FrancophonIA/ELRC3.0 huggingface dataset:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed medac 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Pemetreksed medac 100 mg prašek za koncentrat za raztopino za infundiranje Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Excipients
Slovenian: Pemetreksed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 500 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed medac 500 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 100 mg powder for concentrate for solution for infusion pemetrexed
Slovenian: Pemetreksed medac 100 mg prašek za koncentrat za raztopino za infundiranje pemetreksed
English: − irritation of the skin and itching
Slovenian: − draženje kože in srbenje
English: In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Slovenian: Ker ni podatkov o možnem medsebojnem delovanju pemetrekseda in NSAID-ov z daljšimi razpolovnimi časi, denimo, piroksikama ali rofekoksiba, moramo sočasno dajanje NSAID-ov s pemetreksedom pri bolnikih z blagim do zmernim popuščanjem delovanja ledvic prekiniti vsaj za
English: − blood clots in the lung blood vessels (pulmonary embolism)
Slovenian: − poročali so tudi o bolečinah v okončinah, nizki temperaturi in spremembi barve okončin − krvni strdki v krvnih žilah v pljučih (pljučna embolija)
English: Pancytopenia has been uncommonly reported during clinical trials with pemetrexed.
Slovenian: V kliničnih preskušanjih s pemetreksedom so občasno poročali o pancitopeniji.
English: Grade 34 toxicity
Slovenian: Katerekoli toksičnosti stopnje 3
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95 % CI = 0.94 - 1.15), and overall response rate was 30.6 % (95 % CI = 27.3 - 33.9) for pemetrexed plus cisplatin versus 28.2 % (95 % CI = 25.0 - 31.4) for gemcitabine plus cisplatin.
Slovenian: in celokupno razmerje odziva je bilo 30,6 % (95 % IZ 27,3 - 33,9) za pemetreksedom skupaj s cisplatinom proti 28,2 % (95 % IZ 25,0 - 31,4) za gemcitabin skupaj s cisplatinom.
English: − hair loss
Slovenian: − izguba las − zaprtost
English: Constipation Stomatitis/
Slovenian: Pogosto Bruhanje Mukozitis/
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95 % CI = 0.61 - 1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n = 172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95 % CI = 1.08 - 2.26, p = 0.018).
Slovenian: 8,0 mesecev, prilagojen RT = 0,78; 95 % IZ = 0,61 - 1,00, p = 0,047) in je bila prednostna za docetaksel za ploščatocelično histologijo karcinoma (n = 172, 6,2 proti 7,4 mesecev, prilagojen
English: Log Rank p-value* Time to treatment failure (months) (95 % CI)
Slovenian: Čas do neuspeha zdravljenja (meseci) (95 % IZ)
English: Reconstitute each 100 mg vial with 4.2 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 100 mg viale rekonstituirajte s 4,2 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Ena viala vsebuje 1000 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Reconstitute 1,000 mg vials with 40 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 1000 mg viale rekonstituirajte s 40 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: Reconstitute 500 mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: 500 mg viale rekonstituirajte z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: − pain in the abdomen
Slovenian: − bolečina v prsnem košu
English: medac
Slovenian: Edem
English: Large cell (N = 153)
Slovenian: (N = 153)
English: Posology
Slovenian: Docetaksel
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Ena viala vsebuje 500 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Adjusted hazard ratio (HR) (95% CI)
Slovenian: • Stopnja odzivnosti (%) (95 % IZ)
English: Common Rash/ desquamation
Slovenian: − dehidracija − odpoved ledvic
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Slovenian: Ena viala vsebuje 100 mg pemetrekseda (v obliki dinatrijevega pemetrekseda hemipentahidrata).
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: Vsako 500 mg vialo pripravite z 20 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased” ** Which is derived from the term “renal/genitourinary other” *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2
Slovenian: * Glejte CTC Nacionalnega inštituta za rakava obolenja, različico 2, za vsako stopnjo toksičnosti, razen izraza “znižan očistek kreatinina”.
English: OTHER Cytotoxic.
Slovenian: DRUGI PODATKI Citotoksično.
English: Reconstitute each 1,000 mg vial with 40 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Slovenian: Vsako 1000 mg vialo pripravite s 40 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje brez konzervansa, da dobite raztopino, ki vsebuje 25 mg/ml pemetrekseda.
