FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a summary of the European public assessment report (EPAR) for Ruconest.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ruconest.
English: What is the risk associated with Ruconest?
Slovenian: Kakšna tveganja so povezana z zdravilom Ruconest?
English: Ruconest is available as a powder (with or without solvent) that is made up into a solution for injection.
Slovenian: Zdravilo Ruconest je na voljo kot prašek (z vehiklom ali brez njega) za pripravo raztopine za injiciranje.
English: When it is given during an angioedema attack, conestat alfa stops this excessive activity, helping to relieve the patient's symptoms.
Slovenian: Če se konestat alfa daje med napadom angioedema, ta ustavi prekomerno delovanje in pomaga lajšati bolnikove simptome.
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 Ruconest.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: The company will also provide prescribers with an alert card for their patients.
Slovenian: Prav tako bo zdravnikom, ki bodo predpisovali zdravilo, priskrbela tudi opozorilno izkaznico za bolnike.
English: Ruconest is a medicine used to treat attacks of hereditary angioedema in adults and adolescents.
Slovenian: Zdravilo Ruconest se uporablja za zdravljenje napadov hereditarnega (dednega) angioedema pri odraslih in mladostnikih.
English: The C1 esterase inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Slovenian: Beljakovina, imenovana zaviralec esteraze C1, je potrebna za nadzor sistemov „komplementa“ in „kontakta“, tj. skupkov beljakovin v krvi, ki se borijo proti okužbam in povzročajo vnetja.
English: Ruconest can only be obtained with a prescription and treatment should be started under the supervision of a doctor with experience in diagnosing and treating hereditary angioedema.
Slovenian: Predpisovanje in izdaja zdravila Ruconest je le na recept, zdravljenje pa se lahko uvede le pod nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem dednega angioedema.
English: The company that markets Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy.
Slovenian: Družba, ki izdeluje zdravilo Ruconest, bo zdravstvenim delavcem, ki naj bi predpisovali to zdravilo, zagotovila izobraževalno gradivo z informacijami o njegovi pravilni uporabi in opozorili glede tveganja za pojav alergije.
English: The CHMP decided that Ruconest's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Ruconest večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Ruconest was more effective than placebo at improving the symptoms of patients having an attack of angioedema.
Slovenian: Zdravilo Ruconest je bilo pri izboljševanju simptomov pri bolnikih, ki so imeli napad angioedema, učinkovitejše od placeba.
English: Ruconest was studied in two main studies involving a total of 70 adults and adolescents with hereditary angioedema caused by low levels of C1 esterase inhibitor protein.
Slovenian: Zdravilo Ruconest so raziskovali v dveh glavnih študijah s skupno 70 odraslimi in mladostniki z dednim angioedemom, ki ga povzročajo nizke ravni beljakovine, imenovane zaviralec esteraze C1.
English: When an attack occurred, the patients were given Ruconest or placebo (a dummy treatment).
Slovenian: Bolniki so med napadom prejeli zdravilo Ruconest ali placebo (zdravilo brez zdravilne učinkovine).
English: Ruconest contains the active substance conestat alfa.
Slovenian: Zdravilo Ruconest vsebuje zdravilno učinkovino konestat alfa.
English: How does Ruconest work?
Slovenian: Kako zdravilo Ruconest deluje?
English: Ruconest is used in patients with hereditary angioedema that is linked to naturally low levels of a protein called ‘C1 esterase inhibitor'.
Slovenian: Zdravilo Ruconest se uporablja pri bolnikih z dednim angioedemom, ki je povezan z naravno nizkimi ravnmi beljakovine, imenovane zaviralec esteraze C1.
English: For the full list of all side effects reported with Ruconest, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ruconest, glejte navodilo za uporabo.
English: The active substance in Ruconest, conestat alfa, is a copy of the C1 esterase inhibitor protein and wor ks in the same way as the natural human protein.
