FrancophonIA/ELRC3.0 huggingface dataset:
English: 7) Screw the pipette clockwise into the luer lock connector of the vial adapter.
Slovenian: 7) Privijte pipeto v smeri urnega kazalca v priključek luer lock na nastavku za vialo.
English: - if you are taking any eye drops containing corticosteroids (e.g. to treat an ocular inflammation) or preservatives (e.g. benzalkonium chloride, polyquaternium-1, benzododecinium bromide, cetrimide).
Slovenian: - če imate rak očesa, saj bi lahko to zdravilo poslabšalo rak. - če jemljete katere koli kapljice za oko, ki vsebujejo kortikosteroide (npr. za zdravljenje vnetja očesa) ali konzervanse (npr. benzalkonijev klorid, polikvaternij-1, benzododecinijev bromid, cetrimid).
English: OXERVATE 20 µg/ml eye drops cenegermin
Slovenian: OXERVATE 20 mikrogramov/ml kapljice za oko, raztopina cenegermin
English: OXERVATE may cause mild to moderate eye discomfort, such as eye pain, to the patient.
Slovenian: Zdravilo OXERVATE lahko pri bolniku povzroči blago do zmerno neugodje v očesu, kot je bolečina v očesu.
English: The patient will receive a weekly carton containing 7 vials of OXERVATE.
Slovenian: Bolnik prejme tedensko škatlo s 7 vialami zdravila OXERVATE.
English: 3) Without removing the vial adapter from its blister pack, connect the vial adapter to the vial by firmly pushing the vial adapter down vertically until it snaps into place over the neck of the vial and the spike of the vial adapter pierces through the vial's rubber stopper.
Slovenian: 3) Ne da bi odstranili nastavek za vialo iz pretisnega omota, ga namestite na vialo, in sicer tako, da odločno potisnete nastavek za vialo naravnost navzdol, tako da zdrsne preko vratu viale, njegova konica pa predre gumijasti zamašek viale.
English: 11) Once it has been correctly filled, unscrew the pipette from the luer lock connector of the vial adapter.
Slovenian: 11) Ko je pipeta pravilno napolnjena, jo odvijte s priključka luer lock na nastavku za vialo.
English: • Screw the pipette (clockwise) into the connector part of the vial adapter (picture 5).
Slovenian: • Privijte pipeto v smeri urnega kazalca v priključek nastavka za vialo (slika 5).
English: INSTRUCTION ON USE
Slovenian: Navodilo za uporabo
English: Talk to your doctor if you are pregnant or think you may be pregnant.
Slovenian: Če ste noseči ali menite, da bi lahko bili noseči, se posvetujte z zdravnikom.
English: Once a vial is opened store below 25 °C or store in a refrigerator.
Slovenian: Po odprtju vialo shranjujte pri temperaturi do 25 °C ali pa jo shranjujte v hladilniku.
English: Ocular cancer
Slovenian: Rak očesa
English: OXERVATE contains the active ingredient cenegermin.
Slovenian: Zdravilo OXERVATE vsebuje učinkovino cenegermin.
English: Pull down your lower eyelid, folding between the inner eyelid and the eyeball.
Slovenian: Povlecite spodnjo veko navzdol, tako da boste razkrili gubo med notranjo stranjo veke in očesnim zrklom.
English: Hydrochloric acid
Slovenian: L-metionin voda za injekcije klorovodikova kislina natrijev hidroksid dušik
English: • Remove and discard the packaging of the vial adapter.
Slovenian: • Odstranite in zavrzite ovojnino nastavka za vialo.
English: OXERVATE 20 micrograms/ml eye drops, solution
Slovenian: IME ZDRAVILA OXERVATE 20 mikrogramov/ml kapljice za oko, raztopina
English: The spike of the vial adapter should pierce through the vial's rubber stopper.
Slovenian: Konica nastavka bi morala predreti gumijasti zamašek viale.
English: • inflammation of the eye;
Slovenian: • vnetje očesa,
English: Disodium hydrogen phosphate, anhydrous Sodium dihydrogen phosphate, dihydrate Hydroxypropylmethylcellulose Polyethylene glycol 6000
Slovenian: natrijev dihidrogenfosfat dihidrat, hidroksipropilmetilceluloza, polietilenglikol 6000,
English: • Once it has been correctly filled, unscrew the pipette from the connector part of the vial adapter.
