FrancophonIA/ELRC3.0 huggingface dataset:
English: An antiinflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxespira infusion.
Croatian: U pivotalnoj kliničkoj studiji inicijalna infuzija docetaksela započela se primjenjivati dan nakon prve doze trastuzumaba.
English: It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Croatian: Ako se ne može izbjeći istovremena primjena snažnog CYP3A4 inhibitora (npr. ketokonazola, itrakonzola, klaritromicina, indinavira, nefazodona, nelfinavira, ritonavira, sakvinavira, telitromicina i vorikonazola), nužan je poman klinički nadzor, a može biti potrebna i prilagodba doze docetaksela za vrijeme terapije snažnim inhibitorom CYP3A4 (vidjeti dio 4.4).
English: The company provided data from the published literature on docetaxel.
Croatian: Nije zabilježen statistički značajan učinak prednizona na farmakokinetiku docetaksela.
English: The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated.
Croatian: Sav materijal korišten za razrjeđivanje i primjenu lijeka treba zbrinuti sukladno standardnim procedurama.
English: Taxespira is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Croatian: Docetaksel se ne smije primjenjivati u bolesnika s početnom vrijednošću neutrofila < 1500 stanica/mm
English: Because Taxespira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Time se omogućuje kontinuirano praćenje omjera koristi i rizika lijeka.
English: How does Taxespira work?
Croatian: Kako čuvati Taxespira
English: How is Taxespira used?
Croatian: Kako primjenjivati Taxespira
English: Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide.
Croatian: Docetaksel je antineoplastik koji djeluje poticanjem skupljanja tubulina u stabilne mikrotubule i inhibira njihovo razdvajanje što ima za posljedicu značajno smanjenje slobodnog tubulina.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects
Croatian: Rijetko je zabilježena pojava suzenja s/bez konjunktivitisa, poput slučajeva opstrukcije suznog kanala što rezultira prekomjernim suzenjem.
English: Taxespira is used with prednisone or prednisolone (anti-inflammatory medicines);
Croatian: Poremećaji probavnog sustava konstipacija; ezofagitis/disfagija/ odinofagija (G3/4:
English: EPAR summary for the public
Croatian: TAC skupini
English: Other information about Taxespira
Croatian: Drugi lijekovi i Taxespira
English: This summary was last updated in 01-2016.
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: For more information about treatment with Taxespira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Ako se pojave ili pogoršaju tegobe s plućima (vrućica, nedostatak zraka ili kašalj), odmah o tome obavijestite svog liječnika, bolničkog ljekarnika ili medicinsku sestru.
English: The name of the medicine was changed to Taxespira on 12 October 2015.
Croatian: Ovaj lijek se zove Taxespira.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taxespira, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na tiskanoj uputi o lijeku mora se navesti naziv i adresa proizvođača odgovornog za puštanje navedene serije u promet.
English: No additional studies in humans were needed as Taxespira is a generic medicine that is given by infusion and contains the same active substance as Taxotere.
Croatian: Rijetko su zabilježeni pojava dehidracije kao posljedica gastrointestinalnih poremećaja, gastrointestinalna perforacija, ishemični kolitis, kolitis i neutropenijski enterokolitis.
English: Taxespira is used with cisplatin and 5-fluorouracil (other cancer medicines);
Croatian: Preporučene modifikacije doziranja u slučajevima toksičnosti u bolesnika liječenih docetakselom u kombinaciji s cisplatinom i 5-fluoruracilom (5-FU):
English: Taxespira contains the active substance docetaxel and is a ‘generic medicine'.
Croatian: Jedan ml otopine sadrži 20 mg docetaksela (u obliku docetaksel trihidrata).
English: Taxespira is a cancer medicine used to treat the following types of cancer:
Croatian: Ukupno 1006 bolesnika s KPS ≥ 60 randomizirani su prema liječenju u sljedeće skupine:
English: Further information can be found in the summary of the risk management plan.
Croatian: Detaljnije informacije pogledati u sažetku opisa svojstava lijeka za trastuzumab.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Taxespira has been shown to be comparable to Taxotere.
Croatian: Medijan vremena do prvog pogoršanja, prema WHO izvedbenom statusu, bio je značajno dulji u TPF skupini u odnosu na PF skupinu.
English: • head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread).
Croatian: • Indukcijska kemoterapija nakon koje slijedi radioterapija (TAX 323) Za indukcijsko liječenje neoperabilnog, lokalno uznapredovalog karcinoma skvamoznih stanica glave i vrata (engl.
English: The company also showed that Taxespira solution for infusion has comparable quality to that of Taxotere.
