FrancophonIA/ELRC3.0 huggingface dataset:
English: Chronic continuous infusions of epoprostenol in patients with pulmonary arterial hypertention/scleroderma spectrum of diseases (PAH/SSD) were studied in a prospective, open, randomised trial of 12 weeks' duration comparing epoprostenol plus conventional therapy (N = 56) to conventional therapy alone (N = 55).
Maltese: L-infużjonijiet kroniċi kontinwi ta' epoprostenol f'pazjenti bi pressjoni arterjali pulmonari għolja/spettru ta' mard tal-iskleroderma (PAH/SSD) ġew studjati fi prova klinika prospettiva, miftuħa u aleatorja b'dewmien ta' 12-il ġimgħa li fihom, epoprostenol flimkien mat-terapija konvenzjonali (N = 56) tqabblu mat-terapija konvenzjonali waħedha (N = 55).
English: The MAH submitted a proposal for harmonisation of the Quality module.
Maltese: Il-MAH issottometta proposta għall-armonizzazzjoni tal-modulu dwar il-Kwalità.
English: Eight patients received 21 epoprostenol dialyses in emergency studies.
Maltese: Tmien pazjenti rċievew 21 dijaliżi b'epoprostenol fi studji ta' emerġenza.
English: Nineteen patients received 51 heparin dialyses and 19 received 44 epoprostenol dialyses in major controlled studies.
Maltese: Dsatax-il pazjent irċievew 51 dijaliżi b'heparin u 19 irċievew 44 dijaliżi b'epoprostenol fi studji kbar ikkontrollati.
English: Functional Class III-IV symptoms to improve exercise capacity (see section 5.1).
Maltese: III-IV tal-WHO sabiex itejjeb il-kapaċità ta' eżerċizzju (ara sezzjoni 5.1).
English: Flolan is indicated for the treatment of pulmonary arterial hypertension (PAH) (idiopathic or heritable PAH and PAH associated with connective tissue diseases) in patients with WHO
Maltese: Flolan huwa indikat għat-trattament ta' pressjoni arterjali pulmonari għolja (PAH) (PAH idjopatika jew li tintiret u PAH assoċjata ma' mard tat-tessut konnettiv) f'pazjenti b'sintomi tal-Klassi
English: Other Sections of the SmPC
Maltese: Konklużjonijiet xjentifiċi
English: This section is one of the identified for harmonisation.
Maltese: Din is-sezzjoni hija waħda minn dawk identifikati għal armonizzazzjoni.
English: The following data from clinical studies have been presented by the MAH and discuss during the assessment of these procedure.
Maltese: Id-dejta li ġejja mill-istudji kliniċi ġiet ippreżentata mill-MAH u tiddiskuti l-valutazzjoni ta' dawn ilproċeduri.
English: The CHMP assessed the data from the available clinical studies, post-marketing data and published literature and agreed with the following contraindications:
Maltese: Is-CHMP ivvaluta d-dejta mill-istudji kliniċi disponibbli, id-dejta ta' wara t-tqegħid fis-suq u t-tagħrif ippubblikat u qabel mal-kontra-indikazzjonijiet li ġejjin:
English: In major controlled studies and emergency studies, major clotting occurred in approximately 9% (n=56) of all epoprostenol dialyses and in <1% (n=1) of heparin dialyses.
Maltese: Fi studji kkontrollati kbar, seħħew emboli kbar f'madwar 9% (n=56) tad-dijaliżijiet kollha b'epoprostenol u f'<1% (n=1) tad-dijaliżijiet b'heparin.
English: It also agreed on the recommended schedule of infusion in adults.
Maltese: Sar qbil ukoll dwar l-iskeda rakkomandata ta' infużjoni fl-adulti.
English: Section 4.2 - Posology and method of administration There were differences in Section 4.2 of the SmPCs across Member States.
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata Kien hemm differenzi fis-Sezzjoni 4.2 tal-SmPCs bejn l-Istati Membri.
English: The proposal for changes in section 4.8 was mainly based on the Core Safety Profile (CSP) which has been agreed in 2009 during the PSUR Worksharing Procedure (IE/H/PSUR/0018/001).
