FrancophonIA/ELRC3.0 huggingface dataset:
English: Onzeald was expected to be used to treat adults with advanced breast cancer that had spread to the brain and other parts of the body and who have already received other treatments.
Slovenian: Zdravilo Onzeald naj bi se uporabljalo za zdravljenje odraslih bolnikov z napredovalim rakom dojke, pri katerih se je rak razširil v možgane in druge dele telesa ter so že prejeli druge oblike zdravljenja.
English: Onzeald is a cancer medicine that contains the active substance etirinotecan pegol.
Slovenian: Onzeald je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino etirinotekanpegol.
English: The CHMP considered that the benefit of Onzeald in the treatment of advanced breast cancer that had spread to the brain and other parts of the body had not been sufficiently demonstrated.
Slovenian: Odbor CHMP je menil, da koristi zdravila Onzeald pri zdravljenju napredovalega raka dojk, ki se je razširil v možgane in druge dele telesa, niso bile zadostno dokazane.
English: The company that applied for authorisation is Nektar Therapeutics UK Limited.
Slovenian: Vlogo za pridobitev dovoljenja za promet z zdravilom je predložila družba Nektar Therapeutics UK Limited.
English: Refusal of the marketing authorisation for Onzeald (etirinotecan pegol)
Slovenian: Zavrnitev vloge za dovoljenje za promet z zdravilom Onzeald (etirinotekanpegol)
English: By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die.
Slovenian: Z zaviranjem encima prepreči rakavim celicam, da bi se razmnoževale, zato te sčasoma odmrejo.
English: 5 August 2011
Slovenian: 5. avgust 2011
English: The mutual recognition procedure (UK/V/0354/001/MR) started on 26 November 2009.
Slovenian: Postopek medsebojnega priznavanja (UK/V/0354/001/MR) se je začel 26. novembra 2009.
English: On 2 July 2010, the United Kingdom, as Reference Member State, referred the matter to the European Medicines Agency under Article 33(4) of Directive 2001/82/EC, due to concerns raised by the Concerned Member State, Ireland, that the safety and efficacy of the product had not been sufficiently demonstrated.
Slovenian: Združeno kraljestvo je kot referenčna država članica 2. julija 2010 v skladu s členom 33(4) Direktive 2001/82/ES zadevo napotilo na Evropsko agencijo za zdravila zaradi zadržkov, ki jih je izpostavila zadevna država članica Irska, in sicer da varnost in učinkovitost zdravila nista bili zadostno dokazani.
English: The marketing authorisation holder, Norbrook Laboratories Ltd, submitted an application for Combimox via a mutual recognition procedure in Ireland on the basis of the marketing authorisation granted by the United Kingdom.
Slovenian: Imetnik dovoljenja za promet z zdravilom družba Norbrook Laboratories Ltd je predložila vlogo za zdravilo Combimox prek postopka medsebojnega priznavanja na Irskem na podlagi dovoljenja za promet z zdravilom, ki je bilo odobreno v Združenem kraljestvu.
English: Combimox Lactating Cow Intramammary Suspension (Combimox) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Slovenian: Zdravilo Combimox Lactating Cow Intramammary Suspension (Combimox) je intramamarna suspenzija, ki vsebuje amoksicilin, klavulansko kislino in prednizolon.
English: Combimox is intended for the treatment of mastitis in lactating cows.
Slovenian: Zdravilo Combimox je namenjeno zdravljenju mastitisa pri kravah v obdobju laktacije.
English: Based on the evaluation of the rapporteur's assessment of the currently available data, the CVMP considered that the benefit/risk profile of Combimox Lactating Cow Intramammary Suspension is
Slovenian: CVMP je zato po presoji ocene trenutno razpoložljivih podatkov, ki jo je opravil poročevalec, menil, da je razmerje med koristmi in tveganji za zdravilo Combimox Lactating Cow Intramammary Suspension negativno, in 6. aprila 2011 sprejel mnenje, v katerem priporoča zavrnitev odobritve dovoljenja za promet z zdravilom in začasen umik obstoječega dovoljenja za promet.
English: Numient levodopa / carbidopa
Slovenian: Numient levodopa/karbidopa
English: Other information about Numient
Slovenian: Druge informacije o zdravilu Numient
English: What measures are being taken to ensure the safe and effective use of Numient?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Numient?
English: They can be taken with or without food, but should not be taken at the same time as high protein meals, which can reduce absorption.
Slovenian: Lahko se jemljejo s hrano ali brez nje, vendar se ne smejo jemati hkrati z obroki, bogatimi z beljakovinami, saj lahko te zmanjšajo absorpcijo zdravila.
English: The patient should then swallow the food immediately without chewing.
Slovenian: Bolnik mora nato hrano pogoltniti takoj in brez žvečenja.
