FrancophonIA/ELRC3.0 huggingface dataset:
English: [Invented name] 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded (see sections 4.4 and 5.1).
Maltese: [Isem Ivvintat] 400 mg, pilloli miksija b'rita mhux irrakkomandati għall-użu bħala monoterapija tal-marda infjammatorja ħafifa sa moderata tal-pelvi, iżda għandu jingħata flimkien ma' sustanza anti-batterika xierqa oħra (e.ż. cephalosporin) minħabba żjieda fir-reżistenza għal moxifloxacin ta' Neisseria gonorrhoeae sakemm ma tiġix eskluża Neisseria gonorrhoeae reżistenti għal moxifloxacin (ara sezzjonijiet 4.4 u 5.1).
English: In vitro resistance to moxifloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Moxifloxacin is a poor substrate for active efflux mechanisms in Gram-positive organisms.
Maltese: Reżistenza in vitro għal moxifloxacin tinkiseb permezz ta' proċess ta' passi wara xulxin permezz ta' mutazzjonijiet fis-sit immirat fiż-żewġ topoisomerases tat-tip II, DNA gyrase u topoisomerase IV.
English: No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
Maltese: L-ebda aġġustament fid-doża ma' huwa meħtieġ f'pazjenti b'indeboliment tal-funzjoni renali ħafif sa sever jew f'pazjenti fuq dijalisi kronika i.e. emodijalisi u dijalisi peritoneali ambulatorja kontinwa (ara sezzjoni 5.2 għal aktar dettalji).
English: In clinical practice these cases are usually restricted to cases when a combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae is not possible or in cases of therapeutic failure with a different therapy.
Maltese: Fil-prattika klinika dawn il-każijiet ġeneralment kienu ristretti għal każijiet fejn ma jkunx possibbli li ssir kombinazzjoni ma' aġent approvat attiv kontra N. gonorrhoeae reżistenti għal fluoroquinolone jew f'każijiet ta' falliment terapewtiku b'terapija differenti.
English: - Cases of fulminant hepatitis potentially leading to life-threatening liver failure have been reported with moxifloxacin (see section 4.8).
Maltese: B'moxifloxacin ġew irrapportati każijiet ta' epatite fulminanti li potenzjalment iwasslu għallinsuffiċjenza tal-fwied ta' periklu għall-ħajja (ara sezzjoni 4.8).
English: Moxifloxacin is mainly bound to serum albumin.
Maltese: Fil-biċċa l-kbira, Moxifloxacin huwa mwaħħal ma' l-albumina fis-serum.
English: [Invented name] 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
Maltese: 14-il ġurnata [Isem Ivvintat] 400 mg, pilloli miksija b'rita ġew studjati fi provi kliniċi sa 14-il ġurnata ta' kura.
English: Interstitial fluid
Maltese: Fluwidu interstizjali
English: The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp.
Maltese: Konċentrazzjonijiet ogħla fil-plażma huma osservati f'voluntiera b'saħħithom b'piż tal-ġisem baxx (bħal nisa) u f'voluntiera anzjani.
English: [Invented name] 400 mg film-coated tablets are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin.
Maltese: [Isem Ivvintat] 400 mg, pilloli miksija b'rita huma ndikati għall-kura tal-infezzjonijiet mill-batterji li ġejjin:
English: In vitro Susceptibility Data
Maltese: Tagħrif ta' Suxxettibilitài in vitro
English: [Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed) - Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Maltese: Pnewmonja miksuba mill-komunità, minbarra każijiet severi Sinożite akuta mill-batterji (iddijanjostikata b'mod adegwat) - Marda infjammatorja ħafifa sa moderata tal-pelvi (i.e. infezzjonijiet ta' l-apparat ġenitali ta' fuq tal-mara, inkluż salfinġite u endometrite), mingħajr axxess tubo-ovarjan jew pelviku assoċjat.
