FrancophonIA/ELRC3.0 huggingface dataset:
English: Veterinary medicinal products containing colistin as a sole active substance for oral administration in food producing animals are widely used in almost all EU Member States.
Slovenian: Zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin kot edino zdravilno učinkovino in se uporabljajo peroralno pri živalih za proizvodnjo živil, so splošno razširjena zdravila v skoraj vseh državah članicah EU.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP menil, da je splošno razmerje med tveganji in koristmi za ta zdravila še vedno pozitivno, če se upoštevajo spremembe informacij o zdravilu.
English: Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist.
Slovenian: Za peroralne oblike kolistina, vključno s praškom, raztopino, predmešanico, tabletami in pasto, so bila izdana dovoljenja za promet, zlasti za zdravljenje skupin ali jat, in sicer za zdravljenje in preprečevanje različnih določenih bolezni prebavil, ki jih povzročajo občutljive bakterije družine Enterobacteriacea (npr. Salmonella in Escherichia coli), vendar obstajajo tudi dovoljenja za promet z zdravili z manj podrobnimi indikacijami.
English: On 12 May 2014, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing colistin to be administered orally.
Slovenian: Evropska komisija je dne 12. maja 2014 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2011/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin in se uporabljajo peroralno.
English: No written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders.
Slovenian: Predlagatelji in imetniki dovoljenja za promet z zdravilom niso podali pisnih pripomb na priporočila in predlagane spremembe informacij o zdravilu.
English: Therefore, on 11 December 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally.
Slovenian: Odbor je zato 11. decembra 2014 soglasno sprejel pozitivno mnenje ter priporočil spremembo pogojev dovoljenj za promet z zdravili za uporabo v veterinarski medicini, ki vsebujejo kolistin in se uporabljajo peroralno.
English: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
Slovenian: 2 Spremenjene smernice odbora CVMP o povzetku glavnih značilnosti zdravila za protimikrobna zdravila (EMEA/CVMP/SAGAM/383441/2005) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/02/WC500070670.pdf
English: Opinion following an Article 351 referral for veterinary medicinal products containing colistin to be administered orally
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 351 za zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin in se uporabljajo peroralno
English: The CVMP was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) 2.
Slovenian: Odbor CVMP je bil naprošen, da poda mnenje o ukrepih, ki bi jih morali sprejeti, da bi zagotovili preudarno uporabo kolistina pri živalih za proizvodnjo živil po vsej EU in čim bolj zmanjšali morebitna tveganja, povezana z uporabo opredeljenih zdravil, ter med drugim mnenje o tem, ali je treba v informacije o zdravilu vključiti ustrezne indikacije in opozorila o preudarni uporabi
English: 1 Article 35 of Directive 2001/82/EC, as amended 2 CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom in/ali omejiti indikacije opredeljenih zdravil ob upoštevanju spremenjenih smernic odbora CVMP o povzetku glavnih značilnosti zdravila za protimikrobna zdravila (EMEA/CVMP/SAGAM/383441/2005) 2.
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Slovenian: Številka (EU) dovoljenja za promet
English: suspension: 2.5 ml; emulsion: 2.5 ml
Slovenian: suspenzija: 2,5 ml ; emulzija: 2,5 ml
English: Intramuscular use suspension (H1N1): vial (glass); emulsion (adjuvant): vial (glass)
Slovenian: suspenzija in emulzija za emulzijo za injiciranje intramuskularna uporaba suspenzija (H1N1): viala (steklo); emulzija (adjuvans): viala (steklo)
English: 2 x 25 vials (emulsion)
Slovenian: 50 vial (suspenzija) 2 x 25 vial (emulzija)
English: Strength Pharmaceutical Form
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: A/California/7/2009 (H1N1)v like strain (X-179A) 3.75 micrograms** * propagated in eggs ** haemagglutinin
Slovenian: Po premešanju 1 odmerek (0,5 ml) vsebuje: inaktivirane delce virusa gripe, ki vsebujejo antigene*, ki ustrezajo: sevu A/California/7/2009 (X-179A) podobnemu sevu A/California/7/2009 (H1N1)v
English: improved in 14% of the patients.
