FrancophonIA/ELRC3.0 huggingface dataset:
English: Entolimod TMC was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 11 January 2016, for the treatment of acute radiation syndrome.
Croatian: Entolimod TMC dobio je status lijeka za rijetku bolest (lijeka protiv bolesti koje nisu česte) 11. siječnja 2016. za liječenje akutnog sindroma zračenja.
English: On 31 July 2018, TMC Pharma Services Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Entolimod TMC, intended to be used to reduce the risk of death following exposure to potentially lethal amounts of radiation.
Croatian: Dana 31. srpnja 2018. tvrtka TMC Pharma Services Ltd službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući zahtjev za stavljanje u promet lijeka Entolimod TMC, koji se trebao primjenjivati za smanjenje rizika od smrti nakon izlaganja potencijalno smrtonosnim razinama zračenja.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21 September 2018 EMA/632431/2018 EMEA/H/C/004656
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom21. rujna 2018.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with the medicine.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja ili programa milosrdnog davanja lijeka Entolimod TMC koji su u tijeku.
English: The CHMP's main concern was that there was insufficient evidence from studies, including the macaque study, to determine the effects of the medicine in humans and how it should be used.
Croatian: Glavni razlog za zabrinutost CHMP-a bila je nedostatnost dokaza iz ispitivanja, uključujući i iz ispitivanja na makaki majmunima, na osnovu kojih bi se utvrdili učinci lijeka na ljude te način njegove primjene.
English: What is Entolimod TMC?
Croatian: Što je Entolimod TMC?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Entolimod TMC could not have been approved to reduce the risk of death following exposure to potentially lethal amounts of radiation.
Croatian: Na temelju pregleda podataka u trenutku povlačenja, CHMP je smatrao da postoje razlozi za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće odobriti lijek Entolimod TMC za smanjenje rizika od smrti nakon izloženosti potencijalno smrtonosnim razinama zračenja.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Entolimod TMC did not outweigh its risks.
Croatian: Stoga je CHMP u vrijeme povlačenja zahtjeva smatrao kako koristi od lijeka Entolimod TMC ne nadmašuju s njim povezane rizike.
English: Entolimod TMC works by attaching to a protein on the surface of cells known as toll-like receptor 5 (TLR5).
Croatian: Entolimod TMC djeluje vezivanjem na bjelančevinu na površini stanica naziva receptor TLR5.
English: How does Entolimod TMC work?
Croatian: Kako djeluje Entolimod TMC?
English: What was Entolimod TMC expected to be used for?
Croatian: Za što se Entolimod TMC trebao koristiti?
English: Withdrawal of the marketing authorisation application for Entolimod TMC (entolimod) EMA/632431/2018
Croatian: EMA/632431/2018
English: Further information on the orphan designation can be found here.
Croatian: Ovdje možete pronaći dodatne informacije o uvrštenju lijekova na popis lijekova za rijetke bolesti.
English: Change the patch on the same two days every week, for example, every Sunday and Wednesday or Monday and Thursday.
Croatian: Mijenjajte flaster na ista dva dana svakog tjedna, na primjer, svake nedjelje i srijede ili ponedjeljkom i četvrtkom.
English: Thereafter, steady concentrations are maintained for up to 96 hours.
Croatian: Nakon toga, stabilne koncentracije održavaju se u trajanju do 96 sati.
English: If you forget to change the patch after 3-4 days:
Croatian: Ako zaboravite promijeniti flaster nakon 3-4 dana:
English: The pump is now primed and ready for use.
Croatian: Pumpica je sada pripremljena i spremna za uporabu.
English: Both patients recovered fully with symptomatic treatment.
Croatian: Oba su se bolesnika u potpunosti oporavila uz simptomatsko liječenje.
English: Using Kentera with food and drink
Croatian: Kentera s hranom i pićem
English: It may harm them even if their symptoms are the same as yours.
Croatian: Može im štetiti, čak i ako su njihovi simptomi bolesti jednaki Vašima.
