FrancophonIA/ELRC3.0 huggingface dataset:
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC,
Maltese: Billi • Il-kumitat ikkunsidra l-proċedura ta' referenza taħt l-Artikolu 30 tad-Direttiva 2001/83/KE,
English: In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
Maltese: B'konklużjoni, is-CHMP adotta kliem armonizzat għas-Sezzjoni 4.2.
English: However, having reviewed the submitted data, including studies by Kristo, 2005, Falagas, 2008, Zervos, 2003 as well as a Cochrane systematic review conducted by Ahovuo-Saloranta, 2008, a meta-anlysis by Young, 2008 and a systematic review by Ip, 2005, the CHMP considered the proposed indication to be acceptable.
Maltese: Madankollu, wara li rreveda d-dejta ppreżentata, inklużi studji minn Kristo, 2005, Falagas, 2008, Zervos, 2003 kif ukoll reviżjoni sistematika ta' Cochrane li saret minn Ahovuo-Saloranta, 2008, meta-analiżi minn Young, 2008 u reviżjoni sistematika minn Ip, 2005, is-CHMP ikkunsidra li l-indikazzjoni proposta hija aċċettabbli.
English: Having reviewed the minimum inhibitory concentrations (MIC) distributions for common respiratory pathogens such as penicillin-intermediate S. pneumoniae, H. influenzae and M.catarrhalis (Bulitta et al, 2009), the CHMP considered that the changes in MIC distributions over the last decades have impacted the suitability of cefuroxime axetil in this indication.
Maltese: Wara li rreveda d-distribuzzjonijiet tal-konċentrazzjonijiet inibitorji minimi (MICs) għal patoġeni respiratorji komuni bħal S. pneumoniae, H. influenzae and M.catarrhalis intermedjati millpeniċillina (Bulitta et al, 2009), is-CHMP ikkunsidra li l-bidliet fid-distribuzzjonijiet tal-MICs f'dawn laħħar għexieren ta' snin affettwaw l-adegwatezza ta' sefuroxima axetil f'din l-indikazzjoni.
English: • The committee reviewed the data submitted by the MAH, including data from clinical trials, published literature and other clinical documentation, justifying the proposed harmonisation of the product information;
Maltese: • Il-kumitat irreveda d-dejta ppreżentata mill-MAH, inkluża dejta minn provi kliniċi, ir-riċensjoni ppubblikata u dokumentazzjoni klinika oħra, li tiġġustifika l-armonizzazzjoni proposta talinformazzjoni dwar il-prodott;
English: In children, the CHMP similarly recommended a dosage of 15 mg/kg BID (250 mg twice daily up to 500 mg daily) for the cystitis indication.
Maltese: Fit-tfal, is-CHMP irrakkomanda bl-istess mod doża ta' 15 mg/kg BID (250 mg darbtejn kuljum sa 500 mg kuljum) għall-indikazzjoni taċ-ċistite.
English: For the paediatric population, the CHMP agreed that the dosage should be 15 mg/kg twice daily, to a maximum of 250 mg twice daily.
Maltese: Għall-popolazzjoni pedjatrika, is-CHMP qabel li d-doża għandha tkun 15 mg/kg darbtejn kuljum, sa massimu ta' 250 mg darbtejn kuljum.
English: Community acquired pneumonia
Maltese: Pulmonite akkwistata mill-komunità
English: In conclusion, the CHMP adopted harmonised posology recommendations for adults and children.
Maltese: Bħala konklużjoni, is-CHMP adotta rakkomandazzjonijiet ta' posoloġija armonizzati għall-adulti u għat-tfal.
English: Having reviewed the submitted data, including studies by Aujard, 1995, Gooch, 1993 and Scholz, 2004, as well as studies by the German Society for Paediatric Infectious Diseases and an open, parallel group MAH-sponsored study conducted in general practice centres in the UK, France and Germany in 1989, the CHMP considered that the data supported the proposed indication.