Slovenian: Zdravilna učinkovina v zdravilu Ruconest, konestat alfa, je kopija beljakovine, imenovane zaviralec esteraze C1, ki učinkuje enako kot naravna človeška beljakovina.
English: How is Ruconest used?
Slovenian: Kako se zdravilo Ruconest uporablja?
English: This mechanism takes place at high concentrations.
Slovenian: Ta mehanizem se pojavi pri visokih koncentracijah.
English: Over 50 different enzymes have been identified.
Slovenian: Identificiranih je bilo več kot 50 različnih encimov.
English: The interpretation of the EU legislation and consideration of compliance with the legal provisions of Article 6(3) of the Directive are not within the remit of the Committee and therefore these issues are not addressed in the assessment of the referral procedure.
Slovenian: Interpretacija zakonodaje EU in ugotavljanje skladnosti z zakonskimi določbami člena 6(3) Direktive ne spadata v pristojnost Odbora, zato ta vprašanja v oceni postopka napotitve niso bila obravnavana.
English: There are insufficient data available to support the currently approved indications.
Slovenian: Razpoložljivi podatki niso zadostni, da bi podprli trenutno odobrene indikacije.
English: Croatia PROPHARMA VET d.o.o.
Slovenian: Hrvaška PROPHARMA VET d.o.o.
English: Croatia Krka - Farma d.o.o.
Slovenian: Hrvaška Krka - Farma d.o.o.
English: Thus, the use of these products may present a serious risk to animal health in terms of lack of efficacy, as well as target animal safety.
Slovenian: Uporaba teh zdravil lahko torej predstavlja resno tveganje za zdravje živali v smislu pomanjkanja učinkovitosti ter tudi za varnost ciljne živalske vrste.
English: Additionally, development of antimicrobial resistance towards gentamicin would present a serious risk both to human and animal health.
Slovenian: Poleg tega bi razvoj odpornosti mikrobov proti gentamicinu predstavljal resno tveganje tako za zdravje ljudi kot živali.
English: The marketing authorisations of the products concerned by this referral procedure are assumed to have been granted by the national competent authorities on the basis of Article 6(3) of Directive 2001/82/EC.
Slovenian: Za dovoljenja za promet z zdravili, ki jih zadeva ta napotitveni postopek, se predvideva, da so jih odobrili pristojni nacionalni organi na podlagi člena 6(3) Direktive 2001/82/ES.
English: Referral procedures on the basis of Article 35 of Directive 2001/82/EC require a clearly formulated question referred to the Committee.
Slovenian: V napotitvenih postopkih na podlagi člena 35 Direktive 2001/82/ES je treba Odboru predložiti jasno opredeljeno vprašanje.
English: Whenever possible, use of the product should be based on susceptibility testing of the bacteria isolated from the animal.
Slovenian: Kadar je mogoče, mora uporaba zdravila temeljiti na testiranju občutljivosti bakterij, izoliranih iz živali.
English: With relation to the already approved target species horses, the wording below should be used:
Slovenian: V povezavi z že odobreno ciljno živalsko vrsto, konji, je treba uporabiti besedilo v nadaljevanju:
English: The Committee concluded that most of the current broad indications would not be supported by data.
Slovenian: Odbor je zaključil, da podatki ne podpirajo večine trenutnih širokih indikacij.
English: The CVMP notes that pursuant to Article 36 of the Directive, its obligation is to consider the matter concerned and issue a reasoned opinion within the appropriate time limit.
Slovenian: Odbor CVMP je upošteval, da mora v skladu s členom 36 Direktive obravnavati zadevo in izdati obrazloženo mnenje v ustreznem časovnem roku.
English: Spain MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
Slovenian: Španija MEVET, S.A.U Poligono Industrial El Segre, Parcela 409-410
English: The scope of referral procedures is limited to evaluation of quality, safety and efficacy of veterinary medicinal products.
Slovenian: Obseg napotitvenih postopkov je omejen na ovrednotenje kakovosti, varnosti in učinkovitosti zdravil za uporabo v veterinarski medicini.
