natgillin/translations-raw huggingface dataset:
In June 2005, a MR procedure started for a type II variation to add the indication of “Contrast enhanced MRI of other body regions: liver, kidneys” and the following posology and method of administration/dosage: “CE-MRI of other body regions: The recommended dose for adults is 0.1 mmol per kilogram body weight (mmol/kg BW).
Junija leta 2005 se je začel postopek medsebojnega priznavanja za variacijo tipa II za dodatek indikacije „z izboljšanim kontrastnim izvedeno magnetnoresonančno slikanje drugih delov telesa: jeter in ledvic” ter odmerjanja in načina uporabe: „CE-MRI drugih predelov telesa: priporočen odmerek za odrasle znaša 0,1 mmol na kilogram telesne teže (mmol/kg BW).
The questions identified pertained to insufficient data on the evaluation of disseminated liver disease that could justify an extrapolation to the general population undergoing examinations of liver and kidney.
Vprašanja so se nanašala na nezadostne podatke o ocenjevanju diseminirane bolezni jeter, ki bi lahko utemeljila ekstrapolacijo na splošno populacijo, na kateri se opravljajo preiskave jeter in ledvic.
Gadovist/Gadograf 1.0 mmol/ml contains gadobutrol, a neutral macrocyclic gadolinium (Gd) complex with contrast-enhancing properties, which is used for magnetic resonance imaging (MRI).
Zdravilo Gadovist/Gadograf 1,0 mmol/ml vsebuje gadobutrol, nevtralni makrociklični kompleks gadolinija (Gd), katerega lastnost je izboljšanje kontrasta, in se uporablja pri magnetnoresonančnem slikanju (MRI).
MRI is a widely used technique for the evaluation and detection of diffuse liver disease as well as for further characterisation of focal liver disease.
MRI je splošno uporabljana tehnika za ocenjevanje in ugotavljanje difuznih bolezni jeter in za nadaljnjo opredelitev žariščnih bolezni jeter.
In its response the Applicant addressed the issue of clinical utility by comparing Gadovist-enhanced with Magnevistenhanced MRI and underlined the diagnostic efficacy of Gadovist/Gadograf.
V odgovoru je prosilec odgovoril na vprašanje o klinični uporabnosti, tako da je primerjal magnetnoresonančno slikanje, izboljšano z zdravilom Gadovist, in magnetnoresonančno slikanje, izboljšano z zdravilom Magnevist, ter poudaril diagnostično učinkovitost zdravila Gadovist/Gadograf.
Gd-based contrast agents are frequently administered prior to contrast-enhanced dynamic liver MRI and may improve both detection and classification of focal liver lesions.
Kontrastna sredstva, ki temeljijo na elementu Gd, se pogosto dajejo pred dinamičnim magnetnoresonančnim slikanjem jeter z izboljšanjem kontrasta in lahko izboljšajo ugotavljanje in klasifikacijo žariščnih lezij jeter.
“Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant”.
„Magnetnoresonančno slikanje jeter ali ledvic z izboljšanim kontrastom z namenom klasificirati lezije kot benigne ali maligne pri bolnikih z močnim sumom na žariščne lezije ali pri tistih z dokazanimi žariščnimi lezijami“.
Gadograf is not recommended for use in population below age 18 due to a lack of data on efficacy and safety.
Zdravilo Gadograf ni priporočeno za uporabo pri osebah, mlajših od 18 let, zaradi pomanjkanja podatkov o učinkovitosti in varnosti.“ Evropska komisija je 13. aprila 2007 mnenje odbora CHMP spremenila v odločbo.
500 mg Powder for concentrate for solution for infusion
500 mg Prašek za koncentrat za raztopino za infundiranje
Intravenous use vial (glass)
Intravenska uporaba Viala (steklo)
Strength Pharmaceutical Form Route of Administration
(Izmišljeno) ime Jakost Farmacevtska oblika Pot uporabe
Pharmaceutical Form Route of Administration
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
Invented name Strength Pharmaceutical Form Route of administration
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina velikost pakiranja
25 mg
25 mg tableta
They are available under several trade names and in different formulations.
Na voljo so pod različnimi trgovskimi imeni in v različnih formulacijah.
This means that the medicine will no longer be available.
To pomeni, da zdravilo ne bo več na voljo.
The review of flupirtine was initiated on 26 October 2017 at the request of Germany, under Article 31 of Directive 2001/83/EC.
Pregled flupirtina se je začel 26. oktobra 2017 na zahtevo Nemčije v skladu s členom 31 Direktive 2001/83/ES.
