FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that the available data show that the effect of benfluorex in the treatment of diabetes is only limited.
Slovenian: CHMP je ugotovil, da razpoložljivi podatki kažejo, da je učinek benfluoreksa pri zdravljenju sladkorne bolezni majhen.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of benfluorex no longer outweigh its risks, and that all marketing authorisations for medicines containing benfluorex should be revoked throughout the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da koristi benfluoreksa ne odtehtajo več z njim povezanih tveganj in da je treba dovoljenja za promet z zdravili, ki vsebujejo benfluoreks, preklicati po vsej Evropski uniji (EU).
English: Company responses provided on:
Slovenian: Odgovori družbe poslani dne:
English: Therefore, on the basis of the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of benfluorex-containing medicines do not outweigh their risks, and therefore recommended that the marketing authorisation of these medicines be revoked.
Slovenian: CHMP je po oceni teh podatkov in znanstveni razpravi v Odboru menil, da koristi zdravil, ki vsebujejo benfluoreks, ne odtehtajo z njimi povezanih tveganj, zato je priporočil preklic dovoljenja za promet s temi zdravili.
English: Since its marketing authorisation, the safety of benfluorex has been reviewed several times.
Slovenian: Od prve odobritve dovoljenja za promet z benfluoreksom je bila njegova varnost večkrat pregledana.
English: Benfluorex was used as an add-on treatment in patients with diabetes who are overweight.
Slovenian: Benfluoreks se je uporabljal kot dodatno zdravljenje pri bolnikih s sladkorno boleznijo in prekomerno telesno težo.
English: based on each patient's symptoms and risk profile.
Slovenian: Uporabiti je treba ustrezne alternativne načine zdravljenja glede na bolnikove simptome in profil tveganja.
English: As a result, benfluorex-containing medicines were taken off the market in France.
Slovenian: vsa zdravila, ki vsebujejo benfluoreks, v Franciji umaknjena iz prometa.
English: • Patients who are currently treated with benfluorex-containing medicines should, when convenient,
Slovenian: • Bolniki, ki se trenutno zdravijo z zdravili, ki vsebujejo benfluoreks, morajo ob naslednji priložnosti obiskati zdravnika, da bo spremenil njihov recept.
English: on 2 May 2007.
Slovenian: dne 2. maja 2007.
English: This summary was last updated in 06-2010.
Slovenian: Povzetek je bil nazadnje posodobljen 06-2010.
English: As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 12 August 2010.
Slovenian: Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 12. avgusta 2010.
English: This helps to protect against the disease.
Slovenian: To pomaga pri obrambi pred boleznijo.
English: A second dose may be given after an interval of at least three weeks.
Slovenian: Drugi odmerek lahko sledi po vsaj treh tednih.
English: In children aged from six to 35 months of age, the use of a second dose has been shown to increase the immune response.
Slovenian: Pri otrocih, starih od šest do 35 mesecev, je bilo dokazano, da uporaba drugega odmerka poveča imunski odziv.
English: The virus has been first inactivated (killed) so that it does not cause any disease.
Slovenian: Virus je bil naprej inaktiviran (uničen), tako da ne povzroča bolezni.
English: The marketing authorisation is valid for five years, after which it can be renewed.
Slovenian: Dovoljenje za promet z zdravilom velja pet let, nato ga je mogoče podaljšati.
English: Focetria was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Slovenian: Zdravilo Focetria je bilo prvotno odobreno v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
English: The outer membranes that contain the surface antigens have then been extracted and purified.
Slovenian: Zunanje membrane, ki vsebujejo površinske antigene, so bile nato izločene in prečiščene.
English: The vaccine can only be obtained with a prescription.
Slovenian: Cepivo se dobi samo na recept.
English: In both studies, the vaccine was shown to bring about protective levels of antibodies to a satisfactory level, in line with the criteria laid down by the CHMP.
Slovenian: V obeh študijah je bilo dokazano, da cepivo povzroči nastanek zadovoljivih zaščitnih ravni protiteles v skladu z merili, ki jih je določil CHMP.
