FrancophonIA/ELRC3.0 huggingface dataset:
English: Searches were also conducted in the FDA Adverse Event Reporting System (AERS) database and in the WHO Vigibase database.
Maltese: Twettaq wkoll tiftix fid-database tas-Sistema ta' Rapportar tal-Avvenimenti Avversi (AERS) tal-FDA u fid-database ta' WHO Vigibase.
English: The MAH justified the deletion of ADRs using the Empirical Bayesian Data Mining techniques to compute disproportionality scores from the MAH's global safety database.
Maltese: L-MAH iġġustifika t-tħassir tal-ADRs permezz tat-tekniki ta' Data Mining Bajesjan Empiriku biex jiġu kkalkolati l-punteġġi ta' sproporzjonalità mid-database tas-sigurtà globali tal-MAH.
English: For the indication “stable angina pectoris” there were several divergences.
Maltese: Għall-indikazzjoni “anġina pectoris stabbli” kien hemm diversi diverġenzi.
English: The CHMP asked the MAH to comment on the following contraindications: stroke in the past 6 months, Hypertrophic cardiomyopathy, Atrioventricular block grade 2 and 3, Severe renal impairment (GFR <30 ml/min, creatinine > 1.8 mg/dl), Severe hepatic impairment/liver cirrhosis, Breast-feeding women/breast feeding infants and treatment with calcium channel blockers.
Maltese: Is-CHMP talab lill-MAH biex jikkummenta dwar il-kontraindikazzjonijiet li ġejjin: puplesija fl-aħħar 6 xhur, Kardjomijopatija ipertrofika, Imblokk atrijoventrikulari tal-grad 2 u 3, Indeboliment renali sever (GFR <30 ml/min, kreatinina> 1.8 mg/dl), Indeboliment epatiku sever/ċirrożi tal-fwied, Nisa li jreddgħu/trabi li qed jitreddgħu u kura b'imblokkaturi tal-kanali tal-kalċju.
English: − SK/H/PSUR/0006/002, PSUR (01 Jan 2010 to 31 Dec 2012), finalised 4 December 2013 and where no changes to the Product Information were proposed.
Maltese: − SK/H/PSUR/0006/002, PSUR (1 ta' Jannar 2010 sal-31 ta' Diċembru 2012), iffinalizzata fl4 ta' Diċembru 2013 u fejn ma ġiet proposta ebda bidla fl-Informazzjoni dwar il-Prodott.
English: Therefore such combinations should be avoided (see section 4.5).'
Maltese: Għalhekk kombinazzjonijiet bħal dawn għandhom jiġu evitati (ara sezzjoni 4.5).”
English: The different MSs had “stable angina pectoris and vasospastic angina (variant of Prinzmetal's angina)”, “Prophylaxis of angina pectoris (stable and vasospastic forms)”, “Angina pectoris” and “Stable exertional angina pectoris; Plendil can be given as monotherapy or can be combined with a beta blocker.
Maltese: L-Istati Membri differenti kellhom “anġina pectoris stabbli u anġina vażospastika (varjant tal-anġina ta' Prinzmetal)”, “Profilassi ta' anġina pectoris (forom stabbli u vażopastiċi)”, “Anġina pectoris” u “Anġina pectoris stabbli waqt strapazz”;
English: The wording on section 4.8 was divergent.
Maltese: Il-formulazzjoni dwar is-sezzjoni 4.8 kienet diverġenti.
English: Section 4.3 - Contraindications Divergences were found in section 4.3 of the SmPC.
Maltese: Sezzjoni 4.3 - Kontraindikazzjonijiet Instabu diverġenzi fis-sezzjoni 4.3 tal-SmPC.
English: The MAH proposed not to include the indication vasospastic angina in the harmonised SmPC.
Maltese: LMAH ippropona li l-indikazzjoni anġina vażospastika ma tiġix inkluża fl-SmPC armonizzat.
English: The use in combination with potent inhibitors or inducers of CYP3A4 is more appropriately addressed in sections 4.5 and 5.2 of the MAH proposal for a harmonised EU SmPC for Plendil.
Maltese: L-użu flimkien ma' inibituri jew indutturi qawwija ta' CYP3A4 huwa indirizzat b'mod aktar xieraq fissezzjonijiet 4.5 u 5.2 tal-proposta tal-MAH għal SmPC armonizzat tal-UE għal Plendil.
