natgillin/translations-raw huggingface dataset:
The current guideline on the conduct of bioequivalence studies (EMA/CVMP/016/00-Rev.2) gives no exemption from the need to conduct in vivo bioequivalence studies for parenterally administered solutions when the strength of the active substance differs from that of the reference product and evidence suggests that this change does have the potential to influence the rate and possibly the extent of absorption; 
Trenutne smernice o izvajanju bioekvivalenčnih študij (EMA/CVMP/016/00-Rev.2) ne izvzemajo potrebe po izvajanju bioekvivalenčnih študij in vivo za parenteralno injicirane raztopine, pri katerih je jakost zdravilne učinkovine drugačna od jakosti zdravilne učinkovine referenčnega zdravila, in dokazi navajajo, da ta sprememba lahko potencialno vpliva na hitrost in morda tudi obseg absorpcije.
The applicant submitted an application for a decentralised procedure for Melosolute 40 mg/ml solution for injection for cattle, pigs and horses. 
Predlagatelj je predložil vlogo za decentralizirani postopek za zdravilo Melosolute 40 mg/ml raztopina za injiciranje za govedo, prašiče in konje.
The relevant guidance gives no exemption from the need to conduct in vivo bioequivalence studies for parenterally administered solutions when the strength of the active substance differs from that of the reference product and evidence suggests that this change does have the potential to influence the rate and possibly the extent of absorption. 
Relevantne smernice ne izvzemajo potrebe po izvajanju bioekvivalenčnih študij in vivo za parenteralno injicirane raztopine, pri katerih je jakost zdravilne učinkovine drugačna od jakosti zdravilne učinkovine referenčnega zdravila, in dokazi navajajo, da ta sprememba lahko potencialno vpliva na stopnjo in morda tudi obseg absorpcije.
The applicant should have provided a blood-level comparative pharmacokinetic study between Melosolute 40 mg/ml and the reference product. 
Predlagatelj bi moral predložiti primerjalno farmakokinetično študijo na krvni ravni med zdravilom Melosolute 40 mg/ml in referenčnim zdravilom.
The timing and sparsity of sampling of tissues does not allow tissue residue concentrations to be used as a surrogate for plasma levels that would allow an estimation of blood Cmax and AUC. 
Časovna razporeditev in razpršenost vzorčenja tkiva ne omogoča uporabe koncentracij ostankov tkiva kot nadomestka za plazemske koncentracije, s pomočjo katerih bi lahko podali oceno vrednosti C
The benefit-risk balance for pigs remains inconclusive in absence of adequate information on the safety and efficacy of the product. 
Vrednotenje razmerja med tveganji in koristmi Zaradi pomanjkanja ustreznih informacij o varnosti in učinkovitosti zdravila razmerje med tveganji in koristmi za prašiče ostaja nedoločeno.
The Committee considered whether the bioequivalence of the test product with the reference product in the target species pigs had been proven, based on the available data. 
Na podlagi razpoložljivih podatkov je Odbor preučil, ali je bila za ciljne vrste prašičev dokazana bioekvivalenca testnega zdravila z referenčnim zdravilom.
This is a ‘hybrid' application according to Article 13(3) Directive 2001/82/EC, as amended, referring to the centrally authorised reference product Metacam 20 mg/ml solution for injection for cattle, pigs and horses (EU/2/97/004). 
V skladu s členom 13(3) dopolnjene Direktive 2001/82/ES gre za „hibridno“ vlogo, ki se opira na referenčno zdravilo Metacam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje (EU/2/97/004), odobreno po centraliziranem postopku.
• The pharmaceutical similarity of Melosolute 40 mg/ml and Metacam 20 mg/ml formulations. 
• Farmacevtska podobnost zdravila Melosolute 40 mg/ml in zdravila Metacam 20 mg/ml.
It should be noted that for cattle and horses, the applicant is exempt from providing an in vivo bioequivalence study under waiver 7.1.a of the CVMP guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/00-Rev.2)1 (Bioequivalence GL). 
