FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee is of the opinion that the evidence for clinically significant efficacy of dihydroergotoxine in the proposed indication “symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia” is very limited.
Maltese: Il-Kumitat huwa tal-fehma li l-evidenza għal effikaċja klinikament sinifikanti ta' dihydroergotoxine fl-indikazzjoni proposta “kura sintomatika ta' indeboliment konjittiv fl-anzjani, minbarra l-marda ta' Alzheimer u d-dimenzja” hija limitata ħafna.
English: The primary mechanism of action of dihydroergotoxine and other ergoloids is unclear at the present time.
Maltese: Il-mekkaniżmu primarju ta' azzjoni ta' dihydroergotoxine u ergoloids oħra attwalment mhuwiex magħruf.
English: • The Committee maintained its opinion that the benefit-risk balance of dihydroergotoxine containing products:
Maltese: • Il-Kumitat żamm l-opinjoni tiegħu li l-bilanċ tal-benefiċċju-riskju ta' prodotti li fihom dihydroergotoxine:
English: Overall, the CHMP reiterated that the risk minimisation measures proposed by the MAH are not considered by the Committee to effectively reduce the risk of fibrotic reactions and ergotism.
Maltese: B'mod ġenerali, is-CHMP tenna li l-miżuri għall-minimizzazzjoni tar-riskji proposti mill-MAH mhumiex meqjusin mill-Kumitat li jnaqqsu r-riskju ta' reazzjonijiet fibrotiċi u ergotiżmu b'mod effettiv.
English: − Is not favourable for symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia) and in the latter proposed indication ‘symptomatic treatment of cognitive impairment in elderly, excluding Alzheimer's disease and dementia'.
Maltese: − Mhuwiex favorevoli għall-kura sintomatika ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku fl-anzjani (minbarra l-marda ta' Alzheimer u tipi oħra ta' dimenzja) u flindikazzjoni tal-aħħar proposta ‘kura sintomatika ta' indeboliment konjittiv fl-anzjani, minbarra l-marda ta' Alzheimer u d-dimenzja'.
English: − Is not favourable for symptomatic treatment of veno-lymphatic insufficiency.
Maltese: − Mhuwiex favorevoli għall-kura sintomatika ta' insuffiċjenza veno-limfatika.
English: These included changing the prescription status, limiting treatment duration in certain conditions, contraindicating the product in patients with pre-existing fibrosis or in association with other drugs, the issuing of a DHPC highlighting the risk, a checklist for prescribers, and a pharmacological in vitro study for 5-HT subclass receptors affinity to the product.
Maltese: Dawn kienu jinkludu tibdil tal-istatus tal-preskrizzjoni, li t-tul tal-kura tiġi limitata f'ċerti kundizzjonijiet, ilkontraindikazzjoni tal-prodott f'pazjenti b'fibrożi pre-eżistenti jew b'rabta ma' mediċini oħra, il-ħruġ ta' DHPC li tenfasizza r-riskju, lista ta' kontroll għal dawk li jippreskrivu, u studju farmakoloġiku in vitro għall-affinità tar-riċetturi tas-subklassi ta' 5-HT mal-prodott.
English: − Is not favourable for ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin.
Maltese: − Mhuwiex favorevoli għall-kura anċillari ta' tnaqqis fil-preċiżjoni viżiva u disturbi fil-kamp viżiv preżumibbilment ta' oriġini vaskulari.
English: Based on the overall documentation provided, the CHMP concluded that the studies suffer from substantial methodological deficiencies which preclude any conclusion on the efficacy of the product.
Maltese: Abbażi tad-dokumentazzjoni ġenerali pprovduta, is-CHMP ikkonkluda li l-istudji jbatu minn nuqqasijiet metodoloġiċi sostanzjali li jipprekludu kwalunkwe konklużjoni dwar l-effikaċja tal-prodott.
English: The marketing authorisation holders (MAHs) submitted all available efficacy data from clinical trials and observational studies, including data that became available since the granting of the initial marketing authorisation.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs) ippreżentaw id-dejta kollha disponibbli dwar l-effikaċja minn provi kliniċi u studji ta' osservazzjoni, inkluż dejta li saret disponibbli sa mill-għoti tal-awtorizzazzjoni għat-tqegħid fis-suq inizjali.
