FrancophonIA/ELRC3.0 huggingface dataset:
English: Pigs: Meat and offal: 5 days.
Croatian: Svinje: meso i jestive iznutrice: 5 dana.
English: Pigs: meat and offal: 5 days.
Croatian: Svinje: Meso i jestive iznutrice: 5 dana.
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10.0 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Jedna subkutana injekcija u dozi od 0,5 mg meloksikama/kg tjelesne težine (tj. 10,0 ml/100 kg tjelesne težine) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Croatian: Svinje: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj. 2,0 ml/100 kg tjelesne mase) u kombinaciji s antibiotskom terapijom, kako je odgovarajuće.
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/150 kg body weight) in combination with antibiotic therapy, as appropriate.
Croatian: Svinje: Jedna intramuskularna injekcija u dozi od 0,4 mg meloksikama/kg tjelesne mase (tj. 2,0 ml/150 kg tjelesne mase) u kombinaciji s antibiotskom terapijom, kako je odgovarajuće.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/002
English: MARKETING AUTHORISATION NUMBER(S) EU/2/09/098/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/09/098/005
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Jedna subkutana ili intravenska injekcija u dozi od 0,5 mg meloksikama/kg tjelesne mase (tj. 2,5 ml/100 kg tjelesne mase) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
English: Single subcutaneous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/150 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Croatian: Jedna subkutana injekcija u dozi od 0,5 mg meloksikama/kg tjelesne mase (tj. 2,5 ml/150 kg tjelesne mase) u kombinaciji s antibiotskom terapijom ili oralnom rehidracijskom terapijom, kako je odgovarajuće.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle.
Croatian: U junadi, nakon jedne subkutane doze od 0,5 mg meloksikama/kg, vrijednost Cmax od 2,1 µg/ml postignuta je za 7,7 sati.
English: Equidae
Croatian: konji (Equidae)
English: Date of first authorisation: 3 March 2017
Croatian: Datum prvog odobrenja: 3. ožujka 2017
English: - Contact with your eyes must be avoided.
Croatian: - Mora se izbjegavati kontakt s očima.
English: The response criteria were the same as for CAILS.
Croatian: Kriteriji odgovora bili su isti kao i za CAILS.
English: Response rates (%)
Croatian: Stope odgovora (%)
English: Ratio 95% CI
Croatian: Omjer 95 % CI
English: Do not give this medicine to children and adolescents under the age of 18 years because the safety and effectiveness have not been established for this age group.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima mlađima od 18 godina jer sigurnost i djelotvornost za ovu dobnu skupinu nisu još ustanovljene.
English: Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients.
Croatian: Kutane reakcije preosjetljivosti zabilježene su u 2,3 % liječenih bolesnika.
English: The safety and efficacy of Ledaga in children aged 0 to 18 years have not been established.
Croatian: Sigurnost i djelotvornost gela Ledaga u djece u dobi od 0 do 18 godina nisu još ustanovljene.
English: The safety profile observed in elderly patients was consistent with that in the overall patient population.
Croatian: Sigurnosni profil uočen u starijih bolesnika odgovarao je onom u ukupnoj populaciji bolesnika.
English: Your doctor may restart the treatment upon improvement of your symptoms.
Croatian: Vaš liječnik može ponovo započeti liječenje nakon što dođe do poboljšanja simptoma.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: Ask your pharmacist how to throw away used nitrile gloves, the plastic bag and the medicine you no longer use.
Croatian: Pitajte svog ljekarnika kako baciti korištene nitrilne rukavice, plastičnu vrećicu i lijek koji više ne koristite.
English: • The opening of the tube is covered with a foil safety seal.
Croatian: • Otvor tube pokriven je sigurnosnom pokrovnom folijom.
English: Ledaga is for use in adults only.
Croatian: Ledaga se koristi samo u odraslih.
English: What Ledaga is and what it is used for
Croatian: Što je Ledaga i za što se koristi
English: Do not apply Ledaga more than once per day.
Croatian: Nemojte primjenjivati gel Ledaga češće od jednom na dan.
English: - Tell your doctor if you have ever had an allergic reaction to chlormethine.
Croatian: - Obavijestite svog liječnika jeste li ikada imali alergijsku reakciju na klormetin.
English: Other medicines and Ledaga
Croatian: Drugi lijekovi i Ledaga
English: A small number of subjects (6.3%, 8/128) treated with Ledaga utilised topical corticosteroids.
