natgillin/translations-raw huggingface dataset:
Why submit: Scope
Zakaj je potrebna predložitev: obseg
To ensure the quality of data submitted to the EudraVigilance database, at least one user from each organisation should receive training.
Da bi zagotovili kakovost podatkov, vnesenih v podatkovno bazo EudraVigilance, se mora vsaj en uporabnik iz posamezne organizacije ustrezno usposobiti.
The submission of medicinal product data by marketing-authorisation holders (MAHs) is a legal requirement introduced by Article 57(2) of Regulation (EC) No 726/2004.
Predložitev podatkov o zdravilu s strani imetnikov dovoljenja za promet z zdravilom je zakonska zahteva, ki jo določa člen 57(2) Uredbe (ES) št. 726/2004.
Marketing-authorisation holders were initially required to submit information on medicinal products for human use by 2 July 2012.
Imetniki dovoljenja za promet z zdravilom so prvotno morali predložiti informacije o zdravilih za uporabo v humani medicini do 2. julija 2012.
This is to ensure that privacy and security measures are in place and that the principles of integrity, accountability and availability of data are adhered to.
Registracija je potrebna zato, da se zagotovijo varnost in varstvo zasebnosti ter spoštovanje načel integritete, odgovornosti in razpoložljivosti podatkov.
• strengthening transparency and communication with the Agency's stakeholders by establishing the European medicines web portal, granting access to safety data, efficiently exchanging data within the EU Network and international partners, and supporting communication between the Agency's Committees and pharmaceutical industry.
• krepitev preglednosti in komunikacije z interesnimi skupinami Agencije z vzpostavitvijo evropskega spletnega portala o zdravilih, zagotavljanjem dostopa do podatkov o varnosti, učinkovito izmenjavo podatkov znotraj mreže EU in z mednarodnimi partnerji ter s spodbujanjem komunikacije med odbori Agencije in farmacevtsko industrijo.
• facilitating the coordination of regulatory decisions and actions to safeguard public health, e.g. to support referral procedures, the establishment of a repository of Periodic Safety Update Reports (PSURs) and literature monitoring;
• spodbujanje usklajevanja regulativnih odločitev in ukrepov za varovanje javnega zdravja, na primer za podporo pri napotitvenih postopkih, vzpostavitvi registra redno posodobljenih poročil o varnosti zdravil (PSUR) in spremljanju literature;
Electronic submission of medicinal product information by marketing-authorisation holders
Elektronska predložitev informacij o zdravilu za imetnike dovoljenja za promet z zdravilom
For enquiries related to the EU SME definition please contact the SME office (sme@ema.europa.eu).
Za vprašanja, povezana z opredelitvijo MSP v EU, se obrnite na urad za MSP (sme@ema.europa.eu).
• coding of substance and product information reported in Individual Case Safety Reports (ICSRs) within the Eudravigilance system to support Pharmacovigilance signal management activities and the performance of data analysis and business intelligence at the Agency;
• šifriranje predloženih informacij o učinkovini in zdravilu v varnostnih poročilih o posameznih primerih (ICSR) znotraj sistema Eudravigilance, da bi podprli dejavnosti upravljanja signalov farmakovigilance ter izvajanje analiz podatkov in poslovno obveščanje pri Agenciji;
The aim of the data submission is to establish a complete inventory of all medicines authorised for human use in the EEA, including medicines authorised centrally via the EMA and those authorised at national level via the National Competent Authorities (NCAs).
Cilj predložitve podatkov je, da bi zagotovili celovit popis vseh zdravil, odobrenih za uporabo v humani medicini v EGS, vključno z zdravili, odobrenimi po centraliziranem postopku, ki ga vodi EMA, in zdravili, ki jih na nacionalni ravni odobrijo pristojni nacionalni organi.
For enquires on how to register contact the Eudravigilance registration office (eudravigilanceregistration@ema.europa.eu).
Za vprašanja o postopku registracije se obrnite na urad za registracijo v sistem Eudravigilance (eudravigilanceregistration@ema.europa.eu).
