FrancophonIA/ELRC3.0 huggingface dataset:
English: Question 4 - Is the VMP intended for use in a minor species that is reared and treated similarly to a major species for which an EIA (Environmental Impact Assessment) already exists?
Slovenian: Vprašanje 4 - Ali je zdravilo za uporabo v veterinarski medicini namenjeno za uporabo pri manj pomembni vrsti, ki se vzreja in goji podobno kot pomembnejša vrsta, za katero presoja vplivov na okolje (EIA, Environmental Impact Assessment) že obstaja?
English: PECSOIL- Intensively reared animals = 1.036 µg.kg-1
Slovenian: PECTLA- živali v intenzivni reji = 1,036 µg.kg-1
English: Based on this, the applicant argued that the horse should be classed as “minor use/minor species” and that no Phase II risk assessment is required.
Slovenian: Na podlagi tega je predlagatelj mnenja, da bi konji morali soditi v skupino »manjše uporabe/manj pomembne vrste« ter da faza II ocenjevanja tveganja ni potrebna.
English: The PEC in soil were calculated for intensively reared animals and pasture animals, according to the CVMP Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-corr).
Slovenian: Izračunana je bila PEC (predvidena koncentracija v okolju) v prsti za živali v intenzivni reji in pašne živali, v skladu s smernico CVMP o oceni vpliva zdravil za uporabo v veterinarski medicini na okolje v podporo smernicama VICH GL6 in GL38 (EMEA/CVMP/ERA/418282/2005-popr.).
English: No adequate data for Tier B were provided by the applicant to assess the long-term effects on dung fauna organisms caused by the use of the product.
Slovenian: Predlagatelj ni predložil ustreznih podatkov za stopnjo B, ki bi omogočali oceno dolgoročnih učinkov uporabe zdravila na organizme, prisotne v gnoju.
English: For two soil exposure scenarios the PECSOIL values did not exceed the 100 µg/kg threshold value as stated in the VICH Guideline for Phase I assessments of veterinary medicines.
Slovenian: Pri teh dveh scenarijih izpostavljenosti vrednosti PECTLA nista presegli mejne vrednosti 100 µg/kg, kot je navedeno v smernici VICH za fazo I ocenjevanja za zdravila za uporabo v veterinarski medicini.
English: A separate file for justification of exemption from phase II was not specifically given.
Slovenian: Ločena dokumentacija za utemeljitev izvzetja iz faze II ni bila posebej predložena.
English: The Marketing Authorisation Holder provided an updated environmental risk assessment.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil posodobljeno oceno tveganja za okolje.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/ APPLICANT(S)
Slovenian: DODATEK I IME, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA, ŽIVALSKE VRSTE, POTI UPORABE IN IMETNIK/PREDLAGATELJ(I) DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: 2.1 Updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II
Slovenian: 2.1 Posodobljena ocena tveganja za okolje v skladu s smernicami CVMP v zvezi s to tematiko, vključno z morebitno utemeljitvijo za izvzetje faze II
English: Ecomectin 18.7 mg/g Oral Paste for Horses is a generic product and as such an environmental risk assessment is now required under Directive 2001/82, as amended.
Slovenian: Ecomectin 18,7 mg/g peroralna pasta za konje spada med generična zdravila, za katera pa se zdaj v skladu z Direktivo 2001/82, kakor je bila spremenjena, zahteva priprava ocene tveganja za okolje.
English: The Marketing Authorisation Holder considers that the guidelines were written primarily for new molecules where the risk to the environment has not been characterized and that it is not the case for ivermectin-containing veterinary medicinal products that have been in extensive worldwide use for nearly 25 years and that real risk or detrimental environmental effect attributable to ivermectin-based veterinary medicinal products would have been observed.
Slovenian: Imetnik dovoljenja za promet z zdravilom meni, da so bile smernice v prvi vrsti izdelane za nove molekule, katerih tveganje za okolje še ni bilo opredeljeno, in da slednje ne velja za primer veterinarskih zdravil, vsebujočih ivermektin, ki se na široko uporabljajo po vsem svetu že skoraj 25 let, sicer bi bili resnična tveganja ali škodljivi učinki na okolje, ki bi jih bilo mogoče pripisati veterinarskim zdravilom na osnovi invermektina, doslej že opaženi.
English: The applicant considers that the level of use in horses in terms of animal numbers and dose level, compared to other pasture animals (cattle and sheep) is low and that consequently the use in the horse will have limited impact on the environment.
Slovenian: Predlagatelj meni, da je stopnja uporabe zdravila pri konjih, kar se tiče števila živali in višine odmerkov, v primerjavi z drugimi pašnimi živalmi (govedo in ovce) majhna, zaradi česar bo imela uporaba tega zdravila pri konjih zgolj omejen učinek na okolje.