Slovenian: • Ko je pipeta pravilno napolnjena, jo odvijte s priključka nastavka za vialo.
English: • Peel-off the back of the vial adapter blister pack (picture 2).
Slovenian: • Snemite folijo pretisnega omota nastavka za vialo (slika 2).
English: You will receive a new supply of OXERVATE each week, for the duration of the treatment period.
Slovenian: V obdobju zdravljenja boste vsak teden prejeli novo zalogo zdravila OXERVATE.
English: Best corrected distance visual acuity
Slovenian: Največja korigirana ostrina na daljavo zdravilo OXERVATE vehikel (vrednost p)
English: Special populations Elderly:
Slovenian: Starejši bolniki:
English: Your vision may be temporarily blurred immediately after using this medicine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Takoj po uporabi tega zdravila je vaš vid lahko začasno zamegljen.
English: Once the vial adapter has been connected correctly, it should not be removed from the vial (picture 3).
Slovenian: ga ne smete več odstraniti z viale (slika 3).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL - MULTI-DOSE VIAL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: A new OXERVATE supply will be issued each week for the duration of the treatment period.
Slovenian: V obdobju zdravljenja bo bolnik vsak teden prejel novo zalogo zdravila OXERVATE.
English: Use only with the vial adapters, pipettes and disinfectant wipes provided separately.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Uporabljajte samo z nastavki za viale, pipetami in razkužilnimi robčki, ki ste jih prejeli ločeno.
English: 1 ml of solution contains 20 micrograms of cenegermin.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN 1 ml raztopine vsebuje 20 mikrogramov cenegermina.
English: Eye pain was the most frequently reported adverse reaction, followed by eye irritation and abnormal sensation in the eye, when considering the whole population treated with the medicinal product (i.e. population included in clinical trials also on indications other than neurotrophic keratitis).
Slovenian: Ob upoštevanju celotne populacije, zdravljene s tem zdravilom (torej populacijo tudi z drugimi indikacijami razen nevrotrofičnega keratitisa, vključeno v klinične študije), je bil neželeni učinek, o katerem so najpogosteje poročali, bolečina v očesu, ki sta ji sledili razdraženost očesa in nenormalen občutek v očesu.
English: • excessive ingrowth of blood vessels into the cornea; • infection of the cornea with pus and swelling.
Slovenian: • prekomerno vraščanje krvnih žil v roženico,
English: One ml of solution contains 20 micrograms of cenegermin*.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 20 mikrogramov cenegermina*.
English: Speak to your doctor first if you intend to stop using OXERVATE.
Slovenian: Če nameravate prenehati uporabljati zdravilo OXERVATE, se najprej posvetujte z zdravnikom.
English: Method of administration For ocular use only.
Slovenian: Samo za okularno uporabo.
English: Uncommon Corneal abscess Nervous system disorders Common
Slovenian: Organski sistem Pogostnost Neželeni učinek Infekcijske in parazitske bolezni občasni absces roženice
English: SPECIAL STORAGE CONDITIONS
Slovenian: Posebne skupine bolnikov
English: Package leaflet: Information for the patient OXERVATE 20 micrograms/ml eye drops, solution cenegermin ▼This medicine is subject to additional monitoring.
Slovenian: IME ZDRAVILA IN POT(I) UPORABE OXERVATE 20 µg/ml kapljice za oko cenegermin okularna uporaba
English: • Take a single disinfectant wipe and gently clean the surface of the valve on the connector part of the vial adapter (picture 4).
Slovenian: • Vzemite en razkužilni robček in nežno obrišite površino ventila na priključku nastavka za vialo
English: oxervate
Slovenian: Odmerjanje
English: Very common Eye pain Common
Slovenian: Bolezni živčevja pogosti glavobol
English: The dose must not be increased more than once in any 24 hour period.
Slovenian: Odmerka ni dovoljeno povečati več kot enkrat v 24 urah.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Prialt on 21 February 2005..
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Prialt, veljavno po vsej Evropski uniji, izdala 21. februarja 2005.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 17 January 2014.
Slovenian: Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 17. januarja 2014.
