natgillin/translations-raw huggingface dataset:
For non-radiographic axial spondyloarthritis, Simponi was compared with placebo over 16 weeks in one main study involving 198 patients who had the disease without evidence of ankylosing spondylitis but with signs of inflammation and who had not responded adequately to treatment with NSAIDs.
Kod aksijalnog spondiloartritisa Simponi je uspoređen s placebom tijekom 16 tjedana u jednom glavnom ispitivanju koje je uključivalo 198 bolesnika s ovom bolešću bez dokaza ankilozantnog spondilitisa, ali sa znakovima upale, koji nisu adekvatno reagirali na terapiju NSAID-ovima.
In the first study, around 51% of patients receiving induction treatment with Simponi (starting at 200 mg) responded to treatment after 6 weeks, compared with around 30% of patients given placebo.
U prvom je ispitivanju 51 % bolesnika koji su primali indukcijsku terapiju lijekom Simponi (s početnom dozom od 200 mg) reagiralo na liječenje nakon 6 tjedana, u usporedbi s oko 30 % bolesnika koji su primili placebo.
Simponi contains the active substance golimumab.
Lijek Simponi sadrži djelatnu tvar golimumab.
• moderately to severely active ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut).
• umjerenog do teškog aktivnog ulceroznog kolitisa (bolesti koja uzrokuje upalu i čireve na stijenci crijeva).
In the first study, in which patients were also given methotrexate, after 14 weeks, 55% patients who received Simponi (49 out of 89) achieved 20% reductions compared with 33% (44 out of 133) of patients who received placebo.
U prvom ispitivanju u kojem su bolesnici također primili metotreksat, nakon 14 tjedana u 55 % bolesnika koji su primili lijek Simponi (49 od 89) došlo je do 20 %-tnog smanjenja, u usporedbi s 33 % (44 od133) bolesnika koji su primili placebo.
In the second study, after 14 weeks, 35% of patients who received Simponi alone (54 out of 153) achieved 20% reductions in the number and severity of symptoms compared with 18% of patients who received placebo (28 out of 155).
U drugom ispitivanju, nakon 14 tjedana, u 35 % bolesnika koji su primili samo Simponi (54 od 153) došlo je do 20 %-tnog smanjenja broja i težine simptoma, u usporedbi s 18 % bolesnika koji su primili placebo (28 od 155).
• active rheumatoid arthritis (a disease causing inflammation of the joints).
• aktivnog reumatoidnog artritisa (bolesti koja uzrokuje upalu zglobova).
In the second study, around 50% of patients receiving maintenance treatment with Simponi 100 mg and around 47% of those given Simponi 50 mg responded to treatment after 54 weeks, compared with around 31% of patients given placebo.
U drugom je ispitivanju oko 50 % bolesnika koji su primili terapiju održavanja lijekom Simponi od 100 mg i oko 47 % bolesnika koji su primili Simponi od 50 mg reagiralo na liječenje nakon 54 tjedna, u usporedbi s 31 % bolesnika koji su primili placebo.
How is Simponi used?
Kako se Simponi primjenjuje?
For rheumatoid arthritis, Simponi was compared with placebo (a dummy treatment) in three studies involving 1,542 patients with moderate to severe rheumatoid arthritis, including patients who had not received or responded adequately to other treatments.
Kod reumatoidnog artritisa Simponi je uspoređen s placebom (prividnim liječenjem) u trima ispitivanjima koja su obuhvatila 1 542 bolesnika s umjerenim do ozbiljnim reumatoidnim artritisom, uključujući bolesnike koji prethodno nisu primili drugu terapiju ili na nju nisu adekvatno reagirali.
For ankylosing spondylitis, Simponi was compared with placebo over 24 weeks in one main study involving 356 patients who had not responded adequately to other treatments.
Kod ankilozantnog spondilitisa Simponi je uspoređen s placebom tijekom 24 tjedna u jednom glavnom ispitivanju na 356 bolesnika koji nisu adekvatno reagirali na druge terapije.
