FrancophonIA/ELRC3.0 huggingface dataset:
English: Livensa should not be used in people who may be hypersensitive (allergic) to testosterone or any of the other ingredients.
Slovenian: Zdravila Livensa ne smejo uporabljati osebe, ki utegnejo biti preobčutljive (alergične) na testosteron ali katero koli drugo sestavino zdravila.
English: The active substance in Livensa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Slovenian: Zdravilna učinkovina v zdravilu Livensa, testosteron, je naravni spolni hormon, ki se tvori pri moških in v manjši meri pri ženskah.
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 Livensa.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Livensa, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because testosterone is a male sex hormone, women who are taking Livensa should be monitored to see if they develop any ‘androgenic' side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Slovenian: Ker je testosteron moški spolni hormon, je treba ženske, ki uporabljajo zdravilo Livensa, spremljati, da bi ugotovili, ali se pri njih pojavljajo „androgeni“ neželeni učinki (pojavljanje moških značilnosti), kot so rast dlake na obrazu, znižanje glasu ali izpadanje las.
English: The company will review all of the ongoing studies with Livensa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Slovenian: Pregledala bo vse študije z zdravilom Livensa, ki so v teku, da bi proučila morebitna dolgoročna tveganja, ki vključujejo rak dojke, rak endometrija (rak maternične sluznice) in neželene učinke, ki vplivajo na srce in ožilje.
English: Women using Livensa should also use oestrogens, but not of the type known as ‘conjugated oestrogens' because the combination of these with Livensa is not as effective as the combination of other types of oestrogen with Livensa.
Slovenian: Ženske, ki uporabljajo zdravilo Livensa, morajo prejemati tudi estrogen, vendar ne vrste estrogena, ki se imenuje „konjugirani estrogen“, ker ta v kombinaciji z zdravilom Livensa ni tako učinkovit kot druge vrste estrogena v kombinaciji z zdravilom Livensa.
English: Livensa releases testosterone through the skin into the bloodstream to produce testosterone levels that match the levels seen before removal of the womb and ovaries.
Slovenian: Zdravilo Livensa sprosti testosteron skozi kožo v krvni obtok, s čimer se vzpostavi raven testosterona, ki ustreza ravni, izmerjeni pred odstranitvijo maternice in jajčnikov.
English: The most common side effects with Livensa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip) and reactions at the site of application of the patch (redness and itching).
Slovenian: Najpogostejši neželeni učinki zdravila Livensa (opaženi pri več kot 1 bolnici od 10) so hirsutizem (povečana rast dlak, zlasti na bradi in nad zgornjo ustnico) in reakcije na mestu namestitve obliža (rdečica in srbenje).
English: Livensa is used to treat lack of sexual thoughts and desire that is causing distress in women who have had their womb and both ovaries removed.
Slovenian: Zdravilo Livensa se uporablja za zdravljenje pomanjkanja spolne želje in misli, ki povzroča čustveno stisko pri ženskah, ki so jim odstranili maternico in oba jajčnika.
English: The CHMP decided that Livensa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Livensa večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: When the results of the two studies were looked at together, the women who used Livensa had an average of 1.07 more satisfying sexual episodes than the women who used placebo over a four-week period.
Slovenian: Analiza skupnih rezultatov obeh študij je pokazala, da so ženske, ki so uporabljale zdravilo Livensa, v štiritedenskem obdobju imele v povprečju za 1,07 več zadovoljivih spolnih odnosov kot ženske, ki so uporabljale placebo.
English: Livensa was compared with placebo (a patch containing no active substance).
Slovenian: Zdravilo Livensa so primerjali s placebom (obližem, ki ni vseboval zdravilne učinkovine).
English: What is the risk associated with Livensa?
Slovenian: Kakšna tveganja so povezana z zdravilom Livensa?
English: The company that makes Livensa will monitor some of the side effects of Livensa closely, such as its androgenic side effects.
Slovenian: Družba, ki proizvaja zdravilo Livensa, bo skrbno spremljala nekatere neželene učinke zdravila Livensa, kot so na primer njegovi androgeni neželeni učinki.
English: On average, women who had three satisfying sexual episodes in a four-week period before treatment had around five episodes over four weeks after using Livensa for six months.
Slovenian: V povprečju so ženske, ki so imele pred zdravljenjem povprečno tri zadovoljive spolne odnose v štiritedenskem obdobju, po šestmesečnem jemanju zdravila Livensa imele okoli pet zadovoljivih spolnih odnosov v štiritedenskem obdobju.
English: Livensa is a transdermal patch (a patch that delivers a medicine across the skin).
Slovenian: Zdravilo Livensa je transdermalni obliž (obliž, ki dovaja zdravilo skozi kožo).