Croatian: Za kombinaciju docetaksel/karboplatin nije se mogla dokazati ekivalentna ili neinferiorna djelotvornost u usporedbi s referentnom kombinacijom liječenja VCis.
English: What are the benefits and risks of Taxespira?
Croatian: Pozitivan omjer koristi i rizika za TAC u odnosu na FAC ostao je nepromijenjen.
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Croatian: Taxespira u kombinaciji s cisplatinom i 5-fluorouracilom je indiciran za liječenje bolesnika s metastatskim adenokarcinomom želuca, uključujući adenokarcinom gastroezofagealnog spoja, koji nisu prethodno primali kemoterapiju za metastatsku bolest.
English: • Check the dose is still correct.
Croatian: • Provjerite je li doza još uvijek ispravna.
English: Each bottle contains 250 capsules.
Croatian: Svaka boca sadrži 250 kapsula.
English: • Treatment usually starts with a low dose.
Croatian: • Liječenje obično započinje niskom dozom.
English: • Unusually slow movements or movements you cannot control
Croatian: • Neuobičajeno spori pokreti ili pokreti koje ne možete kontrolirati
English: • You can also mix your medicine with water in a small glass.
Croatian: • Možete pomiješajti lijek s vodom u maloj čaši.
English: E-08210 Barberà del Vallès, Barcelona Spain
Croatian: E-08210 Barberà del Vallès, Barcelona Španjolska
English: • Bathing, swimming or showering should not affect the patch.
Croatian: • Kupanje, plivanje ili tuširanje ne bi trebalo utjecati na flaster.
English: • Do not open or crush the capsules.
Croatian: • Nemojte otvarati niti lomiti kapsule.
English: Prometax can be used with food, drink and alcohol.
Croatian: Prometax se može koristiti uz hranu, piće i alkohol.
English: Make sure the patch does not loosen during these activities.
Croatian: Pazite da se flaster ne odlijepi tijekom tih aktivnosti.
English: • The patch can be used in everyday situations, including bathing and during hot weather.
Croatian: • Flaster se može koristiti u svakodnevnim situacijama, uključujući tijekom kupanja i za vrućeg vremena.
English: Having multiple patches on your body could expose you to an excessive amount of this medicine which could be potentially dangerous.
Croatian: Više flastera zalijepljenih na Vašem tijelu moglo bi Vas izložiti prevelikoj količini ovog lijeka, što potencijalno može biti opasno.
English: If you find you have forgotten to take your dose of Prometax, wait and take the next dose at the usual time.
Croatian: Ako primijetite da ste zaboravili uzeti svoju dozu Prometaxa, pričekajte i uzmite iduću dozu u uobičajeno vrijeme.
English: The patient reminder card should contain the following key messages:
Croatian: Kartica s podsjetnikom za bolesnika treba sadržavati sljedeće ključne poruke:
English: Source: Study D2340-Table 11-6 and Table 11-7
Croatian: Izvor: Ispitivanje D2340-Tablica 11-6 i Tablica 11-7
English: Can you wear your Prometax transdermal patch when you are bathing, swimming, or in the sun?
Croatian: Možete li nositi Prometax transdermalni flaster dok se kupate, plivate ili boravite na suncu?
English: You may wish to experiment with different locations when applying a new patch, to find ones that are most comfortable for you and where clothing will not rub on the patch.
Croatian: Možda ćete htjeti isprobati neka druga mjesta za stavljanje novog flastera, kako biste našli ona koja su Vam najugodnija i na kojima odjeća neće trljati flaster.
English: • Pull the plunger upwards until it reaches the right mark for the dose that your doctor has prescribed.
Croatian: • Povlačite klip prema gore dok ne dosegne oznaku za dozu koju je propisao Vaš liječnik.
English: They are packed in blisters available in three different pack sizes (28, 56 or 112 capsules) and plastic bottles of 250 capsules, but these may not all be available in your country.
Croatian: Pakirane su u blistere dostupne u tri različite veličine pakiranja (28, 56 ili 112 kapsula) i u plastične boce od 250 kapsula, no moguće je da sva pakiranja nisu dostupna na Vašem tržištu.
English: • Only one patch per day.
Croatian: • Samo jedan flaster dnevno.
English: Do not apply a new patch to the same skin area twice within 14 days.
Croatian: Nemojte stavljati novi flaster na isto mjesto na koži unutar 14 dana.
English: If it helps you, you may write, for example, the day of the week, on the patch with a thin ball point pen.
Croatian: Ako će Vam to pomoći, možete na flaster napisati, primjerice, dan u tjednu tankom kemijskom olovkom.
