FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder considers that the guidelines were written primarily for new molecules where the risk to the environment has not been characterized and that it is not the case for ivermectin-containing veterinary medicinal products that have been in extensive worldwide use for nearly 25 years and that real risk or detrimental environmental effect attributable to ivermectin-based veterinary medicinal products would have been observed.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq iqis li l-linji gwida nkitbu primarjament għal molekuli ġodda fejn ir-riskju għall-ambjent ma kienx ġie ikkaratterizzat u li dan mhuwiex il-każ għal prodotti mediċinali veterinarji li fihom l-ivermectin li ilhom f'użu estensiv madwar id-dinja għal kważi 25 sena u r-riskju efffettiv kif ukoll l-effett ambjentali ta' ħsara attribwiti għal prodotti mediċinali veterinarji ibbażati fuq l-ivermectin kienu jkunu ġew osservati.
English: Recommended dose
Maltese: Doża irrakomandata
English: The PEC in soil were calculated for intensively reared animals and pasture animals, according to the CVMP Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-corr).
Maltese: (EMEA/CVMP/ERA/418282/2005-corr).
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/ APPLICANT(S)
Maltese: TAL-PRODOTTI MEDIĊINALI, SPEĊI TA' L-ANNIMALI, MOD KIF U MNEJN JINGĦATA, U DETENTUR/APPLIKANT(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ.
English: 2.1 Updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II
Maltese: 2.1 Valutazzjoni tar-Riskju Ambjentali aġġornata skond il-linji gwida tas-CVMP dwar is-suġġett, inkluża kwalunkwe ġustifikazzjoni għal eżenzjoni mill-Fażi II
English: The Marketing Authorisation Holder should discuss and propose, if considered appropriate, possible risk mitigation measures to be included in the SPC of the product.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiddiskuti u jipproponi, jekk ikkunsidrati adattati, miżuri possibbli għat-tnaqqis tar-riskju biex jiġu inklużi fl-SPC ta' dan ilprodott.
English: The Marketing Authorisation Holder should provide complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment;
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jipprovdi tagħrif sħiħ sottomess lill-Istat Membru ta' Riferenza u s-CMD(v) fir-rigward tal-valutazzjoni tar-riskju ambjentali;
English: Oral explanations were heard on 10 October 2007.
Maltese: L-ispjegazzjonijiet fil-fomm instemgħu fl-10 ta' Ottubru 2007.
English: Interferon alfa-2a; interferon alfa-2b; interferon beta-1a; interferon beta-1b; peginterferon alfa-2a; peginterferon alfa2b; peginterferon beta-1a - Pulmonary arterial hypertension (EPITT no 18059)
Maltese: Interferon alfa-2a; interferon alfa-2b; interferon beta-1a; interferon beta-1b; peginterferon alfa-2a; peginterferon alfa2b; peginterferon beta-1a - Ipertensjoni arterjali tal-pulmun (EPITT nru 18059)
English: Daclatasvir; sofosbuvir; sofosbuvir, ledipasvirArrhythmia (EPITT no 18177)
Maltese: Daclatasvir; sofosbuvir; sofosbuvir, ledipasvir - Arritmija (EPITT nru 18177)
English: Adopted at the 7-10 April 2015 PRAC
Maltese: Adottati fil-PRAC ta' bejn is-7 u l-10 ta' April 2015
English: Trabectedin - Capillary leak syndrome (EPITT no 18115)
Maltese: 3. Trabectedin - Sindromu ta' tnixxija kapillari (EPITT nru 18115)
English: No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), amiodarone, disopyramide, propafenone, flecainide, mexilitine, quinidine or antacids.