Maltese: Il-proposta għal bidliet fis-sezzjoni 4.8 kienet primarjament ibbażata fuq il-Profil tas-Sigurtà Ewlieni (CSP) li sar qbil dwaru fl-2009 matul il-Proċedura ta' Qsim tax-Xogħol tal-PSUR (IE/H/PSUR/0018/001).
English: Epoprostenol sodium is also indicated for the treatment of pulmonary arterial hypertension (PAH).
Maltese: Sodju epoprostenol huwa indikat ukoll għat-trattament ta' pressjoni arterjali pulmonari għolja (PAH).
English: The indications authorised in various Member States are: Pulmonary Arterial Hypertension and Renal dialysis.
Maltese: Pressjoni Arterjali Pulmonari Għolja u Dijaliżi renali.
English: A statistically significant increase in cardiac index (CI), and statistically significant decreases in mean pulmonary arterial pressure (PAPm), mean right atrial pressure (RAPm), pulmonary vascular resistance (PVR), and mean systemic arterial pressure (SAPm) after 12 weeks of treatment were observed in patients who received epoprostenol chronically compared to those who did not.
Maltese: Wara 12-il ġimgħa trattament f'pazjenti li rċievew epoprostenol b'mod kroniku ġiet osservata żieda statistikament sinifikanti fl-indiċi kardijaku (CI) kif ukoll tnaqqis statistikament sinifikanti fil-pressjoni arterjali pulmonari medja (PAPm), il-pressjoni atrijali leminija medja (RAPm), ir-reżistenza vaskulari pulmonari (PVR), u l-pressjoni arterjali sistemika medja (SAPm), meta mqabbla ma' dawk li ma rċievewhx.
English: Based on the above, the CHMP considers the benefit/risk ratio of Flolan and associated names to be favourable and the harmonised Product Information documents to be approvable.
Maltese: Fuq il-bażi ta' dak li ntqal sa issa, is-CHMP iqis li l-proporzjon benefiċċji/riskji ta' Flolan u ismijiet assoċjati huwa wieħed favorevoli u li d-dokumenti tal-Informazzjoni dwar il-Prodott huma approvabbli.
English: There are differences in wording of the contraindications across Member States and detail given with respect to these contraindications.
Maltese: Hemm differenzi fit-test tal-kontra-indikazzjonijiet bejn l-Istati Membri u d-dettall mogħti fir-rigward ta' dawn il-kontra-indikazzjonijiet.
English: Differences identified include, events occurring during infusion, ischemia in patients with severe angina.
Maltese: Id-differenzi identifikati jinkludu avvenimenti li jseħħu matul l-infużjoni, iskemija f'pazjenti b'anġina severa.
English: The CHMP was requested to assess the available data on the indications and confirm the wording proposed by the MAH.
Maltese: Is-CHMP intalab jivvaluta d-dejta disponibbli dwar l-indikazzjonijiet u jikkonferma t-test propost mill-MAH.
English: The CHMP assessed the submitted data and recommended the re-arrangement of this section by separating the posology in the administration of epoprostenol for PAH during short-term (acute) dose ranging versus long-term continuous infusion.
Maltese: Is-CHMP ivvaluta d-dejta sottomessa u rrakkomanda l-arranġament mill-ġdid ta' din is-sezzjoni billi tiġi separata l-pożoloġija fl-għoti ta' epoprostenol għall-PAH matul sejbien tad-doża (akuta) f'perjodu qasir kontra infużjoni kontinwa fit-tul.
English: • The committee considered the identified divergences for Flolan and associated names regarding the therapeutic indications, posology, the contraindications and warnings.
Maltese: • Il-kumitat ikkunsidra d-diverġenzi identifikati għal Flolan u ismijiet assoċjati rigward lindikazzjonijiet terapewtiċi, il-pożoloġija, il-kontra-indikazzjonijiet u t-twissijiet.
English: Patients were assigned to 1 of 4 bleeding risk groups prior to receiving their first study dialysis.
Maltese: Il-pazjenti tqassmu fi gruppi ta' riskju ta' fsad minn 1 sa 4 qabel ma rċievew lewwel dijaliżi tal-istudju.
English: • The committee reviewed the data submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the Product Information.