For the full list of restrictions with Simponi, see the package leaflet.
Potpuni popis ograničenja za lijek Simponi potražite u uputi o lijeku.
For psoriatic arthritis, Simponi was compared with placebo over 24 weeks in one main study involving 405 patients who had not responded adequately to other treatments.
Kod psorijatičnog artritisa, Simponi je uspoređen s placebom tijekom 24 tjedna u jednom glavnom ispitivanju koje je obuhvatilo 405 bolesnika koji nisu adekvatno reagirali na druge terapije.
Of the patients who received Simponi, 71% (69 out of 97) had 20% reductions in the number and severity of symptoms after 16 weeks, compared with 40% of patients who were given placebo (40 out of 100).
U bolesnika koji su primali Simponi, u 71 % (69 od 97) njih došlo je do 20 %-tnog smanjenja broja i težine simptoma nakon 16 tjedana, u usporedbi s 40 % bolesnika koji su primali placebo (40 od 100).
Of the patients who received Simponi, 59% (82 out of 138) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 22% of patients who were given placebo (17 out of 78).
U bolesnika koji su primali Simponi, u 59 % (82 od 138) njih došlo je do 20 %-tnog smanjenja broja i težine simptoma, u usporedbi s 22 % bolesnika koji su primali placebo (17 od 78).
For ulcerative colitis, Simponi was compared with placebo in two main studies in patients who had not responded to or could not use other treatments.
Kod ulceroznog kolitisa Simponi je uspoređen s placebom u dvama glavnim ispitivanjima na bolesnicima koji nisu reagirali na prethodne terapije ili za koje druge terapije nisu bile primjerene.
Of the patients who received Simponi, 51% (74 out of 146) had 20% reductions in the number and severity of symptoms after 14 weeks, compared with 9% of patients who were given placebo (10 out of 113).
U bolesnika koji su primali Simponi, u 51 % (74 od 146) njih došlo je do 20 %-tnog smanjenja broja i težine simptoma, u usporedbi s 9 % bolesnika koji su primali placebo (10 od 113).
For the full list of side effects reported with Simponi, see the package leaflet.
Potpuni popis nuspojava zabilježenih pri primjeni lijeka Simponi potražite u uputi o lijeku.
17 June 2015
17. lipnja 2015.
Adoption of CMDh agreement:
Usvajanje sporazuma CMDh-a:
16 October 2015
16. listopada 2015.
Implementation of the agreement by the Member States (submission of the variation type IB by the Marketing Authorisation Holder):
Provedba sporazuma u državama članicama (nositelj odobrenja za stavljanje lijeka u promet predaje izmjenu tipa IB):
May 2015 CMDh meeting
Sastanak CMDh-a u svibnju 2015.
Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Dostavljanje prijevoda dodataka sporazumu nacionalnim nadležnim tijelima:
Data in the elderly patients are very limited.
Podaci za starije bolesnike vrlo su ograničeni.
Very common: may affect more than 1 in 10 people are listed below:
Vrlo često: mogu se javiti u više od 1 na 10 osoba, navedene su niže:
If you forget to take a dose,take your capsules as soon as you remember.
Ako ste zaboravili uzeti dozu, uzmite kapsule čim se sjetite.
Date of latest renewal: 22 July 2016
Datum posljednje obnove odobrenja: 22. srpnja 2016.
Co. Meath,
Meath,
Eventually, the amyloid causes the symptoms of this disease.
Na kraju će amiloid izazvati simptome ove bolesti.
Component of a multipack, can't be sold separately.
Sastavni dio višestrukog pakiranja, ne može se prodavati zasebno.
The Physician Information Leaflet should contain the following key messages:
Informativni letak za liječnike treba sadržavati sljedeće ključne poruke:
• Vaginal infection in women
• vaginalna infekcija u žena
In case of overdose, standard supportive measures should be instituted as required.
