FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypocalcaemia can occur at any time during therapy with XGEVA.
Maltese: Ipokalċimija tista' sseħħ fi kwalunkwe ħin matul it-terapija b'XGEVA.
English: Other medicines and XGEVA
Maltese: Kif taħżen XGEVA
English: • potency of the medicinal product that inhibits bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy.
Maltese: • qawwa tal-prodott mediċinali li jinibixxi assorbiment mill-ġdid tal-għadam (riskju ogħla għal komposti potenti ħafna), mnejn jingħata (riskju ogħla għall-għoti parenterali) u d-doża kumulattiva ta' terapija għall-assorbiment mill-ġdid tal-għadam.
English: Description of selected adverse reactions
Maltese: Kategorija tal-frekwenza Reazzjonijiet avversi
English: In two phase II single-arm clinical trials in patients with giant cell tumour of bone, hypocalcaemia was reported in 5.7% of patients.
Maltese: II bi grupp wieħed f'pazjenti b'tumur taċ-ċelluli ġganti tal-għadam, ipokalċimija kienet irrappurtata f'5.7% tal-pazjenti.
English: Equilis Te Equilis Te
Maltese: Te Equilis Te
English: Date of last renewal: 10/06/2015
Maltese: Data tal-aħħar tiġdid: 10/06/2015
English: 375 µg
Maltese: 375 mikrogrammi
English: ATC vet code: QI05AB03
Maltese: QI05AB03
English: To stimulate active immunity against tetanus.
Maltese: Biex tistimula immunità attiva kontra t-tetnu.
English: PACKAGE SIZE 10 x 1 dose
Maltese: 10 x 1 doża
English: 125 µg
Maltese: 125 mikrogrammi
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Tetanus toxoid 40 Lf/ml
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA U SUSTANZI OĦRA Tetanus toxoid 40 Lf/ml
English: Emil-von-Behring-Str. 76 35 041 Marburg Germany
Maltese: GSK Vaccines GmbH Emil-von Behring-Str.76 35 041 Marburg
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer
Maltese: Wim de Körverstraat 35 5831 AN Boxmeer
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa matul il-perjodu ta' kura waħda) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: V1 V2
Maltese: T1 T2
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/07/2005
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08/07/2005
English: V3
Maltese: T3
English: V4
Maltese: T4
English: Intervet International B.V. NL-5831 AN Boxmeer
Maltese: NL-5831 AN Boxmeer
English: Concurrent active and passive immunisation (emergency vaccination)
Maltese: Immunità attiva u passiva f daqqa (tilqima ta' emerġenza)
English: Purified Saponin
Maltese: PARIR SABIEX
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI Għall-użu intramuskolari
English: Package sizes:
Maltese: Daqs tal-paketti:
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi elenkati f‘sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: In very rare cases a local reaction exceeding 5 cm and possibly persisting longer than 2 days may occur.
Maltese: F'każijiet rari, reazzjoni lokali li teċċedi l-5cm u possibilment iddum aktar minn jumejn tista' seħħ.
English: Phosphate buffer Chloride buffer
Maltese: Phosphate buffer, Chloride buffer, Traċċi ta' formalina Saponin purifikat Kolesterol Phosphatidylcholine
English: Administer 1 ml of vaccine intramuscularly.
Maltese: Għall-użu intramuskolari.
English: 62.5 µg For the full list of excipients, see section 6.1
Maltese: 62.5 mikrogrammi Għal-lista sħiħa tal-ingredjenti mhux attivi, ara s-sezzjoni 6.1.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) 470/2009.
Maltese: Is-sustanza attiva hija ta' oriġini bijoloġika intenzjonata li tipproduċi immunità attiva, u għaldaqstant ma taqax taħt ir-Regolament (KE) 470/2009.
English: Equilis Te [a clear pictogram of a horse]
Maltese: VETERINARJU Equilis Te [stampa ċara ta' żiemel]
English: Lactose
Maltese: Żwiemel
English: Lot {number}
Maltese: Skeda għat-tilqim:
English: 1 ml suspension in type I glass pre-filled syringe, containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Maltese: 1 ml suspensjoni f'siringa tal-ħġieġ tip I, mimlija għal-lest bi planġer b'tarf tal-gomma halogenobutyl u magħluq b'tapp tal-gomma halogenobutyl.
English: Concurrent use of Equilis Te and Tetanus-Serum from Intervet may reduce active immunity against tetanus compared to horses vaccinated with Equilis Te in the absence of tetanus antitoxin serum.
