natgillin/translations-raw huggingface dataset:
- Cardboard box with 10 x 50 dose vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
Kartonska škatla z 10 vialami s 50 odmerki cepiva, in kartonska škatla z 10 vialami z 10 ml vehikla.
- Plastic box with 25 x 1 dose vials of vaccine and 25 vials containing 0.5 ml of solvent.
Plastična škatla s 25 vialami z 1 odmerkom cepiva in 25 vialami z 0,5 ml vehikla.
- Plastic box with 5 x 1 dose vials of vaccine and 5 vials containing 0.5 ml of solvent.
Plastična škatla z 5 x vialo z 1 odmerkom cepiva in 5 x vialo z 0,5 ml topila.
A transient temperature increase of 1 - 2 °C can commonly occur.
Pogosto lahko pride do prehodnega povišanja temperature za 1-2° C. V prvih dveh tednih po cepljenju lahko pogosto opazimo na mestu injiciranja majhno, nebolečo oteklino (največ 2 cm premera).
Special warnings for each target species: Vaccinate healthy animals only.
Posebna opozorila za vsako ciljno vrsto:
Packaging: - Plastic box with 5 x 1 dose vial of vaccine and 5 vials containing 0.5 ml of solvent.
Plastična škatla s 5 vialami z 1 odmerkom cepiva in 5 vialami z 0,5 ml vehikla.
QUANTITY OF THE ACTIVE SUBSTANCE(S)
NAVEDBA UČINKOVIN(E)
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
PODATKI NA ZUNANJI OVOJNINI
1 Previously known as Zevtera.
Prvotno znano kot Zevtera.
What did the company present to support its application?
Kaj je podjetje predložilo v podporo svoji vlogi?
18 February 2010 EMA/83783/2010 EMEA/H/C/883
EMA/476144/2010 EMEA/H/C/000883
What were the CHMP's main concerns that led to the refusal
Kateri so bili glavni zadržki CHMP, ki so privedli do zavrnitve?
The company that applied for the authorisation is Janssen-Cilag International N.V.
Vlogo za dovoljenje je podala družba Janssen-Cilag International N.V.
‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has t might affect the response to treatment.
„Zapleteno“ pomeni, da je okužbo težko zdraviti, ker se je razširila na tkiva globoko pod kožo, morda bo potrebno operativno zdravljenje ali pa se pri bolniku pojavljajo druga stanja, ki lahko vplivajo na odziv na zdravljenje.
What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Kakšne so posledice te zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe?
What is Zeftera?
Kaj je zdravilo Zeftera?
On 18 February 2010, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product for the treatment of adults with complicated skin and soft-tissue infections.
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 18. februarja 2010 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Zeftera, namenjenim zdravljenju zapletenih okužb kože in mehkih tkiv pri odraslih.
This prevents the bacteria from building the walls that surround their cells, which kills the bacteria.
S tem bakterijam preprečuje gradnjo zidu, s katerim ogradijo svoje celice, in jih tako uniči.
What was Zeftera expected to be used for?
Za kaj naj bi se zdravilo Zeftera uporabljalo?
The active substance in Zeftera, ceftobiprole, is an antibiotic that belongs to the group ‘cephalosporins'.
Zdravilna učinkovina zdravila Zeftera, ceftobiprol, je antibiotik, ki sodi v skupino „cefalosporinov“.
The Commi therefore recommended that, in light of the uncertainty surrounding the results, th not be granted marketing authorisation.
Odbor je tako priporočil, da se zaradi negotovosti glede zanesljivosti rezultatov zdravilu dovoljenje za promet ne odobri.
How is Zeftera expected to work?
Kako naj bi zdravilo Zeftera delovalo?
The company informed the CHMP that that there are no consequences for patients in clinical trials with Zeftera and that there are no compassionate use programmes in progress with Zeftera.
Družba je obvestila CHMP, da zavrnitev nima nobenih posledic za bolnike, ki sodelujejo v kliničnih preskušanjih zdravila Zeftera, programi sočutne uporabe zdravila Zeftera pa se ne izvajajo.
In bo effectiveness was the number of patients whose infection had been cured at the
Glavno merilo učinkovitosti pri obeh študijah je bilo število bolnikov, pri katerih je bila okužba ob koncu zdravljenja ozdravljena.
is active against several types of bacteria, including methicillin-resistant Staphylococcus d in humans.
