FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine Glenmark is also effective in maintaining improvement in patients who have responded to an initial course of treatment.
Slovenian: Zdravilo Olanzapine Glenmark je prav tako učinkovito za vzdrževanje izboljšanja stanja pri bolnikih, ki so se odzvali na začetno zdravljenje.
English: Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Slovenian: Razpon odmerkov je običajno od 5 do 20 mg na dan. Bolniki, starejši od 65 let, in bolniki z zmanjšanim delovanjem jeter ali ledvic bodo morda potrebovali nižji začetni odmerek, in sicer 5 mg na dan.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Olanzapine Glenmark.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark on 3 December 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Olanzapine Glenmark, veljavno po vsej Evropski uniji, izdala 3. decembra 2009.
English: This means that Olanzapine Glenmark is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Zyprexa.
English: Olanzapine Glenmark olanzapine
Slovenian: Olanzapine Glenmark olanzapin
English: Because Olanzapine Glenmark is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Olanzapine Glenmark generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Olanzapine Glenmark is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Slovenian: Zdravilo Olanzapine Glenmark se uporablja tudi za zdravljenje zmernih do težkih maničnih epizod (izjemno privzdignjeno razpoloženje) pri odraslih.
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 Olanzapine Glenmark.
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: The CHMP concluded that, in accordance with EU requirements, Olanzapine Glenmark has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Olanzapine Glenmark primerljivo raven kakovosti kot zdravilo Zyprexa ter da mu je biološko enakovredno.
English: What are the benefits and risks of Olanzapine Glenmark?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Olanzapine Glenmark?
English: Olanzapine Glenmark is a ‘generic medicine'.
Slovenian: Olanzapine Glenmark je „generično zdravilo“.
English: The Committee recommended that Olanzapine Glenmark be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Olanzapine Glenmark izda dovoljenje za promet.
English: Because Olanzapine Glenmark is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine Zyprexa.
Slovenian: Ker je zdravilo Olanzapine Glenmark generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu.
English: Other information about Olanzapine Glenmark
Slovenian: Druge informacije o zdravilu Olanzapine Glenmark
English: The active substance in Olanzapine Glenmark, olanzapine, is an antipsychotic medicine.
Slovenian: Zdravilna učinkovina zdravila Olanzapine Glenmark, olanzapin, je antipsihotično zdravilo.
English: Olanzapine Glenmark is used to treat adults with schizophrenia.
Slovenian: Zdravilo Olanzapine Glenmark se uporablja za zdravljenje shizofrenije pri odraslih.
English: Olanzapine Glenmark is a medicine containing the active substance olanzapine.
Slovenian: Olanzapine Glenmark je zdravilo, ki vsebuje zdravilno učinkovino olanzapin.
English: Why has Olanzapine Glenmark been approved?
Slovenian: Zakaj je bilo zdravilo Olanzapine Glenmark odobreno?
English: How has Olanzapine Glenmark been studied?
Slovenian: Kako je bilo zdravilo Olanzapine Glenmark raziskano?
English: What is Olanzapine Glenmark used for?
Slovenian: Za kaj se zdravilo Olanzapine Glenmark uporablja?
English: What is Olanzapine Glenmark?
Slovenian: Kaj je zdravilo Olanzapine Glenmark?
English: How does Olanzapine Glenmark work?
Slovenian: Kako zdravilo Olanzapine Glenmark deluje?
English: How is Olanzapine Glenmark used?
Slovenian: Kako se zdravilo Olanzapine Glenmark uporablja?
English: Yes.
Slovenian: Da.
English: Frequently asked questions
Slovenian: Najpogosteje zastavljena vprašanja
English: Did you know?
Slovenian: Ali ste vedeli?
English: What does this mean?
Slovenian: Kaj to pomeni?
English: What happens to my report after I've sent it?
Slovenian: Kaj se zgodi z mojim poročilom, potem ko ga pošljem?
English: Patients' organisations in your country may also be able to help.
Slovenian: Prav tako vam morda lahko pomagajo organizacije bolnikov v vaši državi.
English: Are my personal data protected?
Slovenian: Ali so moji osebni podatki varovani?
English: The symbol does not mean that your medicine is unsafe.
Slovenian: Simbol ne pomeni, da vaše zdravilo ni varno.