Maltese: L-użu flimkien ta' Equilis Te u Tetanus-Serum tal-Intervet jista' jnaqqas l-immunità attiva kontra t-tetnu meta mqabbla ma' żwiemel oħra mlaqqma bl-Equilis Te biss (mingħajr antitoxin serum tat-tetnu).
English: In that case, the first dose (V1) of vaccine can be given concurrently with the appropriate prophylactic dose of Tetanus-Serum at a separate injection site, using separate syringes and needles.
Maltese: F'dak il-każ, l-ewwel doża (T1) tal-vaċċin tista' tingħata flimkien mad-doża profilattika adatta ta' Tetanus-Serum iżda f'post tal-injezzjoni differenti u b'labar u siringi differenti.
English: Flocculation equivalents; corresponds with ≥ 30 IU/ml guinea pig serum in the Ph. Eur.
Maltese: Qies ekwivalenti ta' flokulazzjoni; jikkorrispondu ma' ≥30IU/ml serum tal-fenek tal-Indi fit-test ta' potenza tal-Farmakopeja Ewropea
English: In case of increased infection risk or insufficient colostrum intake, an additional initial injection can be given at the age of 4 months followed by the full vaccination programme (primary vaccination course at 6 months of age and 4 weeks later)
Maltese: F'kas ta' riskju akbar ta' infezzjoni jew nuqqas ta teħid ta' kolostrum, tilqima addizzjonali tista' tingħata fir-raba xahar segwita bil-programm komplut ta' vaċċinazzjoni (l-ewwel kors ta' tiqim ta' 6 xhur u doża oħra 4 ġimgħat wara).
English: Safety and efficacy data are available which demonstrate that this vaccine can be administered on the same day but not mixed with Tetanus Serum from Intervet (see section 8).
Maltese: Hemm informazzjoni fuq is-sigurtà u l-effiċjenza li turi li l-vaċċin jista' jingħata fl-istess ġurnata imma mhux imħallat mat-Tetanus Serum minn Intervet (ara sezzjoni 8).
English: Pharmacotherapeutic group: Inactivated bacterial vaccine.
Maltese: Vaċċin batteriku inattivat Kodici veterinarja ATC:
English: 1 ml suspension in type I glass vial closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.
Maltese: In-natura u l-għamla tal-ewwel ippakkjar 1 ml suspensjoni f'kunjett tal-ħġieġ tip I magħluq b'tapp tal-gomma halogenobutyl u ssiġillat b'kappa tal-aluminjum.
English: 125 µg Phosphatidylcholine 62.5 µg
Maltese: 62.5 mikrogrammi
English: Name and address of the manufacturers of the biological active substance GSK Vaccines GmbH
Maltese: Isem u indirizz tal-manufatturi tas-sustanza bijoloġika attiva
English: A clear opalescent suspension.
Maltese: Suspensjoni opalaxxenti ċara.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U L-MANIFATTUR RESPONSABBLI
English: EU/2/05/055/001 EU/2/05/055/002
Maltese: TAL-AWTORIZZAZZJONI TAL-KUMMERĊ EU/2/05/055/001
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/ ).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Pain at the injection site can occur in rare cases which may result in temporary functional discomfort (stiffness).
Maltese: Uġigħ fil-post tal-injezzjoni jista' jseħħ li f'każijiet rari jista' jirriżulta fi skumdità funzjonali temporanja (ebusija).
English: Traces of formaldehyde Purified Saponin
Maltese: Sustanzi mhux attivi Saponin purifikat
English: Following the administration of a double dose of vaccine, no side effects other than those described under section 4.6 have been observed except for some depression at the day of vaccination.
Maltese: Wara injezzjoni doppja ta' vaċċin, l-ebda effett mhux mixtieq, apparti dawk deskritti f'sezzjoni 4.6 ma ġie osservat ħlief għal ftit sintomi ta' dipressjoni fil-jum tal-vaċċinazzjoni.
English: In very rare cases, fever, sometimes accompanied by lethargy and inappetence, may occur for 1 day, and up to 3 days in exceptional circumstances.
Maltese: F'każijiet rari ħafna, deni, kultant akkompanjat b'letarġija u nuqqas ta' aptit, jista' jseħħ għal ġurnata, u sa 3 ijiem f'ċirkustanzi eċċezzjonali.
English: Active immunisation of horses from 6 months of age against tetanus to prevent mortality.
