FrancophonIA/ELRC3.0 huggingface dataset:
English: Application site reactions occurred more frequently after imiquimod than after vehicle, however, incidence and intensity of these reactions were not different from that seen in the licensed indications in adults.
Slovenian: Vendar pogostost in intenzivnost teh reakcij ni odstopala od tistih, ki so jih opazovali pri registriranih indikacijah in odraslih osebah.
English: A different therapy is recommended if the treated lesion(s) shows insufficient response to Aldara.
Slovenian: V kolikor odziv zdravljenih lezij na zdravilo Aldara ni zadosten, se priporoča drugačno zdravljenje.
English: Application Instructions - (Mon, Tues, Wed, Thurs and Fri) 1.
Slovenian: Navodila za nanos (ponedeljek, torek, sreda, četrtek in petek) 1.
English: Thereof 4 of 242 patients (1.7%) of the imiquimod and 7 of 237 patients (3.0%) of the diclofenac group were found to have a histological progression to invasive SCC within the 3-year period.
Slovenian: Histološko napredovanje v invazivni SCC v obdobju 3 let so potrdili pri 4 od 242 bolnikov (1,7 %) v skupini z imikvimodom in 7 od 237 bolnikov (3,0 %) v skupini z diklofenakom.
English: • If the treated site becomes too uncomfortable, wash the cream off with mild soap and water.
Slovenian: • Če se na področju nanosa kreme pojavi neprijeten ali pekoč občutek, kremo sperite z blagim milom in vodo.
English: If required by the patient's discomfort or the severity of the local skin reaction, a rest period of several days may be taken.
Slovenian: Zdravljenje se lahko za nekaj dni prekine zaradi nelagodja bolnika ali resnosti lokalne reakcije na koži.
English: No quantifiable levels (>5 ng/ml) of drug were detected in serum after single or multiple topical doses.
Slovenian: Po enkratnem in večkratnem topičnem odmerku v serumu ni bilo zaznavnih koncentracij imikvimoda (>5 ng/ml).
English: Aldara 5% cream Imiquimod Cutaneous use
Slovenian: Aldara 5 % krema imikvimod dermalna uporaba
English: Application site reaction
Slovenian: Reakcija na mestu aplikacije pogosti
English: Skin infections during treatment with imiquimod have been observed.
Slovenian: Med zdravljenjem z imikvimod kremo so opazili kožne infekcije.
English: Lethargy
Slovenian: Urtikarija
English: Nervous system disorders: Headache
Slovenian: Bolezni živčevja: Glavobol pogosti pogosti
English: Vulval disorder
Slovenian: Spremembe vulve
English: Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single dose of 200 mg imiquimod which corresponds to the content of approximately 16 sachets.
Slovenian: Pri slučajnem zaužitju enkratnega odmerka 200 mg imikvimoda, kar ustreza vsebini približno 16 vrečk, se lahko pojavijo slabost, bruhanje, glavobol, bolečine v mišicah in vročina.
English: Application site hyperaesthesia
Slovenian: Hiperstezija na mestu aplikacije
English: The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Slovenian: Nošenje tesnih obvez med zdravljenjem z imikvimod kremo ni priporočljivo.
English: Imiquimod cream should be used with caution in organ transplant patients (refer to section 4.5).
Slovenian: Pri bolnikih po presaditvi organov imikvimod kremo uporabljamo previdno (glejte poglavje 4.5).
English: Superficial basal cell carcinoma:
Slovenian: Površinski karcinom bazalnih celic:
English: Sweating increased
Slovenian: Povečano potenje
English: Fungal infection
Slovenian: Okužba z glivami
English: Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were demonstrated in a pharmacokinetic study.
Slovenian: V farmakokinetični raziskavi so po topični aplikaciji imikvimoda dokazali povečanje sistemskih vrednosti interferona alfa in drugih citokinov.
