FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine can reduce the severity of symptoms caused by acute (short-lived) babesiosis (the disease caused by infection with B. canis, with weakness, fever and jaundice) and anaemia (low red blood cell counts).
Slovenian: babezioza (bolezen, ki jo povzroča okužba z B. canis in jo spremljajo šibkost, povišana telesna temperatura in zlatenica) in anemija (nizka koncentracija rdečih krvnih celic).
English: What is Nobivac Piro used for?
Slovenian: Za kaj se zdravilo Nobivac Piro uporablja?
English: Further one main field study was performed, including dogs of at least six months of age of various breeds who received two injections of Nobivac Piro three weeks apart.
Slovenian: stari najmanj šest mesecev, ki so prejeli dve injekciji zdravila Nobivac Piro v razmiku treh tednov.
English: Nobivac Piro contains small amounts of antigens (soluble parasite antigens) from B. canis and the related species B. rossi that have been extracted from cultures of the parasites in red blood cells.
Slovenian: Zdravilo Nobivac Piro vsebuje majhne količine antigenov (topnih parazitskih antigenov) zajedavca B. canis in sorodne vrste B. rossi,
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Nobivac Piro exceed the risks for active immunisation of dogs of six months or older against B. canis to reduce the severity of clinical signs associated with acute babesiosis (B. canis) and anaemia as measured by packed cell volume, and recommended that Nobivac Piro be given a marketing authorisation.
Slovenian: Nobivac Piro pri aktivni imunizaciji psov, starih šest mesecev ali več, proti B. canis z namenom zmanjšanja resnosti kliničnih znakov, povezanih z akutno babeziozo (B. canis) in anemijo, določeno s hematokritom, večje od z njim povezanih tveganj.
English: How does Nobivac Piro work?
Slovenian: Kako zdravilo Nobivac Piro deluje?
English: What is Nobivac Piro?
Slovenian: Kaj je zdravilo Nobivac Piro?
English: This overview was last updated in 06-2018.
Slovenian: Pregled je bil nazadnje posodobljen 06-2018.
English: For these patients other treatment options should be considered.
Slovenian: Pri teh bolnikih je treba razmisliti o drugih možnostih zdravljenja.
English: The majority of side effects are mild and short-lived.
Slovenian: Večina neželenih učinkov je blagih in kratkotrajnih.
English: Regarding safety, side effects were mostly mild and transient, but it was recommended that the longterm safety of the medicine be further investigated.
Slovenian: Kar zadeva varnost, so bili neželeni učinki večinoma blagi in prehodni, vendar pa je bilo priporočeno, da se dolgoročna varnost zdravila nadalje prouči.
English: What measures are being taken to ensure the safe and effective use of Cerdelga?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cerdelga?
English: The European Medicines Agency decided that Cerdelga's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Cerdelga večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Further information on Cerdelga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Cerdelga so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: All patients switching from enzyme replacement should be regularly monitored for disease progression.
Slovenian: Pri vseh bolnikih, ki preidejo z nadomestnega encimskega zdravljenja, je treba redno spremljati napredovanje bolezni.
English: Patients who break down the medicine at normal speed take 1 capsule twice a day, while those who break down the medicine slowly take 1 capsule once a day.
Slovenian: Bolniki, pri katerih se zdravilo razgrajuje z normalno hitrostjo, jemljejo eno kapsulo dvakrat na dan, bolniki, pri katerih se zdravilo razgrajuje počasi, pa jemljejo eno kapsulo enkrat na dan.
English: Cerdelga received a marketing authorisation valid throughout the EU on 19 January 2015.
Slovenian: Za zdravilo Cerdelga je bilo 19. januarja 2015 izdano dovoljenje za promet, veljavno po vsej EU.
English: The most common serious side effect is fainting, in 8 out of every 1,000 patients.
Slovenian: Najpogostejši resni neželeni učinek je omedlevica; ta se lahko pojavi pri 8 od 1 000 bolnikov.
English: Before starting treatment, the patient is tested to see how rapidly their bodies break down the medicine.
Slovenian: Pred začetkom zdravljenja je treba pri bolniku preveriti, kako hitro se zdravilo v njegovem telesu razgrajuje.
English: The company will also keep record of patients treated with Cerdelga to look at the long-term safety of the medicine.
