FrancophonIA/ELRC3.0 huggingface dataset:
English: Relistor is not recommended for patients who have very severe kidney problems that require dialysis (a blood clearance technique).
Slovenian: Zdravilo Relistor ni priporočljivo za bolnike, ki imajo hude težave z ledvicami, zaradi česar potrebujejo dializo (tehniko čiščenja krvi).
English: The main measures of effectiveness were the number of patients who had a bowel movement within four hours of the first dose, and the percentage of injections that were successful in producing a bowel movement.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so blato odvedli v štirih urah po prvem odmerku, in delež injekcij, ki so uspešno pospešile odvajanje blata.
English: Patients can inject Relistor themselves once they have been trained appropriately.
Slovenian: Bolniki si lahko po ustreznem usposabljanju zdravilo Relistor injicirajo sami.
English: It is available as a solution for injection in vials or in prefilled syringes.
Slovenian: Na voljo je v obliki raztopine za injiciranje v vialah ali napolnjenih brizgah.
English: The main measure of effectiveness in both studies was the number of patients who had a bowel movement within four hours of the first dose.
Slovenian: Glavno merilo učinkovitosti pri obeh študijah je bilo število bolnikov, ki so odvedli blato v štirih urah po prvem odmerku.
English: Methylnaltrexone bromide is derived from naltrexone, a well-known substance that is used to block the action of opioids.
Slovenian: Metilnaltreksonijev bromid se pridobiva iz naltreksona, dobro znane učinkovine, ki se uporablja za zaviranje delovanja opioidov.
English: The active substance in Relistor, methylnaltrexone bromide, is a ‘mu-opioid receptor antagonist'.
Slovenian: Zdravilna učinkovina v zdravilu Relistor, metilnaltreksonijev bromid, je antagonist muopioidnih receptorjev.
English: Relistor is used to treat constipation caused by opioid painkillers (such as morphine) when laxative medicines have not worked well enough.
Slovenian: Relistor se uporablja za zdravljenje zaprtja, ki ga povzročajo opioidna zdravila za lajšanje bolečin (kot je na primer morfin), kadar je odziv na odvajalno zdravljenje nezadosten.
English: For the full list of all side effects reported with Relistor, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Relistor, glejte navodilo za uporabo.
English: Relistor is usually injected under the skin of the upper legs, belly or upper arms.
Slovenian: Zdravilo Relistor se običajno injicira v podkožje stegna, trebuha ali nadlahti.
English: Results showed that 34% of patients receiving Relistor (102 out of 298) had a bowel movement within four hours after the first injection, compared with 10% of those receiving placebo (16 out of 162).
Slovenian: Rezultati so pokazali, da je 34 % (102 od 298) bolnikov, ki so prejeli zdravilo Relistor, blato odvedlo v štirih urah po prvem injiciranju zdravila v primerjavi z 10 % (16 od 162) tistih, ki so prejeli placebo.
English: The second study also looked at the number of patients who had a bowel movement at least twice within four hours of the first four doses.
Slovenian: V drugi študiji so proučevali število bolnikov, pri katerih je do odvajanja blata prišlo vsaj dvakrat v štirih urah po prvih štirih odmerkih.
English: Opioids relieve pain by attaching to ‘opioid receptors' in the brain and spinal cord.
Slovenian: Opioidi lajšajo bolečine tako, da se vežejo na receptorje opioidov v možganih in hrbtenjači.
English: When opioids attach to the gut receptors, the mobility of the gut is reduced, leading to constipation.
Slovenian: Kadar se opioidi vežejo na receptorje v črevesju, se njegovo delovanje upočasni, kar povzroča zaprtje.
English: Relistor contains the active substance methylnaltrexone bromide.
Slovenian: Zdravilo Relistor vsebuje zdravilno učinkovino metilnaltreksonijev bromid.
English: In the second study, 52% of the patients receiving Relistor had a bowel movement at least twice within four hours of the first four doses (32 out of 62), compared with 8% of those receiving placebo (6 out of 71).
Slovenian: Pri drugi študiji je 52 % (32 od 62) bolnikov, ki so prejeli zdravilo Relistor, odvedlo blato vsaj dvakrat v štirih urah po prvih štirih odmerkih v primerjavi z 8 % (6 od 71) bolnikov, ki so prejeli placebo.
English: In patients who are receiving palliative care (treatment of the symptoms of a serious disease that is not intended to lead to cure), Relistor is given as an injection under the skin, once every two days, in addition to the usual laxative medicines.
