FrancophonIA/ELRC3.0 huggingface dataset:
English: The procedure was referred to the CHMP, who raised a number of issues through a List of Questions and a subsequent List of Outstanding Issues, which were addressed by the Applicant.
Maltese: Il-proċedura ġiet riferuta lis-CHMP, li qajjem numru ta' argumenti permezz ta' Lista ta' Mistoqsijiet u Lista ta' Kwistjonijiet Pendenti, li ġew indirizzati mill-Applikant.
English: These effects may be symptoms of a severe allergic (hypersensitivity) reaction.
Maltese: Dawn l-effetti jistgħu jkunu sintomi ta' reazzjoni allerġika (sensittività eċċessiva) severa.
English: Mean between-group difference (95% confidence limits) p-Valuea a p-Value for treatment difference in change from baseline (ANOVA)
Maltese: Valur pa a Valur p għad-differenza fil-kura għal bidla mil-linja bażi (ANOVA)
English: - The CHMP considers the efficacy of Oracea to reduce papulopustular lesions in adult patients with facial rosacea to be sufficiently demonstrated,
Maltese: - Is-CHMP jikkunsidra li l-effikaċja ta' Oracea biex tnaqqas leżjonijiet papulopustulari f'pazjenti adulti b'rosacea tal-wiċċ intweriet biżżejjed,
English: The applicant concluded that higher mg/kg doses led to higher plasma concentrations, but did not lead to increased clinical efficacy and that anti-inflammatory-dose doxycycline (40-mg formulation) conferred peak anti-inflammatory efficacy in the treatment of rosacea.
Maltese: L-applikant ikkonkluda li dożi mg/kg iktar għoljin wasslu għal konċentrazzjonijiet fil-plażma iktar għoljin, iżda ma wasslux għal żieda fl-effikaċja klinika u li doża anti-infjammatorja ta' doxycycline (formulazzjoni 40-mg) tat effikaċja massima antiinfjammatorja fil-kura ta' rosacea.
English: 40 mg Modified-release capsule, hard Oral
Maltese: 40 mg Kapsula li terħi l-mediċina b'mod modifikat, iebsa
English: • Pain
Maltese: • Uġigħ
English: Renal impairment
Maltese: Tqala u Treddigħ
English: What ORACEA looks like and contents of the pack ORACEA is a modified-release hard capsule.
Maltese: Id-Dehra ta' ORACEA u l-kontenuti tal-pakkett: ORACEA hija kapsula iebsa li terħi l-mediċina b'mod modifikat.
English: Concomitant use not recommended:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: • Difficulty in swallowing
Maltese: Indeboliment tal-fwied
English: • Skin rashes or hives
Maltese: • Ħsara fil-fwied
English: Finally, the CHMP also acknowledged the difficulty in breaking down the different subgroups of rosacea since symptoms often overlap between the different subtypes and recognised that Oracea is aimed towards the treatment of papules and pustules rather than treatment of rosacea as a whole or treatment of a specific subtype.
Maltese: Finalment, is-CHMP għaraf ukoll id-diffikultà fl-analiżi tas-sottogruppi differenti ta' rosacea minħabba li s-sintomi ta' spiss jitrikkbu bejn is-sottotipi differenti u rrikonoxxa li Oracea hija mmirata lejn il-kura ta' papuli u pustuli milli l-kura ta' rosacea in ġenerali jew kura ta' sottotip speċifiku.
English: The daily dose is 40 mg (1 capsule).
Maltese: Id-doża ta' kuljum hija 40 mg (kapsula waħda).
English: Doxycycline is excreted in the urine and faeces as unchanged active substance.
Maltese: Doxycycline jitneħħa fl-awrina u fl-ippurgar bħala sustanza attiva mhux mibdula.
English: The following side effects may occur commonly (affects 1 to 10 users in 100) during treatment with ORACEA:
Maltese: L-effetti sekondarji li ġejjin jistgħu jseħħu b'mod komuni (jaffettwaw minn persuna waħda sa 10 minn kull 100 li qed jużawh) waqt kura b'ORACEA:
English: The administration of tetracyclines during the second and the third trimesters results in permanent discolouration of the deciduous teeth in the offspring.