U slučaju predoziranja, po potrebi se trebaju uvesti standardne potporne mjere.
15 INSTRUCTIONS ON USE
15. UPUTE ZA UPORABU
Tafamidis is highly protein bound (99.9%) in plasma.
Tafamidis je u visokom postotku (99,9%) vezan za proteine u plazmi.
No dosage adjustment is required for elderly patients (≥ 65 years).
Nije potrebno prilagođavati dozu u starijih bolesnika (u dobi od ≥ 65 godina).
Talk to your doctor, pharmacist or nurse before taking Vyndaqel.
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Vyndaqel.
TTR is a protein that carries other substances, such as hormones, through the body.
TTR je protein koji prenosi druge tvari, kao što su hormoni, po tijelu.
Dose and time linearity
Linearnost doze i vremena
Amyloid can build up around your nerves and in other places in your body, preventing them from working normally.
Amiloid se može nakupiti oko živaca i na drugim mjestima u tijelu i tako spriječiti njihovo normalno funkcioniranje.
• The active substance is tafamidis.
• Djelatna tvar je tafamidis.
You should not take more capsules than your doctor tells you to.
Ne smijete uzeti više kapsula nego što Vam je rekao liječnik.
Do not stop taking Vyndaqel without first speaking to your doctor.
Nemojte prestati uzimati Vyndaqel bez prethodnog razgovora s liječnikom.
If you take more capsules than you have been told to take, contact your doctor.
Ako uzmete više kapsula nego što Vam je rečeno da uzmete, obratite se svom liječniku.
If you are allergic to tafamidis meglumine or any of the other ingredients of this medicine (listed in section 6).
ako ste alergični na tafamidismeglumin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
Liver effects were seen at doses above (>3) human exposure and have generally been shown to be reversible.
Učinci na jetru opaženi su pri dozama većima (>3) od izloženosti ljudi i općenito su se pokazali reverzibilnima.
Tafamidis meglumine is a specific stabilizer of transthyretin.
Tafamidismeglumin je specifični stabilizator transtiretina.
If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder's local office number that is provided in this leaflet.
Ako se ova uputa slabo vidi ili ju je teško pročitati ili biste je voljeli dobiti u drugačijem obliku, obratite se na broj telefona lokalnog nositelja odobrenja koji se nalazi u ovoj uputi.
Summary of safety profile
Sažetak profila sigurnosti
Vyndaqel % change relative to Placebo
Vyndaqel % promjena u odnosu na placebo
No cases of acute overdose have been reported.
Nije zabilježen niti jedan slučaj akutnog predoziranja.
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Ova uputa je zadnji puta revidirana u {MM/GGGG}.
Cmax(ss) and Cmin(ss) was 2.7 and 1.6 µg/ml, respectively.
Cmax(ss) iznosio je 2,7 µg/ml, a Cmin(ss) 1,6 µg/ml.
Vyndaqel is therefore not used for children and adolescents.
Vyndaqel se stoga ne primjenjuje u djece i adolescenata.
Studies in animals have shown developmental toxicity (see section 5.3).
Ispitivanja na životinjama pokazala su razvojnu toksičnost (vidjeti dio 5.3).
Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, fertility and early embryonic development, genotoxicity and carcinogenic potential.
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, plodnosti i ranog embrionalnog razvoja, genotoksičnosti i kancerogenog potencijala.
• You should not take Vyndaqel if you are pregnant or breast-feeding.
• Ne smijete uzimati Vyndaqel ako ste trudni ili dojite.
Physicians should monitor patients and continue to assess the need for other therapy, including the need for liver transplantation, as part of this standard of care.
Liječnici trebaju nadzirati bolesnike i nastaviti s procjenom potrebe za drugom terapijom, uključujući potrebu za transplantacijom jetre, kao dio ove standardne njege.