Maltese: • Il-kumitat analizza d-dejta sottomessa mill-MAH mill-istudji kliniċi eżistenti, id-dejta dwar ilfarmakoviġilanza u t-tagħrif ippubblikat li jiġġustifikaw l-armonizzazzjoni proposta talInformazzjoni dwar il-Prodott.
English: Following all the changes in the SmPC there are several corresponding changes to the Package Leaflet After the corrections were implemented a Readability Testing was performed which was submitted and assessed during the referral procedure.
Maltese: Wara li ġew implimentati l-korrezzjonijiet, sar Test tal-Leġibbiltà li ġie sottomess u vvalutat matul il-proċedura ta' riferiment.
English: Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients, supplemental oxygen and diuretics in two thirds of the patients, oral vasodilators in 40% of the patients, and digoxin in a third of the patients.
Maltese: It-terapija konvenzjonali varjat fost il-pazjenti u inkludiet uħud jew kull waħda minn dawn li ġejjin: antikoagulanti fi prattikament il-pazjenti kollha, ossiġenu u dijuretiċi addizzjonali f'żewġ terzi tal-pazjenti, vasodilataturi orali f'40% tal-pazjenti, u digoxin f'terz mill-pazjenti.
English: Most epoprostenol dialyses (67%) that required replacement of artificial kidney were completed subsequently with epoprostenol without clotting.
Maltese: Ħafna mid-dijaliżijiet b'epoprostenol (67%) li kienu jeħtieġu bidla tal-kilwa artifiċjali tlestew sussegwentement b'epoprostenol mingħajr emboli.
English: Conventional therapy varied among patients and included some or all of the following: anticoagulants in essentially all patients; oral vasodilators, diuretics, and digoxin in one half to two thirds of patients; and supplemental oxygen in about half the patients.
Maltese: It-terapija konvenzjonali varjat fost il-pazjenti u inkludiet uħud jew kull waħda minn dawn li ġejjin: antikoagulanti fi prattikament il-pazjenti kollha; vasodilataturi orali, dijuretiċi, u digoxin f'nofs sa żewġ terzi mill-pazjenti; u ossiġenu addizzjonali fi kważi nofs il-pazjenti.
English: Improvements from baseline in cardiac index (0.33 vs. -0.12 L/min/m2), stroke volume (6.01 vs. -1.32 mL/beat), arterial oxygen saturation (1.62 vs. -0.85%), mean pulmonary artery pressure (-5.39 vs.
Maltese: Fuq 12-il ġimgħa, ġiet osservata differenza statistika (p<0.001) fil-bidla mil-linja bażi għas-6MWT filgrupp li rċieva epoprostenol flimkien mat-terapija konvenzjonali meta mqabbel mal-grupp li rċieva terapija konvenzjonali waħedha (medja: 63.5 vs.
English: At the end of the treatment period in the 12 weeks study, survival was improved in NYHA functional Class III and Class IV patients.
Maltese: II tan-New York Heart Association (NYHA), il-pazjenti kollha kienu jew tal-Klassifika funzjonali
English: This was reiterated in the SmPC section.
Maltese: Dan ġie mtenni fis-sezzjoni tal-SmPC.
English: Flolan must not be used chronically in patients who develop pulmonary oedema during dose-ranging.
Maltese: Flolan ma jistax jintuża b'mod kroniku f'pazjenti li jiżviluppaw edema pulmonari matul is-sejbien tad-doża.
English: Flolan is contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients, in patients with congestive heart failure arising from severe left ventricular dysfunction.
Maltese: Flolan huwa kontra-indikat f'pazjenti b'ipersensittività magħrufa għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti, f'pazjenti b'arrest kardijaku konġestiv li jirriżulta minn disfunzjoni severa fil-ventrikolu tax-xellug.
English: Two studies (30 and 31) addressed the possibility that patients' platelets may become refractory to repeated use of epoprostenol and thereby compromise dialysis efficiency with prolonged use.
Maltese: Żewġ studji (30 u 31) indirizzaw il-possibilità li l-pjastrini tal-pazjenti jistgħu jsiru refrattarji għal użu ripetut ta' epoprostenol u għaldaqstant, iqiegħdu f'riskju l-effiċjenza tad-dijaliżi wara użu fit-tul.