Opozoriti je treba, da v skladu z izvzetjem pod točko 7.1.a smernic CVMP o izvajanju bioekvivalenčnih študij za zdravila za uporabo v veterinarski medicini (EMA/CVMP/016/00-Rev.2)1 predlagatelju ni treba predložiti bioekvivalenčne študije in vivo za govedo in konje (bioekvivalenčne smernice).
In order to address the concerns raised by the referral, the applicant presented a justification for the omission of a bioequivalence study for Melosolute 40 mg/ml solution for injection and the reference product, Metacam 20 mg/ml solution for injection. 
Da bi odgovoril na pomisleke v napotitvenem postopku, je predlagatelj predložil obrazložitev za izključitev bioekvivalenčne študije za zdravilo Melosolute 40 mg/ml raztopina za injiciranje in referenčno zdravilo Metacam 20 mg/ml raztopina za injiciranje.
Meloxicam is a NSAID of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects. 
Njegovo delovanje temelji na zaviranju sinteze prostaglandinov, zato deluje protivnetno, antieksudativno, analgetično in antipiretično.
The proposed indications in cattle, pigs and horses for Melosolute 40 mg/ml are identical to the approved indications for the reference product, Metacam 20 mg/ml solution for injection for cattle, pigs and horses. 
Predlagane indikacije zdravila Melosolute 40 mg/ml za govedo, prašiče in konje so popolnoma enake odobrenim indikacijam za referenčno zdravilo, tj. zdravilo Metacam 20 mg/ml raztopina za injiciranje za govedo, prašiče in konje.
Melosolute differs from the reference product through different strength of the active substance, meloxicam (40 mg/ml versus 20 mg/ml) and a different concentration of one of the excipients. 
Zdravilo Melosolute se od referenčnega zdravila razlikuje v jakosti zdravilne učinkovine meloksikam (40 mg/ml namesto 20 mg/ml) in koncentraciji ene od pomožnih snovi.
Any increase in the rate/extent of absorption has not been quantified for Melosolute 40 mg/ml in a comparative pharmacokinetic study with the reference product and it could have implications in terms of target animal safety. 
V primerjalni farmakokinetični študiji z referenčnim zdravilom ni bilo kvantificirano nobeno povečanje hitrosti/obsega absorpcije za zdravilo Melosolute 40 mg/ml, kar bi lahko imelo posledice za varnost ciljnih živali.
Melosolute 40 mg/ml solution for injection for cattle, pigs and horses contains meloxicam 40 mg/ml. 
Zdravilo Melosolute 40 mg/ml raztopina za injiciranje za govedo, prašiče in konje vsebuje 40 mg/ml meloksikama.
In conclusion, the following points were not adequately addressed by the applicant: (i) the impact of using different studies for comparison of formulation effects, (ii) the choice of time points which are not consistent with the absorption phase, and do not provide evidence of the rate and extent of absorption (iii) the robustness of the data in relation to the precision of the estimates needed to provide accurate comparison between formulations. 
Čeprav so stopnje meloksikama v jetrih in mišičnem tkivu pri vzorčenju po 4 urah podobne za oba odmerka zdravila, to odraža eno časovno točko in ne dokazuje, da bodo plazemsk koncentracije podobne v celotnem trajanju časovne krivulje koncen Predlagatelj prav tako ni pravilno pojasnil naslednjih točk: (i) vpliv uporabe različnih študij za primerjavo učinkov različnih odmerkov, (ii) izbira časovnih točk, ki niso skladne s fazo absorpcije in ne dokazujejo stopnje in obsega absorpcije, (iii) stabilnost podatkov glede na natančnost ocen, potrebnih za ustrezno primerjavo med različnima odmerkoma.
Meloxicam appeared to be more rapidly absorbed from the 40 mg/ml compared to the 20 mg/ml injection site, as suggested from the residue depletion data at the first (4 hours) sampling time-point, where the injection site levels were lower and kidney levels higher for the 40 mg/ml formulation. 