Maltese: L-għoti ta' tetracyclines waqt it-tieni u t-tielet trimestru wassal għal bidla permanenti fil-kulur tassnien tal-ħalib tat-tarbija.
English: Printing inks
Maltese: • Infjammazzjoni tas-sinuses
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI [Biex timtela mill-pajjiż partikolari]
English: • Inflammation or ulceration of the gullet
Maltese: • Infjammazzjoni tal-ġilda li tikkawża qxur
English: Gastric lavage should be considered.
Maltese: Jista' jkollok bżonn terġa' taqrah.
English: Peak plasma levels were generally achieved at 2 to 3 hours after administration.
Maltese: Livelli massimi fil-plażma ġeneralment intlaħqu minn 2 sa 3 sigħat wara l-għoti.
English: To avoid oesophageal irritation and ulceration, adequate fluids (water) should be taken with this medicinal product (see section 4.2).
Maltese: Biex jiġi evitat irritazzjoni u ulċerazzjoni ta' l-esofagu, għandhom jittieħdu biżżejjed fluwidi (ilma) ma' dan il-prodott mediċinali (ara sezzjoni 4.2). ORACEA għandu jinbela' waqt li f'pożizzjoni bilqiegħda jew wieqfa.
English: Adverse reactions seen in repeat dose studies in animals include hyperpigmentation of the thyroid and tubular degeneration in the kidney.
Maltese: Reazzjonijiet avversa li dehru fi studji b'doża ripetuta fil-bhejjem jinkludu iperpigmentazzjoni tattirojde u deġenerazzjoni tubolari fil-kilwa.
English: • Allergic (hypersensitivity) reaction throughout the body*
Maltese: • Diffikultà biex tibla'
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE
English: 13 February 2013
Maltese: 13 ta' Frar 2013
English: What is calcitonin?
Maltese: X'inhu calcitonin?
English: After a re-examination, the Committee confirmed its recommendation on 15 November 2012.
Maltese: Wara eżaminazzjoni mill-ġdid, il-Kumitat ikkonferma r-rakkomandazzjoni tiegħu fil15 ta' Novembru 2012.
English: The CHMP also reviewed post-marketing safety data, randomised controlled studies and experimental cancer studies.
Maltese: Is-CHMP irreveda wkoll dejta ta' sigurtà ta' wara t-tqegħid fis-suq, studji każwali kkontrollati u studji sperimentali tal-kanċer.
English: − hypercalcaemia caused by cancer.
Maltese: − iperkalċemija ikkawżata mill-kanċer.
English: • Calcitonin will no longer be used for the treatment of osteoporosis.
Maltese: • Calcitonin mhux se jibqa' jintuża għall-kura tal-osteoporożi.
English: These findings were made available to EU national authorities in November 2010.
Maltese: Dawn is-sejbiet saru disponibbli għall-awtoritajiet nazzjonali tal-UE f'Novembru 2010.
English: Calcitonin-containing medicines have been available in the EU as solutions for injection or infusion (drip into a vein) since 1973, and as a nasal spray since 1987.
Maltese: Mediċini li fihom calcitonin ilhom disponibbli fl-UE bħala soluzzjonijiet għal injezzjoni jew infużjoni (dripp ġo vina) sa mill-1973, u bħala sprej għall-imnieħer mill-1987.
English: Calcitonin, manufactured in the laboratory, is used in medicines to treat or prevent conditions that involve the loss of calcium from the bones.
Maltese: Calcitonin, manifatturat fil-laboratorju, jintuża f'mediċini fil-kura jew fil-prevenzjoni ta' kundizzjonijiet li jinvolvu t-telf ta' kalċju mill-għadam.
English: It has been used in the EU for treating osteoporosis (a disease that makes bones fragile), Paget's disease (a bone disease that involves bone remodelling and can cause deformity), and hypercalcaemia (increased blood calcium) caused by cancer.
Maltese: Kien jintuża fl-UE għall-kura tal-osteoporożi (marda li tagħmel lgħadam fraġli), fil-marda ta' Paget (marda tal-għadam li tinvolvi r-rimudellar tal-għadam u tista' tikkawża deformità), u fl-iperkalċemija (żieda fil-kalċju fid-demm) ikkawżat mill-kanċer.
