natgillin/translations-raw huggingface dataset:
- during pregnancy and lactation (see section 4.6).” The Committee noted that some contra-indications that were included in the SPC in some Member States could be removed.
- med nosečnostjo in dojenjem (glejte poglavje 4.6).“ Odbor je opazil, da se lahko nekatere kontraindikacije, ki so bile vključene v povzetku glavnih značilnosti zdravila v nekaterih državah članicah, odstranijo.
19 February 2009
29. maja 2009, 16. oktobra 2009
For patients with coronary heart disease after percutaneous coronary interventions, the CHMP agreed that the recommended daily dose is 80 mg.
CHMP se je strinjal, da je pri bolnikih s koronarno srčno boleznijo po perkutanem koronarnem intervencijskem posegu primeren dnevni odmerek 80 mg.
On 9 February 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Lescol in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Lescol v EU, je 9. februarja 2000 zadevo napotila na CHMP.
Primary means that the hypercholesterolaemia does not have any identifiable cause.
Primarna hiperholesterolemija pomeni, da so ravni holesterola v krvi visoke, primarna pa pomeni, da hiperholesterolemija nima očitnega vzroka.
- in patients with active liver disease, or unexplained, persistent elevations in serum transaminases
- pri bolnikih z aktivnim obolenjem jeter ali z nepojasnjenim trajnim zvišanjem vrednosti transaminaz v serumu (glejte poglavja 4.2, 4.4 in 4.8);
Company responses provided on: 29 May 2009, 16 October 2009 Opinion date:
Datum začetka napotitevnega postopka: 19. februar 2009 Odgovori družbe, poslani dne::
Lescol has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Lescol potrebno usklajevanje.
The referral procedure started on 15 September 2011.
Napotitveni postopek se je začel 15. septembra 2011.
INN Pharmaceutical form
INN Farmacevtska oblika
• dietary supplementation.
• prehranska dopolnila.
The detailed grounds for the re-examination were submitted on 10 June 2013.
Podrobne razloge za zahtevo za ponoven pregled sta podali 10. junija 2013.
2 WHO (2004): Background document for development of WHO Guidelines for Drinking-water Quality WHO/SDE/WSH/03.04/114
2 SZO (2004): Background document for development of WHO Guidelines for Drinking-water Quality WHO/SDE/WSH/03.04/114
However, in this case no data on acute toxicity using more sensitive acute endpoints were available.
Vendar v tem primeru niso bili na voljo nobeni podatki o akutni toksičnosti z uporabo bolj občutljivih akutnih končnih točk.
In general, as in this case, absence of pharmacovigilance data cannot be used as justification of the absence of any adverse effects in consumers.
Na splošno, kot v tem primeru, odsotnosti farmakovigilančnih podatkov ni mogoče uporabiti kot utemeljitev odsotnosti kakršnih koli neželenih učinkov pri potrošnikih.
It could only be considered that the data obtained in this study do not contradict the in vitro data.
Upošteva se lahko samo, da podatki iz te študije niso v nasprotju s podatki in vitro.
In the EU presence of harmful residues in food in concentrations above the level considered as safe is not permissible.
V EU prisotnost nevarnih ostankov v hrani pri koncentracijah, ki so višje od ravni, ocenjenih kot varne, ni dovoljena.
National Competent Authorities, coordinated by a reference Member State, shall ensure that the following condition is fulfilled by the marketing authorisation holders:
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, morajo zagotoviti, da imetniki dovoljenj za promet z zdravili izpolnijo naslednji pogoj:
CVMP conclusion after re-examination
Zaključek odbora CVMP po ponovnem pregledu
3 Archer, JA and Judson, GJ (1994): Availability of Barium Selenate administered orally to sheep.
3 Archer, JA in Judson, GJ (1994): Availability of Barium Selenate administered orally to sheep.
However, the evaluation of consumer safety concerns needs to consider all possible adverse effects (not only the most severe), and these are unlikely to be detected by pharmacovigilance systems.
