FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH did not agree with the PhVWP/CMD(h) agreed SPC wording for all antidepressants for Section 4.8, since suicidal ideation is not considered an adverse reaction in adult patients, but agreed to comply with the mandated class labelling.
Slovenian: Po pregledu so bili na seznam vključeni tudi mrazenje, zmedenost, depersonalizacija (izguba zavesti o lastni osebnosti), glavobol, menstrualne motnje, palpitacije in polakisurija (pogosto mokrenje).Imetnik dovoljenja za promet z zdravilom se ni strinjal z odobrenim besedilom delovne skupine za farmakovigilanco/Usklajevalne skupine za postopek medsebojnega priznavanja in decentralizirani postopek za zdravila za uporabo v humani medicini za vse antidepresive v poglavju 4.8, saj razmišljanje o samomoru ne spada med neželene učinke pri odraslih bolnikih, vendar je soglašal, da bo upošteval predpisano označevanje razredov.
English: Caution should be exercised in patients whose underlying conditions might be compromised by increases in heart rate.
Slovenian: Pri bolnikih, pri katerih se zaradi zvišanja srčne frekvence lahko poslabša osnovna bolezen, je treba zdravilo uporabljati previdno.
English: CNS-active substances
Slovenian: KLINIČNI PODATKI
English: Whereas
Slovenian: {Ime}
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 50 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Slovenian: Efexor in povezana imena (glejte Dodatek I) 50 mg tablete [Glejte Dodatek I - Izpolni država članica.]
English: Use in elderly patients
Slovenian: Uporaba pri starostnikih
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 75 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Slovenian: Efexor in povezana imena (glejte Dodatek I) 75 mg tablete [Glejte Dodatek I - Izpolni država članica.]
English: Venlafaxine and ODV exhibit linear kinetics over the dose range of 75 mg to 450 mg/day.
Slovenian: V razponu odmerkov od 75 mg do 450 mg/dan je kinetika venlafaksina in ODV linearna.
English: NAME OF THE MEDICINAL PRODUCT Efexor and associated names (see Annex I) 25 mg tablets [See Annex I - To be completed nationally] Venlafaxine
Slovenian: Efexor in povezana imena (glejte Dodatek I) 25 mg tablete [Glejte Dodatek I - Izpolni država članica.]
English: 25 mg
Slovenian: 25 mg tablete
English: • Metabolism/nutritional disorders
Slovenian: • Presnova in prehranske motnje
English: 4.5 Interaction with other medicinal products and other forms of interaction Monoamine Oxidase Inhibitors (MAOI)
Slovenian: Zaviralci monoaminooksidaz (MAO)
English: Call your doctor or pharmacist immediately if you take more than the amount of Efexor prescribed by your doctor.
Slovenian: Če ste vzeli več zdravila Efexor, kot vam ga je predpisal zdravnik, takoj pokličite svojega zdravnika ali farmacevta.
English: Abnormality of accommodation, Mydriasis, Visual disturbance,
Slovenian: Čutila motnje akomodacije, midriaza, motnje vida motnje okušanja, tinitus glavkom z zaprtim zakotjem
English: Close supervision of patients, and in particular those at high risk, should accompany drug therapy, especially in early treatment and following dose changes.
Slovenian: Med zdravljenjem, še posebej po uvedbi zdravljenja in pri vsaki spremembi odmerka, je treba bolnike skrbno nadzirati.
English: The MAH was asked to identify differences between the listed adverse events in the nationally approved SPCs and the MAH's CDS, and to organise Section 4.8 according to the MedDRA system organ class.
Slovenian: Povzetek glavnih značilnosti zdravila, poglavje 4.8: Neželeni učinki Imetnik dovoljenja za promet z zdravilom je bil naprošen, da opredeli neskladja med navedenimi neželenimi učinki v nacionalno odobrenih povzetkih glavnih značilnosti zdravila in osnovnim varnostnim listom (CDR - Core Data Sheet) imetnika dovoljenja za promet z zdravilom ter da uredi poglavje 4.8 v skladu s klasifikacijo organov sistema MedDRA. Imetnik dovoljenja za promet je zaključil oba, oceno okvar sečil in pojav krvavitev v prebavilih, ter se strinjal, da ju doda na seznam neželenih učinkov.