English: 24010 León Spain
Slovenian: 24010 León Španija
English: The reference product is Gentaject 10% solution for injection for horses which has been authorised in Ireland since 1988 (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
Slovenian: Referenčno zdravilo je zdravilo Gentaject 10-odstotna raztopina za injiciranje za konje, ki je od leta 1988 odobreno na Irskem (VPA 10976/2/1; Franklin Pharmaceuticals Ltd).
English: Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona
Slovenian: Constitución, 1 Planta baja 3 08960 Sant Just Desvern Barcelona Španija
English: Thus only the scientific questions posed to the CVMP in the referral notification have been considered and are reported below.
Slovenian: Zato so bila obravnavana samo znanstvena vprašanja, ki so bila odboru CVMP zastavljena v obvestilu o napotitvi in so navedena v nadaljevanju.
English: Over-use of gentamicin products might result in an increased risk of the theoretical concept of adaptive resistance.
Slovenian: Čezmerna uporaba zdravil, ki vsebujejo gentamicin, bi lahko povzročila povečano tveganje za teoretični koncept adaptivne odpornosti.
English: Since the reference product is only authorised in Ireland, the concept of the European reference product has been applied in this MRP.
Slovenian: Ker je referenčno zdravilo odobreno samo na Irskem, je bil v tem postopku z medsebojnim priznavanjem uporabljen koncept evropskega referenčnega zdravila.
English: 43206 Tarragona Spain
Slovenian: 43206 Tarragona Španija
English: All other dosing regimens appear to be approved based on expert reports, scientific publications and PK/PD characteristics.
Slovenian: Kot kaže, so vsi ostali režimi odmerjanja odobreni na podlagi izvedenskih poročil, znanstvenih publikacij in farmakokinetičnih/farmakodinamičnih lastnosti.
English: Lithuania LABORATORIOS SYVA, S.A. Av. Párroco Pablo Díez, 49-57 24010, León
Slovenian: LABORATORIOS SYVA, S.A. Av. Párroco Pablo Díez, 49-57 24010, León
English: To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid under- or over-dosing.
Slovenian: Da bi zagotovili ustrezno odmerjanje, je treba čim natančneje določiti telesno maso, saj se s tem prepreči premajhno ali preveliko odmerjanje.
English: ATCvet code: QJ01GB03
Slovenian: Oznaka ATC vet: QJ01GB03
English: Where blood monitoring is available, target peak plasma gentamicin concentrations should be approximately 16-20 µg/ml.
Slovenian: Kadar je spremljanje krvi mogoče, morajo biti ciljne najvišje koncentracije gentamicina v plazmi približno 16-20 µg/ml.
English: Spain LABORATORIOS SYVA, S.A.U.
Slovenian: Španija LABORATORIOS SYVA, S.A.U.
English: Gentamicin is used for first or second choice treatments in a variety of clinical situations in horses.
Slovenian: Gentamicin se uporablja kot zdravilo prve ali druge izbire za različne klinične primere pri konjih.
English: In order to reduce the nephrotoxic risk, adequate hydration of animals under treatment should be ensured, and fluid therapy should be instituted, if required.
Slovenian: Da bi zmanjšali tveganje za nefrotoksičnost, je treba zagotoviti zadostno hidracijo zdravljenih živali in po potrebi uvesti tekočinsko zdravljenje.
English: Ozzano Emilia (Bologna) Italy
Slovenian: Ozzano Emilia (Bologna) Italija
English: Furthermore, higher approved doses (e.g. Genta Equine 10% solution for injection) may pose a threat to target animal safety due to the known nephrotoxicity of gentamicin.
Slovenian: Poleg tega bi večji odobreni odmerki (npr. zdravila Genta Equine 10-odstotna raztopina za injiciranje) lahko ogrozili varnost ciljne živalske vrste zaradi znane nefrotoksičnosti gentamicina.
