FrancophonIA/ELRC3.0 huggingface dataset:
English: Xanthan gum, soybean phosphatidylcholine, polysorbate 80, triglycerides medium-chain, isopropyl alcohol, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, propylene glycol, sodium benzoate (E211), purified water.
Maltese: Xanthan gum, soybean phosphatidylcholine, polysorbate 80, triglycerides medium-chain, isopropyl alcohol, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, propylene glycol, sodium benzoate (E211), ilma ppurifikat.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 December 2011
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 14 Diċembru 2011
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000
Maltese: Il frekwenzi huma definiti bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), Rari ħafna (<1/10,000), u mhux magħrufa (ma jistgħux jiġu stmati mid-dejta disponibbli).
English: Photodynamic therapy with Ameluz (66.3%) was significantly more effective than with placebo (12.5%, p < 0.0001).
Maltese: (66.3%) kienet ferm aktar effettiva milli bi plaċebo (12.5%, p < 0.0001).
English: Biofrontera Pharma GmbH sucursal en España Tel: 900 974943 ameluz-es@biofrontera.com
Maltese: GmbH sucursal en España Tel: 900 974943 ameluz-es@biofrontera.com
English: After 24 hours, the mean cumulative absorption (including accumulation in the dermis) through human skin was 0.2% of the administered dose.
Maltese: Wara 24 siegħa, l-assorbiment kumulattiv medju (inkluż l-akkumulazzjoni fid-dermis) minn ġol-ġilda umana kien ta' 0.2% tad-doża amministrata.
English: Use of immunosupressants
Maltese: Użu ta' immunosoppressanti
English: Biofrontera Bioscience GmbH Hemmelrather Weg 201 51377 Leverkusen Germany
Maltese: Biofrontera Bioscience GmbH Hemmelrather Weg 201 51377 Leverkusen
English: - ulcer
Maltese: - ulċera
English: Adverse reaction
Maltese: MANIFATTUR RESPOSABBLI
English: n.a.
Maltese: A.
English: Generally, side effects are of mild or moderate intensity, typically occurring during illumination or 1 to 4 days after.
Maltese: Ġeneralment, l-effetti sekondarji huma ta' intensità ħafifa jew moderata, normalment iseħħu waqt ittidwil jew jum 1 sa 4 ijiem wara.
English: PPS - non-inferiority 49 79.8 +/- 23.6 49 76.5 +- 26.5 FAS - superiority 51 78.7 +/- 25.8 51 75.0 +/- 28.1
Maltese: PPS - non-inferjorità 49 79.8 +/- 23.6 49 76.5 +- 26.
English: • The other ingredients are: disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, propylene glycol, purified water, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soybean phosphatidylcholine, triglycerides medium-chain, xanthan gum.
Maltese: • Is-sustanzi l-oħra huma: disodium phosphate dihydrate, isopropyl alcohol, polysorbate 80, propylene glycol, ilma ppurifikat, sodium benzoate (E211), sodium dihydrogen phosphate dihydrate, soybean phosphatidylcholine, triglycerides medium-chain, xanthan gum.
English: • propylene glycol: May cause skin irritation.
Maltese: • propylene glycol:
English: • ulcer
Maltese: • ulċera
English: Table 1: Summary of related adverse drug reactions (ADRs) reported in patients treated with photodynamic therapy with 5-aminolaevulinic acid System organ class
Maltese: Tabella 1: Sommarju tar-reazzjonijiet avversi tal-mediċina (ADRs) relatati rrappurtati f'pazjenti kkurati b'terapija fotodinamika b'5-aminolaevulinic acid Sistema tal-klassifika talorgani
English: Pharmacotherapeutic group: Antineoplastic agents, sensitizers used in photodynamic/radiation therapy, ATC code: L01XD04
Maltese: Aġenti antineoplastiċi, sensitizzanti użati fit-terapija fotodinamika/birradjazzjoni, Kodiċi ATC:
English: Risk of allergic reaction
Maltese: Riskju ta' reazzjoni allerġika
English: Lesion recurrence rates after 6 and 12 months were 2.9% and 6.7%, respectively, for Ameluz, and 4.3% and 8.2% for MAL.
