FrancophonIA/ELRC3.0 huggingface dataset:
English: Although the studies did not use the medicine in the same way as currently authorised, the review concluded that the risk of serious infection had some relevance to the authorised use.
Slovenian: Čeprav se v študijah zdravilo ni uporabljalo na način, za katerega je trenutno odobreno, je pregled pokazal, da je tveganje za resno okužbo pomembno za odobreno uporabo.
English: • You will have regular blood tests to check if you have a low white blood cell count, as a low count can put you at more risk of developing an infection.
Slovenian: • Imeli boste redne krvne preiskave, da bodo preverili, ali imate nizko število belih krvnih celic, saj imate lahko zaradi tega večje tveganje za okužbo.
English: The percentage of deaths in the treatment arms was 8% in the CLL study and 8% and 5% in the lymphoma studies, compared with 3%, 6% and 1% respectively in the placebo arms.
Slovenian: Odstotek smrti v skupinah bolnikov, ki so prejemali zdravilo, je bil 8 % v študiji KLL ter 8 in 5 % v študijah limfoma, v primerjavi s 3, 6 oziroma 1 % v skupinah bolnikov, ki so prejemali placebo.
English: The CHMP has confirmed the recommendations from the PRAC review, and its opinion will now be sent to the European Commission for a final legally binding decision.
Slovenian: Odbor CHMP je potrdil priporočila na podlagi pregleda odbora PRAC in njegovo mnenje je bilo poslano Evropski komisiji, ki je izdala končno pravno zavezujočo odločbo.
English: Because some infections have occurred after patients had finished their cancer treatment, you will have to keep taking these antibiotics for 2 to 6 months after stopping Zydelig.
Slovenian: Ker so se nekatere okužbe pojavile, ko so bolniki prenehali z zdravljenjem proti raku, boste morali te antibiotike jemati še 2 do 6 mesecev po prenehanju jemanja zdravila Zydelig.
English: Low white cell counts can indicate an increased risk of infection and treatment may need to be interrupted.
Slovenian: Nizko število belih krvnih celic lahko kaže na večje tveganje za okužbo, zaradi česar bo zdravljenje morda treba prekiniti.
English: • If you are taking Zydelig, you will receive antibiotics to prevent a type of lung infection (Pneumocystis jirovecii pneumonia).
Slovenian: • Če jemljete zdravilo Zydelig, boste prejeli antibiotike za preprečevanje določene vrste pljučne okužbe (pljučnice, ki jo povzroča Pneumocystis jirovecii).
English: • You should not stop Zydelig without speaking to your doctor.
Slovenian: • Zdravila Zydelig ne prenehajte jemati, dokler se ne posvetujete z zdravnikom.
English: Patients should be monitored for respiratory signs and symptoms.
Slovenian: Bolnike je treba spremljati glede pojava znakov in simptomov na dihalih.
English: The review, which was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), was started because of deaths seen in 3 studies in which Zydelig was given to patient groups for whom it is not licensed, or in unlicensed combinations with other medicines.
Slovenian: Pregled, ki ga je opravil Odbor za oceno tveganja na področju farmakovigilance (PRAC) agencije EMA, je bil sprožen zaradi smrti bolnikov, ki so jih zabeležili v treh študijah, kjer so zdravilo Zydelig dajali skupinam bolnikov, za katere to ni odobreno, ali v neodobrenih kombinacijah z drugimi zdravili.
English: • These studies included patients with disease characteristics that were different from those covered by the currently approved indications for Zydelig and investigated use with treatment combinations that are not currently licensed and which may have influenced the infection rate.
Slovenian: • Te študije so vključevale bolnike z značilnostmi bolezni, ki so bile drugačne od značilnosti, zajetih v trenutno odobrenih indikacijah za zdravilo Zydelig, v njih pa so preučevali uporabo s kombinacijami zdravil, ki trenutno niso odobrene in ki so morda vplivale na delež okužb.
English: The additional deaths were mainly caused by infections, including Pneumocystis jirovecii pneumonia and cytomegalovirus infections.