Slovenian: Podjetje bo tudi vodilo evidenco bolnikov, zdravljenih z zdravilom Cerdelga, da bo proučilo dolgoročno varnost zdravila.
English: Patients who have not been tested or whom results of the test are not clear should also not take this medicine.
Slovenian: Prav tako ga ne smejo jemati bolniki, pri katerih test ni bil opravljen ali rezultati testa niso jasni.
English: Other information about Cerdelga
Slovenian: Druge informacije o zdravilu Cerdelga
English: Cerdelga is available as capsules (84 mg) to be taken by mouth.
Slovenian: Zdravilo Cerdelga je na voljo v obliki kapsul (84 mg), ki se jemljejo peroralno.
English: As for all medicines, data on the use of Cerdelga are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Cerdelga stalno spremljajo.
English: In this study, the disease remained stable in 85% of patients who switched to Cerdelga for a year and in 94% of patients who continued with enzyme replacement therapy.
Slovenian: V tej študiji je bolezen ostala stabilna pri 85 % bolnikov, ki so za eno leto prešli na zdravilo Cerdelga, in pri 94 % bolnikov, ki so nadaljevali nadomestno encimsko zdravljenje.
English: Cerdelga is a medicine used for the long-term treatment of type-1 Gaucher disease in adults.
Slovenian: Cerdelga je zdravilo, ki se uporablja za dolgotrajno zdravljenje Gaucherjeve bolezni tipa 1 pri odraslih.
English: What benefits of Cerdelga have been shown in studies?
Slovenian: Kakšne koristi zdravila Cerdelga so se pokazale v študijah?
English: An overview of Cerdelga and why it is authorised in the EU
Slovenian: Pregled zdravila Cerdelga in zakaj je odobreno v EU
English: Why is Cerdelga authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Cerdelga odobreno v EU?
English: Gaucher disease is rare, and Cerdelga was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 December 2007.
Slovenian: Gaucherjeva bolezen je redka, zato je bilo zdravilo Cerdelga 4. decembra 2007 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: The disease is caused by the lack of an enzyme for breaking down fat.
Slovenian: Bolezen povzroča pomanjkanje encima za razgradnjo maščobe.
English: Cerdelga must not be taken by some patients with liver problems or those taking certain medicines that can interfere with the ability of the body to break down the medicine.
Slovenian: Zdravila Cerdelga ne smejo jemati nekateri bolniki s težavami z jetri ali bolniki, ki jemljejo določena zdravila, ki lahko vplivajo na sposobnost telesa za razgradnjo zdravila.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cerdelga have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cerdelga upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Cerdelga are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Cerdelga, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Patients who took Cerdelga also showed an improvement of other signs of the disease such as a reduction in liver size and increased levels of haemoglobin (the protein in red blood cells that carries oxygen).
Slovenian: Pri bolnikih, ki so jemali zdravilo Cerdelga, so se poleg tega izboljšali tudi drugi znaki bolezni, saj je na primer prišlo do zmanjšanja velikosti jeter in zvišanja ravni hemoglobina (beljakovine v rdečih krvnih celicah, ki prenaša kisik).
English: Patients whose bodies break down this medicine very rapidly (‘ultrarapid metabolisers') should not take Cerdelga.
Slovenian: Bolniki, pri katerih se zdravilo razgrajuje zelo hitro („zelo hitri presnavljalci“), zdravila Cerdelga ne smejo jemati.
English: Another study looked at Cerdelga in 159 patients whose disease was well controlled by enzyme replacement therapy.
Slovenian: V drugi študiji so zdravilo Cerdelga preučevali pri 159 bolnikih, katerih bolezen je bila dobro obvladana z nadomestnim encimskim zdravljenjem.
English: For more information about using Cerdelga, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Cerdelga glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: This causes symptoms such as anaemia (low red blood cell counts), tiredness, easy bruising, an enlarged spleen and liver, and bone pain and fractures.
Slovenian: To povzroča simptome, kot so anemija (nizko število rdečih krvnih celic), utrujenost, pogosto nastajanje modric, povečana vranica in jetra, bolečine v kosteh ter zlomi kosti.
English: Gaucher disease is a genetic condition, in which a fat called glucosylceramide (or glucocerebroside) builds up in the body, typically in the liver, spleen and bone.