English: Patients with clinically significant response (%)
Croatian: Bolesnici s klinički značajnim odgovorom (%)
English: • Then, remove the syringe from the bottle.
Croatian: • Zatim odvojite štrcaljku od boce.
English: • Hyperactivity (high level of activity, restlessness)
Croatian: • Hiperaktivnost (visoka razina aktivnosti, nemir)
English: PC: [folding box only] SN: [folding box only] NN: [folding box only]
Croatian: PC: [samo kutija] SN: [samo kutija] NN: [samo kutija]
English: • Changes in tests which show how well the liver is working
Croatian: • Promijenjene vrijednosti na pretragama koje pokazuju koliko dobro radi jetra
English: • To benefit from your medicine, take it every day.
Croatian: • Da bi Vam ovaj lijek koristio, uzimajte ga svaki dan.
English: Any used or unused transdermal patches should be disposed of in accordance with local requirements or returned to the pharmacy.
Croatian: Sve iskorištene ili neiskorištene transdermalne flastere valja zbrinuti sukladno lokalnim propisima ili vratiti u ljekarnu.
English: • A few tiny bubbles are not important and will not affect your dose in any way.
Croatian: • Prisutnost nekoliko manjih mjehurića nije važna i neće utjecati na dozu.
English: Not known (frequency cannot be estimated from the available data)
Croatian: Nepoznato (učestalost nuspojava ne može se procijeniti iz dostupnih podataka)
English: Based on CMH test (van Elteren test) blocking for country.
Croatian: Na temelju CMH testa (van Elterenovog testa) blokiranjem za zemlju.
English: For patients starting treatment for the first time and for patients restarting Prometax after treatment interruption, please begin with the second picture.
Croatian: Za bolesnike koji po prvi put počinju liječenje i za bolesnike koji ponovno počinju primjenjivati Prometax nakon prekida liječenja, počnite od druge slike.
English: Rivastigmine transdermal patches were not phototoxic and considered to be a non-sensitiser.
Croatian: Rivastigmin transdermalni flasteri nisu fototoksični i smatra se da nisu senzibilizatori.
English: If you accidentally take more Prometax than you should, inform your doctor.
Croatian: Ako slučajno uzmete više Prometaxa nego biste trebali, obavijestite svog liječnika.
English: 95% CI p-value
Croatian: DLSM 95% CI pvrijednos t
English: Stir and drink all of the mixture.
Croatian: Promiješajte i popijte cijeli sadržaj.
English: Date of first authorisation: 04 December 1998 Date of latest renewal: 21 May 2008
Croatian: Datum posljednje obnove odobrenja: 21. svibnja 2008.
English: • Dehydration (losing too much fluid)
Croatian: • Dehidracija (gubitak previše tekućine)
English: • Do not use any patch that is damaged or shows signs of tampering.
Croatian: • Ne koristiti flaster koji je oštećen ili ima znakove otvaranja.
English: Always use Prometax transdermal patches exactly as your doctor has told you.
Croatian: Uvijek uzmite Prometax transdermale flastere točno onako kako Vam je rekao liječnik.
English: You should only open the sachet when you are ready to apply the patch.
Croatian: Vrećicu otvorite tek kada ste spremni postaviti flaster.
English: Anxiety, depression, delirium, agitation
Croatian: Anksioznost, depresija, delirij, agitacija
English: • Difficulty sleeping
Croatian: • Teškoće sa spavanjem
English: Every 24 hours take off the previous patch before putting ONE new patch on to ONLY ONE of the following possible locations.
Croatian: Svaka 24 sata uklonite prethodni flaster prije nego što stavite JEDAN novi flaster na SAMO JEDNO od sljedećih mogućih mjesta.
English: The incidence of application site skin reactions leading to discontinuation was higher in the Asian population with 4.9% and 8.4% in the Chinese and Japanese population respectively.
Croatian: Incidencija kožnih reakcija na mjestu primjene koje su dovele do prekida terapije bila je viša u azijskoj populaciji, s 4,9% u kineskoj i 8,4% u japanskoj populaciji.
English: Peel off one side of the protective liner and do not touch the sticky part of the patch with the fingers.
Croatian: Povucite jednu stranu zaštitne folije i ne dodirujte prstima ljepljivi dio flastera.
English: However, Prometax may be used in this patient population and close monitoring is necessary.
Croatian: Međutim, Prometax se može koristiti u ovoj populaciji bolesnika te je nužno pažljivo praćenje.