English: Do not use in known cases of renal dysfunction.
Slovenian: Ne uporabite v primeru znanega nepravilnega delovanja ledvic.
English: Latvia CP - Pharma Handelsges.
Slovenian: CP - Pharma Handelsges.
English: Austria Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien
Slovenian: Avstrija Vana GmbH Wolfgang Schmälzl Gasse 6 1020 Wien
English: Therefore, on 14 February 2014, Denmark presented to the European Medicines Agency (‘the Agency') a referral notification under Article 35 of Directive 2001/82/EC, for all veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Slovenian: Danska je zato dne 14. februarja 2014 Evropski agenciji za zdravila („Agenciji“) predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so na voljo v obliki raztopin za injiciranje za konje.
English: As only very limited data are available to support all the current indications in horses the CVMP focused in their review mainly on the assessment of current scientific literature and minimum inhibitory concentration (MIC) data.
Slovenian: Ker so razpoložljivi podatki, s katerimi bi lahko podprli vse trenutne indikacije pri konjih, zelo omejeni, se je odbor CVMP v pregledu osredotočil predvsem na oceno trenutne znanstvene literature in podatkov o minimalni inhibitorni koncentraciji (MIK).
English: Spain Industrial Veterinaria, S.A. Esmeralda, 19
Slovenian: Španija Industrial Veterinaria, S.A. Esmeralda, 19
English: Spain LABIANA LIFE SCIENCE, S.A. C/ Venus, 26
Slovenian: Španija LABIANA LIFE SCIENCE, S.A. C/ Venus, 26
English: However, studies in laboratory animals have shown evidence of fetal nephrotoxicity.
Slovenian: Laboratorijske študije na živalih so pokazale znake fetalne nefrotoksičnosti.
English: There are several mechanisms by which various strains of bacteria have developed resistance against aminoglycosides like gentamicin.
Slovenian: Obstaja več mehanizmov, preko katerih so različni sevi bakterij razvili odpornost proti aminoglikozidom, kot je gentamicin.
English: Enzymatic modification results in highlevel resistance.
Slovenian: Encimska modifikacija povzroči visoko stopnjo odpornosti.
English: Spain B.BRAUN VETCARE, S.A. Crta.
Slovenian: Španija B.BRAUN VETCARE, S.A. Crta.
English: The dosing regimen must not be exceeded.
Slovenian: Režim odmerjanja se ne sme preseči.
English: Latvia Huvepharma AD 33 James Boucher Blvd. Sofia 1407
Slovenian: Huvepharma AD 33 James Boucher Blvd. Sofia 1407
English: The substance is highly polar, hydrophilic and transport appears to be an active process closely linked to electron transport, oxidative phosphorylation and the respiratory quinones in the cell membrane.
Slovenian: Učinkovina je zelo polarna in hidrofilna, njen prenos pa je aktiven proces, ki je tesno povezan s prenosom elektronov, oksidativno fosforilacijo in respiratornimi kinoni v celični membrani.
English: Spain CENAVISA Camí Pedra Estela s/n 43205 Reus Tarragona) Spain
Slovenian: Španija CENAVISA Camí Pedra Estela s/n 43205 Reus
English: Spain POLICHEM S.L.U.
Slovenian: Španija POLICHEM S.L.U.
English: The CVMP Antimicrobials Working Party (AWP) and Efficacy Working Party (EWP) were consulted on several aspects of a safe dosing regimen of gentamicin in horses.
Slovenian: Delovno skupino odbora CVMP za antibiotike (AWP) in delovno skupino za učinkovitost (EWP) so zaprosili za mnenje o različnih vidikih varnega režima odmerjanja gentamicina pri konjih.
English: • on the basis of the available data, the CVMP considered that all other indications and dosage regimens in horses should be deleted from the product information;
Slovenian: • odbor CVMP je na podlagi razpoložljivih podatkov menil, da je treba vse ostale indikacije in režime odmerjanja pri konjih izbrisati iz informacij o zdravilu;
English: Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primeru znane preobčutljivosti za zdravilno učinkovino ali katero koli pomožno snov.
