natgillin/translations-raw huggingface dataset:
Supporting field studies on zinc accumulation in soils were not available during the referral procedure under Article 33(4) of Directive 2001/82/EC for Gutal (EMEA/V/A/108).
Podporne terenske študije o kopičenju cinka v prsti v okviru napotitvenega postopka v skladu s členom 33(4) Direktive 2001/82/ES za zdravilo Gutal (EMEA/V/A/108) niso bile na voljo.
The CVMP considered that the combinations of zinc oxide, recommended for the prevention of nonspecific diarrhoea during the post-weaning period, with any antimicrobial substance recommended for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), are not justified.
Odbor CVMP je presodil, da kombinacije cinkovega oksida, priporočenega za preprečevanje nespecifične driske v obdobju po odstavitvi, s katero koli protimikrobno učinkovino, priporočeno za zdravljenje in metafilakso driske, ki jo povzročajo ciljni patogeni, niso utemeljene.
modulates expression of pro-inflammatory cytokines and tight junction protein in early weaned pigs.
Diosmectite - zinc oxide composite improves intestinal barrier function, modulates expression of pro-inflammatory cytokines and tight junction protein in early weaned pigs.
The marketing authorisation holder also argues the lack of justification for rejecting risk mitigation measures proposed during the procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108).
Imetnik dovoljenja za promet z zdravilom tudi trdi, da ni zavrnitev ukrepov za zmanjšanje tveganja, predlaganih v okviru postopka v skladu s členom 33(4) Direktive 2001/82 za zdravilo Gutal (EMEA/V/A/108), ni utemeljena.
Nonetheless, for each compartment, risks have been identified for some scenarios at each application rate investigated.
Ne glede na to so bila pri nekaterih scenarijih tveganja ugotovljena v vseh ekosistemih in pri vseh preučevanih odmerkih.
According to recently published data, zinc used in animal farming might increase the prevalence of antibiotic resistant bacteria due to co-selection for antimicrobial resistance genes.
Glede na nedavno objavljene podatke bi lahko cink, uporabljen pri vzreji živali, zaradi koselekcije genov za protimikrobno odpornost povečal prevalenco bakterij, odpornih proti antibiotikom.
30 g/100 g 18,45 g/100 g
30 g/100 g g/100 g peroralni prašek
Several published studies demonstrated during in vivo experiments or by investigating environmental isolates a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistant bacteria (LA-MRSA) or of multi-resistant bacterial clones (E. coli).
V več objavljenih študijah je bila v poskusih in vivo ali s preučevanjem izolatov iz okolja dokazana povezava med velikimi odmerki dodanega cinka v krmo in prevalenco bakterij s protimikrobno odpornostjo (LA-MRSA) ali večkratno odpornih bakterijskih klonov (E. coli).
This beneficial effect of zinc oxide was demonstrated at a dose of 100 mg/kg bw per day (equivalent to 2500 ppm in feed), administered during 12-14 days from weaning.
Ta pozitivni učinek cinkovega oksida je bil dokazan pri odmerku 100 mg/kg telesne mase na dan (kar ustreza 2 500 ppm v krmi), ki se daje 12-14 dni po odstavitvi.
The CVMP does not agree with the marketing authorisation holder's argument that the initial benefit-risk assessment was concluded to be positive for the procedure under Article 33(4) of Directive 2001/82 for Gutal (EMEA/V/A/108).
Odbor CVMP se ne strinja z utemeljitvijo imetnika dovoljenja za promet z zdravilom, da je bila prvotna ocena razmerja med tveganji in koristmi v postopku v skladu s členom 33(4) Direktive 2001/82 za zdravilo Gutal (EMEA/V/A/108) pozitivna.
The CVMP considers that the environmental risks identified by the yearly accumulation of zinc in soil from the spreading of manure in agricultural land cannot be controlled with risk mitigation measures.
Odbor CVMP meni, da tveganja za okolje zaradi vsakoletnega kopičenja cinka v tleh zaradi gnojenja kmetijskih zemljišč ni mogoče nadzorovati z ukrepi za zmanjšanje tveganja.