Croatian: Mali broj ispitanika (6,3 %, 8/128) liječenih gelom Ledaga koristio je topikalne kortikosteroide.
English: If you use Ledaga more than you should
Croatian: Ako primijenite više gela Ledaga nego što ste trebali
English: Contents of the pack and other information What Ledaga contains
Croatian: Sadržaj pakiranja i druge informacije Što Ledaga sadrži
English: Frequencies were defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Croatian: (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In the EE population, the percentage of patients who achieved a confirmed response by CAILS was similar between disease stages IA (79.6 %) and IB-IIA (73.2%).
Croatian: U EE populaciji je postotak bolesnika koji su postigli potvrđen odgovor prema CAILS bio sličan za stadije IA (79,6 %) i IB-IIA (73,2 %).
English: The ratio of response and the 95% confidence interval in the ITT population were 1.226 (0.974-1.552) for CAILS and 1.017 (0.783-1.321) for SWAT and therefore consistent with those in the EE population for both the overall CAILS and SWAT responses.
Croatian: Omjer odgovora i 95 %-tni interval pouzdanosti u ITT populaciji iznosio je 1,226 (0,974-1,552) za CAILS i 1,017 (0,783-1,321) za SWAT te je tako konzistentan s onim u EE populaciji za oba ukupna odgovora, CAILS i SWAT.
English: What Ledaga looks like and contents of the pack
Croatian: Kako Ledaga izgleda i sadržaj pakiranja
English: o Instruction on how to accurately use, open and dispose a plastic bag should be printed on the plastic bag.
Croatian: o Upute o tome kako točno upotrijebiti, otvoriti i zbrinuti plastičnu vrećicu trebaju biti otisnute na plastičnoj vrećici.
English: Results in other secondary endpoints (response in percentage of body surface area affected, time to first confirmed CAILS response, duration of first confirmed CAILS response and time to disease progression) were consistent with those for CAILS and SWAT.
Croatian: Rezultati drugih sekundarnih mjera ishoda (odgovor u postotku zahvaćene površine tijela, vrijeme do prvog potvrđenog odgovora CAILS, trajanje prvog potvrđenog odgovora CAILS i vrijeme do progresije bolesti) bili su u skladu s onima za CAILS i SWAT.
English: In order to minimise and prevent the Important Identified Risk of “Toxicity to mucous membranes / eye” and the Important Potential Risk of “Secondary exposure to someone other than the patient”, the MAH shall ensure that, the following additional risk minimisation measures are fulfilled in each Member State (MS) where Ledaga is marketed:
Croatian: Kako bi se umanjio i spriječio važan identificirani rizik “toksičnost za sluznice / oči” te važan potencijalni rizik “sekundarna izloženost drugih osoba osim bolesnika”, nositelj odobrenja će osigurati da se u svakoj državi članici u kojoj će Ledaga biti stavljena tržište, ispune sljedeće dodatne mjere minimizacije rizika:
English: - if you are allergic (hypersensitive) to chlormethine or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični (preosjetljivi) na klormetin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Do not use an opened or unopened tube of Ledaga after 60 days of storage in the refrigerator.
Croatian: Nemojte koristiti otvorenu ili neotvorenu tubu gela Ledaga nakon što je 60 dana čuvana u hladnjaku.
English: EXP Discard 60 days after defrosting: ../../....
Croatian: EXP Baciti 60 dana nakon odmrzavanja: ../../....
English: Store and transport frozen.
Croatian: POSEBNE MJERE ČUVANJA Čuvati i prevoziti zamrznuto.
English: - Caregivers must wear disposable nitrile gloves when applying this medicine to patients (this is a special type of glove; ask your doctor or pharmacist if you have questions).
Croatian: Njegovatelji moraju nositi jednokratne nitrilne rukavice pri nanošenju ovog lijeka bolesniku (to je posebna vrsta rukavica; ako imate kakvih pitanja, obratite se liječniku ili ljekarniku).
English: It attaches to the DNA of dividing cells, like cancer cells, which stops them from multiplying and growing.
Croatian: On se veže za DNK stanica koje se dijele, kao što su stanice raka, i tako sprječava njihovo umnožavanje i rast.
English: Tell your doctor if you get any new damaged areas or ulcers on your skin.
Croatian: Obavijestite svog liječnika ako Vam se pojave nova zahvaćena područja ili ulceracije na koži.
