natgillin/translations-raw huggingface dataset:
The MAHs within 2 months of the Commission Decision should liaise with the National Competent Authorities to agree on the timelines for submission of the Risk Management Plans.
Imetniki dovoljenj za promet z zdravilom se morajo v dveh mesecih po odločbi Komisije povezati s pristojnimi nacionalnimi organi in se dogovoriti o časovnem načrtu za predložitev načrtov za obvladovanje tveganj.
• New neoplasm
• novotvorba;
Conditions of the marketing authorisations
Priloga IV Pogoji dovoljenja za promet z zdravilom
• Second neoplasm in childhood cancer survivors
• sekundarna novotvorba pri tistih, ki so v otroški dobi preboleli rakavo obolenje;
(for the morning) and a moon (for the evening).
Na omotu sta sonce (za jutro) in mesec (za večer).
• At the request of the European Medicines Agency.
• na zahtevo Evropske agencije za zdravila.
This dose will usually be given to you in the hospital.
Ta odmerek boste po navadi dobili v bolnišnici.
Experience beyond 12 months is limited.
Izkušenj z uporabo več kot 12 mesecev je malo.
If bleeding occurs appropriate supportive measures should be taken.
Če se pojavi krvavitev, je treba uporabiti ustrezne podporne ukrepe.
nominal significance value; all others are formally statistically significant by pre-defined hierarchical testing.
nominalna vrednost značilnost; vsi drugi so formalno statistično značilni po vnaprej opredeljenem hierarhičnem testiranju.
About 30% of episodes resolved within 7 days.
Približno 30 % epizod je minilo v 7 dneh.
In absolute terms, this risk was higher than in the overall PLATO population.
Absolutno gledano je bilo tveganje večje kot v celotni populaciji PLATO.
The mechanism has not been elucidated.
Mehanizem tega ni razjasnjen.
Your doctor will discuss with you the benefits and risks of taking Possia during this time.
Zdravnik se bo z vami pogovoril o koristih in tveganjih jemanja zdravila Possia med tem časom.
Thus no particular group was identified at risk for any subset of bleeding.
Tako niso identificirali nobene posebne skupine s tveganjem kakšne podskupine krvavitev.
If your feeling of shortness of breath gets worse or lasts a long time, tell your doctor.
Če se vam občutek kratke sape slabša ali traja dolgo časa, povejte zdravniku.
Treatment of overdose should follow local standard medical practice.
Zdravljenje prevelikega odmerjanja mora upoštevati standardno lokalno medicinsko prakso.
This is calculated as 3/9235 which equates to a frequency category of ‘rare'
Izračun je tako 3/9235, kar ustreza kategoriji pogostnosti "redki"
• If you forget to take a dose, just take your next dose as normal.
• Če ste pozabili vzeti odmerek, zgolj vzemite naslednji odmerek kot po navadi.
Take the medicine pack with you.
S seboj vzemite ovojnino zdravila.
These small changes are considered of minimal clinical significance; therefore, ticagrelor can be given with or without food.
Te majhne spremembe veljajo za minimalno klinično pomembne, zato je tikagrelor mogoče jemati s hrano ali brez nje.
• You have had a blood test that showed more than the usual amount of uric acid
• če ste imeli preiskavo krvi, ki je pokazala več kot običajno količino sečne kisline.
• When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities
• po prejemu novih informacij, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja,
Figure 1 shows the estimate of the risk to the first occurrence of any event in the composite efficacy
Slika 1 kaže oceno tveganja do prvega pojava kateregakoli dogodka v sestavljeni končni točki učinkovitosti.
• Inflamed stomach (gastritis)
• vnetje želodca (gastritis)
• Bleeding - some bleeding is common.
• Krvavitev - nekatere krvavitve so pogoste.
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
• POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
You have been given Possia because you have had:
Zdravilo Possia ste dobili, ker ste imeli:
Your doctor will usually also tell you to take acetylsalicylic acid.
Zdravnik vam bo po navadi predpisal tudi jemanje acetilsalicilne kisline.
The primary variable of interest was the occurrence of ventricular pauses ≥3 seconds.
Primarna spremenljivka zanimanja je bil pojav ventrikularnih pavz ≥ 3 sekunde.
Possia is not recommended for children and adolescents under 18 years.
Otroci Zdravilo Possia ni priporočljivo za otroke in mladostnike, mlajše od 18 let.
• Do not take a double dose (two doses at the same time) to make up for the forgotten dose.
• Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnji odmerek.