Slovenian: Zdravilo Relistor se pri bolnikih, ki prejemajo paliativno oskrbo (zdravljenje simptomov bolezni, ki pa ne vodi k ozdravitvi), injicira v podkožje vsak drugi dan poleg običajnih odvajalnih zdravil.
English: How does Relistor work?
Slovenian: Kako zdravilo Relistor deluje?
English: Looking at the results of the two studies taken together, 55% of the patients receiving Relistor had a bowel movement within four hours of the first dose (91 out of 165), compared with 15% of the patients receiving placebo (18 out of 123).
Slovenian: Skupni rezultati obeh študij kažejo, da je 55 % (91 od 165) bolnikov, ki so prejeli zdravilo Relistor, odvajalo blato v štirih urah po prvem injiciranju v primerjavi s 15 % (18 od 123) bolnikov, ki so prejeli placebo.
English: Relistor can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Relistor je le na recept.
English: Relistor was shown to be more effective than placebo (a dummy treatment) at stimulating bowel movement in two main studies involving a total of 288 patients with an advanced illness and constipation caused by opioids.
Slovenian: Zdravilo Relistor se je v dveh glavnih študijah, v kateri je bilo vključenih skupaj 288 bolnikov z napredovalo boleznijo in zaprtjem, ki ga povzroča jemanje opioidov, izkazalo za učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri pospeševanju odvajanja blata.
English: How is Relistor used?
Slovenian: Kako se zdravilo Relistor uporablja?
English: The dose of Relistor should be reduced in patients who have severe kidney problems.
Slovenian: Pri bolnikih, ki imajo težko ledvično okvaro, je treba odmerek zdravila Relistor prilagoditi.
English: Key elements to be included in the educational material
Slovenian: Ključni elementi, ki morajo biti vključeni v izobraževalnem materialu
English: • Information on the identified and potential risks.
Slovenian: • informacije o znanih in možnih nevarnostih.
English: The MAH shall agree the details of an educational programme with the National Competent Authorities and must implement such programme nationally to ensure that, prior to prescribing, all physicians are provided with a healthcare professional information pack containing the following:
Slovenian: Imetnik dovoljenja za promet z zdravilom (MAH) se mora z nacionalnimi pristojnimi organi dogovoriti o podrobnostih izobraževalnega programa in mora ta program uvesti nacionalno, s čimer bo zagotovil, da bodo pred začetkom predpisovanja vsi zdravniki prejeli paket z zdravstvenimi profesionalnimi informacijami, ki bo vseboval:
English: • Educational material
Slovenian: • izobraževalni material,
English: • Summary of Product Characteristics (SPC) and Package Leaflet and Labelling
Slovenian: • povzetek glavnih značilnosti zdravila (SPC) in navodilo za uporabo in označevanje.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Slovenian: Države članice morajo zagotoviti, da bodo izpolnjeni vsi pogoji ali uveljavljene vse omejitve za varno in učinkovito uporabo spodaj opisanih zdravil:
English: • Information on gel depot formation and possible injections site reactions
Slovenian: • informacije o oblikovanju gelskega depoja in možnih reakcijah na mestu injiciranja,
English: • Instructions for administration
Slovenian: • navodila za uporabo,
English: • Posology
Slovenian: • odmerjanje,
English: The Reference Member States were Germany, Hungary, Norway, Poland, Slovakia, Spain, United Kingdom.
Slovenian: Zadevne države članice so bile Nemčija, Madžarska, Norveška, Poljska, Slovaška, Španija in Združeno kraljestvo.
English: 1 Article 29(2) of Directive 2001/83/EC, as amended.
Slovenian: 1 Člen 29(2) Direktive 2001/83/ES, kot je bila spremenjena.
English: The CHMP appointed Dr. J.F.F.
Slovenian: CHMP je imenoval dr. J.F.F.
English: The final opinion was converted into a Decision by the European Commission on 11/10/2006.
Slovenian: Končno mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 11/10/2006.
English: Lekkerkerker (Netherlands) as Rapporteur and Dr. Hudson (United Kingdom) as Co-rapporteur.
Slovenian: Lekkerkerkerja (Nizozemska) za poročevalca in dr. Hudsona (Združeno kraljestvo) za soporočevalca.
English: A positive opinion was adopted 28 June 2006.
Slovenian: Pozitivno mnenje je bilo sprejeto 28. junija 2006.
English: The Mutual Recognition Procedure started on 21 October 2005.
Slovenian: Postopek za medsebojno priznavanje se je začel 21. oktobra 2005.
English: The Denmark referred the reasons for disagreement to the EMEA on 31 March 2006.