English: Inherently resistant organisms
Maltese: Organiżmi reżistenti b'mod inerenti
English: Anaerobes
Maltese: Qawwa
English: The CHMP considered that QT-prolongation in PID should however be carefully addressed by the MAH in future PSURs.
Maltese: Is-CHMP ikkunsidra madankollu li t-titwil tat-taqsima QT fil-PID għandha tiġi indirizzata b'attenzjoni mill-MAH f'PSURs futuri.
English: - Due to adverse effects on the cartilage in juvenile animals (see section 5.3) the use of moxifloxacin in children and adolescents < 18 years is contraindicated (see section 4.3).
Maltese: Minħabba effetti avversi fuq il-kartilaġini ta' annimali frieħ (ara sezzjoni 5.3) l-użu ta' moxifloxacin fit-tfal u l-adoloxxenti < 18-il sena huwa kontra-indikat (ara sezzjoni 4.3).
English: In this referral procedure, the CHMP focused on the risk of more frequent QT-prolongation in women in the light of the prolonged treatment regimen in PID (14 days vs. 5-10 days), on the risk of coadministration with other QT-affecting substances and on the possible adverse effects on cartilage in the treatment population.
Maltese: F'din il-proċedura ta' riferiment, is-CHMP iffoka fuq ir-riskju ta' titwil aktar frekwenti tat-taqsima QT fin-nisa fid-dawl ta' programmi itwal ta' trattament fil-PID (14-il jum meta mqabbla ma' bejn 5 u għaxart ijiem), fuq ir-riskju ta' meta jingħata flimkien ma' sustanzi oħra li jaffettwaw il-QT u fuq leffetti sekondarji possibbli fuq il-qarquċa fil-popolazzjoni ttrattata.
English: In clinical practice, this would mean that moxifloxacin should be used in combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae (e.g. a cephalosporin) for empirical treatment of PID unless moxifloxacinresistant N. gonorrhoeae can be excluded.
Maltese: Fil-prattika klinika, dan kien ifisser li moxifloxacin għandu jintuża flimkien ma' l-aġent approvat attiv kontra N. gonorrhoeae (per eżempju cephalosporin) għat-trattament tal-PID sakemm ma tkunx tista' tiġi eskluża N.gonorrhoeae reżistenti għal moxifloxacin.
English: On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Maltese: Fuq bażi ta' studji farmakokinetiċi li twettqu s'issa f'pazjenti b'insuffiċjenza tal-fwied (Child Pugh A, B), mhux possibli li jiġi determinat jekk hemmx xi differenzi meta mqabbel ma' voluntiera b'saħħithom.
English: - The Committee considered that no additional safety concerns were expected with the claimed indication in comparison to the previously approved indications.
Maltese: - Il-Kumitat ikkunsidra li ma kienx mistenni iktar tħassib ma' l-indikazzjoni kklejmjata meta mqabbla ma' l-indikazzjonijiet approvati qabel.
English: The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair.
Maltese: L-azzjoni batteriċida ta' moxifloxacin tirriżulta mill-inibizzjoni taż-żewġ topoisomerases tat-tip II (DNA gyrase u topoisomerase IV) meħtieġa għar-replikazzjoni, transkrizzjoni u tiswija tad-DNA talbetterji.
English: There is insufficient experience in the clinical use of moxifloxacin in patients with impaired liver function.
Maltese: M'hemm biżżejjed esperjenza fl-użu kliniku ta' moxifloxacin f'pazjenti b'indeboliment fil-funzjoni tal-fwied.
English: Strength
Maltese: Ġermanja
English: * Non-species related breakpoints have been determined mainly on the basis of pharmacokinetic/pharmacodynamic data and are independent of MIC distributions of specific species.
Maltese: > 1 mg/l * Punti kritiċi mhux relatati ma' speċi ġew determinati primarjament fuq il-bażi ta' tagħrif farmakokinetiku/farmakodinamiku u huma indipendenti mid-distribuzzjonijiet ta' MIC għallispeċi speċifiċi.