Take Possia around the same time everyday (for example, one tablet in the morning and one in the evening).
(npr. eno tableto zjutraj in eno zvečer).
Your doctor will decide if it needs treatment or further
Zdravnik bo presodil, ali so potrebni zdravljenje ali nadaljnje preiskave.
No data are available (see section 5.1 and 5.2).
Podatkov ni na voljo (glejte poglavji 5.1 in 5.2).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report
V skladu s smernico CHMP o sistemih za obvladovanje tveganj za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
Possia may be resumed after the cause of bleeding has been identified and controlled.
Uporaba zdravila Possia se lahko nadaljuje, ko je vzrok krvavitve ugotovljen in obvladan.
Thus, the carcinogenicity findings are considered unlikely to be relevant for humans.
Zato ni verjetno, da bi bili izsledki o kancerogenosti pomembni za človeka.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Pred uporabo natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Minor Bleed: Requires medical intervention to stop or treat bleeding.
Blaga krvavitev: Zahteva medicinsko posredovanje za ustavitev ali zdravljenje krvavitve.
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata bit navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
ARR = absolute risk reduction; RRR = relative risk reduction = (1-Hazard ratio) x 100%.
ARR = absolutno zmanjšanje tveganja RRR = relativno zmanjšanje tveganja = (1 - razmerje ogroženosti) x 100 %.
• You can take the tablet with or without food.
• Tableto lahko vzamete s hrano ali brez nje.
• Allergic reaction - a rash, itching, or a swollen face or swollen lips/tongue may be signs of an allergic reaction (see section 2: What you need to know before you take Possia).
• alergijska reakcija - izpuščaj, srbenje ali otekel obraz ali otekle ustnice/jezik so lahko znak alergijske reakcije (glejte poglavje 2: Kaj morate vedeti preden boste vzeli zdravilo Possia).
Possia is to be used in adults only.
Zdravilo Possia je namenjeno za uporabo samo pri odraslih.
There was no difference in overall fatal bleeds.
Ni bilo razlik v vseh krvavitvah s smrtnim izidom.
The systemic exposure to the active metabolite is approximately 30-40% of that obtained for ticagrelor.
Sistemska izpostavljenost aktivnemu presnovku je približno 30 do 40 % tiste, ki je dosežena s tikagrelorjem.
• A similar effect on other statins metabolised by CYP3A4 cannot be excluded.
• Podobnega učinka drugih statinov, ki se presnavljajo s CYP3A4, ni mogoče izključiti.
Discuss with your doctor if you notice any of the following:
Posvetujte se z zdravnikom, če opazite kaj od naslednjega:
Clopidogrel (%/year) N=9186
Klopidogrel (%/leto) n = 9186
• You have asthma or other lung problem or breathing difficulties.
• e imate astmo, druge težave s pljui ali težave z dihanjem.
• Your heart rate is abnormally low (usually lower than 60 beats per minute) and you do not already have in place a device that paces your heart (pacemaker).
• e imate nenormalno poasen srni utrip (po navadi manj kot 60 utripov na minuto) in še nimate nameš ene naprave, ki spodbuja srce (spodbujevalnika).
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Possia therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom Possia, upoštevaje koristi dojenja za otroka in koristi zdravljenja za žensko.
• The starting dose is two tablets at the same time (loading dose of 180 mg).
• Začetni odmerek sta dve tableti hkrati (polnilni odmerek 180 mg).
Patients taking Possia should also take ASA daily, unless specifically contraindicated.
Bolniki, ki jemljejo zdravilo Possia, morajo jemati tudi ASA, če ni posebej kontraindicirana.
This will tell you whether you have taken the
Tako boste videli, ali ste odmerek že vzeli.
Do not throw away any medicinesvia wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
For further information, please refer to section 5.1.
Za dodatne informacije glejte poglavje 5.1.
The safety and efficacy of Possia in children below the age of 18 in the approved adult indication has not been established.
Varnost in učinkovitost zdravila Possia pri otrocih do 18. leta starosti nista ugotovljeni za indikacije, odobrene za odrasle.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that increase your risk of bleeding:
Še zlasti morate svojemu zdravniku ali farmacevtu povedati, če uporabljate katero od naslednjih zdravil, ki povečajo tveganje krvavitev:
These increases are not considered clinically significant.
Ta povečanja ne veljajo za klinično pomembna.
This includes medicines that you buy without a prescription, dietary supplements and herbal remedies.