Slovenian: Danska je agenciji EMEA posredovala razloge za nesoglasje dne 31. marca 2006.
English: These Member States were not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Slovenian: Omenjene države članice niso mogle doseči soglasja v zvezi z medsebojnim priznavanjem dovoljenja za promet z zdravilom, ki ga je izdala referenčna država članica.
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Slovenian: Seznam zadevnih imen proizvodov je naveden v Dodatku I. Znanstveni zaključki so podani v Dodatku II skupaj s Povzetkom glavnih značilnosti zdravila v Dodatku III.
English: The arbitration procedure started on 27 April 2006.
Slovenian: Arbitražni postopek se je začel 27. aprila 2006.
English: During the June 2006 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names, that the objections raised should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Slovenian: Med svojim zasedanjem junija 2006 je CHMP na podlagi vseh posredovanih podatkov in znanstvene razprave v okviru Odbora, sprejel mnenje, da je razmerje med tveganji in koristmi za zdravilo Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena ugodno, ter da podani ugovori ne bi smeli preprečiti podelitve dovoljenja za promet z zdravilom, ter da je treba Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo referenčne države članice dopolniti.
English: The scope of the referral was to agree whether Doxazosin “Winthrop” 4mg prolonged release tablets differ significantly with regards to the release profile from the originator product with potential for increased incidence of adverse events such as dizziness and hypotension, whether there were significant differences in performance of test batches in the single dose phase of studies 5208 and 1995 and whether the applicant has deviated from CHMP guidelines on the design of the bioequivalence studies, particularly in relation to the effect of food.
Slovenian: Namen napotitve je bil doseči soglasje o tem, ali se zdravilo Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem, kar se tiče profila sproščanja, pomembno razlikuje od originatorjevega zdravila, in ali je možnost pojavov neželenih učinkov, kot so omotica in hipotenzija, morebiti povečana; nadalje ali so bile razlike v rezultatih iz študij 5208 in 1995 testnih serij pri enkratnem odmerjanju pomembne, ter končno ali se je vlagatelj oddaljil od smernic CHMP o načrtovanju bioekvivalenčnih raziskav, zlasti kar se tiče učinka, ki bi ga lahko imela hrana.
English: Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (Doxazosin) is receptor alfa blocking agent used in the treatment of patients with essential hypertension and in the symptomatic treatment of patients with benign prostatic hyperplasia.
Slovenian: Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena (Doxazosin) vsebujejo snov, ki blokira receptor alfa in se uporablja za zdravljenje bolnikov z esencialno hipertenzijo in simptomatično zdravljenje bolnikov z benigno hiperplazijo prostate.
English: Winthrop Pharmaceuticals UK Ltd submitted applications for mutual recognition of Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names on the basis of the marketing authorisation granted by the Denmark on 30 September 2002.
Slovenian: Družba Winthrop Pharmaceuticals UK Ltd je podala vloge za medsebojno priznavanje zdravila Doxazosin »Winthrop« 4 mg tablete s podaljšanim sproščanjem in povezana imena na podlagi dovoljenja za promet z zdravilom, ki ga je izdala Danska dne 30. septembra 2002.
English: Supplementary information was provided by the Marketing Authorisation Holder on 23 May 2006.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil dodatne informacije dne 23. maja 2006, ustna pojasnila pa je podal 27. junija 2006.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names International Non-Proprietary Name (INN): Doxazosin
Slovenian: Doxazosin “Winthrop” 4 mg tablete s podaljšanim sproščanjem in povezana imena Mednarodno nelastniško ime (INN): Doxazosin
English: The study should be based on an agreed protocol.
Slovenian: Študija mora temeljiti na dogovorjenem protokolu.
English: 31 December
Slovenian: 31. decembra
English: Date of first authorisation: 15 November 2012 Date of latest renewal: 13 July 2017
Slovenian: Datum prve odobritve: 15. november 2012 Datum zadnjega podaljšanja: 13. julij 2017
English: The level of efficacy varied between the individual anatomical locations.
Slovenian: Raven učinkovitosti se je razlikovala med posameznimi anatomskimi lokacijami.
English: No overall differences in safety or efficacy were observed between younger and older patients.
Slovenian: Med mlajšimi in starejšimi bolniki niso opazili splošnih razlik v varnosti ali učinkovitosti.
English: 8 weeks after randomisation
Slovenian: 8 tednov po randomizaciji
English: Results demonstrated no systemic absorption.
Slovenian: Rezultati niso pokazali sistemske absorpcije.