English: • Chest pain - this may be caused by heart spasm
Croatian: • Bol u prsima - može biti uzrokovan stezanjem srca
English: • The patch should be replaced by a new one after 24 hours.
Croatian: • Flaster treba zamijeniti novim nakon 24 sata.
English: Multipack: 60 (2 packs of 30) transdermal patches Multipack: 90 (3 packs of 30) transdermal patches
Croatian: Višestruko pakiranje: 60 (2 pakiranja od 30) transdermalnih flastera Višestruko pakiranje: 90 (3 pakiranja od 30) transdermalnih flastera
English: - Each patch is sealed in its own protective sachet.
Croatian: Svaki je flaster zapakiran u vlastitu zaštitnu vrećicu.
English: • Severe confusion
Croatian: • Teška zbunjenost
English: Put the sticky side of the patch on the upper or lower back, upper arm or chest and then peel off the second side of the protective liner.
Croatian: Stavite ljepljivu stranu flastera na gornji ili donji dio leđa, nadlakticu ili prsa i zatim povucite drugi dio zaštitne folije.
English: Misuse of the medicinal product and dosing errors resulting in overdose
Croatian: Neodgovarajuća primjena lijeka i pogreške u doziranju koje rezultiraju predoziranjem
English: 28 hard capsules 56 hard capsules 112 hard capsules
Croatian: 28 tvrdih kapsula 56 tvrdih kapsula 112 tvrdih kapsula
English: Other medicines and Prometax
Croatian: Drugi lijekovi i Prometax
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Croatian: Rivastigmin se ne bi trebao koristiti za vrijeme trudnoće osim u slučaju jasne potrebe.
English: • Seeing things that are not there (hallucinations)
Croatian: • Priviđanje stvari koje nisu prisutne (halucinacije)
English: • Your doctor will slowly increase your dose depending on how you respond to treatment.
Croatian: • Liječnik će polako povećavati dozu, ovisno o Vašem odgovoru na liječenje.
English: • Seeing things that are not really there (hallucinations)
Croatian: • Priviđanje stvari kojih zapravo nema (halucinacije)
English: Absolute bioavailability after a 3 mg dose is about 36%  13%.
Croatian: Apsolutna bioraspoloživost nakon doze od 3 mg iznosi oko 36%±13%.
English: Apply one patch per day.
Croatian: Primijeniti jedan flaster dnevno.
English: The MAH shall ensure that, following discussions and agreement with the National Competent Authorities in each Member State where Prometax patch is marketed, all physicians who are expected to prescribe Prometax patch are provided with an information pack containing the following elements:
Croatian: Nositelj odobrenja dužan je osigurati da nakon razgovora i usuglašavanja s nacionalnim nadležnim tijekom u svakoj državi članici u kojoj se Prometax flaster nalazi na tržištu, svi liječnici za koje se očekuje da će propisivati Prometax flaster imaju informacijski paket koji sadrži sljedeće elemente:
English: N is the number of patients with an assessment at baseline (last assessment in the initial openlabel phase) and with at least 1 post-baseline assessment (for the LOCF).
Croatian: N je broj bolesnika s procjenom na početku (posljednja procjena u početnoj otvorenoj fazi) i s najmanje 1 procjenom nakon određivanja početnih vrijednosti (za LOCF).
English: If you take more Prometax than you should
Croatian: Ako uzmete više Prometaxa nego što ste trebali
English: If you accidentally apply more than one patch, remove all the patches from your skin, then inform your doctor that you have accidentally applied more than one patch.
Croatian: Ako ste zabunom stavili više od jednog flastera, skinite sve flastere sa svoje kože i obavijestite liječnika da ste slučajno stavili više od jednog flastera.
English: n/a n/a
Croatian: n/p n/p
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational material with the National Competent Authority.
Croatian: Prije stavljanja na tržite u svakoj državi članici nositelj odobrenja za stavljanje gotovog lijeka u promet dužan je usuglasiti konačni sadržaj edukativnih materijala s nacionalnim nadležnim tijelom.
English: • The patch should not be cut into pieces.
Croatian: • Flaster se ne smije rezati na komadiće.
English: • to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases;
Croatian: • bolesnicima koji imaju predispozicije za urinamu opstrukciju i napadaje, budući da kolinomimetici mogu izazvati ili pogoršati te bolesti;
English: Hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar rivastigmin, druge derivate karbamata ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: 24-week placebo-controlled study
Croatian: 24-tjedno placebom kontrolirano ispitivanje
English: Your doctor will tell you which Prometax transdermal patch is most suitable for you.
Croatian: Liječnik će Vam reći koji je Prometax transdermalni flaster najprikladniji za Vas.
