FrancophonIA/ELRC3.0 huggingface dataset:
English: Data from the drug-drug interaction (DDI) evaluation portion of a clinical study in patients with breast cancer showed that there was no drug interaction between palbociclib and letrozole when the 2 medicinal products were coadministered.
Maltese: Id-data mill-parti tal-evalwazzjoni tal-interazzjonijiet bejn mediċina u oħra ta' studju kliniku f'pazjenti b'kanċer tas-sider turi li ma kienx hemm interazzjoni tal-mediċina bejn palbociclib u letrozole meta żżewġ prodotti mediċinali ingħataw flimkien.
English: PALOMA-2 (intent-to-treat population) - Efficacy results based on primary and updated cutoff dates
Maltese: PALOMA-2 (popolazzjoni bl-intenzjoni li tiġi ttrattata) - Riżultati dwar l-effikaċja abbażi tad-dati ta' għeluq primarji u aġġornati
English: Infectionsb Blood and lymphatic system disorders
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: The mean fraction unbound (fu) of palbociclib in human plasma in vivo increased incrementally with worsening hepatic function.
Maltese: Il-frazzjoni medja mhux marbuta (fu) ta' palbociclib fi plasma umana in vivo żdiedet b'mod inkrimentali hekk kif il-funzjoni tal-fwied bdiet tiggrava.
English: The results from the investigator-assessed PFS and final OS data from PALOMA-3 study are presented in Table 8.
Maltese: Ir-riżultati mid-data tal-PFS (progression free survival - sopravivenza mingħajr progressjoni) u l-OS finali evalwata mill-investigatur mill-istudju PALOMA-3 huma ppreżentati f'Tabella 8.
English: IBRANCE is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer: - in combination with an aromatase inhibitor; - in combination with fulvestrant in women who have received prior endocrine therapy (see section 5.1).
Maltese: IBRANCE huwa indikat għat-trattament ta' kanċer tas-sider pożittiv għar-riċetturi tal-ormoni (HR, hormone receptor), negattiv għar-riċetturi 2 tal-fattur tat-tkabbir epidermali tal-bniedem (HER2, human epidermal growth factor receptor 2) lokalment avvanzat jew metastatiku:
English: Steady state was achieved within 8 days following repeated once daily dosing.
Maltese: L-istat fiss intlaħaq fi żmien 8 ijiem wara doża ripetuta ta' darba kuljum.
English: In addition, cardiovascular effects (QTc prolongation, decreased heart rate, and increased RR interval and systolic blood pressure) were identified in telemetered dogs at ≥4 times human clinical exposure based on Cmax.
Maltese: Barra minn hekk, titwil tal-effetti kardjovaskulari QTc, tnaqqis fir-rata ta' taħbit tal-qalb, u żieda flintervall tal-RR u tal-pressjoni tad-demm sistolika) kienu identifikati fi klieb telemetrati f'≥4 darbiet lesponiment kliniku fil-bnedmin abbażi tas-Cmax.
English: IBRANCE contains lactose
Maltese: GĦAMLA KWALITATTIVA
English: Stomatitisg
Maltese: Pożoloġija
English: • Pravastatin and rosuvastatin used to treat high cholesterol levels.
Maltese: • Pravastatin u rosuvastatin, użati sabiex jittrattaw il-livelli għoljin tal-kolesterol.
English: At any time:
Maltese: NN:
English: HDPE bottle with a PP closure containing 21 hard capsules.
Maltese: Fliexken tal-HDPE b'tapp tal-PP li fih 21 kapsuli ibsin.
English: Efficacy results in patients with visceral or non-visceral disease from PALOMA-2 study (intent-to-treat population; 31-May-2017 cutoff date) Visceral Disease
Maltese: Riżultati dwar l-effikaċja f'pazjenti b'mard vixxerali u mhux vixxerali minn studju PALOMA-2 (popolazzjoni bl-intenzjoni li tiġi ttrattata; id-data tal-għeluq 31 ta' Mejju 2017)
English: Data from a clinical study in patients with breast cancer showed that there was no clinically relevant drug interaction between palbociclib and fulvestrant when the two medicinal products were coadministered.
Maltese: Id-data minn studju kliniku f'pazjenti b'kanċer tas-sider turi li ma kienx hemm interazzjoni talmediċina klinikament rilevanti bejn palbociclib u fulvestrant meta ż-żewġ mediċini ngħataw flimkien.