Slovenian: Dodatne smrti so v glavnem povzročile okužbe, vključno s pljučnico, ki jo povzroča Pneumocystis jirovecii, in okužbami s citomegalovirusom.
English: • Patients should be informed about the risk of serious infections with Zydelig.
Slovenian: • Bolnike je treba obvestiti, da pri zdravljenju z zdravilom Zydelig obstaja tveganje za resne okužbe.
English: Some changes have now been made in how the medicine is used to ensure it is given as safely as possible.
Slovenian: Za zagotovitev čim varnejšega dajanja je bilo uvedenih nekaj sprememb pri načinu uporabe zdravila.
English: • Your doctor will regularly check you for signs of infections.
Slovenian: • Zdravnik bo redno preverjal, ali so prisotni znaki okužbe.
English: CHMP confirms recommendations for use of Zydelig
Slovenian: Odbor CHMP potrjuje priporočila za uporabo zdravila
English: Zydelig is a cancer medicine containing the active substance idelalisib.
Slovenian: Zydelig je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino idelalizib.
English: Zydelig should also not be started in patients with any generalised infection.
Slovenian: Zdravilo Zydelig se prav tako ne sme uvesti pri bolnikih s kakršno koli generalizirano okužbo.
English: The CHMP opinion will now be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States in due course.
Slovenian: Mnenje odbora CHMP je bilo predloženo Evropski komisiji, ki je dne 15.09.2016 izdala končno pravno zavezujočo odločbo, ki velja za vse države članice EU.
English: In the EU, Zydelig is authorised for the treatment of two cancers of white blood cells, chronic lymphocytic leukaemia and follicular lymphoma (one of a group of cancers called non-Hodgkin's lymphomas).
Slovenian: V EU je zdravilo Zydelig odobreno za zdravljenje dveh vrst raka belih krvnih celic, tj. kronične limfocitne levkemije in folikularnega limfoma (enega iz skupine rakov, imenovanih ne-Hodgkinovi limfomi).
English: • All patients should receive prophylaxis for P. jirovecii pneumonia during Zydelig treatment and for 2 to 6 months after stopping treatment.
Slovenian: • Vsi bolniki morajo med zdravljenjem z zdravilom Zydelig in še 2 do 6 mesecev po prenehanju zdravljenja prejemati profilaktično zdravljenje za pljučnico, ki jo povzroča P. jirovecii.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 July 2016 EMA/488322/2016
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: In addition, following an interim precautionary recommendation not to start Zydelig treatment in previously untreated patients with CLL that has certain genetic mutations1, the CHMP now concludes that treatment with Zydelig can again be started in these patients provided they alternative treatments are not suitable and provided that the measures to prevent infection are followed.
Slovenian: Poleg tega po vmesnem varnostnem priporočilu, da se zdravljenje z zdravilom Zydelig ne sme uvesti pri predhodno nezdravljenih bolnikih s KLL, ki imajo določene genske mutacije1, je odbor CHMP zaključil, da se lahko zdravljenje z zdravilom Zydelig ponovno uvede pri teh bolnikih, če druge vrste zdravljenj zanje niso primerne in ob upoštevanju ukrepov za preprečevanje okužbe.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Slovenian: Priporočila odbora PRAC so bila poslana Odboru za zdravila za uporabo v humani medicini (CHMP), odgovornemu za vprašanja glede zdravil za uporabo v humani medicini, ki je mnenje agencije sprejel 21. julija 2016.
English: • In follicular lymphoma, Zydelig is used on its own in patients whose disease has not responded to two previous treatments.
Slovenian: • Pri folikularnem limfomu se zdravilo Zydelig uporablja kot samostojno zdravilo pri bolnikih, katerih bolezen se ni odzvala na dve predhodni zdravljenji.
English: Patients should be monitored for infection and given antibiotics during and after treatment
Slovenian: Bolnike je treba spremljati glede okužb in jim dajati antibiotike med zdravljenjem in po njem21.
English: • There have been reports of serious infections in clinical studies with the cancer medicine Zydelig.