English: Very common Very common Very common
Slovenian: Pruritus na mestu aplikacije zelo pogosti zelo pogosti zelo pogosti
English: A total of 126 of 242 patients treated with imiquimod (52.1%) and 84 of 237 patients treated with topical diclofenac (35.4%) showed complete clinical clearance of the treated AK field at week 20 (i.e. about 8 weeks after the end of the initial treatment cycle); a difference of 16.6% (95% CI: 7.7% to 25.1%).
Slovenian: Pri skupno 126 od 242 bolnikov, zdravljenih z imikvimodom (52,1 %) in 84 od 237 bolnikov, zdravljenih s topičnim diklofenakom (35,4 %), se je pokazala popolna klinična ozdravitev lezij na zdravljenem AK predelu v 20. tednu (t.j.
English: Paraesthesia
Slovenian: Parestezija
English: Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Slovenian: Pri bolnikih, zdravljenih z imikvimodom, so poročali tudi o nekaterih sistemskih neželenih učinkih, vključno z mialgijo (2 %).
English: Where such reactions have occurred at the urethral meatus, some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation and treatment of the affected area.
Slovenian: V nekaterih primerih je bila potrebna nujna uvedba katetra in zdravljenje prizadetega področja.
English: - If any get any side effects talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Vaginal pain
Slovenian: Atrofični vaginitis
English: Skin and subcutaneous tissue disorders:
Slovenian: Bolezni kože in podkožja: Pruritus
English: Imiquimod cream should be used with caution in patients with autoimmune conditions (refer to section 4.5).
Slovenian: Imikvimod kremo pri bolnikih z avtoimunskimi boleznimi uporabljamo previdno (glejte poglavje 4.5).
English: Application site inflammation
Slovenian: Brazgotina na mestu aplikacije
English: Actinic keratosis
Slovenian: Aktinična keratoza
English: Common effects include pain, burning, irritation or redness.
Slovenian: Pogosti neželeni učinki so: bolečina, pekoč občutek, draženje ali rdečica.
English: Pustules
Slovenian: Otrplost
English: 56% of the patients have been free of hypopigmentation; hyperpigmentation has not been reported.
Slovenian: O hiperpigmentaciji ni bilo poročil.
English: Diarrhoea
Slovenian: Letargija
English: Application site paraesthesia
Slovenian: Parestezija na mestu aplikacije pogosti
English: How to store Aldara cream
Slovenian: Shranjevanje kreme Aldara
English: Very common Common
Slovenian: Pustule pogosti
English: Pain in extremity
Slovenian: Bolečine v okončinah
English: Eye disorders Conjunctival irritation
Slovenian: Očesne bolezni Draženje veznice
English: In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of imiquimod patients reported at least one adverse event.
Slovenian: V treh preskušanjih z odmerjanjem trikrat tedensko so bili bolniki zdravljeni v do 2 stopnjah, ki so trajale po 4 tedne.
English: Application site irritation
Slovenian: Razjeda na mestu aplikacije
English: Folliculitis
Slovenian: Vulvitis
English: This leaflet was last revised in (MM/YYYY).
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Use in the paediatric patient population is not recommended.
Slovenian: Uporaba pri otrocih se ne priporoča.
English: Skin ulcer
Slovenian: Kožna razjeda
English: There is limited experience in the use of imiquimod cream in the treatment of men with foreskinassociated warts.
Slovenian: Izkušnje z zdravljenjem bradavic na kožici penisa z imikvimod kremo so omejene.
English: One sachet contains enough cream to cover a wart area of 20 cm2 (approx. 3 square inches).
Slovenian: Količina kreme v eni vrečki zadostuje za prekritje 20 cm področja z bradavicami.
English: Application Instructions - (Mon, Wed and Fri)
Slovenian: Navodila za nanos (ponedeljek, sreda in petek)
English: Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aldara cream.
Slovenian: Če se ne počutite dobro med uporabo kreme Aldara, čim prej obvestite svojega zdravnika ali farmacevta.
