FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about treatment with Temozolomide Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Temozolomide Accord pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Temozolomide Accord is used first with radiotherapy and then on its own;
Croatian: Temozolomide Accord se prvo koristi istodobno s radioterapijom, a zatim kao monoterapija;
English: Temozolomide Accord is a ‘generic medicine'.
Croatian: Temozolomide Accord je „generički lijek”.
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temozolomide Accord is being used alone or with other treatments, and how the patient responds to treatment.
Croatian: Doza i broj doza ovise o tipu tumora koji se liječi, o činjenici je li bolesnik ranije primio terapiju, da li se Temozolomide Accord koristi kao monoterapija ili u kombinaciji s drugim liječenjem te kako bolesnik odgovara na liječenje.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Accord.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Temozolomide Accord.
English: The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Hospira on 15 March 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Temozolomide Hospira na snazi u Europskoj uniji od 15. ožujka 2010.
English: This means that Temozolomide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Croatian: Drugim riječima, Temozolomide Accord je sličan „referentnom lijeku” koji je već odobren u Europskoj uniji pod nazivom Temodal.
English: Because Temozolomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Temozolomide Accord generički lijek i bioekvivalent referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Accord has been shown to have comparable quality and to be bioequivalent to Temodal.
Croatian: CHMP je zaključio kako je, u skladu s preduvjetima EU-a, potvrđeno kako Temozolomide Accord posjeduje usporedivu kvalitetu te je bioekvivalentan s lijekom Temodal.
English: Temozolomide Accord temozolomide
Croatian: Temozolomide Accord temozolomid
English: The Committee recommended that Temozolomide Accord be given marketing authorisation.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje u promet lijeka Temozolomide Accord.
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour).
Croatian: • u odraslih bolesnika s novodijagnosticiranim multiformnim glioblastomom (agresivnim tipom malignog glioma).
English: Temozolomide Accord is a cancer medicine that contains the active substance temozolomide.
Croatian: Temozolomide Accord je lijek protiv raka koji sadrži djelatnu tvar temozolomid.
English: Treatment with Temozolomide Accord should be prescribed by a doctor with experience in the treatment of brain tumours.
Croatian: Liječenje lijekom Temozolomide Accord smiju propisivati samo liječnici s iskustvom u onkološkom liječenju tumora mozga.
English: Because Temozolomide Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Croatian: Budući da je Temozolomide Accord generički lijek, ispitivanja na bolesnicima bila su ograničena na utvrđivanje činjenice je li riječ o bioekvivalentu referentnom lijeku Temodal.
English: Temozolomide Accord is used on its own in these patients.
Croatian: Temozolomide Accord se koristi kao monoterapija u ovih bolesnika.
English: What are the benefit and risk of Temozolomide Accord?
Croatian: Koje su koristi i rizici lijeka Temozolomide Accord?
English: Other information about Temozolomide Accord:
Croatian: Ostale informacije o lijeku Temozolomide Accord
English: The active substance in Temozolomide Accord, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Croatian: Djelatna tvar lijeka Temozolomide Accord, temozolomid, ubraja se u grupu citostatika pod nazivom alkilirajući pripravci.
English: What is Temozolomide Accord?
Croatian: Što je Temozolomide Accord?
English: Why has Temozolomide Accord been approved?
Croatian: Zašto je Temozolomide Accord odobren?
English: How is Temozolomide Accord used?
Croatian: Kako se Temozolomide Accord koristi?
English: What is Temozolomide Accord used for?
Croatian: Za što se Temozolomide Accord koristi?
English: How does Temozolomide Accord work?
Croatian: Kako djeluje Temozolomide Accord?
English: How has Temozolomide Accord been studied?
Croatian: Kako je Temozolomide Accord ispitivan?
English: • if you have long-term or repeated infections.
Croatian: • ako imate dugoročne ili ponavljane infekcije.
English: The following information is intended for medical or healthcare professionals only.
Croatian: Sljedeće informacije namijenjene su samo medicinskim ili zdravstvenim radnicima.
English: Patients should be closely monitored.
Croatian: Bolesnike je potrebno pažljivo pratiti.
English: You may see a small air bubble, which is normal.
Croatian: Možda ćete vidjeti mjehurić zraka, što je normalno.
English: • if you have Crohn's disease.
Croatian: • ako imate Crohnovu bolest.