English: EPAR summary for the public ziconotide
Slovenian: Povzetek EPAR za javnost zikonotid
English: The third study looked at the use of the medicine over three weeks.
Slovenian: V tretji študiji so raziskovali uporabo zdravila v tritedenskem obdobju.
English: Other information about Prialt
Slovenian: Druge informacije o zdravilu Prialt
English: What measures are being taken to ensure the safe and effective use of Prialt?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Prialt?
English: The dose should be gradually increased, preferably every two days or more, to obtain the best balance between pain relief and possible side effects.
Slovenian: Odmerek je treba postopoma povečevati, priporočljivo vsaka dva dni ali več, da se doseže najboljše razmerje med učinkom lajšanja bolečine in morebitnimi neželenimi učinki.
English: A risk management plan has been developed to ensure that Prialt is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Prialt je bil pripravljen načrt obvladovanja tveganj.
English: What benefit has Prialt shown during the studies?
Slovenian: Kakšne koristi je zdravilo Prialt izkazalo med študijami?
English: This is a summary of the European public assessment report (EPAR) for Prialt.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Prialt.
English: It decided that Prialt's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zaključil je, da so koristi zdravila Prialt večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Prialt may need to be diluted before use, especially with the lower doses needed at the start of treatment.
Slovenian: Zdravilo bo morda treba pred uporabo razredčiti, še posebno v primeru nižjih odmerkov, ki so potrebni na začetku zdravljenja.
English: For more information about treatment with Prialt, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Prialt preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: The most common side effects with Prialt (seen in more than 1 patient in 10) are confusion, dizziness, nystagmus (uncontrolled eye movement), impaired memory (forgetfulness), headache, somnolence (sleepiness), blurred vision, nausea (feeling sick), vomiting, abnormal gait (difficulty walking) and asthenia (weakness).
Slovenian: Najpogostejši neželeni učinki zdravila Prialt (opaženi pri več kot 1 bolniku od 10) so zmedenost, omotičnost, nistagmus (nenadzorovano premikanje oči), pozabljivost, glavobol, somnolenca (zaspanost), zamegljen vid, navzeja (slabost), bruhanje, nenormalna drža (težave pri hoji) in astenija (šibkost).
English: In all of the studies, the main measure of effectiveness was the change in the Visual Analog Scale of Pain Intensity (VASPI).
Slovenian: Glavno merilo učinkovitosti v vseh študijah je bila sprememba na vizualno analogni lestvici jakosti bolečine (VASPI).
English: The maximum dose is 21.6 micrograms per day.
Slovenian: Največji dnevni odmerek znaša 21,6 mikrograma na dan.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Prialt can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote za zdravilo Prialt je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Most patients need doses lower than 9.6 micrograms per day.
Slovenian: Večina bolnikov potrebuje odmerke, ki ne presegajo 9,6 mikrograma na dan.
English: Two of the studies were short-term, lasting five or six days: one in pain due to cancer or AIDS, and one in pain due to other causes such as nerve damage.
Slovenian: Dve študiji sta bili kratkotrajni in sta trajali pet oziroma šest dni: prva je obravnavala bolečine, ki so posledice raka ali aidsa, druga pa bolečine drugačnega izvora, kot je poškodba živcev.
English: The company that makes Prialt is carrying out a study looking at the long-term use of the medicine, looking in particular at the possibility of development of tolerance to treatment (when doses of a medicine that used to be effective become less effective over time).
Slovenian: Družba, ki izdeluje zdravilo Prialt, izvaja študijo, v kateri proučujejo dolgotrajno uporabo zdravila in še posebno možnost razvoja tolerance za zdravilo (ko na začetku učinkoviti odmerki zdravila sčasoma postanejo manj učinkoviti).
English: What is the risk associated with Prialt?
Slovenian: Kakšna tveganja so povezana z zdravilom Prialt?
English: This is a score given by the patients of their pain on a scale from 0 mm (no pain) to 100 mm (maximum pain).
Slovenian: To je jakost bolečine, kakor jo ocenijo bolniki sami, na lestvici od 0 mm (brez bolečin) do 100 mm (najmočnejša bolečina).
English: Why has Prialt been approved?
