FrancophonIA/ELRC3.0 huggingface dataset:
English: Where high levels of maternal antibodies against rhinotracheitis, calicivirosis or panleucopenia components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens, which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Slovenian: Kjer je pričakovati visoke titre maternalnih protiteles proti komponentam rinotraheitisa, kaliciviroze ali panleukopenije (na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam, ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
English: Revaccination: - the first revaccination must be carried out for all components one year after the primary vaccination course, - subsequent revaccinations must be carried out: every year for the feline leukaemia component and at intervals of up to three years for the rhinotracheitis, calicivirosis and panleucopenia components.
Slovenian: Ponovno cepljenje: - prvo ponovno cepljenje je potrebno opraviti za vse komponente eno leto po osnovnem cepljenju, - naslednja ponovna cepljenja je potrebno opraviti: enkrat letno za komponento leukemije mačk in v obdobjih do 3 leta za komponente rinotraheitisa, kaliciviroze in panleukopenije.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJ ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: The product was shown to reduce excretion of feline calicivirus at onset of immunity and for one year after vaccination.
Slovenian: Cepivo dokazano zmanjšuje izločanje kalici virusa mačk ob nastopu imunosti in do enega leta po cepljenju.
English: Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs, - against feline panleucopenia to prevent mortality and clinical signs, - against leukaemia to prevent persistent viraemia and clinical signs of the related disease.
Slovenian: Aktivna imunizacija 8 tednov starih mačk in starejših: - proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj, - proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj,, - proti mačji panleukopeniji, za preprečevanje smrtnosti in ublažitev kliničnih znamenj, - proti leukemiji mačk, za preprečitev perzistentne viremije in ublažitev kliničnih znamenj bolezni.
English: Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Slovenian: Prebodna steklenička iz stekla tipa 1, ki vsebuje 1 odmerek liofilizata, in prebodna steklenička iz stekla tipa I, ki vsebuje vehikel; obe zaprti z gumijastim zamaškom in zaščiteni z aluminijasto zaporko.
English: The duration of immunity after the last re-vaccination is 3 years for the rhinotracheitis, calicivirosis and panleucopenia components, and 1 year for the feline leukaemia component.
Slovenian: Trajanje imunosti je 3 leta po zadnjem ponovnem cepljenju za komponente kužnega rinotraheitisa, kaliciviroze in panleukopenije, ter 1 leto za komponento leukemije mačk.
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and FCV G1 strains) antigens .......................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Slovenian: Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................. ≥ 104,9 CCID501 Inaktivirani antigeni kalici virusa mačk (seva FCV 431 in G1) ....................... ≥ 2,0 enot v testu ELISA Atenuiran virus panleukopenije mačk (PLI IV) .............................................................. ≥ 103,5 CCID501
English: Stimulates active immunity against feline rhinotracheitis virus, feline calicivirus, feline panleucopenia virus and feline leukaemia virus.
Slovenian: Vzpodbuja aktivno imunost proti virusu kužnega rinotraheitisa, kalicivirusu ter virusu panleukopenije in leukemije mačk.
English: Gentamicin, at most .......................................................................................................................... 23 µg Solvent:
Slovenian: Gentamicin, največ ............................................................................................................................. 23 µg Vehikel:
English: It is recommended that a test for FeLV antigenaemia be carried out prior to vaccination.
Slovenian: Pred cepljenjem je priporočljivo opraviti test na prisotnost antigenov v krvi proti FeLV.
English: Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.
Slovenian: Cepivo proti virusnemu rinotraheitisu, kalicivirusu, panleukopeniji in leukemiji mačk.
English: PACKAGE LEAFLET FOR: Purevax RCP FeLV lyophilisate and solvent for suspension for injection
Slovenian: NAVODILO ZA UPORABO ZA: Purevax RCP FeLV liofilizat in vehikel za suspenzijo za injiciranje
English: FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 10 7.2 CCID501 1 cell culture infective dose 50%.
Slovenian: Rekombinantni poxvirus kanarčkov ki vsebuje antigen virusa mečje levkemije(vCP97) ≥ 107,2 CCID501 1: 50% infektivni odmerek za celično kulturo
English: Purevax RCP FeLV lyophilisate and solvent for suspension for injection
Slovenian: Purevax RCP FeLV Liofilizat in vehikel za suspenzijo za injiciranje
English: Purevax RCP FeLV Lyophilisate and solvent for suspension for injection.
