FrancophonIA/ELRC3.0 huggingface dataset:
English: The vaccine must not be used in people who have problems with their immune system, either because they have a disease such as leukaemia, lymphoma, acquired immune deficiency syndrome (AIDS), or because they are taking medicines that affect the immune system.
Slovenian: Prav tako ga ne smejo uporabljati osebe, ki imajo težave z imunskim sistemom, bodisi ker imajo bolezen, kot je levkemija, limfom ali sindrom pridobljene imunske pomanjkljivosti (aids), ali ker jemljejo zdravilo, ki vpliva na imunski sistem.
English: What is the risk associated with Zostavax?
Slovenian: Kakšna tveganja so povezana z zdravilom Zostavax?
English: Zostavax was more effective than placebo in preventing shingles.
Slovenian: Zdravilo Zostavax je bilo pri preprečevanju pasovca učinkovitejše od placeba.
English: The studies looked at the ability of the vaccine to stimulate the production of antibodies against varicella-zoster virus in the blood, four weeks after injection.
Slovenian: V študijah so proučevali zmožnost cepiva za spodbujanje tvorbe protiteles proti virusu varicella-zoster v krvi štiri tedne po prejetju cepiva.
English: Herpes zoster, or shingles, is a disease caused by the reactivation of the varicella-zoster virus, the same virus that causes chickenpox.
Slovenian: Herpes zoster ali pasovec je bolezen, ki jo povzroči reaktivacija virusa varicella-zoster, tj. istega virusa, ki povzroči tudi norice.
English: Two further studies looked at Zostavax in over 1,000 patients aged 50 years or older, of whom 389 were between 50 and 59 years of age.
Slovenian: V nadaljnjih dveh študijah so cepivo Zostavax proučevali pri več kot 1 000 bolnikih, starejših od 50 let, med katerimi jih je 389 bilo starih od 50 do 59 let.
English: Zostavax must not be used in people who are hypersensitive (allergic) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine such as neomycin (an antibiotic).
Slovenian: Cepivo Zostavax ne sme uporabljati osebe, ki so preobčutljive za (alergične na) katere koli sestavine zdravila ali katero koli snov, ki jo je mogoče v cepivu najti v sledeh (v zelo nizkih koncentracijah), kot je na primer neomicin (antibiotik).
English: Zostavax shingles (herpes zoster) vaccine (live)
Slovenian: Zostavax cepivo proti pasovcu (herpesu zostru) (živo)
English: Zostavax is used to vaccinate people aged 50 years or older, to prevent herpes zoster (also known as zoster or shingles) and the long-lasting nerve pain that may follow the disease (post-herpetic neuralgia).
Slovenian: Zdravilo Zostavax se uporablja za cepljenje ljudi, starejših od 50 let, za preprečevanje herpesa zostra (znanega tudi kot zoster ali pasovec) in dolgotrajne bolečine v živcu, ki se lahko razvije po bolezni (postherpetična nevralgija).
English: The risk of developing shingles increases with age and seems to be linked to a decline in immunity (protection) against varicella-zoster virus.
Slovenian: Tveganje za razvoj pasovca se povečuje s starostjo in je verjetno povezano z oslabitvijo imunosti (telesne obrambe) proti virusu varicella-zoster.
English: Sometimes, after many years, and for reasons which are not fully understood, the virus becomes active again, and the patient develops shingles, a painful,
Slovenian: Včasih postane virus po več letih iz razlogov, ki še niso povsem pojasnjeni, znova dejaven in pri bolniku povzroči razvoj pasovca.
English: The main study of Zostavax compared the vaccine with placebo (a dummy) vaccine in around 39,000 patients aged between 59 and 99 years.
Slovenian: V glavni študiji so cepivo Zostavax primerjali s placebom (cepivom brez zdravilne učinkovine) pri približno 39 000 bolnikih, starih od 59 do 99 let.
