FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as a ‘spot-on' solution in pipettes already filled with the correct amount needed to treat one dog depending on its weight.
Slovenian: Na voljo je v obliki raztopine za kožni nanos v merilnih kapalkah, predhodno napolnjenih z ustrezno količino zdravila, potrebnega za zdravljenje enega psa glede na njegovo telesno maso.
English: Certifect is used in dogs to treat and prevent infestations with ticks and fleas, and to treat infestations with chewing lice.
Slovenian: Zdravilo Certifect se uporablja pri psih za zdravljenje in preprečevanje infestacij s klopi in bolhami ter za zdravljenje infestacij z zajedavskimi ušmi.
English: Other studies were performed to investigate if Certifect reduced the risk of transmission of certain tick-borne diseases.
Slovenian: Druge študije so bile izvedene, da bi se ugotovilo, ali zdravilo Certifect zmanjšuje tveganje za prenos nekaterih s klopi prenosljivih bolezni.
English: Contact with the application site should be avoided.
Slovenian: Izogibati se je treba stika z mestom nanosa.
English: The content of one full Certifect pipette (appropriate to the dog's weight) is applied directly to the dog's skin, after parting its fur, in two separate spots (halfway down the back of the neck, and at the base of the neck).
Slovenian: Vsebina ene polne merilne kapalke zdravila Certifect se (glede na telesno maso psa) nanese neposredno na kožo psa, tako da se razmakne dlaka in se zdravilo nanese na dve različni mesti (na zgornji del hrbta in na zatilje).
English: Both fipronil and amitraz kill adult parasites while (S)-methoprene kills parasites at the egg or larval stage.
Slovenian: Fipronil in amitraz uničujeta odrasle zajedavce, (S)-metopren pa uničuje zajedavce v fazi jajčeca ali ličinke.
English: If accidental exposure to the eyes occurs, the eyes should be rinsed with water and in case of accidental exposure to the skin the skin should be washed with soap and water.
Slovenian: V primeru nenamerne izpostavitve oči zdravilu Certifect, je treba oči nemudoma temeljito izprati z vodo, v primeru nenamerne izpostavitve kože, pa to umiti z vodo in milom.
English: Dogs may show some temporary reactions at the site of application (skin discolouration, hair loss, itching or redness).
Slovenian: Lahko se pojavijo začasne reakcije na mestu nanosa (razbarvanje kože, izpadanje dlake, srbenje ali rdečica).
English: Fipronil works on channels in the cells of the nervous system of ticks and fleas, blocking the transfer of ions in and out of cells,
Slovenian: Fipronil deluje na kanale v celicah živčnega sistema klopov in bolh ter zavira prenos ionov v celice in iz njih, kar povzroča nenadzorovano delovanje osrednjega živčnega sistema in smrt teh zajedavcev.
English: What is Certifect used for?
Slovenian: Za kaj se zdravilo Certifect uporablja?
English: For a full list of all side effects reported with Certifect, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Certifect, glejte navodilo za uporabo.
English: If side effects are seen, immediate medical assistance should be sought and the package leaflet or label shown to the doctor.
Slovenian: Če se pojavijo neželeni učinki, se je treba nemudoma posvetovati z zdravnikom in mu pokazati navodilo za uporabo ali ovojnino.
English: How has Certifect been studied?
Slovenian: Kako je bilo zdravilo Certifect raziskano?
English: What is Certifect?
Slovenian: Kaj je zdravilo Certifect?
English: How does Certifect work?
Slovenian: Kako zdravilo Certifect deluje?
English: Influenza virus surface antigens*, inactivated: A/Vietnam/1194/2004 (H5N1) - like strain used (NIBRG-14) 7.5 micrograms** per 0.5 ml dose * propagated in eggs ** expressed in microgram haemagglutinin.
Slovenian: Površinski antigeni virusa influence*, inaktivirani: uporabljen sevu A/Vietnam/1194/2004 (H5N1) - podoben sev, (NIBRG-14) 7,5 mikrogramov** na 0,5 ml odmerka * razmnožen v jajcih ** izraženo v mikrogramih hemaglutinina
English: Packaging Content (concentration) Package size
Slovenian: Vsebina Velikost pakiranja
English: If taken without food the medicine may not work properly.