English: (nasopharyngitis, rhinitis)
Croatian: (nazofaringitis, rinitis)
English: Such signs are listed under “Serious side effects” in section 4.
Croatian: Takvi znakovi navedeni su pod naslovom „Ozbiljne nuspojave“ u dijelu 4.
English: Look out for infections and allergic reactions
Croatian: Pazite na infekcije i alergijske reakcije
English: • if you have tuberculosis.
Croatian: • ako imate tuberkulozu.
English: Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Croatian: Obratite se svom liječniku ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete.
English: • if you have ever had an allergic reaction to latex.
Croatian: • ako ste ikada imali alergijsku reakciju na lateks.
English: Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.
Croatian: Liječnik će Vam redovito pratiti stanje kako bi provjerio da terapija ima željeni učinak.
English: • if you are taking, have recently taken or might take any other medicines.
Croatian: • ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Correct Incorrect
Croatian: Pravilno Nepravilno
English: For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment.
Croatian: Za sve prethodno navedene indikacije dostupni podaci ukazuju na to da se klinički odgovor obično postiže unutar 16 tjedana liječenja.
English: Time (Weeks)
Croatian: Vrijeme (tjedni)
English: • if you currently have an infection
Croatian: • ako trenutno imate infekciju.
English: These improvements were sustained up to week 52.
Croatian: Ta su se poboljšanja održala do 52. tjedna.
English: Spinal mobility
Croatian: Spinalna mobilnost
English: Physical function and health-related quality of life
Croatian: Tjelesna funkcija i kvaliteta života povezana sa zdravljem
English: • swelling of the face, lips, tongue or throat
Croatian: • oticanje lica, usnica, jezika ili grla
English: These improvements were maintained for 52 weeks (studies 1 and 2).
Croatian: Ta su se poboljšanja održala tijekom 52 tjedna (1. i 2. ispitivanje).
English: Exposure was dose proportional across all dosing regimens.
Croatian: Izloženost je bila proporcionalna dozi u svim režimima doziranja.
English: Cosentyx is not recommended for children and adolescents (under 18 years of age) because it has not been studied in this age group.
Croatian: Cosentyx se ne preporučuje za djecu i adolescente (mlađe od 18 godina) zato što nije bio ispitivan u ovoj dobnoj skupini.
English: Patients in these studies had a diagnosis of PsA of at least five years.
Croatian: Bolesnici u tim ispitivanjima imali su dijagnozu PsA najmanje pet godina.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, osim ako metoda rekonstitucije isključuje rizik mikrobne kontaminacije, lijek treba upotrijebiti odmah.
English: If you use more Cosentyx than you should
Croatian: Ako primijenite više Cosentyxa nego što ste trebali
English: The safety and efficacy of Cosentyx in children below the age of 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost Cosentyxa u djece mlađe od 18 godina nisu još ustanovljene.
English: The preparation time from piercing the stopper until end of reconstitution takes 20 minutes on average and should not exceed 90 minutes.
Croatian: Priprema od bušenja čepa do završetka rekonstitucije traje u prosjeku 20 minuta i ne bi smjela trajati duže od 90 minuta.
English: After initial weekly dosing during the first month, time to reach the maximum concentration was between 31 and 34 days based on population pharmacokinetic analysis.
Croatian: Nakon početnog tjednog doziranja tijekom prvog mjeseca, vrijeme do postizanja maksimalne koncentracije bilo je između 31 i 34 dana na temelju populacijske farmakokinetičke analize.
English: • Never try to reuse your pen.
Croatian: • Nikada nemojte pokušavati ponovno upotrijebiti svoju brizgalicu.
English: Patients randomised to “retreatment as needed” did not achieve adequate maintenance of response and therefore a fixed monthly maintenance regimen is recommended.
Croatian: Bolesnici randomizirani na „ponovno liječenje prema potrebi“ nisu postigli odgovarajuće održavanje odgovora, pa se stoga preporučuje fiksni mjesečni režim održavanja.
English: Week 24 data are presented in Table 6.
Croatian: Podaci iz 24. tjedna prikazani su u Tablici 6.
English: • athlete's foot (tinea pedis)
Croatian: • atletsko stopalo (tinea pedis)
English: Of these, over 11,700 patients were exposed to secukinumab for at least one year.
