FrancophonIA/ELRC3.0 huggingface dataset:
English: o Patients weighing < 60 kg should have a reduced maintenance dose of 5 mg
Maltese: Għandha tintuża doża ta' manteniment ta' 5 mg.
English: NAME OF THE MEDICINAL PRODUCT Efient 5 mg film-coated tablets prasugrel
Maltese: TAL-PRODOTT MEDIĊINALI Efient 5 mg pilloli miksija b'rita prasugrel
English: Prasugrel Prior to Coronary Angiographya (N=2037)
Maltese: Koronarjaa (N=2037)
English: Heparin:
Maltese: Digoxin:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Patients weighing < 60 kg
Maltese: - tiżen inqas minn 60 kg.
English: Prasugrel had no effect on fertility of male and female rats at oral doses up to an exposure 240 times the recommended daily human maintenance dose (based on mg/m2).
Maltese: Fertilità Prasugrel ma kellu l-ebda effett fuq il-fertilità ta' firien maskili u femminili b'dożi mill-ħalq sa espożizzjoni ta' 240 darba aktar mid-doża ta' manteniment irrakkomandata għall-umani li tittieħed kuljum (ibbażata fuq mg/m2).
English: If a patient is to undergo elective surgery, and an antiplatelet effect is not desired, Efient should be discontinued at least 7 days prior to surgery.
Maltese: Jekk pazjent se ssirlu kirurġija mhux urġenti, u mhux mixtieq effett kontra l-plejtlits, Efient għandu jitwaqqaf mill-anqas 7 ijiem qabel il-kirurġija.
English: There is limited therapeutic experience in patients with mild and moderate hepatic dysfunction (see section 4.4).
Maltese: L-esperjenza terapewtika f'pazjenti b'indeboliment talkliewi hija limitata (ara sezzjoni 4.4).
English: Nonfatal stroke
Maltese: Puplesija mhux fatali
English: Rash Ecchymosis
Maltese: Reazzjoni Avversa
English: Renal impairment:
Maltese: Tiħux Efient:
English: • “non steroidal anti inflammatory drugs” for pain and fever (such as ibuprofen, naproxen, etoricoxib).
Maltese: • “mediċini antinfjammatorji li mhumiex sterojdi” għall-uġigħ u d-deni (bħal ibuprofen,
English: In a 30-day study (ACCOAST) in 4033 patients with NSTEMI with elevated troponin who were scheduled for coronary angiography followed by PCI within 2 to 48 hours after randomization, subjects who received prasugrel 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI (n=2037) had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (n=1996).
Maltese: Fi studju kliniku ta' pazjenti b'NSTEMI (l-istudju ACCOAST), fejn il-pazjenti kellhom ippjanat li ssirilhom anġjografija koronarja fi żmien sagħtejn sa 48 siegħa minn meta ntagħżlu b'mod arbitrarju, il-pazjenti li ngħataw doża ta' kkargar ta' 30 mg, b'medja ta' 4 sigħat qabel l-anġjografija koronarja segwita minn doża ta' kkargar ta' 30 mg fil-ħin tal-PCI kellhom żieda fir-riskju ta' fsada non-CABG peri-proċedurali u ebda benefiċċju addizzjonali meta mqabbla ma' pazjenti li ngħataw doża ta'
English: Non-Coronary Artery Bypass Graft (CABG) related bleeding In TRITON, the frequency of patients experiencing a non-CABG related bleeding event is shown in Table 1.
Maltese: F'TRITON, il-frekwenza ta' pazjenti li esperjenzaw avveniment ta' fsada relatata ma' non-CABG tidher f'Tabella 1.
English: Of these, bleeding was the most common adverse reaction for both drugs leading to study drug discontinuation (2.5% for prasugrel and 1.4% for clopidogrel).
Maltese: Minn dawn, il-fsada kienet ir-reazzjoni avversa l-aktar komuni għaż-żewġ mediċini li waslet għat-twaqqif tal-mediċina taħt studju(2.5% għal prasugrel u 1.4% għal clopidogrel).
English: Česká republika ELI LILLY ČR, s.r.o.
Maltese: Česká republika ELI LILLY
English: Fatal Symptomatic ICHd
Maltese: Fatali ICH sintomatikad
English: Patients taking Efient should also take ASA daily (75 mg to 325 mg).
Maltese: Il-pazjenti rċevew ukoll ASA (75 mg sa 325 mg darba kuljum).