English: • dry cough
Maltese: • sogħla xotta
English: A total of 335 patients in the palbociclib plus fulvestrant arm and 166 patients in the fulvestrant only arm completed the questionnaire at baseline and at least 1 postbaseline visit.
Maltese: Total ta' 335 pazjent fil-parti tal-istudju dwar palbociclib flimkien ma' fulvestrant, u 166 pazjent fil-parti tal-istudju dwar fulvestrant biss temmew il-kwestjonarju fil-linja bażi u mill-anqas żjara waħda ta' wara l-linja bażi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 125 MG CAPSULES
Maltese: KARTUNA TA' BARRA - 125 MG KAPSULI
English: Following oral administration of a single 125 mg dose of [14C]palbociclib to humans, the major primary metabolic pathways for palbociclib involved oxidation and sulphonation, with acylation and glucuronidation contributing as minor pathways.
Maltese: C]palbociclib lill-bnedmin, il-passaġġi metaboliċi primarji maġġuri għal palbociclib involvew l-ossidazzjoni u s-sulfonazzjoni, bl-aċilazzjoni u bilglukoronidazzjoni jikkontribwixxu bħala passaġġi minuri.
English: Data from a DDI study in healthy male subjects indicated that palbociclib exposures were comparable when a single dose of palbociclib was coadministered with multiple doses of tamoxifen and when palbociclib was given alone.
Maltese: Id-data minn studju tal-interazzjonijiet bejn mediċina u oħra f'individwi rġiel f'saħħithom indikat li lesponimenti ta' palbociclib kienu komparabbli meta doża waħda ta' palbociclib ingħatat flimkien ma' diversi dożi ta' tamoxifen u meta palbociclib ingħata waħdu.
English: No dose adjustment of IBRANCE is required for patients with mild, moderate or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min).
Maltese: L-ebda aġġustament fid-doża ta' IBRANCE mhu meħtieġ għal pazjenti b'indeboliment ħafif, moderat jew sever tal-kliewi (tneħħija tal-kreatinina [CrCl] ≥15 mL/min).
English: IBRANCE 100 mg hard capsules Each hard capsule contains 100 mg of palbociclib.
Maltese: IBRANCE 100 mg kapsuli ibsin Kull kapsula iebsa fiha 100 mg ta' palbociclib.
English: A total of 521 pre/peri- and postmenopausal women who had progressed on or within 12 months from completion of adjuvant endocrine therapy or on or within 1 month from prior endocrine therapy for advanced disease, were randomised 2:1 to palbociclib plus fulvestrant or placebo plus fulvestrant and stratified by documented sensitivity to prior hormonal therapy, menopausal status at study entry (pre/peri- versus postmenopausal), and presence of visceral metastases.
Maltese: intgħażlu b'mod każwali fi proporzjon ta' 2:1 għal palbociclib flimkien ma' fulvestrant jew plaċebo flimkien ma' fulvestrant, u stratifikati permezz ta' sensittività dokumentata għal terapija ormonali minn qabel, status tal-menopawsa meta daħlu fl-istudju (qabel ma kellhom il-menopawsa/waqt ilmenopawsa meta mqabbla ma' dawk li kienu għaddew mill-menopawsa), u l-preżenza ta' metastasi vixxerali.
English: Palbociclib is a weak, time-dependent inhibitor of CYP3A following daily 125 mg dosing at steady state.
Maltese: Palbociclib huwa inibitur dgħajjef ta' CYP3A dipendenti fuq iż-żmien wara doża ta' kuljum ta' 125 mg fl-istat fiss.
English: Grade 4 n (%)
Maltese: Grad 3 % Grad 4 % Il-Gradi Kollha
English: A 6.9-month difference in median OS in the palbociclib plus fulvestrant arm compared with the placebo plus fulvestrant arm was observed; this result was not statistically significant at the prespecified significance level of 0.0235 (1-sided).
Maltese: Kienet osservata differenza ta' 6.9 xhur fl-OS medjan fil-fergħa ta' palbociclib flimkien ma' fulvestrant meta mqabbla mal-fergħa ta' plaċebo flimkien ma' fulvestrant; dan ir-riżultat ma kienx statistikament sinifikanti fil-livell ta' sinifikat speċifikat minn qabel ta' 0.0235 (naħa waħda).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 100 mg palbociclib.
Maltese: Kull kapsula fiha 100 mg palbociclib.