English: PECSOIL- Pasture animals = 0.48 µg.kg-1
Slovenian: PECTLA- pašne živali = 0,48 µg.kg-1
English: Oral Paste.
Slovenian: Peroralna pasta.
English: The paste is given by oral route.
Slovenian: Pasta se daje peroralno.
English: Ivermectin 18.7 mg/g
Slovenian: Ivermektin 18,7 mg/g
English: Strength Animal speciesFrequency and route of administration
Slovenian: Živalska vrsta Pogostost in pot
English: The Marketing Authorisation Holder should provide complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment;
Slovenian: Imetnik dovoljenja za promet mora predložiti celovite informacije, ki jih je predložil referenčni državi članici in usklajevalni skupini CMD(v) v zvezi z oceno tveganja za okolje;
English: The Committee concludes that, since the product is intended for use in a minor species (horses) that is reared and treated similarly to a major species, the conclusions on the Environmental Risk Assessment of the major species apply, the product should be exempt from providing a Phase II assessment and that no risk mitigation measures should be included in the SPC of the product.
Slovenian: Odbor je zaključil, da je z ozirom na dejstvo, da je zdravilo namenjeno za uporabo pri manj pomembni vrsti (konjih), ki se vzreja in goji podobno kot pomembnejša vrsta, zaradi česar zanjo veljajo zaključki presoje vplivov na okolje za pomembnejše vrste, zdravilo mogoče izvzeti iz faze II ocenjevanja ter da v povzetek glavnih značilnosti tega zdravila ni potrebno vključiti ukrepov za zmanjševanje tveganj.
English: The Marketing Authorisation Holder should discuss and propose, if considered appropriate, possible risk mitigation measures to be included in the SPC of the product.
Slovenian: Imetnik dovoljenja za promet mora preučiti in predlagati, če je ustrezno, morebitne ukrepe za zmanjšanje tveganja, ki bi jih bilo mogoče vključiti v povzetek glavnih značilnosti zdravila.
English: The Marketing Authorisation Holder should provide an updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II;
Slovenian: Imetnik dovoljenja za promet mora predložiti posodobljeno oceno tveganja za okolje v skladu s smernicami CVMP v zvezi s to tematiko, vključno z morebitno utemeljitvijo za izvzetje faze II;
English: The Marketing Authorisation Holder considers it inconceivable that the risks posed to the environment associated with the use of Ecomectin 18.7 mg/g Oral Paste for Horses in particular are any greater than those posed by other ivermectin-based products, particularly as the concentration of the active ingredient and the proposed usage regime is identical to that of the reference and other similar products.
Slovenian: Imetniku dovoljenja za promet z zdravilom se zdi nepredstavljivo, da bi lahko bila tveganja za okolje, povezana z uporabo peroralne paste za konje Ecomectin 18,7 mg/g, kakor koli večja od tveganj, ki jih predstavljajo druga zdravila na osnovi ivermektina, še zlasti zato, ker sta koncentracija zdravilne učinkovine in predlagan režim uporabe enaka kot pri referenčnem zdravilu in drugih podobnih zdravilih.
English: The use of Ecomectin 18.7 Oral Paste for Horses does not result in an increase of the exposure to the environment compared to products for major species and therefore the conclusions of their environmental impact assessment is applicable for this product for horses.
Slovenian: Uporaba peroralne paste za konje Ecomectin 18,7 mg/g, v primerjavi z zdravili za pomembnejše vrste, ne povečuje izpostavljenosti okolja, zato so zaključki presoje njihovih vplivov na okolje prenosljivi na to zdravilo za konje.
English: An environmental risk was detected during the risk assessment Phase II Tier A for dung fauna organisms.
Slovenian: Med stopnjo A faze II ocenjevanja tveganja je bilo ugotovljeno tveganje za okolje v zvezi z organizmi, prisotnimi v gnoju.
English: Member State Marketing Authorisation Holder/Applicant
Slovenian: Država članica Imetnik/predlagatelj dovoljenja za promet z zdravilom
English: Horses are reared under similar conditions to livestock or, alternatively to housed livestock such as pigs, for which species ivermectin has a well-established use, orally and by other routes of administration.
Slovenian: Vzreja konjev poteka pod podobnimi pogoji kot vzreja živine oz. živine v staji, kot so prašiči, pri teh vrstah pa je uporaba ivermektina široko uveljavljena, in sicer tako s peroralnim kot drugimi načini uporabe.