Slovenian: pri 14 % bolnikov.
English: Further information on Cufence can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/cufence
Slovenian: Nadaljnje informacije za zdravilo Cufence so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/cufence
English: What measures are being taken to ensure the safe and effective use of Cufence?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cufence?
English: The European Medicines Agency therefore decided that Cufence's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Cufence večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: Cufence must be stored in a refrigerator (between 2ºC and 8ºC).
Slovenian: Zdravilo Cufence je treba hraniti v hladilniku (na temperaturi od 2 °C do 8 °C).
English: What benefits of Cufence have been shown in studies?
Slovenian: Kakšne koristi zdravila Cufence so se pokazale v študijah?
English: The recommended daily dose is 4 to 8 capsules in adults, and 2 to 5 capsules in children.
Slovenian: Priporočeni dnevni odmerek pri odraslih je 4 do 8 kapsul, pri otrocih pa 2 do 5 kapsul.
English: Other information about Cufence
Slovenian: Druge informacije o zdravilu Cufence
English: The capsules are taken in 2 to 4 divided doses.
Slovenian: Kapsule se porazdelijo v 2 do 4 odmerke.
English: As for all medicines, data on the use of Cufence are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Cufence stalno spremljajo.
English: Cufence should be taken on an empty stomach, at least one hour before or two hours after meals.
Slovenian: Zdravilo Cufence je treba vzeti na tešče vsaj eno uro pred obrokom ali dve uri po njem.
English: Cufence is available as 200 mg capsules.
Slovenian: Zdravilo Cufence je na voljo v obliki 200-miligramskih kapsul.
English: Trientine has been used for over 30 years to treat patients with Wilson's disease.
Slovenian: Trientin se pri zdravljenju bolnikov z Wilsonovo boleznijo uporablja že več kot 30 let.
English: What is Cufence and what is it used for?
Slovenian: Kaj je zdravilo Cufence in za kaj se uporablja?
English: Why is Cufence authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Cufence odobreno v EU?
English: What are the risks associated with Cufence?
Slovenian: Kakšna tveganja so povezana z zdravilom Cufence?
English: The safety of Cufence has been shown to be similar to that of other trientine medicines.
Slovenian: Varnost zdravila Cufence se je izkazala za podobno kot pri drugih zdravilih, ki vsebujejo trientin.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cufence have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cufence upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: An overview of Cufence and why it is authorised in the EU
Slovenian: Pregled zdravila Cufence in zakaj je odobreno v EU
English: Side effects reported with Cufence are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Cefence, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: In a study of medical records of 77 patients treated with trientine for at least six months, symptoms of liver disease improved in almost half (49%) of the patients treated, and neurological symptoms
Slovenian: V študiji zdravstvenih kartotek 77 bolnikov, zdravljenih s trientinom najmanj šest mesecev, so se simptomi bolezni jeter izboljšali pri skoraj polovici (49 %) zdravljenih bolnikov, nevrološki simptomi pa
English: It works by attaching to copper in the body and forming a complex that is then eliminated in the urine and faeces.
Slovenian: Deluje tako, da se veže na baker v telesu in tako tvori kompleks, ki se nato izloči z urinom in blatom.
English: A small proportion of patients had deteriorating symptoms: 5% with worsening liver symptoms and 3% with worsening neurological symptoms.
Slovenian: Pri majhnem deležu bolnikov so se simptomi poslabšali: pri 5 % so se poslabšali simptomi bolezni jeter, pri 3 % pa nevrološki simptomi.
English: Cufence (trientine dihydrochloride) EMA/410631/2019
Slovenian: Cufence (trientinijev diklorid) EMA/325626/2019
English: For more information about using Cufence, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Cufence glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: In some patients, neurological deterioration can occur at the start of the treatment, with symptoms such as dystonia (involuntary muscle contractions), stiffness, tremor (shaking) and dysarthria (difficulty speaking).