English: Hepatic impairment
Maltese: Komuni ħafna Stomatite
English: Based on the 31-May-2017 data cutoff date, this reduction in risk continued to be observed in the following subgroups: (1) patients with either visceral metastases (HR of 0.62 [95% CI: 0.47, 0.81], median progression-free survival [mPFS] 19.3 months versus 12.3 months) or without visceral metastases (HR of 0.50 [95% CI: 0.37, 0.67], mPFS 35.9 months versus 17.0 months) and (2) patients with either bone only disease (HR of 0.41 [95% CI: 0.26, 0.63], mPFS 36.2 months versus 11.2 months) or without bone-only disease (HR of 0.62 [95% CI: 0.50, 0.78], mPFS 24.2 months versus 14.5 months).
Maltese: [95% CI: 0.37, 0.67], mPFS 35.9 xhur kontra 17.0 xhur) u (2) pazjenti jew b'marda tal-għadam biss (HR ta' 0.41 [95% CI: 0.26, 0.63], mPFS 36.2 xhur kontra 11.2 xhur) jew mingħajr marda tal-għadam biss (HR ta' 0.
English: Given the reduced effect on gastric pH of H2-receptor antagonists and local antacids compared to PPIs, no clinically relevant effect of H2-receptor antagonists or local antacids on palbociclib exposure is expected when palbociclib is taken with food.
Maltese: Minħabba l-effett imnaqqas tal-pH gastriku tal-antagonisti tar-riċetturi ta' H2 u l-antiaċidi lokali meta mqabbla mal-PPIs, l-ebda effett klinikament rilevanti tar-riċetturi ta' H2 u l-antiaċidi lokali fuq lesponiment ta' palbociclib huwa mistenni meta palbociclib jittieħed mal-ikel.
English: In faeces, the sulfamic acid conjugate of palbociclib was the major drug-related component, accounting for 25.8% of the administered dose.
Maltese: Fl-ippurgar, il-konjugat tal-aċidu sulfamiku ta' palbociclib kien il-komponent maġġuri relatat mal-mediċina, fejn ammonta għal 25.
English: In vitro, the uptake of palbociclib into human hepatocytes occurred mainly via passive diffusion.
Maltese: In vitro, l-użu ta' palbociclib fl-epatoċiti umani seħħew l-aktar permezz ta' diffużjoni passiva.
English: In the dosing range of 25 mg to 225 mg, the area under the curve (AUC) and Cmax increase proportionally with dose in general.
Maltese: Fil-medda tad-doża ta' 25 mg sa 225 mg, l-erja taħt il-kurva l-AUC u s-Cmax jiżdiedu b'mod proporzjonali maddoża b'mod ġenerali.
English: a Preferred Terms (PTs) are listed according to MedDRA 17.1. b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
Maltese: It-Termini Ppreferuti (PTs) huma elenkati skont MedDRA 17.1. .
English: Ovarian ablation or suppression with an LHRH agonist is mandatory when pre/perimenopausal women are administered IBRANCE in combination with an aromatase inhibitor, due to the mechanism of action of aromatase inhibitors.
Maltese: F'pazjenti li għandhom sintomi respiratorji ġodda jew li qed jaggravaw u li huma suspettati li żviluppaw ILD/pulmonite, ippawża IBRANCE immedjatament u vvaluta l-pazjent.
English: Infections and infestations
Maltese: ILD/pulmonite
English: Visceral Disease
Maltese: Bijotrasformazzjoni
English: Since IBRANCE has myelosuppressive properties, it may predispose patients to infections.
Maltese: Minħabba li IBRANCE m'għandux karatteristiċi majelosoppressivi, jista' jippredisponi l-pazjenti għal infezzjonijiet.
English: Kaplan-Meier plot of progression-free survival (investigator assessment,
Maltese: Punti tat-tmiem sekondarji tal-effikaċja ( Evalwazzjoni tal-investigatur)
English: Additional efficacy measures (OR and TTR) assessed in the sub-groups of patients with or without visceral disease are displayed in Table 9.
Maltese: Miżuri ta' effikaċja addizzjonali (OR u TTR) vvalutati fis-sotto gruppi ta' pazjenti bi jew mingħajr ilmarda vixxri huma murija fit-Tabella 9.
English: • Alfentanil used for anaesthesia in surgery; fentanyl used in pre-procedures as a pain reliever as well as an anaesthetic.
Maltese: • Alfentanil użat għal-loppju fil-kirurġija; fentanyl użat fil-proċeduri minn qabel bħala sustanza li ttaffi l-uġigħ kif ukoll bħala loppju.
English: When the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor (see section 4.5).