Maltese: Wara li rreveda d-dejta ppreżentata, inklużi studji minn Aujard, 1995, Gooch, 1993 u Scholz, 2004, kif ukoll studji mis-Soċjetà Ġermaniża għall-Mard Infettiv Pedjatriku u studju miftuħ, bi grupp parallel sponsorjat mill-MAH li sar fl-1989 f'ċentri ta' prattika ġenerali fir-Renju Unit, Franza u lĠermanja, is-CHMP ikkunsidra li d-dejta kienet tappoġġja l-indikazzjoni proposta.
English: Lyme disease
Maltese: Il-marda ta' Lyme
English: The CHMP reviewed the data from five randomised controlled studies, two of which included patients aged >12 years (Nadelman 1995; Lugar 1995), one which included patients aged >15 years (Cerar 2010), one study including children aged < 15 years (Arnez 1995) and one study including children aged between 6 months - 12 years.
Maltese: Is-CHMP irreveda d-dejta minn ħames studji kkontrollati u aleatorji, li tnejn minnhom kienu jinkludu pazjenti ta' >12-il sena (Nadelman 1995; Lugar 1995), wieħed kien jinkludi pazjenti ta' >15-il sena (Cerar 2010), studju li kien jinkludi tfal ta' < 15-il sena (Arnez 1995) u studju li kien jinkludi tfal bejn is-6 xhur u t-12-il sena.
English: The CHMP reviewed all available data and also noted that less susceptible pathogens cannot be managed by using higher doses of cefuroxime axetil than the maximum daily dose of 500 mg, due to the toxic degradation products of cefuroxime axetil and a lack of safety data.
Maltese: Is-CHMP irreveda d-dejta kollha disponibbli u nnota wkoll li patoġeni inqas suxxettibbli ma jistgħux ikunu kkontrollati permezz ta' dożi ta' sefuroxima axetil ogħla mid-doża massima ta' 500 mg kuljum, minħabba l-prodotti ta' degradazzjoni tossika ta' sefuroxima axetil u nuqqas ta' dejta dwar is-sigurtà.
English: For Lyme disease, the CHMP considered that the existing clinical data supported treatment for 14 days, with a range of 10 to 21 days (European Union Concerted Action on Lyme Borreliosis, 2010), in adults and in paediatric patients.
Maltese: Għall-marda ta' Lyme, is-CHMP ikkunsidra li d-dejta klinika eżistenti kienet tappoġġja l-kura għal 14-il ġurnata, b'medda ta' 10 sa 21 jum (Azzjoni Miftiehma tal-Unjoni Ewropea dwar il-Lyme Borreliosis, 2010), fl-adulti u fil-pazjenti pedjatriċi.
English: A referral under Article 30(2) of Directive 2001/83/EC was therefore triggered to resolve these divergences and thus harmonise the Product Information (PI) across the EU.
Maltese: Għaldaqstant ingħata bidu għal proċedura ta' referenza taħt l-Artikolu 30(2) tadDirettiva 2001/83/KE sabiex jissolvew dawn id-diverġenzi u b'hekk tiġi armonizzata l-Informazzjoni dwar il-Prodott (PI) madwar l-UE.
English: The CHMP also noted that the 2009 European Guideline on the Diagnosis and Treatment of Gonorrhoea in Adults does not include cefuroxime on the list of antibiotics recommended in this indication, due to its suboptimal pharmacokinetic and pharmacodynamic (PK/PD) characteristics which may lead to worse effectiveness and to the selection of the resistant bacteria strains (Aison et al, 2004).
Maltese: Is-CHMP innota wkoll li l-Linji Gwida Ewropej tal-2009 dwar id-Dijanjosi u l-Kura ta' Gonorreja fl-Adulti ma jinkludux sefuroxima fil-lista ta' antibijotiċi rrakkomandati f'din lindikazzjoni, minħabba l-karatteristiċi farmakokinetiċi u farmakodinamiċi (PK/PD) mhux daqshekk tajbin tiegħu li jistgħu jwasslu għal inqas effikaċja u għall-għażla tar-razez batteriċi reżistenti (Aison et al, 2004).
