FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have experienced severe chest pain (unstable angina or heart attack), your doctor may give you 300 mg of Clopidogrel Acino (4 tablets of 75 mg) once at the start of treatment.
Maltese: Jekk kellek uġigħ sever f'sidrek (anġina instabbli jew attakk tal-qalb), it-tabib jista' jagħtik 300 mg ta' Clopidogrel Acino (4 pilloli ta' 75 mg) darba fil-bidu tal-kura.
English: Patients suffering from acute coronary syndrome:
Maltese: Pazjenti li għandhom is-sindromu koronarju akut:
English: Clopidogrel Acino 75 mg film-coated tablets Clopidogrel
Maltese: Clopidogrel Acino 75 mg pilloli miksija b'rita Clopidogrel
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking clopidogrel 75 mg/day.
Maltese: 3% (5 µM ta' aggregazzjoni tal-plejtlits ikkaġunat millADP) li huwa simili għal dak ta' adulti li jieħdu 75 mg/ġurnata ta' clopidogrel.
English: As with other antiplatelet agents, clopidogrel should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with ASA, heparin, glycoprotein IIb/IIIa inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) including Cox-2 inhibitors, or selective serotonin reuptake inhibitors (SSRIs), or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Maltese: Bħal fil-każ ta' sustanzi oħra kontra l-plejtlets, clopidogrel għandu jintuża b'kawtela f'pazjenti li jista' jkollhom riskju ta' iktar dmija minn trawma, operazzjoni jew kundizzjonijiet patoloġiċi oħra u pazjenti li jkunu qed jirċievu l-kura b'ASA, heparin, inibituri ta' glycoprotein IIb/IIIa jew mediċini kontra l-infjammazzjoni li m'humiex sterojdi (NSAIDs) li jinkludu l-inibituri ta' Cox-2, jew inibituri selettivi tal-ġbir mill-ġdid ta' serotonin (SSRIs), jew prodotti mediċinali marbuta ma' riskju ta'fsada bħal pentoxifylline (ara sezzjoni 4.5).
English: In adult patients with atrial fibrillation who have at least one risk factor for vascular events, are not suitable for treatment with Vitamin K antagonists (VKA) and who have a low bleeding risk, clopidogrel is indicated in combination with ASA for the prevention of atherothrombotic and thromboembolic events, including stroke.
Maltese: F'pazjenti adulti b'fibrillazzjoni atrijali li għallinqas għandhom fattur wieħed ta' riskju għal avvenimenti vaskulari u li ma jistgħux jieħdu t-terapija ta' kontra l-vitamina K (VKA) u li għandhom riskju baxx ta' fsada, clopidogrel flimkien ma' ASA huwa indikat għall-prevenzjoni ta' avvenimenti aterotrombotiċi u tromboemboliċi li jinkludu l-attakk ta' puplesija.
English: Rare side effect (may affect up to 1 in 1000 people): Vertigo, enlarged breasts in males.
Maltese: -Effetti sekondarji rari (jistgħu jaffettwaw sa 1 minn kull 1000 persuna): Vertigo, tkabbir tas-sider fl-irġiel.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinstab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Musculoskeletal , connective tissue and bone disorders
Maltese: Disturbi muskoluskeltrali, tat-tessut konnettiv u flgħadam
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino 75 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Clopidogrel Acino 75 mg pilloli miksija b'rita
English: Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA)
Maltese: Bis-segment mhux ST elevat (anġina instabbli jew infart mijokardijaku mhux-mewġa-Q): ilkura bi clopidogrel għandha tinbeda b'doża waħda qawwija tal-bidu ta' 300 mg u titkompla b'75 mg darba kuljum (b'acetylsalicylic acid (ASA) 75 mg-325 mg kuljum).
English: Jaundice; severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes intaste of food.
Maltese: -Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna): suffejra; uġigħ addominali qawwi flimkien ma' jew mingħajr uġigħ fid-dahar; deni, diffikultajiet finnifs kultant assoċjati mas-sogħla; reazzjonijiet allerġiċi ġeneralizzati (per eżempju, sensazzjoni ta' sħana ma' ġismek kollu b'skonfort ġenerali f'daqqa sakemm tħossok ħażin); nefħa fil-ħalq; infafet fil ġilda; reazzjoni allerġika fil-ġilda; uġigħ fil-ħalq (stomatite); tnaqqis fil-pressjoni tad-demm; konfużjoni; alluċinazzjonijiet; uġigħ fil-ġogi; uġigħ muskolari; tibdil fit-togħma ta' l-ikel.