Slovenian: Gaucherjeva bolezen je genska bolezen, pri kateri se maščoba, imenovana glukozilceramid (ali glukocerebrozid), kopiči v telesu, predvsem v jetrih, vranici in kosteh.
English: What is Cerdelga and what is it used for?
Slovenian: Kaj je zdravilo Cerdelga in za kaj se uporablja?
English: What are the risks associated with Cerdelga?
Slovenian: Kakšna tveganja so povezana z zdravilom Cerdelga?
English: The company that markets Cerdelga will provide doctors and patients with educational materials to ensure that only patients with type-1 Gaucher disease are treated with Cerdelga and that Cerdelga is not used in some patients with liver problems and together with other medicines which can significantly alter its blood levels.
Slovenian: Podjetje, ki trži zdravilo Cerdelga, bo zdravnikom in bolnikom priskrbelo izobraževalno gradivo, da zagotovi, da bodo zdravilo Cerdelga prejemali samo bolniki z Gaucherjevo boleznijo tipa 1 in da se to zdravilo ne bo uporabljajo pri nekaterih bolnikih s težavami z jetri in skupaj z drugimi zdravili, ki lahko bistveno spremenijo ravni zdravila Cerdelga v krvi.
English: The active substance in Cerdelga, eliglustat, works by blocking the action of an enzyme involved in the production of the glucosylceramide fat.
Slovenian: Učinkovina zdravila Cerdelga, eliglustat, deluje tako, da zavira encim, ki sodeluje pri tvorbi glukozilceramida.
English: The most common side effect seen with Cerdelga is dyspepsia (heartburn) in approximately 6 out of 100 patients.
Slovenian: Najpogostejši neželeni učinek, opažen pri zdravilu Cerdelga, je dispepsija (zgaga); pojavi se lahko pri približno 6 od 100 bolnikov.
English: In a study of 40 previously untreated patients with type-1 Gaucher disease, patients taking Cerdelga had a 28% reduction in spleen size, compared with a 2% increase in those taking placebo (a dummy treatment) after 9 months of treatment.
Slovenian: V študiji s 40 predhodno nezdravljenimi bolniki z Gaucherjevo boleznijo tipa 1 se je po devetih mesecih zdravljenja pri bolnikih, ki so jemali zdravilo Cerdelga, velikost vranice zmanjšala za 28 %, pri bolnikih, ki so jemali placebo (zdravilo brez učinkovine), pa se je povečala za 2 %.
English: Cerdelga can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of Gaucher disease.
Slovenian: Predpisovanje in izdaja zdravila Cerdelga je le na recept, zdravljenje z njim pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem Gaucherjeve bolezni.
English: Studies show that Cerdelga is effective at treating the disease, including reducing the size of enlarged spleens and livers.
Slovenian: Študije so pokazale, da zdravilo Cerdelga učinkovito zdravi bolezen in zmanjšuje velikost povečane vranice in jeter.
English: Because the build-up of this fat in organs like the spleen, liver and bones is responsible for the symptoms of type-1 Gaucher disease, reducing its production helps prevent its build-up, and thereby helps the affected organs to function better.
Slovenian: Ker simptome Gaucherjeve bolezni tipa 1 povzroča kopičenje te maščobe v organih, kot so vranica, jetra in kosti, je z zmanjšanjem njene tvorbe kopičenje preprečeno, s tem pa se prizadetim organom omogoči boljše delovanje.
English: Cerdelga contains the active substance eliglustat.
Slovenian: Zdravilo Cerdelga vsebuje učinkovino eliglustat.
English: For the full list of side effects reported for Cerdelga, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Cerdelga, glejte navodilo za uporabo.
English: How is Cerdelga used?
Slovenian: Kako se zdravilo Cerdelga uporablja?
English: Studies show that Cerdelga is effective in improving the symptoms of the disease for a majority of previously untreated patients with type-1 Gaucher disease and in keeping the disease stable in most patients previously treated by enzyme replacement.
Slovenian: Študije kažejo, da zdravilo Cerdelga učinkovito izboljšuje simptome bolezni pri večini predhodno nezdravljenih bolnikov z Gaucherjevo boleznijo tipa 1 in ohranja bolezen stabilno pri večini bolnikov, ki so bili predhodno zdravljeni z nadomestnim encimskim zdravljenjem, vendar se manjši delež bolnikov (približno 15 %), ki so z nadomestnega encimskega zdravljenja prešli na zdravilo Cerdelga, po enem letu zdravljenja ni optimalno odzval.