English: For the cystitis indication, the CHMP recommended an adult dosing regimen of 250 mg BID, to ensure adequate urinary concentrations of cefuroxime and thus the eradication of the key uropathogens implicated.
Maltese: Għall-indikazzjoni taċ-ċistite, is-CHMP irrakkomanda skema ta' dożi għall-adulti ta' 250 mg BID, sabiex jiżgura konċentrazzjonijiet urinarji adegwati ta' sefuroxima u għalhekk il-qerda tal-uropatoġeni ewlenin involuti.
English: The CHMP noted that the bacterial species most frequently involved in skin and soft tissue infections (i.e. staphylococci and streptococci) are sensitive to cefuroxime.
Maltese: Is-CHMP innota li l-ispeċji batterjali l-aktar krekwenti, involuti fl-infezzjonijiet tal-ġilda u tat-tessuti rotob (jiġifieri stafilokokki u streptokokki) huma sensittivi għal sefuroxima.
English: Skin and soft tissue infections
Maltese: Infezzjonijiet tal-ġilda u tat-tessuti rotob
English: The CHMP considered that the available clinical and PK/PD data confirm that a twice daily regimen of cefuroxime axetil is an effective dosage and that the use of cefuroxime axetil given three times daily is unsupported by the clinical and safety data.
Maltese: Is-CHMP ikkunsidra li d-dejta klinika u dik dwar il-PK/PD disponibbli jikkonfermaw li skema ta' darbtejn kuljum ta' sefuroxima axetil hija doża effettiva u li l-użu ta' sefuroxima axetil mogħti tliet darbiet kuljum mhuwiex appoġġjat mid-dejta klinika u dik dwar is-sigurtà.
English: Regarding patients with hepatic impairment, the CHMP noted that there is no available data.
Maltese: Rigward il-pazjenti b'indeboliment tal-fwied, is-CHMP innota li m'hemmx dejta disponibbli.
English: The CHMP also adopted a harmonised wording for the remaining sections of the Zinnat SmPC and brought the labelling and the package leaflet in line with the adopted harmonised SmPC.
Maltese: Is-CHMP adotta wkoll kliem armonizzat għas-sezzjonijiet l-oħrajn tal-SmPC ta' Zinnat u kkonforma t-tikketta u l-fuljett ta' tagħrif mal-SmPC armonizzat adottat.
English: Annex II Scientific conclusions and grounds for the variation to the terms of the Marketing Authorisations
Maltese: Anness II Konklużjonijiet xjentifiċi u raġunijiet għall-varjazzjoni fit-termini talAwtorizzazzjonijiet għat-Tqegħid fis-Suq
English: The CHMP considered that no suitable dosing regimen could be identified to provide adequate coverage for less susceptible pathogens which have MIC up to 1 mg/L.
Maltese: IsCHMP ikkunsidra li ma setgħet tiġi identifikata l-ebda skema ta' dożar li tipprovdi kopertura adegwata għal patoġeni inqas suxxettibbli li għandhom MICs sa 1 mg/L.
English: Overall summary of the scientific evaluation of Zinnat and associated names (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Zinnat u ismijiet assoċjati (ara l-Anness I)
English: Zinnat contains cefuroxime axetil which is an oral pro-drug of cefuroxime, a second generation cephalosporin antibacterial agent.
Maltese: Zinnat kien approvat għall-ewwel darba fl-Ewropa lejn l-aħħar tas-snin tmenin u huwa disponibbli bħala formulazzjonijiet orali.
English: Having reviewed the submitted clinical documentation, which consisted of four adequately designed relatively large (>300 patients) double-blinded, comparative studies, the CHMP considered the proposed indication to be acceptable.
Maltese: Wara li rreveda d-dokumentazzjoni klinika ppreżentata, li kienet tikkonsisti f'erba' studji komparattivi, imfassla b'mod adegwat, relattivament kbar (>300 pazjent) u mingħajr l-għarfien taż-żewġ naħat, is-CHMP ikkunsidra li l-indikazzjoni proposta hija aċċettabbli.