Slovenian: Če se zdravilo vzame brez hrane, morda ne bo pravilno delovalo.
English: The recommended dose is four capsules three times a day (a total of 12 capsules a day).
Slovenian: Priporočeni odmerek je štiri kapsule trikrat na dan (skupaj 12 kapsul na dan).
English: This is a summary of the European public assessment report (EPAR) for Victrelis.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Victrelis.
English: The full EPAR for Victrelis 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 Victrelis je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It should be taken with food (a meal or light snack).
Slovenian: Zdravilo se mora jemati skupaj s hrano (obrokom ali lahkim prigrizkom).
English: However, the Committee decided that the medicine's benefits outweighed its risk and recommended that it be granted marketing authorisation.
Slovenian: Odbor je kljub temu menil, da so koristi zdravila večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: What measures are being taken to ensure the safe use of Victrelis?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Victrelis?
English: The company that makes Victrelis will ensure that all doctors expected to prescribe the medicine are provided with an educational pack with detailed information on the medicine, including information on the risk of anaemia and other side effects.
Slovenian: Družba, ki izdeluje zdravilo Victrelis, bo zagotovila, da bodo vsi zdravniki, ki naj bi predpisovali to zdravilo, prejeli izobraževalni paket z natančnimi informacijami o zdravilu, vključno z informacijami o tveganju za anemijo in drugih neželenih učinkih.
English: For a list of these medicines see the summary of product characteristics (also part of the EPAR).
Slovenian: Za celoten seznam teh zdravil glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: When the enzyme is blocked, the virus does not replicate normally and this slows down the rate of replication, helping to eliminate the virus.
Slovenian: Z zaustavitvijo delovanja encima se virus ne more normalno razmnoževati, kar upočasni hitrost njegovega razmnoževanja in pomaga pri uničevanju virusa.
English: What benefit has Victrelis shown during the studies?
Slovenian: Kakšne koristi je zdravilo Victrelis izkazalo med študijami?
English: These medicines can be harmful at high levels in the blood and it is important to avoid taking them when taking Victrelis.
Slovenian: Ta zdravila so lahko škodljiva, kadar so v krvi prisotna v visokih koncentracijah, zato je pomembno, da jih med zdravljenjem z zdravilom Victrelis ne jemljete.
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
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Victrelis, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev
English: Two main studies involving 1,099 previously untreated and 404 previously treated patients with chronic hepatitis C genotype 1 infection and compensated liver disease were carried out.
Slovenian: Izvedeni sta bili dve glavni študiji, v kateri je bilo vključenih 1 099 predhodno nezdravljenih bolnikov in 404 predhodno zdravljeni bolniki z okužbo s kroničnim hepatitisom C genotipa 1 in s kompenzirano boleznijo jeter.
English: It must not be used in patients with autoimmune hepatitis (hepatitis caused by an immune disorder) or in pregnant women.
Slovenian: Ne smejo ga uporabljati bolniki z avtoimunskim hepatitisom (hepatitisom, ki ga povzročajo obolenja imunskega sistema) ali nosečnice.
English: Victrelis is to be used in patients with compensated liver disease who have not been treated before or whose previous treatment has failed.
Slovenian: Zdravilo Victrelis se uporablja pri bolnikih s kompenzirano boleznijo jeter, ki še niso bili zdravljeni ali pri katerih predhodno zdravljenje ni bilo uspešno.
English: Victrelis was also shown to be effective in some patients whose treatment was shortened following blood tests in which the virus could no longer be detected in their blood.
Slovenian: Zdravilo Victrelis se je izkazalo kot učinkovito tudi pri nekaterih bolnikih, pri katerih je bilo zdravljenje skrajšano zaradi izvidov krvnih preiskav, ki so pokazale, da v krvi ni več zaznanega virusa.
English: The effects of Victrelis were first tested in experimental models before being studied in humans.
Slovenian: Učinki zdravila Victrelis so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri
English: Why has Victrelis been approved?
Slovenian: Zakaj je bilo zdravilo Victrelis odobreno?
