FrancophonIA/ELRC3.0 huggingface dataset:
English: In women planning to become pregnant all efforts should be made to switch to appropriate alternative treatment prior to conception, if possible.
Slovenian: Pri ženskah, ki nameravajo zanositi, si je treba prizadevati, da bi prešle na drugo ustrezno zdravilo, preden zanosijo, če je to mogoče.
English: This compares to 2-3 babies in ever 100 born to women who don't have epilepsy.
Slovenian: Med otroki žensk brez epilepsije je ta delež 2 do 3 na 100 otrok.
English: Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of <invented name> during pregnancy (see section 4.6).
Slovenian: Seznaniti jih je treba s tveganji uporabe zdravila <Izmišljeno ime> med nosečnostjo (glejte poglavje 4.6).
English: [This section should be amended to include the following box]
Slovenian: [To poglavje je treba dopolniti, tako da vključuje naslednji okvir]
English: <Invented name> is contraindicated for prophylaxis of migraine attacks in pregnancy and women of childbearing potential who are not using effective methods of contraception during treatment with valproate (see sections 4.4 and 4.6 above).
Slovenian: Zdravilo <Izmišljeno ime> je kontraindicirano za profilakso migrenskih napadov pri nosečnicah in ženskah v rodni dobi, ki med zdravljenjem z valproatom ne uporabljajo učinkovite kontracepcije (glejte poglavji 4.4 in 4.6, zgoraj).
English: - Withdrawal syndrome (such as, in particular, agitation, irritability, hyper-excitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates whose mothers have taken valproate during the last trimester of their pregnancy.
Slovenian: - Novorojenčkom mater, ki so v zadnjem trimesečju nosečnosti jemale valproat, se lahko pojavi odtegnitveni sindrom (npr. zlasti agitiranost, razdražljivost, hiperekscitabilnost, trzavica, hiperkinezija, motnje toničnosti, tremor, konvulzije in motnje hranjenja).
English: • During pregnancy, maternal tonic clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child. [The sentence below should be inserted only where the marketing authorisation currently includes the epilepsy and/or bipolar indications]
Slovenian: • Med nosečnostjo lahko tonično-klonični napadi ali status epilepticus s hipoksijo pri materi še posebej ogrozijo življenje matere in nerojenega otroka.
English: • Make sure you are using an effective method of contraception.
Slovenian: • Poskrbite za učinkovito kontracepcijsko zaščito.
English: Section 4.3 Contraindications [The text below is only to be implemented where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Slovenian: Poglavje 4.3 Kontraindikacije [Spodnje besedilo je treba uporabiti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]
English: <Invented name> treatment must be started and supervised by a doctor specialised in the treatment of <epilepsy> <or> <bipolar disorders>.
Slovenian: Zdravljenje z zdravilom <Izmišljeno ime> mora začeti in nadzorovati zdravnik specialist za zdravljenje <epilepsije> <ali> <bipolarne motnje>.
English: <Invented name> should be initiated and supervised by a specialist experienced in the management of <epilepsy> <or> <bipolar disorder>.
Slovenian: Zdravljenje z zdravilom <Izmišljeno ime> mora uvesti in nadzorovati specialist, ki ima izkušnje z vodenjem <epilepsije> <ali> <bipolarne motnje>.
English: Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy.
Slovenian: Med nosečnostjo uporabljani valproat lahko povzroči prirojene hibe in težave v zgodnjem otrokovem razvoju.
English: [This sentence below should be adapted to National requirements] Make sure you read the patient booklet and sign the Acknowledgement of Risk form which should be given to you and discussed with you by your doctor or pharmacist.
Slovenian: Prebrati morate knjižico za bolnice in podpisati Obrazec o seznanitvi s tveganji; to dvoje vam mora izročiti zdravnik ali farmacevt, ki se mora o tem z vami tudi pogovoriti.
English: If you are continuing treatment with valproate but you don't plan to have a baby make sure you are using an effective method of contraception.
Slovenian: NADALJEVANJE ZDRAVLJENJA, ČE NE NAMERAVATE ZANOSITI Če nadaljujete zdravljenje z valproatom in ne načrtujete nosečnosti, poskrbite za učinkovito kontracepcijsko zaščito.
