FrancophonIA/ELRC3.0 huggingface dataset:
English: As for all medicines, data on the use of Tafinlar are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Tafinlar stalno spremljajo.
English: This was based on one main study involving 250 patients, which measured how long patients lived until their disease got worse.
Slovenian: Ta ugotovitev je temeljila na eni glavni študiji, ki je vključevala 250 bolnikov in v kateri so merili čas preživetja bolnikov do poslabšanja bolezni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tafinlar 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 Tafinlar upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: An overview of Tafinlar and why it is authorised in the EU
Slovenian: Pregled zdravila Tafinlar in zakaj je odobreno v EU
English: The dose of Tafinlar either used alone or in combination with trametinib is 150 mg twice a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal).
Slovenian: Odmerek zdravila Tafinlar, ki se uporablja samostojno ali v kombinaciji s trametinibom, je 150 mg dvakrat na dan na prazen želodec (vsaj eno uro pred obrokom ali dve uri po njem).
English: Treatment with Tafinlar must be started and supervised by a doctor experienced in the use of cancer medicines.
Slovenian: Zdravljenje z zdravilom Tafinlar mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: What benefits of Tafinlar have been shown in studies?
Slovenian: Kakšne koristi zdravila Tafinlar so se pokazale v študijah?
English: • melanoma (a skin cancer) that has spread or cannot be removed surgically.
Slovenian: • melanoma (kožnega raka), ki se je razširil ali ga ni mogoče kirurško odstraniti.
English: Tafinlar's side effects were considered acceptable and manageable with appropriate measures.
Slovenian: Neželeni učinki zdravila Tafinlar veljajo za sprejemljive in jih je mogoče obvladovati z ustreznimi ukrepi.
English: • advanced non-small cell lung cancer.
Slovenian: • napredovalega nedrobnoceličnega pljučnega raka.
English: What is Tafinlar and what is it used for?
Slovenian: Kaj je zdravilo Tafinlar in za kaj se uporablja?
English: Side effects reported with Tafinlar are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Tafinlar, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Why is Tafinlar authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Tafinlar odobreno v EU?
English: Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo.
Slovenian: Približno 40 % bolnikov, zdravljenih s kombinacijo učinkovin, je po 3,5 leta bodisi umrlo bodisi se je pri njih bolezen ponovila; med bolniki, ki so prejemali placebo, je bilo takih 59 %.
English: The European Medicines Agency decided that Tafinlar's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Tafinlar pri raku z mutacijo BRAF V600 večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: For more information about using Tafinlar, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Tafinlar glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What are the risks associated with Tafinlar?
Slovenian: Kakšna tveganja so povezana z zdravilom Tafinlar?
English: Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600'.
Slovenian: Tafinlar je zdravilo proti raku, ki se uporablja za zdravljenje odraslih, katerih rakave celice imajo posebno gensko mutacijo (spremembo), imenovano „BRAF V600“.
English: The most common side effects with Tafinlar (which may affect more than 1 in 10 people) are papilloma (warts), headache, nausea, vomiting, hyperkeratosis (thickening and toughening of the skin), hair loss, rash, joint pain, fever and tiredness.
Slovenian: Najpogostejši neželeni učinki zdravila Tafinlar (ki se lahko pojavijo pri več kot 1 bolniku od 10) so papilomi (bradavice), glavobol, navzeja (slabost), bruhanje, hiperkeratoza (odebelitev in otrdelost kože), izpadanje las, izpuščaji, bolečine v sklepih, povišana telesna temperatura in utrujenost.
English: The Agency also found it to be of benefit in patients with advanced melanoma that had been removed surgically.
Slovenian: Ugotovila je tudi, da je koristno pri bolnikih z napredovalim melanomom, ki so ga kirurško odstranili.
English: Tafinlar can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back.
Slovenian: Po kirurškem posegu zaradi napredovalega melanoma se zdravljenje običajno nadaljuje 12 mesecev, razen če se bolezen ponovi.
English: Two additional studies on melanoma that had spread to other parts of the body or could not be removed surgically looked at using the combination of Tafinlar with trametinib.