English: ST segment elevation acute myocardial infarction, in combination with ASA in medically treated patients eligible for thrombolytic therapy.
Maltese: - Infart mijokardijaku akut b'segment ST elevat, flimkien ma' ASA f'pazjenti ittrattati bilmediċini u eliġibbli għat-terapija trombolitika
English: Other concomitant therapy: Since clopidogrel is metabolised to its active metabolite partly by CYP2C19, use of medicinal products that inhibit the activity of this enzyme would be expected to result in reduced drug levels of the active metabolite of clopidogrel.
Maltese: Peress li parti mill-metaboliżmu ta' clopidogrel għall-metabolit attiv tiegħu jsir minn CYP2C19, huwa mistenni li l-użu tal-prodotti mediċinali li jinibixxu l-attività ta' din l-enzima jwasslu għal tnaqqis fillivell tal-metabolit attiv ta' clopidogrel.
English: NAME OF THE MEDICINAL PRODUCT Clopidogrel Acino 75 mg film-coated tablets Clopidogrel
Maltese: TAL-PRODOTT MEDIĊINALI Clopidogrel Acino 75 mg pilloli miksija b'rita Clopidogrel
English: Clopidogrel Acino is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack, or death).
Maltese: Clopidogrel Acino jittieħed mill-adulti biex inaqqas ir-riskju li emboli tad-demm (trombi) jifformaw fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: Clopidogrel has been tested in a range of in vitro and in vivo genotoxicity studies, and showed no genotoxic activity.
Maltese: Clopidogrel huwa indikat fl-adulti għall-prevenzjoni ta' avvenimenti aterotrombotiċi f':
English: Method of administration For oral use
Maltese: MANIFATTURA RESPONSABBLI
English: Posology
Maltese: Epistassi
English: Clopidogrel Acino contains hydrogenated castor oil May cause stomach upset or diarrhoea.
Maltese: Clopidogrel Acino fih castor oil idroġenat Jista' jikkawża taqlib ta' l-istonku u dijarrea.
English: Each film-coated tablet contains 75 mg of clopidogrel (as besilate).
Maltese: Kull pillola miksija b'rita fiha 75 mg ta' clopidogrel (bħala besilate).
English: Clopidogrel is a product, one of whose metabolites is an inhibitor of platelet aggregation.
Maltese: Clopidogrel huwa pro-mediċina, b'metabolit minnhom ikun inibitur tal-aggregazzjoni tal-plejtlits.
English: It is unknown whether clopidogrel is excreted in human breast milk.
Maltese: Ma ġiex stabbilit formalment l-aħjar tul tal-kura.
English: • You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4).
Maltese: Għandek ukoll tgħid lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt il-ġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew ta' l-għajnejn (suffejra) (ara sezzjoni 4).
English: Fevaxyn Pentofel contains mineral oil.
Maltese: Fevaxyn Pentofel fih żejt minerali.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni abbażi tar-rakkomandazzjonijiet talCVMP, aqra d-Diskussjoni Xjentifika (parti wkoll mill-EPAR).
English: In the trial to observe side effects, there were no side effects in 94.2 % of cats for the first vaccination and no side effects observed for 99 % of cats for the second vaccination.
Maltese: Fl-istudju biex jiġu osservati l-effetti sekondarji, f'94.2% tal-qtates ma kienx hemm effetti sekondarji għall-ewwel tilqima u f'99% tal-qtates ma kien osservat l-ebda effett sekondarju għat-tieni tilqima.
English: For cats 9 weeks and older, two doses are given at an interval of 3 to 4 weeks.
Maltese: Għall-qtates ta' 9 ġimgħat jew iktar, iż-żewġ dożi jingħataw f'intervall ta' bejn 3 u 4 ġimgħat.