Maltese: Ir-rati ta' rikorrenza tal-leżjonijiet wara 6 u 12-il xahar kienu 2.9% u 6.7%, rispettivament għal Ameluz, u 4.3% u 8.2% għal MAL.
English: Patients with more than 1 BCC
Maltese: Pazjenti b'aktar minn 1 BCC
English: Concomitant use of medicinal products with known phototoxic or photoallergic potential such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines may enhance the phototoxic reaction to photodynamic therapy.
Maltese: John's wort(fexfiex), griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones u tetracyclines jista' jżid ir-reazzjoni fototossika għat terapija fotodinamika.
English: Blister, dry skin, petechiae
Maltese: Infafet, ġilda xotta, petechiae
English: Application site erythema (%) Application site pain (%) mild moderate severe mild moderate severe
Maltese: Uġigħ fis-sit tal applikazzjoni (%) ħafifa moderata severa ħafif moderat sever
English: - pustules
Maltese: - skumdità
English: A risk to the suckling child cannot be excluded.
Maltese: Ir-riskju gћat-trabi li qegћdin jiġu mreddgћin mhux eskluż.
English: A distance of at least 1 cm is to be maintained.
Maltese: filwaqt li żżomm distanza ta' mill-inqas 1 ċm.
English: The red light source was either a narrow light spectrum lamp (Aktilite CL 128 or Omnilux PDT) or a lamp with a broader and continuous light spectrum (Waldmann PDT 1200 L, or Hydrosun Photodyn 505 or 750).
Maltese: 128 jew Omnilux PDT) jew lampa bi spettru usa' u kontinwu (Waldmann PDT 1200 L, jew Hydrosun Photodyn 505 jew 750).
English: In a phase II clinical trial, 5-aminolaevulinic acid and protoporphyrin IX serum levels and ALA urine levels were measured before, 3 and 24 hours after administration of Ameluz for photodynamic treatment.
Maltese: Distribuzzjoni Fi prova klinika ta' fażi-II, il-livelli tal-5-aminolaevulinic acid u protoporphyrin IX serum u l-livelli tal-ALA fl-awrina tkejlu qabel, 3 u 24 siegħa wara l-amministrazzjoni ta' Ameluz għall-kura fotodinamika.
English: Ameluz was also compared with placebo treatment in a randomised, double-blind clinical trial enrolling 122 AK patients.
Maltese: Ameluz tqabbel ma' kura bi plaċebo fi prova klinika randomizzata, double-blind li ngaġġat 122 pazjent b'AK.
English: At application site: Discoloration, ulcer, swelling, inflammation, hypersensitivity*1
Maltese: iperalġeżja, emorraġija, sħana, sensittività eċċessiva*1
English: The red light source provided either a narrow spectrum around 630 nm at a light dose of 37 J/cm2 (Aktilite CL 128) or a broader and continuous spectrum in the range between 570 and 670 nm at a light dose of 170 J/cm2 (Photodyn 750).
Maltese: Is-sors ta' dawl aħmar ipprovda jew spettru ta' dawl ta' madwar 630 nm f'doża ta' dawl ta' 37 J/ċm2 (Aktilite CL 128) jew spettru usa' u kontinwu fil-firxa ta' bejn 570 u 670 nm f'doża ta' dawl ta' 170 J/ċm2 (Photodyn 750).