English: Why has Livensa been approved?
Slovenian: Zakaj je bilo zdravilo Livensa odobreno?
English: For the full list of all side effects reported with Livensa, see the
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Livensa, glejte navodilo za uporabo.
English: The full EPAR for Livensa can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Livensa je na voljo tukaj.
English: What is Livensa used for?
Slovenian: Za kaj se zdravilo Livensa uporablja?
English: How does Livensa work?
Slovenian: Kako zdravilo Livensa deluje?
English: How has Livensa been studied?
Slovenian: Kako je bilo zdravilo Livensa raziskano?
English: How is Livensa used?
Slovenian: Kako se zdravilo Livensa uporablja?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Possia to AstraZeneca on 03 December 2010.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Possia, veljavno po vsej Evropski uniji, odobrila družbi AstraZeneca dne 03 decembra 2010.
English: The full EPAR for Possia can be searched for 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 Possia je voljo na spletni strani agencije website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: They should continue treatment for up to a year unless, the doctor asks them to stop taking the medicine.
Slovenian: Zdravljenje lahko traja do enega leta, razen če zdravnik presodi, da je treba jemanje zdravila prekiniti.
English: The effects of Possia were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Possia so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: The starting dose of Possia is two tablets taken at once, followed by a regular dose of one tablet taken twice a day.
Slovenian: Začetni odmerek zdravila Possia sta dve tableti, ki ju bolnik vzame hkrati, sledi pa redni odmerek ene tablete dvakrat dnevno.
English: Other information about Possia
Slovenian: Druge informacije o zdravilu Possia
English: This means that it helps to prevent blood clots from forming.
Slovenian: To pomeni, da pripomore k preprečevanju nastajanja krvnih strdkov.
English: This is a summary of the European public assessment report (EPAR) for Possia.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Possia.
English: Patients should also be taking aspirin as directed by their doctor.
Slovenian: Bolniki morajo jemati tudi aspirin po navodilih zdravnika.
English: It must also not be used in patients taking other medicines which have a strong blocking effect on one of the liver enzymes (CYP3A4).
Slovenian: Uporabljati ga ne smejo tudi bolniki, ki jemljejo druga zdravila z močnim zaviralnim učinkom na enega od jetrnih encimov (CYP3A4).
English: What benefit has Possia shown during the studies?
Slovenian: Kakšne koristi je zdravilo Possia izkazalo med študijami?
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
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Possia, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The CHMP decided that Possia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Possia večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: In the main study, 9.3% of the patients taking Possia had another heart attack, stroke or died from a cardiovascular disease compared with 10.9% of patients taking clopidogrel.
Slovenian: V glavni študiji je imelo 9,3 % bolnikov, ki so jemali zdravilo Possia, drugi srčni infarkt ali kap ali pa so umrli zaradi srčno-žilne bolezni, v primerjavi z 10,9 % bolnikov, ki so jemali klopidogrel.
English: What is the risk associated with Possia?
Slovenian: Kakšna tveganja so povezana z zdravilom Possia?
English: The main measure of effectiveness was based on the number of patients having another heart attack, a stroke or dying from a cardiovascular disease.
Slovenian: Glavno merilo učinkovitosti je temeljilo na številu bolnikov z drugim srčnim infarktom, kapjo ali smrtjo zaradi srčno-žilne bolezni.
English: For more information about treatment with Possia, read the package leaflet (also part of the EPAR) or contact your doctor or
Slovenian: Za več informacij o zdravljenju z zdravilom Possia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The CHMP noted that the main study showed that, compared with clopidogrel, Possia reduces the risk of heart attacks and cardiovascular deaths.
Slovenian: CHMP je ugotovil, da je glavna študija pokazala, da zdravilo Possia v primerjavi s klopidogrelom zmanjša tveganje srčnega infarkta in smrti zaradi srčno-žilnih bolezni.
English: Possia is a medicine that contains the active substance ticagrelor.
Slovenian: Possia je zdravilo, ki vsebuje zdravilno učinkovino tikagrelor.
English: Possia should not be used in people who may be hypersensitive (allergic) to ticagrelor or any of the other ingredients.
Slovenian: Zdravila Possia ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) tikagrelor ali katero koli drugo sestavino zdravila.
English: The most common side effects with Possia (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), bleeding in the skin or below the skin, bruising, and bleeding at the procedural site (where a blood vessel has been punctured).
Slovenian: Najpogostejši neželeni učinki zdravila Possia (opaženi pri 1 do 10 bolnikih izmed 100) so dispneja (težave z dihanjem), epistaksa (krvavitev iz nosu), gastro-intestinalna krvavitev (krvavitev v želodec ali črevesje), krvavitev v kožo ali pod kožo, podplutbe in krvavitev na mestu posega (kjer je bila predrta žila).
