FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tavanic 250 mg and 500 mg film-coated tablets are indicated in acute bacterial sinusitis, acute exacerbation of chronic bronchitis, community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterial agents are not recommended.
Slovenian: • je zdravilo Tavanic 250 mg in 500 mg filmsko obložene tablete indicirano za akutni bakterijski sinuzitis, akutno eksacerbacijo kroničnega bronhitisa, pljučnico, pridobljeno v skupnosti, ter komplicirane okužbe kože in mehkega tkiva samo, če drugi pogosto uporabljani antibiotiki niso priporočljivi.
English: • Tavanic 5mg/ml solution for infusion is indicated in community-acquired pneumonia and complicated skin and soft tissue infections only when other commonly used antibacterials are not recommended.
Slovenian: • je zdravilo Tavanic 5 mg/ml raztopina za infundiranje indicirano za pljučnico, pridobljeno v skupnosti, ter komplicirane okužbe kože in mehkega tkiva samo, če drugi pogosto uporabljani antibiotiki niso priporočljivi.
English: They are also indicated in pyelonephritis and complicated urinary tract infections (UTI), chronic bacterial prostatitis, uncomplicated cystitis and for the post-exposure prophylaxis and curative treatment of
Slovenian: Indicirano je tudi za pielonefritis, komplicirane okužbe sečil, kronični bakterijski prostatitis, nekomplicirani cistitis ter profilakso proti antraksu po izpostavitvi z inhalacijo in kurativno zdravljenje inhalacijskega antraksa;
English: Tavanic was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Tavanic potrebna uskladitev.
English: chronic bacterial prostatitis, and for the post-exposure prophylaxis and curative treatment of
Slovenian: Indicirano je tudi za pielonefritis, komplicirane okužbe sečil, kronični bakterijski prostatitis ter profilakso proti antraksu po izpostavitvi z inhalacijo in kurativno zdravljenje inhalacijskega antraksa.
English: This cycle of treatment is repeated every two weeks, until the disease gets worse or the patient cannot tolerate the treatment.
Slovenian: Tak cikel zdravljenja se ponavlja vsaka dva tedna, dokler se bolezen ne poslabša ali bolnik ne more prenašati zdravljenja.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zaltrap on 1 February 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zaltrap, veljavno po vsej Evropski uniji, izdala 1. februarja 2013.
English: What measures are being taken to ensure the safe and effective use of Zaltrap?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zaltrap?
English: The main measure of effectiveness was the average length of time that patients survived after treatment.
Slovenian: Glavno merilo učinkovitosti je bilo povprečno preživetje bolnikov po zdravljenju.
English: What is Zaltrap and what is it used for?
Slovenian: Kaj je zdravilo Zaltrap in za kaj se uporablja?
English: The full EPAR for Zaltrap 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 Zaltrap je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Although medicines containing the same active substance are available for injection into the eye, Zaltrap must not be injected into the eye as it was not developed for such use and may cause local damage.
Slovenian: Čeprav so zdravila z enako zdravilno učinkovino na voljo za injiciranje v oko, se zdravila Zaltrap ne sme injicirati v oko, ker ni bilo razvito za tako uporabo in lahko povzroči lokalne poškodbe.
English: What benefits of Zaltrap have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Zaltrap izkazalo v študijah?
English: Other information about Zaltrap
Slovenian: Druge informacije o zdravilu Zaltrap
English: This is a summary of the European public assessment report (EPAR) for Zaltrap.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zaltrap.
English: It is not intended to provide practical advice on how to use Zaltrap.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What are the risks associated with Zaltrap?
Slovenian: Kakšna tveganja so povezana z zdravilom Zaltrap?
English: Although Zaltrap is associated with significant side effects, which can be severe enough to force treatment to be stopped, the results of the large main study show that there is a small but clinically significant benefit in prolonging the life of treated patients in whom previous treatment failed.
Slovenian: Čeprav je zdravilo Zaltrap povezano s pomembnimi neželenimi učinki, ki so lahko dovolj resni, da zahtevajo ukinitev zdravljenja, rezultati velike glavne študije kažejo, da obstaja majhna, a klinično pomembna korist pri podaljševanju preživetja zdravljenih bolnikov, pri katerih je bilo predhodno zdravljenje neuspešno.
English: Zaltrap is given as an infusion (drip) into the vein over one hour, at a dose of 4 mg per kilogram body weight.
