natgillin/translations-raw huggingface dataset:
• panic reaction 
• povečano zanimanje za spolnost, • panična reakcija,
Blood glucose increased Blood glucose decreased Glycosylated haemoglobin increased 
Preiskave povišana vrednost kreatinfosfokinaze v krvi zvišana vrednost glukoze v krvi znižana vrednost glukoze v krvi zvišana vrednost glikoziliranega hemoglobina povečan obseg pasu zmanjšana vrednost holesterola v krvi zmanjšana vrednost trigliceridov v krvi nihanje vrednosti glukoze v krvi
Description of selected adverse reactions 
Opis posameznih neželenih učinkov Reakcije na mestu injiciranja
Nausea 
Natrij
Completed suicide Suicide attempt Pathological gambling Impulse-control disorders Binge eating 
Psihiatrične motnje agitacija anksioznost nemir nespečnost misli na samomor psihotične motnje halucinacije blodnje hiperseksualnost panična reakcija depresija čustvena labilnost apatija disforija motnje spanja bruksizem zmanjšan libido sprememba razpoloženja samomor poskus samomora patološko hazardiranje motnje nadzora impulzov kompulzivno prenajedanje kompulzivno nakupovanje poriomanija zivčnost agresija
Contents of the pack and other information 
Shranjevanje zdravila Abilify Maintena Vsebina pakiranja in dodatne informacije
The recommended needle for deltoid administration is a 25 mm (1 inch), 23 gauge hypodermic safety needle; for obese patients, a 38 mm (1.5 inch), 22 gauge hypodermic safety needle should be used. 
- ena 3 ml injekcijska brizga za enkratno uporabo s konico Luer Lock, - en nastavek za vialo, - ena 25 mm podkožna varnostna igla velikosti 23 z varnostnim pripomočkom, - ena 38 mm podkožna varnostna igla velikosti 22 z varnostnim pripomočkom, - ena 51 mm podkožna varnostna igla velikosti 21 z varnostnim pripomočkom, - navodila za uporabo injekcijske brizge in igle.
It is used for the treatment of: 
Uporablja se za zdravljenje:
Further information on Mekinist can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Mekinist so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Mekinist is available as tablets (0.5 and 2 mg). 
Zdravilo Mekinist je na voljo v obliki tablet (0,5 mg in 2 mg).
What measures are being taken to ensure the safe and effective use of Mekinist? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mekinist?
The dose of Mekinist is 2 mg once a day taken on an empty stomach (at least 1 hour before or 2 hours after a meal) and at around the same time every day. 
Odmerek zdravila Mekinist je 2 mg, jemlje pa se enkrat na dan na prazen želodec (vsaj eno uro pred obrokom ali dve uri po obroku) ter vsak dan ob približno istem času.
Other information about Mekinist 
Druge informacije o zdravilu Mekinist
Mekinist received a marketing authorisation valid throughout the EU on 30 June 2014. 
Za zdravilo Mekinist je bilo 30. junija 2014 izdano dovoljenje za promet, veljavno po vsej EU.
As for all medicines, data on the use of Mekinist are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Mekinist stalno spremljajo.
Treatment with Mekinist must be started and supervised by a doctor experienced in the use of cancer medicines. 
Zdravljenje z zdravilom Mekinist mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Mekinist have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Mekinist upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of Mekinist and why it is authorised in the EU 
Pregled zdravila Mekinist in zakaj je odobreno v EU
Why is Mekinist authorised in the EU? 
Zakaj je bilo zdravilo Mekinist odobreno v EU?
What benefits of Mekinist have been shown in studies? 
Kakšne koristi zdravila Mekinist so se pokazale v študijah?
What are the risks associated with Mekinist? 
Kakšna tveganja so povezana z zdravilom Mekinist?
The use of Mekinist and dabrafenib led to a response in over 60% of the patients, compared with 23% of patients using dabrafenib alone. 
Z uporabo zdravila Mekinist in dabrafeniba je prišlo do odziva pri več kot 60 % bolnikov v primerjavi s 23 % bolnikov, ki so jemali samo dabrafenib.
Mekinist's side effects were considered acceptable and manageable with appropriate measures. 
Neželeni učinki zdravila Mekinist veljajo za sprejemljive in jih je mogoče obvladovati z ustreznimi ukrepi.
Side effects reported with Mekinist are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Mekinist, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
This was based on a main study involving 322 patients who received either Mekinist or the comparator medicine and which measured how long patients lived until their disease got worse. 