English: Editorial changes and clarifications were requested by the CHMP in the table of ADRs.
Maltese: Ilbidliet u l-kjarifiki editorjali ntalbu mis-CHMP fit-tabella tal-ADRs.
English: The median baseline value for the conventional therapy group and epoprostenol plus conventional therapy group was 240 meters and 270 meters, respectively.
Maltese: Il-punt ta' tmiem primarju tal-effikaċja għall-istudju kien titjib fis-6MWT. Ilvalur medju tal-linja bażi għall-grupp tat-terapija konvenzjonali u għall-grupp ta' epoprostenol flimkien mat-terapija konvenzjonali kien ta' 240 metru u 270 metru, rispettivament.
English: Each patient was randomly assigned to a sequence of heparin or epoprostenol dialyses and received up to 6 dialyses per entry in study 19 and up to 3 dialyses per entry in study 27.
Maltese: Kull pazjent ġie assenjat b'mod aleatorju għal sekwenza ta' dijaliżi b'heparin jew epoprostenol u rċieva sa 6 dijaliżijiet għal kull entrata fl-istudju 19 u sa 3 dijaliżijiet għal kull entrata fl-istudju 27.
English: NovoMix (insulin aspart)
Maltese: NovoMix (insulina aspart)
English: Further information on NovoMix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/novomix.
Maltese: ema.europa.eu/medicines/human/EPAR/novomix.
English: NovoMix is a replacement insulin.
Maltese: NovoMix huwa insulina ta' sostituzzjoni.
English: It is available as:
Maltese: Huwa disponibbli bħala:
English: Other information about NovoMix
Maltese: Informazzjoni oħra dwar NovoMix
English: NovoMix 50 and NovoMix 70 can only be used in adults (from 18 years of age).
Maltese: NovoMix 50 u NovoMix 70 jistgħu jintużaw biss f'adulti (minn 18-il sena 'l fuq).
English: NovoMix 30 gave almost identical results as biphasic human insulin 30 (a combination of 30% rapidacting and 70% intermediate-acting human insulin) in 294 adults with type 1 diabetes (when the pancreas cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively), and in 167 patients aged between 10 and 17 years with type 1 diabetes.
Maltese: NovoMix 30 ta kważi l-istess riżultati bħal insulina umana bifażika 30 (kombinazzjoni ta' 30% ta' insulina umana li taħdem malajr u 70% li taħdem b'rata intermedja) f'294 adult b'dijabete tat-tip 1 (meta l-frixa ma tkunx tista' tipproduċi l-insulina) jew dijabete tat-tip 2 (meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effettiv), u f'167 pazjent ta' bejn l-10 snin u s-17-il sena bid-dijabete tat-tip 1.
English: NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than biphasic human insulin 30 in 664 patients with type 1 or type 2 diabetes.
Maltese: NovoMix 50 u NovoMix 70 taw kontroll ġenerali aħjar tal-glukożju fid-demm minn insulina umana bifażika 30 f'664 pazjent bid-dijabete tat-tip 1 jew tat-tip 2.
English: In 5 studies involving a total of around 1,350 patients with type 2 diabetes, adding NovoMix medicines to other diabetes medicines (metformin, sulphonylureas, pioglitazone and liraglutide) also resulted in better control of blood glucose than the other medicines or NovoMix used alone.
Maltese: F'5 studji li involvew total ta' madwar 1,350 pazjent bid-dijabete tat-tip 2, iż-żieda ta' mediċini NovoMix ma' mediċini oħrajn kontra d-dijabete (metformina, sulfonilureas, pioglitazone u liraglutide) ukoll irriżultat f'kontroll aħjar tal-glukożju fid-demm mill-mediċini l-oħra jew minn NovoMix użat waħdu.
English: What are the risks associated with NovoMix?
Maltese: X'inhuma r-riskji assoċjati ma' NovoMix?
English: NovoMix medicines contain the active substance insulin aspart (100 units/ml) combined with protamine to make it longer acting.