It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Odgovorna je za zagotovitev enotnih varnostnih standardov za zdravila, ki so v EU odobrena po nacionalnih postopkih.
2 These cases have been reported in the European database of suspected adverse drug reaction reports (Eudravigilance) between April 2013 and December 2017
2 O teh primerih so poročali v evropsko podatkovno zbirko poročil o domnevnih neželenih učinkih (Eudravigilance) med aprilom 2013 in decembrom 2017
The opening of these channels reduces the excessive electrical activity that leads to many pain states.
Odprtje teh kanalčkov zmanjša čezmerno električno aktivnost, ki povzroča številna bolečinska stanja.
Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Estonia, Germany, Latvia, Lithuania, Luxembourg, Poland, Portugal, and Slovakia.
Zdravila, ki vsebujejo flupirtin, so odobrena od 80. let 20. stoletja in so trenutno na voljo v naslednjih državah članicah EU: v Estoniji, Nemčiji, Latviji, Litvi, Luksemburgu, na Poljskem, Portugalskem in Slovaškem.
This means that it opens specific pores on nerve cells called potassium channels.
To pomeni, da odpira posebne pore na živčnih celicah, imenovane kalijevi kanalčki.
The PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a position on 21 March 2018.
Priporočila odbora PRAC so bila poslana Usklajevalni skupini za postopek z medsebojnim priznavanjem in decentralizirani postopek - zdravila za uporabo v humani medicini (CMDh), ki je sprejela stališče 21. marca 2018.
• Alternative treatment options are available.
• Na voljo so druge možnosti zdravljenja.
• Six observational studies showed a lack of compliance with the measures that were introduced to minimise the risk of hepatotoxicity.
• Šest opazovalnih študij je pokazalo neupoštevanje ukrepov, uvedenih za zmanjšanje tveganja za hepatotoksičnost.
The CMDh therefore agreed that patients taking flupirtine-containing medicines continue to be exposed to serious risks which outweigh the benefits of these medicines.
Skupina CMDh se je zato strinjala, da so bolniki, ki jemljejo zdravila, ki vsebujejo flupirtin, še naprej izpostavljeni resnim tveganjem, ki presegajo koristi teh zdravil.
• Healthcare professionals in the EU countries where flupirtine is marketed will receive a letter with detailed information on the appropriate actions to be taken, including when the medicine will become unavailable.
• Zdravstveni delavci v državah EU, kjer se flupirtin trži, bodo prejeli dopis s podrobnimi informacijami o ustreznih ukrepih, vključno s podatkom o tem, od kdaj zdravila ne bodo več na voljo.
• Patients with any questions should speak to their healthcare professional.
• Bolniki, ki imajo kakršna koli vprašanja, naj se posvetujejo z zdravstvenim delavcem.
• Healthcare professionals should consider alternative treatments for patients.
• Zdravstveni delavci morajo razmisliti o drugih možnostih zdravljenja za bolnike.
It also assessed cases of serious liver damage reported since the 2013 review.
Ocenjevali so tudi primere resnih poškodb jeter, o katerih so poročali od leta 2013.
• These medicines are being taken off the market in the EU because of a risk of serious liver injury.
• Ta zdravila se jemljejo s trga v EU zaradi tveganja za resno poškodbo jeter.
The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which made a set of recommendations.
Pregled je najprej opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC), ki je odgovoren za presojo varnostnih vprašanj v zvezi z zdravili za uporabo v humani medicini, in podal več priporočil.
The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Skupina CMDh je organ, ki zastopa države članice EU ter Islandijo, Lihtenštajn in Norveško.
Since the CMDh adopted its position by consensus, it will be directly implemented by the Member States where the medicines are authorised, according to an agreed timetable.
Skupina CMDh je soglasno sprejela svoje stališče, zato bodo morale države članice, v katerih so zdravila odobrena, v skladu z dogovorjeno časovnico neposredno izvajati ukrepe.
• Restrictions introduced in 2013, which included limiting flupirtine use to two weeks and regular monitoring of liver function tests, have not been sufficiently followed in clinical practice.
• Omejitve, uvedene leta 2013, ki so vključevale omejitev uporabe flupirtina na dva tedna in redno spremljanje delovanja jeter s preiskavami, se v klinični praksi niso dovolj upoštevale.
The review, carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), looked at the available data including studies evaluating whether the 2013 restrictions were followed in clinical practice.
V okviru pregleda, ki ga je opravil Odbor za ocenjevanje tveganja na področju farmakovigilance (PRAC) agencije EMA, so preučili razpoložljive podatke, vključno s študijami, ki so ocenjevale, ali se omejitve iz leta 2013 v klinični praksi upoštevajo.