English: Pharmaceutical Strength Animal species Frequency and route Recommended dose
Slovenian: Živalska vrsta Pogostost in pot uporabe zdravila
English: Holder/Applicant invented name form of administration
Slovenian: Država članica Imetnik/predlagatelj dovoljenja za Izmišljeno Farmacevtska Jakost
English: Ecomectin 18.7 mg/g Oral Paste for Horses
Slovenian: Ecomectin 18,7 mg/g peroralna pasta za konje
English: Ivermax 18.7 mg/g Oral Paste for Horses
Slovenian: Ivermax 18,7 mg/g peroralna pasta za konje
English: Animec 18.7 mg/g Oral Paste for Horses
Slovenian: Animec 18,7 mg/g peroralna pasta za konje
English: Divamectin 18.7 mg/g Oral Paste for Horses
Slovenian: Divamectin 18,7 mg/g peroralna pasta za konje
English: Tizoval 18.7 mg/g Oral Paste for Horses
Slovenian: Tizoval 18,7 mg/g peroralna pasta za konje
English: Vetimec 18.7 mg/g Oral Paste for Horses
Slovenian: Vetimec 18,7 mg/g peroralna pasta za konje
English: Use only if no other alternative if available.
Slovenian: Uporabite ga samo, če ni na voljo nobene druge možnosti.
English: Consequently, the PRAC has agreed the following:
Slovenian: Zato se je dogovoril o naslednjem:
English: Adopted at the 7-10 April 2015 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 7. in 10. aprilom 2015
English: Interaction not studied.
Slovenian: Medsebojnega delovanja niso proučevali.
English: Only Summary of Products Characteristics for Daklinza
Slovenian: Samo povzetek glavnih značilnosti zdravila za zdravilo Daklinza
English: Interferon alfa-2a; interferon alfa-2b; interferon beta-1a; interferon beta-1b; peginterferon alfa-2a; peginterferon alfa2b; peginterferon beta-1a - Pulmonary arterial hypertension (EPITT no 18059)
Slovenian: Interferon alfa-2a; interferon alfa-2b; interferon beta-1a; interferon beta-1b; peginterferon alfa-2a; peginterferon alfa2b; peginterferon beta-1a - pljučna arterijska hipertenzija (EPITT št. 18059)
English: Considering the seriousness of the condition, the PRAC concluded that an update of the product information is warranted.
Slovenian: Glede na resnost bolezni je zaključil, da je potrebna posodobitev informacij o zdravilu.
English: “*Class label for interferon products, see below Pulmonary arterial hypertension.” Section 4.8c
Slovenian: „*Velja za skupino zdravil, ki vsebujejo interferone - glejte Pljučna arterijska hipertenzija spodaj.“ Poglavje 4.8c
English: Daclatasvir; sofosbuvir; sofosbuvir, ledipasvirArrhythmia (EPITT no 18177)
Slovenian: Daklatasvir; sofosbuvir; sofosbuvir, ledipasvir - aritmija (EPITT št. 18177)
English: The PRAC has noted that amiodarone was involved in cases with the most suggestive causal relationship.
Slovenian: Ugotovil je, da je bil amiodaron prisoten pri primerih z najopaznejšo vzročno povezavo.
English: Due to the long half-life of amiodarone, appropriate monitoring should also be carried out for patients who have discontinued amiodarone within the past few months and are to be initiated on <adapt according to the product>.
Slovenian: Zaradi dolge razpolovne dobe amiodarona je treba ustrezno spremljati tudi bolnike, ki so prekinili zdravljenje z amiodaronom v zadnjih nekaj mesecih in bodo začeli zdravljenje z <prilagodite glede na zdravilo>.
English: • The MAHs should distribute a direct healthcare professional communication (DHPC) according to the text and communication plan agreed with the PRAC and CHMP
Slovenian: • imetniki dovoljenj za promet z zdravili morajo razposlati neposredno obvestilo za zdravstvene delavce v skladu z besedilom in načrtom obveščanja, ki sta ju potrdila odbora PRAC in CHMP;
English: • Taking into account that the mechanism for the drug-drug interaction with amiodarone remains unclear, the MAHs should ensure that planned non-clinical studies investigate both the potential pharmacodynamic and pharmacokinetic effects.
Slovenian: • ker mehanizem za medsebojno delovanje zdravil z amiodaronom še vedno ni pojasnjen, morajo imetniki dovoljenj za promet z zdravili zagotoviti, da bodo v načrtovanih predkliničnih študijah raziskali morebitne farmakodinamične in farmakokinetične učinke.
English: Close monitoring is recommended if this medicinal product is administered with <brand name> (see sections 4.4 and 4.8).