English: - If you were born with or have had any condition with certain abnormal electrocardiogram (ECG, electrical recording of the heart) changes, have salt imbalance in the blood, especially low concentrations of potassium in the blood (hypokalaemia) which are currently not corrected by treatment, have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of abnormal heart rhythms (arrhythmias), or you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines).
Maltese: - Jekk inti twelidt bi jew kellek kull kundizzjoni b'ċerti bidliet mhux normali flelettrokardjogramm (ECG, irrekordjar ta' l-elettriku tal-qalb), għadek żbilanċ tal-melħ fid-demm, speċjalment konċentrazzjonijiet baxxi ta' potassju fid-demm (ipokalimja) li bħalissa mhux ikkoreġuti b'kura, għandek rata tal-qalb baxxa ħafna (bradikardija), għandek qalb dgħajjfa (insuffiċjenza tal-qalb), għandek passat ta' ritmu tal-qalb mhux normali (arritmija), jew qed tieħu mediċini oħra li jwasslu għal ċerti bidliet mhux normali fl-ECG (ara sezzjoni Meta tieħu mediċini oħra).
English: The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
Maltese: Il-preżenza tassostitwent voluminuż bicycloamine fil-pożizzjoni C-7 tipprevjeni effluss attiv, assoċjat mal l-ġeni norA jew pmrA li jidrhu f'ċerti batterja pożittivi għal Gram.
English: Drugs inhibiting peristalsis are contraindicated in this situation.
Maltese: Mediċini li jinibixxu l-peristalsi huma kontra-indikati f'din is-sitwazzjoni.
English: Do not take [Invented name] 400 mg film-coated tablets - If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients (see section 6.
Maltese: - Jekk inti allerġiku/a (tbagħti minn sensittività eċċessiva) għas-sustanza attiva moxifloxacin, anti-bijotiċi quinolones oħra jew għal xi sustanzi oħra (ara sezzjoni 6.
English: The CHMP considered that due to the emergence of fluoroquinolone-resistant N. gonorrhoeae strains moxifloxacin should not be used in empirical monotherapy of mild to moderate PID, unless a resistance against moxifloxacin can be ruled out.
Maltese: Is-CHMP ikkunsidra li minħabba t-tkattir ta' razez ta' N. gonorrhoeae reżistenti għal fluoroquinolone, moxifloxacin ma għandux jintuża fil-monoterapija empirika tal-PID ħafifa jew moderata, sakemm ma tkunx tista' tiġi eskluża reżistenza għal kontra moxifloxacin.
English: Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens.
Maltese: Moxifloxacin għandu attività in vitro kontra firxa wiesgħa ta' patoġeni pożittivi għal Gram u negattivi għal Gram.
English: - Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
Maltese: Sensittività eċċessiva għal moxifloxacin, quinolones oħra jew għal xi sustanzi mhux attivi.
English: Available data demonstrated no evidence for increased cardiac morbidity related to oral moxifloxacin therapy when compared to comparator antibiotic therapy, especially in a younger female population, although in other trials QT interval prolongation and torsades de pointes were more common in women than in men.
Maltese: Id-dejta disponibbli ma wriet l-ebda evidenza ta' żieda fil-morbidità relatata mat-terapija orali b'moxifloxacin meta mqabbla ma' terapija antibijotika, speċjalment f'popolazzjoni femminili iżgħar, għalkemm fi studji oħra ittitwil tal-QT u t-torsades de pointes kienu iktar komuni fin-nisa milli fl-irġiel.
English: When taking [Invented name] 400 mg film-coated tablets - The risk of cardiac abnormalities may increase with increase of the dose.
Maltese: Meta tieħu [Isem Ivvintat] 400mg pilloli miksija b'rita - Ir-riskju ta' anormalitajiet tal-qalb jista' jiżjied ma' żjieda fid-doża.
English: - Antibiotic associated colitis (incl.
