natgillin/translations-raw huggingface dataset:
Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with Steglujan (see sections 4.2, 4.4, and 4.8). 
Za zmanjšanje tveganja za hipoglikemijo bo zato v kombinaciji z zdravilom Steglujan morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavja 4.2, 4.4 in 4.8).
No dose adjustment for sitagliptin is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9). 
Pri bolnikih z blago ali zmerno okvaro jeter (ocena po Child-Pugh-u  9) odmerka sitagliptina ni treba prilagoditi.
Temporary interruption of treatment with Steglujan should be considered until the fluid loss is corrected. 
Dokler izguba tekočine ni odpravljena, pride v poštev začasna prekinitev zdravljenja z zdravilom Steglujan.
Sitagliptin is also a substrate of P-gp, which may also be involved in mediating the renal elimination of sitagliptin. 
Sitagliptin je tudi substrat za p-glikoprotein, ki je prav tako lahko vključen pri izločanju sitagliptina skozi ledvice, vendar pa ciklosporin, zaviralec p-glikoproteina, ni zmanjšal ledvičnega očistka sitagliptina.
If pancreatitis is suspected, Steglujan and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Steglujan should not be restarted. 
Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila Steglujan in drugih zdravil, ki bi lahko povzročila pankreatitis.
Do not drive or use any tools or machines if you feel dizzy while taking Steglujan. 
Če se med jemanjem zdravila Steglujan počutite omotični, ne upravljajte vozil in ne uporabljajte nobenega orodja ali strojev.
Consideration may also be given to stopping treatment with ertugliflozin/sitagliptin in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene. 
Pri bolnikih, pri katerih se pojavijo dogodki, ki lahko vodijo do amputacije, kot so kožne razjede na spodnjih okončinah, okužba, osteomielitis ali gangrena, je treba razmisliti o prekinitvi zdravljenja z ertugliflozinom/sitagliptinom.
In addition, patients should be alerted to the risk of hypoglycaemia when Steglujan is used in combination with insulin or an insulin secretagogue and to the elevated risk of adverse reactions related to volume depletion, such as postural dizziness (see sections 4.2, 4.4, and 
Če se zdravilo Steglujan uporablja v kombinaciji z insulinom ali insulinskim sekretagogom, je treba poleg tega bolnike opozoriti na tveganje za hipoglikemijo in na povečano tveganje za neželene učinke, povezane s hipovolemijo, kot je posturalna omotica (glejte poglavja 4.2, 4.4 in 4.8).
Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose. 
Po peroralni uporabi 100 mg odmerka pri zdravih osebah se je sitagliptin hitro absorbiral; največje koncentracije v plazmi (mediana vrednost tmax) so se pojavile v 1 do 4 urah po odmerku, povprečna vrednost AUC sitagliptina v plazmi je bila 8,52 M•ur, vrednost Cmax je bila 950 nM. Absolutna biološka uporabnost sitagliptina je približno 87 %.
Steglujan 5 mg/100 mg film-coated tablets Steglujan 15 mg/100 mg film-coated tablets 
Steglujan 5 mg/100 mg filmsko obložene tablete Steglujan 15 mg/100 mg filmsko obložene tablete
Death from any cause 
Smrt zaradi katerega koli vzroka 547 (7,5)
The proportion of subjects having at least 1 increase in haemoglobin > 2.0 g/dL was higher in the ertugliflozin 5 mg and 15 mg groups (4.7% and 4.1%, respectively) compared to the placebo group (0.6%). 
Mediana sprememb v odstotkih od izhodišča za 5 mg oz. 15 mg ertugliflozina v primerjavi s placebom je znašala za trigliceride -3,9 % oz. -1,7 % za ertugliflozin in 4,5 % za placebo Delež oseb z najmanj 1 povečanjem hemoglobina > 2,0 g/dl je bil večji v skupinah, v katerih so prejemali 5 mg oz. 15 mg ertugliflozina (4,7 % oz. 4,1 %) kot v skupini, ki je prejemala placebo (0,6 %).
The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 l. The fraction of sitagliptin reversibly bound to plasma proteins is low (38%). 
Pri zdravih osebah je povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po enkratnem 100 mg intravenskem odmerku sitagliptina približno 198 litrov.
Steglujan 15 mg/100 mg film-coated tablets 
Steglujan 15 mg/100 mg filmsko obložene tablete
Steglujan 5 mg/100 mg film-coated tablets Steglujan 15 mg/100 mg film-coated tablets ertugliflozin/sitagliptin 
Steglujan 5 mg/100 mg filmsko obložene tablete Steglujan 15 mg/100 mg filmsko obložene tablete ertugliflozin/sitagliptin
Immune system disorders 
Po uporabi peroralne raztopine
Therefore, a lower dose of insulin or insulin secretagogue may be required to minimise the risk of hypoglycaemia when used in combination with Steglujan (see sections 4.2 and 4.5). 