Croatian: Od toga je više od 11 700 bolesnika bilo izloženo sekukinumabu najmanje godinu dana.
English: There were no reported cases of more severe neutropenia.
Croatian: Nije bilo zabilježenih slučajeva teže neutropenije.
English: Possible serious infection - the signs may include:
Croatian: Moguća ozbiljna infekcija - znakovi mogu uključivati:
English: • if you are allergic to secukinumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na sekukinumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • severe allergic reaction with shock (anaphylactic reaction)
Croatian: • teška alergijska reakcija sa šokom (anafilaktička reakcija)
English: • if you have ulcerative colitis.
Croatian: • ako imate ulcerozni kolitis.
English: Your doctor will decide if and when you may restart the treatment.
Croatian: Vaš liječnik će odlučiti hoćete li ponovo započeti liječenje i kada ga možete ponovo započeti.
English: The number of PsA patients with axial involvement was too small to allow meaningful assessment.
Croatian: Broj bolesnika s PsA-om s aksijalnom zahvaćenošću bio je premali da bi omogućio značajnu procjenu.
English: Improvements were shown in all components of the ACR scores, including patient assessment of pain.
Croatian: Poboljšanja su se pokazala u svim komponentama ACR rezultata, uključujući bolesnikovu procjenu boli.
English: Cosentyx can potentially cause serious side effects, including infections and allergic reactions.
Croatian: Cosentyx potencijalno može uzrokovati ozbiljne nuspojave, uključujući infekcije i alergijske reakcije.
English: By touching them, the syringe guard may be activated too early.
Croatian: Ako ih dodirnete, štitnik štrcaljke mogao bi se prerano aktivirati.
English: Be careful not to touch the syringe guard wings before use.
Croatian: Pazite da ne dodirujete krilca štitnika štrcaljke prije uporabe.
English: All patients were followed for up to 52 weeks following first administration of study treatment.
Croatian: Svi bolesnici bili su praćeni do 52 tjedna nakon prve primjene ispitivane terapije.
English: The CL was not impacted by gender.
Croatian: Spol nije utjecao na CL.
English: Check the green indicator fills the window:
Croatian: Provjerite je li zeleni indikator ispunio prozorčić:
English: Your doctor will decide how much Cosentyx you need and for how long.
Croatian: Vaš liječnik će odlučiti koliko Cosentyxa trebate i koliko dugo.
English: Serious allergic reaction - the signs may include:
Croatian: Ozbiljna alergijska reakcija - znakovi mogu uključivati:
English: In addition, one study assessed a chronic treatment regimen versus a “retreatment as needed” regimen [SCULPTURE].
Croatian: Uz to, jednim se ispitivanjem ocjenjivao režim kroničnog liječenja naspram režima „liječenja prema potrebi“ [SCULPTURE].
English: Neutropenia <1.0-0.5x10
Croatian: Neutropenija <1,0-0,5x10
English: Other medicines and Cosentyx
Croatian: Drugi lijekovi i Cosentyx
English: However, secukinumab should not be given to patients with active tuberculosis.
Croatian: Međutim, sekukinumab se ne smije davati bolesnicima s aktivnom tuberkulozom.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on 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); and not known (cannot be estimated from the available data).
Croatian: Uz to, odgovarajuća kategorija učestalosti za svaku nuspojavu temelji se na sljedećoj konvenciji: vrlo često (≥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); i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • if you are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.
Croatian: • ako primate bilo koju drugu terapiju za psorijazu, kao što je neki drugi imunosupresiv ili fototerapija ultraljubičastim (UV) svjetlom.
English: If you have received more Cosentyx than you should or the dose has been administered sooner than according to your doctor's prescription, inform your doctor.
Croatian: Ako ste primili više Cosentyxa nego što ste trebali ili je doza primijenjena ranije nego što je trebalo u skladu s liječničkim receptom, obavijestite svog liječnika.
English: Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment.
Croatian: Potrebno je razmotriti prekid liječenja u bolesnika koji nisu imali odgovor do 16. tjedna liječenja.
English: Date of first authorisation: 15 January 2015 Date of latest renewal: 03 September 2019
Croatian: Datum posljednje obnove odobrenja: 03. rujna 2019.
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Croatian: Radi sigurnosti i zdravlja, kako Vas tako i drugih, igle i upotrijebljene štrcaljke ne smiju se nikada ponovno koristiti.