English: Efient 10 mg film-coated tablets Efient 5 mg film-coated tablets Prasugrel
Maltese: Efient 10 mg pilloli miksija b'rita Efient 5 mg pilloli miksija b'rita Prasugrel
English: Bleeding risk
Maltese: Riskju ta' fsada
English: For patients who received their thienopyridine within 3 days prior to CABG, the frequencies of TIMI major or minor bleeding were 26.7% (12 of 45 patients) in the prasugrel group, compared with 5.0% (3 of 60 patients) in the clopidogrel group.
Maltese: TIMI kienu ta' 26.7% (12 minn 45 pazjent) fil-grupp ta' prasugrel, meta mqabbel ma' 5.0% (3 minn 60
English: Subjects with diabetes had significant reductions in the primary and all secondary composite endpoints.
Maltese: Suġġetti bid-dijabete kellhom tnaqqis sinifikanti fir-riżultati finali komposti primarji u fis-sekondarji kollha.
English: Therapeutic experience with prasugrel is limited in patients with renal impairment (including ESRD) and in patients with moderate hepatic impairment.
Maltese: L-esperjenza terapewtika b'prasugrel f'pazjenti b'indeboliment tal-kliewi (inkluż ESRD) u f'pazjenti b'indeboliment moderat tal-fwied hija limitata.
English: Hypersensitivity reactions including angioedema have been reported in patients receiving prasugrel, including in patients with a history of hypersensitivity reaction to clopidogrel.
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluża l-anġjoedima ġew irrapportati f'pazjenti li qed jirċievu prasugrel, inkluż f'pazjenti b'passat ta' reazzjoni ta' sensittività eċċessiva għal clopidogrel.
English: b Other standard therapies were used as appropriate.
Maltese: b Terapiji standard oħra ġew użati kif xieraq.
English: The requirements 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 webportal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: • ≥ 75 years of age (see below).
Maltese: • ≥75 sena (ara hawn taħt).
English: The maximum inhibition by prasugrel of ADP-induced platelet aggregation is 83% with 5 µM ADP and 79% with 20 µM ADP, in both cases with 89% of healthy subjects and patients with stable atherosclerosis achieving at least 50% inhibition of platelet aggregation by 1 hour.
Maltese: 79% b'20 µM ADP, fiż-żewġ każijiet b'89% tas-suġġetti b'saħħithom u pazjenti b'aterosklerosi li kellhom mill-anqas 50% inibizzjoni ta' aggregazzjoni ta' plejtlits f'siegħa.
English: Higher inhibition of platelet aggregation was observed in patients switched to prasugrel 10 mg compared with those treated with clopidogrel 150 mg.
Maltese: Ġiet osservata inibizzjoni ogħla ta' aggregazzjoni ta' plejtlits fil-pazjenti li nqalbu għal 10 mg prasugrel meta mqabbel ma' dawk ikkurati b'150 mg clopidogrel.
English: • Bruising
Maltese: • Tbenġil
English: Subcutaneous haematoma
Maltese: Emorraġija fir-rektum
English: Each tablet contains 10 mg prasugrel (as hydrochloride).
Maltese: Kull pillola fiha 10 mg prasugrel (bħala hydrochloride)
English: OTHER <MON, TUE, WED, THU, FRI, SAT, SUN>
Maltese: OĦRAJN T,Tl,E,Ħ,Ġ,S,Ħ
English: Because of the potential for increased risk of bleeding, chronic NSAIDs (including COX-2 inhibitors) and Efient should be coadministered with caution (see section 4.4).
Maltese: Minħabba l-potenzjal ta' riskju akbar ta' fsada, NSAIDs kroniċi (fosthom inibituri ta' COX-2) u Efient għandhom jingħataw flimkien b'kawtela (ara sezzjoni 4.4).
English: Retroperitoneal haemorrhage Rectal haemorrhage Haematochezia Gingival bleeding
Maltese: • Għadd baxx tal-emoglobina jew taċ-ċelloli ħomor tad-demm (anemija)
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take Efient.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, b'nuqqas ta' Lapp lactase jew b'assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu Efient.
English: Platelet aggregation gradually returned to baseline values after treatment in 7 to 9 days after administration of a single 60 mg loading dose of prasugrel and in 5 days following discontinuation of maintenance dosing at steady-state.
Maltese: L-aggregazzjoni ta' plejtlits reġgħet lura bil-mod għall-valuri fil-linja bażi wara l-kura f'7 sa 9 ijiem wara li ngħatat doża waħda ta' kkargar ta' 60 mg prasugrel u f'5 ijiem wara t-twaqqif tad-dożaġġ ta' manteniment fi steady state.
