FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Erelzi is a biosimilar medicine, the studies on effectiveness and safety of etanercept carried out with Enbrel do not all need to be repeated for Erelzi.
Slovenian: Zdravilo Erelzi je „podobno biološko zdravilo“, zato vseh študij o učinkovitosti in varnosti etanercepta, izvedenih z zdravilom Enbrel, z zdravilom Erelzi ni treba ponavljati.
English: Treatment is started and supervised by specialised doctors with experience in diagnosing and treating the diseases Erelzi is used for.
Slovenian: Zdravljenje začne in nadzoruje zdravnik specialist, ki ima izkušnje z diagnosticiranjem in zdravljenjem bolezni, za katere se uporablja zdravilo Erelzi.
English: Treatment with 50 mg twice a week can also be used during the first 12 weeks of treatment for plaque psoriasis.
Slovenian: V prvih 12 tednih zdravljenja psoriaze v plakih se lahko 50-miligramski odmerek uporabi tudi dvakrat na teden.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Erelzi have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Erelzi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: This substance is involved in causing inflammation and is found at high levels in patients with the diseases that Erelzi is used to treat.
Slovenian: Ta snov sodeluje pri nastanku vnetij in je v visokih koncentracijah prisotna pri bolnikih z boleznimi, za katerih zdravljenje se uporablja zdravilo Erelzi.
English: For more information about treatment with Erelzi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Erelzi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Why is Erelzi approved?
Slovenian: Zakaj je bilo zdravilo Erelzi odobreno?
English: For practical information about using Erelzi, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Erelzi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Erelzi is available as prefilled syringes and pens containing a solution for injection.
Slovenian: Zdravilo Erelzi je na voljo v obliki napolnjenih injekcijskih brizg in peresnikov, ki vsebujejo raztopino za injiciranje.
English: • certain forms of juvenile idiopathic arthritis (diseases causing inflammation in the joints, with first appearance in childhood or adolescence);
Slovenian: • določenih oblik juvenilnega idiopatskega artritisa (bolezni, ki povzročajo vnetje sklepov in se prvič pojavijo v otroštvu ali adolescenci);
English: For detailed information on the use of Erelzi in all conditions, see the summary of product characteristics (also part of the EPAR).
Slovenian: Več informacij o uporabi zdravila Erelzi za vsa obolenja je na voljo v povzetku glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Therefore, the CHMP's view was that, as for Enbrel, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Enbrel odtehtajo znana tveganja.
English: Erelzi contains the active substance etanercept and is a ‘biosimilar medicine'.
Slovenian: Zdravilo Erelzi vsebuje zdravilno učinkovino etanercept in je „podobno biološko zdravilo“.
English: For the full list of all side effects reported with Erelzi, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Erelzi, glejte navodilo za uporabo.
English: The reference medicine for Erelzi is Enbrel.
Slovenian: Referenčno zdravilo za zdravilo Erelzi je zdravilo Enbrel.
English: The injection is given under the skin and the patient or their carer can give the injection if they have been trained appropriately.
Slovenian: Bolniki in njihovi negovalci injekcijo lahko dajejo sami, če so bili ustrezno usposobljeni.
English: • rheumatoid arthritis (a disease causing inflammation of the joints) in adults, used with another medicine, methotrexate, or alone;
Slovenian: • revmatoidnega artritisa (bolezni, ki povzroča vnetje sklepov) pri odraslih, pri čemer se uporablja skupaj z metotreksatom ali samostojno;
English: Laboratory studies comparing Erelzi with Enbrel have shown that the active substance in Erelzi is highly similar to that in Enbrel in terms of structure, purity and biological activity.
Slovenian: Laboratorijske študije, v katerih so zdravilo Erelzi primerjali z zdravilom Enbrel, so pokazale, da je zdravilo Erelzi po zgradbi, čistosti in biološkem delovanju zelo podobno zdravilu Enbrel.
English: • psoriatic arthritis (psoriasis with inflammation of the joints) in adults and adolescents;
Slovenian: • psoriatičnega artritisa (psoriaze z vnetjem sklepov) pri odraslih in mladostnikih;
English: • plaque psoriasis (a disease causing red, scaly patches on the skin) in adults and children;
Slovenian: • psoriaze v plakih (bolezni, ki povzroča rdeče luskaste zaplate na koži) pri odraslih in otrocih;
English: • axial spondyloarthritis (a chronic inflammatory disease of the spine) in adults when there are no abnormalities seen on x-ray.