English: The CHMP considered that, although the risk of fibrotic reactions and ergotism associated with dihydroergotoxine is rare, it is established and these are severe adverse events with a possible fatal outcome.
Maltese: Is-CHMP ikkunsidra li, għalkemm ir-riskju ta' reazzjonijiet fibrotiċi u ergotiżmu assoċjati ma' dihydroergotoxine huwa rari, huwa stabbilit u dawn huma avvenimenti avversi severi b'possibbiltà ta' eżitu fatali.
English: Further information on the HMPC assessment of woody nightshade stem medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini taz-zokk tal-ħelwa morra, inklużi ddettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Woody nightshade stem EMA/HMPC/261736/2013
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: For detailed information on the data assessed by the HMPC, see the HMPC assessment report.
Maltese: Għal informazzjoni dettaljata dwar l-istudji vvalutati mill-HMPC, ara r-rapport ta' valutazzjoni tal-HMPC.
English: The HMPC concluded that, on the basis of its long-standing use, woody nightshade stem can be used for the relief of the symptoms of repeated episodes of mild eczema (itchy, red rash).
Maltese: L-HMPC ikkonkluda li, fuq il-bażi tal-użu antik u stabbilit tiegħu, iz-zokk tal-ħelwa morra jista' jintuża għas-solliev tas-sintomi ta' episodji ripetuti ta' ekżema ħafifa (raxx aħmar bil-ħakk).
English: What are the risks associated with woody nightshade stem medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini taz-zokk tal-ħelwa morra?
English: Further information on the risks associated with woody nightshade stem medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini taz-zokk tal-ħelwa morra, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: Herbal medicines containing comminuted woody nightshade stem are usually available for soaking in water (infusion or decoction) to produce a liquid to be applied to the skin.
Maltese: Il-mediċini erbali li fihom iz-zokk imfarrak tal-ħelwa morra ġeneralment jiġu għat-tgħaddis fl-ilma (infużjoni jew dekozzjoni) biex jipproduċu likwidu biex jiġi applikat fuq il-ġilda.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of woody nightshade stem.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali taz-zokk tal-ħelwa morra.
English: The HMPC took into account the well documented use of woody nightshade stem for this indication.
Maltese: L-HMPC ikkunsidra l-użu dokumentat sewwa taz-zokk tal-ħelwa morra għal din l-indikazzjoni.
English: How are woody nightshade stem medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini taz-zokk tal-ħelwa morra?
English: Any applications for the licensing of medicines containing woody nightshade stem have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iz-zokk tal-ħelwa morra għandha titressaq lill-awtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li ser jivvalutaw l-applikazzjoni għallmediċina erbali u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing woody nightshade stem.
Maltese: Il-konklużjonijiet talHMPC jiġu kkunsidrati mill-Istati Membri tal-UE waqt l-evalwazzjoni tal-applikazzjonijiet għal-liċenzjar ta' mediċini erbali li fihom iz-zokk tal-ħelwa morra.
English: It is infused over 30 minutes.
Maltese: L-infużjoni ssir fi żmien 30 minuta.
English: The full EPAR for Invanz 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: Invanz is an antibiotic.
Maltese: Invanz huwa antibijotiku.
English: Invanz contains the active substance ertapenem.
Maltese: Invanz fih is-sustanza attiva ertapenem.
English: Prevention of infections after colorectal surgery
Maltese: Prevenzjoni tal-infezzjonijiet wara kirurġija kolorettali
English: Invanz was compared with ceftriaxone (another antibiotic) for the treatment of adults with communityacquired pneumonia (866 patients) and urinary tract infections (592 patients), and with a combination of piperacillin and tazobactam for the treatment of abdominal infections (655 patients), gynaecological infections (412 patients), skin and soft tissue infections (infections of the skin and the tissues just beneath the skin, 540 patients); and foot infections in diabetes patients (576 patients).
Maltese: Invanz tqabbel ma' ceftriaxone (antibijotiku ieħor) għall-kura ta' adulti bil-pulmonite akkwiżita millkomunità (866 pazjent) u infezzjonijiet urinarji (592 pazjent), u ma' kombinazzjoni ta' piperacillin u tazobactam għall-kura ta' infezzjonijiet addominali (655 pazjent), infezzjonijiet ġinekoloġiċi (412-il pazjent), infezzjonijiet tal-ġilda u tat-tessut artab (infezzjonijiet tal-ġilda u tat-tessuti li huma eżattament taħt il-ġilda, 540 pazjent); u infezzjonijiet fis-saqajn f'pazjenti bid-dijabete (576 pazjent).