To je temeljilo na eni glavni študiji, ki je vključevala 322 bolnikov, ki so prejemali bodisi zdravilo Mekinist bodisi primerjalno zdravilo, v študiji pa so merili čas preživetja bolnikov do poslabšanja bolezni.
Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo. 
Približno 40 % bolnikov, zdravljenih s kombinacijo učinkovin, je po treh letih in pol bodisi umrlo ali se jim je bolezen ponovila; med bolniki, ki so prejemali placebo, pa je bilo takih 59 %.
What is Mekinist and what is it used for? 
Kaj je zdravilo Mekinist in za kaj se uporablja?
For more information about using Mekinist, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Mekinist glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The European Medicines Agency decided that Mekinist's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Mekinist pri zdravljenju raka z mutacijo BRAF V600 večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Mekinist can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back. 
Po kirurškem posegu zaradi napredovalega melanoma se zdravljenje običajno nadaljuje 12 mesecev, razen če se bolezen ponovi.
The most common side effects with Mekinist (which may affect more than 1 in 5 people) are rash, diarrhoea, tiredness, peripheral oedema (swelling, especially of ankles and feet), nausea and acneiform dermatitis (acne-like inflammation of the skin). 
Najpogostejši neželeni učinki zdravila Mekinist (ki se lahko pojavijo pri več kot 1 bolniku od 5) so izpuščaj, driska, utrujenost, periferni edem (otekanje, zlasti stopal in gležnjev), navzeja in akneiformni dermatitis (aknam podobno vnetje kože).
In melanoma and non-small cell lung cancer with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division. 
Pri melanomu in nedrobnoceličnem pljučnem raku z mutacijo BRAF V600 je prisotna nenormalna oblika beljakovine BRAF, ki aktivira drugo beljakovino, imenovano MEK, ki sodeluje pri spodbujanju delitve celic.
When Mekinist is taken in combination with dabrafenib the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash. 
Kadar se zdravilo Mekinist jemlje v kombinaciji z dabrafenibom, so najpogostejši neželeni učinki (ki se lahko pojavijo pri več kot 1 bolniku od 5) povišana telesna temperatura, utrujenost, navzeja, mrzlica, glavobol, driska, bruhanje, bolečine v sklepih in izpuščaj.
In an additional study Mekinist did not show any benefit when given to patients who did not respond to previous treatment with another cancer medicine that blocked BRAF. 
V dodatni študiji zdravila Mekinist, v kateri so ga dajali bolnikom, ki se niso odzvali na predhodno zdravljenje z drugim zdravilom, ki zavira beljakovino BRAF, niso opazili nobenih koristi.
Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called 'BRAF V600'. 
Zdravilo Mekinist je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje odraslih, katerih rakave celice imajo posebno gensko mutacijo (spremembo), imenovano „BRAF V600“.
The Agency considered that Mekinist when used alone or in combination with dabrafenib had shown a clinically relevant benefit in patients with non-small cell lung cancer or with melanoma that had spread or could not be removed surgically. 
Ocenila je, da je zdravilo Mekinist, kadar se je uporabljal samostojno ali v kombinaciji z dabrafenibom, izkazalo klinično pomembne koristi pri bolnikih z drobnoceličnim pljučnim rakom ali melanomom, ki se je razširil ali ga ni mogoče kirurško odstraniti.
Patients given the combination lived on average 25.6 months versus 18 months with vemurafenib. 
Bolniki, ki so prejemali kombinacijo učinkovin, so povprečno živeli 25,6 meseca v primerjavi z 18 meseci pri jemanju vemurafeniba.
Two additional studies on melanoma that had spread to other parts of the body or could not be removed surgically looked at using the combination of Mekinist and dabrafenib. 
V dveh dodatnih študijah pri melanomu, ki se je razširil na druge dele telesa ali ga ni bilo mogoče kirurško odstraniti, so proučevali uporabo kombinacije zdravila Mekinist in dabrafeniba.
Patients taking Mekinist lived on average for 4.8 months before their disease getting worse, compared with 1.5 months for patients given dacarbazine or paclitaxel. 
Bolniki, ki so jemali zdravilo Mekinist, so živeli povprečno 4,8 meseca, preden se jim je bolezen poslabšala, bolniki, ki so jemali dakarbazin ali paklitaksel, pa 1,5 meseca.
This leads cancers to develop by allowing uncontrolled division of cells. 
To privede do nenadzorovane delitve celic in s tem razvoja raka.
In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Mekinist and dabrafenib given for 1 year was compared with placebo (a dummy treatment). 
