FrancophonIA/ELRC3.0 huggingface dataset:
English: After the main study had finished, patients had the option to receive treatment with Deltyba for 6 months in an extension study.
Slovenian: Po zaključku glavne študije so imeli bolniki možnost, da zdravilo Deltyba šest mesecev prejemajo v okviru podaljšane študije.
English: The company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.
Slovenian: Podjetje, ki trži zdravilo Deltyba, bo priskrbelo izobraževalno gradivo za zdravstvene delavce in v njem pojasnilo, kako se zdravilo varno uporablja, da ne pride do težav, kot so pojav odpornosti in neželeni učinki za srce, ter opisalo tveganja pri nosečnicah in doječih materah.
English: Other information about Deltyba
Slovenian: Druge informacije o zdravilu Deltyba
English: It must also not be used in patients who are taking certain other medicines that affect the way Deltyba is broken down in the body.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, ki jemljejo nekatera druga zdravila, ki vplivajo na presnovo zdravila Deltyba v telesu.
English: Since Deltyba has been given conditional authorisation, the company that markets Deltyba will carry out further studies to confirm the long-term effectiveness and safety of Deltyba.
Slovenian: Ker je zdravilo Deltyba pridobilo pogojno dovoljenje za promet, bo podjetje, ki ga trži, izvedlo nadaljnje študije v podporo dolgoročni učinkovitosti in varnosti zdravila Deltyba.
English: Deltyba is a medicine that is used in adults with tuberculosis affecting the lung and that is multi-drug resistant (resistant to at least isoniazid and rifampicin, the two standard tuberculosis medicines).
Slovenian: Deltyba je zdravilo, ki se uporablja pri odraslih s tuberkulozo, ki prizadene pljuča in je odporna proti več zdravilom (odporna najmanj proti izoniazidu in rifampicinu, standardnima zdraviloma za zdravljenje tuberkuloze).
English: Looking at the results of these follow-up studies together, 2 years after starting treatment 75% of patients who received Deltyba for 6 months or more had no bacteria in their sputum compared with 55% of patients who received Deltyba for 2 months or less.
Slovenian: Skupni rezultati obeh nadaljnjih študij kažejo, da dve leti po začetku zdravljenja bakterij v izpljunku ni več imelo 75 % bolnikov, ki so prejemali zdravilo Deltyba šest mesecev ali več, in 55 % bolnikov, ki so zdravilo Deltyba prejemali dva meseca ali manj.
English: What are the risks associated with Deltyba?
Slovenian: Kakšna tveganja so povezana z zdravilom Deltyba?
English: After 2 months of treatment more than 40% of the patients who were taking Deltyba no longer had the bacteria in their sputum compared with 30% of the patients who were taking placebo.
Slovenian: Po dveh mesecih zdravljenja bakterij v izpljunku ni več imelo več kot 40 % bolnikov, ki so jemali zdravilo Deltyba, in 30 % bolnikov, ki so jemali placebo.
English: It should be used according to official guidelines on treating multi-drug resistant tuberculosis.
Slovenian: Uporabljati ga je treba v skladu z uradnimi smernicami za zdravljenje tuberkuloze, odporne proti več zdravilom.
English: The active substance in Deltyba, delamanid, is an antibiotic active against M. tuberculosis.
Slovenian: Učinkovina zdravila Deltyba, delamanid, je antibiotik, ki učinkuje proti M. tuberculosis.
English: Patients in the study were given Deltyba or placebo (a dummy treatment) for 2 months in addition to their other treatments.
Slovenian: Bolniki v študiji so dva meseca poleg drugih zdravil prejemali zdravilo Deltyba ali placebo (zdravilo brez učinkovine).
English: What information is still awaited for Deltyba?
Slovenian: Katere informacije o zdravilu Deltyba še pričakujemo?
English: Deltyba can only be obtained with a prescription and treatment should be started and monitored by a doctor who is experienced in the treatment of multi-drug resistant tuberculosis.
Slovenian: Predpisovanje in izdaja zdravila Deltyba je le na recept, zdravljenje z njim pa lahko uvede in nadzoruje le zdravnik z izkušnjami z zdravljenjem tuberkuloze, odporne proti več zdravilom.
English: Furthermore the medical need for new agents to treat multi-drug resistant tuberculosis was highlighted.