English: Pancreatitis
Slovenian: Imipramin
English: Special Senses
Slovenian: DRUGI PODATKI
English: • Sight and hearing disorders Common: blurred vision
Slovenian: Pogosti: zamegljen vid
English: The reference product is authorised in Belgium since 1985.
Slovenian: Referenčno zdravilo je v Belgiji odobreno od leta 1985.
English: It may be administered by parenteral route.
Slovenian: Lahko se daje po parenteralni poti.
English: Samples from treated animals were collected at 4, 8, 12, 16, 20, 24 and 28 days after the end of treatment.
Slovenian: Vzorci zdravljenih živali so bili zbrani 4, 8, 12, 16, 20, 24 in 28 dni po koncu zdravljenja.
English: • A new residue depletion study is required regardless of whether the dosing regimen has changed or not.
Slovenian: • Potrebna je nova študija o izločanju ostankov ne glede na to, ali se je režim odmerjanja spremenil ali ne.
English: Justification of the dose and the duration of treatment are required.
Slovenian: Zahtevana je utemeljitev odmerka in trajanja zdravljenja.
English: o Potential effect(s) on the user safety;
Slovenian: o morebitni učinki na varnost uporabnika,
English: The national competent authorities shall ensure that the following conditions are fulfilled by the concerned marketing authorisation holders:
Slovenian: Pristojni nacionalni organi bodo zagotovili, da bodo zadevni imetniki dovoljenja za promet z zdravilom izpolnili naslednje pogoje:
English: o Environmental impact assessment;
Slovenian: o ocena vpliva na okolje,
English: The sampling size in target strains was not optimal to distinguish between wild type and a population with acquired resistance determinants.
Slovenian: Velikost vzorčenja v ciljnih sevih ni bila optimalna, da bi bilo mogoče razlikovati med divjo vrsto in populacijo s pridobljenimi determinantami odpornosti.
English: • If efficacy is demonstrated for a different dosage regimen compared to the authorised dosage regimen at the time of marketing authorisation suspension, the following points should be reviewed from a safety point of view:
Slovenian: • Če je učinkovitost dokazana za režim odmerjanja, ki je drugačen od režima, odobrenega v času začasnega umika dovoljenja za promet, je treba z varnostnega vidika pregledati naslednje točke:
English: Moreover, product administration at an inappropriate dose poses an added risk of resistance development.
Slovenian: Poleg tega dajanje zdravila v neustreznih odmerkih predstavlja dodatno tveganje za razvoj odpornosti.
English: The reference product is ‘Gabbrovet solution injectable', which has been authorised in a few Member States.
Slovenian: Referenčno zdravilo je zdravilo „Gabbrovet raztopina za injiciranje“, ki je bilo odobreno v nekaj državah članicah.
English: o Potential effects on target animal tolerance.
Slovenian: o morebitni učinki na prenašanje zdravila pri ciljnih živalih.
English: While target animal safety was not in the scope of this referral, there are no known adverse events in pigs.
Slovenian: Čeprav ta napotitev ni obsegala varnosti ciljnih živali, pri prašičih ne obstajajo nobeni znani neželeni dogodki.
English: Within this referral procedure, one of the marketing authorisation holders proposed the following indications as an amendment to the current indications:
Slovenian: V tem napotitvenem postopku je eden od imetnikov dovoljenja za promet z zdravilom kot dopolnilo trenutnim indikacijam predlagal naslednje indikacije:
English: The target species are pigs and the route of administration is intramuscular.
Slovenian: Ciljna vrsta so prašiči, pot uporabe zdravila pa je intramuskularna.
English: Hence, the veterinary medicinal product could be expected to be effective against E. coli as shown by the sensitivity results of a recent study, where 76% of the strains would be sensitive.