English: Zostavax is a vaccine that is available as a powder and solvent to be made up into a solution for injection.
Slovenian: Zostavax je cepivo, ki je na voljo v obliki praška in vehikla za pripravo raztopine za injiciranje.
English: The CHMP decided that Zostavax's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Zostavax večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Zostavax is given as a single dose injected under the skin or into the muscle, preferably around the shoulder.
Slovenian: Zdravilo Zostavax se injicira v enkratnem odmerku v podkožje ali mišico, po možnosti v predel ramena.
English: Fewer people developed shingles after vaccination with Zostavax than placebo: 315 of the 19,254 patients who received Zostavax had shingles during the study, compared with 642 of the 19,247 who received placebo.
Slovenian: Število oseb, pri katerih se je razvil pasovec, je bilo manjše v skupini, ki je prejela cepivo Zostavax, kot v skupini, ki je prejela placebo: med študijo se je pasovec pojavil pri 315 bolnikih od 19 254, ki so prejeli cepivo Zostavax, v primerjavi s 642 bolniki od 19 247 tistih, ki so prejeli placebo.
English: The active substance is the attenuated (weakened) varicella-zoster virus.
Slovenian: Zdravilna učinkovina je atenuiran (oslabljen) virus varicella-zoster.
English: The additional two studies showed that patients vaccinated with Zostavax had blood levels of antibodies against varicella-zoster virus that were about two to three times higher four weeks after vaccination.
Slovenian: Dodatni dve študiji sta pokazali, da so imeli bolniki, cepljeni z zdravilom Zostavax, štiri tedne po cepljenju v krvi okoli dva- do trikrat višje ravni protiteles proti virusu varicella-zoster.
English: Why has Zostavax been approved?
Slovenian: Zakaj je bilo zdravilo Zostavax odobreno?
English: For the full list of all side effects reported with Zostavax, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri zdravilu Zostavax, glejte navodilo za uporabo.
English: Zostavax was also more effective than placebo in preventing post-herpetic neuralgia: 27 of the Zostavax patients had post-herpetic neuralgia, compared with 80 in the placebo group.
Slovenian: Cepivo Zostavax je bilo učinkovitejše od placeba tudi pri preprečevanju postherpetične nevralgije: razvila se je pri 27 bolnikih, ki so prejeli cepivo Zostavax, v primerjavi z 80 bolniki iz skupine, ki je prejela placebo.
English: Zostavax is a vaccine that was shown to ‘boost' this immunity, protecting against shingles and the pain associated with it.
Slovenian: Cepivo Zostavax dokazano okrepi omenjeno imunost, s čimer zagotavlja zaščito pred pasovcem in z njim povezano bolečino.
English: The rash takes usually several weeks to clear, and may be followed by severe long-lasting pain (post-herpetic neuralgia) in the area where the rash was.
Slovenian: Po navadi izgine šele po nekaj tednih, zatem pa se lahko v predelu, na katerem je bil izpuščaj, pojavi dolgotrajna huda bolečina (postherpetična nevralgija).
English: What is Zostavax used for?
Slovenian: Za kaj se zdravilo Zostavax uporablja?
English: blistering rash typically in one part of the body.
Slovenian: Pasovec je boleč, mehurčast kožni izpuščaj, ki se običajno pojavi na enem delu telesa.
English: What is Zostavax?
Slovenian: Kaj je zdravilo Zostavax?
English: How has Zostavax been studied?
Slovenian: Kako je bilo zdravilo Zostavax raziskano?
English: How is Zostavax used?
Slovenian: Kako se zdravilo Zostavax uporablja?
English: Shingles develops in people who have had chickenpox earlier in life, generally as a child. After chickenpox, the varicella-zoster virus stays in the body, in the nervous system, in a ‘dormant' (inactive) state.
Slovenian: Po noricah ostane virus varicella-zoster v telesu v živčnem sistemu v „speči“ (neaktivni) obliki.