English: Approximately 75% of patients had no prior pharmacological treatment for incontinence.
Croatian: Približno 75% bolesnika nije prethodno farmakološki liječilo inkontinenciju.
English: Allow the area to dry completely.
Croatian: Pričekajte da se područje potpuno osuši.
English: Of these 188 patients (38%) were 65 years of age and older and exhibited no overall differences in safety or effectiveness compared to younger patients.
Croatian: Od njih je 188 (38 %) bolesnika bilo u dobi od 65 godina ili starije i kod njih se sveukupno nisu pokazale razlike u sigurnosti i učinkovitosti u odnosu na mlađe bolesnike.
English: If you use more Kentera than you should
Croatian: Ako primijenite više Kentere nego što ste trebali
English: Patients should be monitored until symptoms resolve.
Croatian: Bolesnike je potrebno pratiti dok simptomi ne nestanu.
English: Currently available data are described in section 4.8 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 4.8, međutim nije moguće dati preporuku o doziranju.
English: Very rarely will the patch come off completely.
Croatian: Vrlo rijetko flaster otpada u potpunosti.
English: - Freshly washed, but dry and cool (wait a few minutes after taking a hot bath or shower).
Croatian: - upravo oprano, ali osušeno i ohlađeno (pričekajte nekoliko minuta nakon vruće kupke ili tuša).
English: Drowsiness may be increased by consumption of alcohol.
Croatian: Omamljenost se može povećati konzumacijom alkohola.
English: Studies in animals have shown minor reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su manju reproduktivnu toksičnost (vidjeti dio 5.3).
English: FURTHER INFORMATION What Kentera contains
Croatian: DRUGE INFORMACIJE Što Kentera sadrži
English: Press for at least 10 seconds to make sure the patch will stay in place.
Croatian: Držite ga pritisnutim najmanje 10 sekundi kako biste se uvjerili da će ostati na mjestu.
English: Kentera must not be taken by mouth.
Croatian: Kentera se ne smije uzimati na usta.
English: WHAT KENTERA IS AND WHAT IT IS USED FOR
Croatian: Što je Kentera i za što se koristi
English: It is important you read and follow these directions on how to use the Kentera pump properly.
Croatian: Važno je pročitati i pridržavati se ovih uputa o načinu kako se ispravno koristi pumpica Kentera.
English: Repeat until the sachet is empty.
Croatian: Ponovite dok se vrećica ne isprazni.
English: Do not apply a patch to the same place on your body for at least 1 week.
Croatian: Nemojte primjenjivati flaster na isto mjesto na tijelu najmanje 1 tjedan.
English: Bathing, showering, swimming and exercise:
Croatian: Kupanje, tuširanje, plivanje i vježbanje:
English: How to remove
Croatian: Kako ga ukloniti
English: Apply as directed above.
Croatian: Primijenite prema gore navedenim uputama.
English: These results were evident after the first month of treatment and were maintained throughout double-blind treatment as shown in the table below.
Croatian: Ti su rezultati bili očiti nakon prvog mjeseca liječenja i održani su tijekom cijelog dvostruko slijepog liječenja kao što je prikazano u tablici u nastavku.
English: A small amount of baby oil may also be used to remove any excess residue.
Croatian: Možete upotrijebiti i malu količinu ulja za bebe da biste uklonili moguće ostatke.
English: However, in the absence of understanding the association between maternal toxicity and developmental effect, the relevance to human safety cannot be addressed.
Croatian: Međutim, kako nedostaje razumijevanje povezanosti između toksičnosti kod majke i učinka na razvoj, ne može se ustvrditi značaj za sigurnost ljudi.
English: When changing the patch, remove the old patch slowly.
Croatian: Kada mijenjate flaster, uklanjajte stari flaster polako.
English: A new application site should be selected with each new patch to avoid reapplication to the same site within 7 days.
Croatian: Potrebno je odabrati novo mjesto primjene za svaki novi flaster, kako bi se izbjegla ponovna primjena na istom mjestu unutar 7 dana.