Slovenian: Zato je mogoče pričakovati, da bo zdravilo za uporabo v veterinarski medicini učinkovito proti bakteriji E. coli, kot kažejo rezultati občutljivosti v nedavni študiji, v kateri je bilo občutljivih 76 % sevov.
English: Therefore a withdrawal period cannot be reliably estimated.
Slovenian: Zato karence ni mogoče zanesljivo oceniti.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration, marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, imetnikov dovoljenj za promet z zdravilom v državah članicah
English: In the case of E. coli, the PK/PD analysis was only favourable for strains with MICs equal to or below 4.44 µg/ml.
Slovenian: Pri E. coli je bila analiza PK/PD ugodna le za seve z MIC, ki je bila enaka ali manjša od 4,44 µg/ml.
English: However, there are no pre-clinical and clinical data supporting the indication for the treatment of MMA in sows.
Slovenian: Ni pa nobenih predkliničnih in kliničnih podatkov, ki bi podpirali indikacijo za zdravljenje sindroma MMA pri svinjah.
English: Luxembourg Ceva Sante Animale NV Metrologielaan 6
Slovenian: Luksemburg Ceva Sante Animale NV Metrologielaan 6
English: The product showed no accumulation during the treatment period (5 days).
Slovenian: V obdobju zdravljenja (5 dni) ni bilo znakov kopičenja zdravila.
English: Muscle of injection site is not the most reliable tissue for withdrawal time calculation, as it is often characterised by a high variability in residues levels, confirmed also in this case by the limited number of samples with concentrations above limit of quantification (2/4 on Day 12).
Slovenian: Mišica na mestu injiciranja ni najzanesljivejše tkivo za izračun karence, ker je zanjo pogosto značilna velika spremenljivost ravni ostankov, kar je tudi v tem primeru potrjevalo omejeno število vzorcev s koncentracijami nad mejo določljivosti (2/4 na 12. dan).
English: Furthermore, the duration of treatment has not been justified and no clinical data have been provided by the marketing authorisation holder to justify the recommended dose.
Slovenian: Poleg tega trajanje zdravljenja ni utemeljeno in imetnik dovoljenja za promet z zdravilom ni predložil nobenih kliničnih podatkov, ki bi utemeljevali priporočeni odmerek.
English: Overall summary of the scientific evaluation of Veterinary medicinal products containing paromomycin to be administered parenterally to pigs (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem (glejte Prilogo I)
English: The withdrawal period was determined in animals with a mean weight of 37.2 kg (range of 32 to 42.8 kg) treated according to the recommended posology at the longest duration of treatment.
Slovenian: Karenca je bila določena pri živalih s povprečno maso 37,2 kg (razpon od 32 do 42,8 kg), zdravljenih v najdaljšem času trajanja zdravljenja v skladu s priporočenim odmerjanjem.
English: The withdrawal period should be based on robust and complete data (animal phase and validation of the analytical method) in accordance with the guidelines in force.
Slovenian: Podlaga za karenco morajo biti realni in popolni podatki (faza preskušanja na živalih in potrditev analitične metode) v skladu z veljavnimi smernicami.
English: In order to justify efficacy of the product, susceptibility data were provided for E. coli and A. pleuropneumoniae and a pharmacokinetics/pharmacodynamics (PK/PD) analysis was performed.
Slovenian: Za utemeljevanje učinkovitosti zdravila so bili predloženi podatki o dovzetnosti za bakterije E. coli in A. pleuropneumoniae, izvedena pa je bila tudi farmakokinetična/farmakodinamična (PK/PD) analiza.
English: In conclusion, the CVMP considered that the efficacy of these veterinary medicinal products was not supported for any indication and posology.
Slovenian: Odbor CVMP je tako menil, da učinkovitost teh zdravil za uporabo v veterinarski medicini ni bila podprta za nobeno indikacijo in nobeno odmerjanje.
English: Paromomycin belongs to the group of aminoglycoside antibiotics.
Slovenian: Paromomicin spada v skupino aminoglikozidnih antibiotikov.
English: The most relevant tissues for the presence of paromomycin residue were muscle at the injection site and kidney.