Slovenian: • Iz kliničnih študij z zdravilom Zydelig za zdravljenje raka so poročali o resnih okužbah.
English: • In chronic lymphocytic leukaemia, Zydelig is used in combination with another medicine (rituximab) in patients who have received at least one previous treatment and in previously untreated patients who have genetic mutations in their cancer cells called 17p deletion or TP53 mutation and who are not eligible for other therapies.
Slovenian: • Pri kronični limfocitni levkemiji se zdravilo Zydelig uporablja v kombinaciji z drugim zdravilom (rituksimabom) pri bolnikih, ki so prejemali vsaj eno predhodno zdravljenje, in pri predhodno nezdravljenih bolnikih, ki imajo v rakavih celicah genske mutacije, imenovane delecija 17p ali mutacija TP53, in za katere druga zdravljenja niso primerna.
English: If the patient develops severe neutropenia, treatment with Zydelig may have to be interrupted, in line with the updated SmPC.
Slovenian: Če se pri bolniku pojavi huda nevtropenija, bo zdravljenje z zdravilom Zydelig skladno s posodobljenim povzetkom glavnih značilnosti zdravila morda treba prekiniti.
English: • Provided that strengthened measures are followed to minimise the risk of infection (see below), Zydelig can continue to be used in combination with rituximab in CLL patients who have received at least one prior therapy, and as monotherapy in patients with follicular lymphoma that is refractory to two lines of treatment.
Slovenian: • Ob upoštevanju okrepljenih dejavnosti za zmanjševanje tveganja za okužbo (glejte spodaj) se lahko zdravilo Zydelig še naprej uporablja v kombinaciji z rituksimabom pri bolnikih s KLL, ki so prejemali vsaj eno predhodno zdravljenje, in kot monoterapija pri bolnikih s folikularnim limfomom, neodzivnim na dve obliki zdravljenja.
English: The CHMP (EMA's Committee for Medicinal Products for Human Use) has confirmed that the benefits of Zydelig (idelalisib) in the treatment of the blood cancers chronic lymphocytic leukaemia (CLL) and follicular lymphoma outweigh the risk of side effects.
Slovenian: julija 2016 je odbor CHMP (Odbor za zdravila za uporabo v humani medicini agencije EMA) potrdil, da koristi zdravila Zydelig (idelalizib) pri zdravljenju krvnih rakov, tj. kronične limfocitne levkemije (KLL) in folikularnega limfoma, odtehtajo tveganja za neželene učinke.
English: • Zydelig may also be used in combination with rituximab, as first line treatment in CLL in the presence of 17p deletion or TP53 mutation provided patients cannot take any alternative treatment and provided again that the below measures are followed to reduce the risk of infection.
Slovenian: • Zdravilo Zydelig se lahko prav tako uporablja v kombinaciji z rituksimabom kot zdravilo prve izbire pri bolnikih s KLL, pri katerih je prisotna delecija 17p ali mutacija TP53, če bolniki ne morejo prejemati nobenega alternativnega zdravljenja in ob upoštevanju spodnjih dejavnosti za zmanjševanje tveganja za okužbo.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended and specific guidance is included in the updated summary of product characteristics (SmPC).
Slovenian: V posodobljeni povzetek glavnih značilnosti zdravila so vključena tudi priporočila glede rednega kliničnega in laboratorijskega spremljanja okužb s citomegalovirusom ter posebna navodila.
English: GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL;
Slovenian: GS-US-313-0124, randomizirana, dvojno slepa, s placebom nadzorovana študija III. faze o učinkovitosti in varnosti idelaliziba v kombinaciji z rituksimabom za predhodno zdravljeni iNHL;
English: GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL;
Slovenian: GS-US-313-0125, randomizirana, dvojno slepa, s placebom nadzorovana študija III. faze o učinkovitosti in varnosti idelaliziba v kombinaciji z bendamustinom in rituksimabom za predhodno zdravljeni iNHL.