1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Skupina CMDh je regulativni organ za zdravila, ki zastopa države članice Evropske unije (EU), Islandijo, Lihtenštajn in Norveško.
The CMDh agreed with the PRAC conclusion that the restrictions introduced in 2013 have not been sufficiently followed, and cases of serious liver injury, including liver failure, still occurred.
Skupina CMDh se je strinjala z zaključkom odbora PRAC, da omejitve, uvedene leta 2013, niso bile upoštevane v zadostni meri, primeri resnih poškodb jeter, vključno z jetrno odpovedjo, pa so se še vedno pojavljali.
• Strict measures to try to reduce this risk were introduced in 2013 but have not been put into practice widely enough, and liver injury has continued to be reported.
• Leta 2013 so uvedli stroge ukrepe, namenjene zmanjšanju tega tveganja, vendar se v praksi niso dovolj izvajali in še naprej so poročali o poškodbah jeter.
While the use of flupirtine-containing products has decreased, the measures implemented have not been effective at minimising the risk.
Uporaba zdravil, ki vsebujejo flupirtin, se je sicer zmanjšala, vendar uvedeni ukrepi niso zadoščali za zmanjšanje tveganja.
The EMA recommendation was the outcome of a review of flupirtine medicines which was started because liver problems continued to be reported even after measures were introduced in 2013 to manage this risk.
Priporočilo agencije EMA je bilo izid pregleda zdravil s flupirtinom, ki so ga sprožili, ker so tudi po uvedbi ukrepov za obvladovanje tveganja leta 2013 še naprej poročali o težavah z jetri.
• Flupirtine-containing medicines are being taken off the market in the EU because of the risk of serious liver injury.
• Zdravila, ki vsebujejo flupirtin, se jemljejo s trga v EU zaradi tveganja za resno poškodbo jeter.
Flupirtine works as a ‘selective neuronal potassium channel opener'.
Flupirtin deluje kot „selektivni odpiralec kalijevih kanalčkov v živčnih celicah“.
In order to protect public health, the CMDh endorsed the PRAC recommendation to withdraw the marketing authorisations of flupirtinecontaining medicines.
Skupina CMDh je zaradi zaščite javnega zdravja podprla priporočilo odbora PRAC za umik dovoljenj za promet z zdravili, ki vsebujejo flupirtin.
Serious liver problems continued to be reported despite previous restrictions in use
Kljub predhodnim omejitvam uporabe še naprej poročajo o resnih težavah z jetri
These measures had included limiting flupirtine use to no more than 2 weeks in patients with acute pain who could not use other painkillers, and carrying out weekly tests of liver function during treatment.
Ti ukrepi so vključevali omejitev uporabe flupirtina na največ dva tedna, in sicer pri bolnikih z akutno bolečino, ki ne smejo uporabljati drugih protibolečinskih zdravil, in izvajanje tedenskih preiskav delovanja jeter med zdravljenjem.
• Since 2013, cases of serious liver injury, including 23 cases of acute liver failure, some of which were fatal or led to transplantation have been reported following flupirtine use.2 The reactions are unpredictable and the exact mechanism by which flupirtine causes liver injury is not known.
• Od leta 2013 so po uporabi flupirtina poročali o primerih resne poškodbe jeter, vključno s 23 primeri akutne jetrne odpovedi, od katerih so bili nekateri smrtni ali pa so pripeljali do presaditve.2 Odziva na zdravilo ni mogoče napovedati in ni znano, po kakšnem sistemu flupirtin povzroča poškodbo jeter.
• Flupirtine-containing medicines have been used to treat acute (short-term) pain for up to two weeks in adults who cannot use other painkillers (such as non-steroidal anti-inflammatory drugs (NSAIDs) and weak opioids).
• Zdravila, ki vsebujejo flupirtin, se uporabljajo za zdravljenje akutne (kratkotrajne) bolečine v obdobju do dveh tednov pri odraslih, ki ne morejo uporabljati drugih protibolečinskih zdravil (kot so nesteroidna protivnetna zdravila in šibki opioidi).
In addition, no further measures to reduce the risk of liver problems could be identified.
Poleg tega ni bilo mogoče določiti nobenih nadaljnjih ukrepov za zmanjšanje tveganja za težave z jetri.
• Since 2013, cases of serious liver injury, including 23 cases of acute liver failure (sudden loss of liver function), some of which were fatal or led to transplantation have been reported following flupirtine use.
