FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant then proposed to use: - a dropper insert for doses between 12.5 µg and 50 µg (5 to 20 drops) and - a 3 mL oral syringe for doses between 50 µg and 200 µg (0.5 to 2 mL) According to the proposed Summary of Product Characteristics (SmPC), the dropper insert will be mainly used for administration to paediatric patients as well as for initial dosing of adults and children over 12 years.
Slovenian: Predlagatelj je nato predlagal uporabo: - kapalnega vložka za odmerke med 12,5 µg in 50 µg (od 5 do 20 kapljic) ter - 3-mL brizge za peroralno dajanje za odmerke med 50 µg in 200 µg (od 0,5 do 2 mL).
English: The excipients are glycerol, propylene glycol, ethanol and purified water, which comply with the respective Ph.Eur monographs.
Slovenian: Pomožne snovi so glicerol, propilen glikol, etanol in prečiščena voda, ki so v skladu z ustreznimi monografijami Evropske farmakopeje.
English: This represents an impractical means of dosing babies and small infants, and will result in further variability in dosing volumes associated with use of a second administration device.
Slovenian: Ta način odmerjanja pri dojenčkih in majhnih otrocih ni praktičen ter zaradi uporabe dodatnega aplikatorja povzroča dodatno nihanje volumna odmerka.
English: Therefore any deviation from vertical orientation, such as an attempt to slow the drop rate will result in inaccurate drop volume.
Slovenian: Tako se pri vsakem odklonu od navpičnega položaja, če na primer skušamo upočasniti padanje kapljic,
English: Therefore, co-administration of ethanol and propylene glycol can lead to raised and potentially toxic levels of the latter.
Slovenian: Zaradi tega lahko sočasna uporaba etanola in propilen glikola pripelje do povišanih, potencialno toksičnih ravni propilen glikola.
English: As ethanol is used to solubilise levothyroxine, its use is not considered to be essential in this formulation, based on the relatively poor solubility of levothyroxine in ethanol when compared to propylene glycol.
Slovenian: Ker se za raztapljanje levotiroksina uporablja etanol, se njegova uporaba ne šteje za bistveno v tem pripravku, saj je levotiroksin sorazmerno slabše topen v etanolu kot v propilen glikolu.
English: Published literature highlights the potential for significant variability in both drop rate and volume for low viscosity solutions such as this product, where bottle orientation is not vertical.
Slovenian: V objavljeni literaturi je poudarjena možnost za precejšnje nihanje hitrosti in volumna kapljic pri raztopinah z nizko viskoznostjo, kot je npr. obravnavano zdravilo, kadar steklenička ni v navpičnem položaju.
English: Since both propylene glycol and ethanol share a common metabolic pathway the combination of ethanol and propylene glycol is a concern.
Slovenian: Ker imata propilen glikol in etanol enako metabolno pot, njuna kombinacija vzbuja zaskrbljenost.
English: Levothyroxine Alapis is a solution with low viscosity, which gives a fast drop rate.
Slovenian: Zdravilo Levothyroxine Alapis je raztopina z nizko viskoznostjo, zaradi česar kapljice padajo hitreje.
English: In addition there are concerns in vulnerable adults such as those suffering from alcoholism, as well as in patients with hepatic impairment and epilepsy.
Slovenian: Obstajajo tudi pomisleki v zvezi z ranljivimi populacijami odraslih, kot so alkoholiki, bolniki z okvaro jeter in epilepsijo;
English: Levothyroxine Alapis is an oral drop solution containing levothyroxine sodium as active substance (100 mcg/ml).
Slovenian: Zdravilo Levothyroxine Alapis je raztopina v obliki peroralnih kapljic, ki kot zdravilno učinkovino vsebuje natrijev levotiroksin (100 mcg/ml).
English: Since no consensus could be reached on the issues relating to medication errors due to the method of administration of the oral drops and the safety of excipients ethanol and propylene glycol in the paediatric population, the CMDh referred the matter to the CHMP under Article 29(4) of Directive
Slovenian: Ker ni bilo mogoče doseči dogovora o vprašanjih, povezanih z napakami pri uporabi zdravila zaradi načina dajanja kapljic za peroralno uporabo in varnosti pomožnih snovi etanola in propilen glikola v pediatrični populaciji, je Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh) zadevo v skladu s členom 29(4) Direktive 2001/83 predložila Odboru za zdravila za uporabo v humani medicini (CHMP).
English: The active substance levothyroxine, is an established active substance described in the European Pharmacopoeia.
Slovenian: Zdravilna učinkovina levotiroksin je uveljavljena zdravilna učinkovina, opisana v Evropski farmakopeji.