English: Ledaga contains alcohol and is therefore considered flammable.
Croatian: Ledaga sadrži alkohol te se stoga smatra zapaljivim.
English: If reintroduction of treatment is tolerated for at least 1 week, the frequency of application can be increased to every other day for at least 1 week and then to once-daily application if tolerated.
Croatian: Ako se ponovno uvođenje liječenja dobro podnosi tijekom najmanje jednog tjedna, učestalost primjene može se povećati na svaki drugi dan tijekom najmanje jednog tjedna, a zatim se može prijeći na primjenu jednom dnevno ako se dobro podnosi.
English: The dosing recommendation for elderly patients ( ≥ 65 years old) is the same as for younger adult patients (see section 4.8).
Croatian: Preporuka za doziranje u starijih bolesnika (≥ 65 godina starosti) ista je kao i za mlađe odrasle bolesnike (vidjeti dio 4.8).
English: Do not apply the medicine near the eyes, to the inside of the nostrils, the inside of the ear or on the lips.
Croatian: Ne nanosite lijek blizu očiju, u nosnice, u uho niti na usne.
English: Talk to your doctor or pharmacist before using Ledaga.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego primijenite gel Ledaga.
English: Do not stop using your medicine until your doctor advises you to do so.
Croatian: Nemojte prekidati primjenu lijeka sve dok Vam to ne kaže liječnik.
English: The dose is the same for elderly patients (aged 65 years and older) as for younger adult patients (aged 18 years and older).
Croatian: Doziranje u starijih bolesnika (u dobi od 65 godina i starijih) isto je kao i za mlađe odrasle bolesnike (u dobi od 18 godina i starije).
English: Ledaga has no or negligible influence on the ability to drive or use machines.
Croatian: Ledaga ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: - Remove the cap from the tube just before use.
Croatian: - Odvijte zatvarač s tube neposredno prije primjene.
English: A decision must be made whether to discontinue breast-feeding or to discontinue Ledaga therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the breastfeeding mother.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje lijekom Ledaga, uzimajući u obzir korist dojenja za dijete i korist liječenja za majku koja doji.
English: A complete response was defined as a confirmed CAILS score of 0.
Croatian: Potpuni odgovor definiran je kao potvrđen rezultat CAILS jednak 0.
English: Chlormethine is a bifunctional alkylating agent that inhibits rapidly proliferating cells.
Croatian: Klormetin je bifunkcionalni alkilirajući agens koji inhibira brzo proliferirajuće stanice.
English: EXP Discard 60 days after defrosting
Croatian: EXP Baciti 60 dana nakon odmrzavanja
English: Non-inferiority was considered to have been demonstrated if the lower bound of the 95% confidence interval around the ratio of response rates (Ledaga/comparator) was greater than or equal to 0.75.
Croatian: Smatralo se da je neinferiornost dokazana ako je donja granica 95 %-tnog intervala pouzdanosti za omjer stopa odgovora (Ledaga/lijek za usporedbu) bila veća ili jednaka 0,75.
English: If you apply more than recommended, talk to your doctor.
Croatian: Ako primijenite više gela nego što je preporučeno, obratite se liječniku.
English: In the controlled clinical trial, 31% (79/255) of the study population were aged 65 years or older.
Croatian: Starija populacija U kontroliranom kliničkom ispitivanju, 31 % (79/255) ispitivane populacije bilo je u dobi od 65
English: Occlusive (air- or water-tight) dressings should not be used on areas of the skin where Ledaga was applied.
Croatian: Okluzivni se zavoji (nepropusni za zrak ili vodu) ne smiju koristiti na područjima kože na koja je nanesen gel Ledaga.
English: Rinse the affected area right away for at least 15 minutes with large amounts of water, and seek medical assistance as soon as possible.
Croatian: Odmah ispirite zahvaćeno područje velikim količinama vode tijekom najmanje 15 minuta i potražite liječničku pomoć što je prije moguće.
English: Study medicinal product was to be applied topically once daily for 12 months.
Croatian: Ispitivani lijek trebao se nanositi topikalno, jednom dnevno, tijekom 12 mjeseci.
English: It may also cause blindness and severe permanent injury to your eyes.
Croatian: Također može uzrokovati trajnu tešku ozljedu očiju i sljepoću.
English: The tube should not be used and the pharmacist should be contacted if the seal is missing, punctured, or lifted.