English: How does Zostavax work?
Slovenian: Kako zdravilo Zostavax deluje?
English: 23 August 2012
Slovenian: 23. avgust 2012
English: The European Commission issued a decision on 23 August 2012.
Slovenian: Evropska komisija je sklep izdala dne 23. avgusta 2012.
English: Zinnat should be used twice a day at different doses depending on the condition it is used to treat.
Slovenian: Zdravilo Zinnat se mora jemati dvakrat dnevno v različnih odmerkih glede na bolezen, za katero se uporablja.
English: This prevents the bacteria from building their cell walls, and eventually kills them.
Slovenian: S tem bakterijam prepreči, da bi zgradile celične stene, zaradi česar te postopoma odmrejo.
English: Why was Zinnat reviewed?
Slovenian: Zakaj je bilo zdravilo Zinnat pregledano?
English: It is also available under other trade names: Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos, Zoref.
Slovenian: Na voljo je tudi pod drugimi lastniškimi imeni: Cefuroxima Allen, Cefuroxima Solasma, Elobact, Nivador, Oraxim, Selan, Zinadol, Zipos, Zoref.
English: Zinnat is authorised in the EU via national procedures.
Slovenian: Zdravilo Zinnat je v EU odobreno z nacionalnimi postopki.
English: On 24 May 2012, the European Medicines Agency completed a review of Zinnat.
Slovenian: Evropska agencija za zdravila je 24. maja 2012 je zaključila pregled zdravila Zinnat.
English: Zinnat is marketed in all EU Member States, as well as Iceland.
Slovenian: Zdravilo Zinnat je na trgu v vseh državah članicah EU in Islandiji.
English: Having harmonised the indications, the CHMP also harmonised the recommendations on the use of Zinnat in adults and children and in patients with reduced kidney and liver function.
Slovenian: Po uskladitvi indikacij je CHMP uskladil tudi priporočila glede uporabe zdravila Zinnat pri odraslih in otrocih ter bolnikih z zmanjšanim delovanjem ledvic in jeter.
English: The active substance, cefuroxime axetil, belongs to the group ‘cephalosporins'.
Slovenian: Zdravilna učinkovina, cefuroksim aksetil, spada v skupino „cefalosporinov“.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the different EU countries.
Slovenian: To je privedlo do razhajanj glede uporabe zdravila po posameznih državah članicah , kot je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v različnih državah EU.
English: • Uncomplicated skin and soft tissue infections.
Slovenian: • nezapletenih okužb kože in mehkih tkiv;
English: The CHMP concluded that Zinnat should be used in adults and children from three months of age for the following conditions:
Slovenian: CHMP je zaključil, da se lahko zdravilo Zinnat uporablja pri odraslih in otrocih od tretjega meseca starosti za zdravljenje:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Zinnat in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Zinnat.
English: Zinnat is an antibiotic used to treat certain infections caused by bacteria, including respiratory tract infections such as tonsillitis and pharyngitis (infections of the throat), urinary tract infections (infections of the structures that carry urine), skin infections, soft-tissue infections (infections of tissues just below the skin) and Lyme disease (bacterial infection transmitted to humans by infected ticks).
Slovenian: Zdravilo Zinnat je antibiotik, ki se uporablja za zdravljenje določenih bakterijskih okužb, vključno z okužbami dihal, kot sta tonzilitis in faringitis (okužbi žrela), okužbami sečil (okužbe struktur, ki proizvajajo in odvajajo urin), okužbami kože, okužbami mehkih tkiv (okužbe podkožnih tkiv) in lymske borelioze (bakterijska okužba, ki jo na ljudi prenašajo okuženi klopi).
English: The CHMP agreed that Zinnat should no longer be used to treat community acquired pneumonia (infection of the lungs acquired outside the hospital) and gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae) because not enough clinical data are available to support these indications.