English: In very rare cases there is an anaphylactic reaction (severe allergy) with oedema (fluid under the skin), pruritus, respiratory and cardiac distress, severe gastrointestinal signs or shock during the first hours after vaccination.
Maltese: F'każijiet rari ħafna jista' jkun hemm reazzjoni anafilattika (allerġija severa) b'nefħa (fluwidu taħt ilġilda), prurite, stress respiratorju jew tal-qalb, sinjali gastrointestinali severi jew xokk matul l-ewwel ftit sigħat wara t-tilqima.
English: Why has Fevaxyn Pentofel been approved?
Maltese: Għaliex ġie approvat Fevaxyn Pentofel?
English: What is Fevaxyn Pentofel?
Maltese: X'inhu Fevaxyn Pentofel?
English: Fevaxyn Pentofel has been studied against Feline Leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, as well as against disease caused by feline panleukopenia virus.
Maltese: Fevaxyn Pentofel ġie studjat kontra l-feline leukaemia, kontra l-mardiet respiratorji kkawżati millfeline rhinotracheitis virus, feline calicivirus u feline Chlamydophila felis, kif ukoll kontra l-mardiet ikkawżati mill-feline panleukopenia virus.
English: What are the side effects of Fevaxyn Pentofel?
Maltese: X'inhuma l-effetti sekondarji ta' Fevaxyn Pentofel?
English: Fevaxyn Pentofel has been shown to be effective against Feline Leukaemia, against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis, as well as against disease caused by feline panleukopenia virus.
Maltese: Intwera li Fevaxyn Pentofel kien effettiv kontra l-feline leukaemia, kontra l-mardiet respiratorji kkawżati mill-feline rhinotracheitis virus, feline calicivirus u feline Chlamydophila felis, kif ukoll minn mardiet ikkawżati mill-feline panleukopenia virus.
English: Fevaxyn Pentofel is used to immunise healthy cats of 9 weeks or older against feline panleukopenia and feline leukaemia and against respiratory diseases caused by feline rhinotracheitis virus, feline calicivirus and feline Chlamydophila felis.
Maltese: Fevaxyn Pentofel jintuża għat-tlaqqim ta' qtates f'saħħithom ta' 9 ġimgħat jew iktar kontra l-feline panleukopenia u l-feline leukaemia u kontra l-mardiet respiratorji kkawżati mill-feline rhinotracheitis virus, feline calicivirus u feline Chlamydophila felis.
English: Some vaccinated cats may develop reactions to the vaccine, which include temporary fever, vomiting, anorexia (not eating), and/or depression, which usually disappear within 24 hours.
Maltese: Xi qtates imlaqqma jistgħu jiżviluppaw reazzjonijiet għat-tilqima, li jistgħu jinkludu deni temporanju, remettar, anoressija (nuqqas ta' aptit), u/jew dipressjoni, li ġeneralment jieqfu fi żmien 24 siegħa.
English: Fevaxyn Pentofel contains the following inactivated viruses: feline panleukopenia virus, feline rhinotracheitis virus, feline calicivirus, feline leukaemia virus, and the inactivated bacterium feline Chlamydophila felis.
Maltese: Fevaxyn Pentofel hu tilqima għall-qtates li jikkonsisti minn soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest. Fevaxyn Pentofel jikkonsisti minn dawn il-vajrusijiet inattivati: feline panleukopenia virus, feline rhinotracheitis virus, feline calicivirus, feline leukaemia virus, u l-batterju inattivat feline Chlamydophila felis.
English: How does Fevaxyn Pentofel work?
Maltese: Għal xiex jintuża Fevaxyn Pentofel?
English: Other information about Fevaxyn Pentofel:
Maltese: Tagħrif ieħor dwar Fevaxyn Pentofel:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Fevaxyn Pentofel are greater than any risks to immunise healthy cats of 9 weeks or older against feline viruses.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għal Użu Veterinarju (CVMP) qabel li l-benefiċċji ta' Fevaxyn Pentofel huma ikbar minn kwalunkwe riskju għat-tilqim ta' qtates f'saħħithom ta' 9 ġimgħat jew iktar kontra l-vajrusijiet felini.