Slovenian: Pri nekaterih bolnikih se lahko na začetku zdravljenja pojavi nevrološko poslabšanje s simptomi, kot so distonija (nenamerno krčenje mišic), togost, tremor (tresenje) in dizartrija (težave pri govorjenju).
English: Cufence (trientine dihydrochloride)
Slovenian: Cufence (trientinijev diklorid)
English: The most common side effect with Cufence (which may affect up to 1 in 10 people) is nausea (feeling sick), especially when starting treatment.
Slovenian: Najpogostejši neželeni učinek zdravila Cufence (ki se lahko pojavi pri največ 1 osebi od 10) je navzeja (siljenje na bruhanje), zlasti na začetku zdravljenja.
English: Cufence is used in patients who cannot take D-penicillamine, another medicine for this condition.
Slovenian: Zdravilo Cufence se uporablja pri bolnikih, ki ne smejo jemati D-penicilamina, tj. drugega zdravila za to bolezen.
English: Cufence is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage.
Slovenian: Zdravilo Cufence se uporablja za zdravljenje bolnikov, starih 5 let ali več, ki imajo Wilsonovo bolezen, tj. genetsko motnjo, pri kateri se baker iz hrane nalaga v telesu, še posebej v jetrih in možganih, kjer povzroča okvare.
English: Although Dpenicillamine is the main treatment for this condition, trientine is effective at improving the symptoms of liver and neurological disease in patients who cannot take this medicine.
Slovenian: Čeprav je D-penicilamin glavno zdravilo za zdravljenje te bolezni, je trientin učinkovit pri izboljševanju simptomov jeter in nevrološke bolezni pri bolnikih, ki tega zdravila ne morejo jemati.
English: The company that markets Cufence will conduct a study to further characterise the effectiveness of trientine in the treatment of Wilson's disease, including its effect on the associated liver, neurological or psychiatric symptoms and what the dose should be during early treatment.
Slovenian: Podjetje, ki trži zdravilo Cufence, bo izvedlo študijo za nadaljnjo opredelitev učinkovitosti trientina pri zdravljenju Wilsonove bolezni, vključno z njegovim učinkom na jetrne, nevrološke ali psihiatrične simptome, povezane s to boleznijo, in določitvijo odmerka, ki se lahko uporablja med zgodnjim zdravljenjem.
English: For the full list of side effects and restrictions of Cufence, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Cufence glejte navodilo za uporabo.
English: Duodenitis (inflammation of the duodenum, the part of the gut leading out of the stomach) and severe colitis (inflammation in the large bowel causing pain and diarrhoea) have also been reported.
Slovenian: Prav tako so poročali o duodenitisu (vnetju dvanajstnika, tj. dela črevesa, ki izhaja iz želodca) in hudem kolitisu (vnetju debelega črevesa, ki povzroča bolečine in drisko).
English: Cufence can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Slovenian: Predpisovanje in izdaja zdravila Cufence je le na recept, zdravljenje pa sme uvesti le zdravnik specialist, ki ima izkušnje z zdravljenjem Wilsonove bolezni.
English: How does Cufence work?
Slovenian: Kako zdravilo Cufence deluje?
English: The active substance in Cufence, trientine, has been shown to improve symptoms of liver and neurological disease in patients with Wilson's disease who could no longer take D-penicillamine.
Slovenian: Dokazano je bilo, da učinkovina v zdravilu Cufence, trientin, izboljšuje simptome bolezni jeter in nevrološke bolezni pri bolnikih z Wilsonovo boleznijo, ki ne morejo več jemati D-penicilamina.
English: The active substance in Cufence, trientine, is a chelating agent.
Slovenian: Učinkovina v zdravilu Cufence, trientin, je kelator.
English: How is Cufence used?
Slovenian: Kako se zdravilo Cufence uporablja?
English: Cufence contains the active substance trientine dihydrochloride.
Slovenian: Zdravilo Cufence vsebuje učinkovino trientinijev diklorid.
English: Skin rash may affect up to 1 in 100 people.