English: Effectiveness was measured as absence of infection 4 weeks after treatment, which involved 952 adults.
Maltese: L-effikaċja tkejlet bħala n-nuqqas ta' infezzjoni 4 ġimgħat wara l-kura, li fiha ħadu sehem 952 adult.
English: This is a summary of the European public assessment report (EPAR) for Invanz.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Invanz.
English: Other information about Invanz
Maltese: Informazzjoni oħra dwar Invanz
English: Invanz is given at a dose of 1 g once a day in adults and adolescents.
Maltese: Invanz jingħata f'doża ta' 1 g darba kuljum fl-adulti u fl-adoloxxenti.
English: What are the risks associated with Invanz?
Maltese: X'inhuma r-riskji assoċjati ma' Invanz?
English: Why is Invanz approved?
Maltese: Għaliex ġie approvat Invanz?
English: In studies in children, Invanz was compared with ceftriaxone (for community-acquired pneumonia, 389 children) and with ticarcillin/clavulanate (for intra-abdominal infections, 105 children).
Maltese: Fi studji fuq it-tfal, Invanz tqabbel ma' ceftriaxone (għall-pulmonite akkwiżita mill-komunità, 389 tifel u tifla) u ma' ticarcillin/clavulanate (għal infezzjonijiet intraaddominali, 105 itfal).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Invanz on 18 April 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Invanz fit-18 ta' April 2002.
English: Infection was absent in about 60% patients given Invanz compared with 49% of patients given cefotetan.
Maltese: Ma kienx hemm infezzjoni f'madwar 60% tal-pazjenti li ngħataw Invanz meta mqabbla ma' 49% tal-pazjenti li ngħataw cefotetan.
English: The active substance in Invanz, ertapenem, belongs to the group of antibiotics known as ‘carbapenems'.
Maltese: Is-sustanza attiva f'Invanz, l-ertapenem, tagħmel parti mill-grupp ta' antibijotiċi magħrufin bħala “karbapenemi”.
English: Invanz is also used in adults to prevent infection after colorectal surgery (surgery in the lower part of the bowel, including the rectum).
Maltese: Invanz jintuża fl-adulti biex jipprevjeni infezzjoni wara kirurġija kolorettali (kirurġija fin-naħa t'isfel talmusrana, inkluż ir-rektum).
English: For younger patients (3 months to 12 years), a dose of 15 mg per kilogram body weight is given twice a day, up to a total of 1 g per day.
Maltese: Għall-pazjenti li huma iżgħar fletà (minn 3 xhur sa 12-il sena), doża ta' 15 mg għal kull kilogramma tal-piż tal-ġisem tingħata darbtejn kuljum, sa mhux aktar minn total ta' 1 g kuljum.
English: In children, Invanz was as effective as the comparator antibiotics and had similar effectiveness to that in adults.
Maltese: Fit-tfal, Invanz kien effettiv daqs l-antibijotiċi komparaturi u kien effettiv b'mod simili għal kif kien fl-adulti.
English: • infections within the abdomen;
Maltese: • infezzjonijiet fl-addome;
English: Invanz was as effective as ceftriaxone or piperacillin/tazobactam for the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and foot infections in diabetes patients: Invanz was effective for 87 to 94% of patients compared with 83 to 92% for the comparator antibiotics.
Maltese: Invanz kien effettiv għal 87 sa 94% tal-pazjenti meta mqabbel ma' 83 sa 92% għall-antibijotiċi komparaturi.
English: The CHMP noted that Invanz was shown to be effective, albeit with a limited number of severe cases treated during the studies for abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections.
Maltese: Is-CHMP innota li Invanz wera li kien effettiv, minkejja għadd limitat ta' każijiet gravi kkurati matul l-istudji għal infezzjonijiet addominali, pulmonite akkwiżita mill-komunità, infezzjonijiet ġinekoloġiċi u infezzjonijiet fis-saqajn f'pazjenti bid-dijabete.
English: Treatment of infections
Maltese: Kura ta' infezzjonijiet
English: Invanz was compared with cefotetan for preventing infection after colorectal surgery.
Maltese: Invanz tqabbel ma' cefotetan għall-prevenzjoni tal-infezzjoni wara kirurġija kolorettali.
