FrancophonIA/ELRC3.0 huggingface dataset:
English: The metabolism of cangrelor is independent of organ function and does not interfere with other drugs metabolised by hepatic enzymes.
Slovenian: Presnova kangrelorja ni odvisna od delovanja organov in ne vpliva na druga zdravila, ki jih presnavljajo jetrni encimi.
English: From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba zdravilo porabiti takoj, razen če metoda rekonstitucije/redčenja izključuje tveganje mikrobne kontaminacije.
English: Intracranial haemorrhage
Slovenian: Intrakranialna krvavitev
English: gastrointestinal tract, in the abdomen, or in the urine or from injection or catheter sites,
Slovenian: v trebuhu ali kri v urinu ali iz mesta injiciranja ali vstavitve katetra;
English: • You suffer from impaired kidney function or require dialysis.
Slovenian: • imate okvarjeno delovanje ledvic ali se zdravite z dializo.
English: Metabolism of cangrelor is not dependent on CYPs and CYP isoenzymes are not inhibited by therapeutic concentrations of cangrelor or its major metabolites.
Slovenian: Presnova kangrelorja ni odvisna od CYP, terapevtske koncentracije kangrelorja ali njegovih glavnih presnovkov pa ne zavirajo izoencimov CYP.
English: Kengrexal is intended for intravenous use, only after reconstitution and dilution.
Slovenian: Zdravilo Kengrexal se uporablja intravensko po rekonstituciji in redčenju.
English: In pivotal studies conducted in patients undergoing PCI, there were more intracranial bleeds at 30 days with cangrelor (0.07%) than with clopidogrel (0.02%), of which 4 bleeds with cangrelor and 1 bleed with clopidogrel were fatal.
Slovenian: V osrednjih študijah, izvedenih pri bolnikih, ki so jim opravili PKI, je bilo več intrakranialnih krvavitev po 30-dnevni uporabi kangrelorja (0,07 %), kot pri uporabi klopidogrela (0,02 %), pri čemer so bile 4 krvavitve s kangrelorjem in 1 krvavitev s klopidogrelom smrtne.
English: Powder for concentrate for solution for injection/infusion in a glass vial.
Slovenian: Prašek za koncentrat za raztopino za injiciranje/infundiranje v stekleni viali.
English: • bleeding in the eye, brain (including stroke), pelvis and lung,
Slovenian: • krvavitev v očesu, možganih (vključno z možgansko kapjo), medenici in pljučih; • krvavitev iz mesta ran;
English: • fluid discharge from injection or catheter sites.
Slovenian: • iztekanje tekočine iz mesta injiciranja ali vstavitve katetra.
English: Allow any foam to settle.
Slovenian: Počakajte, da se morebitna pena poleže.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: What Kengrexal looks like and contents of the pack
Slovenian: Izgled zdravila Kengrexal in vsebina pakiranja
English: Cangrelor N=5,462
Slovenian: Kangrelor N = 5.462
English: Mannitol Sorbitol
Slovenian: manitol sorbitol natrijev hidroksid
English: Moderate
Slovenian: Zmerna
English: Cangrelor exhibits inhibition of activation and aggregation of platelets as shown by aggregometry (light transmission and impedance), point-of care assays, such as the VerifyNow P2Y12test, VASP-P and flow cytometry.
Slovenian: Kangrelor zavira aktivacijo in agregacijo trombocitov, kot kažejo agregometrija (svetlobna transmisija in impedanca), testi mesta oskrbe, kot so test VerifyNow P2Y12, VASP-P in pretočna citometrija.
English: Avoid vigorous mixing.
Slovenian: Ne mešajte sunkovito.
English: In pivotal studies conducted in patients undergoing PCI, there were more cardiac tamponades at 30 days with cangrelor (0.12%) than with clopidogrel (0.02%), (see section 4.8).
Slovenian: V osrednjih študijah, izvedenih pri bolnikih, ki so jim opravili PKI, je bilo več srčnih tamponad po 30-dnevni uporabi kangrelorja (0,12 %), kot pri uporabi klopidogrela (0,02 %) (glejte poglavje 4.8).
