FrancophonIA/ELRC3.0 huggingface dataset:
English: Jenzyl was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 August 2005 and 28 October 2005 for the treatment of soft tissue sarcoma and primary malignant bone tumours.
Maltese: Jenzyl kien ikklassifikat bħala ‘mediċina orfni' (mediċina li tintuża fil-mard rari) fis-26 ta' Awwissu 2005 u fit-28 ta' Ottubru 2005 għall-kura ta' sarkoma tat-tessut artab u tumuri primarji malinni tal-għadam.
English: On 27 November 2012, Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy.
Maltese: Fis-27 ta' Novembru 2012, Merck Sharp & Dohme Limited għarrfet uffiċjalment lill-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għallawtorizzazzjoni għat-tqegħid fis-suq għal Jenzyl, għall-kura ta' manteniment ta' pazjenti b'sarkoma metastatika tat-tessut artab jew b'sarkoma tal-għadam li kienu rċevew kura preċedenti b'kimoterapija.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP kien evalwa d-dokumentazzjoni pprovduta mill-kumpanija u fformula lista ta' mistoqsijiet.
English: In terms of safety, the CHMP was concerned by the high frequency of side effects interfering with the patient's wellbeing as well as some uncommon but potentially lifethreatening side effects.
Maltese: F'termini ta' sigurtà, is-CHMP kien imħasseb bil-frekwenza għolja ta' effetti sekondarji li jinterferixxu mal-benesseri tal-pazjent kif ukoll xi effetti sekondarji mhux komuni imma potenzjalment ta' periklu għall-ħajja.
English: In the body, ridaforolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Maltese: Fil-ġisem, ridaforolimus l-ewwel teħel ma' proteina msejħa FKBP-12 li tinstab fiċċelloli biex tagħmel ‘kumpless'.
English: What was Jenzyl expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Jenzyl?
English: Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma (a type of cancer that affects the soft, supporting tissues of the body) or bone sarcoma (bone cancer) that are metastatic (have spread to other parts of the body).
Maltese: Jenzyl kien mistenni li jintuża fil-kura ta' adulti b'sarkoma tat-tessut artab (tip ta' kanċer li jaffettwa ttessuti ta' sostenn rotob tal-ġisem) jew b'sarkoma tal-għadam (kanċer tal-għadam) metastatiċi (ikunu nfirxu lejn partijiet oħra tal-ġisem).
English: The CHMP was concerned that taking Jenzyl only led to a small increase in the time patients lived until their disease got worse compared with placebo (18 versus 15 weeks in patients who had one or more regimens of previous chemotherapy, and 16 versus 10 weeks in patients who had received two or three previous regimens of chemotherapy).
Maltese: Is-CHMP kien imħasseb li t-teħid ta' Jenzyl wassal biss għal żieda żgħira fiż-żmien li l-pazjenti għexu sakemm il-marda tagħhom marret għall-agħar meta mqabbel ma' plaċebo (18 kontra 15-il ġimgħa f'pazjenti li kellhom reġimen preċedenti wieħed jew aktar ta' kimoterapija, u 16 kontra 10 ġimgħat f'pazjenti li kienu rċevew żewġ jew tliet reġimens preċedenti ta' kimoterapija).
English: The active substance in Jenzyl, ridaforolimus, blocks the action of an enzyme called ‘mammalian target of rapamycin' (mTOR), which regulates the growth and division of cells in the body and which has increased activity in patients with sarcoma.
Maltese: Is-sustanza attiva f'Jenzyl, ridaforolimus, timblokka l-azzjoni ta' enzima msejħa ‘mira mammifera ta' rapamycin' (mTOR), li tirregola t-tkabbir u d-diviżjoni ta' ċelloli fil-ġisem u li għandha żieda fl-attività f'pazjenti b'sarkoma.
English: Withdrawal of the marketing authorisation application for Jenzyl (ridaforolimus)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat tqegħid fis-suq għal Jenzyl (ridaforolimus)
English: How is Jenzyl expected to work?
Maltese: Kif huwa mistenni li jaħdem Jenzyl?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy.
Maltese: Abbażi tar-reviżjoni tad-dejta u t-tweġibiet tal-kumpanija għal-lista ta' mistoqsijiet tas-CHMP, fil-ħin tal-irtirar, is-CHMP kellu xi tħassib u kien tal-opinjoni provviżorja li Jenzyl ma setax jiġi approvat għallkura ta' pazjenti b'sarkoma metastatika tat-tessut artab jew b'sarkoma tal-għadam bħala terapija ta' manteniment.