English: Application site erythema
Slovenian: Eritmatozen izpuščaj
English: Arthralgia
Slovenian: Astenija
English: Upper respiratory tract infection Uncommon Vulvitis
Slovenian: Okužba zgornjih dihal
English: Uterovaginal prolapse
Slovenian: ZUNANJA OVOJNINA
English: Application site bleeding
Slovenian: Krvavitev na mestu aplikacije pogosti
English: The equivalence limits were set at 80 - 125 %.
Slovenian: Omejitve enakovrednosti so bile postavljene pri 80-125 %.
English: The Applicant should justify:
Slovenian: Predlagatelj mora obrazložiti naslednje:
English: (Invented) Name Strength
Slovenian: Izmišljeno ime Ime
English: Conclusion of the assessment of the Applicant response to the List of Outstanding Issues
Slovenian: Zaključki vrednotenja odgovorov predlagatelja na seznam nerešenih vprašanj
English: The Applicant is required to present this discussion.
Slovenian: Predlagatelj mora predstaviti to razlago.
English: Critical Evaluation
Slovenian: Kritično ovrednotenje
English: c) Pooling of stages is justified based on safety and efficacy, taking into account the particularities of salbutamol and its site of action.
Slovenian: c) Združevanje stopenj je utemeljeno na podlagi varnosti in učinkovitosti, ob upoštevanju posebnosti salbutamola in njegovega mesta delovanja.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF SABUMALIN AND ASSOCIATED NAMES (SEE ANNEX I)
Slovenian: SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA SABUMALIN IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I)
English: For stages with a small deposition of particles and a relatively high standard deviation it is particularly critical to reach a confidence interval within the defined limits.
Slovenian: Pri stopnjah z majhno mero odlaganja delcev in relativno visoko standardno deviacijo je še posebej pomembno doseči interval zaupanja znotraj opredeljenih omejitev.
English: In the opinion of the CHMP, this small difference is not expected to be clinically significant and a pharmacodynamic study does not seem to be required.
Slovenian: Po mnenju odbora CHMP se ne pričakuje, da bo ta majhna razlika klinično pomembna, farmakodinamična študija pa se ne zdi potrebna.
English: Therefore, the different cloud size/shape or the humid environment that exists in the respiratory tree may be relevant.
Slovenian: Zaradi tega so morda pomembne različne velikosti/oblike oblaka ali vlažno okolje, ki obstaja v dihalnih poteh.
English: The fine particle dose ratio was 1.01 and the corresponding confidence interval was 0.97 - 1.04 and the data therefore clearly demonstrate that the expected spacer effect is identical for test and reference product.
Slovenian: Razmerje odmerka drobnih delcev je bilo 1,01, ustrezajoč interval zaupanja pa je bil 0,97-1,04, tako da podatki jasno kažejo, da je pričakovani učinek podaljška enak za testno in referenčno zdravilo.
English: a) The Applicant quoted the EMEA draft guideline on orally inhaled products (OIP) which offers the possibility to pool different stages of the Andersen Cascade Impactor.
Slovenian: a) Predlagatelj je navedel osnutek smernice agencije EMEA za peroralno inhalirana zdravila (OIP), ki daje možnost združevanja različnih stopenj Andersenovega kaskadnega impaktorja.
English: On the basis of these data the two formulations are considered to exhibit an equivalent therapeutic ratio and to be clinically interchangeable”.
Slovenian: Na teh podatkih temelji mnenje, da obe formulaciji izkazujeta enakovredno terapevtsko razmerje in sta klinično medsebojno zamenljivi“.
English: In absolute terms, the values outside the +/20% limit represent a negligible mean difference which is clinically irrelevant in the context of any overall potential increase in systemic exposure.
Slovenian: V absolutnem smislu predstavljajo vrednosti zunaj ±20-odstotne omejitve zanemarljivo povprečno razliko, ki nima kliničnega pomena glede kakršnega koli morebitnega povečanja sistemske izpostavitve.
English: c. The Applicant should discuss why the ranges of particles that are deposited in the large conducting intrathoracic airways are pooled instead of investigating them with the highest accuracy and precision in the large possible number of categories (stages).
