natgillin/translations-raw huggingface dataset:
Age, sex, weight, race, geographic region, concurrent conditions, concomitant therapy, and medical history, including a previous stroke or transient ischaemic attack, all did not predict either overall or non-procedural PLATO Major bleeding.
Starost, spol, telesna masa, rasa, geografska regija, sočasne bolezni, sočasna zdravljenja in zdravstvena anamneza, vključno s predhodno možgansko kapjo ali tranzitorno ishemično atako, niso bili napovedniki ne vseh in ne s postopki nepovezanih krvavitev po PLATO.
• After this starting dose, the usual dose is one tablet of 90 mg twice a day for up to 12 months unless your doctor tells you differently.
• Po tem začetnem odmerku je običajen odmerek ena tableta 90 mg dvakrat na dan do 12 mesecev,
Similar to the overall PLATO study, total PLATO Major bleeding did not differ between ticagrelor and clopidogrel, regardless of CYP2C19 or ABCB1 genotype.
Podobno kot v študij PLATO v celoti se vse hude krvavitve po PLATO med tikagrelorjem in klopidogrelom niso razlikovale, ne glede na genotip CYP2C19 ali ABCB1.
EU/1/10/656/005 168 film-coated tablets EU/1/10/656/006 100x1 film-coated tablets
EU/1/10/656/001 60 filmsko obloženih tablet EU/1/10/656/002 180 filmsko obloženih tablet EU/1/10/656/003 14 filmsko obloženih tablet EU/1/10/656/004 56 filmsko obloženih tablet EU/1/10/656/005 168 filmsko obloženih tablet EU/1/10/656/006 100x1 filmsko obložena tableta
• unstable angina (angina or chest pain that is not well controlled).
• nestabilno angino pektoris (tj. bolečino v prsih, ki ni dobro obvladana).
Following oral administration of ticagrelor 90 mg under fasted conditions, Cmax is 529 ng/ml and AUC is 3451 ng*h/ml.
Po peroralni uporabi 90 mg tikagrelorja na tešče je Cmax 529 ng/ml in AUC 3451 ng.h/ml.
The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human
Imetnik dovoljenja za promet z zdravilom bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v RMP, predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Holter Substudy
Holterska podštudija
Treatment is recommended for up to 12 months unless discontinuation of Possia is clinically indicated (see section 5.1).
Zdravljenje je priporočljivo nadaljevati do 12 mesecev, razen če je prenehanje uporabe zdravila Possia klinično indicirano (glejte poglavje 5.1).
- sudden numbness or weakness of your arm, leg or face, especially if only on one side of the
• Znake možganske kapi, na primer: - nenadno omrtvelost ali šibkost roke, noge ali obraza, še zlasti, če se pojavi le na eni strani
Co-administration of Possia and levonorgestrel and ethinyl estradiol increased ethinyl estradiol exposure approximately 20% but did not alter the pharmacokinetics of levonorgestrel.
Sočasna uporaba zdravila Possia ter levonorgestrela in etinilestradiola je povečala izpostavljenost etinilestradiolu za približno 20 %, farmakokinetike levonorgestrela pa ni spremenila.
If a CABG procedure is planned, ticagrelor bleeding risk is increased compared to clopidogrel when discontinued within less than 96 hours prior to procedure.
Če je načrtovana koronarna obvodna operacija (CABG), je tveganje krvavitev s tikagrelorjem večje kot s klopidogrelom, če se uporaba preneha v manj kot 96 urah pred posegom.
The mechanism for the hepatic adenomas is likely due to a rodent-specific enzyme induction in the liver.
Mehanizem nastanka jetrnih adenomov je verjetno posledica za glodalce specifične encimske indukcije v jetrih.
AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden or
AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Švedska ali
Switching from prasugrel to Possia has not been investigated.
Prehod s prasugrela na zdravilo Possia ni raziskan.
This is because of the increased risk of bleeding.
Obstaja namreč večje tveganje krvavitev.
There are no or limited amount of data from the use of ticagrelor in pregnant women.
O uporabi tikagrelorja pri nosečnicah podatkov ni ali jih je malo.
Studies in animals have shown reproductive toxicity (see section 5.3).