Slovenian: V dveh dodatnih študijah pri melanomu, ki se je razširil na druge dele telesa ali ga ni bilo mogoče kirurško odstraniti, so proučevali uporabo kombinacije zdravila Tafinlar in trametiniba.
English: The Agency considered that Tafinlar when used alone or in combination with trametinib had shown clinically relevant benefit in patients with advanced non-small cell lung cancer or with melanoma that had spread or could not be removed surgically.
Slovenian: Menila je, da je zdravilo Tafinlar, kadar se je uporabljalo samostojno ali v kombinaciji s trametinibom, izkazalo klinično pomembne koristi pri bolnikih z napredovalim nedrobnoceličnim pljučnim rakom ali melanomom, ki se je razširil ali ga ni mogoče kirurško odstraniti.
English: In melanoma and non-small cell lung cancer with the BRAF V600 mutation, the abnormal form of BRAF plays a role in the development of the cancer by allowing uncontrolled division of the tumour cells.
Slovenian: Pri melanomu in nedrobnoceličnem pljučnem raku z mutacijo BRAF V600 nenormalna oblika beljakovine BRAF vpliva na razvoj raka tako, da omogoča nenadzorovano deljenje tumorskih celic.
English: Patients given the combination lived for 11 months without their disease worsening, compared with 8.8 months for those given Tafinlar alone.
Slovenian: Bolniki, ki so prejemali kombinacijo učinkovin, so brez poslabšanja bolezni živeli 11 mesecev, bolniki, ki so prejemali samo zdravilo Tafinlar, pa 8,8 meseca.
English: When Tafinlar is taken in combination with trametinib, the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.
Slovenian: Kadar se zdravilo Tafinlar jemlje v kombinaciji s trametinibom, so najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 5) povišana telesna temperatura, utrujenost, navzeja, mrzlica, glavobol, driska, bruhanje, bolečine v sklepih in izpuščaj.
English: In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Tafinlar and trametinib given for 1 year was compared with placebo (a dummy treatment).
Slovenian: V študiji, ki je vključevala 870 bolnikov z melanomom v III. stadiju, ki so ga kirurško odstranili, so kombinacijo zdravila Tafinlar in trametiniba, ki so jo dajali eno leto, primerjali s placebom (zdravilom brez učinkovine).
English: Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
Slovenian: Zdravilo Tafinlar se uporablja samostojno ali v kombinaciji z drugim zdravilom za zdravljenje raka, trametinibom;
English: Patients taking Tafinlar lived on average 6.9 months before the disease got worse, compared with 2.7 months in patients given dacarbazine.
Slovenian: Bolniki, ki so jemali zdravilo Tafinlar, so brez poslabšanja bolezni živeli povprečno 6,9 meseca, bolniki, ki so jemali dakarbazin, pa 2,7 meseca.
English: Tafinlar contains the active substance dabrafenib.
Slovenian: Zdravilo Tafinlar vsebuje učinkovino dabrafenib.
English: For the full list of side effects and restrictions with Tafinlar, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Tafinlar glejte navodilo za uporabo.
English: In a second study involving 704 patients, Tafinlar with trametinib was compared with another medicine for melanoma, vemurafenib.
Slovenian: V drugi študiji, v kateri so sodelovali 704 bolniki, so zdravilo Tafinlar v kombinaciji s trametinibom primerjali z drugim zdravilom za zdravljenje melanoma, vemurafenibom.
English: The use of Tafinlar and trametinib led to a response in over 60% of the patients, compared with 23% of patients using Tafinlar alone.
Slovenian: Do odziva je prišlo pri več kot 60 % bolnikov, ki so jemali zdravilo Tafinlar in trametinib, ter pri 23 % bolnikov, ki so jemali zdravilo Tafinlar kot samostojno zdravilo.
English: In one main study, 171 patients with non-small cell lung cancer received either Tafinlar combined with trametinib or Tafinlar alone.
Slovenian: V eni glavni študiji je 171 bolnikov z nedrobnoceličnim pljučnim rakom prejemalo bodisi zdravilo Tafinlar v kombinaciji s trametinibom bodisi samo zdravilo Tafinlar.
English: The active substance in Tafinlar, dabrafenib, works by blocking BRAF, a protein involved in stimulating cell division.
