FrancophonIA/ELRC3.0 huggingface dataset:
English: A reduction in the rate of infusion of Vectibix may be necessary in cases of infusion-related reactions (see section 4.4).
Slovenian: Če se pojavijo z infundiranjem povezane reakcije, je lahko potrebna upočasnitev hitrosti infundiranja zdravila Vectibix (glejte poglavje 4.4).
English: Vectibix in combination with oxaliplatin-based chemotherapy in patients with mutant RAS mCRC or for whom RAS tumour status is unknown
Slovenian: Zdravilo Vectibix v kombinaciji s kemoterapijo na podlagi oksaliplatina pri bolnikih z mKRR z mutantnim RAS oz. bolnikih z mKRR, pri katerih stanje RAS tumorja ni znano
English: Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix (see section 4.4).
Slovenian: Pri bolnikih, zdravljenih z zdravilom Vectibix, so opazili življenjsko ogrožujoče infekcijske zaplete in infekcijske zaplete s smrtnim izidom, vključno z nekrotizirajočim fasciitisom in sepso (glejte poglavje 4.4).
English: Your doctor will check your blood levels of several substances such as magnesium, calcium and potassium in your blood before you start Vectibix treatment.
Slovenian: Pred začetkom zdravljenja z zdravilom Vectibix vam bo zdravnik naredil preiskave krvi, s katerimi bo preveril koncentracijo različnih snovi v krvi, kot so magnezij, kalcij in kalij v krvi.
English: Localised infection
Slovenian: Bolezni prebavil
English: However, an increased number of serious adverse reactions were reported in elderly patients treated with Vectibix in combination with FOLFIRI or FOLFOX chemotherapy compared to chemotherapy alone (see section 4.8).
Slovenian: Vendar pa so pri starejših bolnikih, ki so prejemali zdravilo Vectibix v kombinaciji s kemoterapijo FOLFIRI ali FOLFOX, poročali o več resnih neželenih učinkih, kot pri tistih, ki so prejemali samo kemoterapijo (glejte poglavje 4.8).
English: • The incidence of neutralising antibodies (excluding predose positive patients) was < 1%;
Slovenian: • Incidenca nevtralizirajočih protiteles (izključeni bolniki, pozitivni pred odmerkom in prehodno pozitivni bolniki) je bila < 1 %.
English: FOLFIRI (months) Median (95% CI)
Slovenian: FOLFIRI (meseci) Mediana (95 % IZ)
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih z infundiranjem povezane reakcije1
English: A shortened progression-free survival and overall survival time were observed in a clinical study in patients with mutant RAS tumours who received panitumumab and FOLFOX (see sections 4.4 and 5.1).
Slovenian: V klinični študiji so pri preiskovancih s tumorji z mutantnim RAS, ki so dobivali panitumumab in FOLFOX, ugotovili krajši čas do napredovanja bolezni in skrajšano celokupno preživetje (glejte poglavji 4.4 in 5.1).
English: FOLFOX (months) Median (95% CI)
Slovenian: FOLFOX (meseci) Mediana (95 % IZ)
English: • hair loss (alopecia); mouth ulcers and cold sores (stomatitis); inflammation of the mouth
Slovenian: • izpadanje las (alopecija), razjede v ustih in ocvirki (stomatitis), vnetje ust (vnetje sluznice),
English: Discard the vial and any liquid remaining in the vial after the single-use.
Slovenian: Po enkratni uporabi viale zavrzite vialo in morebitno tekočino, ki je ostala v viali.
English: Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution for infusion.
Slovenian: Ena viala vsebuje 100 mg panitumumaba v 5 ml ali 400 mg panitumumaba v 20 ml koncentrata za raztopino za infundiranje.
English: • ulcerative keratitis (a serious condition of ulceration of the front part of the eye (cornea)
Slovenian: • ulcerativni keratitis (resno stanje razjede sprednjega dela očesa (roženice), ki zahteva takojšnje zdravljenje),
English: The efficacy of Vectibix in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (FOLFOX) was evaluated in a randomised, controlled trial of 1,183 patients with mCRC with the primary endpoint of PFS. Other key endpoints included the OS, ORR, time to response, time to progression (TTP), and duration of response.
Slovenian: Učinkovitost zdravila Vectibix v kombinaciji z oksaliplatinom, 5-fluorouracilom (5-FU) in levkovorinom (FOLFOX) so ocenili v randomiziranem, kontroliranem preskušanju pri 1.183 bolnikih z mKRR, v katerem je bil primarni opazovani dogodek PFS.
