FrancophonIA/ELRC3.0 huggingface dataset:
English: Two open-label, randomised, controlled clinical trials compared the long-term effects of imiquimod with those of topical diclofenac in patients with actinic keratosis with respect to the risk of progression to in situ or invasive squamous cell carcinoma (SCC).
Maltese: Żewġ provi kliniċi open-label, randomised, ikkontrollati qabblu l-effetti fit-tul ta' imiquimod ma' dawk ta' diclofenac topiku f'pazjenti b'keratosi aktinika fir-rigward tar-riskju ta' progressjoni għal karċinoma taċ-ċellula skwamuża (SCC - squamous cell carcinoma) in situ jew invażiva.
English: You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Aldara cream (8% patients).
Maltese: Tista' ukoll tħoss ħakk (32% tal-pazjenti), sensazzjoni ta' ħruq (26% pazjenti) jew uġigħ f'postijiet fejn tkun applikajt il-krema Aldara (8% tal-pazjenti).
English: Dry thoroughly.
Maltese: Ixxotta sew.
English: These trials failed to demonstrate efficacy of imiquimod at any of the tested dosage regimens (3x/week for ≤16 weeks and 7x/week for ≤8 weeks).
Maltese: Dawn il-provi naqsu milli juru l-effikaċja ta' imiquimod f'kull doża li ġiet ittestjata (3X/fil-gimgha ghal ≤ 16 il-gimgha u 7X/fil-gimgha ghal ≤ 8 gimghat).
English: One-year data from two combined observational studies indicate a recurrence rate of 27% (35/128 patients) in those patients who became clinically clear after one or two courses of treatment.
Maltese: Dejta fuq sena minn żewġ studji t'osservazzjoni kombinati jindikaw stat ta' rikorrenza ta' 27% (35/128 pazjent) f'dawk il-pazjenti li saru klinikament ċari wara kors jew tnejn ta' trattament.
English: Rhinitis
Maltese: Remettar
English: Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Maltese: Xi reazzjonijiet avversi sistematiċi, li jinkludu uġigħ fil-muskolu (2%) ġew rapportati f'pazjenti trattati b'imiquimod.
English: Mylan Pharmaceuticals, S.L.
Maltese: United Kingdom Mylan Products Ltd.
English: There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema).
Maltese: Hemm assoċjazzjoni bejn ir-rata ta' tneħħija kompleta u l-intensità tar-reazzjonijiet tal-ġilda lokali (e.ż. eritema).
English: Vascular disorders:
Maltese: Keratosi aktinika:
English: Pharyngo laryngeal pain
Maltese: Popolazzjoni pedjatrika
English: - Each Aldara 5% cream sachet contains 250 mg of a white to slightly yellow cream.
Maltese: Kull qartas ta' krema Aldara ta' 5% fih 250 mg ta' krema bajda li tkanġi daqsxejn fl-isfar.
English: There are no data available on the use of imiquimod in children and adolescents in the approved indications.
Maltese: M'hemmx data dwar l-uzu ta' “imiquimod” fit-tfal u fl-adoloxxenti fl-indikazzjonijiet approvati.
English: External genital warts:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: The most frequently reported adverse events from the trials judged probably or possibly related to imiquimod cream are application site disorders, with a frequency of 28.1%.
Maltese: L-aktar każijiet avversi frekwentament rapportati mill-provi li probabilment jew possibilment huma dikjarati li setgħu seħħew minħabba l-krema imiquimod huma disturbi tas-sit ta' l-applikazzjoni, bi frekwenza ta' 28.1%.
English: Actinic keratosis in adults
Maltese: Keratosi aktinika fl-adulti
English: Each containing 250 mg of cream.
Maltese: Kull wieħed fih 250 mg ta' krema.
English: Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects.
Maltese: Inqas minn 0.9% ta' doża wahda applikata topikament ta' imiquimod radjoattiv gie assorbit mill-gilda ta' suggetti bnedmin.
English: An interruption of dosing should be considered if intense local inflammatory reactions occur (see section 4.4) or if infection is observed at the treatment site.
Maltese: Waqfien tad-doża għandha tiġi konsidrata jekk ikun hemm reazzjonijiet infjammatorji lokali intensi (ara sezzjoni 4.4) jew jekk ikun hemm infezzjoni fuq is-sit tat-trattament.