Slovenian: Zdravilo Zaltrap se daje z infundiranjem (kapalno infuzijo) v veno v obdobju ene ure in v odmerku 4 mg na kilogram telesne mase.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zaltrap have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zaltrap upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Zaltrap was investigated in one main study involving 1,226 adults with metastatic colorectal cancer that had not responded to oxaliplatin-based treatment.
Slovenian: Zdravilo Zaltrap so raziskovali v eni glavni študiji, ki je vključevala 1 226 odraslih z metastatskim kolorektalnim rakom, ki se ni odzval na zdravljenje na osnovi oksaliplatina.
English: Why is Zaltrap approved?
Slovenian: Zakaj je bilo zdravilo Zaltrap odobreno?
English: Overall, the European Medicines Agency decided that Zaltrap's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Zaltrap večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: In this study, Zaltrap was more effective than placebo at increasing survival of patients: patients treated with Zaltrap plus FOLFIRI lived an average of 13.5 months, whereas patients treated with placebo and FOLFIRI lived an average of 12.1 months.
Slovenian: V tej študiji je bilo zdravilo Zaltrap učinkovitejše od placeba pri podaljševanju preživetja bolnikov: bolniki, zdravljeni z zdravilom Zaltrap in shemo FOLFIRI, so živeli povprečno 13,5 meseca, bolniki, zdravljeni s placebom in shemo FOLFIRI, pa 12,1 meseca.
English: As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, so helping to slow down the growth of tumours.
Slovenian: Zaradi tega se rakave celice ne morejo več oskrbovati s krvjo ter dobivajo premalo kisika in hranil, kar pripomore k upočasnjeni rasti tumorjev.
English: The medicine contains the active substance aflibercept.
Slovenian: Zdravilo vsebuje zdravilno učinkovino aflibercept.
English: Zaltrap is a cancer medicine used to treat adults with metastatic colorectal cancer (cancer of the large bowel that has spread to other parts of the body) for whom treatment based on another medicine, oxaliplatin, has not worked or the cancer got worse.
Slovenian: Zaltrap je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z metastatskim kolorektalnim rakom (rakom debelega črevesa, ki se je razširil na druge dele telesa), pri katerih zdravljenje na osnovi drugega zdravila, oksaliplatina, ni delovalo ali pa se je rak poslabšal.
English: For more information about treatment with Zaltrap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Zaltrap preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: By binding to VEGF and PlGF, aflibercept stops them having an effect.
Slovenian: Z vezavo na VEGF in PIGF jima aflibercept prepreči učinkovanje.
English: Zaltrap is used with FOLFIRI, which is a treatment combining the medicines irinotecan, 5-fluorouracil, and folinic acid.
Slovenian: Zdravilo Zaltrap se uporablja skupaj s shemo FOLFIRI, tj. zdravljenjem, ki vključuje zdravila irinotekan, 5-fluorouracil in folno kislino.
English: Zaltrap can only be obtained with a prescription and treatment should be supervised by a doctor who is experienced in using cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Zaltrap je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: For practical information about using Zaltrap, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Zaltrap naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: This is then followed by the FOLFIRI treatment.
Slovenian: Temu sledi zdravljenje po shemi FOLFIRI.
English: The most common side effects with Zaltrap in combination with FOLFIRI (which may affect more than 20 patients in 100) are leucopenia and neutropenia (low levels of white cells in the blood, including the type that fight infections), diarrhoea, proteinuria (protein in the urine), increased blood levels of liver enzymes (aspartate and alanine transaminases), stomatitis (inflammation of the mouth), tiredness, thrombocytopenia (low blood platelet counts), hypertension (high blood pressure), weight loss, decreased appetite, epistaxis (nose bleeds), abdominal pain, dysphonia (speech disturbance), increases in creatinine in the blood (a marker of kidney problems), and headache.
Slovenian: Najpogostejši neželeni učinki zdravila Zaltrap v kombinaciji s shemo FOLFIRI (ki se lahko pojavijo pri več kot 20 bolnikih od 100) so levkopenija in nevtropenija (nizko število belih krvnih celic v krvi, vključno s tistimi, ki se borijo proti okužbam), driska, proteinurija (beljakovine v urinu), zvišane ravni jetrnih encimov (aspartat- in alanin-transaminaz) v krvi, stomatitis (vnetje ustne sluznice), utrujenost, trombocitopenija (nizko število krvnih ploščic), hipertenzija (visok krvni tlak), izguba telesne mase, zmanjšan apetit, epistaksa (krvavitev iz nosu), bolečine v trebuhu, disfonija (motnja govora), zvišan kreatinin v krvi (označevalec delovanja ledvic) in glavobol.