Vendar pa je pri oceni tveganj za varnost potrošnikov treba upoštevati vse možne neželene učinke (ne samo najresnejših), ki pa jih sistemi farmakovigilance verjetno ne odkrijejo.
Based on the data available at the time of the MRL evaluation it was assumed that the available fraction would be very low.
Na podlagi takrat razpoložljivih podatkov ocene MRL se je predpostavljalo, da bo razpoložljiva frakcija zelo nizka.
This figure is much higher than what was assumed when the MRL decision was taken.
Odstotek je veliko višji, kot so predvidevali, ko so določili MRL.
Residues recovered from the injection site in cattle were in the range from 77% to 99% of the injected doses at 30 to 119 days following injection.
Količina ostankov, ki so jih zasledili na mestu injiciranja pri govedu, je znašala od 77 % do 99 % injiciranih odmerkov še 30 do 119 dni po injiciranju.
With regard to acute toxicity reference is made to studies measuring LD50 values.
Kar zadeva akutno toksičnost se sklicuje na študije, v katerih so merili vrednosti LD50.
The marketing authorisation holders should provide data and propose measures that will ensure consumer safety following use of the products and in particular:
Imetniki dovoljenja za promet z zdravili morajo predložiti podatke in predlagati ukrepe, s katerimi bodo zagotovili varnost potrošnikov pri uporabi zdravil, in še zlasti upoštevati naslednje:
The appropriateness of the covered time period needs to be justified and advice provided on identification and removal of the contaminated injection site area.
Ustreznost določenega časovnega obdobja je treba utemeljiti in predložiti nasvete za prepoznavanje in odstranitev kontaminiranih mest injiciranja.
For consumer safety any adverse effects, even mild ones, are relevant and therefore the reference dose to be considered is the level at which no adverse effects (NO(A)EL) can be expected.
Za varnost potrošnikov so relevantni vsi neželeni učinki, tudi blagi, zato je treba upoštevati referenčni odmerek na ravni, pri kateri se ne pričakujejo nobeni neželeni učinki (NO(A)EL).
The grounds for re-examination of the CVMP opinion of 10 April 2013 focused on the following arguments:
Razlogi za zahtevo za ponoven pregled mnenja, ki ga je 10. aprila 2013 podal odbor CVMP, so bili osredotočeni na naslednje:
Among available products, long acting injectables represent a convenient alternative but there are other possibilities including:
Dolgo delujoča zdravila za injiciranje so praktična alternativa poleg razpoložljivih zdravil, vendar obstajajo tudi druge možnosti, kot na primer:
The decentralised procedure was finalised during the referral procedure and the resulting national marketing authorisations have been granted except in Germany.
Decentralizirani postopek je bil zaključen med napotitvenim postopkom in izdana so bila nacionalna dovoljenja za promet z zdravili, razen v Nemčiji.
At present no appropriate withdrawal periods can be set for these veterinary medicinal products.
Trenutno za ta zdravila za uporabo v veterinarski medicini ni mogoče določiti ustrezne karence.
The study also showed that even one year after treatment high amounts of selenium were found at the injection site (up to 53.229 mg/kg).
Študija je prav tako pokazala, da so celo eno leto po zdravljenju na mestu injiciranja odkrili velike količine selena (do 53,229 mg/kg).
Unmarked injection sites are not clearly identifiable in all animals, especially if long periods of time elapse between injection and slaughter.
Neoznačena mesta injiciranja je nemogoče jasno prepoznati pri vseh živalih, zlasti kadar je med injiciranjem in zakolom poteklo dlje časa.
Following the CVMP opinion of 10 April 2013 on this referral procedure, Cross Vetpharm Group Limited and Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) requested a reexamination of that CVMP opinion.
Potem ko je odbor CVMP 10. aprila 2013 podal mnenje v zvezi s tem napotitvenim postopkom, sta družbi Cross Vetpharm Group Limited in Tairgi Tread-Lia Baile na Sceilge Teo (Ballinskelligs Veterinary Products - BVP) zahtevali ponoven pregled tega mnenja.