English: In pivotal studies conducted in patients undergoing PCI dyspnoea (including exertional dyspnoea) occurred more commonly in patients treated with cangrelor (1.3%) than clopidogrel (0.4%).
Slovenian: V osrednjih študijah, izvedenih pri bolnikih, ki so jim opravili PKI, se je dispneja (vključno z dispnejo po naporu) pojavila pogosteje pri bolnikih, zdravljenih s kangrelorjem (1,3 %) kot pri bolnikih, zdravljenih s klopidogrelom (0,4 %).
English: In pivotal studies conducted in patients undergoing PCI, events of acute renal failure (0.1%), renal failure (0.1%) and increased serum creatinine (0.2%) were reported to occur after administration of cangrelor in clinical trials (see section 4.8).
Slovenian: V osrednjih študijah, izvedenih pri bolnikih, ki so jim opravili PKI, so po dajanju kangrelorja v kliničnih preskušanjih poročali o dogodkih akutne ledvične odpovedi (0,1 %), ledvične odpovedi (0,1 %) in povečanja kreatinina v serumu (0,2 %) (glejte poglavje 4.8).
English: Intravenous use after reconstitution and dilution.
Slovenian: intravenska uporaba po rekonstituciji in redčenju
English: Using Kengrexal reduces the risk that this procedure will cause a clot to form and block the blood vessels again.
Slovenian: Uporaba zdravila Kengrexal zmanjša tveganje, da bi med tem postopkom nastajali strdki in ponovno zamašili žilo.
English: Kengrexal is a white to off-white freeze-dried powder.
Slovenian: Zdravilo Kengrexal je bel do belkast liofiliziran prašek.
English: Clopidogrel (N=12,542)
Slovenian: Klopidogrel (N = 12.542)
English: The medicinal product should be inspected visually for particulate matter after reconstitution.
Slovenian: Zdravilo je treba po rekonstituciji in pred uporabo vizualno pregledati, ali vsebuje delce.
English: - If you get any side effects, talk to your doctor.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: • 4 micrograms per kilogram body weight per minute by infusion (drip), for at least 2 hours.
Slovenian: • 30 mikrogramov na kilogram telesne mase z injekcijo, ki mu takoj sledijo • 4 mikrogrami na kilogram telesne mase na minuto z infundiranjem (kapanjem), ki bo trajalo najmanj 2 uri.
English: Clopidogrel (N=5,527)
Slovenian: Klopidogrel (N = 5.527)
English: Cangrelor has a half-life of three to six minutes.
Slovenian: Razpolovni čas kangrelorja je tri do šest minut.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija, trombocitopenija
English: Cangrelor N=5,470
Slovenian: Kangrelor N = 5.470
English: The powder should be reconstituted immediately prior to dilution and use.
Slovenian: Prašek morate rekonstituirati tik pred redčenjem in uporabo.
English: After reconstitution 1 mL of concentrate contains 10 mg cangrelor and after dilution 1 mL of solution contains 200 micrograms cangrelor.
Slovenian: Po rekonstituciji 1 ml koncentrata vsebuje 10 mg kangrelorja, po redčenju 1 ml raztopine pa vsebuje 200 mikrogramov kangrelorja.
English: The vial should be reconsituted immediately prior to dilution and use.
Slovenian: Viale je treba rekonstituirati tik pred redčenjem in uporabo.
English: Onset of P2Y12 inhibition occurs rapidly upon cangrelor administration.
Slovenian: Zaviranje P2Y12 nastopi kmalu po dajanju kangrelorja.
English: The mean steady state concentration of cangrelor during a constant intravenous infusion of 4 micrograms/kg/min is 488 ng/mL.
Slovenian: 4 mikrogramov/kg/min je 488 ng/ml.
English: If you get any side effects, talk to your doctor.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom.
English: Thrombotic events at 48 hours in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Slovenian: Preglednica 3: Trombotični dogodki po 48 urah v študiji CHAMPION PHOENIX (populacija mITT)
English: You must tell your doctor before receiving this medicine if you have HFI.
Slovenian: Preden boste dobili zdravilo, morate zdravniku povedati, da imate dedno intoleranco za fruktozo.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Each vial contains 50 mg cangrelor.