English: Do not apply Kentera in an area that is not approved.
Croatian: Nemojte primjenjivati Kenteru na područje koje nije odobreno.
English: Inflicted injury
Croatian: Zadobivene ozljede
English: How to use the sachets:
Croatian: Kako koristiti vrećice:
English: If urinary tract infection is present, an appropriate antibacterial therapy should be started.
Croatian: Ako je prisutna infekcija mokraćnih putova, potrebno je započeti odgovarajuću antibakterijsku terapiju.
English: Kentera contains alcohol and is considered flammable.
Croatian: Kentera sadrži alkohol i smatra se zapaljivom.
English: To apply Kentera: Step 1: Choose a spot for the patch that is:
Croatian: Primijenite Kenteru ovako: 1. korak: Odaberite mjesto za flaster koje je:
English: Kentera is not recommended for use in children and adolescents under 18 years old.
Croatian: Kentera se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: The metered dose should be applied immediately.
Croatian: Odmjerena doza mora se odmah primijeniti.
English: Date of first authorisation: 15/06/2004 Date of latest renewal: 30/04/2009
Croatian: Datum posljednje obnove odobrenja: 30.04.2009.
English: If not, take it off and put a new patch on a new spot.
Croatian: U suprotnome, skinite ga i stavite novi flaster na novo mjesto.
English: Pharmacovigilance System:
Croatian: Farmakovigilancijski sustav:
English: This leaflet was last approved in
Croatian: Ova uputa je zadnji puta odobrena u.
English: Activities that may lead to excessive sweating, or exposure to water or extreme temperature may contribute to adhesion problems.
Croatian: Aktivnosti koje mogu izazvati prekomjerno znojenje ili izlaganje vodi ili ekstremnim temperaturama mogu pridonijeti problemima s adhezijom.
English: Do not continue rubbing after Kentera has dried.
Croatian: Nemojte nastavljati trljati nakon što se Kentera osušila.
English: • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON
Croatian: • UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU ZADANI
English: Electrocardiogram abnormal, electrocardiogram change, blood chloride increased
Croatian: Abnormalan elektrokardiogram, promjene na elektrokardiogramu, povišena razina klorida u krvi
English: Important: Kentera is for application to the skin only.
Croatian: Važno: Kentera je isključivo za primjenu na kožu.
English: Apply a single dose as soon as you realise you have missed an application.
Croatian: Primijenite jednokratnu dozu čim se sjetite da ste preskočili primjenu.
English: Consumption of grapefruit juice may also influence metabolism of oxybutynin.
Croatian: Konzumacija soka od grejpfruta može također utjecati na metabolizam oksibutinina.
English: If the patch comes off:
Croatian: Ako flaster otpadne:
English: The product should not come in contact with an open flame.
Croatian: Lijek ne smije doći u kontakt s otvorenim plamenom.
English: The most commonly reported adverse drug reactions were application site reactions, occurring in 23.1% of patients.
Croatian: Najčešće prijavljivane nuspojave bile su reakcije na mjestu primjene, i to u 23,1% bolesnika.
English: Alcohol or other strong solvents may cause skin irritation and should not be used.
Croatian: Alkohol i ostala jaka otapala mogu prouzročiti iritaciju kože i ne bi ih se smjelo koristiti.
English: Taking other medicines
Croatian: Primjena drugih lijekova
English: If it sticks firmly all over, leave it on.
Croatian: Ako se čvrsto zalijepi cijelom površinom, ostavite ga na mjestu.
English: After the priming step is complete, 30 full doses will remain in the pump.
Croatian: Nakon što ste dovršili pripremu, u pumpici ostaje 30 punih doza.
English: This redness should disappear within several hours after removal of the patch.
Croatian: Ovo crvenilo bi trebalo nestati unutar nekoliko sati nakon uklanjanja flastera.
English: Take special care when driving or using machinery.
Croatian: Posebno pazite kad upravljate vozilima ili strojevima.
English: The most commonly reported adverse reaction was dry mouth (Kentera 6.9%, placebo 2.8%).