Maltese: - Infezzjoni akuta tas-sinusis (sinożite akuta mill-batterja)
English: Plasma
Maltese: Plażma
English: - Pelvic inflammatory disease may be caused by fluoroquinolone resistant Neisseria gonorrhoeae.
Maltese: - Marda infjammatorja tal-pelvi tista' tkun ikkawżata minn Neisseria gonorrhoeae reżistenti għal fluoroquinolone.
English: Before you take [Invented name] …, Take special care …, Before taking [Invented name] 400 mg film-coated tablets).
Maltese: Qabel ma tieħu [Isem Ivvintat]…, Oqgħod attent ħafna …, Qabel tieħu [Isem Ivvintat] 400mg pilloli miksija b'rita).
English: Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also effect susceptibility to moxifloxacin.
Maltese: Mekkaniżmi ta' reżistenza oħra bħall-barrieri għall-permeabilità (komuni f'Pseudomonas aeruginosa) u mekkaniżmi ta' effluss jistgħu wkoll jaffettwaw is-suxxettibilità għal moxifloxacin.
English: It is approved for the treatment of the following bacterial infections if they are caused by bacteria susceptible to moxifloxacin: - Acute exacerbation of chronic bronchitis - Community acquired pneumonia, except severe cases - Acute bacterial sinusitis (adequately diagnosed).
Maltese: - Tqanqil akut tal-bronkite kronika - Infezzjonijiet tal-pulmun miksuba mill-komunità, ħlief każijiet severi - Sinusite batterika akuta (b'dijanjosi xierqa).
English: It contains the active
Maltese: Fih is
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FILGRASTIM RATIOPHARM
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) FILGRASTIM
English: The active substance in Filgrastim ratiopharm, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Maltese: Is-sustanza attiva f'Filgrastim ratiopharm, filgrastim hija simili ħafna għal proteina umana msejjħa stimulazzjoni tal-kolownja granuloċijto (G-CSF).
English: Filgrastim ratiopharm is a ‘biosimilar' medicine.
Maltese: Filgrastim ratiopharm hija mediċina ‘bijosimili'.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Maltese: • Inaqqas iż-żmien ta' newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm) u lkaż li jkun hemm newtropenija febbrili (newtropenija fil-fwied) f'pazjenti li jirċievu lkemoterapija (trattament tal-kanċer) li huwa ċitotossiku (joqtol iċ-ċelloli);
English: The reference medicine for Filgrastim ratiopharm is Neupogen.
Maltese: Il-mediċina ta' referenza għal Filgrastim ratiopharm hija Neupogen.
English: Treatment with Filgrastim ratiopharm and Neupogen brought about similar reductions in duration of severe neutropenia.
Maltese: Trattament bir-Filgrastim ratiopharm u n-Neupogen ġab tnaqqis simili fiż-żmien ta' newtropenija severa.
English: During the first 21-day chemotherapy cycle, patients treated with either Filgrastim ratiopharm or Neupogen had severe neutropenia for an average of 1.1 days, compared with 3.8 days in those receiving placebo.
Maltese: Matul l-ewwel 21 jum ta' ċiklu kemoterapewtiku, pazjenti trattati b'kemm Filgrastim ratiopharm jew Neupogen kellhom newtropenija severa għal medja ta' 1.1 jum, kumparat ma' 3.8 jum f'dak li jirċievu placebo.
English: The European Commission granted a marketing authorisation valid throughout the EU for Filgrastim ratiopharm to ratiopharm GmbH on 15 September 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Filgrastim ratiopharm lil Addmedica fil-15 ta' Settembru 2008.
English: For more information on biosimilar medicines, see the question-and-answer
Maltese: Għal aktar informazzjoni dwar il-mediċini bijosimili, ara d-dokument ta' ‘mistoqsija u
English: What is the risk associated with Filgrastim ratiopharm?
Maltese: X'inhu r-riskju assoċjat ma' Filgrastim ratiopharm?
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part
Maltese: Jekk trid aktar informazzjoni abbażi tar-rakkomandazzjonijiet ta' CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: How has Filgrastim ratiopharm been studied?
