FrancophonIA/ELRC3.0 huggingface dataset:
English: Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have tolerated previous treatment with human immunoglobulin.
Maltese: B'mod rari, l-immunoglobulina tal-epatite B umana tista' tikkaġuna tnaqqis fil-pressjoni tad-demm b'reazzjoni anafilattika, anki f'pazjenti li ttolleraw kura b'immunoglobulina umana fil-passat.
English: Immunoglobulins like Zutectra have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.
Maltese: L-immunoglobulini bħal Zutectra ma kinux assoċjati ma' infezzjonijiet ikkawżati minn epatite A jew parvovirus B19, possibbilment minħabba li huma protetti bl-antikorpi kontra dawn l-infezzjonijiet, li jinsabu fil-prodott..
English: Antibody levels >100 IU/l should be maintained.
Maltese: antikorpi ta' > 100 IU/l għandhom jinżammu.
English: In case of shock, standard medical treatment for shock should be implemented.
Maltese: F'każ ta' xokk, il-kura medika standard għal xokk għandha tiġi implimentata.
English: Most side effects observed with Zutectra were mild to moderate in nature.
Maltese: Il-maġġoranza tal-effetti sekondarji osservati b'Zutectra kienu minn ħfief sa moderati fin-natura tagħhom.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus.
Maltese: Il-miżuri li jittieħdu huma kkunsidrati li huma effettivi għal viruses miksijin b'rita bħal virus tal immunodefiċjenza umana, il-virus tal-epatite B u l-virus tal-epatite Ċ, u għal viruses non-enveloped tal-epatite A.
English: Muscle spams
Maltese: Mhux komuni
English: Biotest AG Landsteinerstr.
Maltese: Biotest AG
English: Tel.: +49 6103 801-0 Fax: +49 6103 801-150 Email: mail@biotest.com
Maltese: Fax: + 49 6103 801-150
English: Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA.
Maltese: Individwi li għandhom defiċjenza fl-IgA għandhom il-potenzjal li jiżviluppaw antikorpi
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi mmodifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The open, prospective, single-arm clinical trial enrolled 23 liver transplant recipients, who had been receiving intravenous hepatitis B immunoglobulin prophylaxis and subsequently switched to subcutaneous Zutectra.
Maltese: Il-prova klinika miftuħa, prospettiva, b'fergħa waħda irreġistrat 23 pazjenti li kellhom trapjant tal fwied, li kienu qed jirċievu profilassi ġol-vini bl-immunoglobulini kontra l-epatite B u li sussegwentement qalbu għal Zutectra taħt il-ġilda.
English: België/Belgique/Belgien Infarama BVBA Stationsstraat 27
Maltese: België/Belgique/Belgien
English: In addition patient or caregiver must comply with the injection technique as well as with the dosing regimen to ensure anti-HBs trough serum levels > 100 IU/l after extended periods between level controls.
Maltese: Flimkien ma' dan, il-pazjent jew il-persuna li tkun tieħu ħsiebu, jridu jkunu konformi mat-teknika tal-injezzjoni kif ukoll mad-dożaġġ tal-kors biex jiżguraw livelli minimi fis serum ta' anti-HBs ta' > 100 IU/l wara perijodi estensivi bejn il-kontrolli tal-livelli.
English: Pregnancy
Maltese: MANIFATTURI
English: Fatigue, tiredness
Maltese: Użu għal taħt il-ġilda ISEM
English: The ADRs reported in four trials are summarised and categorised according to the MedDRA system organ class and frequency below.
Maltese: L-ADRs irrappurtati f'erba' provi huma murija fil-qosor hawn taħt u kkategorizzati skont il-klassi tal organi tas-sistema MedDRA u skont il-frekwenza.
English: Biotest AG Landsteinerstrasse 5 D-63303 Dreieich Tel: + 49 6103 801-0
Maltese: D-63303 Dreieich Tel: + 49 6103 801-0
English: Zutectra is intended for subcutaneous (under the skin) injection.