English: The mean exposure (AUC) of the active metabolite of prasugrel is approximately 30 to 40% higher in healthy subjects and patients with a body weight of < 60 kg compared to those weighing ≥ 60 kg. Prasugrel should be used with caution in patients with a body weight of < 60 kg due to the potential risk of bleeding in this population (see section 4.4).
Maltese: L-espożizzjoni medja (AUC) tal-metabolit attiv ta' prasugrel hija madwar 30 sa 40% ogħla f'suġġetti b'saħħithom u pazjenti b'piż tal-ġisem ta' <60 kg ikkomparaw ma' dawk li jiżnu ≥60 kg.
English: It is rapidly hydrolysed in the intestine to a thiolactone, which is then converted to the active metabolite by a single step of cytochrome P450 metabolism, primarily by CYP3A4 and CYP2B6 and to a lesser extent by CYP2C9 and CYP2C19.
Maltese: prinċipalment minn CYP3A4 u CYP2B6 u anqas minn CYP2C9 u CYP2C19.
English: Prasugrel is a weak inhibitor of CYP2B6.
Maltese: Prasugrel huwa inibitur dgħajjef ta' CYP2B6.
English: Eye haemorrhage
Maltese: Ematoma taħt ilġilda
English: • While you are taking Efient:
Maltese: • Waqt li qed jittieħed Efient:
English: Efient, which contains the active substance prasugrel, belongs to a group of medicines called antiplatelet agents.
Maltese: Efient, li fih is-sustanza attiva prasugrel, jifforma parti minn grupp ta' mediċini msejħa sustanzi ta' kontra l-plejtlets.
English: Injury, poisoning and procedural complications
Maltese: Korriment, avvelenament u komplikazzjonijiet ta'
English: This is due to an increase in exposure to the active metabolite of prasugrel, and an increased risk of bleeding in patients with body weight < 60 kg when given a 10 mg once daily dose compared with patients ≥ 60 kg (see sections 4.4, 4.8 and 5.2).
Maltese: Dan minħabba espożizzjoni ogħla għallmetabolit attiv ta' prasugrel, u riskju akbar ta' fsada f'pazjenti b'piż tal-ġisem <60 kg meta jingħataw doża ta' 10 mg darba kuljum meta mqabbel ma' pazjenti ≥60 kg (ara sezzjonijiet 4.4, 4.8 u 5.2).
English: • Skin rash
Maltese: • Raxx tal-ġilda
English: Switching data: Following administration of 75 mg clopidogrel once daily for 10 days, 40 healthy subjects were switched to prasugrel 10 mg once daily with or without a loading dose of 60 mg.
Maltese: Wara li ngħatat 75 mg clopidogrel darba kuljum għal 10 ijiem, 40 suġġett b'saħħtu nqalbu għal prasugrel 10 mg darba kuljum bid-doża ta' kkargar ta' 60 mg jew mingħajrha.
English: No dose adjustment is necessary in subjects with mild to moderate hepatic impairment (Child Pugh class A and B) (see section 5.2).
Maltese: Pugh klassi A u B) (ara sezzjoni 5.2).
English: Haemoptysis
Maltese: FARMAĊEWTIKU
English: Tabulated summary of adverse reactions
Maltese: Sommarju ta' reazzjonijiet avversi b'forma tabulari
English: Use of any thienopyridine within 5 days before enrolment was an exclusion criterion.
Maltese: L-użu ta' xi thienopyridine fi żmien 5 ijiem qabel ir-reġistrazzjoni kien kriterju ta' esklużjoni.
English: Primary Composite Outcome Events Cardiovascular (CV) death, non fatal MI, or non fatal stroke
Maltese: mewt karjovaskulari (CV), infart mijikardijaku (MI) mhux fatali, jew puplesija mhux fatali.
English: EXP
Maltese: Ematurja
English: In TRITON, for every 1000 patients treated with Efient, there were 22 fewer patients with myocardial infarction, and 5 more with non-CABG-related TIMI major haemorrhages, compared with patients treated with clopidogrel.
Maltese: F'TRITON, għal kull 1000 pazjent ikkurat b'Efient, kien hemm 22 pazjent anqas b'infart mijokardijaku, u 5 aktar b'emorraġiji maġġuri skont TIMI relatata ma' non-CABG, meta mqabbel ma' pazjenti kkurati b'clopidogrel.