Slovenian: Učinkovina v zdravilu Tafinlar, dabrafenib, deluje tako, da zavira beljakovino BRAF, ki sodeluje pri spodbujanju delitve celic.
English: By blocking the action of the abnormal BRAF, Tafinlar helps to slow down the growth and spread of the cancer.
Slovenian: Zdravilo Tafinlar z zaviranjem delovanja nenormalne beljakovine BRAF prispeva k upočasnitvi rasti in širjenja raka.
English: Tafinlar has been studied in patients whose cancer had the BRAF V600 mutation.
Slovenian: Zdravilo Tafinlar so proučevali pri bolnikih, katerih rakave celice so imele mutacijo BRAF V600.
English: In one study 423 patients were given either the combination or Tafinlar alone.
Slovenian: V eni študiji je 423 bolnikov prejelo bodisi kombinacijo učinkovin bodisi zdravilo Tafinlar kot samostojno zdravljenje.
English: Patients given the combination lived 25.6 months on average, versus 18 months with vemurafenib.
Slovenian: Bolniki, ki so prejemali kombinacijo učinkovin, so povprečno živeli 25,6 meseca, bolniki, ki so prejemali vemurafenib, pa 18 mesecev.
English: How does Tafinlar work?
Slovenian: Kako zdravilo Tafinlar deluje?
English: How is Tafinlar used?
Slovenian: Kako se zdravilo Tafinlar uporablja?
English: Treatment may need to be interrupted or stopped, or the dose reduced, if certain side effects occur.
Slovenian: Če se pri bolniku pojavijo nekateri neželeni učinki, bo morda treba začasno ali trajno prekiniti zdravljenje ali zmanjšati odmerek.
English: It is used for the treatment of:
Slovenian: Zdravilo Tafinlar se uporablja za zdravljenje:
English: It is used in combination with trametinib.
Slovenian: Zdravilo Tafinlar se uporablja v kombinaciji s trametinibom.
English: • advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;
Slovenian: • napredovalega melanoma (v III. stadiju) po prestanem kirurškem posegu.
English: Tafinlar was more effective than the cancer medicine dacarbazine at controlling melanoma that had spread to other parts of the body or could not be removed surgically.
Slovenian: Zdravilo Tafinlar je bilo pri nadziranju melanoma, ki se je razširil na druge dele telesa ali ga ni bilo mogoče kirurško odstraniti, učinkovitejše od druge učinkovine za zdravljenje raka, imenovane dakarbazin.
English: Strength Pharmaceutical form Route of administration
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
English: Take the remaining doses at the correct time.
Slovenian: Preostale odmerke vzemite ob pravilnem času.
English: 30 months 90 days after first opening.
Slovenian: 90 dni po prvem odprtju.
English: Each double-blind study period lasted 2 weeks.
Slovenian: Vsako dvojno slepo obdobje študije je trajalo 2 tedna.
English: Unknown a)
Slovenian: Neznana a)
English: Take it as soon as you remember unless it is nearly time to take the next dose.
Slovenian: Vzemite ga takoj, ko se spomnite, razen če je že skoraj čas, da vzamete naslednji odmerek.
English: Dosing this medicinal product more than 5 times per day is not recommended.
Slovenian: Odmerjanje tega zdravila več kot 5-krat na dan ni priporočljivo.
English: All efficacy data is based on 84 patients who completed the study with the exception of patient diary data which is based on 83.
Slovenian: Vsi podatki o učinkovitosti temeljijo na 84 bolnikih, ki so končali študijo, razen podatkov o prehrani bolnikov, ki temeljijo na podatkih 83 bolnikov.
English: It cannot be excluded that heating may change the properties of the medicinal product.
Slovenian: Ni mogoče izključiti, da segrevanje lahko spremeni lastnosti zdravila.
English: Data in the ASCEND-PD study were analysed using a standard mixed-model analysis of variance.
Slovenian: Podatke v študiji ASCEND-PD so analizirali s standardnim mešanim modelom analize variance.
English: This is because the medicine may affect the results of some tests.
Slovenian: To je zato, ker to zdravilo lahko vpliva na rezultate nekaterih preiskav.
English: In between these periods, all patients received open-label Numient treatment for 1 week.