English: How is Zaltrap used?
Slovenian: Kako se zdravilo Zaltrap uporablja?
English: The active substance in Zaltrap, aflibercept, is a protein that attaches to vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF), substances that circulate in the blood and make blood vessels grow.
Slovenian: Zdravilna učinkovina v zdravilu Zaltrap, aflibercept, je beljakovina, ki se veže na žilni endotelijski rastni faktor (VEGF) in placentni rastni faktor (PIGF), tj. snovi, ki krožita po krvi in omogočata rast žil.
English: The most common effects that led to treatment being permanently stopped were problems with the circulation including hypertension, infections, tiredness, diarrhoea, dehydration, stomatitis, neutropenia, proteinuria, and pulmonary embolism (a clot in a blood vessel supplying the lungs).
Slovenian: Najpogostejši neželeni učinki, ki so privedli do trajne ukinitve zdravljenja, so bili težave z obtokom, vključno s hipertenzijo, okužbe, utrujenost, driska, dehidracija, stomatitis, nevtropenija, proteinurija in pljučna embolija (strdek v žili, ki oskrbuje pljuča).
English: Zaltrap was compared with placebo (a dummy treatment) when added to FOLFIRI.
Slovenian: Zdravilo Zaltrap so primerjali s placebom (zdravilom brez zdravilne učinkovine) ob dodajanju zdravljenju po shemi FOLFIRI.
English: For the full list of all side effects reported with Zaltrap, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zaltrap, glejte navodilo za uporabo.
English: For further details, see the package leaflet.
Slovenian: Za več informacij glejte navodilo za uporabo.
English: Treatment should be discontinued, delayed, or the dose may have to be adjusted, in patients who develop certain side effects.
Slovenian: Pri bolnikih, pri katerih se pojavijo določeni neželeni učinki, je treba zdravljenje prekiniti, odložiti ali zmanjšati odmerek.
English: How does Zaltrap work?
Slovenian: Kako zdravilo Zaltrap deluje?
English: 1000 mg Granules for oral suspension Oral use
Slovenian: 1000mg Zrnca za peroralno raztopinoPeroralna uporaba vrečka (alu)
English: (Invented) nameStrength Pharmaceutical Form Route of AdministrationImmediate PackagingPack size
Slovenian: Farmacevtska oblika Pot uporabe
English: 21 January 2013
Slovenian: 21. januar 2013
English: The European Commission issued a decision on this opinion on 21 January 2013.
Slovenian: Evropska komisija je izdala sklep o tem mnenju 21. januarja 2013.
English: Questions and answers on the review of tolperisonecontaining medicines
Slovenian: Vprašanja in odgovori v zvezi s pregledom zdravil, ki vsebujejo tolperizon
English: The full changes made to the information to doctors and patients are detailed here.
Slovenian: Vse spremembe informacij za zdravnike in bolnike so na voljo tukaj.
English: On 21 June 2012, the European Medicines Agency completed a review of the safety and effectiveness of tolperisone.
Slovenian: Evropska agencija za zdravila je 21. junija 2012 opravila pregled varnosti in učinkovitosti tolperizona.
English: After re-examination, the Committee confirmed these recommendations on 18 October 2012.
Slovenian: CHMP je po ponovnem pregledu 18. oktobra 2012 ta priporočila potrdil.
English: Medicines containing tolperisone are available as tablets and/or solution for injection in Bulgaria, Cyprus, Czech Republic, Germany, Hungary, Latvia, Lithuania, Poland, Romania and Slovakia, under various trade names.
Slovenian: Zdravila, ki vsebujejo tolperizon, so na voljo v obliki tablet in/ali raztopine za injiciranje v Bolgariji, na Cipru, Češkem, v Nemčiji, na Madžarskem, v Latviji, Litvi, na Poljskem, v Romuniji in na Slovaškem pod različnimi tržnimi imeni.
English: If symptoms of hypersensitivity occur, treatment should be stopped immediately.
Slovenian: Če se pojavijo preobčutljivostni simptomi, je treba zdravljenje nemudoma prekiniti.
English: What is tolperisone?
Slovenian: Kaj je tolperizon?
English: In Germany, several indications approved in other countries were not authorised because the German medicines agency considered that tolperisone's effectiveness had not been proven in those indications.