English: All patients who are prescribed Cerdelga will be provided with a patient alert card. All healthcare professionals who are expected to prescribe Cerdelga will be provided with a prescriber guide.
Slovenian: Vsi zdravstveni delavci, ki bodo predvidoma predpisovali zdravilo Cerdelga, bodo prejeli vodnik za zdravnike, ki predpisujejo zdravilo.
English: How does Cerdelga work?
Slovenian: Kako zdravilo Cerdelga deluje?
English: Currently available data are described in Sections 4.8and 5.2.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavju 4.8 in 5.2.
English: Date of first authorisation: 12 August 2013 Date of latest renewal: 26 April 2018
Slovenian: Datum prve odobritve: 12. avgust 2013 Datum zadnjega podaljšanja: 26. april 2018
English: Not known***
Slovenian: neznana***
English: • Do not take a double dose to make up for a forgotten dose.
Slovenian: • Ne vzemite dvojnega odmerka za nadomestitev pozabljenega odmerka.
English: The required dose is determined using the following formula:
Slovenian: Potreben odmerek določimo z uporabo naslednje formule:
English: This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Slovenian: To lahko storite tako, da viali pustite na sobni temperaturi približno eno uro ali ju nekaj minut držite v rokah.
English: This effect occurs immediately and is known to depend to a large extent on the level of polymerisation of the protein.
Slovenian: Ta učinek se pojavi takoj in znano je, da je v veliki meri odvisen od stopnje polimerizacije proteina.
English: Let blood flow back to the end of the tube.
Slovenian: Pustite, da kri teče nazaj do konca cevke.
English: • you notice that the medicine stops working properly (bleeding is not stopped).
Slovenian: • opazite, da zdravilo ne deluje več pravilno (krvavitev se ne ustavi) .
English: • the severity of your disease
Slovenian: • resnosti vaše bolezni,
English: Please contact your doctor immediately if: • you notice symptoms of allergic reactions
Slovenian: Prosimo, da nemudoma obvestite zdravnika če: • opazite simptome alergijskih reakcij
English: 6-12 years
Slovenian: 6-12 let
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Slovenian: Trombin zatem pretvori fibrinogen v fibrin in lahko se oblikuje strdek.
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba pripravljeno zdravilo uporabiti takoj.
English: • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: • Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: An appropriate dose should be re-administered every 12 - 24 hours.
Slovenian: Ustrezni odmerek je treba ponovno dati na vsakih 12 - 24 ur.
English: • Do not use this medicine after the expiry date, which is stated on the label and carton.
Slovenian: • Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: The patient should be observed for any immediate reaction.
Slovenian: Bolnika je treba opazovati glede pojava kakršne koli takojšnje reakcije.
English: As Voncento contains both FVIII and VWF, it is important to know which factor you most need.
Slovenian: Ker zdravilo Voncento vsebuje tako FVIII in VWF, je pomembno vedeti, kateri faktor najbolj potrebujete.
English: • If you are allergic to VWF or FVIII or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na VWF ali FVIII ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Reconstitution and withdrawal must be carried out under aseptic conditions.
Slovenian: Rekonstitucijo in izsesanje izvajajte pod aseptičnimi pogoji.
English: • your clinical condition
Slovenian: • vašega kliničnega stanja,
English: Frequency of doses (hours) / Duration of therapy (days)
Slovenian: Pogostnost odmerkov (ure) / trajanje zdravljenja (dnevi)
English: Follow the directions given to you by your doctor.
Slovenian: Upoštevajte navodila, ki vam jih je dal zdravnik.
English: - VWF produces delayed correction of the associated FVIII deficiency.
Slovenian: - VWF povzroči zakasnjeno izboljšanje povezanega pomanjkanja FVIII.
English: Voncento can be used for all age groups.
Slovenian: Zdravilo Voncento se lahko uporablja pri vseh starostnih skupinah.
English: Hypersensitivity (allergic reactions)
Slovenian: Preobčutljivost (alergijske reakcije)
English: • The reconstituted product should preferably be used immediately.