English: Plendil can also be used in the treatment of vasospastic (Prinzmetal's) angina”.
Maltese: Plendil jista' jintuża wkoll fil-kura ta' anġina vażospastika (ta' Prinzmetal)”.
English: The findings in the reproduction studies do not demonstrate evidence of direct fetotoxicity.
Maltese: Is-sejbiet flistudji dwar ir-riproduzzjoni ma jurux evidenza ta' fetotossiċità diretta.
English: The total published experience of felodipine in vasospastic angina pectoris and the accumulated safety information is too limited to define a robust benefit risk ratio.
Maltese: L-esperjenza totali ppubblikata ta' felodipine f'anġina pectoris vażospastika u l-informazzjoni dwar is-sigurtà akkumulata hija limitata wisq biex tiddefinixxi proporzjon robust bejn il-benefiċċju u rriskju.
English: Modifications relate to deletion of unnecessary and outdated wording, table format and addition of Hypotension as an adverse drug reaction (ADR).
Maltese: Modifiki relatati mat-tħassir ta' formulazzjoni mhux meħtieġa u skaduta, il-format tat-tabella u ż-żieda ta' Ipotensjoni bħala reazzjoni avversa tal-mediċina (ADR).
English: ‘Concomitant administration of drugs that strongly induce or inhibit CYP3 A4 enzymes result in extensively decreased or increased plasma levels of felodipine, respectively.
Maltese: ”L-għoti konkomittanti tal-mediċini li jinduċu jew jinibixxu b'mod qawwi l-enzimi CYP3 A4 jirriżulta fi tnaqqis jew f'żieda b'mod estensiv tal-livelli ta' felodipine fil-plażma, rispettivament.
English: The MAH considered an EB05 >1.8 a possible signal i.e. the event is reported disproportional often in association with that drug.
Maltese: L-MAH ikkunsidra sinjal possibbli ta' EB05 >1.8 jiġifieri l-avveniment ikun irrapportat sproporzjonat ħafna drabi b'rabta ma' dik il-mediċina.
English: In nonclinical reproductive toxicity studies there were foetal developmental effects, which are considered to be due to the pharmacological action of felodipine'.
Maltese: Fi studji tat-tossiċità riproduttiva mhux klinika kien hemm effetti fl-iżvilupp tal-fetu, li huma kkunsidrati dovuti għall-azzjoni farmakoloġika ta' felodipine”.
English: The CHMP endorsed the MAH proposal of having “Hypertension” as the wording for this indication.
Maltese: Is-CHMP approva l-proposta tal-MAH li għal din l-indikazzjoni tintuża “Ipertensjoni” bħala l-formulazzjoni.
English: Felodipine is a dihydropyridine-type calcium channel blocker (calcium antagonist) and is indicated for the control of hypertension and in many countries also for the treatment of stable angina pectoris.
Maltese: Felodipin huwa imblokkatur tal-kanal tal-kalċju tat-tip dihydropyridine (antagonista tal-kalċju) u huwa indikat għall-kontroll ta' ipertensjoni u f'ħafna pajjiżi anki għall-kura ta' anġina pectoris stabbli.
English: The section 4.2 was divergent across MSs.
Maltese: Is-sezzjoni 4.2 kienet diverġenti fl-Istati Membri kollha.
English: Some MSs were missing a text referring to absorption, distribution, metabolism and elimination.
Maltese: Xi wħud mill-Istati Membri ma kellhomx test li jirreferi għall-assorbiment, id-distribuzzjoni, il-metaboliżmu u leliminazzjoni.
English: • the scope of the referral was the harmonisation of the Summary of Products Characteristics, labelling and package leaflet,
Maltese: • il-kamp ta' applikazzjoni tar-riferiment kien l-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodotti, it-tikkettar u l-fuljett ta' tagħrif,
English: The wording was divergent for this section across EU SmPCs.
Maltese: Il-formulazzjoni kienet diverġenti għal din is-sezzjoni fl-SmPCs tal-UE kollha.
English: Section 4.5 - Interaction with other medicinal products and other forms of interaction For the section 4.5, the MAH proposed to use the text from the CSP, with one addition and one deletion as per CDS.
Maltese: Sezzjoni 4.5 - Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Għas-sezzjoni 4.5, l-MAH ippropona li jintuża t-test mis-CSP, b'żieda waħda u tħassir wieħed skont is-CDS.