English: The company presented the results of one main study involving 711 patients with metastatic soft tissue sarcoma or bone sarcoma who have received up to four cycles of one, two or three alternative chemotherapy regimens.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju ewlieni wieħed li fih ħadu sehem 711-il pazjent b'sarkoma metastatika tat-tessut artab jew b'sarkoma tal-għadam li kienu rċevew sa erba' ċikli ta' reġimen wieħed, tnejn jew tlieta ta' kimoterapija alternattiva.
English: Av. D. João II,
Maltese: D. João II,
English: Κιλκίς 35, 2234 Λατσιά
Maltese: Κιλκίς 35, 2234
English: 7 Офис сграда „Сердика Офиси“ 1505 София
Maltese: Офис сграда „Сердика Офиси“ 1505
English: 61352 Bad Homburg Germany
Maltese: 61352 Bad Homburg
English: Depression Irritability
Maltese: Depressjoni Irritabilità
English: Αγίου Δημητρίου 63 17456 Άλιμος
Maltese: Αγίου Δημητρίου 63 17456
English: Meda AB Pipers väg 2A 170 73 Solna Sweden
Maltese: Meda AB Pipers väg 2A 170 73 Solna L-Isvezja
English: Cream.
Maltese: Krema.
English: Vilnius LT-09303
Maltese: LT-09303
English: Summary of the safety profile:
Maltese: Sommarju tal-profil ta' sigurtà:
English: - The active substance is imiquimod.
Maltese: - Is-sustanza attiva hi imiquimod.
English: EU/1/12/783/001 14 sachets EU/1/12/783/002 28 sachets EU/1/12/783/003 56 sachets
Maltese: EU/1/12/783/001 14-il qartas EU/1/12/783/002 28 qartas EU/1/12/783/003 56 qartas
English: Herpes simplex
Maltese: Herpes simplex (xlieqa)
English: Mylan Products Ltd. Station Close Potters Bar Hertfordshire EN6 1TL
Maltese: Station Close Potters Bar Hertfordshire EN6 1TL
English: Erythema multiforme Stevens Johnson syndrome Cutaneous lupus erythematosus
Maltese: Erythema multiforme Sindrome Stevens Johnson Lupus erythematosus tal-ġilda Iperpigmentazzjoni tal-ġilda
English: White soft paraffin Polysorbate 60
Maltese: Paraffin abjad artab Polysorbate 60
English: Loughborough Leicestershire LE11 5SF, United Kingdom
Maltese: Loughborough Leicestershire LE11 5SF, Ir-Renju Unit
English: Meda Health Sales Ireland Ltd. Unit 34/35, Block A, Dunboyne Business Park, Dunboyne, Co Meath, Ireland Tel: +353 1 802 66 24
Maltese: Unit 34/35, Block A, Dunboyne Business Park, Dunboyne, Co Meath, Ireland Tel: +353 1 802 66 24
English: Cream 14 sachets 28 sachets 56 sachets
Maltese: Krema 14-il qartas 28 qartas 56 qartas
English: Rare (≥ 1/10,000 to < 1/1,000);
Maltese: Rari (≥ 1/10,000 sa < 1/1,000);
English: This difference was not statistically significant.
Maltese: Din id-differenza ma kinitx statistikament sinifikanti.
English: Fertility No clinical data are available, potential risk for human is unknown.
Maltese: Fertilità Peress li m'hemmx dejta klinika disponibbli, ir-riskju potenzjali għall-bniedem mhux magħruf.
English: This includes studies with immunosuppressive medicinal products.
Maltese: Dan jinkludi studji bi prodotti mediċinali immunosoppressivi.
English: Dolenjska cesta 242c 1000 Ljubljana Tel: +386 1 23 63 180
Maltese: GSP Proizvodi d.o.o. Dolenjska cesta 242c 1000 Ljubljana Tel: +386 1 23 63 180
English: Methyl parahydroxybenzoate (E 218) 2.0 mg/g cream Propyl parahydroxybenzoate (E 216) 0.2 mg/g cream Cetyl alcohol 22.0 mg/g cream Stearyl alcohol 31.0 mg/g cream Benzyl alcohol 20.0 mg/g cream
Maltese: Methyl parahydroxybenzoate (E 218) 2.0 mg /g krema Propyl parahydroxybenzoate (E 216) 0.2 mg /g krema Cetyl alcohol 22.0 mg /g krema Stearyl alcohol 31.0 mg /g krema Benzyl alcohol 20.