Slovenian: Zakaj je bilo zdravilo Prialt odobreno?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that Prialt provides an alternative to other intrathecal painkillers, such as opioids.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je lahko zdravilo Prialt nadomestno zdravilo za druga intratekalna zdravila proti bolečinam, kot so npr. opioidi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Prialt, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Prialt in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The starting dose of Prialt is 2.4 micrograms per day.
Slovenian: Začetni odmerek zdravila Prialt znaša 2,4 mikrograma na dan.
English: What information is still awaited for Prialt?
Slovenian: Katere informacije o zdravilu Prialt še pričakujemo?
English: Because the number of patients who have long-term pain that requires painkillers to be injected directly into the spine is low, the disease is considered ‘rare', and Prialt was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001.
Slovenian: Ker je bolnikov s kroničnimi bolečinami, ki potrebujejo protibolečinska zdravila z neposrednim vbrizgavanjem v hrbtenico, malo, velja ta bolezen za redko, zato je bilo zdravilo Prialt 9. julija 2001 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Prialt.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Treatment with Prialt should only be carried out by a doctor who has experience in the intrathecal dosing of medicines.
Slovenian: Zdravljenje z zdravilom Prialt lahko izvajajo le zdravniki, ki imajo izkušnje z intratekalnim omerjanjem zdravil.
English: The full EPAR for Prialt 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 Prialt je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Prialt must not be used in patients at the same time as intrathecal chemotherapy (medicines to treat cancer that are injected into the spinal canal).
Slovenian: Zdravilo Prialt se pri bolnikih ne sme uporabljati sočasno z intratekalno kemoterapijo (zdravili za zdravljenje raka, ki se vbrizgajo v hrbtenični kanal).
English: Prialt was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Slovenian: Zdravilo Prialt je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi zdravila na voljo le omejene informacije.
English: For the full list of all side effects and restrictions with Prialt, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Prialt glejte navodilo za uporabo.
English: Prialt was more effective than placebo in the first two studies.
Slovenian: V prvih dveh študijah se je zdravilo Prialt izkazalo za učinkovitejše od placeba.
English: Ziconotide acts by blocking special pores called calcium channels on the surface of the nerve cells that transmit the pain signals.
Slovenian: Zikonotid deluje tako, da zavira posebne pore, imenovane kalcijevi kanalčki, na površini živčnih celic, ki skrbijo za prenašanje bolečinskih signalov.
English: In the third study, there was a trend for Prialt to be more effective than placebo, with the VASPI score changing from 81 mm before treatment to 68 mm in patients receiving Prialt and to 74 mm in patients receiving placebo.
Slovenian: V tretji študiji se je pri uporabi zdravila Prialt pokazalo, da je v primerjavi s placebom to učinkovitejše, saj so se vrednosti na lestvici VASPI z 81 mm pred zdravljenjem znižale na 68 mm pri bolnikih, ki so prejemali zdravilo Prialt, in na 74 mm pri bolnikih, ki so prejemali placebo.
English: The active substance in Prialt, ziconotide, is a copy of a natural substance called omega-conopeptide, which is found in the venom of a type of sea snail.
Slovenian: Zdravilna učinkovina zdravila Prialt, zikonotid, je kopija v naravi prisotne snovi, imenovane omega konopeptid, ki jo je mogoče najti v strupu določene vrste morskega polža.
English: Prialt is used to treat severe, long-term pain in adults who need a painkiller by intrathecal injection (injection into the space that surrounds the spinal cord and the brain).
Slovenian: Zdravilo Prialt se uporablja za zdravljenje hudih, kroničnih bolečin pri odraslih, ki potrebujejo zdravilo proti bolečinam z intratekalno injekcijo (vbrizganjem v prostor, ki obdaja hrbtenjačo in možgane).
English: Prialt is a solution for infusion that contains the active substance ziconotide.
Slovenian: Zdravilo Prialt je raztopina za infundiranje, ki vsebuje zdravilno učinkovino zikonotid.
English: Prialt must be given as a very slow continuous infusion through an intrathecal catheter (a tube inserted into the spinal canal) using an infusion pump capable of delivering an accurate amount of the medicine.
Slovenian: Zdravilo Prialt se daje kot zelo počasna in neprekinjena infuzija prek intratekalnega katetra (cevke, ki jo vstavijo v hrbtenični kanal) in infuzijske črpalke, ki lahko prečrpa natančno odmerjeno količino zdravila.