Maltese: Zutectra hu għal injezzjoni subkutanea (taħt il-ġilda) biss.
English: This can be an allergic reaction or a serious allergic reaction (anaphylactic shock).
Maltese: spażmi muskolari reazzjonijiet allerġiċi (sensittività eċċessiva)
English: Compliance according to anti-HBs serum levels could be shown for 57 (of 61) patients (93%), with no values below 100 IU/l and a mean anti-HBs serum level of 254.3 IU/l at the final visit.
Maltese: (93%), b'ebda valur taħt 100 IU/l u b'livell ta' anti-HBs fis-serum ta' 254.3 IU/l fl-aħħar viżita.
English: Furthermore the following reactions have been reported once only: tiredness (fatigue) high blood pressure (hypertension) inflammation of the nose and throat (nasopharyngitis) muscle spasm allergic reactions (hypersensitivity) abnormal heartbeat (palpitations), cardiac discomfort itching (pruritus), rash pain in the mouth and throat
Maltese: Kumplikazzjonijiet potenzjali ta' spiss jistgħu jiġu evitati billi jiġi żgurat li l-pazjenti: ma jkunux sensittivi għal immunoglobulina normali umana, billi fil-bidu tagħti l-infużjoni talprodott mediċinali bil-mod; jkunu ssorveljati bl-attenzjoni għal kwalunkwe sintomi matul il-perijodu ta' l-injezzjoni.
English: Tel: + 351 21 193 14 20
Maltese: PT-1050 139 Lisboa Tel: + 351 21 193 14 20
English: SE-102 34 Stockholm Tlf:+ 46 10 130 99 80
Maltese: Tlf:+ 46 10 130 99 80
English: The following side effects have been reported with Zutectra:
Maltese: L-effetti sekondarji li ġejjin kienu rrappurtati b'Zutectra:
English: Biotest Hungaria Kft. Torbágy u. 15/A H-2045 Törökbálint Tel.: + 36 23 511 311
Maltese: Törökbálint Tel.: + 36 23 511 311
English: Keep this leaflet.
Maltese: IU ta' Zutectra.
English: LIST OF EXCIPIENTS Excipients: Glycine, water for injections.
Maltese: Is-sustanzi l-oħra huma glycine u ilma għall-injezzjonijiet.
English: 2 years.
Maltese: IU, 1000
English: One pre-filled syringe of 1 ml contains Human hepatitis B immunoglobulin 500 IU.
Maltese: Siringa waħda mimlija għal-lest ta' 1 ml fiha Immunoglobulina tal-epatite B umana 500
English: Interference with serological testing
Maltese: Tfixkil waqt ittestjar seroloġiku
English: How to store Zutectra
Maltese: Jekk tinsa tuża Zutectra
English: This product was submitted under article 10.3 of the Directive 2001/83/EC.
Maltese: 3 tad-Direttiva 2001/83/KE.
English: Al. Jerozolimskie 146 A PL-02-305 Warszawa
Maltese: Jerozolimskie 146 A PL-02-305 Warszawa
English: A-1120 Wien
Maltese: A-1120
English: Whereas:
Maltese: Billi:
English: Applicant
Maltese: L-Applikant
English: Very rare side effects (fewer than 1 of 10,000 patients treated):
Maltese: Effetti sekondarji rari ħafna (f'inqas minn 1 minn kull 10,000 pazjent ittrattati) :
English: Slovenia
Maltese: Slovenja
English: Nycomed GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Germany
Maltese: 2 D-78467 Konstanz Germany
English: Gentsesteenweg 615 B-B1080 Brussels
Maltese: B-B1080 Brussels
English: United Kingdom Nycomed GmbH Byk-Gulden-Str. 2
Maltese: Nycomed GmbH Byk-Gulden-Str.