Maltese: L-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' xi wieħed mill-prodotti mediċinali mhija mistennija meta daclatasvir jingħata flimkien ma' xi wieħed minn dawn li ġejjin: inibituri PDE-5, prodotti mediċinali fil-klassi tal-inibitur ACE (eż. enalapril), prodotti mediċinali fil-klassi tal-antagonist tar-riċettur angiotensin II (eż. losartan, irbesartan, olmesartan, candesartan, valsartan), amiodarone, disopyramide, propafenone, flecainide, mexilitine, quinidine jew antaċidi.
English: Pulmonary arterial hypertension [Interferon alfa-containing products]
Maltese: Ipertensjoni arterjali tal-pulmun [Prodotti li fihom interferon alfa]
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction Amiodarone
Maltese: Sezzjoni 4.5 - Interazzjoni ma' prodotti mediċnali oħra u forom oħra ta' interazzjoni Amiodarone
English: Section 4 - Possible side effects
Maltese: Sezzjoni 4 - Effetti sekondarji possibbli [Prodotti li fihom interferon alfa]
English: Section 4.8 - Undesirable effects [Interferon alfa and beta containing products] “Pulmonary arterial hypertension*” should be added under the System Organ Class (SOC) “Respiratory, thoracic and mediastinal disorders” with the frequency “not known”.
Maltese: Sezzjoni 4.8 - Effetti mhux mixtieqa [Prodotti li fihom interferon alfa u beta] “Ipertensjoni arterjali tal-pulmun*” għandha tiżdied taħt “Disturbi respiratorji, toraċiċi u medjastinali” bil-frekwenza “mhux magħruf” tas-Sistema tal-Klassifika tal-Organi (SOC). “*Tikketta tal-klassi għall-prodotti interferon, ara taħt Ipertensjoni arterjali tal-pulmun.” Sezzjoni 4.8c
English: Cases of pulmonary arterial hypertension (PAH) have been reported with interferon alfa products, notably in patients with risk factors for PAH (such as portal hypertension, HIV infection, cirrhosis).
Maltese: Każijiet ta' ipertensjoni arterjali tal-pulmun (PAH) ġew irrapportati bi prodotti interferon alfa, b'mod partikolari b'fatturi ta' riskju għal PAH (bħal ipertensjoni portali, infezzjoni HIV, ċirrożi).
English: • Light-headedness
Maltese: • Sturdament
English: • The MAHs should distribute a direct healthcare professional communication (DHPC) according to the text and communication plan agreed with the PRAC and CHMP
Maltese: • L-MAHs għandhom iqassmu komunikazzjoni diretta lill-professjonisti tal-kura tas-saħħa (DHPC) skont it-test u l-pjan ta' komunikazzjoni maqbul mal-PRAC u s-CHMP
English: Description of selected adverse reactions
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula
English: The PRAC has noted that amiodarone was involved in cases with the most suggestive causal relationship.
Maltese: Il-PRAC innota li amiodarone kien involut f'każijiet bir-relazzjoni kawżali l-aktar suġġestiva.
English: [Interferon alfa-containing products]
Maltese: [Prodotti li fihom interferon beta]
English: Only Summary of Products Characteristics for Daklinza
Maltese: Sommarju tal-Karatteristiċi tal-Prodott għal Daklinza biss
English: The PRAC has assessed cases of severe arrhythmia associated with the use of sofosbuvir (including in combination with ledipasvir) and/or daclatasvir, in particular in patients with established cardiac disorders and treated with bradycardic medications.
Maltese: Il-PRAC ivvaluta każijiet ta' arritmija severa assoċjati mal-użu ta' sofosbuvir u/jew daclatasvir, b'mod partikolari f'pazjenti b'disturbi fil-qalb stabbiliti u kkurati b'mediċini bradikardijaċi.
English: Based on published clinical and non-clinical data and on spontaneous reports, the PRAC considers that a causal relationship between the use of interferons alfa and beta and the development of pulmonary arterial hypertension, a rare but severe event, cannot be excluded.