English: • Actinic keratosis
Maltese: • Keratosi aktinika
English: These protocol mandated clinical sign assessments indicate that severe erythema (31%) severe erosions (13%) and severe scabbing and crusting (19%) were very common in these trials with imiquimod cream applied 5 times weekly.
Maltese: Dawn l-istimi tas-sinjali kliniċi obbligati bi protokoll jindikaw li eritema serja (31%), tnawwir serju (13%), u tnixxif u qxur (19%) kienu komuni ħafna f'dawn il-provi kliniċi bil-krema imiquimod applikata 5 darbiet fil-ġimgħa (ara sezzjoni 4.4 għal aktar dettalji).
English: External genital warts, superficial basal cell carcinoma and actinic keratosis:
Maltese: ● Jekk qed tiġi trattat għal karċinoma ta' ċellola bażali:
English: Very common side effects (likely to occur in more than 1 in 10 patients) Common side effects (likely to occur in fewer than 1 in 10 patients) Uncommon side effects (likely to occur in fewer than 1 in 100 patients) Rare side effects (likely to occur in fewer than 1 in 1,000 patients) Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).
Maltese: Il frekwenza tal-effetti sekondarji jigu ikklasifikati hekk Effetti sekondarji komuni hafna (x`aktarx li jigru f`aktar minn 1 minn kull 10 pazjenti Effetti sekondarji komuni (x`aktarx li jigru f`anqas minn 1 minn kull 10 pazjenti Effetti sekondarji mhux komuni (x`aktarx li jigru f`anqas minn 1 minn kull 100 pazjent Effetti sekondarji rari (x`aktarx li jigru f`anqas minn 1 minn kull 1,000 pazjenti Effetti sekondarji rari hafna (x`aktarx li jigru f`anqas minn 1 minn kull 10,000 pazjenti
English: Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg.
Maltese: Studji fil-fniek rrivelaw doża letali dermali ta' aktar minn 5g/kg.
English: Skin infections during treatment with imiquimod have been observed.
Maltese: Infezzjonijiet tal-ġilda matul it-trattament b'imiquimod ġew osservati.
English: The treated AK field was located on the balding scalp or face with a contiguous area of about 40 cm² for both treatment groups presenting with a median number of 7 clinically typical AK lesions at baseline.
Maltese: Iż-żona ta' AK ittrattata kienet tinsab fuq il-qorriegħa li qed titfartas jew fil-wiċċ b'erja kontigwa ta' madwar 40 cm² għażżewġ gruppi ta' trattament li ppreżentaw b'numru medjan ta' 7 leżjonijiet klinikament tipiċi ta' AK fil-linja bażi.
English: Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events (refer to section 4.8 and 4.9)
Maltese: Applikazzjoni fuq gilda maqsuma jista iwassal biex jigi assorbit aktar imiquimod li jista jwassal ghal riskju akbar ta effetti mhux mixtieqa (irriferi ghal sezzjoni 4.8 u
English: Data from an open-label clinical trial suggest that subjects with more than 8 AK lesions showed a decreased rate of complete clearance compared to patients with less than 8 lesions.
Maltese: Dejta minn prova klinika bit-tikketta tidher tissuġerixxi li pazjenti b'aktar minn 8 leżjonijiet dovuti għal keratosi aktinika(AK) wrew tnaqqis fir-rata ta' tneħħija kompleta meta mqabbla ma' pazjenti b'inqas minn 8 feriti.
English: - Each box contains 12 or 24 single-use polyester/aluminium foil sachets.
Maltese: Kull kaxxa fiha 12-il jew 24-il qartas f'folja tal-polyester/aluminju li jintuża darba.
English: During the 6 to 10 hour treatment period, showering or bathing should be avoided.
Maltese: F'dak il-perijodu ta' trattament ta' bejn 6 sa 10 sigħat, għandu jiġi evitat li wieħed jinħasel f'banju jew f'doċċa.
English: Application Instructions - (Mon, Tues, Wed, Thurs and Fri) 1.
Maltese: Struzzjonijiet t'applikazzjoni - (It-Tnejn, It-Tlieta, L-Erbgħa, Il-Ħamis u L-Ġimgħa) 1.
English: Common effects include pain, burning, irritation or redness.
Maltese: Effetti komuni jinkludu uġigħ, ħruq, irritazzjoni jew ħmura.