English: Once you are of childbearing age, you will need to make sure you use an effective method of contraception throughout your treatment.
Slovenian: V rodni dobi boste morali ves čas zdravljenja uporabljati učinkovito kontracepcijo.
English: UNPLANNED PREGNANCY WHILST CONTINUING TREATMENT [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Slovenian: NENAČRTOVANA NOSEČNOST MED NADALJEVANJEM ZDRAVLJENJA [Spodnji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo "profilaksa migrenskih napadov".]
English: • Valproate can be harmful to unborn children when taken by a woman during pregnancy.
Slovenian: • Če ženska jemlje valproat med nosečnostjo, lahko valproat škoduje nerojenemu otroku.
English: Possible side effects [This section should be amended to include the below wording in all indications]
Slovenian: [To poglavje je treba dopolniti, tako da vključuje spodnje besedilo za vse indikacije]
English: CONTINUING TREATMENT AND CONSIDERING TRYING FOR A BABY [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Slovenian: NADALJEVANJE ZDRAVLJENJA, ČE NAMERAVATE ZANOSITI [Spodnji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo "profilaksa migrenskih napadov".]
English: Valproate therapy should only be continued after a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of
Slovenian: Zdravljenje z valproatom se sme nadaljevati le, ko zdravnik, ki ima izkušnje z vodenjem <epilepsije> <ali> <bipolarne motnje>, ponovni oceni koristi in tveganja takšnega zdravljenja za bolnico.
English: Both valproate monotherapy and valproate polytherapy are associated with abnormal pregnancy outcomes.
Slovenian: Tveganje, povezano z izpostavljenostjo valproatu med nosečnostjo Nenormalni izidi nosečnosti spremljajo tako monoterapijo kot politerapijo z valproatom.
English: [All text below should be inserted only where the marketing authorisation currently includes the indications for epilepsy and/or bipolar disorder].
Slovenian: [Vse spodnje besedilo je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija in/ali bipolarna motnja.]
English: [The paragraph below should be inserted only where the marketing authorisation currently includes the indication “prophylaxis of migraine attacks”].
Slovenian: [Spodnji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo "profilaksa migrenskih napadov".]
English: - Cases of hypothyroidism have been reported in neonates whose mothers have taken valproate during pregnancy.
Slovenian: - Pri novorojenčkih mater, ki so med nosečnostjo jemale valproat, so bili opisani primeri hipotiroidizma.
English: [The following sentence should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Slovenian: [Naslednji stavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]
English: [All text below should be inserted only where the marketing authorisation currently includes the indications epilepsy and/or bipolar disorders] Valproate therapy should not be discontinued without a reassessment of the benefits and risks of the treatment with valproate for the patient by a physician experienced in the management of <epilepsy> <or> <bipolar disorder>.
Slovenian: Zdravljenja z valproatom se ne sme prekiniti, dokler zdravnik, ki ima izkušnje z vodenjem <epilepsije> <ali> <bipolarne motnje>, ponovno ne oceni koristi in tveganja takšnega zdravljenja za bolnico.
English: [The text below should be inserted only where the marketing authorisation currently includes indications for the epilepsy and/or bipolar disorder].
Slovenian: [Spodnje besedilo je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija in/ali bipolarna motnja.]
English: - Cases of hypoglycaemia have been reported in neonates whose mothers have taken valproate during the third trimester of their pregnancy.
Slovenian: - Pri novorojenčkih mater, ki so v prvem trimesečju nosečnosti jemale valproat, so bile opisane hipoglikemije.
English: [The following paragraph should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Slovenian: [Naslednji odstavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]
English: [The sentence below should be inserted only where the marketing authorisation currently includes indications for the epilepsy and/or bipolar disorder].
Slovenian: [Spodnji stavek je treba vstaviti le v državah, kjer trenutno dovoljenje za promet vključuje indikacijo epilepsija in/ali bipolarna motnja.]
English: [The paragraph below should be included in this section where the marketing authorisation currently includes the indication prophylaxis of migraine attacks]
Slovenian: [Spodnji stavek je treba vstaviti v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov]
English: Do not stop taking your medicine until your doctor tells you to. [The text below should be inserted in all indications].
