FrancophonIA/ELRC3.0 huggingface dataset:
English: Icandra is indicated in the treatment of type 2 diabetes mellitus: - Icandra is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Maltese: Icandra huwa indikat għall-kura ta' dijabete mellitus tat-tip 2: - Icandra huwa indikat għall-kura ta' pazjenti adulti li ma jistgħux jiksbu kontroll gliċemiku xieraq bl-ogħla doża li jifilħu ta' metformin li jittieħed mill-ħalq waħdu jew li diġà qed jiġu kkurati b'taħlita ta' vildagliptin u metformin bħala pilloli separati.
English: Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets
Maltese: Icandra 50 mg/850 mg pilloli miksija b'rita Icandra 50 mg/1000 mg pilloli miksija b'rita
English: If no adequate strength of Icandra is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Icandra, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: - Do not use Icandra if you are pregnant or breast-feeding (see also “Do not take Icandra”).
Maltese: - Tużax Icandra jekk int tqila jew qed tredda' (ara wkoll “Tiħux Icandra”).
English: - Icandra is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.
Maltese: - Icandra huwa indikat biex jingħata flimkien ma' sulphonylurea (i.e terapija ta' kombinazzjoni tripla) bħala aġġunt għad-dieta u l-eżerċizzju f'pazjenti adulti li mhux qed jiġu kkontrollati b'mod adegwat b'metformin u b'sulphonylurea.
English: Icandra is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multipacks containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Maltese: Icandra jiġi f'pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b'rita u f'pakketti b'ħafna li jkun fihom 120 (2x60), 180 (3x60) jew 360 (6x60) pillola miksija b'rita.
English: Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Informazzjoni għall-utent Icandra 50 mg/850 mg pilloli miksija b'rita Icandra 50 mg/1000 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: - Icandra is indicated in triple combination therapy with insulin as an adjunct to diet and exercise to improve glycaemic control in adult patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Maltese: - Icandra huwa indikat għal terapija ta' kombinazzjoni tripla mal-insulina bħala aġġunt għad-dieta u l-eżerċizzju sabiex jitjieb il-kontroll gliċemiku f'pazjenti adulti meta l-insulina f'doża stabbli u metformin waħedhom ma jipprovdix kontroll gliċemiku xieraq.
English: Icandra 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Maltese: Icandra 50 mg/1000 mg pilloli miksija b'rita huma pilloli sofor skuri, ovali b'“NVR” fuq naħa waħda u “FLO” fuq l-oħra.
English: Avoid excessive alcohol intake while taking Icandra since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol meta tkun qed tieħu Icandra peress li dan jista' jżid ir-riskju ta' aċidożi lattika (jekk jogħġbok ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Icandra 50 mg/850 mg film-coated tablets
Maltese: Icandra 50 mg/850 mg pilloli miksija b'rita
English: The dose of Icandra should provide vildagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Maltese: Id-doża ta' Icandra għandha tipprovdi doża ta' 50 mg vildagliptin darbtejn kuljum (100 mg doża totali ta' kuljum) u doża ta' metformin simili għad-doża li qed tittieħed diġà.
English: Icandra is used to treat adult patients with type 2 diabetes.
Maltese: Icandra jintuża għall-kura ta' pazjenti adulti bid-dijabete tat-tip 2.
English: Do not take Icandra - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Icandra - jekk inti allerġiku għal vildagliptin, metformin jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: EU/1/08/484/019-024 EU/1/08/484/031-033
Maltese: EU/1/08/484/031-033
English: Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Icandra (see sections 4.2, 4.3 and 4.8).
Maltese: Pazjenti b'indeboliment epatik, inklużi pazjenti li jkollhom ALT jew AST qabel il-kura > 3 darbiet ULN, m'għandhomx jiġu kkurati b'Icandra (ara sezzjonijiet 4.2, 4.3 u 4.8).
English: - Each Icandra 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Maltese: - Kull pillola miksija b'rita ta' Icandra fiha 50 mg vildagliptin u 1000 mg metformin hydrochloride (jikkorrispondu għal 780 mg metformin).
English: What Icandra looks like and contents of the pack Icandra 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Maltese: Icandra 50 mg/850 mg pilloli miksija b'rita huma pilloli sofor, ovali b'“NVR” fuq naħa waħda u “SEH” fuq l-oħra.