This trend of zinc accumulation on agricultural soils from the veterinary use of zinc oxide has been recently reported by Bak et al. (2015).
O navedeni težnji kopičenja cinka na kmetijskih zemljiščih zaradi uporabe cinkovega oksida v veterinarski medicini so nedavno poročali Bak idr.
The data available shows a beneficial effect of zinc oxide at the dose of 100 mg/kg bw per day (equivalent to 2500 ppm zinc in feed), given in the feed for 12-14 days.
Razpoložljivi podatki kažejo na pozitivne učinke cinkovega oksida v odmerku 100 mg/kg telesne mase na dan (kar ustreza 2 500 ppm cinka v prehrani), ki se daje v krmo 12-14 dni.
• the CVMP considered that based on the available data the efficacy of veterinary medicinal products containing zinc oxide for prevention of post-weaning diarrhoea in piglets is demonstrated;
• odbor CVMP je presodil, da je na podlagi razpoložljivih podatkov učinkovitost zdravil za uporabo v veterinarski medicini, ki vsebujejo cinkov oksid, za preprečevanje driske po odstavitvi pri prašičkih dokazana;
• the CVMP considered that based on the available data the combination of zinc oxide, for the prevention of unspecific diarrhoea during the post-weaning period, with sulfaguanidine, for treatment and metaphylaxis of diarrhoea induced by target pathogen(s), is not justified;
• odbor CVMP je presodil, da na podlagi razpoložljivih podatkov kombinacija cinkovega oksida za preprečevanje nespecifične driske v obdobju po odstavitvi in sulfagvanidina za zdravljenje in metafilakso driske, ki jo povzročajo ciljni patogeni, ni utemeljena;
Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a strong correlation between high doses of zinc supplementation in food and an increase in the prevalence of antimicrobial resistant bacteria.
V več objavljenih študijah je bila dokazana (v poskusih in vivo ali s preučevanjem izolatov iz okolja) močna povezava med velikimi odmerki dodanega cinka v krmo in povečanjem prevalence bakterij s protimikrobno odpornostjo.
Consequently, the CVMP considers that the environmental risks identified by the yearly accumulation of zinc in soil from the spreading of manure in agricultural land cannot be solely controlled with the aforementioned risk mitigation measures.
Zato odbor CVMP meni, da tveganja za okolje zaradi vsakoletnega kopičenja cinka v prsti zaradi gnojenja kmetijskih zemljišč ni mogoče nadzorovati samo z navedenimi ukrepi za zmanjšanje tveganja.
The marketing authorisation holder Huvepharma presented a pragmatic approach on their exposure assessment on Gutal and considered the results from a model used by EFSA (the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010))19 for estimating the environmental exposure from the use of zinc oxide as feed additive.
Imetnik dovoljenja za promet z zdravilom Huvepharma je predstavil pragmatični pristop k svoji oceni izpostavljenosti za zdravilo Gutal in upošteval rezultate modela, ki ga je uporabila agencija EFSA (vmesni dinamični model za kovine (IDMM), ki so ga razvili Monteiro idr.
For sediment systems, since the sediment predicted environmental concentration (PEC) was derived (EU RAR, 2010) there have been significant changes in the way sediment concentrations are determined.
V zvezi s sistemi sedimentov je prišlo do precejšnjih sprememb načina določanja koncentracij v sedimentih, ker je bila izpeljana napovedana okoljska koncentracija za sedimente (PEC) (poročilo EU RAR, 2010).
Several published studies demonstrated (during in vivo experiments or by investigating environmental isolates) a correlation between high doses of zinc supplementation in food and the prevalence of antimicrobial resistance.
V več objavljenih študijah je bila dokazana (v poskusih in vivo ali s preučevanjem izolatov iz okolja) povezava med velikimi odmerki dodanega cinka v krmo in prevalenco protimikrobne odpornosti.