English: Date of first authorisation: 23/08/2012 Date of latest renewal: 22/03/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 23/08/2012 Data tal-aħħar tiġdid: 22/03/2017
English: Zyclara contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol
Maltese: Zyclara fih methylparahydroxybenzoate, propylparahydroxybenzoate, cetyl alcohol, stearyl alcohol u benzyl alcohol
English: C/ Plom, 2-4, 5ª planta 08038 - Barcelona Tel: +34 900 102 712
Maltese: Mylan Pharmaceuticals, S.L. C/ Plom, 2-4, 5ª planta 08038 - Barcelona Tel: +34 900 102 712
English: Chaussée de la Hulpe 166 Terhulpsesteenweg 1170 Brussels
Maltese: Meda Pharma S.A./N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 1170 Brussels
English: Zyclara 3.75% cream
Maltese: Zyclara 3.75% krema
English: Each gram of cream contains 37.5 mg of imiquimod.
Maltese: Kull gramma ta' krema fiha 37.5 mg ta' imiquimod.
English: 170 09 Solna Sweden
Maltese: 170 09 Solna L-Isvezja
English: Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events (see section 4.8 and 4.9).
Maltese: Applikazzjoni fuq ġilda maqsuma tista' twassal għal assorbiment sistemiku akbar ta' imiquimod li jwassal għal riskju akbar ta' avvenimenti avversi (ara sezzjoni 4.8 u 4.9).
English: Interactions with systemic medicinal products would be limited by the minimal percutaneous absorption of imiquimod cream.
Maltese: Interazzjonijiet ma' prodotti mediċinali sistemiċi jkunu limitati minħabba assorbiment minimu mill-ġilda tal-krema imiquimod.
English: Maximum daily dose is 2 sachets (500 mg = 2 sachets of 250 mg each).
Maltese: Doża massima ta' kuljum hija 2 qratas (500 mg = 2 qratas ta' 250 mg kull wieħed).
English: This medicine contains 5 mg benzyl alcohol in each sachet.
Maltese: Din il-mediċina fiha 5 mg benzyl alcohol f'kull qartas.
English: Each sachet contains 9.375 mg of imiquimod in 250 mg cream (100 mg of cream contains 3.75 mg imiquimod).
Maltese: Kull qartas fih 9.375 mg ta' imiquimod f'250 mg ta' krema (100 mg ta' krema fiha 3.75 mg imiquimod).
English: Myalgia Arthralgia
Maltese: Majalġja Artralġja
English: Zyclara 3.75% cream imiquimod
Maltese: Zyclara 3.75% krema Imiquimod
English: Pharmacotherapeutic group: Antibiotics and chemotherapeutics for dermatological use, antivirals, ATC Code: D06BB10
Maltese: Antibijotiċi u kimoterapewtiċi għall-użu dermatoloġiku, antivirali, Kodiċi ATC:
English: Common (≥ 1/100 to < 1/10);
Maltese: Komuni (≥ 1/100 sa < 1/10);
English: For the combined trials the complete clearance rate of the full face or balding scalp under imiquimod 3.75% cream was 35.6% (57/160 patients, CI 28.2%, 43.6 %) under vehicle 6.3% (10/159 patients, CI 3.1%, 11.3%) at the 8-week post-treatment visit.
Maltese: Għall-provi kkombinati r-rata ta' tneħħija kompluta għall-wiċċ kollu jew qorriegħa li qed tiqriegħ taħt krema imiquimod 3.75% kienet ta' 35.6% (57/160 pazjent, CI 28.2%, 43.6%) u taħt krema mingħajr mediċina kienet ta' 6.3% (10/159 pazjent, CI 3.1%, 11.3%) fil-vista ta' wara 8 ġimgħat wara l-kura.
English: Each sachet contains 9.375 mg of imiquimod in 250 mg cream (3.75%).
Maltese: Kull qartas fih 9.375 mg ta' imiquimod f'250 mg ta' krema (3.75 %).
English: Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to simulated solar ultraviolet radiation (UVR).