Slovenian: • aksialnega spondiloartritisa (kronične vnetne bolezni hrbtenice) pri odraslih, kadar bolezenske spremembe na rentgenskih slikah niso vidne.
English: How is Erelzi used?
Slovenian: Kako se zdravilo Erelzi uporablja?
English: • ankylosing spondylitis (a disease causing inflammation of the joints of the spine) in adults;
Slovenian: • ankilozirajočega spondilitisa (bolezni, ki povzroča vnetje sklepov v hrbtenici) pri odraslih;
English: How does Erelzi work?
Slovenian: Kako zdravilo Erelzi deluje?
English: Erelzi was also shown to be as effective as Enbrel in one main study involving 531 adults with plaque psoriasis.
Slovenian: V glavni študiji, ki je vključevala 531 odraslih s psoriazo v plakih, so dokazali tudi, da je zdravilo Erelzi enako učinkovito kot zdravilo Enbrel.
English: Studies were carried out to show that Erelzi produces similar levels of the active substance in the body to Enbrel.
Slovenian: Opravljena je bila študija, ki je pokazala, da je količina zdravilne učinkovine v telesu pri zdravilu Erelzi podobna kot pri zdravilu Enbrel.
English: This summary was last updated in October 2016.
Slovenian: Povzetek je bil nazadnje posodobljen oktobra 2016.
English: This effect increases with higher doses and/or repeated treatments.
Slovenian: Ta učinek se povečuje s povečevanjem odmerka in/ali ponovljenimi zdravljenji.
English: People must not eat, drink or smoke while using the medicine.
Slovenian: Ljudje med uporabo zdravila ne smejo jesti, piti ali kaditi.
English: Heavily contaminated clothes should be changed immediately and washed before re-use.
Slovenian: Močno kontaminirana oblačila je treba takoj preobleči in jih pred ponovno uporabo oprati.
English: In each location 20 test groups were compared to 12 control groups treated with flumethrin (another medicine effective against parasites).
Slovenian: Na vsaki lokaciji so 20 testnih skupin primerjali z 12 kontrolnimi skupinami, zdravljenimi s flumetrinom (drugim zdravilom, ki deluje proti parazitom).
English: The full EPAR for VarroMed 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 VarroMed je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The dose is adjusted to the colony size.
Slovenian: Odmerek se prilagodi velikosti kolonije.
English: Treatment should be given in the late afternoon or evening when bees are less likely to be flying.
Slovenian: Zdravljenje je treba izvajati pozno popoldne ali zvečer, ko čebele manj pogosto izletajo.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that VarroMed's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da so koristi zdravila VarroMed večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is a summary of the European public assessment report (EPAR) for VarroMed.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo VarroMed.
English: The average effectiveness of VarroMed to kill mites (measured by the number of dead mites found at the bottom of the hive) was 88% for winter, 92% for spring and 85% for autumn treatments.
Slovenian: Povprečna učinkovitost zdravila VarroMed pri uničevanju varoj (merjena s številom poginulih varoj, najdenih na dnu panja) je bila pri zimskem zdravljenju 88 %, pri spomladanskem 92 % in pri jesenskem 85 %.
English: The effectiveness of VarroMed was investigated in field studies in European countries with different climates, both continental climate and Mediterranean climate.
Slovenian: Učinkovitost zdravila VarroMed so preučevali v terenskih študijah v evropskih državah z različnimi podnebji, celinskim in sredozemskim.
English: The most common side effect with VarroMed (which may affect more than 1 in 10 bee colonies) is an increased number of deaths of worker bees.
Slovenian: Najpogostejši neželeni učinek zdravila VarroMed (ki lahko prizadene več kot 1 od 10 čebeljih kolonij) je povečano število smrti čebel delavk.
English: Varroa mite and honey bee mortality were monitored twice weekly for 4 weeks during treatment until one week after treatment.
Slovenian: Umrljivost varoj in medonosnih čebel so spremljali dvakrat tedensko v obdobju 4 tednov med zdravljenjem in en teden po zdravljenju.
English: People should avoid contact with the skin, eyes and mucous membranes (moist body surfaces such as lining of mouth).
Slovenian: Ljudje se morajo izogibati stiku s kožo, očmi in sluznicami (vlažnimi telesnimi površinami, kot je ustna sluznica).
English: The groups were treated during winter (in the absence of brood), spring and autumn (in the presence of brood) and included colonies of different sizes (5,000 to 30,000 bees) and different infestation levels.
Slovenian: Skupine so zdravili pozimi (v odsotnosti zalege), spomladi in jeseni (v prisotnosti zalege), vključevale pa so kolonije različnih velikosti (od 5 000 do 30 000 čebel) in različne stopnje infestacije.