English: The induction of alpha interferon and other cytokines following imiquimod cream application to genital wart tissue has also been demonstrated in clinical studies.
Maltese: Is-sensitizzazzjoni ta' alpha interferon u ċitokini oħra wara l-applikazzjoni tal-krema imiquimod għal felul li jinsab fit-tessut ġenitali ġie stabbilit fi studji kliniċi.
English: Minimal systemic absorption of imiquimod 5% cream across the skin of 58 patients with actinic keratosis was observed with 3 times per week dosing for 16 weeks.
Maltese: L-assorbiment sistematiku minimu ta' krema ta' 5% imiquimod tul il-ġilda ta' 58 pazjent b'keratosi aktinika ġiet osservata b'dożaġġ ta' 3 darbiet fil-ġimgħa għal 16-il ġimgħa.
English: Discomfort
Maltese: Skonfort
English: Application site ulcer
Maltese: Informazzjoni għall-utent
English: LE11 5SF, United Kingdom
Maltese: Loughborough Leicestershire LE11 5SF, ir-Renju Unit
English: If you decide to have sexual relations while you still have warts, apply Aldara cream after - not before - sexual activity.
Maltese: Jekk tiddeċiedi li trid li jkollok relazzjonijiet sesswali waqt li għad għandek il-felul, applika l-krema Aldara wara - mhux qabel - l-attività sesswali.
English: Nervous system disorders: Headache
Maltese: Disturbi fis-sistema nervuża:
English: Genital candidiasis
Maltese: Kandidjasi ġenitali
English: Gastrointestinal disorders: Nausea
Maltese: Disturbi gastro-intestinali:
English: Eyelid oedema
Maltese: Uġigħ vaġinali
English: Dyspareunia
Maltese: Għejja
English: Imiquimod is an immune response modifier.
Maltese: Imiquimod huwa modifikatur li jirrispondi fis-sistema immuni.
English: Patient reported adverse reactions from 185 patients treated with imiquimod cream in placebo controlled phase III clinical studies for superficial basal cell carcinoma are presented below.
Maltese: Reazzjonijiet avversi rapportati minn pazjenti f'185 pazjent li kienu qed jużaw il-krema imiquimod fi studji kliniċi ta' fażi
English: Results are emerged from a meta-analysis of both trials.
Maltese: Inħarġu riżultati minn metaanaliżi taż-żewġ provi.
English: How to use Aldara cream 4.
Maltese: Applika l-krema Aldara 3 darbiet fil-ġimgħa.
English: A total of 126 of 242 patients treated with imiquimod (52.1%) and 84 of 237 patients treated with topical diclofenac (35.4%) showed complete clinical clearance of the treated AK field at week 20 (i.e. about 8 weeks after the end of the initial treatment cycle); a difference of 16.6% (95% CI: 7.7% to 25.1%).
Maltese: Total ta' 126 minn 242 pazjent ittrattati b'imiquimod (52.1%) u 84 minn 237 pazjent ittrattati b'diclofenac topiku (35.
English: How to store Aldara cream
Maltese: Tużax il-krema Aldara
English: Flushing
Maltese: Infafet
English: In animal models imiquimod is effective against viral infections and acts as an antitumour agent principally by induction of alpha interferon and other cytokines.
Maltese: F'annimali mudelli, imiquimod huwa effettiv kontra l-infezzjonijiet virali u jaħdem bħala aġent ewlieni kontra t-tumuri bl-indukrar ta' alpha interferon u ċitokini oħra.
English: Diarrhoea
Maltese: Dajsurja
English: Abdominal pain
Maltese: Uġgħ addominali
English: (139/185) of patients.
Maltese: N = 185
English: Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use.
Maltese: Waslu rapporti ta' ipopigmentazzjoni u iperpigmentazzjoni lokalizzata wara l-użu bil-krema imiquimod.
English: Early signs of stricture may include local skin reactions (e.g. erosion, ulceration, oedema, induration), or increasing difficulty in retracting the foreskin.
Maltese: Sinjali bikrija ta' kontrazzjoni jistgħu jinkludu reazzjonijiet lokali tal-ġilda (p.e. tgħawwir, ulċerazzjoni, edema, twebbis), jew diffikultajiet akbar biex tiritratta l-prepuzju.
English: • Do not use Aldara cream until the area to be treated has healed after previous drug or surgical treatment.