Slovenian: Poleg tega je poudarila medicinsko potrebo po novih zdravilih za zdravljenje tuberkuloze, ki je odporna proti več zdravilom.
English: Deltyba contains the active substance delamanid.
Slovenian: Zdravilo Deltyba vsebuje učinkovino delamanid.
English: The Agency considered that the benefits of Deltyba had been shown for patients with multi-drug resistant tuberculosis affecting the lung.
Slovenian: Agencija je menila, da so se koristi zdravila Deltyba pokazale pri bolnikih s tuberkulozo, ki je odporna proti več zdravilom in prizadene pljuča.
English: How is Deltyba used?
Slovenian: Kako se zdravilo Deltyba uporablja?
English: How does Deltyba work?
Slovenian: Kako zdravilo Deltyba deluje?
English: For the full list of side effects of Deltyba, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Deltyba, glejte navodilo za uporabo.
English: Further information on Sixmo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/sixmo.
Slovenian: Nadaljnje informacije o zdravilu Sixmo so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/sixmo.
English: Sixmo (buprenorphine)
Slovenian: Sixmo (buprenorfin)
English: It contains the active substance buprenorphine.
Slovenian: Vsebuje učinkovino buprenorfin.
English: The company will also provide an alert card which patients should carry at all times and show to other healthcare professionals before receiving any medical treatment.
Slovenian: Prav tako bo zagotovilo opozorilno kartico, ki jo morajo imeti bolniki vedno pri sebi in jo pokazati drugim zdravstvenim delavcem pred začetkom katerega koli zdravljenja.
English: What measures are being taken to ensure the safe and effective use of Sixmo?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Sixmo?
English: The European Medicines Agency therefore decided that Sixmo's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Sixmo večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The medicine can therefore be used in a controlled way to help prevent withdrawal symptoms and reduce the urge to misuse other opioids.
Slovenian: Zdravilo se lahko tako nadzorovano uporablja za preprečevanje odtegnitvenih simptomov in zmanjševanje potrebe po zlorabi drugih opioidov.
English: Other information about Sixmo
Slovenian: Druge informacije o zdravilu Sixmo
English: As for all medicines, data on the use of Sixmo are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Sixmo stalno spremljajo.
English: The patient receives four implants, which are inserted under local anaesthesia in the inner side of the upper arm and kept in place for 6 months.
Slovenian: Bolnik prejme štiri implantate, ki se vstavijo pod lokalno anestezijo na notranjo stran nadlahti in so vstavljeni šest mesecev.
English: Sixmo is an implant used to treat dependence on opioid drugs such as heroin or morphine.
Slovenian: Sixmo je implantat, ki se uporablja za zdravljenje odvisnosti od opioidov, kot sta heroin in morfin.
English: An overview of Sixmo and why it is authorised in the EU
Slovenian: Pregled zdravila Sixmo in zakaj je odobreno v EU
English: Sixmo is used in adults who are already stable while taking buprenorphine under the tongue (no more than 8 mg/day), and who are also receiving medical, social and psychological support.
Slovenian: Zdravilo Sixmo se uporablja pri odraslih, ki so že stabilizirani s podjezičnim buprenorfinom (ne več kot 8 mg/dan) ter ki prejemajo tudi medicinsko, socialno in psihološko podporo.
English: The most common side effects related to the insertion and removal of the implant are pain, itching, bruising, bleeding, reddening of the skin and rash at the site of the implant.
Slovenian: Najpogostejši neželeni učinki zdravila, povezani z vstavitvijo in odstranitvijo implantata, so bolečina, srbenje, modrice, krvavitev, pordelost kože in izpuščaj na mestu implantata.
English: What is Sixmo and what is it used for?
Slovenian: Kaj je zdravilo Sixmo in za kaj se uporablja?
English: Why is Sixmo authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Sixmo odobreno v EU?
English: What are the risks associated with Sixmo?
Slovenian: Kakšna tveganja so povezana z zdravilom Sixmo?
English: In addition, the company will conduct a study to investigate breakages and other complications during the insertion and removal of the implants in clinical practice.
Slovenian: Izvedlo bo tudi študijo, v kateri bo proučilo pretrganine ali druge zaplete med vstavljanjem in odstranjevanjem implantatov v klinični praksi.