English: Victrelis can slow down the rate at which certain medicines are broken down in the liver.
Slovenian: Zdravilo Victrelis lahko upočasni hitrost razkrajanja nekaterih zdravil v jetrih.
English: The European Commission granted a marketing authorisation valid throughout the European Union for
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Victrelis, veljavno po vsej Evropski uniji,
English: The main measure of effectiveness was the number of patients who had no detectable virus in their blood 24 weeks after the end of the treatment and could therefore be
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih 24 tednov po zaključku zdravljenja v krvi ni bilo zaznanega virusa, kar
English: It blocks an enzyme called HCV NS3 protease, which is found on the hepatitis C virus of the type 1 genotype and is involved in the virus's replication.
Slovenian: Zavira encim, imenovan proteaza HCV NS3, ki je prisoten na virusu hepatitisa C genotipa 1 in vpliva na razmnoževanje virusa.
English: The other most common side effects with Victrelis are fatigue (tiredness), nausea (feeling sick), headache and dysgeusia (taste disturbances).
Slovenian: Drugi najpogostejši neželeni učinki pri uporabi zdravila Victrelis so utrujenost, navzeja (slabost), glavobol in disgevzija (motnje okušanja).
English: For more information about treatment with Victrelis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Victrelis preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is the risk associated with Victrelis?
Slovenian: Kakšna tveganja so povezana z zdravilom Victrelis?
English: In the study of previously untreated patients, 66% of patients who received Victrelis for 44 weeks (242 out 366) were cured compared with 38% of those who received placebo (137 out of 363).
Slovenian: V študiji s predhodno nezdravljenimi bolniki je bilo ozdravljenih 66 % (242 od 366) bolnikov, ki so 44 tednov prejemali zdravilo Victrelis, v primerjavi z 38 % (137 od 363) tistih, ki so prejemali placebo.
English: All patients also received peginterferon alfa and ribavirin.
Slovenian: Vsi bolniki so prejemali tudi peginterferon alfa in ribavirin.
English: Victrelis must not be used in people who are hypersensitive (allergic) to boceprevir or any of the other ingredients.
Slovenian: Zdravila Victrelis ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) boceprevir ali katero koli drugo sestavino zdravila.
English: Victrelis is a medicine that contains the active substance boceprevir.
Slovenian: Victrelis je zdravilo, ki vsebuje zdravilno učinkovino boceprevir.
English: The active substance in Victrelis, boceprevir, is a protease inhibitor.
Slovenian: Zdravilna učinkovina zdravila Victrelis, boceprevir, je zaviralec proteaze.
English: In both studies Victrelis was compared with placebo (a dummy treatment).
Slovenian: Zdravilo Victrelis so v obeh študijah primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: In a second study in patients in whom previous treatment had failed, the cure rate was 67% (107 out of 161) for patients who received Victrelis for 44 weeks compared with 21% (17 out of 80) for those
Slovenian: V drugi študiji, v katero so bili vključeni bolniki, pri katerih predhodno zdravljenje ni bilo uspešno, je bilo ozdravljenih 67 % (107 od 161) bolnikov, ki so 44 tednov prejemali zdravilo Victrelis, v primerjavi z 21 % (17 od 80) bolnikov, ki so prejemali placebo.
English: Compensated liver disease is when the liver is damaged but is
Slovenian: Kompenzirana bolezen jeter pomeni, da so jetra poškodovana, vendar še vedno lahko normalno delujejo.
English: Treatment with Victrelis should be started and monitored by a doctor experienced in managing chronic
Slovenian: Zdravljenjem z zdravilom Victrelis mora uvesti in spremljati zdravnik, ki ima izkušnje z zdravljenjem
English: It is available as capsules
Slovenian: Na voljo je v obliki kapsul (200 mg).
English: For more information on how to use Victrelis, including its combination with peginterferon alfa and ribavirin and the length of treatment, see the summary of product characteristics (also part of the EPAR).
Slovenian: Več informacij o načinu uporabe zdravila Victrelis, pa tudi glede kombinacije s peginterferonom alfa in ribavirinom ter trajanja zdravljenja, je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: For the full list of all side effects reported with Victrelis, see the
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Victrelis, glejte navodilo za uporabo.