English: The final study report shall be submitted:
Slovenian: Končno poročilo študije je treba predložiti do:
English: Long term efficacy
Slovenian: Dolgoročna učinkovitost
English: to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: do < 1/1.000); zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: This leaflet was last revised in.
Slovenian: Navodilo je bilo nazadnje revidirano .
English: gel 3 tubes
Slovenian: gel 3 tube
English: Actinic keratosis does not occur in children, and this medicine must not be used in children and adolescents under 18 years of age.
Slovenian: Aktinična keratoza se ne pojavlja pri otrocih, zato tega zdravila ne smete uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Local skin responses
Slovenian: Lokalni odzivi kože
English: d p<0.001; compared to vehicle by logistic regression with treatment, study and anatomical location.
Slovenian: d p < 0,001; v primerjavi z vehiklom glede na logistično regresijo z zdravljenjem, študijo in anatomsko umestitvijo.
English: Contact your doctor if these local skin reactions get severe.
Slovenian: Obrnite se na svojega zdravnika, če te lokalne kožne reakcije postanejo hude.
English: The tube is for single use only and should be discarded after use (see section 6.6).
Slovenian: Tuba je namenjena samo enkratni uporabi, zato jo po uporabi zavrzite (glejte poglavje 6.6).
English: gel 2 tubes
Slovenian: gel 2 tubi
English: Patients were followed every 3 months for 12 months (see table 5).
Slovenian: Bolnike so spremljali 12 mesecev vsake 3 mesece (glejte preglednico 5).
English: Back of Hand
Slovenian: Roka Hrbtni del dlani
English: - If you are allergic to ingenol mebutate or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na ingenolmebutat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Wash the area with soap and water.
Slovenian: Umijte mesto z milom in vodo.
English: - Do not apply more gel than your doctor has advised.
Slovenian: - Ne nanašajte več gela, kot vam je naročil zdravnik.
English: Treatment effect may not be adequately assessed until resolution of local skin responses.
Slovenian: Učinka zdravljenja morda ne bo mogoče ustrezno oceniti, dokler se ne pozdravijo lokalni odzivi kože.
English: - Allow the area to dry for 15 minutes.
Slovenian: - Počakajte 15 minut, da se posuši.
English: At 12 months, the complete clearance rates in these groups were 31% and 19% respectively.
Slovenian: V 12. mesecu sta bili stopnji popolne ozdravitve v teh skupinah 31 % in 19 %.
English: If you have been prescribed two different strengths for treatment of two different areas you should make sure that you use the prescribed strength on the correct area.
Slovenian: Če so vam predpisali dve različni jakosti gela za zdravljenje na dveh različnih mestih, morate poskrbeti, da boste uporabljali predpisano jakost na pravem mestu.
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, other chemotherapeutics, ATC code: D06BX02.
Slovenian: Farmakoterapevtska skupina: antibiotiki in kemoterapevtiki za uporabo v dermatologiji, drugi kemoterapevtiki, oznaka ATC: D06BX02.
English: 149 patients in the Picato group and 140 in the vehicle group were followed for 12 months.
Slovenian: 149 bolnikov v skupini z zdravilom Picato in 140 v skupini z vehiklom so spremljali 12 mesecev.
English: The trial included a large group of severely sun-damaged patients.
Slovenian: Preskušanje je vključevalo veliko skupino bolnikov s hujšimi poškodbami zaradi sonca.
English: If you use Picato for treatment of the neck
Slovenian: Če uporabljate zdravilo Picato za zdravljenje vratu
English: Othera aOther includes shoulder, back, leg.
Slovenian: Prsni koš Drugoa aDrugo vključuje ramo, hrbet, nogo.
English: - Avoid sunlight as much as possible (including sunlamps and tanning beds).
Slovenian: - Čim bolj se izogibajte sončni svetlobi (tudi svetilkam za sončenje in solarijem).
English: Experience with more than one treatment course
Slovenian: Izkušnje z več kot enim ciklom zdravljenja
English: You should avoid the use of Picato if you are pregnant.
Slovenian: Izogibajte se uporabi zdravila Picato, če ste noseči.
English: Seek medical attention right away if you experience an allergic reaction that may include swelling of the mouth, tongue or throat when using this medicine.
Slovenian: Nemudoma poiščite zdravniško pomoč, če ob uporabi tega zdravila doživite alergijsko reakcijo, ki lahko zajema otekanje ustne votline, jezika ali grla.
English: The PRAC is of the opinion that a thorough review is needed of the impact of all available data related to skin malignancies, including the results of study LP0041-63, on the benefit risk balance of Picato.