Slovenian: Med temi obdobji so vsi bolniki 1 teden prejemali odprto zdravljenje z zdravilom Numient.
English: The daily dose must be determined by careful titration.
Slovenian: Dnevni odmerek je treba določiti s previdnim titriranjem.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostost (ni mogoče oceniti iz razpoložljivih podatkov).
English: This reaction does not change upon boiling the urine sample.
Slovenian: Ta reakcija se ne spremeni po segrevanju vzorca urina.
English: However, your doctor may decide to give you Numient if the expected benefits of treatment outweigh possible risks to the unborn child.
Slovenian: Kljub temu se vaš zdravnik lahko odloči, da vam bo predpisal zdravilo Numient, če pričakovane koristi zdravljenja odtehtajo morebitno tveganje za nerojenega otroka.
English: If your diet contains too much protein (meat, eggs, milk, cheese), Numient may not work as well as it should.
Slovenian: Če vaša prehrana vsebuje preveč beljakovin (mesa, jajc, mleka, sira), zdravilo Numient morda ne bo delovalo, kot bi moralo.
English: Main study results are summarized in Table 5.
Slovenian: Rezultati Glavni rezultati študije so povzeti v preglednici 5.
English: These differences are primarily explained by the lower body weight in females.
Slovenian: Te razlike je mogoče razložiti z manjšo telesno maso pri ženskah.
English: In the ADVANCE-PD study, the Clinical Global Impression of Change was also assessed.
Slovenian: Pri študiji ADVANCE-PD so ocenili tudi klinični globalni vtis o spremembi (Clinical Global Impression of Change).
English: Pyridoxine is not effective in reversing the actions of this combination medicinal product.
Slovenian: Piridoksin ni učinkovit pri odpravljanju učinkov tega kombiniranega zdravila.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na steklenici poleg oznake »EXP«.
English: What Numient is and what it is used for
Slovenian: Kaj je zdravilo Numient in za kaj ga uporabljamo
English: You must swallow your capsules whole.
Slovenian: Kapsule morate pogoltniti cele.
English: Numient with food and drink
Slovenian: Zdravilo Numient skupaj s hrano in pijačo
English: If you have had levodopa before, your doctor will determine the appropriate starting dose regimen based on your current levodopa dose
Slovenian: Če ste prej jemali levodopo, bo zdravnik določil ustrezen režim začetnega odmerjanja na podlagi vašega trenutnega odmerka levodope.
English: Ferrous sulphate (used to treat anaemia caused by low levels of iron in the blood).
Slovenian: železov sulfat (ki se uporablja za zdravljenje anemije, ki je posledica nizkih ravni železa v krvi).
English: In case of an overdose, you may feel confused or agitated, and your heart rate may be slower or faster than normal.
Slovenian: V primeru prevelikega odmerka se boste morda počutili zmedeno ali vznemirjeno, vaš srčni utrip je pa lahko počasnejši ali hitrejši kot sicer.
English: Therefore, the medicinal product should not be heated or added to hot food.
Slovenian: Zato se zdravila ne sme segrevati ali dodajati vroči hrani.
English: Alcohol interaction
Slovenian: Interakcije z alkoholom
English: Very common (may affect more than 1 in 10 people)
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov):
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
Slovenian: O nenadnem nastopu spanca med dnevnimi aktivnostmi brez zavedanja ali opozorilnih znakov so poročali zelo redko.
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Slovenian: Dodatno obravnavanje mora upoštevati klinične indikacije ali priporočila nacionalnega centra za zastrupitve, kjer so na voljo.
English: Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Slovenian: Svojemu zdravniku povejte, če se pri vas pojavi tako vedenje, z njim se boste pogovorili, kako obravnavati ali zmanjšati te simptome.
English: Furthermore a reduction of dose or termination of therapy may be considered.
Slovenian: Poleg tega bo morda treba pretehtati možnost zmanjšanja odmerka ali prekinitve zdravljenja.
English: Levodopa is bound to plasma protein only to a small extent (10-30%).
Slovenian: Levodope se v majhni meri veže na beljakovine v plazmi (10-30 %).
English: In both studies the primary endpoint was the percentage “off” time during waking hours.
Slovenian: Pri obeh študijah je bil primarni opazovani dogodek odstotek časa »izklopa« v času, ko so bili bolniki budni.
