natgillin/translations-raw huggingface dataset:
Significant recommendations for approval in 2010 Public-health benefits of medicines for human use recommended for approval in 2010
Koristi zdravil za uporabo v humani medicini, priporočenih za odobritev v letu 2010, za javno zdravje
Initial evaluation covers activities relating to the processing of marketing authorisation applications for medicines, from pre-submission discussion with future applicants, through evaluation by the CHMP, to the granting of a marketing authorisation by the European Commission.
Začetna ocena zajema dejavnosti v zvezi z obdelavo vlog za izdajo dovoljenja za promet za zdravila, od razprave s prihodnjimi vlagatelji pred predložitvijo vloge, prek presoje, ki jo opravi Odbor za zdravila za uporabo v humani medicini (CHMP), do tega, da Evropska komisija izda dovoljenje za promet z zdravilom .
• A designated orphan medicine intended for the treatment of Gaucher disease.
• zdravilo s statusom zdravila sirote, namenjeno zdravljenju gaucherjeve bolezni.
Figure 16.
Graf 16.
Applications for maximum residue limits (MRLs)
Vloge za mejne vrednosti ostankov
Paediatric-investigation-plan (PIP) applications
Vloge za načrt pediatričnih raziskav
Figure 5.
Graf 5.
• A nasally administered influenza vaccine intended for the prophylaxis of influenza in children.
• cepivo proti gripi, ki se daje skozi nos in je namenjeno profilaksi gripe pri otrocih;
Referrals started Referrals finalised
Začete napotitve Dokončane napotitve
Figure 9.
Graf 9.
• EMA and Massachusetts Institute of Technology launch a joint project on regulatory science.
začneta izvajati skupni projekt o regulativni znanosti.
Requests received Requests finalised
Dokončani zahtevki
Figure 17.
Graf 17.
Figure 15.
Graf 15.
• Joint EMA and European Commission workshop starts reflection process on the way forward for the
• Na skupni delavnici agencije EMA in Evropske komisije se začne razmislek o prihodnji usmeritvi agencije in evropske regulativne mreže.
Veterinary medicines
Zdravila za uporabo v veterinarski medicini
Figure 12.
Graf 12.
Figure 14.
Graf 14.
Figure 10.
Graf 10.
Figure 7.
Graf 7.
Figure 11.
Graf 11.
Post-authorisation activities relate to variations of marketing authorisations, including extensions of marketing authorisations and transfers of marketing authorisations.
Dejavnosti po izdaji dovoljenja za promet z zdravilom Dejavnosti po izdaji dovoljenja za promet z zdravilom se nanašajo na spremembe dovoljenj za promet z zdravilom, vključno z razširitvami dovoljenj za promet z zdravilom in prenosi dovoljenj za promet z zdravilom.
EEA and non-EEA adverse-drug-reaction reports received
Prejeta poročila o neželenih učinkih zdravil iz EGP in izven EGP
Figure 13.
Graf 13.
Referral procedures
Postopki napotitve
PIP applications, including waivers and deferrals Clinical indications in PIP applications Full compliance-check applications
Klinične indikacije v vlogah za PIP
Post-authorisation activities relate to variations, extensions of marketing authorisations and transfers of marketing authorisations.
Dejavnosti po izdaji dovoljenja za promet z zdravilom Dejavnosti po izdaji dovoljenja za promet z zdravilom se nanašajo na spremembe, razširitve dovoljenj za promet z zdravilom in prenose dovoljenj za promet z zdravilom.
• EMA and European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP)
• Agencija EMA in Evropska mreža centrov za farmakoepidemiologijo in farmakovigilanco (ENCePP) začneta izvajati program „študij ENCePP“, ki so zajamčeno pregledne in najsodobnejše študije o varnosti.
Figure 6.
Graf 6.
• EMA recommends suspension of Avandia, Avandamet and Avaglim over cardiovascular concerns.