English: Inactivated Bordetella pertussis strain** ≥ 4 IU Hepatitis B virus surface Antigen recombinant** (S protein)*** 10 micrograms * adsorbed on aluminium oxide hydrated Total: 0.26 milligrams Al ** adsorbed on aluminium phosphate Total: 0.37 milligrams Al3+
Maltese: Antiġen tas-superfiċje ta' l-epatite B rekombinanti** (proteina S)*** 10 mikrogrammi *adsorbit fuq aluminium oxide idratat
English: Diphtheria toxoid* ≥ 30 IU Tetanus toxoid*
Maltese: Toxoid tat-tetnu *
English: ≥ 60 IU
Maltese: t x
English: Packaging Content
Maltese: Kontenut
English: *** produced on genetically-engineered yeast cells (Saccharomyces cerevisiae)
Maltese: ** adsorbit fuq aluminium phosphate
English: 1 dose (0.5 ml) contains:
Maltese: 1 Doża 1 (0.5 ml) fiha: Toxoid tad-difterite*
English: Invented name Strength Pharmaceutical Form Route of administration
Maltese: Qawwa Għamla farmaċewtika
English: l t o r d
Maltese: Numru talproċedura ta' l-EMEA
English: It may harm them,
Maltese: Iftaħ il-folja u aqla' lkapsula.
English: Gastrointestinal disorders Dyspepsia
Maltese: Disturbi gastrointestinali Dispepsja
English: Repeat steps 3a to 3c.
Maltese: Irrepeti stadji 3a sa 3ċ.
English: Also contains: lactose and magnesium stearate.
Maltese: Fih ukoll: lactose u magnesium stearate.
English: Date of first authorisation: 19 September 2013 Date of latest renewal: 22 May 2018
Maltese: Data tal-aħħar tiġdid: 22 Mejju 2018
English: Ultibro Breezhaler showed similar adverse reactions to the individual components.
Maltese: Ultibro Breezhaler wera reazzjonijiet avversi simili għall-komponenti individwali.
English: Supportive and symptomatic treatment is indicated.
Maltese: Għandha tingħata kura supportiva u sintomatika.
English: Improvements versus indacaterol and glycopyrronium were 0.26 and 0.21, respectively.
Maltese: It-titjib kontra indacaterol u glycopyrronium kien ta' 0.26 u 0.21, rispettivament.
English: 6 x 1 capsules + 1 inhaler 10 x 1 capsules + 1 inhaler 12 x 1 capsules + 1 inhaler 30 x 1 capsules + 1 inhaler 90 x 1 capsules + 1 inhaler
Maltese: 6 x1 kapsuli + inhaler wieħed 10 x 1 kapsuli + inhaler wieħed 12 x1 kapsula + inhaler wieħed 30 x1 kapsula + inhaler wieħed 90 x1 kapsula + inhaler wieħed
English: Step 1d:
Maltese: Stadju 1d:
English: After intravenous infusion the volume of distribution of indacaterol during the terminal elimination phase was 2557 litres indicating an extensive distribution.
Maltese: Wara infużjoni fil-vini l-volum tad-distribuzzjoni tal-indacaterol matul il-fażi ta' eliminazzjoni terminali kien ta' 2557 litru li juri distribuzzjoni estensiva.
English: Capsule content Lactose monohydrate Magnesium stearate
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Kontenut tal-kapsula Lactose monohydrate Magnesium stearate
English: Treatment for 90 days [90 x 1 capsules + 1 inhaler only].
Maltese: Trattament għal 90 jum [90 x 1 kapsuli + inhaler wieħed biss].
English: Musculoskeletal and connective tissue disorders Musculoskeletal pain
Maltese: Disturbi muskoluskelettriċi u tat-tessuti konnettivi Uġigħ muskoluskelettriku
English: Each capsule contains 110 microgram indacaterol and 50 microgram glycopyrronium.
Maltese: Kull kapsula fiha 110 mikrogramma indacaterol u 50 mikrogramma glycopyrronium.
English: Oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4.
Maltese: Instabu metaboliti ossidattivi f'inkubazzjonijiet b'CYP1A1, CYP2D6, u CYP3A4 rrikombinanti.