A summary of results from a study performed by Johansen et al. in Denmark in 20072 considering the effects of zinc oxide on post weaning diarrhoea in piglets have been provided.
na Danskem leta 20072 in s katero so preučevali učinke cinkovega oksida na drisko po odstavitvi pri prašičkih.
Moreover,
Ob upoštevanju naslednjega:
According to recently published data, zinc used in animal farming might promote the spread of antimicrobial resistance (MRSA) due to co-resistance.
Glede na nedavno objavljene podatke bi lahko cink, uporabljen pri vzreji živali, zaradi sočasne odpornosti pospešil širjenje protimikrobne odpornosti (MRSA).
MEDITEK Zn 500 mg/g perorální prášek
MEDITEK Zn 500 mg/g perorální prášek cinkov oksid 622 mg/g peroralni prašek
Trckova M, Lorencova A, Hazova K, Sramkova Zajacova Z. 2015.
Animal Feed Science and Technology 181, p. 65 - 71. 5 Trckova M, Lorencova A, Hazova K, Sramkova Zajacova Z. 2015.
Therefore, while soils and surface waters can both be corrected for bioavailability, a correction has not been possible for the calculation of the sediment PECs in this environmental risk assessment.
To pomeni, da je bilo mogoče pri tej oceni tveganja za okolje popraviti izračune za tla in površinske vode glede na biološko uporabnost, kar pa ne velja za izračune vrednosti PEC v sedimentu.
On the other hand, using the bioavailability correction approach, and considering within this approach that bioavailability is dependent on soil type and the time zinc was incorporated onto soil (i.e., zinc aging), the bioavailable fraction was for both
Po drugi strani je bila s pristopom popravka zaradi biološke uporabnosti in z upoštevanjem dejstva v okviru tega pristopa, da je biološka uporabnost odvisna od vrste tal in časa absorpcije cinka v prst (tj. staranja cinka), določena vrednost PNECtla 26 mg/kg (16,3 mg/kg za peščena tla in 14,4 mg/kg za glinena tla).
Sulfaguanidine and zinc oxide combination
Kombinacija sulfagvanidina in cinkovega oksida
Premix for medicated feeding stuff
predmešanica za zdravilno krmno mešanico
13 Metal bioavailability assessment tool (M-BAT) - link 14 Arche Consulting Soil PNEC calculator - link making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)15.
13 Metal bioavailability assessment tool (M-BAT) - link 14 Arche Consulting Soil PNEC calculator - link prisotnost oborjenim mineralnih faz, npr. železovih (oksi)hidroksidov in manganovih oksidov, ter vsebnost organske snovi v sedimentih.
Zinc oxide 622 mg/g (500 mg zinc/g)
Tekrozink 500 mg/g perorálny prášok cinkov oksid 622 mg/g (500 mg zinc/g)
480 mg/g 25 mg/g
480 mg/g 25 mg/g prašek za peroralno dajanje
MIKROP - VLP ZINEK premix
MIKROP - VLP ZINEK premix cinkov oksid 492 mg/g predmešanica
However, it is apparent that, for all compartments, RQs will be exceeded either immediately (sediment) or eventually (soil, ground-, and surface waters), and these risks must be addressed.
Vendar je očitno, da so količniki tveganja preseženi v vseh ekosistemih, bodisi takoj (v sedimentih) bodisi sčasoma (tla,
23 CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal products (EMA/CVMP/ERAWP/409328/2010) - link treated manure to different areas of land, but also because of the trade on manure between Member States and possibility for manure containing high concentrations of zinc oxide being used in susceptible soil types.
23 CVMP reflection paper on risk mitigation measures related to the environmental risk assessment of veterinary medicinal kopičenje cinka, in čeprav je to v skladu z merili iz dokumenta o presoji odbora CVMP23, je to dejansko težko uresničiti, ne le v primerih, ko gnoja zdravljenih živali ni mogoče vnesti na različne dele zemljišča, temveč tudi zaradi trgovine z gnojem med državami članicami in možnosti, da se gnoj, ki vsebuje visoke koncentracije cinkovega oksida, uporabi v občutljivih vrstah tal.