Slovenian: Odbor PRAC meni, da je potreben temeljit pregled vpliva vseh razpoložljivih podatkov, povezanih z malignimi obolenji kože, vključno z rezultati študije LP0041-63, na razmerje med tveganji in koristmi zdravila Picato.
English: - Do not swallow this medicine.
Slovenian: - Zdravila ne zaužijte.
English: Do not apply Picato on open-wounds or damaged skin.
Slovenian: Ne nanašajte zdravila Picato na odprte rane ali poškodovano kožo.
English: If you have previously used Picato or other similar medicines tell your doctor before starting the treatment.
Slovenian: Če ste pred tem uporabljali zdravilo Picato ali druga podobna zdravila, to povejte svojemu zdravniku pred začetkom zdravljenja.
English: Remove the cap from the tube just before use.
Slovenian: Pokrovček s tube odstranite tik pred uporabo.
English: Management of overdose should consist of treatment of clinical symptoms.
Slovenian: Obravnava prevelikega odmerjanja naj obsega zdravljenje kliničnih simptomov.
English: Risk of progression to squamous cell carcinoma
Slovenian: Tveganje za napredovanje v skvamozni karcinom
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
English: 285 Cashel Road, Crumlin, Dublin 12 Ireland
Slovenian: 285 Cashel Road, Crumlin, Dublin 12 Irska
English: In rabbits there were no major abnormalities.
Slovenian: Pri kuncih ni bilo večjih nenormalnosti.
English: The compliance rate was high, with 98% of the patients completing these studies.
Slovenian: Odstotek bolnikov, ki se redno zdravili, je bil visok, pri čemer je 98 % bolnikov zaključilo študiji.
English: LEO Laboratories Ltd. 285 Cashel Road Crumlin, Dublin 12 Ireland
Slovenian: LEO Laboratories Ltd. 285 Cashel Road Crumlin, Dublin 12 Irska
English: However, due to the nature of the disease, excessive exposure to sunlight (including sunlamps and tanning beds) should be avoided or minimised.
Slovenian: Vendar pa se je treba zaradi narave bolezni izogibati čezmerni izpostavitvi sončni svetlobi (tudi porjavitvenim svetilkam in solarijem) ali izpostavitev čim bolj zmanjšati.
English: The side effects may get worse for up to 1 week after you have stopped using this medicine.
Slovenian: Neželeni učinki se lahko slabšajo še 1 teden po prenehanju uporabe tega zdravila.
English: There are no data from the use of ingenol mebutate in pregnant women.
Slovenian: Podatkov o uporabi ingenolmebutata pri nosečnicah ni.
English: Do not re-use the tubes once opened.
Slovenian: Odprtih tub ne uporabite ponovno.
English: Elderly population No dose adjustment is required (see section 5.1).
Slovenian: Starejši bolniki Prilagoditev odmerka ni potrebna (glejte poglavje 5.1).
English: Picato must not be ingested.
Slovenian: Zdravila Picato se ne sme zaužiti.
English: On the treatment area:
Slovenian: Na zdravljenem mestu:
English: Additionally, the product information should be varied concerning ingenol mebutate use and the risk of skin malignancy.
Slovenian: Poleg tega je treba spremeniti informacije o zdravilu v zvezi z uporabo ingenolmebutata in tveganjem za maligno obolenje kože.
English: c Of these, 38 subjects were previously treated in a vehicle controlled phase 3 study and 38 subjects were previously treated in an uncontrolled phase 3 study.
Slovenian: c 38 oseb je bilo predhodno zdravljenih v študiji 3. faze, nadzorovani z vehiklom, 38 oseb pa je bilo predhodno zdravljenih v nenadzorovani študiji 3. faze.
English: What Picato is and what it is used for
Slovenian: Kaj je zdravilo Picato in za kaj ga uporabljamo
English: What Picato is and what it is used for What you need to know before you use Picato How to use Picato
Slovenian: Kaj je zdravilo Picato in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Picato Kako uporabljati zdravilo Picato
English: Should the symptoms described above intensify beyond the first week after you have stopped using this medicine, or if there is discharge of pus, you might have an infection and should contact your doctor or pharmacist.
Slovenian: Če se zgoraj opisani simptomi okrepijo po preteku prvega tedna od prenehanja uporabe tega zdravila ali če iz mesta izteka gnoj, imate morda okužbo in morate obiskati svojega zdravnika ali farmacevta.
English: Other medicines and Picato
Slovenian: Druga zdravila in zdravilo Picato