• Agencija EMA izda priporočilo o umiku dovoljenja za promet za zdravila Avandia, Avandamet in
Human medicines
Zdravila za uporabo v humani medicini
Orphan medicines designation
Dodelitev statusa zdravil sirot
Fourth quarter: October-December 2010
Zadnje četrtletje: oktober-december 2010
Post-authorisation activities
Prejete vloge za dejavnosti po izdaji dovoljenja za promet z zdravilom
New medicinal products Generic medicinal products
Generična zdravila
Herbal medicines
Zdravila rastlinskega izvora
Post-authorisation applications received
Prejeti zahtevki
The final opinion was converted into a Decision by the European Commission on 6 September 2013.
Končno mnenje je bilo 6. septembra 2013 spremenjeno v sklep Evropske komisije.
The referral started on 12 April 2012.
Postopek se je začel 12. aprila 2012.
The Committee appointed Mr G. J. Schefferlie as rapporteur and Dr B. Kolar as co-rapporteur.
Za poročevalca in soporočevalca sta bila imenovana g. G. J. Schefferlie oziroma dr. B. Kolar.
Written explanations were provided by the applicants and marketing authorisation holders on 17 September 2012, 3 January 2013 and 9 May 2013.
Imetniki dovoljenja za promet z zdravilom so 17. septembra 2012, 3. januarja 2012 in 9. maja 2013 predložili pisna pojasnila.
Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Obe spojini imata širok spekter antiparazitskega delovanja in tvorita podobno paralizo pri glistah in parazitskih členonožcih.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s spremembami povzetka glavnih značilnosti zdravila, označevanja in navodil za uporabo v Prilogi III.
Based on the evaluation of the currently available data, the CVMP considered that overall benefit-risk profile for these products remains positive subject to changes of the product information related to harmonisation of the withdrawal periods, inclusion of warning sentences concerning the use in dairy animals and environmental risk mitigation measures.
Na podlagi ocene trenutno razpoložljivih podatkov je odbor CVMP menil, da splošni profil razmerja med tveganji in koristmi teh zdravil ostaja pozitiven, če se spremenijo informacije o zdravilu, tako da se uskladijo karence ter vključijo opozorilni stavki, povezani z uporabo pri živalih za proizvodnjo mleka, in ukrepi za zmanjševanje tveganj za okolje.
The CVMP was requested to give its opinion regarding the adequacy and consumer safety of the withdrawal periods for all injectable and pour-on veterinary medicinal products containing doramectin and whether there is a risk to the environment and the need for risk mitigation measures following use of the products concerned.
Odbor CVMP so prosili, da poda svoje mnenje o primernosti in varstvu potrošnikov v zvezi s karencami za vsa zdravila za uporabo v veterinarski medicini za injiciranje ali kožni poliv, ki vsebujejo doramektin, ter o tem, ali sta prisotna tveganje za okolje in potreba po ukrepih za zmanjševanje tveganj po uporabi zadevnih zdravil.
On 22 March 2012, the Netherlands presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Nizozemska je 22. marca 2012 Evropski agenciji za zdravila predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za vsa zdravila za uporabo v veterinarski medicini za injiciranje ali kožni poliv, ki vsebujejo doramektin in so namenjena uporabi pri vrstah sesalcev za proizvodnjo živil.
Therefore, the Committee adopted a positive opinion on 12 June 2013, recommending variations to the terms of the marketing authorisations for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species.
Odbor je zato 12. junija 2013 izdal pozitivno mnenje, ki priporoča spremembe pogojev dovoljenj za promet z vsemi zdravili za uporabo v veterinarski medicini za injiciranje ali kožni poliv, ki vsebujejo doramektin, in so namenjena za uporabo pri vrstah sesalcev za proizvodnjo živil.
