FrancophonIA/ELRC3.0 huggingface dataset:
English: If significant licking does occur, a brief period of hypersalivation may rarely be observed in cats As with other macrocyclic lactones, reversible neurological signs, including seizures, have been very rarely observed after use of the veterinary medicinal product in both dogs and cats.
Maltese: Kif jiġri ma' macrocyclic lactones oħrajn, f'każijiet rari ħafna, wara li jintuża lprodott ġew osservati sinjali newroloġiċi, inklużi aċċessjonijiet, li huma riversibbli.
English: 1 pipette 4 pipettes 24 pipettes x 0.25 ml
Maltese: Pipetti 24 Pipetta
English: 60 mg/ml solution Selamectin 15 mg
Maltese: Evicto 15 mg għall-klieb u l-qtates soluzzjoni 60 mg/ml
English: EVICTO 15 mg spot on solution for cats and dogs ≤ 2.5 kg EVICTO 30 mg spot on solution for dogs 2.6 - 5.0 kg EVICTO 45 mg spot on solution for cats 2.6 - 7.5 kg EVICTO 60 mg spot on solution for cats 7.6 - 10.0 kg EVICTO 60 mg spot on solution for dogs 5.1 - 10.0 kg EVICTO 120 mg spot on solution for dogs 10.1 - 20.0 kg EVICTO 240 mg spot on solution for dogs 20.1 - 40.0 kg EVICTO 360 mg spot on solution for dogs 40.1 - 60.0 kg
Maltese: EVICTO 15 mg soluzzjoni għal użu topikali għall-qtates u għall-klieb ≤ 2.5 kg EVICTO 30 mg soluzzjoni għal użu topikali għall-klieb 2.6-5.0 kg EVICTO 45 mg soluzzjoni għal użu topikali għall-qtates 2.6-7.5 kg EVICTO 60 mg soluzzjoni għal użu topikali għall-qtates 7.6-10.0 kg EVICTO 60 mg soluzzjoni għal użu topikali għall-klieb 5.1-10.0 kg EVICTO 120 mg soluzzjoni għal użu topikali għall-klieb 10.
English: PACKAGE LEAFLET: Evicto spot-on solution
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: Selamectin was also administered at 3 times the recommended dose to breeding male and female cats and dogs, including pregnant and lactating females nursing their litters and at 5 times the recommended dose to ivermectin-sensitive Collies, and no undesirable effects were observed.
Maltese: Wara li jiġi applikat il-prodott mediċinali veterinarju, il-briegħed adulti u larva fuq l-annimal jinqatlu u ma jkunx hemm aktar bajd vijabbli.
English: Selamectin paralyses and/or kills a wide range of invertebrate parasites through interference with their chloride channel conductance causing disruption of normal neurotransmission.
Maltese: Selamektin tipparaliżża u/jew toqtol firxa wiesgħa ta' parassiti invertebrati billi tfixkel il-kunduttivita' tal-kanali tal-kloru u b'hekk tikkawża tħarbit fin-newrotrasmissjoni normali.
English: Treatment of biting lice infestations (Trichodectes canis) Treatment of sarcoptic mange (caused by Sarcoptes scabiei) Treatment of adult intestinal roundworms (Toxocara canis).
Maltese: Kwalunkwe prodott mediċinali veterinarju li ma ġiex użat jew materjal għar-rimi li huwa derivat minn dan il-prodott mediċinali veterinarju għandhom jintremew skont kif jitolbu r-regolamenti lokali.
English: Evicto 30 mg spot-on solution for dogs 2.6-5.0 kg Evicto 60 mg spot-on solution for dogs 5.1-10.0 kg
Maltese: Pipetta waħda ta' EVICTO 60 mg għal klieb 5.1-10.0 kg
English: 120 mg/ml solution Selamectin 60 mg
Maltese: Evicto 60 mg għall-klieb soluzzjoni 120 mg/ml
English: Dogs (kg) Product
Maltese: DAQS TAL-PAKKETT
English: 120 mg/ml solution Selamectin 30 mg
Maltese: Evicto 30 mg għall-klieb soluzzjoni 120 mg/ml
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Maltese: TAS-SUSTANZA ATTIVA / SUSTANZI ATTIVI
English: 120 mg/ml solution Selamectin 360 mg
Maltese: Evicto 360 mg għall-klieb soluzzjoni 120 mg/ml
English: What is Syner-Kinase?