Maltese: Immunizzazzjoni attiva għal żwiemel mill-età ta' sitt xhur kontra t-tetnu biex tippreveni l-imwiet.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis Te suspension for injection for horses
Maltese: VETERINARJU Equilis Te suspensjoni għall-injezzjoni għaż-żwiemel
English: Equilis Te
Maltese: Equilis
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Maltese: F'każ li tinjetta lilek innifsek, fittex parir mediku mal-ewwel u qis li turi l-fuljett ta' informazzjoni filpakkett jew it-tikketta lit-tabib.
English: To be supplied only on veterinary prescription.
Maltese: Tħallatx ma' ebda prodott veterinarju ieħor.
English: 42 months
Maltese: 42 xahar
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Maltese: U METODU TA' AMMINISTRAZZJONI
English: PHARMACEUTICAL PARTICULARS
Maltese: Grupp farmakoterapewtiku:
English: Concurrent active and passive immunisation (emergency vaccination) The vaccine can be used together with Tetanus-Serum for treatment of injured horses that have not been immunised against tetanus.
Maltese: Deċiżjoni li tuża dan il-vaċċin qabel jew wara kwalunkwe prodott veterinarju ieħor trid tittieħed skont il-każ.
English: The first revaccination is given not later than 17 months after the primary vaccination course.
Maltese: L-ewwel revaċċinazzjoni tingħata mhux aktar tard mis 17-il xahar wara l-ewwel kors ta' vaċċinazzjoni.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Maltese: U INGREDJENT(I) OĦRA Kull doża ta' 1ml fiha:
English: This will lead to a passive protection against tetanus for at least 21 days after concurrent administration.
Maltese: Dan iwassal għall-protezzjoni passiva kontra t-tetnu għal tal-anqas 21 ġurnata wara li jkunu ngħataw is-serum u t-tilqima flimkien.
English: Pack size blister (PVC/alu) 90 x 1 tablets (unit dose)
Maltese: 90 x 1 pillola (doża waħda)
English: This summary was last updated in 03-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 03-2010.
English: The European Commission granted a marketing authorisation valid throughout the EU for Avandamet to SmithKline Beecham Ltd. on 20 October 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Avandamet lil SmithKline Beecham Ltd. fl-20 ta' Ottubru 2003.
English: This document is a summary of the European Public Assessment Report (EPAR) for Avandamet.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR).
English: rosiglitazone and metformin hydrochloride
Maltese: Avandamet rożiglitażon u metformina kloridrat
English: It is available as tablets (yellow: 1 mg rosiglitazone and 500 mg metformin hydrochloride, and 2 mg rosiglitazone and 1,000 mg metformin hydrochloride; pale pink: 2 mg rosiglitazone and 500 mg metformin hydrochloride; pink: 4 mg rosiglitazone and 1,000 mg metformin
Maltese: Hija tiġi bħala pilloli (sofor: 1 mg rożiglitażin u 500 mg metformina kloridrat, u 2 mg rożiglitażon u 1, 000 mg metformin idroklorid; roża ċar:
English: The maximum recommended daily dose is 8 mg/2,000 mg.
Maltese: Id-doża massima rakkommandata kuljum hija ta' 8 mg/2,000 mg.
English: It must not be used in patients who have heart failure (an inability of the heart to pump enough blood around the body), an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, diseases that could affect the oxygen supply to the tissues (such as lung or heart problems, a recent heart attack or shock), problems with their liver or kidneys, acute alcohol intoxication (excessive alcohol consumption), alcoholism, or complications of diabetes (diabetic ketoacidosis or diabetic coma).
Maltese: Ma għandux jintuża f'pazjenti li għandhom problemi gravi tal-qalb (inkapaċità tal-ipppumpjar ta' demm biżżejjed madwar il-ġisem), ‘sindromu koronarju akut' bħal anġina stabbli (uġiegħ fis-sider ta' tip sever li jibdel l-intensità) jew ċerti tipi ta' attakki tal-qalb, mard li jista' jaffettwa l-provvista tal-ossiġnu lejn it-tessuti (bħal problem tal-pulmun u tal-qalb, attakk talqalb reċenti jew xokk), problem fil-fwied jew kliewi tagħhom, intossikazzjoni akuta bl-alkoħol (konsum eċċessiv tal-alkoħol), alkoħoliżmu, jew kumplikazzjonijiet tad-dijabete (dijabete ketoacidosis jew koma dijabetika).
English: What is the risk associated with Avandamet?
Maltese: Għal xiex jintuża Avandamet ?
English: The full EPAR for Avandamet can be found here.
Maltese: Għaliex ġiet approvata Avandamet?
English: Avandamet is used in patients who are not satisfactorily controlled on metformin (an antidiabetes medicine) used on its own and at the maximum possible dose (‘dual therapy').