To velja tudi za zdravila, ki ste jih dobili brez recepta, za prehranske dodatke in za zeliščna zdravila.
Frequency categories are defined according to the following conventions: Very common (≥1/10), Common (≥1/100 to 1/10), Uncommon (≥1/1,000 to 1/100), Rare (≥1/10,000 to 1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
Take Possia on a regular basis and for as long as your doctor keeps prescribing it.
Zdravilo Possia jemljite redno in toliko časa, kot vam ga zdravnik predpisuje.
Overall outcome of bleeding rates in the PLATO study are shown in Table 2.
Krvavitve Celotne rezultate deležev krvavitev v študiji PLATO prikazuje preglednica 2.
These differences are not considered clinically significant (see section 4.2).
Te razlike ne veljajo za klinično pomembne (glejte poglavje 4.2).
Similar increases in AUC and Cmax were observed for all atorvastatin acid metabolites.
Podobna povečanja AUC in Cmax so ugotovili za vse presnovke atorvastatina.
Do not stop taking Possia without talking to your doctor.
Ne prenehajte jemati zdravila, ne da bi se posvetovali s svojim zdravnikom.
Date of first authorisation: 3 December 2010
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 03 december 2010
These very small blood cells help stop bleeding by clumping together to plug tiny holes in blood vessels that are cut or damaged.
Te zelo majhne krvne celice pomagajo ustaviti krvavitev tako, da se sprimejo in zamašijo drobne odprtine v prerezanih ali poškodovanih žilah.
Recoveries of ticagrelor and the active metabolite in urine were both less than 1% of the dose.
Pojavljanje tikagrelorja in aktivnega presnovka v urinu je bilo za oba manj kot 1 % odmerka.
• Feeling short of breath - this is common.
• Kratko sapo - to je pogosto.
The mechanism for uterine tumors is likely hormonal imbalance which can lead to tumors in rats.
Mehanizem nastanka tumorjev maternice je verjetno hormonsko neravnovesje, ki lahko pri podganah povzroči tumorje.
Ticagrelor produced irregular cycles (mostly extended cycles) in female rats, but did not affect overall fertility in male and female rats.
Tikagrelor je pri podganjih samicah povzročil neredne cikluse (večinoma podaljšane), ni pa vplival na celotno plodnost podganjih samcev ali samic.
Possia may have similar effect on lovastatin.
Zdravilo Possia morda podobno vpliva na lovastatin.
This suggests it is appropriate to treat patients with ticagrelor for up to 12 months (see section 4.2).
To kaže, da je bolnike ustrezno s tikagrelorjem zdraviti do 12 mesecev (glejte poglavje 4.2).
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
• v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja),
Multiple related adverse reaction terms have been grouped together in the table and include medical terms as described below:
Več sorodnih izrazov za neželene učinke je v preglednici skupaj razvrščenih v skupine in vključujejo spodaj navedene medicinske izraze:
The primary route of elimination for the active metabolite is most likely via biliary secretion.
Primarna pot odstranjevanja aktivnega presnovka je najverjetneje z biliarno sekrecijo.
Ticagrelor is also a P-gp substrate and a weak P-gp inhibitor and may increase the exposure of P-gp substrates.
Tikagrelor je tudi substrat P-gp in šibek zaviralec P-gp in lahko poveča izpostavljenost substratom P-gp.
Therefore, premature discontinuation of treatment
Zato se je treba izogniti prezgodnjemu prenehanju zdravljenja.
If clinically indicated, Possia should be used with caution in the following patient groups:
Če je zdravilo Possia klinično indicirano, ga je treba previdno uporabljati v naslednjih skupinah bolnikov:
Also tell your doctor that because you are taking Possia, you may have an increased risk of bleeding if your doctor gives you fibrinolytics, often called ‘clot dissolvers', such as streptokinase or alteplase.
Zdravniku tudi povejte, da imate lahko zaradi jemanja zdravila Possia večje tveganje krvavitev, če vam zdravnik da fibrinolitike (pogosto jih imenujejo tudi "zdravila za raztapljanje strdkov"), kakršna sta streptokinaza ali alteplaza.
The European Medicines Agency has waived the obligation to submit the results of studies with Possia in all subsets of the paediatric population in the granted indication (see section 4.2 and 5.2).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Possia za vse skupine pediatrične populacije pri odobreni indikaciji (glejte poglavji 4.2 in 5.2).
All-cause mortality d
Umrljivost zaradi vseh vzrokov
The mean t1/2 was approximately 7 hours for ticagrelor and 8.5 hours for the active metabolite.