English: The CHMP asked the MAH to further discuss the totality of available data on felodipine and dihydropyridine calcium channel blockers to support the indication of vasospastic angina, since currently calcium channel blockers are in prominent position for this indication.
Maltese: Is-CHMP talab lill-MAH biex jiddiskuti aktar it-totalità tad-data disponibbli dwar l-imblokkaturi tal-kanali ta' felodipine u l-kalċju ta' dihydropyridine biex tiġi appoġġjata l-indikazzjoni anġina vażospastika, peress li l-imblokkaturi tal-kanali tal-kalċju attwalment huma f'pożizzjoni prominenti għal din lindikazzjoni.
English: The CHMP accepted the proposal from the MAH to adopt the contraindications: pregnancy; Hypersensitivity to felodipine or ‘any of the excipients listed in section 6.1'; decompensated heart failure, instead of uncompensated heart failure as previously; acute myocardial infarction; unstable angina pectoris; haemodynamically significant cardiac valvular obstruction and dynamic cardiac outflow obstruction as the harmonised text.
Maltese: Ipersensittività għal felodipine jew “għal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1”; insuffiċjenza tal-qalb dikumpensata, minflok insuffiċjenza tal-qalb mhux ikkumpensata bħal qabel; infart mijokardijaku akut; anġina pectoris instabbli; ostruzzjoni valvulari emodinamikament sinifikanti u ostruzzjoni dinamika tal-ħruġ tal-qalb bħala t-test armonizzat.
English: The CHMP addressed a list of questions to the MAH, pointing out the sections of the products SmPC where divergences existed.
Maltese: Is-CHMP indirizza lista ta' mistoqsijiet lill-MAH, fejn indika s-sezzjonijiet tal-SmPC tal-prodotti fejn kienu jeżistu diverġenzi.
English: The CHMP endorsed the MAH proposal on a minor re-wording of section 4.9 of the CSP and to implement it as the harmonised text across EU MS.
Maltese: Is-CHMP approva l-proposta tal-MAH dwar formulazzjoni mill-ġdid minuri tas-sezzjoni 4.9 tas-CSP u biex tiġi implimentata bħala t-test armonizzat fl-Istati Membri tal-UE kollha.
English: In a nonclinical reproductive study in the rat (see section 5.3), there were effects on fetal development but no effect on fertility at doses approximating to therapeutic.
Maltese: Fi studju riproduttiv mhux kliniku fil-firien (ara sezzjoni 5.3), kien hemm effetti fuq l-iżvilupp fetali iżda ebda effett fuq ilfertilità f'dożi li jqarrbu dawk terapewtiċi.
English: Section 4.6 - Fertility, pregnancy and lactation The wording in section 4.6 was divergent.
Maltese: Sezzjoni 4.6 - Fertilità, tqala u treddigħ
English: There are no data on the effects of felodipine on patient fertility.
Maltese: M'hemm ebda dejta dwar l-effetti ta' felodipine fuq il-fertilità tal-pazjent.
English: Considering that gingival enlargement is a known adverse reaction to treatment with felodipine and it is preventable by good oral hygiene, the CHMP endorsed the MAH proposal on including the warning “mild gingival enlargement has been reported in patients with pronounced gingivitis/periodontitis” in the section 4.4 of the harmonised EU SmPC for Plendil.
Maltese: Peress li t-tkabbir tal-ħanek huwa reazzjoni avversa magħrufa għall-kura b'felodipine u jista' jiġi evitat b'iġjene orali tajba, is-CHMP approva l-proposta tal-MAH dwar l-inklużjoni tat-twissija “ġie rapportat tkabbir ħafif tal-ħanek f'pazjenti b'ġinġivite/perjodontite qawwija” fis-sezzjoni 4.4 talSmPC armonizzat tal-UE għal Plendil.
English: The CHMP therefore considers it necessary to include the following text in Section 4.4, including a reference to Section 4.5:
Maltese: Għalhekk, isCHMP ħass il-ħtieġa li jinkludi t-test li ġej fis-Sezzjoni 4.4, inkluż referenza għas-Sezzjoni 4.5:
English: The CHMP endorsed the MAH opinion on adopting the CDS text with some modifications, since it covers the pharmacokinetic properties of felodipine.
Maltese: Is-CHMP approva l-opinjoni tal-MAH dwar l-adozzjoni tat-test tas-CDS b'xi modifiki, peress li jkopri l-proprjetajiet farmakokinetiċi ta' felodipine.