• Od leta 2013 so po uporabi flupirtina poročali o primerih resne poškodbe jeter, vključno s 23 primeri akutne jetrne odpovedi (nenadnega prenehanja delovanja jeter), od katerih so bili nekateri smrtni ali pa so pripeljali do presaditve.
Flupirtine is a medicine used to treat acute (short-lived) pain for up to 2 weeks, in patients who cannot use other painkillers such as opioids or nonsteroidal anti-inflammatory medicines (NSAIDs).
Flupirtin je zdravilo, ki se uporablja za zdravljenje akutne (kratkotrajne) bolečine v obdobju do dveh tednov pri bolnikih, ki ne morejo uporabljati drugih protibolečinskih zdravil, kot so opioidi ali nesteroidna protivnetna zdravila.
The CMDh1 has endorsed EMA's recommendation to withdraw the marketing authorisation for the pain medicine flupirtine, because of the risk of serious liver injury.
Skupina CMDh1 je zaradi tveganja za resno poškodbo jeter podprla priporočilo agencije EMA za umik dovoljenja za promet z zdravilom za protibolečinsko zdravilo flupirtin.
• In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.
• Poleg tega ni bilo mogoče določiti nobenih nadaljnjih ukrepov za povečanje upoštevanja omejitev ali za zmanjšanje tveganja za težave z jetri.
In addition, no further measures to increase adherence to the restrictions nor adequately reduce the risk of liver problems could be identified.
Poleg tega ni bilo mogoče določiti nobenih nadaljnjih ukrepov za povečanje upoštevanja omejitev ali za zmanjšanje tveganja za težave z jetri.
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravil, poti uporabe in imetnikov dovoljenja za promet v državah članicah
Freeze-Dried Powder
Liofiliziran prašek
Sterile freezedried powder for solution for infusion
Sterilen liofiliziran prašek za raztopino za infundiranje
Package size
Pot uporabe Ovojnina Vsebina Velikost pakiranja
Maximum efficacy is achieved within 48 hours.
Maksimalna učinkovitost je dosežena v 48 urah.
These changes do not affect the safety or efficacy of the veterinary medicinal product.
Te spremembe ne vplivajo na varnost ali učinkovitost zdravila.
All blisters in a box are the same size.
Vsi blistri v škatli so enake velikosti.
It is therefore recommended to treat the animals during the evening.
Zato je priporočljivo zdraviti živali zvečer.
This is not a sign of intoxication and disappears within minutes without treatment.
To ni znak zastrupitve in izgine v nekaj minutah brez zdravljenja.
In very rare cases temporary local hair loss may occur.
V zelo redkih primerih se lahko pojavi začasna lokalna izguba dlake.
*- Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - Common (more than 1 but less than 10 animals in 100 animals) - Uncommon (more than 1 but less than 10 animals in 1,000 animals ) - Rare (more than 1 but less than 10 animals in 10,000 animals) - Very rare (less than 1 animal in 10,000 animals, including isolated reports).
* Zelo pogosti (neželeni učinki so se pojavili pri več kot 10 živalih v enem ciklusu zdravljenja) - Pogosti (pri več kot 1, vendar manj kot pri 10 živalih od 100 živali) - Občasni (pri več kot 1, vendar manj kot pri 10 živalih od 1000 živali) - Redki (pri več kot 1, vendar manj kot pri 10 živalih od 10.000 živali) - Zelo redki (pri manj kot 1 živali od 10.000 živali, vključno s posamičnimi poročili)
Do not administer orally or via any other route.
Ne dajajte ga peroralno ali na kakšen drug način.
Recently treated animals are not allowed to sleep with owners, especially children.
Pravkar zdravljene živali ne smejo spati z lastniki, še posebej ne z otroci.
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable
PREPOVED PRODAJE, OSKRBE IN/ALI UPORABE Ni smiselno
Avoid direct contact with skin, eyes or mouth.
Izogibajte se direktnemu stiku s kožo, očmi ali usti.
These results are consistent with laboratory efficacy studies showing activity for up to 56 days post-treatment.
Ti rezultati so bili v skladu z laboratorijskimi študijami učinkovitosti, ki so pokazale delovanje do 56. dneva po zdravljenju.
Gamma-hexalactone
Gama-heksalakton
Wash hands thoroughly after use.
Po dajanju si dobro umijte roke.
Metaflumizone was still measurable in the hair 56 days following treatment.
Metaflumizon je bilo v dlaki možno izmeriti 56 dni po zdravljenju.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/.
Maximum concentrations in the hair were generally reached between 1 to 2 days post-treatment and gradually declined through 56 days posttreatment.
Maksimalna koncentracija v dlaki je dosežena med 1. in 2. dnevom po zdravljenju in se postopoma znižuje v 56 dnevih po zdravljenju.