English: NAME OF THE MEDICINAL PRODUCT Ameluz 78 mg/g gel
Maltese: Ameluz 78 mg/g ġel
English: 51377 Leverkusen, Germany Tel: +49 214 87632 66, Fax: +49 214 87632 90 Email: ameluz@biofrontera.com
Maltese: 51377 Leverkusen, Il-Ġermanja Tel: +49 214 87632 66, Fax:
English: Mottled or irregular pigmentation
Maltese: Pigmentazzjo ni bid-dbabar jew irregolari
English: • nervousness
Maltese: • uġigħ • nervożiżmu
English: Efficacy and safety of Ameluz for the treatment of actinic keratosis (AK) has been evaluated in 696 patients enrolled in clinical trials.
Maltese: L-effikaċja u s-sigurtà ta' Ameluz għall-kura tal-keratosi aktinika (actinic keratosis, AK) ġew evalwati fi 696 pazjent fi provi kliniċi.
English: It is used to treat:
Maltese: c) Tidwil:
English: In this study, photodynamic therapy with Ameluz was tested for non-inferiority to a cream containing 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4oxopentanoate]).
Maltese: inferjorità għal krema li fiha 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4-oxopentanoate])
English: This therapy is known as photodynamic therapy (PDT).
Maltese: Din it-terapija hija magħrufa bħala terapija fotodinamika (PDT - photodynamic therapy).
English: Lesions of mild severity were cleared by 99.1 % vs. 49.2 %, those of moderate severity by 91.7 % vs. 24.1 % for treatment with Ameluz and placebo, respectively.
Maltese: 49.2%, dawk ta' severità moderata b'91.7% vs. 24.1% għall-kura b'Ameluz u plaċebo, rispettivament.
English: Treatment of basal cell carcinoma (BCC):
Maltese: Kura ta' karċinoma taċ-ċelluli bażali (BCC):
English: burning pain), irritation, pruritus, oedema, scab, exfoliation, induration, paraesthesia
Maltese: Eritema, uġigħ (inkluż uġigħ bil-ħruq), irritazzjoni, ħakk, edema, skorċa, tqaxxir, twebbis, parasteżija
English: Ameluz does not increase 5-aminolaevulinic acid or protoporphyrin IX plasma levels following topical application.
Maltese: Ameluz ma jżidx il-livelli tal-5-aminolaevulinic acid jew tal-protoporphyrin IX plasma wara applikazzjoni topika.
English: Cosmetic outcome assessed 12 weeks after the last photodynamic therapy (with baseline sum score 0 excluded) was judged as: very good or good in 43.1% of subjects in the Ameluz group, 45.2% in the MAL group and 36.4% in the placebo group; and unsatisfactory or impaired in 7.9%, 8.1% and 18.2% of subjects, respectively.
Maltese: Ir-riżultat kosmetiku vvalutat 12-il ġimgħa wara l-aħħar terapija fotodinamika (bis-somma tal-linja bażi 0 eskluża) kien iġġudikat bħala: tajjeb ħafna jew tajjeb fi 43.1% tas-suġġetti fil-grupp ta' Ameluz, 45.2% fil-grupp MAL u 36.4% fil-grupp tal-plaċebo; u mhux sodisfaċenti jew indebolit f'7.9%, 8.1% u 18.2% tas-suġġetti rispettivament.
English: In a randomised, observer blinded clinical trial with 571 AK patients and a follow-up duration of 6 and 12 months, photodynamic therapy with Ameluz was tested for non-inferiority to a commercially registered cream containing 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4-oxopentanoate]) and superiority over placebo.
Maltese: Fi prova klinika, randomizzata, bl-osservatur ‘blinded' b'571 pazjent b'AK u b'segwitu ta' 6 u 12-il xahar, it-terapija fotodinamika b'Ameluz ġiet ittestjata għan-non-inferjorità għal krema rreġistrata b'mod kummerċjali li fiha 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4-oxopentanoate]) u s-superjorità fuq plaċebo.
English: The increased effects correlate with the higher clearance rate of narrow spectrum lamps (see section 5.1).