Slovenian: Kadar se to zdravilo uporablja sočasno z zdravilom <tržno ime>, se priporoča skrbno spremljanje (glejte poglavji 4.4 in 4.8).
English: Pulmonary arterial hypertension [Interferon alfa-containing products]
Slovenian: Pljučna arterijska hipertenzija [Zdravila, ki vsebujejo interferon alfa]
English: Based on published clinical and non-clinical data and on spontaneous reports, the PRAC considers that a causal relationship between the use of interferons alfa and beta and the development of pulmonary arterial hypertension, a rare but severe event, cannot be excluded.
Slovenian: Odbor PRAC na podlagi objavljenih kliničnih in predkliničnih podatkov ter spontanih poročil meni, da ni mogoče izključiti vzročne povezave med uporabo interferonov alfa in beta ter razvojem pljučne arterijske hipertenzije, ki je redek, vendar hud neželen dogodek.
English: In the light of available evidence from case reports in EudraVigilance and from data submitted by the MAH, the PRAC has agreed that there is a reasonable possibility of a causal relationship between capillary leak syndrome and the use of trabectedin.
Slovenian: Odbor PRAC se je ob upoštevanju razpoložljivih dokazov iz poročil o primerih v podatkovni zbirki EudraVigilance in podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, strinjal, da obstaja razumna možnost za vzročno povezavo med sindromom povečane prepustnosti kapilar in uporabo trabektedina.
English: Cases are potentially life threatening, therefore amiodarone should only be used in patients on <brand name> when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated.
Slovenian: Primeri so lahko smrtno nevarni, zato se lahko amiodaron pri bolnikih, ki prejemajo zdravilo <tržno ime>, uporablja samo, če drugih nadomestnih antiaritmikov ne prenašajo ali če so ti pri njih kontraindicirani.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction Amiodarone
Slovenian: Poglavje 4.5 - Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Amiodaron
English: The PRAC has assessed cases of severe arrhythmia associated with the use of sofosbuvir (including in combination with ledipasvir) and/or daclatasvir, in particular in patients with established cardiac disorders and treated with bradycardic medications.
Slovenian: Odbor PRAC je ocenil primere hude aritmije, povezane z uporabo sofosbuvirja in/ali daklatasvirja, zlasti pri bolnikih z ugotovljenimi srčnimi boleznimi, ki se zdravijo z zdravili za zdravljenje bradikardije.
English: No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), amiodarone, disopyramide, propafenone, flecainide, mexilitine, quinidine or antacids.
Slovenian: Pri sočasni uporabi daklatasvirja in katerega koli od naslednjih zdravil: zaviralcev PDE-5, zdravil iz skupine zaviralcev ACE (npr. enalapril), zdravil iz skupine antagonistov angiotenzina II (npr. losartan, irbesartan, olmesartan, kandesartan, valsartan), amiodarona, dizopiramida, propafenona, flekainida, meksilitina, kinidina ali antacidov ni pričakovati nobenih klinično pomembnih učinkov na farmakokinetiko katerega od navedenih zdravil.
English: Should concomitant use of amiodarone be considered necessary it is recommended that patients are closely monitored when initiating <brand name>.
Slovenian: Kadar se presodi, da je sočasna uporaba amiodarona potrebna, se ob uvajanju zdravljenja z zdravilom <tržno ime> priporoča skrbno spremljanje bolnikov.
English: • Fainting Other medicines and <brand name> Tell your doctor if you take any of the following medicines: amiodarone, used to treat irregular heart beats
Slovenian: Druga zdravila in zdravilo <tržno ime> Obvestite zdravnika, če jemljete katero koli od naslednjih zdravil: amiodaron, ki se uporablja za zdravljenje nerednega srčnega utripa.
English: Package Leaflet for Sovaldi, Harvoni, Daklinza Section 2 - What you need to know before you take <brand name> Warnings and precautions Talk to your doctor or pharmacist before taking <brand name> you currently take, or have taken in the last few months, the medicine amiodarone to treat irregular heartbeats (your doctor may consider alternative treatments if have taken this medicine) Tell your doctor immediately if you are taking any medicines for heart problems and during treatment you experience:
Slovenian: Navodilo za uporabo za zdravila Sovaldi, Harvoni in Daklinza Poglavje 2 - Kaj morate vedeti, preden boste vzeli zdravilo <tržno ime> Opozorila in previdnostni ukrepi Posvetujte se z zdravnikom ali farmacevtom, preden začnete jemati zdravilo <tržno ime>, če: jemljete ali ste v zadnjih nekaj mesecih jemali zdravilo amiodaron za zdravljenje nerednega srčnega utripa (če jemljete ali ste jemali to zdravilo, bo zdravnik morda razmislil o drugih možnostih zdravljenja).
