FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose should be reduced or treatment interrupted depending on whether the disease has worsened, the severity of any side effects and the levels of platelets (components that help the blood to clot) and neutrophils (a type of white blood cell that helps fight infection).
Slovenian: Zdravnik mora glede na poslabšanje bolezni, resnost neželenih učinkov ter število trombocitov (sestavnih delov krvi, ki pomagajo pri njenem strjevanju) in nevtrofilcev (vrste belih krvnih celic, ki pomagajo v boju proti okužbam) v krvi odmerek zmanjšati ali pa zdravljenje prekiniti.
English: Why is Lenalidomide Accord authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Lenalidomide Accord odobreno v EU?
English: Lenalidomide Accord is used:
Slovenian: Zdravilo Lenalidomide Accord se uporablja:
English: Lenalidomide Accord is available as capsules of various strengths to be taken by mouth.
Slovenian: Zdravilo Lenalidomide Accord je na voljo v obliki kapsul različnih jakosti, ki se jemljejo peroralno.
English: • in combination with melphalan (a cancer medicine) and prednisone (an anti-inflammatory medicine) for the treatment of adults with previously untreated multiple myeloma, who cannot have a stem cell transplant;
Slovenian: • v kombinaciji z melfalanom (zdravilom za zdravljenje raka) in prednizonom (protivnetnim zdravilom) za zdravljenje odraslih s predhodno nezdravljenim diseminiranim plazmocitomom, pri katerih ni mogoče opraviti presaditve matičnih celic;
English: • in combination with dexamethasone (an anti-inflammatory medicine), for the treatment of adults with previously untreated (newly diagnosed) multiple myeloma, who cannot have a stem cell transplant;
Slovenian: • v kombinaciji z deksametazonom (protivnetnim zdravilom) za zdravljenje odraslih s predhodno nezdravljenim (novo odkritim) diseminiranim plazmocitomom, pri katerih ni mogoče opraviti presaditve matičnih celic;
English: Therefore, the Agency's view was that, as for Revlimid, the benefit of Lenalidomide Accord outweighs the identified risk and it can be authorised for use in the EU.
Slovenian: Zato je menila, da koristi zdravila Lenalidomide Accord enako kot pri zdravilu Revlimid odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
English: How has Lenalidomide Accord been studied?
Slovenian: Kako je bilo zdravilo Lenalidomide Accord raziskano?
English: How does Lenalidomide Accord work?
Slovenian: Kako zdravilo Lenalidomide Accord deluje?
English: How is Lenalidomide Accord used?
Slovenian: Kako se zdravilo Lenalidomide Accord uporablja?
English: These measures should help protect the environment.
Slovenian: Ti ukrepi pomagajo varovati okolje.
English: Avoid multiple vial broaching.
Slovenian: Izogibajte se večkratnemu prebadanju viale.
English: These resolved within a maximum of 25 days.
Slovenian: Te reakcije izzvenijo v največ 25 dneh.
English: The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora obvestiti Evropsko komisijo o načrtih trženja za zdravilo, ki je predmet tega dovoljenja.
English: No information is available on the use of the vaccine in seropositive animals including those with maternally derived antibodies.
Slovenian: Na voljo ni nobenih informacij o uporabi cepiva pri seropozitivnih živalih vključno s tistimi z maternalnimi protitelesi.
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Slovenian: a) Bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Slovenian: *(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT-PCR, kar kaže, da virusni genom ni prisoten)
English: Do not mix with any other veterinary medicinal product.
Slovenian: Ne mešajte z nobenim drugim zdravilom.
English: Primary vaccination:
Slovenian: Osnovno cepljenje:
English: The level of efficacy for other species may differ from that observed in cattle.
Slovenian: Učinkovitost pri drugih vrstah se lahko razlikuje od dokazane učinkovitosti pri govedu.
English: *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in cattle.
Slovenian: *Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri govedu.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of bluetongue.