Ceftobiprol učinkuje proti več vrstam bakterij, vključno proti bakteriji Staphylococcus aureus (MRSA), odporni na meticilin.
The first study compared Zeftera with vancomycin (another an ceftazidime (another cephalosporin antibiotic) in 828 patients.
V prvi študiji so primerjali rezultate zdravljenja z zdravilom Zeftera v primerjavi z vankomicinom (drug antibiotik, učinkovit proti MRSA) pri 784 bolnikih, v drugi študiji pa zdravljenje z zdravilom Zeftera v primerjavi s kombinacijo vankomicina in ceftazidima (drug cefalosporinski antibiotik) pri 828 bolnikih.
Refusal of the marketing authorisation for Zeftera
Zavrnitev dovoljenja za promet z zdravilom Zeftera (ceftobiprol)
The effects of Zeftera were first tested in experimental models before being studie The company presented results of two main studies involving adults with complicated ski tissue infections.
Podjetje je predstavilo rezultate dveh glavnih študij z odraslimi bolniki z zapletenimi okužbami kože in mehkih tkiv.
These subsequent inspections showed that the studies had not been conducted in ‘good clinical practice' (GCP) in some beneficial to patients, the CHMP was concerned about how reliable the results were.
Čeprav so rezultati študije kazali, da je zdravilo za bolnike učinkovito, pa je CHMP izrazil zadržke glede zanesljivosti rezultatov.
In November 2008, the CHMP gave a positive opinion on Zeftera, recomm marketing authorisatio study sites by the Food and Drug Administration (FDA) in the United States of A concerns over the way the main clinical studies were conducted.
CHMP je novembra 2008 izdal pozitivno mnenje o zdravilu Zeftera in priporočil, da se za zdravilo odobri dovoljenje za promet.
Zeftera was expected to be used to treat adults with complicated infections of th other conditions tha
Zdravilo Zeftera naj bi se uporabljalo za zdravljenje odraslih bolnikov z zapletenimi okužbami kože in „mehkih tkiv“ pod kožo.
or infusion (drip into a vein).
Zdravilo Zeftera je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
The Committee therefore that the European Commission stop the authorisation process for the medicine wh inspections were carried out.
Vendar je Odbor pozneje prejel podatke o inšpekcijskem pregledu mest študij s strani Urada za zdravila in živila v Združenih državah Amerike (FDA), zaradi katerih je ustavil postopek za odobritev zdravila.
t may request a the opinion within 15 days of receipt of notification of this negative opinion.
Predlagatelj je zahteval ponovno presojo mnenja.
ending that it be granted n. However, the Committee later received information about an inspection of merica that identified requested ile further compliance with sites.
Med ponovnim pregledom je Odbor pregledal nadaljnje analize podatkov iz študij in inšpekcijskih pregledov.
Zeftera is a powder that is made up into a solution f substance ceftobiprole.
Vsebuje zdravilno učinkovino ceftobiprol.
Secondary generalisation occurs when the overactivity later reaches the whole brain.
Sekundarna generalizacija nastane, ko čezmerna aktivnost pozneje doseže celotne možgane.
The oral solution may be mixed in a glass of water before it is taken.
Peroralno raztopino je pred zaužitjem mogoče zmešati v kozarcu vode.
This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
To je vrsta epilepsije, kjer preveč električne aktivnosti na eni strani možganov povzroči simptome, kot so nenadni trzajoči gibi enega dela telesa, motnje sluha, voha ali vida, otrplost ali nenaden strah.
Lower doses are used in patients who have problems with their kidneys (such as older patients).
Manjši odmerki se uporabljajo pri bolnikih, ki imajo težave z ledvicami (npr. starejši bolniki).
The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Natančen način delovanja levetiracetama še ni znan, vendar se zdi, da vpliva na beljakovino, imenovano sinaptični vezikularni protein 2A, ki se nahaja v prostorih med živci in sodeluje pri sproščanju sporočilnih kemikalij iz živčnih celic.
Epilepsy is caused by excessive electrical activity in the brain.
Epilepsijo povzroča čezmerna električna aktivnost v možganih.
years of age with juvenile myoclonic epilepsy;
12. leta dalje z juvenilno mioklonsko epilepsijo;
It is available as oblong tablets (250 mg, 500 mg, 750 mg and 1000 mg) and as an oral solution (100 mg/ml).