Študije na živalih so pokazale reproduktivne toksične učinke (glejte poglavje 5.3).
• You have had a stroke caused by bleeding in the brain.
• če ste kdaj imeli možgansko kap zaradi krvavitve v možganih.
The Cmax of the active metabolite was unchanged and the AUC was decreased by 46%, respectively.
Cmax aktivnega presnovka se ni spremenila, njegova AUC pa se je zmanjšala za 46 %.
Ticagrelor demonstrates linear pharmacokinetics and exposure to ticagrelor and the active metabolite (AR-C124910XX) are approximately dose proportional up to 1260 mg.
Tikagrelor ima linearno farmakokinetiko in izpostavljenost tikagrelorju in njegovemu aktivnemu presnovku (AR-C124910XX) sta približno sorazmerni odmerku do 1260 mg.
• Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of Possia dosing.
• Bolniki, sočasno zdravljeni z zdravili, ki lahko povečajo tveganje krvavitev (npr. nesteroidna protivnetna zdravila (NSAID), peroralni antikoagulansi in/ali fibrinolitiki) v 24 urah od uporabe zdravila Possia.
If you forget to take Possia
Če ste pozabili vzeti zdravilo Possia
Ask your pharmacist how to throw away medicines you no longer use .
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Total MI includes silent MI, with date of event set to date when discovered.
Vsi MI vključujejo neme MI, pri čemer je kot datum dogodka upoštevan datum ugotovitve.
Similarly, when removing all procedure related bleeds, more bleeding occurred with ticagrelor than with clopidogrel (Table 2).
Tudi po izločitvi vseh s postopki povezanih krvavitev je bilo, podobno, več krvavitev s tikagrelorjem kot s klopidogrelom (preglednica 2).
Exploratory analyses suggest a possible association with ASA dose such that reduced efficacy was observed with ticagrelor with increasing ASA doses.
Eksploratorne analize so pokazale možno povezavo med odmerkom ASA, tako da je bila opažena manjša učinkovitost tikagrelorja z večanjem odmerkov ASA.
Reproductive system and breast disorders Vaginal bleeding (including metrorrhagia)
Motnje reprodukcije in dojk nožnična krvavitev (vključno z metroragijo)
Possia is expected to have no or negligible influence on the ability to drive and use machines.
Za zdravilo Possia se pričakuje, da nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
CYP3A4 is the major enzyme responsible for ticagrelor metabolism and the formation of the active metabolite and their interactions with other CYP3A substrates ranges from activation through to inhibition.
CYP3A4 je glavni encim, odgovoren za presnovo tikagrelorja in nastanek aktivnega presnovka; njuna medsebojna delovanja z drugimi substrati CYP3A segajo od aktivacije do zavrtja.
Figure 1 - Time to first occurrence of CV death, MI and Stroke (PLATO)
Čas do prvega pojava kardiovaskularne smrti, MI in možganske kapi (PLATO)
- sudden confusion, difficulty speaking or understanding others - sudden difficulty in walking or loss of balance or co-ordination - suddenly feeling dizzy or sudden severe headache with no known cause These are signs of a kind of stroke caused by bleeding into the brain.
- nenadno zmedenost, težave z govorjenjem ali razumevanjem tistega, kar vam povedo drugi, - nenadne težave s hojo ali izgubo ravnotežja ali koordinacije gibov, - nenadno omotico ali nenaden hud glavobol brez znanega vzroka.
Few patients in PLATO had fatal bleeds: 20 (0.2%) for ticagrelor and 23 (0.3%) for clopidogrel (see section 4.4).
Malo bolnikov v PLATO je imelo krvavitve s smrtnim izidom: 20 (0,2 %) pri tikagrelorju in 23 (0,3 %) pri klopidogrelu (glejte poglavje 4.4).
Chronic daily ASA doses to accompany Possia should be 75-150 mg (see section 4.2 and 4.4).
Kronični dnevni odmerki ASA ob uporabi zdravila Possia morajo biti od 75 do 150 mg (glejte poglavji 4.2 in 4.4).