English: Your report is used solely for the scientific evaluation of the medicine.
Slovenian: Vaše poročilo se uporablja izključno za znanstveno vrednotenje zdravila.
English: If possible, you should provide the following information when making your report:
Slovenian: Če je mogoče, pri pripravi poročila navedite naslednje podatke:
English: What information should I report?
Slovenian: Katere podatke naj sporočim?
English: All personal information related to the reporting of a side effect is processed in accordance with EU data protection legislation.
Slovenian: Vsi osebni podatki, povezani s poročanjem o neželenem učinku, se obdelujejo v skladu z zakonodajo EU o varstvu podatkov.
English: We are always learning more about medicines.
Slovenian: Ves čas odkrivamo nove informacije o zdravilih.
English: You can also check the publicly available European database (www.adrreports.eu) or contact your national medicines authority for further information.
Slovenian: Prav tako lahko preverite evropsko podatkovno zbirko (www.adrreports.eu) ali se za več informacij obrnete na pristojni nacionalni zdravstveni organ.
English: You can also report a side effect on behalf of someone in your care, such as a child or relative.
Slovenian: Prav tako lahko o neželenem učinku poročate v imenu nekoga v vaši oskrbi, na primer otroka ali sorodnika.
English: Your report, along with other reports on the medicine, will be reviewed by medicines safety experts to see if there is any new information (known as a 'safety signal').
Slovenian: Vaše poročilo bodo skupaj z drugimi poročili o zdravilu pregledali strokovnjaki s področja varnosti zdravil, ki bodo preverili, ali vsebujejo kakšen nov podatek (znan tudi kot „varnostni signal“).
English: As a patient, you have the right to report unwanted side effects of medicines directly to the authorities.
Slovenian: Kot bolnik imate pravico, da poročate o neželenih učinkih zdravil neposredno pristojnim organom.
English: Your doctor or pharmacist can help you complete your report, and you can also request that they send the report on your behalf.
Slovenian: Poročilo vam lahko pomaga izpolniti vaš zdravnik ali farmacevt, ki ga lahko prosite tudi, da pošlje poročilo v vašem imenu.
English: For more details, and to report online, please check the website of your national authority (use these links to ensure you are reporting to the appropriate website).
Slovenian: Če želite več informacij ali poročati preko spletnega obrazca, obiščite spletno stran vašega nacionalnega pristojnega organa (uporabite te povezave, da boste zagotovo poročali na pravo spletno stran).
English: Where can I find information on side effects that have already been reported with the medicine?
Slovenian: Kje lahko najdem informacije o neželenih učinkih, o katerih so že poročali pri uporabi zdravila?
English: The inverted black triangle symbol '▼' serves as a reminder to report any suspected side effects, either because the medicine is new or because there is a particular need to find out more about its long-term safety.
Slovenian: Navzdol obrnjen črn trikotnik „▼“ opozarja na to, da je treba poročati o katerih koli domnevnih neželenih učinkih, bodisi ker je zdravilo novo ali ker je treba izvedeti več o njegovi dolgoročni varnosti.
English: Although they are tested extensively in clinical trials before they are authorised, not everything can be known about their side effects until they have been used by many people over time.
Slovenian: Čeprav jih pred odobritvijo dovoljenja za promet preskusijo v obsežnih kliničnih preskušanjih, vsega o njihovih neželenih učinkih ne moremo vedeti, dokler zdravil dalj časa ne uporablja večje število ljudi.
English: After evaluating the safety signal and all other relevant data, medicines authorities may issue new warnings or advice on how the medicine should be used, and can even stop its use.
Slovenian: Pristojni zdravstveni organi lahko po oceni varnostnega signala in vseh ostalih pomembnih podatkov izdajo nova opozorila ali nasvete o tem, kako naj se zdravilo uporablja, lahko pa tudi prepovejo njegovo uporabo.
English: • the description of the side effect;
Slovenian: • opis neželenega učinka;
English: • any other health conditions that the person who experienced the side effect may have.
Slovenian: • katera koli druga zdravstvena stanja, ki so morda prisotna pri osebi, pri kateri se je pojavil neželeni učinek.