English: Strength
Maltese: EFFETTI
English: Treatment-related adverse events were seen in 3.8% and 5% of patients treated with 160 or 640 micrograms per day of ciclesonide respectively.
Maltese: Lavvenimenti avversi marbuta mal-kura kienu osservati fi 3.8% u 5% tal-pazjenti kkurati b'160 jew 640 mikrogramma kuljum ta' ciclesonide rispettivament.
English: The inhaler is an aluminium canister containing 120 doses of either 40 µg, 80 µg or 160 µg ex actuator, corresponding to 50, 100, or 200 µg per puff ex valve.
Maltese: L-inalatur huwa kanister ta' l-aluminju li fih 120 doża ta' 40 µg, 80 µg jew 160 µg ex actuator, li jikkorrespondu għal 50, 100, jew 200 µg għal kull għafsa.
English: Alvesco may affect the normal production of corticosteroids in your body.
Maltese: Alvesco jista' jaffettwa l-produzzjoni normali ta' kortikosterojdi f'ġismek.
English: Uncommon side effects (fewer than 1 in every 100 patients treated):
Maltese: Effetti sekondarji mhux komuni (f'inqas minn 1 minn kull 100 pazjent ittrattati):
English: Gentsesteenweg 615 B-1080 Brussels
Maltese: B-1080 Brussels
English: Member State
Maltese: MEMBRI
English: Nycomed Pharma Sp. z o.o.
Maltese: Sp. z o.o.
English: In four clinical trials, ciclesonide has been shown to reduce airway hyperresponsivenes to adenosine monophosphate in hyperreactive patients with maximal effect observed at the dose of 640 micrograms.
Maltese: F'erba' provi kliniċi, intwera li ciclesonide inaqqas l-iper-rispons tal-pajp tan-nifs għal adenosine monophosphate f'pazjenti iper-reattivi b'effett massimu li kien osservat fid-doża ta' 640 mikrogramma.
English: However, Alvesco delivers the same level of dose from minus 10°C to plus 40°C.
Maltese: Madankollu, Alvesco jforni l-istess livell ta' doża f'temperatura ta' -10°C sa +40°C.
English: The scientific rationale for difference of opinion regarding the proposed SPC Type II variations' wording of ciclesonides' dose effectiveness on reducing the frequency of exacerbations in severe asthma as drafted in Sections 4.2 and 5.1 by the RMS on the 19th October 2007 following the CMDh hearing.
Maltese: Ir-raġuni xjentifika għad-differenza ta' l-opinjoni dwar il-formolazzjoni tal-kliem proposta għallvarjazzjonijiet tat-Tip II ta' l-SPC ta' l-effikaċja tad-dożi ta' ciclesonide fuq it-tnaqqis fil-frekwenza ta' tqanqiliet fl-ażżma severa kif imfassla fit-Taqsimiet 4.2 u 5.1 mill-RMS fid-19 ta' Ottubru 2007 wara s-smigħ tas-CMDh.
English: Compared to placebo, treatment with ciclesonide 320, 640, and 1280 micrograms/day did not statistically significantly lower the 24-hour time averages of plasma cortisol (AUC(0-24)/24 hours) nor was a dose-dependent effect seen.
Maltese: Meta mqabbel mal-plaċebo, il-kura b'ciclesonide 320, 640, u 1,280 mikrogramma/kuljum ma naqqsitx b'mod statistikament sinifikanti l-medji tal-ħin ta' 24 siegħa ta' cortisol fil-plażma (AUC(0-24)/24 siegħa) u lanqas ma kien osservat effett li jiddependi mid-doża.
English: The CHMP referred to the NfG on the Clinical Investigation of Medicinal Products in the Treatment of Asthma CPMP/EWP/2922/01, and was of the opinion that the MAH had not adequately justified the inclusion of the 320µg/d and 640µg/d ciclesonide.