Maltese: X'inhu Syner-Kinase?
English: The marketing authorisation holder, Syner-Medica Ltd, requested that the marketing authorisation for Syner-Kinase granted in the UK on 29 September 2006 be recognised in France, Germany, the Netherlands and Spain (the ‘concerned Member States').
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Syner-Medica Ltd, talab li l-awtorizzazzjoni għattqegħid fis-suq għal Syner-Kinase li ngħatat fir-Renju Unit fid-29 ta' Settembru 2006 tiġi rikonoxxuta fi Franza, fil-Ġermanja, fin-Netherlands u fi Spanja (l-“Istati Membri kkonċernati”).
English: EMA recommends authorisation of Syner-Kinase (urokinase) in the EU EMA/299749/2019
Maltese: L-EMA tirrakkomanda l-awtorizzazzjoni ta' Syner-Kinase (urokinażi) fl-UEEMA/446073/2019
English: Syner-Kinase is a medicine used to dissolve blood clots in the lungs, in deep veins, in arteries in the arms, hands, legs and feet, or in catheters or cannulae (surgical tubes) placed in a vein.
Maltese: Syner-Kinase huwa mediċina li tintuża biex tħoll l-emboli tad-demm fil-pulmun, f'vini fondi, fl-arterji fid-dirgħajn, fl-idejn, fir-riġlejn u fis-saqajn, jew f'kateters jew kannuli (tubi kirurġiċi) imqiegħda ġo vina.
English: The review of Syner-Kinase was initiated on 26 July 2018 at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' Syner-Kinase nbeda fis-26 ta' Lulju 2018 fuq talba tar-Renju Unit, skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE.
English: demonstrated that the production of the semi-purified urokinase (an intermediate step in the production of the active substance) is adequately controlled, and that this intermediate is manufactured at a site that complies with the principles and guidelines of Good Manufacturing Practice (GMP).
Maltese: kumpanija wriet li l-produzzjoni tal-urokinażi semipurifikata (pass intermedju fil-produzzjoni tassustanza attiva) hija kkontrollata b'mod adegwat, u li din is-sustanza intermedja tiġi manifatturata f'sit li jikkonforma mal-prinċipji u l-linji gwida ta' Prassi Tajba ta' Manifattura (PTM).
English: Having reviewed the available data, EMA considered that Syner-Kinase is comparable to the urokinase products mentioned in the published literature, and that the data are adequate to support its proposed use.
Maltese: Wara li rrieżaminat id-data disponibbli, l-EMA kkunsidrat li Syner-Kinase huwa komparabbli malprodotti tal-urokinażi msemmija fil-letteratura ppubblikata, u li d-data hija adegwata biex tappoġġja lużu propost tiegħu.
English: EMA completes review following disagreement among EU Member States
Maltese: L-EMA lestiet rieżami wara nuqqas ta' qbil fost l-Istati Membri tal-UE
English: Syner-Kinase contains the active substance urokinase, a natural enzyme that helps to dissolve blood clots in the body.
Maltese: Syner-Kinase fih is-sustanza attiva urokinażi, enzima naturali li tgħin biex tħoll l-emboli taddemm fil-ġisem.
English: On 28 February 2019, the European Medicines Agency completed a review of Syner-Kinase and associated names following a disagreement among EU Member States regarding its authorisation.
Maltese: Fit-28 ta' Frar 2019, l-Aġenzija Ewropea għall-Mediċini lestiet rieżami ta' Syner-Kinase u ismijiet assoċjati wara nuqqas ta' qbil fost l-Istati Membri tal-UE dwar l-awtorizzazzjoni tiegħu.
English: EMA recommends authorisation of Syner-Kinase (urokinase) in the EU
Maltese: L-EMA tirrakkomanda l-awtorizzazzjoni ta' Syner-Kinase
English: A European Commission decision valid throughout the EU was issued on 16/05/2019.
Maltese: Fis-16/05/2019 inħarġet deċiżjoni tal-Kummissjoni Ewropea valida fl-UE kollha.