Slovenian: Ena viala vsebuje 50,0 mg kangrelorja.
English: Thrombotic events at 30 days in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Slovenian: Preglednica 4: Trombotični dogodki po 30 dneh v študiji CHAMPION PHOENIX (populacija mITT)
English: Retroperitoneal haemorrhage,* peritoneal haematoma, gastrointestinal haemorrhage a
Slovenian: Bolezni prebavil retroperitonealna krvavitev*, peritonealni hematom krvavitev v prebaviliha
English: Following the administration of a 30 micrograms/kg bolus followed by a 4 micrograms/kg/min infusion (the PCI dose), platelet inhibition is observed within two minutes.
Slovenian: Po dajanju 30 mikrogramov/kg bolusa, ki mu je sledila infuzija 4 mikrogramov/kg/min (odmerek PKI), so v dveh minutah opazili zaviranje trombocitov.
English: Treatment with Kengrexal may increase the risk of cardiac tamponade.
Slovenian: Zdravljenje z zdravilom Kengrexal lahko poveča tveganje za srčno tamponado.
English: Cangrelor (N=12,565)
Slovenian: Kangrelor (N = 12.565)
English: Bleeding can be serious, and fatal outcomes have been reported.
Slovenian: Krvavitev je lahko resna,
English: Following the administration of a 30 microgram/kg bolus followed by a 4 microgram/kg/min infusion, platelet inhibition is observed within two minutes.
Slovenian: Po dajanju 30 mikrogramov/kg bolusa, ki mu je sledila infuzija 4 mikrogramov/kg/min, so v dveh minutah opazili zaviranje trombocitov.
English: Haematocrit decreased, haemoglobin decreased**
Slovenian: Preiskave zmanjšanje vrednosti hematokrita, zmanjšanje vrednosti hemoglobina**
English: The bolus and infusion should be administered from the infusion solution.
Slovenian: Bolus in infuzija se dajeta kot raztopina za infundiranje.
English: Rash, pruritus, urticaria f
Slovenian: pruritus, urtikarijaf angioedem
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA
English: After reconstitution 1 mL contains 10 mg cangrelor.
Slovenian: Po rekonstituciji 1 ml vsebuje 10 mg kangrelorja.
English: How to store Kengrexal
Slovenian: Shranjevanje zdravila Kengrexal
English: After reconstitution 1 mL of concentrate contains 10 mg cangrelor.
Slovenian: Po rekonstituciji 1 ml koncentrata vsebuje 10 mg kangrelorja.
English: Uncommon side effects: may affect up to 1 in 100 people
Slovenian: Pogosti neželeni učinki: pojavijo se lahko pri največ 1 od 10 bolnikov
English: Cangrelor (N=5,529)
Slovenian: Kangrelor (N = 5.529)
English: Aseptic procedures should be used for the preparation of Kengrexal.
Slovenian: Priprava zdravila Kengrexal mora potekati z aseptičnimi postopki.
English: • Bleeding leading to fluid around the heart, blood in the chest cavity or bleeding from the nose,
Slovenian: Občasni neželeni učinki: pojavijo se lahko pri največ 1 od 100 bolnikov • krvavitev, ki povzroči tekočino okoli srca, kri v prsni votlini ali krvavitev iz nosu, v prebavilih,
English: Treatment with Kengrexal may increase the risk of bleeding.
Slovenian: Zdravljenje z zdravilom Kengrexal lahko poveča tveganje za krvavitve.
English: In pivotal studies conducted in patients undergoing PCI, GUSTO (Global Use of Strategies to Open Occluded Arteries), moderate and mild bleeding events were more common in patients treated with cangrelor than in patients treated with clopidogrel, see section 4.8.
Slovenian: V ključnih študijah, ki so jih opravili pri bolnikih, ki so jim opravili PKI, so bile zmerne in blage krvavitve GUSTO (Global Use of Strategies to Open Occluded Arteries) pogostejše pri bolnikih,
English: Upper gastrointestinal haemorrhage, mouth haemorrhage, gingival bleeding, oesophageal haemorrhage, duodenal ulcer haemorrhage, haematemesis, lower gastrointestinal haemorrhage, rectal haemorrhage, haemorrhoidal haemorrhage, haematochezia.