English: Ticagrelor stops the platelets aggregating by blocking the action of a substance called ADP when it attaches to the surface of the platelets.
Slovenian: Tikagrelor prepreči agregacijo trombocitov tako, da zavira delovanje snovi, imenovane ADP, ko se pritrdi na površino trombocitov.
English: Possia is used together with aspirin to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as heart attacks or strokes.
Slovenian: Zdravilo Possia se uporablja skupaj z aspirinom za preprečevanje aterotrombotičnih dogodkov (težav zaradi krvnih strdkov in zatrditve arterij), kot sta srčni infarkt in kap.
English: Possia was compared with clopidogrel (another inhibitor of platelet aggregation) in a main study involving over 18,000 adults who had had a heart attack or had unstable angina.
Slovenian: Zdravilo Possia so primerjali s klopidogrelom (drugim zaviralcem agregacije trombocitov) v glavni študiji, v katero je bilo vključenih več kot 18 000 odraslih z nestabilno angino ali po srčnem infarktu.
English: For the full list of all side effects reported with Possia, see the
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Possia, glejte navodilo za uporabo.
English: It must not be used in patients who have moderate to severe liver disease or are currently bleeding, or in patients who have had a stroke caused by bleeding within the brain.
Slovenian: Ne smejo ga uporabljati bolniki z zmernim do hudim obolenjem jeter ali krvavitvijo in bolniki po kapi zaradi krvavitve v možganih.
English: The active substance in Possia, ticagrelor, is an inhibitor of platelet aggregation.
Slovenian: Zdravilna učinkovina v zdravilu Possia, tikagrelor, je zaviralec agregacije trombocitov.
English: The doctor may, for health reasons, tell them not to take aspirin.
Slovenian: Zaradi zdravstvenih razlogov pa lahko zdravnik aspirin odsvetuje.
English: Possia was shown to be beneficial to patients who have had a heart attack or unstable angina.
Slovenian: Zdravilo Possia se je izkazalo kot koristno za bolnike z nestabilno angino ali po srčnem infarktu.
English: It is used in adults who have had a heart attack or have unstable angina (a type of chest pain caused by problems with the blood flow to
Slovenian: Uporablja se pri odraslih bolnikih po srčnem infarktu ali pri tistih z nestabilno angino (vrsto bolečine v prsnem košu zaradi težav s pretokom krvi v srce).
English: When the blood clots, this is due to special cells in the blood called platelets aggregating (sticking together).
Slovenian: Kri se strjuje zaradi agregacije (zlepljanja) posebnih celic v krvi, imenovanih trombociti.
English: It is available as round, yellow
Slovenian: Na voljo je v obliki okroglih, rumenih tablet (90 mg).
English: However Possia was not more effective than clopidogrel in
Slovenian: Vendar zdravilo Possia v primerjavi s klopidogrelom ni bilo učinkovitejše pri zmanjševanju tveganja kapi.
English: How does Possia work?
Slovenian: Kako zdravilo Possia deluje?
English: Terrosa teriparatide
Slovenian: Terrosa teriparatid
English: This means that Terrosa is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: What measures are being taken to ensure the safe and effective use of Terrosa?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Terrosa?
English: The full EPAR for Terrosa 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 Terrosa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Terrosa must not be used during pregnancy or breastfeeding.
Slovenian: Ne sme se uporabljati med nosečnostjo in dojenjem.
English: This was considered sufficient to conclude that Terrosa will behave in the same way in terms of effectiveness and safety.
Slovenian: To je zadostovalo za zaključek, da se bo zdravilo Terrosa z vidika učinkovitosti in varnosti vedlo enako.
English: This is a summary of the European public assessment report (EPAR) for Terrosa.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Terrosa.
English: The most common side effect with Terrosa (seen in more than 1 patient in 10) is pain in the arms or legs.
Slovenian: Najpogostejši neželeni učinek zdravila Terrosa (opažen pri več kot 1 bolniku od 10) so bolečine v rokah ali nogah.
English: Terrosa must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Slovenian: Zdravilo Terrosa se ne sme uporabljati pri bolnikih, ki imajo druga obolenja kosti, kot so Pagetova bolezen, kostni rak ali metastaze v kosteh (rak, ki se je razširil na kosti), bolnikih, ki so bili na obsevanju okostja, ali bolnikih, ki imajo hiperkalciemijo (visoke ravni kalcija v krvi), tistih z nepojasnjeno visokimi ravnmi alkalne fosfataze (vrste encima) ali hudim obolenjem ledvic.
English: A study in 54 healthy women has shown that the same doses of the two medicines given by injection under the skin produced similar levels of the active substance teriparatide in the body.