The frequency of possible side effects listed below is defined using the following convention: common (affects 1 to 10 users in 100); uncommon (affects 1 to 10 users in 1,000); rare (affects 1 to 10
Pogostnost možnih spodaj navedenih neželenih učinkov je opredeljena po naslednjem dogovoru: pogosti (pojavijo se pri 1 do 10 od 100 bolnikov); občasni (pojavijo se pri 1 do 10 od 1.000 bolnikov); redki (pojavijo se pri 1 do 10 od 10.000 bolnikov).
Discontinuation of treatment due to non-procedural bleeding was more common for ticagrelor (2.9%) than for clopidogrel (1.2%; p<0.001).
Prekinitve zdravljenja zaradi krvavitev, nepovezanih s postopki, so bile s tikagrelorjem pogostejše (2,9 %) kot s klopidogrelom (1,2 %, p < 0,001).
In female rats, ticagrelor at high dose showed an increased incidence of uterine tumors (adenocarcinomas) and an increased incidence of hepatic adenomas.
Pri podganjih samicah je tikagrelor v velikih odmerkih spremljala večja incidenca tumorjev maternice (adenokarcinomov) in večja incidenca adenomov jeter.
The expected effect of excessive Possia dosing is prolonged duration of bleeding risk associated with platelet inhibition.
Pričakovani učinek čezmernega odmerjanja zdravila Possia je podaljšanje tveganja krvavitev, povezano z zavrtjem trombocitov.
Effects of other medicinal products on Possia
Učinki drugih zdravil na zdravilo Possia
If you get any side effects, talk to your doctor or pharmacist, but do not stop taking Possia until you have spoken to them.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom, vendar ne nehajte jemati zdravila Possia, dokler niste govorili z njim.
Dyspnoea was reported by 13.8% of patients treated with Possia and by 7.8% of patients treated with clopidogrel.
Dispneja je bila opisana pri 13,8 % bolnikov, zdravljenih z zdravilom Possia, in pri 7,8 % bolnikov, zdravljenih s klopidogrelom.
This is because Possia can affect the way some medicines work and some medicines
Zdravilo Possia namreč lahko vpliva na delovanje nekaterih zdravil in nekatera zdravila lahko vplivajo na zdravilo Possia.
Its use in patients with moderate to severe hepatic impairment is therefore contraindicated (see section 4.3, 4.4 and 5.2).
Njegova uporaba pri bolnikih z zmerno do hudo okvaro jeter je zato kontraindicirana (glejte poglavja 4.3, 4.4 in 5.2).
Women should use appropriate contraceptive measures to avoid pregnancy while taking this medicine.
Ženske morajo med jemanjem tega zdravila uporabljati ustrezno kontracepcijsko zaščito za preprečitev nosečnosti.
Ingestion of a high-fat meal resulted in a 21% increase in ticagrelor AUC and 22% decrease in the active metabolite Cmax but had no effect on ticagrelor Cmax or the AUC of the active metabolite.
Zaužitje zelo mastnega obroka je povzročilo 21 % povečanje tikagrelorjeve AUC in 22 % zmanjšanje Cmax aktivnega presnovka, ni pa vplivalo na Cmax tikagrelorja ali AUC aktivnega presnovka.
• You have moderate to severe liver disease
• če imate zmerno do hudo bolezen jeter.
• History of intracranial haemorrhage (see section 4.8).
• Anamneza intrakranialne krvavitve (glejte poglavje 4.8).
Patients can be switched from clopidogrel to ticagrelor without any interruption of antiplatelet effect (see section 4.2).
Bolniki lahko preidejo s klopidogrela na tikagrelor brez prekinitve antiagregacijskega učinka (glejte poglavje 4.2).
P-glycoprotein (P-gp) substrates (including digoxin, cyclosporin) Concomitant administration of Possia increased the digoxin Cmax by 75% and AUC by 28%.
Substrati P-glikoproteina (P-gp) (vključno z digoksinom, ciklosporinom) Sočasna uporaba zdravila Possia je povečala Cmax digoksina za 75 % in njegovo AUC za 28 %.
Patients self-identified as Black had an 18% lower bioavailability of ticagrelor compared to Caucasian patients.