Croatian: Najčešće prijavljena nuspojava bila su suha usta (Kentera 6,9%, placebo 2,8%).
English: No cases of overdose have been reported with Kentera.
Croatian: Nisu prijavljeni slučajevi predoziranja s Kenterom.
English: Mark the schedule you plan to follow and remember always to change your patch on the same two days of the week you have chosen on your calendar.
Croatian: Označite raspored kojeg se planirate pridržavati i uvijek se sjetite zamijeniti postojeći flaster novim flasterom na ta dva dana u tjednu koje ste odabrali na kalendaru.
English: Northern Ireland BT51 3RP
Croatian: Sjeverna Irska BT51 3RP
English: Make sure to wear only one patch at a time and wear your patch continuously, until it is time to apply a new one.
Croatian: Uvjerite se da uvijek imate samo jedan flaster i nosite ga stalno, dok nije vrijeme za primjenu novog.
English: The results of the study indicate that showering after one hour does not affect the overall systemic exposure to oxybutynin.
Croatian: Rezultati ispitivanja pokazuju da tuširanje nakon jednog sata ne utječe na ukupnu sistemsku izloženost oksibutininu.
English: Steady-state conditions are reached after the seventh day of administration.
Croatian: Stanje dinamičke ravnoteže doseže se nakon sedmog dana primjene.
English: - If you are hypersensitive (allergic) to oxybutynin or any of the ingredients of Kentera.
Croatian: Ako ste preosjetljivi (alergični) na oksibutinin ili neki drugi sastojak Kentere.
English: Remaining active ingredients of the patch may have harmful effects if reaching the aquatic environment.
Croatian: Preostale djelatne tvari flastera mogu imati štetno djelovanje ako stignu do vodenog okruženja.
English: A 14-week, open-label treatment was available for a subset of patients who completed the double-blind period.
Croatian: Otvoreno 14-tjedno liječenje bilo je dostupno za podskupinu bolesnika koja je dovršila dvostruko slijepo razdoblje.
English: Women of childbearing potential/Contraception in males and females Women of childbearing age should be tested for pregnancy before beginning therapy, and during therapy utilise some form of pregnancy contraceptive.
Croatian: Žene reproduktivne dobi/Kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju napraviti test na trudnoću prije početka terapije i tijekom terapije koristiti neki oblik kontracepcije.
English: Like all medicines, Kentera can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Kentera može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: Always use Kentera exactly as your doctor has told you.
Croatian: Uvijek primijenite Kenteru točno onako kako Vam je rekao liječnik.
English: Do not expose the patch to the sun.
Croatian: Ne izlažite flaster suncu.
English: Always place the small protective cap back firmly on the tip of the pump nozzle and the large pump cover over the top of the pump after each use.
Croatian: Uvijek vratite mali zaštitni zatvarač čvrsto na vrh mlaznice pumpice i veliki pokrov pumpice preko vrha pumpice nakon svake uporabe.
English: The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1 of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Croatian: Nositelj odobrenja mora osigurati da je farmakovigilancijski sustav, prikazan u Modulu 1.8.1. Odobrenja za stavljanje lijeka u promet, ustrojen i funkcionalan prije i za vrijeme dok je lijek na tržištu.
English: After 30 doses, discard the Kentera pump.
Croatian: Nakon 30 doza bacite pumpicu Kentera.
English: Avoid contact with eyes, nose, open sores, recently shaved skin, and skin with rashes or other areas not approved for the application of Kentera.
Croatian: Izbjegavajte dodir s očima, nosom, otvorenim ranama, nedavno obrijanom kožom i kožom s osipima ili s drugim područjima koji nisu odobreni za primjenu Kentere.
English: - Do not cut the sachet with scissors, which might damage the patch inside.
Croatian: - Nemojte rezati vrećicu škarama jer bi to moglo oštetiti flaster koji se u njoj nalazi.
English: Oxybutynin may antagonize prokinetic therapies.