English: Icandra 50 mg/1000 mg film-coated tablets
Maltese: Icandra 50 mg/1000 mg pilloli miksija b'rita
English: Symptoms of lactic acidosis include: vomiting stomach ache (abdominal pain) muscle cramps a general feeling of not being well with severe tiredness difficulty in breathing reduced body temperature and heartbeat
Maltese: Sintomi ta' aċidożi lattika jinkludu: - rimettar - uġigħ fl-istonku (uġigħ addominali) - bugħawwieġ fil-muskoli - sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa - diffikultà biex tieħu n-nifs - temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: No data are available with regard to overdose of Icandra.
Maltese: M'hemmx dejta dwar doża eċċessiva b'Icandra.
English: Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
Maltese: Kull pillola miksija b'rita fiha 50 mg vildagliptin u 1000 mg metformin hydrochloride (li jikkorrispondi għal 780 mg ta' metformin).
English: How to store Icandra
Maltese: Jekk tieqaf tieħu Icandra
English: Taking Icandra with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Maltese: Jekk Icandra jittieħed mal-ikel jew eżatt wara l-ikel jista' jnaqqas is-sintomi gastrointestinali assoċjati ma' metformin (ara wkoll sezzjoni 5.2).
English: The recommended dose is one film-coated tablet of either 50 mg/850 mg or 50 mg/1000 mg taken twice a day.
Maltese: Id-doża rrakkomandata hija pillola waħda miksija b'rita ta' 50 mg/850 mg jew ta' 50 mg/1000 mg meħuda darbtejn kuljum.
English: Caution should be exercised in patients with a history of acute pancreatitis.
Maltese: Għandu jkun hemm attenzjoni f'pazjenti b'passat ta' pankreatite akuta.
English: Some patients have had the following side effects while taking Icandra and insulin:
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu Icandra u l-insulina:
English: • Lactic acidosis (very rare: may affect up to 1 user in 10,000): Icandra may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Maltese: • Aċidożi lattika (rari ħafna: tista' taffettwa sa persuna 1 minn kull 10,000 li qed jużawh):
English: - Each Icandra 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Maltese: Kull pillola miksija b'rita fiha 50 mg vildagliptin u 850 mg metformin hydrochloride (li jissarraf f'660 mg ta' metformin).
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma.
Maltese: Sintomi gastro-intestinali, l-aktar ippurgar artab, ippurgar mukuż, dijarea u, b'dożi ogħla, demm flippurgar dehru fil-klieb.
English: United Kingdom Novartis Pharmaceuticals UK Ltd. Tel: +44 1276 698370
Maltese: Mylan Pharmaceuticals, S.L. Tel: +34 93 378 64 00
English: The safety and efficacy of Icandra in children and adolescents (< 18 years) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Icandra fit-tfal u l-adoloxxenti (< 18-il sena) għadhom ma ġewx determinati s'issa.
English: Store in the original package (blister) in order to protect from moisture.
Maltese: Aħżen fil-pakkett oriġinali (folja) sabiex tilqa' mill-umdità.
English: Icandra is not recommended for use in children and adolescents (< 18 years).
Maltese: Icandra mhux irrakkomandat għall-użu fit-tfal u adolexxenti (< 18-il sena).
English: Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Maltese: Metformin għandu jitwaqqaf fil-ħin ta' kirurġija taħt anestesija ġenerali, fis-sinsla tad-dahar jew epidurali.
English: Other information about Intanza
Maltese: Informazzjoni oħra dwar Intanza
English: This is a summary of the European public assessment report (EPAR) for Intanza.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Intanza.
English: Intanza is a vaccine.
Maltese: Intanza huwa vaċċin.
English: Intanza contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type).
Maltese: Intanza fih 15-il mikrogramma ta' kull waħda mit-tliet razez differenti (varjetajiet) tal-virus tal-influwenza (sottotip H1N1, A/California/7/2009, NYMC
English: Intanza contains fragments from three different strains of flu virus.
Maltese: Intanza fih frammenti minn tliet razez differenti tal-virus tal influwenza.
English: Influenza vaccine (split virion, inactivated)
Maltese: Vaċċin tal-influwenza (virjon maqsum, diżattivat)
English: The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, muscle pain and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching).
Maltese: L-effetti sekondarji l-aktar komuni b'Intanza (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, uġigħ fil-muskoli u reazzjonijiet fis-sit tal-injezzjoni (ħmura, nefħa, twebbis tal-ġilda, uġigħ u ħakk).