English: • information on the person who has had the side effect (such as age and sex);
Slovenian: • podatke o osebi, pri kateri se je pojavil neželeni učinek (na primer starost in spol);
English: You cannot always be certain that what you are experiencing is caused by the medicine, but by reporting suspected side affects you can help the authorities in their investigations, which will lead to safer medicines.
Slovenian: Včasih ne morete biti povsem prepričani, da je to, kar ste opazili, povzročilo zdravilo, vendar pa lahko s tem, ko poročate o domnevnih neželenih učinkih, pomagate pristojnim organom pri njihovih raziskavah, s čimer boste prispevali k varnejšim zdravilom.
English: • any other medicines being taken around the same time (including non-prescription medicines,
Slovenian: • katera koli druga zdravila, ki jih je oseba uporabljala približno ob istem času (vključno z zdravili,
English: You can report side effects yourself
Slovenian: O neželenih učinkih lahko poročate sami
English: A side effect (also called an adverse reaction) is an unwanted symptom or effect caused by a medicine.
Slovenian: Neželeni učinek (imenovan tudi stranski učinek zdravila) je neželen simptom ali učinek, ki ga povzroči zdravilo.
English: You can usually report side effects by filling in a form online or from your doctor or local pharmacy.
Slovenian: Običajno lahko o neželenem učinku poročate tako, da izpolnite spletni obrazec ali pa ga sporočite zdravniku ali lokalni lekarni.
English: Why report a side effect?
Slovenian: Zakaj poročati o neželenem učinku?
English: The medicine has a black triangle symbol in its package leaflet.
Slovenian: Zdravilo ima v navodilu za uporabo simbol črnega trikotnika.
English: You should contact them immediately if you have a side effect that you think is serious or that is listed as serious in the package leaflet that comes with your medicine.
Slovenian: Nemudoma se posvetujte, če opazite neželen učinek, ki je po vašem mnenju resen ali je opredeljen kot resen v navodilu za uporabo, ki je priloženo zdravilu.
English: • the batch number of the medicine (found on the packaging);
Slovenian: • številko serije zdravila (ki je odtisnjena na ovojnini);
English: Can I get help with reporting a side effect?
Slovenian: Ali mi lahko kdo pomaga pri poročanju o neželenem učinku?
English: By reporting side effects, you can help to provide more information about medicines, which will ultimately help to make them safer.
Slovenian: S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o zdravilih, s tem pa tudi k temu, da bodo postala varnejša.
English: • the dose and the name of the medicine suspected to have caused the side effect (brand name as well as active ingredient);
Slovenian: • odmerek in ime zdravila, ki je domnevno povzročilo neželeni učinek (tržno ime in zdravilno učinkovino);
English: If you think a medicine has caused a side effect, please check the package leaflet that comes with the medicine for information on how to report it.
Slovenian: Če menite, da je zdravilo povzročilo neželeni učinek, v navodilu za uporabo, ki je priloženo zdravilu, poiščite informacije o tem, kako o njem poročati.
English: herbal remedies and contraceptives);
Slovenian: ki so na voljo brez recepta, zdravili rastlinskega izvora in kontraceptivi);
English: How do I know I've experienced a side effect?
Slovenian: Kako vem, da se je pri meni pojavil neželeni učinek?
English: If you are worried about any suspected side effects from your medicine, please speak to your doctor or pharmacist for advice.
Slovenian: Če ste zaskrbljeni zaradi katerih koli domnevnih neželenih učinkov, se pogovorite z zdravnikom ali farmacevtom.
English: How do I report a side effect?
Slovenian: Kako lahko poročam o neželenem učinku?
English: You can check the package leaflet that comes with the medicine.
Slovenian: Poiščete jih lahko v navodilu za uporabo, ki je priloženo zdravilu.
English: The capsules should be taken with food, preferably at the same time every day.
Slovenian: Kapsule je treba jemati s hrano vsak dan, po možnosti ob približno isti uri.
English: Further information on Silodosin Recordati can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
Slovenian: Nadaljnje informacije o zdravilu Silodosin Recordati so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/silodosin-recordati.
English: The recommended dose is one 8 mg capsule once a day.
Slovenian: Priporočeni odmerek je ena 8-miligramska kapsula enkrat na dan.