This legal provision requires all holders of marketing authorisations for medicinal products for human use in the European Economic Area (EEA) to submit information to the European Medicines Agency (EMA) using the electronic format referred to as Article 57 format or eXtended EudraVigilance Product Report Message (XEVPRM) format.
Ta zakonska določba zahteva, da vsi imetniki dovoljenj za promet z zdravilom za zdravila za uporabo v humani medicini v Evropskem gospodarskem prostoru (EGS) Evropski agenciji za zdravila (EMA) predložijo informacije v elektronski obliki, in sicer v formatu v skladu s členom 57 ali formatu XEVPRM (razširjeno sporočilo s poročilom o zdravilu v EudraVigilance).
For information related to submission of authorised medicines data visit the Data submission webpage.
Za informacije, povezane s predložitvijo podatkov o odobrenih zdravilih, obiščite spletno stran o predložitvi podatkov.
Since July 2012, MAHs are required to submit information on new marketing authorisations granted after 2 July 2012 within 15 calendar days from the date of notification of the granting of the marketing authorisation by the NCA.
Od julija 2012 morajo imetniki dovoljenja za promet z zdravilom predložiti informacije o novih dovoljenjih za promet, odobrenih po 2. juliju 2012, v 15 koledarskih dneh od datuma obvestila o odobritvi dovoljenja za promet z zdravilom, ki ga izda pristojni nacionalni organ.
Information on any amendments to the terms of marketing authorisations following variation, transfer, renewal, suspension, revocation or withdrawal shall be notified to the EMA no later than 30 calendar days from the date on which the amendments have been authorised as per guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Informacije o kakršnih koli spremembah pogojev dovoljenj za promet z zdravilom po spremembi, prenosu, obnovitvi, začasnem umiku, odvzemu ali umiku dovoljenja je treba Evropski agenciji za zdravila sporočiti najkasneje v 30 koledarskih dneh od datuma odobritve sprememb v skladu s smernicami in postopki, opisanimi v Poglavju 3.II: Dokument s smernicami za uporabo razširjenega sporočila s poročilom o zdravilu v EudraVigilance (XEVPRM).
To begin data submission of authorised medicinal products, marketing-authorisation holders need to register with Eudravigilance.
Za predložitev podatkov o odobrenih zdravilih se morajo imetniki dovoljenj za promet z zdravilom najprej registrirati v sistem Eudravigilance.
An eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) training course is available as a face-to-face or e-learning training course.
Na voljo je tečaj usposabljanja za delo z razširjenim slovarjem zdravil EudraVigilance (XEVMPD), ki se lahko izvede v predavalnici ali v obliki e-učenja.
• calculating the Pharmacovigilance Fees payable by MAHs;
• izračun pristojbin za farmakovigilanco, ki jih plačajo imetniki dovoljenja za promet z zdravilom;
Enquiries related to Article 57(2) submissions can be submitted to the EMA via the EMA Service Desk portal (https://servicedesk.ema.europa.eu).
Vprašanja, povezana s predložitvijo podatkov v skladu s členom 57(2), se lahko pošljejo Evropski agenciji za zdravila preko EMA Service Desk portala (https://servicedesk.ema.europa.eu).
By 31 December 2014 MAHs were also required to improve quality of information on authorised medicines submitted to the EMA, bring their medicinal product entries up-to-date and submit additional information in line with the guidance and processes described in Chapter 3.II: Extended EudraVigilance product report message (XEVPRM) user guidance document.
Do 31. decembra 2014 so morali imetniki dovoljenja za promet z zdravilom tudi izboljšati kakovost informacij o odobrenih zdravilih, predloženih Evropski agenciji za zdravila, posodobiti vnesene podatke o svojih zdravilih in predložiti dodatne informacije v skladu s smernicami in postopki, opisanimi v Poglavju 3.II: Dokument s smernicami za uporabo razširjenega sporočila s poročilom o zdravilu v EudraVigilance (XEVPRM).