English: Capsule, hard
Croatian: Kapsula, tvrda
English: Each box contains 28, 56 or
Croatian: Svaka kutija sadržava 28,
English: Talk to your doctor before taking Prometax: - if you have, or have ever had, irregular or slow heartbeat.
Croatian: Obratite se svom liječniku prije nego uzmete Prometax: - ako imate ili ste imali nepravilne ili spore otkucaje srca.
English: The DLSM, 95% CI, and p-value are based on an ANCOVA (analysis of covariance) model adjusted for country and baseline ADAS-cog score.
Croatian: DLSM, 95% CI i p-vrijednost temelje se na modelu ANCOVA (analiza kovacijance) prilagođenom za zemlju i početni rezultat ADAS-cog-a.
English: • The signs of Parkinson's disease get worse or getting similar signs - such as stiff muscles,
Croatian: • Pogoršanje znakova Parkinsonove bolesti ili pojava sličnih znakova - poput ukočenih mišića,
English: Uncommon (may affect up to 1 in 100 people) • Hyperactivity (high level of activity, restlessness)
Croatian: Manje često (mogu se javiti u do 1 na 100 ljudi) • Hiperaktivnost (visoka razina aktivnosti, nemir)
English: If you have not taken Prometax for more than three days, do not take the next dose until you have talked to your doctor.
Croatian: Ako niste uzeli Prometax više od tri dana, nemojte uzimati sljedeću dozu dok se niste posavjetovali sa svojim liječnikom.
English: If you feel dizzy or sleepy, do not drive, use machines or perform any tasks that require your attention.
Croatian: Ako osjećate omaglicu ili pospanos,t nemojte upravljati vozilima i strojevima niti izvoditi bilo kakve zadatke koji zahtijevaju pozornost.
English: • To benefit from treatment, you must apply a new patch every day, preferably at the same time of day.
Croatian: • Da biste imali koristi od liječenja trebate stavljati novi flaster svaki dan, po mogućnosti u isto doba dana.
English: To be swallowed whole without crushing or opening.
Croatian: Kapsule morate progutati cijele bez drobljenja ili otvaranja.
English: Adhesive matrix
Croatian: Adhezivni matriks
English: C-rivastigmine, renal elimination was rapid and essentially complete (>90%) within 24 hours.
Croatian: C, eliminacija putem bubrega bila je brza i u osnovi potpuna (>90%) unutar 24 sata.
English: If this applies to you, tell your doctor and do not take Prometax.
Croatian: Ako se ovo odnosi na Vas, obratite se svom liječniku i nemojte uzimati Prometax.
English: Exposure (AUC∞) to rivastigmine (and metabolite NAP266-90) was highest when the transdermal patch was applied to the upper back, chest, or upper arm and approximately 20-30% lower when applied to the abdomen or thigh.
Croatian: Izloženost (AUC∞) rivastigminu (i metabolitu NAP266-90) bila je najveća kada je transdermalni flaster bio postavljen na gornji dio leđa, prsa ili nadlakticu te otprilike 20-30% niža kad je bio postavljen na abdomen ili natkoljenicu.
English: Atrial Fibrillation
Croatian: Fibrilacija atrija
English: • Then, put the syringe back in its protective case.
Croatian: • Zatim, štrcaljku vratite u njezin zaštitni spremnik.
English: Anorexia, decreased appetite
Croatian: Anoreksija, smanjeni apetit
English: • Trembling or feeling confused
Croatian: • Drhtanje ili osjećaj zbunjenosti
English: • Fast or uneven heartbeat
Croatian: • Brzi ili neujednačeni otkucaji srca
English: Take off your patch and tell your doctor straight away, if you notice any of the following side effects which could become serious:
Croatian: Odmah skinite flaster i obavijestite Vašeg liječnika, ako primijetite bilo koju od navedenih nuspojava koje mogu postati ozbiljne:
English: If you feel faint or confused do not drive, use machines or perform any other tasks that require your attention.
Croatian: Ako se osjećate slabo ili smeteno nemojte upravljati vozilima i strojevima niti izvoditi bilo kakve zadatke koji zahtijevaju pozornost.
English: Used transdermal patches should be folded in half, with the adhesive side inwards, placed in the original sachet and discarded safely and out of the reach and sight of children.
Croatian: Iskorišteni transdermalni flaster treba presaviti na pola, pri čemu ljepljiva strana treba biti okrenuta prema unutra, te staviti u originalnu vrećicu i sigurno ukloniti izvan dohvata i pogleda djece.
English: Hallucination, visual
Croatian: Halucinacije, vidne