English: The CHMP reviewed the dosage recommendations for each individual indication and agreed that infections suspected or proven to be due to less susceptible bacterial species (such as penicillin intermediate S. pneumonia, M. catarrhalis and H. influenzae) should be treated with 500 mg administered every 12 hours.
Maltese: Is-CHMP irreveda rrakkomandazzjonijiet tad-dożi għal kull indikazzjoni individwali u qabel li l-infezzjonijiet maħsuba jew ippruvati li huma kkawżati minn speċji batterjali inqas suxxettibbli (bħal S. pneumonia, M. catarrhalis u H. influenzae intermedjati mill-peniċillina) għandhom ikunu kkurati b'500 mg mogħtija kull 12-il siegħa.
English: The section on paediatric patients was revised extensively, including a revision of the table of dosing recommendations for children below 40 kg to describe dosage and duration per indication as well as the dosing calculations depending on the patient's body mass.
Maltese: Is-sezzjoni dwar il pazjenti pedjatriċi kienet riveduta b'mod estensiv, inkluża reviżjoni tat-tabella tarrakkomandazzjonijiet tad-dożi għat-tfal ta' inqas minn 40 kg sabiex jiddeskrivi d-doża u ż-żmien għal kull indikazzjoni kif ukoll il-kalkolazzjonijiet tad-dożi skont il-piż tal-ġisem tal-pazjent.
English: Zinnat was included in the list of products for Summary of Product Characteristics (SmPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the abovementioned product.
Maltese: Zinnat kien inkluż fil-lista ta' prodotti għallarmonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC), minħabba deċiżjonijiet nazzjonali diverġenti meħuda mill-Istati Membri rigward l-awtorizzazzjoni tal-prodott imsemmi hawn fuq.
English: The CHMP removed the option of parenteral-to-oral sequential therapy for all patients,, due to the significant reduction in exposure to the active drug when switching to the oral formulation.
Maltese: Is-CHMP neħħa l-għażla ta' kura parenterali għal orali sekwenzjali għallpazjenti kollha, minħabba t-tnaqqis sinifikanti fl-espożizzjoni għall-mediċina attiva meta wieħed jaqleb għall-formulazzjoni orali.
English: The CHMP inserted a statement advising that the cefuroxime axetil suspension formulation is not bioequivalent to the tablet formulation and are not substitutable on a milligram-per-milligram basis, due to differences in bioavailability and the time-concentration curve.
Maltese: Is-CHMP innota l-grad kbir ta' diverġenzi fl-indikazzjonijiet approvati mill-pajjiżi u għalhekk irreveda d-dejta disponibbli li tappoġġja kull indikazzjoni individwali.
English: The CHMP noted the large degree of divergences in the nationally approved posologies and recommendations and therefore reviewed the available data to support a harmonised Section 4.2.
Maltese: Is-CHMP innota l-ammont kbir ta' diverġenzi fil-posoloġiji u r-rakkomandazzjonijiet approvati millpajjiżi u għalhekk irreveda d-dejta disponibbli b'appoġġ għal Sezzjoni 4.2 armonizzata.
English: Based on the available data, including one double blind study and several supporting studies, the CHMP concluded that there is sufficient data in support of the indication “uncomplicated skin and soft tissue infections”.
Maltese: Skont id-dejta disponibbli, inkluż studju mingħajr l-għarfien taż-żewġ naħat u diversi studji ta' appoġġ, is-CHMP ikkonkluda li hemm biżżejjed dejta b'appoġġ għall-indikazzjoni “infezzjonijiet mhux ikkumplikati tal-ġilda u tat-tessuti rotob”.
English: Based on the available data, the CHMP concluded that cefuroxime axetil is not suitable in the treatment of uncomplicated gonorrhoea (urethritis and cervicitis) and therefore recommends the removal of the proposed indication.
Maltese: Skont id-dejta disponibbli, is-CHMP ikkonkluda li sefuroxima axetil mhuwiex adattat fil-kura ta' gonorrea mhux ikkomplikata (uretrite u ċerviċite) u għaldaqstant jirrakkomanda t-tneħħija tal-indikazzjoni proposta.