English: Study TADO tested the use of prasugrel (n=171) vs placebo (n=170) in patients, ages 2 to less than 18 years of age, with sickle cell anaemia for reduction of vaso occlusive crisis in a phase III study.
Maltese: L-istudju TADO ttestja l-użu ta' prasugrel (n=171) vs plaċebo (n=170) f'pazjenti, b'etajiet minn sentejn sa inqas minn 18-il sena, b'anemija tat-tip sickle cell għal tnaqqis f'krisi vaso okklussiva f'studju ta' fażi
English: The phase 3 TRITON study compared Efient (prasugrel) with clopidogrel, both co-administered with ASA and other standard therapy.
Maltese: Sindromu Koronarju Akut (ACS -Acute Coronary Syndrome) L-istudju TRITON ta' fażi 3 qabbel Efient (prasugrel) ma' clopidogrel, it-tnejn li huma ngħataw flimkien ma' ASA u terapija oħra standard.
English: TIMI major bleedingc Life-threateningd Fatal
Maltese: - mard renali (tal-kliewi) jew problemi moderati fil-fwied
English: Uncommon side effects (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100)
English: Life-threateningc
Maltese: Indeboliment tal-kliewi
English: Results of a pharmacodynamic/pharmacogenomic study in 720 Asian ACS PCI patients demonstrated that higher levels of platelet inhibition are achieved with prasugrel compared to clopidogrel, and that prasugrel 60-mg loading dose/10-mg maintenance dose is an appropriate dose regimen in Asian subjects who weigh at least 60 kg and are less than 75 years of age (see section 4.2).
Maltese: wrew li prasugrel meta mqabbel ma' clopidogrel kiseb livelli ogħla ta' inibizzjoni tal-plejtlits u li doża ta' kkargar ta' 60 mg/ doża ta' manteniment ta'10mg ta' prasugrel hija skeda ta' dożaġġ tajba għal suġġetti Ażjatiċi li għandhom piż ta' għallinqas 60 kg u li għandhom inqas minn 75 sena (ara sezzjoni4.2).
English: Patients ≥ 75 years of age have greater sensitivity to bleeding and higher exposure to the active metabolite of prasugrel (see sections 4.4, 4.8, 5.1 and 5.2).
Maltese: Pazjenti ≥ 75 sena għandhom tendenza ogħla ta' fsada u espożizzjoni akbar għal metabolit attiv ta' prasugrel (ara sezzjonijiet 4.4,
English: The usual dose of Efient is 10 mg per day.
Maltese: Normalment, id-doża ta' Efient hi ta' 10 mg kuljum.
English: The benefit was primarily due to a significant decrease in non-fatal MI (see Table 3).
Maltese: Il-benefiċċju prinċipalment seħħ minħabba tnaqqis sinifikanti f'MI mhux fatali (ara Tabella 3).
English: If you weigh less than 60 kg or are more than 75 years of age, the dose is 5 mg Efient per day.
Maltese: Jekk tiżen inqas minn 60 kg jew għandek iżjed minn 75 sena, id-doża hi ta' 5 mg ta' Efient kuljum.
English: Concomitant administration with chronic NSAIDs has not been studied.
Maltese: NSAIDs kroniċi.
English: There is no difference in exposure among Chinese, Japanese, and Korean subjects.
Maltese: M'hemmx differenza flespożizzjoni bejn suġġetti Ċiniżi, Ġappuniżi u Koreani.
English: Efient is to be administered concomitantly with acetylsalicylic acid (ASA).
Maltese: Efient għandu jingħata flimkien ma' acetylsalicylic acid (ASA).
English: and 4.8).
Maltese: 4.8, 5.1 u 5.2).
English: Elderly:
Maltese: Eparina:
English: In the All ACS population, prasugrel was associated with a lower incidence of CV death, non-fatal MI, or non-fatal stroke compared to clopidogrel, regardless of baseline characteristics such as age, sex, body weight, geographical region, use of GPIIb/IIIa inhibitors, and stent type.
Maltese: mingħajr kunsiderazzjoni tal-karateristiċi bażilari bħall-età, is-sess, il-piż tal-ġisem, ir-reġjun ġeografiku, l-użu ta' inibituri ta' GPIIb/IIIa, it-tip ta' stent.
English: Excipient(s) with known effect
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA
English: Concomitant administration of Efient with coumarin derivatives other than warfarin has not been studied.
Maltese: It-teħid ta' Efient flimkien ma' derivattivi ta' coumarin minbarra warfarin ma ġiex studjat.