English: Silodosin Recordati (silodosin) EMA/815843/2018
Slovenian: Silodosin Recordati (silodozin) EMA/815843/2018
English: For men with moderate kidney problems, the starting dose should be 4 mg once a day.
Slovenian: Pri moških z zmernimi težavami z ledvicami je začetni odmerek 4 mg enkrat na dan.
English: In two of the studies the IPSS was around 21 points at the start of the study.
Slovenian: Na začetku dveh študij je bil rezultat vprašalnika IPSS okoli 21 točk.
English: When enlarged, it can cause problems with the flow of urine.
Slovenian: Če je povečana, lahko povzroči težave pri uriniranju.
English: The most common side effect with Silodosin Recordati (which may affect more than 1 in 10 people) is a reduction in the amount of semen released during ejaculation.
Slovenian: Najpogostejši neželeni učinek zdravila Silodosin Recordati (ki se lahko pojavi pri več kot 1 osebi od 10) je zmanjšanje količine semena, ki se sprosti med ejakulacijo.
English: The European Medicines Agency therefore decided that Silodosin Recordati'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 Silodosin Recordati večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Three main studies in over 1,800 men showed that Silodosin Recordati was effective at reducing symptoms of BPH, such as problems with urinating.
Slovenian: Tri glavne študije pri več kot 1 800 moških so pokazale, da je bilo zdravilo Silodosin Recordati učinkovito pri zmanjševanju simptomov BPH, kot so težave pri uriniranju.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Silodosin Recordati have 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 Silodosin Recordati upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: What measures are being taken to ensure the safe and effective use of Silodosin Recordati?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Silodosin Recordati?
English: Side effects reported with Silodosin Recordati are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Silodosin Recordati, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Silodosin Recordati, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Silodosin Recordati glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: The prostate gland is an organ found at the base of the bladder in men.
Slovenian: Prostata je organ, ki leži na dnu mehurja pri moških.
English: The symptoms were measured using the international prostate symptom score (IPSS).
Slovenian: Simptomi so bili izmerjeni z uporabo mednarodnega vprašalnika o simptomih prostate (IPSS).
English: In the third study, the IPSS was around 19 points before treatment and fell by 7 points with Silodosin Recordati compared with 6.7 points in men who took tamsulosin (another medicine used for BPH) and 4.7 points with placebo.
Slovenian: V tretji študiji je bil rezultat IPSS pred zdravljenjem približno 19 točk in se je po jemanju zdravila Silodosin Recordati zmanjšal za 7 točk v primerjavi s 6,7 točke pri moških, ki so jemali tamsulozin (drugo zdravilo za zdravljenje BPH), ter 4,7 točke pri tistih, ki so jemali placebo.
English: Silodosin Recordati can only be obtained with a prescription and is available as capsules (4 and 8 mg).
Slovenian: Predpisovanje in izdaja zdravila Silodosin Recordati je le na recept, na voljo pa je v obliki kapsul (4 mg in 8 mg).
English: When these receptors are activated, they cause the muscles controlling the flow of urine to contract.
Slovenian: Ko se ti receptorji aktivirajo, povzročijo, da se mišice, ki nadzorujejo pretok urina, skrčijo.
English: Silodosin Recordati (silodosin)
Slovenian: Silodosin Recordati (silodozin)
English: The active substance in Silodosin Recordati, silodosin, is an alpha-adrenoreceptor antagonist.
Slovenian: Učinkovina v zdravilu Silodosin Recordati, silodozin, je antagonist alfa-adrenoreceptorjev.
English: As for all medicines, data on the use of Silodosin Recordati are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Silodosin Recordati stalno spremljajo.
English: Silodosin Recordati is a medicine used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Slovenian: Silodosin Recordati je zdravilo, ki se uporablja za zdravljenje simptomov benigne hiperplazije prostate (BHP, razširjene prostate) pri odraslih.
English: Silodosin Recordati is effective at reducing problems with urinating in men with BPH and its side effects are comparable to those seen with other medicines of the same class.
Slovenian: Zdravilo Silodosin Recordati je učinkovito pri zmanjševanju težav pri uriniranju moških z BPH, njegovi neželeni učinki pa so primerljivi s tistimi, ki veljajo za druga zdravila iz istega razreda.