Povprečni t1/2 je bil približno 7 ur za tikagrelor in 8,5 ure za aktivni presnovek.
This is a substance present in many medicines used to prevent blood clotting.
To je učinkovina, ki jo vsebujejo številna zdravila za preprečevanje krvnih strdkov.
It is usually mild to moderate in intensity and often resolves without need for treatment discontinuation.
Po navadi je blaga do zmerna in pogosto mine, ne da bi bilo treba zdravljenje prekiniti.
The result appeared early (absolute risk reduction [ARR] 0.6% and Relative Risk Reduction [RRR] of 12% at 30 days), with a constant treatment effect over the entire 12 month period, yielding ARR 1.9% per year with RRR of 16%.
Rezultat se je pojavil zgodaj (absolutno zmanjšanje tveganja [ARR - Absolute Risk Reduction] 0,6 % in relativno zmanjšanje tveganja [RRR - Relative Risk Reduction] 12 % po 30 dneh), s stalnim terapevtskim učinkom med celotnim 12-mesečnim obdobjem, kar pomeni ARR 1,9 % na leto in RRR 16 %.
It might be due to your heart disease or another cause, or it might be a side effect of Possia.
Lahko je posledica bolezni srca ali kakšnega drugega vzroka, lahko pa je tudi neželen učinek zdravila Possia.
When radiolabeled ticagrelor is administered, the mean recovery of radioactivity is approximately 84% (57.8% in faeces, 26.5% in urine).
Po uporabi radioaktivno označenega tikagrelorja je povprečni delež izločene radioaktivnosti 84 % (57,8 % v blatu, 26,5 % v urinu).
Combined efficacy and safety composite
Kombinirano učinkovitost in varnost skupaj
No evidence of clinically significant adverse interactions with these medicinal products was observed.
Znakov klinično pomembnega neželenega medsebojnega delovanja s temi zdravili niso opazili.
Fatal CABG bleeding occurred in 6 patients in each treatment group (see section 4.4).
S CABG povezana krvavitev s smrtnim izidom se je pojavila pri 6 bolnikih v vsaki terapevtski skupini (glejte poglavje 4.4).
The mean absolute bioavailability of ticagrelor was estimated to be 36%.
Ocenjena povprečna absolutna biološka uporabnost tikagrelorja je bila 36 %.
Lapses in therapy should also be avoided.
Izogibati se je treba tudi izpuščanju odmerkov.
• You are allergic (hypersensitive) to ticagrelor or any of the other ingredients of Possia (listed in section 6).
• e ste alergini (preobutljivi) na tikagrelor ali katerokoli sestavino zdravila Possia (naštete so v poglavju 6).
Round, biconvex, yellow tablets marked with ‘90' above ‘T' on one side and plain on the other.
Okrogla, bikonveksna rumena tableta z oznako "90" nad "T" na eni strani in brez oznak na drugi strani.
This medicinal product does not require any special storage conditions.
Za shranjevanje zdravila niso potrebna posebna navodila.
However, severe bleeding is uncommon, but can be life threatening.
Hude krvavite pa so sicer le občasne, a so lahko smrtno nevarne.
Within these subgroups renal-related serious adverse events and adverse events leading to discontinuation of study drug were similar between treatment groups.
V teh podskupinah so bili resni ledvični neželeni učinki in neželeni učinki, ki so povzročili prenehanje uporabe raziskovanega zdravila, med terapevtskima skupinama podobni.
Therefore, the use of Possia in patients at known increased risk for bleeding should be balanced against the benefit in terms of prevention of atherothrombotic events.
Zato je treba uporabo zdravila Possia pri bolnikih z večjim tveganjem krvavitev pretehtati v primerjavi s koristmi preprečevanja aterotrombotičnih dogodkov.
• ‘oral anticoagulants' often referred to as 'blood thinners' which include warfarin.
• "peroralne antikoagulanse" (pogosto jih imenujejo "zdravila za redčenje krvi"), med katere spada varfarin.
• the clot can partly block the blood vessels to the heart - this reduces the blood flow to the heart and can cause chest pain which comes and goes (called ‘unstable angina').
• strdek delno zamaši srčno žilo - to zmanjša pretok krvi v srčno mišico in lahko povzroči bolečine v prsih, ki pridejo in minejo (to imenujemo "nestabilna angina pektoris").