If it is within 6 hours before your next dose, skip the missed dose and take the next dose at the usual time.
Ako je preostalo manje od 6 sati do sljedeće doze, preskočite dozu koju ste propustili i uzmite sljedeću u uobičajeno vrijeme.
In repeated dose toxicity studies the liver appeared as a target organ for toxicity in the different species tested.
U ispitivanjima toksičnosti ponovljenih doza, jetra se činila ciljnim organom toksičnosti u različitih ispitanih vrsta.
Concomitant administration of food decreased the rate of absorption, but not the extent of absorption.
Istodobna primjena hrane smanjila je brzinu apsorpcije, ali ne i veličinu apsorpcije.
mBMI was derived as the product of serum albumin and Body Mass Index.
mBMI je određen kao umnožak serumskog albumina i indeksa tjelesne mase.
These results support the administration of tafamidis with or without food.
Ovi rezultati podupiru primjenu tafamidisa s hranom ili bez nje.
No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis meglumine.
Nisu provedena ispitivanja interakcija kojima bi se procijenio učinak drugih lijekova na tafamidismeglumin.
Therequirements for submission of periodic safety update reports for this medicinal product are set out in the list of 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.
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.
Pharmacokinetic parameters were similar after single and repeated administration of 20 mg dose, indicating a lack of induction or inhibition of tafamidis metabolism.
Farmakokinetički parametri bili su slični nakon primjene jednokratne i ponovljene doze od 20 mg, što ukazuje na nedostatak indukcije ili inhibicije metabolizma tafamidisa.
The effects of tafamidis on cardiac disease progression have not yet been adequately characterised.
Učinci tafamidisa na napredovanje srčane bolesti još nisu primjereno opisani.
• Push capsule through the exposed aluminium foil.
• protisnite kapsulu kroz otkrivenu aluminijsku foliju.
Pfizer Europe MA EEIG (as MA Holder logo)
Pfizer Europe MA EEIG (kao logotip nositelja odobrenja)
PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters.
PVC/PA/Al/PVC-Al/PET/papir perforirani blister s jediničnim dozama.
This medicine has been authorised under ‘exceptional circumstances'.
Ovaj lijek je odobren u “iznimnim okolnostima”.
Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (1/10), Common (1/100 to <1/10), and Uncommon (1/1,000 to <1/100).
Niže navedene nuspojave prikazane su prema MedDRA klasifikaciji organskih sustava (SOC) i kategorijama učestalosti korištenjem ove standardne konvencije: vrlo često (1/10), često (1/100 i <1/10) i manje često (1/1000 i <1/100).
As Vyndaqel works by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized, and your disease may progress.
Budući da Vyndaqel djeluje tako da stabilizira TTR protein, ako prestanete uzimati Vyndaqel, taj protein više neće biti stabiliziran i može doći do napredovanja bolesti.
• The need to counsel patients on important risks associated with Vyndaqel therapy and appropriate precautions when using the medicine, particularly the avoidance of pregnancy and the need for effective contraception.
• Bolesnike je potrebno upozoriti na važne rizike povezane s terapijom Vyndaqelom i odgovarajućim mjerama opreza kad se uzima ovaj lijek, osobito izbjegavanja trudnoće i potrebe za učinkovitom kontracepcijom.
Pharmacotherapeutic group: Other nervous system drugs, ATC code N07XX08 Mechanism of action
Farmakoterapijska skupina: drugi lijekovi za živčani sustav, ATK oznaka: N07XX08
The soft capsules should be swallowed whole, not crushed or cut, and taken with or without food.
Meke kapsule trebaju se progutati cijele i ne smiju se drobiti niti rezati, a mogu se uzeti s hranom ili bez nje.
The adverse reactions were generally mild or moderate in severity.
Nuspojave su općenito bile blage ili umjerene težine.
The soft capsule should be swallowed whole, not crushed or cut.
Meka se kapsula mora progutati cijela, ne smije se drobiti niti rezati.