Slovenian: Purevax RCP FeLV liofilizat in vehikel za suspenzijo za injiciranje
English: Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and panleucopenia components, and 2 weeks after primary vaccination course for feline leukaemia component.
Slovenian: Imunost proti kužnemu rinotraheitisu, kalicivirozi, in panleukopeniji mačk nastopi 1 teden po osnovnem cepljenju.
English: Per dose of 1 ml: FHV (F2 strain) ................................................................................................................. ≥ 104.9 CCID50
Slovenian: FHV (sev F2) ..................................................................................................................... ≥ 104,9 CCID50 FCV (seva 431 in G1) ....................................................................................... ≥ 2,0 enot v testu ELISA FPV (PLI IV) ..................................................................................................................... ≥ 103,5 CCID50
English: FeLV recombinant canarypox virus (vCP97) ................................................................. ≥ 107.2 CCID501.
Slovenian: Atenuiran virus panleukopenije mačk (PLI IV) ................................................................ ≥ 103,5 CCID501
English: Gentamicin, at most .......................................................................................................................... 23 µg
Slovenian: Gentamicin, največ ........................................................................................................................... 23 µg
English: FeLV recombinant canarypox virus (vCP97)................................................................... ≥ 107.2 CCID50.
Slovenian: rekombinantni poxvirus kanarčkov, ki vsebuje antigen virusa mačje levkemije (vCP97) ≥ 107,2 CCID50
English: Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain) ....................................... ≥ 104.9 CCID501 Inactivated feline calicivirus (FCV 431 and G1 strains) antigens ................................... ≥ 2.0 ELISA U. Attenuated feline panleucopenia virus (PLI IV) ............................................................. ≥ 103.5 CCID501
Slovenian: Zdravilne učinkovine: Atenuirani herpes virus rinotraheitisa mačk (sev FHV F2) ............................................... ≥ 104,9 CCID501
English: 21 January 2011
Slovenian: 21 januar 2011
English: The European Commission issued a decision on 21 January 2011.
Slovenian: Evropska komisija je odločbo izdala dne 21 januarja 2011.
English: It is used to treat hypertension (high blood pressure).
Slovenian: Uporablja se za zdravljenje hipertenzije (visokega krvnega tlaka).
English: Vascace Plus is authorised in the EU via national procedures.
Slovenian: Zdravilo Vascace Plus je v EU odobreno z nacionalnimi postopki.
English: The recommended dosage of Vascace Plus is one tablet administered once daily.
Slovenian: Priporočeni odmerek zdravila Vascace Plus je ena tableta enkrat na dan.
English: Vascace Plus is also available in the EU under other trade names: Co-Inhibace, Dynorm Plus, Inhibace Plus and Inibace Plus.
Slovenian: Zdravilo Vascace Plus je v EU na voljo tudi pod drugimi tržnimi imeni: Co-Inhibace, Dynorm Plus, Inhibace Plus in Inibace Plus.
English: Why was Vascace Plus reviewed?
Slovenian: Zakaj je bilo zdravilo Vascace Plus pregledano?
English: The European Medicines Agency has completed a review of Vascace Plus.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Vascace Plus.
English: The combination of the two active substances has an additive effect, reducing the blood pressure more than either medicine alone.
Slovenian: Kombinacija obeh zdravilnih učinkovin ima aditiven učinek, saj krvni tlak znižuje bolj kot vsako posamezno zdravilo.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: Zaradi tega je med državami članicami prišlo do razhajanj glede uporabe zdravila, kakor je razvidno iz povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, v katerih je zdravilo na trgu.
English: It works by increasing urine output, reducing the volume of fluid in the blood and lowering the blood pressure.
Slovenian: Deluje tako, da povečuje izločanje urina, zmanjšuje količino tekočine v krvi in znižuje krvni tlak.
English: What is Vascace Plus?
Slovenian: Kaj je zdravilo Vascace Plus?