Maltese: Abbażi tad-data klinika u mhux klinika ppubblikata f'rapporti spontanji, il-PRAC jikkunsidra li relazzjoni kawżali bejn l-użu ta' interferons alfa u beta u l-iżvilupp ta' ipertensjoni arterjali tal-pulmun, avveniment rari iżda serju, ma tistax tiġi eskluża.
English: In the light of available evidence from case reports in EudraVigilance and from data submitted by the MAH, the PRAC has agreed that there is a reasonable possibility of a causal relationship between capillary leak syndrome and the use of trabectedin.
Maltese: Fid-dawl tal-evidenza disponibbli mir-rapporti ta' każijiet f'EudraVigilance u minn data sottomessa millMAH, il-PRAC qabel li hemm possibbiltà raġonevoli ta' relazzjoni kawżali bejn sindromu ta' tnixxija kapillari u l-użu ta' trabectedin.
English: Events were reported at various time points including up to several years after starting treatment with interferon beta.
Maltese: Avvenimenti ġew irrapportati f'diversi punti ta' żmien, anki sa diversi snin wara l-bidu tal-kura b'interferon beta.
English: Events were reported at various time points typically several months after starting treatment with interferon alfa.
Maltese: Avvenimenti ġew irrapportati f'diversi punti ta' żmien, ġeneralment diversi xhur wara li nbdiet il-kura b'interferon alfa.
English: Severe Bradycardia and Heart Block
Maltese: Arritmiji kardijaċi
English: Close monitoring is recommended if this medicinal product is administered with <brand name> (see sections 4.4 and 4.8).
Maltese: Huwa rrakkomandat monitoraġġ mill-qrib jekk dan il-prodott mediċinali jingħata ma' <isem kummerċjali> (ara s-sezzjonijiet 4.4 u 4.8).
English: Cases of severe bradycardia and heart block have been observed when <brand name> is used in combination with <adapt according to the product> and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Maltese: Każijiet ta' bradikardija severa u mblokkar tal-qalb ġew osservati meta <isem kummerċjali> intuża flimkien ma' <adatta skont il-prodott> u amiodarone konkomitanti u/jew mediċini oħrajn li jbaxxu rrata ta' taħbit tal-qalb (ara s-sezzjonijiet 4.4 u 4.5).
English: • Taking into account that the mechanism for the drug-drug interaction with amiodarone remains unclear, the MAHs should ensure that planned non-clinical studies investigate both the potential pharmacodynamic and pharmacokinetic effects.
Maltese: • Meta jitqies li l-mekkaniżmu għall-interazzjoni bejn mediċina u oħra b'amiodarone jibqa' mhux ċar, l-MAHs għandhom jiżguraw li l-istudji mhux kliniċi ppjanati jinvestigaw kemm l-effetti farmakodinamiċi kif ukoll dawk farmakokinetiċi potenzjali.
English: • The MAHs of Sovaldi, Harvoni and Daklinza should submit a variation within 1 month, to amend the product information as described below (<new text underlined / text to be removed with strikethrough>)
Maltese: • L-MAHs ta' Sovaldi, Harvoni u Daklinza għandhom jissottomettu varjazzjoni fi żmien xahar, biex jemendaw l-informazzjoni dwar il-prodott kif deskritt hawn taħt (<test ġdid sottolinjat / test li għandu jitneħħa b'ingassar (strikethrough)>)
English: 28-35 days
Maltese: 28-35 jum
English: • the 90
Maltese: • in-90
English: SOC / Preferred term.
Maltese: SOC/Terminu ppreferut.
English: ® TT (Anti-FIIa) 1.36 fold, respectively.
Maltese: ® TT (Anti-FIIa) 1.36 darbiet, rispettivament.
English: - The active substance is dabigatran.
Maltese: - Is-sustanza attiva hi dabigatran.