English: Why has Intanza been approved?
Maltese: Għaliex ġie approvat Intanza?
English: The full EPAR for Intanza can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Intanza jinstab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Għal aktar informazzjoni rigward il-kura b'Intanza, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Intanza is used to vaccinate adults aged 60 years and over against flu, especially those who are at an increased risk of developing complications from the disease.
Maltese: Intanza jintuża fit-tilqim tal-adulti li għandhom 60 sena u aktar kontra l-influwenza, speċjalment dawk li jkunu f'riskju ikbar li jiżviluppaw komplikazzjonijiet mill-marda.
English: Intanza must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9.
Maltese: Intanza m'għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi, għal kwalunkwe waħda mis-sustanzi l-oħra, jew għal kwalunkwe komponent li jista' jinsab f'ammonti żgħar ħafna bħal bajd (l-ovalbumina, proteini tat-tiġieġ), neomiċina, formaldeid jew ottossinol 9.
English: What is the risk associated with Intanza?
Maltese: Kif jaħdem Intanza?
English: In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the comparator vaccines.
Maltese: Fil-persuni ta' 60 sena u aktar, il-qawwa ta' 15-il mikrogramma li ngħatat ipprovdiet livell tajjeb ta' protezzjoni daqs il-vaċċini komparaturi.
English: Later seasonal formulations of Intanza have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main studies.
Maltese: Il-formulazzjonijiet staġunali ta' Intanza li ġew wara wrew li pproduċew risponsi simili mill-antikorpi kontra t-tliet razez tal-influwenza inklużi fil-vaċċin għal dawk osservati fl-istudji ewlenin.
English: In the five original studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains.
Maltese: Fil-ħames studji oriġinali, kemm Intanza kif ukoll il-vaċċin komparatur kisbu livelli xierqa ta' antikorpi għall-protezzjoni kontra t-tliet razez ta' virus tal-influwenza.
English: In one study in people aged 60 years and over, Intanza was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response).
Maltese: Fi studju wieħed ta' persuni ta' 60 sena u aktar, Intanza tqabbel ma' vaċċin tal-influwenza li fih aġġuvant (taħlita miżjuda li ttejjeb ir-rispons immunitarju).
English: The CHMP decided that Intanza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Intanza huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Intanza is given as one ‘intradermal' injection into the upper layer of the skin, using a special micro-injection system.
Maltese: Intanza jingħata bħala injezzjoni ‘intradermali' waħda fis-saff ta' fuq tal-ġilda, bl-użu ta' sistema speċjali ta' mikroinjezzjoni.
English: The antibodies will then help to protect against the disease caused by these strains of flu virus.
Maltese: Lantikorpi mbagħad jgħinu biex jipproteġu kontra l-mard ikkawżat minn dawn ir-razez ta' virus talinfluwenza.
English: 0.01 % Gel
Maltese: 0.01 % Ġell
English: Content
Maltese: Ippakketjar
English: 15 g l t o r
Maltese: 15 g
English: Tube (polythylene)
Maltese: Mnjen jingħata
English: Invented name Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Il-Kontenut Daqs tal-pakkett
English: Further information on Ameluz 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: Ameluz received a marketing authorisation valid throughout the EU on 14 December 2011.
Maltese: Ameluz irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fl-14 ta' Diċembru 2011.
English: Actinic keratosis cleared up in 78% (194 out of 248) of patients treated with Ameluz, compared with 64% (158 out of 246) of patients treated with Metvix and 17% (13 out of 76) of patients treated with placebo.
Maltese: Il-keratożi aktinika telqet fi 78 % (194 minn 248) tal-pazjenti kkurati b'Ameluz, meta mqabbel ma' 64 % (158 minn 246) tal-pazjenti kkurati b'Metvix u 17 % (13 minn 76) tal-pazjenti kkurati bilplaċebo.
English: Ameluz contains the active substance 5-aminolaevulinic acid.
Maltese: Ameluz fih is-sustanza attiva 5-aminolaevulinic acid.
English: The most common side effects with Ameluz (seen in more than 1 patient in 10) are reactions at the site of application, including erythema (reddening of the skin), pain (including burning pain), irritation, itching, oedema (swelling), scab formation, exfoliation (skin peeling), hardening of the skin and paraesthesia (sensations like numbness, tingling, pins and needles).