English: The Agency concluded that the benefits of Syner-Kinase outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation.
Maltese: L-Aġenzija kkonkludiet li l-benefiċċji ta' Syner-Kinase huma akbar mir-riskji tiegħu, u l-awtorizzazzjoni għattqegħid fis-suq mogħtija fir-Renju Unit tista' tiġi rikonoxxuta fi Stati Membri oħra tal-UE fejn ilkumpanija applikat għal awtorizzazzjoni għat-tqegħid fis-suq.
English: The Agency also considered that the data provided by the company show that the purification process is suitable for the removal of possible viral and prion impurities.
Maltese: L-Aġenzija kkunsidrat ukoll li d-data pprovduta mill-kumpanija turi li l-proċess ta' purifikazzjoni huwa adattat għat-tneħħija ta' impuritajiet virali u prijoniċi possibbli.
English: The grounds for the referral were concerns that the data provided by the company, which included published data on other urokinase-containing medicines, were not sufficient to demonstrate that the benefits of Syner-Kinase outweigh its risks.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib li d-data pprovduta mill-kumpanija, li kienet tinkludi data ppubblikata dwar mediċini oħra li fihom l-urokinażi, ma kinitx biżżejjed biex turi li l-benefiċċji ta' Syner-Kinase huma akbar mir-riskji tiegħu.
English: Finally, the company
Maltese: (urokinażi) fl-UE
English: Dr Alar Irs (Estonia)
Maltese: Dr Alar Irs (Estonja)
English: Ref. EMEA/CHMP/137577/2009 EMEA/H/A-30/998
Maltese: EMEA/150573/2009 EMEA/H/A-30/998
English: 24 April 2008
Maltese: 24 ta' April 2008
English: Dr Liv Mathison (Norway)
Maltese: Dr Liv Mathison (Norveġja)
English: Diovan can also be available in the EU and the EEA under other trade names: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg, and Varexan.
Maltese: Diovan jista' jkun disponibbli wkoll fl-UE u ż-ŻEE taħt ismijiet ta' marka oħrajn: Angiosan, Cordinate, Dalzad, Diovane, Kalpress, Miten, Novacard, Provas, Rixil, Tareg, u Varexan.
English: Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Maltese: Artikolu 30 tad-Direttiva 2001/83/KE kif emendata, referenza fuq il-bażi ta' deċiżjonijiet differenti adottati mill-Istati membri
English: What is Diovan?
Maltese: X'inhu Diovan?
English: London, 18 February 2009 Doc.
Maltese: Londra, 18 ta' Frar 2009 Dok ta' Ref.
English: The review was carried out under an ‘Article 30' referral1.
Maltese: Ir-reviżjoni saret skont riferiment tal-‘Artikolu 30'1.
English: Referral start date:
Maltese: Data tal-opinjoni:
English: Questions and answers on the referral for Diovan film coated tablets and hard capsules containing valsartan 40, 80, 160 or 320 mg
Maltese: Mistoqsija u tweġa dwar ir-referenza għall-pilloli miksija b'rita Diovan u kapsuli iebsa ta' 40, 80, 160 jew 320 mg li fihom valsartan
English: However, the triple combination of an ACE inhibitor, a beta blocker and valsartan is not recommended (see sections 4.4 and 5.1).
Maltese: Madankollu, il-kombinazzjoni tripla ta' inibitur ACE, imblokkatur beta u valsartan mhix rakkomandata (ara taqsimiet 4.4 u 5.1).
English: The Committee also concluded that the 320 mg dose provides a modest, but statistically significant additional reduction in blood pressure compared to 160 mg and a similarly modest increase in the rate of blood pressure control.
Maltese: Il-Kumitat ikkonkluda wkoll li d-doża ta' 320 mg tipprovdi tnaqqis addizzjonali żgħir, iżda statistikament sinifikanti fil-pressjoni tad-demm meta mqabbla ma' 160 mg u żieda daqstant żgħira fir-rata tal-kontroll tal-pressjoni taddemm.
English: Diovan is authorised in the European Union (EU) via national procedures.
Maltese: Diovan huwa awtorizzat fl-Unjoni Ewropea (UE) permezz ta' proċeduri nazzjonali.