Regarding the potential for risk reduction when complying with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to limit direct entry to water courses, but would not affect the zinc reaching water surface by leaching and run-off processes.
Kar zadeva morebitno zmanjšanje tveganja pri upoštevanju lokalnih ali nacionalnih predpisov o najmanjši razdalji od odprte vode, na kateri se sme gnojiti, je odbor CVMP menil, da bi se lahko uporabljalo samo za omejevanje neposrednega vnosa v vodotoke, vendar bi cink zaradi izpiranja in odtekanja še vedno dosegel površinsko vodo in pitno vodo.
Regarding the risk mitigation measure for compliance with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to prevent direct entry to water courses, but would not affect the zinc reaching surface water and drinking water by leaching and run-off processes.
Kar zadeva ukrep za zmanjšanje tveganja glede upoštevanja lokalnih ali nacionalnih predpisov glede najmanjše razdalje od odprte vode, na kateri se sme gnojiti, je odbor CVMP menil, da bi se lahko uporabljal samo za preprečevanje neposrednega vnosa v vodotoke, vendar bi cink zaradi izpiranja in odtekanja še vedno dosegel površinsko vodo in pitno vodo.
Regarding the risk mitigation measure for compliance with local or national rules for the minimum distance from open water at which manure should be spread, the CVMP considered that this would only be applicable to prevent direct entry to water courses, but would not affect the zinc reaching water surface and drinking water through leaching and run-off processes.
Kar zadeva ukrep za zmanjšanje tveganja glede upoštevanja lokalnih ali nacionalnih predpisov o najmanjši razdalji od odprte vode, na kateri se sme gnojiti, je odbor CVMP menil, da bi se lahko uporabljal samo za preprečevanje neposrednega vnosa v vodotoke, vendar bi cink zaradi izpiranja in odtekanja še vedno dosegel površinske vode in pitno vodo.
• the CVMP considered that based on the available data risks to the environment have been identified, due to accumulation of zinc, for all scenarios, either immediately (sediment, some soil and surface water types) or delayed (other soil types, ground-, and surface waters); the CVMP acknowledged that all predictive models have an inherent degree of uncertainty in their parameterisation, and the results generated (i.e., time estimates) are based on a limited amount of input data which is likely to influence the model output;
• odbor CVMP je presodil, da so bila na podlagi razpoložljivih podatkov zaradi kopičenja cinka ugotovljena tveganja za okolje pri vseh scenarijih, in sicer takojšnja (v sedimentih, nekaterih vrstah tal in površinskih voda) ali zapoznela (v drugih vrstah tal, podtalnici in površinskih vodah).
During the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure.
V navedenem postopku za zdravilo Gutal je bila kot morebiten ukrep za zmanjšanje tveganja upoštevana možnost, da v zaporednih letih ne bi gnojili istega dela zemlje in bi tako upočasnili kopičenje cinka.
Zinc oxide as a sole active substance
Cinkov oksid kot edina zdravilna učinkovina
For this referral procedure, and to support the risk assessment on zinc from its oral use as a veterinary medicinal product in food producing animals, Bak et al. (2015)22 analysed for a 28 year period following application of pig slurry.
Za ta napotitveni postopek in kot podporo oceni tveganja za cink zaradi peroralne uporabe v obliki zdravila za uporabo v veterinarski medicini pri vrstah za proizvodnjo živil so Bak idr.
According to recently published data, zinc used in animal farming might promote the spread of antibiotic resistance due to co-resistance.
Glede na nedavno objavljene podatke bi lahko cink, uporabljen pri vzreji živali, zaradi sočasne odpornosti pospešil širjenje odpornosti proti antibiotikom.
• the CVMP considered that the overall benefit-risk balance for the for veterinary medicinal products containing zinc oxide to be administered orally to food producing species is negative, as the benefits of zinc oxide for the prevention of diarrhoea in pigs do not outweigh the risks for the environment; the CVMP has recommended the refusal of the granting of the marketing authorisations and the withdrawal of the existing marketing authorisations for veterinary medicinal products containing zinc oxide to be administered orally to food producing species as referred in Annex I.