English: Other sections of the prescribing information such as those on special warnings, interactions with other medicines, and pregnancy and lactation and side effects were also harmonised.
Slovenian: V podatkih o predpisovanju zdravila so bila usklajena tudi druga poglavja, in sicer poglavja s posebnimi opozorili, o interakcijah z drugimi zdravili, o nosečnosti in dojenju ter o neželenih učinkih.
English: It must not be used in patients with a history of angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor, in patients with hereditary or idiopathic angioedema or in patients with kidney impairment or anuria (a condition in which a patient cannot make or pass urine).
Slovenian: Zdravila ne smejo uporabljati bolniki z anamnezo angioedema (podkožnega otekanja) v povezavi s predhodnim zdravljenjem z zaviralcem ACE, bolniki z dednim ali idiopatskim angioedemom ali bolniki z okvarjenim delovanjem ledvic ali anurijo (boleznijo, pri kateri bolniki ne morejo izločati urina).
English: Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg) EMA/652293/2010
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Vascace Plus in povezanimi imeni (cilazapril/hidroklorotiazid tablete, 5/12,5 mg) EMA/652293/2010
English: Vascace Plus is a medicine that contains the active substances cilazapril and hydrochlorothiazide.
Slovenian: Vascace Plus je zdravilo, ki vsebuje zdravilni učinkovini cilazapril in hidroklorotiazid.
English: The CHMP recommended that Vascace Plus should be used for the treatment of hypertension in patients whose blood pressure is not adequately controlled with cilazapril alone.
Slovenian: CHMP je priporočil, da se zdravilo Vascace Plus uporablja za zdravljenje hipertenzije pri bolnikih, pri katerih samostojno zdravljenje s cilazaprilom ne zagotavlja ustreznega uravnavanja krvnega tlaka.
English: Cilazapril is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Slovenian: Cilazapril je „zaviralec angiotenzinske konvertaze (ACE)“.
English: Questions and answers on Vascace Plus and associated names (cilazapril/hydrochlorothiazide tablets, 5/12.5 mg)
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Vascace Plus in povezanimi imeni (cilazapril/hidroklorotiazid tablete, 5/12,5 mg)
English: Vascace Plus should not be used in patients who are hypersensitive (allergic) to cilazapril or other ACE inhibitors, hydrochlorothiazide or other thiazides diuretics, or to any other ingredients of the medicine.
Slovenian: Zdravila Vascace Plus ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) cilazapril ali druge zaviralce ACE, hidroklorotiazid ali druge tiazidne diuretike ali na katero koli drugo sestavino zdravila.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Vascace Plus in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Vascace Plus.
English: By blocking the production of this hormone, cilazapril allows the blood vessels to widen, thereby reducing blood pressure.
Slovenian: Cilazapril z zaviranjem tvorjenja tega hormona omogoča širjenje krvnih žil in tako znižuje krvni tlak.
English: On 20 November 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace Plus in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Vascace Plus v EU, je dne 20. novembra 2009 zadevo napotila na CHMP.
English: Vascace Plus was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Usklajevalna skupina za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Vascace Plus potrebno usklajevanje.
English: Any Grade 3 or 4 in the previous cycle
Slovenian: Vsaka 3. ali 4. stopnja v predhodnem ciklu
English: PROBABILITY OF SURVIVAL
Slovenian: VERJETNOST PREŽIVETJA
English: How often will you be given HALAVEN?
Slovenian: Kako pogosto boste dobili zdravilo HALAVEN?
English: Your doctor will determine how many cycles of treatment you should receive.
Slovenian: Vaš zdravnik bo določil, koliko ciklov zdravljenja potrebujete.
English: The use of gloves, goggles, and protective clothing is recommended.
Slovenian: Priporoča se uporaba rokavic, očal in zaščitnih oblačil.
English: This patient group has not been studied.
Slovenian: Te skupine bolnikov niso preučili.
English: This result was confirmed with an updated overall survival analysis carried out at 77% of events.
Slovenian: Ta rezultat je bil potrjen s posodobljeno analizo celokupnega preživetja, opravljeno pri 77 % dogodkov.
English: Rare or not known
Slovenian: Redki ali neznani
English: The frequency of this condition is not known but it can be life-threatening.