English: The CHMP endorsed following text: No dosage adjustment is required for patients with a creatinine clearance >10ml/min.
Maltese: Mhux meħtieġ l-aġġustament tad-doża għal pazjenti bi clearance tal-kreatinina >10ml/min.
English: The CHMP endorsed the use of Diovan in the “treatment of essential hypertension”.
Maltese: Is-CHMP approva l-użu ta' Diovan fil-“kura ta' ipertensjoni essenzjali”.
English: • the use of Diovan with ACE inhibitors and betablockers (triple combination) in chronic heart failure,
Maltese: • l-użu ta' Diovan ma' inibituri ACE u mblokkaturi beta (kombinazzjoni tripla) f'insuffiċjenza tal-qalb kronika,
English: In conclusion, the CHMP endorsed the following text: “The recommended starting dose of Diovan is 40 mg twice daily.
Maltese: Għalhekk, is-CHMP approva t-test li ġej: “Id-doża tal-bidu rakkomandata ta' Diovan hija ta' 40 mg darbtejn kuljum.
English: Why was Diovan reviewed?
Maltese: Għalfejn ġie rivedut Diovan?
English: It can be used on its own and in combination with ACE inhibitors.
Maltese: Jista' jintuża waħdu jew f'kombinazzjoni ma' inibituri ACE.
English: The CHMP also aligned the contraindication for the use of Diovan during pregnancy or lactation with recent the recommendations of the Pharmacovigilance experts, and therefore recommended that the contraindication in pregnancy be removed and the recommendation for the use during breast feeding be: “Because no information is available regarding the use of valsartan during breastfeeding, Diovan (Valsartan) is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant”.
Maltese: Is-CHMP ġab il-kontraindikazzjoni għall-użu ta' Diovan waqt it-tqala jew it-treddiegħ f'linja marrakkomandazzjonijiet reċenti tal-esperti tal-Farmakoviġilanza, u għaldaqstant irrakkomanda li l kontraindikazzjoni fit-tqala titneħħa u li r-rakkomandazzjoni għall-użu matul it-treddiegħ għandha tkun: “Minħabba li m'hemm l-ebda informazzjoni disponibbli rigward l-użu ta' valsartan matul ittreddiegħ, Diovan (Valsartan) mhux rakkomandat u huwa aħjar l-użu ta' kuri alternattivi bi profili ta' sigurtà stabbiliti aħjar waqt it-treddiegħ, b'mod speċjali waqt it-treddiegħ ta' tarbija tat-twelid jew tarbija li twieldet qabel iż-żmien”.
English: The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Maltese: Id-doża massima ta' kuljum mogħtija fil-provi kliniċi hija ta' 320 mg f'dożi maqsuma.
English: Diovan has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Diovan ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar ir-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati - Bniedem (CMD(h)).
English: The European Medicines Agency (EMEA) has completed a review of Diovan (and associated names).
Maltese: L-Aġenzija Ewropea għall-Mediċini (EMEA) lestiet l-analiżi ta' Diovan (u ismijiet assoċjati).
English: • dosage recommendations in patients with renal and hepatic impairment.
Maltese: • ir-rakkomandazzjonijiet ta' dożi għal pazjenti bi problemi renali u epatiċi.
English: Diovan works by blocking the effect of angiotensin II.
Maltese: Diovan jaħdem billi jimblokka l-effett ta' anġjotensina II.
English: In heart failure, Diovan is used when other types of medicines used in heart failure such as Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers, cannot be used.
Maltese: Fl-insuffiċjenza tal-qalb, Diovan jintuża meta ma jistgħux jintużaw tipi oħra ta' mediċini użati fl-insuffiċjenza tal-qalb bħal inibituri tal-Enzima li Tikkonverti l-Anġjotensina (ACE) jew imblokkaturi beta.
English: In patients with mild to moderate hepatic impairment without cholestasis the dose of valsartan should not exceed 80 mg (see section 4.4).
Maltese: Id-doża ta' valsartan m'għandhiex taqbeż it-80 mg f'pazjenti bi problemi epatiċi żgħar jew moderati mingħajr kolestażi (ara taqsima 4.4).