English: • Non-inferiority p-value (HR) Progression free survival (months)
Slovenian: Preživetje brez napredovanja (meseci)
English: Skin and sub-cutaneous tissue disorders
Slovenian: populacija in histološke podskupine
English: Common Conjunctivitis
Slovenian: Verjetnost skupnega preživetja
English: Pemetrexed at a dose of 500 mg/m² was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Slovenian: Pemetreksed kot edino učinkovino so preučevali v odmerku 500 mg/m² pri
English: Common Vomiting Mucositis/ stomatitis
Slovenian: Gemcitabin/cisplatin
English: Docetaxel N = 276
Slovenian: N = 276
English: Common Neuropathy-sensory 7.4
Slovenian: Pogosto Nevropatija - senzorna
English: Ethnic origin and race
Slovenian: Etnično poreklo in rasa
English: The volume of distribution (Vss) is approximately 21 litres.
Slovenian: Volumen porazdelitve (Vss) znaša približno 21 litrov.
English: • age ≥ 75 years
Slovenian: • starost ≥ 75 let
English: Take the card
Slovenian: Vzemite kartico.
English: • The use of coagulation tests and their interpretation
Slovenian: • opis uporabe koagulacijskih testov in njihova interpretacija
English: These medicinal products should not be administered simultaneously.
Slovenian: Teh zdravil se ne sme dajati sočasno.
English: Your doctor might change your anticoagulant treatment as follows:
Slovenian: Zdravnik bo morda zamenjal vaše antikoagulantno zdravljenje, kot sledi:
English: A risk to newborns and infants cannot be excluded.
Slovenian: Tveganja za dojenega novorojenčka in dojenčka ni mogoče izključiti.
English: Doctor's telephone:
Slovenian: Zdravnikova tel. številka:
English: • Active clinically significant bleeding.
Slovenian: • Aktivna, klinično pomembna krvavitev.
English: The reduction in exposure is not considered clinically relevant.
Slovenian: Menijo, da zmanjšanje izpostavljenosti ni klinično pomembno.
English: Data from clinical trials are only available for the Rotachrom
Slovenian: Podatki iz kliničnih preskušanj so na voljo le za Rotachrom
English: Plasma protein binding in humans is approximately 87%.
Slovenian: Vezava na plazemske beljakovine pri človeku je približno 87 %.
English: • Swallow the mixture.
Slovenian: • Pogoltnite mešanico.
English: Eliquis can be given for three different medical conditions.
Slovenian: Zdravilo Eliquis se lahko uporablja za tri različna zdravstvena stanja.
English: Date of latest renewal: 14 January 2016
Slovenian: Datum prve odobritve: 18. maj 2011 Datum zadnjega podaljšanja: 14. januar 2016
English: * Dose adjusted population based on 2 of 3 dose reduction criteria in the ARISTOTLE study.
Slovenian: * Populacija s prilagoditvijo odmerka na podlagi 2 od 3 meril za zmanjšanje odmerka v študiji ARISTOTLE.
English: • That all patients should be provided with a Patient alert card and be counselled about:
Slovenian: • da morajo vsi bolniki prejeti opozorilno kartico za bolnika in biti poučeni o:
English: If the bleeding does not stop on its own, seek medical attention immediately.
Slovenian: Če krvavitev ne preneha sama od sebe, nemudoma poiščite zdravniško pomoč.
English: As per available medical guidelines, short duration of treatment (at least 3 months) should be based on transient risk factors (e.g., recent surgery, trauma, immobilisation).
Slovenian: Skladno z razpoložljivimi medicinskimi smernicami mora kratkotrajno zdravljenje (najmanj 3 mesece) temeljiti na prehodnih dejavnikih tveganja (npr. nedavni kirurški poseg, poškodba, imobilizacija).
English: Indication:
Slovenian: Indikacija:
English: Surgery and invasive procedures
Slovenian: Kirurški posegi in invazivni postopki
English: Of these, 836 patients (33.7%) participated in the AMPLIFY study prior to enrollment in the AMPLIFY-EXT study.
Slovenian: Od teh bolnikov jih je 836 (33,7 %) pred vključitvijo v študijo AMPLIFY-EXT sodelovalo v študiji AMPLIFY.
English: Patients were exposed to study drug for a mean of 14 months.