Slovenian: Ne prenehajte jemati zdravila, dokler vam tega ne naroči zdravnik.
English: [The following sentence should be inserted only where the marketing authorisation currently includes the indication prophylaxis of migraine attacks] In women planning to become pregnant or who are pregnant valproate therapies should be stopped.
Slovenian: [Spodnji odstavek je treba vključiti v to poglavje v državah, kjer trenutno dovoljenje za promet vključuje indikacijo za profilakso migrenskih napadov] Zdravljenje z zdravilom <Izmišljeno ime> sme uvesti in nadzorovati le specialist, ki ima izkušnje z vodenjem migrene.
English: Further information on Bavencio can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/bavencio.
Slovenian: Nadaljnje informacije za zdravilo Bavencio so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/bavencio.
English: If no reactions have occurred by the fourth infusion, the treating doctor may decide to stop giving these medicines before subsequent infusions.
Slovenian: Če do četrte infuzije ne pride do nobene reakcije, se lahko lečeči zdravnik odloči, da bo ta zdravila pred naslednjimi infuzijami nehal dajati.
English: Bavencio received a conditional marketing authorisation valid throughout the European Union on 18 September 2017.
Slovenian: Za zdravilo Bavencio je bilo 18. septembra 2017 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Bavencio?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bavencio?
English: The European Medicines Agency decided that Bavencio's benefits 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 Bavencio večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: As for all medicines, data on the use of Bavencio are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Bavencio stalno spremljajo.
English: Patients with MCC that has spread and come back after initial treatment with chemotherapy have very limited treatment options.
Slovenian: Bolniki s KMC, ki se je razširil in se po začetnem zdravljenju s kemoterapijo znova pojavil, imajo zelo omejene možnosti zdravljenja.
English: Although the response rates to Bavencio are not outstanding, the duration of the response (at least 6 months) is important for these patients, since the responses seen with chemotherapy medicines are of shorter duration.
Slovenian: Čeprav stopnja odziva na zdravilo Bavencio ni izjemna, je za te bolnike trajanje odziva (vsaj šest mesecev) pomembno, saj je trajanje odzivov, opaženih pri kemoterapevtskih zdravilih, krajše.
English: Other information about Bavencio
Slovenian: Druge informacije o zdravilu Bavencio
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bavencio have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Bavencio upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Why is Bavencio authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Bavencio odobreno v EU?
English: An overview of Bavencio and why it is authorised in the EU
Slovenian: Pregled zdravila Bavencio in zakaj je odobreno v EU
English: Side effects reported with Bavencio are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Bavencio, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: In both its uses, Bavencio is given in a dose of 800 mg once every 2 weeks as an infusion (drip) into a vein that lasts around 1 hour..
Slovenian: Pri obeh vrstah uporabe se zdravilo Bavencio daje v odmerku 800 mg enkrat vsake dva tedna z infundiranjem (kapalno infuzijo) v veno, ki traja približno eno uro.
English: Longer follow-up was needed to draw a reliable conclusion on how well patients given Bavencio and axitinib survive overall.
Slovenian: Potrebno je daljše nadaljnje opazovanje, da bi lahko prišli do zanesljivega zaključka o tem, kako dobro je na splošno preživetje bolnikov, ki so prejemali zdravilo Bavencio in aksitinib.
English: Treatment should continue as long as the patient benefits from it or side effects become unacceptable.
Slovenian: Zdravljenje se nadaljuje, dokler bolniku koristi oziroma do pojava nesprejemljivih neželenih učinkov.
English: The side effects of the combination were consistent with what was expected, and were considered acceptable given the nature of the condition being treated.
Slovenian: Neželeni učinki kombinacije so sorazmerni s pričakovanimi in veljajo za sprejemljive glede na zdravljeno bolezen.
English: For more information about using Bavencio, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Bavencio glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What is Bavencio and what is it used for?
Slovenian: Kaj je zdravilo Bavencio in za kaj se uporablja?
English: What benefits of Bavencio have been shown in studies?
Slovenian: Kakšne koristi zdravila Bavencio so se pokazale v študijah?