Slovenian: krvavitev v zgornja prebavila, krvavitev v usta, krvavitev dlesni, ezofagealna krvavitev, krvavitev razjede na dvanajstniku, hematemeza, krvavitev v spodnja prebavila, krvavitev iz rektuma, hemoroidna krvavitev, hematohezija b.
English: After dilution 1 mL contains 200 micrograms cangrelor.
Slovenian: Po redčenju 1 ml raztopine vsebuje 200 mikrogramov kangrelorja.
English: * Including events with fatal outcome.
Slovenian: poročali pa so tudi o smrtnih izidih.
English: Hypersensitivity reactions may occur after treatment with Kengrexal.
Slovenian: Po zdravljenju z zdravilom Kengrexal se lahko pojavijo preobčutljivostne reakcije.
English: Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor.
Slovenian: Ena viala vsebuje 50 mg kangrelorja v obliki tetranatrijevega kangrelorata.
English: Intravenous use
Slovenian: Način uporabe
English: Kengrexal 50 mg powder for concentrate cangrelor
Slovenian: Kengrexal 50 mg prašek za koncentrat kangrelor intravenska uporaba
English: White to off-white lyophilised powder.
Slovenian: prašek za koncentrat za raztopino za injiciranje/infundiranje Bel do belkast liofiliziran prašek.
English: Haemorrhage intracranial d *
Slovenian: Bolezni živčevja intrakranialna krvavitevd *
English: Angioedema
Slovenian: Dojenje
English: The active substance is cangrelor.
Slovenian: Učinkovina je kangrelor.
English: • bruising,
Slovenian: • modrice;
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja (dispneja ob naporu)
English: Treatment with Kengrexal may increase the risk of intracranial haemorrhage.
Slovenian: Zdravljenje z zdravilom Kengrexal lahko poveča tveganje za intrakranialno krvavitev.
English: Hypersensitivity
Slovenian: preobčutljivost
English: For example, if you have a medical condition that affects blood clotting or because of another medical condition that may increase the risk of bleeding such as a recent serious injury, any recent surgery, history of a stroke or a transient ischaemic attack or recent bleeding from your stomach or gut.
Slovenian: • imate povečano tveganje za krvavitev ali menite, da imate morda povečano tveganje za krvavitev - imate na primer zdravstveno stanje, ki vpliva na strjevanje krvi, ali zaradi drugega zdravstvenega stanja, ki lahko poveča tveganje za krvavitev, kot je nedavna resna poškodba,
English: Neoplasms benign, malignant and unspecified (includes cysts and polyps)
Slovenian: Benigne, maligne in neopredeljene novotvorbe
English: Impairment of fertility
Slovenian: Vpliv na plodnost
English: Chiesi Farmaceutici S.p.A. Τηλ: + 39 0521 2791
Slovenian: Τηλ: + 39 0521 2791
English: Ear haemorrhage
Slovenian: Ledvična okvara
English: Pulmonary haemorrhage
Slovenian: Srčne bolezni srčna tamponada
English: Immune system disorders
Slovenian: Bolezni imunskega sistema anafilaktična reakcija
English: Kengrexal 50 mg powder for concentrate for solution for injection/infusion cangrelor
Slovenian: Kengrexal 50 mg prašek za koncentrat za raztopino za injiciranje/infundiranje.
English: Haematoma <5 cm, haemorrhage
Slovenian: Žilne bolezni hematom < 5 cm, krvavitev hemodinamska nestabilnost krvavitev iz rane, žilna psevdoanevrizma
English: Very rare side effects: may affect up to 1 in 10,000 people
Slovenian: Zelo redki neželeni učinki: pojavijo se lahko pri največ 1 od 10.000 bolnikov • krvavitev pod kožo ali okoli očesa;
English: Application site bleeding, catheter site haemorrhage or haematoma, infusion site haemorrhage or haematoma.
Slovenian: krvavitev na mestu aplikacije, krvavitev ali hematom na mestu katetra, krvavitev ali hematom na mestu infundiranja c.
