FrancophonIA/ELRC3.0 huggingface dataset:
English: Sodium hydroxide (E524) (for pH adjustment) and/or Hydrochloric acid diluted (E507) (for pH adjustment)
Slovenian: 6.1 Seznam pomožnih snovi dinatrijev edetat (E386) polisorbat 80 (E433) brezvodna laktoza natrijev hidroksid (E524) (za uravnavo pH) in/ali razredčena klorovodikova kislina (E507) (za uravnavo pH)
English: Concomitant administration of fosaprepitant with active substances that inhibit CYP3A4 activity (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, and protease inhibitors) should be approached cautiously, as the combination is expected to result in several-fold increased plasma concentrations of aprepitant (see section 4.4).
Slovenian: Vpliv drugih zdravil na farmakokinetiko aprepitanta kot posledica uporabe fosaprepitanta 150 mg Pri sočasni uporabi fosaprepitanta in zdravilnih učinkovin, ki zavirajo aktivnost CYP3A4 (npr. ketokonazol, itrakonazol, vorikonazol, posakonazol, klaritromicin, telitromicin, nefazodon in zaviralci proteaze), je potrebna previdnost, saj pri sočasni uporabi pričakujemo večkratno zvišanje plazemskih koncentracij aprepitanta (glejte poglavje 4.4).
English: See the product information for the selected 5-HT3 antagonist for appropriate dosing information.
Slovenian: Za ustrezne informacije o odmerjanju glejte navodilo za uporabo za izbrani antagonist 5-HT3.
English: Uncommon side effects (may affect up to 1 in 100 people) are: - dizziness, sleepiness, - acne, rash, - anxiousness, - burping, nausea, vomiting, heartburn, stomach pain, dry mouth, passing wind, - increased painful or burning urination, - weakness, generally feeling unwell, - reddening of the face/skin, hot flush, - fast or irregular heartbeats, blood pressure increased,
Slovenian: Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov) so: - omotica, zaspanost, - akne, izpuščaj, - tesnoba, - spahovanje, siljenje na bruhanje, bruhanje, zgaga, bolečine v želodcu, suha usta, vetrovi,
English: Ear and labyrinth disorders tinnitus rare
Slovenian: Ušesne bolezni, vključno z motnjami labirinta tinitus redki
English: Intrauterine devices (IUDs) that release hormones may not work adequately when taken together with IVEMEND.
Slovenian: - Kontraceptivi, ki lahko vključujejo kontracepcijske tablete, obliže, vsadke in določene maternične vložke, ki sproščajo hormone, lahko pri uporabi skupaj z zdravilom IVEMEND ne zagotavljajo ustrezne zaščite.
English: Standard dose of 5-HT3 antagonists.
Slovenian: standardni odmerek antagonista 5-HT3 Za pravilno odmerjanje glejte navodilo za uporabo za izbrani antagonist 5-HT3.
English: CARTON 150 mg
Slovenian: ŠKATLA 150 mg
English: §Overall = 0 to 120 hours post-initiation of chemotherapy.
Slovenian: § Celotna faza = 0 do 120 ur po začetku kemoterapije.
English: Fosaprepitant was rapidly converted to aprepitant in in vitro incubations with liver preparations from humans.
Slovenian: Pri in vitro inkubaciji s humanimi jetrnimi celicami se je fosaprepitant hitro pretvoril v aprepitant.
English: Use of oral aprepitant not required Read the package leaflet before use.
Slovenian: Pred uporabo preberite priloženo navodilo!
English: No dose adjustment is necessary for patients with mild hepatic impairment.
Slovenian: Pri bolnikih z blago okvaro jeter odmerka ni treba prilagoditi.
English: Skin and subcutaneous tissue disorders erythema uncommon
Slovenian: Bolezni kože in podkožja eritem občasni
English: The total exposure of CYP3A4 substrates may increase up to 2-fold on Days 1 and 2 after coadministration with a single 150 mg fosaprepitant dose.