English: The most common side effects with Invanz (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea (feeling sick), vomiting, rash (including nappy rash in children), itching, and problems around the area where the medicine is infused (including pain and inflammation of the vein).
Maltese: L-effetti sekondarji l-aktar komuni b'Invanz (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma uġigħ ta' ras, nawżja (tħossok ma tiflaħx), rimettar, raxx (inkluż raxx tal-ħrieqi fi tfal), ħakk, u problemi madwar l-erja ta' fejn issir l-infużjoni tal-mediċina (inkluż uġigħ u infjammazzjoni tal-vina).
English: Invanz can work on a range of different bacteria, which are listed in the summary of product characteristics (also part of the EPAR).
Maltese: Invanz jista' jaħdem fuq firxa ta' batterji differenti, li huma elenkati fis-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: For preventing infection after colorectal surgery in adults, a single dose of Invanz is given within 1 hour before the operation.
Maltese: Għall-prevenzjoni ta' infezzjoni wara kirurġija kolorettali fl-adulti, tingħata doża waħda ta' Invanz siegħa qabel l-operazzjoni.
English: It attaches to certain proteins on the bacteria cells.
Maltese: Din teħel ma' ċerti proteini fuq iċ-ċelloli tal-batterji.
English: However, the data were not sufficient to support the use of Invanz in the treatment of urinary tract infections and skin and soft tissue infections, except foot ulcers in diabetes patients.
Maltese: Madankollu, id-data ma kinitx biżżejjed biex tappoġġa l-użu ta' Invanz fil-kura tal-infezzjonijiet urinarji u tal-infezzjonijiet tal-ġilda u tat-tessut artab, ħlief għal ulċeri fissaqajn fpazjenti bid-dijabete.
English: Treatment with Invanz lasts between 3 and 14 days, depending on the type and the severity of the infection.
Maltese: Il-kura b'Invanz iddum bejn 3 ijiem u 14-il jum, skont it-tip u s-severità tal-infezzjoni.
English: How is Invanz used?
Maltese: Kif jaħdem Invanz?
English: The studies examined if the infection was cured after 7 to 28 days of treatment, depending on the type of infection.
Maltese: L-istudji eżaminaw jekk l-infezzjoni fieqitx wara perjodu ta' bejn 7 ijiem u 28 jum ta' kura, skont it-tip ta' infezzjoni.
English: It is available as tablets (100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir).
Maltese: Jiġi bħala pilloli (100 mg lopinavir u 25 mg ritonavir; 200 mg lopinavir u 50 mg ritonavir).
English: The full EPAR and risk management plan summary for Lopinavir/Ritonavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Lopinavir/Ritonavir Mylan jinstabu fis-sit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Lopinavir/Ritonavir Mylan is a ‘generic medicine'.
Maltese: Lopinavir/Ritonavir Mylan huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Lopinavir/Ritonavir Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lopinavir/Ritonavir Mylan.
English: For adults (aged 18 years or over) who are infected with HIV that is likely to respond to medicines in the same class as Lopinavir/Ritonavir Mylan (protease inhibitors) the doctor may prescribe the full daily dose of four 200/50-mg tablets as a single dose.
Maltese: Għal adulti (minn 18-il sena 'il fuq) li huma infettati bl-HIV li x'aktarx tirrispondi għal mediċini fl-istess klassi bħal Lopinavir/Ritonavir Mylan (inibituri protease) it-tabib jista' jippreskrivi d-doża sħiħa ta' kuljum ta' erba' pilloli 200/50-mg bħala doża waħda.
English: Lopinavir/Ritonavir Mylan lopinavir / ritonavir
Maltese: Informazzjoni oħra dwar Lopinavir/Ritonavir Mylan
English: In adults and adolescents (aged 12 years and over), the recommended dose of Lopinavir/Ritonavir Mylan is two 200/50-mg tablets twice a day.
Maltese: Fl-adulti u l-adolexxenti (minn 12-il sena 'l fuq), id-doża rakkomandata ta' Lopinavir/Ritonavir Mylan hija ta' tliet kapsuli jew żewġ pilloli ta' 200/50-mg darbtejn kuljum.
English: The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV.
Maltese: Is-sustanzi attivi f'din il-mediċina, lopinavir u ritonavir, huma inibituri protease: dawn jimblokkaw enzima msejħa protease li għandha sehem fil-replikazzjoni tal-HIV.