English: Numient capsules are taken with a glass of water.
Slovenian: Kapsule zdravila Numient se jemljejo s kozarcem vode.
English: The full EPAR and risk management plan summary for Numient 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) in povzetek načrta obvladovanja tveganj za zdravilo Numient sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: 95 mg/23.75 mg, 145 mg/36.25 mg, 195 mg/48.75 mg and 245 mg/61.25 mg. For further information on how to use Numient, see the summary of product characteristic (also part of the EPAR).
Slovenian: Na voljo je v naslednjih jakostih: 95 mg/23,75 mg, 145 mg/36,25 mg, 195 mg/48,75 mg in 245 mg/61,25 mg. Za več informacij o uporabi zdravila Numient glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Patients who took placebo had an average improvement of 0.6 points.
Slovenian: Pri bolnikih, ki so prejemali placebo, so zabeležili povprečno izboljšanje za 0,6 točke.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Numient's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Numient večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: The doctor may then increase the dose depending on how the condition responds to treatment.
Slovenian: Zdravnik lahko nato poveča odmerek glede na to, kako se bolezen odzove na zdravljenje.
English: The starting dose for patients who have not previously taken levodopa is one capsule containing 95 mg of levodopa and 23.75 mg of carbidopa, three times daily for the first three days.
Slovenian: Začetni odmerek pri bolnikih, ki še niso prejemali levodope, je ena kapsula, ki vsebuje 95 mg levodope in 23,75 mg karbidope, trikrat dnevno prve tri dni.
English: What is Numient and what is it used for?
Slovenian: Kaj je zdravilo Numient in za kaj se uporablja?
English: It is not intended to provide practical advice on how to use Numient.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: This is a summary of the European public assessment report (EPAR) for Numient.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Numient.
English: The combination of levodopa and carbidopa is used in other medicines for Parkinson's disease.
Slovenian: Kombinacija levodope in karbidope se uporablja tudi v drugih zdravilih za Parkinsonovo bolezen.
English: A risk management plan has been developed to ensure that Numient is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Numient je bil pripravljen načrt obvladovanja tveganj.
English: For patients already taking levodopa, the doctor will determine the dose of Numient based on their current treatment.
Slovenian: Pri bolnikih, ki že prejemajo levodopo, bo zdravnik odmerek zdravila Numient določil na podlagi njihovega trenutnega zdravljenja.
English: What benefits of Numient have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Numient izkazalo v študijah?
English: Patients who have difficulty swallowing can have the content of the capsules sprinkled on soft food such as apple sauce, yoghurt or pudding.
Slovenian: Pri bolnikih, ki imajo težave s požiranjem, se lahko vsebina kapsule iztrese na mehko hrano, na primer jabolčno kašo, jogurt ali puding.
English: What are the risks associated with Numient?
Slovenian: Kakšna tveganja so povezana z zdravilom Numient?
English: This study looked at how well the treatments reduced the time when patients have more difficulty moving about, called ‘off periods'.
Slovenian: V tej študiji so preučevali, kako učinkoviti sta bili zdravili pri zmanjševanju časa, ko so imeli bolniki več težav z gibanjem - ta pojav imenujemo „obdobja izklopa“.
English: After 13 weeks, patients taking Numient had off periods of about 24% of their waking hours compared with 30% of waking hours in patients taking the comparator medicine.
Slovenian: Po 13 tednih so obdobja izklopa pri bolnikih, ki so prejemali zdravilo Numient, predstavljala približno 24 % časa, ko so bili budni, v primerjavi s 30 % pri bolnikih, ki so prejemali primerjalno zdravilo.
English: After 30 weeks, patients taking Numient had their symptoms improve by an average of between 11.7 and 14.9 points (depending on dose) on a standard symptom scale (Unified Parkinson's Disease Rating Scale, UPDRS Part II and Part III).
Slovenian: Po 30 tednih so se pri bolnikih, ki so prejemali zdravilo Numient, simptomi v povprečju izboljšali za 11,7 do 14,9 točke (odvisno od odmerka) na standardni lestvici za oceno simptomov (enotna ocenjevalna lestvica za Parkinsonovo bolezen (UPDRS), II.
English: The most frequent side effects with Numient are nausea in (12% of patients), dizziness, headache and involuntary movements (each occurring in 8% of patients), and insomnia (in 6% of patients).
Slovenian: Najpogostejši neželeni učinki zdravila Numient so slabost (pri 12 % bolnikov), omotica, glavobol in nehoteni gibi (vsak od teh pri 8 % bolnikov) ter nespečnost (pri 6 % bolnikov).
English: Why is Numient approved?
Slovenian: Zakaj je bilo zdravilo Numient odobreno?
English: More serious side effects include bleeding from the gut and allergic reactions, and have been reported uncommonly.