Podatki izločanja ostankov po prvem vzorčenju (po 4 urah) nakazujejo, da se meloksikam hitreje absorbira pri injiciranju odmerka 40 m kot pri odmerku 20 mg/ml, ker so bile pri odmerku 40 mg/ml stopnje na mestu injiciranja nižje, stopn v ledvicah pa višje.
The presented studies evaluate the depletion of tissue residues following the administration of the products in the target species using the recommended or proposed dose rate and route of administration, with the purpose of determining when these fall below the MRLs. 
CVMP meni, da se namen in zasnova biokevivalenčnih študij in študij ostankov močno razlikujejo.Predstavljene študije ocenjujejo izločanje ostankov tkiva po injiciranju zdravila v ciljno vrsto z uporabo priporočene ali predlagane stopnje odmerka in poti uporabe, da bi določili, kdaj so parametri pod mejnimi vrednostmi ostankov.
Metacam 5 mg/ml formulation. 
To je Odbor že sprejel za zdravilo Metacam 5 mg/ml.
Melosolute 40 mg/ml solution for injection is administered intramuscularly in pigs, whereas in cattle and horses it is administered intravenously. 
Zdravilo Melosolute 40 mg/ml raztopina za injiciranje se pri prašičih injicira intramuskularno, pri govedu in konjih pa intravensko.
The CVMP acknowledged the similarity of the formulations of the Melosolute 40 mg/ml and Metacam 20 mg/ml in terms of their excipients. 
CVMP je potrdil podobnost pomožnih snovi v zdravilu Melosolute 40 mg/ml in zdravilu Metacam 20 mg/ml.
The applicant has submitted a residue depletion study conducted with Melosolute 40 mg/ml as evidence of the comparative pharmacokinetic profile between their product and Metacam 20 mg/ml. 
Predlagatelj je kot dokaz komparativnega farmakokinetičnega profila med zdravilom Melosolute 40 mg/ml in Metacam 20 mg/ml predložil študijo izločanja ostankov za zdravilo Melosolute 40 mg/ml.
• the residues depletion data provided no firm evidence that allows quantification of any difference in rate and extent of absorption of meloxicam between Melosolute 40 mg/ml and Metacam 20 mg/ml, and therefore to quantify its impact on clinical safety and efficacy; the particulars concerning the target species pigs that were submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC, and consequently do not satisfy the criteria for authorisation in respect of safety and efficacy for the target species pigs. 
• Podatki o izločanju ostankov ne zagotavljajo trdnih dokazov, ki bi omogočali kvantifikacijo kakršnekoli razlike v hitrosti in obsegu absorpcije meloksikama med zdravilom Melosolute 40 mg/ml in zdravilom Metacam 20 mg/ml ter s tem kvantifikacijo njegovega vpliva na klinično varnost in učinkovitost.
This is the standard approach that has been applied in the past for intramuscularly or subcutaneously administered injections when the concentration of the active substance is changed, and it would be possible and scientifically valid for the applicant to conduct a comparative pharmacokinetic study to compare the Melosolute 40 mg/ml formulation with the Metacam 20 mg/ml formulation. 
Za predlagatelja bi bilo možno in znanstveno veljavno, da izvede komparativno farmakokinetično študijo za primerjavo zdravila Melosolute 40 mg/ml z zdravilom Metacam 20 mg/ml.
After first opening: 5 months 
Po prvem odprtju: 5 mesecev
Make sure it is fixed well in place. 
Prepričajte se, da je dobro pritrjen.
Instructions for use for patients or carers: 
Navodila za uporabo za bolnike ali skrbnike:
* Statistically significant (p-value) 
* statistično pomembno (p-vrednost)
- These effects are more likely at the start of the treatment or after a dose increase. 
- Ti učinki so verjetnejši ob začetku zdravljenja ali ob povečanju odmerka.
Formal interaction studies have only been performed in adults. 
Formalne študije medsebojnega delovanja so izvedli le pri odraslih.
Learning and memory function were not affected. 
