FrancophonIA/ELRC3.0 huggingface dataset:
English: Dihydroergocryptine only containing products are approved in other EU Member States but their indications were not in the scope of this referral procedure (e.g. Parkinson's disease) and were excluded from this review.
Slovenian: Zdravila, ki vsebujejo samo dihidroergokriptin, so odobrena v drugih državah članicah, vendar njihove indikacije ne spadajo v sklop tega napotitvenega postopka (npr. Parkinsonova bolezen), zato so bile iz tega pregleda izključene.
English: Overall, the CHMP was of the opinion that no situation could justify exposing a patient to risk of fibrosis and ergotism considering the very limited data on efficacy.
Slovenian: Na splošno je odbor CHMP menil, da nobene okoliščine ne upravičijo izpostavitve bolnika tveganju za fibrozo in ergotizem, še zlasti ker so podatki o učinkovitosti zelo omejeni.
English: The CHMP considered the MAHs proposals for risk minimisation measures.
Slovenian: Odbor CHMP je obravnaval predloge imetnikov dovoljenj za promet z zdravilom glede ukrepov za zmanjšanje tveganja.
English: Based on these data and based on the pharmacological plausibility, dihydroergocryptine is considered to be associated with fibrotic reactions.
Slovenian: Na podlagi teh podatkov in farmakološke verjetnost menijo, da je dihidroergokriptin povezan s fibrotičnimi reakcijami.
English: Under-reporting can also be suspected because the substance is marketed for a long time as well as because fibrosis is already mentioned as an adverse drug reaction in the product information.
Slovenian: Prav tako obstaja sum na preredko poročanje, saj je učinkovina v prometu že dolgo časa in je fibroza že omenjena kot neželeni učinek v informacijah o zdravilu.
English: The clinical efficacy endpoints were numerous and heterogeneous with no defined primary efficacy endpoint.
Slovenian: Klinični opazovani dogodki za učinkovitost so bili številni in heterogeni, primarni opazovani dogodek za učinkovitost pa sploh ni bil opredeljen.
English: From the approved indications of the dihydroergocryptine containing medicinal products the ones that are in the scope of this referral procedure and are approved in at least one Member State are the following (specific wording of the indication may vary from product to product):
Slovenian: Od odobrenih indikacij za zdravila, ki vsebujejo dihidroergokriptin, so indikacije, ki spadajo v sklop tega napotitvenega postopka in so odobrene v vsaj eni državi članici, naslednje (natančno besedilo za indikacijo se lahko med zdravili razlikuje):
English: These included changing the prescription status, limiting treatment duration in certain conditions, contraindicating the product in patients with pre-existing fibrosis or in association with other drugs, the issuing of a DHPC highlighting the risk, a checklist for prescribers, and a pharmacological in vitro study for 5-HT subclass receptors affinity to the product.
Slovenian: Ti so vključevali spremembo statusa za predpisovanje, omejitev trajanja zdravljenja pri nekaterih pogojih, kontraindikacijo zdravila pri bolnikih z obstoječo fibrozo ali kontraindikacijo za kombinacije z drugimi zdravili, izdajo neposrednega obvestila zdravstvenim delavcem, ki izpostavlja tveganje, kontrolni seznam za predpisovalce ter izvedbo farmakološke študije in vitro za afiniteto podrazreda receptorjev 5-HT za zdravilo.
English: Dihydroergocryptine is an ergot alkaloid that has an agonist activity on D2 dopaminergic receptors and a partial agonist activity on D1 receptors.
Slovenian: Dihidroergokriptin je ergot-alkaloid, ki agonistično deluje na D2-dopaminergične receptorje in delno agonistično deluje na D1-receptorje.
English: In fact, dihydroergocryptine being part of the class of ergot derivatives containing medicinal products covered by this procedure is only approved in the above mentioned indications in France and only in combination with caffeine since 1979.
Slovenian: Ker dihidroergokriptin spada v razred zdravil, ki vsebujejo derivate ergot-alkaloidov in jih vključuje ta postopek, je v Franciji odobren samo za zgoraj navedene indikacije in od leta 1979 samo v kombinaciji s kofeinom.
English: Overall, for the indication “symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)”, the MAHs provided 6 publications (dated from 1983 to 1998) with an adequate design (randomised, double-blind, placebo controlled) to support the claim for efficacy, plus one study in vascular cognitive impairment which wasnot further discussed.