English: Initial occurrence Withhold 1 or 2 doses
Slovenian: Prvi pojav zadržite 1 ali 2 odmerka izboljšanje (< 3. stopnja)
English: Blood magnesium decreased
Slovenian: Preiskave zmanjšanje telesne mase znižanje magnezija v krvi
English: Median (months) (95% CI) Hazard ratio (95% CI) PFS
Slovenian: Mediana (meseci) (95 % IZ) Razmerje ogroženosti (95 % IZ) PFS
English: Acetic acid, glacial (for pH-adjustment)
Slovenian: Ocetna kislina, koncentrirana; ledocet (za uravnavanje pH) Voda za injekcije.
English: • eyelid irritation; chapped lips and/or dry lips; eye infection; eyelid infection; nasal dryness;
Slovenian: • draženje vek, razpokane ustnice in/ali suhe ustnice, okužba oči, okužba vek, suhost nosu,
English: Administration of Vectibix
Slovenian: Uporaba zdravila Vectibix
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.
Slovenian: Kombinacija zdravila Vectibix s kemoterapijo, ki vključuje oksaliplatin, je kontraindicirana pri bolnikih z mKRR z mutantnim RAS ali pri katerih stanje RAS ni znano.
English: First-line combination with FOLFOX
Slovenian: Kombinacija s FOLFOX v prvi liniji zdravljenja
English: • The incidence of neutralising antibodies (excluding predose and transient positive patients)
Slovenian: • Incidenca protiteles, ki vežejo panitumumab (izključeni bolniki, pozitivni pred odmerkom)
English: Following the recommended dose regimen (6 mg/kg given once every 2 weeks as a 1-hour infusion), panitumumab concentrations reached steady-state levels by the third infusion with mean (± Standard Deviation [SD]) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/mL, respectively.
Slovenian: Po uporabi priporočene odmerne sheme (6 mg/kg enkrat na 2 tedna v 1-urni infuziji) je koncentracija panitumumaba dosegla stanje dinamičnega ravnovesja do tretje infuzije.
English: Results in patients with wild-type RAS mCRC and mutant RAS mCRC are presented in the table below.
Slovenian: Rezultati pri bolnikih z mKRR z divjim tipom RAS in bolnikih z mKRR z mutantnim RAS so prikazani v spodnji tabeli.
English: The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown (see section 4.4).
Slovenian: Kombinacija zdravila Vectibix in kemoterapije, ki vključuje oksaliplatin, je kontraindicirana pri bolnikih z mKRR z mutantnim RAS in tistih bolnikih z mKRR, pri katerih stanje RAS ni znano (glejte poglavje 4.4).
English: Hypersensitivity1
Slovenian: Bolezni imunskega sistema preobčutljivost1
English: No anti-tumour effects of panitumumab were observed in human tumour xenografts lacking EGFR expression.
Slovenian: Pri človeških tumorskih ksenotransplantatih, ki niso imeli eksprimiranega EGFR, niso ugotovili protitumorskih učinkov panitumumaba.
English: • The incidence of binding antibodies (excluding predose and transient positive patients) was
Slovenian: • Incidenca nevtralizirajočih protiteles (izključeni bolniki, pozitivni pred odmerkom) je bila
English: Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique.
Slovenian: Zdravstveni delavec mora zdravilo Vectibix redčiti z raztopino 9 mg/ml (0,9 %) natrijevega klorida, raztopina za injiciranje v aseptičnih pogojih.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of panitumumab.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala vsebuje 100 mg panitumumaba.
English: Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 94%) treated with Vectibix.
Slovenian: Skoraj pri vseh bolnikih (približno 94 %), zdravljenih z zdravilom Vectibix, se pojavijo dermatološke reakcije, kot farmakološki učinek, opažen pri zaviralcih receptorja za epidermalni rastni faktor (EGFR).
English: Evidence of wild-type RAS (KRAS and NRAS) status is required before initiating treatment with Vectibix.
Slovenian: Pred začetkom zdravljenja z zdravilom Vectibix mora biti potrjeno, da gre za stanje divjega tipa RAS (KRAS in NRAS).
English: Vectibix plus FOLFOX (months) Median (95% CI)
Slovenian: Zdravilo Vectibix in FOLFOX (meseci) Mediana (95 % IZ)
English: A predefined retrospective subset analysis of 143 patients of the 154 patients with wild-type KRAS (exon 2) mCRC was performed, where tumour samples from these patients were tested for additional RAS mutations.