English: Stent thrombosis
Slovenian: Tromboza stenta Smrt
English: Kengrexal contains cangrelor, a direct P2Y12 platelet receptor antagonist that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo.
Slovenian: Zdravilo Kengrexal vsebuje kangrelor, ki je neposredni antagonist receptorjev P2Y12 na trombocitih,
English: Skin neoplasm bleeding
Slovenian: krvavitev iz kožne novotvorbe
English: Epistaxis, haemoptysis
Slovenian: epistaksa, hemoptiza pljučna krvavitev
English: Sodium hydroxide (for pH-adjustment)
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi manitol sorbitol natrijev hidroksid (za uravnavanje pH)
English: Contusion
Slovenian: Odmerjanje
English: Rare side effects: may affect up to 1 in 1,000 people
Slovenian: Redki neželeni učinki: pojavijo se lahko pri največ 1 od 1.000 bolnikov • krvavitev, ki povzroči nizko število krvnih ploščic;
English: Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791
Slovenian: Tel: + 39 0521 2791
English: Treatment with Kengrexal may increase the risk of dyspnoea.
Slovenian: Zdravljenje z zdravilom Kengrexal lahko poveča tveganje dispneje.
English: Mannitol
Slovenian: Blagab
English: Periorbital haematoma, subcutaneous haematoma
Slovenian: Infekcijske in parazitske bolezni hematom, okužba
English: The pharmacokinetics of cangrelor are not affected by gender, age, or renal or hepatic status.
Slovenian: Starost, spol ali stanje ledvic oz. jeter ne vpliva na farmakokinetiko kangrelorja.
English: Primary Endpoint
Slovenian: Primarni opazovani dogodek
English: Haemorrhage urinary tract, e acute renal failure (renal failure)
Slovenian: eritem, eritematozni izpuščaj, pruritični izpuščaj * vključuje dogodke s smrtnim izidom
English: Clopidogrel N=5,469 OR (95% CI)
Slovenian: Klopidogrel N = 5.469
English: Platelet count decreased, red blood cell count decreased, international normalised ratio increased c
Slovenian: povečanje vrednosti kreatinina v krvi zmanjšanje števila trombocitov, zmanjšanje števila rdečih krvnih celic,
English: Nervous system disorders
Slovenian: Organski sistem Pogosti
English: Ear and labyrinth disorders
Slovenian: Ušesne bolezni, vključno z motnjami labirinta krvavitev v ušesu
English: Risk of dyspnoea
Slovenian: Tveganje dispneje
English: Sodium
Slovenian: ZDRAVILA
English: Package leaflet: Information for the patient Kengrexal 50 mg powder for concentrate for solution for injection/infusion cangrelor
Slovenian: Navodilo za uporabo Kengrexal 50 mg prašek za koncentrat za raztopino za injiciranje/infundiranje kangrelor
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Slovenian: Izid postopka v skladu s členom 30 Direktive 2001/83/ES
English: The European Commission issued a decision on this opinion on 26/6/17.
Slovenian: Evropska komisija je o tem mnenju izdala odločbo dne 26/6/17.
English: Vepesid is marketed in 16 EU member States (Austria, Belgium, Croatia, Denmark, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Romania, Slovenia, Spain, Sweden and the United Kingdom) as well as in Norway.
Slovenian: Zdravilo Vepesid se trži v 16 državah članicah EU (v Avstriji, Belgiji, na Hrvaškem, Danskem, v Estoniji, na Finskem, v Nemčiji, na Irskem, v Italiji, Luksemburgu, na Nizozemskem, v Romuniji, Sloveniji, Španiji, na Švedskem in v Združenem kraljestvu) ter na Norveškem.
English: Why was Vepesid reviewed?
Slovenian: Zakaj je bilo zdravilo Vepesid pregledano?
English: On 21 April 2017, the European Medicines Agency completed a review of Vepesid.
Slovenian: Evropska agencija za zdravila je 21. aprila 2017 zaključila pregled zdravila Vepesid.
English: Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).
Slovenian: Druga usklajena poglavja povzetka glavnih značilnosti zdravila vključujejo poglavje 4.4 (posebna opozorila in previdnostni ukrepi), poglavje 4.6 (plodnost, nosečnost in dojenje) in poglavje 4.8 (neželeni učinki).