English: Lopinavir/Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Lopinavir/Ritonavir Mylan jintuża flimkien ma' mediċini antivirali fil-kura ta' adulti u tfal 'il fuq minn sentejn infettati mill-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu minn immunodefiċjenza akkwiżita (AIDS). Lopinavir/Ritonavir Mylan fih is-sustanzi attivi lopinavir u ritonavir.
English: Because Lopinavir/Ritonavir Mylan is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Kaletra.
Maltese: Billi Lopinavir/Ritonavir Mylan huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Kaletra.
English: A risk management plan has been developed to ensure that Lopinavir/Ritonavir Mylan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Lopinavir/Ritonavir Mylan jintuża bl-aktar mod sigur possibbli.
English: Because Lopinavir/Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Lopinavir/Ritonavir Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.
Maltese: Dan iżid il-livelli ta' lopinavir fid-demm, li jippermetti li tintuża doża aktar baxxa ta' lopinavir għall-istess effett antivirali.
English: Other information about Lopinavir/Ritonavir Mylan
Maltese: Kif jintuża Lopinavir/Ritonavir Mylan?
English: Lopinavir/Ritonavir Mylan, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level.
Maltese: Lopinavir/Ritonavir Mylan, meħud flimkien ma' mediċini oħrajn kontra l-HIV, inaqqas l-HIV fid-demm u jżomm il-virus f'livell baxx.
English: What are the benefits and risks of Lopinavir/Ritonavir Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Lopinavir/Ritonavir Mylan?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lopinavir/Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Kaletra.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Lopinavir/Ritonavir Mylan għandu kwalità komparabbli u huwa bijoekwivalenti għal Kaletra.
English: The Committee recommended that Lopinavir/Ritonavir Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Lopinavir/Ritonavir Mylan ikun approvat għall-użu fl-UE.
English: Why is Lopinavir/Ritonavir Mylan approved?
Maltese: Għaliex ġie approvat Lopinavir/Ritonavir Mylan?
English: In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a ‘booster' that slows down the rate at which lopinavir is broken down by the liver.
Maltese: Lopinavir/Ritonavir Mylan jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn tabib li jkollu esperjenza fil-ġestjoni ta' infezzjonijiet tal-HIV.
English: 69800, France
Maltese: 69800, Franza
English: Manufacturer Synthon Hispania SL C/ Castelló no1
Maltese: Manifattur Synthon Hispania SL C/ Castelló no1
English: Carton only: PC:
Maltese: Kartuna biss: PC:
English: The active substance is anagrelide.
Maltese: Is-sustanza attiva hi anagrelide.
English: Clinically relevant interactions
Maltese: Interazzjonijiet klinikament rilevanti
English: Pulmonary infiltrates
Maltese: Infiltrati pulmonari
English: POL. Las Salinas Sant Boi de Llobregat 08830 Barcelona Spain
Maltese: Las Salinas Sant Boi de Llobregat 08830 Barcelona Spanja
English: Manufacturer Synthon Hispania SL, C/ Castelló no1, POL. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spain.
Maltese: Manifattur Synthon Hispania SL, C/ Castelló no1, POL. Las Salinas, Sant Boi de Llobregat, 08830 Barcelona, Spanja.
English: • a platelet count > 1,000 x 109/l or
Maltese: • għadd tal-plejtlets ta' >1,000 x 109/l jew
English: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, France
Maltese: Mylan S.A.S 117 Allée des Parcs, Saint-Priest, 69800, Franza
English: C/ Castello, nº1, Pol. Las Salinas
Maltese: C/ Castello, nº1, Pol. Las Salinas Sant Boi de Llobregat
English: Frequency of adverse reactions
Maltese: Frekwenza ta' reazzjonijiet avversi
English: 117 Allée des Parcs Saint-Priest
Maltese: 117 Allée des Parcs
English: The safety of anagrelide has been examined in 4 open label clinical studies.
Maltese: Is-sigurtà ta' anagrelide ġiet eżaminata f'4 studji kliniċi open label.
English: • Inflammation of the kidneys (tubulointerstitial nephritis).
Maltese: • Infjammazzjoni tal-kliewi (nefrite tubulointerstizjali).
English: Diplopia Vision abnormal
Maltese: Diplopja Vista anormali