Maltese: L-effetti miżjuda jikkorrelataw mar-rata ogħla ta' eliminazzjoni tal-lampi bi spettru dejjaq (ara sezzjoni 5.1).
English: In a clinical trial designed to investigate the sensitization potential of ALA with 216 healthy subjects, 13 subjects (6%) developed allergic contact dermatitis after continuous exposure for 21 days with doses of ALA that were higher than doses normally used in the treatment of AK. Allergic contact dermatitis has not been observed under regular treatment conditions.
Maltese: Fi prova klinika maħsuba biex tinvestiga l-potenzjal ta' sensitizzazzjoni ta' ALA b'216-il individwu b'saħħithom, 13-il individwu (6%) żviluppaw dermatite allerġika tal-kuntatt wara esponiment kontinwu għal 21 jum b'dożi ta' ALA li kienu ogħla minn dożi normalment użati fil-kura ta' AK.
English: An entire tube of placebo and Ameluz followed by PDT was applied in a fixed sequence design with a washout period of 7 days to evaluate baseline and Ameluz dependent plasma concentrations of ALA and PpIX.
Maltese: Tubu sħiħ ta' plaċebo u Ameluz segwit minn PDT ġew applikati f'disinn ta' sekwenza fissa b'perjodu washout ta' 7 ijiem biex jiġu evalwati l konċentrazzjonijiet fil-plażma ta' ALA u PpIX fil-linja bażi li huma dipendenti fuq Ameluz.
English: Total lesion clearance rates were higher for Ameluz (90.4%) compared to MAL (83.2%) and placebo (37.1%).
Maltese: 4%) meta mqabbel ma' MAL (83.2%) u plaċebo (37.1%).
English: Total lesion clearance was higher for Ameluz (81.1%) compared to placebo (20.9%).
Maltese: L-eliminazzjoni totali talleżjoni kienet ogħla għal Ameluz (81.1%) meta mqabbel mal-plaċebo (20.9%).
English: Treatment of actinic keratosis (AK) and field cancerization:
Maltese: Għall-kura ta ' keratosi aktinika (actinic keratosis, AK), sessjoni waħda ta' terapija fotodinamika
English: Following topical application of 5-aminolaevulinic acid (ALA), the substance is metabolized to protoporphyrin IX, a photoactive compound which accumulates intracellularly in the treated actinic keratosis and basal cell carcinoma lesions.
Maltese: Wara l-applikazzjoni topika tal-5-aminolaevulinic acid (ALA), is-sustanza tiġi metabolizzata għal protoporphyrin IX, kompost fotoattiv li jakkumula fiċ-ċelloli fil-leżjonijiet b'keratosi aktinika u karċinoma taċ-ċelluli bażali trattati.
English: Of the BCC lesions, 94.6% were cleared with Ameluz, 92.9% with MAL. For nodular BCC, 89.3% of the lesions were cleared with Ameluz, 78.6% with MAL.
Maltese: Għal BCC nodulari, 89.3% tal-leżjonijiet fiequ b'Ameluz, 78.6% b'MAL.
English: 4.5 Interaction with other medicinal products and other forms of interaction
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta'interazzjoni
English: During the post-marketing phase 20 cases indicative of application site hypersensitivity have been received for Ameluz.
Maltese: Matul il-fażi ta' wara t-tqegħid fis-suq kienu rrapportati 20 każ li jindikaw sensittività eċċessiva fis sit tal-applikazzjoni għal Ameluz.
English: The complete patient clearance rate for Ameluz was 93.4%, compared to 91.8% for the comparator MAL.
Maltese: Ir-rata ta ' fejqan komplet tal-pazjenti għal Ameluz kienet ta' 93.4%, imqabbla ma' 91.8% għallkomparatur MAL.
English: • Hypersensitivity to the active substance, to porphyrins, to soya or peanuts, or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva, għal porphyrins, għas-sojja jew għall-karawett, jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: • The use of Ameluz is not recommended if you use immunosuppressants.