• odbor CVMP je presodil, da je splošno razmerje med tveganji in koristmi veterinarskih zdravil, ki vsebujejo cinkov oksid, za peroralno dajanje vrstam za proizvodnjo živil, negativno, saj koristi cinkovega oksida za preprečevanje driske pri prašičih ne odtehtajo tveganj za okolje;
Suibicol proszek
Suibicol proszek cinkov oksid sulfagvanidin
Zinc oxide 1000 mg/g Oral powder
Zicare cinkov oksid 1000 mg/g peroralni prašek
Colistin and zinc oxide combination
Kombinacija kolistina in cinkovega oksida
Zinc oxide 622mg/g (500 mg zinc/g)
Tekrozink 500 mg/g premix na medikáciu krmiva cinkov oksid 622mg/g (500 mg zinc/g)
Zinc oxide Colistin sulfate
Enteroxid N AMV aniMedica cinkov oksid kolistinijev sulfat
Curative treatment of post-weaning diarrhoeas in piglets is not supported by data provided.
Predloženi podatki ne podpirajo zdravljenja driske po odstavitvi pri prašičkih.
BIOZINK 600 mg/g premix pro medikaci krmiva pro selata
BIOZINK 600 mg/g premix pro medikaci krmiva pro selata cinkov oksid 600 mg/g predmešanica
MEDITEK Zn 500 mg/g premix pro medikaci krmiva
MEDITEK Zn 500 mg/g premix pro medikaci krmiva cinkov oksid 622 mg/g predmešanica
The above risk mitigation measures will only delay the risks identified in all environmental compartments if manure from pigs treated with veterinary medicinal products containing zinc oxide is applied to land.
Ob gnojenju z gnojem prašičev, zdravljenih z zdravili za uporabo v veterinarski medicini, ki vsebujejo cink, bosta zgornja ukrepa za zmanjšanje tveganja le odložila tveganja, ugotovljena pri vseh ekosistemih.
Although during the aforementioned referral procedure for Gutal, the possibility of not spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc was considered as a possible risk mitigation measure, and despite being in line with the criteria set out by the CVMP reflection paper on risk mitigation measures23, it may prove difficult to enact in reality; not only in instances where there may not be the possibility to apply
Čeprav se je v zgorajnavedenem napotitvenem postopku za zdravilo Gutal kot morebiten ukrep za zmanjšanje tveganja upoštevala možnost, da v zaporednih letih ne bi gnojili istega dela zemlje in bi tako upočasnili
Other parameters affecting (lowering) zinc bioavailability in sediments are the presence of precipitated mineral phases, e.g. iron (oxy)hydroxides and manganese oxides, as well as the organic matter content in sediments.
Drugi parametri, ki vplivajo na (znižujejo) biološko uporabnost cinka v sedimentih, so
• You will take your tablets once a day.
• Tablete boste jemali enkrat na dan.
(17) May lead to falls.
(17) Lahko povzroči padce.
Immediate medical treatment may be needed.
Potrebno je lahko takojšnje zdravniško ukrepanje.
- The Committee considered all the available data submitted on the safety and efficacy of quetiapine.
- je odbor proučil vse razpoložljive podatke, predložene v zvezi z varnostjo in učinkovitostjo kvetiapina;
W1K 1LN, UK
W1K 1LN, Velika Britanija
2745-663 Barcarena Portugal
2745-663 Barcarena Portugalska
Children and Adolescents:
Otroci in mladostniki:
It was nevertheless noted that supportive indirect evidence indicates that an effect can be expected after current or earlier failure (insufficient response or intolerance) with one or two antidepressants.
Vendar pa je bilo ugotovljeno, da podporni posredni dokazi kažejo, da je možno pričakovati učinek po trenutnem ali predhodnem neuspehu (nezadosten odziv ali neprenašanje) z enim ali dvema antidepresivoma.
Cheshire SK10 2NA United Kingdom
Cheshire SK10 2NA Velika Britanija
Some medicines for HIV.