Slovenian: Za indikacijo „simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence)“ so imetniki dovoljenj za promet z zdravilom predložili 6 publikacij (z datumom od 1983 do 1998) z zadostnim načrtom (randomiziranim, dvojno slepim, s placebom nadzorovanim), da bi s tem podprli trditve o učinkovitosti, ter eno študijo žilne kognitivne okvare, ki se ni nadalje obravnavala.
English: Data provided during a referral under Article 31 in 2007-2008 (EMEA/H/A-31/881) including dihydroergocryptine showed that several cases of fibrosis either pulmonary or cardiac or retroperitoneal were suspected to be associated to the treatment with dihydroergocryptine use for Parkinson's disease treatment (involving dosage five times higher).
Slovenian: Podatki, predloženi med napotitvenim postopkom v skladu s členom 31 med letoma 2007-2008 (EMEA/H/A-31/881), ki vključuje dihidroergokriptin, so pokazali, da pri mnogih primerih pljučne, srčne ali retroperitonealne fibroze obstaja sum na povezavo z zdravljenjem Parkinsonove bolezni z dihidroergokriptinom (ki je vključevalo petkrat večje odmerjanje).
English: The data from the reported cases of fibrosis (n=3) are limited in order to draw any firm conclusions, however, the risk cannot be excluded considering the improvement observed when dihydroergocryptine/caffeine was discontinued in one of the three reported cases of pulmonary fibrosis occurring with recommended daily dose.
Slovenian: Podatki o poročanih primerih fibroze (n = 3) so omejeni, kar ne omogoča prepričljivih zaključkov, vendar tveganja ni mogoče izključiti, saj so pri enem od treh poročanih primerih pljučne fibroze, ki so se pojavili ob uporabi priporočenega dnevnega odmerka, opazili izboljšanje po prekinitvi uporabe dihidroergokriptina/kofeina.
English: Therefore, other mechanisms inducing fibrosis cannot be excluded, which suggests a causal link between fibrosis and agonism of 5-HT2A and 5-HT1B receptors and also plausible effect on serotonin transporter.
Slovenian: Zato ni mogoče izključiti drugih mehanizmov, ki povzročajo fibrozo, kar kaže na vzročno povezavo med fibrozo in agonizmom receptorjev 5-HT2A ter 5-HT1B in tudi na verjetni učinek na transmitorje serotonina.
English: • The suspension of the marketing authorisation for dihydroergocryptine /caffeine containing medicinal products referred to in Annex I in the event that no other indications are approved as part of their marketing authorisation.
Slovenian: • začasni umik dovoljenj za promet z zdravili, navedenimi v Prilogi I, ki vsebujejo dihidroergokriptin/kofein, če v sklopu njihovega dovoljenja za promet z zdravilom ni drugih odobrenih indikacij.
English: The duration of these studies was short (2 or 3 months) considering the chronic indication approved.
Slovenian: Upoštevajoč odobreno kronično indikacijo so bile te študije kratkotrajne (2 ali 3 mesece).
English: For the indication “ancillary treatment of Raynaud's syndrome”, all the studies submitted in support of this indication were considered by the CHMP of poor methodological quality (i.e. uncontrolled, open designed, with a low number of patients (n=20-37)).
Slovenian: Za vse študije, predložene kot podpora indikaciji „dodatno zdravljenje Raynaudovega sindroma“, je odbor CHMP menil, da je njihova metodološka kakovost slaba (tj. nenadzorovano, z odprtim načrtom in majhnim številom bolnikov (n = 20-37)).
English: • Acute retinopathies of vascular origin
Slovenian: • akutna retinopatija žilnega izvora.
English: Scientific conclusions and grounds for variation to the terms of the marketing authorisations or suspension of the marketing authorisations, as applicable, taking into consideration the approved indications for each product
Slovenian: Priloga II Znanstveni zaključki in podlaga za spremembo pogojev dovoljenj za promet z zdravilom ali začasni umik dovoljenj za promet z zdravilom, kot je primerno, ob upoštevanju odobrenih indikacij za posamezno zdravilo
English: Regarding ergotism, there were several cases reported in the French Pharmacovigilance database where dihydroergocryptine/caffeine was the suspected drug for symptoms related to ergotism.
Slovenian: V francoski farmakovigilančni zbirki podatkov so poročali o mnogih primerih ergotizma, pri čemer je bil domnevno povzročitelj simptomov dihidroergokriptin/kofein.
English: The Committee concluded that the benefit-risk balance of dihydroergocryptine/caffeine containing products is not favourable pursuant to Article 116 of Directive 2001/83/EC for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia) and for ancillary treatment of Raynaud's syndrome.
Slovenian: Odbor je zaključil, da skladno s členom 116 Direktive 2001/83/ES razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokriptin/kofein, ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence) ter dodatno zdravljenje Raynaudovega sindroma.
English: The absence of such reports claimed from the MAH, raised questions to the CHMP with regard to the way that the data collection was performed.
Slovenian: Imetnik dovoljenja za promet z zdravilom je trdil, da takih poročil ni, kar je odbor CHMP opozorilo na način zbiranja podatkov.
English: Agonism to 5-HT2B receptors induces a proliferative response and mitogenicity of the cells expressing this receptor leading to fibrogenesis.
Slovenian: sproži proliferativni odziv in mitogenost celic, ki izražajo ta receptor, kar povzroči fibrogenezo.
English: • The variation to the terms of the marketing authorisation for dihydroergocryptine/caffeine containing medicinal products referred to in Annex I, to delete the below indications from the Product Information (specific wording of the indication may vary from product to product and country to country) as well as any relevant reference to these indications in the Product Information, when there are other therapeutic indications approved as part of their marketing authorisation:
Slovenian: • spremembo pogojev dovoljenj za promet z zdravili, navedenimi v Prilogi I, ki vsebujejo dihidroergokriptin/kofein, tako da se iz informacij o zdravilu izbrišejo spodaj navedene indikacije (natančno besedilo za indikacijo se lahko med zdravili in državami razlikuje) ter druga zadevna sklicevanja na te indikacije, kadar so v sklopu dovoljenja za promet z zdravilom druge odobrene terapevtske indikacije: simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence), dodatno zdravljenje Raynaudovega sindroma;
English: Is not favourable for ancillary treatment of Raynaud's syndrome.
Slovenian: • dodatno zdravljenje Raynaudovega sindroma.
English: • The Committee considered that the benefit-risk balance of dihydroergocryptine/caffeine containing products: Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia).
Slovenian: • odbor je menil, da razmerje med tveganji in koristmi pri zdravilih, ki vsebujejo dihidroergokriptin/kofein: ni ugodno za simptomatsko zdravljenje kronične patološke kognitivne in nevrosenzorične okvare pri starejših (izključujoč Alzheimerjevo bolezen in druge oblike demence), ni ugodno za dodatno zdravljenje Raynaudovega sindroma; zato odbor CHMP skladno s členom 116 Direktive 2001/83/ES priporoča:
English: Grounds for the variation/suspension to the terms of the marketing authorisations
Slovenian: Razlogi za spremembo pogojev dovoljenj za promet z zdravilom ali njihov začasni umik Ob upoštevanju naslednjega:
English: To help avoid possible infections and to ensure that you use the medicine correctly, it is important that you follow these instructions.
Slovenian: Da bi preprečili morebitne okužbe in zagotovili, da zdravilo pravilno uporabljate, je pomembno, da upoštevate ta navodila.
English: Kolodvorska Cesta 27 1234 Menges Slovenia
Slovenian: Kolodvorska cesta 27 1234 Mengeš Slovenija
English: The pre-filled syringe cannot be re-used.
Slovenian: Napolnjene brizge ni mogoče ponovno uporabiti.
English: • if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na pegfilgrastim, filgrastim ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Your doctor may decide that it would be more convenient for you to inject Ziextenzo yourself.
Slovenian: Mogoče se bo zdravnik odločil, da bi bilo za vas prikladneje, če si zdravilo Ziextenzo injicirate sami.
English: Device ACTIVATED - DO NOT USE
Slovenian: Pripomoček AKTIVIRAN - NE
English: If it has expired, return the entire pack to the pharmacy.
Slovenian: Če je rok uporabe potekel, vrnite celoten paket v lekarno.
English: • The recommended site is the front of your thighs.
Slovenian: • Priporočeno mesto je na sprednji strani stegen.
English: Ziextenzo is for use in adults aged 18 and over.
Slovenian: Zdravilo Ziextenzo je namenjeno uporabi pri odraslih, starih 18 ali več let.
English: Its colour may vary from colourless to slightly yellowish.
Slovenian: Njena barva lahko variira od brezbarvne do rahlo rumenkaste.
English: Do not open the carton until you are ready to use the pre-filled syringe.
Slovenian: Ne odprite škatle, dokler niste pripravljeni uporabiti napolnjene brizge.
English: By touching them, the needle guard may be activated too early.
Slovenian: Če se jih dotaknete, se lahko ščitnik igle aktivira prezgodaj.
English: Be careful not to touch the needle guard wings before use.
Slovenian: Pazite, da se pred uporabo ne dotaknete krilc ščitnika igle.
English: The trade name of the administered product should be clearly recorded in the patient file.
Slovenian: Zaščiteno ime uporabljenega zdravila je treba jasno zabeležiti v bolnikovi dokumentaciji.
English: Healthcare providers only
Slovenian: Samo za zdravstveno osebje
English: Do not use the pre-filled syringe if the seal of the blister is broken, as it may not be safe for you to use.
Slovenian: Napolnjene brizge ne uporabite, če je pečat pretisnega omota poškodovan, saj mogoče ni varna za uporabo.
English: When you are ready to use the pre-filled syringe, open the blister and wash your hands thoroughly with soap and water.
Slovenian: Ko ste napolnjeno brizgo pripravljeni uporabiti, odprite pretisni omot in si z milom in vodo temeljito umijte roke.
English: Your doctor has given you Ziextenzo to encourage your bone marrow (part of the bone which makes blood cells) to produce more white blood cells that help your body fight infection.
Slovenian: Vaš zdravnik vam je predpisal zdravilo Ziextenzo, da bi spodbudilo vaš kostni mozeg (tisti del kosti, ki izdeluje krvničke) k izdelavi več belih krvničk, ki pomagajo vašemu telesu boriti se proti okužbam.
English: What Ziextenzo is and what it is used for
Slovenian: Kaj je zdravilo Ziextenzo in za kaj ga uporabljamo
English: The needle guard is intended to protect healthcare professionals, caregivers and patients from accidental needle sticks after the injection.
Slovenian: Ščitnik igle je namenjen za zaščito zdravstvenih delavcev, negovalcev in bolnikov pred naključnimi vbodi po injiciranju.
English: Ziextenzo therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Slovenian: Zdravljenje z zdravilom Ziextenzo morajo uvesti in nadzorovati zdravniki, izkušeni v onkologiji in/ali hematologiji.
English: Do not use if the syringe is broken or activated.
Slovenian: Ne uporabite, če je injekcijska brizga poškodovana ali aktivirana.
English: What Ziextenzo is and what it is used for What you need to know before you use Ziextenzo How to use Ziextenzo
Slovenian: Kaj je zdravilo Ziextenzo in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ziextenzo Kako uporabljati zdravilo Ziextenzo
English: • Choose a different site each time you give yourself an injection.
Slovenian: • Vsakič ko si daste injekcijo, izberite drugo mesto.
English: You can press a cotton ball or gauze onto the injection site and hold it for 10 seconds.
Slovenian: Na mesto injiciranja lahko pritisnete vatiran tampon ali gazo in jo držite 10 sekund.
English: Common cases of leukocytosis (White Blood Count [WBC] > 100 x 109/L) have been reported (see section 4.4).
Slovenian: Pogosto so poročali o primerih levkocitoze (število belih krvničk > 100 x 109/l) (glejte poglavje 4.4).
English: In order to improve the traceability of granulocyte-colony stimulating factors (G-CSFs), the trade name of the administered product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti granulocitne kolonije spodbujajočih faktorjev (G-CSF) je treba v bolnikovi kartoteki jasno zabeležiti zaščiteno ime uporabljenega zdravila.
English: Do not use the pre-filled syringe if any other particulates and/or discolouration are observed.
Slovenian: Napolnjene brizge ne uporabite, če opazite katere koli druge delce in/ali obarvanje.
English: Contents of the pack and other information What Ziextenzo contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Ziextenzo
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Slovenian: • vnetje aorte (velike žile, ki prenaša kri od srca po telesu), glejte poglavje 2.
English: Rates of generation of antibodies against pegfilgrastim are generally low.
Slovenian: Stopnje nastajanja protiteles proti pegfilgrastimu so na splošno nizke.
English: Slowly release the plunger and allow the syringe needle guard to automatically cover the exposed needle.
Slovenian: Počasi sprostite bat in pustite, da ščitnik igle samodejno pokrije izpostavljeno iglo.
English: Ziextenzo left at room temperature for more than 120 hours should be discarded.
Slovenian: Zdravilo Ziextenzo, ki je bilo na sobni temperaturi več kot 120 ur, je treba zavreči.
English: Allow the pre-filled syringe to reach room temperature before injecting.
Slovenian: Pustite napolnjeno injekcijsko brizgo, da pred injiciranjem doseže sobno temperaturo.
English: There may be a small amount of blood at the injection site.
Slovenian: Na mestu injiciranja je lahko vidna majhna količina krvi.