English: What is Prialt used for?
Slovenian: Za kaj se zdravilo Prialt uporablja?
English: What is Prialt?
Slovenian: Kaj je zdravilo Prialt?
English: How has Prialt been studied?
Slovenian: Kako je bilo zdravilo Prialt raziskano?
English: By blocking the flow of calcium into the nerve cells, ziconotide interferes with the transmission of pain signals within the spine.
Slovenian: Z onemogočanje vstopa kalcija v živčne celice zikonotid tako moti prenašanje bolečinskih signalov po hrbtenici in pomaga lajšati bolečino.
English: Before treatment, patients with cancer or AIDS pain had an average VASPI score of 74 mm, and those with other types of pain had a score of 80 mm. After treatment, the scores in patients receiving Prialt decreased to 35 and 54 mm, respectively, while scores in patients receiving placebo were 61 and 72 mm.
Slovenian: Po zdravljenju so se pri bolnikih, ki so jemali zdravilo Prialt, ocene bolečin znižale na 35 oziroma 54 mm, pri bolnikih, ki so jemali placebo, pa na 61 oziroma 72 mm.
English: How is Prialt used?
Slovenian: Kako se zdravilo Prialt uporablja?
English: How does Prialt work?
Slovenian: Kako zdravilo Prialt deluje?
English: Prialt has been compared with placebo (a dummy treatment) in 589 patients with severe long-term pain in three main studies.
Slovenian: Zdravilo Prialt so v treh glavnih študijah, v katere je bilo vključenih 589 bolnikov s hudimi, kroničnimi bolečinami , primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: London, 23 April 2009 Doc.
Slovenian: London, 23. april 2009 Sklic dok.
English: Ref. EMEA/196121/2009
Slovenian: : EMEA/316933/2009
English: The company had initiated an appeal process, but this had not yet finished.
Slovenian: Družba je sprožila pritožbeni postopek, vendar ta še ni zaključen.
English: International non-proprietary name (INN): ixabepilone
Slovenian: Mednarodno nelastniško ime (INN): iksabepilon
English: Questions and answers on the withdrawal of the marketing authorisation for Ixempra
Slovenian: Vprašanja in odgovori v zvezi z umikom vloge za dovoljenje za promet z zdravilom Ixempra
English: The main measures of effectiveness were how long the patients lived without their cancer getting worse and how long they survived.
Slovenian: Glavni merili učinkovitosti sta bili, kako dolgo so bolnice živele brez poslabšanja raka in kako dolgo so preživele.
English: The main measure of effectiveness was the number of patients whose cancer responded to treatment.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnic, pri katerih se je rak odzval na zdravljenje.
English: The effects of Ixempra were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Ixempra so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
English: It was to be used in combination with capecitabine (another anticancer medicine) when previous treatment with cytotoxic medicines (medicines that kill cells that are dividing, such as cancer cells) had failed.
Slovenian: Uporabljali naj bi ga v kombinaciji s kapecitabinom (drugim zdravilom za zdravljenje raka), ko predhodno zdravljenje s citotoksičnimi zdravili (zdravili, ki ubijajo celice, ki se delijo, kot so rakaste celice) ni bilo uspešno.
English: In particular, the Committee was concerned over the risk of patients developing neuropathy (damage to nerve cells), which was a severe and common side effect in patients taking the medicine.
Slovenian: Odbor je imel zadržke zlasti glede tveganja, da se pri bolnicah razvije nevropatija (poškodba živčnih celic), ki je bil resen in pogost neželen učinek pri bolnicah, ki so jemale zdravilo.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes using Ixempra?
Slovenian: Kakšne so posledice umika za bolnice, ki sodelujejo v kliničnih preizkušanjih ali programih sočutne uporabe zdravila Ixempra?
English: Ixabepilone is also expected to affect non-cancer cells such as nerve cells, which could cause side effects.
Slovenian: Iksabepilon naj bi prav tako vplival na nerakaste celice, kot so živčne celice, kar ima lahko neželene učinke.
English: With the skeleton unable to change, the cancer cells cannot divide and they eventually die.
Slovenian: Ker se ogrodje ne more spremeniti, se rakaste celice ne morejo deliti in sčasoma odmrejo.