Na voljo je v obliki podolgovatih tablet (250 mg, 500 mg, 750 mg in 1000 mg) in kot peroralna raztopina (100 mg/ml).
Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Dve zdravili sta biološko enakovredni, kadar tvorita enako raven zdravilne učinkovine v telesu.
• partial-onset seizures with or without generalisation in patients from one month of age;
• napadov parcialnega izvora z generalizacijo ali brez nje pri bolnikih od enega meseca starosti dalje;
The full EPAR for Levetiracetam ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Levetiracetam ratiopharm je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
• myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
• mioklonskih napadov (kratkih, šoku podobnih trzanj mišice ali skupine mišic) pri bolnikih od
This helps Levetiracetam ratiopharm to stabilise electrical activity in the brain and prevent seizures.
To pomaga zdravilu Levetiracetam ratiopharm stabilizirati električno aktivnost v možganih in preprečevati napade.
• primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
• primarno generaliziranih tonično-kloničnih napadov (močnih napadov, ki lahko privedejo do izgube zavesti) pri bolnikih od 12. leta dalje z idiopatsko generalizirano epilepsijo (vrsto epilepsije, ki naj bi imela genetski izvor).
This means that Levetiracetam ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Keppra.
The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam ratiopharm on 26 August 2011.
Evropska komisija je dovoljenje za promet z zdravilom Levetiracetam ratiopharm, veljavno po vsej Evropski uniji, odobrila dne 26. avgusta 2011.
The oral solution is recommended when starting treatment in children under six years old or weighing less than 25 kg.
Peroralna raztopina je priporočljiva pri začetku zdravljenja otrok, mlajših od šest let ali lažjih od 25 kg.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam ratiopharm.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Levetiracetam ratiopharm, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
This can be increased up to 21 mg/kg twice a day.
Ta odmerek je mogoče povečati na 21 mg/kg dvakrat dnevno.
This is a summary of the European public assessment report (EPAR) for Levetiracetam ratiopharm.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Levetiracetam ratiopharm.
For more information about treatment with Levetiracetam ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Levetiracetam ratiopharm preberite navodilo za uporabo zdravila (ki je prav tako del evropskega javnega poročila o oceni zdravila (EPAR)) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Because Levetiracetam ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Levetiracetam ratiopharm generično zdravilo in je biološko enakovredno referenčnemu zdravilu, velja, da so njegove koristi in tveganja enaka kot pri referenčnem zdravilu.
Levetiracetam ratiopharm can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Zdravilo Levetiracetam ratiopharm se lahko pri bolnikih, starejših od 16 let in pri katerih je bila na novo diagnosticirana epilepsija, uporablja samostojno za zdravljenje napadov parcialnega izvora s sekundarno generalizacijo ali brez nje.
The CHMP concluded that, in accordance with EU requirements, Levetiracetam ratiopharm has been shown to have comparable quality and to be bioequivalent to Keppra.
CHMP je zaključil, da se je zdravilo Levetiracetam ratiopharm v skladu z zahtevami EU izkazalo za primerljive kakovosti in biološko enakovredno zdravilu Keppra.
Levetiracetam ratiopharm can also be used as an add-on to other anti-epileptic medicines to treat:
Zdravilo Levetiracetam ratiopharm se lahko uporablja tudi kot dopolnilno zdravljenje k drugim zdravilom proti epilepsiji za zdravljenje:
The dose can be further increased at two-week intervals according to the patient's response, to a maximum dose of 1500 mg twice a day.
Odmerek je mogoče dodatno povečevati v dvotedenskih intervalih glede na odziv bolnika, in sicer na največji odmerek 1500 mg dvakrat dnevno.
In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Pri bolnikih, starih med šest mesecev in 17 let, ki tehtajo manj kot 50 kg, je začetni odmerek 10 mg na kilogram telesne mase dvakrat dnevno in ga je mogoče povečati na 30 mg/kg dvakrat dnevno.
Other information about Levetiracetam ratiopharm
Druge informacije o zdravilu Levetiracetam ratiopharm
When Levetiracetam ratiopharm is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Če se zdravilo Levetiracetam ratiopharm dodaja drugemu zdravilu proti epilepsiji, je začetni odmerek pri bolnikih nad 12 let, ki tehtajo nad 50 kg, 500 mg dvakrat dnevno.