English: VarroMed is intended to be used as part of an integrated varroa control programme, which includes other techniques.
Slovenian: Zdravilo VarroMed je namenjeno uporabi kot del integriranega programa zatiranja varoje, ki vključuje še druge tehnike.
English: In case of accidental spillage onto skin, the affected areas should be washed immediately with running water.
Slovenian: V primeru nenamernega razlitja po koži je treba prizadeta območja nemudoma izprati s tekočo vodo.
English: A significant mite infestation can lead to the collapse of a honey bee colony.
Slovenian: Znatna infestacija z varojo lahko privede do kolapsa kolonije medonosnih čebel.
English: People who are hypersensitive (allergic) to formic acid or oxalic acid should give the medicine with caution.
Slovenian: Ljudje, ki so preobčutljivi za (alergični na) mravljično kislino ali oksalno kislino, morajo zdravilo dajati previdno.
English: It can be used either as a single-dose treatment during the broodless period (winter treatment), or in the presence of brood (spring or autumn treatment) which will usually require repeated treatments.
Slovenian: Uporablja se lahko kot zdravljenje z enkratnim odmerkom v času brez zalege (zimsko zdravljenje) ali v prisotnosti zalege (spomladansko ali jesensko zdravljenje), kar običajno zahteva večkratno zdravljenje.
English: It is not intended to provide practical advice on how to use VarroMed.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: In case of accidental spillage into the eye(s) flush the eye(s) immediately with clear running water for 10 minutes.
Slovenian: V primeru nenamernega razlitja v oči je treba takoj 10 minut izpirati oči s čisto tekočo vodo.
English: What is VarroMed and what is it used for?
Slovenian: Kaj je zdravilo VarroMed in za kaj se uporablja?
English: Why is VarroMed approved?
Slovenian: Zakaj je bilo zdravilo VarroMed odobreno?
English: VarroMed is irritating to the skin and eyes.
Slovenian: Zdravilo VarroMed je dražilno za kožo in oči.
English: VarroMed oxalic acid dihydrate / formic acid
Slovenian: VarroMed oksalna kislina dihidrat/mravljična kislina
English: Children should be kept from contact with VarroMed.
Slovenian: Otroci ne smejo priti v stik z zdravilom VarroMed.
English: What benefits of VarroMed have been shown in studies?
Slovenian: Kakšne koristi je zdravilo VarroMed izkazalo v študijah?
English: Protective clothing, acid-resistant gloves and glasses should be worn during treatment.
Slovenian: Med dajanjem zdravila je treba nositi zaščitno obleko in rokavice ter očala, odporne proti kislini.
English: What are the risks associated with VarroMed?
Slovenian: Kakšna tveganja so povezana z zdravilom VarroMed?
English: VarroMed is available as a bee-hive dispersion (a liquid for use inside the bee hive) and can be obtained without a prescription.
Slovenian: Zdravilo VarroMed je na voljo kot disperzija za čebeljo družino (tekočina za uporabo znotraj panja) in se izdaja brez recepta.
English: Varroosis is a disease of honey bees caused by infestation with a parasite called Varroa mite (Varroa destructor).
Slovenian: Varoza je bolezen medonosnih čebel, ki jo povzroča infestacija s parazitom, imenovanim varoja (Varroa destructor).
English: How both oxalic acid and formic acid work is not well understood.
Slovenian: Način delovanja oksalne kisline in mravljične kisline ni dobro znan.
English: Other information about VarroMed?
Slovenian: Druge informacije o zdravilu VarroMed
English: The withdrawal period for honey from honey bees treated with VarroMed for is ‘zero' days, which means there is no mandatory waiting time.
Slovenian: Karenca za med medonosnih čebel, zdravljenih z zdravilom VarroMed, je nič dni, kar pomeni, da ni obvezne čakalne dobe.
English: Formic acid is thought to kill Varroa mites by blocking the ability of their cells to generate energy; it may also act on mite nerve cells.
Slovenian: Predvideva se, da je učinek oksalne kisline na varoje posledica kislosti zdravila, mravljična kislina pa naj bi varoje uničevala z zaviranjem zmožnosti njihovih celic za presnovo energije, morda pa deluje tudi na živčne celice varoj.
English: For practical information about using VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila VarroMed naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: For more information about treatment with VarroMed, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom VarroMed naj lastniki ali skrbniki živali preberejo navodilo za uporabo ali se posvetujejo z veterinarjem ali farmacevtom.
