FrancophonIA/ELRC3.0 huggingface dataset:
English: On 18 March 2009, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ixempra, for the treatment of locally advanced or metastatic breast cancer.
Slovenian: Družba Bristol-Myers Squibb Pharma EEIG je dne 18. marca 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Ixempra, namenjenim zdravljenju lokalno napredovalega ali metastatskega raka dojke.
English: Ixempra has been studied in three main studies involving women with locally advanced or metastatic breast cancer who had been treated with a number of other anticancer medicines in the past.
Slovenian: Zdravilo Ixempra je bilo raziskano v treh glavnih študijah, v katere so bile vključene ženske z lokalno napredovalim ali metastatskim rakom dojke, ki so bile v preteklosti zdravljene s številnimi drugimi zdravili proti raku.
English: Ixabepilone is expected to block the ability of cells to modify the internal ‘skeleton' that they need to divide and multiply.
Slovenian: Iksabepilon naj bi zavrl sposobnost celic, da spremenijo svoje notranje „ogrodje“, kar je pogoj za njihovo delitev in množenje.
English: Ixempra was expected to be used to treat breast cancer that is locally advanced or metastatic (when the tumour is large or has begun to spread within the body).
Slovenian: Zdravilo Ixempra naj bi se uporabljalo za zdravljenje raka dojke, ki je lokalno napredoval ali metastaziral (ko je tumor velik ali se je začel širiti po telesu).
English: The first study looked at Ixempra given on its own in 128 women, but did not compare it with any other treatment.
Slovenian: V prvi študiji so pri 128 ženskah raziskovali zdravilo Ixempra, prejetega samostojno, vendar ga niso primerjali z nobeno drugo obliko zdravljenja.
English: It was to be available as a powder and a solvent to be made up into a solution for infusion (drip into a vein).
Slovenian: Na voljo naj bi bil v obliki praška in topila za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: The CHMP had given a negative opinion and did not recommend a marketing authorisation for Ixempra for the treatment of locally advanced or metastatic breast cancer.
Slovenian: CHMP je izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Ixempra, namenjenim zdravljenju lokalno napredovalega ali metastatskega raka dojke.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Ixempra and that patients receiving Ixempra as part of a compassionate use programme will continue to receive the medicine.
Slovenian: Družba je obvestila CHMP, da umik nima nobenih posledic za bolnice, ki trenutno sodelujejo v kliničnih preskušanjih z zdravilom Ixempra, in da bodo bolnice, ki prejemajo zdravilo Ixempra v programih sočutne uporabe, zdravilo še naprej prejemale.
English: The active substance in Ixempra, ixabepilone, is a cytotoxic medicine that belongs to a group of medicines called the ‘epothilones'.
Slovenian: Zdravilna učinkovina v zdravilu Ixempra, iksabepilon, je citotoksično zdravilo, ki pripada skupini zdravil, imenovani „epotiloni“.
English: Ixempra is a medicine that contains the active substance ixabepilone.
Slovenian: Ixempra je zdravilo, ki vsebuje zdravilno učinkovino iksabepilon.
English: What is Ixempra?
Slovenian: Kaj je zdravilo Ixempra?
English: The CHMP was concerned that Ixempra's benefits in terms of increasing the time until the cancer got worse did not outweigh the concerns over the medicine's safety.
Slovenian: CHMP je imel glede koristi zdravila Ixempra zadržke, da podaljšanje časa do poslabšanja raka ne odtehta zadržkov glede varnosti zdravila.
English: The other two studies compared the effects of capecitabine given on its own with the effects of Ixempra given in combination with capecitabine in a total of 1,973 women.
Slovenian: V drugih dveh študijah so pri skupno 1 973 ženskah primerjali učinke kapecitabina, prejetega samostojno, z učinki zdravila Ixempra, prejetega v kombinaciji s kapecitabinom.
English: What was Ixempra expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ixempra uporabljalo?
English: How is Ixempra expected to work?
Slovenian: Kako naj bi zdravilo Ixempra delovalo?
English: Therefore, at the time of the withdrawal, the CHMP's view was that the benefits of Ixempra in the treatment of breast cancer did not outweigh the identified risks.
Slovenian: CHMP je v času umika menil, da koristi zdravila Ixempra pri zdravljenju raka dojke ne odtehtajo znanih tveganj.