Slovenian: Tkiva, ki so bila najbolj relevantna za prisotnost paromomicina, so bile mišice na mestu injiciranja in ledvice.
English: An application was submitted under Article 13(1) of Directive 2001/82/EC, i.e. a generic application for a marketing authorisation under the decentralised procedure for the veterinary medicinal product ‘Parofor 175 mg/ml solution for injection', with Belgium as Reference Member State (BE/V/0027/003/DC).
Slovenian: V skladu s členom 13(1) Direktive 2001/82/ES je bila predložena vloga, tj. generična vloga za izdajo dovoljenja za promet z zdravilom v skladu z decentraliziranim postopkom za zdravilo za uporabo v veterinarski medicini „Parofor 175 mg/ml raztopina za injiciranje“, z Belgijo kot referenčno državo članico (BE/V/0027/003/DC).
English: Moreover, this model holds true only for target strains in plasma or tissue sites with equivalent paromomycin distribution, no predictability can be expected against the pathogen located in other tissues.
Slovenian: Poleg tega ta model velja samo za ciljne seve v mestih v plazmi ali tkivu z enako distribucijo paromomicina; ni mogoče pričakovati kakršne koli predvidljivosti proti patogenu v drugih tkivih.
English: Belgium Ceva Sante Animale NV Metrologielaan 6
Slovenian: Ceva Sante Animale NV Metrologielaan 6
English: Moreover, the product was well tolerated.
Slovenian: Poleg tega je bilo prenašanje zdravila dobro.
English: Both the animal and analytical phases of the study were in compliance with GLP requirements and European guidelines.
Slovenian: Faza preskušanja na živalih in analitična faza sta bili skladni z zahtevami dobre laboratorijske prakse in evropskimi smernicami.
English: Belgium therefore considered that it is necessary to refer the matter to the CVMP in the interests of animal health and protecting consumer safety in the Union.
Slovenian: Belgija je zato menila, da je treba v interesu zdravja živali in zaščite varnosti potrošnikov v Uniji zadevo predložiti Odboru za zdravila za uporabo v veterinarski medicini (odboru CVMP).
English: Finally the PK/PD model does not allow justifying the duration of treatment.
Slovenian: Prav tako z modelom PK/PD ni mogoče utemeljiti trajanja zdravljenja.
English: Therefore, the indication against colibacillosis based on an overestimated success from a theoretical modelling, against E. coli strictly located in plasma, for an unjustified duration of treatment and not confirmed by clinical data, is not acceptable.
Slovenian: Zato indikacija delovanja proti kolibacilozi na podlagi precenjenega uspeha delovanja, izpeljanega iz teoretičnega modeliranja, proti bakteriji E. coli, striktno locirani samo v plazmi, z neutemeljenim trajanjem zdravljenja in nepotrjena s kliničnimi podatki ni sprejemljiva.
English: The veterinary medicinal products involved in this referral contain 250 mg/ml paromomycin sulfate as active substance (equivalent to 175 mg/ml paromomycin base or to a paromomycin activity of 175,000 IU/ml).
Slovenian: Zdravila za uporabo v veterinarski medicini, vključena v to napotitev, kot učinkovino vsebujejo 250 mg/ml paromomicin sulfata (enakovredno 175 mg/ml paromomicinove baze ali aktivnosti paromomicina 175 000 IU/ml).
English: The marketing authorisation holder also considered that the veterinary medicinal product could be used to treat Mastitis-Metritis-Agalactia (MMA) syndrome associated with E. coli, but acknowledged that further data are needed to assess the correct dose regimen in adult animals.
Slovenian: Imetnik dovoljenja za promet z zdravilom je menil, da je mogoče zdravilo za uporabo v veterinarski medicini uporabljati za zdravljenje sindroma MMA (mastitis-metritis-agalaktija), povezanega z bakterijo E. coli, vendar je priznal, da so za oceno pravilnega režima odmerjanja pri odraslih živalih potrebni dodatni podatki.
English: • To provide a benefit-risk assessment outlining that the clinical benefits of these veterinary medicinal products outweigh potential risks relating to animal health and the development of resistance, and (if applicable) environmental and user risks.