Slovenian: Pri največ 1 od 100 bolnikov se lahko pojavi kožni izpuščaj.
English: x1 vial
Slovenian: x1 viala
English: As with all therapeutic proteins, there is potential for immunogenicity.
Slovenian: Tako kot pri vseh terapevtskih beljakovinah obstaja možnost imunogenosti.
English: There was no difference in overall survival (OS) seen in either group.
Slovenian: V nobeni skupini niso ugotovili razlik v celokupnem preživetju (OS).
English: Difference (months)
Slovenian: Razlika (meseci)
English: The final concentration should not exceed 10 mg/mL.
Slovenian: Končna koncentracija ne sme preseči 10 mg/ml.
English: Magnesium repletion is recommended, as appropriate.
Slovenian: Priporočljivo je dodajanje magnezija, kot je ustrezno.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C - 8°C.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 °C - 8 °C.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not shake.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Ne pretresajte.
English: • If you have any further questions, ask your doctor.
Slovenian: • Če imate dodatna vprašanja, se posvetujte s svojim zdravnikom.
English: Date of latest renewal: 15 January 2015
Slovenian: Datum prve pridobitve: 3. december 2007 Datum zadnjega podaljšanja: 15. januar 2015
English: It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Slovenian: Pomembno je, da zdravniku poveste, če ste noseči, mislite, da ste noseči, ali nameravate zanositi.
English: The diluted solution must not be frozen.
Slovenian: Razredčene raztopine se ne sme zamrzniti.
English: Other electrolyte disturbances, including hypokalaemia, have also been observed.
Slovenian: Opažali so tudi druge elektrolitske motnje, vključno s hipokaliemijo.
English: If the first infusion is tolerated, then subsequent infusions may be administered over 30 to 60 minutes.
Slovenian: Če bolnik prvo infuzijo dobro prenese, je nadaljnje infuzije mogoče aplicirati v 30 do 60 minutah.
English: The elimination half-life was approximately 7.5 days (range: 3.6 to 10.9 days).
Slovenian: Eliminacijski razpolovni čas je bil približno 7,5 dneva (razpon: od 3,6 do 10,9 dneva).
English: An exploratory analysis showed similar results to those in the previous table.
Slovenian: Eksplorativna analiza je pokazala podobne rezultate kot so prikazani v prejšnji tabeli.
English: During or following treatment you may experience an infusion reaction.
Slovenian: Med ali po zdravljenju se vam lahko pojavi z infuzijo povezana reakcija.
English: Adverse reactions seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Slovenian: Škodljive reakcije, opažene v študijah na živalih pri stopnjah izpostavljenosti, podobnih stopnjam klinične izpostavljenosti, in z možnim pomenom za klinično uporabo so naslednje:
English: It is recommended to maintain this lower infusion rate in all subsequent infusions.
Slovenian: To manjšo hitrost infundiranja je priporočljivo ohraniti tudi pri vseh nadaljnjih infuzijah.
English: The recommended infusion time is approximately 60 minutes.
Slovenian: Priporočeni čas infundiranja je približno 60 minut.
English: The product should be used immediately after dilution.
Slovenian: Zdravilo je treba uporabiti takoj po razredčenju.
English: No new toxicities or worsening of previously recognised toxicities beyond the expected additive effects were observed.
Slovenian: Novih toksičnih učinkov ali poslabšanja predhodno ugotovljenih toksičnih učinkov, razen pričakovanih aditivnih učinkov, niso opazili.
English: However, at doses above 2 mg/kg, the AUC of panitumumab increases in an approximately dose-proportional manner.
Slovenian: Toda ob odmerkih nad 2 mg/kg se AUC panitumumaba povečuje približno sorazmerno odmerku.
English: The efficacy results for the study are presented in the table below.
Slovenian: Rezultati učinkovitosti za to študijo so prikazani v spodnji tabeli.
English: 1 Greater than or equal to grade 3 is defined as severe or life-threatening Special populations
Slovenian: 1 Stopnja, večja ali enaka 3. stopnji, je opredeljena kot huda ali smrtno nevarna.