Učenje in delovanje spomina nista bila prizadeta.
Percent reduction over placebo (%) 
Odstotek zmanjšanja v primerjavi s placebom (%)
However, this is not considered to be a clinically relevant difference. 
Vendar to ne šteje za klinično pomembno razliko.
- The medicine may be taken with or without food. 
- Zdravilo lahko jemljete s hrano ali brez.
After first opening of the bottle, use within 5 months. 
Po prvem odprtju steklenice porabite zdravilo v 5 mesecih.
No safety risks were observed. 
Varnostnih tveganj niso opazili.
The dose per intake for each patient should be calculated using the following formula: 
Odmerek na vnos za vsakega bolnika se izračuna po naslednji formuli:
Belgium (name and address only for outer carton, logo on carton and etiquette) 
Belgija (ime in naslov le za zunanjo škatlo, logotip na škatli in nalepki)
See also section 4.8, paediatric data. 
Glejte tudi poglavje 4.8, pediatrični podatki.
Juvenile animals studies 
Študije pri mladičih živali
Partial seizures are fits that start by only affecting one side of the brain. 
- Parcialni napadi so krči, ki na začetku prizadanejo samo eno stran možganov.
None (monohydroxy derivative, MHD) 
Nič (monohidroksi derivat, MHD)
The types of adverse reactions reported during the first 7 days of treatment were similar to those reported for the overall treatment period. 
Vrste neželenih učinkov, o katerih so poročali med prvimi 7 dnevi zdravljenja, so bili podobni tistim, o katerih so poročali za celotno obdobje zdravljenja.
The terminal plasma half-life (t1/2) is approximately 9 hours. 
Končni plazemski razpolovni čas (t1/2) je približno 9 ur.
Across all studies, 81.7 % of the patients who completed randomized studies were enrolled in the long-term open-label extension studies. 
V vseh študijah se je 81,7 % bolnikov, ki so zaključili randomizirane študije, vključilo v dolgotrajne odprte študije.
Although the exact role of this protein remains to be elucidated it has been shown to modulate exocytosis of neurotransmitters. 
Čeprav natančna vloga tega proteina še ni znana, pa je ugotovljeno, da modulira eksocitozo nevrotransmiterjev.
If a woman decides to become pregnant, the use of brivaracetam should be carefully re-evaluated. 
Če se ženska odloči, da bo zanosila, je treba uporabo brivaracetama ponovno ovrednotiti.
Patients with more than a 25 % increase in POS are shown at left as “worse”. 
Bolniki z več kot 25 % povečanjem parcialnih napadov so prikazani na levi kot »poslabšanje«.
Currently available data are described in section 4.8, 5.1, and 5.2 but no recommendation on a posology can be made. 
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
- If you drink alcohol while taking Briviact the negative effects of alcohol may be increased. 
- Če pijete alkohol, ko jemljete zdravilo Briviact, se lahko negativni učinki alkohola povečajo.
You may feel dizzy and sleepy. 
Morda boste omotični ali zaspani.
The clinical experience in patients ≥ 65 years is limited. 
Klinične izkušnje pri bolnikih starih ≥ 65 let so omejene.
More details are provided below the table. 
Več podrobnosti je navedenih pod preglednico.
The risk of clinically relevant CYP3A4 interactions is considered to be low. 
Tveganje klinično pomembnih interakcij s CYP3A4 se smatra za nizko.
The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for brivaracetam. 
Mehanizem tveganja ni poznan, razpoložljivi podatki pa ne izključujejo možnosti povečanja tveganja pri zdravljenju z brivaracetamom.
Do not stop treatment without talking to your doctor first. 
Ne prekinite zdravljenja, ne da bi se pred tem posvetovali s svojim zdravnikom.
However, as a high proportion of subjects (26%) discontinued from the open-label studies due to lack of efficacy, a selection bias may have occurred, as the subjects who stayed in the study responded better than those who have terminated prematurely. 