English: As mentioned previously, both ethanol and propylene glycol are initially metabolised by alcohol dehydrogenase.
Slovenian: Kot je bilo že navedeno, se etanol in propilen glikol na začetku presnavljata z alkoholno dehidrogenazo.
English: Safety of excipients (ethanol / propylene glycol) in paediatric population The excipients used in Levothyroxine Alapis are ethanol, propylene glycol, glycerol and water and comply with the Ph. Eur monographs.
Slovenian: Varnost pomožnih snovi (etanola/propilen glikola) za pediatrično populacijo V zdravilu Levothyroxine Alapis se uporabljajo pomožne snovi etanol, propilen glikol, glicerol in voda, ki so vse v skladu z monografijami Evropske farmakopeje.
English: Alcohol dehydrogenase preferentially metabolises ethanol prior to metabolising other alcohols, including propylene glycol.
Slovenian: Pri alkoholni dehidrogenazi se etanol metabolizira pred drugimi alkoholi, vključno s propilen glikolom.
English: Levothyroxine Alapis, which is formulated as a highly concentrated solution of a very potent active substance, is associated with adverse events with chronic over-dosing - particularly cardiovascular.
Slovenian: Zdravilo Levothyroxine Alapis, izdelano v obliki visoko koncentrirane raztopine zelo potentne zdravilne učinkovine, se povezuje z neželenimi učinki pri kroničnem predoziranju - zlasti kardiovaskularnimi.
English: Both ethanol and propylene glycol are initially metabolised by alcohol dehydrogenase.
Slovenian: Etanol in propilen glikol sta na začetku metabolizirana z alkoholno dehidrogenazo.
English: Levothyroxine Alapis, which is a highly concentrated solution of a highly potent medicinal product, is associated with adverse events with chronic over-dosing - particularly cardiovascular events.
Slovenian: Zdravilo Levothyroxine Alapis, ki je visoko koncentrirana raztopina zelo potentne zdravilne učinkovine, se povezuje z neželenimi dogodki pri kroničnem previsokem odmerjanjuzlasti kardiovaskularnimi.
English: And therefore the CHMP recommended the refusal of the granting of the marketing authorisation for Levothyroxine Alapis and associated names (see Annex I).
Slovenian: • Odbor je sklenil, da se razmerje med tveganjem in koristjo pri zdravilu Levothyroxine Alapis zato ne šteje za ugodno, je zato CHMP priporočil, da se izdaja dovoljenja za promet z zdravilom zavrne in da se začasno prekliče že odobreno dovoljenje za promet z zdravilom Levothyroxine Alapis in povezanimi imeni (glej Prilogo I).
English: Therefore there are major safety concerns due to the chronic use of the combination of ethanol and propylene glycol in neonates/children.
Slovenian: Zato kronična uporaba kombinacije etanola in propilen glikola pri novorojenčkih/otrocih sproža večje pomisleke o njeni varnosti.
English: Inaccuracy due to the miscounting of the large number of drops administered also contributes to the risk of medication error.
Slovenian: Tveganje za napako pri uporabi zdravila se še poveča zaradi nenatančnosti, ki so lahko posledica napačnega štetja velikega števila kapljic pri posameznem odmerku.
English: The national competent authorities, coordinated by the reference Member State, if applicable, shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Slovenian: Pristojni nacionalni organi, ki jih medsebojno usklajuje referenčna država članica, bodo zagotovili, da bo imetnik dovoljenja za promet z zdravilom izpolnil naslednje pogoje:
English: To be determined by Member States following EC decision
Slovenian: Rok določijo države članice na podlagi sklepa Evropske komisije.
English: The MAHs should circulate a DHPC in accordance with the agreed key messages.
Slovenian: Imetniki dovoljenja za promet z zdravilom bodo razposlali obvestilo za zdravstvene delavce (DHPC) v skladu z dogovorjenimi ključnimi sporočili.
English: 0.5ml (1mg/ml) 14 Vials
Slovenian: Subkutana uporaba Viala (steklena) 0,5ml (1mg/ml)
English: Route of administration
Slovenian: 14 Vial
English: These findings have since been verified.
Slovenian: Te ugotovitve so bile od takrat preverjene.
English: The assay time has been reduced to hours as opposed to almost two weeks needed for the conventional culture.
Slovenian: Čas poskusov se je skrajšal na nekaj ur v primerjavi s skoraj dvema tednoma, ki so potrebni za konvencionalne kulture.
English: Special media and atmosphere are required and the incubation period is long (7-10 days).
Slovenian: Potrebni so posebni mediji in okolje, inkubacijska doba pa je dolga (7-10 dni).