English: Other information about Focetria:
Slovenian: Druge informacije o zdravilu Focetria:
English: The CHMP noted that a single dose was able to trigger immunity to a satisfactory level in adults and children and adolescents aged six months to 17 years.
Slovenian: CHMP je poudaril, da je enojni odmerek sprožil imunost na zadovoljivi ravni pri odraslih ter otrocih in mladostnikih, starih od šest mesecev do 17 let.
English: Focetria is a vaccine.
Slovenian: Zdravilo Focetria je cepivo.
English: The vaccine also contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Slovenian: Cepivo vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za spodbujanje imunskega odziva.
English: Two main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response, one study in 661 healthy adults (including 251 elderly subjects over 60 years of age), and one study in 720 healthy children and adolescents (aged between six months and 17 years).
Slovenian: Izvedeni sta bili dve glavni študiji, v katerih so proučevali sposobnost cepiva, da po shemi dveh odmerkov sproži imunski odziv; v eno študijo je bilo vključenih 661 zdravih odraslih (vključno z 251 starostniki, starejšimi od 60 let), v drugo pa 720 zdravih otrok in mladostnikov (starih od šest mesecev do 17 let).
English: Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Slovenian: Cepivo Focetria se ne sme dajati osebam, ki so imele anafilaktično reakcijo (resno alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli od snovi, ki jih cepivo vsebuje v sledeh (v zelo nizkih količinah), kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), kanamicin ali neomicin sulfat (antibiotika), formaldehid in cetiltrimetilamonijev bromid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Focetria to Novartis Vaccines and Diagnostics S.r.l.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Focetria, veljavno po vsej Evropski uniji, odobrila podjetju Novartis Vaccines and Diagnostics S.r.l.
English: The CHMP decided that Focetria's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Focetria večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: This document is a summary of the European Public Assessment Report (EPAR) for Focetria.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Focetria.
English: The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Slovenian: Imunski sistem bo tako ob ponovni izpostavitvi virusu hitreje tvoril protitelesa.
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against it.
Slovenian: Ko oseba prejme cepivo, imunski sistem prepozna delce virusa kot „tujek“ in proti njemu tvori protitelesa.
English: It is a suspension for injection that contains parts (‘surface antigens') of the influenza (flu) virus.
Slovenian: Je suspenzija za injiciranje, ki vsebuje dele (površinske antigene) virusa influence (gripe).
English: The most common side effects with Focetria (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of the injection (pain, hardening and redness), malaise (feeling unwell), sweating and fatigue (tiredness).
Slovenian: Najpogostejši neželeni učinki zdravila Focetria (opaženi pri več kot 1 bolniku od 10) so bili glavobol, mialgija (bolečine v mišicah), reakcije na mestu injiciranja (bolečine, otrdelost in rdečina), slabost (slabo počutje), znojenje, utrujenost in drhtavica.
English: What benefit has Focetria shown during the studies?
Slovenian: Kakšne koristi je zdravilo Focetria izkazalo v študijah?
English: 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 Focetria.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Focetria, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Focetria was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Slovenian: Zdravilo Focetria je bilo prvotno pripravljeno kot pandemsko cepivo, ki naj bi se uporabljalo med pandemijo gripe A(H1N1), razglašeno junija 2009.
English: In the elderly (over 60 years of age), the second dose must be given.
Slovenian: Ta drugi odmerek morajo prejeti starostniki (starejši od 60 let).
English: Focetria influenza vaccine (H1N1)v (surface antigen, inactivated, adjuvanted)
Slovenian: Focetria cepivo proti gripi (H1N1) (z delci virionov, inaktivirano, z adjuvansom)
English: For the full list of all side effects reported with Focetria, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri cepivu Focetria, glejte navodilo za uporabo.
English: Focetria is given as one dose, injected into the muscle of the shoulder or thigh.
Slovenian: Cepivo Focetria se daje v enkratnem odmerku z injiciranjem v ramensko ali stegensko mišico.
English: Focetria is given according to official recommendations.
Slovenian: Cepivo se daje le v skladu z uradnimi priporočili.
English: For more information about treatment with Focetria, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Focetria preberite navodilo za uporabo (ki je prav tako del EPAR).
English: Why has Focetria been approved?