Vendar pa, ker je visok delež preskušancev (26 %) prekinilo sodelovanje v odprtih študijah zaradi pomanjkanja učinkovitosti, se je lahko pri selekciji pojavila pristranskost, saj so se preskušanci, ki so ostali v študiji odzvali boljše od tistih, ki so jo predčasno zaključili.
Pharmacokinetics is dose-proportional from 10 to at least 600 mg. 
Farmakokinetika je sorazmerna z odmerkom od 10 do vsaj 600 mg.
Due to possible differences in individual sensitivity some patients might experience somnolence, dizziness, and other central nervous system (CNS) related symptoms. 
Zaradi morebitnih razlik v občutljivosti posameznikov lahko nekateri bolniki izkusijo somnolenco, omotičnost in druge simptome, povezane s centralnim živčnim sistemom.
Interaction with alcohol 
Interakcije z alkoholom
You do not need to remove the adaptor after use. 
Po uporabi adapterja ni potrebno odstraniti.
- Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
The 100 mg/day dose was nominally significant. 
Odmerek 100 mg/dan je bil nominalno pomemben.
Although data are limited, the efficacy was comparable to younger subjects. 
Podatkov sicer ni veliko, vendar je bila učinkovitost primerljiva z učinkovitostjo pri mlajših preskušancih.
If not used immediately, in-use storage time and conditions prior to use are the responsibility of the user. 
Če se ne uporabi takoj, je za čas in pogoje shranjevanja odgovoren uporabnik.
You have been given this medicine to lower the number of fits (seizures) you have. 
- To zdravilo vam je bilo predpisano, da bi zmanjšali število krčev (epileptičnih napadov), ki jih imate.
More than 95 % of the dose, including metabolites, is excreted in the urine within 72 hours after intake. 
Več kot 95 % odmerka, vključno s presnovki, se izloči z urinom v 72 urah po zaužitju.
If your doctor asks you to stop taking this medicine they will lower your dose gradually. 
Če vam bo zdravnik naročil, da nehate jemati to zdravilo, bo odmerek zmanjševal postopoma.
All studies had an 8-week baseline period followed by a 12-week treatment period with no uptitration. 
Vse študije so imele 8-tedensko izhodiščno obdobje, ki mu je sledilo 12-tedensko obdobje zdravljenja brez povečevanja odmerka.
- Put the adaptor into the top of the bottle (figure 3). 
- Vstavite adapter v vrh steklenice (slika 3).
In particular, tell your doctor if you are taking any of the following medicines - this is because your doctor may need to adjust your Briviact dose: - Rifampicin - a medicine used to treat bacterial infections. 
Zdravniku povejte zlasti, če jemljete katero od naslednjih zdravil, ker vam bo morda moral prilagoditi odmerek zdravila Briviact: rifampicin - zdravilo, ki se uporablja za zdravljenje bakterijskih okužb.
These partial seizures can spread and extend to larger areas on both sides of the brain - this is called a ‘secondary generalisation'. 
Ti parcialni napadi se lahko razširijo na večja območja na obeh straneh možganov, kar imenujemo
In such cases, it should be used straight after dilution. 
V tem primeru ga je treba porabiti takoj po razredčenju.
If patients missed one dose or more, it is recommended that they take a single dose as soon as they remember and take the following dose at the usual morning or evening time. 
Če bolnik izpusti enega ali več odmerkov, je priporočeno, da vzame en odmerek takoj, ko se spomni, naslednji odmerek pa ob običajnem jutranjem ali večernem času.
- Close the bottle with the plastic screw cap (you do not need to remove the adaptor). 
- Zaprite steklenico s plastično navojno zaporko (adapterja ni treba odstraniti).
Risk related to epilepsy and antiepileptic medicinal products in general For all anti-epileptic drugs, it has been shown that in the offspring of treated women with epilepsy, the prevalence of malformations is two to three times greater than the rate of approximately 3 % in the general population. 