Maltese: Krema imiquimod kienet evalwata f'bioassay għall-fotokarċinoġeniċità fi ġrieden albini bla pil esposti għal radjazzjoni solari ultravjola simulata (UVR).
English: A different therapy is recommended if the treated lesion(s) show(s) insufficient response to Zyclara.
Maltese: Hija rakkomandata terapija differenti jekk il-leżjoni(jiet) ittrattata(i) turi(juru) rispons insuffiċjenti għal Zyclara.
English: Imiquimod is an immune response modifier.
Maltese: Imiquimod huwa modifikatur tar-rispons immuni.
English: Zyclara 3.75% cream contains the active substance imiquimod, which is an Immune Response Modifier (to stimulate the human immune system).
Maltese: Il-krema Zyclara 3.75% fiha s-sustanza attiva imiquimod, li huwa Modifikatur tar-Rispons Immuni (biex jistimula s-sistema immuni tal-bniedem).
English: Squamous cell carcinoma (SCC) was reported in 1.3% (2/160) of patients treated with imiquimod 3.75%, in 0.6% (1/159) treated with vehicle.
Maltese: Karċinoma taċ-ċellula skwamuża (SCC) kienet irrappurtata f'1.3% (2/160) tal-pazjenti kkurati b'imiquimod 3.75%, u f'0.6% (1/159) tal-pazjenti kkurati bi krema mingħajr mediċina.
English: Boxes of 14, 28, and 56 single-use polyester/ white low density polyethylene/ aluminium foil sachets, containing 250 mg of cream.
Maltese: Kaxxi ta' 14, 28, u 56 qartas tal-fojl għall-użu ta' darba magħmul minn polyester/polyethylene abjad ta' densità baxxa/aluminju, li fihom 250 mg ta' krema.
English: - The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, purified water (see also section 2 “Zyclara contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol”).
Maltese: - Is-sustanzi l-oħra huma isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, paraffin abjad artab, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, ilma ppurifikat (ara wkoll sezzjoni 2 “Zyclara fih methyl parahydroxybenzoate, propyl parahydroxybenzoate, cetyl alcohol, stearyl alcohol u benzyl alcohol”).
English: Clinical studies investigating the use of imiquimod 5% cream for the treatment of actinic keratosis have detected a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area.
Maltese: Studji kliniċi li nvestigaw l-użu ta' krema imiquimod 5% għall-kura ta' keratosi aktinika sabu frekwenza ta' 0.4% (5/1214) ta' alopeċja fis-sit ikkurata jew fl-erja tal-madwar.
English: Uncommon (≥ 1/1,000 to < 1/100);
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100);
English: Benzyl alcohol may cause allergic reactions and mild local irritation.
Maltese: Benzyl alcohol jista' jikkawża reazzjonijiet allerġiċi u irritazzjoni lokali ħafifa.
English: Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod 5 % cream use.
Maltese: Intbagħtu rapporti ta' ipopigmentazzjoni u iperpigmentazzjoni lokalizzata wara l-użu ta' krema imiquimod 5%.
English: - Each box contains 14, 28 or 56 single-use polyester/ white low density polyethylene/aluminium foil sachets.
Maltese: - Kull kaxxa fiha 14, 28 jew 56 qartas tal-fojl għall-użu ta' darba magħmul minn polyester/polyethylene abjad ta' densità baxxa/aluminju.
English: Other medicines and Zyclara
Maltese: Mediċini oħra u Zyclara
English: No overall differences in safety or effectiveness were observed between patients 65 years or older and the younger patients.
Maltese: Ma kienux osservati differenzi globali fis-sigurtà jew fl-effettività bejn pazjenti ta' 65 sena jew akbar u pazjenti iżgħar.
English: Methyl parahydroxybenzoate (E 218), and propyl parahydroxybenzoate (E 216) may cause allergic reactions (possibly delayed).
Maltese: Methyl parahydroxybenzoate (E 218), u propyl parahydroxybenzoate (E 216) jistgħu jikkawżaw reazzjonijiet allerġiċi (possibilment ittardjati).
English: Mylan Pharmaceuticals, S.L.
Maltese: Mylan Products Ltd.
English: Infection Pustules
Maltese: Infezzjonijiet u infestazzjonijiet
English: Rare cases of remote site dermatologic reactions, including erythema multiforme, have been reported from clinical trials with imiquimod 5% cream therapy.