Maltese: • Tużax il-krema Aldara sakemm l-erja li qed tiġi trattata tkun fieqet minn trattament preċedenti bil-mediċini jew kirurġiċi.
English: Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).
Maltese: Kull qartas fih 12.5mg ta' imiquimod f`250mg krema (5%) 100 mg krema jkun fiha 5 mg imiquimod
English: Aldara 5% cream Imiquimod Cutaneous use
Maltese: Aldara 5% krema imiquimod Għal użu għall-ġilda
English: Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials.
Maltese: Tnaqqis fl-emoglobina, fl-għadd totali ta' ċelloli tad-demm, newtrofili u plejtlits assoluti ġew osservati fil-provi kliniċi.
English: Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling.
Maltese: Effetti komuni ħafna jinkludu ħmura (61% tal-pazjenti), il-ġilda tittiekel (30% tal-pazjenti), sfoll u nefħa.
English: This includes studies with immunosuppressive drugs.
Maltese: Dan jinkludi studji b'mediċini immunisuppressivi.
English: Topical administration of imiquimod cream resulted in no tumour enhancement at any dose, in comparison with the vehicle cream group.
Maltese: L-amministrazzjoni topika tal-krema imiquimod ma rriżultatx fi tħarrix ta' tumuri fi kwalunkwe doża, meta mqabbel mall-grupp tal-krema vettura.
English: The application surface area was not controlled in the scalp and hands/ arms groups.
Maltese: L-erja superfiċjali t'applikaazzjoni ma ġietx ikkontrollata fil-gruppi tal-qorriegħa u l-idejn/dirgħajn.
English: Dizziness
Maltese: Ekżema
English: In a four-month rat dermal toxicity study, significantly decreased body weight and increased spleen weight were observed at 0.5 and 2.5 mg/kg; similar effects were not seen in a four month mouse dermal study.
Maltese: Fi studju tossiku-dermali fil-firien mifrux fuq erba' xhur, tnaqqis sinjifikanti tal-piż tal-ġisem u żieda fil-piż tal-milsa ġie osservat f'0.5 u 2.5 mg/kg; effetti bhal dawn ma ntwerewx fuq studju dermali tal-ġrieden mifrux fuq erba' xhur.
English: One sachet contains enough cream to cover an area of 25 cm
Maltese: Qartas wieħed fih biżżejjed krema biex ikopri erja ta' felul ta' 25 cm
English: Patient reported adverse reactions from 252 patients treated with imiquimod cream in vehicle controlled phase III clinical studies for actinic keratosis are presented below.
Maltese: Reazzjonijiet avversi rapportati minn pazjenti minn 252 pazjent li kienu qed jużaw il-krema imiquimod fi studji kliniċi ta' fażi
English: In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions judged to be probably or possibly related to imiquimod cream treatment were application site reactions at the wart treatment site (33.7% of imiquimod treated patients).
Maltese: Fil-provi pivitali b'dożaġġ ta' 3 darbiet fil-ġimgha, l-aktar reazzjonijiet avversi tal-mediċina rapportati li ġew iġġudikati li probabilment jew possibilment huma relatati mal-krema imiquimod kienu reazzjonijiet fuq il-lok ta'applikazzjoni fis-sit ta' trattament tal-felul (33.7% ta' pazjenti trattati b'imiquimod).
English: The efficacy of imiquimod applied 3 times per week for one or two courses of 4 weeks, separated by a 4 week treatment-free period, was studied in two double-blind vehicle controlled clinical trials.
Maltese: L-effikaċja ta' imiquimod applikat 3 darbiet fil-ġimgħa għal kors wieħed jew żewġ korsijiet ta' 4 ġimgħat, isseparati b'perijodu mingħajr trattament ta' 4 ġimgħat, ġie studjat f'żewġ provi kliniċi double-blind vehicle controlled.
English: Common effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash.
Maltese: Effetti komuni jinkludu: tingiż u labar, postijiet żgħar fil-ġilda minfuħin, uġigħ, ħruq, irritazzjoni, fsada, ħmura jew raxx.
English: Wash the extra away with mild soap and water.
Maltese: Aħsel iżżejjed b'sapun hafif u ilma.
English: Application site dermatitis
Maltese: Dermatite fis-sit t'applikazzjoni
English: These adverse events are considered at least possibly causally related to treatment with imiquimod.