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Slovenian: Pri uporabi zdravil, ki vsebujejo interferon alfa, so poročali o primerih pljučne arterijske hipertenzije (PAH), zlasti pri bolnikih z dejavniki tveganja zanjo (to so na primer portalna hipertenzija, okužba z virusom HIV ali ciroza).
English: All patients receiving <brand name> in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them.
Slovenian: Vse bolnike, ki prejemajo zdravilo <tržno ime> v kombinaciji z amiodaronom in drugimi zdravili, ki upočasnjujejo srčni utrip, ali brez njih, je treba prav tako opozoriti na simptome bradikardije in srčnega bloka ter jim svetovati, naj ob pojavu simptomov takoj poiščejo zdravniško pomoč.
English: Pulmonary arterial hypertension has been seen at various time points during treatment, including several years after starting treatment with {X}.
Slovenian: Pljučna arterijska hipertenzija se lahko pojavi ob različnih časovnih točkah zdravljenja, vključno nekaj let po začetku zdravljenja z zdravilom {X}.
English: Therefore the PRAC has agreed that the marketing authorisation holders (MAHs) of interferon alfa and beta containing products should submit a variation within 2 months to amend the product information as described below (new text underlined):
Slovenian: Zato se je strinjal, da morajo imetniki dovoljenj za promet z zdravili, ki vsebujejo interferon alfa in beta, v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano):
English: • The MAHs of Sovaldi, Harvoni and Daklinza should submit a variation within 1 month, to amend the product information as described below (<new text underlined / text to be removed with strikethrough>)
Slovenian: • imetniki dovoljenj za promet z zdravili Sovaldi, Harvoni in Daklinza morajo v enem mesecu predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (<novo besedilo je podčrtano/besedilo, ki ga je treba izbrisati, je prečrtano>);
English: • The MAHs should closely monitor all cardiac events with and without the concomitant use of amiodarone, beta-blocking agents and other antiarrhythmic agents and present updates of the cumulative safety reviews in the next PSURs.
Slovenian: • imetniki dovoljenj za promet z zdravili morajo skrbno spremljati vse srčne dogodke, ki se pojavijo ob sočasni uporabi amiodarona, antagonistov adrenergičnih receptorjev beta in drugih antiaritmikov ali brez nje, ter v naslednjih redno posodobljenih poročilih o varnosti zdravila predstaviti posodobljene podatke iz združenih rednih poročil o varnosti zdravil.
English: Therefore, the MAH for trabectedin should submit a variation within 2 months, to amend the product information as described below (new text underlined).
Slovenian: Imetnik dovoljenja za promet s trabektedinom mora zato v dveh mesecih predložiti vlogo za spremembo informacij o zdravilu, kot je opisano spodaj (novo besedilo je podčrtano).
English: Pulmonary arterial hypertension - a disease of severe narrowing of the blood vessels in the lungs resulting in high blood pressure in the blood vessels that carry blood from the heart to the lungs.
Slovenian: Pod neznano pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) je treba dodati: Pljučna arterijska hipertenzija - bolezen, ki povzroči hudo zoženje krvnih žil v pljučih, katerega posledica je visok krvni tlak v žilah, po katerih kri teče iz srca v pljuča.
English: The side effect may develop at various time points during treatment, typically several months after starting treatment with {X}.
Slovenian: Neželeni učinek se lahko pojavi ob različnih časovnih točkah zdravljenja, običajno nekaj mesecev po začetku zdravljenja z zdravilom {X}.
English: Section 4.8 - Undesirable effects [Interferon alfa and beta containing products] “Pulmonary arterial hypertension*” should be added under the System Organ Class (SOC) “Respiratory, thoracic and mediastinal disorders” with the frequency “not known”.
Slovenian: Pod organski sistem „bolezni dihal, prsnega koša in mediastinalnega prostora“ je treba dodati „pljučna arterijska hipertenzija*“ s pogostnostjo „neznana“.
English: The long half-life of amiodarone should be considered when deciding on cases for reviews
Slovenian: Pri določanju primerov, ki bodo pregledani, morajo upoštevati dolgo razpolovno dobo amiodarona;
English: • Palpitations
Slovenian: • zasoplost,
English: [Interferon alfa-containing products]
Slovenian: [Zdravila, ki vsebujejo interferon beta]
English: Summary of Product Characteristics for Sovaldi, Harvoni, Daklinza
Slovenian: Povzetek glavnih značilnosti zdravila za zdravila Sovaldi, Harvoni in Daklinza Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Huda bradikardija in srčni blok