Slovenian: Bolniki so bili preiskovanemu zdravilu izpostavljeni povprečno 14 mesecev.
English: If neurological compromise is noted, urgent diagnosis and treatment is necessary.
Slovenian: V primeru pojava nevrološke prizadetosti je potrebna urgentna diagnostična obravnava in zdravljenje.
English: Show this card to your pharmacist, dentist and any other healthcare professionals that treat you.
Slovenian: Kartico pokažite farmacevtu, zobozdravniku oziroma kateremukoli zdravstvenemu delavcu, ki vas obravnava.
English: This risk of bleeding should be weighed against the urgency of intervention.
Slovenian: To tveganje za pojav krvavitev je treba pretehtati glede na nujnost posega.
English: If surgery or invasive procedures cannot be delayed, appropriate caution should be exercised, taking into consideration an increased risk of bleeding.
Slovenian: Če operacije ali invazivnih postopkov ni mogoče odložiti, je potrebna ustrezna previdnost, ob upoštevanju povečanega tveganja za krvavitve.
English: This includes interventions for which the probability of clinically significant bleeding cannot be excluded or for which the risk of bleeding would be unacceptable.
Slovenian: To vključuje posege, pri katerih verjetnosti za pojav klinično pomembne krvavitve ni mogoče izključiti, oziroma pri katerih bi bilo tveganje za krvavitve nesprejemljivo.
English: Try to take the tablets at the same times every day to have the best treatment effect.
Slovenian: Za najboljši učinek zdravljenja tablete poskušajte jemati vsak dan ob istem času.
English: The PK/PD relationship observed in patients was consistent with that established in healthy subjects.
Slovenian: Razmerje PK/PD, opaženo pri bolnikih, je bilo v skladu z razmerjem, ugotovljenim pri zdravih osebah.
English: You should take the first tablet 12 to 24 hours after your operation.
Slovenian: Prvo tableto morate vzeti 12 do 24 ur po operaciji.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
English: Decisions on initiation and duration of treatment should take established guideline recommendations for anticoagulant treatment in patients undergoing cardioversion into account.
Slovenian: Pri odločitvah glede uvedbe in trajanja zdravljenja je treba upoštevati uveljavljena priporočila smernic za antikoagulacijsko zdravljenje pri bolnikih, pri katerih se izvaja kardioverzija.
English: No systemic embolism events were reported.
Slovenian: O sistemski emboliji niso poročali.
English: Take Eliquis as recommended for the following:
Slovenian: Jemljite zdravilo Eliquis, kot je priporočeno, za naslednje:
English: O-demethylation and hydroxylation at the 3-oxopiperidinyl moiety are the major sites of biotransformation.
Slovenian: O-demetilacija in hidroksilacija na 3-oksopiperidinilnem delu sta glavni mesti biotransformacije.
English: Fatal, n
Slovenian: Smrtne, n
English: AMPLIFY-EXT STUDY
Slovenian: Študija AMPLIFY-EXT
English: The effects of Eliquis on pregnancy and the unborn child are not known.
Slovenian: Učinki zdravila Eliquis na potek nosečnosti in nerojenega otroka niso znani.
English: AVERROES STUDY
Slovenian: ŠTUDIJA AVERROES
English: AVERROES was stopped early based on a recommendation by the independent Data Monitoring Committee due to clear evidence of reduction of stroke and systemic embolism with an acceptable safety profile.
Slovenian: Študija AVERROES se je na osnovi priporočil neodvisnega Odbora za spremljanje podatkov (Data Monitoring Committee) zaključila predčasno, zaradi očitnih dokazov o zmanjšanju pojavnosti možganske kapi in sistemske embolije s sprejemljivim varnostnim profilom.
English: Birth Date:
Slovenian: Datum rojstva:
English: In the event of haemorrhagic complications, treatment must be discontinued and the source of bleeding investigated.
Slovenian: V primeru pojava hemoragičnih zapletov je treba zdravljenje prekiniti in ugotoviti vir krvavitve.
English: • hypertension
Slovenian: • hipertenzija
English: - Name: - Birth Date: - Indication: - Dose : ........mg twice daily - Doctor's Name: - Doctor's telephone:
Slovenian: - Ime: - Datum rojstva: - Indikacija: - Odmerek: ........mg dvakrat na dan - Zdravnikovo ime: - Zdravnikova tel. številka:
English: However, this may increase your risk of bleeding.