Slovenian: Zakaj je bilo zdravilo Focetria odobreno?
English: Focetria is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Slovenian: Zdravilo Focetria je cepivo za zaščito pred gripo, ki jo povzroča virus A (H1N1)v 2009.
English: What is the risk associated with Focetria?
Slovenian: Kakšna tveganja so povezana z uporabo zdravila Focetria?
English: It contains a flu strain called A/California/7/2009 (H1N1)-derived strain NYMC X-181.
Slovenian: Vsebuje sev gripe, imenovan sev NYMC X-181, pridobljen iz seva A/California/7/2009 (H1N1).
English: Focetria contains small amounts of ‘surface antigens' (proteins on the outer membrane of the virus) of a virus called A(H1N1)v 2009.
Slovenian: Zdravilo Focetria vsebuje majhne količine površinskih antigenov (beljakovin na zunanji membrani virusa) virusa A(H1N1)v 2009.
English: The full EPAR for Focetria can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Focetria je na voljo tukaj.
English: What is Focetria used for?
Slovenian: Za kaj se zdravilo Focetria uporablja?
English: How has Focetria been studied?
Slovenian: Kako je bilo zdravilo Focetria raziskano?
English: What is Focetria?
Slovenian: Kaj je zdravilo Focetria?
English: How is Focetria used?
Slovenian: Kako se zdravilo Focetria uporablja?
English: How does Focetria work?
Slovenian: Kako zdravilo Focetria deluje?
English: The reasons for this are not clear.
Slovenian: Vzroki za to niso povsem jasni.
English: This summary was last updated in September 2016.
Slovenian: Povzetek je bil nazadnje posodobljen septembra 2016.
English: Hands should be washed after use.
Slovenian: Po uporabi si je treba umiti roke.
English: It is recommended that animals are treated in the early stages of respiratory disease and that their response is evaluated within 48 hours.
Slovenian: Priporoča se zdravljenje živali v zgodnjih stadijih dihalnih obolenj, njihov odziv na zdravljenje pa se oceni v 48 urah.
English: This is a summary of the European Public Assessment Report (EPAR) for Draxxin.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Draxxin.
English: The European Commission granted a marketing authorisation valid throughout the EU for Draxxin on 23 July 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Draxxin, veljavno po vsej Evropski uniji, izdala 23. julija 2003.
English: The main measure of effectiveness was the change in symptoms over 10 days.
Slovenian: Glavno merilo učinkovitosti je bila sprememba simptomov v desetih dneh.
English: This means that the antibiotic may no longer work on bacteria infecting either animals or humans.
Slovenian: To pomeni, da antibiotik morda nima več učinka na bakterije, s katerimi so okužene živali ali ljudje.
English: It works by attaching to the RNA (the molecules that instruct the cell how to make proteins) within the bacterial cells.
Slovenian: Deluje s pripojitvijo na RNK (molekule, ki celici dajejo navodila, kako tvoriti beljakovine) v celicah bakterij.
English: The full EPAR for Draxxin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Draxxin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
English: If symptoms persist, get worse or come back, treatment should be changed to another antibiotic.
Slovenian: Če simptomi ne pojenjajo, se okrepijo ali se ponovno pojavijo, je treba preiti na zdravljenje z drugim antibiotikom.
English: The main measure of effectiveness was the change in symptoms, including body temperature, breathing and recovery over a period of between two weeks and two months.
Slovenian: Glavno merilo učinkovitosti je bila sprememba jakosti simptomov, vključno s telesno temperaturo, dihanjem in okrevanjem v obdobju od dveh tednov do dveh mesecev.
English: This means to treat at the same time both diseased animals and those clinically healthy animals in close contact with them, to prevent them from developing clinical signs and to prevent further spread of the disease.
Slovenian: To pomeni hkratno zdravljenje obolelih živali in klinično zdravih živali, ki so v tesnem stiku z njimi, za preprečitev razvoja kliničnih znakov pri njih in nadaljnjega širjenja bolezni.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Draxxin's benefits are greater than its risks and recommended that it be approved in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila Draxxin večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Draxxin tulathromycin
Slovenian: Draxxin tulatromicin
English: Other information about Draxxin:
Slovenian: Druge informacije o zdravilu Draxxin:
English: This has not been seen in pigs and sheep after intramuscular injection.