• medicinal products authorised through the mutual recognition procedure;
• za zdravila, odobrena po postopku z medsebojnim priznavanjem;
• medicinal products authorised through the decentralised procedure.
• za zdravila, odobrena po decentraliziranem postopku.
For documents related to submission of authorised medicines data visit the Guidance document webpage.
Za dokumente, povezane s predložitvijo podatkov o odobrenih zdravilih, obiščite spletno stran z dokumenti s smernicami.
When to submit
Kdaj je potrebna predložitev:
MAHs are required to submit to the EMA information on all medicinal products for which they hold a marketing authorisation in the EEA, i.e.:
Imetniki dovoljenja za promet z zdravilom morajo Evropski agenciji za zdravila predložiti informacije o vseh zdravilih, za katera imajo dovoljenje za promet v EGS, kar pomeni:
MAHs are also obliged to maintain the submitted medicinal product information and notify the EMA of any newly authorised medicines or variations to the terms of the marketing authorisation using the XEVPRM format.
Prav tako so imetniki dovoljenja za promet z zdravilom dolžni vzdrževati predložene informacije o zdravilu in Evropsko agencijo za zdravila obvestiti o odobritvi katerega koli novega zdravila ali spremembah pogojev dovoljenja za promet z zdravilom v formatu XEVPRM.
• nationally authorised medicinal products;
• za zdravila, odobrena po nacionalnih postopkih;
• centrally authorised medicinal products;
• za zdravila, odobrena po centraliziranem postopku;
% of treated dogs*
% zdravljenih psov
During the first 21 days of treatment, the quantity of food the animal receives may remain unchanged.
V prvih 21 dneh zdravljenja lahko količina hrane, ki jo prejme žival, ostane nespremenjena.
• This medicine has been prescribed for your dog only and you should not pass it on to others.
• Zdravilo je bilo predpisano samo vašemu psu in ga ne smete dajati drugim.
Generally, the severity of these effects increased with increasing dose.
Na splošno se resnost teh učinkov poveča s povečanjem odmerka.
Your veterinary surgeon will advise you on the type of food your dog will need.
Veterinar vam bo svetoval o vrsti hrane, ki jo potrebuje vaš pes.
* : in line with the recommended treatment schedule
* Skladno s priporočenim režimom zdravljenja.
Once the dog has eaten the complete portion, give the remaining amount of food to the dog.
Ko je pes pojedel cel del, mu dajte preostalo količino hrane.
Thereafter, feeding should be in accordance with energy requirements for maintenance (to be calculated by the veterinarian).
Potem mora biti hranjenje skladno s potrebami po kalorijah za vzdrževanje (izračuna jih veterinar).
This results in blockage of the uptake of dietary lipids.
To povzroča blokado privzema dietnih lipidov.
• in dogs less than 18 months of age.
• je mlajši od 18 mesecev;
In most cases, these effects are mild and transient.
V večini primerov so ti učinki blagi in prehodni.
Interactions with other drug types were not specifically investigated.
Interakcij z drugimi vrstami zdravil niso natančno raziskali.
Butylated hydroxyanisole (E 320)
Butiliran hidroksianizol (E 320)
No specific antidote is available.
Specifičnega protistrupa ni.
Treatment should be given with food.
Zdravilo je treba dajati s hrano.
The most important metabolic transformation is sulphoxidation, which produces three active metabolites.
Najpomembnejša presnovna transformacija je sulfoksidacija, ki proizvede tri aktivne presnovke.
Do not use in dogs less than 18 months of age.
Ne uporabljajte pri psih, mlajših od 18 mesecev.
In addition, hyperkalaemia was occasionally observed.
Poleg tega so občasno ugotovili hiperkaliemijo.
• significant loss of appetite.
• izrazita izguba teka.
Mitratapide has no central effect.
Mitratapid nima učinka na osrednje živčevje.
After each dose, the syringe should be removed from the bottle.
Po vsakem odmerku je treba brizgo odstraniti iz stekleničke.