English: The issue was also investigated in 2009 and 2010 by the EMA's Pharmacovigilance Working Party (PhVWP), but there was insufficient evidence at the time for any regulatory action.
Maltese: Il-kwistjoni ġiet investigata wkoll fl-2009 u fl-2010 mill-Grupp ta' Ħidma tal-Farmakoviġilanza (PhVWP) tal-EMA, iżda dak iż-żmien ma kienx hemm biżżejjed evidenza għal xi azzjoni regolatorja.
English: Questions and answers on the review of calcitonincontaining medicines
Maltese: Mistoqsijiet u tweġibiet dwar ir-reviżjoni ta' mediċini li fihom calcitonin
English: The benefit-risk balance remains positive only for the following uses: treatment of Paget's disease for patients who cannot be treated with alternative treatments, prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, and the treatment of hypercalcaemia caused by cancer.
Maltese: Il-bilanċ tal-benefiċċju-riskju jibqa' pożittiv biss għall-użi li ġejjin: il-kura tal-marda ta' Paget għal pazjenti li ma jistgħux jirċievu kura bi trattamenti alternattivi, il-prevenzjoni ta' telf akut tal-għadam minħabba immobilizzazzjoni f'daqqa bħal pazjenti bi ksur osteoporotiku reċenti, u l-kura ta' iperkalċemija ikkawżata mill-kanċer.
English: Taking into account the limited benefit of calcitonin when used to treat postmenopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin did not outweigh the risks in this condition.
Maltese: Meta jitqies il-benefiċċju limitat ta' calcitonin meta użat fil-kura tal-osteoporożi wara l-menopawża biex inaqqas ir-riskju ta' ksur vertebrali, is-CHMP ikkonkluda li l-benefiċċji ta' calcitonin ma kinux akbar mir-riskji f'din il-kundizzjoni.
English: This review was initiated following preliminary findings from two studies of an unlicensed oral calcitonin medicine, which pointed to a possible association with prostate cancer.
Maltese: Din ir-reviżjoni nbdiet wara sejbiet preliminari minn żewġ studji ta' mediċina orali mhux liċenzjata li kien fiha calcitonin, li indikaw rabta possibbli mal-kanċer tal-prostata.
English: − Paget's disease, restricted to patients who do not respond to alternative treatments or for whom such treatments are not suitable, and with treatment normally limited to three months (longer treatment and periodic retreatment may be considered taking into account the benefits and risks);
Maltese: − marda ta' Paget, ristrett għal pazjenti li ma jirrispondux għal kura alternattiva jew li għalihom, kura bħal din ma tkunx adatta, u b'kura normalment limitata għal tliet xhur (kura itwal u kura perjodika mill-ġdid tista' tiġi kkunsidrata b'kunsiderazzjoni tal-benefiċċji u r-riskji);
English: Why were calcitonin-containing medicines reviewed?
Maltese: Għaliex ġew riveduti l-mediċini li fihom calcitonin?
English: A possible association between calcitonin and prostate cancer was first investigated by the UK medicines regulatory agency in 2004, but a causal association could not be established with the evidence available at the time.
Maltese: Ir-rabta possibbli bejn calcitonin u l-kanċer tal-prostata l-ewwel ġiet investigata mill-aġenzija regolatorja tal-mediċini tar-Renju Unit fl-2004, iżda bl-evidenza disponibbli dak iż-żmien, ma setgħetx tiġi stabbilita rabta kawżali.
English: • Treatment with calcitonin should be limited to the shortest possible time using the smallest effective dose.
Maltese: • Kura b'calcitonin għandha tiġi limitata għall-iqsar żmien possibbli bl-użu tal-iżgħar doża effettiva.
English: • Prescribers should note that calcitonin should no longer be used for the treatment of osteoporosis.
Maltese: • Min jippreskrivi għandu jinnota li calcitonin ma għandux jibqa' jintuża għall-kura tal-osteoporożi.
English: Although the cancer rates reported in the studies were low, the increase in cancer rates seen with calcitonin varied between 0.7% in studies with the oral formulation to 2.4% in the studies with the nasal formulation.