English: Victrelis in combination with peginterferon alfa and ribavirin can lead to a higher rate of anaemia (low red blood cell counts) than is seen in treatment with peginterferon and ribavirin alone.
Slovenian: Zdravilo Victrelis lahko v kombinaciji s peginterferonom alfa in ribavirinom povzroča višjo stopnjo anemije (nizko število rdečih krvnih celic) v primerjavi z zdravljenjem samo s peginterferonom in ribavirinom.
English: The CHMP noted that Victrelis in combination with peginterferon alfa and ribavirin significantly increases the number of patients cured of chronic hepatitis C infection.
Slovenian: CHMP je menil, da zdravilo Victrelis v kombinaciji s peginterferonom alfa in ribavirinom pomembno poveča število bolnikov, pri katerih je okužba s kroničnim hepatitisom C ozdravljena.
English: How does Victrelis work?
Slovenian: Kako zdravilo Victrelis deluje?
English: Victrelis was effective at curing patients with chronic hepatitis C genotype 1 infection who were also treated with peginterferon alfa and ribavirin.
Slovenian: Zdravilo Victrelis je bilo učinkovito pri zdravljenju bolnikov, okuženih s kroničnim hepatitisom C genotipa 1, ki so jih zdravili tudi s peginterferonom alfa in ribavirinom.
English: Victrelis is used to treat adults with chronic (long-term) hepatitis C genotype 1 (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa
Slovenian: Zdravilo Victrelis se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C genotipa 1 (boleznijo jeter zaradi okužbe z virusom hepatitisa C) v kombinaciji z dvema drugima zdraviloma, peginterferonom alfa in ribavirinom.
English: This was an important improvement on results seen with only peginterferon alfa and ribavirin together.
Slovenian: To predstavlja pomembno izboljšanje v primerjavi z rezultati, opaženimi pri zdravljenju samo s peginterferonom alfa in ribavirinom.
English: The patients must first take peginterferon alfa and ribavirin for four weeks, after which they will add Victrelis to the treatment for up to 44 weeks, depending on several factors such as the patient's previous treatment and results of blood tests during treatment.
Slovenian: Bolniki morajo najprej štiri tedne jemati peginterferon alfa in ribavirin, šele nato zdravljenju dodajo zdravilo Victrelis, ki ga jemljejo do 44 tednov.
English: The main increase in side effects seen when adding Victrelis to treatment was anaemia.
Slovenian: Med neželenimi učinki, opaženimi pri dodajanju zdravila Victrelis k tej terapiji, se je najbolj povečalo število primerov anemije.
English: The marketing authorisation holders shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Slovenian: Imetniki dovoljenja za promet z zdravilom izpolnijo spodnje pogoje v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
English: The details of the visual reminder should be agreed at national level and be subject to a user test taking into account input from local patient representatives.
Slovenian: O podrobnostih vizualnega opomnika se je treba dogovoriti na nacionalni ravni, in sicer jih je treba preskusiti z uporabniškim preskusom, pri čemer je treba upoštevati pripombe lokalnih predstavnikov bolnikov.
English: A visual reminder on the outer package to warn patient about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products containing substances related to valproate.
Slovenian: Vizualni opomnik na zunanji ovojnini za opozorilo bolnici o škodi za nerojenega otroka in potrebi po učinkoviti kontracepciji pri uporabi zdravila je treba uvesti pri vseh zdravilih, ki vsebujejo valproatu sorodne snovi.
English: With regards to the studies abovementioned, the MAHs are strongly encouraged to collaborate and perform joint studies.
Slovenian: V zvezi s prej omenjenimi študijami se imetnike dovoljenj za promet z zdravili močno spodbuja k sodelovanju in izvedbi skupnih študij.
English: These should be submitted to the National Competent Authorities: Within 1 month of the Commission decision.
Slovenian: v enem mesecu po sklepu Komisije.
English: MAHs are encouraged to extend the ongoing drug utilisation study (DUS).
Slovenian: Imetnike dovoljenj za promet z zdravili se spodbuja, da študijo o uporabi zdravila (DUS), ki še poteka, podaljšajo.