English: was as high as 53% (8/15) (Jasper (1977)).
Slovenian: ), je znašal 53 % (8/15) (Jasper (1977)).
English: Monitoring the lack of efficacy is a part of the veterinary pharmacovigilance system.
Slovenian: Spremljanje pomanjkanja učinkovitosti je del sistema veterinarske farmakovigilance.
English: (or Mycoplasma bovis) which are currently authorised or pending authorisations in the European Union.
Slovenian: (ali Mycoplasma bovis), ki so trenutno odobrena ali čakajo na odobritev v Evropski uniji.
English: It may be administered by oral or parenteral routes.
Slovenian: Lahko se daje po peroralni ali parenteralni poti.
English: 29% of the composite samples (81/280) and 43% of the quarter milk samples (433/1008) did not yield growth of Mycoplasma.
Slovenian: 29 % sestavljenih vzorcev (81/280) in 43 % vzorcev mleka iz vimenske četrti (433/1008) ni povzročilo rasti mikoplazme.
English: Details of the treatment experiments are scarce, but altogether he described the results as unrewarding.
Slovenian: Podrobnosti o poskusih zdravljenja so redki, vendar je rezultate opisal kot v celoti nezadovoljive.
English: The clinical signs vary but the milk loss is usually significant.
Slovenian: Klinični znaki so različni, vendar je izguba mleka običajno precejšnja.
English: The authors concluded that the risk of misdiagnosis is increased if multiple milk samples are not tested.
Slovenian: Avtorji so ugotovili, da se tveganje za napačno diagnozo poveča, če se ne testira več vzorcev mleka.
English: Infected cows may remain externally normal with few clinical signs, even in severe cases.
Slovenian: Okužene krave lahko ostanejo navzven normalne z nekaj kliničnimi znaki, tudi v hudih primerih.
English: Mycoplasmas do not grow on conventional media; this hampers the diagnosis.
Slovenian: Mikoplazme ne rastejo na konvencionalnih medijih, kar ovira diagnozo.
English: Since then it has spread to cattle worldwide and is known to cause severe economic losses in the herds affected.
Slovenian: Od takrat se je razširila na govedo po vsem svetu in znano je, da povzroča hude gospodarske izgube v prizadetih čredah.
English: 4.2 Indication(s) for use
Slovenian: 4.2 Indikacija(e) za uporabo
English: A negative cultivation result after treatment could, before, have been falsely interpreted as bacteriological cure although at present it is known merely to be a characteristic of the infection.
Slovenian: Negativni rezultat kultivacije po zdravljenju se je v preteklosti lahko zmotno razlagal kot bakteriološka ozdravitev, čeprav je trenutno znano le, da je to značilnost okužbe.
English: is difficult.
Slovenian: težavno.
English: Furthermore, this indication should not be granted for the pending marketing authorisation applications (see Annex I).
Slovenian: Poleg tega ta indikacija ne sme biti odobrena za vloge v postopku pridobivanja dovoljenja za promet (glejte Prilogo I).
English: Affected milk may seem normal but it may also be purulent and/or have abnormal and discoloured secretions.
Slovenian: Prizadeto mleko se lahko zdi normalno, vendar je lahko tudi gnojno in/ali ima nenormalne in razbarvane izločke.
English: Current technologies such as Polymerase Chain Reaction (PCR) have enabled significantly quicker identification of M. bovis.
Slovenian: Sodobne tehnologije, kot je polimerazna verižna reakcija (PCR), so omogočile bistveno hitrejše prepoznavanje bakterije M. bovis.
English: It is a major problem for milk production and animal welfare in the herds affected, and causes severe economic losses.
Slovenian: Predstavlja veliko težavo za proizvodnjo mleka in dobro počutje živali v prizadetih čredah in povzroča hude gospodarske izgube.
English: He reported testing various antimicrobials, including tylosin.
Slovenian: Poročal je o testiranju različnih protimikrobnih zdravil, vključno z tilozinom.
English: The Committee concluded that indications for use should preferably be restricted to those for which efficacy has been proven and general indications without a solid clinical basis should be avoided.
Slovenian: Odbor je sklenil, da je treba indikacije za uporabo prednostno omejiti na tiste, za katere je bila dokazana učinkovitost, in da se je treba izogibati splošnim indikacijam
English: The dose 3 g/cow/day is within the dose range widely authorised in Europe i.e. 4-10 mg/kg/day i.m.
Slovenian: Odmerek 3 g/kravo/dan je v razponu, splošno odobrenem v Evropi, tj. 4-10 mg/kg/dan i.m.
English: The pathogen is highly contagious and causes severe economic losses.