Slovenian: Po sočasni uporabi enkratnega 150 mg odmerka fosaprepitanta in substratov za CYP3A4 se lahko 1. in 2. dan celokupna izpostavljenost substratom za CYP3A4 poveča do 2-krat.
English: Powder for solution for infusion.
Slovenian: vnetje žile na mestu infundiranja.
English: Mild injection site thrombosis has been observed at higher doses without concomitant vesicant chemotherapy.
Slovenian: Pri uporabi večjih odmerkov brez sočasne kemoterapije z vezikanti so poročali o pojavu blage tromboze na mestu injiciranja.
English: Avoid shaking and jetting sodium chloride 9 mg/ml (0.9 %) solution for injection into the vial.
Slovenian: Viale ne smete tresti in 0,9-odstotne (9 mg/ml) raztopine natrijevega klorida za injiciranje ne smete brizgniti v vialo.
English: The fosaprepitant regimen consisted of fosaprepitant 150 mg on Day 1 in combination with oral ondansetron 8 mg for 2 doses and oral dexamethasone 12 mg. On Days 2 and 3, patients in the fosaprepitant group received placebo for ondansetron every 12 hours.
Slovenian: Režim zdravljenja s fosaprepitantom je vključeval 150 mg fosaprepitanta 1. dan v kombinaciji z ondansetronom 8 mg peroralno v 2 odmerkih in deksametazonom 12 mg peroralno.
English: The fosaprepitant regimen consisted of fosaprepitant 150 mg on Day 1 in combination with ondansetron 32 mg IV on Day 1 and dexamethasone 12 mg on Day 1, 8 mg on Day 2, and 8 mg twice daily on Days 3 and 4.
Slovenian: 1. dan in deksametazonom 12 mg 1. dan, 8 mg 2. dan in 8 mg dvakrat na dan 3. in 4. dan.
English: ENDPOINTS*
Slovenian: OPAZOVANI DOGODKI*
English: IVEMEND
Slovenian: Dojenje
English: Vascular disorders hot flush/flushing uncommon
Slovenian: Žilne bolezni navali vročine/zardevanje občasni
English: How to store IVEMEND
Slovenian: Shranjevanje zdravila IVEMEND
English: 5 mg/kg intravenously
Slovenian: 5 mg/kg intravensko največji odmerek 150 mg
English: The reconstituted and diluted solution is stable for 24 hours at 25C.
Slovenian: Po pripravi in redčenju je raztopina stabilna 24 ur pri temperaturi 25 C.
English: 5-HT3 antagonist
Slovenian: 12 mg peroralno antagonist 5-HT3
English: Maximum dose 115 mg
Slovenian: 3 mg/kg intravensko največji odmerek 115 mg
English: 4 mg/kg intravenously
Slovenian: 4 mg/kg intravensko največji odmerek 150 mg
English: 8 mg orally 8 mg orally twice daily
Slovenian: 150 mg intravensko brez brez brez deksametazon 12 mg peroralno 8 mg peroralno 8 mg peroralno dvakrat na dan
English: No dose adjustment is necessary for patients with renal impairment or for patients with ESRD undergoing haemodialysis.
Slovenian: Pri bolnikih z okvaro ledvic in bolnikih s končno ledvično odpovedjo na hemodializi odmerka ni treba prilagoditi.
English: See selected 5-HT3 antagonist prescribing information for the recommended dosage
Slovenian: Glede priporočenega odmerjanja glejte navodila za predpisovanje izbranega antagonista 5-HT3.
English: It is used on its own when other treatments have not worked or are not suitable.
Slovenian: Samostojno se uporablja, kadar druga zdravljenja ne delujejo ali niso primerna.
English: Further information on Trazimera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Trazimera so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients who do not have significant reactions to the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Slovenian: Bolniki, ki nimajo večjih reakcij na prvo 90-minutno infuzijo, lahko naslednje infuzije prejmejo v 30 minutah.