Maltese: L-effetti sekondarji l-aktar komuni b'Ameluz (li dehru f'aktar minn pazjent 1 minn kull 10) huma reazzjonijiet fis-sit tal-applikazzjoni, inkluż eritema (ħmura tal-ġilda), uġigħ (inkluż ħruq), irritazzjoni, ħakk, edema (nefħa), formazzjoni ta' skorċa, esfoljazzjoni (tqaxxir tal-ġilda), ħruxija tal-ġilda u paresteżija (sensazzjonijiet bħal tnemnim, tingiż, jorqdulek is-swaba').
English: Ameluz was at least as effective as Metvix in this study, with cancerous lesions clearing up in 93% (113 out of 121) of patients treated with Ameluz and 92% (101 out of 110) of those treated with the comparator medicine.
Maltese: Ameluz kien tal-inqas effettiv daqs Metvix f'dan listudju, bil-leżjonijiet kanċerużi jitilqu fi 93% (113 minn 121) tal-pazjenti kkurati b'Ameluz u 92% (101 minn 110) ta' dawk ikkurati bil-mediċina komparatur.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom the photosensitising agent is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The condition cleared up in 91% (50 out of 55) of patients given Ameluz, compared with 22% (7 out of 32) given placebo.
Maltese: Il-kondizzjoni telqet f'91 % (50 minn 55) tal-pazjenti kkurati b'Ameluz, meta mqabbel ma' 22 % (7 minn 32) tal-pazjenti kkurati bil-plaċebo.
English: For basal cell carcinoma that cannot be treated surgically, Ameluz was investigated in a study involving 281 patients, in which it was compared with Metvix.
Maltese: Għall-karċinoma taċ-ċellola ta' bażi li ma tistax tiġi kkurata bil-kirurġija, Ameluz ġie investigat fi studju li involva 281 pazjent, fejn tqabbel ma' Metvix.
English: Actinic keratosis cleared up in 66% (53 out of 80) of patients treated with Ameluz, compared with 13% (5 out of 40) of patients treated with placebo.
Maltese: Il-keratożi aktinika telqet f'66 % (53 minn 80) tal-pazjenti kkurati b'Ameluz, meta mqabbel ma' 13 % (5 minn 40) tal-pazjenti kkurati bil-plaċebo.
English: Ameluz is available as a gel (78 mg/g) to be applied to the skin.
Maltese: Ameluz jiġi bħala ġell (78 mg/g) li għandu jiġi applikat fuq il-ġilda.
English: What are the risks associated with Ameluz?
Maltese: Kif jaħdem Ameluz?
English: This kills the cells by reacting with and destroying their components, such as proteins and DNA.
Maltese: Dan joqtol liċ-ċelloli billi jirreaġixxi ma' u jeqred il-komponenti tagħhom, bħal proteini u DNA.
English: Ameluz was more effective than placebo (a dummy treatment) or a comparator medicine when used in photodynamic therapy to treat actinic keratosis or basal cell carcinoma.
Maltese: Ameluz kien iktar effettiv mill-plaċebo (kura finta) jew mediċina komparatur meta ntuża fit-terapija fotodinamika biex jikkura l-keratożi aktinika jew il-karċinoma taċ-ċellola ta' bażi.
English: In the first main study involving 571 patients, Ameluz was compared with placebo and Metvix, a product containing methylaminolaevulinate, used together with a red light for one or two treatment sessions.
Maltese: Fl-ewwel studju ewlieni li involva 571 pazjent, Ameluz tqabbel mal-plaċebo u Metvix, prodott li fih methylaminolaevulinate, użat flimkien ma' dawl aħmar għal sessjoni waħda jew żewġ sessjonijiet ta' kura.
English: Ameluz must not be given to people who are hypersensitive (allergic) to 5-aminolaevulinic acid, porphyrins, soybeans or peanuts, or any of the ingredients.
Maltese: Ameluz m'għandux jingħata lil persuni li jkollhom sensittività eċċessiva (allerġiċi) għal 5aminolaevulinic acid, il-porfirini, il-fażola tas-sojja jew il-karawett, jew għal kwalunkwe wieħed millingredjenti.
English: How does Ameluz work?
Maltese: Kif jintuża Ameluz?
English: Other information about Ameluz
Maltese: Informazzjoni oħra dwar Ameluz
English: When Ameluz is applied to the abnormal skin growths or lesions, the active substance in the medicine, 5-aminolaevulinic acid, is absorbed by cells where it acts as a photosensitising agent (a substance that changes when exposed to light of a certain wavelength).