English: In such patients, cardiac function should be monitored with particular care during the period of initial dose adjustment.
Slovenian: Pri takih bolnikih je treba v obdobju začetnega prilagajanja odmerka še zlasti pozorno spremljati delovanje srca.
English: Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population.
Slovenian: Epidemiološke študije so pokazale, da imajo bolniki s Parkinsonovo boleznijo večje tveganje (2- do približno 6-krat večje) za razvoj melanoma v primerjavi s splošno populacijo.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Patients should be regularly monitored for the development of impulse control disorders.
Slovenian: Bolnike je treba redno spremljati zaradi možnosti razvoja motenj nadzora impulzivnega vedenja.
English: Within each frequency category, the adverse reactions are presented in order of decreasing seriousness.
Slovenian: V kategorijah pogostnosti so neželene reakcije navedene po padajoči resnosti.
English: Concurrent use can, however, cause a worsening of involuntary motor disorders.
Slovenian: Vendar sočasna uporaba lahko poslabša motnje nehotenih motoričnih gibov.
English: Do not heat the medicine/food mixture and do not sprinkle the contents of the capsule on hot food.
Slovenian: Zmesi zdravila in hrane ne segrevajte in ne vsipajte vsebine kapsule na vročo hrano.
English: Because Parkinson's disease is progressive, periodic clinical evaluations are recommended.
Slovenian: Parkinsonova bolezen je progresivna, zato je priporočeno občasno izvajati klinična ocenjevanja.
English: Numient should be administered with a glass of water and can be taken with or without food.
Slovenian: Zdravilo Numient je treba jemati s kozarcem vode, lahko pa se jemlje s hrano ali brez nje.
English: Table 5: Main results of studies in advanced Parkinson's disease Study
Slovenian: Preglednica 5: Glavni rezultati študij napredovale Parkinsonove bolezni Študija
English: Numient should be taken approximately every 6 hours no more than 5 times a day Take this medicine by mouth with a glass of water.
Slovenian: Zdravilo Numient je treba jemati približno vsakih 6 ur in ne več kot 5-krat na dan. Kapsulo vzemite s kozarcem vode.
English: Mental disturbances
Slovenian: Duševne motnje
English: Periodic skin examinations performed by appropriately qualified individuals (e.g., dermatologists) are recommended.
Slovenian: Priporočeni so periodični pregledi kože, ki jih morajo opraviti ustrezno usposobljene osebe (npr. dermatologi).
English: Week 30 (or at early termination)
Slovenian: 30. teden (ali ob predčasni prekinitvi zdravljenja)
English: The European Medicines Agency has waived the obligation to submit the results of studies with Numient in all subsets of the paediatric population in the treatment of idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Numient za vse podskupine pediatrične populacije pri zdravljenju idiopatske Parkinsonove bolezni (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: A total of 393 patients (mean age 63.2 years; 65% male patients) were randomized.
Slovenian: Randomiziranih je bilo skupno 393 bolnikov (povprečna starost 63,2 leta; 65 % moških bolnikov).
English: Numient is recommended to be dosed orally, approximately every 6 hours.
Slovenian: Zdravilo Numient je priporočljivo odmerjati peroralno, približno vsakih 6 ur.
English: After opening the bottle, use within 90 days.
Slovenian: Po odprtju steklenice uporabite zdravilo v 90 dneh.
English: Whether the increased risk observed was due to Parkinson's disease or other factors, such as medicinal products used to treat Parkinson's disease, is unclear.
Slovenian: Ni znano ali je povečano tveganje, ki so ga opazili, posledica Parkinsonove bolezni ali drugih dejavnikov, kot so npr. zdravila za zdravljenje Parkinsonove bolezni.
English: In addition, certain medicinal products used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of levodopa/carbidopa.
Slovenian: Poleg tega lahko nekatera zdravila, ki se uporabljajo za zdravljenje psihoze, poslabšajo simptome Parkinsonove bolezni in zmanjšajo učinkovitost levodope/karbidope.
English: This is because other medicines can affect the way Numient works.
Slovenian: To je zato, ker nekatera zdravila lahko vplivajo na delovanje zdravila Numient.