English: This means that Trazimera is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: For more information on biosimilar medicines, see here.
Slovenian: Za več informacij o podobnih bioloških zdravilih glejte tukaj.
English: What measures are being taken to ensure the safe and effective use of Trazimera?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trazimera?
English: An overview of Trazimera and why it is authorised in the EU
Slovenian: Pregled zdravila Trazimera in zakaj je odobreno v EU
English: It can also be used earlier in treatment, in combination with chemotherapy.
Slovenian: Lahko se uporablja tudi prej v postopku zdravljenja, in sicer v kombinaciji s kemoterapijo.
English: What is Trazimera and what is it used for?
Slovenian: Kaj je zdravilo Trazimera in za kaj se uporablja?
English: Trazimera can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Slovenian: Zdravilo Trazimera lahko povzroča kardiotoksičnost (škoduje srcu), vključno s srčnim popuščanjem (stanjem, pri katerem srce ne deluje tako dobro, kot bi moralo).
English: • metastatic breast cancer (cancer that has spread to other parts of the body).
Slovenian: • metastatskega raka dojke (raka, ki se je razširil na druge dele telesa).
English: Trazimera is a cancer medicine used to treat the following conditions:
Slovenian: Trazimera je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih bolezni:
English: The most common or serious side effects with Trazimera are heart problems, reactions related to the Trazimera infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Slovenian: Najpogostejši ali najresnejši neželeni učinki zdravila Trazimera so težave s srcem, reakcije, povezane z infundiranjem zdravila, zmanjšana količina krvnih celic (zlasti belih krvnih celic), okužbe in težave s pljuči.
English: The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion.
Slovenian: Infuzija lahko povzroči alergijske reakcije, zato je treba bolnika med infundiranjem in po njem spremljati.
English: As for all medicines, data on the use of Trazimera are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Trazimera stalno spremljajo.
English: Why is Trazimera authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Trazimera odobreno v EU?
English: Trazimera can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Trazimera je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: It must not be used in patients whose advanced cancer causes serious breathing problems even when resting, or who need oxygen therapy.
Slovenian: Ne sme se uporabljati pri bolnikih, pri katerih napredovali rak povzroča resne težave z dihanjem celo med počitkom, in bolnikih, ki potrebujejo zdravljenje s kisikom.
English: The dose depends on the patient's body weight, on the condition being treated and on whether Trazimera is given every week or every 3 weeks.
Slovenian: Odmerek je odvisen od telesne mase bolnika, od zdravljene bolezni in od tega, ali se zdravilo Trazimera daje vsak teden ali vsake tri tedne.
English: What benefits of Trazimera have been shown in studies?
Slovenian: Kakšne koristi zdravila Trazimera so se pokazale v študijah?
English: Side effects reported with Trazimera are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Trazimera, se skrbno ovrednotijo in po potrebi sprejmejo ukrepi za zaščito bolnikov.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trazimera 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 Trazimera upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart.
Slovenian: Posebna pozornost je potrebna, če se zdravilo daje bolnikom, ki že imajo težave s srcem ali visok krvni tlak, pri vseh bolnikih pa je treba med zdravljenjem in po njem spremljati delovanje srca.
English: In addition, a main study involving 707 patients with metastatic breast cancer that overexpressed HER2 showed that Trazimera was as effective in treating the condition as Herceptin.
Slovenian: Poleg tega je glavna študija, v katero je bilo vključenih 707 bolnikov z metastatskim rakom dojke, ki je čezmerno izražal beljakovino HER2, pokazala, da je zdravilo Trazimera enako učinkovito pri zdravljenju te bolezni kot zdravilo Herceptin.
English: Trazimera must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Slovenian: Zdravila Trazimera ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) trastuzumab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
English: What are the risks associated with Trazimera?