English: For these ADRs the maximum frequency category was estimated from the upper limit of 95% confidence interval for the point estimate based on regulatory guidelines for estimation of the frequency of adverse reactions from spontaneous reporting.
Slovenian: Za te neželene učinke je bila kategorija največje pogostnosti ocenjena na podlagi zgornje meje 95 % intervala zaupanja za točkovno oceno v skladu z regulatornimi smernicami za ocenjevanje pogostnosti neželenih učinkov na podlagi spontanega poročanja.
English: The maximum frequency estimated from the upper limit of 95% confidence interval for the point estimate, i.e., 3/2,224 (or 0.13%).
Slovenian: Največja pogostnost, ocenjena na podlagi zgornje meje 95 % intervala zaupanja za točkovno oceno, tj. 3/2.224 (ali 0,13 %).
English: Do not administer Vectibix if its appearance is not as described above.
Slovenian: Zdravila Vectibix ne uporabite, če njegov izgled ni takšen, kot je opisano tukaj.
English: The detection of antibody formation is dependent on the sensitivity and specificity of the assay.
Slovenian: Odkritje nastajanja protiteles je odvisno od senzitivnosti in specifičnosti preizkusa.
English: The RAS/BRAF ascertainment was 85% (1,014 of 1,186 randomised patients).
Slovenian: Določitev RAS/BRAF je bila 85 % (1.014 od 1.186 randomiziranih bolnikov).
English: Combination with FOLFIRI
Slovenian: Kombinacija s FOLFIRI
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, vključno z zdravili, ki ste jih dobili brez recepta, in z zdravili rastlinskega izvora.
English: If keratitis is diagnosed, the benefits and risks of continuing treatment should be carefully considered.
Slovenian: Če je diagnosticiran keratitis, je treba skrbno pretehtati koristi in tveganja nadaljevanja zdravljenja.
English: The primary endpoint was PFS.
Slovenian: Primarni opazovani dogodek je bil PFS.
English: Vectibix will be stored in the healthcare facility where it is used.
Slovenian: Zdravilo Vectibix bo shranjeno v zdravstveni ustanovi, kjer bo uporabljeno.
English: The median time to first symptom of dermatologic reaction was 10 days, and the median time to resolution after the last dose of Vectibix was 31 days.
Slovenian: Mediani čas do prvega simptoma dermatoloških reakcij je bil 10 dni, mediani čas do izginotja po zadnjem odmerku zdravila Vectibix pa 31 dni.
English: In some cases, it may cause infected sores requiring medical and/or surgical treatment, or cause severe skin infections that in rare cases could be fatal.
Slovenian: V nekaterih primerih lahko povzročijo okužene rane, ki zahtevajo medicinsko in/ali kirurško zdravljenje, ali lahko povzročijo hude okužbe kože, ki so lahko v redkih primerih smrtni.
English: Tumour samples obtained from the primary resection of colorectal cancer were analysed for the presence of the seven most common activating mutations in the codon 12 and 13 of the KRAS gene.
Slovenian: Vzorce tumorjev, dobljene pri primarni resekciji kolorektalnega raka, so analizirali glede prisotnosti sedmih najpogostejših aktivacijskih mutacij v kodonih 12 in 13 gena KRAS.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko uporabo.
English: This is equivalent to 0.017% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 0,017 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: If patients experience treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Slovenian: Če se bolnikom pojavijo z zdravilom povezani simptomi, ki vplivajo na vid in/ali sposobnost koncentracije in reagiranja, je priporočljivo, da ne vozijo in ne upravljajo strojev, dokler učinek ne mine.
English: • Compared with patients who did not develop antibodies, no relationship between the presence of anti-panitumumab antibodies and pharmacokinetics, efficacy and safety has been observed.
Slovenian: • V primerjavi z bolniki, pri katerih se protitelesa niso razvila, niso ugotovili povezanosti med prisotnostjo protiteles proti panitumumabu ter farmakokinetiko, učinkovitostjo in varnostjo.