Croatian: Tubu se ne smije koristiti, već je potrebno obratiti se ljekarniku ako pokrovna folija nedostaje, probušena je ili odignuta.
English: Apply your next dose when it is due.
Croatian: Sljedeću dozu primijenite u uobičajeno vrijeme.
English: • medical care should be obtained immediately (including ophthalmological consultation if there is eye exposure).
Croatian: • odmah potraže liječničku pomoć (uključujući konzultaciju s oftalmologom u slučaju izloženosti oka).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Management of overdose should consist of washing the exposed area with water.
Croatian: Liječenje predoziranja treba se sastojati od pranja izloženog područja vodom.
English: Thus, the safety of the concomitant use of Ledaga with topical corticosteroids has not yet been established.
Croatian: Zbog toga sigurnost istodobne primjene gela Ledaga i topikalnih kortikosteroida još nije ustanovljena.
English: Patients and caregivers must wash hands after handling Ledaga.
Croatian: Bolesnici i njegovatelji moraju oprati ruke nakon rukovanja gelom Ledaga.
English: The CAILS score was adjusted by removal of the pigmentation score and simplification of the plaque elevation scale.
Croatian: Rezultat CAILS prilagođen je izostavljanjem bodovanja pigmentacije i pojednostavljenjem ljestvice za bodovanje elevacije plakova.
English: Your doctor will determine how long you should use Ledaga for and when treatment may be stopped.
Croatian: Vaš će liječnik odrediti koliko dugo trebate primjenjivati gel Ledaga i kada se liječenje može prekinuti.
English: Upon improvement, treatment with Ledaga can be restarted at a reduced frequency of once every 3 days.
Croatian: Nakon poboljšanja može se ponovno započeti liječenje gelom Ledaga, ali sa smanjenom učestalošću, jednom svaka 3 dana.
English: CAILS = Composite Assessment of Index Lesion Severity; CI = confidence interval; CR = Complete Response; PR = Partial Response; SWAT = Severity Weighted Assessment Tool.
Croatian: Composite Assessment of Index Lesion Severity); CI = interval pouzdanosti; CR = potpuni odgovor; PR = djelomični odgovor; SWAT = ljestvica za procjenu zahvaćenosti kože i težine lezija (od engl.
English: A response was defined as an at least 50% improvement in the baseline CAILS score, confirmed at a subsequent visit at least 4 weeks later.
Croatian: Odgovor je definiran kao poboljšanje za najmanje 50 % u odnosu na početni rezultat CAILS, potvrđeno i na sljedećem posjetu najmanje 4 tjedna kasnije.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 60 g TUBE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTANJEM PAKIRANJU TUBA 60 g
English: For dose modification information in case of skin reactions, see section 4.2.
Croatian: Za informacije o promjeni doze u slučaju kožnih reakcija vidjeti dio 4.2. Preosjetljivost
English: Patients were stratified based on stage (IA vs IB and IIA) and then randomised to receive either Ledaga (equivalent to 0.02% chlormethine HCl) or the comparator (a petroleum-based 0.02% chlormethine HCl ointment).
Croatian: Bolesnici su bili podijeljeni u skupine na temelju stadija (IA naspram IB i IIA), a zatim randomizirani kako bi primali ili gel Ledaga (odgovara 0,02 % klormetina HCl) ili lijek za usporedbu (0,02 % klormetin HCl mast na bazi petroleja).
English: Therefore, the use of this medicine is not recommended during pregnancy and in women of childbearing age not using contraception.
Croatian: Zbog toga se ne preporučuje koristiti ovaj lijek tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Caregivers should remove gloves carefully (turning them inside out during the removal to avoid contact with Ledaga) and wash hands thoroughly with soap and water after removal of gloves.
Croatian: Njegovatelji moraju pažljivo skidati rukavice (izvrćući ih na naopaku stranu tijekom skidanja kako bi se izbjegao kontakt s gelom Ledaga) i temeljito oprati ruke sapunom i vodom nakon skidanja rukavica.
English: A risk to newborns/infants cannot be excluded due to the potential for topical or systemic exposure of the breast-feeding child to chlormethine through contact with the mother's skin.
Croatian: Ne može se isključiti rizik za novorođenče/dojenče zbog mogućnosti topikalne ili sistemske izloženosti dojenčeta klormetinu putem kontakta s majčinom kožom.