Slovenian: Kakšna tveganja so povezana z zdravilom Trazimera?
English: For more information about using Trazimera, see the package leaflet or contact a doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Trazimera glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
Slovenian: Uporablja se tudi v kombinaciji z drugimi zdravili za zdravljenje raka: s paklitakselom ali docetakselom ali drugim razredom zdravil, imenovanim zaviralci aromataze;
English: Other information about Trazimera
Slovenian: Druge informacije o zdravilu Trazimera
English: Because Trazimera is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Trazimera.
Slovenian: Zdravilo Trazimera je podobno biološko zdravilo, zato študij o učinkovitosti in varnosti trastuzumaba, izvedenih z zdravilom Herceptin, z zdravilom Trazimera ni treba ponavljati.
English: It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer.
Slovenian: Zdravilo se daje z 90-minutnim infundiranjem (kapalno infuzijo) v veno vsak teden ali vsake tri tedne pri raku dojke in vsake tri tedne pri raku želodca.
English: In this study, 63% of patients given Trazimera had a complete or partial response to treatment compared with 67% of those given Herceptin.
Slovenian: V tej študiji je popoln ali delen odziv na zdravljenje doseglo 63 % bolnikov, ki so prejemali zdravilo Trazimera, in 67 % bolnikov, ki so prejemali zdravilo Herceptin.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Slovenian: Beljakovina HER2 je čezmerno izražena pri približno četrtini rakov dojke in petini rakov želodca.
English: For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective.
Slovenian: Pri zgodnjem raku dojke zdravljenje poteka eno leto ali dokler se bolezen ne ponovi, pri metastatskem raku dojke in raku želodca pa traja, dokler je učinkovito.
English: For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Trazimera is used before surgery in combination with chemotherapy and then again after surgery on its own;
Slovenian: Pri lokalno napredovalih rakih (vključno z vnetnimi tumorji) ali rakih, širših od 2 cm, se zdravilo Trazimera pred kirurškim posegom uporablja v kombinaciji s kemoterapijo, po posegu pa samostojno;
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Trazimera has been shown overall to have a comparable quality, safety and effectiveness to Herceptin.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Trazimera po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Herceptin.
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Slovenian: • zgodnjega raka dojke (kadar se je rak razširil znotraj dojke ali v podpazdušne žleze, ne pa na druge dele telesa) po kirurškem posegu, kemoterapiji (z zdravili za zdravljenje raka) in radioterapiji (zdravljenju z obsevanjem), če je smiselno.
English: The reference medicine for Trazimera is Herceptin.
Slovenian: Referenčno zdravilo za zdravilo Trazimera je zdravilo Herceptin.
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Slovenian: • metastatskega raka želodca, in sicer v kombinaciji s cisplatinom in bodisi kapecitabinom bodisi fluorouracilom (drugima zdraviloma za zdravljenje raka).
English: The active substance in Trazimera, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein.
Slovenian: Učinkovina v zdravilu Trazimera, trastuzumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino HER2 in se veže nanjo.
English: By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Slovenian: Trastuzumab z vezavo na beljakovino HER2 aktivira celice imunskega sistema, da uničijo tumorske celice.
English: How is Trazimera used?
Slovenian: Kako se zdravilo Trazimera uporablja?
English: Therefore, the Agency's view was that, as for Herceptin, the benefit of Trazimera outweighs the identified risk and it can be authorised.
Slovenian: Agencija je menila, da koristi zdravila Trazimera, enako kot pri zdravilu Herceptin, odtehtajo znana tveganja in se zdravilo lahko odobri.
English: Trazimera is a ‘biosimilar medicine'.
Slovenian: Zdravilo Trazimera je „podobno biološko zdravilo“.
English: Studies have also shown that giving Trazimera produces similar levels of the active substance in the body to giving Herceptin.