Da bi zmanjšali tveganje za hipoglikemijo, bo pri uporabi v kombinaciji z zdravilom Steglujan morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavji 4.2 in 4.5).
In the pool of placebo-controlled studies, the incidence of adverse events related to volume depletion (dehydration, dizziness postural, presyncope, syncope, 
Po združenih podatkih iz s placebom nadzorovanih študij je bila pojavnost neželenih učinkov, povezanih s hipovolemijo (dehidracija, posturalna omotica, predsinkopa, sinkopa, hipotenzija in ortostatska hipotenzija), majhna (< 2 %) in se med skupinami z ertugliflozinom in placebom ni občutno razlikovala.
• Steglujan 15 mg/100 mg film-coated tablets (tablets) are brown, 12.0 x 7.4 mm, almond-shaped, 
• Zdravilo Steglujan 15 mg/100 mg filmsko obložene tablete (tablete) so rjave barve in mandeljnaste oblike, velikosti 12,0 x 7,4 mm, z oznako "555" na eni strani in brez oznake na drugi strani.
Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase 1 and Phase 2 data. 
Glede na analizo populacijske farmakokinetike na podlagi podatkov iz 1. in 2. faze starost ni imela kliničnega pomena za farmakokinetiko sitagliptina.
Steglujan 5 mg/100 mg film-coated tablets 
Steglujan 5 mg/100 mg filmsko obložene tablete
Ertugliflozin 5 mg + Sitagliptin 
ertugliflozin 5 mg + sitagliptin ertugliflozin 15 mg + sitagliptin placebo
o Each Steglujan 5 mg/100 mg film-coated tablet contains 5 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate). 
o Ena filmsko obložena tableta (tableta) zdravila Steglujan 5 mg/100 mg vsebuje 5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 100 mg sitagliptina (v obliki sitagliptinijevega fosfata monohidrata).
• Steglujan 5 mg/100 mg film-coated tablets (tablets) are beige, 12.0 x 7.4 mm, almond-shaped, 
• Zdravilo Steglujan 5 mg/100 mg filmsko obložene tablete (tablete) so bež barve in mandeljnaste oblike, velikosti 12,0 x 7,4 mm, z oznako "554" na eni strani in brez oznake na drugi strani.
Nervous system disorders Common 
Bolezni živčevja pogosti občasni glavobol omotica
o Each Steglujan 15 mg/100 mg film-coated tablet contains 15 mg of ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate). 
o Ena filmsko obložena tableta (tableta) zdravila Steglujan 15 mg/100 mg vsebuje 15 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 100 mg sitagliptina (v obliki sitagliptinijevega fosfata monohidrata).
What Steglujan contains 
Kaj vsebuje zdravilo Steglujan
Each tablet contains 15 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate). 
Ena tableta vsebuje 15 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 100 mg sitagliptina (v obliki sitagliptinijevega fosfata monohidrata).
Each tablet contains 5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 100 mg sitagliptin (as sitagliptin phosphate monohydrate). 
Ena tableta vsebuje 5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 100 mg sitagliptina (v obliki sitagliptinijevega fosfata monohidrata).
Brown, 12.0 x 7.4 mm, almond-shaped, film-coated tablets debossed with “555” on one side and plain on the other side. 
Steglujan 15 mg/100 mg filmsko obložene tablete rjave filmsko obložene tablete, mandljaste oblike, velikosti 12,0 x 7,4 mm, na eni strani z vtisnjeno oznako "555" in brez oznake na drugi strani
Steglujan 5 mg/100 mg film-coated tablets ertugliflozin/sitagliptin 
Steglujan 5 mg/100 mg filmsko obložene tablete ertugliflozin/sitagliptin
Beige, 12.0 x 7.4 mm, almond-shaped, film-coated tablets debossed with “554” on one side and plain on the other side. 
Steglujan 5 mg/100 mg filmsko obložene tablete bež filmsko obložene tablete, mandljaste oblike, velikosti 12,0 x 7,4 mm, na eni strani z vtisnjeno oznako "554" in brez oznake na drugi strani
Steglujan 15 mg/100 mg film-coated tablets ertugliflozin/sitagliptin 
Steglujan 15 mg/100 mg filmsko obložene tablete ertugliflozin/sitagliptin
BLISTER FOR STEGLUJAN 15 mg/100 mg 
PRETISNI OMOT ZA ZDRAVILO STEGLUJAN 15 mg/100 mg
Impairment in renal function 
Okvarjeno delovanje ledvic
Do not take Steglujan 
Ne jemljite zdravila Steglujan
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and OCT. Sitagliptin may be a mild inhibitor of P-gp in vivo. 