Maltese: Kif ġie studjat Filgrastim ratiopharm?
English: Filgrastim ratiopharm was studied to show that it is comparable to the reference medicine, Neupogen.
Maltese: Filgrastim ratiopharm ġie studjat biex jiġi muri li huwa komparabbli mal-mediċina ta' referenza, Neupogen.
English: Why has Filgrastim ratiopharm been approved?
Maltese: Għaliex ġie approvat Filgrastim ratiopharm?
English: This means that Filgrastim ratiopharm is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Maltese: Dan ifisser li Filgrastim ratiopharm huwa simili għal mediċina bijoloġika li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li tinkludi fiha l-istess sustanza attiva (magħrufa bħala ‘mediċina ta' referenza').
English: Other information about Filgrastim ratiopharm:
Maltese: Tagħrif ieħor dwar Filgrastim ratiopharm:
English: Filgrastim ratiopharm is usually given in a specialised treatment centre, although patients who receive it by injection under the skin may inject themselves once they have been trained appropriately.
Maltese: Filgrastim ratiopharm normalment jingħata f'ċentru ta' trattament speċjalizzat, minkejja li pazjenti li jirċievuh b'injezzjoni taħt il-ġilda jistgħu jinjettaw rwieħhom ladarba jiġu mħarrġa sabiex jagħmlu dan.
English: Filgrastim ratiopharm was compared to Neupogen and to placebo (a dummy treatment) in one main study involving 348 patients with breast cancer.
Maltese: Filgrastim ratiopharm ġie kumparat ma' Neupogen u ma' placebo (trattament fint) fi studju prinċipali li kien jinvolvi
English: How does Filgrastim ratiopharm work?
Maltese: Kif jaħdem Filgrastim ratiopharm?
English: For the full list of all side effects reported with Filgrastim ratiopharm, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrappurtata b'Filgrastim ratiopharm, ara l
English: Filgrastim ratiopharm should not be used in people who may be hypersensitive (allergic) to filgrastim
Maltese: Filgrastim ratiopharm m'għandux jintuża minn persuni ipersensittivi (allerġiċi) għal filgrastim
English: It may harm them,
Maltese: (attakk ta' qalb).
English: Date of first authorisation: 16 July 2008 Date of latest renewal: 17 December 2012
Maltese: Data ta' l-aħħar tiġdid: 7 ta' Diċembru 2012
English: België/Belgique/Belgien
Maltese: België/Belgique/Belgien Zentiva, k.s.
English: PVC/PVDC/Aluminium blisters or all aluminium blisters in cardboard cartons containing 7, 14, 28, 30, 50, 84, 90 and 100 film-coated tablets.
Maltese: Folji tal-PVC/PVDC/Aluminju jew folji kollha kemm huma ta' l-aluminju f'kaxxi tal-kartun li fihom 7, 14, 28, 30, 50, 84, 90 u 100 pillola miksija b'rita.
English: Clopidogrel Zentiva contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Maltese: Clopidogrel Zentiva fih clopidogrel u jifforma parti minn grupp ta' mediċini msejħa prodotti mediċinali ta' kontra l-plejtlets.
English: A total of 99.7% of patients received fibrinolytics (fibrin specific: 68.7%, non-fibrin specific: 31.1%), 89.5% heparin, 78.7% beta blockers, 54.7% ACE inhibitors and 63% statins.
Maltese: 31.1%), 89.5% heparin, 78.7% imblokkaturi tar-riċetturi beta, 54.7% inibituri ta' ACE u 63% statins.