English: [xxxx 201x] [Boehringer Ingelheim logo]
Maltese: [xxxx 201x] [logo ta' Boehringer Ingelheim]
English: • SSRIs or SNRIs
Maltese: • SSRIs jew SNRIs
English: Capsule content Tartaric acid Acacia
Maltese: Kontenut tal-kapsula Tartaric acid Acacia
English: Cardioversion (SPAF)
Maltese: Kardjoverżjoni (SPAF)
English: [Pradaxa logo]
Maltese: [logo ta' Pradaxa]
English: ® before any surgery/invasive procedure.
Maltese: ® qabel kwalunkwe proċedura kirurġika/invażiva.
English: Age (years) 65 ≤ and < 75
Maltese: Età (snin) 65 ≤ u < 75
English: th percentile of observations.
Maltese: th percentile tal-osservazzjonijiet.
English: Subacute surgery/interventions
Maltese: Operazzjoni subakuta/interventi
English: th th percentile range).
Maltese: th th medda ta' percentiles).
English: Totals of 2,076 patients (knee) and 3,494 (hip) were treated respectively.
Maltese: Total ta' 2,076 pazjent (irkoppa) u 3,494 (ġenbejn) ġew ikkurati rispettivament.
English: P-gp substrate Digoxin
Maltese: Substrat ta' P-gp Digoxin
English: CrCL(mL/min) 30 ≤ and < 50 50 ≤ and < 80
Maltese: CrCL(mL/min) 30 ≤ u < 50 50 ≤ u < 80
English: The mean CHADS2 and HAS-BLED scores were 1.9 and 1.2, respectively.
Maltese: Ilpunteġġi CHADS2 u HAS-BLED medji kienu 1.9 u 1.2, rispettivament.
English: Pradaxa treatment to Vitamin K antagonists (VKA):
Maltese: Trattament bi Pradaxa għal antagonisti tal-Vitamina K (VKA - Vitamin K antagonists):
English: Pradaxa should be temporarily discontinued.
Maltese: Pradaxa għandu jitwaqqaf temporanjament.
English: Dabigatran prolongs the thrombin time (TT), ECT, and aPTT.
Maltese: II. Dabigatran itawwal il-ħin ta' thrombin (TT), ECT, u aPTT.
English: See further down and sections 4.4, 4.5, 5.1 and 5.2.
Maltese: Ara aktar 'l isfel u sezzjonijiet 4.4, 4.5, 5.1 u 5
English: DVT/PE prevention (RE-MEDY, RESONATE)
Maltese: 300 mg prevenzjoni ta' DVT/PE (RE-MEDY, RESONATE)
English: Cmax and AUC were dose proportional.
Maltese: Is-Cmax u l-AUC kienu proporzjonali mad-doża.
English: Aspartate aminotransferase increased
Maltese: Aspartate aminotransferase ogħla
English: Transporter interactions
Maltese: Interazzjonijiet tat-trasportatur
English: • Bacterial endocarditis
Maltese: • Endokardite batterjali
English: Alanine aminotransferase increased
Maltese: Alanine aminotransferase ogħla
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 18 March 2008
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 18 ta' Marzu, 2008
English: Estimated half-life (hours)
Maltese: Half-life stmata (sigħat)
English: gMean (gCV %; range) half-life [h]
Maltese: gMean (gCV%; medda) half-life [sigħat]
English: Myocardial Infarction (MI)
Maltese: Infart Mijokardijaku (MI - Myocardial Infarction)
English: Parenteral anticoagulants to Pradaxa:
Maltese: Mediċina antikoagulanti parenterali għal Pradaxa:
English: Selective serotonin re-uptake inhibitors (SSRIs) or selective serotonin norepinephrine re-uptake inhibitors (SNRIs)
Maltese: Inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin (SSRIs - selective serotonin re-uptake inhibitors) jew inibituri selettivi tal-assorbiment mill-ġdid ta' serotonin norepinephrine (SNRIsselective serotonin norepinephrine re-uptake inhibitors)
English: Test (trough value) dTT [ng/mL]
Maltese: Test (valur minimu) dTT [ng/mL]
English: Paediatric population (DVT/PE)
Maltese: Popolazzjoni pedjatrika (DVT/PE)
English: - The black printing ink contains shellac, iron oxide black and potassium hydroxide.