English: It is available as tablets (150 mg and 300 mg).
Maltese: Jiġi bħala pilloli (150 mg u 300 mg).
English: EPAR summary for the public aliskiren
Maltese: Sommarju tal-EPAR għall-pubbliku aliskiren
English: The full EPAR for Sprimeo can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Sprimeo jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: When the results of the five studies comparing Sprimeo taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Sprimeo, from an average of 99.4 mmHg at the start of the study.
Maltese: Meta r-riżultati tal-ħames studji li qabblu Sprimeo meħud waħdu ma' plaċebo ġew studjati flimkien, il-pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil-pressjoni dijastolika ta' 9.0 mmHg wara tmien ġimgħat jieħdu 150 mg Sprimeo, minn medja ta' 99.4 mmHg filbidu tat-trattament.
English: Combination studies looked at Sprimeo used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Maltese: L-istudji tat-tqabbil eżaminaw l-effett ta' Sprimeo użat flimkien ma' inibitur ta' ACE (ramipril), ARB (valsartan), ma' beta-blocker (atenolol), u ma' sustanza li timblokka l-kanali tal-kalċju (amlodipina) u sustanza djuretika (idroklorotijażide).
English: Sprimeo is a medicine that contains the active substance aliskiren.
Maltese: Sprimeo hu mediċina li fiha s-sustanza attiva aliskiren.
English: What is Sprimeo?
Maltese: Sprimeo?
English: The recommended dose of Sprimeo is 150 mg once a day.
Maltese: Id-doża rakkomandatata ta' Sprimeo hi 150 mg darba kuljum.
English: The active substance in Sprimeo, aliskiren, is a renin inhibitor.
Maltese: Is-sustanza attiva f'Sprimeo, aliskiren, hi inibitur tar-renina.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sprimeo on 22 August 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sprimeo fit-22 ta' Awwissu 2007.
English: What is the risk associated with Sprimeo?
Maltese: X'inhu r-riskju assoċjat ma' Sprimeo?
English: This is a summary of the European public assessment report (EPAR) for Sprimeo.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sprimeo.
English: The most common side effects with Sprimeo (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels).
Maltese: L-effetti sekondarji l-aktar komuni ta' Sprimeo (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma sturdament, dijarrea, artralġija (uġigħ fil-ġogi) u iperkalemija (livelli għoljin ta' potassju fiddemm).
English: Sprimeo has been studied in 14 main studies involving over 10,000 patients with essential hypertension.
Maltese: Sprimeo ġie studjat f'14-il studju ewlieni li fihom ħadu sehem iktar minn 10,000 pazjent b'ipertensjoni essenzjali.
English: Why has Sprimeo been approved?
Maltese: Għaliex ġie approvat Sprimeo?
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Maltese: Timblokka l-attività ta' enzima umana magħrufa bħala renina, li hija relatata mal-produzzjoni ta' sustanza msejħa anġjotensina I fil-ġisem.
English: How has Sprimeo been studied?
Maltese: Kif ġie studjat Sprimeo?
English: Sprimeo must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Maltese: Sprimeo m'għandux jittieħed ma' ciclosporin, itraconazole jew mediċini oħra magħrufa bħala ‘inibituri qawwija ta' P-glycoprotein' (bħal quinidine).
English: However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Sprimeo should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.
Maltese: Għaldaqstant, is-CHMP iddeċieda li l-benefiċċji ta' Sprimeo huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Sprimeo may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Sprimeo jista' jittieħed waħdu jew flimkien ma' mediċini oħra għall-ipertensjoni, bl-eċċezzjoni ta' ‘inibituri ta' enzimi li jikkonvertu lanġjotensini' (ACE) jew ‘imblokkaturi tar-riċetturi ta' anġjotensina' (ARBs) f'pazjenti bid-dijabete, jew b'indeboliment renali moderat jew sever.
English: How does Sprimeo work?
Maltese: Kif jaħdem Sprimeo?