English: mbH Ostlalandring 13
Slovenian: Ostlalandring 13
English: The relatively low approved dose and the target pathogens indicated for Gentaject 10% solution for injection gave grounds for Denmark to be concerned as to whether the proposed indications and dosage regimen for this product are supported by adequate data, given evidence from recent scientific publications.
Slovenian: Danska je bila zaradi relativno majhnega odobrenega odmerka in ciljnih patogenov, indiciranih za zdravilo Gentaject 10-odstotna raztopina za injiciranje, zaskrbljena glede tega, ali so predlagane indikacije in režim odmerjanja za to zdravilo podprti z zadostnimi podatki, če se upoštevajo dokazi iz novejših znanstvenih publikacij.
English: Spain SUPER´S DIANA, S.L Ctra.
Slovenian: Španija SUPER´S DIANA, S.L Ctra.
English: Spain FATRO IBERICA, S.L.
Slovenian: Španija FATRO IBERICA, S.L.
English: Most of the injectable products for horses containing gentamicin were initially approved in the 1980s and 1990s, and (compared to current requirements) only very limited data are available to support indications or dosing regimens in horses.
Slovenian: Večina zdravil za injiciranje za konje, ki vsebujejo gentamicin, je bila prvotno odobrena v osemdesetih in devetdesetih letih prejšnjega stoletja, razpoložljivi podatki v podporo indikacijam in režimom odmerjanja pri konjih pa so zelo omejeni (glede na trenutno veljavne zahteve).
English: Therefore, the CVMP considers that no dosing regimen should be specified for foals, and currently approved dosing regimens for foals should be deleted from the product information, due to lack of target animal safety data especially concerning nephrotoxicity.
Slovenian: Odbor CVMP je zato menil, da se za žrebeta ne sme določiti noben režim odmerjanja in da je trenutno odobrene režime odmerjanja za žrebeta treba izbrisati iz informacij o zdravilu zaradi pomanjkanja podatkov o varnosti za ciljno živalsko vrsto, zlasti v povezavi z nefrotoksičnostjo.
English: However, no target animal safety studies using a substantiated scientific study design, as recommended in the VICH guideline 431 on target animal safety have been conducted covering the authorised dosing regimens and routes of administration in adult horses and foals, in particular in regard to gentamicin-induced nephrotoxicity.
Slovenian: Vendar pa niso bile izvedene nobene študije o varnosti ciljne živalske vrste, zasnovane kot znanstveno utemeljene študije v skladu s priporočili iz smernic VICH 431 za varnost ciljnih živalskih vrst, ki bi zajele odobrene režime odmerjanja in poti uporabe pri odraslih konjih in žrebetih, zlasti v povezavi z nefrotoksičnostjo, ki jo povzroča gentamicin.
English: There are also isolated reports of ototoxicity with gentamicin.
Slovenian: Obstajajo tudi posamezna poročila o ototoksičnosti, povezani z gentamicinom.
English: Do not exceed the proposed dosing regimen.
Slovenian: Predlaganega režima odmerjanja ne smete preseči.
English: The CVMP considered that this dose was supported by clinical experiences, taking into account that a single daily administration would reduce the risk of nephrotoxicity in adult horses (compared to more frequent daily administrations) and also the risk of the theoretical concept of adaptive resistance.
Slovenian: Odbor CVMP je menil, da ta odmerek podpirajo klinične izkušnje, pri čemer bi z dajanjem zdravila enkrat na dan zmanjšali tveganje za nefrotoksičnosti pri odraslih konjih (v primerjavi z dajanjem večkrat na dan) in tudi tveganje za teoretični koncept adaptivne odpornosti.
English: Safety of gentamicin has not been established in foals and there is a lack of knowledge of the extra effects of gentamicin on foal kidneys, especially neonates.