• If you have further questions, please ask your veterinary surgeon or your pharmacist
• Če imate dodatna vprašanja, se posvetujte z veterinarjem ali farmacevtom.
In addition, treatment should be interrupted and the advice of a veterinarian should be sought where the observed body weight loss is severe and rapid.
Poleg tega je treba zdravljenje prekiniti in se posvetovati z veterinarjem, kadar opazite, da je izguba telesne teže velika in hitra.
Pharmacotherapeutic group: Peripherally acting antiobesity products, ATCvet Code: QA08AB90
Farmakoterapevtska skupina: zdravila proti debelosti s perifernim delovanjem, oznaka ATCvet: QA08AB90
treatment no treatment treatment normal feeding nutrition programme nutrition programme
36.-56. dan zdravljenje brez zdravljenja zdravljenje normalna prehrana dietni program dietni program
Mitratapide also has a slight appetite decreasing effect, which is linked to its mode of action.
Mitratapid ima tudi rahel učinek zmanjševanja teka, ki je povezan z njegovim načinom delovanja.
This can be achieved either with a regular pet food or with a low calorie (diet) pet food.
To lahko dosežete z navadno hrano za hišne živali ali hrano za hišne živali z malo kalorijami (dietno hrano).
Mitratapide is a potent inhibitor of the microsomal triglyceride transfer protein (MTP).
Mitratapid je močan zaviralec beljakovine za prenos mikrosomskih trigliceridov (MTP).
Clinical observation
Klinično opazovanje
Please inform your veterinary surgeon if your dog is taking or has recently taken any other medicines, even those not prescribed.
Obvestite veterinarja, če vaš pes jemlje ali je pred kratkim jemal katero koli zdravilo, tudi če ste ga dobili brez recepta.
In clinical trials, the following weight loss percentages were obtained:
V kliničnih preskušanjih so dobili naslednje odstotke izgube telesne teže:
Administer the product orally during 2 periods of 21 days with an interval of 14 days without treatment in between.
Izdelek uporabljajte peroralno v dveh 21-dnevnih obdobjih z vmesnim presledkom 14 dni brez zdravljenja.
Excretion is rapid and mainly via the faeces.
Izločanje je hitro in večinoma poteka prek blata.
The pharmacokinetic parameters display variable dependency on dose and vary slightly between the first and the second three week treatment periods of a complete treatment schedule.
Farmakokinetični parametri kažejo na spremenljivo odvisnost od odmerka ter se med prvim in drugim tritedenskim obdobjem celotnega režima zdravljenja rahlo spreminjajo.
Typically, these findings normalised, or appeared to be reversing, within two weeks following the end of treatment.
Po navadi so se ti izvidi normalizirali ali so kazali na reverzibilnost v dveh tednih po zaključku zdravljenja.
In clinical trials, treated animals rapidly regained weight following cessation of treatment when diet was not restricted.
V kliničnih preskušanjih so zdravljene živali po prekinitvi zdravljenja hitro pridobile telesno težo, če se prehrana ni omejila.
This is related to the mode of action of the product and should not be considered as an adverse reaction unless it becomes very significant.
To je povezano z načinom delovanja zdravila in ni neželeni učinek, razen če postane zelo izrazit.
Mitratapide and its metabolites bind very extensively (> 99 %) to plasma proteins and distribute to the tissues.
Mitratapid in njegovi presnovki se večinoma (> 99 %) vežejo na beljakovine v plazmi in porazdelijo v tkivih.
Mitratapide therapy should be restricted to one treatment course for an individual dog.
Zdravljenje z mitratapidom je treba pri posameznem psu omejiti na en cikel.
Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism.
Ne uporabite pri psih, pri katerih čezmerno težo ali adipoznost povzroča sočasna sistemska bolezen, kot je hipotiroidizem ali hiperadrenokorticizem.
Fill the syringe by pulling the plunger until it reaches the mark on the dosing pipette corresponding to the correct body weight of the dog.
Brizgo napolnite z vlečenjem bata, dokler ne doseže oznake na pipeti za odmerjanje, ki ustreza telesni teži psa.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Janssen Pharmaceutica N.V.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Janssen Pharmaceutica N.V.