Maltese: Meta Ameluz jiġi applikat fuq it-tkabbir jew leżjonijiet anormali tal-ġilda, is-sustanza attiva filmediċina, 5-aminolaevulinic acid, tiġi assorbita miċ-ċelloli fejn taġixxi bħala aġent fotosensitizzanti
English: In the third study involving 87 patients with field cancerisation (an area of sun damage with several actinic keratosis growths), Ameluz was compared with placebo used for one together with a red light or two treatment sessions.
Maltese: Fit-tielet studju li involva 87 pazjent bil-kanċerizzazzjoni tal-qasam (parti ta' ħsara mix-xemx b'diversi tkabbir ta' keratożi aktinika), Ameluz tqabbel mal-plaċebo użat flimkien ma' sessjoni ta' kura waħda b'dawl aħmar jew żewġ sessjonijiet ta' kura.
English: For the full list of side effects reported with Ameluz, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Ameluz, ara l-fuljett ta' tagħrif.
English: When treating actinic keratosis growths, Ameluz can also be activated by exposure to full daylight.
Maltese: Aktar informazzjoni dwar Ameluz tinstab fis-sit elettroniku tal-Aġenzija:
English: Ameluz can also be used in adults to treat certain types of basal cell carcinoma (a type of skin cancer) when it cannot be treated by surgery.
Maltese: Ameluz jista' jintuża wkoll fl-adulti biex jikkura ċerti tipi ta' karċinoma taċ-ċellola ta' bażi (tip ta' kanċer tal-ġilda) meta ma jkunux jistgħu jiġu kkurati bil-kirurġija.
English: A further study in 52 patients with actinic keratosis found that Ameluz was at least as effective as Metvix at clearing actinic keratosis when used in combination with daylight.
Maltese: Studju ieħor fi 52 pazjent b'keratożi aktinika sab li Ameluz kien tal-inqas effettiv daqs Metvix biex ineħħi l-keratożi aktinika meta jintuża flimkien mad-dawl tax-xemx.
English: The European Medicines Agency concluded that the benefits of treatment with Ameluz were greater than the few and mostly mild side effects, and that Ameluz was more effective and somewhat safer than the standard alternative.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li l-benefiċċji ta' kura b'Ameluz kienu akbar mill-ftit effetti sekondarji li ħafna drabi kienu ħfief, u li Ameluz kien aktar effettiv u kemxejn aktar sigur millalternattiva standard.
English: In the second main study involving 122 patients, Ameluz was compared with placebo used together with a red light for one or two treatment sessions.
Maltese: Fit-tieni studju ewlieni li involva 122 pazjent, Ameluz tqabbel mal-plaċebo użat flimkien ma' dawl aħmar għal sessjoni waħda jew żewġ sessjonijiet ta' kura.
English: Why is Ameluz authorised in the EU?
Maltese: Għaliex Ameluz ġie awtorizzat fl-EU?
English: Ameluz is a medicine used in adults to treat mild to moderate actinic keratoses on the face and scalp as well as the surrounding areas of the skin affected by the condition.
Maltese: Ameluz huwa mediċina li tintuża fl-adulti għall-kura ta' keratożijiet aktiniċi ħfief sa moderati fil-wiċċ u lqorriegħa kif ukoll fil-partijiet ta' madwar il-ġilda affettwati mill-kondizzjoni.
English: An overview of Ameluz and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Ameluz u għaliex huwa awtorizzat fl-UE
English: Elebrato Ellipta (fluticasone furoate / umeclidinium bromide / vilanterol)
Maltese: Elebrato Ellipta (flutikason furoate / bromur talumeklidinju / vilanterol)
English: Further information on Elebrato Ellipta can be found on the Agency's website: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
Maltese: Aktar informazzjoni dwar Elebrato Ellipta tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/ medicines/human/EPAR/elebrato-ellipta.
English: Elebrato Ellipta receiveda marketing authorisation valid throughout the EU on 15 November 2017.
Maltese: Elebrato Ellipta ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil15 ta' Novembru 2017.
English: Vilanterol is a long-acting beta-2 agonist.
Maltese: Il-vilanterol hija agonista beta-2 li jaġixxi fit-tul.
English: Fluticasone furoate is a corticosteroid.
Maltese: Flutikason furoate hija kortikosterojde.