Because Levetiracetam ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Ker je zdravilo Levetiracetam ratiopharm generično zdravilo, so bile študije pri bolnikih omejene na preskuse, v katerih so določali njegovo biološko enakovrednost referenčnemu zdravilu Keppra.
Levetiracetam ratiopharm tablets are swallowed with liquid.
Tablete Levetiracetam ratiopharm se pogoltnejo s tekočino.
In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Pri dojenčkih, starih med enim in šest mesecev, je začetni odmerek 7 mg/kg dvakrat dnevno v obliki peroralne raztopine.
What are the benefits and risks of Levetiracetam ratiopharm?
Kakšne so koristi in tveganja zdravila Levetiracetam ratiopharm?
The Committee recommended that Levetiracetam ratiopharm be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Levetiracetam ratiopharm odobri dovoljenje za promet.
The daily dose can be increased up to 1500 mg twice a day.
Dnevni odmerek je mogoče povečati na največ 1500 mg dvakrat dnevno.
When Levetiracetam ratiopharm is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Zdravilo Levetiracetam ratiopharm se uporablja samostojno, začetni odmerek je 250 mg dvakrat dnevno, ki se po dveh tednih poveča na 500 mg dvakrat dnevno.
Levetiracetam ratiopharm is a ‘generic medicine'.
Zdravilo Levetiracetam ratiopharm je „generično zdravilo“.
Levetiracetam ratiopharm is a medicine that contains the active substance levetiracetam.
Levetiracetam ratiopharm je zdravilo, ki vsebuje zdravilno učinkovino levetiracetam.
The active substance in Levetiracetam ratiopharm, levetiracetam, is an anti-epileptic medicine.
Zdravilna učinkovina zdravila Levetiracetam ratiopharm, levetiracetam, je zdravilo proti epilepsiji.
Why has Levetiracetam ratiopharm been approved?
Zakaj je bilo zdravilo Levetiracetam ratiopharm odobreno?
How has Levetiracetam ratiopharm been studied?
Kako je bilo zdravilo Levetiracetam ratiopharm raziskano?
What is Levetiracetam ratiopharm used for?
Za kaj se zdravilo Levetiracetam ratiopharm uporablja?
How is Levetiracetam ratiopharm used?
Kako se zdravilo Levetiracetam ratiopharm uporablja?
Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Keppra odtehtajo z njim povezana tveganja.
What is Levetiracetam ratiopharm?
Kaj je zdravilo Levetiracetam ratiopharm?
contributing to an environment that stimulates innovation.
prispevanje k okolju, v katerem se spodbujajo inovacije.
This commitment is reflected in the Agency's work programme and budget.
Ta zaveza se odraža v delovnem programu in proračunu agencije.
It is expected that the latter two pieces of legislation will come into effect during 2009.
Pričakuje se, da bosta zadnji dve zakonodajni besedili začeli veljati med letom 2009.
Safety-monitoring of medicines is an area that is continuously being scrutinised, developed and strengthened.
Spremljanje varnosti zdravil je področje, ki se neprestano proučuje, razvija in krepi.
As can be seen from this work programme, activities in the field of recently implemented legislation on paediatric medicines remain complex and dynamic.
Kot je razvidno iz tega delovnega programa, dejavnosti s področja nedavno izvedene zakonodaje o zdravilih za pediatrično uporabo ostajajo kompleksne in dinamične.
The Agency has been, and will continue to be, heavily involved in activities that support innovation and improve availability of medicines.
Agencija je bila in bo še naprej močno vključena v dejavnosti za podporo inovacij in izboljšanje razpoložljivosti zdravil.
As a result, the Agency has grown into a complex organisation that is heavily dependent on effective and efficient information and communication technologies.
Posledično se je razvila v kompleksno organizacijo, ki je močno odvisna od učinkovite in uspešne informacijske in komunikacijske tehnologije.
Where appropriate:
V ospredju bodo:
The Agency has been implementing various new parts of the pharmaceutical legislation over the course of a number of years.
Agencija je mnogo let izvajala različne nove dele farmacevtske zakonodaje.
Both initiatives attempt to improve medicinal product development processes and, therefore, are of importance to the Agency.