Slovenian: CHMP se strinja, da se zdravilo Zinnat ne sme več uporabljati za zdravljenje zunajbolnišnične pljučnice (okužba pljuč, pridobljena zunaj bolnišnice) in gonoreje (spolno prenosljiva bolezen, ki jo povzroča bakterija Neisseria gonorrhoeae), saj ni dovolj kliničnih dokazov, ki bi podpirali ti indikaciji.
English: What is Zinnat?
Slovenian: Kaj je zdravilo Zinnat?
English: The CHMP also decided that Zinnat should no longer be used in sequential therapy (when switching patients from an injectable to an oral treatment) due to a significant reduction in exposure to the active substance when switching to the oral formulation.
Slovenian: CHMP je odločil tudi, da se zdravilo Zinnat ne sme več uporabljati pri sekvenčnem zdravljenju (pri prehodu bolnikov z injekcij na peroralno zdravljenje) zaradi znatnega zmanjšanja izpostavljenosti zdravilni učinkovini pri prehodu na peroralno farmacevtsko obliko.
English: • Acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat).
Slovenian: • akutnega streptokoknega tonzilitisa in faringitisa (okužbi mandeljnov in žrela);
English: • Treatment of early Lyme disease.
Slovenian: • zgodnje oblike Lymske borelioze.
English: On 20 April 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Zinnat in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Zinnat v EU, je 20. aprila 2010 zadevo napotila na CHMP.
English: • Pyelonephritis (kidney infection).
Slovenian: • pielonefritisa (okužbe ledvic);
English: • Cystitis (infection of the bladder).
Slovenian: • cistitisa (okužbe mehurja);
English: • Acute bacterial sinusitis (infection of the sinuses).
Slovenian: • akutnega bakterijskega sinuzitisa (okužba obnosnih votlin);
English: Zinnat was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Zinnat potrebna uskladitev.
English: • Acute otitis media (infection of the middle ear).
Slovenian: • akutnega vnetja srednjega ušesa;
English: Methysergide containing products are currently authorised in the following EU countries: Belgium, France, the Netherlands and the United Kingdom.
Slovenian: Zdravila, ki vsebujejo metizergid, so trenutno odobrena v naslednjih državah EU: v Belgiji, Franciji, na Nizozemskem in v Združenem kraljestvu.
English: However, these results should be taken
Slovenian: Vendar pa je te rezultate treba obravnavati previdno, saj
English: Such adverse effects may be serious and in some cases irreversible and potentially fatal.
Slovenian: Ti neželeni učinki so lahko resni in v nekaterih primerih ireverzibilni, lahko pa so tudi smrtno nevarni;
English: Overall summary of the scientific evaluation of methysergide containing medicinal products (see Annex I)
Slovenian: Splošni povzetek znanstvenega vrednotenja zdravil, ki vsebujejo metizergid (glejte Prilogo I)
English: Existing data seems to show that fibrosis development is not related to patient age.
Slovenian: Obstoječi podatki kažejo, da razvoj fibroze ni povezan s starostjo bolnika.
English: The CHMP highlighted that these results should be taken with caution as these studies are old and generally not carried out with the current upto-date methodology8.
Slovenian: Odbor CHMP je poudaril, da je te rezultate treba obravnavati previdno, saj so študije stare in na splošno niso bile izvedene z najnovejšo metodologijo, ki se uporablja danes8.
English: The majority of patients (92.4%) who developed fibrosis received daily doses of methysergide within the currently recommended (≤ 6 mg/day).
Slovenian: Večina bolnikov (92,4 %), pri katerih se je razvila fibroza, je prejemala dnevne odmerke metizergida, ki so bili znotraj trenutno priporočenih (≤ 6 mg/dan).
English: This is provided that the recommended risk minimisation measures are implemented;
Slovenian: Vse to velja pod pogojem, da se izvajajo priporočeni ukrepi za zmanjšanje tveganja;
English: Two studies, one observational and one prospective, reported less convincing evidence13 where around 26% patients had satisfactory, good or excellent outcomes.