Slovenian: Opravljena je bila vnaprej opredeljena retrospektivna analiza podskupine 143 od 154 bolnikov z mKRR z divjim tipom KRAS (ekson 2), pri kateri so vzorce tumorja teh bolnikov testirali glede dodatnih mutacij RAS. Incidenca teh dodatnih mutacij RAS (KRAS eksonov 3, 4 ter NRAS eksonov 2, 3, 4) v populaciji z divjim tipom KRAS (ekson 2) je bila približno 10 %.
English: Rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in patients treated with Vectibix in the post-marketing setting.
Slovenian: Med uporabo v obdobju trženja so pri bolnikih, zdravljenih z zdravilom Vectibix, poročali o redkih primerih Stevens-Johnsonovega sindroma in toksične epidermalne nekrolize.
English: Seek medical attention immediately if you experience symptoms of an allergic reaction to Vectibix, including but not limited to difficulty breathing, chest tightness, a sensation of choking, dizziness, or fainting.
Slovenian: Če se pojavijo simptomi alergijske reakcije na zdravilo Vectibix, kot npr.: oteženo dihanje, tiščanje v prsih, občutek zadušitve, omotica ali omedlevica, takoj poiščite zdravniško pomoč.
English: Therefore, Vectibix has the potential to cause foetal harm when administered to pregnant women.
Slovenian: Obstaja možnost, da bi pri nosečnici uporabljeno zdravilo Vectibix škodovalo plodu.
English: Psychiatric disorders Insomnia
Slovenian: Psihiatrične motnje nespečnost anksioznost
English: Results in patients with wild-type RAS mCRC and mutant RAS mCRC from the primary analysis are presented in the table below.
Slovenian: Rezultati primarne analize pri bolnikih z mKRR z divjim tipom RAS in bolnikih z mKRR z mutantnim RAS so prikazani v spodnji tabeli.
English: Once treatment is withheld or discontinued, the skin reactions will generally resolve.
Slovenian: Kožne reakcije navadno izginejo ob začasni ali stalni prekinitvi zdravljenja.
English: Conjunctivitis Paronychia1
Slovenian: Infekcijske in parazitske bolezni konjunktivitis paronihija1
English: Eye infection Eyelid infection
Slovenian: Bolezni živčevja glavobol omotica
English: NAME OF THE MEDICINAL PRODUCT Vectibix 20 mg/mL concentrate for solution for infusion panitumumab
Slovenian: Vectibix 20 mg/ml koncentrat za raztopino za infundiranje panitumumab
English: 4 Ulcerative keratitis, skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis are panitumumab ADRs that were reported in the post-marketing setting.
Slovenian: 4 Med obdobjem po prihodu zdravila na trg so kot o neželenih učinkih panitumumaba poročali o ulcerativnem keratitisu, nekrozi kože, Stevens-Johnsonovem sindromu in toksični epidermalni nekrolizi.
English: Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Vectibix, so opazili življenjsko ogrožujoče infekcijske zaplete in infekcijske zaplete s smrtnim izidom, vključno z nekrotizirajočim fasciitisom in sepso.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg panitumumab.
Slovenian: En mililiter koncentrata vsebuje 20 mg panitumumaba.
English: Response rate (investigator assessed)a (95% CI) Stable Disease PFS
Slovenian: Delež odziva (raziskovalčeva ocena)a (95% IZ)
English: Continuing infusion at 60% of original dose
Slovenian: nadaljujte infundiranje s 60 % odmerkom, ki ste ga aplicirali pred pojavom kožnih simptomov ni izboljšanja prekinite uporabo
English: • back pain;
Slovenian: • bolečine v hrbtu,
English: Vectibix plus FOLFIRI (months) Median (95% CI)
Slovenian: Zdravilo Vectibix in FOLFIRI (meseci) Mediana (95 % IZ)
English: Continuing infusion at 80% of original dose
Slovenian: nadaljujte infundiranje z 80 % odmerkom, ki ste ga aplicirali pred pojavom kožnih simptomov ni izboljšanja prekinite uporabo
English: Pulmonary embolism Epistaxis
Slovenian: Srčne bolezni tahikardija cianoza
English: < 1% as detected by the acid-dissociation ELISA and 3.8% as detected by the Biacore assay;
Slovenian: določena s kislinsko-disociacijskim testom ELISA je bila 1 %, določena s preizkusom
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo Vectibix je namenjeno za enkratno uporabo.
English: Skin fissures Acne
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva bolečine v hrbtu bolečine v okončini
English: 1 See section “Description of selected adverse reactions” below 2 See section 4.4 Infusion-related reactions
Slovenian: 2 Glejte poglavje 4.4 Z infundiranjem povezane reakcije.