Opinion following an Article 351 referral for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species
za vsa zdravila za uporabo v veterinarski medicini za injiciranje ali kožni poliv, ki vsebujejo doramektin in so namenjena uporabi pri vrstah sesalcev za proizvodnjo živil
Opinion following an Article 350F referral for all injectable and pour-on veterinary medicinal products containing doramectin that are intended for use in mammalian food producing species
Mnenje o napotitvenem postopku v skladu s členom 350F za vsa zdravila za uporabo v veterinarski medicini za injiciranje ali kožni poliv, ki vsebujejo doramektin in so namenjena uporabi pri vrstah sesalcev za proizvodnjo živil EMA/372468/2013
• Then slowly count to 5.
• Potem počasi preštejte do 5.
• You may hear a second click.
• Morda boste slišali še drugi klik.
Note: You will feel some resistance.
Opomba: Čutili boste nekaj upora.
Date of first authorisation: 26 September 2017
Datum prve odobritve: 26. september 2017
Note: You may see an air bubble; this is normal.
Opomba: Morda boste videli mehurček zraka; to je normalno.
The injection can take up to 20 seconds.
Injiciranje lahko traja do 20 sekund.
These effects were sustained throughout treatment.
Ti učinki so se ohranili med celotnim zdravljenjem.
A: Prepare A1.
A: Priprava A1.
However, there were only 61 patients over 65 years of age included in this analysis.
Vendar pa je bilo v to analizo vključenih le 61 bolnikov, starih več kot 65 let.
Maintenance and Durability of Response (SOLO CONTINUE study)
Vzdrževanje in trajanje odziva (študija SOLO CONTINUE)
Subsequent Doses (every other week)
Nadaljnji odmerki (vsak drugi teden)
Do not recycle the container.
Vsebnika ne reciklirajte.
EXP Date of removal from the refrigerator: / / /
EXP Datum odstranitve iz hladilnika: / / /
Efficacy and safety in this age group were similar to the overall study population.
Učinkovitost in varnost v tej starostni skupini sta bili podobni kot v celotni študijski populaciji.
less than 60 kg
manj kot 60 kg
• Check that the entire window has turned to yellow.
• Preverite, da je celotno okence postalo rumeno.
Recommended injection sites are:
Priporočena mesta injiciranja so:
Most patients with conjunctivitis recovered or were recovering during the treatment period.
Večina bolnikov s konjunktivitisom je že okrevala ali je trenutno okrevala med obdobjem zdravljenja.
For information on live vaccines see section 4.4.
Za več informacij o živih cepivih glejte poglavje 4.4.
60 kg or more
60 kg ali več
Component of a multipack, can't be sold separately.
Sestavni del skupnega pakiranja, ki se ne sme prodajati ločeno.
Initial Dose
Začetni odmerek
• The window will start to turn yellow.
• Okence bo začelo postajati rumeno.
Look at the label:
Poglejte nalepko:
A5: Wait 30 minutes
A5: Počakajte 30 minut
The effects of this medicine in pregnant women are not known; therefore it is preferable to avoid the use of Dupixent in pregnancy unless your doctor advises to use it.
Učinki tega zdravila pri nosečnicah niso znani, zato se je uporabi zdravila Dupixent med obdobjem nosečnosti bolje izogniti, razen če vam zdravnik svetuje, da ga uporabite.
These markers were near maximal suppression after 2 weeks of treatment, except for IgE which declined more slowly.
Označevalci so bili skoraj maksimalno suprimirani po 2 tednih zdravljenja, razen IgE, ki so upadali počasneje.
Steroid reductions should be accomplished gradually (see section 4.4).
Steroide je treba zmanjševati postopoma (glejte poglavje 4.4).
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in serijsko številko uporabljenega zdravila.
If you live in a region where these infections are common or if you are travelling to such a region check with your doctor.
Če živite na območju, kjer so takšne okužbe pogoste, ali če potujete na takšno območje, se posvetujte z zdravnikom.
The needle is inside.
V njem je igla.
• 1 alcohol wipe*
• 1 alkoholni listič*
- if you are allergic to dupilumab or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na dupilumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
These medicines (especially ones called corticosteroids) must be stopped gradually, under the direct supervision of your doctor and dependent on your response to Dupixent.