English: EU/1/08/465/001 14 tablets EU/1/08/465/002 14 tablets EU/1/08/465/003 28 tablets EU/1/08/465/004 28 tablets EU/1/08/465/005 30 tablets EU/1/08/465/006 30 tablets EU/1/08/465/007 50x1 tablets EU/1/08/465/008 50x1 tablets EU/1/08/465/009 84 tablets EU/1/08/465/010 84 tablets EU/1/08/465/011 90 tablets EU/1/08/465/012 90 tablets EU/1/08/465/013 100 tablets EU/1/08/465/014 100 tablets EU/1/08/465/018 7 tablets EU/1/08/465/019 7 tablets EU/1/08/465/021 50 tablets
Maltese: EU/1/08/465/001 14-il pillola EU/1/08/465/002 14-il pillola EU/1/08/465/003 28 pillola EU/1/08/465/004 28 pillola EU/1/08/465/005 30 pillola EU/1/08/465/006 30 pillola EU/1/08/465/007 50x1 pilloli EU/1/08/465/008 50x1 pilloli EU/1/08/465/009 84 pillola EU/1/08/465/010 84 pillola EU/1/08/465/011 90 pillola EU/1/08/465/012 90 pillola EU/1/08/465/013 100 pillola EU/1/08/465/014 100 pillola EU/1/08/465/018 7 pilloli EU/1/08/465/019 7 pilloli EU/1/08/465/021 50 pillola
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER / 30, 50, 50x1, 90 or 100 tablets
Maltese: FOLJI/ 30, 50, 50x1, 90 jew 100 pillola
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose, Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Maltese: Qalba tal-pillola: mannitol (E421), castor oil idroġenat, microcrystalline cellulose, macrogol 6000 u hydroxypropylcellulose b'sostituzzjoni baxxa Rita tal-pillola: lactose monohydrate (iz-zokkor li jinsab fil-ħalib), hypromellose (E464), triacetin (E1518), iron oxide aħmar (E172) u titanium dioxide (E171), Sustanza li tagħti l-lostru: carnauba wax .
English: While you are taking Clopidogrel Zentiva:
Maltese: Clopidogrel Zentiva:
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Maltese: In-numri ta' pazjenti li kellhom punt ko-primarju ta' tmiem (mewt b'CV, MI, puplesija jew iskemija li mhux qed tirrisondi għall-kura) kien 1 035 (16.5%) fil-grupp ikkurat bi clopidogrel u 1 187 (18.8%) fil-grupp ikkurat bil-plaċebo, tnaqqis ta' 14% fir-riskju relattiv) (95% CI ta' 6%-21%, p= 0.0005) għall-grupp ikkurat bi clopidogrel.
English: TROPICAL-ACS (Testing Responsiveness to Platelet Inhibition on Chronic Antiplatelet Treatment for Acute Coronary Syndromes)
Maltese: TOPIC (L-Aħjar Żmien għall-Inibizzjoni tal-Plejtlits wara sindromu Koronarju akut- Timing Of Platelet Inhibition after acute Coronary syndrome)
English: Inconsistent data on the clinical implications of this pharmacokinetic (PK)/pharmacodynamic (PD) interaction in terms of major cardiovascular events have been reported from both observational and clinical studies.
Maltese: Informazzjoni inkonsistenti dwar l-implikazzjonijiet kliniċi ta' din l-interazzjoni farmakokinetika(PK)/farmakodinamika (PD) f'termini ta' avvenimenti kardjovaskulari ewlenin ġew irrapportati sew mill-osservazzjoni kif ukoll mill-istudji kliniċi.
English: Patients were randomized to receive either prasugrel 5 or 10 mg/d (Days 0-14) (n=1306), or prasugrel 5 or 10 mg/d (Days 0-7) then de-escalated to clopidogrel 75 mg/d (Days 8-14) (n=1304), in combination with ASA (<100 mg/day).
Maltese: 5 jew 10 mg/ġ (Ġranet 0-14) (n=1306), jew prasugrel 5 jew 10 mg/ġ (Ġranet 0-7) fejn imbagħad ilqawwa tnaqqset għal clopidogrel 75 mg/ġ (Ġranet 8-14) (n=1304), flimkien ma' ASA (<100 mg/ġurnata).
English: Clopidogrel Zentiva contains lactose.
Maltese: Clopidogrel Zentiva fih lactose.