Slovenian: c. Predlagatelj mora odgovoriti, zakaj je združil razpone delcev, ki se odlagajo v velikih prevodnih intratorakalnih dihalnih poteh, namesto da bi jih preiskal z največjo mero natančnosti in točnosti v velikemu številu možnih kategorij (stopenj)?
English: Question 3 - The Applicant´s justification to widen the acceptance range taken from the draft guideline is not acceptable.
Slovenian: Tretje vprašanje - Predlagateljeva utemeljitev za razširitev razpona sprejemljivosti, dobljena iz osnutka smernice, ni sprejemljiva.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Slovenian: DODATEK I SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH
English: In addition, the Applicant provided a consolidated final protocol consisting of all single protocols retrospectively combined and a retrospectively combined report from all the corresponding study reports including the raw data and study results.
Slovenian: Predlagatelj je poleg tega priskrbel združeni končni protokol, sestavljen iz vseh posameznih, retrospektivno kombiniranih protokolov, ter retrospektivno kombinirano poročilo iz vseh ustreznih poročil o študiji, vključno z neobdelanimi podatki in rezultati študij.
English: Furthermore, the CHMP did not agree that particles larger then 6 µm are not relevant for the demonstration of efficacy, as even such large particles may penetrate to the peripheral airways.
Slovenian: Poleg tega se odbor CHMP ni strinjal z navedbo, da delci, večji od 6 µm, niso pomembni za dokazovanje učinkovitosti, saj tudi tako veliki delci lahko prodrejo do perifernih dihalnih poti.
English: The Applicant provided raw data obtained under humid condition clearly demonstrating that the aerodynamic characteristic of salbutamol sulphate particles do not change under humid conditions.
Slovenian: Predlagatelj je predložil neobdelane podatke, pridobljene v vlažnih pogojih, ki jasno dokazujejo, da se aerodinamične lastnosti delcev salbutamol sulfata ne spremenijo v vlažnih pogojih.
English: The CHMP did not agree that this amount of drug is too small to be relevant and could furthermore not support the Applicant claim that stage 1 is related only to safety.
Slovenian: Odbor CHMP se ni strinjal s tem, da je količina zdravila premajhna, da bi veljala kot pomembna, poleg tega pa ni mogel podpreti trditve predlagatelja, da je 1. stopnja povezana samo z varnostjo.
English: The undesirable reflow from suspension formulation into the canister does not occur if the cans are stored in an inverted or lying position but may occur if the inhaler is stored in an upright position.
Slovenian: Do neželenega ponovnega pretoka iz formulacije suspenzije v vsebnik ne pride, če so pločevinke shranjene v obrnjenem ali ležečem položaju, vendar do njega lahko pride, če je inhalator shranjen v pokončnem položaju.
English: The indication sought is “Symptomatic treatment of bronchoconstriction due to bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD) and emphysema.
Slovenian: Indikacija, za katero je bila predložena vloga, je „simptomatsko zdravljenje bronhospazma zaradi bronhitične astme, kroničnega bronhitisa, kronične obstruktivne pljučne bolezni (COPD) in emfizema.
English: The functionality of the applicator is not affected and therefore the aerosol cloud and the aerodynamic particle size distribution remain the same.
Slovenian: Vpliva na funkcionalnost aplikatorja ni, zato ostaneta oblak aerosola in velikost aerodinamičnih delcev enaka.
English: During drug product development, the Applicant optimised the applicator, modifying the shape of the device to make it possible to store the applicator in the two identified required storage orientations.
Slovenian: Med razvojem zdravila je predlagatelj optimiziral aplikator s spremembo oblike pripomočka, da bi ga bilo možno hraniti v dveh ugotovljenih zahtevanih položajih za shranjevanje.
English: Question 2 - The Applicant´s justification of the selected pooling of stages is not acceptable.
Slovenian: Drugo vprašanje - Predlagateljeva utemeljitev izbranega združevanja stopenj ni sprejemljiva.