English: What benefits of Sixmo have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Sixmo izkazalo v študijah?
English: While the effect of the implants tended to wear off with time in patients not previously treated with buprenorphine, it was maintained in patients who were already stable on low doses of buprenorphine and the use of Sixmo is therefore reserved for these patients.
Slovenian: Medtem ko se je učinek implantatov sčasoma zmanjšal pri bolnikih, ki predhodno niso bili zdravljeni z buprenorfinom, se je ohranil pri bolnikih, ki so že bili stabilni pri majhnih odmerkih buprenorfina, zato je uporaba zdravila Sixmo rezervirana za te bolnike.
English: The active substance in Sixmo, buprenorphine, is a partial opioid agonist (which means that it acts like an opioid but less powerfully).
Slovenian: Učinkovina v zdravilu Sixmo, buprenorfin, je delni opioidni agonist (deluje kot opioid, vendar ni tako močan).
English: Sixmo must not be used together with medicines known as ‘opioid antagonists' (naltrexone and nalmefene).
Slovenian: Zdravilo Sixmo se ne sme uporabljati sočasno z zdravili, znanimi kot „antagonisti opioidov“ (naltrekson in nalmefen).
English: Side effects reported with Sixmo are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Sixmo, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sixmo have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Sixmo upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: For more information about using Sixmo, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Sixmo glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Sixmo (which may affect up to 1 in 10 people) include headache, constipation and difficulty sleeping.
Slovenian: Najpogostejši neželeni učinki zdravila Sixmo (ki se lahko pojavijo pri največ 1 bolniku od 10) so glavobol, zaprtje in motnje spanja.
English: The main studies showed that Sixmo was more effective than placebo and at least as effective as sublingual buprenorphine at treating opioid dependence.
Slovenian: Glavne študije so pokazale, da je bilo zdravilo Sixmo učinkovitejše od placeba in vsaj enako učinkovito kot podjezični buprenorfin pri zdravljenju odvisnosti od opioidov.
English: Sixmo must not be used by patients with severe respiratory insufficiency (inability to breathe properly), patients with severe liver problems, and patients who are intoxicated with alcohol or are experiencing alcohol withdrawal symptoms.
Slovenian: Zdravilo Sixmo se ne sme uporabljati pri bolnikih s hudo respiratorno insuficienco (dihalno stisko), bolnikih s hudo okvaro jeter ter pri bolnikih, ki so pod vplivom alkohola ali imajo simptome odtegnitve alkohola.
English: In both of these studies, the number of urine tests that were negative for opioid use decreased towards the end of the treatment period, indicating a reduction of the effect of Sixmo over time.
Slovenian: V obeh študijah se je število urinskih testov, ki so bili negativni na uživanje opioidov, zmanjšalo proti koncu obdobja zdravljenja, kar kaže na zmanjšanje učinka zdravil Sixmo skozi čas.
English: Treatment with Sixmo must be under the supervision of a healthcare professional experienced in the management of opioid dependence.
Slovenian: Zdravljenje z zdravilom Sixmo mora potekati pod nadzorom zdravstvenega delavca, ki ima izkušnje z obvladovanjem odvisnosti od opioidov.
English: Three studies involving a total of 627 patients with opioid dependence showed that Sixmo is effective at reducing patients' intake of opioids.
Slovenian: Tri študije, v katerih je sodelovalo 627 bolnikov z odvisnostjo od opioidov, so pokazale, da je zdravilo Sixmo učinkovito pri zmanjševanju uživanja opioidov pri bolnikih.
English: The company that markets Sixmo will set up an educational programme for doctors who are expected to prescribe Sixmo to provide detailed information about the surgical procedure for the insertion and removal of the implant.
Slovenian: Podjetje, ki trži zdravilo Sixmo, bo pripravilo izobraževalni program za zdravnike, ki naj bi predpisovali to zdravilo, s podrobnimi informacijami o kirurškem postopku za vstavitev in odstranitev implantata.
English: Sixmo is available as an implant to be inserted under the skin, which continuously releases buprenorphine into the body.
Slovenian: Zdravilo Sixmo je na voljo kot implantat, ki se vstavi pod kožo in stalno sprošča buprenorfin v telo.