This is related to the mode of action of the product and should not be considered as a side effect, unless it becomes very significant (this is when your dog stops eating for two consecutive days).
To je povezano z načinom delovanja zdravila in ni neželeni učinek, razen če postane zelo izrazit (to pomeni, da pes v dveh zaporednih dneh odklanja hrano);
Butylated hydroxyanisole (E 320) 2 mg/ml For a full list of excipients, see section 6.1
Butiliran hidroksianizol (E 320) 2 mg/ml Celoten seznam pomožnih snovi, glejte razdelek 6.1.
Therefore, for dogs receiving treatments in addition to the product, drug interactions should be monitored closely.
Zato je treba pri psih, ki poleg zdravljenja s tem zdravilom prejemajo tudi druga zdravila, skrbno spremljati njihove interakcije.
Day 22-35
22.-35. dan
If accidental eye contact occurs, flush immediately with copious amounts of water.
Če pride do naključnega stika z očmi, takoj sperite z veliko količino vode.
The use in dogs for breeding purposes has not been evaluated.
Uporabe pri psih za namene razmnoževanja niso ocenili.
Placebo vomiting : occasional ( 3x) vomiting : repeated (> 3 x) diarrhoea / soft stools anorexia / decreased appetite lethargy / weakness * data from 360 dogs over the whole treatment period.
Placebo bruhanje: občasno (≤ 3-krat) bruhanje: ponavljajoče (> 3-krat) driska/mehko blato anoreksija/zmanjšan tek letargija/šibkost * Podatki za 360 psov za celotno obdobje zdravljenja.
Do not use after the expiry date stated on the label and carton (EXP.).
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na nalepki in škatli (EXP).
Following oral administration, the bioavailability of mitratapide (parent compound and metabolites) is in the range from 55 to 69%, the volume of distribution is approximately 5 l/kg.
Po peroralni uporabi je biološka uporabnost mitratapida (izvirne spojine in presnovkov) med 55 in 69 %, volumen distribucije pa približno 5 l/kg.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne neželene učinke ali druge učinke, ki niso omenjeni v teh navodilih, obvestite svojega veterinarja.
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
BESEDILO "SAMO ZA ŽIVALI" IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE, če je navedba smiselna
• if your dog is hypersensitive (allergic) to mitratapide or to any of the other ingredients.
• je preobčutljiv za (alergičen na) mitratapid ali katero koli sestavino;
A colourless to slightly yellow solution.
Brezbarvna do rahlo rumena raztopina.
Accumulation of triglycerides inside the enterocytes may be followed by decreased appetite.
Akumulaciji trigliceridov v enterocitih lahko sledi zmanjšan tek.
In order to allow proper dosing, the dog should be weighed on day 1 and day 35 (this is at the start of each treatment period).
Da bi omogočili ustrezno odmerjanje, je treba psa stehtati prvi in 35. dan (na začetku vsakega obdobja zdravljenja).
Percentages of dogs per weight loss category for mitratapide versus placebo:
Odstotki psov na kategorijo izgube telesne teže za mitratapid v primerjavi s placebom:
US field trial pooled data weight loss category placebo mitratapide placebo mitratapide placebo mitratapide
Kategorija izgube telesne teže placebo mitratapid placebo mitratapid placebo mitratapid
Laboratory animals and dogs rapidly absorb orally administered mitratapide.
Pri laboratorijskih živalih in psih se peroralni odmerek mitratapida hitro absorbira.
The terminal plasma half-life is 6.3 hours for mitratapide, 9.8 hours and 11.7 hours for the sulphoxides, respectively, and 44.7 hours for the sulphone metabolite.
Končni razpolovni čas v plazmi za mitratapid je 6,3 ure, za sulfokside 9,8 in 11,7 ure ter 44,7 ure za presnovek sulfona.
Administration of mitratapide to dogs results in reduced uptake of dietary lipids, dose dependent decreases in serum cholesterol and triglyceride and an increased presence of triglyceride containing droplets in enterocytes.