English: Having assessed the data available, the CHMP agreed that valsartan 80 mg can be used as a starting dose in patients with reduced kidney function.
Maltese: Wara li evalwa d-dejta disponibbli, is-CHMP qabel li valsartan ta' 80 mg jista' jintuża bħala doża tal-bidu f'pazjenti b'indeboliment fil-funzjoni tal-kliewi.
English: But considering that valsartan given on its own is at least as effective as captopril (an ACE inhibitor) given on its own in the reduction of total mortality after an acute MI, the CHMP endorsed the harmonised indication: Treatment of clinically stable patients with symptomatic heart failure or asymptomatic left ventricular systolic dysfunction after a recent (12 hours - 10 days) myocardial infarction.
Maltese: Il-kura ta' pazjenti b'insuffiċjenza tal-qalb sintomatika jew disfunzjoni sistolika tal-ventrikolu tax-xellug asintomatika klinikament stabbli wara infart mijokardijaku reċenti (12-il siegħa- 10 ijiem).
English: The CHMP discussed three areas where there was a divergence:
Maltese: Is-CHMP iddiskuta tliet oqsma li fihom kien hemm differenzi:
English: The CHMP endorsed the following text: “If a medicinal product that affects potassium levels is considered necessary in combination with valsartan, monitoring of potassium plasma levels is advised”.
Maltese: Is-CHMP approva t-test li ġej: “Jekk prodott mediċinali li jaffettwa l-livelli tal-potassju huwa kkunsidrat li hu meħtieġ f'kombinazzjoni ma' valsartan, huwa rakkomandat il-monitoraġġ tal-livelli tal-potassju filplażma ”.
English: The CHMP considered the need to harmonise a number of precautions for use:
Maltese: Is-CHMP approva t-test li ġej:
English: Diovan can be used to treat patients with hypertension (high blood pressure), patients who just have had a heart attack (between 12 hours and 10 days earlier), or patients with heart failure when they show signs that their heart not working fully, such as shortness of breath, and swelling of the feet and legs due to fluid build-up.
Maltese: Diovan jista' jintuża fil-kura ta' pazjenti bl-ipertensjoni (pressjoni għolja tad-demm), pazjenti li għad kemm kellhom attakk tal-qalb (bejn 12-il siegħa u 10 ijiem qabel), jew pazjenti b'insuffiċjenza talqalb meta dawn juru sinjali li qalbhom mhix taħdem kif suppost, bħal qtugħ ta' nifs, u nefħa fis-saqajn u r-riġlejn minħabba l-akkumulazzjoni ta' fluwidu.
English: Company responses provided on: 20 October 2008 Opinion date:
Maltese: Tweġibiet tal-Kumpanija pprovduti 20 ta' Ottubru 2008
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Diovan in the European Union (EU) and the European Economic Area (EEA).
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li hemm il-ħtieġa li l-informazzjoni tal-preskrizzjoni għal Diovan tkun armonizzata fl-Unjoni Ewropea (UE) u fiż-Żona Ekonomika Ewropea (ŻEE).
English: The Committee noted that there has been no study of valsartan in patients with severe kidney failure, but they did not identify any possible safety issue has he primary route of elimination of valsartan is via the digestive (biliary), not renal route The CHMP therefore recommended that the contraindication be removed.
Maltese: Il-Kumitat innota li ma kien hemm l-ebda studju ta' valsartan f'pazjenti b'indeboliment serju tal-kliewi, iżda ma identifika l-ebda kwistjoni ta' sigurtà possibbli minħabba li r-rotta primarja tat-tneħħija ta' valsartan hija permezz tar-rotta diġestiva (biljari), mhux ir-rotta renali.
English: Valsartan may be administered with other heart failure therapies.
Maltese: Valsartan jista' jingħata ma' terapiji oħra tal-insuffiċjenza tal-qalb.
English: Special precautions
Maltese: Prekawzjonijiet speċjali
English: The Committee noted that some Member States (MSs) had a limitation of the use of Diovan after MI to patients intolerant to ACE inhibitors.
Maltese: Il-Kumitat innota li xi Stati Membri (MSs) kellhom limitazzjoni fl-użu ta' Diovan wara
English: The 320 mg strength was not available in all markets.