English: All MAHs should have in place a Risk management plan (RMP).
Slovenian: Poleg tega morajo imeti vsi imetniki dovoljenj za promet z zdravili vzpostavljen načrt za obvladovanje tveganj:
English: The MAHs of medicinal products with substances related to valproate shall develop and submit educational materials according to agreed core elements.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo oblikovati in predložiti izobraževalna gradiva v skladu z dogovorjenimi bistvenimi elementi.
English: The MAHs of medicinal products with substances related to valproate shall conduct a retrospective observational study to investigate the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo izvesti retrospektivno opazovalno študijo za raziskavo povezave med očetovo izpostavljenostjo valproatu ter tveganjem prirojenih anomalij in motenj razvoja živčevja, vključno z avtizmom, pri potomcih.
English: The MAHs of medicinal products with substances related to valproate shall perform a drug utilisation study to assess the effectiveness of the new risk minimisation measures and to further characterise the prescribing patterns for valproate.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo izvesti študijo o uporabi zdravila, da ocenijo učinkovitost novih ukrepov za zmanjševanje tveganj in nadaljnjo opredelitev vzorcev predpisovanja valproata.
English: These materials should ensure that prescriber are informed and the patients understand and acknowledge the risks associated with valproate in-utero exposure.
Slovenian: Ta gradiva morajo zagotoviti, da so zdravniki, ki predpisujejo zdravilo, in bolnice poučeni ter razumejo tveganja, povezana z izpostavljenostjo valproatu v maternici, in potrjujejo seznanjenost z njimi.
English: The MAHs of medicinal products with substances related to valproate shall conduct a PASS preferably based on existing registries to further characterise the foetal anticonvulsant syndrome in children with valproate in utero exposure as compared to other anti-epileptic drugs.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo - po možnosti na podlagi obstoječih evidenc - izvesti študijo PASS za nadaljnjo opredelitev antikonvulzivnega sindroma pri plodu pri otrocih, izpostavljenih valproatu in utero, v primerjavi z drugimi zdravili proti epilepsiji.
English: The MAHs of medicinal products with substances related to valproate shall conduct an observational study to evaluate and identify the best practices for switching of valproate in clinical practice.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo izvesti opazovalno študijo, da ocenijo in odkrijejo dobre prakse prehoda z valproata na druga zdravila v klinični praksi.
English: The MAHs of medicinal products with substances related to valproate shall perform a survey among patients to assess knowledge of the patients with regards to PPP as well as receipt/use of educational materials.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo med bolniki izvesti raziskavo, da ocenijo njihovo znanje in ravnanje glede prednostnih vzorcev predpisovanja ter prejem/uporabo neposrednih sporočil za bolnike in izobraževalnih gradiv.
English: The MAHs of medicinal products with substances related to valproate shall perform a survey among HCP to assess knowledge of HCP and behaviour with regard to PPP as well as receipt/use of DHPC and educational materials.
Slovenian: Imetniki dovoljenj za promet z zdravili, ki vsebujejo valproatu sorodne snovi, morajo med zdravstvenimi delavci izvesti raziskavo, da ocenijo njihovo znanje in ravnanje glede prednostnih vzorcev predpisovanja ter prejem/uporabo neposrednih sporočil za zdravstvene delavce in izobraževalnih gradiv.
English: Each dose (2 ml) contains:
Slovenian: En odmerek (2 ml) vsebuje:
English: 6.2 Major incompatibilities
Slovenian: 6.2 Glavne Inkompatibilnosti
English: ATCvet code: QI09AL
Slovenian: Oznaka ATC vet: QI09AL
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Vsakdo, ki namerava proizvajati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in uporabljati to zdravilo , se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Date of first authorization: 06/11/2015.
Slovenian: Datum pridobitve dovoljenja za promet: 06/11/2015.
English: Incompatibilities: Do not mix with any other vaccine or immunological product.
Slovenian: Inkompatibilnosti: Ne uporabljajte z ostalimi cepivi ali imunološkimi zdravili.
English: The excipients 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC dovoljenje snovi za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa, ne spadajo v področje uporabe Uredbe (ES) št. 470/2009 kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.