Slovenian: Tega niso opazili pri prašičih in ovcah po injiciranju zdravila v mišico.
English: The main measure of effectiveness was the proportion of cattle whose disease was cured after three weeks.
Slovenian: Glavno merilo učinkovitosti je bil delež goveda, ki je bilo po treh tednih ozdravljeno.
English: However, some bacteria can develop resistance against tulathromycin, which will reduce its effectiveness.
Slovenian: Kljub temu se lahko pri nekaterih bakterijah razvije odpornost proti tulatromicinu, kar zmanjša njegovo učinkovitost.
English: Two weeks after treatment 84% of Draxxin-treated sheep were successfully treated compared to 82% of tilmicosin-treated sheep.
Slovenian: Dva tedna po zdravljenju je bilo uspešno ozdravljenih 84 % ovac, zdravljenih z zdravilom Draxxin, v primerjavi z 82 % ovac, ki so prejemale tilmikozin.
English: However, the third study found no difference between the effectiveness of Draxxin, oxytetracycline and placebo.
Slovenian: Vendar pa v tretji študiji niso ugotovili nobene razlike med učinkovitostjo zdravila Draxxin, oksitetraciklina in placeba.
English: The medicine should only be used for metaphylaxis in cattle and pigs once the presence of the disease in the herd has been established, and if animals are expected to develop the disease within two to three days.
Slovenian: Zdravilo se lahko za metafilakso pri govedu in prašičih uporablja šele potem, ko je bila v čredi ugotovljena prisotnost bolezni in če se pričakuje, da se bo pri njih v dveh do treh dneh razvila bolezen.
English: It should also not be used at the same time as other macrolide antibiotics or lincosamides (another type of antibiotic medicine).
Slovenian: Prav tako se ne sme uporabljati sočasno z drugimi makrolidnimi antibiotiki ali linkozamidi (drugo vrsto antibiotičnega zdravila).
English: This prevents the bacteria being able to make vital proteins and stops them growing and multiplying.
Slovenian: To bakterijam preprečuje, da bi lahko tvorile življenjsko pomembne beljakovine ter zaustavi njihovo rast in razmnoževanje.
English: Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.
Slovenian: S pridobitvijo odpornosti proti antibiotikom dobijo bakterije sposobnost za rast kljub prisotnosti antibiotika, ki bi jih sicer običajno uničil ali omejil njihovo rast.
English: For cattle the meat withdrawal period is 22 days, for pigs it is 13 days and for sheep it is 16 days.
Slovenian: Karenca za goveje meso je 22 dni, za prašičje 13 dni in jagnjetino 16 dni.
English: In all studies, Draxxin was at least as effective as the comparator medicines.
Slovenian: V vseh študijah je bilo zdravilo Draxxin vsaj tako učinkovito kot primerjalna zdravila.
English: Looking at the studies taken together, it was more effective than placebo.
Slovenian: Ob presoji vseh študij skupaj je bilo učinkovitejše od placeba.
English: For the best results sheep with foot rot should be kept in a dry environment.
Slovenian: Za dosego boljših rezultatov je treba ovce z nalezljivo šepavostjo držati v suhem okolju.
English: The main measure of effectiveness was the proportion of pigs that completed the full three or six weeks of each study without needing to be removed from the study because of SRD.
Slovenian: Glavno merilo učinkovitosti je bil delež prašičev, ki so bili v študijo vključeni celotno obdobje treh ali šestih tednov trajanja posamezne študije, ne da bi jih bilo treba izločiti iz nje zaradi dihalnega obolenja.
English: Draxxin is available as a solution for injection (25 mg/ml and 100 mg/ml).
Slovenian: Zdravilo Draxxin je na voljo v obliki raztopine za injiciranje (25 mg/ml in 100 mg/ml).
English: • Early stages of foot rot in sheep caused by Dichelobacter nodosus, which requires systemic treatment (treatment with a medicine given by mouth or by injection).