Maltese: Ilmediċini NovoMix fihom is-sustanza attiva l-insulina aspart (100 unità/ml) flimkien mal-protamina biex jagħmluh jaġixxi aktar fit-tul.
English: As for all medicines, data on the use of NovoMix are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' NovoMix hija ssorveljata kontinwament.
English: The medicines are normally given shortly before a meal, but can be given just after a meal if necessary.
Maltese: Il-mediċini normalment jingħataw ftit ħin qabel ikla, iżda jistgħu jingħataw eżatt wara ikla jekk ikun hemm bżonn.
English: Side effects reported with NovoMix are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'NovoMix huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex ilpazjenti jiġu protetti.
English: NovoMix received a marketing authorisation valid throughout the EU on 1 August 2000.
Maltese: NovoMix ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-1 ta' Awwissu 2000.
English: The medicines are given by injection under the skin of the abdomen (belly), thigh, upper arm or buttock.
Maltese: Il-mediċini jingħataw b'injezzjoni taħt il-ġilda tal-addome (iż-żaqq), il-koxxa, iddriegħ ta' fuq jew il-warrani.
English: NovoMix contains both insulin aspart and a longer-acting form called insulin aspart protamine, which is absorbed more slowly and works for longer.
Maltese: NovoMix fih kemm l-insulina aspart kif ukoll il-forma li taħdem aktar fit-tul imsejħa insulina aspart protamina, li tiġi assorbita iktar bil-mod u taħdem iktar fittul.
English: NovoMix 30 can be used in patients from 10 years of age.
Maltese: NovoMix 30 jista' jintuża f'pazjenti minn 10 snin 'il fuq.
English: For the full list of side effects and restrictions of NovoMix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' NovoMix, ara l-fuljett ta' tagħrif.
English: Several studies have found NovoMix to be effective either at reducing glycosylated haemoglobin (HbA1c, a substance which indicates how well blood glucose is controlled over 12 to 28 weeks) or in reducing blood glucose levels after a meal.
Maltese: Diversi studji sabu li NovoMix hu effettiv jew biex inaqqas l-emoglobina glikosilata (HbA1c, sustanza li tindika kemm il-glukożju fid-demm huwa kkontrollat tajjeb minn 12 għal 28 ġimgħa) jew biex inaqqas il-livelli ta' glukożju fid-demm wara ikla.
English: The active substance in NovoMix, insulin aspart, is absorbed faster by the body than natural insulin and it starts working soon after it is injected.
Maltese: Is-sustanza attiva f'NovoMix, l-insulina aspart, tiġi assorbita aktar malajr mill-ġisem mill-insulina naturali u tibda taħdem ftit wara li tiġi injettata.
English: How does NovoMix work?
Maltese: Kif jaħdem NovoMix?
English: The most common side effect with NovoMix (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose levels).
Maltese: L-effett sekondarju l-aktar komuni bi NovoMix (li jista' jaffettwa aktar minn persuna 1 minn kull 10) hu ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: NovoMix acts in the same way as naturally produced insulin and helps glucose from the blood to enter cells.
Maltese: NovoMix jaġixxi bl-istess mod bħal insulina prodotta b'mod naturali u jgħin lill-glukożju mid-demm biex jidħol fiċ-ċelloli.
English: Why is NovoMix authorised in the EU?
Maltese: Għaliex NovoMix ġie awtorizzat fl-UE?
English: 18 May 2011
Maltese: 18 ta' Mejju 2011
English: What is Isotretinoin?
Maltese: X'inhuwa Isotretinoin?
English: Isotretinoin capsules from Ranbaxy are a generic medicine based on a ‘reference medicine', Roaccutane, which has been marketed in the EU since 1984.
Maltese: Il-kapsuli Isotretinoin tad-ditta Ranbaxy huma mediċina ġenerika bbażata fuq il-‘mediċina ta' referenza', Roaccutane, li ilha tiġi kkummerċjalizzata fl-UE sa mill-1984.
English: Ranbaxy (UK) Limited submitted the generic isotretinoin-containing medicine for mutual recognition on the basis of the initial authorisation granted by the United Kingdom (the ‘reference Member State') on 20 November 2006.
