, zlasti pri bolnikih z zmanjšanim delovanjem ledvic;
English: • Patients with shock, severe hypotension (low blood pressure), or heart problems such as ‘left ventricular dysfunction with low filling pressure' or ‘cardiac decompensation';
Slovenian: • bolnikih v šoku, s hudo hipotenzijo (nizkim krvnim tlakom) ali težavami s srcem, kot sta disfunkcija levega prekata z nizkim polnilnim tlakom ali srčna dekompenzacija;
English: • Medicines that have a blood pressure-lowering effect.
Slovenian: • zdravila, ki znižujejo krvni tlak.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Ikorel and Dancor.
Slovenian: Po uskladitvi indikacij je odbor CHMP uskladil tudi priporočila o načinu uporabe zdravil Ikorel in Dancor.
English: • Patients with a build-up of fluids in the lungs (acute pulmonary oedema).
Slovenian: • bolnikih z nabrano tekočino v pljučih (akutni pljučni edem).
English: • Patients suffering from hypovolaemia (low blood volume);
Slovenian: • bolnikih, ki imajo hipovolemijo (majhen volumen krvi);
English: Why were Ikorel and Dancor reviewed?
Slovenian: Zakaj sta bili zdravili Ikorel in Dancor pregledani?
English: • Patients taking medicines known as ‘phosphodiesterase 5 inhibitors' and/or ‘soluble guanylate cyclase stimulators', since this can lead to a serious drop in blood pressure;
Slovenian: • bolnikih, ki jemljejo zdravila, imenovana zaviralci fosfodiesteraze tipa 5 in/ali spodbujevalci topne gvanilat-ciklaze, saj lahko to privede do resnega upada krvnega tlaka;
English: The CHMP agreed that Ikorel and Dancor must not be used in:
Slovenian: Odbor CHMP se je strinjal, da se zdravili Ikorel in Dancor ne smeta uporabljati pri:
English: • Aspirin or medicines called NSAIDs (non-steroid anti-inflammatory drugs), because these patients are at higher risk of developing complications of ulcers, such as bleeding in the stomach or gut;
Slovenian: • aspirin ali zdravila, imenovana nesteroidna protivnetna zdravila, saj imajo ti bolniki povišano tveganje za razvoj komplikacij razjed, kot je krvavitev v želodcu ali črevesju;
English: These ulcers are difficult to treat and usually resolve only when treatment with Ikorel or Dancor is stopped.
Slovenian: Te razjede je težko zdraviti in se običajno zacelijo šele, ko bolnik preneha zdravljenje z zdravilom Ikorel ali Dancor.
English: Ikorel and Dancor should no longer be used to prevent heart problems, such as a heart attack, in patients with stable coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle), because the available clinical data do not support this indication.
Slovenian: Zdravili Ikorel in Dancor se ne bi smeli več uporabljati za preprečevanje težav s srcem, kot je srčni infarkt, pri bolnikih s stabilno koronarno boleznijo srca (boleznijo srca, ki jo povzroča zapora krvnih žil, ki dovajajo kri v srčno mišico), saj razpoložljivi klinični podatki ne podpirajo te indikacije.
English: What are Ikorel and Dancor?
Slovenian: Kaj sta zdravili Ikorel in Dancor?
English: In patients particularly predisposed to headaches, the starting dose can be lowered to 5 mg twice a day.
Slovenian: Pri bolnikih, ki so posebno nagnjeni h glavobolom, je mogoče začetni odmerek znižati na 5 mg dvakrat na dan. Glede na to, kako se bolnik odziva na zdravilo in ga prenaša, je mogoče odmerek povečati na največ 40 mg dvakrat na dan.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je na podlagi predloženih podatkov in znanstvene razprave v odboru menil, da je treba po vsej EU uskladiti povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo.