FrancophonIA/ELRC3.0 huggingface dataset:
English: Theraloc was designated as an orphan medicinal product on 2 September 2004.
Slovenian: Zdravilo Theraloc je bilo dne 2. septembra 2004 določeno kot zdravilo sirota.
English: The CHMP was also concerned about the medicine's safety.
Slovenian: CHMP je prav tako izrazil zadržke glede varnosti zdravila.
English: Questions and answers on the withdrawal of the marketing application for Theraloc
Slovenian: VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom Theraloc
English: Theraloc was to be used when the glioma was ‘resistant' (it did not respond to other treatments) or ‘recurrent' (it had come back after previous treatment).
Slovenian: Zdravilo Theraloc naj bi se uporabljalo, ko je gliom „odporen“ (se ni odzival na druga zdravljenja) ali „ponavljajoč“ (se je ponovil po predhodnem zdravljenju).
English: The effects of Theraloc were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Theraloc so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: Theraloc was not compared with any other treatment.
Slovenian: Zdravila Theraloc niso primerjali z nobenim drugim zdravilom.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Theraloc?
Slovenian: Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Theraloc?
English: On 1 December 2008, Oncoscience AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Theraloc, for the treatment of children and adolescents with resistant or recurrent high-grade glioma.
Slovenian: Družba Oncoscience AG je dne 1. decembra 2008 je uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti svojo vlogo za dovoljenje za promet z zdravilom Theraloc, namenjenim za zdravljenje otrok in mladostnikov z odpornim ali ponavljajočim se gliomom visoke stopnje.
English: Theraloc was expected to be used to treat adolescents and children from the age of three years with high-grade glioma.
Slovenian: Zdravilo Theraloc naj bi se uporabljalo za zdravljenje mladostnikov in otrok od tretjega leta starosti z gliomom visoke stopnje.
English: The application was at day 173 when the company withdrew.
Slovenian: Družba je vlogo umaknila na 173. dan postopka.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Slovenian: Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je bilo oblikovano tako, da prepozna in se veže na specifièno strukturo (imenovano antigen), ki se nahaja na določenih celicah v telesu.
English: Theraloc has been studied in one main study involving 47 children and adolescents with glioma who had no treatments available that could cure their disease.
Slovenian: Zdravilo Theraloc so raziskali v eni glavni študiji, ki je vključevala 47 otrok in mladostnikov z gliomom, pri katerih zdravila, ki bi lahko ozdravila njihovo bolezen, niso bila na voljo.
English: Glioma is a type of brain tumour that begins in ‘glial' cells (the cells that surround and support nerve cells).
Slovenian: Gliom je oblika možganskega tumorja, ki se začne v glialnih celicah (celicah, ki obdajajo in podpirajo živčne celice).
English: Following the CHMP's opinion, it usually takes around two months for the European Commission to grant a licence.
Slovenian: Potem ko CHMP poda svoje mnenje, Evropska komisija v približno dveh mesecih izda dovoljenje.
English: A patient was classified as a responder if the tumours disappeared, shrank or stayed the same size.
Slovenian: Bolnika so uvrstili med odzivne, če so tumorji izginili, se zmanjšali ali ostali nespremenjeni.
English: What is Theraloc?
Slovenian: Kaj je zdravilo Theraloc?
English: No information was provided on whether the body would produce antibodies against the medicine and there was a high rate of serious side effects.
Slovenian: Podatki o tem, ali bi telo proizvedlo protitelesa proti zdravilu, niso bili na voljo, poleg tega pa so zabeležili visoko stopnjo resnih neželenih učinkov.
English: Nimotuzumab binds to an antigen called epidermal growth factor receptor (EGFR), a protein that can be found on the surface of certain tumour cells.
Slovenian: Nimotuzumab se veže na antigen, imenovan receptor za epidermalni rastni faktor (EGFR), beljakovino, ki se nahaja na površini nekaterih tumorskih celic.
English: The Committee had concerns that the benefits of Theraloc had not been demonstrated, because the main study did not show a benefit in terms of survival and none of the patients treated with Theraloc showed a complete disappearance of the tumours.
Slovenian: Odbor je menil, da koristi zdravila Theraloc niso bile dokazane, saj glavna študija ni pokazala koristi v smislu preživetja in pri nobenem bolniku, zdravljenim z zdravilom Theraloc, ni tumor v celoti izginil.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Theraloc could not have been approved for the treatment of children and adolescents with recurrent high-grade glioma.
Slovenian: Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Theraloc ni mogoče odobriti za zdravljenje otrok in mladostnikov s ponavljajočim gliomom visoke stopnje.
English: Theraloc is a concentrate that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Theraloc je koncentrat, ki se pripravi v raztopino za infundiranje (vnašanje po kapljicah v veno).
English: The active substance in Theraloc, nimotuzumab, is a monoclonal antibody.
Slovenian: Zdravilna učinkovina zdravila Theraloc, nimotuzumab, je monoklonsko protitelo.
English: What was Theraloc expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Theraloc uporabljalo?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials or compassionate use programmes with Theraloc.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Theraloc.
English: When activated, EGFR helps the tumour cells grow, multiply and spread.
Slovenian: Ko je receptor za epidermalni rastni faktor aktiviran, pomaga pri rasti, razmnoževanju in širjenju tumorskih celic.
English: How is Theraloc expected to work?
Slovenian: Kako naj bi zdravilo Theraloc delovalo?
English: The CHMP was concerned that the company had not supplied sufficient evidence to demonstrate that Theraloc could be made in a reliable manner, and that insufficient information was provided on the way the product was treated by the body.
Slovenian: CHMP je bil izrazil zaskrbljenost, da družba ni predložila zadostnih dokazov glede zanesljivosti priprave zdravila Theraloc in da so podatki o presnovi zdravila v telesu nezadostni.
English: It contains the active substance nimotuzumab.
Slovenian: Vsebuje zdravilno učinkovino nimotuzumab.
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Theraloc had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Slovenian: CHMP je v času umika menil, da koristi zdravila Theraloc niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
English: By blocking EGFR, nimotuzumab was expected to slow down the progression of glioma.
Slovenian: Pričakovali so, da bo nimotuzumab z zaviranjem receptorjev za epidermalni rastni faktor upoèasnil napredovanje glioma.
English: Uferstrasse 15
Slovenian: Uferstraße 15
English: (Study 070701)
Slovenian: (študija 070701)
English: Do not infuse any faster than 4 mL per minute.
Slovenian: Ne infundirajte hitreje kot 4 ml na minuto.
English: Filtration does not influence dosage calculations.
Slovenian: Filtracija ne vpliva na izračune odmerka.
English: 2304 Orth an der Donau AUSTRIA
Slovenian: 2304 Orth an der Donau AVSTRIJA
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.
Slovenian: Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za obdobje 3 ur pri temperaturi 25 °C.
English: In all three studies, subjects were evaluated in the non-bleeding state.
Slovenian: V vseh treh študijah so bili preiskovanci ocenjeni v stanju brez krvavitve.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
Slovenian: Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
English: ATC code: B02BD10
Slovenian: Oznaka ATC: B02BD10
English: In patients with the disease the blood does not clot normally leading to a prolonged bleeding time.
Slovenian: Pri bolnikih z boleznijo se kri ne strjuje normalno, kar vodi do podaljšanega časa krvavitve.
English: This will be checked by your doctor.
Slovenian: Zdravnik bo stanje preveril.
English: It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.
Slovenian: Uporablja se, če zdravljenje z drugim zdravilom, dezmopresinom, ni učinkovito ali ne pride v poštev
English: If such inhibitors occur, the condition may manifest itself as an inadequate clinical response.
Slovenian: Če se pojavijo taki inhibitorji, se bo stanje lahko pokazalo kot nezadosten klinični odziv.
English: Neutralizing antibodies (Inhibitors)
Slovenian: Nevtralizirajoča protitelesa (inhibitorji)
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Slovenian: Ker je o teh reakcijah prostovoljno poročala populacija neznane velikosti, ni vedno mogoče zanesljivo oceniti pogostosti ali določiti vzorčne povezave z izpostavitvijo zdravilu.
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: Kategorije pogostnosti so bile opredeljene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Start of treatment
Slovenian: Začetek zdravljenja
English: Within each frequency grouping, undesirable effects are presented in the order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
English: Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment.
Slovenian: Hudi simptomi, med katere sodijo težave z dihanjem in omotica, zahtevajo takojšnje nujno medicinsko zdravljenje.
English: In general, the frequency of VEYVONDI dosing for post-operative substitution should range from twice a day to every 48 hours.
Slovenian: Na splošno mora biti pogostnost odmerjanja zdravila VEYVONDI za pooperativno nadomeščanje od dvakrat na dan do na vsakih 48 ur.
English: These could be early symptoms of a hypersensitivity reaction.
Slovenian: To so lahko zgodnji simptomi preobčutljivostne reakcije.
English: Clb IR at Cmax c
Slovenian: IR pri Cmax c
English: Your doctor may adjust the dose according to your laboratory results.
Slovenian: Zdravnik vam bo morda glede na rezultate laboratorijskih preiskav prilagodil odmerek.
English: FVIII products may contain varying amounts of VWF.
Slovenian: Zdravila s FVIII lahko vsebujejo različne količine VWF.
English: The rate of administration should be slow enough to ensure the comfort of the patient, up to a maximum of 4 mL/min.
Slovenian: Hitrost dajanja mora biti dovolj počasna, da zagotavlja ugodje bolnika, znašati pa sme do največ 4 ml/min.
English: Doing so may harm medicine.
Slovenian: S tem lahko škodujete zdravilu.
English: Do not dispose of these supplies in ordinary household trash.
Slovenian: Teh pripomočkov ne odvrzite med običajne gospodinjske odpadke.
English: Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel SWITZERLAND
Slovenian: Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel ŠVICA
English: - This medicine is for single use only.
Slovenian: - To zdravilo je samo za enkratno uporabo.
English: Your doctor will calculate your dose of VEYVONDI (in international units or IU).
Slovenian: Zdravnik bo izračunal vaš odmerek zdravila VEYVONDI (v mednarodnih enotah ali i.e.).
English: EXP: Use immediately or within 3 hours after reconstitution.
Slovenian: EXP: Zdravilo uporabite nemudoma oziroma najpozneje v 3 urah po rekonstituciji.
English: Detailed instructions for reconstitution and admnistration are given at the end of this package leaflet.
Slovenian: Podrobna navodila za rekonstitucijo in uporabo so navedena na koncu tega navodila za uporabo.
English: If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VEYVONDI and provide appropriate supportive care.
Slovenian: Če se pojavijo znaki in simptomi hudih alergijskih reakcij, nemudoma prekinite dajanje zdravila VEYVONDI in zagotovite ustrezno podporno oskrbo.
English: Known allergic reaction to mouse or hamster proteins.
Slovenian: Dokazana alergijska reakcija na beljakovine miši ali hrčka.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben armakovigilančni ali povezan z zmanjševanjem tveganja).
English: Wash your hands and put on clean exam gloves (the use of gloves is optional).
Slovenian: Umijte si roke in si nadenite čiste rokavice za enkratno uporabo (uporaba rokavic je neobvezna).
English: Therefore, patients experiencing hypersensitivity or anaphylactic reactions should be tested and evaluated for the presence of an inhibitor.
Slovenian: Zato je treba bolnike s preobčutljivostno ali anafilaktično reakcijo pregledati in oceniti glede navzočnosti inhibitorja.
English: If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use.
Slovenian: Če uporabljate zdravilo VEYVONDI doma, bo zdravnik poskrbel, da boste poučeni, kako zdravilo infundirati in koliko ga morate uporabiti.
English: In the 2 spontaneous post-marketing cases reported, the symptoms resolved and the patients fully recovered in 20 minutes to 4 hours upon stopping the infusion.
Slovenian: V dveh spontanih primerih po začetku trženja so simptomi izginili, bolnika pa sta si povsem opomogla po 20 minutah oziroma po 4 urah po prekinitvi infundiranja.
English: Therefore, patients at risk have to be monitored for early signs of thrombosis, and prophylaxis measures against thromboembolism should be instituted according to current recommendations and standard of care.
Slovenian: Zato je treba bolnike s tveganjem spremljati za zgodnje znake tromboze in uvesti preventivne ukrepe proti trombemboliji v skladu z veljavnimi priporočili in standardom oskrbe.
English: 13 If you need more than one vial of VEYVONDI to make up your dose:
Slovenian: 13 Če potrebujete več kot eno vialo zdravila VEYVONDI za vaš odmerek:
English: You will be monitored carefully for the possibility of having developed these inhibitors.
Slovenian: Zato vas bodo skrbno spremljali glede nastanka teh zaviralcev.
English: Subsequent infusions:
Slovenian: Naslednje infuzije:
English: Patients treated with this product may develop hypersensitivity reactions to these non-human mammalian proteins.
Slovenian: Pri bolnikih, ki se zdravijo s tem zdravilom, se lahko pojavijo preobčutljivostne reakcije na te beljakovine sesalcev ne-humanega izvora.
English: Dosing guidance should be done based on the IR.
Slovenian: Navodila za odmerjanje morajo temeljiti na IR.
English: • Leave the syringe attached to the vial until an additional vial is prepared.
Slovenian: • Brizgo pustite na viali, dokler ne pripravite dodatne viale.
English: Adverse Reaction by Preferred Term (PT)
Slovenian: Neželeni učinki po prednostnih izrazih (PT)
English: Disconnect the empty syringe.
Slovenian: Odstranite prazno brizgo.
English: The clinical safety, efficacy and PK data were assessed in 3 completed trials, (070701, 071001 and 071101) which enrolled patients with VWD.
Slovenian: Podatke o klinični varnosti, učinkovitosti in farmakokinetiki so ocenili v 3 zaključenih preskušanjih (070701, 071001 in 071101), v katerih so bili vključeni bolniki z VWB.
English: There is a low risk that you may experience a hypersensitivity reaction (a severe, sudden allergic reaction) to VEYVONDI.
Slovenian: Obstaja majhno tveganje, da bi lahko pri vas nastopila preobčutljivostna reakcija (huda, nenadna alergijska reakcija) na zdravilo VEYVONDI.
English: In case large volumes of VEYVONDI are required, it is possible to pool two vials of VEYVONDI together.
Slovenian: Če so potrebne velike količine zdravila VEYVONDI, je mogoče združiti dve viali zdravila VEYVONDI.
English: Lack of VWF increases the tendency to bleed.
Slovenian: Pomanjkanje VWF povzroči nagnjenost h krvavitvam.
English: Image example
Slovenian: Slikovni primer
English: The amount of air should equal the amount of reconstituted VEYVONDI that you will withdraw from the vial.
Slovenian: Količina zraka mora biti enaka količini rekonstituiranega zdravila VEYVONDI, ki jo boste odvzeli iz viale.
English: Healthcare professionals should balance the potential risks and only prescribe VEYVONDI if needed
Slovenian: Zdravnik mora presoditi morebitna tveganja in predpisati zdravilo VEYVONDI le po potrebi.
English: Table 5 Pharmacokinetic Assessment of VWF:RCo f
Slovenian: Preglednica 5 Farmakokinetična ocena VWF:RCo f
English: Experience in the treatment of pregnant or breast-feeding women is not available.
Slovenian: Izkušenj z zdravljenjem pri nosečnicah ali doječih materah ni.
English: VEYVONDI should not be used in the treatment of Haemophilia A.
Slovenian: Zdravilo VEYVONDI se ne sme uporabljati pri zdravljenju hemofilije A.
English: 14 The contents of two vials may be drawn into a single syringe.
Slovenian: 14 Vsebino dveh vial lahko povlečete v eno brizgo.
English: You can have an allergic reaction to VEYVONDI.
Slovenian: Lahko imate alergijsko reakcijo na zdravilo VEYVONDI.
English: Use the reconstituted product (after mixing the powder with the supplied water) as soon as possible and within three hours.
Slovenian: Rekonstituirano zdravilo (po mešanju praška s priloženo vodo) porabite čimprej, najkasneje v treh urah.
English: It is manufactured by recombinant DNA (rDNA) technology in the Chinese Hamster Ovary (CHO) cell line without the addition of any exogenous human-or animal-derived protein in the cell culture process, purification or final formulation.
Slovenian: Izdelan je s tehnologijo rekombinantne DNA (rDNA) v celični liniji jajčnika kitajskega hrčka (CHO) brez dodajanja eksogenih človeških ali živalskih beljakovin pri postopku celične kulture, prečiščevanja ali končne priprave.
English: The safety and efficacy of VEYVONDI in children aged 0 to 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila VEYVONDI pri otrocih, starih od 0 do 18 let, še nista bili dokazani.
English: This should be taken into consideration if you are on a controlled sodium diet.
Slovenian: To je treba upoštevati, če ste na dieti z nadzorovanim vnosom natrija.
English: VEYVONDI is usually infused into a vein (intravenously) by your doctor or nurse.
Slovenian: Zdravilo VEYVONDI vam običajno v veno (intravensko) infundira zdravnik ali medicinska sestra.
English: It is strongly recommended that every time that VEYVONDI is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Slovenian: Zelo priporočljivo je, da se vsakič, ko bolnik prejme zdravilo VEYVONDI, zabeležita ime in serijska številka zdravila, da se ohrani povezava med bolnikom in serijo zdravila.
English: Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.
Slovenian: Zdravnik bo izračunal odmerek zdravila VEYVONDI, ki je najbolj primeren za vas, kako pogosto in kako dolgo ga morate prejemati.
English: VEYVONDI is a rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process.
Slovenian: Zdravilo VEYVONDI je faktor rVWF, ki poleg vseh multimerov v plazmi vsebuje zelo velike multimere, saj med izdelavo ni izpostavljen proteolizi z ADAMTS13.
English: A bleed could be considered major if red blood cell transfusion is either required or potentially indicated or if bleeding occurs in a critical anatomical site (e.g., intracranial or gastrointestinal haemorrhage).
Slovenian: Krvavitev se lahko šteje za večjo, če je transfuzija rdečih krvnih celic potrebna ali potencialno indicirana ali če se krvavitev pojavi na kritičnem anatomskem mestu (npr. krvavitev v glavi ali prebavilih).
English: In major bleeding episodes, maintain trough levels of VWF:RCo greater than 50% for as long as deemed necessary.
Slovenian: Pri večjih krvavitvah vzdržujte najnižje ravni VWF:RCo višje od 50 % toliko časa, kolikor je to potrebno.
English: Sustained increase of FVIII:C was observed by six hours after a single infusion of VEYVONDI.
Slovenian: Trajno zvišanje ravni FVIII:C so opazili šest ur po enkratni infuziji zdravila VEYVONDI.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravila ne uporabite takoj, je za čas shranjevanja zdravila v odprti embalaži in pogoje pred uporabo odgovoren uporabnik, pri čemer naj čas shranjevanja ne bi bil daljši od 24 ur pri temperaturi od 2 do 8 °C, razen če je bila rekonstitucija opravljena v nadzorovanih in validiranih aseptičnih pogojih.
English: Place the vials on a flat surface.
Slovenian: Viali položite na ravno površino.
English: The complete dose of VEYVONDI should be administered followed by rFVIII within 10 minutes.
Slovenian: Treba je dati celoten odmerek zdravila VEYVONDI, ki mu v 10 minutah sledi rFVIII.
English: Based on experience from clinical studies, once VWF has been replaced, endogenous FVIII levels will remain normal or near normal as long as VEYVONDI is continued to be administered.
Slovenian: Na podlagi izkušenj iz kliničnih študij ravni endogenega FVIII po nadomestitvi VWF ostanejo normalne ali skoraj normalne, dokler dajemo zdravilo VEYVONDI.
English: Von Willebrand disease is an inherited bleeding disorder caused by the lack or an insufficient amount of von Willebrand factor.
Slovenian: Von Willebrandova bolezen je prirojena motnja strjevanja krvi, ki jo povzroča pomanjkanje ali nezadostna količina von Willebrandovega faktorja.
English: If flakes or particles are seen, do not use the solution and notify your doctor.
Slovenian: Če opazite kosmiče ali delce, ne uporabljajte raztopine in obvestite svojega zdravnika.