Slovenian: Uporaba tega cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU o kontroli bolezni modrega jezika.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Slovenian: SPC so dovoljenje snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against bluetongue virus (BTV).
Slovenian: Pri tej kategoriji živali uporabite cepivo le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja in/ali v skladu s trenutnimi smernicami pristojnih državnih organov za cepljenje proti virusu modrikastega jezika (BT).
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Slovenian: Za vsak program ponovnega cepljenja se je potrebno dogovoriti s pristojnimi nacionalnimi organi ali odgovornim veterinarjem, upoštevajoč pri tem epidemiološko situacijo.
English: 17813 Vall de Bianya
Slovenian: 17813 Vall de Bianya Girona
English: Local reactions may increase slightly following the second dose in this case lasting up to 15 days.
Slovenian: Lokalne reakcije se lahko nekoliko povečajo po drugem odmerku in trajajo do 15 dni.
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Medsebojno delovanje z drugimi zdravili in druge oblike interakcij: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Shelf life of the veterinary medicinal product as packaged for sale: 1 year.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 1 leto.
English: Shelf life after first opening the immediate packaging: use immediately after broaching.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: porabite takoj po načetju.
English: High density polyethylene (HDPE) vials of 20, 100 or 240 ml with chlorobutyl elastomer rubber stopper and aluminium seal containing 10, 50 or 120 doses of vaccine.
Slovenian: 20 ml, 100 ml ali 240 ml-viale iz polietilena visoke gostote (HDPE) z zamaškom iz klorobutilnega elastomera in aluminijsko zaporko, ki vsebujejo 10, 50 ali 120 odmerkov cepiva.
English: A transient increase in rectal temperature, not exceeding 2.7 C, was commonly observed during the 48 hours following vaccination in field safety studies.
Slovenian: Prehodno povišanje rektalne temperature, ki ne presega 2,7 °C je bilo pogosto opaženo 48 ur po cepljenju v terenskih varnostnih študijah.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multiinjection type vaccination system when larger dose presentations are used.
Slovenian: Da bi se izognili naključni kontaminaciji cepiva med uporabo, je pri večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
English: Potassium dihydrogen phosphate Disodium hydrogen phosphate dihydrate Sodium chloride
Slovenian: Kalijev dihidrogenfosfat Natrijev hidrogenfosfat dihidrat Natrijev klorid
English: Per dose of 2 ml:
Slovenian: V odmerku 2 ml:
English: To stimulate active immunity against bluetongue virus, serotypes 1 and 8 in cattle.
Slovenian: Za stimulacijo aktivne imunosti proti virusu bolezni modrikastega jezika, serotipa 1 in 8, pri govedu.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Slovenian: NAČIN IN POT(I) UPORABE Intramuskularma uporaba.
English: PACKAGE LEAFLET: Zulvac 1+8 Bovis Suspension for injection for cattle
Slovenian: NAVODILO ZA UPORABO Zulvac 1+8 Bovis Suspenzija za injiciranje za govedo
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Slovenian: Takoj po odpiranju in med istim postopkom porabite naenkrat celotno vsebino stekleničke.
English: Potassium chloride
Slovenian: Kalijev klorid
English: Avoid bubble formation, as this can be irritating at the site of injection.
Slovenian: Izogibajte se nastanku zračnih mehurčkov, saj le-ti lahko povzročijo draženje na mestu dajanja.
English: Manufacturer responsible for batch release: Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Proizvajalec, odgovoren za sproščanje serij: Zoetis Manufacturing & Research Spain, S.L.
English: Revaccination:
Slovenian: Ponovno cepljenje:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/03/2012.
Slovenian: Datum pridobitve dovoljenja za promet: 08/03/2012 Datum podaljšanja dovoljenja za promet: 13/12/2016
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20 ml, 1 x 100 ml or 240 ml
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml ali 1 x 240 ml
English: Off-white or pink liquid
Slovenian: Belkasta ali roza obarvana tekočina.
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Slovenian: Varnost in učinkovitost zdravila ni bila ugotovljena pri plemenskih živalih.