V kliničnih študijah sitagliptin ni pomembno spremenil farmakokinetike metformina, gliburida, simvastatina, rosiglitazona, varfarina ali peroralnih kontraceptivov.
Kriptazen received a marketing authorisation valid throughout the EU on 8 February 2019. 
Zdravilo Kriptazen je pridobilo dovoljenje za promet, veljavno po vsej Evropski uniji, 8. februarja 2019.
Further information on Kriptazen can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/Kriptazen. 
Nadaljnje informacije o zdravilu Kriptazen so na voljo na spletni strani agencije: ema.europa.eu/medicines/veterinary/EPAR/Kriptazen.
What are the benefits and risks of Kriptazen? 
Kakšne so koristi in tveganja, povezani z zdravilom Kriptazen?
Other information about Kriptazen 
Druge informacije o zdravilu Kriptazen
The European Medicines Agency concluded that, in accordance with EU requirements, Kriptazen has been shown to be comparable to Halocur. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Kriptazen primerljivo z zdravilom Halocur.
What is Kriptazen and what is it used for? 
Kaj je zdravilo Kriptazen in za kaj se uporablja?
Why is Kriptazen authorised in the EU? 
Zakaj je zdravilo Kriptazen odobreno v EU?
An overview of Kriptazen and why it is authorised in the EU 
Pregled zdravila Kriptazen in zakaj je odobreno v EU
Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Halocur, and do not need to be repeated for Kriptazen. 
Študije o koristih in tveganjih učinkovine pri odobrenem načinu uporabe so že bile izvedene z referenčnim zdravilom Halocur, zato jih ni treba ponoviti za zdravilo Kriptazen.
No additional studies were needed as Kriptazen is a water based oral solution containing the same active substance and other ingredients as the reference medicine. 
Dodatne študije niso bile potrebne, ker je Kriptazen peroralna raztopina na vodni osnovi, ki vsebuje enako učinkovino in druge sestavine zdravila kot referenčno zdravilo.
The withdrawal period for meat from newborn calves treated with Kriptazen is 13 days. 
Karenca za meso novorojenih telet, zdravljenih z zdravilom Kriptazen, je 13 dni.
Because Kriptazen is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Kriptazen generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The precautions are the same as for the reference medicine since Kriptazen is a generic medicine. 
Previdnostni ukrepi so enaki kot pri referenčnemu zdravilu, saj je zdravilo Kriptazen generično zdravilo.
For prevention of diarrhoea, treatment should start within 24 to 48 hours of birth; for reducing diarrhoea, treatment should start within 24 hours of the start of the diarrhoea. 
Zdravilo se en teden daje novorojenim teletom enkrat na dan. Za preprečevanje driske je treba zdravljenje začeti v 24 do 48 urah po skotitvi, medtem ko je treba zdravljenje za zmanjševanje driske začeti v 24 urah po začetku driske.
every medicine, the company provided studies on the quality and manufacture of Kriptazen. 
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Kriptazen.
Kriptazen contains the active substance halofuginone and is a ‘generic medicine'. 
Zdravilo Kriptazen vsebuje učinkovino halofuginon in je „generično zdravilo“.
This means that Kriptazen contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Halocur. 
To pomeni, da vsebuje enako učinkovino in ima enak način delovanja kot referenčno zdravilo Halocur, ki je že odobreno v Evropski uniji (EU).
Safety information has been included in the summary of product characteristics and the package leaflet for Kriptazen, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers. 
V povzetek glavnih značilnosti zdravila Kriptazen in navodilo za uporabo so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in lastniki ali skrbniki živali.
Kriptazen is a medicine used to treat newborn calves to prevent or reduce diarrhoea caused by an organism called Cryptosporidium parvum. 
Kriptazen je zdravilo, ki se uporablja za zdravljenje novorojenih telet, da se prepreči ali zmanjša driska, ki jo povzroči organizem, imenovan Cryptosporidium parvum.
For more information about using Kriptazen, see the package leaflet or contact your veterinarian or pharmacist. 
Za več informacij glede uporabe zdravila Kriptazen glejte navodilo za uporabo ali se posvetujte z veterinarjem ali farmacevtom.