While the injection sites may not be visible residues levels are still unsafe for human consumption.
Čeprav mesta injiciranja morda niso vidna, ravni ostankov še vedno niso varne za prehrano ljudi.
In principle LD50 is not accepted as an endpoint from which calculations are made to estimate toxicity relevant for consumer risk assessments, acknowledging that the LD50 is a very severe endpoint (where half of the test animals die).
Vrednost LD50 načeloma ni sprejeta kot končna točka, ki se uporabi za izračun ocene toksičnosti, relevantne za oceno tveganja za potrošnike, saj je treba upoštevati, da je vrednost LD50 zelo resna končna točka (pri kateri polovica preizkusnih živali umre).
The condition for lifting the suspension of the marketing authorisations is described in annex III.
Pogoj za preklic začasnega umika dovoljenj za promet z zdravili je opredeljen v Prilogi III.
The CVMP assessed the detailed grounds for the re-examination and the CVMP's conclusions in relation to each of the bullets above are summarised below:
Odbor CVMP je proučil podrobne razloge za zahtevo za ponoven pregled; njegovi zaključki v zvezi z vsako od zgornjih točk so povzeti v nadaljevanju:
Furthermore, while it is the case that the ADI is based on repeated exposure, the alternative threshold proposed by the marketing authorisation holders (i.e. the LD50) is not appropriate as this represents the value at which 50% mortality is expected.
Poleg tega v nasprotju s sprejemljivim dnevnim vnosom, ki temelji na ponavljajoči se izpostavljenosti, alternativna mejna vrednost, ki sta jo predlagala imetnika dovoljenja za promet z zdravilom (tj. LD50), ni primerna, saj predstavlja vrednost, pri kateri se pričakuje 50-odstotna smrtnost.
The indication of significant oral bioavailability was also supported by an in vivo study in sheep (Archer and Judson, 1994)3.
Indikacija pomembne peroralne biološke uporabnosti je bila podprta tudi s študijo in vivo pri ovcah (Archer in Judson, 1994)3.
On 14 September 2011, the Federal Office of Consumer Protection and Food Safety of Germany submitted a notification for a referral procedure under Article 35 of Directive 2001/82/EC for all long acting formulations for injection containing barium selenate for all food producing species.
Dne 14. septembra 2011 je nemški Zvezni urad za varstvo potrošnikov in varnost živil predložil obvestilo o napotitvenem postopku po členu 35 Direktive 2001/82/ES za vse dolgo delujoče formulacije za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil.
• the CVMP considered that risk management measures to avoid injection site residues are currently not in place and could not be identified in this procedure due to a lack of information and sufficient data to evaluate such measures;
• odbor CVMP je menil, da trenutno ne obstajajo nobeni ukrepi za obvladovanje tveganja, ki bi lahko pomagali preprečiti zaužitje ostankov z mesta injiciranja, prav tako pa jih zaradi pomanjkanja informacij in zadostnih podatkov, potrebnih za oceno takih ukrepov, ni bilo mogoče opredeliti v okviru tega postopka;
Considering that the lowest LD50 is less than 10 times the possible consumer's exposure it is obvious that also a fraction of an injection site might cause toxicity if ingested.
Ker je najnižja vrednost LD50 manj kot desetkratnik možne izpostavljenosti potrošnika, je jasno, da lahko v primeru zaužitja že majhen kos mesta injiciranja povzroči toksičnost.
The complete list of all veterinary medicinal products involved in this referral procedure is provided in annex I above.
Celoten seznam vseh zdravil za uporabo v veterinarski medicini, vključenih v ta napotitveni postopek, najdete v Prilogi I zgoraj.
However, injection sites cannot be expected to be identifiable months or possibly years following administration.
Vendar pa je nemogoče pričakovati, da bi mesta injiciranja odkrili več mesecev ali morda celo let po dajanju.