English: Animal studies have not been conducted to evaluate the carcinogenic potential of secukinumab.
Croatian: Nisu provedena ispitivanja na životinjama za ocjenjivanje karcinogenog potencijala sekukinumaba.
English: Secukinumab has the potential to increase the risk of infections.
Croatian: Sekukinumab bi mogao povećati rizik od infekcija.
English: You must look out for signs of these conditions while you are taking Cosentyx.
Croatian: Morate obratiti pozornost na znakove ovih stanja dok uzimate Cosentyx.
English: The safety profile of secukinumab is consistent across all indications.
Croatian: Sigurnosni profil sekukinumaba je ujednačen u svim indikacijama.
English: Then talk to your doctor to discuss when you should inject the next dose.
Croatian: Zatim se obratite svom liječniku da provjerite kada biste trebali ubrizgati sljedeću dozu.
English: Across studies, absolute bioavailabilities in the range between 60 and 77% were calculated.
Croatian: U svim ispitivanjima su izračunate apsolutne bioraspoloživosti u rasponu od 60 do 77%.
English: Outcome (p-value versus placebo)
Croatian: Ishod (p-vrijednost u odnosu na placebo)
English: You should not be given certain types of vaccines (live vaccines) while using Cosentyx.
Croatian: Ne smijete dobiti određene vrste cjepiva (živa cjepiva) dok uzimate Cosentyx.
English: Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Croatian: U nekih bi se bolesnika s početnim djelomičnim odgovorom stanje moglo poboljšati uz nastavak liječenja i nakon 16 tjedana.
English: Any remaining solution in the vial must not be used and should be discarded in accordance with local requirements.
Croatian: Preostala otopina u bočici ne smije se koristiti i mora se zbrinuti u skladu s lokalnim zahtjevima.
English: The majority of IgG elimination occurs via intracellular catabolism, following fluid-phase or receptor mediated endocytosis.
Croatian: Većina eliminacije IgG-a događa se putem intracelularnog katabolizma, nakon fluidne faze endocitoze ili endocitoze posredovane receptorom.
English: • low blood pressure, which can cause dizziness or light-headedness
Croatian: • niski krvni tlak, koji može uzrokovati omaglicu ili ošamućenost
English: If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you remember.
Croatian: Ako ste zaboravili ubrizgati dozu Cosentyxa, ubrizgajte sljedeću dozu čim se sjetite.
English: The injection site is the place on the body where you are going to use the syringe.
Croatian: Mjesto primjene injekcije je mjesto na tijelu na kojem ćete upotrijebiti štrcaljku.
English: For all studies, the primary endpoint was American College of Rheumatology (ACR) 20 response.
Croatian: Za sva ispitivanja mjera primarnog ishoda bila je odgovor prema Američkom koledžu za reumatologiju (ACR) 20.
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu metodu kontracepcije tijekom liječenja i najmanje 20 tjedana nakon liječenja.
English: Improvements in HAQ-DI scores were seen regardless of previous anti-TNFα exposure.
Croatian: Poboljšanja u rezultatima HAQ-DI-ja bila su opažena bez obzira na prethodnu izloženost anti-TNFα.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC10
Croatian: Farmakoterapijska skupina: Imunosupresivi, inhibitori interleukina, ATK oznaka: L04AC10
English: Cosentyx is for long-term treatment.
Croatian: Cosentyx je namijenjen dugoročnom liječenju.
English: Tell your doctor or pharmacist before using Cosentyx:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što primijenite Cosentyx:
English: Specific locations/forms of plaque psoriasis
Croatian: Posebne lokacije/oblici plak psorijaze
English: Effect of weight on pharmacokinetics Secukinumab clearance and volume of distribution increase as body weight increases.
Croatian: Učinak težine na farmakokinetiku Klirens sekukinumaba i volumen distribucije rastu s povećanjem tjelesne težine.
English: Quality of life/patient-reported outcomes
Croatian: Kvaliteta života/ishodi prema izvješćima bolesnika
English: Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity.
Croatian: Doze do 30 mg/kg (otprilike 2000 do 3000 mg) primijenjene su intravenski u kliničkim ispitivanjima bez toksičnosti koja bi ograničila dozu.
English: It is not dangerous to stop using Cosentyx.
Croatian: Nije opasno prestati koristiti Cosentyx.