English: Comparator N=95
Croatian: N=95
English: The efficacy and safety of Ledaga were assessed in a randomised, multicentre, observer-blinded, active-controlled, non-inferiority clinical trial (Study 201) of 260 adult patients with Stage IA (141), IB (115), and IIA (4) MF-type CTCL who had received at least one prior skin-directed therapy.
Croatian: Djelotvornost i sigurnost gela Ledaga bile su procijenjene u randomiziranom, multicentričnom, aktivno kontroliranom kliničkom ispitivanju neinferiornosti u kojem ispitivač nije znao koji lijek bolesnici primaju (Ispitivanje 201) na 260 odraslih bolesnika sa stadijima IA (141), IB (115) i IIA (4) bolesti CTCL tipa MF koji su prethodno primali najmanje jednu vrstu liječenja na koži.
English: • Ledaga should be supplied with a transparent, sealable, child-resistant plastic bag to prevent secondary exposure and contamination when Ledaga is stored in the refrigerator:
Croatian: • Ledaga treba biti isporučena u prozirnoj, plastičnoj vrećici sa zatvaračem, sigurnoj za djecu kako bi se spriječila sekundarna izloženost i kontaminacija kada se Ledaga čuva u hladnjaku:
English: For storage conditions after defrosting Ledaga, see section 6.3.
Croatian: Uvjete čuvanja nakon odmrzavanja gela Ledaga vidjeti u dijelu 6.3.
English: There were no reports of systemic tumours after topical administration of chlormethine.
Croatian: Nije bilo izvještaja o pojavi sistemskih tumora nakon topikalne primjene klormetina.
English: After defrosting 60 days in the refrigerator (+2 °C to +8 °C).
Croatian: Nakon odmrzavanja 60 dana u hladnjaku (+2 °C do +8 °C).
English: SWAT Overall Response (CR+PR)
Croatian: Ukupni odgovor prema SWAT (CR+PR)
English: • The active substance is chlormethine.
Croatian: • Djelatna tvar je klormetin.
English: After defrosting, store in a refrigerator.
Croatian: Nakon odmrzavanja čuvati u hladnjaku.
English: Each tube contains 10.5 grams of propylene glycol and 6 micrograms of butylhydroxytoluene.
Croatian: Svaka tuba sadrži 10,5 grama propilenglikola i 6 mikrograma butilhidroksitoluena.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ledaga in all subsets of the paediatric population in cutaneous T-cell lymphoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Ledaga u svim podskupinama pedijatrijske populacije za kožni T-stanični limfom (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Patients should be monitored for development of skin cancers during and after discontinuation of treatment with chlormethine.
Croatian: Bolesnike treba pratiti zbog mogućnosti nastanka raka kože tijekom i nakon prekida liječenja klormetinom.
English: This medicine is not expected to have any effect on your ability to drive or to use machines.
Croatian: Ne očekuje se utjecaj ovog lijeka na sposobnost upravljanja vozilima i rada sa strojevima.
English: - If this medicine gets in your mouth or nose, it can cause pain, redness, and ulcers that may be severe.
Croatian: - Ako Vam ovaj lijek dospije u usta ili nos, može uzrokovati bol, crvenilo i ulceracije koje mogu biti ozbiljne.
English: Hypersensitivity to chlormethine or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na klormetin ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Other findings in animals included embryo-lethality and growth retardation when administered as a single injection.
Croatian: Ostali nalazi u životinja uključivali su smrt embrija i usporavanje rasta pri jednokratnoj primjeni injekcijom.
English: Table 1 CAILS and SWAT-confirmed response rates by 12 months in Study 201 (efficacy evaluable population)
Croatian: Tablica 1 Stope odgovora potvrđene rezultatima CAILS i SWAT nakon 12 mjeseci u ispitivanju 201 (EE populacija)
English: CAILS Overall Response (CR+PR)
Croatian: Ukupni odgovor prema CAILS (CR+PR)
English: • A patient alert card, sized to be included in Ledaga outer packaging, together with the Patient Information Leaflet (PIL) is provided to all patients and caregivers who are expected to administer and use Ledaga.
Croatian: • Karticu s upozorenjima za bolesnika, veličine koja omogućava da bude uključena u vanjsko pakiranje gela Ledaga, zajedno s uputom o lijeku, dobit će svi bolesnici i njegovatelji za koje se pretpostavlja da će primjenjivati i upotrebljavati gel Ledaga.