FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are switching from dispersible tablets to the new film-coated tablets, you will need a smaller dose.
Slovenian: Če z disperzibilnih tablet prehajate na filmsko obložene tablete, boste potrebovali manjši odmerek.
English: Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in patients with beta thalassemia or other blood disorders in which patients do not have enough normal haemoglobin in the blood.
Slovenian: Zdravilo Exjade je zdravilo, ki se uporablja za zdravljenje kronične preobremenitve z železom (prevelike količine železa v telesu) pri bolnikih z beta talasemijo ali drugo krvno boleznijo, pri kateri bolniki v krvi nimajo dovolj normalnega hemoglobina.
English: • Bioavailability of film-coated tablets is higher than of the dispersible tablets and the strength of film-coated tablets is correspondingly lower.
Slovenian: • Biološka razpoložljivost filmsko obloženih tablet je večja kot pri disperzibilnih tabletah, njihova jakost pa temu ustrezno manjša.
English: Exjade is a medicine used to remove excessive iron from the blood of patients with beta thalassemia or other blood disorders which result in excessive iron in the blood.
Slovenian: Zdravilo Exjade je zdravilo, ki se uporablja za odstranjevanje prevelike količine železa iz krvi bolnikov z beta talasemijo in drugimi krvnimi boleznimi, pri katerih pride do prevelike količine železa v krvi.
English: The two types of tablets can be easily distinguished by their shape, and the design of the outer cartons and blisters.
Slovenian: Obe vrsti tablet se zlahka razlikujeta po obliki ter po zasnovi zunanjih škatel in pretisnih omotov.
English: Swallowed whole with some water or crushed and sprinkled on soft food (e.g. yogurt or apple sauce)
Slovenian: Tablete je treba pogoltniti cele z vodo ali zdrobljene in primešane mehki hrani (npr. jogurtu ali jabolčni kaši)
English: • Exjade dispersible tablets will not be available in the future.
Slovenian: • Disperzibilne tablete zdravila Exjade v prihodnosti ne bodo več na voljo.
English: • Exjade (deferasirox) is now available as film-coated tablets in addition to the already authorised dispersible tablets.
Slovenian: • Zdravilo Exjade (deferasiroks) je zdaj na voljo v obliki filmsko obloženih tablet in v obliki že odobrenih disperzibilnih tablet.
English: Excipient: lactose
Slovenian: Pomožna snov: laktoza
English: Educational material will be given to patients and healthcare professionals using Exjade (deferasirox), following the introduction of a film-coated tablet to the already authorised dispersible tablet.
Slovenian: Izobraževalno gradivo bodo prejeli bolniki in zdravstveni delavci, ki uporabljajo zdravilo Exjade (deferasiroks), ko bodo poleg že odobrenih disperzibilnih tablet uvedene filmsko obložene tablete.
English: The education material will advise that the doses for the two types of Exjade tablets are different.
Slovenian: V izobraževalnem gradivu bo navedeno, da se odmerki med različnimi vrstami tablet zdravila Exjade razlikujejo.
English: Both types of tablets will be available for some time, which will allow doctors to switch patients from dispersible tablets to film-coated tablets.
Slovenian: Nekaj časa bosta na voljo obe vrsti tablet, kar bo zdravnikom omogočilo, da bodo pri bolnikih disperzibilne tablete zamenjali s filmsko obloženimi.
English: Contains lactose
Slovenian: Vsebuje laktozo
English: • Your doctor will have worked out the dose of Exjade you need.
Slovenian: • Odmerek zdravila Exjade, ki ga potrebujete, bo določil zdravnik.
English: The patient may receive too little or too much of the medicine if the dose is not correct when changing from one type of tablet to another.
Slovenian: Pri neustreznem odmerku zaradi prehoda z ene vrste tablet na drugo lahko bolnik prejme premalo ali preveč zdravila.
English: After this time Exjade dispersible tablets will no longer be marketed.
Slovenian: Po tem času disperzibilnih tablet zdravila Exjade ne bo več na tržišču.
English: A smaller dose is needed of the new film-coated tablets compared to that of the dispersible tablet.
Slovenian: Pri novih filmsko obloženih tabletah je v primerjavi z disperzibilnimi tabletami potreben manjši odmerek.
English: • Both types of tablets will be available for a limited period to allow doctors to switch patients from the dispersible tablets to the film-coated tablets.