English: This dose might be repeated if needed.
Slovenian: Ta odmerek se lahko po potrebi ponovi.
English: Homogenous white suspension after resuspension.
Slovenian: Homogena bela suspenzija po re-suspendiranju.
English: Date of latest renewal: 12 June 2008
Slovenian: Datum zadnjega podaljšanja: 12. junija 2008
English: Warning: Never use any other type of route but the open flow connection.
Slovenian: Opozorilo: Nikoli ne uporabljajte katere koli druge poti razen povezave z direktnim pretokom.
English: Not known*
Slovenian: neznana*
English: Do not inject air into the vial.
Slovenian: Ne vbrizgavajte zraka v vialo.
English: This leaflet is available in all EU/EEA languages on the European Agency website.
Slovenian: To navodilo za uporabo je na voljo v vseh uradnih jezikih EU/EGP na spletni strani Evropske agencije za zdravila.
English: Other routes of administration not specified in section 4.2 above (e.g. intracoronary injection) are not recommended.
Slovenian: Druge poti uporabe, ki niso navedene zgoraj, v poglavju 4.2 (npr. intrakoronarno injiciranje), niso priporočljive.
English: Vials are intended for single use only.
Slovenian: Viale so namenjene samo za enkratno uporabo.
English: * Reactions for which no frequency rate can be provided due to lack of clinical trial data have been classified as “Not known”.
Slovenian: * Reakcije, za katere pogostnost ni na voljo zaradi pomanjkanja podatkov iz kliničnih preskušanj, so bile razvrščene kot “neznana”.
English: The primary route of elimination of radioactivity was the urine.
Slovenian: Glavna pot izločanja radioaktivnosti je izločanje z urinom.
English: - Any pressure instability within the vial should be avoided since it may cause disruption of microspheres and loss of contrast effect.
Slovenian: - Kakršni koli nestabilnosti tlaka v viali se je treba izogibati, ker lahko povzroči predrtje mikrosfer in izgubo kontrastnega učinka.
English: Storage at room temperature (up to 25°C) for 1 day is acceptable.
Slovenian: Shranjevanje pri sobni temperaturi (do 25 ºC) za 1 dan je sprejemljivo.
English: A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious reaction should occur.
Slovenian: Postopek ukrepanja naj bo izdelan vnaprej in na voljo naj bodo potrebna zdravila ter oprema za takojšnje zdravljenje, v primeru pojava hude reakcije.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno dostopni podatki so opisani v poglavju 5.1, vendar priporočil o odmerjanju kontrastnega sredstva ni mogoče dati.
English: Use during anaesthesia with halothane and oxygen has not been studied.
Slovenian: Uporabe med anestezijo s halotanom in kisikom niso proučevali.
English: However, because OPTISON is based on human albumin (the main protein in our blood), it is highly unlikely that it will have any harmful effects in pregnancy.
Slovenian: Ker pa je osnova kontrastnega sredstva OPTISON humani albumin (glavna beljakovina v naši krvi), skoraj ni verjetno, da bi imelo kakršne koli škodljive učinke na nosečnost.
English: Higher doses produce greater contrast effect of longer duration.
Slovenian: Večji odmerki povzročijo večji kontrastni učinek z daljšim trajanjem.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 May 1998
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJ ZA PROMET Z ZDRAVILOM Datum pridobitve dovoljenja za promet: 18. maja 1998
English: Unopened vial in the outer packaging: 2 years.
Slovenian: Neodprta viala v zunanji ovojnini: 2 leti.
English: Resuspend before use.
Slovenian: Pred uporabo resuspendirajte.
English: The disposition and elimination of the albumin microspheres have not been studied in humans.
Slovenian: Razporeditev in izločanje mikrosfer albumina pri človeku niso proučevali.
English: Care should therefore be exercised.
Slovenian: Zato je potrebna previdnost.
English: - Use the suspension within 30 minutes after withdrawal.
Slovenian: - Suspenzijo uporabite v največ 30 minutah po tem, ko ste jo odvzeli.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c (7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Before administering OPTISON, please see section 6.6 for instructions for use/handling.
Slovenian: Pred dajanjem kontrastnega sredstva OPTISON, preberite poglavje 6.6 za navodila za pripravo in ravnanje.
English: In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse events.