• nekatera zdravila za zdravljenje HIV,
Different dosing schedules exist for each indication.
Za vsako indikacijo obstajajo različne sheme odmerjanja.
Hyperprolactinemia16
hiperprolaktinemija16
Abnormal dreams and nightmares Suicidal ideation and suicidal behaviour20
nenavadne sanje in nočne more samomorilno razmišljanje in samomorilno vedenje20
Elderly people If you are elderly your doctor may change your dose.
Starejše osebe Če ste starejša oseba, vam zdravnik lahko spremeni odmerek.
¾Perform new EU Multi-Country Drug Utilisation Study (EU DUS) in accordance with an agreed protocol.
¾ izvesti novo večdržavno študijo EU o uporabi zdravil (EU DUS) v skladu z dogovorjenim protokolom.
Angioedema6, Stevens-Johnson syndrome6
angioedem6, Stevens-Johnsonov sindrom6
This risk persists until significant remission occurs.
Takšno tveganje obstaja, vse dokler ne pride do popolnega umika bolezni.
Children and adolescents (10 to 17 years of age)
Otroci in mladostniki (stari od 10 do 17 let)
An updated version of the Risk Management Plan should be submitted by 30th September 2010 in line with the annual submission of the Period Safety Update Report for Seroquel XR and reflecting the above conditions.
posodobljeno različico načrta za obvladovanje tveganja je treba predložiti do 30. septembra 2010 v skladu z letno vložitvijo redno posodobljenega poročila o varnosti zdravila za zdravilo Seroquel XR, odražati pa mora zgoraj navedene pogoje.
The data showed an additive effect at week 3.
Podatki so pokazali aditiven učinek po 3 tednih.
The safety and efficacy of quetiapine during human pregnancy have not yet been established.
Varnost in učinkovitost kvetiapina med nosečnostjo pri človeku nista ugotovljeni.
However, survival has also been reported following acute overdoses of up to 30 grams.
Vendar pa so poročali tudi o preživetju bolnikov po akutnem prevelikem odmerjanju do 30 gramov kvetiapina.
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suiciderelated events).
Depresija je povezana z večjim tveganjem za pojav samomorilnih misli, samopoškodovanja in samomorilnosti (s samomorom povezani dogodki).
Therefore, Seroquel XR should only be used during pregnancy if the benefits justify the potential risks.
Zato naj bi zdravilo Seroquel SR med nosečnostjo uporabili le, če koristi upravičujejo možna tveganja.
Distribution: Quetiapine is approximately 83% bound to plasma proteins.
Porazdelitev: Kvetiapin je približno 83 % vezan na beljakovine.
Smaller decreases in total T3 and reverse T3 were seen only at higher doses.
Manjša znižanja celotnega T3 in reverznega T3 so opažali le pri večjih odmerkih.
FI - Finland AstraZeneca Oy Luomanportti 3
FI - Finska AstraZeneca Oy Luomanportti 3
Therefore, patients should be advised not to drive or operate machinery, until individual susceptibility to this is known.
Zato je treba bolnikom svetovati, naj ne vozijo in ne upravljajo s stroji, dokler ni znana njihova individualna dovzetnost za to.
Dry mouth
suha usta
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SEROQUEL XR AND ASSOCIATED NAMES (see Annex I)
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SEROQUEL XR IN Z NJIM POVEZANIH IMEN (glejte Dodatek I)
Note: The frequency is consistent to that observed in adults, but irritability might be associated with different clinical implications in children and adolescents as compared to adults.
Opomba: Pogostnost se ujema z ugotovljeno pri odraslih, toda razdražljivost ima lahko pri otrocih in mladostnikih drugačne klinične posledice kot pri odraslih
The safety profile in the MDD population was shown consistent with the already known safety profile of quetiapine in other indications.
Dokazano je bilo, da je varnostni profil v populaciji z MDD skladen z že znanim varnostnim profilom kvetiapina pri drugih indikacijah.
Irritability4
razdražljivost4
DATE OF REVISION OF THE TEXT
DATUM ZADNJE REVIZIJE