Maltese: - Il-linka sewda ta' l-istampar fiha shellac, iron oxide black u potassium hydroxide.
English: The median CrCL in RE-LY was 68.4 mL/min.
Maltese: Il-medjan ta' CrCL f'RE-LY kien ta' 68.4 mL/min.
English: 18 months (%)
Maltese: Inċidenzi (%)
English: Capsule shell Carrageenan Potassium chloride Titanium dioxide Indigo carmine (E132) Hypromellose
Maltese: Qoxra tal-kapsula Carrageenan Potassium chloride Titanium dioxide Indigo carmine (E132) Hypromellose
English: Incidences (%) Risk ratio over enoxaparin 95 % CI
Maltese: Inċidenzi (%) Proporzjon tar-riskju fuq enoxaparin 95% CI
English: e.g. rifampicin, St. John´s wort (Hypericum perforatum), carbamazepine, or phenytoin
Maltese: John's wort (Hypericum perforatum), carbamazepine, jew phenytoin
English: Limited data is available in patients < 50 kg (see section 5.2).
Maltese: Data limitata hija disponibbli f'pazjenti li jiżnu < 50 kg (ara sezzjoni 5.2).
English: 60 x 1 hard capsule
Maltese: 60 x 1 kapsula iebsa
English: RE-MODEL (knee)
Maltese: RE-MODEL (irkoppa)
English: Table 11: Adverse reactions
Maltese: Tabella 11: Reazzjonijiet avversi
English: glomerular filtration rate (CrCL,) [mL/min]
Maltese: rata ta' filtrazzjoni glomerulari (CrCL,) [mL/min]
English: Protease inhibitors such as ritonavir
Maltese: Inibituri ta' protease bħal ritonavir
English: RE-NOVATE (hip)
Maltese: RE-NOVATE (ġenbejn)
English: Statistical superiority was also analysed.
Maltese: Is-superjorità statistika ġiet analizzata wkoll.
English: Similar values for CrCL were found in RE-COVER II.
Maltese: Valuri simili għal CrCL instabu f'RE-COVER II.
English: No clinically relevant ethnic differences among Caucasians, African-American, Hispanic, Japanese or Chinese patients were observed.
Maltese: Ma ġew osservati l-ebda differenzi etniċi klinikament rilevanti fost pazjenti Kawkasi, AfrikaniAmerikani, Ispaniċi, Ġappuniżi jew Ċiniżi.
English: The patient population was 64 % male, 70 % Caucasian and 16 % Asian.
Maltese: Il-popolazzjoni ta' pazjenti kienet ta' 64% irġiel, 70% Kawkasi u 16% Asjatiċi.
English: In these four phase III trials, 16,709 patients were exposed to Pradaxa (see Table 9).
Maltese: III, 16,709 pazjenti kienu esposti għal Pradaxa (ara Tabella 9).
English: Gastroesophagitis
Maltese: Gastroesofaġite
English: Component of a multipack, can´t be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Catheter ablation for atrial fibrillation (SPAF)
Maltese: Asportazzjoni tal-kateter għal fibrillazzjoni atrijali (SPAF)
English: No difference was found for major bleeding (hazard ratio 0.97, CI 0.88 - 1.07).
Maltese: Ma nstabet l-ebda differenza għal fsada maġġuri (proporzjon ta' periklu 0.97, CI 0.88 - 1.07).