Maltese: Is-CHMP irrefera lill-NfG dwar l-Investigazzjoni Klinika tal-Prodotti Mediċinali fit-Trattament ta' lAżżma CPMP/EWP/2922/01, u kien tal-fehma li d-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fisSuq (MAH) ma kienx iġġustifika adegwatament l-inklużjoni tad-dożi ta' 320µg kuljum u 640µg kuljum ta' ciclesonide.
English: Double-blind placebo-controlled trials of 12-weeks duration in adults and adolescents have shown that treatment with ciclesonide resulted in improved lung function as measured by FEV1 and peak expiratory flow, improved asthma symptom control, and decreased need for inhaled beta-2 agonist.
Maltese: Provi double-blind, ikkontrollati bil-plaċebo, li damu 12-il ġimgħa fuq adulti u adolexxenti, urew li lkura b'ciclesonide irriżultat f'funzjoni mtejba tal-pulmun kif imkejla minn FEV1 u mill-fluss massimu respiratorju, kontroll imtejjeb tas-sintomi ta' l-ażżma u tnaqqis fil-ħtieġa ta' agonist ta' beta-2 li jinġibed man-nifs.
English: At the end of the 12 week study period, the results showed a statistically significant difference between the doses of 160 micrograms and 640 micrograms/day ciclesonide with regard to the occurrence of an exacerbation after the first day of the study: 43 patients/339 (= 12.7%) in the 160 micrograms/day group and 23 patients/341 (6.7%) in the 640 micrograms/day group (Hazard ratio=0.526; p= 0.0134).
Maltese: 43 pazjent/339 (=12.7%) fil-grupp li kien qed jingħata 160 mikrogrmma /kuljum u 23 pazjent/341 (6.7%) fil-grupp li kien qed jingħata 640 mikrogramma/kuljum (Proporzjon tal-periklu=0.526; p=0.0134).
English: Norway
Maltese: In-Norveġja
English: A controlled study compared 24-hour plasma cortisol AUC in 26 adult asthmatic patients following 7 days of treatment.
Maltese: Studju kkontrollat qabbel l-AUC ta' 24 siegħa ta' cortisol fil-plażma f'26 pazjent ażżmatiku wara 7 ijiem ta' kura.
English: Alvesco 40 Inhaler, 80 Inhaler and 160 Inhaler are products containing ciclesonide, delivered in a pressurized metered dose inhaler containing ethanolic hydrofluoroalkane-134A as propellant.
Maltese: Inhaler huma prodotti li fihom ciclesonide, li jiġu f'inalatur taħt pressa li jipprovdi dożi mkejla li fihom idroflworoalkanu etanoliku (ethanolic hydrofluoroalkane)-134A bħala propellant.
English: Iceland
Maltese: L-islanda
English: Slovak Republic ALTANA Pharma AG Byk-Gulden-Str. 2
Maltese: Pharma AG Byk-Gulden-Str.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT(S), MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, L-APPLIKANT(I), ID-DETENTURI TA` LAWTORIZZAZZJONI GĦAT-TQEGĦID
English: Such a study must comply with the Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma CPMP/EWP/2922/01.
Maltese: Studju bħal dan għandu jkun konformi manNota għall-Gwida dwar l-Investigazzjoni Klinika ta' Prodotti Mediċinali fit-Trattament ta' l-Ażżma CPMP/EWP/2922/01.
English: These rare side effects may include: - reduced rate of growth in adolescents - a thinning of the bones - possible clouding of the lens of the eye (cataracts) causing blurred vision - loss of vision caused by abnormally high pressure in the eye (glaucoma) - moon-shaped face, weight gain in the upper body and thinning arms and legs (Cushingoid features or Cushing syndrome).