Maltese: • L-użu ta' Ameluz mhux rakkomandat jekk tuża immunosoppressanti.
English: confusion and disorientation*, Dysaesthesia
Maltese: Amnesija globali temporanja (li tinkludi konfużjoni u diżorjentazzjoni)*, Disestesija
English: Hypopigmentation
Maltese: MEDIĊINALI
English: The red light source provided a narrow spectrum around 635 nm at a light dose of 37 J/cm2 (BF-RhodoLED).
Maltese: madwar 635 nm f'doża ta' dawl ta' 37 J/cm2 (BF-RhodoLED).
English: Overdose following topical administration is unlikely and has not been reported in clinical studies.
Maltese: Doża eċċessiva wara amministrazzjoni topika mhijiex probabbli u ma ġietx irrapportata fi studji kliniċi.
English: Ameluz was tested for non-inferiority to a cream containing 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4-oxopentanoate]) commercially registered for daylight PDT.
Maltese: 16% methyl-aminolevulinate (MAL, methyl-[5-amino-4-oxopentanoate]).
English: MAL Patient number n (%)
Maltese: Ameluz Numru ta' pazjenti n (%)
English: Patient recurrence rates were 24.5 % and 14.3 % after 6 months, and additionally 12.2 % and 0 % after 12 months for Ameluz and placebo, respectively.
Maltese: Ir-rati ta' rikorrenza tal-pazjenti kienu 24.5% u 14.3% wara 6 xhur, u addizzjonalment 12.2% u 0% wara 12
English: Broad spectrum
Maltese: Spettru dejjaq
English: The study demonstrated the non-inferiority of Ameluz compared to MAL cream [lower 97.5% -confidence limit 0.0].
Maltese: L-istudju wera n-nuqqas ta' inferjorità ta' Ameluz meta mqabbel mal-krema MAL [limitu ta' kunfidenza tal-inqas 97.5% 0.0].
English: Broad spectrum Ameluz
Maltese: • Evita li tapplika Ameluz
English: Before PDT (%) 12 months after PDT (%)
Maltese: PDT (%)
English: Patient distribution in the subgroups was similar for both products and represents the distribution in the general population, where more than 70% of BCCs are located in the head/trunk region.
Maltese: Id-distribuzzjoni tal-pazjenti fis-sottogruppi kienet simili għaż-żewġ prodotti, u tirrappreżenta ddistribuzzjoni fil-popolazzjoni ġenerali, fejn aktar minn 70% tal-BCCs jinsabu fir-reġjun tar-ras/tronk.
English: In clinical phase III, a total of 436 patients were treated with Ameluz.
Maltese: III, total ta' 436 pazjent ġew ikkurati b'Ameluz.
English: Protoporphyrin IX is activated by illumination with red light of a suitable wavelength and energy.
Maltese: Protoporphyrin IX huwa attivat bit-tidwil. b'wavelength u enerġija xierqa.
English: Eyelid oedema, vision blurred, visual impairment
Maltese: Edema fil-kappell tal-għajnejn, vista mċajpra, indeboliment tal-vista
English: Table 3b: Total Lesion Clearance (Percentage of Completely Cleared Individual Lesions) N BF-200 ALA Mean + SD (%)
Maltese: Tabella 3b: Fejqan Sħiħ tal-Leżjonijiet (Perċentwali ta' Leżjonijiet Individwali li Fiequ Kompletament)
English: Photodynamic therapy (PDT) may be a precipitating factor for transient global amnesia in very rare instances.
Maltese: Riskju ta' Amnesija Globali Temporanja (Transient Global Amnesia, TGA) Terapija fotodinamika (Photodynamic therapy, PDT) tista ' tkun fattur preċipitanti għal amnesija globali temporanja f'każijiet rari ħafna.