Slovenian: • Predložiti oceno razmerja med tveganji in koristmi, v kateri bo opisano, da klinične koristi teh zdravil za uporabo v veterinarski medicini odtehtajo morebitna tveganja, povezana z zdravjem živali in razvojem odpornosti, ter (če bo smiselno) tveganja za okolje in uporabnika.
English: The mechanism of action of paromomycin has been well described as well as the mechanisms of antimicrobial resistance to paromomycin.
Slovenian: Mehanizem delovanja paromomicina in mehanizmi protimikrobne odpornosti proti paromomicinu so dobro opisani.
English: However, a number of deficiencies in the study were noted related to the storage of the samples, the stability of the residues in storage conditions, the wide range of recovery in muscle and the absence of a ring-shaped control surrounding the excised injection site core sample.
Slovenian: Vendar je bilo v študiji opaženih več pomanjkljivosti, povezanih s shranjevanjem vzorcev, stabilnostjo ostankov v pogojih shranjevanja, širokim razponom obnovitve v mišici in odsotnosti obročastega kontrolnega vzorca, ki obkroža izrezani vzorec jedra na mestu injiciranja.
English: Considering that colibacillosis is a disease complex (including neonatal diarrhoea, post-weaning diarrhoea, oedema disease, septicemia, polyserositis, coliform mastitis, and urinary tract infection) and is caused by different types of Escherichia coli (enteropathogenic E. coli, Shiga-toxin producing E. coli, enterotoxigenic E. coli, etc.), the marketing authorisation holders should define the clinical indication(s) as precisely as possible by including also the sub-category (age and production type) of the target animals.
Slovenian: Ker je kolibaciloza kompleks bolezni (vključno z neonatalno drisko, drisko po odstavljanju, edemsko boleznijo, septikemijo, poliserozitisom, koliformnim mastitisom in okužbo urinarnega trakta) in ker jo povzročajo različne vrste bakterij Escherichia coli (enteropatogena E. coli, toksin Šiga, ki proizvaja bakterijo E. coli, enterotoksigena E. coli itd.), morajo imetniki dovoljenj za promet čim natančneje določiti klinične indikacije, tudi z vključitvijo podkategorije (starost in vrsta proizvodnje) ciljnih živali.
English: However, the deficiencies noted in the study (absence of data on storage stability, the wide recovery rates in muscle samples and the absence of ring sample in the sampling of the injection site) cannot be covered by any safety span.
Slovenian: Vendar pomanjkljivosti, opaženih v študiji (odsotnost podatkov o stabilnosti shranjevanja, širok razpon hitrosti obnavljanja v vzorcih mišic in odsotnost obročastega vzorca pri vzorčenju mesta injiciranja), ni mogoče zajeti z nobeno varnostno rezervo.
English: Regarding A. pleuropneumoniae, the PK/PD analysis based on the inhibitory quotient (Cmax/MIC >8 to 10) shows that only 10% of the target bacterial population would be sensitive to paromomycin administered at the recommended posology.
Slovenian: V zvezi z bakterijo A. pleuropneumoniae analiza PK/PD na podlagi inhibicijskega koeficienta (Cmax/MIC > 8 do 10) kaže, da bi bilo za paromomicin, ki bi se dajal v priporočenem odmerku, občutljivih le 10 % ciljne populacije bakterij.
English: For antimicrobials like paromomycin, whose efficacy is concentration-dependent, high plasma concentration levels relative to the MIC of the pathogen (Cmax/MIC ratio, also known as the inhibitory quotient or IQ) are a major determinant of clinical efficacy; a Cmax/MIC ratio > 8-10 is suggested to achieve optimal efficacy.
Slovenian: Pri protimikrobnih zdravilih, kot je paromomicin, katerega učinkovitost je odvisna od koncentracije, so glavna determinanta klinične učinkovitosti visoke ravni koncentracije plazme glede na MIC patogena (razmerje Cmax/MIC, znano tudi kot inhibicijski kvocient ali IQ); kaže, da je za doseganje optimalne učinkovitosti potrebno razmerje Cmax/MIC > 8-10.