List of the names, pharmaceutical forms, strength of the veterinary medicinal products, animal species, route of administration, withdrawal period and applicant/marketing authorisation holders in the member states
Seznam imen, farmacevtskih oblik in jakosti zdravil za uporabo v veterinarski medicini, živalskih vrst, poti uporabe, karence in imetnikov dovoljenja za promet z zdravilom v državah članicah
The procedure involved 3 veterinary medicinal products with 18 marketing authorisations granted nationally or subject to on-going applications under a decentralised procedure.
V postopek so bila vključena tri zdravila za uporabo v veterinarski medicini z 18 dovoljenji za promet, ki so bila izdana na nacionalni ravni ali so njihove vloge v teku v okviru decentraliziranega postopka.
It was noted in the MRL summary report that measures should be in place to avoid consumption of injection sites.
Vendar pa so v povzetku poročila o MRL navedli, da bi bilo treba sprejeti ukrepe za preprečevanje uživanja mesta injiciranja.
Thus the figure of 5% bioavailability is still considered appropriate for use in residue calculations;
Zato se šteje, da je pri izračunih ostankov še vedno ustrezno upoštevati 5-odstotno biološko uporabnost;
Selenium is an essential micronutrient for animals as well as humans, but is highly toxic if taken in excess and has only a very small safety margin between vital and toxic dose levels.
Selen je življenjsko pomembno mikrohranilo tako za živali kot za ljudi, ki pa je v prekomernih količinah tudi zelo strupeno, pri čemer obstaja zelo tanka varnostna meja med življenjsko pomembnimi in strupenimi ravnmi odmerkov.
• although a number of concerns in relation to the in vitro bioavailability study were raised, the CVMP accepted the overall conclusion of the study and used a figure of 5% in its calculations of bioavailable residues.
• kljub številnim pomislekom v zvezi s študijo biološke uporabnosti in vitro se je odbor CVMP strinjal s splošnim zaključkom študije in pri svojih izračunih biološko uporabnih ostankov uporabil vrednost 5 %.
In 1999 the CVMP assessed barium selenate in the context of an application for the establishment of maximum residue limits under Regulation (EEC) No 2377/90.
Odbor CVMP je barijev selenat leta 1999 ocenil v okviru vloge za določitev najvišjih mejnih vrednosti ostankov v skladu z Uredbo (EGP) št. 2377/90.
However, the design of this study did not allow for an estimation of the bioavailable selenium fraction and thus these data are supportive only.
Vendar zasnova te študije ni omogočala ocene biološke uporabnosti frakcije selena, zato so ti podatki zgolj podporni.
CVMP has now been presented with data from an in vitro study simulating conditions in the human gastrointestinal tract.
CVMP je zdaj prejel podatke iz študije in vitro, v kateri so simulirali pogoje v človeškem prebavnem traktu.
Background (MRL status)
Osnovne informacije (informacije o MRL)
This product was excluded from the referral procedure accordingly, but the data made available to the CVMP concerning the product were taken into account in this assessment.
Zdravilo je bilo zato izključeno iz napotitvenega postopka, podatki, ki so bili predloženi odboru CVMP v zvezi z zdravilom, pa so bili upoštevani pri oceni.
Any health based reference value must be capable of reflecting non-serious adverse effects;
Vsaka orientacijska vrednost, ob upoštevanju katere naj ne bi bilo tveganja za zdravje, mora odražati tudi neželene učinke, ki niso resni;
In addition residue depletion data generated with a product containing a colourant specifically aimed at marking the injection site (ferric oxide), injection sites were not clearly identifiable in all animals and could not be completely removed.
Poleg tega s podatki o izločanju ostankov, pridobljenimi z izdelkom z barvilom, specifično usmerjenim na označevanje mesta injiciranja (železov oksid), mesta injiciranja niso bila jasno prepoznana pri vseh živalih in jih zato ni bilo mogoče v celoti odstraniti.
• the CVMP acknowledged that pharmacovigilance systems can be expected to detect extremely serious cases of poisoning resulting from use of veterinary medicinal products containing barium selenate.