Croatian: Oksibutinin može antagonizirati prokinetičke terapije.
English: BT51 3RP Northern Ireland
Croatian: BT51 3RP Sjeverna Irska
English: Adverse reactions were observed in embryotoxicity studies in the rabbit.
Croatian: Nuspojave su primijećene u ispitivanjima embriotoksičnosti u kunića.
English: - Apply immediately to your skin; do not keep or store the patch outside the sealed sachet.
Croatian: - Odmah primijenite na kožu; nemojte držati ili čuvati flaster izvan hermetički zatvorene vrećice.
English: The efficacy and safety of Kentera were evaluated in patients with urge urinary incontinence in a single Phase 3 study.
Croatian: Djelotvornost i sigurnost Kentere procijenjene su u bolesnika s urgentnom urinarnom inkontinencijom u jednom ispitivanju faze III.
English: Apply immediately upon opening.
Croatian: Primijenite odmah nakon otvaranja.
English: If it does, try putting the same patch back on the same spot.
Croatian: Ako otpadne, pokušajte ga vratiti na isto mjesto.
English: The majority of patients were Caucasian (86.3%) and female (89.2%), with a mean age of 59.4 years (range: 18 to 88 years).
Croatian: (86,3%) i žene (89,2%), srednje vrijednosti starosne dobi od 59,4 godine (raspon: od 18 do 88 godina).
English: At a concentration of 0.4 mg/kg/day oxybutynin administered subcutaneously, the occurrence of organ anomalies is significantly increased, but is observed only in the presence of maternal toxicity.
Croatian: Pri koncentraciji od 0,4 mg/kg/dan oksibutinina primijenjenog supkutano, pojava anomalija organa značajno se povećava, ali se zapaža samo u prisutnosti toksičnosti kod majke.
English: The expiry date refers to the last date of the month.
Croatian: Rok valjanosti odnosi se na zadnji dan mjeseca.
English: Kentera contains alcohol and is considered flammable and should not come in contact with an open flame.
Croatian: Kentera sadrži alkohol i smatra se zapaljivom te ne smije doći u kontakt s otvorenim plamenom.
English: The patch is designed to re-stick.
Croatian: Flaster je izrađen tako da se ponovno zalijepi.
English: Since treatment with oxybutynin may cause decreased perspiration, there is an increased risk of fever and heat stroke if you are exposed to high environmental temperatures.
Croatian: Budući da liječenje oksibutininom može prouzročiti smanjenje znojenja, postoji povećani rizik od vrućice i toplinskog udara ako ste izloženi visokim okolišnim temperaturama.
English: Printed on the inside flap of your Kentera package, you will find a Kentera calendar checklist that will help you to remember your dosing schedule.
Croatian: Na unutarnjoj preklopnici pakiranja Kentere, otisnuta je kontrolna lista u obliku kalendara koja će Vam pomoći zapamtiti raspored uzimanja doze.
English: How to use the multidose container with metering pump:
Croatian: Kako koristiti višedozni spremnik s odmjernom pumpicom:
English: Oxybutynin is a racemic (50:50) mixture of R- and S-isomers.
Croatian: Oksibutinin je racemična (50:50) smjesa R- i S-izomera.
English: As soon as you remember, remove the old patch and apply a new one to a new spot on your abdomen, hips or buttocks.
Croatian: Čim se sjetite, uklonite stari flaster i primijenite novi na novo mjesto na trbuhu, kukovima ili stražnjici.
English: You should not use Kentera if you are pregnant unless your doctor has told you to.
Croatian: Ne smijete uzimati Kenteru ako ste trudni, osim ako Vam to liječnik nije izričito rekao.
English: - Without touching the sticky surface, firmly press the patch, adhesive face down, onto the part of the abdomen, hips or buttocks you have selected for application.
Croatian: - Bez dodirivanja ljepljive površine, čvrsto pritisnite flaster, ljepljivom stranom prema dolje, na dio trbuha, kukova ili stražnjice koji ste odabrali za primjenu.
