natgillin/translations-raw huggingface dataset:
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.
In the detailed grounds for the re-examination of the opinion the MAH argued that the three out of eight kidney samples with amoxicillin concentrations higher than the MRL at 21 and 27 days after the last administration should be considered artefacts because of the abnormal kinetic depletion residue profile.
V podrobnostih o podlagi za svojo prošnjo za ponovno preučitev mnenja MAH trdi, da je treba tri izmed osmih vzorcev ledvic s koncentracijami amoksicilina višjimi od MRL na 21. in 27. dan po zadnjem dajanju, imeti za artefakte zaradi nenormalnega kinetičnega profila izločanja ostankov.
Strength Animal species Frequency and route of administration
Živalska vrsta Pogostost in način uporabe zdravila
Furthermore, the method provided was validated over a range using fortified samples.
Poleg tega je bila uporabljena metoda potrjena z uporabo ojačanih vzorcev v določenem obsegu.
In order to ensure a harmonised conclusion on the establishment of the withdrawal periods, it is highly recommended that any new residue depletion studies intended for the lifting of the suspensions of the marketing authorisations are submitted to the CVMP for assessment.
Da bi zagotovili usklajen sklep o določitvi karenc, je močno priporočljivo, da se morebitne nove raziskave izločanja ostankov, namenjene za odpravo začasnega preklica dovoljenja za promet, predložijo v oceno CVMP.
The MAH finally argued that the fluorimetric method used was capable of detecting residues of amoxicillin degradation products, and thus, the concentrations reported may have been overestimated.
Nazadnje je MAH trdil, da je bilo z uporabljeno fluorimetrično metodo možno zaznati ostanke produktov, ki nastanejo ob razgradnji amoksicilina, in so torej sporočene koncentracije lahko previsoko ocenjene.
Assuming the MAH has a valid scientific point, and thus the method should have included an additional clean-up step to improve recovery, the weakness of this argument was that all sample results could therefore be understated.
Ob predpostavki, da MAH ponuja veljavno znanstveno razlago in bi torej metoda za izboljšanje obnovljivosti morala vključevati dodaten očiščevalni korak, pa je bil ta argument pomanjkljiv, saj bi to pomenilo, da bi lahko bili vsi rezultati iz vzorcev nezadostni.
15 mg amoxicillin/kg bw (equivalent to 1ml/10 kg)
15 mg amoksicilina/kg tt (enakovredno 1ml/10 kg)
As a validated method was used with appropriate controls, the CVMP did not consider it appropriate to invalidate the method whilst arguing for its validity for all other results.
Ker je bila potrjena metoda uporabljena z ustreznimi kontrolami, je CVMP menil, da je ni primerno razveljaviti, in hkrati trditi, da je veljavna za vse druge rezultate.
In a complementary study, eight pigs were slaughtered at 30 and 36 days after treatment with Suramox.
V dopolnilni raziskavi je bilo zaklanih osem prašičev 30 in 36 dni po zdravljenju z zdravilom Suramox.
The data available did not allow establishing a reliable withdrawal period based on residues in kidney by either the statistical or the alternative method.
Razpoložljivi podatki niso omogočali zanesljive določitve karence glede na ostanke v ledvicah niti po statistični niti po alternativni metodi.
As the validation data fell within accepted specifications, the CVMP could not agree that it was appropriate to simply dismiss the findings above the MRL as artefacts.
Ker so potrjeni podatki znotraj sprejetih specifikacij, se CVMP ne more strinjati, da je primerno izsledke, ki presegajo MRL, enostavno prezreti kot artefakte.
These samples were chilled, homogenized and stored at -80°C until analysis 4 to 6 months later; the storage stability was confirmed.
Vzorce so ohladili, homogenizirali in do analize, 4 do 6 mesecev kasneje, hranili pri -80 °C; obstojnost skladiščenja je bila potrjena.
For the referral procedure, the MAH presented one residue study in cattle and one in pigs.
Za napotitveni postopek obravnave je MAH predstavil eno raziskavo ostankov pri govedu in eno pri prašičih.