English: Paromomycin has broad spectrum activity against numerous Gram-positive and Gram-negative bacteria and acts in a concentrationdependent manner.
Slovenian: Paromomicin deluje širokospektralno proti številnim grampozitivnim in gramnegativnim bakterijam, njegov način delovanja pa je odvisen od koncentracije.
English: Samples of the target tissues were analysed by HPLC method coupled with MS/MS detection.
Slovenian: Vzorci ciljnih tkiv so bili analizirani z metodo HPLC, ki ji je bilo dodano zaznavanje MS/MS.
English: Due to the deficiencies noted in the study, a withdrawal period cannot be covered by any safety margin.
Slovenian: Zaradi pomanjkljivosti, opaženih v študiji, karence ni mogoče zajeti z nobeno varnostno rezervo.
English: • To provide adequate clinical data in support of an indication against colibacillosis at the recommended dose and duration of treatment.
Slovenian: • Zagotoviti ustrezne klinične podatke v podporo indikaciji za uporabo proti kolibacilozi v priporočenem odmerku in s priporočenim trajanjem zdravljenja.
English: • the CVMP concluded that the benefit-risk assessment for veterinary medicinal products containing paromomycin to be administered parenterally to pigs is negative because there were inadequate data to support efficacy of these veterinary medicinal products for the proposed indications at the recommended treatment dose and that this deficiency poses a risk of ineffective treatment and antimicrobial resistance development; the CVMP has recommended the suspension of the marketing authorisations for veterinary medicinal products containing paromomycin to be administered parenterally to pigs as referred in Annex I. The conditions to lift the suspension of the marketing authorisations are set out in Annex III.
Slovenian: • odbor CVMP je zaključil, da je ocena razmerja med tveganji in koristmi pri zdravilih za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem, negativna, ker za predlagane indikacije v priporočenem odmerku za zdravljenje ni bilo ustreznih podatkov v podporo učinkovitosti teh zdravil za uporabo v veterinarski medicini, ter da to pomanjkanje predstavlja tveganje za neučinkovito zdravljenje in razvoj protimikrobne odpornosti; je odbor CVMP priporočil umik dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo paromomicin za parenteralno dajanje prašičem iz Priloge I. Pogoji za preklic začasnega umika dovoljenj za promet z zdravilom so določeni v Prilogi III.
English: A pharmacokinetic study was carried out in target animals at the recommended dose (14 mg/kg bodyweight of paromomycin).
Slovenian: Pri ciljnih živalih je bila izvedena farmakokinetična študija v priporočenem odmerku (14 mg paromomicina/kg telesne mase).
English: Scientific conclusions and grounds for suspension of the marketing authorisations
Slovenian: Znanstveni zaključki in podlaga za začasni umik dovoljenj za promet z zdravilom
English: The currently authorised indications are unspecific and no specific pathogens are mentioned, i.e. for the treatment of bacterial infections caused by pathogens which are susceptible to paromomycin or for bacterial infections of the respiratory tract, uro-genital tract, mastitis, enteritis, abscess, wounds, canine leishmaniosis and surgery.
Slovenian: Trenutno odobrene indikacije so nespecifične in omenjen ni noben specifični patogen, tj. za zdravljenje bakterijskih okužb, ki jih povzročajo patogeni, dovzetni za paromomicin, ali za bakterijske okužbe dihalnih poti in urogenitalnega trakta, mastitis, enteritis, absces, rane, pasjo leishmaniozo in operacije.
English: The same marketing authorisation holder provided data in order to justify the use of ‘Gabbrovet solution injectable' in pigs at a dose of 14 mg paromomycin base/kg bodyweight for 5 consecutive days.
Slovenian: Isti imetnik dovoljenja za promet z zdravilom je predložil podatke za utemeljitev uporabe zdravila Gabbrovet raztopina za injiciranje pri prašičih v odmerku 14 mg paromomicinove baze/kg telesne mase v petih zaporednih dneh.