English: 2 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL;
Slovenian: GS-US-312-0123, randomizirana, dvojno slepa, s placebom nadzorovana študija III. faze o učinkovitosti in varnosti idelaliziba v kombinaciji z bendamustinom in rituksimabom za predhodno nezdravljeno KLL;
English: Your doctor may stop your treatment with Zydelig if your white blood cell count is too low.
Slovenian: Če imate prenizko število belih krvnih celic, bo zdravnik vaše zdravljenje z zdravilom Zydelig morda prekinil.
English: All patients treated with Zydelig should be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia during treatment and this should be continued for up to 6 months after treatment with Zydelig has stopped.
Slovenian: Vsi bolniki, zdravljeni z zdravilom Zydelig, morajo med zdravljenjem prejemati preventivno zdravilo proti okužbi pljuč s pljučnico, ki jo povzroča Pneumocystis jirovecii.
English: • Increased rates of serious adverse effects including deaths were seen in the treatment arm of 3 clinical trials2 evaluating the addition of Zydelig to standard therapy in first-line treatment of CLL and relapsed indolent non-Hodgkin lymphoma.
Slovenian: • V treh kliničnih preskušanjih2, v katerih so vrednotili dodajanje zdravila Zydelig k standardnemu zdravljenju pri prvi izbiri zdravljenja KLL in ponovljenem indolentnem ne-Hodgkinovem limfomu, so v skupini bolnikov, ki je prejemala zdravilo, opazili povečano pogostnost resnih neželenih učinkov, vključno s smrtnimi primeri.
English: Emphasise that patients should persist with the treatment.
Slovenian: poudarjajo, da mora bolnik z zdravljenjem nadaljevati,
English: That cough decreases with repeated use of the product and should stabilize after the first month or so.
Slovenian: se kašelj zmanjšuje s ponavljajočo uporabo zdravila in se bo približno po prvem mesecu stabiliziral.
English: These are only of nuisance value for most patients
Slovenian: predstavljajo za večino bolnikov le neprijetnost,
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA POGOJI IN OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: The Member States shall ensure that all physicians who are expected to prescribe or use Colobreathe are provided with a healthcare professional and patient educational pack containing the following:
Slovenian: Države članice morajo poskrbeti, da bodo vsi zdravniki, ki bodo predpisovali zdravilo Colobreathe, prejeli paket izobraževalnega gradiva za zdravstvene delavce in navodila za bolnike, ki vsebuje:
English: • “Physician DVD” information in “leaflet form” for those physicians who do not have access to a
Slovenian: • podatke »DVD za zdravnika« v »obliki brošure z navodili« za zdravnike, ki nimajo dostopa do predvajalnika DVD
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: The Member States shall agree the final healthcare professional and patient educational pack with the Marketing Authorization Holder (MAH) prior to launch of the product in their territory.
Slovenian: Države članice se bodo pred dajanjem zdravila na svoje tržišče z imetnikom dovoljenja za promet z zdravilom dogovorile o končnem izobraževalnem gradivu.
English: player
Slovenian: Razlaga o pripomočku
English: lamivudine
Slovenian: lamivudin
English: It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Slovenian: Deluje tako, da zavira delovanje reverzne transkriptaze, tj. encima, ki ga virus HIV potrebuje za izdelavo genskih navodil za tvorbo še več virusov, potem ko je okužil celico.
English: Patients who cannot swallow tablets should use an oral solution of lamivudine, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it.
Slovenian: Bolniki, ki ne morejo pogoltniti celih tablet, naj uporabijo peroralno raztopino lamivudina ali pa naj tablete zdrobijo in jih tik pred zaužitjem zmešajo z majhno količino hrane ali pijače.
English: The full EPAR for Lamivudine Teva Pharma B.V. 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 Lamivudine Teva Pharma B.V je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information about treatment with Lamivudine Teva Pharma B.V., read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Lamivudine Teva Pharma B.V preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Lamivudine Teva Pharma B.V. is used in combination with other antiviral medicines to treat adults and children infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Lamivudine Teva Pharma B.V se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih in otrok, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV), to je virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: This means that Lamivudine Teva Pharma B.V. is similar to a ‘reference medicine' already authorised in the European Union (EU) called Epivir.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Epivir.