It also limits the spread of the disease by preventing the formation of oocysts, which are a stage in the lifecycle of the parasite where it is infectious and which are passed in the faeces. 
Prav tako omejuje širjenje bolezni s preprečevanjem nastajanja oocist, ki so razvojna stopnja življenjskega kroga zajedavca, ki so kužne in prehajajo v iztrebke.
This is a parasite belonging to the ‘protozoa' family that invades the digestive system, producing an infection called cryptosporidiosis that results in diarrhoea. 
To je parazit iz družine „protozojev“, ki se naseli v prebavni sistem in povzroči okužbo, imenovano kriptosporidioza, ki povzroča drisko.
The active substance in Kriptazen, halofuginone lactate, prevents the growth of Cryptosporidium parvum. 
Učinkovina v zdravilu Kriptazen, halofuginon laktat, preprečuje rast zajedavca Cryptosporidium parvum.
Kriptazen should be given after feeding. 
Zdravilo Kriptazen je treba dati po krmljenju.
Kriptazen can only be obtained with a prescription and is available as an oral solution (liquid to be given by mouth). 
Predpisovanje in izdaja zdravila Kriptazen je le na recept, na voljo pa je v obliki peroralne raztopine (tekočine za zaužitje skozi usta).
How is Kriptazen used? 
Kako se zdravilo Kriptazen uporablja?
Therefore, the Agency's view was that, as for Halocur, the benefit of Kriptazen outweighs the identified risk and it can be authorised for use in the EU. 
Zato je menila, da koristi zdravila Kriptazen enako kot pri zdravilu Halocur odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How does Kriptazen work? 
Kako zdravilo Kriptazen deluje?
How has Kriptazen been studied? 
Kako je bilo zdravilo Kriptazen raziskano?
1 Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Romania, Spain, Sweden, Slovenia, Slovakia and the United Kingdom 
1 Avstrija, Belgija, Češka, Danska, Francija, Nemčija, Grčija, Irska, Italija, Poljska, Portugalska, Romunija, Španija, Švedska, Slovenija, Slovaška in Združeno kraljestvo
The European Commission issued a decision on 22 March 2016. 
Evropska komisija je sklep izdala 22. marca 2016.
Outcome of a procedure under Article 78 of Directive 2001/82/EC 
Izid postopka v skladu s členom 78 Direktive 2001/82/ES
Accordingly, the CVMP was requested to give its opinion on the matter concerning animal safety. 
Odbor CVMP je bil v skladu s tem pozvan k predložitvi svojega mnenja o vprašanju varnosti živali.
Questions and answers on Closamectin Pour-On Solution and associated names EMA/672999/2015 
Vprašanja in odgovori v zvezi z zdravilom Closamectin Pour-On Solution in povezanimi imeni EMA/672999/2015
Closamectin Pour-On Solution and associated names contain closantel and ivermectin and are authorised in several European Union (EU) Member States1 via decentralised and national procedures. 
Zdravilo Closamectin Pour-On Solution in povezana imena vsebujejo klozantel in ivermektin ter so bila odobrena v več državah članicah Evropske unije (EU)1 z decentraliziranim postopkom in nacionalnimi postopki.
The product was also recalled at veterinary clinic and wholesale level. 
Zdravilo je bilo odpoklicano tudi na ravni veterinarskih klinik in veleprodaje.
It was also recommended that the suspension of the marketing authorisation for CLOSAMECTIN POURON SOLUTION POUR BOVINS in France be lifted. 
Priporočeno je bilo tudi, da se začasni umik dovoljenja za promet z zdravilom CLOSAMECTIN POUR-ON SOLUTION POUR BOVINS v Franciji odpravi.
Between 25 May 2011 and 31 May 2015 the French medicines regulatory agency (Agence Nationale du Médicament Vétérinaire (ANMV)) received a total of 123 adverse event reports involving CLOSAMECTIN POUR-ON POUR BOVINS in which 401 animals were affected and 121 died. 
Od 25. maja 2011 do 31. maja 2015 je francoska regulativna agencija za zdravila (Agence Nationale du Médicament Vétérinaire (ANMV)) prejela skupno 123 poročil o neželenih učinkih v zvezi z zdravilom CLOSAMECTIN POUR-ON POUR BOVINS, ki so zadevali 401 okuženo žival, od katerih jih je 121 poginilo.
Although the overall incidence of adverse events was considered to be within acceptable limits (0.006% in the last annual periodic safety update report ) the continued occurrence of serious adverse events and the severity of subsequent losses on farms in France were considered significant, which led to the suspension of the marketing authorisation in France on 6 July 2015. 