English: Kentera transdermal patch:
Croatian: Kentera transdermalni flaster:
English: Kentera led to consistent improvements in overactive bladder symptoms compared with placebo.
Croatian: Kentera je dovela do konzistentnih poboljšanja u simptomima hiperaktivnog mokraćnog mjehura u usporedbi s placebom.
English: Kentera has a concentration of oxybutynin sufficient to maintain continuous transport over the 3 to 4 day dosing interval.
Croatian: Kentera ima dovoljnu koncentraciju oksibutinina za održavanje stalnog prijenosa tijekom 3 do 4 dana intervala doziranja.
English: Rotating approved application sites with each dose may help in reducing the risk of developing skin irritations.
Croatian: Mijenjanje odobrenog mjesta primjene prilikom svake nove doze može pomoći u smanjivanju rizika od razvijanja iritacija kože.
English: (See Figure D).
Croatian: (Pogledajte sliku D).
English: After use the patch still contains substantial quantities of active ingredients.
Croatian: Nakon primjene, flaster još sadrži znatne količine djelatnih tvari.
English: Significant positive effects were also noted for each subscale domain of the IIQ and for six of ten quality of life domains, including the incontinence impact domain, of the King's Health Questionnaire (KHQ) as shown in the table below.
Croatian: Značajni pozitivni učinci zapaženi su i za svako područje podljestvice upitnika IIQ i za šest od deset područja kvalitete života, uključujući područje utjecaja inkontinencije, u KHQ (King's Health
English: Gel 30 sachets of 1 gram.
Croatian: 30 vrećica s 1 gramom.
English: Step 2: Open the sachet that contains the patch.
Croatian: 2. korak: Otvorite vrećicu koja sadrži flaster.
English: Based on clinical trial experience no dose adjustment is considered necessary in this population.
Croatian: Na temelju iskustva iz kliničkih ispitivanja, smatra se da nije potrebno prilagođavanje doze za tu populaciju.
English: Other adverse reactions reported were application site pruritus (Kentera 2.1%, placebo 0.8%), application site dermatitis (Kentera 1.8%, placebo 0.3%), dizziness (Kentera 1.5%, placebo 0.5%), headache (Kentera 1.5%, placebo 2.8%), constipation (Kentera 1.3%, placebo 1.0%), and pruritus (Kentera 1.3%, placebo 1.3%).
Croatian: Druge prijavljene nuspojave bile su svrbež na mjestu primjene (Kentera 2,1%, placebo 0,8%), dermatitis na mjestu primjene (Kentera 1,8%, placebo 0,3%), omaglica (Kentera 1,5%, placebo 0,5%), glavobolja (Kentera 1,5%, placebo 2,8%), konstipacija (Kentera 1,3%, placebo 1,0%) i svrbež (Kentera 1,3%, placebo
English: - If you have digestion problems caused by reduced emptying of the stomach after a meal you should consult your doctor before using Kentera.
Croatian: Ako imate probavnih smetnji prouzročenih smanjenim pražnjenjem želuca nakon jela, morate se obratiti liječniku prije primjene Kentere.
English: Thus based on current clinical evidence no need for dose adjustment in elderly patients is considered necessary.
Croatian: Stoga se, na temelju aktualnih kliničkih dokaza, smatra da u starijih bolesnika nije potrebno prilagođavanje doze.
English: Kentera is not recommended for use in the paediatric population.
Croatian: Kentera se ne preporučuje za primjenu u pedijatrijskoj populaciji.
English: Kentera should not be used during pregnancy unless clearly necessary.
Croatian: Kentera se ne smije primjenjivati tijekom trudnoće osim ako je to izričito neophodno.
English: If irritation persists, please contact your doctor.
Croatian: Ako je iritacija i dalje prisutna, obratite se liječniku.
English: - Gently bend the patch and remove the first piece of protective liner, which covers the sticky surface of the patch.
Croatian: Nježno presavijte flaster i uklonite prvi dio zaštitnog sloja, koji prekriva ljepljivu površinu flastera.