Slovenian: • Pripravljeno zdravilo je najbolje uporabiti takoj.
English: In case of shock, the current medical standards for shock treatment should be observed.
Slovenian: primeru šoka moramo upoštevati trenutne zdravstvene standarde za zdravljenje šoka.
English: The injection/infusion rate should not exceed 6 ml per minute.
Slovenian: Hitrost injiciranja/infundiranja naj ne presega 6 ml na minuto.
English: The amount of VWF and FVIII you need to take and the duration of treatment depend on:
Slovenian: Količina VWF in FVIII, ki jo morate vzeti in trajanje zdravljenja sta odvisna od:
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at room temperature (below 25 °C).
Slovenian: Po rekonstituciji so kemijsko in fizikalno obstojnost med uporabo dokazali za 8 ur pri sobni temperaturi (do 25 °C).
English: This also applies to any unknown or emerging viruses or other types of infections.
Slovenian: To velja tudi za katere koli neznane ali nove viruse ter druge vrste okužb.
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Upoštevajte, da letna stopnja krvavitve (ABR - annualized bleeding rate) ni primerljiva med različnimi koncentrati faktorjev in med različnimi kliničnimi študijami.
English: There are no data on fertility available.
Slovenian: Plodnost Podatkov o plodnosti ni na voljo.
English: The table presented below is according to the MedDRA system organ classification.
Slovenian: Spodnja preglednica je pripravljena v skladu s klasifikacijo organskih sistemov MedDRA.
English: • inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: • vključitev korakov pri obdelavi krvi ali plazme, ki lahko inaktivirajo ali odstranijo viruse.
English: <6 years
Slovenian: <6 let
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Slovenian: Uvedeni ukrepi so lahko omejeno učinkoviti proti virusom brez ovojnice, kot je parvovirus B19.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: V skladu s 114. členom Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: The vials must not be heated above body temperature (37 ºC).
Slovenian: Vial ne smete segrevati na temperaturo, ki je višja od telesne (37 ºC).
English: Lack of either factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Slovenian: Pomanjkanje katerega koli faktorja pomeni, da se kri ne strjuje tako hitro kot bi se morala in je zato povečana verjetnost za krvavitve.
English: Without opening the vials, warm the Voncento powder and the liquid to room or body temperature.
Slovenian: Brez da bi odprli viali, segrejte prašek Voncento in tekočino na sobno ali telesno temperaturo.
English: The pharmacokinetic data in patients with von Willebrand disease are very similar to those observed in the adult population.
Slovenian: Farmakokinetični podatki pri bolnikih s von Willebrandovo boleznijo so zelo podobni tistim, ki so jih opazili pri odrasli populaciji.
English: ** produced from plasma of human donors ***The VWF activity is determined using the WHO Standard for VWF.
Slovenian: ** pridobljen iz plazme človeških darovalcev *** Aktivnost VWF je določena s pomočjo WHO standarda za VWF.
English: This also applies to unknown or emerging viruses and other pathogens.
Slovenian: To velja tudi za neznane in nove viruse ter druge patogene.
English: Life-threatening haemorrhages 60 - 100
Slovenian: Življenjsko nevarne krvavitve 60 - 100
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Slovenian: Pričakuje se, da bo pogostnost, vrsta in resnost neželenih učinkov pri otrocih enaka kot pri odraslih.
English: • for individuals with a weakened immune system or with an increased production of red blood cells due to certain types of anaemia (e.g. sickle cell anaemia or haemolytic anaemia).
Slovenian: • za posameznike z oslabljenim imunskim sistemom ali s povečano proizvodnjo rdečih krvnih celic zaradi nekaterih vrst anemij (npr. anemija srpastih celic ali hemolitična anemija).
English: • The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
Slovenian: • Prašek je treba zmešati z vehiklom (tekočino) in ga pod aseptičnimi pogoji posesati iz viale.
English: The FVIII/VWF complex consists of two molecules (FVIII and VWF) with different physiological functions.
Slovenian: Kompleks FVIII/VWF sestavljata dve molekuli (FVIII in VWF) z različnima fiziološkima delovanjema.
English: Your doctor should give you treatment to prevent thrombosis.
Slovenian: Zdravnik vam bo dal zdravljenje za preprečevanje tromboze.