V študiji, ki je vključevala 870 bolnikov z melanomom v III. stadiju, ki so ga kirurško odstranili, so kombinacijo zdravila Mekinist in dabrafeniba, ki so jo bolnikom dajali eno leto, primerjali s placebom (zdravilom brez učinkovine).
The active substance in Mekinist, trametinib, works by blocking MEK and by preventing its activation by BRAF, thereby slowing down the growth and spread of the cancer. 
Učinkovina v zdravilu Mekinist, trametinib, deluje tako, da neposredno zavira beljakovino MEK, beljakovini BRAF pa prepreči, da bi jo aktivirala, s čimer upočasni rast in širjenje raka.
Mekinist is used on its own or in combination with another cancer medicine, dabrafenib; 
Zdravilo Mekinist se uporablja samostojno ali v kombinaciji z drugim zdravilom za zdravljenje raka, dabrafenibom;
For the full list of side effects and restrictions of Mekinist, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Mekinist glejte navodilo za uporabo.
In one study, 423 patients were given either the combination or dabrafenib alone. 
V eni študiji je 423 bolnikov prejelo bodisi kombinacijo obeh učinkovin bodisi samo dabrafenib.
Patients given the combination lived for 11 months without their disease worsening compared with 8.8 months for those given dabrafenib alone. 
Bolniki, ki so prejemali kombinacijo učinkovin, so brez poslabšanja bolezni živeli 11 mesecev, bolniki, ki so prejemali samo dabrafenib, pa 8,8 meseca.
In a second study involving 704 patients, Mekinist with dabrafenib was compared with another medicine for melanoma, vemurafenib. 
V drugi študiji, ki je vključevala 704 bolnike, so zdravilo Mekinist v kombinaciji z dabrafenibom primerjali z drugim zdravilom za zdravljenje melanoma, vemurafenibom.
In one main study, 171 patients with non-small cell lung cancer received either dabrafenib combined with Mekinist or dabrafenib alone. 
V eni glavni študiji je 171 bolnikov z nedrobnoceličnim pljučnim rakom prejemalo bodisi dabrafenib v kombinaciji z zdravilom Mekinist bodisi samo dabrafenib.
How does Mekinist work? 
Kako zdravilo Mekinist deluje?
Mekinist has been studied in patients whose cancer had the BRAF V600 mutation. 
Zdravilo Mekinist so proučevali pri bolnikih, katerih rakave celice so imele mutacijo BRAF V600.
Mekinist contains the active substance trametinib. 
Zdravilo Mekinist vsebuje učinkovino trametinib.
How is Mekinist used? 
Kako se zdravilo Mekinist uporablja?
It is used in combination with dabrafenib. 
Zdravilo Mekinist se uporablja v kombinaciji z dabrafenibom.
Mekinist was more effective than the cancer medicines dacarbazine or paclitaxel at controlling melanoma that had spread to other parts of the body or could not be removed surgically. 
Zdravilo Mekinist je bilo pri nadziranju melanoma, ki se je razširil na druge dele telesa ali ga ni bilo mogoče kirurško odstraniti, učinkovitejše od drugih zdravil za zdravljenje raka, dakarbazina ali paklitaksela.
• advanced (stage III) melanoma after surgery for it. Mekinist is used in combination with dabrafenib; 
• napredovalega melanoma (v III. stadiju) po prestanem kirurškem posegu.
Milk: 2.5 days 
Mleko: 2,5 dni
Re-examination of the opinion 
Ponovna preučitev mnenja
Or variations of that name as referred to in Annex I 
Ali različic tega imena, kot so navedene v Dodatku I.
Meat and offal: Cattle: 58 days Pigs: 35 days 
Meso in drobovina: govedo: 58 dni prašiči: 35 dni
Assessment of new data further to the request for re-consideration by the European Commission 
Ocena novih podatkov, predloženih po zahtevi za ponovno preučitev s strani Evropske komisije
Marketing Authorisation pending 2 Reference Member State for the Mutual recognition Procedure 
1 Odobritev dovoljenja za promet v teku 2 Referenčna država članica za postopek medsebojnega priznavanja
It was evident that penicillin residues have caused allergic reactions in consumers and that some of these reactions have been serious. 
Očitno je bilo, da so ostanki penicilina povzročili alergijske reakcije pri potrošnikih in da so bile nekatere teh reakcij resne.
The CVMP concluded that this was not scientifically justified. 
CVMP je menil, da to ni bilo znanstveno utemeljeno.
However an ADI for penicillins was not established. 
Kljub temu ADI za peniciline ni bil določen.
At slaughter, the left (first) injection site was taken for local tolerance assessment. 