Slovenian: Resnejši neželeni učinki vključujejo krvavitve iz črevesja in alergijske reakcije, o njih pa so poročali občasno.
English: These types of capsules are known as modifiedrelease capsules.
Slovenian: Tovrstne kapsule imenujemo kapsule s prirejenim sproščanjem.
English: Studies show that Numient is effective at reducing symptoms in patients with early and late stage Parkinson's disease.
Slovenian: Študiji kažeta, da je zdravilo Numient učinkovito pri zmanjševanju simptomov pri bolnikih s Parkinsonovo boleznijo v zgodnji in pozni fazi.
English: For more information about treatment with Numient, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Numient preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Numient, 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 Numient in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: In a study of 381 patients with early stage Parkinson's disease, Numient at various doses was more effective at improving symptoms than placebo (a dummy treatment).
Slovenian: V študiji, v kateri je sodelovalo 381 bolnikov s Parkinsonovo boleznijo v zgodnji fazi, je bilo zdravilo Numient učinkovitejše pri izboljševanju simptomov kot placebo (zdravilo brez zdravilne učinkovine).
English: Numient contains levodopa which converts into dopamine in the brain and helps to restore dopamine levels.
Slovenian: Zdravilo Numient vsebuje levodopo, ki se v možganih pretvori v dopamin in pomaga ponovno vzpostaviti ravni dopamina.
English: Both groups had off periods of about 36-37% at the start of the study.
Slovenian: Pri obeh skupinah je ta delež na začetku študije znašal približno
English: In Numient, a portion of the active substances is released immediately, while the remaining is released gradually, leading to more steady levodopa levels.
Slovenian: V zdravilu Numient se del zdravilnih učinkovin sprosti takoj, preostanek pa se sprošča postopoma, s čimer se dosežejo bolj stabilne ravni levodope.
English: For practical information about using Numient, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Numient naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It must also not be used in patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors or in patients with a history of certain medical conditions.
Slovenian: Prav tako ga ne smejo uporabljati bolniki, ki jemljejo zdravila, imenovana neselektivni zaviralci monoaminoksidaze, ali bolniki, ki so preboleli določene bolezni.
English: Another benefit is the way the active substances are formulated in Numient, which helps maintain more steady levodopa levels.
Slovenian: Naslednja korist je način sproščanja zdravilnih učinkovin v zdravilu Numient, ki pomaga ohranjati stabilnejše ravni levodope.
English: It contains the active substances levodopa and carbidopa.
Slovenian: Vsebuje zdravilni učinkovini levodopo in karbidopo.
English: The carbidopa in Numient stops the levodopa from converting into dopamine while still in the general circulation, before it has reached the brain.
Slovenian: Karbidopa v zdravilu Numient preprečuje, da bi se levodopa v domapin pretvorila že v splošnem krvnem obtoku, torej še preden doseže možgane.
English: Numient is used in adults to treat the symptoms of Parkinson's disease, a progressive brain disorder that causes shaking and muscular stiffness and slows down movement.
Slovenian: Zdravilo Numient se uporablja za zdravljenje simptomov Parkinsonove bolezni, tj. napredujoče bolezni možganov, ki povzroča tresenje in otrdelost mišic ter upočasnjuje izvajanje gibov, pri odraslih.
English: How is Numient used?
Slovenian: Kako se zdravilo Numient uporablja?
English: Numient must not be used in patients with narrow angle glaucoma (an eye disorder) or pheochromocytoma (a tumour of the adrenal glands).
Slovenian: Zdravila Numient ne smejo uporabljati bolniki z glavkomom z ozkim zakotjem (očesno boleznijo) ali feokromocitomom (tumorjem nadledvične žleze).
English: How does Numient work?
Slovenian: Kako zdravilo Numient deluje?
English: Numient is available as capsules to be taken by mouth.
Slovenian: Zdravilo Numient je na voljo v obliki kapsul, ki se jemljejo peroralno.
English: A second study compared Numient with another treatment containing levodopa and carbidopa in 393 patients with advanced Parkinson's disease.
Slovenian: V drugi študiji, v kateri je sodelovalo 393 bolnikov z napredovalo Parkinsonovo boleznijo, so primerjali zdravilo Numient z drugim zdravilom, ki vsebuje levodopo in karbidopo.
English: Numient can only be obtained with a prescription and it is available in the following strengths:
Slovenian: Izdaja zdravila Numient je le na recept.
English: These local reactions gradually reduce and disappear without need for treatment.
Slovenian: Te lokalne reakcije se postopoma zmanjšajo in izginejo ne da bi bilo potrebno zdravljenje.
English: Before use allow the vaccine to reach room temperature.
Slovenian: Pred uporabo naj cepivo doseže sobno temperaturo.