Ta zdravila (zlasti kortikosteroidna zdravila) je treba opustiti postopoma, pod neposrednim nadzorstvom zdravnika in odvisno od vašega odziva na zdravilo Dupixent.
Dupilumab should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Dupilumab naj bi med nosečnostjo uporabljali le, če možna korist upravičuje možno tveganje za plod.
• cold sores (on lips and skin)
• herpes (na ustnicah in koži)
• Check that you have the correct product and dose.
• Preverite, da imate pravo zdravilo in pravi odmerek.
An enhanced pre- and post-natal developmental study revealed no adverse effects in maternal animals or their offspring up to 6 months post-partum/post-birth.
Razširjena študija pred- in poporodnega razvoja ni pokazala neželenih učinkov pri samicah materah ali njihovem potomstvu do 6 mesecev po porodu/po rojstvu.
Dupilumab is intended for long-term treatment.
Dupilumab je namenjen za dolgotrajno zdravljenje.
Push the plunger rod down slowly and steadily as far as it will go until the syringe is empty.
Bat počasi in enakomerno potisnite, kolikor daleč gre, dokler ni brizga prazna.
In addition, Dupixent helps improve your sleep disturbance and overall quality of life.
Poleg tega zdravilo Dupixent pomaga izboljšati motnje spanja in celotno kakovost življenja.
The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient's level of asthma control.
Potrebo po nadaljnjem zdravljenju je treba oceniti vsaj enkrat na leto na podlagi zdravnikove ocene stopnje urejenosti bolnikove astme.
Similar results were observed in VENTURE.
Podobne rezultate so opažali v študiji VENTURE.
Atopic Medical History % Overall (AD %, NP %, AR %)
Zdravstvena anamneza atopije, % v celoti (AD %, NP %, AR %)
• fainting, dizziness, feeling lightheaded (low blood pressure)
• omedlevica, omotica, občutek vrtoglavosti (nizek krvni pritisk)
- if you have recently had or are due to have a vaccination.
- če ste nedavno opravili kakšno cepljenje ali imate predvideno kakšno cepljenje.
Clinical efficacy and safety in asthma
Klinična učinkovitost in varnost pri astmi
How much Dupixent is given and for how long
Koliko zdravila Dupixent se daje in kako dolgo
Thereafter, resume dosing at the regular scheduled time.
Potem je treba zdravilo naprej uporabljati ob redno predvidenem času.
Efficacy data from this study suggests that clinical benefit provided at week 16 was sustained through week 52.
Podatki o učinkovitosti iz te študije kažejo, da se je klinična korist, dosežena 16. teden, ohranila do 52.
Your doctor will decide how much Dupixent you need and for how long.
Zdravnik bo presodil, koliko zdravila Dupixent potrebujete in koliko časa ga morate uporabljati.
Oral Corticosteroid Reduction Study (VENTURE)
Študija zmanjševanja peroralnih kortikosteroidov (VENTURE)
Patients with known helminth infections were excluded from participation in clinical studies.
Bolniki, ki so imeli znano okužbo s helminti, niso bili vključeni v klinične študije.
Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Nekaterim bolnikom, ki se uvodoma odzovejo le delno, se lahko stanje pozneje izboljša, če se zdravljenje nadaljuje več kot 16 tednov.
Name and address of the manufacturer(s) of the biological active substance(s) REGENERON PHARMACEUTICALS INC.
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin) REGENERON PHARMACEUTICALS INC.
If a dose is missed, administer the dose as soon as possible.
V primeru pozabljenega odmerka je treba odmerek uporabiti čim prej.
Press down
Pritisnite dol
Immune responses to vaccination were assessed in a study in which patients with atopic dermatitis were treated once weekly for 16 weeks with 300 mg of dupilumab.
Imunske odzive na cepljenje so ocenili v študiji, v kateri so bolnike z atopijskim dermatitisom 16 tednov enkrat na teden zdravili s 300 mg dupilumaba.
The medium ICS dose was defined as equal to 500 mcg fluticasone or equivalent per day.