English: The Varroa mite feeds on the haemolymph (blood) of adult bees and on brood (developing stages of the honey bee) resulting in damage and / or death of bees; the mite can also help spread of viruses and bacteria.
Slovenian: Varoja se hrani s hemolimfo (krvjo) odraslih čebel in z zalego (razvojnimi stopnjami medonosnih čebel), kar povzroči poškodbe in/ali smrt čebel.
English: VarroMed is a medicine used to treat varroosis in honey bee colonies.
Slovenian: VarroMed je zdravilo, ki se uporablja za zdravljenje varoze v kolonijah medonosnih čebel.
English: VarroMed contains the active substances oxalic acid dihydrate and formic acid.
Slovenian: Zdravilo VarroMed vsebuje zdravilni učinkovini oksalno kislino dihidrat in mravljično kislino.
English: VarroMed can be used on colonies with and without brood.
Slovenian: Zdravilo VarroMed se lahko uporablja pri kolonijah z zalego ali brez nje.
English: The withdrawal period is the time required after administration of a medicine before honey may be used for human consumption.
Slovenian: Karenca je čas, ki mora preteči po dajanju zdravila, preden se lahko med uporabi za prehrano ljudi.
English: The European Commission granted a marketing authorisation valid throughout the EU for VarroMed on 2 February 2017.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom VarroMed, veljavno po vsej Evropski uniji, izdala
English: How is VarroMed used?
Slovenian: Kako se zdravilo VarroMed uporablja?
English: VarroMed must not be given during nectar flow, when honey is produced by bees, and should not be used when honey chambers are attached to the hive.
Slovenian: Zdravilo VarroMed se ne sme uporabljati med čebeljo pašo, ko čebele proizvajajo med, ali ko so na panj pritrjena medišča.
English: How does VarroMed work?
Slovenian: Kako zdravilo VarroMed deluje?
English: VarroMed is trickled onto bees in the brood chamber of the hive.
Slovenian: Zdravilo VarroMed se nakaplja na čebele v presledkih plodišča.
English: 10 ml (3.5 mg/ml) 2 vials
Slovenian: 10 ml (3,5 mg/ml) 2 viali
English: 10 ml (3.5 mg/ml) 5 (5 x 1) vials (multipack)
Slovenian: 10 ml (3,5 mg/ml) 5 (5 x 1) vial (večje pakiranje)
English: 10 ml (3.5 mg/ml) 1 vial
Slovenian: 10 ml (3,5 mg/ml) 1 viala
English: The referral procedure was initiated on 19 May 2011.
Slovenian: Napotitveni postopek se je začel 19. maja 2011.
English: PWS is a genetic disorder.
Slovenian: PWS je genetska motnja.
English: Puberty development is also delayed and often incomplete.
Slovenian: Tudi razvoj v puberteti je zakasnjen in pogosto nepopoln.
English: The latter two may lead to childhood obesity.
Slovenian: Slednji dve lahko vodita v otroško debelost.
English: There were no deaths reported.
Slovenian: O smrti niso poročali.
English: Thus body composition would have been a key endpoint.
Slovenian: Posledično bi morala biti sestava telesa ključna končna točka.
English: The diagnosis is based on a genetic test and on clinical findings.
Slovenian: Diagnoza temelji na genetskem testu in kliničnih ugotovitvah.
English: All children were Caucasian.
Slovenian: Vsi otroci so bili belci.
English: The safety profile of somatropin-containing products is well known.
Slovenian: Varnostni profil zdravil, ki vsebujejo somatropin, je dobro znan.
English: Scientific conclusions and grounds for refusal presented by the EMA
Slovenian: Znanstveni zaključki in podlaga za zavrnitev, ki jih je predložila Evropska agencija za zdravila
English: However, the practice of data collection on body composition differed across the three centers.
Slovenian: Vendar pa se je praksa zbiranja podatkov o sestavi telesa med tremi centri razlikovala.
English: Children with PWS often have concomitant growth hormone deficiency (GHD) (40 to 100%, depending on the provocation test used).
Slovenian: Otroci s PWS imajo pogosto sočasno pomanjkanje rastnega hormona (PRH) (40 do 100 %, odvisno od uporabljenega provokacijskega testa).
English: Most females with PWS suffer from amenorrhea.
Slovenian: Večina žensk s PWS trpi za amenorejo.
English: Overall, the retrospective data collected were insufficient and of poor quality.
Slovenian: Na splošno so bili zbrani retrospektivni podatki nezadostni in slabe kakovosti.
English: One center did not collect body composition data at all and from the other two centers data were only available in 11 children.