English: By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Maltese: Bl-imblukkar tal-produzzjoni tal-anġjotensina I, il-livelli kemm ta' anġjotensina I kif ukoll ta' anġjotensina II jonqsu.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sprimeo.
Maltese: Sprimeo waħdu kien iktar effikaċi mill-plaċebo u kien effikaċi daqs it-trattamenti komparattivi fittnaqqis tal-pressjoni.
English: For the full list of all side effects reported with Sprimeo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi Sprimeo, ara l-fuljett ta' tagħrif.
English: 09 September 2019 EMA/502527/2019
Maltese: 09 ta' Settembru 2019 EMA/609691/2019
English: They are sold under several brand names including Broncho Munal, Broncho Vaxom, Buccalin, Immubron, Immucytal, Ismigen, Lantigen B, Luivac, Ommunal, Paspat, Pir-05, Polyvaccinum, Provax, Respivax and Ribomunyl.
Maltese: Huma jinbiegħu taħt diversi ismijiet ta' marki inkluż Broncho Munal, Broncho Vaxom, Buccalin, Immubron, Immucytal, Ismigen, Lantigen B, Luivac, Ommunal, Paspat, Pir-05, Polyvaccinum, Provax, Respivax u Ribomunyl.
English: They are available in Austria, Belgium, Bulgaria, Czech Republic, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal, Romania, Slovakia and Slovenia.
Maltese: Huma disponibbli flAwstrija, il-Belġju, il-Bulgarija, ir-Repubblika Ċeka, il-Ġermanja, il-Greċja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, u s-Slovenja.
English: The review of bacterial lysate medicines was initiated on 28 June 2018 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' mediċini bil-liżati batteriċi nbeda fit-28 ta' Ġunju 2018 fuq talba tal-Italja, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 09 September 2019.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE fid-9 ta' Settembru 2019.
English: These medicines are taken by mouth (as capsules, tablets, granules/powder for making up an oral mixture or drops), dissolved under the tongue (as tablets), inhaled through the nose (as a liquid) or given by injection into a muscle or under the skin.
Maltese: Dawn il-mediċini jittieħdu mill-ħalq (bħala kapsuli, pilloli, granuli/trab biex jagħmlu taħlita orali jew qtar), maħlula taħt l-ilsien (bħala pilloli), jittieħdu man-nifs mill-imnieħer (bħala likwidu) jew mogħtija b'injezzjoni ġo muskolu jew taħt il-ġilda.
English: • The indications of bacterial lysate medicines have been restricted to prophylaxis of recurrent respiratory tract infections, with the exception of pneumonia.
Maltese: • L-indikazzjonijiet ta' mediċini bil-liżati batteriċi ġew ristretti għall-profilassi ta' infezzjonijiet rikorrenti tas-sistema respiratorja, bl-eċċezzjoni tal-pulmonite.
English: On 27 June 2019, EMA recommended that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia.
Maltese: Fis-27 ta' Ġunju 2019, l-EMA rrakkomandat li l-mediċini bil-liżati batteriċi li huma awtorizzati għal kundizzjonijiet respiratorji għandhom jintużaw biss għall-prevenzjoni ta' infezzjonijiet respiratorji rikorrenti, bl-eċċezzjoni tal-pulmonite.
English: • The prescribing information of the medicines is being updated with the new indication and a warning against use for prevention of pneumonia.
Maltese: • L-informazzjoni ta' preskrizzjoni dwar il-mediċini qed tiġi aġġornata bl-indikazzjoni l-ġdida u twissija kontra l-użu għall-prevenzjoni tal-pulmonite.
English: Bacterial lysate medicines should not
Maltese: Aktar dwar il-mediċini
English: In the review, EMA's human medicines committee (CHMP) considered the results of clinical studies, data on side effects reported with these medicines, and advice from an expert group on infectious diseases.
Maltese: Fir-rieżami, il-kumitat għall-mediċini għall-użu mill-bniedem tal-EMA (CHMP) qies ir-riżultati ta' studji kliniċi, data dwar effetti sekondarji rrappurtati b'dawn il-mediċini, u pariri minn grupp espert dwar mard infettiv.