English: KRAS and NRAS genes encode small, GTP-binding proteins involved in signal transduction.
Slovenian: KRAS in NRAS aktivirajo različni dražljaji, vključno s tistim od EGFR.
English: Mucosal inflammation Oedema peripheral
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost pireksija astenija vnetje sluznice periferni edemi bolečine v prsih bolečina mrzlica
English: Skin reactions were the most frequently occurring adverse reactions in patients receiving panitumumab in combination with chemotherapy.
Slovenian: Med bolniki, ki so prejemali panitumumab v kombinaciji s kemoterapijo, so bili najpogostejši neželeni učinki kožne reakcije.
English: Growth of eyelashes Lacrimation increased Ocular hyperaemia Dry eye
Slovenian: Očesne bolezni blefaritis rast trepalnic močnejše solzenje očesna hiperemija suho oko srbenje oči draženje oči ulcerativni keratitis1,4 keratitis1 draženje vek
English: Improved (< grade 3)
Slovenian: Ob tretjem pojavu zadržite 1 ali 2 odmerka izboljšanje (< 3. stopnja)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3 December 2007
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 26 weeks duration in cynomolgus monkeys.
Slovenian: V študijah toksičnosti ponavljajočih se odmerkov, trajajočih do 26 tednov pri opicah cynomolgus, ki so dobivale panitumumab v odmerkih približno ekvivalentnih priporočenemu odmerku za človeka, sta bili glavni opaženi spremembi izpuščaj na koži in driska.
English: Continuing infusion at 100% of original dose
Slovenian: nadaljujte infundiranje s 100 % odmerkom, ki ste ga aplicirali pred pojavom kožnih simptomov ni izboljšanja prekinite uporabo
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
English: • FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.
Slovenian: • Zdravilo FABLYN povzroča morfološke spremembe, še posebno cistično atrofijo endometrija.
English: • Based on the clinical trials, the morphologic changes caused by FABLYN are benign and do not require further investigation unless vaginal bleeding occurs.
Slovenian: • Na osnovi kliničnih preskušanj so morfološke spremembe, ki jih povzroči zdravilo FABLYN, benigne in ne zahtevajo nadaljnjih preiskav, razen pri pojavu krvavitev iz nožnice.
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:
Slovenian: Države članice bodo morale zagotoviti, da se bodo vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila izvajali.
English: • References to authoritative international guidelines relevant for uterine surveillance.
Slovenian: • Navedba verodostojnih mednarodnih smernic, ki se nanašajo na spremljanje stanja maternice,
English: • The need to stop treatment with FABLYN and investigate when unexplained uterine bleeding
Slovenian: • Potreba po prekinitvi zdravljenja z zdravilom FABLYN in raziskavi vzrokov za pojav
English: SmPC, including contraindication of FABLYN in patients with active or past history of VTE.
Slovenian: • Priporočeni pristopi zmanjšanja tveganja za pojava venskih trombemboličnih dogodkov temeljijo na SmPC, vključno s kontraindikacijo zdravila FABLYN pri bolnicah z aktivno vensko trombembolično boleznijo ali boleznijo v anamnezi.
English: • FABLYN increases risk of venous thromboembolism (VTE).
Slovenian: Izobraževalni program mora vsebovati naslednja ključna sporočila: • Zdravilo FABLYN poveča tveganje za pojav venskih trombemboličnih dogodkov (VTE
English: (Invented) name Strength Pharmaceutical form Route of administration
Slovenian: (Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
English: 28 x 1 tablets (calendar pack)
Slovenian: 28 x 1 tableta (koledarsko pakiranje)
English: 50 tablet
Slovenian: 28 x 1 tableta
English: Adopted at the 9-12 February 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 9. in 12. februarjem 2015
English: PRAC recommendations on signals for update of the product information
Slovenian: Priporočila odbora PRAC o znakih za posodobitev informacij o zdravilu
English: The package leaflets should be updated accordingly.
Slovenian: Ustrezno je treba posodobiti tudi navodilo za uporabo.
English: Aripiprazole - Hyperprolactinaemia (EPITT no 18086)
Slovenian: Aripiprazol - hiperprolaktinemija (EPITT št. 18086)
English: Following the variations of the marketing authorisations for these products, the MAH for any product with the same active substance should submit a respective variation application.
Slovenian: Po spremembi dovoljenj za promet s tema zdraviloma morajo imetniki dovoljenja za promet s katerim koli zdravilom, ki vsebuje isto zdravilno učinkovino, predložiti ustrezno vlogo za spremembo.