Slovenian: En center podatkov o sestavi telesa sploh ni zbiral, podatki drugih dveh centrov pa so bili na voljo le za 11 otrok.
English: Norditropin was approved in accordance with Article 8(3) of Directive 2001/83/EC.
Slovenian: Zdravilo Norditropin je bilo odobreno v skladu s členom 8(3) Direktive 2001/83/ES.
English: • The Committee considered the notification of the referral triggered by Denmark under Article 13 of Commission Regulation (EC) No 1234/2008.
Slovenian: • Odbor je preučil obvestilo o napotitvenem postopku, ki ga je sprožila Danska v skladu s členuom13 Uredbe Komisije (ES) št. 1234/2008;
English: Another point of concern was the fact that based on the wording of the inclusion criteria it was doubtful whether all patients have been included in the study from the respective centres.
Slovenian: Naslednji zadržek je povzročilo dejstvo, da na podlagi besedila vključitvenih kriterijev ni bilo jasno, ali so bili v študijo vključeni vsi bolniki iz zadevnih centrov.
English: “Improvement of growth and body composition in children with Prader-Willi syndrome (PWS) confirmed by appropriate genetic testing”.
Slovenian: „Izboljšanje rasti in sestave telesa pri otrocih s Prader-Willijevim sindromom (PWS), potrjenim z ustreznim genetskim testiranjem“.
English: Even children who had only received one dose of Norditropin could be included.
Slovenian: Vključiti je bilo mogoče celo otroke, ki so prejeli le en odmerek zdravila Norditropin.
English: The efficacy of Norditropin on key secondary endpoints such as body composition and height velocity is unknown.
Slovenian: Učinkovitost zdravila Norditropin pri ključnih sekundarnih končnih točkah, kot sta sestava telesa in hitrost rasti, ni znana.
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 20 April 2011, Denmark triggered a referral under Article 13 of Commission Regulation EC No 1234/2008.
Slovenian: Ker referenčna in zadevne države članice niso dosegle sporazuma v zvezi s spremembo, je Danska 20. aprila 2011 sprožila napotitveni postopek v skladu s členom 13 Uredbe Komisije ES št.
English: Grounds for refusal Whereas
Slovenian: Podlaga za zavrnitev Ob upoštevanju naslednjega:
English: Safety was assessed by adverse events, HbA1c, IGF-I, haematology, TSH, total T3 and T4, free T3 and T4.
Slovenian: Varnost so ocenili z neželenimi dogodki, HbA1c, IGF-I, hematologijo, TSH, celokupnima T3 in T4, prostima T3 in T4.
English: In the GHLiquid-1961 study forty-one (41) children in Europe with genetically documented PWS were enrolled (19 girls and 22 boys).
Slovenian: V študijo GHLiquid-1961 je bilo vključenih enainštirideset (41) otrok iz Evrope z genetsko dokumentiranim PWS (19 deklic in 22 dečkov).
English: Height velocity would also have been a valuable endpoint, however no data are available.
Slovenian: Tudi hitrost rasti bi bila koristna končna točka, a v zvezi z njo ni razpoložljivih podatkov.
English: The incidence of PWS is 1 in about 10,000 to 29,000 live births.
Slovenian: Pojavi se pri enem od približno 10 000 do 29 000 živorojenih otrok.
English: Data from 11 out of 41 children were too scarce to draw any conclusion on this endpoint.
Slovenian: Podatki za 11 od 41 otrok so bili prepičli, da bi lahko na njihovi podlagi sklepali na to končno točko.
English: • The Committee is of the opinion that the data submitted by the MAH in particular to support efficacy are considered limited since they are derived from a retrospective, observational, noncomparative study.
Slovenian: • Odbor meni, da se podatki, ki jih je imetnik dovoljenja za promet predložil posebej za podporo učinkovitosti, štejejo za omejene, saj so izpeljani iz retrospektivne, opazovalne, neprimerjalne študije.
English: In order to demonstrate efficacy and safety in the applied indication, the application dossier was based on the study GHLiquid-1961.
Slovenian: Kot dokazilo za učinkovitost in varnost za vloženo indikacijo je vloga za pridobitev dovoljenja za promet temeljila na študiji GHLiquid-1961.
English: Thirty-three (33.26%) adverse events in 17 (41.5%) children were assessed as probably/possibly related to Norditropin treatment.
Slovenian: Triintrideset (33,26 %) neželenih dogodkov pri 17 (41,5 %) otrocih je bilo ocenjenih kot verjetno/mogoče povezanih z zdravljenjem z zdravilom Norditropin.