Bolniki, ki so se opredelili za črnce, so imeli 18 % manjšo biološko uporabnost tikagrelorja kot bolniki-belci.
Marketing Authorisation Holder and Manufacturer
Imetnik dovoljenja za promet in izdelovalec
Patients in PLATO receiving ticagrelor took a variety of statins, with no concern of an association with statin safety among the 93% of the PLATO cohort taking these medicinal products.
Bolniki, ki so v študiji PLATO dobivali tikagrelor, so jemali različne statine; pri 93 % kohorte PLATO, ki je jemala ta zdravila, ni bilo nobenih pomislekov v zvezi z varnostjo statinov.
Patients of Asian descent have a 39% higher mean bioavailability compared to Caucasian patients.
Bolniki azijskega porekla imajo 39 % večjo povprečno biološko uporabnost kot bolniki-belci.
Possia contains the active substance called ticagrelor.
Zdravilo Possia vsebuje zdravilno učinkovino, imenovano tikagrelor.
No studies on the effects of Possia on the ability to drive and use machines have been performed.
Študije o vplivu zdravila Possia na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
Co-administration of ticagrelor with doses of simvastatin exceeding 40 mg daily could cause adverse effects of simvastatin and should be weighed against potential benefits.
Sočasna uporaba tikagrelorja in več kot 40 mg simvastatina na dan lahko povzroči neželene učinke simvastatina in jo je treba pretehtati glede na možne koristi.
The metabolite parent ratios are 0.28 for Cmax and 0.42
Razmerje presnovek matična snov je za Cmax 0,28 in za AUC 0,42.
Studies in rats and rabbits have shown reproductive toxicity, with slightly reduced maternal body weight gain and reduced neonatal viability and birth weight, with delayed growth.
Študije na podganah in kuncih so pokazale reproduktivne toksične učinke z rahlo zmanjšanim porastom telesne mase samic, manjšo viabilnostjo novoskotenih mladičev, manjšo telesno maso ob skotitvi ter upočasnjeno rast.
(%/yr)
ARRa (%/leto)
This belongs to a group of medicines called
To zdravilo spada v skupino zdravil, imenovanih antiagregacijska zdravila.
• Moderate to severe hepatic impairment (see section 4.2, 4.4 and 5.2).
• Zmerna do huda okvara jeter (glejte poglavja 4.2, 4.4 in 5.2).
A combined efficacy and safety composite (CV death, MI, stroke, or PLATO-defined ‘Total Major' bleeding) indicates that the benefit in efficacy of Possia compared to clopidogrel is not offset by the major bleeding events (ARR 1.4%, RRR 8%, HR 0.92; p=0.0257) over 12 months after ACS.
Kombinirana sestavljena točka učinkovitosti in varnosti (KV smrt, MI, možganska kap ali "vse hude" krvavitve po opredelitvi PLATO) kaže, da koristi glede učinkovitosti zdravila Possia v primerjavi s klopidogrelom ne odpravijo hudi krvavitveni dogodki (ARR 1,4 %, RRR 8 %, razmerje ogroženosti 0,92, p = 0,0257) v 12 mesecih po akutnem koronarnem sindromu.
In the phase 3 pivotal trial (PLATO [PLATelet Inhibition and Patient Outcomes], 18,624 patients) key exclusion criteria included an increased risk for bleeding, clinically important thrombocytopenia or anaemia, previous intracranial bleed, gastrointestinal bleed within the past 6 months or major surgery within the past 30 days.
V ključnem preskušanju 3. faze PLATO ([PLATelet Inhibition and Patient Outcomes], 18.624 bolnikov) so bili med ključnimi merili za nevključitev večje tveganje krvavitev, klinična pomembna trombocitopenija ali anemija, predhodna intrakranialna krvavitev, gastrointestinalna krvavitev v zadnjih 6 mesecih ali večja operacija v zadnjih 30 dneh.
Effects of Possia on other medicinal products
Učinki zdravila Possia na druga zdravila
• The active substance is ticagrelor.
• Zdravilna učinkovina je tikagrelor.
CYP2C19 and ABCB1 genotyping of 10,285 patients in PLATO provided associations of genotype groups with PLATO outcomes.