English: Table 2: Haemorrhagic and Non-haemorrhagic adverse reactions System Organ
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: Haematuria
Maltese: Ematoma
English: CV death, nonfatal MI, or nonfatal stroke CV death
Maltese: Ir-rati ta' fsada maġġuri skont TIMI (inklużi ta' periklu għall-ħajja, fatali u
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation are similar in patients with moderate renal impairment (GFR 30<50 ml/min/1.73m2) and healthy subjects.
Maltese: plejtlits ta' prasugrel kienu simili f'suġġetti b'indeboliment tal-kliewi moderat (GFR 30
English: Class
Maltese: Piż
English: Monitoring for signs of hypersensitivity in patients with a known allergy to thienopyridines is advised (see section 4.8).
Maltese: Huwa rrakkomandat li wieħed joqgħod attent għas-sinjali ta' sensittività eċċessiva f'pazjenti magħrufa li huma allerġiċi għat-thienopyridines (ara sezzjoni 4.8).
English: * ICH=intracranial haemorrhage.
Maltese: * ICH=emorraġija fir-ras.
English: Bleeding Risk Associated with Timing of Loading Dose in NSTEMI In a clinical study of NSTEMI patients (the ACCOAST study), where patients were scheduled to undergo coronary angiography within 2 to 48 hours after randomization, patients given a 30 mg loading dose on average 4 hours prior to coronary angiography followed by a 30 mg loading dose at the time of PCI had an increased risk of non-CABG peri-procedural bleeding and no additional benefit compared to patients receiving a 60 mg loading dose at the time of PCI (see sections 4.2 and 4.4).
Maltese: Fi prova klinika ta' pazjenti b'NSTEMI (l-istudju ACCOAST), fejn il-pazjenti kellhom ippjanat li ssirilhom anġjografija koronarja fi żmien sagħtejn sa 48 siegħa minn meta ntagħżlu b'mod arbitrarju, doża ta' kkargar ta' prasugrel mogħtija f'medja ta' 4 sigħat qabel anġjografija koronarja żiedet irriskju ta' fsada maġġuri u minuri peri-proċedurali meta mqabbla ma' doża ta' kkargar ta' prasugrel mogħtija fl-istess ħin tal-PCI.
English: In a study in subjects with stable atherosclerosis, the mean AUC of the active metabolite in patients ≥75 years old taking 5 mg prasugrel was approximately half that in patients < 65 years old taking 10 mg prasugrel, and the antiplatelet effect of 5 mg was reduced but was non-inferior compared to 10 mg.
Maltese: F'studju f'pazjenti b'aterosklerożi stabbli, il-medja tal-AUC tal-metabolit attiv f'pazjenti ≥ 75 sena li kienu qed jieħdu 5 mg prasugrel kienet ta' madwar nofs dik tal-pazjenti < 65 sena li kienu qed jieħdu 10 mg prasugrel u l-effett kontra l-plejtlits tal-5 mg kien anqas iżda ma kienx inferjuri meta mqabbel mal-10 mg.
English: 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċi Kategorija farmakoterapewtika:
English: TIMI Major bleedingb
Maltese: • Demm mal-ippurgar
English: In the All ACS population, analysis of each of the secondary endpoints showed a significant benefit (p < 0.001) for prasugrel versus clopidogrel.
Maltese: 001) għal prasugrel kontra clopidogrel.
English: In clinical pharmacology studies, after adjusting for body weight, the AUC of the active metabolite was approximately 19% higher in Chinese, Japanese, and Korean subjects compared to that of Caucasians, predominantly related to higher exposure in Asian subjects < 60 kg.
Maltese: Fi studji tal-farmakoloġija klinika, wara l-aġġustament għall-piż tal-ġisem, AUC tal-metabolit attiv kien madwar 19% ogħla f'suġġetti Ċiniżi, Ġappuniżi u Koreani meta mqabbel ma' dak tal-Kawkażi, ilbiċċa l-kbira relatat ma' espożizzjoni ogħla f'suġġetti Asjatiċi <60 kg.
English: Administration of the 60 mg prasugrel loading dose in the fasted state may provide most rapid onset of action (see section 5.2).
Maltese: L-għoti fuq stonku vojt tad doża ta' kkargar ta' 60 mg prasugrel jista' jipprovdi l-aktar mod mgħaġġel biex jibda jaħdem (ara sezzjoni 5.2).
English: Lot:
Maltese: Sess:
English: NAME OF THE MEDICINAL PRODUCT Efient 10 mg film-coated tablets prasugrel
Maltese: Efient 10 mg pilloli miksija b'rita prasugrel
English: Pharmacokinetics of prasugrel and its inhibition of platelet aggregation were similar in subjects with mild to moderate hepatic impairment compared to healthy subjects.