English: ATCvet code: QI08AA
Slovenian: Oznaka ATC vet: QI08AA
English: Revaccination: 12 months after vaccination.
Slovenian: Ponovno cepljenje: 12 mesecev po cepljenju.
English: Each dose of 0.5 ml contains:
Slovenian: Vsak 0,5 ml odmerek vsebuje:
English: Onset of immunity: 1 week.
Slovenian: Nastop imunosti: 1 teden.
English: No available data.
Slovenian: Ni podatkov.
English: Keep the bottle in the outer carton in order to protect from light.
Slovenian: Vialo shranjujte v zunanji ovojnini, da se zaščiti pred svetlobo.
English: Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
Slovenian: Cepljenje kuncev je sprožilo proizvajanje protiteles za inhibicijo hemaglutinacije, ki so učinkovala vsaj 12 mesecev.
English: Date of first authorisation: 22 September 2016
Slovenian: Datum pridobitve dovoljenja za promet: 22/09/2016
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: Vial label (1, 10 or 40 doses)
Slovenian: Viala (1, 10 ali 40 odmerkov)
English: Overdose (symptoms, emergency procedures, antidotes): No available data.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Ni podatkov.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Slovenian: Tega zdravila na smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP.
English: Pregnant does should be handled with special care to avoid stress and risk of abortion
Slovenian: Z brejimi kunčicami je potrebno ravnati previdno, da se zmanjša morebitni stres in tveganje za abortus.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovino, na dodatek ali na katero koli pomožno snov.
English: Detailed information on this veterinary medicinal product us available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/.)
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC so dovoljene substance za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
English: Shelf life after first opening the immediate packaging: Use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: Uporabite takoj.
English: Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za zajce in kunce (leporidae), inaktivirana virusna cepiva.
English: The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Slovenian: Cepivo omogoča zaščito le proti virusu RHDV2, saj navzkrižna zaščita proti klasičnemu virusu RHDV
English: Incompatibilities: Do not mix with any other veterinary medicinal products.
Slovenian: Inkompatibilnosti: Ne mešajte z nobenim drugim zdravilom za uporabo v veterinarski medicini.
English: Duration of immunity: 12 months demonstrated by challenge
Slovenian: Trajanje imunosti: 12 mesecev dokazano s študijo izpostavljenosti.
English: Nodules or swelling (< 2 cm) can be very commonly observed in the injection site, which may last 24 hours.
Slovenian: Na mestu injiciranja se zelo pogosto pojavijo noduli ali oteklina (< 2 cm), ki lahko trajajo 24 ur.
English: This slight temperature increase resolves spontaneously without treatment by day 5 post vaccination.
Slovenian: Rahlo povišanje temperature se brez zdravljenja povrne na normalno vrednost do 5. dne po cepljenju.
English: Laboratory studies in pregnant doe in the last third of gestation have not been produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Slovenian: Z laboratorijskimi študijami na kunčicah v zadnji tretjini brejosti niso bili dokazani teratogeni, fetotoksični ali toksični učinki na mater.
English: If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Slovenian: Če vam je bilo to zdravilo nenamerno injicirano, se takoj posvetujte z zdravnikom, čeprav je bila injicirana le majhna količina, in mu pokažite navodilo za uporabo.
English: Whitish emulsion.
Slovenian: Belkasta emulzija.
English: Expert, prompt, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Slovenian: Potreben je strokoven, TAKOJŠEN, kirurški poseg ter morda tudi takojšnja incizija in izpiranje injiciranega mesta, zlasti če so prizadete tudi kite ali mehka tkiva prsta.
English: Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall.
Slovenian: Uporabite 1 odmerek (0,5 ml) cepiva za kunce starejše od 30 dni in ga vbrizgajte pod kožo v bočno torakalno steno.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovine biološkega izvora namenjene vzbujanju aktivne imunosti, niso vključene v Uredbo (ES)
English: Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Slovenian: +34 972 430661 E-pošta: hipra@hipra.com
English: Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections
Slovenian: Seznam pomožnih snovi mineralno olje tiomersal sorbitan monooleat polisorbat 80 natrijev klorid kalijev klorid natrijev hidrogenfosfat dodekahidrat kalijev dihidrogenfosfat voda za injekcije
English: For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Slovenian: Za aktivno imunizacijo kuncev od 30. dneva starosti dalje, z namenom zmanjševanja poginov zaradi virusa hemoragične bolezni kuncev tipa 2 (RHDV2).
English: Laboratorios Hipra S.A. Avda.
Slovenian: LaboratoriosHipra S.A. Avda.
English: To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
Slovenian: Za spodbujanje aktivne imunosti proti virusu hemoragične bolezni kuncev tipa 2 (RHDV2).
English: Shake well before administration.
Slovenian: Pred uporabo dobro pretresite.