Slovenian: Študija pri 54 zdravih ženskah je pokazala, da enaki odmerki obeh zdravil, dani z injiciranjem pod kožo, povzročijo podobno raven zdravilne učinkovine teriparatid v telesu.
English: What benefits of Terrosa have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Terrosa izkazalo v študijah?
English: Other information about Terrosa
Slovenian: Druge informacije o zdravilu Terrosa
English: Thus, as for Forsteo, the benefit outweighs the identified risks and the Committee recommended that Terrosa be given marketing authorisation.
Slovenian: Ker njegove koristi enako kot pri zdravilu Forsteo odtehtajo znana tveganja, je Odbor priporočil, da se za zdravilo Terrosa izda dovoljenje za promet.
English: What are the risks associated with Terrosa?
Slovenian: Kakšna tveganja so povezana z zdravilom Terrosa?
English: It is not intended to provide practical advice on how to use Terrosa.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Why is Terrosa approved?
Slovenian: Zakaj je bilo zdravilo Terrosa odobreno?
English: What is Terrosa and what is it used for?
Slovenian: Kaj je zdravilo Terrosa in za kaj se uporablja?
English: Because Terrosa is a biosimilar medicine, the studies on effectiveness and safety of teriparatide carried out with Forsteo do not need to be repeated for Terrosa.
Slovenian: Zdravilo Terrosa je podobno biološko zdravilo, zato študij učinkovitosti in varnosti teriparatida, izvedenih z zdravilom Forsteo, z zdravilom Terrosa ni treba ponavljati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Terrosa 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 Terrosa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The reference medicine for Terrosa is Forsteo.
Slovenian: Referenčno zdravilo za zdravilo Terrosa je zdravilo Forsteo.
English: For more information about treatment with Terrosa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Terrosa preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Further, Terrosa and Forsteo produced similar effects on calcium levels in the blood.
Slovenian: Poleg tega sta imeli zdravili Terrosa in Forsteo podoben učinek na raven kalcija v krvi.
English: Gradually, the bones become less dense and more likely to break.
Slovenian: Kosti se tako postopoma redčijo in postajajo posledično bolj lomljive.
English: For practical information about using Terrosa, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Terrosa naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Terrosa is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:
Slovenian: Zdravilo Terrosa se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri naslednjih skupinah:
English: In these patients, Terrosa has been shown to significantly reduce vertebral (spine) and non-vertebral fractures (broken bones), but not those of the hip;
Slovenian: Pri teh bolnicah je bilo dokazano, da zdravilo Terrosa znatno zmanjšuje pojavnost zlomov vretenc (hrbtenice) in nevretenčnih zlomov, ne pa tudi zlomov kolka;
English: Patients should receive calcium and vitamin D supplements if they do not get enough from their diet. Terrosa can be used for up to two years.
Slovenian: Bolniki morajo jemati tudi dodatek kalcija in vitamina D, če ju ne dobivajo dovolj s prehrano.
English: Osteoporosis can also occur as a side effect of glucocorticoid treatment in men and women.
Slovenian: Osteoporoza se lahko pri moških in ženskah pojavi tudi kot neželeni učinek zdravljenja z glukokortikoidi.
English: The active substance in Terrosa, teriparatide, is identical to part of the human parathyroid hormone.
Slovenian: Zdravilna učinkovina v zdravilu Terrosa, teriparatid, je enaka delu humanega paratiroidnega hormona.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence showing that Terrosa has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je obravnaval podatke, ki so dokazovali, da je zdravilo Terrosa po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Forsteo in da se v telesu enako razporeja.
English: For the full list of all side effects reported with Terrosa, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Terrosa, glejte navodilo za uporabo.
English: Terrosa is a ‘biosimilar medicine'.
Slovenian: Zdravilo Terrosa je „podobno biološko zdravilo“.
English: Terrosa contains the active substance teriparatide.
Slovenian: Zdravilo Terrosa vsebuje zdravilno učinkovino teriparatid.
English: How is Terrosa used?
Slovenian: Kako se zdravilo Terrosa uporablja?
English: The two-year course of Terrosa should be given only once during a patient's lifetime.
Slovenian: Bolnik v času življenja ne sme prejeti več kot en postopek dveletnega zdravljenja z zdravilom Terrosa.
English: How does Terrosa work?
Slovenian: Kako zdravilo Terrosa deluje?
English: Laboratory studies comparing Terrosa with Forsteo have shown that the active substance in Terrosa is highly similar to that in Forsteo in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Terrosa primerjali z zdravilom Forsteo, so pokazale, da je zdravilna učinkovina zdravila Terrosa po zgradbi, čistosti in biološkem delovanju zelo podobna zdravilni učinkovini zdravila Forsteo.