Maltese: Il-farmakokinetika u l-inibizzjoni ta' l-aggregazzjoni ta' plejtlits ta' prasugrel kienu simili f'suġġetti b'indeboliment tal-fwied ħafif jew moderat meta mqabbel ma'
English: Biotransformation
Maltese: Anġjografija
English: Because of the potential for increased risk of bleeding, warfarin and Efient should be co-administered with caution (see section 4.4).
Maltese: Minħabba lpotenzjal ta' riskju akbar ta' fsada, warfarin u Efient għandhom jingħataw flimkien b'kawtela (ara sezzjoni 4.4).
English: Primary Composite Outcome Events
Maltese: STEMI Avvenimenti Primarji Komposti li Seħħew
English: Weight
Maltese: TIKKETTAR
English: Effects of Efient on other medicinal products Digoxin:
Maltese: Effett ta' Efient fuq prodotti mediċinali oħra
English: Exposure in subjects of African and Hispanic descent is comparable to that of Caucasians.
Maltese: Afrikana u Spanjola jew Latin-Amerikana hija komparabbli ma' dik tal-Kawkażi.
English: The use of Efient in patients ≥ 75 years of age is generally not recommended.
Maltese: Normalment l-użu ta' Efient f'pazjenti ≥ 75 sena mhux rakkomandat..
English: Therefore, both medicinal products can be administered concomitantly.
Maltese: Għaldaqstant, iż-żewġ prodotti mediċinali jistgħu jittieħdu flimkien.
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC22.
Maltese: Tużax din il-mediċina wara d-data ta' skadenza li tidher fuq il-folja u fuq il-kaxxa wara EXP.
English: c Any intracranial haemorrhage or any clinically overt bleeding associated with a fall in haemoglobin ≥5 g/dL.
Maltese: c Kull emorraġija fir-ras jew kull fsada li tidher klinikament u assoċjata ma' waqa' ta' emoglobina ta' ≥5 g/dL.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 10 mg FILM-COATED TABLETS
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mill-arja u mill-umdità
English: N HbA1c (%)
Maltese: HbA1c (%)
English: Race and Ethnicity
Maltese: Razza u Etniċità
English: Store below 30°C.
Maltese: Aħżen f'temperatura taħt 30°C.
English: • The active substance is insulin aspart.
Maltese: • Is-sustanza attiva hi insulina aspart.
English: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd Denmark
Maltese: Novo Nordisk A/S Novo Allé DK-2880 Bagsværd
English: 2880 Bagsværd Denmark
Maltese: 2880 Bagsværd
English: Further important information
Maltese: Informazzjoni importanti addizzjonali
English: (0.43→0.43 units/kg/day).
Maltese: 43→0.43 unità/kg/jum).
English: 1 x 3 mL + 7 NovoFine Plus needles 1 x 3 mL + 7 NovoFine needles 1 x 3 mL + 7 NovoTwist needles 5 x 3 mL
Maltese: 1 x 3 mL + 7 labar NovoFine Plus 1 x 3 mL + 7 labar NovoFine 1 x 3 mL + 7 labar NovoTwist 5 x 3 mL
English: • danazol - for endometriosis
Maltese: • danazol - għall-endometrijosi
English: Table 2 Adverse reactions from clinical trials MedDRA System Organ Class
Maltese: Tabella 2 Reazzjonijiet avversi minn provi kliniċi Sistema tal-klassifika tal-organi MedDRA
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Phenol
English: more than 108
Maltese: iktar minn 108
English: Date of first authorisation: 09 January 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 09 Jannar 2017
English: • anabolic steroids - such as testosterone
Maltese: • sterojdi anaboliċi - bħal testosterone
English: DK-2880 Bagsværd, Denmark
Maltese: DK-2880 Bagsværd, Id-Danimarka
English: The therapeutic experience in patients ≥ 75 years of age is limited.
Maltese: L-esperjenza terapewtika f'pazjenti ta' ≥75 sena hija limitata.
English: Insulin aspart has a low binding affinity to plasma proteins (< 10%), similar to that seen with regular human insulin.
Maltese: Insulina aspart għandha affinità baxxa ta' rabta mal-proteini fil-plażma (<10%), li hija simili għal dak osservat b'insulina umana regolari.
English: 0.04 [-0.04;0.12]D
Maltese: 04]CE