Slovenian: V preskušanju I. faze so zdravi prostovoljci prejemali odmerke do 44,0 ml kontrastnega sredstva OPTISON in niso doživeli nobenih pomembnih neželenih dogodkov.
English: The perflutren levels detected in blood following this dosage were too low and transient to accurately determine pharmacokinetic parameters.
Slovenian: Izmerjene ravni perflutrena v krvi po teh odmerkih so bile premajhne in prehodne, da bi lahko natančno določili farmakokinetične parametre.
English: Duration of useful contrast effect at the recommended dose is adequate to perform a complete echocardiographic examination including Doppler assessment.
Slovenian: Trajanje uporabnega kontrastnega učinka pri priporočenem odmerku zadostuje za izvedbo kompletne ehokardiografske preiskave, vključno z Dopplerjevo oceno.
English: Although these biological side effects have not been reported in humans, the use of a low mechanical index and enddiastolic triggering is recommended.
Slovenian: Čeprav o teh bioloških neželenih učinkih niso poročali pri človeku, je priporočljiva uporaba nizkega mehanskega indeksa in proženje na koncu diastole.
English: You can also report side effects directly via the national reporting system.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje.
English: OPTISON must not be mixed with other medicinal products.
Slovenian: Kontrastnega sredstva OPTISON se ne sme mešati z drugimi zdravili.
English: Hypersensitivity has been reported.
Slovenian: Poročali so o preobčutljivosti.
English: Unknown frequency (side effects where frequency cannot be estimated from the available data):
Slovenian: Neznana pogostnost (neželeni učinki, katerih pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
English: A dose of 3.0 ml is usually sufficient, but some patients may need higher doses.
Slovenian: Običajno zadošča odmerek 3,0 ml, vendar nekateri bolniki lahko potrebujejo večje odmerke.
English: The total dose should not exceed 8.7 ml per patient.
Slovenian: Skupni odmerek na bolnika ne sme preseči 8,7 ml.
English: The following instructions should be followed: - Cold solutions taken directly from the refrigerator should not be injected.
Slovenian: Upoštevajte naslednja navodila: - Hladnih raztopin, vzetih direktno iz hladilnika, ne smete injicirati.
English: The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with subsequent full recovery.
Slovenian: Neželeni učinki po uporabi kontrastnega sredstva OPTISON v III. fazi kliničnih študij pri ljudeh so bili blagi do zmerni s kasnejšim popolnim okrevanjem.
English: - Insert a 20 G plastic cannula in a large antecubital vein, preferably of the right arm.
Slovenian: - Vstavite 20 G plastično kanilo v veliko antekubitalno veno, po možnosti desne roke.
English: PHARMACEUTICAL FORM Dispersion for injection.
Slovenian: FARMACEVTSKA OBLIKA Disperzija za injiciranje.
English: OPTISON could be repeatedly administered, however, the clinical experience is limited.
Slovenian: OPTISON se lahko uporablja večkrat, vendar so klinične izkušnje omejene.
English: What OPTISON is and what it is used for What you need to know before you use OPTISON How to use OPTISON
Slovenian: Kaj je kontrastno sredstvo OPTISON in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili kontrastno sredstvo OPTISON Kako uporabljati kontrastno sredstvo OPTISON
English: Systemic haemodynamic parameters and ECGs were also evaluated.
Slovenian: Prav tako je potekalo ocenjevanje sistemskih hemodinamskih parametrov in EKG
English: - Complete resuspension is indicated by a uniformly opaque white suspension and absence of any material on stopper and vial surfaces.
Slovenian: - Popolno resuspendiranje označuje enakomerno bela motna suspenzija in odsotnost kakršne koli snovi na površini zamaška in viale.
English: Low mechanical index was used for ultrasound imaging.
Slovenian: Za ultrazvočno slikanje je bil uporabljen nizek mehanični indeks.
English: As a consequence of the complex relationship between the concentration of the microspheres and the ultrasound signal, data processing within the ultrasound equipment and the fact that each individual responds differently due to variability in cardiac and pulmonary function, a strict dose/response relationship cannot be defined.
Slovenian: Zaradi kompleksnosti povezave med koncentracijo mikrosfer in ultrazvočnega signala, obdelave podatkov v opremi za ultrazvočno slikanje in dejstva, da se vsak posameznik odzove drugače zaradi variabilnosti delovanja srca in pljuč, natančnega razmerja med odmerkom/in odzivom ni mogoče določiti.