English: It must also not be used by patients who cannot have an MRI scan and by patients who have had an excessive formation of scar tissue, as this would make locating and removing the implants more difficult.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih, pri katerih ni mogoče opraviti slikanja z magnetno resonanco, in tistih, ki imajo v anamnezi pretirano brazgotinjenje, saj bi to otežilo iskanje in odstranjevanje implantatov.
English: The side effects of Sixmo are those expected for a buprenorphine medicine and side effects linked to the implant itself are considered manageable.
Slovenian: Neželeni učinki zdravila Sixmo so tisti, ki se pričakujejo za zdravila z buprenorfinom, neželeni učinki, povezani s samim implantatom, pa so obvladljivi.
English: Sixmo can only be obtained by ‘special' prescription.
Slovenian: Predpisovanje in izdaja zdravila Sixmo je le na „poseben“ recept.
English: The first study compared Sixmo with placebo (dummy) implants in 163 patients who had not received buprenorphine before.
Slovenian: V prvi študiji so zdravilo Sixmo primerjali z implantati s placebom (brez učinkovine) pri 163 bolnikih, ki pred tem niso prejemali buprenorfina.
English: The insertion and removal of the implant must be performed by a doctor who is experienced in minor surgery and has been trained to carry out the insertion and removal procedures.
Slovenian: Implantate Sixmo sme vstavljati in odstranjevati le zdravnik, ki je pristojen za izvajanje manjših kirurških posegov in je usposobljen za izvajanje postopkov vstavljanja in odstranjevanja.
English: During the 6 months of treatment, the percentage of negative urine tests for opioids was around 31% for Sixmo, 13% for placebo and 33% for sublingual buprenorphine.
Slovenian: V šestmesečnem obdobju zdravljenja je bil odstotek urinskih testov, ki so bili negativni na opioide, okoli 31 % pri uporabi zdravila Sixmo, 13 % pri jemanju placeba in 33 % pri uporabi podjezičnega buprenorfina.
English: During the first 4 months of treatment, the percentage of negative urine tests for opioids was around 40% for patients treated with Sixmo, compared with around 28% for those treated with placebo.
Slovenian: V prvih štirih mesecih zdravljenja je bil odstotek urinskih testov, ki so bili negativni na opioide, pri bolnikih, ki so bili zdravljeni z zdravilom Sixmo, okoli 40 % v primerjavi s približno 28 % pri bolnikih, ki so bili zdravljeni s placebom.
English: The second study in 287 patients who had not received buprenorphine before compared Sixmo with placebo implants and with sublingual buprenorphine (given under the tongue).
Slovenian: V drugi študiji, v katero je bilo vključenih 287 bolnikov, ki predhodno niso prejemali buprenorfina, so zdravilo Sixmo primerjali z implantati s placebom in podjezičnim buprenorfinom.
English: How does Sixmo work?
Slovenian: Kako zdravilo Sixmo deluje?
English: For the full list of side effects of Sixmo, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov zdravila Sixmo glejte navodilo za uporabo.
English: How is Sixmo used?
Slovenian: Kako se zdravilo Sixmo uporablja?
English: The third study compared Sixmo with sublingual buprenorphine in 177 patients whose opioid dependence was already being managed with sublingual buprenorphine at a daily dose of up to 8 mg. After 6 months of treatment, around 96% of patients who received Sixmo responded to treatment (i.e. there was no evidence of opioid use in at least 4 out of 6 months) compared with around 88% in patients on sublingual buprenorphine.
Slovenian: Po šestih mesecih zdravljenja se je na zdravljenje odzvalo približno 96 % bolnikov, ki so prejemali zdravilo Sixmo (tj. ni bilo dokazov o uživanju opioidov v najmanj štirih od šestih mesecev), v primerjavi s približno 88 % pri bolnikih, ki so prejemali podjezični buprenorfin.
English: NeoRecormon is available in various strengths from 500 to 50,000 international units (IU).
Slovenian: Zdravilo NeoRecormon je na voljo v različnih jakostih od 500 do 50 000 mednarodnih enot (i.e.).
English: The European Commission granted a marketing authorisation valid throughout the European Union for NeoRecormon on 17 July 1997.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom NeoRecormon, veljavno po vsej Evropski uniji, izdala 17. julija 1997.
English: The multidose formulation of NeoRecormon contains benzyl alcohol and must not be given to children below three years of age.