• odbor CVMP se je strinjal, da je mogoče pričakovati, da bodo sistemi farmakovigilance odkrili zelo resne primere zastrupitev, ki so posledica uporabe zdravil za uporabo v veterinarski medicini, ki vsebujejo barijev selenat.
• the CVMP concluded that the study by Archer and Judson (1994)3 could not be used for the purpose of determining bioavailability.
• odbor CVMP je zaključil, da študije, ki sta jo izvedla Archer in Judson (1994)3, ni mogoče uporabiti pri določanju biološke uporabnosti.
Consequently trimming of the injection site is not considered to represent a fully effective risk mitigation measure;
Posledično izrezovanje mesta injiciranja ni popolnoma učinkovit ukrep za zmanjšanje tveganja;
Marketing authorisation not granted
Dovoljenje za promet z zdravilom ni bilo izdano
Cattle (young): 3-8 ml
6-10 ml govedo (mlado govedo): 3-8 ml teleta: 1-2 ml
Therefore, removal of injection sites at slaughterhouses is not considered to be a sufficient risk management measure to reliably prevent consumption of injection site tissue.
Zato odstranitev mest injiciranja ob zakolu ni primeren ukrep za obvladovanje tveganja, s katerim bi bilo mogoče zanesljivo preprečiti zaužitje tkiva z mesta injiciranja.
Despite this, residue levels at the injection site were highly variable, suggesting that sampling failed to identify the true injection site accurately and consistently.
Kljub temu so bile ravni ostankov na mestu injiciranja zelo spremenljive, kar nakazuje, da vzorčenje mesta injiciranja ni določilo natančno in dosledno.
In 2000, following the CVMP recommendation barium selenate was included in Annex II of Regulation (EEC) No 2377/90 for bovine and ovine species, and is, subsequent to the implementation of Regulation (EC) 470/2009 replacing Regulation 2377/90, included in Table 1 of the Annex of Regulation (EU) No 37/2010 for bovine and ovine species, with no maximum residue limit (MRL) required.
Leta 2000 je bil barijev selenat po priporočilu odbora CVMP vključen v Prilogo II k Uredbi (EGP) št. 2377/90 za govedo in ovce in je od izvajanja Uredbe (ES) 470/2009, ki je nadomestila Uredbo 2377/90, vključen v razpredelnico 1 v prilogi k Uredbi (EU) št.
Suitable risk mitigation measures have to be proposed and supported by appropriate scientific data which demonstrate that selenium residues in edible tissues from treated animals, including the injection site, exceeding the upper tolerable intake value of 0.3 mg/person/day do not enter the food chain.
Ustrezni ukrepi za zmanjšanje tveganja morajo biti predlagani in utemeljeni na podlagi primernih znanstvenih podatkov, ki dokazujejo, da ostanki selena v užitnih tkivih zdravljenih živali, vključno z mestom injiciranja, ki presegajo zgornjo mejo dopustnega vnosa 0,3 mg/osebo/dan, ne vstopijo v prehranjevalno verigo.
Despite the slow rate of residue depletion, a withdrawal period of 31 days for cattle meat and offal has been set for the concerned veterinary medicinal products (see annex I).
Kljub počasni stopnji izločanja ostankov je bila za zadevna zdravila za uporabo v veterinarski medicini določena karenca 31 dni za goveje meso in organe (glejte Prilogo I).
Based on the lowered upper tolerable limit (0.3 mg/person/day) for selenium intake, the new information on bioavailability of residues and additional toxicity data in humans, a review of the MRL opinion for barium selenate is recommended in order to protect human health, in accordance with Article 11 of Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May
Priporočil je, da se na podlagi znižane zgornje meje (0,3 mg/osebo/dan) dopustnega vnosa selena, novih informacij o biološki uporabnosti ostankov in dodatnih podatkov o toksičnosti pri ljudeh za zaščito zdravja ljudi izvede pregled mnenja v zvezi z MRL barijevega selenata v skladu s členom 11 Uredbe (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009.