Slovenian: Nemčiji nekatere indikacije, ki so odobrene v drugih državah, niso bile sprejete, saj je nemška agencija za zdravila presodila, da učinkovitost tolperizona za te indikacije ni bila dokazana.
English: As tolperisone-containing medicines have been developed by different companies and have been authorised through national procedures in the EU Member States, they are used to treat different conditions in different countries.
Slovenian: Ker so zdravila, ki vsebujejo tolperizon, razvila različna podjetja in so bila odobrena v nacionalnih postopkih v državah članicah EU, se v različnih državah uporabljajo za zdravljenje različnih obolenj.
English: The Committee also reviewed the available postmarketing data on spontaneous reports of side effects.
Slovenian: Odbor je pregledal tudi razpoložljive podatke iz obdobja trženja o spontanih poročilih v zvezi s stranskimi učinki.
English: On 15 July 2011, it asked the CHMP to issue an opinion on whether the marketing authorisations for tolperisone-containing products should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: 15. julija 2011 je zaprosila odbor CHMP, naj izda mnenje o tem, ali je treba dovoljenja za promet z zdravili, ki vsebujejo tolperizon, v celotni EU ohraniti, spremeniti, začasno umakniti ali preklicati.
English: What are the conclusions of the CHMP?
Slovenian: Kakšni so zaključki Odbora CHMP?
English: However, the study only included adults with post-stroke spasticity.
Slovenian: Vendar pa je študija vključevala le odrasle s spastičnostjo po možganski kapi.
English: The CHMP noted that most of the studies with oral tolperisone, performed in the 1960s and 1970s, were of a lower standard than that expected today.
Slovenian: Odbor CHMP je opozoril, da je večina študij, ki so bile opravljene s peroralnim tolperizonom v 60. in 70. letih prejšnjega stoletja, nižjega standarda, kot je zahtevan v današnjem času.
English: Tolperisone is a muscle relaxant.
Slovenian: Tolperizon je mišični relaksant.
English: The CHMP confirmed the above conclusions after re-examining its opinion.
Slovenian: Odbor CHMP je po ponovnem pregledu svojega mnenja potrdil gornje sklepe.
English: The Committee therefore recommended that the product information should be updated to reflect this risk and include a warning on the signs of hypersensitivity.
Slovenian: Odbor je zato priporočil posodobitev podatkov o zdravilu tako, da bodo odražali to tveganje in vključevali opozorilo o znakih preobčutljivosti.
English: • Patients should note that symptoms of hypersensitivity can include flushing, rash, severe itching of the skin (with raised lumps), wheezing, difficulty breathing, difficulty in swallowing, fast heartbeat, low blood pressure and fast decrease in blood pressure.
Slovenian: • Bolniki naj se zavedajo, da lahko preobčutljivostni simptomi vključujejo vročinske oblive, izpuščaj, hudo srbečico kože (z dvignjenimi bulicami), sopenje, oteženo dihanje, oteženo požiranje, hiter srčni utrip, nizek krvni tlak in hiter padec krvnega tlaka.
English: Why were tolperisone-containing medicines reviewed?
Slovenian: Zakaj je bil za zdravila, ki vsebujejo tolperizon, opravljen pregled?
English: Tolperisone-containing medicines have been authorised in several countries in the EU since the 1960s for the treatment of muscle spasms (involuntary contractions) and spasticity caused by different conditions.
Slovenian: Zdravila, ki vsebujejo tolperizon, so v EU odobrena že od 60. let prejšnjega stoletja za zdravljenje mišičnih spazmov (nehotenih krčev) in spastičnosti, ki jo povzročajo različna obolenja.
English: The available data to support the use of tolperisone-containing medicines in locomotor diseases, vascular diseases, rehabilitation following surgery and Little's disease are limited and not convincing.
Slovenian: Razpoložljivi podatki, ki bi podprli uporabo zdravil, ki vsebujejo tolperizon, pri obolenjih lokomotornega sistema, žilnih boleznih, rehabilitaciji po kirurškem posegu in Littlovi bolezni, so omejeni in niso prepričljivi.
English: • Patients currently using tolperisone for any other indication or using injectable tolperisone should speak to their doctor at their next routine appointment so they can switch to an appropriate alternative treatment.