However, the difference in clearance would not be clinically significant and would not result in clinically relevant different steady-state levels compared to younger subjects.
Međutim, razlika u klirensu ne bi bila klinički značajna i ne bi rezultirala klinički značajno različitim razinama u stanju dinamičke ravnoteže u usporedbi s onima u mlađih ispitanika.
You should inform your doctor or pharmacist if you are taking any of the following:
Obavijestite svog liječnika ili ljekarnika ako uzimate neki od sljedećih lijekova:
As patients with moderate hepatic impairment have lower TTR levels than healthy subjects, dosage adjustment is not necessary as the stoichiometry of tafamidis with its target protein TTR would be sufficient for stabilization of the TTR tetramer.
Kako bolesnici s umjerenim oštećenjem jetre imaju niže razine TTR od zdravih ispitanika, prilagodba doze nije potrebna jer bi stehiometrija tafamidisa s njegovim ciljnim proteinom TTR bila dovoljna za stabilizaciju TTR tetramera.
This route of biotransformation is plausible in humans, as approximately 59% of the total administered dose is recovered in faeces, and approximately 22% recovered in urine.
Ovo je vjerojatno put biotransformacije u ljudi, jer se približno 59% ukupne primijenjene doze otkrije u stolici, a približno 22% u mokraći.
Tafamidis meglumine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Тafamidis meglumin se ne preporučuje u trudnoći i u žena reproduktivne dobi koje ne koriste kontracepciju.
Vyndaqel, can prevent TTR from breaking up and forming amyloid deposits.
Vyndaqel može spriječiti raspadanje TTR-a i stvaranje depozita amiloida.
In clinical trials of healthy volunteers, the highest dose of tafamidis given was 480 mg in a single dose and 60 mg once daily for two weeks.
U kliničkim ispitivanjima sa zdravim dobrovoljcima najviša primijenjena doza tafamidisa bila je 480 mg u jednokratnoj dozi i 60 mg jedanput na dan tijekom dva tjedna.
To remove capsule: tear off one individual blister, peel the paper at the curved arrow and push through the aluminium foil.
Da biste izvadili kapsulu: odvojite jedan pojedinačni dio blistera, odlijepite papir kod zakrivljene strelice i protisnite kroz aluminijsku foliju.
The secondary endpoints demonstrated that tafamidis meglumine treatment resulted in less deterioration of neurologic function and improved nutritional status (mBMI) compared with placebo, as shown in the following table.
Sekundarne mjere ishoda pokazale su da je terapija tafamidismegluminom rezultirala manjim propadanjem neurološke funkcije i poboljšanim stanjem uhranjenosti (mBMI) u usporedbi s placebom, kako je prikazano u sljedećoj tablici.
Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.
Smatra se da Vyndaqel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
In vitro data also indicated that tafamidis meglumine does not significantly inhibit cytochrome P450 enzymes CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6.
In vitro podaci također su pokazali da tafamidismeglumin ne inhibira značajno enzime citokroma P450 CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19 i CYP2D6.
• That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Vyndaqel since there is limited knowledge about the clinical safety due to the rare nature of transthyretin amyloidosis.
• Bolesnicima treba savjetovati da posjete liječnika u vezi s nuspojavama i da liječnici/ljekarnici trebaju prijaviti sumnju na nuspojave Vyndaqela budući da je poznavanje kliničke sigurnosti ograničeno zbog rijetke učestalosti transtiretinske amiloidoze.
Within the planned post-authorisation sub-study of the THAOS registry the MAH shall evaluate in non-V30M patients the effects of Vyndaqel on disease progression and its long term safety as detailed in a CHMP agreed protocol, and shall provide yearly updates on the collected data within the annual re-assessment.