English: (cannot be estimated from the available data).
Slovenian: neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: This also applies to any unknown or emerging viruses or other types of infections.
Slovenian: To velja tudi za vse znane ali nove viruse in druge vrste okužb.
English: This study did not assess the effect of OPTISON on visualisation of cardiac or pulmonary structures.
Slovenian: V študiji se ni ocenjevalo učinka zdravila OPTISON na vizualni prikaz srčnih ali pljučnih struktur.
English: - Resuspend the microspheres in the syringe immediately before injection by holding the syringe horizontally between the palms of the hands and rolling it quickly back and forth for no less than 10 seconds.
Slovenian: - Mikrosfere resuspendirajte v brizgi tik pred injiciranjem tako, da držite brizgo vodoravno med dlanmi in jih hitro obračate naprej in nazaj najmanj 10 sekund.
English: High levels of radioactivity were also retained in lungs for a considerable time, approx. 10% of the total dose 40 minutes after dose administration (cf. 35% in liver).
Slovenian: Visoke ravni radioaktivnosti so se tudi precej dolgo zadrževale v pljučih, približno 10 % celokupnega odmerka še 40 minut po dajanju odmerka (oziroma 35 % v jetrih).
English: OPTISON should be used in these categories of patients only after careful consideration and monitored closely during and after administration.
Slovenian: teh skupinah bolnikov smemo uporabljati kontrastno sredstvo OPTISON samo po skrbnem premisleku in ob stalnem nadzoru med in po dajanju.
English: - if you have severe pulmonary hypertension (systolic pulmonary artery pressure > 90 mm Hg).
Slovenian: - če imate hudo pljučno hipertenzijo (sistolični pljučni arterijski tlak > 90 mm Hg).
English: Therefore, the medicine should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the doctor.
Slovenian: Zato se kontrastno sredstvo ne sme uporabljati v nosečnosti, razen če je korist večja od tveganja in je po presoji zdravnika uporaba nujna.
English: Microspheres in this size range contribute to the contrast effect by generating strongly enhanced echoes.
Slovenian: Mikrosfere tega razpona velikosti prispevajo h kontrastnemu učinku s tvorbo močno ojačanih odbojev.
English: The dose of OPTISON will therefore have to be adjusted individually, although clinical studies have shown that an initial dose of 0.5 - 3.0 ml per patient can be recommended for left heart opacification.
Slovenian: Zato je treba odmerek kontrastnega sredstva OPTISON individualno prilagajati, čeprav so klinične študije pokazale, da lahko za opacifikacijo levega srca priporočimo začetni odmerek 0,5 do 3,0 ml na bolnika.
English: - Inject the suspension through the plastic cannula, no smaller than 20 G at a maximum injection rate of 1.0 ml/s.
Slovenian: - Injicirajte suspenzijo skozi plastično kanilo, ki ni manjša od 20 G, pri maksimalni hitrosti injiciranja 1,0 ml/s.
English: How to use OPTISON
Slovenian: Kako uporabljati kontrastno sredstvo OPTISON
English: Finished product after rubber stopper perforation: 30 minutes.
Slovenian: Pripravljeno kontrastno sredstvo po predrtju gumijastega zamaška: 30 minut.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Slovenian: Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, ki so bili pripravljeni iz človeške krvi ali plazme, so med drugim izbor darovalcev, pregled posameznih darovanj in zbirov plazme na specifične markerje okužbe ter vključitev učinkovitih postopkov za inaktivacijo/odstranitev virusov.
English: Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: Izdelovalci teh zdravil pri obdelovanju krvi ali plazme prav tako vključujejo postopke, ki lahko inaktivirajo ali odstranijo viruse.
English: These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections.
Slovenian: Ti vključujejo skrben izbor darovalcev krvi in plazme, da se zagotovi izključitev prenašalcev okužb, ter preiskovanje vsake darovane enote in zbirov plazme za pokazatelje virusov/okužb.
English: Following intravenous injection of 0.21 to 0.33 ml/kg of OPTISON to healthy volunteers, the perflutren component of OPTISON was rapidly and nearly completely eliminated in less than 10 minutes with a dominating pulmonary elimination half-life of 1.3±0.7 minutes.