Uporaba mitratapida pri psih povzroči zmanjšan privzem dietnih lipidov, zmanjšanje vrednosti holesterola in trigliceridov v serumu, odvisno od odmerka, in povečano prisotnost trigliceridov, ki vsebujejo kapljice v enterocitih.
Your veterinary surgeon should monitor closely the intake of any other medicines in addition to the product.
Veterinar mora skrbno spremljati sočasen vnos katerega koli drugega zdravila.
The pipette should be washed and dried and the cap should be screwed back on tightly.
Pipeto je treba oprati in posušiti ter spet tesno priviti pokrovček.
PACKAGE SIZE 120 ml
VELIKOST PAKIRANJA 120 ml
Shelf-life after first opening the container: 3 months.
Rok uporabnosti po prvem odpiranju vsebnika: 3 mesece.
In case of accidental overdosing, symptomatic therapy should be administered.
Če pride do naključnega prevelikega odmerjanja, je treba uvesti simptomatsko zdravljenje.
Where treatment is interrupted due to vomiting, it is recommended that when treatment is resumed, the product should be administered after a meal.
Kadar se zdravljenje prekine zaradi bruhanja, se priporoča, da se ob ponovnem začetku zdravljenja zdravilo daje po obroku.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE LABEL AMBER GLASS BOTTLE 120 and 210 ml
PODATKI, KI MORAJO BITI NAVEDENI NA STIČNI OVOJNINI NALEPKA NA RUMENORJAVI 120- IN 210-MILILITRSKI STEKLENIČKI
Therefore, administer the product with the syringe onto a portion of the food.
Zato zdravilo z brizgo nakapajte na del hrane.
In fed dogs, a single dose of 0.63 mg mitratapide/kg bodyweight results in maximum concentrations of the parent substance in plasma of on average 0.012 g/ml attained 3.5 hours after dosing; the sulphoxide metabolites reach maximum concentration of on average 0.0136 g/ml and 0.0168 g/ml, respectively after 6.5 hours and 8.5 hours; the sulphone metabolite reaches 0.0092 g/ml after 17.5 hours.
Pri hranjenih psih je enkratni odmerek 0,63 mg mitratapida/kg telesne teže povzročil največje koncentracije izvirne snovi v plazmi, katerih povprečje je 0,012 µg/ml, doseženo 3,5 ure po odmerjanju; presnovka sulfoksida največjo koncentracijo dosežeta po 6,5 ure, ko je njeno povprečje 0,0136 µg/ml, in 8,5 ure, ko je njeno povprečje 0,168 µg/ml; presnovek sulfona po 17,5 ure doseže koncentracijo 0,0092 µg/ml.
In most of the cases, these side effects are mild and do not last very long.
V večini primerov so ti neželeni učinki blagi in kratkotrajni.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/063/001-3
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/063/001-3
The absorption of lipid soluble drugs used concomitantly with mitratapide has not been investigated.
Absorpcije zdravil, topnih v lipidih, ki so se uporabila sočasno z mitratapidom, niso raziskali.
D. STATEMENT OF THE MRLs Not applicable.
D NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL) Navedba ni smiselna.
Do not use in dogs during pregnancy and lactation.
Ne uporabite pri psih med brejostjo in laktacijo.
Introducing appropriate lifestyle changes (e.g. increased exercise), in conjunction with this weight management programme, may provide additional benefits.
Dodatne koristi se lahko v kombinaciji s programom za obravnavo telesne teže dosežejo z uvajanjem ustreznih sprememb življenjskega sloga (npr. povečana telesna aktivnost).
In case of accidental self-administration, seek medical advice immediately and show the package leaflet or the label to the physician.
Ob nenamerni samoaplikaciji se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali nalepko na zunanji ovojnini.
It is assumed that these effects are mediated by MTP inhibition at the level of the enterocyte.
Domnevajo, da je za te učinke odgovorno zaviranje MTP na stopnji enterocitov.