Slovenian: Večodmerna formulacija zdravila NeoRecormon vsebuje benzilalkohol in se ne sme dajati otrokom, mlajšim od treh let.
English: It is also available as a pre-filled syringe.
Slovenian: Na voljo je tudi kot predhodno napolnjena brizga.
English: The full EPAR for NeoRecormon 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 NeoRecormon je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for NeoRecormon.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NeoRecormon.
English: What measures are being taken to ensure the safe and effective use of NeoRecormon?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila NeoRecormon?
English: It is available as a powder and solvent in a multidose vial, to be made up into a solution for injection.
Slovenian: Na voljo je kot prašek in vehikel v večodmerni viali za pripravo raztopine za injiciranje.
English: For more information about treatment with NeoRecormon, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom NeoRecormon preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: • to prevent anaemia in premature babies;
Slovenian: • preprečevanje anemije pri nedonošenčkih;
English: The CHMP decided that NeoRecormon's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila NeoRecormon večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: The most common side effects (seen in between 1 and 10 patients in 100) are hypertension (high blood pressure), headache and thromboembolic events (formation of blood clots in the blood vessels).
Slovenian: Najpogostejši neželeni učinki (opaženi pri 1 do 10 bolnikih od 100) so hipertenzija (visok krvni tlak), glavobol in tromboembolični dogodki (nastajanje krvnih strdkov v krvnih žilah).
English: The main measures of effectiveness in most of the studies were whether NeoRecormon increased haemoglobin levels or whether it reduced the need for blood transfusions.
Slovenian: Glavna merila učinkovitosti v večini študij so se nanašala na vprašanje, ali zdravilo NeoRecormon poveča ravni hemoglobina v krvi oziroma ali zmanjšuje potrebo po transfuziji krvi.
English: A risk management plan has been developed to ensure that NeoRecormon is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila NeoRecormon je bil pripravljen načrt obvladovanja tveganj.
English: The effectiveness of NeoRecormon to treat or prevent anaemia has been studied in many studies including anaemia in chronic renal failure (1,663 patients, including some comparative studies against placebo (a dummy treatment)), autologous blood transfusion (419 patients, comparison with placebo), anaemia in premature babies (177 babies, comparison with no treatment), and in cancer patients (1,204 patients with different types of cancer, comparison with placebo).
Slovenian: Učinkovitost zdravila NeoRecormon pri zdravljenju ali preprečevanju anemije je bila proučevana v številnih študijah, ki so vključevale anemijo pri kronični ledvični odpovedi (1 663 bolnikov, vključno z nekaterimi primerjalnimi študijami v primerjavi s placebom, tj. zdravilom brez zdravilne učinkovine), avtologno transfuzijo krvi (419 bolnikov, primerjava s placebom), anemijo pri nedonošenčkih (177 dojenčkov, primerjava z stanjem brez zdravljenja) in pri bolnikih z rakom (1 204 bolniki z različnimi vrstami raka, primerjava s placebom).
English: Other information about NeoRecormon
Slovenian: Druge informacije o zdravilu NeoRecormon
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 NeoRecormon.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: NeoRecormon was more effective than placebo at increasing haemoglobin levels in patients with various types of anaemia, including those with chronic renal failure.
Slovenian: Zdravilo NeoRecormon je bilo pri povečevanju ravni hemoglobina učinkovitejše od placeba pri bolnikih z različnimi vrstami anemije, vključno s tistimi s kronično ledvično odpovedjo.
English: It contains the active substance epoetin beta.
Slovenian: Vsebuje zdravilno učinkovino epoetin beta.
English: NeoRecormon must not be used in patients who have poorly controlled high blood pressure.
Slovenian: Zdravilo NeoRecormon se ne sme uporabljati pri bolnikih, pri katerih visok krvni tlak ni zadovoljivo nadzorovan.
English: What benefit has NeoRecormon shown during the studies?
Slovenian: Kakšne koristi je zdravilo NeoRecormon izkazalo med študijami?
English: • to treat anaemia that is causing symptoms in adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer that does not affect the bone marrow);
Slovenian: • zdravljenje anemije, ki povzroča simptome pri odraslih, ki prejemajo kemoterapijo za zdravljenje nemieloidnega raka (raka, ki ne prizadene kostnega mozga);