Srednji odmerek IKS je bil opredeljen kot enak 500 mcg flutikazona ali enakovredno na dan.
• eye infection
• okužba oči
If the window does not turn completely yellow, remove the pen and call your healthcare provider.
Če okence ne postane povsem rumeno, peresnik odstranite in se obrnite na svojega zdravnika.
Look at the label
Poglejte nalepko
Exacerbations per Year
Poslabšanja na leto
Therefore, patients receiving dupilumab may receive concurrent inactivated or non-live vaccinations.
Bolniki, ki prejemajo dupilumab, torej sočasno lahko dobijo inaktivirana ali neživa cepiva.
The improvement in pruritus NRS occurred in conjunction with the improvement of objective signs of atopic dermatitis.
Izboljšanje ocene srbenja NRS se je pojavilo skupaj z izboljšanjem objektivnih znakov atopijskega dermatitisa.
Such signs are listed under “Serious side effects” in section 4.
Ti znaki so navedeni v 4. poglavju pod naslovom "Resni neželeni učinki".
• Do not inject through clothes.
• Ne injicirajte skozi oblačila.
The mutagenic potential of dupilumab has not been evaluated; however monoclonal antibodies are not expected to alter DNA or chromosomes.
Mutagenega potenciala dupilumaba niso ocenili, vendar ni pričakovati, da bi monoklonska protitelesa spremenila DNA ali kromosome.
All patients were on oral corticosteroids for at least 6 months prior to the study initiation.
Vsi bolniki so prejemali peroralne kortikosteroide najmanj 6 mesecev pred začetkom študije.
• swelling of the face, mouth, and tongue
• otekanje obraza, ust in jezika
16-Week Monotherapy Studies (SOLO 1 and SOLO 2)
16-tedenski študiji monoterapije (SOLO 1 in SOLO 2)
It is not known whether this is caused by Dupixent.
Ni znano, ali to povzroča zdravilo Dupixent.
If dupilumab treatment interruption becomes necessary, patients can still be successfully re-treated.
Če je zdravljenje z dupilumabom treba prekiniti, je bolnike kljub temu mogoče uspešno ponovno zdraviti.
Step 4: Wait 45 minutes
4. korak: Počakajte 45 minut
QUEST was a 52-week confirmatory study which included 1,902 patients (12 years of age and older).
Študija QUEST je bila 52-tedenska potrditvena študija, ki je zajela 1.902 bolnikov (v starosti 12 let ali več).
These events usually, but not always, may be associated with the reduction of oral corticosteroid therapy.
Ti dogodki so po navadi, ne pa vedno, povezani z zmanjšanjem peroralnih kortikosteroidov.
Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity with dupilumab.
Tako kot pri vseh terapevtskih beljakovinah tudi pri dupilumabu obstaja možnost imunogenosti.
Percent Reduction
Odstotek zmanjšanja
Week 52 (FAS Week 52)b
52. teden (FAS 52. teden)b
There are limited amount of data from the use of dupilumab in pregnant women.
Podatkov o uporabi dupilumaba pri nosečnicah je malo.
IL-4 and IL-13 are major drivers of human type 2 inflammatory disease, such as atopic dermatitis and asthma.
IL-4 in IL-13 sta pri človeku glavna gonilna dejavnika vnetne bolezni tipa 2, kakršni sta atopijski dermatitis in astma.
A total of 305 patients were treated with dupilumab for at least 1 year.
Skupno 305 bolnikov so zdravili z dupilumabom vsaj 1 leto.
What you need to know before you use Dupixent 3.
Kaj morate vedeti, preden boste uporabili zdravilo Dupixent 3.
Conjunctivitis and related events
Konjunktivitis in povezani dogodki
*Items not included in the carton
*Ti elementi niso priloženi v škatli.
This usually, but not always, happens in people who also take a steroid medicine which is being stopped or for which the dose is being lowered.
To se ponavadi, ne pa vedno, zgodi pri osebah, zdravljenih z nekim steroidnim zdravilom, ki se ga preneha uporabljati ali se mu zmanjša odmerek.