English: Lactation: Can be used during lactation.
Slovenian: Brejost : Lahko se uporablja v obdobju brejosti .
English: 2nd injection: 3 weeks after 1st injection.
Slovenian: 2. injekcija: 3 tedne po prvem cepljenju
English: For active immunisation of cattle from 3 months of age for the prevention* of viraemia caused by bluetongue virus (BTV), serotypes 1 and 8.
Slovenian: Za aktivno imunizacijo goveda, starejšega od 3 mesecev, za preprečitev* viremije, ki jo povzroča virus modrikastega jezika (BT), serotipa 1 in 8.
English: Shake gently immediately before use.
Slovenian: Neposredno pred uporabo rahlo pretresite.
English: Name and address of the manufacturer of the biological active substance Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke (bioloških) učinkovine (učinkovin) Zoetis Manufacturing & Research Spain, S.L.
English: Aluminium hydroxide, saponin and thiomersal.
Slovenian: Aluminijev hidroksid, saponin in tiomersal.
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 3 months of age.
Slovenian: Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja:
English: Pack of 1 bottle of 10 doses (20 ml).
Slovenian: Pakiranje z 1 vialo z 10 odmerki (20 ml).
English: PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Slovenian: 20 ml (10 odmerkov) 100 ml (50 odmerkov) 240 ml (120 odmerkov)
English: Zero days.
Slovenian: KARENCA Nič dni
English: Official control authority batch release is required for this product.
Slovenian: Za to zdravilo je potreben postopek uradne kontrole in sproščanja (OCABR postopek).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vial label 100 ml or 240 ml
Slovenian: PODATKI NA STIČNI OVOJNINI Nalepka na viali 100 ml ali 240 ml
English: Duration of immunity: 12 months after completion of the primary vaccination course.
Slovenian: Trajanje imunosti: 12 mesecev po končanem osnovnem cepljenju .
English: PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses)
Slovenian: 100 ml (50 odmerkov) 240 ml (120 odmerkov)
English: Do not use after the expiry date which is stated on the carton and label after EXP. Once broached use immediately.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po {EXP}.
English: Pack sizes
Slovenian: VELIKOST PAKIRANJA
English: Pack of 1 bottle of 120 doses (240 ml).
Slovenian: Pakiranje z 1 vialo s 120 odmerki (240 ml).
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus ATCvet code: QI02AA08.
Slovenian: Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.
English: Onset of immunity: 21 days after completion of the primary vaccination course.
Slovenian: Začetek imunosti: 21 dni po končanem osnovnem cepljenju.
English: 2nd injection: after 3 weeks.
Slovenian: 1. injekcija: od 3 meseca starosti.
English: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1, Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02.
Slovenian: Inaktiviran virus modrega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 Inaktiviran virus modrega jezika, serotip 8, sev BTV-8/BEL2006/02
English: Pack of 1 bottle of 50 doses (100 ml).
Slovenian: Pakiranje z 1 vialo s 50 odmerki (100 ml).
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Slovenian: Če se cepivo uporablja pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost.
English: Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Slovenian: Lokalne reakcije v velikosti do 5 cm v premeru so bile zelo pogosto opažene in reakcije v velikosti >5 cm v premeru so bile pogosto opažene po večkratnem dajanju enkratnega odmerka v v terenskih varnostnih študijah.
English: Adjuvants: Aluminium hydroxide
Slovenian: Aluminijev hidroksid
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001 (20 ml)
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/001 (20 ml)
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of two-fold overdose.
Slovenian: Po dajanju dvojnega odmerka se pri 10 % živali v 24 urah po injiciranju lahko pojavi prehodno povišanje rektalne temperature do 2°.
English: EXPIRY DATE EXP {month/year} Once broached use immediately.