Slovenian: • Določen čas bosta na voljo obe vrsti tablet, da bodo lahko zdravniki pri bolnikih disperzibilne tablete zamenjali s filmsko obloženimi.
English: • The following table describes the differences between the two formulations: Film-coated tablets
Slovenian: • Razlike med obema formulacijama so opisane v spodnji preglednici: Filmsko obložene tablete Disperzibilne tablete (v opuščanju)
English: • Read the package leaflet and other information you have been given with your tablets.
Slovenian: • Preberite navodilo za uporabo in druge informacije, ki ste jih prejeli skupaj s tabletami, saj vsebujejo pomembne podatke o vašem zdravljenju in jemanju zdravila.
English: Dispersible tablets (to be discontinued)
Slovenian: Razpon odmerkov (odrasli in otroci)
English: The European Commission granted a marketing authorisation valid throughout the EU for CoAprovel on 15 October 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom CoAprovel, veljavno po vsej Evropski uniji, odobrila dne 15. oktobra 1998.
English: The full EPAR for CoAprovel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo CoAprovel je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel.
Slovenian: Irbesartan je kot samostojno zdravilo v Evropski uniji (EU) odobren od leta 1997 pod imenoma Karvea in Aprovel.
English: Other information about CoAprovel
Slovenian: Druge informacije o zdravilu CoAprovel
English: This is a summary of the European public assessment report (EPAR) for CoAprovel.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo CoAprovel.
English: CoAprovel irbesartan / hydrochlorothiazide
Slovenian: CoAprovel irbesartan/hidroklorotiazid
English: What benefit has CoAprovel shown during the studies?
Slovenian: Kakšne koristi je zdravilo CoAprovel izkazalo med študijami?
English: The CHMP decided that CoAprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila CoAprovel večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: For more information about treatment with CoAprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom CoAprovel preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for CoAprovel.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo CoAprovel, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Slovenian: Najpogostejši neželeni učinki zdravila CoAprovel (opaženi pri 1 do 10 bolnikih od 100) so omotica, navzeja (slabost) ali bruhanje, nenormalno uriniranje, utrujenost in povečane vrednosti dušika sečnine v krvi (BUN, produkta razgradnje beljakovin), kreatinina (produkta metabolizma mišic) in kreatin kinaze (encima, ki ga najdemo v mišicah).
English: What is the risk associated with CoAprovel?
Slovenian: Kakšna tveganja so povezana z zdravilom CoAprovel?
English: It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide).
Slovenian: Na voljo je v obliki tablet (150 mg ali 300 mg irbesartana in 12,5 mg hidroklorotiazida; 300 mg irbesartana in 25 mg hidroklorotiazida).
English: For the full list of all side effects reported with CoAprovel, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila CoAprovel, glejte navodilo za uporabo.
English: The dose of CoAprovel to be used depends on the dose of irbesartan or hydrochlorothiazide that the patient was taking before.
Slovenian: Odmerek zdravila CoAprovel, ki ga naj bolnik jemlje, je odvisen od odmerka irbesartana ali hidroklorotiazida, ki ga je bolnik jemal prej.
English: CoAprovel must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Slovenian: Zdravila CoAprovel ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) irbesartan, hidroklorotiazid, sulfonamide ali katero koli drugo sestavino zdravila.
English: CoAprovel is used in adults who have essential hypertension (high blood pressure) that is not adequately controlled by irbesartan or hydrochlorothiazide alone.
Slovenian: Zdravilo CoAprovel se uporablja pri odraslih z esencialno hipertenzijo (visokim krvnim tlakom), ki ni ustrezno uravnana z uporabo zgolj irbesartana ali zgolj hidroklorotiazida.
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Slovenian: Kombinacija obeh zdravilnih učinkovin daje pri zniževanju krvnega tlaka boljše rezultate kot katera koli od obeh učinkovin posamično.
English: Why has CoAprovel been approved?
Slovenian: Zakaj je bilo zdravilo CoAprovel odobreno?
English: It can be used with hydrochlorothiazide to treat hypertension.
Slovenian: Uporablja se lahko v kombinaciji s hidroklorotiazidom za zdravljenje visokega krvnega tlaka.