English: Table 6: Transporter interactions
Maltese: Tabella 6: Interazzjonijiet tat-trasportatur
English: 10 days (knee replacement surgery) or 28-35 days (hip replacement surgery)
Maltese: 10 ijiem (operazzjoni ta' sostituzzjoni talirkoppa) jew 28-35 jum (operazzjoni ta' sostituzzjoni talġenbejn)
English: Laboratory coagulation parameters
Maltese: Parametri tal-koagulazzjoni tal-laboratorju
English: After multiple doses a terminal half-life of about 12-14 hours was observed.
Maltese: Wara dożi multipli, ġiet osservata half-life terminali ta' madwar 12-14-il siegħa.
English: • Thrombocytopenia or functional platelet defects
Maltese: • Tromboċitopenija jew difetti funzjonali tal-plejtlits
English: Surgery and interventions
Maltese: Operazzjoni u interventi
English: SPAF and DVT/PE
Maltese: SPAF u DVT/PE
English: Pradaxa dabigatran etexilate
Maltese: Pradaxa® jista' jiġi dijalizzat
English: No clinically relevant inter-ethnic differences among Caucasian, African-American, Hispanic, Japanese or Chinese patients were observed regarding dabigatran pharmacokinetics and pharmacodynamics.
Maltese: Ma ġew osservati l-ebda differenzi klinikament rilevanti interetniċi fost pazjenti Kawkasi, AfrikaniAmerikani, Ispaniċi, Ġappuniżi jew Ċiniżi fir-rigward tal-farmakokinetika u l-farmakodinamika ta' dabigatran.
English: Limited clinical data in patients < 50 kg are available.
Maltese: Dejta klinika limitata hi disponibbli f'pazjenti li jiżnu ≤ 50 kg.
English: Four positional isomers, 1-O, 2-O, 3-O, 4-O-acylglucuronide exist, each accounts for less than 10 % of total dabigatran in plasma.
Maltese: Jeżistu erba' positional isomers, 1-O, 2-O, 3-O, 4-O-acylglucuronide, u kull wieħed minnhom fih inqas minn 10% mit-total ta' dabigatran fil-plażma.
English: With a loading dose of 300 mg or 600 mg clopidogrel, dabigatran AUCτ,ss and Cmax,ss were increased by about 30-40 % (see section 4.4) .
Maltese: B'doża għolja tal-bidu ta' 300 mg jew 600 mg clopidogrel, l-AUCτ,ss u Cmax,ss ta' dabigatran żdiedu b'madwar 30-40% (ara sezzjoni 4.4).
English: Dabigatran etexilate is a substrate for the efflux transporter P-gp.
Maltese: Dabigatran etexilate hu substrat għat-trasportatur tal-effluss P-gp.
English: INFORMATION IN BRAILLE Pradaxa 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pradaxa 75 mg
English: Table 9: Other interactions
Maltese: Tabella 9: Interazzjonijiet oħra
English: - The other ingredients are tartaric acid, acacia, hypromellose, dimeticone 350, talc, and hydroxypropylcellulose.
Maltese: - Is-sustanzi l-oħra huma tartaric acid, acacia, hypromellose, dimeticone 350, talc, u hydroxypropylcellulose.
English: Dabigatran is subject to conjugation forming pharmacologically active acylglucuronides.
Maltese: Dabigatran hu suġġett għal konjugazzjoni li tifforma acylglucuronides farmakoloġikament attivi.
English: Gastrointestinal disorders Gastrointestinal haemorrhage
Maltese: Disturbi gastro-intestinali Emorraġija gastrointestinali
English: ECT [x-fold upper limit of normal] aPTT [x-fold upper limit of normal] INR
Maltese: ECT [x-darbiet tal-limitu ta' fuq tan-normal] aPTT [x-darbiet tal-limitu ta' fuq tan-normal] INR
English: In actively controlled VTE prevention trials 6,684 patients were treated with 150 mg or 220 mg Pradaxa daily.
Maltese: Fi provi ta' prevenzjoni ta' VTE kkontrollati attivament 6,684 pazjent kienu kkurati b'150 mg jew 220 mg ta' Pradaxa kuljum.