English: Step 2a:
Maltese: Stadju 2a:
English: Step 3b:
Maltese: Stadju 3b:
English: In vitro inhibition studies demonstrated that glycopyrronium bromide has no relevant capacity to inhibit CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4/5, the efflux transporters MDR1, MRP2 or MXR, and the uptake transporters OCT1 or OCT2.
Maltese: Studji in vitro dwar l-inibizzjoni wrew li glycopyrronium bromide m'għandux kapaċità relevanti li jinibixxi CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 jew CYP3A4/5, ittrasportaturi tal-effluss MDR1, MRP2 jew MXR, u t-trasportaturi tal-uptake OCT1 jew OCT2.
English: CYP3A4 is concluded to be the predominant isoenzyme responsible for hydroxylation of indacaterol.
Maltese: Ġie konkluż li CYP3A4 huwa l-iżoenzima predominanti responsabbli għall-idrosillazzjoni tal-indacaterol.
English: Medical attention may be needed.
Maltese: Jista' jkollok bżonn ta' attenzjoni medika.
English: The pharmacological effects of beta2-adrenoceptor agonists, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP).
Maltese: L-effetti farmakoloġiċi tal-agonisti beta2-adrenoriċetturi, inkluż ta' indacaterol, huma sa ċertu punt attribwiti lillistimulazzjoni tal-adenyl cyclase intraċellulari, l-enżima li tikkatalizza l-bidla tal-adenosina trifosfat (ATP) f'adenosina monofosfat-3', 5' ċikliku (AMP ċikliku).
English: Excipient(s) with known effect Each capsule contains 23.5 mg lactose (as monohydrate).
Maltese: Kull kapsula fiha 23.5 mg lactose (bħala monohydrate).
English: • tiredness.
Maltese: • sturdament.
English: The in vitro human plasma protein binding of glycopyrronium was 38% to 41% at concentrations of 1 to 10 nanograms/ml.
Maltese: It-twaħħil in vitro talproteini mal-plażma umana ta' glycopyrronium kien ta' bejn 38% u 41% f'konċentrazzjonijiet ta' bejn 1 u 10 nanogrammi/ml.
English: This is because it has not been studied in this age group.
Maltese: Dan minħabba li ma ġietx studjata fost dan il-grupp ta' età.
English: Trough and peak FEV1:
Maltese: L-anqas u l-ogħla FEV1:
English: Step 3a:
Maltese: Stadju 3a:
English: A hydroxylated derivative was the most prominent metabolite in serum.
Maltese: L-iktar metabolit prominenti fis-serum kien derivattiv idrosillat.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
Maltese: Studji f'annimali ma wrewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva waqt espożizzjonijiet relevanti klinikament (ara sezzjoni 5.3).
English: The number of all COPD exacerbations/patient-years was 3.34 for Ultibro Breezhaler (2,893 events), 3.92 for glycopyrronium (3,294 events) and 3.89 for tiotropium (3,301 events).
Maltese: In-numru ta' kull taħrix ta' COPD/snin ta' pazjent kien ta' 3.34 għal Ultibro Breezhaler (2,893 avveniment), 3.92 għal glycopyrronium (3,294 avveniment) u 3.89 għal tiotropium (3,301 avveniment).
English: Capsule chamber
Maltese: Taqqab il-kapsula darba
English: Component of a multipack.
Maltese: Komponent ta' pakkett li fih ħafna pakketti.
English: The Ultibro Breezhaler clinical Phase III development programme included six studies in which over 8,000 patients were enrolled: 1) a 26-week placebo- and active-controlled (indacaterol once daily, glycopyrronium once daily, open-label tiotropium once daily) study; 2) a 26-week active-controlled (fluticasone/salmeterol twice daily) study; 3) a 64-week active-controlled (glycopyrronium once daily, open-label tiotropium once daily) study; 4) a 52-week placebo-controlled study; 5) a 3-week placeboand active-controlled (tiotropium once daily) exercise tolerance study; and 6) a 52-week activecontrolled (fluticasone/salmeterol twice daily) study.