English: Although the dose of Bavencio in these studies was based on the patients' body weight, the company also supplied supporting data to show that Bavencio could be given in a standard dose, regardless of weight.
Slovenian: Čeprav je odmerek zdravila Bavencio v teh študijah temeljil na telesni masi bolnikov, je podjetje predložilo tudi podporne podatke, iz katerih je razvidno, da se zdravilo Bavencio lahko daje v standardnem odmerku, ne glede na telesno maso.
English: What are the risks associated with Bavencio?
Slovenian: Kakšna tveganja so povezana z zdravilom Bavencio?
English: In addition, early data from an ongoing study indicate that the majority of patients who have not had previous chemotherapy also respond to treatment with Bavencio, with a similar duration of response.
Slovenian: Poleg tega zgodnji podatki iz potekajoče študije kažejo, da se večina bolnikov, ki se predhodno niso zdravili s kemoterapijo, tudi odziva na zdravljenje z zdravilom Bavencio, pri čemer je trajanje odziva podobno.
English: The company that markets Bavencio will issue educational materials for patients containing important information about possible side effects of Bavencio, particularly immune-related reactions, and how to manage them.
Slovenian: Podjetje, ki trži zdravilo Bavencio, bo izdalo izobraževalno gradivo za bolnike, v katerem bodo navedene pomembne informacije o možnih neželenih učinkih zdravila Bavencio, še posebej reakcije, povezane z imunskim sistemom, in načini njihovega obvladovanja.
English: For MCC, Bavencio has been given ‘conditional approval'.
Slovenian: Za zdravljenje KMC je zdravilo Bavencio pridobilo „pogojno dovoljenje za promet“.
English: The average time patients lived without their disease getting worse was around 13 months in those given Bavencio and axitinib versus 8 months in those given sunitinib.
Slovenian: Povprečni čas, ko so bolniki živeli brez poslabšanja bolezni, je bil približno 13 mesecev pri tistih, ki so prejemali zdravilo Bavencio in aksitinib, v primerjavi z osmimi meseci pri bolnikih, ki so prejemali sunitinib.
English: The active substance in Bavencio, avelumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand-1' (PD-L1), which is present on the surface of many cancer cells.
Slovenian: Učinkovina v zdravilu Bavencio, avelumab, je monoklonsko protitelo, vrsta beljakovine, zasnovane tako, da prepozna beljakovino, imenovano „ligand 1 za receptor programirane celične smrti 1“ (PD-L1), ki je prisotna na površini številnih rakavih celic, in se veže nanjo.
English: Bavencio can only be obtained with a prescription, and treatment should be started and monitored by a doctor experienced in the treatment of cancer.
Slovenian: Predpisovanje in izdaja zdravila Bavencio je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem raka.
English: PD-L1 usually attaches to cells of the immune (defence) system called T cells, preventing the T cells from attacking the cancer cells.
Slovenian: PD-L1 se veže na celice imunskega (obrambnega) sistema, imenovane celice T, katerim preprečuje, da bi napadle rakave celice.
English: By attaching to PD-L1, Bavencio prevents the cancer cells from switching off the T cells, thereby increasing the ability of the T cells to kill the cancer cells.
Slovenian: Z vezavo na PD-L1 zdravilo Bavencio prepreči, da bi rakave celice onemogočile delovanje celic T, s čimer poveča sposobnost celic T za uničevanje rakavih celic.
English: The safety of Bavencio for this use is considered acceptable and side effects manageable with the additional measures put in place.
Slovenian: Varnost zdravila Bavencio pri tej uporabi velja za sprejemljivo, neželeni učinki pa za obvladljive, če so vzpostavljeni dodatni ukrepi.
English: Since Bavencio has been granted a conditional approval for MCC, the company that markets the medicine will provide further data from the ongoing study of patients who did not receive chemotherapy before starting treatment with Bavencio.
Slovenian: Ker je zdravilo Bavencio pridobilo pogojno dovoljenje za promet za zdravljenje KMC, bo podjetje, ki ga trži, zagotovilo nadaljnje podatke iz potekajoče študije o bolnikih, ki pred začetkom zdravljenja z zdravilom Bavencio niso prejemali kemoterapije.