Maltese: Meta l-inibitur qawwi jitwaqqaf, żid id-doża ta' IBRANCE (wara 3-5 half-lives tal-inibitur) għad-doża użata qabel il-bidu tal-inibitur qawwi ta' CYP3A (ara sezzjoni 4.5).
English: Randomised Phase 3 Study PALOMA-2: IBRANCE in combination with letrozole
Maltese: Meta tirkupra għal Grad ≤2, ibda ċ-ċiklu ġdid bl-istess doża.
English: Studies in adults
Maltese: Studji fl-adulti
English: Further information on Zinforo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zinforo
Maltese: Aktar informazzjoni dwar Zinforo tinstab fis-sit web talAġenzija: ema.europa.eu/medicines/human/EPAR/zinforo
English: Zinforo is an antibiotic.
Maltese: Zinforo huwa antibijotiku.
English: This overview was last updated in 06-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'06-2019.
English: Zinforo contains the active substance ceftaroline fosamil.
Maltese: Zinforo fih is-sustanza attiva ċeftarolina fosamil.
English: Other information about Zinforo
Maltese: Informazzjoni oħra dwar Zinforo
English: Zinforo received a marketing authorisation valid throughout the EU on 23 August 2012.
Maltese: Zinforo ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-23 ta' Awwissu 2012.
English: In laboratory studies Zinforo was active against certain bacteria against which other antibiotics belonging to the beta-lactam class do not work (meticillin-resistant Staphylococcus aureus (MRSA) and penicillin non-susceptible Streptococcus pneumoniae (PNSP)).
Maltese: Fi studji fil-laboratorju Zinforo kien attiv kontra ċerti batterji li antibijotiċi oħra li jappartjenu għallklassi tal-betalattami ma jaħdmux kontrihom (Staphylococcus aureus reżistenti għall-metiċillina (MRSA) u Streptococcus pneumoniae mhux suxxettibbli għall-peniċillina (PNSP)).
English: Zinforo is given by infusion (drip) into a vein usually over 5 to 60 minutes.
Maltese: Zinforo jingħata b'infużjoni (dripp) ġo vina normalment fuq perjodu ta' bejn ħames minuti u 60 minuta.
English: In adults and adolescents from 12 years of age weighing at least 33 kg, the usual dose is 600 mg every 12 hours.
Maltese: Fl-adulti u fl-adoloxxenti minn 12-il sena 'l fuq li jiżnu mill-inqas 33 kg, id-doża normali hija ta' 600 mg kull 12-il siegħa.
English: What are the risks associated with Zinforo?
Maltese: X'inhuma r-riskji assoċjati ma' Zinforo?
English: For some serious skin infections, the recommended dose is 600 mg every 8 hours, with each infusion lasting 120 minutes.
Maltese: Għal ċerti infezzjonijiet serji tal-ġilda, id-doża rakkomandata hija ta' 600 mg kull tmien sigħat, u kull infużjoni tingħata fuq perjodu ta' 120 minuta.
English: The active substance in Zinforo, ceftaroline fosamil, is a type of antibiotic called cephalosporin belonging to the group ‘beta-lactams'.
Maltese: Is-sustanza attiva f'Zinforo, iċ-ċeftarolina fosamil, hija tip ta' antibijotiku msejjaħ ċefalosporina li jappartjeni għall-grupp tal-‘betalattamiċi'.
English: In a study of patients with complicated skin and soft tissue infection, 87% of the patients receiving Zinforo were cured (304 out of 351), compared with 86% of the patients receiving the combination of vancomycin and aztreonam (297 out of 347).
Maltese: Fi studju fuq pazjenti b'infezzjoni kkumplikata tal-ġilda u tat-tessut artab, 87 % tal-pazjenti li ngħataw Zinforo ġew ikkurati (304 minn 351), meta mqabbla ma' 86 % tal-pazjenti li ngħataw il-kombinazzjoni ta' vankomycin u aztreonam (297 minn 347).
English: In a second study, 85% of patients receiving Zinforo were cured (291 out of 342) compared with 86% of the patients receiving the combination of vancomycin and aztreonam (289 out of 338).
Maltese: Fit-tieni studju, 85 % tal-pazjenti li ngħataw Zinforo ġew ikkurati (291 minn 342) meta mqabbla ma' 86 % tal-pazjenti li ngħataw il-kombinazzjoni ta' vankomycin u aztreonam (289 minn 338).
English: It interferes with the production of complex molecules called peptidoglycans, which are essential components of bacterial cell walls.