Maltese: Dawn l-effetti sekondarji rari jistgħu jinkludu: - tnaqqis fir-rata tat-tkabbir fl-adolexxenti - irquqija ta' l-għadam - possibbiltà li l-lenti ta' l-għajnejn tiċċajpar (katarretti) u tikkawża vista mċajpra - telf tal-vista kkawżat minn pressjoni għolja b'mod anormali fl-għajnejn (glawkoma) - wiċċ f'forma ta' qamar, żieda fil-piż fin-naħa ta' fuq tal-ġisem u d-dirgħajn u r-riġlejn jirqaqu
English: After stimulation with 1 and 250 micrograms cosyntropin, no significant changes in plasma cortisol levels were observed versus placebo.
Maltese: Wara stimulazzjoni b' 1 u 250 mikrogramma ta' cosyntropin, ma kien osservat l-ebda tibdil sinifikanti fillivelli ta' cortisol fil-plażma kontra l-plaċebo.
English: Corticosteroid tablets can lead to more side effects than a corticosteroid inhaler such as Alvesco.
Maltese: Il-pilloli kortikosterojdi jistgħu jwasslu għal iktar effetti sekondarji minn inhaler tal-kortikosterojdi bħal Alvesco.
English: CONDITIONS CONSIDERED ESSENTIAL FOR THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT INCLUDING PHARMACOVIGILANCE
Maltese: U SIGUR TALPRODOTT MEDIĊINALI INKLUŻA L-FARMAKOVIĠILANZA
English: In a 12-week study of 680 severe asthmatics, previously treated with 500 - 1000 micrograms fluticasone propionate per day or equivalent, 87.3% and 93.3% of patients remained exacerbation-free during treatment with 160 or 640 micrograms of ciclesonide, respectively.
Maltese: Fi studju li dam 12-il ġimgħa fuq 680 pazjent b'ażżma severa li fil-passat kienu kkurati b'500 -1000 mikrogramma ta' fluticasone propionate kuljum jew ekwivalenti, 87.3% u 93.3% talpazjenti baqgħu ħielsa mill-aggravament ta' l-ażżma matul il-kura b'160 jew 640 mikrogramma ta' ciclesonide, rispettivament.
English: The MAH was asked to explain the different feasible scientific approaches for conducting a well designed study comparing 160 µg, 320 µg and 640 µg in order to clarify the efficacy/safety ratio of 160 µg compared to 320 µg and 640 µg in severe asthmatics.
Maltese: L-MAH intalab ifisser il-metodi xjentifiċi fattibbli differenti għat-twettiq ta' studju ddisinjat tajjeb biex iqabbel 160 µg, 320 µg u 640 µg biex jikkjarifika l-bilanċ bejn l-effikaċja u r-riskju ta' 160 µg meta mqabbla ma' 320 µg u 640 µg fl-ażżmatiċi severi.
English: • bad taste, burning, inflammation, irritation, dryness of mouth or throat
Maltese: • togħma ħażina, ħruq, infjammazzjoni, irritazzjoni, nixfa fil-ħalq jew fil-gerżuma
English: The CHMP was concerned with the MAH's continued reliance on the results of study MI-140 and its recognized insufficiencies: a short term study of 3 months instead of a minimum of 6 months; the lack of a 320µg/d arm; and the debatable value of improvement in severe exacerbations at the higher 640 dose with no further improvement in lung function.
Maltese: Is-CHMP kien imħasseb mill-fatt li l-MAH kontinwament ibbaża fuq ir-riżultati ta' l-istudju MI-140 u l-limitazzjonijiet magħrufa tiegħu: studju qasir ta' 3 xhur minflok minimu ta' 6 xhur; innuqqas ta' grupp li ngħata 320µg kuljum; u l-valur dibattibbli tat-titjib fit-tqanqiliet severi f'dożi ikbar minn tas-640 mingħajr iktar titjib fil-funzjoni tal-pulmun.
English: When should I use my Alvesco inhaler?
Maltese: Meta għandi nuża l-inhaler Alvesco?
English: - The proposed wording for Sections 3, 4 and 5 of the Package Leaflet at the end of the CMDh procedure have been amended accordingly.