Slovenian: EXP {mesec/leto}
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/001
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Slovenian: Vsak 2 ml odmerek vsebuje:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/139/002
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/12/139/002
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each 2 ml dose contains:
Slovenian: Vsak odmerek (2 ml) vsebuje:
English: A transient increase in rectal temperature, not exceeding 2 C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Po dajanju dvojnega odmerka se pri 10 % živali v 24 urah po injiciranju lahko pojavi prehodno povišanje rektalne temperature do 2 °C.
English: Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
Slovenian: Lokalne reakcije, manjše od 2 cm v premeru so bile zelo pogosto opažene, medtem ko so bile reakcije do 5 cm v premeru opažene pogosto po enkratnem odmerku v terenskih varnostnih študijah.
English: Special warnings for each target species:
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto: Cepite samo zdrave živali.
English: Active substance(s):
Slovenian: NAVEDBA UČINKOVIN(E) IN
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 20 ml (10 doses)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
English: Packaging Content Package size Withdrawal period
Slovenian: Način uporabe Pakiranje Vsebina Velikost pakiranja
English: This has been subject to previous reviews leading to risk minimisation measures at national level.
Slovenian: To je bil tudi predmet predhodnih preučevanj, ki so privedli do ukrepov za zmanjšanje tveganj na nacionalnih ravneh.
English: • For bromocriptine: Restriction of the maximum dose to 30 mg per day.
Slovenian: • Za bromokriptin: Omejitev največjega odmerka na dan na 30 mg dnevno.
English: A contraindication for patients treated for a long period and with pre-existing cardiac valulopathy .
Slovenian: Kontraindikacija za bolnike, zdravljene dolgo časa in s predhodno prisotno kardialno valvulopatijo.
English: A warning on the possible risk of fibrosis in patients taking these medicines at high doses for long periods.
Slovenian: Opozorilo o možnih tveganjih fibroze pri bolnikih, ki ta zdravila jemljejo v večjih odmerkih in dlje časa.
English: Four main observational studies looked into the risk of cardiac valvulopathy in patients treated with dopamine agonists for Parkinson's disease (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
Slovenian: V štirih glavnih opazovalnih študijah so opazovali tveganje pojava srčne valvulopatije pri bolnikih s Parkinsonovo boleznijo, zdravljenimi z agonisti dopamina (Zanettini et al., NEJM, 2007; Schade et al., NEJM 2007; Yamamoto et al., Neurology 2006; Peralta et al., Movement Disorders 2006).
English: This warning includes recommendations for the monitoring of patients for signs of fibrosis during treatment.
Slovenian: Opozorilo vključuje priporočilo, da je treba med zdravljenjem opazovati bolnike zaradi pojava znakov fibroze..
English: On 21 June 2007, the UK asked the CHMP, under article 31 of Directive 2001/83/EC, as amended, to review the risk of fibrosis and cardiac valvulopathy associated with the use of all ergot-derived dopamine agonists, and to provide an opinion on whether the marketing authorisations for all products of the class should be maintained, varied, suspended or withdrawn.
Slovenian: Dne 21. junija 2007 je Združeno kraljestvo v skladu s členom 31 Direktive 2001/83/ES, kakor je bila spremenjena, zaprosilo Odbor za zdravila za uporabo v humani medicini, predlog za ponovno preučitev tveganj fibroznih obolenj in srčne valvulopatije, povezanih z uporabo iz rženega rožička pridobljenih agonistov dopamina, ter poda mnenje o tem, ali naj ostanejo dovoljenja za promet z vsemi zdravili te skupine še dalje veljavna, oziroma se spremenijo, začasno ukinejo ali umaknejo.
English: The degree of 5-HT2B receptor agonism varies across ergot derived dopamine agonists and fits well with the difference in incidence rates of fibrotic events for the different ergot-products (C.Hofmann et al., Clin Neuropharmacol, 2006).
Slovenian: Stopnja agonističnega delovanja na receptor 5-HT2B se razlikuje med posameznimi agonisti dopamina, ki so pridobljeni iz rženega rožička, in dobro ustreza razlikam v pojavnosti dogodkov fibroze v različnih skupinah zdravil, pridobljenih iz rženega rožička (C.Hofmann et al., Clin Neuropharmacol, 2006).