English: It works by blocking receptors (targets) called alpha1A adrenoreceptors in the prostate gland, the bladder and the urethra (the tube that leads from the bladder to the outside of the body).
Slovenian: Deluje tako, da zavira receptorje (prijemališča), ki se imenujejo alfa1A adrenoreceptorji v prostati, mehurju in sečnici (cev, ki vodi iz mehurja in odvaja seč iz telesa).
English: Intra operative floppy iris syndrome (IFIS) occurs in some patients taking alpha adrenoreceptor antagonists and may lead to complications during cataract surgery.
Slovenian: Sindrom intraoperativne ohlapne šarenice (IFIS) se pojavi pri nekaterih bolnikih, ki jemljejo antagoniste alfa-adrenoreceptorjev, in lahko povzroči zaplete med kirurškim posegom sive mrene.
English: After 12 weeks, the IPSS fell by 6.4 points in the men who took Silodosin Recordati compared with 3.5 points in the men who took placebo (a dummy treatment).
Slovenian: Po 12 tednih se je rezultat IPSS zmanjšal za 6,4 točke pri moških, ki so vzeli zdravilo Silodosin Recordati, v primerjavi s 3,5 točke pri moških, ki so jemali placebo (zdravilo brez učinkovine).
English: By blocking these receptors, silodosin allows these muscles to relax, making it easier to pass urine and relieving the symptoms of BPH.
Slovenian: Silodozin z zaviranjem teh receptorjev pomaga mišicam, da se sprostijo, kar olajša pretok urina in ublaži simptome BPH.
English: An overview of Silodosin Recordati and why it is authorised in the EU
Slovenian: Pregled zdravila Silodosin Recordati in zakaj je odobreno v EU
English: This medicine is identical to Urorec, which has been authorised in the EU since 29 January 2010.
Slovenian: Zdravilo Silodosin Recordati je enako zdravilu Urorec, za katerega je bilo dovoljenje za promet v EU izdano 29. januarja 2010.
English: Why is Silodosin Recordati authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Silodosin Recordati odobreno v EU?
English: Other information about Silodosin Recordati
Slovenian: Druge informacije o zdravilu Silodosin Recordati
English: What benefits of Silodosin Recordati have been shown in studies?
Slovenian: Kakšne koristi zdravila Silodosin Recordati so se pokazale v študijah?
English: IFIS is a condition that makes the iris floppy.
Slovenian: IFIS je stanje, ko postane šarenica ohlapna.
English: What is Silodosin Recordati and what is it used for?
Slovenian: Kaj je zdravilo Silodosin Recordati in za kaj se uporablja?
English: For the full list of side effects and restrictions of Silodosin Recordati, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Silodosin Recordati glejte navodilo za uporabo.
English: What are the risks associated with Silodosin Recordati?
Slovenian: Kakšna tveganja so povezana z zdravilom Silodosin Recordati?
English: How is Silodosin Recordati used?
Slovenian: Kako se zdravilo Silodosin Recordati uporablja?
English: How does Silodosin Recordati work?
Slovenian: Kako zdravilo Silodosin Recordati deluje?
English: Member State (EU/EEA)
Slovenian: Država članica EU/EGP
English: HU - Hungary PannonPharma Kft. Pannonpharma út 1.
Slovenian: HU - Madžarska PannonPharma Kft. Pannonpharma út 1.
English: Aminocaproic acid containing medicinal products with Marketing Authorisation in the European Union
Slovenian: Zdravila, ki vsebujejo aminokaprojsko kislino, z dovoljenjem za promet v Evropski uniji
English: 2500 mg/10 ml
Slovenian: Epsicaprom 25 2500 mg/10 ml
English: Bial - Aristegui, Produtos Farmacêuticos,S.A.
Slovenian: PT - Portugalska Bial - Aristegui, Produtos Farmacêuticos,S.A.
English: solution for injection
Slovenian: Raztopina za injiciranje
English: List of the invented names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: ROTTAPHARM, S.L.
Slovenian: ES - Španija ROTTAPHARM, S.L.
English: Diagonal 67-69 08019 Barcelona España
Slovenian: 08019 Barcelona
English: ES - Spain
Slovenian: España
English: • At request of the European Medicines Agency;
Slovenian: • na zahtevo Evropske agencije za zdravila;