Maltese: Id-doża ta' 320 mg ma kinitx disponibbli fis-swieq kollha.
English: Uptitration to 80 mg and 160 mg twice daily should be done at intervals of at least two weeks to the highest dose, as tolerated by the patient.
Maltese: Iż-żieda fid-doża għal 80 mg u 160 mg darbtejn kuljum għandha ssir f'distanza ta' mill-anqas ġimgħatejn sal-ogħla doża, kif ittollerat mill-pazjent.
English: The CHMP also discussed the indications in the treatment of heart failure and after a recent myocardial infarction (MI).
Maltese: Is-CHMP iddiskuta wkoll l-indikazzjonijiet fil-kura tal-insuffiċjenza tal-qalb u wara infart mijokardijaku reċenti (MI).
English: The full EPAR for Libertek can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Libertek jista' jiġi kkonsultat fis-sit elettoniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Libertek
Maltese: Informazzjoni oħra dwar Libertek
English: Libertek is a medicine that contains the active substance roflumilast.
Maltese: Libertek huwa mediċina li fiha s-sustanza attiva roflumilast.
English: The active substance in Libertek, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Maltese: Is-sustanza attiva f'Libertek, ir-roflumilast, tagħmel parti minn grupp ta' mediċini li jissejħu ‘inibituri ta' tip 4 ta' fosfodjesterażi (PDE4)'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Libertek on 28 February 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Libertek valida fl-Unjoni Ewropea kollha fit- 28 ta' Frar 2011.
English: This is a summary of the European public assessment report (EPAR) for Libertek.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Libertek.
English: Libertek is used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Maltese: Libertek jintuża fil-kura tal-mard pulmonari ostruttiv kroniku (COPD) sever f'adulti li għandhom bronkite kronika (infjammazzjoni fit-tul tal-passaġġi tan-nifs), u li s-COPD tagħhom tfeġġ b'mod frekwenti.
English: The most common side effects with Libertek (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Maltese: L-effetti sekondarji l-aktar komuni b'Libertek (li dehru f'bejn pazjent wieħed u għaxra minn kull mija) huma tnaqqis fil-piż, tnaqqis fl-aptit, insomnija (diffikultà fl-irqad), uġigħ ta' ras, dijarea, nawżja (dardir) u wġigħ addominali (uġigħ fl-istonku).
English: What benefit has Libertek shown during the studies?
Maltese: Liema benefiċċju wera Libertek waqt l-istudji mwettqa?
English: Libertek has been compared with placebo (a dummy treatment) in two main studies involving over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Maltese: Libertek tqabbel ma' plaċebo (kura finta) f'żewġ studji prinċipali li involvew aktar minn 3,000 adult b'COPD severa li kellhom mill-anqas feġġa waħda tal-marda tagħhom fl-aħħar sena.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku roflumilast
English: Libertek roflumilast
Maltese: Kif jintuża Libertek?
English: What is Libertek?
Maltese: X'inhu Libertek?
English: After considering all of the available data on the effects of the medicine, the Committee decided that Libertek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Wara li kkunsidra d-data kollha disponibbli dwar l-effetti tal-mediċina, ilKumitat iddeċieda li l-benefiċċji ta' Libertek huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The CHMP noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Libertek in patients with severe COPD.
Maltese: Is-CHMP innota li kien hemm ħtieġa ta' kuri ġodda għal COPD u li l-istudji ewlenin urew benefiċċju modest ta' Libertek f'pazjenti b'COPD sever.
English: After a year, the patients who took Libertek had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Maltese: Wara sena, il-pazjenti li ħadu Libertek kellhom żieda medja ta' 40 ml filwaqt li dawk li kienu ngħataw il-plaċebo kellhom tnaqqis medju ta' 9 ml.
English: How has Libertek been studied?
Maltese: Kif ġie studjat Libertek?
English: In addition, the patients who took Libertek had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Maltese: Barra minn hekk, il-pazjenti li ħadu Libertek kellhom medja ta' feġġiet moderati jew severi talmarda tagħhom ta' 1.1, meta mqabbel ma' 1.4 feġġiet fil-pazjenti li ħadu l-plaċebo.