Obe pobudi stremita k izboljšanju postopkov za pripravo zdravil in sta zato pomembni za agencijo.
fostering transparency, communication and provision of information;
spodbujanje preglednosti, obveščanja in zagotavljanja informacij;
Continuous fostering and developing of the scientific capacity of the network is therefore the EMEA's perennial objective.
Nadaljnje spodbujanje in razvoj znanstvenih zmogljivosti v mreži je zato stalni cilj agencije EMEA.
strengthening the European medicines network;
okrepitev Evropske mreže zdravil;
Preparatory work has been undertaken in 2008, and the Agency should be in a position to start commissioning pharmacoepidemiological studies in 2009.
Pripravljalna dela so se začela leta 2008, agencija pa bi morala leta 2009 začeti izvajati farmakoepidemiološke študije.
In addition, the year 2008 saw some quality issues with products whose active ingredients were manufactured outside the EU.
Poleg tega so se leta 2008 pojavila vprašanja glede kakovosti zdravil, katerih zdravilne učinkovine so bile proizvedene zunaj EU.
The EMEA has prepared for the creation of a new scientific committee - the Committee for Advanced Therapies - that will become fully operational in 2009.
Agencija EMEA je ustanovila nov znanstveni odbor - Odbor za napredno zdravljenje -, ki bo začel v celoti delovati leta 2009.
The EMEA remains committed to improving the availability of veterinary medicines, and will focus its efforts in three major areas to achieve this.
Agencija EMEA bo še naprej zavezana k izboljšanju razpoložljivosti veterinarskih zdravil ter se bo, da bi to zagotovila, osredotočila na prizadevanja na treh glavnih področjih.
This year, the Agency will further support collaboration within the network and benchmarking activities (BEMA1), and will provide input into efforts aimed at strengthening the capacity of the network.
Letos bo agencija še naprej spodbujala sodelovanje v mreži in primerjalne analize (BEMA1) ter spodbujala prizadevanja za krepitev zmogljivosti mreže.
further improving the effectiveness and efficiency of the Agency's core activities, including consolidation of the EMEA's international strategy in the light of global challenges;
nadaljnje izboljšanje učinkovitosti in uspešnosti glavnih dejavnosti agencije, vključno z utrditvijo mednarodne strategije agencije EMEA glede na globalne spremembe;
The Agency's work programme is shaped by a number of trends, scientific, political and other developments that will dominate the Agency's environment in 2009.
Delovni program agencije narekujejo številni trendi, znanstvene, politične in druge razvojne smernice, ki bodo leta 2009 ključno vplivale na delovno okolje agencije.
The results of various process-improvement initiatives, process analyses and staff surveys show that it is now time for the Agency to refocus some of its IT resources on improving corporate information systems as a step towards a fully electronic working environment.
Končni rezultati različnih pobud za izboljšanje postopkov, postopkovnih analiz in kadrovskih raziskav kažejo, da je zdaj čas, da agencija nameni nekaj svojih virov informacijske tehnologije za izboljšanje svojega informacijskega sistema in zagotovi popolno elektronsko delovno okolje.
An important part of the ERMS is the implementation of the European Network of Centres for Pharmacovigilance and Pharmacoepidemiology (ENCePP).
Pomemben del ERMS je izvajanje Evropske mreže centrov za farmakovigilanco in farmakoepidemiologijo (ENCePP).
This work is being carried out both in internal fora and within the framework of the Innovative Medicines Initiative.
To delo se izvaja v okviru notranjih forumov in pobude za inovativna zdravila.
In the field of innovation, the EMEA will dedicate its efforts and resources to the work of the Innovative Medicines Initiative and the European Technology Platform for Global Animal Health.
Na področju inovacij bo agencija EMEA namenila svoja prizadevanja in sredstva za delo na področju pobude za inovativna zdravila in evropske tehnološke platforme za globalno zdravstveno varstvo živali.
Additionally, following internal preparatory work and consultation, the EMEA will adjust its organisational structure to enable the Agency to deliver on its mission in a more effective and efficient way.
Poleg tega bo agencija EMEA po notranjih pripravljalnih delih in posvetovanjih prilagodila svojo organizacijsko strukturo, da bi zagotovila uspešnejše in učinkovitejše izvajanje svojega poslanstva.