Maltese: Din taħdem billi tinterferixxi mal-produzzjoni ta' molekuli kumplessi msejħin peptidoglikani, li huma komponenti essenzjali tal-ħitan taċ-ċelloli batterjali.
English: Among those with complicated community-acquired pneumonia, 90% of the patients treated with Zinforo were cured, compared with 100% of those receiving ceftriaxone plus vancomycin.
Maltese: Fost dawk bil-pulmonite kkumplikata akkwiżita f'komunità, 90 % tal-pazjenti kkurati b'Zinforo ġew ikkurati, meta mqabbla ma' 100 % ta' dawk li ngħataw ceftriaxone flimkien vancomycin.
English: As for all medicines, data on the use of Zinforo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zinforo hija ssorveljata kontinwament.
English: In another study, 81% of patients receiving Zinforo were cured (235 out of 289) compared with 76% of the patients receiving ceftriaxone (206 out of 273).
Maltese: Fi studju ieħor, 81 % tal-pazjenti li ngħataw Zinforo ġew ikkurati (235 minn 289) meta mqabbla ma' 76 % tal-pazjenti li ngħataw ceftriaxone (206 minn 273).
English: In a children's study of complicated skin and soft tissue infection, 94% of the children receiving Zinforo were cured (101 out of 107), compared with 87% of those receiving vancomycin or cefazolin, with or without aztreonam (45 out of 52).
Maltese: Fi studju fit-tfal b'infezzjoni kkumplikata tal-ġilda u tat-tessut artab, 94 % tat-tfal li ngħataw Zinforo ġew ikkurati (101 minn 107), meta mqabbla ma' 87 % ta' dawk li ngħataw vancomycin jew cefazolin, b'aztreonam jew mingħajru (45 minn 52).
English: Zinforo (ceftaroline fosamil)
Maltese: Zinforo (ċeftarolina fosamil) EMA/362092/2019
English: The most common side effects with Zinforo (seen in more than 3% of patients) are diarrhoea, headache, nausea (feeling sick) and pruritus (itching).
Maltese: L-effetti sekondarji l-aktar komuni b'Zinforo (li dehru f'aktar minn 3 % tal-pazjenti) huma dijarea, uġigħ ta' ras, nawżja (tħossok ma tiflaħx), u prurite (ħakk).
English: For community-acquired pneumonia, one study showed that 84% of the patients receiving Zinforo were cured (244 out of 291), compared with 78% of the patients receiving ceftriaxone (233 out of 300).
Maltese: Fil-pulmonite mittieħda mill-komunità, studju wieħed wera li 84 % tal-pazjenti li ngħataw Zinforo ġew ikkurati (244 minn 291), meta mqabbla ma' 78 % tal-pazjenti li ngħataw ceftriaxone (233 minn 300).
English: Among children with community-acquired pneumonia that required hospital stay, 88% of those on Zinforo were cured (94 out of 107), compared with 89% of those receiving ceftriaxone.
Maltese: Fost it-tfal bil-pulmonite mittieħda mill-komunità li kienet tenħtieġ rikovru l-isptar, 88 % ta' dawk li ngħataw Zinforo ġew ikkurati (94 minn 107), meta mqabbla ma' 89 % ta' dawk li ngħataw ceftriaxone.
English: • community-acquired pneumonia (an infection of the lungs that is caught outside of hospital).
Maltese: • pulmonite akkwiżita f'komunità (infezzjoni tal-pulmuni li tittieħed barra mill-isptar).
English: It does so by blocking enzymes, called penicillin-binding protein transpeptidases, that are involved in the last steps of bacterial cell wall production.
Maltese: Din tagħmel hekk billi timblokka enzimi, imsejħin transpeptidażi tal-proteini li jeħlu bil-peniċillina, li huma involuti fl-aħħar stadji tal-produzzjoni tal-ħitan taċ-ċelloli batterjali.
English: In children and adolescents weighing less than 33 kilograms, the dose depends on the patient's weight.
Maltese: Fit-tfal u fl-adoloxxenti li jiżnu inqas minn 33 kilogramma, id-doża tiddependi mill-piż tal-pazjent.
English: Zinforo was as effective as other antibiotics in curing skin and soft tissue infections and pneumonia in adults.
Maltese: Zinforo kien effettiv daqs l-antibijotiċi l-oħra fil-kura ta' infezzjonijiet tal-ġilda u tat-tessut artab talpulmonite fl-adulti.
English: The Agency also noted that in laboratory studies Zinforo had shown activity against certain bacteria, such as MRSA, against which other beta-lactam antibiotics do not work.