Slovenian: Po intravenski injekciji 0,21 do 0,33 ml/kg kontrastnega sredstva OPTISON zdravim prostovoljcem se perflutrenska sestavina kontrastnega sredstva OPTISON hitro in skoraj popolno izloči v manj kot 10 minutah, z vodilnim pljučnim eliminacijskim razpolovnim časom 1,3±0,7 minut.
English: Thus, vent the vial with a sterile spike or with a sterile 18 G needle before withdrawing the suspension into the injection syringe.
Slovenian: Tako v viali napravite luknjo s sterilno konico ali sterilno 18 G iglo, preden suspenzijo povlečete v injekcijsko brizgo.
English: In the rabbit embryotoxicity study, a significant increase in the number of foetuses with dilated ventricles in the brain was observed (see section 4.6).
Slovenian: V embriotoksikološki študiji na zajcih so opazili pomembno širjenje možganskih ventriklov pri številnih fetusih (glejte poglavje 4.6).
English: OPTISON contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Slovenian: Kontrastno sredstvo OPTISON vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Undesirable Effects
Slovenian: Neželeni učinki
English: Do not inject air into the vial as this will damage the product.
Slovenian: Ne injicirajte zraka v vialo, ker to poškoduje kontrastno sredstvo.
English: A separate syringe should be used.
Slovenian: Uporabljati je treba ločeno injekcijsko brizgo.
English: Reported side effects following the use of OPTISON:
Slovenian: Neželeni učinki, o katerih so poročali po uporabi kontrastnega sredstva OPTISON:
English: - The OPTISON vial must be inverted and gently rotated for approximately three minutes to completely resuspend the microspheres.
Slovenian: - Vialo kontrastnega sredstva OPTISON morate obrniti navzdol in nežno vrteti približno tri minute, da se mikrosfere popolnoma resuspendirajo.
English: OPTISON in the non-resuspended form has a white layer of microspheres on top of the liquid phase that requires resuspension before use.
Slovenian: Kontrastno sredstvo OPTISON ima v ne-resuspendirani obliki na vrhu tekoče faze belo plast mikrosfer, ki jih je treba pred uporabo resuspendirati.
English: Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/or recurrent thromboembolism, renal or hepatic end-stage disease.
Slovenian: Takšna klinična stanja vključujejo sindrom dihalne stiske pri odraslih, uporabo umetne ventilacije s pozitivnim tlakom na koncu izdiha, hudo srčno popuščanje (NYHA IV), endokarditis, akutni miokardni infarkt s trajajočo angino pektoris ali nestabilno angino pektoris, srce z umetnimi srčnimi zaklopkami, akutna stanja sistemskih vnetij ali sepsa, znana stanja hiperaktivnega koagulacijskega sistema in/ali rekurentni tromboembolizem, zadnja faza ledvične ali jetrne bolezni.
English: OPTISON improves the visualization of the inner cardiac walls in patients where the walls are difficult to see.
Slovenian: Kontrastno sredstvo OPTISON izboljša upodobitev notranjih sten srca pri bolnikih, pri katerih je te stene težje videti.
English: The experience of OPTISON in severely ill patients is limited.
Slovenian: Izkušnje s kontrastnim sredstvom OPTISON pri hudo bolnih bolnikih so omejene.
English: Rare severe allergic reactions (anaphylaxis) have been associated with the administration of human albumin products.
Slovenian: Redke hude alergijske reakcije (anafilaksija) so bile povezane z uporabo zdravil s humanimi albumini.
English: 3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with coloured plastic flip-off top.
Slovenian: 3-mililitrska viala iz stekla tipa I, zaprta z bromobutilnim gumijastim zamaškom, prevlečenim z aluminijasto kapico z barvnim plastičnim vrhom, ki se odtrga.
English: Once the rubber stopper has been penetrated, the contents should be used within 30 minutes and any unused product discarded.
Slovenian: Po predrtju gumijastega zamaška je treba vsebino uporabiti v največ 30 minutah in neuporabljeno kontrastno sredstvo zavreči.
English: Other medicines and OPTISON Tell your doctor if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: If you are given more OPTISON than you should Effects suspected to be due to overdose have not been reported.
Slovenian: O učinkih, za katere bi sumili, da so posledica prevelikega odmerjanja, niso poročali.
English: Like all medicines, OPTISON can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi kontrastno sredstvo OPTISON neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.