Slovenian: Pogostnost te bolezni ni znana, je pa lahko smrtno nevarna.
English: The doctor may also then decide to reduce the dose you are given.
Slovenian: Zdravnik se lahko odloči tudi, da bo zmanjšal odmerek, ki ga boste dobili.
English: Dose reduction recommendations for retreatment are shown in the following table.
Slovenian: Priporočila za zmanjšanje odmerka za ponovno zdravljenje so predstavljena v naslednji tabeli.
English: HALAVEN 71 Dacarbazine
Slovenian: HALAVEN 71 dakarbazin
English: The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height.
Slovenian: Odmerek, ki ga boste prejeli, temelji na vaši telesni površini (izraženo v kvadratnih metrih ali m2), kar se izračuna iz vaše telesne mase in višine.
English: In the event of extravasation, treatment should be symptomatic.
Slovenian: V primeru ekstravazacije mora biti zdravljenje simptomatsko.
English: Number of Events
Slovenian: Število dogodkov
English: HALAVEN is for intravenous use.
Slovenian: Zdravilo HALAVEN je namenjeno za intravensko uporabo.
English: Date of latest renewal: 19 November 2015
Slovenian: Datum prve odobritve: 17. marec 2011 Datum zadnjega podaljšanja: 19. november 2015
English: Antiemetic prophylaxis including corticosteroids should be considered.
Slovenian: Treba je razmisliti o antiemetični profilaksi, vključno s kortikosteroidi.
English: The transport protein involved in this process is unknown.
Slovenian: Beljakovina za prenos, ki sodeluje v tem procesu, ni znana.
English: Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal.
Slovenian: Glede na rezultate vaših krvnih preiskav se lahko zdravnik odloči, da bo dajanje zdravila prestavil, dokler se rezultati krvnih preiskav ne vrnejo na normalne.
English: If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.
Slovenian: Če kar koli od navedenega velja za vas, povejte zdravniku, ki bo morda prekinil zdravljenje ali zmanjšal odmerek zdravila.
English: In the event of an overdose, the patient should be closely monitored.
Slovenian: V primeru prevelikega odmerjanja morate bolnika natančno spremljati.
English: Halaven is not recommended for children aged under 18 with paediatric sarcomas as it is not yet known how well it works in this age group.
Slovenian: Zdravilo Halaven ni priporočljivo za otroke, mlajše od 18 let, s pediatričnimi sarkomi, ker še ni znano, kako dobro deluje v tej starostni skupini.
English: The dose of eribulin should not be re-escalated after it has been reduced.
Slovenian: Odmerka eribulina ne zvišujte ponovno, ko je bil enkrat zmanjšan.
English: In the pivotal trials, the corresponding publications and in some other regions e.g. the United States and Switzerland, the recommended dose is based on the salt form (eribulin mesilate).
Slovenian: V ključnih preskušanjih, ustrezni publikaciji in v nekaterih drugih regijah, npr. v Združenih državah Amerike in Švici, temelji priporočeni odmerek na obliki soli (eribulinijev mesilat).
English: Overall, the safety profiles in the breast cancer and soft tissue sarcoma patient populations were similar.
Slovenian: V celoti gledano sta bila varnostna profila v populacijah bolnikov z rakom dojke in sarkomom mehkih tkiv podobna.
English: Creatinine clearance was estimated with the Cockcroft-Gault formula.
Slovenian: Očistek kreatinina so ocenili s Cockcroft-Gaultovo enačbo.
English: Consider discontinuation
Slovenian: Razmislite o prekinitvi
English: These may be signs of a condition called sepsis - a severe and serious reaction to an infection.
Slovenian: To so lahko znaki stanja, ki se imenuje sepsatežka in resna reakcija na okužbo.