English: However, for some substances, clinical efficacy and safety is not represented by a specific stage but a range of stages and therefore, comparison of individual stages cannot detect differences between formulations that may have clinical relevance.
Slovenian: Vendar pri nekaterih snoveh klinična učinkovitost in varnost nista predstavljeni s točno določeno stopnjo temveč z več stopnjami, zato s primerjavo posameznih stopenj ni mogoče odkriti razlik med formulacijami, ki imajo morda klinični pomen.
English: Therefore, the CHMP concluded that the products should be considered as interchangeable.
Slovenian: Zaradi tega je odbor CHMP zaključil, da je treba zdravili upoštevati kot medsebojno zamenljivi.
English: In addition, because two clinical studies are submitted for demonstration of in vivo equivalence and for confirming the in vitro data, the in vitro results obtained under humid condition become less important.
Slovenian: Ker sta bili poleg tega predloženi tudi dve klinični študiji za dokazovanje in vivo enakovrednosti in za potrditev in vitro podatkov, postanejo in vitro rezultati, pridobljeni v vlažnih pogojih, manj pomembni.
English: This difference is not expected to be of clinical relevance and the two products are therefore considered to exhibit an equivalent bronchodilator response.
Slovenian: Ker se pričakuje, da ta razlika nima kliničnega pomena, se upošteva, da imata obe zdravili enakovreden bronhodilatacijski odziv.
English: The Applicant responded to the outstanding issues during an Oral Explanation held during the November CHMP meeting.
Slovenian: Predlagatelj je med ustnim pojasnilom, ki je potekalo med novembrskim zasedanjem odbora CHMP, odgovoril na nerešena vprašanja.
English: Major objections were raised and because the main issues on quality (in vitro equivalence to the reference product) and the insufficiency of the clinical studies could not be resolved, the procedure was referred to CHMP by a number of objecting concerned member states.
Slovenian: Ugotovljeni so bili večji zadržki in ker glavnih vprašanj glede kakovosti (in vitro enakovrednost z referenčnim zdravilom) in nezadostnosti kliničnih študij ni bilo mogoče rešiti, je več ugovarjajočih zadevnih držav članic zadevo napotilo na CHMP.
English: Prophylaxis of exercise and allergen induced asthma.” The Applicant submitted pharmaceutical and clinical efficacy and safety documentation, but a number of Member States did not consider the product to be approvable based on the submitted in vitro data only.
Slovenian: Preventivno zdravljenje napada astme, sproženega z naporom in alergeni.“ Predlagatelj je predložil dokumentacijo o farmacevtski in klinični učinkovitosti in varnosti, vendar je več držav članic menilo, da zdravila ni mogoče odobriti zgolj na podlagi predloženih in vitro podatkov.
English: The reference product in SE is Ventoline Evohaler, 0.1 mg/dose (GlaxoSmithKline AB).
Slovenian: Referenčno zdravilo v znanstvenem vrednotenju je Ventolin Evohaler, 0,1 mg/odmerek (GlaxoSmithKline AB).
English: The Applicant should provide evidence based on sensitive clinical studies (preferably studies investigating the relative potency) that a 20 % difference lacks of clinical relevance.
Slovenian: Predlagatelj mora na podlagi občutljivih kliničnih študij (po možnosti študij, v katerih se preiskuje relativna jakost), predložiti dokaze, da 20-odstotna razlika nima kliničnega pomena.
English: Question 7 - In order to complete the comparative study between the reference and the test products, a comparative repriming study after storage at lying position (0°C) (initial stage of can life and partially emptied can) should be carried out to confirm their similarity of behaviour.
Slovenian: Sedmo vprašanje - Da bi zaključili primerjalno študijo med referenčnim in testnim zdravilom, je treba izvesti študijo ponovnega polnjenja po shranjevanju v ležečem položaju (0 °C) (začetna stopnja življenjske dobe pločevinke in delno izpraznjene pločevinke) za potrditev podobnosti njunih obnašanj.