Pri zakolu so levo (prvo) mesto injiciranja vzeli za oceno lokalne tolerance.
Two intramuscular injections at 48 hours interval 
Dve injekciji intramuskularno z vmesnim intervalom 48 ur
Reports of further cases, which were not available to JECFA, had also been reported in the published literature. 
Poročila o dodatnih primerih, ki JEFCA niso bila na razpolago, so bila prav tako navedena v objavljeni literaturi.
Invented name 
Izmišljeno ime izdelka
Whilst the finding of amoxicillin concentrations above the MRL at two time points following the apparent clear result at 14 days could be an artefact, it could equally be argued that it was the results at 14 days that proved unreliable. 
Medtem ko bi najdene koncentracije amoksicilina nad MRL v dveh časovnih točkah, ki sta sledili očitno čistem rezultatu po 14 dneh, lahko bile artefakt, pa je možno trditi tudi, da so rezultati dobljeni po 14 dneh tisti, ki so nezanesljivi.
In addition the analytical method for the determination of the residues was not sufficiently validated. 
Prav tako analitična metoda za določanje ostankov ni bila zadovoljivo potrjena.
Amoxicillin All food producing species 
Amoksicilin Vse vrste za proizvodnjo živil
The MAH further argued that the method used was probably not robust enough and cited a recent publication that mentions the need for deproteinization steps to improve method recovery. 
MAH je nadalje trdil, da uporabljena metoda verjetno ni bila dovolj robustna in citiral nedavno publikacijo, v kateri je omenjeno, da so za izboljšanje metode obnovljivosti potrebni deproteinizacijski koraki.
The first injection was given in the muscles of the left side of the neck, the second injection was given 48 hours later in the right side of the neck. 
Prvi odmerek je bil injiciran v mišice leve strani vratu, druga injekcija je bila dana 48 ur kasneje na desno stran vratu.
The CVMP concluded that the statistical method could not be used based on the data of the new study provided. 
CVMP je zaključil, da na podlagi predloženih podatkov iz nove študije ni mogoče uporabiti statistične metode.
Only residues at the injection sites were investigated. 
Preučevani so bili le ostanki na mestih injiciranja.
In setting maximum residue limits (MRLs) for the penicillins, the CVMP adopted the same approach as the Joint FAO/WHO Expert Committee on Food Additives (JECFA). 
Pri določanju najvišjih vrednosti ostankov (MRL) za peniciline, je CVMP sprejel enak pristop kot Skupni strokovni odbor FAO/WHO za aditive za živila (JECFA).
In addition the data were derived from animals weighting approximately 200 kg and receiving only one injection per dose administration, which are not necessarily representative of heavier animals requiring multiple injections. 
Poleg tega so bili podatki vzeti pri živalih s telesno težo približno 200 kg, ki so prejele le eno injekcijo na dani odmerek in niso nujno reprezentativne za težje živali, ki potrebujejo več injekcij.
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS, ANIMAL SPECIES, FREQUENCY AND ROUTES OF ADMINISTRATION, RECOMMENDED DOSES, WITHDRAWAL PERIODS AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES CONCERNED BY THE REFERRAL 
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI, ŽIVALSKIH VRST, POGOSTOSTI IN NAČINOV UPORABE ZDRAVILA, PRIPOROČENIH ODMERKOV, KARENCE IN IMETNIKOV DOVOLJENJA ZA PROMET V DRŽAVAH ČLANICAH, NA KATERE SE NAPOTITVENI POSTOPEK NANAŠA
Therefore withdrawal periods for cattle and pigs could not be recommended. 
Posledično karenc za govedo in prašiče ni mogoče priporočiti.
Assessment of residue depletion studies initially submitted 
Ocena prvotno predloženih raziskav izločanja ostankov
On this basis MRLs for amoxicillin and other penicillins were proposed by the CVMP, and amoxicillin is currently entered in Annex I of Council Regulation (EEC) No 2377/90, in accordance with the following table: 
Na podlagi tega je CVMP predlagal MRL za amoksicilin in druge peniciline, amoksicilin pa je trenutno uvrščen v Prilogo I Uredbe Sveta (EGS) št. 2377/90, v skladu z naslednjo preglednico:
- the CVMP assessed the information provided by the Marketing Authorisation Holder in response to the list of questions agreed by the CVMP, the argumentation provided by the Marketing Authorisation Holder in support of the request for the re-examination of the opinion and new residue data made available by the Marketing Authorisation Holder during the re-consideration of the opinion requested by the European Commission; 
- CVMP je ocenil podatke, ki jih je posredoval imetnik dovoljenja za promet v odgovor na seznam vprašanj, ki so zanimala CVMP, argumente, ki jih je imetnik dovoljenja za promet predložil v podporo svoji prošnji za ponovno preučitev mnenja, ter nove podatke o ostankih, ki jih je imetnik dovoljenja za promet dal na voljo med ponovno preučitvijo mnenja, izvedeno na zahtevo Evropske komisije;
Several cases of allergic reactions in humans following the ingestion of food containing penicillin residues were reviewed. 