Maltese: Dawn il-każijiet avversi huma konsidrati li ta' lanqas huma possibilment b'mod każwali relatati mat-trattament b'imiquimod.
English: Erectile dysfunction
Maltese: Artralġja
English: Inflammation c) Frequently occurring adverse events:
Maltese: Infezzjonijiet u infestazzjonijiet:
English: No clinical experience exists with the use of imiquimod cream in immunocompromised patients.
Maltese: Ma teżisti ebda esperjenza klinika dwar l-użu tal-krema imiquimod għal pazjenti immunokompromessi.
English: There have been postmarketing reports of elevated liver enzymes.
Maltese: Wara it-tqegħid fis-suq, kien hemm rapporti ta' livelli oghlja ta' enzimi tal-fwied.
English: Rectal disorder
Maltese: Disturbi tar-rektum
English: Postmarketing reports of suspected alopecia occurring during the treatment of sBCC and EGW have been received.
Maltese: Waslu rapporti ta' wara ttqegħid fis-suq li hemm suspett t'alopeċja waqt it-trattament ta' sBCC u EGW.
English: Other local reactions such as induration, ulceration, scabbing, and vesicles have also been reported.
Maltese: Reazzjonijiet lokali oħra bħalma hi ebusija, ulċerazzjoni, inkrostar, u nuffat ġew rapportati wkoll.
English: The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Maltese: L-użu tal-faxxa okklusiva mhix rakkomandata b'terapija bil-krema imiquimod.
English: Pharyngitis
Maltese: Sturdament
English: These reductions are not considered to be clinically significant in patients with normal haematologic reserve.
Maltese: Dan it-tnaqqis mhux ikkonsidrat li hu klinikament sinifikattiv f'riżerva ematoloġika normali.
English: A patient with recurrent AK lesions (as defined above) in the completely cleared field had a chance of about 80% to become completely cleared again following an additional imiquimod treatment cycle compared with a chance of about 50% for a re-treatment with topical diclofenac.
Maltese: Pazjent b'leżjonijiet rikorrenti ta' AK (kif definit hawn fuq) f'żona mfejqa kompletament kellu ċans ta' madwar 80% li jfieq kompletament mill-ġdid wara ċiklu addizjonali ta' trattament b'imiquimod meta mqabbel ma' ċans ta' madwar 50% għal trattament mill-ġdid b'diclofenac topiku.
English: Rash erythematous
Maltese: Raxx eritematosi
English: s. r.o.
Maltese: U L-UŻU
English: In immunocompromised patients, repeat treatment with imiquimod cream is not recommended.
Maltese: F'pazjenti immunikompromessi, trattament ripetut bil-krema imiquimod m'huwiex rakkomandat.
English: Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling, scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flulike symptoms and tiredness.
Maltese: Mhux komuni li xi pazjenti jħossu bidliet fis-sit t'applikazzjoni (tnixxija, infjammazzjoni, nefħa, ilġilda tinkiser, il-ġilda tifforma skorċa hi u qiegħda tfiq, infafet, dermatite) jew irritabilità, tħossok marid, ħalq xott, sintomi bħal ta' l-influwenza u għejja.
English: See 4.2 and 4.4 for information on rest periods.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 4-8 weeks after the end of treatment.
Maltese: L-eżitu kliniku tat-terapija jista' jiġi stabbilit wara r-riġenerazzjoni tal-ġilda trattata, madwar 4-8 ġimgħat wara t-tmiem tat-trattament.
English: The excipients methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Maltese: L-eċċipjenti methylhydroxybenzoate (E218) u propylhydroxybenzoate (E216) jistgħu jikkaġunaw reazzjonijiet allerġiċi (possibbilment ittardjati).
English: In very rare cases, severe reactions at the urethral meatus have resulted in dysuria in women (see section 4.4).
Maltese: F'każijiet rari ħafna, reazzjonijiet qawwija fil-meatus uretrali wassal għal disurja fin-nisa (ara sezzjoni 4.4).
English: • Superficial basal cell carcinoma.
Maltese: • Karċinoma superfiċjali taċ-ċellola bażali.
English: Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience.
Maltese: Tnaqqis fil-parametri ematoloġiċi li jinħtieġu intervent kliniku ġew rapportati fl-esperjenza wara ttqegħid fis-suq.