Unutar planiranog podispitivanja registra THAOS nakon odobrenja za stavljanje lijeka u promet, nositelj odobrenja procijenit će u ne-V30M bolesnika učinke Vyndaqela na napredovanje bolesti i njegovu dugoročnu sigurnost kako je opisano u planu ispitivanja dogovorenom s CHMP-om i svake će godine osigurati nadopune prikupljenih podataka unutar godišnje procjene.
The overall clinical data reflect exposure of 127 TTR amyloid polyneuropathy patients to 20 mg of tafamidis meglumine administered daily for an average of 538 days (ranging from 15 to 994 days).
Sveukupni klinički podaci odražavaju izloženost 127 bolesnika s TTR amiloidnom polineuropatijom tafamidismegluminom u dozi od 20 mg na dan koji se primjenjivao u prosjeku 538 dana (u rasponu od 15 do 994 dana).
After oral administration of the soft capsule, the maximum plasma concentration (Cmax) is achieved at a median time (tmax) of 2 hours after dosing in the fasted state.
Nakon oralne primjene meke kapsule, najviša koncentracija u plazmi (Cmax) postiže se nakon medijana vremena (tmax) od 2 sata nakon primjene doze natašte.
Do not use this medicine after the expiry date which is stated on the blister card and on the carton.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji.
• If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.
• Ako možete zatrudnjeti, morate koristiti kontracepciju za vrijeme liječenja i tijekom jednog mjeseca nakon prestanka liječenja.
TTR amyloid polyneuropathy is caused by a protein called TTR that does not work properly.
TTR amiloidnu polineuropatiju uzrokuje protein koji se zove TTR i koji ne funkcionira ispravno.
As there are no data available regarding the use of tafamidis meglumine post-liver transplantation, tafamidis meglumine should be discontinued in patients who undergo liver transplantation.
Kako nema dostupnih podataka o primjeni tafamidismeglumina nakon transplantacije jetre, primjenu tafamidismeglumina treba prekinuti u bolesnika koji se podvrgnu transplantaciji jetre.
Based on repeated measures analysis of variance with change from baseline as the dependent variable, an unstructured covariance matrix, treatment, month and treatment-by-month as fixed effects, and subject as a random effect in the model.
Na temelju ponovljenih mjerenja u analizi varijance s promjenom u odnosu na početnu vrijednost kao ovisnom varijablom, nestrukturiranom matricom kovarijance, terapijom, mjesecom i terapijom po mjesecu kao fiksnim učincima te ispitanikom kao slučajnim učinkom u modelu.
Available pharmacodynamic/toxicological data in animals have shown excretion of tafamidis in milk.
Dostupni farmakodinamički/toksikološki podaci u životinja pokazali su da se tafamidis izlučuje u mlijeko liječenih žena.
The reported treatment-related adverse events were mild to moderate and included: headache, somnolence, myalgia, insomnia, hordeolum, photosensitivity reaction, and presyncope.
Prijavljene nuspojave povezane s terapijom bile su blage do umjerene te su uključivale: glavobolju, somnolenciju, mijalgiju, nesanicu, ječmenac (hordeolum), reakciju fotoosjetljivosti i presinkopu.
These intermediates then misassemble into soluble oligomers, profilaments, filaments, and amyloid fibrils.
Ti se međuspojevi potom krivo spajaju u topljive oligomere, profilamente, filamente i amiloidne fibrile.
Eighty-six of the 91 patients completing the 18 month treatment period subsequently enrolled in an open label extension study, where they all received once daily 20 mg tafamidis meglumine for an additional 12 months.
Potom je 86 od 91 bolesnika koji su završili terapiju u trajanju od 18 mjeseci bilo uključeno u produžetak ispitivanja otvorenog tipa u kojem su svi primali 20 mg tafamidismeglumina jedanput na dan tijekom dodatnih 12 mjeseci.
• Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate or a frequent need to urinate)
• infekcija mokraćnog sustava (simptomi mogu uključivati: bol i žarenje pri mokrenju ili učestala potreba za mokrenjem)