Slovenian: Vendar pa to lahko poveča tveganje za krvavitve.
English: • Crush the tablets with a pestle and mortar.
Slovenian: • Tablete zdrobite s pestilom in možnarjem.
English: • Lesion or condition if considered a significant risk factor for major bleeding.
Slovenian: • Lezija ali bolezensko stanje, če le-ta predstavlja pomemben dejavnik tveganja za večje krvavitve.
English: Available data in animals have shown excretion of apixaban in milk.
Slovenian: Razpoložljivi podatki pri živalih kažejo na izločanje apiksabana v mleko.
English: Fold the card and keep it with you at all times
Slovenian: Kartico prepognite in jo imejte ves čas pri sebi.
English: ARISTOTLE STUDY
Slovenian: ŠTUDIJA ARISTOTLE
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe apixaban are provided with the following educational material:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da vsi zdravniki, ki bodo predvidoma predpisovali apiksaban, prejmejo naslednja izobraževalna gradiva:
English: • Recommendations for dose adjustment in at risk populations, including renal or hepatic impairment patients
Slovenian: • priporočila o prilagajanju odmerka pri populacijah s povečanim tveganjem, vključno z bolniki z okvaro ledvic ali jeter
English: This includes interventions for which any bleeding that occurs is expected to be minimal, non-critical in its location or easily controlled.
Slovenian: To vključuje posege, pri katerih se pričakuje, da bo vsaka krvavitev, do katere pride, kar najmanjša, glede mesta pojava nekritična ali pa jo bo mogoče brez težav nadzorovati.
English: Key secondary endpoints of major bleeding and all cause death were tested in a pre-specified hierarchical testing strategy to control the overall type 1 error in the trial.
Slovenian: Ključne sekundarne opazovane dogodke, večjo krvavitev in vse vzroke smrti, so ocenjevali v predhodno določeni hierarhični strategiji testiranja za nadzor splošne napake tipa 1 v preskušanju.
English: ADVANCE-2 (knee)
Slovenian: ADVANCE-2 (koleno)
English: • Recommended dosages and guidance on the posology for different indications
Slovenian: • priporočene odmerke in navodila za odmerjanje pri različnih indikacijah
English: Take the medicine pack with you, even if there are no tablets left.
Slovenian: Ovojnino zdravila vzemite s seboj, tudi če je prazna.
English: The risk may also be increased by traumatic or repeated epidural or spinal puncture.
Slovenian: Večje tveganje predstavlja tudi travmatska ali ponavljajoča se epiduralna ali spinalna punkcija.
English: Depending on local availability, a consultation of a coagulation expert should be considered in case of major bleedings.
Slovenian: Glede na lokalno razpoložljivost je treba v primeru večjih krvavitev razmisliti o posvetu s strokovnjakom za koagulacijo.
English: For preventing blood clots from re-occurring following completion of 6 months of treatment
Slovenian: Za preprečevanje ponovitve krvnih strdkov po koncu 6-mesečnega zdravljenja.
English: If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Eliquis.
Slovenian: Če težko pogoltnete celo tableto, se pogovorite z zdravnikom o drugih možnostih jemanja zdravila Eliquis.
English: In rat milk, a high milk to maternal plasma ratio (Cmax about 8, AUC about 30) was found, possibly due to active transport into the milk.
Slovenian: V podganjem mleku so pri materah ugotovili visoko razmerje med mlekom in plazmo (Cmax približno 8, AUC približno 30), kar je lahko posledica aktivnega transporta v mleko.
English: Therapy should be continued long-term.
Slovenian: Zdravljenje je treba nadaljevati dolgo časa.
English: Effect of apixaban on other medicinal products
Slovenian: Učinek apiksabana na druga zdravila
English: All treated n = 2,673
Slovenian: Vsi zdravljeni n = 2.673
English: Separate your language as needed (this is facilitated by the perforated edges)
Slovenian: Odtrgajte kartico v vašem jeziku, če je to potrebno (v pomoč so naluknjani robovi).
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacijo varnosti tega zdravila.
English: Treatment of DVT or PE
Slovenian: Zdravljenje GVT ali PE
English: For all patients undergoing cardioversion, confirmation should be sought prior to cardioversion that the patient has taken apixaban as prescribed.