English: Section 4.4 - Special warnings and precautions for use Divergences were found in section 4.4 of the SmPC.
Maltese: Sezzjoni 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Instabu diverġenzi fis-sezzjoni 4.4 tal-SmPC.
English: Some MSs were missing text from the CSP and some MSs had different text.
Maltese: Xi Stati Membri kellhom xi test nieqes mis-CSP u xi Stati Membri kellhom test differenti.
English: In conclusion, based on the assessment of the MAH proposal and responses and following the discussions of the Committee, the CHMP adopted harmonised sets of Product Information documents of Plendil and associated names.
Maltese: Bħala konklużjoni, fuq il-bażi tal-valutazzjoni tal-proposta u r-risponsi tal-MAH u wara ddiskussjonijiet tal-Kumitat, is-CHMP adotta settijiet armonizzati ta' dokumenti ta' Informazzjoni dwar il-Prodott ta' Plendil u ismijiet assoċjati.
English: The MAH provided the CHMP with the justification of the reason why “Reproductive toxicity studies have demonstrated foetotoxicity effects” should not be in the harmonised EU SmPC for Plendil.
Maltese: L-MAH ipprovda lis-CHMP bil-ġustifikazzjoni tar-raġuni għala “Studji tat-tossiċità riproduttiva wrew effetti ta' fetotossiċità” ma għandhiex tkun fl-SmPC armonizzat tal-UE għal Plendil.
English: The wording for hypertension was divergent in all EU MSs.
Maltese: Il-formulazzjoni għall-ipertensjoni kienet diverġenti fl-Istati Membri tal-UE kollha.
English: The wording on section 5.2 was divergent across MSs.
Maltese: Il-formulazzjoni dwar is-sezzjoni 5.2 kienet diverġenti fl-Istati Membri kollha.
English: The divergences were due to differences in the indication, recommendation in maximum daily dose and down titration.
Maltese: Id-diverġenzi kienu dovuti minħabba ddifferenzi fl-indikazzjoni, rakkomandazzjoni fid-doża massima ta' kuljum u titrazzjoni ‘l isfel.
English: A pre-referral meeting between the EMA and marketing authorisation holder (MAH) was held on 14 October 2013.
Maltese: Fl-14 ta' Ottubru 2013 ġiet organizzata laqgħa ta' qabel ir-riferiment bejn l-EMA u d-detentur tal-awtorizzazzjoni għat-tqegħid suq (MAH).
English: The MAH agreed to include “In non-clinical reproductive toxicity studies there were a foetal developmental effects, which are considered to be due to the pharmacological action of felodipine.”
Maltese: L-MAH qabel li jinkludi “Fi studji tat-tossiċità riproduttiva mhux klinika kien hemm effetti fl-iżvilupp tal-fetu, li huma kkunsidrati dovuti għall-azzjoni farmakoloġika ta' felodipine.”
English: However, outside the referenced trials, no significant publication have been found, limiting the total reported material on felodipine use in vasospastic angina to around 30 patients.
Maltese: Madankollu, barra l-provi referenzjati, ma nstabet ebda pubblikazzjoni sinifikanti, li tillimita lmaterjal totali rrapportat dwar l-użu ta' felodipine f'anġina vażospastika għal madwar 30 pazjenti.
English: The CHMP requested the MAH to shorten the text related to pharmacodynamic properties since it included parts of limited clinical relevance or not considered justified by clinical evidence.
Maltese: Is-CHMP talab lill-MAH biex iqassar it-test relatat mal-proprjetajiet farmakodinamiċi peress li kien jinkludi partijiet ta' rilevanza klinika limitata jew li ma jitqisux iġġustifikati minn evidenza klinika.
English: The MAH agreed and included that ‘Plendil contains castor oil, which can cause stomach upset and diarrhoea'.
Maltese: L-MAH qabel u inkluda li ‘Plendil fih iż-żejt tar-riġnu, li jista' jikkawża taqlib tal-istonku u dijarea'.
English: Three European procedures have been completed leading to agreed wording in Plendil Summary of Product Characteristics (SmPCs):
Maltese: Tlestew tliet proċeduri Ewropej li wasslu għall-formulazzjoni maqbula fis-Sommarju talKaretteristiċi tal-Prodott (SmPCs) ta' Plendil:
English: Section 4.1 - Therapeutic Indications Plendil is indicated for:
Maltese: Plendil huwa indikat għal:
English: The information on castor oil is given under section 2 and section 6 of the proposed harmonised SmPC text and the MAH is of the opinion that castor oil is an excipient in Plendil tablets in an amount too small to have any effects, except for possibly hypersensitivity and hypersensitivity to any component of the product is a contraindication.