English: CoAprovel in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Slovenian: Zdravilo CoAprovel se v kombinaciji z zdravili, ki vsebujejo aliskiren (ki se uporablja za zdravljenje esencialne hipertenzije), ne sme uporabljati pri bolnikih s sladkorno boleznijo ali zmerno do hudo ledvično okvaro.
English: How has CoAprovel been studied?
Slovenian: Kako je bilo zdravilo CoAprovel raziskano?
English: Care must be taken when using CoAprovel with other medicines that have an effect on blood potassium levels.
Slovenian: Posebna previdnost je potrebna, če se zdravilo CoAprovel jemlje sočasno z drugimi zdravili, ki vplivajo na koncentracijo kalija v krvi.
English: Increasing the dose to 300 mg irbesartan and 25 mg hydrochlorothiazide may give a further decrease in blood pressure.
Slovenian: S povečanjem odmerka na 300 mg irbesartana v kombinaciji s 25 mg hidroklorotiazida se lahko krvni tlak še dodatno zniža.
English: CoAprovel is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: CoAprovel je zdravilo, ki vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: CoAprovel must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Slovenian: Zdravila CoAprovel prav tako ne smejo uporabljati bolniki s hudim obolenjem jeter, ledvic ali žolčnika ali bolniki s prenizko koncentracijo kalija v krvi ali s previsoko koncentracijo kalcija v krvi.
English: The full list of these medicines is given in the Package Leaflet.
Slovenian: Za celoten seznam teh zdravil glejte navodilo za uporabo.
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of CoAprovel.
Slovenian: V podporo uporabi zdravila CoAprovel so bile uporabljene študije z zdraviloma Karvea in Aprovel, uporabljenima skupaj z hidroklorotiazidom v ločenih tabletah.
English: What is CoAprovel used for?
Slovenian: Za kaj se zdravilo CoAprovel uporablja?
English: CoAprovel may be added to some other treatments for hypertension.
Slovenian: Zdravilo CoAprovel se lahko uvede sočasno z nekaterimi drugimi zdravili za zdravljenje visokega krvnega tlaka.
English: CoAprovel was more effective than placebo (a dummy treatment) and than hydrochlorothiazide alone in reducing diastolic blood pressure.
Slovenian: Zdravilo CoAprovel je bilo pri zniževanju diastoličnega krvnega tlaka učinkovitejše od placeba (zdravila brez zdravilne učinkovine) in od hidroklorotiazida kot samostojnega zdravila.
English: How is CoAprovel used?
Slovenian: Kako se zdravilo CoAprovel uporablja?
English: CoAprovel contains two active substances, irbesartan and hydrochlorothiazide.
Slovenian: Zdravilo CoAprovel vsebuje dve zdravilni učinkovini, irbesartan in hidroklorotiazid.
English: How does CoAprovel work?
Slovenian: Kako zdravilo CoAprovel deluje?
English: What is CoAprovel?
Slovenian: Kaj je zdravilo CoAprovel?
English: Your doctor will confirm whether you should change to another treatment.
Slovenian: Zdravnik vam bo povedal, ali je treba pri vas spremeniti zdravljenje.
English: The review of ergot derivatives was initiated on 18 January 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled derivatov ergot-alkaloidov je bil sprožen dne 18. januarja 2012 na zahtevo Francije v skladu s členom 31 Direktive 2001/83/ES.
English: • The available efficacy data for the described indications were considered to be very limited.
Slovenian: • razpoložljivi podatki o učinkovitosti pri navedenih indikacijah so bili zelo omejeni.
English: • If you are unsure whether you are affected, or if you have any questions, speak with your doctor or pharmacist.
Slovenian: • Če niste prepričani, ali omejitve veljajo tudi za vaše zdravilo, ali če imate kakršna koli vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: The severity of such adverse effects and their possible fatal outcome was underlined.
Slovenian: Odbor je izpostavil resnost teh neželenih učinkov in njihov morebitni smrtni izid.
English: 25 October 2013 EMA/652753/2013
Slovenian: 18. december 2013 EMA/27446/2014
English: More about the medicine
Slovenian: Več o zdravilih
English: In addition, scientific advisory groups held in December 2012 and October 2013 did not consider there was evidence of a therapeutic need for ergot derivatives in the indications covered by the review.