English: Serious side effects include immune-related and infusion-related reactions, anaemia (low red blood cell counts), difficulty breathing and abdominal pain.
Slovenian: Hudi neželeni učinki vključujejo reakcije, povezane z imunskim sistemom in infuzijo, anemijo (nizko število rdečih krvnih celic), težave z dihanjem in bolečine v trebuhu.
English: Bavencio is a cancer medicine used to treat adults with Merkel cell carcinoma (MCC), a type of skin cancer, when the cancer has spread to other parts of the body.
Slovenian: Bavencio je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih s karcinomom Merklovih celic (KMC), vrsto kožnega raka, ki se je razširil na druge dele telesa.
English: In a main study involving 886 patients with advanced RCC, who had not been previously treated, Bavencio infusion in combination with axitinib by mouth was compared with standard treatment using another cancer medicine, sunitinib.
Slovenian: V glavni študiji, v katero je bilo vključenih 886 bolnikov z napredovalim KLC, ki predhodno niso bili zdravljeni, so infundiranje zdravila Bavencio v kombinaciji z aksitinibom, vzetim peroralno, primerjali s standardnim zdravljenjem z drugim zdravilom za zdravljenje raka, in sicer s sunitinibom.
English: In a main study involving 88 patients with metastatic MCC who had received previous treatment with chemotherapy (cancer medicines), around 33% of patients (29 out of 88) were considered to have had a reduction in tumour size or no sign of it after treatment with the medicine; in most of these patients, the response lasted for at least 6 months.
Slovenian: V glavni študiji, ki je vključevala 88 bolnikov z metastatskim KMC, predhodno zdravljenih s kemoterapijo (zdravili za zdravljenje raka), se je po zdravljenju z zdravilom Bavencio pri približno 33 % (29 od 88) bolnikov tumor zmanjšal ali izginil; pri večini teh bolnikov je odziv trajal vsaj šest mesecev.
English: For the full list of side effects and restrictions of Bavencio, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Bavencio glejte navodilo za uporabo.
English: What information is still awaited for Bavencio?
Slovenian: Katere informacije o zdravilu Bavencio še pričakujemo?
English: Before the first 4 infusions of Bavencio, the patient receives an antihistamine and paracetamol to help prevent infusion-related reactions, such as reddening of the skin, chills, fever, back or abdominal (belly) pain, allergic reactions and difficulty breathing.
Slovenian: Bolnik pred prvimi štirimi infuzijami zdravila Bavencio prejme antihistaminik in paracetamol za preprečevanje reakcij, povezanih z infuzijo, kot so pordelost kože, mrzlica, povišana telesna temperatura, bolečine v hrbtu ali trebuhu, alergijske reakcije in težave z dihanjem.
English: In patients with advanced RCC, Bavencio plus axitinib has been shown to improve the length of time patients survive without their disease getting worse, when compared with sunitinib, though how long patients survive overall remains to be shown.
Slovenian: Pri bolnikih z napredovalim KLC je zdravilo Bavencio v kombinaciji z aksitinibom v primerjavi s sunitinibom podaljšalo čas preživetja bolnikov brez poslabšanja bolezni, vendar je treba še dokazati, kako dolgo preživijo na splošno.
English: How does Bavencio work?
Slovenian: Kako zdravilo Bavencio deluje?
English: When Bavencio is used with axitinib the most common side effects of the combination, which may affect more than 1 in 5 people, are diarrhoea, high blood pressure, tiredness, nausea, dysphonia (hoarseness), decreased appetite, hypothyroidism (reduced thyroid function), cough, headache, breathing difficulties and arthralgia (joint pain).
Slovenian: Kadar se zdravilo Bavencio uporablja z aksitinibom, so najpogostejši neželeni učinki te kombinacije, ki lahko prizadenejo več kot 1 osebo od 5, driska, visok krvni tlak, utrujenost, navzeja, disfonija (hripavost), zmanjšan apetit, hipotiroizem (zmanjšano delovanje ščitnice), kašelj, glavobol, težave z dihanjem in artralgija (bolečine v sklepih).