Preučili so več primerov alergijske reakcije pri ljudeh po zaužitju hrane, vsebujoče ostanke penicilina.
Target tissue 
MRL Ciljno tkivo
Whereas: - the CVMP considered the referral made under Article 35 of Directive 2001/82/EC in the interest of the Community regarding consumer safety for national marketing authorisations for Suramox 15% LA or variations of that name as referred to in Annex I; 
Ob upoštevanju naslednjega: - Odbor je obravnaval napotitev, sproženo v skladu s členom 35 Direktive 2001/82/ES v interesu Skupnosti glede varnosti potrošnika, v zvezi z nacionalnimi dovoljenji za promet z zdravilom Suramox 15 % LA ali različic tega imena, kot so navedene v Dodatku I;
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUSPENSION OF THE MARKETING AUTHORISATIONS 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA ZAČASNI PREKLIC DOVOLJENJA ZA PROMET Z ZDRAVILOM
Marker residue 
Označevalec ostanka
Being aware of cases of allergic reactions at very low doses, JECFA recommended that the daily intake of benzylpenicillin from food be kept as low as practicable, and in any case below 30 µg parent drug per person. 
Zaradi primerov alergijskih reakcij pri zelo nizkih odmerkih je JEFCA priporočil, naj bo dnevni vnos benzilpenicilina s hrano tako nizek, kakor je to praktično mogoče, in na vsak način manjši od 30 µg sorodnega zdravila na osebo.
- the CVMP, having considered the data provided concluded that the currently established withdrawal periods for cattle and pigs are inadequate to ensure that foodstuffs obtained from the treated animals do not contain residues which might constitute a health hazard to the consumer; 
- CVMP je ob upoštevanju predloženih podatkov zaključil, da trenutno določene karence za goveje in prašičje meso niso dovolj ustrezne, da bi zagotovili, da živila, proizvedena iz zdravljenih živali, ne vsebujejo ostankov zdravila, ki bi utegnil predstavljati nevarnost za zdravje potrošnika;
The data generated from these studies however, did not allow, at that stage, to establish withdrawal periods for cattle or pigs with the desired level of reliability. 
Vendar izsledki teh raziskav na tej stopnji ne omogočajo določitve karence za govedo ali prašiče z želeno stopnjo zanesljivosti.
The CVMP set MRLs such that consumer intake from all foods would not exceed this 30 µg threshold. 
CVMP je določil take MRL, da vnos z vso hrano pri potrošniku ne preseže te meje 30 µg.
the CVMP recommends the suspension of the marketing authorisations for Suramox 15% LA or variations of that name as referred in Annex I, presented as injectable suspension for pigs and cattle. 
CVMP priporoča umik dovoljenj za promet z zdravilom Suramox 15 % LA in različic tega imena kot so navedene v Dodatku I, ki so na voljo kot suspenzija za injiciranje za prašiče in govedo.
The MAH initially provided residue data in cattle and pigs using the product under consideration at the recommended dose treatment. 
MAH je prvotno priskrbel podatke o ostankih pri govedu in prašičih, ki so bili zdravljeni s priporočenim odmerkom obravnavanega izdelka.
Amoxicillin was previously evaluated by the CVMP together with other penicillins, in order to establish maximum residue limits (MRLs). 
Predhodno je CVMP ocenil amoksicilin skupaj z ostalimi penicilini, da bi določil najvišje mejne vrednosti ostankov zdravila (MRL).
Neither the statistical (large extrapolation) nor the alternative approach (values above the MRL at the last time point) could be applied to the data provided, and therefore a withdrawal period could not be set according to the “Note for guidance: Approach towards harmonisation of withdrawal periods” (EMEA/CVMP/036/95-FINAL). 
Ker ni bil za priskrbljene podatke primeren niti statističen (velika ekstrapolacija) niti alternativen pristop (vrednosti nad MRL ob zadnji časovni točki), karenca v skladu z »Navodila: Pristop k usklajevanju karenc« (EMEA/CVMP/036/95-FINAL) ni bila določena.