Slovenian: • Bolniki, ki trenutno uporabljajo tolperizon za katero koli drugo indikacijo ali ki uporabljajo tolperizon za injiciranje, naj se posvetujejo s svojim zdravnikom ob naslednjem načrtovanem pregledu, da bodo lahko prešli na ustrezno alternativno zdravljenje.
English: Only in the treatment of spasticity caused by neurological diseases was a study considered to be of acceptable quality, showing a moderate improvement of 32% in spasticity with oral tolperisone, compared with a 14% improvement in the placebo (a dummy treatment) group.
Slovenian: Le za študijo zdravljenja spastičnosti, povzročene z nevrološkimi obolenji, so menili, da je sprejemljive kakovosti, saj je prikazala zmerno izboljšanje za 32 % pri spastičnosti v skupini s peroralnim tolperizonom v primerjavi s 14 % izboljšanjem v skupini s placebom (zdravilom brez zdravilne učinkovine).
English: The CHMP reviewed data on the effectiveness of oral and injectable tolperisone in the different indications, including data from published clinical studies and analyses of various studies provided by the companies that market these medicines.
Slovenian: Odbor CHMP je pregledal podatke o učinkovitosti tolperizona, ki se daje peroralno in ki se injicira, za različne indikacije, vključno s podatki iz objavljenih kliničnih študij in analiz različnih študij, ki so jih posredovala podjetja, ki ta zdravila tržijo.
English: These include neurological diseases (related to the brain or nerves, such as multiple sclerosis), locomotor diseases (related to the spine and large joints such as the hip), vascular diseases (related to the blood vessels), rehabilitation following surgery, and Little's disease (also known as cerebral palsy, a rare disease where there is damage to parts of the brain that control movement).
Slovenian: Ta vključujejo nevrološke bolezni (povezane z možgani ali živci, kakršna je npr. multipla skleroza), obolenja lokomotornega sistema (povezana s hrbtenico in velikimi sklepi, kot je kolk), vaskularne bolezni (povezane s krvnimi žilami), rehabilitacijo po kirurškem posegu in Littlovo bolezen (znano tudi kot možganska paraliza - redka bolezen, pri kateri so poškodovani deli možganov, ki nadzirajo gibanje).
English: The Committee also recommended that the marketing authorisations for tolperisonecontaining medicines given by injection should be revoked throughout the European Union (EU).
Slovenian: Odbor je prav tako priporočil, naj se dovoljenja za promet z zdravili, ki vsebujejo tolperizon in se jih daje z injiciranjem, v vsej Evropski uniji (EU) prekliče.
English: Consequently, the German medicines agency considered that a full assessment of the benefit-risk balance of tolperisone should be carried out in all approved indications.
Slovenian: Posledično je nemška agencija za zdravila odločila, da je treba opraviti popolno oceno razmerja med tveganji in koristmi tolperizona za vse odobrene indikacije.
English: • Prescribers are advised that injectable tolperisone should no longer be used in the EU.
Slovenian: • Zdravnike je treba obvestiti, da tolperizona za injiciranje v EU ne smejo več uporabljati.
English: Doctors should stop prescribing tolperisone for any other indication.
Slovenian: Zdravniki naj prenehajo predpisovati tolperizon za druge indikacije.
English: Regarding the safety of tolperisone, the CHMP noted that more than half of the spontaneous reports of side effects with tolperisone were hypersensitivity reactions, while only a small number of hypersensitivity reports had been observed during the clinical trials that supported tolperisone's marketing authorisation.
Slovenian: V zvezi z varnostjo tolperizona je odbor CHMP opozoril, da je bila več kot polovica spontanih poročil o stranskih učinkih s tolperizonom preobčutljivostnih reakcij, medtem ko so opazili le manjše število poročil o preobčutljivosti med kliničnimi preskušanji, ki so podprla dovoljenje za promet z zdravili, ki vsebujejo tolperizon.
English: The exact way tolperisone works is not known, but it is thought to act in the brain and spinal cord to reduce the nerve impulses that make the muscles contract and become rigid.
Slovenian: Natančen mehanizem delovanja tolperizona ni povsem znan, predvidevajo pa, da s svojim delovanjem v možganih in hrbtenjači onemogoča živčne impulze, zaradi katerih se mišice krčijo in postanejo toge.
English: In addition, numerous reports of hypersensitivity (allergic) reactions to tolperisone had been reported post marketing in Germany.
Slovenian: Poleg tega so v Nemčiji v obdobju trženja prejeli številna poročila o preobčutljivostnih (alergijskih) reakcijah na tolperizon.