Medicinal products metabolised by CYP2C9
Zdravila, ki se presnavljajo s CYP2C9
A weakly significant treatment interaction was observed with region whereby the HR for the primary endpoint favours ticagrelor in the rest of world but favours clopidogrel in North America, which represented approximately 10% of the overall population studied (interaction p-value=0.045).
Šibko značilno terapevtsko interakcijo so ugotovili z regijo, pri čemer je razmerje ogroženosti za primarni opazovani dogodek v korist tikagrelorja v preostalih delih sveta, v korist klopidogrela pa v Severni Ameriki, ki je predstavljala približno 10 % celotne raziskovane populacije (vrednost p za interakcijo = 0,045).
BLISTER (10 TABLETS)
PRETISNI OMOT (10 TABLET)
Treating 54 ACS patients with ticagrelor instead of clopidogrel will prevent 1 atherothrombotic event; treating 91 will prevent 1 CV death (see Figure 1 and Table 3).
Zdravljenje 54 bolnikov z akutnimi koronarnimi sindromi s tikagrelorjem namesto s klopidogrelom bo preprečilo 1 aterotrombotičen dogodek, zdravljenje 91 bolnikov bo preprečilo 1 kardiovaskularno smrt (glejte sliko 1 in preglednico 3).
Switching from clopidogrel to ticagrelor results in an absolute IPA increase of 26.4% and switching from ticagrelor to clopidogrel results in an absolute IPA decrease of 24.5%.
Prehod s klopidogrela na tikagrelor povzroči absolutno povečanje IPA za 26,4 %, prehod s tikagrelorja na klopidogrel pa absolutno zmanjšanje IPA za 24,5 %.
Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC24
Farmakoterapevtska skupina: zaviralci agregacije trombocitov brez heparina Oznaka ATC: B01AC24
The steady state volume of distribution of ticagrelor is 87.5 l. Ticagrelor and the active metabolite is extensively bound to human plasma protein (>99.0%).
Volumen porazdelitve tikagrelorja v stanju dinamičnega ravnovesja je 87,5 l. Tikagrelor in njegov aktivni presnovek sta v veliki meri vezana na človeške beljakovine v plazmi (> 99,0 %).
In 2.2% of patients, investigators considered the dyspnoea causally related to treatment with Possia.
Pri 2,2 % bolnikov so raziskovalci dispnejo ocenili za vzročno povezano z uporabo zdravila Possia.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If a patient is to undergo elective surgery and antiplatelet effect is not desired, Possia should be discontinued 7 days prior to surgery (see section 5.1).
Če ima bolnik predvideno elektivno operacijo in antiagregacijski učinek ni zaželen, je treba uporabo zdravila Possia prekiniti 7 dni pred operacijo (glejte poglavje 5.1).
A patient who misses a dose of Possia should take only one 90 mg tablet (their next dose) at its scheduled time.
Če bolnik izpusti odmerek zdravila Possia, naj vzame le eno 90-mg tableto (svoj naslednji odmerek) ob predvidenem času.
• You can check when you last took a tablet of Possia by looking on the blister.
• Kdaj ste vzeli zadnjo tableto zdravila Possia, lahko preverite tako, da pogledate na pretisni omot.
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 medicinal product is
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, ki je predložen v modulu 1.8.1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo v promet in ves čas trženja zdravila.
You may be at increased risk of bleeding.
Obstaja lahko večje tveganje krvavitev.
• Patients with a propensity to bleed (e.g. due to recent trauma, recent surgery, coagulation disorders, active or recent gastrointestinal bleeding).
• Bolniki, nagnjeni h krvavitvam (npr. zaradi nedavne poškodbe, nedavne operacije, koagulacijskih motenj, aktivne ali nedavne gastrointestinalne krvavitve).
Antifibrinolytic therapy (aminocaproic acid or tranexamic acid) and/or recombinant factor VIIa may increase haemostasis.
Antifibrinolitično zdravljenje (aminokaprojska kislina ali traneksaminska kislina) in/ali rekombinantni faktor VIIa lahko povečajo hemostazo.
No information is available concerning treatment of patients on renal dialysis and therefore Possia is not recommended in these patients.
Informacij o zdravljenju bolnikov na dializi ni, zato zdravila Possia pri teh bolnikih ni priporočljivo uporabljati.
These differences are not considered clinically significant.
Te razlike ne veljajo za klinično pomembne.
Absorption of ticagrelor is rapid with a median tmax of approximately 1.5 hours.
Absorpcija tikagrelorja je hitra in mediani tmax je približno 1,5 ure.