Slovenian: Pri vseh bolnikih, pri katerih se izvaja kardioverzija, je treba pred kardioverzijo potrditi, da je bolnik jemal apiksaban, kot so mu ga predpisali.
English: With improving monitoring of INR the observed benefits of apixaban compared to warfarin regarding all cause death diminish.
Slovenian: Z izboljšanjem spremljanja INR so se opažene prednosti apiksabana v primerjavi z varfarinom glede vseh vzrokov smrti zmanjšale.
English: Gender Exposure to apixaban was approximately 18% higher in females than in males.
Slovenian: Spol Pri ženskah je bila izpostavljenost apiksabanu za približno 18 % večja kot pri moških.
English: • Guidance regarding surgery or invasive procedure, and temporary discontinuation
Slovenian: • navodila glede operacij ali invazivnih posegov in začasne prekinitve zdravljenja
English: What Eliquis is and what it is used for
Slovenian: Kaj je zdravilo Eliquis in za kaj ga uporabljamo
English: Renal impairment In patients with mild or moderate renal impairment, the following recommendations apply:
Slovenian: Okvara ledvic Pri bolnikih z blago ali zmerno okvaro ledvic veljajo naslednja priporočila:
English: Lapses in therapy should be avoided and if anticoagulation with Eliquis must be temporarily discontinued for any reason, therapy should be restarted as soon as possible.
Slovenian: Prekinitvam zdravljenja se je treba izogibati, če pa je antikoagulantno zdravljenje z zdravilom Eliquis iz kateregakoli vzroka treba začasno prekiniti, je treba z zdravljenjem čimprej ponovno začeti.
English: Given the predictable, dose-proportional pharmacokinetic profile of apixaban, the bioavailability results from the conducted studies are applicable to lower apixaban doses.
Slovenian: Glede na predvidljiv, od odmerka odvisen farmakokinetični profil apiksabana, rezultati biološke uporabnosti iz opravljenih študij veljajo tudi za manjše odmerke apiksabana.
English: Indwelling epidural or intrathecal catheters must be removed at least 5 hours prior to the first dose of Eliquis.
Slovenian: Epiduralni ali intratekalni kateter je treba odstraniti vsaj 5 ur pred uporabo prvega odmerka zdravila Eliquis.
English: Pharmacotherapeutic group: Antithrombotic agents, direct factor Xa inhibitors, ATC code: B01AF02
Slovenian: Farmakoterapevtska skupina: antitrombotiki, neposredni zaviralci faktorja Xa, oznaka ATC: B01AF02
English: The risk of these events may be increased by the post-operative use of indwelling epidural catheters or the concomitant use of medicinal products affecting haemostasis.
Slovenian: Tveganje za pojav teh zapletov se lahko poveča pri pooperativni uporabi epiduralnih katetrov ali sočasni uporabi zdravil, ki vplivajo na hemostazo.
English: Swallow the tablet with a drink of water.
Slovenian: Tableto pogoltnite skupaj s požirkom vode.
English: In the study, the incidence in major bleeding for both apixaban doses was not statistically different from placebo.
Slovenian: V študiji se pojavnost večjih krvavitev pri obeh odmerkih apiksabana ni statistično razlikovala od placeba.
English: - Anaemia which may cause tiredness or paleness - Bleeding including:
Slovenian: anemija, ki lahko povzroči utrujenost ali bledico krvavitve, vključno:
English: Administration of prothrombin complex concentrates (PCCs) or recombinant factor VIIa may also be considered.
Slovenian: Razmisliti je treba tudi o uporabi koncentratov protrombinskih kompleksov (PCCs - Prothrombin complex concentrates) ali rekombinantnega faktorja VIIa.
English: In the absence of other criteria for dose reduction (age, body weight), no dose adjustment is necessary (see section 5.2).
Slovenian: V odsotnosti drugih meril za zmanjšanje odmerka (starost, telesna masa) prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Blood clots may break off and travel to the brain and lead to a stroke or to other organs and prevent normal blood flow to that organ (also known as a systemic embolism).
Slovenian: Krvni strdki se lahko odtrgajo in zaidejo v možgane, kar lahko vodi do možganske kapi, ali pa v druge organe in tako preprečijo normalen pretok krvi skozi organ (kar se imenuje tudi sistemska embolija).