Slovenian: V dveh študijah, od katerih je bila ena opazovalna, druga pa prospektivna, so zbrali manj prepričljive dokaze13, saj so zadovoljive, dobre ali odlične rezultate zabeležili pri približno 26 % bolnikov.
English: The indication should be restricted to patients with functional disability in whom other treatments have failed.
Slovenian: Indikacijo je treba omejiti na bolnike s funkcionalno nezmožnostjo, pri katerih druga zdravljenja niso bila učinkovita.
English: However, cases have also been reported with treatment duration up to six months, so occurrence of fibrosis with short-term treatment cannot be excluded.
Slovenian: Vendar pa so o primerih poročali tudi pri zdravljenju, ki je trajalo do šest mesecev, tako da pojava fibroze med kratkotrajnim zdravljenjem ni mogoče izključiti.
English: Regarding the risk of retroperitoneal fibrosis, there is evidence of increased risk in patients treated with methysergide (200 versus 1.3 per 100 000 patients)23,24.
Slovenian: Kar zadeva tveganje za retroperitonealno fibrozo, obstajajo dokazi o povečanem tveganju pri bolnikih, zdravljenih z metizergidom (200 v primerjavi z 1,3 na 100 000 bolnikov)23,24.
English: In addition, further trials comparing methysergide with placebo or comparators were also presented, some of which also showed efficacy of methysergide compared to placebo in this indication5,6,7.
Slovenian: Poleg tega so bila predložena tudi dodatna preskušanja, v katerih so metizergid primerjali s placebom ali primerjalnimi zdravili, in nekatera od teh prav tako kažejo na učinkovitost metizergida v primerjavi s placebom pri tej indikaciji5,6,7.
English: Methysergide is an ergot alkaloid, first described in clinical practice in 1959.
Slovenian: Metizergid je ergot alkaloid, ki so ga v klinični praksi prvič opisali leta 1959.
English: Serious intolerance or contra-indication to a first line drug is regarded as treatment failure.
Slovenian: Resna intoleranca in kontraindikacija za zdravilo prve izbire se štejeta za neuspešno zdravljenje.
English: Methysergide is to be used only following unsuccessful treatment with other standard classes of drugs after sufficient treatment duration (at least 4 months) at the maximal tolerated dose.
Slovenian: Metizergid se lahko uporablja samo po neuspešnem zdravljenju z drugimi standardnimi vrstami zdravil, ki je potekalo dovolj časa (najmanj 4 mesece) pri največjem tolerančnem odmerku.
English: In addition, development of fibrosis appears to be correlated to treatment duration, as most patients developed fibrotic events after long-term therapy (at least one year).
Slovenian: Poleg tega se zdi, da je razvoj fibroze povezan s trajanjem zdravljenja, saj so se pri večini bolnikov fibrozni dogodki pojavili po dolgotrajnem zdravljenju (po najmanj enem letu).
English: The incidence rates of valvular and pulmonary fibrosis in patients treated with methysergide was shown to be similar to those of the general population19,20,21,22.
Slovenian: Incidenca valvularne in pljučne fibroze pri bolnikih, zdravljenih z metizergidom, je bila podobna incidenci pri splošni populaciji19,20,21,22.
English: In this respect, the CHMP took note of the fact that one of the marketing authorisation holders of the products for which this indication is approved informed the CHMP of their intention to voluntarily withdraw the indication “diarrhoea caused by carcinoid syndrome”.
Slovenian: Ob tem je odbor CHMP upošteval dejstvo, da je eden od imetnikov dovoljenja za promet z zdravili, za katera je odobrena ta indikacija, obvestil odbor, da namerava prostovoljno umakniti indikacijo „driska, ki jo povzroča karcinoidni sindrom“.