Metaflumizone is a sodium channel antagonist and disrupts nerve function resulting in paralysis and death of insects.
Metaflumizon je antagonist natrijevih kanalov in prekine živčne funkcije, čemur sledi paraliza in smrt insektov.
For optimum control of flea problems in a multi-pet household, all pets in the household should be treated with a suitable insecticide.
Za optimalno kontrolo bolhavosti v gospodinjstvu z več živalmi, bi bilo treba vse živali v tem gospodinjstvu zdraviti s primernim insekticidom.
Synperonic NCA 830
Seznam pomožnih snovi Synperonic NCA 830
The recommended minimum dose is 40 mg metaflumizone/kg bodyweight, equivalent to 0.20ml/kg bodyweight.
Priporočen minimalen odmerek je 40 mg metaflumizona/kg telesne mase, kar ustreza 0,20 ml/kg telesne mase.
Metaflumizone is active against fleas due to non-systemic exposure of the parasites on the skin and hair.
Metaflumizon učinkuje proti bolham z nesistemsko izpostavitvijo parazitov na koži in dlaki.
Excipients For a full list of excipients, see section 6.1.
Pomožne snovi: Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Children should not be allowed to play with treated animals until the application site is dry.
Otroci se ne smejo igrati z zdravljeno živaljo, dokler ni mesto nanosa suho.
In addition, it is recommended to treat the environment with a suitable insecticide.
Prav tako je priporočljivo s primernim insekticidom tretirati tudi okolje.
Treatment schedule:
Načrt zdravljenja:
Do not smoke, drink or eat while handling the product.
Med dajanjem zdravila je prepovedano kaditi, piti ali jesti.
The MAH must ensure that the system of pharmacovigilance, as described in Part I of the marketing authorisation application, is in place and functioning before and whilst the veterinary medicinal product is on the market.
Imetnik dovoljenja za promet mora zagotoviti, da je sistem farmakovigilance, predložen kot je opisan v delu I vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
Kent CT13 9NJ United Kingdom
Kent CT13 9NJ Združeno Kraljestvo
DATE ON WHICH THE PACKAGE INSERT WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) http://www.ema.europa.eu/
Avoid direct contact with treated animals until the application site is dry.
Izogibajte se direktnemu stiku z zdravljeno živaljo, dokler ni mesto nanosa suho.
After topical administration at a single site on the cat's neck at the base of the skull, metaflumizone levels in plasma were too low to allow the calculation of standard pharmacokinetic parameters.
Po topikalnem dajanju na eno mesto vratu na zatilje glave mačke, so bile koncentracije metaflumizona v plazmi prenizke za izračun standardnih farmakokinetičnih parametrov.
Shelf life of the veterinary medicinal product as packaged for sale: 3 years 6.4.
Rok uporabnosti zdravila v pakiranju za prodajo: 3 leta.
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Skladno s sklepom mora imetnik dovoljenja za promet obvestiti Evropsko komisijo o načrtih trženja zdravila.
Do not apply the veterinary medicinal product to the surface of the cat's hair coat.
Zdravila ne nanašajte na površino dlake.
Hold the pipette upright, bend the tip of the pipette to break the tip along the scored line.
Držite merilno kapalko pokonci ter upognite konico tako, da se le ta zlomi po zarezani črti.
Each unit dose (pipette) of ProMeris delivers:
Vsak odmerek (merilna kapalka) ProMeris-a vsebuje:
Treatment and prevention of flea infestations (Ctenocephalides canis and C. felis) in cats.
Zdravljenje in preprečevanje bolhavosti (Ctenocephalides canis in C. felis) pri mačkah.
MARKETING AUTHORISATION NUMBER(S) EU/2/06/064/001-004
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/06/064/001-004
No adverse effects were observed in cats aged 8 weeks and older treated 7 times at two-week intervals with 3-5 times the recommended dose.
Pri mačkah, starih 8 tednov ali več, zdravljenih 7-krat v dvotedenskih intervalih s 3 - 5-kratnim priporočenim odmerkom ni bilo opaziti neželenih učinkov.
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances
KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina:
For cutaneous use only.
Samo za demalno uporabo.
For optimal control of flea infestation, the veterinary medicinal product can be administered at 4 to 6 week intervals throughout the flea season or the treatment schedule can be based on the local epidemiological situation.
Za optimalno kontrolo bolhavosti lahko zdravilo nanašate v 4 do 6 tedenskih intervalih med sezono bolh, lahko pa načrt zdravljenja temelji na lokalni epidemiološki situaciji.