English: The study included 4,859 patients on dabigatran etexilate (55% treated with 150 mg bid, 43% treated with 110 mg bid, 2% treated with 75 mg bid).
Maltese: L-istudju kien jinkludi 4,859 pazjent fuq dabigatran etexilate (55% ittrattati b'150 mg bid, 43% ittrattati b'110 mg bid, 2% ittrattati b'75 mg bid).
English: Duration of maintenance dose
Maltese: Tul tad-doża ta' manteniment
English: Nervous system disorders Intracranial haemorrhage
Maltese: Disturbi fis-sistema nervuża Emorraġija intrakranjali
English: INFORMATION IN BRAILLE Pradaxa 110 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pradaxa 110 mg
English: Tables 20-22 display details of key results in the overall population:
Maltese: Tabelli 20-22 juru dettalji tar-riżultati ewlenin fil-popolazzjoni totali:
English: Patients were randomized to dabigatran etexilate 110 mg bid dualtherapy, dabigatran etexilate 150 mg bid dual-therapy or warfarin triple-therapy.
Maltese: Ilpazjenti kienu randomised għal terapija doppja b'dabigatran etexilate 110 mg bid, terapija doppja b'dabigatran etexilate 150 mg bid jew terapija tripla b'warfarin.
English: Symptomatic DVT 95 % confidence interval
Maltese: DVT sintomatika 95% intervall ta' kunfidenza
English: • Esophagitis, gastritis or gastroesophageal reflux
Maltese: • Esofaġite, gastrite jew rifluss gastroesofagali
English: Pharmacotherapeutic group: antithrombotic agents, direct thrombin inhibitors, ATC code: B01AE07.
Maltese: Kategorija farmakoterapewtika: sustanzi antitrombotiċi, inibituri thrombin diretti, Kodiċi ATC:
English: Concomitant administration of 90 mg ticagrelor b.i.d.
Maltese: L-għoti fl-istess ħin ta' 90 mg ta' ticagrelor b.i.d.
English: Pharmacodynamic and kinetic factors
Maltese: Fatturi farmakodinamiċi u kinetiċi
English: Renal function (CrCL in mL/min)
Maltese: Funzjoni talkliewi (CrCL f'mL/min)
English: Table 18: Hazard Ratio and 95 % CI for stroke/systemic embolism by subgroups
Maltese: Tabella 18: Proporzjon ta' Periklu u 95% CI għal puplesija/emboliżmu sistemiku skont issottogruppi
English: Test (trough value)
Maltese: Test (valur minimu)
English: Pradaxa treatment to parenteral anticoagulant:
Maltese: Trattament bi Pradaxa għal mediċina antikoagulanti parentali:
English: Peel off the backing foil and remove the capsule.
Maltese: Qaxxar il-backing foil u neħħi l-kapsula.
English: PHARMACEUTICAL FORM AND CONTENTS 10 x 1 hard capsule
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 10 x 1 kapsula iebsa
English: In the pooled RE-COVER and RE-COVER II studies, a total of 5,153 patients were randomised and 5,107 were treated.
Maltese: Fl-istudji miġbura RE-COVER u RE-COVER II, total ta' 5,153 pazjent intgħażlu b'mod każwali u 5,107 ġew ikkurati.
English: •An instruction how to take Pradaxa
Maltese: • It-teħid ta' Pradaxa
English: Table 23: Hazard Ratio and 95 % CI for stroke/systemic embolism by subgroups
Maltese: Tabella 23: Proporzjon ta' Periklu u 95% CI għal puplesija/emboliżmu sistemiku skont issottogruppi
English: Recovery of the total radioactivity ranged from 88-94 % of the administered dose by 168 hours post dose.
Maltese: L-irkuprar tar-radjuattività totali varja minn 88-94% tad-doża mogħtija sa 168 siegħa wara l-għoti tad-doża.