English: An unsatisfactory or impaired cosmetic outcome was judged for 3.8% of the subjects in the Ameluz group and in 22.5% of the subjects in the placebo group.
Maltese: 3.8% tas-suġġetti fil-grupp ta' Ameluz meta mqabbel ma' 22.5% tas-suġġetti fil-grupp ta' plaċebo.
English: - allergic reaction1
Maltese: - reazzjoni allerġika
English: There is no relevant use of Ameluz in the paediatric population.
Maltese: M'hemm l-ebda użu relevanti ta' Ameluz fil-popolazzjoni pedjatrika.
English: Efficacy and safety of Ameluz for the treatment of basal cell carcinoma (BCC) with a thickness of <2mm has been evaluated in 281 patients enrolled in a phase III clinical trial.
Maltese: L-effikaċja u s-sigurtà ta' Ameluz għall-kura ta' karċinoma taċ-ċelluli bażali (basal cell carcinoma, BCC) bi ħxuna ta' <2 mm ġew evalwati f'281 pazjent li kienu rreġistrati fi prova klinika ta ' fażi
English: If Ameluz is accidentally ingested, systemic toxicity is unlikely.
Maltese: Jekk Ameluz jinbela' b'mod aċċidentali, it-tossiċità sistemika mhijiex probabbli.
English: Hyperpigmentation
Maltese: Disturbi psikjatriċi
English: This is to be expected as the therapeutic principle of photodynamic therapy is based on phototoxic effects of protoporphyrin IX which is synthesized from the active ingredient 5-aminolaevulinic acid.
Maltese: Dan huwa mistenni billi l-prinċipju terapewtiku tat-terapija fotodinamika huwa bbażat fuq l-effetti fototossiċi tal protoporphyrin IX li hu sintetizzat mis-sustanza attiva l-5-aminolaevulinic acid.
English: Care is taken to avoid bleeding.
Maltese: Oqgħod attent biex tiġi evitata fsada.
English: Risk of mucous membrane and eye irritation
Maltese: Riskju ta' irritazzjoni tal-membrana mukuża u tal-għajnejn
English: Table 2b: Efficacy and adverse reactions (transient pain and erythema) occurring at the application site during photodynamic therapy with different light sources for the treatment of AK Light source
Maltese: Tabella 2b: Effikaċja u reazzjonijiet avversi (uġigħ temporanju u eritema) li jseħħu fis-sit tal applikazzjoni matul terapija fotodinamika b'sorsi differenti ta' dawl għall-kura ta ' AK Sors ta' dawl
English: In vitro dermal absorption into human skin was studied using Ameluz containing radiolabelled 5-aminolaevulinic acid (ALA).
Maltese: L-assorbiment dermali in vitro fil-ġilda umana ġie studjat bl-użu ta' Ameluz li fih il-5-aminolaevulinic acid (ALA) radjutikkettjat.
English: The probability to require only one treatment with Ameluz and remain completely cleared 12 months later was 34.5% on average with all lamps.
Maltese: Il-probabbiltà li jkun hemm bżonn biss ta' kura waħda b'Ameluz u l pazjent jibqa' mfejjaq kompletament 12-il xahar wara, kellha medja ta' 34.5% bil-lampi kollha.
English: • superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
Maltese: • karċinoma taċ-ċelluli bażali superfiċjali u/jew nodulari, li ma tkunx adattata għal kura kirurġika minħabba l-possibbiltà ta ' morbidità relatata mal-kura u/jew riżultat kożmetiku batut fl-adulti.
English: Do not use this medicine after the expiry date which is stated on the tube and carton after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tubu u l-kartuna wara EXP.
English: The efficacy of Ameluz in combination with daylight PDT was tested in a randomised, observer-blind, intra-individual phase III clinical trial enrolling 52 patients with 3-9 AKs on each side of the face and/ or scalp.