English: Clinically important, active infection, e.g. active tuberculosis (see section 4.4).
Croatian: Klinički važna, aktivna infekcija, npr. aktivna tuberkuloza (vidjeti dio 4.4).
English: The stream of sterile water for injections should be directed onto the powder.
Croatian: Mlaz sterilne vode za injekcije treba biti usmjeren na prašak.
English: After proper training in subcutaneous injection technique, patients may self-inject Cosentyx if a physician determines that this is appropriate.
Croatian: Nakon odgovarajuće obuke iz tehnike primjene supkutanih injekcija bolesnici si mogu sami ubrizgavati Cosentyx ako liječnik utvrdi da je to primjereno.
English: The primary endpoint was ASAS 20 at week 16.
Croatian: Mjera primarnog ishoda bila je ASAS 20 u 16. tjednu.
English: This medicine is for single use only.
Croatian: Ovaj lijek je namijenjen samo za jednokratnu uporabu.
English: No dose recommendations can be made.
Croatian: Ne mogu se dati preporuke o doziranju.
English: A caregiver may also give you your Cosentyx injection after proper training.
Croatian: Osoba koja Vas njeguje također Vam može dati injekciju Cosentyxa nakon odgovarajuće obuke.
English: What Cosentyx is and what it is used for
Croatian: Što je Cosentyx i za što se koristi
English: ** p values versus etanercept: p=0.0250
Croatian: ** p vrijednosti u odnosu na etanercept: p=0,0250
English: If you have active psoriatic arthritis you will first be given other medicines.
Croatian: Ako imate aktivni psorijatični artritis, prvo ćete dobiti druge lijekove.
English: IGA mod 2011 “clear” or “almost clear” response n (%)
Croatian: Odgovor IGA mod 2011 „čista“ ili „gotovo čista“ n (%)
English: Cosentyx reduces the inflammation and other symptoms of the disease.
Croatian: Cosentyx smanjuje upalu i druge simptome bolesti.
English: • fever, flu-like symptoms, night sweats
Croatian: • vrućicu, simptome nalik gripi, noćno znojenje
English: However, if you stop, your psoriasis, psoriatic arthritis or ankylosing spondylitis symptoms may come back.
Croatian: Međutim, ako prestanete, Vaši simptomi psorijaze, psorijatičnog artritisa ili ankilozantnog spondilitisa mogli bi se vratiti.
English: ** p values versus placebo and adjusted for multiplicity: p<0.0001.
Croatian: ** p vrijednosti u odnosu na placebo i prilagođeno za višestrukost: p<0,0001.
English: The onset of action of secukinumab occurred as early as week 2.
Croatian: Do nastupa djelovanja sekukinumaba došlo je već u 2. tjednu.
English: Total score
Croatian: Ukupni rezultat
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the Instructions for Use in the package leaflet.
Croatian: Za uputu o rekonstituciji lijeka prije primjene vidjeti dio 6.6 i Upute za uporabu u uputi o lijeku.
English: If you forget to use Cosentyx If you have missed a Cosentyx injection, talk to your doctor.
Croatian: Ako ste zaboravili primijeniti Cosentyx Ako ste propustili injekciju Cosentyxa, obratite se svom liječniku.
English: Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction.
Croatian: Prestanite uzimati Cosentyx i odmah se obratite svom liječniku ili potražite liječničku pomoć ako primijetite bilo kakve znakove koji upućuju na moguću ozbiljnu infekciju ili alergijsku reakciju.
English: About half of the treatment-emergent anti-drug antibodies were neutralising, but this was not associated with loss of efficacy or pharmacokinetic abnormalities.
Croatian: Oko polovica protutijela koja su se javila tijekom liječenja bila su neutralizirajuća, ali to nije bilo povezano s gubitkom djelotvornosti ili farmakokinetičkim nepravilnostima.
English: Anti-tuberculosis therapy should be considered prior to initiation of secukinumab in patients with latent tuberculosis.
Croatian: Terapiju protiv tuberkuloze potrebno je razmotriti prije početka primjene sekukinumaba u bolesnika s latentnom tuberkulozom.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2ºC to 8ºC.
Croatian: Kemijska i fizička stabilnost nakon otvaranja dokazana je za razdoblje od 24 sata na temperaturi od 2 ºC do 8 ºC.