English: In order to evaluate the safety of methysergide, the CHMP considered data from literature and safety database including spontaneous and literature reports.
Slovenian: Da bi ocenil varnost metizergida, je odbor CHMP proučil podatke iz literature in zbirke podatkov o varnosti, vključno s spontanimi poročili in poročili iz literature.
English: This is subject to the agreed warnings, other changes to the product information and additional risk minimisation measures.
Slovenian: Vse to velja pod pogojem, da se upoštevajo dogovorjena opozorila, druge spremembe informacij o zdravilu in dodatni ukrepi za zmanjšanje tveganja.
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for methysergide containing medicinal products.
Slovenian: • odbor CHMP je obravnaval napotitev v skladu s členom 31 Direktive 2001/83/ES za zdravila, ki vsebujejo metizergid;
English: Therefore, the potential causal association between fibrotic reactions and methysergide cannot be excluded.
Slovenian: Morebitne vzročne povezave med fibroznimi reakcijami in metizergidom zato ni mogoče izključiti.
English: − Is not favourable for the treatment of diarrhoea caused by carcinoid disease.
Slovenian: − ni ugodno za zdravljenje driske, ki jo povzroča karcinoidna bolezen.
English: Since fibrotic reactions are believed to be associated with persistent agonist activation of the 5-HT2B receptor, long-term treatment with methysergide will expose patients to the potential for tissue fibrosis mediated by its principal active metabolite, methylergometrine.
Slovenian: Ker so fibrozne reakcije domnevno povezane z nenehno aktivacijo receptorja 5-HT2B z agonisti, bodo bolniki med dolgotrajnim zdravljenjem z metizergidom izpostavljeni tveganju za fibrozo tkiva, ki jo povzroča njegov glavni aktivni presnovek, metilergometrin.
English: Based on this, France considered that the benefit risk balance of methysergide containing products should be reviewed and triggered a referral under Article 31 of Directive 2001/83/EC.
Slovenian: Francija je zato menila, da je treba ponovno pregledati razmerje med tveganji in koristmi zdravil, ki vsebujejo metizergid, in sprožila napotitveni postopek v skladu s členom 31 Direktive 2001/83/ES.
English: with caution as methods of detection of fibrosis used in these studies are not sensitive enough, in particular for valvular fibrosis.
Slovenian: metode za odkrivanje fibroze, ki so jih uporabili v teh študijah, niso bile dovolj občutljive, še zlasti ne za odkrivanje valvularne fibroze.
English: These included restricted duration of treatment, optimal dose of treatment, specialist supervision and information for prescribing physicians and patients' organisation.
Slovenian: Ti ukrepi vključujejo omejitev trajanja zdravljenja, optimalen odmerek zdravila, nadzor specialista in informacije za zdravnike, ki predpisujejo zdravilo, ter organizacije za bolnike.
English: Methysergide binds with varying affinities to a range of serotonergic receptors (5-HT receptors).
Slovenian: Metizergid se z različno afiniteto veže na več vrst serotoninergičnih receptorjev (receptorji 5-HT).
English: Warnings on the risk of fibrosis should be included in the product information, alongside measures to monitor patients for development of fibrosis, and these should also be communicated to prescribers and patients using educational material.
Slovenian: V informacije o zdravilu je treba vključiti opozorila o tveganju za fibrozo, skupaj z ukrepi za spremljanje bolnikov glede razvoja fibroze, in o vsem tem obvestiti zdravnike in bolnike z razdelitvijo izobraževalnega gradiva.
English: Taking into account the number of fibrosis cases reported and the probable under reporting, the risk of fibrotic reactions associated with methysergide cannot be excluded.
Slovenian: Ob upoštevanju števila primerov fibroze, o katerih so poročali, in verjetnega pomanjkljivega poročanja, tveganja za fibrozne reakcije, povezane z metizergidom, ni mogoče izključiti.