Maltese: Reazzjonijiet dermatoloġiċi f'siti l-bogħod miż-żona kkurata Każijiet rari ta' reazzjonijiet dermatoloġiċi f'siti l-bogħod miż-żona kkurata, inkluż eritema multiforme, ġew irrappurtati minn provi kliniċi b'terapija bi krema imiquimod 5%.
English: It is the lead compound of the imidazoline family.
Maltese: Huwa l-kompost maġġuri tal-familja imidazoline.
English: During a pharmacokinetic study with imiquimod 3.75% cream following application of 2 sachets once daily (18.75 mg imiquimod/day) for up to three weeks to the entire face and/or scalp (approximately 200 cm2), low systemic absorption of imiquimod was observed in patients with AK. Steady-state levels were achieved in 2 weeks and time to maximal concentrations (Tmax) ranged between 6 and 9 hours after last application.
Maltese: Waqt studju dwar il-farmakokinetika bi krema imiquimod 3.75% wara applikazzjoni ta' 2 qratas darba kuljum (18.75 mg imiquimod/kuljum) għal mhux aktar minn tliet ġimgħat fuq il-wiċċ kollu u/jew qorriegħa (madwar 200 cm2), assorbiment sistemiku baxx ta' imiquimod kien osservat f'pazjenti b'AK.
English: There is also a possibility that existing inflammation may temporarily worsen.
Maltese: Hemm ukoll il-possibbiltà li infjammazzjoni eżistenti tista' taggrava temporanjament.
English: When applied topically, systemic overdose with imiquimod cream is unlikely due to minimal percutaneous absorption.
Maltese: Meta applikat lokalment, doża eċċessiva sistemika b'krema imiquimod hija improbabbli minħabba assorbiment minimu mill-ġilda.
English: The following side effects with imiquimod were reported:
Maltese: Kienu rrappurtati l-effetti sekondarji li ġejjin b'imiquimod:
English: In animal models imiquimod is effective against viral infections and acts as an antitumour agent principally by inducing release of alpha interferon and other cytokines.
Maltese: F'mudelli ta' annimali imiquimod huwa effettiv kontra infezzjonijiet virali u jaġixxi bħala sustanza kontra t-tumuri prinċipalment permezz tal-induzzjoni tar-reħa ta' alpha interferon u ta' ċitokini oħra.
English: Biotransformation Orally administered imiquimod is rapidly and extensively metabolised into two main metabolites.
Maltese: Imiquimod mogħti mill-ħalq jiġi metabolizzat b'mod rapidu u estensiv f'żewġ metaboliti prinċipali.
English: No special requirements.
Maltese: Ilma ppurifikat
English: - experience with imiquimod 5% cream
Maltese: - esperjenza bi krema imiquimod 5%.
English: Metabolism and nutrition disorders Common
Maltese: Disturbi fil-metaboliżmu u nnutrizzjoni
English: After about 8 hours, wash the area where Zyclara was applied with mild soap and water.
Maltese: Wara madwar 8 sigħat, aħsel iż-żona fejn kien applikat Zyclara b'sapun ħafif u ilma.
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 dwar tossiċità dermali fuq il-far fuq perijodu ta' erba' xhur, kien osservat tnaqqis sinifikanti fil-piż tal-ġisem u fil-piż tal-milsa b'0.5 u 2.5 mg/kg; effetti simili ma kienux osservati fi studju dermali fuq il-ġurdien fuq perijodu ta' erba' xhur.
English: Zyclara (per application: up to 2 sachets, 250 mg imiquimod cream per sachet) should be applied once daily before bedtime to the skin of the affected treatment field (area) for two treatment cycles of 2 weeks each separated by a 2-week no-treatment cycle or as directed by the physician.
Maltese: Zyclara (kull applikazzjoni: sa 2 qratas, 250 mg krema imiquimod kull qartas) għandu jiġi applikat darba kuljum qabel l-irqad lill-ġilda tal-parti affetwata li għandha tiġi kkurata (erja) għal żewġ ċikli ta' kura ta' ġimagħtejn kull wieħed separati minn ċiklu ta' ġimagħtejn bla kura, jew kif ordnat mittabib.
English: - Each Zyclara 3.75% cream sachet contains 250 mg of a white to slightly yellow cream with a uniform appearance.