English: Vepesid is authorised in the EU via national procedures.
Slovenian: Zdravilo Vepesid je bilo v EU odobreno po nacionalnih postopkih.
English: Vepesid capsules should be taken on an empty stomach.
Slovenian: Kapsule zdravila Vepesid je treba jemati na prazen želodec.
English: • small-cell lung cancer;
Slovenian: • drobnoceličnega pljučnega raka;
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: Zato je med državami članicami prišlo do razlik v načinu, kako naj se zdravilo uporablja, kar je razvidno iz razlik v povzetkih glavnih značilnosti zdravila, označevanju in navodilih za uporabo v državah, kjer se zdravilo trži.
English: What is Vepesid?
Slovenian: Kaj je zdravilo Vepesid?
English: 4.3 Contra-indications
Slovenian: Kontraindikacije
English: Vepesid is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Slovenian: Vepesid je zdravilo proti raku, ki se uporablja za zdravljenje raka mod, pljučnega raka, raka jajčnikov in krvnih rakov (Hodgkinovega in ne-Hodgkinovega limfoma ter akutne mieloične levkemije).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Vepesid in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba uskladiti podatke o predpisovanju zdravila Vepesid v Evropski uniji (EU).
English: The usual dose of Vepesid is 100 to 200 mg per m2 of body surface area for 5 days in a row or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks.
Slovenian: Odmerek zdravila Vepesid temelji na priporočenem odmerku za intravenska zdravila z etopozidom, pri čemer je peroralni odmerek 100 mg primerljiv z intravenskim odmerkom 75 mg. Običajni odmerek zdravila Vepesid je od 100 do 200 mg na m2 telesne površine 5 dni zaporedoma ali 200 mg/m2/dan 1., 3. in 5. dan vsake 3 do 4 tedne.
English: 4.2 Posology and method of administration
Slovenian: Odmerjanje in način uporabe
English: The CHMP recommended that Vepesid should be used in combination with other cancer treatments to treat the following cancers in adults:
Slovenian: Odbor CHMP je priporočil, naj se zdravilo Vepesid uporablja v kombinaciji z drugimi zdravili proti raku za zdravljenje naslednjih vrst raka pri odraslih:
English: • non-epithelial ovarian cancer.
Slovenian: • neepitelijskega raka jajčnikov.
English: • Hodgkin's lymphoma as second-line treatment;
Slovenian: • Hodgkinovega limfoma kot druga izbira zdravljenja;
English: In addition, the CHMP recommended Vepesid for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Slovenian: Poleg tega je odbor CHMP priporočil, naj se zdravilo Vepesid uporablja za zdravljenje epitelijskega raka jajčnikov, odpornega proti zdravljenju z zdravili, ki vsebujejo platino, brez navedbe, da se mora uporabljati v kombinaciji z drugimi zdravili.
English: The areas of the SmPC harmonised include:
Slovenian: Usklajena področja povzetka glavnih značilnosti zdravila vključujejo:
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs and package leaflets should be harmonised across the EU.
Slovenian: Odbor CHMP je na podlagi predloženih podatkov in znanstvene razprave v odboru menil, da je treba povzetke glavnih značilnosti zdravila in navodila za uporabo uskladiti po vsej EU.
English: It is also available in the EU under the trade name Vepesid K. The company that markets these medicines is Bristol-Myers Squibb.
Slovenian: Ta zdravila trži farmacevtska družba Bristol-Myers Squibb.
English: Vepesid should not be taken at the same time as vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be taken by breast-feeding women.
Slovenian: Bolniki z oslabljenim imunskim sistemom zdravila Vepesid ne smejo jemati sočasno s cepljenjem proti rumeni mrzlici ali drugimi živimi cepivi, prav tako ga ne smejo jemati doječe matere.
English: Vepesid contains the active substance etoposide and is available as capsules to be taken by mouth.
Slovenian: Zdravilo Vepesid vsebuje zdravilno učinkovino etopozid in je na voljo v obliki kapsul, ki se jemljejo peroralno.