English: Section 4: Possible side effects Uncommon side effects (may affect up to 1 in 100 people): Increased blood levels of the hormone prolactin.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): Zvišane ravni hormona prolaktina v krvi.
English: Having considered the available evidence in EudraVigilance, the MAH's clinical trials and pharmacovigilance databases and the literature, the PRAC has agreed that the MAH of Abilify and Abilify Maintena should submit variations within 2 months, to amend the product information as described below (new text underlined).
Slovenian: Po proučitvi razpoložljivih dokazov iz zbirke podatkov EudraVigilance, kliničnih preskušanj imetnika dovoljenja za promet ter zbirk farmakovigilančnih podatkov in literature se je odbor PRAC strinjal, da mora imetnik dovoljenj za promet z zdraviloma Abilify in Abilify Maintena v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
English: Summary of product characteristics (SmPC) Section 4.8:
Slovenian: Povzetek glavnih značilnosti zdravila Poglavje 4.8:
English: In clinical trials for the approved indication(s) and post-marketing, both increase and decrease in serum prolactin as compared to baseline was observed with aripiprazole (section 5.1).
Slovenian: V kliničnih preskušanjih pri odobreni(-h) indikaciji(-ah) in med trženjem so pri uporabi aripiprazola opazili zvišanje in znižanje serumskih koncentracij prolaktina v primerjavi z izhodiščem (poglavje 5.1).
English: Having considered the available evidence the PRAC has agreed that the MAHs of amiodarone for intravenous administration should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Slovenian: Po proučitvi razpoložljivih dokazov se je odbor PRAC strinjal, da morajo imetniki dovoljenj za promet z amiodaronom za intravensko uporabo v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
English: This could be an illness called ‘syndrome of inappropriate anti-diuretic hormone secretion' (SIADH).
Slovenian: To so lahko znaki bolezni, imenovane „sindrom neustreznega izločanja antidiuretičnega hormona (SIADH)“.
English: Frequency ‘uncommon': Hyperprolactinaemia
Slovenian: Pogostnost „občasna“: hiperprolaktinemija
English: Feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable.
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) Slabo počutje, občutek zmedenosti ali šibkosti, slabost (navzea), izguba teka, razdražljivost.
English: Amiodarone - Syndrome of inappropriate antidiuretic hormone secretion (SIADH) (EPITT no 18091)
Slovenian: Amiodaron - sindrom neustreznega izločanja antidiuretičnega hormona (SIADH) (EPITT št. 18091)
English: Very rare: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
Slovenian: Zelo redki: sindrom neustreznega izločanja antidiuretičnega hormona (SIADH)
English: In addition, the MAH should describe the data on hyper- and hypoprolactinaemia in the SmPCs' sections 5.1.
Slovenian: Poleg tega mora imetnik dovoljenj za promet z zdraviloma v poglavju 5.1 povzetka glavnih značilnosti zdravila opisati podatke o hiperprolaktinemiji in hipoprolaktinemiji.
English: Section 4.8 - Undesirable effects: Tabulated list of adverse reactions: Endocrine disorders
Slovenian: Povzetek glavnih značilnosti zdravila Poglavje 4.8 - Neželeni učinki:
English: PRAC recommendations on signals for update of the product information EMA/PRAC/118045/2015
Slovenian: 26 februar 2015 EMA/PRAC/149187/2015
English: EU/1/16/1109/001
Slovenian: EU/1/16/1109/001 Zavicefta
English: 2000 mg / 500 mg
Slovenian: 2000 mg / 500 mg Prašek za koncentrat za raztopino za infundiranje
English: Intravenous use vial (glass)
Slovenian: Intravenska uporaba viala (steklena) 10 vial
English: Zavicefta
Slovenian: Jakost
English: EMA/618757/2017
Slovenian: EMA/618757/2017 EMEA/H/C/004319
English: This means that Cyltezo is highly similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je zelo podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: The full EPAR for Cyltezo 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 Cyltezo je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Cyltezo.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Cyltezo.
English: Treatment response was measured as a 20% or more improvement in symptom score, which was seen after 12 and 24 weeks of treatment in 67% and 69% respectively of those given Cyltezo.
Slovenian: Odziv na zdravljenje so merili kot izboljšanje po lestvici simptomov za 20 % ali več, kar so po 12 tednih opazili pri 67 %, po 24 tednih pa pri 69 % bolnikov, ki so prejemali zdravilo Cyltezo.
English: What is Cyltezo and what is it used for?
Slovenian: Kaj je zdravilo Cyltezo in za kaj se uporablja?