Maltese: L-Aġenzija nnotat ukoll li fi studji fil-laboratorju Zinforo wera attività kontra ċerti batterji, bħal MRSA, li antibijotiċi betalattamiċi oħra ma jaħdmux
English: The European Medicines Agency concluded that Zinforo was effective in treating complicated skin and soft tissue infections and community-acquired pneumonia and its side effects in both adults and children were manageable.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li Zinforo kien effettiv fil-kura ta' infezzjonijiet ikkumplikati tal-ġilda u tat-tessut artab u ta' pulmonite akkwiżita f'komunità u li l-effetti sekondarji kemm fl-adulti kif ukoll fit-tfal kienu maniġġabbli.
English: However, as there were uncertainties about the effects of Zinforo in patients with certain very severe infections these effects will be investigated in further studies.
Maltese: Madankollu, peress li kien hemm inċertezzi dwar l-effetti ta' Zinforo f'pazjenti b'ċerti infezzjonijiet severi ħafna dawn l-effetti ser jiġu investigati fi studji ulterjuri.
English: 7 Офис сграда „Сердика Офиси“ 1505 София
Maltese: 7 Офис сграда „Сердика Офиси“ 1505
English: Κιλκίς 35, 2234 Λατσιά Τηλ.
Maltese: Κιλκίς 35, 2234
English: Mylan Healthcare Sp. z o.o.
Maltese: Mylan Healthcare Sp. z o.o. ul.
English: Meda AB Pipers väg 2A 170 73 Solna Sweden
Maltese: Meda AB Pipers väg 2 170 73 Solna L-Isvezja
English: Dose proportionality was not observed.
Maltese: Il-proporzjonalità tad-doża ma ġietx osservata.
English: 4.8 Undesirable effects a) General Description:
Maltese: .8 Effetti mhux mixtieqa a) Deskrizzjoni Ġenerali:
English: Meda Health Sales Ireland Ltd. Unit 34/35, Block A Dunboyne Business Park Dunboyne
Maltese: Unit 34/35, Block A Dunboyne Business Park Dunboyne
English: 250 mg cream
Maltese: 250 mg krema
English: Mylan Medical SAS 40-44 rue Washington
Maltese: Mylan Medical SAS 40-44 rue Washington 75008 Paris
English: United Kingdom Mylan Products Ltd. Station Close Potters Bar Hertfordshire EN6 1TL
Maltese: Station Close Potters Bar Hertfordshire EN6 1TL
English: Serious skin reactions have been reported rarely.
Maltese: Reazzjonijiet serji tal-ġilda ġew irrapportati rarament.
English: EU/1/98/080/001 12 sachets EU/1/98/080/002 24 sachets
Maltese: EU/1/98/080/001 12-il qartas EU/1/98/080/002 24 qartas
English: Calea Floreasca nr. 169A Floreasca Business Park 014459 București Tel.: +40372 579 000
Maltese: BGP PRODUCTS SRL Reprezentanța Romania Calea Floreasca nr. 169A Floreasca Business Park 014459 București Tel.: +40372 579 000
English: Manufacturer 3M Health Care Limited Derby Road
Maltese: Il-Manifattur 3M Health Care Limited Derby Road
English: Uterovaginal prolapse
Maltese: Prolassi uterovaġinali
English: Vaginitis atrophic
Maltese: Vaginite atropika
English: Aldara cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol
Maltese: Il-krema Aldara fiha methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol u benzyl alcohol
English: • Small superficial basal cell carcinomas (sBCCs) in adults.
Maltese: • Karċinomi superfiċjali żgħar taċ-ċelloli bażali (sBCCs) f'adulti.
English: These results were statistically significant (p<0.001) by comparison with the vehicle group, 3% (6/179) and 2% (3/179) respectively.
Maltese: 001) bi tqabbil mal-vehicle group, 3% (6/179) u 2% (3/179) rispettivament.
English: ALDARA 5% cream
Maltese: ALDARA 5% krema
English: Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 5.1).
Maltese: Imiquimod kien investigat fi studji kliniċi ikkontrollati b'pazjenti pedjatriċi (irriferi ghal sezzjoni 4.2 u 5.1).
English: Corresponding recurrence rates for vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions).
Maltese: Rati ta' rikorrenza korrispondenti għal vettura kienu 47% (8/17-il pazjent) u 7.5% (6/80 leżjoni).
English: Imiquimod has no direct antiviral activity.
Maltese: Imiquimod m'għandux effett antivirali dirett.
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