Maltese: - Kull qartas ta' krema Zyclara 3.75% fih 250 mg ta' krema bajda sa kemmxejn fl-isfar b'dehra uniformi.
English: Some systemic adverse reactions, including headache 6% (10/160), fatigue 4% (7/160), were reported by Zyclara treated patients in clinical trials.
Maltese: 4% (7/160), kienu rrappurtati minn pazjenti kkurati b'Zyclara fi provi kliniċi.
English: Inflammation
Maltese: Qoxra
English: Two open-label randomized, controlled studies investigated the long-term effects of imiquimod 5% (and not with this 3.75% product) in comparison to topical diclofenac (3% gel).
Maltese: Żewġ studji open-label, randomised, u kkontrollati investigaw l-effetti fit-tul ta' imiquimod 5% (u mhux b'dan il-prodott ta' 3.75%) meta mqabbel ma' diclofenac topiku (ġel 3%).
English: Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials investigating the use of imiquimod 5% cream.
Maltese: Disturbi fis-sistema tad-demm Tnaqqis fl-emoglobina, fl-għadd ta' ċelluli bojod tad-demm, newtrofili assoluti u plejtlits kien osservat fi provi kliniċi li nvestigaw l-użu ta' krema imiquimod 5%.
English: Chaussée de la Hulpe 166 Terhulpsesteenweg B-1170 Brussels Belgique / Belgien Tél/Tel: +32 (0)2 5 04 08 11
Maltese: Meda Pharma S.A./N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg B-1170 Brussels Belgique / Belgien Tél/Tel:
English: Very common (≥ 1/10);
Maltese: Komuni ħafna (≥ 1/10);
English: Imiquimod induces the release of interferon alpha (IFN-α) and other cytokines from a variety of human and animal cells (e.g. from human monocytes/macrophages and keratinocytes).
Maltese: Imiquimod jinduċi r-reħa ta' interferon alpha (IFN-α) u ta' ċitokini oħra minn varjetà ta' ċelluli tal-bnedmin u tal-annimali (eż. minn monoċiti/makrofaġi u keratinoċiti tal-bniedem).
English: Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
Maltese: Cetyl alcohol u stearyl alcohol jistgħu jikkawżaw reazzjonijiet lokali fil-ġilda (eż. dermatite tal kuntatt).
English: Koranska 2
Maltese: ANNESS II
English: These local skin reactions may be related to the stimulation of local immune response.
Maltese: Dawn ir-reazzjonijiet lokali fil-ġilda jistgħu jkunu relatati ma' stimulazzjoni ta' rispons immuni lokali.
English: Very common (may affect more than 1 in 10 people) - Skin redness, scabbing, skin scaling, discharge, skin dryness, skin swelling, skin ulcer, and reduced skin pigmentation at the application site
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) - Ħmura fil-ġilda, qoxra, ġilda titqaxxar, tisfija, ġilda xotta, nefħa fil-ġilda, ulċera fil-ġilda, u tnaqqis fil-pigmentazzjoni tal-ġilda fis-sit tal-applikazzjoni
English: In some individuals a lowering of blood counts was noted (frequency not known).
Maltese: F'xi individwi kien innutat tnaqqis fl-għadd tad-demm (frekwenza mhux magħrufa).
English: The efficacy of Zyclara was studied in two double-blind, randomized, vehicle-controlled clinical studies.
Maltese: L-effikaċja ta' Zyclara ġiet studjata f'żewġ studji kliniċi double-blind, randomised, u kkontrollati bi krema mingħajr mediċina.
English: MEDA Pharma spol.
Maltese: Meda Pharma
English: Excipients: isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, purified water.
Maltese: polysorbate 60, sorbitan stearate, glycerol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), xanthan gum, ilma ppurifikat.
English: Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were also observed in human data.
Maltese: Żjidiet fil-livelli sistemiċi ta' alpha interferon u ta' ċitokini oħra wara applikazzjoni topika ta'
English: Meda Pharma SIA 101 Mūkusalas str. Rīga LV‐1004
Maltese: SIA 101 Mūkusalas str.
English: Patients had 5-20 typical visible or palpable AK lesions in an area that exceeded 25 cm2 on either the face or balding scalp.
Maltese: Il-pazjenti kellhom 5-20 ferita tipika viżibbli jew palpabbli ta' AK f'żona li ma taqbisx 25 cm2 fuq il-wiċċ jew il-qorriegħa li qed tiqriegħ.