Čeprav je bilo ocenjeno, da je skupna pojavnost neželenih učinkov znotraj dopustnih meja (0,006 % v zadnjem letnem redno posodobljenem poročilu o varnosti zdravila), so bili stalni pojavi resnih neželenih učinkov in resnost posledičnih poginov na kmetijah v Franciji ocenjeni kot pomembni, zaradi česar je bilo
• conditions of the marketing authorisations concerning risk mitigation and surveillance measures. 
• se upoštevajo pogoji v zvezi z dovoljenjem za promet z zdravilom glede ukrepov za zmanjšanje tveganja in nadzornih ukrepov.
The adverse events principally related to neurological signs (ataxia, recumbency, paresis/paralysis and blindness) and/or gastrointestinal disorders (diarrhoea, anorexia etc.) some of which had a fatal outcome. 
Neželeni učinki so se v glavnem nanašali na nevrološke znake (ataksijo, nezmožnost vstajanja, parezo/paralizo in slepoto) in/ali bolezni prebavil (diarejo, anoreksijo itd.); nekateri so se končali s poginom.
Questions and answers on Closamectin Pour-On Solution and associated names 
Vprašanja in odgovori v zvezi z zdravilom Closamectin Pour-On Solution in povezanimi imeni
On 8 October 2015, the European Medicines Agency (the Agency) completed a review of the animal safety of Closamectin Pour-On Solution and associated names. 
Evropska agencija za zdravila (EMA) je 8. oktobra 2015 zaključila pregled varnosti zdravila Closamectin Pour-On Solution in povezanih imen pri živalih.
This included a review of scientific literature regarding the pharmacology and toxicology of ivermectin and closantel, cumulative pharmacovigilance experience following use of the products in the EU since 2009, a comparison with ivermectin-based products and with ivermectin/closantel injectable formulations held by the MAH, investigations carried out by the MAH to identify possible factors involved in reported adverse events and proposals for risk mitigation measures and actions. 
Ti so vključevali pregled znanstvene literature glede farmakoloških in toksikoloških značilnosti ivermektina in klozantela, skupne farmakovigilančne izkušnje, ki izhajajo iz uporabe teh zdravil v EU od leta 2009, primerjavo z zdravili, ki temeljijo na ivermektinu, in s formulacijami ivermektina/klozantela za injiciranje, ki jih proizvaja imetnik dovoljenja za promet z zdravilom, preiskave, ki jih je izvedel imetnik dovoljenja za promet z zdravilom, da bi opredelil morebitne dejavnike, ki so vplivali na neželene učinke, o katerih so poročali, ter predloge za ukrepe za zmanjšanje tveganja.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to: 
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru je odbor CVMP zaključil, da koristi zdravila Closamectin Pour-On Solution in povezanih imen še vedno odtehtajo tveganja, če:
Why were Closamectin Pour-On Solution and associated names reviewed? 
Zakaj so bili zdravilo Closamectin Pour-On Solution in povezana imena pregledani?
• variation of the marketing authorisations for Closamectin Pour-On Solution and associated names to amend the summary of product characteristics and package leaflet to include new precautionary measures and adverse reactions; and 
• se spremenijo dovoljenja za promet z zdravilom Closamectin Pour-On Solution in povezanimi imeni tako, da se spremenita povzetek glavnih značilnosti zdravila in navodilo za uporabo, tako da vključujeta nove previdnostne ukrepe in neželene učinke; ter
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Closamectin Pour-On Solution and associated names continue to outweigh their risks subject to variation of the marketing authorisations to include new adverse reactions and precautionary measures and conditions concerning risk mitigation and surveillance measures. 
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da koristi zdravila Closamectin Pour-On Solution in povezanih imen še vedno odtehtajo tveganja, če se spremenijo dovoljenja za promet z zdravilom, tako da vključujejo nove neželene učinke in previdnostne ukrepe, ter se upoštevajo pogoji glede ukrepov za zmanjšanje tveganja in nadzornih ukrepov.
What is Closamectin Pour-On Solution and associated names? 
Kaj so zdravilo Closamectin Pour-On Solution in povezana imena?
To investigate the potential relation between the adverse events observed and Closamectin Pour-On Solution and associated names, the CVMP considered the data provided by the marketing authorisation holder (MAH). 
Da bi odbor CVMP raziskal morebitno povezavo med opaženimi neželenimi učinki in zdravilom Closamectin Pour-On Solution in povezanimi imeni, je proučil podatke, ki jih je predložil imetnik dovoljenja za promet z zdravilom.