Slovenian: • zgodnjih stadijev nalezljive šepavosti ovac, ki jo povzroča bakterija Dichelobacter nodosus in ki zahteva sistemsko zdravljenje (zdravljenje z zdravili, ki se dajejo peroralno ali z injiciranjem).
English: What is Draxxin and what is it used for?
Slovenian: Kaj je zdravilo Draxxin in za kaj se uporablja?
English: Why is Draxxin approved?
Slovenian: Zakaj je bilo zdravilo Draxxin odobreno?
English: The most common side effects with Draxxin in sheep (which may affect more than 1 in 10 sheep) are short lived signs of discomfort (head shaking, rubbing the injection site and backing away) lasting only a few minutes.
Slovenian: Najpogostejši neželeni učinki zdravila Draxxin pri ovcah (ki lahko prizadanejo več kot eno ovco od 10) so kratkotrajni znaki nelagodja (stresanje z glavo, drgnjenje na mestu injiciranja in izmikanje), ki trajajo samo nekaj minut.
English: What are the risks associated with Draxxin?
Slovenian: Kakšna tveganja so povezana z zdravilom Draxxin?
English: Draxxin is used to treat the following diseases if they are caused by bacteria that are sensitive to tulathromycin:
Slovenian: Uporablja se za zdravljenje naslednjih bolezni, če jih povzročajo bakterije, ki so občutljive za tulatromicin:
English: What benefits of Draxxin have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Draxxin izkazalo v študijah?
English: Draxxin is given as a single injection of 2.5 mg per kilogram bodyweight.
Slovenian: Zdravilo Draxxin se daje kot enkratna injekcija v odmerku 2,5 mg na kilogram telesne mase.
English: It is also the time required after administration of a medicine before milk can be used for human consumption.
Slovenian: Pomeni tudi čas, ki mora preteči po dajanju zdravila, preden se lahko mleko uporabi za prehrano ljudi.
English: In the treatment studies, the cattle were infected with BRD-causing bacteria, but the cattle in the prevention studies had no symptoms of the disease.
Slovenian: V študijah zdravljenja bolezni so bile živali okužene z bakterijami, ki povzročajo dihalna obolenja goveda, živali, vključene v študije preprečevanja bolezni, pa niso imele nobenih simptomov bolezni.
English: A single 2.5 mg/kg dose of Draxxin was effective in treating and preventing further outbreak of BRD in cattle and SRD in pigs.
Slovenian: Enkratni odmerek v višini 2,5 mg/kg zdravila Draxxin je bil učinkovit pri zdravljenju in preprečevanju nadaljnjega izbruha dihalnih obolenj pri govedu in prašičih.
English: In sheep, Draxxin is injected into the neck muscle.
Slovenian: Pri ovcah se zdravilo Draxxin injicira v vratno mišico.
English: Draxxin should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics.
Slovenian: Zdravilo Draxxin se ne sme uporabljati pri živalih, ki so preobčutljive za (alergične na) makrolidne antibiotike.
English: Draxxin may also cause sensitisation (redness, itching and swelling) if it comes into contact with the skin.
Slovenian: Zdravilo Draxxin lahko povzroči tudi senzibilizacijo (rdečico, srbenje in oteklino), če pride v stik s kožo.
English: Draxxin must not be used in animals that are producing milk for human consumption, or in pregnant animals intended to produce milk for human consumption within two months of their expected date of giving birth.
Slovenian: Zdravilo Draxxin se ne sme uporabljati pri živalih, katerega mleko je namenjeno prehrani ljudi, in brejih živalih, katerih mleko je namenjeno prehrani ljudi, v dveh mesecih pred pričakovano kotitvijo.
English: The 25 mg/ml solution for injection is for pigs only whilst the 100 mg/ml solution for injection is for cattle, pigs and sheep.
Slovenian: Raztopina za injiciranje z jakostjo 25 mg/ml se uporablja samo pri prašičih, raztopina za injiciranje z jakostjo 100 mg/ml pa je namenjena za uporabo pri govedu, prašičih in ovcah.
English: • infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis;
Slovenian: • infekcioznega govejega keratokonjuktivitisa (IBK), tj. obolenja oči, ki ga povzroča bakterija Moraxella bovis;