Maltese: L-informazzjoni dwar iż-żejt tar-riġnu tingħata taħt is-sezzjoni 2 u s-sezzjoni 6 tat-test armonizzat propost tal-SmPC u lMAH huwa tal-fehma li ż-żejt tar-riġnu huwa eċċipjent fil-pilloli ta' Plendil f'ammont li huwa żgħir wisq biex ikollu xi effett, ħlief għall-possibbiltà ta' ipersensittività u ipersensittività għal kwalunkwe komponent tal-prodott hija kontraindikata.
English: The final agreed wording is as follows: ‘Felodipine should not be given during pregnancy.
Maltese: Il-formulazzjoni finali maqbula hija kif ġejja: ”Felodipine m'għandux jingħata matul it-tqala.
English: Finally the CHMP requested the MAH to add a warning on castor oil.
Maltese: L-MAH qabel mal-formulazzjoni proposta hawn fuq.
English: The MAH agreed to remove the parts suggested by the CHMP.
Maltese: LMAH qabel li jneħħi l-partijiet issuġġeriti mis-CHMP.
English: Restless legs syndrome (frequency uncommon (≥ 1/1,000 to < 1/100))
Maltese: Sindromu ta' saqajn irrikwieti (frekwenza mhux komuni (≥ 1/1,000 sa < 1/100))
English: Flucloxacillin - Acute generalized exanthematous pustulosis (AGEP)(EPITT no 18773)
Maltese: 2. Flucloxacillin - Raxx ġeneralizzat akut tal-ponot (AGEP)(EPITT nru 18773)
English: Olanzapine - Restless legs syndrome (EPITT no 18659)
Maltese: 3. Olanzapine - Sindromu ta' saqajn irrikwieti (EPITT nru 18659)
English: budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Maltese: Kortikosterojdi inklużi betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
English: Cobicistat containing products: cobicistat; cobicistat, atazanavir sulfate; cobicistat, darunavir; cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide; cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarateDrug interaction with corticosteroids leading to adrenal suppression (EPITT no 18647)
Maltese: Prodotti li fihom cobicistat: cobicistat; cobicistat, atazanavir sulfate; cobicistat, darunavir; cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide; cobicistat, elvitegravir, emtricitabine, tenofovir disoproxil fumarateInterazzjoni tal-mediċini ma' kortikosterojdi li twassal għal suppressjoni adrenali (EPITT Nru 18647)
English: Cobicistat containing products
Maltese: Prodotti li fihom cobicistat
English: Uncommon side effects (may affect up to 1 in 100 people) include hypersensitivity (e.g. swelling in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones in the blood and urine) or coma; seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; problems with speech; slow heart rate; sensitivity to sunlight; bleeding from nose; abdominal distension; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods; and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100) jinkludu sensittività eċċessiva (eż. nefħa fil-ħalq u l-gerżuma, ħakk, raxx); dijabete jew l-aggravar tad-dijabete, xi kultant assoċjata ma' ketoaċidożi (ketoni fid-demm u fl-awrina) jew koma; aċċessjonijiet, normalment assoċjati ma' storja ta' aċċessjonijiet (epilessija); ebusija fil-muskoli jew spażmi (inklużi movimenti flgħajnejn); sindromu ta' saqajn irrikwieti; problemi biex titkellem; rata baxxa ta' taħbit tal-qalb; sensittività għax-xemx; fsada mill-imnieħer; nefħa addominali; telf tal-memorja jew nisi; inkontinenza urinarja; nuqqas ta' kapaċità li tgħaddi l-awrina; telf tax-xagħar; assenza jew tnaqqis filmestrwazzjoni; u bidliet fis-sider fl-irġiel u fin-nisa bħal produzzjoni mhux normali tal-ħalib tas-sider jew tkabbir anormali.
English: Cases of Cushing's syndrome and adrenal suppression have been reported.
Maltese: Ġew irrappurtati każijiet ta' sindromu ta' Cushing u ta' suppressjoni adrenali.