Maltese: Għalkemm ir-rati tal-kanċer irrapportati fl-istudji kienu baxxi, iż-żieda fir-rati tal-kanċer li dehru b'calcitonin kienu jvarjaw bejn 0.7% fl-istudji bilformulazzjoni orali għal 2.4% fl-istudji bil-formulazzjoni għall-imnieħer.
English: − prevention of acute bone loss due to sudden immobilisation, with a recommended treatment period of two weeks and a maximum treatment period of four weeks;
Maltese: − prevenzjoni ta' telf akut tal-għadam minħabba immobilizzazzjoni f'daqqa, b'perjodu rakkomandat ta' kura ta' ġimagħtejn u perjodu massimu ta' kura ta' erba' ġimgħat;
English: • Calcitonin will only be available as a solution for injection and infusion, and should only be used for:
Maltese: • Calcitonin se jkun disponibbli biss bħala soluzzjoni għal injezzjoni u infużjoni, u għandu jintuża biss għall-:
English: On 19 July 2012, the European Medicines Agency completed a review of the benefits and risks of calcitonin-containing medicines, concluding that there was evidence of a small increased risk of cancer with long-term use of these medicines.
Maltese: Fid-19 ta' Lulju 2012, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni tal-benefiċċji u r-riskji ta' mediċini li fihom calcitonin, u kkonkludiet li kien hemm evidenza ta' żieda żgħira fir-riskju ta' kanċer blużu fit-tul ta' dawn il-mediċini.
English: Patients being treated for osteoporosis with calcitonin nasal sprays or other formulations are advised to speak to their doctor at a routine appointment, who will recommend suitable alternative treatment.
Maltese: Pazjenti li jkunu qed jirċievu kura għall-osteoporożi bi sprejs għall-imnieħer li fihom calcitonin jew formulazzjonijiet oħra huma avżati jkellmu lit-tabib tagħhom waqt appuntament ta' rutina, li jirrakkomanda kura alternattiva adatta.
English: The CHMP noted that the available data suggest that a higher proportion of patients treated with calcitonin for long periods of time may develop cancer of various types, compared with patients taking placebo.
Maltese: Is-CHMP innota li d-dejta disponibbli tissuġġerixxi li meta mqabbla ma' pazjenti li kienu qed jieħdu plaċebo, kien hemm proporzjon ogħla ta' pazjenti li kienu qed jieħdu kura b'calcitonin għal perjodi twal li jistgħu jiżviluppaw kanċer ta' tipi differenti.
English: As the nasal spray is only used in osteoporosis, the CHMP recommended that this formulation should no longer be used.
Maltese: Peress li l-isprej għall-imnieħer jintuża biss fl-osteoporożi, is-CHMP irrakkomanda li din il-formulazzjoni ma għandhiex tibqa' tintuża.
English: The full EPAR for Tysabri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This summary was last updated in 04-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 04-2017.
English: It contains the active substance natalizumab.
Maltese: Fih is-sustanza attiva natalizumab.
English: The most common side effects seen in studies with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (itchy rash), headache, dizziness, vomiting, nausea (feeling sick), joint pain, rigors (shaking chills), fever and tiredness.
Maltese: Fl-istudji, l-effetti sekondarji l-aktar komuni b' Tysabri (li dehru f' bejn pazjent 1 u 10 minn 100) kienu infezzjoni tal-passaġġ urinarju (infezzjoni tal-istrutturi li jġorru l-awrina), nażofarinġite (infjammazzjoni tal-imnieħer u l-gerżuma), urtikarja (raxx bil-ħakk), uġigħ ta' ras, sturdament, remettar, nawżja (dardir), uġigħ fil-ġogi, tertir (tkexkix ta' bard), deni u għeja.
English: Other information about Tysabri
Maltese: Informazzjoni oħra dwar Tysabri
English: This is a summary of the European public assessment report (EPAR) for Tysabri.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Tysabri.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody which targets a protein called ‘α4β1 integrin' found on the surface of white blood cells involved in inflammation.
Maltese: Is-sustanza attiva f' Tysabri, in-natalizumab, hija antikorp monoklonali li għandha fil-mira proteina msejħa "α4β1 integrin" li tinsab fil-wiċċ taċ-ċelloli bojod tad-demm involuti fl-infjammazzjoni.
English: Tysabri was effective at reducing the number of relapses and the worsening of disability (as measured with the Expanded Disability Status Scale).