LD50 in rats and mice for selenate and selenite are typically in a range of approximately 1 mg/kg bw to 10 mg/kg bw.
Vrednosti LD50 za selenat in selenit pri podganah in miših so običajno v razponu od približno 1 mg/kg telesne mase do 10 mg/kg/telesne mase.
It should be noted that during the referral procedure the marketing authorisations for a veterinary medicinal product authorised for use in sheep were voluntarily withdrawn by the marketing authorisation holder.
Opozoriti je treba, da je imetnik dovoljenja za promet z zdravilom med napotitvenim postopkom prostovoljno umaknil dovoljenja za promet z zdravili za uporabo v veterinarski medicini, odobrena za uporabo pri ovcah.
Overall summary of the scientific evaluation of long acting formulations for injection containing barium selenate for all food producing species (see annex I)
Splošni povzetek znanstvenega vrednotenja dolgo delujočih formulacij za injiciranje, ki vsebujejo barijev selenat, za vse živalske vrste za proizvodnjo živil (glejte Prilogo I)
This lower-bound estimate did not take into account that under acid pH conditions (gastric acid) and in the presence of sulphate ions (average intake in food of 500 mg/person/day, (WHO, 2004))2 the solubility may considerably increase.
Pri tej oceni spodnje meje niso upoštevali dejstva, da je lahko v kislih pogojih (želodčna kislina) in ob prisotnosti sulfatnih ionov (povprečen vnos s hrano znaša 500 mg/osebo/dan, (WHO, 2004))2 topnost veliko večja.
• risks could be further mitigated by dividing the dose into two injections given into opposite sides of the neck; in practice risks will also be mitigated as Official Veterinarians working at slaughterhouse will see blemishes resulting from barium selenate injections and ensure that the relevant areas of tissue are discarded;
• tveganja bi bilo mogoče dodatno zmanjšati tako, da bi odmerek razdelili in ga dali z dvema injekcijama v nasprotna predela vratu; v praksi bodo tveganja manjša tudi zaradi dejstva, da bodo uradni veterinarji v klavnicah opazili znake injiciranja barijevega selenata in poskrbeli za odstranitev teh delov tkiva;
Barium selenate fulfils a valuable role in the treatment and prevention of nutritional muscular dystrophy (white muscle disease), poor reproductive performance and ill thrift due to selenium deficiency.
Barijev selenat ima pomembno vlogo pri zdravljenju in preprečevanju prehranske mišične distrofije (bolezni belih mišic), zmanjšane sposobnosti razmnoževanja in slabšega napredovanja na telesni teži zaradi pomanjkanja selena.
Also human data give evidence of severe acute effects of selenium at oral dose levels of 5 mg to 22.3 mg selenium/kg (as sodium selenite or sodium selenate), with partly fatal outcomes.
Prav tako so v podatkih na ljudeh zabeležili resne akutne učinke selena pri peroralnih odmerkih od 5 mg do 22,3 mg selena/kg (v obliki natrijevega selenita ali natrijevega selenata) z deloma smrtnimi izidi.
• conclusions on bioavailability in sheep drawn from the Archer and Judson (1994)3 study cannot be readily extrapolated to humans;
• zaključkov o biološki uporabnosti pri ovcah na podlagi študije, ki sta jo izvedla Archer in Judson (1994)3, ni mogoče preprosto ekstrapolirati na ljudi;
Applicant/Marketing Authorisation Holder
Predlagatelj / Imetnik dovoljenja za promet z zdravilom
As previous studies indicated, barium selenate remains at the injection site for a long time.
Kot so pokazale prejšnje študije, barijev selenat na mestu injiciranja ostane dolgo časa.
• the CVMP noted that the guideline on injection site residues applies similarly independent on whether the injection is given subcutaneously or intramuscularly;
• odbor CVMP je upošteval, da se smernice o ostankih na mestu injiciranja uporabljajo podobno, ne glede na to, ali se zdravilo injicira subkutano ali intramuskularno;