Na podlagi genotipizacije 10285 bolnikov glede CYP2C19 in ABCB1 v študiji PLATO so analizirali povezanost genotipskih skupin z izidi v študiji PLATO.
Ticagrelor has not been evaluated in a paediatric population (see section 4.2 and 5.1).
Pediatrična populacija Tikagrelor v pediatrični populaciji ni ovrednoten (glejte poglavji 4.2 in 5.1).
To study the occurrence of ventricular pauses and other arrhythmic episodes during PLATO, investigators performed Holter monitoring in a subset of nearly 3000 patients, of whom approximately 2000 had recordings both in the acute phase of their ACS and after one month.
Za proučitev pojavljanja ventrikularnih pavz in drugih epizod motenj srčnega ritma so v študiji PLATO opravili holtersko monitorizacijo v podskupini skoraj 3000 bolnikov, od katerih jih je približno 2000 imelo posnetke tako v akutni fazi akutnega koronarnega sindroma kot po enem mesecu.
Intracranial bleeding: There were more intracranial non-procedural bleeds with ticagrelor (n=27 bleeds in 26 patients, 0.3%) than with clopidogrel (n=14 bleeds, 0.2%), of which 11 bleeds with ticagrelor and 1 with clopidogrel were fatal.
Intrakranialna krvavitev: S tikagrelorjem je bilo več intrakranialnih krvavitev, nepovezanih s postopki (n = 27 krvavitev pri 26 bolnikih, 0,3 %) kot s klopidogrelom (n = 14 krvavitev, 0,2 %); od teh je bilo smrtnih 11 krvavitev s tikagrelorjem in 1 s klopidogrelom.
If you take more Possia than you should, talk to a doctor or go to hospital straight away.
Če ste vzeli večji odmerek zdravila Possia, kot bi smeli Če vzamete več zdravila Possia, kot bi smeli, se morate takoj posvetovati z zdravnikom ali iti v bolnišnico.
The use of Possia is contraindicated in patients with active pathological bleeding, in those with a history of intracranial haemorrhage, and in patients with moderate to severe hepatic impairment (see section 4.3).
Uporaba zdravila Possia je kontraindicirana pri bolnikih z aktivno patološko krvavitvijo, bolnikih z anamnezo intrakranialne krvavitve in bolnikih z zmerno do hudo okvaro jeter (glejte poglavje 4.3).
Tabulated summary of adverse reactions The following adverse reactions have been identified following studies with Possia (Table 1).
Tabeliran povzetek neželenih učinkov Po študijah z zdravilom Possia so ugotovili naslednje neželene učinke (preglednica 1).
In rats minor developmental anomalies were seen at a maternal toxic dose (safety margin of 5.1).
Pri podganah so pri odmerkih, toksičnih za samice, opazili manjše razvojne nepravilnosti (varnostna meja 5,1).
90% of patients had final extent IPA
90 % bolnikov je imelo končno IPA do 2. ure po odmerku > 70 %.
In clinical pharmacology studies, the exposure (Cmax and AUC) to ticagrelor in Japanese subjects was approximately 40% (20% after adjusting for body weight) higher compared to that in Caucasians.
V kliničnih farmakoloških študijah je bila izpostavljenost (Cmax in AUC) tikagrelorju pri japonskih preiskovancih približno 40 % večja (20 % večja po korekciji za telesno maso) kot pri belcih.
In the event of overdose, observe for these potential adverse reactions and consider ECG monitoring
V primeru prevelikega odmerjanja je treba bolnika spremljati glede teh možnih neželenih učinkov in v poštev pride EKG-nadzor.
For any information about this medicine, please contact the local representative of the Marketing
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
However, platelets can also form clots inside diseased blood vessels in the heart and brain.
Vendar lahko trombociti tudi povzročijo nastanek krvnih strdkov v bolnih žilah v srcu ali možganih.
Based on a relationship observed in PLATO between maintenance ASA dose and relative efficacy of ticagrelor compared to clopidogrel, co-administration of Possia and high maintenance dose ASA (>300 mg) is not recommended (see section 5.1).