- the CVMP considered that based on the residue depletion data provided concerning the depletion of residues of amoxicillin when administered by injection it was not possible to establish a withdrawal period for cattle and pigs as:
- CVMP je menil, da na podlagi predloženih podatkov o izločanju ostankov v zvezi z izločanjem ostankov amoksicilina, kadar je ta injiciran, ni bilo mogoče določiti karence za govedo in prašiče, ker:
Liver Kidney Milk
Mišica Maščoba Jetra Ledvica Mleko
When providing oral explanations to the Committee concerning the new data submitted the MAH agreed however that withdrawal periods for cattle could not be set on the basis of the data available.
Vendar pa se je pri podajanju ustne razlage v zvezi z novo predloženimi podatki Odboru imetnik dovoljenja za promet strinjal, da na podlagi razpoložljivih podatkov ni mogoče določiti karenc za govedo.
Considering that the study was GLP-compliant, the CVMP cannot lightly dismiss the results in question, especially as there were a total of three ‘positive' samples found.
Ob upoštevanju, da je bila raziskava v skladu z dobro laboratorijsko prakso, CVMP ne more kar tako prezreti teh rezultatov, zlasti ker so bili v celoti najdeni trije "pozitivni" rezultati.
Benzylpenicillin was considered by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) at its 36th meeting in 1990.
Na 36. seji Skupnega strokovnega odbora FAO/WHO za aditive za živila (JECFA) leta 1990 je bil obravnavan benzilpenicilin.
Establishment of the withdrawal period following consideration of all residue studies for pigs and cattle available
Določitev karence na podlagi upoštevanja vseh razpoložljivih raziskav ostankov pri prašičih in govedi
From the original residue depletion study in pigs, the CVMP concluded that the kidney was the limiting tissue for the establishment of a withdrawal period.
Na podlagi prvotne študije o izločanju ostankov pri prašičih je CVMP zaključil, da so bila ledvice omejevalno tkivo za določitev karence.
However, the residue depletion profile in kidney indicated a non-regular profile.
Vendar je profil izločanja ostankov v ledvicah pokazal neredno izločanje.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SURAMOX 15% LA3
ZNANSTVENI ZAKLJUČKI SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SURAMOX 15 %
Pharmacologically active substance
Farmakološka učinkovina
The injection sites contained the highest residue concentrations followed by kidney.
Mesta injiciranja so vsebovala najvišje koncentracije ostankov, na drugem mestu so sledile ledvice.
With the submission of the new residue study for cattle the MAH proposed a withdrawal period of 96 days based on the statistical method.
Ob predložitvi novih raziskav ostankov za govedo je imetnik dovoljenja za promet predlagal karenco 96 dni, temelječo na statistični metodi.
In order to consider lifting the suspension of the marketing authorisations residue depletion data on later time points allowing to establish withdrawal periods for both cattle and pigs meat and offal would be necessary.
Za odpravo umika dovoljenja za promet z zdravilom bi bili potrebni podatki o izločanju ostankov za kasnejše časovne točke, ki bi omogočali določitev karenc za meso in drobovino govedi in prašičev.
Sixteen cattle were slaughtered at 7, 14, 46 and 57 days after treatment with Suramox.
Šestnajst glav govedi je bilo zaklanih 7, 14, 46 in 57 dni po zdravljenju z zdravilom Suramox.
Residues in kidney ranged from below the limit of quantification to 150 µg/kg at 7 days and were below the limit of quantification at later time points.
Ostanki v ledvicah so bili po 7 dneh v razponu od vrednosti pod mejo kvantifikacije do 150 µg/kg, ob drugih časovnih točkah pa pod mejo kvantifikacije.
However, taking into account also the two new residue depletion studies in pigs, the CVMP concludes that the totality of the data indicates that the residue depletion at the injection site will determine the withdrawal period.
Vendar pa CVMP, upoštevaje tudi dve novi raziskavi izločanja ostankov pri prašičih, ugotavlja, da celokupni podatki nakazujejo, da je za določitev karence odločilno izločanje ostankov.