Maltese: - Il-formulazzjoni ta' kliem proposta għat-Taqsimiet 3, 4 u 5 tal-Fuljett ta' Tagħrif fi tmiem talproċedura tas-CMDh ġiet konformament emendata
English: The National Competent Authorities, coordinated by the Reference Member State shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holder:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti, ikkoordinati mill-Istat Membru ta' Referenza għandhom jiżguraw li dawn il-kundizzjonijiet jiġu mwettqa mid-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fisSuq:
English: How to store Alvesco
Maltese: KIF TUŻA ALVESCO
English: Alvesco 160 Inalador 160 µg
Maltese: Inalador 160 µg
English: The data presented in the responses only reiterated the fact that there is no effective dose ranging data comparing 160, 320 and 640µg/d.
Maltese: Id-dejta ppreżentata fir-risposta issaħħaħ il-fatt li ma hemmx dejta effettiva li tqabbel id-dożi ta' 160, 320 u 640µg kuljum.
English: In a clinical trial involving 164 adult male and female asthmatic patients, ciclesonide was given at doses of 320 micrograms or 640 micrograms/day over 12 weeks.
Maltese: Fi prova klinika li kienet tinvolvi 164 pazjentażżmatiku adulti rġiel u nisa, ciclesonide ngħata f'dożi ta' 320 mikrogramma jew 640 mikrogramma/kuljum fuq perijodu ta' 12-il ġimgħa.
English: Study MI-129 did not define an adequate primary endpoint in accordance with the current guidelines for asthma.
Maltese: Listudju MI-129 ma ddeffiniex punt tat-tmiem primarju adegwat skond il-linji gwida attwali għallażżma.
English: Once orally inhaled, ciclesonide is enzymatically converted in the lungs to the principal metabolite (C21-desmethylpropionyl-ciclesonide) which has a pronounced anti-inflammatory activity and is thus considered as the active metabolite.
Maltese: Ġaladarba jinġibed mannifs mill-ħalq, ciclesonide jinbidel enzimatikament fil-pulmuni għal metabolit prinċipali (C21-desmethylpropionyl-ciclesonide) li għandu attività prominenti kontra l-infjammazzjoni, u għaldaqstant hu kkunsidrat bħala l-metabolit attiv.
English: The risk/benefit analysis of the use of higher doses of ciclesonide in the treatment of severe asthmatics, as the supportive data, interpreted according to the CHMP guidelines, do not allow authorization of regular daily doses in excess of 160 micrograms in the intended populations.
Maltese: L-analiżi tar-riskju/benefiċċju ta' l-użu ta' dożi ogħla ta' ciclesonide fit-trattament ta' l-ażżmatiċi severi, billi d-dejta ta' appoġġ, interpretata skond il-gwida tas-CHMP, ma tippermettix lawtorizzazzjoni ta' dożi regolari kuljum ikbar minn 160 mikrogramma fil-popolazzjoni tat-trattament.
English: The CHMP was of the opinion that the MAH had identified a feasible target patient population in the response.
Maltese: Is-CHMP kien tal-fehma li l-MAH kien identifika popolazzjoni fil-mira fattibbli fir-rispons.
English: It is important that you take Alvesco regularly every day, even if you feel better.
Maltese: Hu importanti li tieħu Alvesco regolarment kuljum, anki jekk tħossok aħjar.
English: Pharmaceutical Form Route of administration
Maltese: Għamla Farmaċewtika
English: Mikrogramm Dosieraerosol
Maltese: Amavio 40 µg Dosieraerosol
English: - Keep this leaflet.
Maltese: Ittaqqabx il-kontenitur.
English: Additionally, the MAH agreed to amend the wording for Section 5.1 in order to include more detail on Study M1 140, to indicate that there was a statistically significant difference between the doses of 160 micrograms/day and 640 micrograms/day ciclesonide with regards to the occurrence of an exacerbation after the first day of the study.