Maltese: Tysabri kien effettiv fit-tnaqqis tal-għadd ta' rikaduti u l-aggravar tad-diżabilità (kif imkejjel bl-Iskala tal-Istatus tad-Diżabilità Estiża - Expanded Disability Status Scale).
English: What are the risks associated with Tysabri?
Maltese: X' inhuma r-riskji assoċjati ma' Tysabri?
English: About 6% of the patients in studies developed long-lasting antibodies against natalizumab, which reduced the medicine's effectiveness.
Maltese: Madwar 6% tal-pazjenti fl-istudji żviluppaw antikorpi għall-perjodu twil kontra n-natalizumab, li naqqsu l-effikaċja tal-mediċina.
English: Why is Tysabri approved?
Maltese: Għaliex ġie approvat Tysabri?
English: A second study showed that adding Tysabri to treatment with another medicine, interferon beta-1a, was more effective than adding placebo, reducing the risk of disability getting worse and the number of relapses.
Maltese: It-tieni studju wera li ż-żieda ta' Tysabri ma' kura b' mediċina oħra, interferon beta-1a, kienet aktar effettiva miż-żieda tal-plaċebo, u naqqset ir-riskju tal-aggravar tad-diżabilità u l-għadd ta' rikaduti.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Maltese: Sklerożi multipla hija marda tan-nervituri, fejn l-infjammazzjoni teqred il-kisja protettiva madwar iċċelloli tan-nervituri.
English: In a study comparing Tysabri with placebo (a dummy treatment), the number of MS attacks in Tysabritreated patients fell by about 68% after a year, compared with the patients who received placebo.
Maltese: Fi studju li qabbel Tysabri ma' plaċebo (kura finta), l-għadd ta' attakki ta' MS f'pazjenti kkurati b' Tysabri naqas b' madwar 68% wara sena, meta mqabbel mal-pazjenti li rċevew plaċebo.
English: In addition, the risk of disability getting worse was reduced by 42% over two years with Tysabri in comparison with placebo.
Maltese: Barra minn hekk, ir-riskju li d-diżabilità tmur għall-agħar naqas bi 42% fuq sentejn b' Tysabri meta mqabbel ma' plaċebo.
English: Finally, a third study, still ongoing, has shown the average number of MS attacks per year falling from 1.99 to 0.22 in Tysabri-treated patients (regardless of which disease-modifying treatment they had previously used),.
Maltese: Fl-aħħar nett, it-tielet studju, li għadu għaddej, wera li l-għadd medju ta' attakki ta' MS fis-sena naqas minn 1.99 għal 0.22 fil-pazjenti kkurati b' Tysabri (irrelevanti minn liema kura li timmodifika lmarda kienu użaw preċedentement).
English: Tysabri can increase the risk of infections, including the brain infection PML.
Maltese: Tysabri jista' jżid ir-riskju tal-infezzjonijiet, inkluża l-infezzjoni tal-moħħ PML. PML hija kondizzjoni serja ħafna li tista' tirriżulta f' diżabilità severa jew f' mewt.
English: Treatment with Tysabri should be started and continuously supervised by a doctor who is experienced in treating diseases of the nervous system and has access to a magnetic resonance imaging (MRI) scanner.
Maltese: Il-kura b' Tysabri għandha tinbeda u tkun sorveljata kontinwament minn tabib b' esperjenza fil-kura ta' mard tas-sistema nervuża u li għandu aċċess għal skanner tal-immaġini tar-reżonanza manjetika (magnetic resonance imaging (MRI)).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri on 27 June 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Tysabri valida fl-Unjoni Ewropea kollha fis-27 ta' Ġunju 2006.
English: Tysabri is used in the type of MS known as ‘relapsing-remitting' MS, when the patient has attacks (relapses) in between periods with no symptoms (remissions).
Maltese: Tysabri jintuża f' tip ta' MS magħrufa bħala MS "reċidiva-remittenti", meta l-pazjent ikollu attakki (reċidivi) bejn perjodi mingħajr sintomi (remittenti).
English: Tysabri is a medicine for treating adults with multiple sclerosis (MS) that has failed to respond to another disease-modifying therapy or is rapidly getting worse.