Slovenian: Poleg tega so znanstveno svetovalne skupine, ki so se sestale decembra 2012 in oktobra 2013, menile, da ni dokazov o terapevtski potrebi po uporabi derivatov ergot-alkaloidov pri indikacijah, obravnavanih v pregledu.
English: Restrictions on use of medicines containing ergot derivatives
Slovenian: Omejitev uporabe zdravil, ki vsebujejo derivate ergotalkaloidov
English: Patients were young (mean age 41 years-old), with a short time to onset after starting dihydroergotamine (less than 2 months, mean: 2 days).
Slovenian: Bolniki so bili mladi (v povprečju so bili stari 41 let), neželeni učinki pa so se pojavili zelo kmalu po začetku uporabe dihidroergotamina (v manj kot 2 mesecih, v povprečju pa v 2 dneh).
English: They will remain authorised for use by patients in those indications.
Slovenian: Pri teh indikacijah jih bodo bolniki lahko še naprej uporabljali.
English: These indications were not included in the CHMP review; therefore these products will remain authorised and may continue to be used in those indications.
Slovenian: Te indikacije so bile izvzete iz pregleda odbora CHMP, zato so ta zdravila še naprej odobrena in se lahko uporabljajo pri teh indikacijah.
English: Fibrosis can be a serious, sometimes fatal disease, which is often difficult to diagnose because of delayed symptoms and may be irreversible.
Slovenian: Fibroza je lahko resna in včasih tudi smrtna bolezen, ki jo je zaradi zapoznelih simptomov pogosto težko odkriti in je lahko tudi trajna.
English: The French medicines agency asked the CHMP to carry out an assessment of the benefit-risk balance and to issue an opinion on whether the marketing authorisations for these medicines should be maintained, varied, suspended or withdrawn across the European Union.
Slovenian: Francoska agencija za zdravila je odbor CHMP zaprosila, da oceni razmerje med tveganji in koristmi ter izda mnenje o tem, ali naj se dovoljenja za promet s temi zdravili v Evropski uniji ohranijo, spremenijo, začasno umaknejo ali ukinejo.
English: − Symptomatic treatment of veno-lymphatic insufficiency.
Slovenian: − simptomatsko zdravljenje veno-limfatične insuficience.
English: • Patients currently taking these medicines for any of the above indications should have their treatment reviewed at a routine (non-urgent) medical appointment.
Slovenian: • Pri bolnikih, ki jemljejo ta zdravila za katero koli od navedenih indikacij, je treba ob naslednjem rednem (neurgentnem) obisku pri zdravniku ponovno oceniti predpisano zdravljenje.
English: The review was initiated due to concerns identified by the French National Agency for the Safety of Medicine and Health Products (ANSM) in a national pharmacovigilance review in 2011.
Slovenian: Pregled je bil sprožen zaradi zadržkov, ki so se pojavili med nacionalnim farmakovigilančnim pregledom, ki ga je leta 2011 opravila Francoska nacionalna agencija za varnost zdravil in medicinskih pripomočkov (ANSM).
English: In the EU, medicines containing ergot derivatives have been authorised by national procedures and have been marketed under various trade names.
Slovenian: Zdravila, ki vsebujejo derivate ergot-alkaloidov, so bila v EU odobrena po nacionalnih postopkih in se tržijo pod različnimi trgovskimi imeni.
English: − Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II);
Slovenian: − dodatno zdravljenje intermitentne klavdikacije pri simptomatski periferni arterijski okluzivni bolezni (PAOD stadij II);
English: At the request of a manufacturer of medicines containing dihydroergotoxine, one of the ergot derivatives, the CHMP carried out a re-examination of its opinion on this medicine.
Slovenian: Na zahtevo izdelovalca zdravil, ki vsebujejo dihidroergotoksin, enega od derivatov ergot-alkaloidov, je nato opravil ponoven pregled mnenja o tem zdravilu.
English: On 27 June 2013, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended restricting the use of medicines containing ergot derivatives.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je dne 27. junija 2013 priporočil omejitev uporabe zdravil, ki vsebujejo derivate ergot-alkaloidov.
English: benefits in these indications was very limited, the CHMP concluded that the benefits in the concerned indications did not outweigh the risk of fibrosis and ergotism.
Slovenian: Ob upoštevanju dejstva, da so dokazi o koristih teh zdravil pri navedenih indikacijah zelo omejeni, je odbor CHMP zaključil, da koristi pri zadevnih indikacijah ne odtehtajo tveganja za fibrozo in ergotizem.