Maltese: Barra minn hekk, id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) aċċetta li jemenda il-formulazzjoni tal-kliem għat-Taqsima 5.1 sabiex jinkludi iktar dettalji dwar l-Istudju M1 140, biex jindika li kien hemm differenza statisitika sinifikattiva bejn id-dożi ta' 160 mikrogrammi/jum u 640 mikrogrammi/jum ta' ciclesonide fir-rigward ta' l-okkorrenza ta' taħrix wara l-ewwel jum ta' l-istudju.
English: Regular check-ups will also identify any side effects early on and reduce the chances of them worsening.
Maltese: Visti regolari għandhom jidentifikaw ukoll kwalunkwe effetti sekondarji minn kmieni, u jnaqqsu ċ-ċansijiet tagħhom li jmorru għall-agħar.
English: No study was performed to compare 160 micrograms, 320 micrograms and 640 micrgrams daily dose in patients with severe asthma.
Maltese: Ma sar l-ebda studju biex iqabbel doża ta' kuljum ta' 160 mikrogramma, 320 mikrogramma u 640 mikrogramma f'pazjenti b'ażżma severa.
English: Ciclesonide is a glucocorticoid used to treat obstructive airway disease.
Maltese: Ciclesonide huwa glukokortikojde użat għat-trattament tal-mard ostruttiv tal-pajp tan-nifs.
English: - The proposed wording for Section 4.2 of the SPC at the end of CMDh procedure has been amended to reflect that in severe asthmatics, a 12 week study has shown that a dose of 640µg/d (given 320µg/d twice daily) has demonstrated a reduction in the frequency of exacerbations but without an improvement in lung function.
Maltese: - Il-formolazzjoni tal-kliem proposta għat-Taqsima 4.2 tas-Sommarju tal-Karatteristiċi tal-Prodott fi tmiem il-proċedura tal-CMDh ġiet emendata biex tirrifletti li fl-ażżmatiċi severi, kien hemm studju ta' 12-il ġimgħa li wera li doża ta' 640µg kuljum (mogħtija bħala 320µg darbtejn kuljum) wasslet għal tnaqqis fil-frekwenza tat-tqanqiliet ta' l-ażżma iżda mingħajr titjib fil-funzjoni tal-pulmun.
English: ANNEX IV CONDITIONS OF THE MARKETING AUTHORISATION(S)
Maltese: TAS-SOMMARJU(I)
English: The Package Leaflet amendments include a note on increasing the dosage of Alvesco up to 640 micrograms/day, delivered as 320 micrograms twice daily, for a short period in patients who experience a worsening of their asthma symptoms.
Maltese: Din tista' tkun sa 640 mikrogramma kuljum, fornuta bħala 320 mikrogramma darbtejn kuljum iżda m'hemm lebda dejta disponibbli li tikkonferma l-effett terapewtiku addizzjonali wara 3 xhur b'dawn iddożi ogħla.
English: • skin rash and/or eczema causing itching and redness.
Maltese: Aqra sew dan il-fuljett kollu qabel tibda tuża din il-mediċina - Żomm dan il-fuljett.
English: Denmark
Maltese: Id-Danimarka
English: Dosing recommendation for adults and adolescents:
Maltese: Rakkomandazzjoni tad-dożaġġ għall-adulti u għall-adolexxenti:
English: • If you have just started to use this medicine instead of, or as well as, taking corticosteroid tablets, see section 2, Patients who are already taking corticosteroid tablets.
Maltese: • Jekk tkun għadek kif bdejt tuża din il-mediċina minflok, jew flimkien mat-teħid ta' pilloli kortikosterojdi, ara sezzjoni 2, Pazjenti li diġà qed jieħdu pilloli kortikosterojdi
English: Do not store above 50°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 50°C.
English: Finland
Maltese: Il-Finlandja
English: Alvesco 160 Inhalátor 160 µg
Maltese: Inhalátor 160 µg