English: The recommended dose of Lamivudine Teva Pharma B.V. for adults and children weighing at least 25 kg is 300 mg a day.
Slovenian: za odrasle in otroke, ki tehtajo vsaj 25 kg, je 300 mg na dan.
English: Therefore, the CHMP's view was that, as for Epivir, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Epivir odtehtajo znana tveganja.
English: The European Commission granted a marketing authorisation valid throughout the EU for Lamivudine Teva Pharma B.V. on 10 December 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Lamivudine Teva Pharma B.V , veljavno po vsej Evropski uniji, izdala 10. decembra 2009.
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 Lamivudine Teva Pharma B.V.
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: This is a summary of the European public assessment report (EPAR) for Lamivudine Teva Pharma B.V.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lamivudine Teva Pharma B.V.
English: An oral solution of lamivudine can be used to achieve the appropriate dose.
Slovenian: Ustrezen odmerek se lahko doseže z uporabo peroralne raztopine lamivudina.
English: What measures are being taken to ensure the safe and effective use of Lamivudine Teva Pharma B.V.?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lamivudine Teva Pharma B.V.
English: Because Lamivudine Teva Pharma B.V. 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: generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Lamivudine Teva Pharma B.V. does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Slovenian: ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: The active substance in Lamivudine Teva Pharma B.V., lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Slovenian: Zdravilna učinkovina v zdravilu Lamivudine Teva Pharma B.V., lamivudin, je zaviralec nukleozidne reverzne transkriptaze (NRTI).
English: What are the benefits and risks of Lamivudine Teva Pharma B.V.?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Lamivudine Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V., taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: v kombinaciji z drugimi protivirusnimi zdravili zmanjša količino virusa HIV v krvi in ga ohranja na nizki ravni.
English: Because Lamivudine Teva Pharma B.V. is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Epivir.
Slovenian: generično zdravilo, so bile študije pri ljudeh omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Epivir.
English: Other information about Lamivudine Teva Pharma B.V.
Slovenian: Druge informacije o zdravilu Lamivudine Teva Pharma B.V.
English: The CHMP concluded that, in accordance with EU requirements, Lamivudine Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Epivir.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Lamivudine Teva Pharma B.V.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lamivudine Teva Pharma B.V. 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 Lamivudine Teva Pharma B.V.
English: What is Lamivudine Teva Pharma B.V.?
Slovenian: Kaj je zdravilo Lamivudine Teva Pharma B.V.
English: The Committee recommended that Lamivudine Teva Pharma B.V. be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Lamivudine Teva Pharma B.V.
English: Lamivudine Teva Pharma B.V. is an antiviral medicine containing the active substance lamivudine.
Slovenian: je protivirusno zdravilo, ki vsebuje zdravilno učinkovino lamivudin.
English: Why has Lamivudine Teva Pharma B.V. been approved?
Slovenian: Zakaj je bilo zdravilo Lamivudine Teva Pharma B.V.
English: Date of latest renewal: 19 july 2017
Slovenian: Datum zadnjega podaljšanja: 19 julij 2017
English: - If you are pregnant or believe you may be pregnant.
Slovenian: − Če ste noseči ali menite, da bi lahko bili noseči.
English: Time points for measurements were 2 minutes, 30 minutes, 1 hour, 4 hours, 6 hours, 12 hours, 24 hours, 2 days, 4 days, 6 days.
Slovenian: Časovne točke meritev so bile 2 minuti, 30 minut, 1 ura, 4 ure, 6 ur, 12 ur, 24 ur, 2 dni, 4 dni, 6 dni.
English: Special precautions for relatives, carers and hospital staff are provided in section 6.6.
Slovenian: Posebni previdnostni ukrepi za sorodnike, negovalce in bolnišnično osebje so navedeni v poglavju 6.6.
English: adult female (60 kg)
Slovenian: odrasla ženska (60 kg)
English: You will not have to store this medicinal product.
Slovenian: Tega zdravila vam ne bo treba shranjevati.