English: • If you are being treated for actinic keratosis
Maltese: ● Jekk qed tiġi trattat għal keratosi aktinika
English: The systemic exposure data demonstrated that the extent of absorption of imiquimod following topical application to the MC lesional skin of the paediatric patients aged 6-12 years was low and comparable to that observed in healthy adults and adults with actinic keratosis or superficial basal cell carcinoma.
Maltese: Dejta fuq l-“imiquimod” applikat fuq il-ġilda tal-wiċċ b`lessjoni ta MK f`pazjenti pedjatriċi ta` eta ta' bejn 6-12 il-sena turi li l-ammont li gie assorbit sistematikament kienu baxxi w jikkumparaw ma dawk li ġew osservati f`adulti b`saħħitom w adulti b`keratosi aktinika jew karċinoma superfiċjali taċ-ċelluli bażali.
English: The treatment frequency and duration differ for genital warts, basal cell carcinoma and actinic keratosis (see specific instructions for each indication).
Maltese: Il-frekwenza tat-trattament u t-tul ivarja għal felul ġenitali, karċinoma taċ-ċellola bażali u keratosi aktinika (ara struzzjonijiet speċifiċi għal kull indikazzjoni).
English: Treatment with imiquimod cream can be resumed after the skin reaction has moderated.
Maltese: It-trattament bil-krema imiquimod jista' jissokta wara li rreazzjoni fuq il-ġilda tkun immoderat.
English: Imiquimod cream may weaken condoms and diaphragms, therefore concurrent use with imiquimod cream is not recommended.
Maltese: It-trattament bil-krema imiquimod jista' tissokta wara li r-reazzjoni fuq il-ġilda tkun immoderat.
English: Renal and urinary disorders: Dysuria
Maltese: TWISSIJA(JIET) SPEĊJALI
English: Target tumours were histologically confirmed single primary superficial basal cell carcinomas with a minimum size of 0.5 cm and a maximum diameter of 2 cm. Tumours located within 1 cm of the eyes, nose, mouth, ears or hairline were excluded.
Maltese: Tumuri bersalljati kienu istoloġikament konfermati li kienu karċinomi superfiċjali ta' ċellula bażali b'daqs minimu ta' 0.5 ċm u b'dijametru massimu ta' 2 ċm.
English: The equivalence limits were set at 80 - 125 %.
Maltese: Il-limiti tal-ekwivalenza ġew stabbiliti għal 80 - 125 %.
English: The reference product in SE is Ventoline Evohaler, 0.1 mg/dose (GlaxoSmithKline AB).
Maltese: Il-prodott ta' referenza fl-SE huwa Ventoline Evohaler, 0.1 mg/doża (GlaxoSmithKline AB).
English: The indication sought is “Symptomatic treatment of bronchoconstriction due to bronchial asthma, chronic bronchitis, chronic obstructive pulmonary disease (COPD) and emphysema.
Maltese: L-indikazzjoni mfittxija hija “Trattament sintomatiku ta' bronkokostrizzjoni minn ażma tal-bronki, bronkite kronika, marda pulmonari ostruttiva kronika (COPD) u enfisema.
English: The marketing applications were submitted as hybrid applications under Article 10(3) of Directive 2001/83/EC and the EU reference product is Sultanol Dosier-Aerosol 100 µg/dose, Druckgasinhalation, suspension, (GlaxoSmithKline).
Maltese: L-applikazzjonijiet għat-tqegħid fis-suq ġew ippreżentati bħala applikazzjonijiet ibridi skont l-Artikolu 10(3) tad-Direttiva 2001/83/KE u l-prodott ta' referenza tal-UE huwa Sultanol Dosier-Aerosol 100 μg/doża, Druckgasinhalation, sospensjoni, (GlaxoSmithKline).
English: The difference for stage 3 amounts to a mean difference of only 3.27% (i.e. 38.17 µg) of the pooled fine particle dose for stages 3/4/5.
Maltese: Id-differenza għall-istadju 3 tammonta għal differenza medja ta' 3.27% (jiġifieri 38.17 µg) biss tad-doża ta' partiċelli fini raggruppati għall-istadji 3/4/5.
English: Salbutamol Sandoz mikrogrammi/annuses
Maltese: Salbutamol Sandoz mikrogrammi/annus es