Slovenian: Patogen je zelo nalezljiv in povzroča velike gospodarske izgube.
English: It is active mostly against Gram-positive bacteria and mycoplasmas.
Slovenian: Deluje predvsem proti po Gramu pozitivnim bakterijam in mikoplazmam.
English: These veterinary medicinal products are also indicated for the treatment of several other diseases including respiratory and gastrointestinal infections, but these indications fall outside the scope of this referral procedure.
Slovenian: Ta zdravila za uporabo v veterinarski medicini so navedena tudi za zdravljenje nekaterih drugih bolezni, vključno z dihalnimi in gastrointestinalnimi okužbami, vendar te indikacije ne sodijo na področje uporabe tega napotitvenega postopka.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for the treatment of conditions caused by sensitive organisms.
Slovenian: Tilozin in njegove fosfatne in tartratne soli se uporabljajo v veterinarski medicini za zdravljenje stanj, ki jih povzročajo občutljivi organizmi.
English: Instead several comprehensive review articles dealing with mycoplasma mastitis have been published (Pfützner and Sachse (1996)4, Nicholas and Ayling (2003)5, Gonzalez and Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
Slovenian: Namesto tega je bilo objavljenih več obsežnih preglednih člankov, ki obravnavajo mikoplazmatski mastitis (Pfützner in Sachse (1996)4, Nicholas in Ayling (2003)5, Gonzalez in Wilson (2003)6, Maunsell et al. (2011)7, Fox (2012)8, Nicholas et al. (2016)9).
English: (see Annex I)
Slovenian: (glejte Prilogo I)
English: Jasper was also one of the first to question the efficacy of antimicrobials in the treatment of mycoplasma mastitis.
Slovenian: Jasper je bil tudi eden izmed prvih, ki je dvomil o učinkovitosti protimikrobnih zdravil pri zdravljenju mikoplazmatskega mastitisa.
English: (see Annex I) in order to amend the summary of product characteristics, labelling and package leaflet in line with recommended changes in the product information as set out in Annex III.
Slovenian: (glejte Prilogo I), in sicer je treba popraviti povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo v skladu s priporočenimi spremembami informacij o zdravilu, opredeljenimi v Prilogi III.
English: In 1977 Jasper 2 described natural resolution of the disease as unpredictable and recognised the danger of intermittently shedding cows.
Slovenian: Leta 1977 je Jasper2 opisal naravni potek bolezni kot nepredvidljiv in prepoznal nevarnost pri kravah, pri katerih se patogen izloča občasno.
English: In case of old products where data are sparse indications should be reviewed and revised, based on the current scientific knowledge, where appropriate.
Slovenian: Pri starih zdravilih, kjer so podatki skopi, je treba, kjer je to potrebno, indikacije pregledati in spremeniti na podlagi obstoječega strokovnega znanja.
English: The major pathogen among the genera is Mycoplasma bovis that was first isolated from bovine mastitis in the USA in the 1960s.
Slovenian: Glavni patogen iz rodu je bakterija Mycoplasma bovis, ki je bila prvič izolirana iz mastitisa pri govedu v ZDA v 60. letih 20. stoletja.
English: For the same reasons sensitivity testing of Mycoplasma spp.
Slovenian: Iz istih razlogov je preizkušanje občutljivosti Mycoplasma spp.
English: In addition to the spread to other quarters, hematologic dissemination of mycoplasma to other parts of the body, e.g. joints, respiratory tract and ears, is possible.
Slovenian: Poleg širjenja na druge vimenske četrti je mogoče hematološko širjenje mikoplazme na druge dele telesa, npr. sklepe, dihala in ušesa.
English: The marketing authorisation holder for the reference medicinal product ‘Tylan 200 mg/ml', Elanco Animal Health, agreed with the concerns raised and concluded that there is a lack of reliable pre-clinical and clinical data in support of the respective indication.
Slovenian: Imetnik dovoljenja za promet za referenčno zdravilo „Tylan 200 mg/ml“ Elanco Animal Health se je strinjal s pomisleki in ugotovil, da je premalo zanesljivih predkliničnih in kliničnih podatkov v podporo ustrezni indikaciji.
English: 1 CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf
Slovenian: 1 CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/11/WC500118230.pdf brez trdne klinične osnove.
English: It is generally accepted that all use of antimicrobials increases the risk of antimicrobial resistance and thus to minimise the risk of transmission of those resistance to the public and animals all unnecessary use should be carefully avoided.
Slovenian: Na splošno velja, da vsaka uporaba protimikrobnih zdravil povečuje nevarnost za protimikrobno odpornost, zato se je treba za zmanjšanje tveganja za prenos te odpornosti na ljudi in živali skrbno izogibati vsem nepotrebnim uporabam.