Maltese: Avandamet jintuża f'pazjenti li mhumiex ikkontrollati biżżejjed b'metformin (mediċina anti dijabetika) meta użat waħdu u bid-doża massima possibbli ('terapija doppja').
English: The recommended starting dose of Avandamet is 4 mg rosiglitazone and 2,000 mg metformin hydrochloride a day.
Maltese: Id-doża tal-bidu rakkommandata ta' Avandamet hija ta' 4 mg rożiglitażon u 2,000 mg metformina idrokloridrat kuljum.
English: Avandamet is a medicine that contains two active substances, rosiglitazone and metformin hydrochloride.
Maltese: Avandamet huwa mediċina li fiha żewġ sustanzi attivi rosiglitazone (rożiglitażon) u metformina kloridrat (metformin hydrochloride).
English: What benefit has Avandamet shown during the studies?
Maltese: Kif ġie studjat Avandamet?
English: Avandamet can also be used with a sulphonylurea (another type of antidiabetes medicine) in patients who are not satisfactorily controlled on metformin and a sulphonylurea at their maximum possible
Maltese: Avandamet jista' jintuża wkoll ma'sulphonylurea (tip ieħor ta' mediċina anti dijabetika) f'pazjenti li mhumiex ikkontrollati b'mod soddisfaċenti b'metformin u sulphonylurea meta wżati bid-dożi massimi possibbli tagħhom (‘terapija tripla').
English: • metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Maltese: • Il-metformina fundamentalment taħdem billi tinibixxi l-produzzjoni ta' glukożju u tnaqqas l assorbiment tiegħu fl-intestin.
English: For the full list of all side effects reported with Avandamet, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' leffetti avversi kollha rrappurtati b'Avandamet, ara l-Fuljett mal-Pakkett.
English: The most common side effect with Avandamet (seen in more than 1 patient in 10) is gastrointestinal symptoms (such as feeling sick, vomiting, diarrhoea, stomach ache and loss of appetite).
Maltese: L-effetti sekondarji l-aktar komuni b'Avandamet (li dehru f'aktar minn pazjent 1 minn kull 10) huma nawżea (dardir), remettar, dijarrea, uġigħ addominali (ta' żaqq) u telf tal-aptit.
English: • rosiglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces;
Maltese: • Rożiglitażon jagħmel iċ-ċelluli (tax-xaħam, tal-muskoli u tal-fwied) aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi;
English: In triple therapy, when starting treatment in patients who are already taking metformin and a sulphonylurea, Avandamet is given so that the patient receives 4 mg of rosiglitazone a day, and the same dose of metformin as before.
Maltese: F'terapija tripla, meta jibda trattament f'pazjenti li diġà jieħdu metformina u sulfonilurea, Avandamet jingħata biex il-pazjent ikun qed jieħu 4 mg/jum ta' rożiglitażon, u l-istess doża ta' metformina bħal qabel.
English: It is given in two divided doses, either as two 1-mg/500-mg tablets or one
Maltese: Dan jingħata f'żewġ dożi diviżi, jew ta' pilloli 1-mg/500 - mg doppji jew pillola waħda ta' 2-mg/1,000-mg.
English: Rosiglitazone has been authorised in the European Union (EU) as Avandia since 2000, to be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Maltese: Rożiglitażon ġie awtorizzat fl-Unjoni Ewropea (UE) bħala Avandia mill-2000, sabiex jintuża malmetformina f'pazjenti bid-dijabete tat-tip 2 li mhumiex ikkontrollati biżżejjed fuq il-metformina biss.
English: The studies of Avandia taken with metformin as separate tablets were used to support the use of Avandamet.
Maltese: L-istudji ta' Avandia meħud mal-metformina bħala pilloli separate ġew użati biex jiġi sostnut l-użu ta' Avandamet.
English: In triple therapy, one study looked at the effect of adding rosiglitazone to a sulphonylurea (glibenclamide) and metformin in 1,202 patients whose blood glucose was not being controlled
Maltese: Fit-terapja tripla, studju wieħed ħares lejn l-effett taż-żjieda ta' rożiglitażon mas-sulfonilurea (glibenclamide) u metformina f'1,202 pazjent li l-glukożju fid-demm tagħhom ma kienx qed jiġi kkontrollat biżżejjed.
English: Adding rosiglitazone to treatment with metformin and a sulphonylurea brought about a small but significant
Maltese: Iż-żieda ta' rożiglitażon mat-trattament b'metformina u sulfonilurea tagħti tnaqqis żejjed żgħir iżda sinifikanti fillivelli ta' HbAlc.