Tveganja, povezana z epilepsijo in antiepileptiki na splošno Za vse antiepileptike so dokazali, da je pri potomcih zdravljenih žensk z epilepsijo prevalenca malformacij od dva- do trikrat višja kot stopnja v splošni populaciji, ki je približno 3 %.
The safety profile in elderly patients appears to be similar to that observed in younger adult patients. 
Varnostni profil pri starejših bolnikih je podoben tistemu pri mlajših odraslih bolnikih.
The renal clearance of these non active metabolites was decreased 10-fold. 
Ledvični očistek teh neaktivnih presnovkov se je zmanjšal za 10-krat.
Check with your doctor which one you should use. 
Posvetujte se z zdravnikom, katero naj uporabite.
The efficacy outcomes are summarized in Table 2. 
Rezultati učinkovitosti so zbrani v preglednici 2.
An additional adverse reaction reported in children was psychomotor hyperactivity 
Dodatni neželeni učinek, o katerem so poročali pri otrocih, je bila psihomotorična hiperaktivnost
Patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. 
Bolnike je treba spremljati zaradi znakov samomorilnega razmišljanja in vedenja ter razmisliti o ustreznem zdravljenju.
Discontinuation of anti-epileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus. 
Prekinitev zdravljenja z antiepileptiki lahko povzroči poslabšanje bolezni, kar bi lahko škodovalo materi in plodu.
In patients who were followed up in the open-label extension studies for up to 8 years, the safety profile was similar to that observed in the short-term, placebo-controlled studies. 
Pri bolnikih, ki so jih spremljali v podaljšanih odprtih študijah za obdobje do 8 let, je bil varnostni profil podoben tistemu, ki so ga opazili v kratkotrajnih študijah, nadzorovanih s placebom.
Briviact with alcohol - Combining this medicine with alcohol is not recommended. 
Zdravilo Briviact skupaj z alkoholom - Jemanje tega zdravila skupaj z alkoholom ni priporočljivo.
Patients should be advised not to drive a car or to operate other potentially hazardous machines until they are familiar with the effects of brivaracetam on their ability to perform such activities. 
Bolnikom je treba svetovati, da ne vozijo avta ali uporabljajo drugih potencialno nevarnih strojev, dokler niso seznanjeni z učinki brivaracetama na njihovo sposobnost opravljanja takih dejavnosti.
Genotoxicity studies have not detected any mutagenic or clastogenic activity. 
Študije genotoksičnosti niso ugotovile mutagene ali klastogene aktivnosti.
The median baseline seizure frequency across the 3 studies was 9 seizures per 28 days. 
Mediana izhodiščne pogostnosti napadov v 3 študijah je bila 9 napadov v 28 dneh.
There are limited safety data from open-label studies in children from 1 month to <4 years of age. 
Na voljo je omejeno število podatkov o varnosti iz odprtih študij pri otrocih, starih od 1 meseca do < 4 leta.
Patients with rare hereditary problems of fructose intolerance should not take this medicine. 
Bolniki z redko dedno intoleranco na fruktozo ne smejo jemati tega zdravila.
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX23 
Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki; oznaka ATC: N03AX23
At the end of the evaluation period, subjects may have been eligible for entry into a long-term follow-up study continuing on their last received dose (see section 4.8). 
Ob koncu obdobja ocenjevanja so bili lahko preskušanci primerni za vstop v dolgotrajno študijo sledenja, v kateri so še naprej jemali zadnji prejeti odmerek (glejte poglavje 4.8).
Open-label extension studies 
Podaljšane odprte študije
Opening date (Only for outer carton) 
Datum odprtja (Samo za škatlo.)
Depression, anxiety, insomnia, irritability 
Depresija, anksioznost, insomnija, razdražljivost
Calendar days: Mon., Tue.,Wed., Thu., Fri., Sat., Sun. 
Koledarski dnevi: pon., tor., sre., čet., pet., sob., ned.
There is insufficient data to determine the clinical significance of this effect in pregnancy. 
Ni dovolj podatkov, da bi lahko določili klinični pomen tega učinka med nosečnostjo.