English: If you use more Ziextenzo than you should
Slovenian: Če ste uporabili večji odmerek zdravila Ziextenzo, kot bi smeli
English: Other medicines and Ziextenzo
Slovenian: Druga zdravila in zdravilo Ziextenzo
English: You may see a small air bubble in the liquid.
Slovenian: V tekočini lahko vidite majhen mehurček zraka.
English: Keep the plunger pressed fully down while you hold the syringe in place for 5 seconds.
Slovenian: Bat držite v celoti pritisnjen, iglo pa držite na mestu 5 sekund.
English: If you develop or are likely to develop cancers of the blood, you should not use Ziextenzo, unless instructed by your doctor.
Slovenian: Če se vam bodo pojavili ali je verjetno, da se vam bodo pojavili krvni raki, ne smete uporabljati zdravila Ziextenzo, razen če vam to naroči zdravnik.
English: Pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Pegfilgrastima ni priporočljivo uporabljati med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: If leukocyte counts exceed 50 x 109/L after the expected nadir, this medicine should be discontinued immediately.
Slovenian: Če število levkocitov po pričakovanem najmanjšem številu preseže 50 x 109/l, je treba nemudoma prenehati z zdravljenjem s tem zdravilom.
English: Return the Ziextenzo pre-filled syringe and the package to your pharmacy.
Slovenian: Napolnjeno injekcijsko brizgo in paket vrnite v svojo lekarno.
English: You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
Slovenian: Uporabite lahko tudi spodnji del trebuha, ne smete pa uporabiti predela 5 centimetrov okrog popka.
English: • Alcohol swab.
Slovenian: • Alkoholni zloženec.
English: Pegfilgrastim has not been tested in pregnant women.
Slovenian: Pegfilgrastima pri nosečnicah niso preskusili.
English: If you are injecting yourself and have forgotten a dose of Ziextenzo, you should contact your doctor to discuss when you should inject the next dose.
Slovenian: Če ste si pozabili injicirati zdravilo Ziextenzo Če si zdravilo injicirate sami in ste pozabili uporabiti odmerek zdravila Ziextenzo, se morate posvetovati z zdravnikom, da se bosta dogovorila, kdaj si morate injicirati naslednji odmerek.
English: The safety and efficacy of pegfilgrastim in children has not yet been established.
Slovenian: Varnost in učinkovitost pegfilgrastimapri otrocih še nista bili dokazani.
English: What you need to know before you use Ziextenzo Do not use Ziextenzo
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Ziextenzo Ne uporabljajte zdravila Ziextenzo
English: Do not shake Ziextenzo vigorously as this may affect its activity.
Slovenian: Zdravila Ziextenzo ne smete močno stresati, ker to lahko vpliva na njegovo delovanje.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Slovenian: podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Push the needle all the way in to ensure that the medicine can be fully administered.
Slovenian: Iglo potisnite vse do konca, da zagotovite, da je zdravilo dano v celoti.
English: Ziextenzo is a biosimilar medicinal product.
Slovenian: Zdravilo Ziextenzo je podobno biološko zdravilo.
English: The safety and efficacy of pegfilgrastim for the mobilisation of blood progenitor cells in patients or healthy donors have not been adequately evaluated.
Slovenian: Varnosti in učinkovitosti pegfilgrastima za mobilizacijo matičnih krvotvornih celic pri bolnikih ali zdravih dajalcih niso primerno ovrednotili.
English: It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Slovenian: Pomembno je, da si zdravila ne poskušate injicirati sami, razen če vas je za to usposobil zdravnik, medicinska sestra ali farmacevt.
English: If a caregiver is giving you the injection, the outer upper arms may also be used.
Slovenian: Če vam da injekcijo negovalec, lahko uporabite tudi zunanji del nadlakti.
English: The injection site is the place on the body where you are going to use the pre-filled syringe.
Slovenian: Mesto injiciranja je mesto na telesu, na katerem boste napolnjeno brizgo uporabili.
English: ▼This medicinal product is subject to additional monitoring.
Slovenian: ▼Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: You can help by reporting any side effects you may get.
Slovenian: Tudi sami lahko prispevate k temu tako, da poročate o katerem koli neželenem učinku zdravila, ki bi se utegnil pojaviti.
English: Profile of median pegfilgrastim serum concentration and absolute neutrophil count (ANC) in chemotherapy treated patients after a single 6 mg injection
Slovenian: Profil mediane serumske koncentracije pegfilgrastima in absolutnega števila nevtrofilcev (ANC - 'absolute neutrophil count') pri bolnikih, zdravljenih s kemoterapijo, po eni sami 6-miligramski injekciji