English: Invented Name Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika
English: Strength
Maltese: MEMBRI
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Maltese: TAL-PRODOTT(I) MEDIĊINALI, MNEJN JINGĦATA, ID
English: (Invented) name
Maltese: LISTA TA`
English: Route of administration
Maltese: Mnjen jingħata
English: Marketing authorisation holder
Maltese: ANNESS I
English: EMA/603289/2014 EMEA/H/C/003745
Maltese: EMEA/H/C/003745
English: The full EPAR and risk management plan summary for Duaklir Genuair can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Duaklir Genuair jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Duaklir Genuair aclidinium bromide / formoterol fumarate dihydrate
Maltese: Duaklir Genuair bromur tal-aklidinju / diidrat tal-fumarat tal-formoterol
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duaklir Genuair on 19 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Duaklir Genuair fid-19 ta' Novembru 2014.
English: Results showed that, after six months of treatment, the increase in FEV1 (measured one hour after an inhalation) was 293 milliliters (ml) more with Duaklir Genuair than with placebo and 118 ml more with Duaklir Genuair than with aclidinium alone.
Maltese: Ir-riżultati uwrew li, wara sitt xhur ta' kura, iż-żieda fl-FEV1 (imkejla siegħa wara teħid man-nifs) kienet ta' 293 millilitri (ml) aktar bi Duaklir Genuair milli bi plaċebo u 118 ml aktar bi Duaklir Genuair milli blaklidinju waħdu.
English: Duaklir Genuair is used for maintenance (regular) treatment.
Maltese: Duaklir Genuair jintuża għal trattament ta' manutenzjoni (regolari).
English: Duaklir Genuair is a medicine used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Duaklir Genuair huwa mediċina li tintuża biex ittaffi s-sintomi ta' mard pulmonari ostruttiv kroniku (COPD) fl-adulti.
English: This is a summary of the European public assessment report (EPAR) for Duaklir Genuair.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Duaklir Genuair.
English: Side effects with Duaklir Genuair are similar to those with the individual components.
Maltese: L-effetti sekondarji bi Duaklir Genuair huma simili għal dawk bil-komponenti individwali.
English: Duaklir Genuair has been studied in 2 main studies involving over 3,400 patients with COPD, in which it was compared with aclidinium alone, formoterol alone and placebo (a dummy treatment).
Maltese: Duaklir Genuair ġie studjat f'2 studji ewlenin li involvew aktar minn 3,400 pazjent b'COPD, fejn tqabbel mal-aklidinju waħdu, formoterol waħdu u plaċebo (kura finta).
English: Duaklir Genuair contains two active substances: aclidinium bromide and formoterol fumarate dihydrate.
Maltese: Duaklir Genuair fih żewġ sustanzi attivi: bromur tal-aklidinju / diidrat tal-fumarat tal-formoterol.
English: Why is Duaklir Genuair approved?
Maltese: Għaliex ġie approvat Duaklir Genuair?
English: Other information about Duaklir Genuair
Maltese: Informazzjoni oħra dwar Duaklir Genuair
English: A risk management plan has been developed to ensure that Duaklir Genuair is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Duaklir Genuair jintuża bl-aktar mod sigur possibbli.
English: What are the risks associated with Duaklir Genuair?
Maltese: X'inhuma r-riskji assoċjati ma' Duaklir Genuair?
English: Regarding safety, the number of side effects reported with Duaklir Genuair was low and did not raise any major safety concern.
Maltese: Fir-rigward tas-sigurtà, in-numru ta' effetti sekondarji rrapportati bi Duaklir Genuair kien baxx u ma qajjem ebda tħassib serju għas-sigurtà.
English: The most common side effects (seen in around 7 patients in 100) are nasopharyngitis (inflammation of the nose and throat) and headache.
Maltese: L-aktar effetti sekondarji l-aktar komuni (li dehru f'bejn 7 minn kull 100) huma nażofarinġite (infjammazzjoni talimnieħer u tal-gerżuma) u uġigħ ta' ras.
English: The CHMP noted that Duaklir Genuair was shown to significantly improve lung function in patients with COPD compared with placebo, although the improvement observed when Duaklir Genuair was compared with one of the components on its own, formoterol, was small.
Maltese: Is-CHMP innota li Duaklir Genuair intwera li jtejjeb b'mod sinifikanti l-funzjoni tal-pulmuni f'pazjenti b'COPD meta mqabbel mal-plaċebo, għalkemm it-titjib osservat meta Duaklir Genuair tqabbel ma' wieħed millkomponenti waħdu, formoterol, kien wieħed żgħir.