English: Undesirable effects (Table)
Maltese: Effetti mhux mixtieqa (Tabella)
English: Package leaflet 4 - Possible side effects
Maltese: Fuljett ta' tagħrif 4 - Effetti sekondarji possibbli
English: Frequency not known: AGEP - acute generalized exanthematous pustulosis (see section 4.4)
Maltese: AGEP - raxx ġeneralizzat akut tal-ponot (ara sezzjoni 4.4)
English: Adopted at the 24-27 October 2016 PRAC
Maltese: Adottata fil-PRAC ta' bejn il-24-27 ta' Ottubru 2016
English: It is important to tell your doctor if you are taking: corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Maltese: Kortikosterojdi primarjament metabolizzati minn CYP3A (inklużi betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
English: In case of AGEP diagnosis, flucloxacillin should be discontinued and any subsequent administration of flucloxacillin contra-indicated.
Maltese: F'każ ta' dijanjożi ta' AGEP, flucloxacillin għandu jitwaqqaf u kwalunkwe amministrazzjoni sussegwenti ta' flucloxacillin tiġi kontraindikata.
English: The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthematous pustulosis (AGEP) (see section 4.8).
Maltese: L-okkorrenza ta' eritema ġeneralizzata bid-deni assoċjata ma' ponta fil-bidu tal-kura, tista' tkun sintomu ta' raxx ġeneralizzat akut tal-ponot (AGEP, ara sezzjoni 4.8).
English: Summary of product characteristics (SmPC) of cobicistat containing products N.B: For Evotaz, Section 4.4 warning should be maintained.
Maltese: Sommarju tal-karatteristiċi tal-prodott ta' prodotti li fihom cobicistat N.B: Għal Evotaz, it-twissija ta' Sezzjoni 4.4 għandha tinżamm.
English: SmPC of all corticosteroids other than beclomethasone (excluding cutaneous formulations) - Double strikethrough represents deletion as compared to the PRAC recommendation published on the 26th September 2016.
Maltese: L-SmPC tal-kortikosterojdi kollha għajr beclomethasone (minbarra formulazzjonijiet għall-ġilda) - Lingassar doppju jirrappreżenta t-tħassir meta mqabbel mar-rakkomandazzjoni tal-PRAC fis-26 ta' Settembru 2016.
English: A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
Maltese: Raxx aħmar u bil-qxur, b'daqqiet taħt il-ġilda u nfafet (exanthematous pustulosis).
English: Beclomethasone is less dependent on CYP3A metabolism than some other corticosteroids, and in general interactions are unlikely; however the possibility of systemic effects with concomitant use of strong CYP3A inhibitors (e.g. ritonavir, cobicistat) cannot be excluded, and therefore caution and appropriate monitoring is advised with the use of such agents.
Maltese: Beclomethasone huwa anqas dipendenti fuq il-metaboliżmu tas-CYP3A minn xi kortikosterojdi oħrajn, u b'mod ġenerali l-interazzjonijiet mhumiex probabbli; madankollu l-possibbiltà ta' effetti sistemiċi bl-użu konkomitanti ta' inibituri tas-CYP3A qawwija (eż. ritonavir, cobicistat) ma tistax tiġi eskluża, u għalhekk hija rrakkomandata kemm il-kawtela kif ukoll monitoraġġ xieraq meta jintużaw aġenti bħal dawn.
English: PL of all corticosteroids other than beclomethasone (excluding cutaneous formulations)
Maltese: Il-kortikosterojdi kollha għajr beclomethasone (minbarra formulazzjonijiet għall-ġilda)
English: No changes have been made to the product information wording for cobicistat containing products as compared to the PRAC recommendation published on the 26th September 2016.
Maltese: Ma sar l-ebda tibdil għall-kliem tal-informazzjoni tal-prodott għal prodotti li fihom cobicistat meta mqabbel mar-rakkomandazzjoni tal-PRAC ippubblikata fis-26 ta' Settembru 2016.
English: Strength Pharmaceutical form
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata
English: EMA/364550/2015 EMEA/H/C/002800
Maltese: EMA/364550/2015
English: Unituxin dinutuximab
Maltese: Unituxin dinutuksimab
English: GM-CSF and interleukin-2.
Maltese: GM-CSF, interleukin-2 u isotretinoin.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Unituxin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Unituxin contains the active substance dinutuximab.
Maltese: Unituxin fih is-sustanza attiva dinutuksimab.