English: Time (months) NUMBER OF PATIENTS AT RISK:
Slovenian: ČAS (meseci) ŠTEVILO BOLNIKOV S TVEGANJEM:
English: Effects of eribulin on the pharmacokinetics of other medicines
Slovenian: Učinki eribulina na farmakokinetiko drugih zdravil
English: Reoccurrence of any haematological or non-haematological adverse reactions as specified above
Slovenian: Ponovni pojav katerih koli hematoloških ali nehematoloških neželenih učinkov, kot je opredeljeno zgoraj
English: If you experience any of the following serious symptoms, stop taking HALAVEN and seek medical attention straightaway:
Slovenian: Če opazite kakega od resnih simptomov, ki so navedeni v nadaljevanju, prenehajte jemati zdravilo HALAVEN in nemudoma poiščite zdravniško pomoč:
English: Within each frequency grouping, undesirable effects are presented in order of decreasing frequency.
Slovenian: V razvrstitvah pogostosti so neželeni učinki navedeni po padajoči pogostnosti.
English: The pack sizes are cartons of 1 or 6 vials.
Slovenian: Velikosti pakiranja so škatle z 1 ali 6 vialami.
English: See section 4.2 for treatment recommendations.
Slovenian: Glejte poglavje 4.2 za priporočila o zdravljenju.
English: The safety profile of eribulin in elderly patients (≥ 65 years of age) was similar to that of patients <65 years of age except for asthenia/fatigue which showed an increasing trend with age.
Slovenian: Varnostni profil eribulina za starejše bolnike (≥65 let starosti) je bil podoben kot pri bolnikih, starih <65 let, razen astenije/utrujenosti, ki sta z naraščajočo starostjo kazali trend naraščanja.
English: Each carton contains either 1 or 6 vials.
Slovenian: Ena škatla vsebuje bodisi 1 ali 6 vial.
English: Both adverse reactions resolved with supportive care.
Slovenian: Oba neželena učinka sta s podpornim zdravljenjem izzvenela.
English: Unchanged eribulin represented most of the total radioactivity in faeces and urine.
Slovenian: Nespremenjeni eribulin predstavlja večino od skupne radioaktivnosti v blatu in urinu.
English: Frequency categories are defined as: 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) and very rare (< 1/10,000).
Slovenian: Kategorije pogostnosti so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000).
English: The usual dose of HALAVEN is 1.23 mg/m2, but this may be adjusted by your doctor based on your blood test results or other factors.
Slovenian: Običajni odmerek zdravila HALAVEN je 1,23 mg/m2, vendar ga lahko zdravnik prilagodi glede na izide vaših krvnih preiskav in druge dejavnike.
English: New onset or worsening of pre-existing peripheral neuropathy has also been reported.
Slovenian: Poročali so tudi o novem začetku ali poslabšanju že obstoječe periferne nevropatije.
English: Eribulin is weakly bound to plasma proteins.
Slovenian: Eribulin se slabo veže na beljakovine plazme.
English: If you have any further questions about the use of this medicine, ask your doctor.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
English: It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment.
Slovenian: Zdravilo lahko povzroči tudi stalne težave s plodnostjo v prihodnosti za moške, ki ga uporabljajo, zato se morajo pred začetkom zdravljenja pogovoriti z zdravnikom.
English: Eribulin is mainly (up to 70%) eliminated through biliary excretion.
Slovenian: Eribulin se izloča pretežno (do 70 %) prek žolča.
English: Patients should be advised not to drive or use machines if they feel tired or dizzy.
Slovenian: Bolnikom je treba povedati, naj ne vozijo in upravljajo s stroji, če so utrujeni ali omotični.
English: PROPORTION OF PATIENTS ALIVE
Slovenian: DELEŽ ŽIVIH BOLNIKOV
English: TIME (months) NUMBER OF PATIENTS AT RISK
Slovenian: ČAS (meseci) ŠTEVILO BOLNIKOV S TVEGANJEM
English: Testicular toxicity has been observed in rats and dogs (see section 5.3).
Slovenian: Pri podganah in psih so opazili testikularno toksičnost (glejte poglavje 5.3).
English: Pregnant staff should not handle HALAVEN.
Slovenian: Nosečnice ne smejo rokovati z zdravilom HALAVEN.
English: Patients should be closely monitored for signs of peripheral motor and sensory neuropathy.
Slovenian: Bolnike je treba skrbno nadzirati za znake periferne motorične in senzorične nevropatije.
English: Do not use HALAVEN: - if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila HALAVEN: - če ste alergični na eribulinijev mesilat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).