Endpoints were assessed at weeks 51 or 52.
Opazovane dogodke so ocenili 51. ali 52. teden.
• Check the expiration date.
• Preverite datum izteka roka uporabnosti.
Step 5: Choose
5. korak: Izberite mesto
Do not inject through clothes.
Ne injicirajte skozi oblačila.
The responder rate was defined as an improvement in score of 0.5 or more (scale range 0-6 for ACQ-5 and 1-7 for AQLQ(S)).
Delež odziva je bil opredeljen kot izboljšanje ocene za 0,5 ali več (lestvica od 0 do 6 pri ACQ-5 in od 1 do 7 pri AQLQ(S)).
Helminth infection
Okužba s helminti
DRI12544 was a 24-week dose-ranging study which included 776 patients (18 years of age and older).
DRI12544 je bila 24-tedenska študija razpona odmerkov, ki je zajela 776 bolnikov (starih 18 let ali več).
The safety profile observed was similar to that seen in adults.
Opažene varnostne značilnosti so bile podobne kot pri odraslih.
In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.
V primeru prevelikega odmerjanja bolnika nadzirajte glede znakov in simptomov neželenih učinkov in nemudoma uvedite ustrezno simptomatsko zdravljenje.
The adverse event profile in adolescents was generally similar to the adults.
Profil neželenih učinkov pri mladostnikih je bil na splošno podoben kot pri odraslih.
Although no differences in safety or efficacy were observed between older and younger adult atopic dermatitis patients, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.
Čeprav med starejšimi in mlajšimi starostniki z atopijskim dermatitisom niso ugotovili razlik v varnosti in učinkovitosti, število bolnikov, starih 65 let ali več, ni bilo zadostno, da bi ugotovili, ali se odzovejo drugače kot mlajši starostniki.
Both play a major role in causing the signs and symptoms of asthma.
Ti dve imata pomembno vlogo pri nastanku znakov in simptomov astme.
An evaluation of the available evidence related to IL-4Rα inhibition and animal toxicology data with surrogate antibodies does not suggest an increased carcinogenic potential for dupilumab.
Ovrednotenje dokazov, ki so na voljo o zavrtju IL-4Rα, in toksikoloških podatkov pri živalih z nadomestnimi protitelesi ne kaže, da bi imel dupilumab večji kancerogeni potencial.
Pinch a fold of skin at the injection site, as shown in the picture.
Stisnite gubo kože na mestu injiciranja, kot prikazuje slika.
• To help prevent accidental needle injury, each pre-filled syringe has a needle shield that is automatically activated to cover the needle after you have given your injection.
• Za pomoč pri preprečevanju naključnih poškodb z iglo je vsaka napolnjena injekcijska brizga opremljena s ščitnikom igle; ta se samodejno sproži in prekrije iglo, potem ko ste injicirali zdravilo.
Blocking the IL-4/IL-13 pathway with dupilumab in patients decreases many of the mediators of type 2 inflammation.
Blokiranje poti IL-4/IL-13 z dupilumabom bolnikom zniža številne mediatorje vnetja tipa 2.
The most common adverse reactions were injection site reactions, conjunctivitis, blepharitis, and oral herpes.
Najpogostejši neželeni učinki so bili reakcije na mestu injiciranja, konjunktivitis, blefaritis in oralni herpes.
Table 6: Results of the primary and secondary endpoints in CAFE study Placebo + TCS
Preglednica 6: Rezultati primarnega in sekundarnih opazovanih dogodkov v študiji CAFE Placebo + LKS
Live and live attenuated vaccines should not be given concurrently with dupilumab as clinical safety and efficacy has not been established.
Sočasno z dupilumabom se ne sme uporabljati živih in živih oslabljenih cepiv, ker klinična varnost in učinkovitost nista ugotovljeni.
Conjunctivitis allergic Eye pruritus Blepharitis
Pogosti alergijski konjunktivitis srbenje oči blefaritis