Maltese: Tysabri huwa mediċina għall-kura tal-adulti bi sklerożi multipla (MS) li ma rrispondietx għal terapija oħra li timmodifika l-marda jew li sejra għall-agħar b'ritmu mgħaġġel.
English: It will also supply all doctors who prescribe Tysabri with an educational pack that includes information on the safety of Tysabri, including information on which patients may be at a higher or lower risk of PML.
Maltese: Se tissupplixxi wkoll lit-tobba kollha li jippreskrivu Tysabri b' pakkett edukattiv li jinkludi informazzjoni dwar issigurtà ta' Tysabri, inkluża informazzjoni dwar liema pazjenti jistgħu jkunu f' riskju ogħla jew aktar baxx ta' PML.
English: Patients should receive this information when starting Tysabri, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment.
Maltese: Il-pazjenti għandhom jirċievu din l-informazzjoni hekk kif jibdew Tysabri, meta jkomplu l-kura għal aktar minn sentejn, u meta jwaqqfu l-kura, peress li r-riskju ta' PML jippersisti għal 6 xhur wara li titwaqqaf il-kura.
English: • Section 4: Possible side effects
Maltese: • Sezzjoni 4: Effetti sekondarji possibbli
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti tal-Istati Membri, flimkien mal-Istat Membru ta' Referenza, kif xieraq, b'konformità mal-proċeduri stabbiliti f'Kapitolu 4 ta' Titolu III tad-Direttiva 2001/83/KE.
English: Tabulated list of adverse reactions “Pneumonia (in COPD patients)” to be listed as “Common” adverse drug reaction in the “Infections and infestations” SOC.
Maltese: Lista tabulata ta' reazzjonijiet avversi “Pulmonite (f'pazjenti b'COPD)” li għandha tiġi elenkata bħala reazzjoni avversa għall-mediċina “Komuni” fl-SOC “Infezzjonijiet u Infestazzjonijiet”.
English: • Section 4.8 Undesirable effects
Maltese: • Sezzjoni 4.8 Effetti mhux mixtieqa
English: • increased mucus production, change in mucus colour
Maltese: • żieda fil-produzzjoni tal-mukus, bidla fil-kulur tal-mukus
English: Annex III Amendments to relevant sections of the product information
Maltese: Anness III Emendi għas-sezzjonijiet rilevanti tal-informazzjoni tal-prodott
English: Risk factors for pneumonia in patients with COPD include current smoking, older age, low body mass index (BMI) and severe COPD.
Maltese: It-tobba għandhom jibqgħu viġilanti għall-iżvilupp possibbli ta' pulmonite f'pazjenti b'COPD, għaliex ilkaratteristiċi kliniċi ta' dawn l-infezzjonijiet jikkoinċidu ma' sintomi ta' taħrixiet ta' COPD. Fatturi ta' riskju għal pulmonite f'pazjenti b'COPD jinkludu tipjip attwali, età ikbar, kurrenti, indiċi talmassa tal-ġisem baxx (BMI, body mass index) u COPD severa.
English: Amendments to relevant sections of the product information
Maltese: Emendi fl-Informazzjoni tal-Prodott
English: The following information should be implemented in the product information of inhaled corticosteroids with a COPD indication.
Maltese: L-informazzjoni li ġejja għandha tiġi implimentata fl-informazzjoni tal-prodott ta' kortikosterojdi li jinġibdu man-nifs b'indikazzjoni ta' COPD.
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while taking <active substance> they could be symptoms of a lung infection:
Maltese: Pulmonite (infezzjoni tal-pulmun) f'pazjenti b'COPD (effett sekondarju komuni) Għid lit-tabib tiegħek jekk ikollok kwalunkwe minn dawn li ġejjin waqt li tkun qed tieħu <sustanza attiva> għax jistgħu jkunu sintomi ta' infezzjoni tal-pulmun:
English: If the current SmPC or package leaflet includes corresponding information in any other sections, it should be deleted in order to avoid repeated or contradictory information.
Maltese: Jekk l-SmPC jew il-fuljett ta' tagħrif attwali jinkludu informazzjoni korrispondenti fi kwalunkwe sezzjoni oħra, din għandha titħassar sabiex jiġi evitat tagħrif ripetut jew kontradittorju.