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF BROMOCRIPTINE, DIHYDROERGOCRYPTINE AND LISURIDE AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA BROMOKRIPTINA, DIHIDROERGOKRIPTINA IN LIZURIDA IN Z NJIMI POVEZANIH IMEN (GLEJTE DODATEK I)
English: As a result, cabergoline and pergolide containing medicinal products are indicated only as 2nd line therapy in Parkinson's disease, and their use is contraindicated for patients with evidence of valve problems.
Slovenian: Zaradi tega so zdravila, ki vsebujejo kabergolin in pergolid indicirana le kot zdravljenje druge izbire pri zdravljenju Parkinsonove bolezni, njihova uporaba pa je kontraindicirana pri bolnikih z dokazanimi težavami srčne zaklopke.
English: Ergot derived dopamine agonists are mainly used to treat Parkinson's disease, either on their own or in combination with other medicines.
Slovenian: Agonisti dopamina, pridobljeni iz rženega rožička, se v glavnem uporabljajo za zdravljenje Parkinsonove bolezni, samostojno ali v kombinaciji z drugimi zdravili.
English: Spontaneous cases of fibrotic reactions were reported for all ergot derived dopamine agonists, especially at high doses and after long period of treatment.
Slovenian: O spontanih primerih fibroznih reakcij so poročali pri uporabi vseh agonistov dopamina, pridobljenih iz rženega rožička, zlasti pri večjih odmerkih in po daljših obdobjih zdravljenja.
English: They are also used to treat conditions including hyperprolactinaemia and prolactinoma, and to prevent lactation and migraine.
Slovenian: Uporabljajo se tudi za zdravljenje drugih stanj, kot sta hiperprolaktinemija in prolaktinoma ter za preprečevanje laktacije in migren.
English: • For bromocriptine and dihydroergocryptine:
Slovenian: • Za bromokriptin in dihidroergokriptin:
English: In view of the differences in the level risk amongst ergot derived dopamine agonists, the CHMP recommended that a separate opinion is issued for cabergoline and pergolide.
Slovenian: Zaradi razlik v stopnji tveganja pri uporabi različnih agonistov dopamina, pridobljenih iz rženega rožička, je CHMP predlagal, da se za kabergolin in pergolid izda ločeno mnenje.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Slovenian: DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
English: - In view of the available data, the Committee concluded that the risk of fibrotic events, including valvulopathy, is not equal for all ergot-derived dopamine agonists.
Slovenian: - Glede na razpoložljive podatke je Odbor odločil, da tveganje fibroznih dogodkov, vključno z srčno valvulopatijo, ni enako pri vseh agonistih dopamina, pridobljenih iz rženega rožička.
English: - The CHMP, as a consequence, recommended amendments to the relevant sections of the Summary of product characteristics and Package leaflets for the medicinal products containing bromocriptine, dihydroergocryptine and lisuride (see Annex III).
Slovenian: - CHMP je posledično priporočil dopolnitev ustreznih poglavij povzetka glavnih značilnostih zdravila in navodila za uporabo zdravil, ki vsebujejo bromokriptin, dihidroergokriptin in lizurid (glejte Dodatek III).
English: The Schade study reported higher adjusted incidence rate ratio (IRR) for symptomatic valvular regurgitation for cabergoline and pergolide, compared to bromocriptine, lisuride, and non ergot derived dopamine agonists pramipexole and ropirinole for which no cases were reported.
Slovenian: Rezultati študije Schade so pokazali višje prilagojeno razmerje stopnje pojavnosti (IRR) simptomatske regugitacije valvul pri bolnikih, zdravljenih z kabergolinom in pergolidom, v primerjavi s tistimi, zdravljenimi z bromokriptinom, lizuridom in drugimi agonisti dopamina, ki niso pridobljeni iz rženega rožička, na primer pramipeksol in ropinirol, pri katerih ni bilo poročil o takšnih primerih.