English: • Cases of ergotism or potentially related symptoms were most frequently reported with dihydroergotamine.
Slovenian: • o primerih ergotizma ali simptomih, ki bi lahko bili povezani z njim, so najpogosteje poročali pri uporabi dihidroergotamina.
English: The CHMP noted that there is a plausible mechanism by which ergot-derivatives could cause fibrosis and ergotism.
Slovenian: Odbor CHMP je ugotovil, da obstaja verjeten mehanizem, s katerim bi derivati ergot-alkaloidov lahko povzročali fibrozo in ergotizem.
English: − Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in the elderly (excluding Alzheimer's disease and other dementia);
Slovenian: − simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence);
English: The CHMP noted the difficulty of diagnosing fibrosis (due to delayed onset of symptoms) and the probability of under-reporting of fibrotic reactions.
Slovenian: Odbor CHMP je izpostavil, da je fibrozo težko odkriti (zaradi zapoznelega nastopa simptomov) in da zato obstaja verjetnost, da niso poročali o vseh fibrotičnih reakcijah;
English: − Orthostatic hypotension;
Slovenian: − ortostatska hipotenzija;
English: The re-examination concluded on 24 October 2013 with the Committee maintaining its previous recommendation, which will now be sent to the European Commission.
Slovenian: Ponoven pregled mnenja se je zaključil dne 24 ktobra 2013, odbor pa je potrdil svoja prejšnja priporočila.
English: The varying affinity for serotoninergic receptors of the different ergot derivatives, and the therapeutic doses used, may explain the differences observed in reporting frequencies for the fibrotic reactions.
Slovenian: Različna afiniteta za serotoninergične receptorje, ki jo imajo različni derivati ergot-alkaloidov in uporabljeni terapevtski odmerki bi lahko pojasnila razlike, opažene pri pogostnosti poročanja o fibrotičnih reakcijah;
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin;
Slovenian: − dodatno zdravljenje zmanjšane ostrine vida in motenj vidnega polja, za katere se domneva, da so žilnega izvora;
English: Medicines containing ergot derivatives have an effect on blood circulation and they have been used for decades to treat conditions involving circulatory problems.
Slovenian: Zdravila, ki vsebujejo derivate ergot-alkaloidov, učinkujejo na krvni obtok in se že desetletja uporabljajo za zdravljenje bolezni, za katere so značilne težave s prekrvavitvijo.
English: They have also been used for treating chronic pathological cognitive and neurosensorial impairment (problems with memory and sensation) and for preventing migraine headaches.
Slovenian: Uporabljajo se tudi za zdravljenje kroničnih patoloških kognitivnih in nevrosenzoričnih okvar (težav s spominom in občutljivostjo) ter za preprečevanje migrenskih glavobolov.
English: − Ancillary treatment of Raynaud's syndrome;
Slovenian: − dodatno zdravljenje Raynaudovega sindroma;
English: This is based on a review of data showing an increased risk of fibrosis (formation of excess connective tissue that can damage organs and body structures) and ergotism (symptoms of ergot poisoning, such as spasms and obstructed blood circulation) with these medicines.
Slovenian: Priporočila temeljijo na pregledu podatkov, ki kažejo, da uporaba teh zdravil poveča tveganje za fibrozo (tvorbo odvečnega vezivnega tkiva, ki lahko poškoduje organe in telesne strukture) ter ergotizem (simptome zastrupitve z ergot-alkaloidi, kot so krči in zapora krvnega obtoka).
English: In its review, the CHMP considered all available data on the benefits and risks of ergot derivatives, including data from clinical studies, post-marketing safety reports and the published literature.
Slovenian: Med pregledom je odbor CHMP proučil vse razpoložljive podatke o koristih in tveganjih, povezanih z derivati ergot-alkaloidov, vključno s podatki iz kliničnih študij, poročil o varnosti iz obdobja trženja in objavljene literature.
English: • Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis, through serotoninergic receptor activation, which is extensively described in the literature.
Slovenian: • znano je, da lahko derivati ergot-alkaloidov povzročijo fibrozo, še zlasti fibrozo srčne zaklopke, z aktivacijo serotoninergičnih receptorjev, kar je obširno opisano v literaturi.