Slovenian: Varnost gentamicina ni bila dokazana pri žrebetih, prav tako pa je premalo znanega o dodatnih učinkih gentamicina na ledvica žrebet, zlasti novorojenih.
English: Belgium EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgium
Slovenian: EMDOKA bvba John Lijsenstraat 16 B-2321 Hoogstraten Belgija
English: The use of the products has been limited to an indication for which gentamicin is considered efficacious on the basis of the data and information available.
Slovenian: Uporaba zdravil je bila omejena na indikacijo, za katero je bilo na podlagi razpoložljivih podatkov in informacij ocenjeno, da je gentamicin pri njej učinkovit.
English: Pharmacokinetics of gentamicin change considerably in the first 2 weeks of a foal's life - plasma concentrations of gentamicin are more difficult to achieve in neonatal foals and gentamicin is retained longer in the body, especially kidneys, compared to adults leading to a higher likelihood of gentamicin-induced nephrotoxicity.
Slovenian: Farmakokinetika gentamicina se v prvih 2 tednih življenja žrebeta močno spremeni - pri novorojenih žrebetih se težje dosežejo plazemske koncentracije gentamicina, prav tako pa gentamicin dlje časa ostane v telesu, zlasti v ledvicah, kot pri odraslih konjih, kar povzroči večjo verjetnost za nefrotoksičnost zaradi gentamicina.
English: Gentamicin is de-activated in the presence of inflammatory debris, low oxygen environments and low pH.
Slovenian: Gentamicin preneha učinkovati v prisotnosti vnetnega debrisa, v okoljih z malo kisika in pri nizkem pH.
English: Only very limited data are available to support the range of indications and dose regimens and the CVMP was asked to review the data available and to recommend scientifcally justified indications and a safe and efficacious dosing regimen in horses.
Slovenian: Razpoložljivi podatki v podporo različnim indikacijam in režimom odmerjanja so zelo omejeni, zato je bil odbor CVMP zaprošen, naj pregleda razpoložljive podatke in priporoči znanstveno utemeljene indikacije ter varen in učinkovit režim odmerjanja za konje.
English: This monitoring includes assessing relevant kidney parameters in blood (e.g. creatinine and urea) and urinalysis (e.g. gamma glutamyl transferase/creatinine ratio).
Slovenian: Spremljanje mora vključevati ocenjevanje pomembnih ledvičnih parametrov v krvi (npr. kreatinina in sečnine) ter preiskave urina (npr. razmerje med gama-glutamiltransferazo in kreatininom).
English: In addition, there are only limited choices available for the treatment of Gram-negative infections in horses, and clinical experience has shown that gentamicin is effective in adult horses at a single daily dose of 6.6 mg/kg bw (intravenously) over 3-5 days.
Slovenian: Poleg tega so za zdravljenje okužb z gramnegativnimi bakterijami pri konjih na voljo omejene možnosti, klinične izkušnje pa kažejo, da je gentamicin učinkovit pri odraslih konjih v enkratnem dnevnem odmerku 6,6 mg/kg telesne mase (intravensko), ki se daje 3-5 dni.
English: Slovakia Fatro S.p.A.
Slovenian: Slovaška Fatro S.p.A.
English: During this MRP Denmark noted that the originator and the generic products have different indications and dosing regimens.
Slovenian: Med postopkom z medsebojnim priznavanjem je Danska ugotovila, da imata originatorsko in generično zdravilo različne indikacije in režime odmerjanja.
English: The CVMP recommended a dosing regimen for adult horses of 6.6 mg/kg once daily for 3-5 days, accompanied by strong warnings in the product literature about the lack of target animal safety data.
Slovenian: Odbor CVMP je priporočil režim odmerjanja za odrasle konje 6,6 mg/kg enkrat na dan 3-5 dni, skupaj z močnim opozorilom v informacijah o zdravilu glede pomanjkljivih podatkov o varnosti za ciljno živalsko vrsto.