Glede na razmerje med vzdrževalnim odmerkom ASA in relativno učinkovitostjo tikagrelorja v primerjavi s klopidogrelom, ugotovljeno v študiji PLATO, sočasna uporaba zdravila Possia in visokega vzdrževalnega odmerka ASA (> 300 mg) ni priporočljiva (glejte poglavje 5.1).
Ticagrelor should be used with caution in patients with history of asthma and/or COPD.
Tikagrelor je treba previdno uporabljati pri bolnikih z astmo in/ali KOPB.
In addition, caution should be exercised when administering Possia concomitantly with medicinal products known to induce bradycardia.
Poleg tega je potrebna previdnost, če je zdravilo Possia uporabljeno skupaj z zdravili, ki povzročajo bradikardijo.
CALENDAR BLISTER (14 TABLETS)
KOLEDARSKI PRETISNI OMOT (14 TABLET)
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte s svojim zdravnikom ali s farmacevtom.
• Simvastatin - Co-administration of ticagrelor with simvastatin increased simvastatin Cmax by 81% and AUC by 56% and increased simvastatin acid Cmax by 64% and AUC by 52% with some individual increases equal to 2 to 3 fold.
• Simvastatin - Sočasna uporaba tikagrelorja in simvastatina je povečala Cmax simvastatina za 81 % in njegovo AUC za 56 %; Cmax simvastatinske kisline je povečala za 64 % in njeno AUC za 52 %, pri nekaterih posameznikih pa so bila povečanja 2- do 3-kratna.
In patients with Acute Coronary Syndromes (ACS), premature discontinuation with any antiplatelet therapy, including Possia, could result in an increased risk of cardiovascular death, or myocardial infarction due to the patient's underlying disease.
Bolnikom z akutnimi koronarnimi sindromi (ACS - Acute Coronary Syndrome) lahko prezgodnje prenehanje uporabe kateregakoli antiagregacijskega zdravila, tudi zdravila Possia, poveča tveganje kardiovaskularne smrti ali miokardnega infarkta zaradi njihove osnovne bolezni.
Pharmacokinetic studies performed with radio-labeled ticagrelor have shown that the parent compound and its metabolites are excreted in the milk of rats (see section 4.6).
Farmakokinetične študije z radioaktivno označenim tikagrelorjem so pokazale, da se matična spojina in njeni presnovki izločajo v mleku podgan (glejte poglavje 4.6).
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
If you stop taking Possia
Če ste prenehali jemati zdravilo Possia
EU/1/10/656/002 180 film-coated tablets
EU/1/10/656/001-006
There were no adverse clinical consequences associated with this imbalance (including syncope or pacemaker insertion) in this patient population (see section 5.1).
S to razliko v tej populaciji bolnikov niso bile povezane kakšne neželene klinične posledice (vključno s sinkopo ali vstavitvijo srčnega spodbujevalnika) (glejte poglavje 5.1).
Uric acid increase
Zvišanje sečne kisline
Therefore, due to the limited clinical experience, Possia should be used with caution in these patients (see section 5.1).
Zato je treba zdravilo Possia zaradi skromnih kliničnih izkušenj pri takšnih bolnikih uporabljati previdno (glejte poglavje 5.1).
PLATO included patients with baseline congestive heart failure, chronic obstructive pulmonary disease, or asthma; these patients, and the elderly, were more likely to report dyspnoea.
Študija PLATO je zajela bolnike, ki so izhodiščno imeli srčno popuščanje, kronično obstruktivno pljučno bolezen ali astmo; pri teh in pa pri starejših bolnikih je bila verjetnost dispneje večja.
Ticagrelor had no effect on male or female fertility in animals (see section 5.3).
Plodnost Tikagrelor pri živalih ni vplival na moško ali žensko plodnost (glejte poglavje 5.3).
Since co-administration of Possia with desmopressin did not decrease template-bleeding time, desmopressin is unlikely to be effective in managing clinical bleeding events (see section 4.5).
Sočasna uporaba zdravila Possia z dezmopresinom ni skrajšala standardiziranega časa krvavitve ("template bleeding time"), zato ni verjetno, da bi bil dezmopresin učinkovit za obvladovanje kliničnih krvavitev (glejte poglavje 4.5).