Slovenian: Študije so pokazale tudi, da zdravilo Trazimera vzpostavi podobne ravni učinkovine v telesu kot zdravilo Herceptin.
English: Laboratory studies comparing Trazimera with Herceptin have shown that the active substance in Trazimera is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Trazimera primerjali z zdravilom Herceptin, so pokazale, da je učinkovina zdravila Trazimera po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Herceptin.
English: Trastuzumab also stops HER2 from producing signals that cause the tumour cells to grow.
Slovenian: S tem tudi prepreči, da bi beljakovina HER2 tvorila signale, ki spodbujajo rast tumorskih celic.
English: How does Trazimera work?
Slovenian: Kako zdravilo Trazimera deluje?
English: Trazimera can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells.
Slovenian: To pomeni, da na površini rakavih celic v velikih količinah nastaja beljakovina, imenovana HER2.
English: Trazimera contains the active substance trastuzumab.
Slovenian: Zdravilo Trazimera vsebuje učinkovino trastuzumab.
English: Invokana canagliflozin
Slovenian: Invokana kanagliflozin
English: Other information about Invokana
Slovenian: Druge informacije o zdravilu Invokana
English: The tablets are taken once a day, preferably before the first meal of the day.
Slovenian: Tablete se jemljejo enkrat na dan, najbolje pred prvim dnevnim obrokom.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invokana on 15.11.2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Invokana, veljavno po vsej Evropski uniji, odobrila 15.11.2013.
English: What measures are being taken to ensure the safe and effective use of Invokana?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Invokana?
English: The full EPAR for Invokana 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 Invokana je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is not intended to provide practical advice on how to use Invokana.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: What benefits of Invokana have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Invokana izkazalo v študijah?
English: Invokana has been evaluated in 9 main studies involving a total of around 10,000 patients with type 2 diabetes.
Slovenian: Zdravilo Invokana so proučevali v 9 glavnih študijah, v katere so vključili skupno približno 10 000 bolnikov s sladkorno boleznijo tipa 2.
English: What is Invokana and what is it used for?
Slovenian: Kaj je zdravilo Invokana in za kaj se uporablja?
English: This is a summary of the European public assessment report (EPAR) for Invokana.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Invokana.
English: A risk management plan has been developed to ensure that Invokana is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Invokana je bil pripravljen načrt obvladovanja tveganj.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Invokana's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Invokana večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Invokana is available as tablets (100 and 300 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Invokana je na voljo v obliki tablet (100 in 300 mg) in se izdaja le na recept.
English: The recommended starting dose is 100 mg once a day.
Slovenian: Priporočeni začetni odmerek je 100 mg enkrat na dan.
English: What are the risks associated with Invokana?
Slovenian: Kakšna tveganja so povezana z zdravilom Invokana?
English: A study was also performed in patients with moderately reduced kidney function, and one in older patients aged between 55 and 80 years.
Slovenian: Izvedli so tudi študijo pri bolnikih z zmerno zmanjšanim delovanjem ledvic in študijo pri starejših bolnikih, starih od 55 do 80 let.
English: This leads to high levels of glucose in the blood.
Slovenian: Posledica so visoke ravni glukoze v krvi.
English: If appropriate, the dose can be increased to 300 mg once a day.
Slovenian: Po potrebi se lahko odmerek poveča na 300 mg enkrat na dan.
English: Regarding its safety, this was considered similar to other medicines of the same class (SGLT2 inhibitors).
Slovenian: Ugotovljeno je bilo tudi, da je varnost zdravila podobna kot pri drugih zdravilih iz iste skupine (zaviralcih SGLT2).
English: In patients with moderately reduced kidney function the dose should be limited to 100 mg once a day.
Slovenian: Pri bolnikih z zmerno zmanjšanim delovanjem ledvic je treba odmerek omejiti na 100 mg enkrat na dan.
English: Why is Invokana approved?
Slovenian: Zakaj je bilo zdravilo Invokana odobreno?