Maltese: III li fiha l-osservatur ma kienx jaf x'mediċina ngħatat fejn ġew irreġistrati 52 pazjent bi 3-9 AKs fuq kull naħa tal-wiċċ u/ jew tal-qorriegħa.
English: Fertility There are no data available on the effect of 5-aminolaevulinic acid on fertility.
Maltese: M'hemm l-ebda data disponibbli dwar l-effett ta' 5-aminolaevulinic acid fuq il-fertilità.
English: A therapy session can be administered for single or multiple lesions, or entire treatment fields.
Maltese: Tista' tiġi amministrata sessjoni ta' terapija għal leżjonijiet singoli u multipli, jew kampijiet sħaħ ta' kura.
English: Ameluz was superior to placebo with respect to patient complete clearance rates (90.9% vs. 21.9% for Ameluz and placebo, respectively; p < 0.0001) and lesion complete clearance rates (94.3% vs. 32.9%, respectively; p < 0.0001), as controlled 12 weeks after the last PDT.
Maltese: Ameluz kien superjuri meta mqabbel mal-plaċebo fir-rigward ta' rati ta' tneħħija kompleti tal-pazjenti (90.9% vs. 21.9% għal Ameluz u lplaċebo, rispettivament;
English: The most common signs and symptoms are application site irritation, erythema, pain, and oedema.
Maltese: L-aktar sinjali u sintomi komuni huma irritazzjoni fis-sit tal-applikazzjoni, eritema, uġigħ u edema.
English: If amnesia is observed, the PDT must be discontinued immediately (see section 4.8).
Maltese: Jekk tiġi osservata amnesija, il-PDT għandha titwaqqaf immedjatament (ara sezzjoni 4.8).
English: 1 g Ameluz contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
Maltese: U KWANTITATTIVA Gramma (g) ġel fiha 78 mg tal-5-aminolaevulinic acid (bħala hydrochloride).
English: Adverse events and tolerability were comparable for both treatments.
Maltese: L-avvenimenti avversi u t-tollerabilità kienu komparabbli għaż-żewġ trattamenti.
English: Non-clinical data reveal no special hazard for humans based on dermal toxicity studies or studies reported in the literature of repeated dose toxicity, genotoxicity and reproductive toxicity.
Maltese: Informazzjoni mhux klinika ma turi l-ebda periklu speċjali għall-bnedmin skont l-istudji dwar it tossiċita dermali jew studji rrapportati f'letteratura tat-tossiċità tad-doża ripetuta, ġenotossiċità u ttossiċità riproduttiva.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram contains 78 mg of 5-aminolaevulinic acid (as hydrochloride).
Maltese: • Is-sustanza attiva hi 5-aminolaevulinic acid 1 g Ameluz fiha 78 mg ta 5-aminolaevulinic acid (bħala hydrochloride).
English: • Known photodermatoses of varying pathology and frequency, e.g. metabolic disorders such as aminoaciduria, idiopathic or immunological disorders such as polymorphic light reaction, genetic disorders such as xeroderma pigmentosum, and diseases precipitated or aggravated by exposure to sun light such as lupus erythematoides or phemphigus erythemtoides.
Maltese: Disturbi metaboliċi bħal aminoaciduria, disturbi idjopatiċi jew immunoloġiċi bħal reazzjoni polimorfika għad-dawl, disturbi ġenetiċi bħal xerodema pigmentosum u mard preċipitat jew aggravat bl-espożizzjoni għad-dawl tax-xemx bħal-lupus erythematoides jew phemphigus erythemtoides.
English: Total patient clearance (%)
Maltese: Eliminazzjon i totali millpazjenti (%)
English: • medicines to treat bacterial infection with active substance names beginning with “sulfa” or ending in “oxacin” or “cycline”, such as tetracycline
Maltese: • mediċini biex tiġi kkurata infezzjoni batterjali bl-ismijiet tas-sustanza attiva jibdew b'“sulfa”
English: Grade
Maltese: TIKKETTAR