Maltese: Il-programm ta' żvilupp ta' Ultibro Breezhaler f'Fażi III kien jinkludi sitt studji li matulhom issieħbu aktar minn 8,000 pazjent: 1) studju ta' 26 ġimgħa kkontrollat bil-plaċebo u bl-attiv (indacaterol darba kuljum, glycopyrronium darba kuljum, tiotropium open-label darba kuljum); 2) studju ta' 26 ġimgħa kkontrollat bl-attiv (fluticasone/salmeterol darbtejn kuljum); 3) studju ta' 64 ġimgħa kkontrollat blattiv (glycopyrronium darba kuljum, tiotropium open-label darba kuljum); 4) studju ta' 52 ġimgħa kkontrollat bi plaċebo; 5) studju ta' 3 ġimgħat dwar it-tolleranza għall-eżerċizzju ikkontrollat bi plaċebo u b'attiv (tiotropium darba kuljum); u 6) studju ta' 52 ġimgħa kkontrollat bl-attiv (fluticasone/salmeterol darbtejn kuljum).
English: This medicine contains lactose (23.5 mg per capsule).
Maltese: Din il-mediċina fiha l-lactose (23.5 mg f'kull kapsula).
English: Ultibro Breezhaler further showed superiority in reducing the annualised rate of all exacerbations by 11% versus fluticasone/salmeterol (p=0.003).
Maltese: Ultibro Breezhaler wera wkoll superjorità fit-tnaqqis tarrata anwalizzata ta' kull taħrix bi 11% meta mqabbel ma' fluticasone/salmeterol (p=0.003).
English: The highest dose level of 464 micrograms/86 micrograms Ultibro Breezhaler also showed a higher proportion of absolute QTcF values >450 ms (12.2% vs. 5.7% for placebo).
Maltese: L-ogħla livell ta' doża ta' 464 mikrogramma/86 mikrogramma Ultibro Breezhaler wera wkoll proporzjon ogħla talvaluri assoluti tal-QTcF ta' >450 ms (12.2% kontra 5.7% għall-plaċebo).
English: • pain that affects the muscles, ligaments, tendons, joints and bones.
Maltese: • uġigħ li jaffettwa l-muskoli, ligamenti, tendini, ġogi u għadam.
English: A higher percentage of patients receiving Ultibro Breezhaler responded with a clinically meaningful improvement in SGRQ score (defined as a decrease of at least 4 units from baseline) at week 26 compared to placebo (63.7% and 56.6% respectively, p=0.088) and tiotropium (63.7% Ultibro Breezhaler vs. 56.4% tiotropium, p=0.047), at week 64 compared to glycopyrronium and tiotropium (57.3% Ultibro Breezhaler versus 51.8% glycopyrronium, p=0.055; versus 50.8% tiotropium, p=0.051, respectively), and at week 52 compared to fluticasone/salmeterol (49.2% Ultibro Breezhaler vs. 43.7% fluticasone/salmeterol, odds ratio: 1.30, p<0.001).
Maltese: Persentaġġ ogħla ta' pazjenti mogħtija Ultibro Breezhaler irrispondew b'titjib sinjifikanti klinikament fl-iskor tal-SGRQ (iddefinit bħala tnaqqis ta' mill-inqas 4 unitajiet mil-linjabażi) fis-26 ġimgħa mqabbel mal-plaċebo (63.7% u 56.6% rispettivament, p=0.088) u tiotropium (63.7% Ultibro Breezhaler kontra 56.4% tiotropium, p=0.047), fl-64 ġimgħa mqabbel ma' glycopyrronium u tiotropium (57.3% Ultibro Breezhaler kontra 51.8% glycopyrronium, p=0.055; kontra 50.8% tiotropium, p=0.051, rispettivament), u mat-52 ġimgħa meta mqabbel ma' fluticasone/salmeterol (49.2% Ultibro Breezhaler vs. 43.7% fluticasone/salmeterol, proporzjon ta' probabbiltà:
English: Dental caries
Maltese: Toqba talkapsula
English: The safety profile is characterised by typical anticholinergic and beta-adrenergic symptoms related to the individual components of the combination.
Maltese: Il-profil ta' sigurtà hu kkaratterizzat b'sintomi antikolinerġiċi u beta-adrenerġiċi tipiċi b'rabta malkomponenti individwali tal-kombinazzjoni.
English: Multipacks containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.
Maltese: Pakketti multipli li fihom 96 (4 pakketti ta' 24x1) kapsula iebsa u 4 inhalers.