English: The Applicant considered that the results from study 2007-59-DOS-5 demonstrate bioequivalence in terms of rate and extent of the total systemic absorption of inhaled salbutamol.
Slovenian: Predlagatelj je menil, da rezultati študije 2007-59-DOS-5 kažejo na biološko enakovrednost, kar zadeva hitrost in obseg celotne sistemske absorpcije inhaliranega salbutamola.
English: The pooling method used and the addition of the spacer is likely to mask differences in quality between the two products.
Slovenian: Uporabljena metoda združevanja in dodatek podaljška po vsej verjetnosti zakrijeta razlike v kakovosti med obema zdraviloma.
English: As seen in the interim analysis, the intra-subject variability for the pulmonary deposition study is about twice as high as for the systemic safety study, demonstrating that variability increases when only pulmonary deposition is assessed.
Slovenian: Kot je pokazala vmesna analiza, je variabilnost med osebami za študijo odlaganja v pljučih približno dvakrat večja kot v primeru sistemske varnostne študije, kar dokazuje, da se variabilnost veča, če se vrednoti samo odlaganje v pljučih.
English: The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/83/EC and the EU reference product is Sultanol Dosier-Aerosol 100 µg/dose, Druckgasinhalation, suspension, (GlaxoSmithKline).
Slovenian: Vloge za dovoljenje za promet z zdravilom so bile predložene v obliki hibridnih vlog v skladu s členom 10(3) Direktive 2001/83/ES, referenčno zdravilo v EU pa je Sultanol Dosier-Aerosol 100 µg/odmerek, inhalacijska raztopina pod tlakom, suspenzija, (GlaxoSmithKline).
English: The difference for stage 3 amounts to a mean difference of only 3.27% (i.e. 38.17 µg) of the pooled fine particle dose for stages 3/4/5.
Slovenian: Razlika na 3. stopnji predstavlja povprečno razliko, ki znaša samo 3,27 % (tj. 38,17 µg) v primerjavi z združenim odmerkom drobnih delcev za 3., 4. in 5. stopnjo.
English: Based on the draft OIP guideline, the Applicant initiated two parmacokinetic studies, both with a single dose administration of 800 µg salbutamol in healthy volunteers: studies 2007-59-DOS-5 (systemic safety study) and 2007-76-DOS-6 (pulmonary deposition study).
Slovenian: Na podlagi osnutka smernice za peroralno inhalirana zdravila je predlagatelj začel izvajati dve farmakokinetični študiji, obe z uporabo enega samega odmerka 800 µg salbutamola pri zdravih prostovoljcih: študiji 2007-59-DOS-5 (študija sistemske varnosti) in 2007-76-DOS-6 (študija odlaganja v pljučih).
English: Moreover, the in vitro data for larger particle deposition together with the total (lung +gut) systemic bioavailability as AUC show evidence of overall systemic equivalence.
Slovenian: Poleg tega in vitro podatki za odlaganje večjih delcev skupaj s celotno (pljuča + črevesje) sistemsko biološko razpoložljivostjo v obliki AUC dokazujejo skupno sistemsko enakovrednost.
English: Following an additional request for clinical spacer studies, the Applicant decided to extend the previously submitted in vitro equivalence study with spacer use, including 7 generic and 10 reference batches (compared to 2 and 3 previously).
Slovenian: Po zahtevi za dodatne klinične študije s podaljškom se je predlagatelj odločil razširiti predhodno predloženo študijo in vitro enakovrednosti z uporabo podaljška, ki je vključevala 7 generičnih in 10 referenčnih serij (v primerjavi z dvema in tremi serijami predhodno).
English: Applicant also decided to generate additional spacer data in order to obtain more reliable information on the particle size distribution when the compared inhalers are fitted with their respective spacer devices.
Slovenian: Predlagatelj se je odločil tudi za pridobivanje dodatnih podatkov o podaljšku, da bi pridobil zanesljivejše informacije o porazdelitvi velikosti delcev, kadar so primerjani inhalatorji opremljeni s pripadajočimi podaljševalnimi pripomočki.