English: Tylosin belongs to macrolides which have been classified as critically important antimicrobials both in veterinary and human medicine.
Slovenian: Tilozin pripada makrolidom, ki so razvrščeni kot kritično pomembna protimikrobna zdravila tako v veterinarski kot v humani medicini.
English: Macrolides are categorised as critically important antimicrobials both in human and veterinary medicine however tylosin is not used in human medicine.
Slovenian: Makrolidi so kategorizirani kot kritično pomembne protimikrobne učinkovine tako v humani kot veterinarski medicini, vendar pa se tilozin ne uporablja v humani medicini.
English: Often more than one quarter is affected and there is a marked drop in milk production.
Slovenian: Pogosto je prizadetih več vimenskih četrti in zaradi tega je občutno zmanjšana proizvodnja mleka.
English: or Mycoplasma bovis'.
Slovenian: ali Mycoplasma bovis“.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration and applicants/marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe in predlagateljev/imetnikov dovoljenj za promet z zdravilom v državah članicah
English: The use of tylosin as a veterinary medicine has been discussed in the CVMP reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in food-producing animals in the European Union: development of resistance and impact on human and animal health (EMA/CVMP/SAGAM/741087/2009)1.
Slovenian: Uporaba tilozina kot zdravila za uporabo v veterinarski medicini je bila obravnavana v dokumentu o presoji odbora CVMP glede uporabe makrolidov, linkozamidov in streptograminov (MLS) pri živalih za proizvodnjo živil v Evropski uniji: razvoj odpornosti in vpliv na zdravje ljudi in živali (EMA/CVMP/SAGAM/741087/2009)1.
English: The proportion of cows that were found to be M. bovis positive after 5 days of tylosin treatment (3g/cow/day i.m.)
Slovenian: Delež krav, ki so bile pozitivne na bakterijo M. bovispo 5-dnevnem zdravljenju s tilozinom (3 g/kravo/dan i.m.
English: The common view shared in these reviews is that mycoplasma mastitis is untreatable or unresponsive to antimicrobial treatment and that quick identification of infected animals is crucial to prevent the spread of the pathogen in the herd.
Slovenian: Skupno stališče teh preglednih člankov je, da je mikoplazmatski mastitis neozdravljiv ali neodziven na protimikrobno zdravljenje in da je za preprečevanje širjenja patogena v čredi ključnega pomena hitra opredelitev okuženih živali.
English: M. bovis is a highly contagious udder pathogen that is easily spread.
Slovenian: Bakterija M. bovis je zelo nalezljiv patogen vimena, ki se zlahka širi.
English: Tylosin is a macrolide antibiotic which is produced by Streptomyces fradiae.
Slovenian: Tilozin je makrolidni antibiotik, ki ga proizvajajo bakterije družine Streptomyces fradiae.
English: M. bovis is a highly contagious udder pathogen which typically causes mastitis that affects several quarters as it is capable of hematologic dissemination.
Slovenian: M. bovis je zelo nalezljiv patogen vimena, ki običajno povzroča mastitis, ki prizadene več vimenskih četrti, saj se lahko širi po hematološki poti.
English: Therefore, on 22 June 2016, Finland initiated a referral procedure under Article 35 of Directive 2001/82/EC, for veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Slovenian: Zato je Finska 22. junija 2016 začela napotitveni postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo tilozin, ki se dajejo parenteralno in so namenjena zdravljenju mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.
English: It is ineffective against Enterobacteriaceae.
Slovenian: Ne deluje proti bakterijam družine Enterobacteriaceae.
English: As the aforementioned indications have been included in the product information of these veterinary medicinal products for many years, the Committee considered that information on the removal of the indication should be given, thus the following warning sentence should be added to the product information: ‘The efficacy data do not support the use of tylosin for the treatment of bovine mastitis caused by Mycoplasma spp.
Slovenian: Ker so bile zgoraj navedene indikacije več let vključene v informacije o teh zdravilih za uporabo v veterinarski medicini, je Odbor ocenil, da bi bilo treba zagotoviti informacije o odpravi indikacije in informacijam o zdravilu dodati naslednji opozorilni stavek: „Podatki o učinkovitosti ne podpirajo uporabe tilozina za zdravljenje mastitisa pri govedu, ki ga povzroča bakterija Mycoplasma spp.“.
English: from the bovine mastitis indications for the concerned tylosin injectable products in the European Union.
Slovenian: iz indikacij za mastitis pri govedu za zadevna zdravila za injiciranje, ki vsebujejo tilozin, v Evropski uniji.