Maltese: Ranbaxy (UK) Limited issottomettiet il-mediċina ġenerika li fiha l-isotretinoina għal rikonoxximent reċiproku fuq il-bażi tal-awtorizzazzjoni inizjali mogħtija mir-Renju Unit (l-‘Istat Membru ta' Referenza') fl-20 ta' Novembru 2006.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the generic isotretinoin-containing medicine from Ranbaxy (UK) Limited.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina ġenerika li fiha l-isotretinoina tadditta Ranbaxy (UK) Limited.
English: Isotretinoin is a retinoid (a substance derived from vitamin A) that is used to treat severe acne that has not responded to standard treatments.
Maltese: Isotretinoin huwa retinojde (sustanza li ġejja mill-vitamina A) li jintuża fil-kura ta' akne severa li ma tkunx wieġbet għal kuri standard.
English: Why was Isotretinoin reviewed?
Maltese: Għalxiex ġie rivedut Isotretinoin?
English: The grounds for the referral were that the bioequivalence study to show that Ranbaxy's isotretinoin capsules produce the same levels of active substance in the body as Roaccutane had been performed under fasting conditions.
Maltese: Ir-raġunijiet għar-riferiment kienu li l-istudju ta' bijoekwivalenza biex juri li l-kapsuli tal-isotretinoina ta' Ranbaxy jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem bħal Roaccutane sar taħt kundizzjonijiet ta' sawm.
English: However, the Member States were not able to reach an agreement and the United Kingdom referred the matter to the CHMP for arbitration on 29 July 2010.
Maltese: Madankollu l-Istati Membri ma setgħux jilħqu ftehim u r-Renju Unit irrefera l-kwistjoni lis-CHMP għallarbitraġġ fid-29 ta' Lulju 2010.
English: Acne is a skin disease caused by an excessive production of sebum (the skin's natural oil) from overactive sebaceous glands in the skin.
Maltese: L-akne hija marda tal-ġilda kkawżata minn produzzjoni eċċessiva ta' sebum (iż-żejt naturali tal-ġilda) minn glandoli sebaċeji fil-ġilda li huma attivi żżejjed.
English: The company wanted the authorisation to be recognised in France and Spain (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta fi Franza u fi Spanja (l-‘Istati Membri kkonċernati').
English: The CHMP considered that demonstration of bioequivalence in the fed state was essential and in line with current guidance on investigation of bioequivalence.
Maltese: Is-CHMP ikkunsidra li l-wiri ta' bijoekwivalenza fl-istat mhux ta' sawm kien essenzjali u f'konformità mal-linji gwida attwali dwar l-investigazzjoni ta' bijoekwivalenza.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence of the generic isotretinoin capsules to the reference medicinal product has not been shown according to the current requirements.
Maltese: Fuq il-bażi tal-evalwazzjoni tad-dejta attwalment disponibbli u d-diskussjoni xjentifika li saret filKumitat, is-CHMP ikkonkluda li skont ir-rekwiżiti attwali, il-bijoekwivalenza tal-kapsuli ġeneriċi talisotretinoina mal-prodott mediċinali ta' referenza ma ntwerietx.
English: As the product information states that the capsules should be taken with food, Spain considered that a bioequivalence study under fed conditions would be required for the granting of the marketing authorisation.
Maltese: Minħabba li l-informazzjoni dwar il-prodott tgħid li l-kapsuli għandhom jittieħdu mal-ikel, Spanja kkunsidrat li biex tingħata awtorizzazzjoni għat-tqegħid fis-suq jenħtieġ isir studju ta' bijoekwivalenza taħt kundizzjonijiet mhux ta' sawm.
English: Isotretinoin works by decreasing the size and activity of the sebaceous glands in the skin, reducing sebum production and inflammation in the skin.
Maltese: L-isotretinoina taħdem billi tnaqqas id-daqs u l-attività tal-glandoli sebaċeji fil-ġilda, u b'hekk tnaqqas il-produzzjoni tas-sebum u l-infjammazzjoni fil-ġilda.
English: Pharmaceutical form
Maltese: Għamla farmaċe wtika
English: 100 x 1 tablets (unit dose)
Maltese: Folja (PVC/PVDC/Aluminju) 100 x 1 pillola (doża waħda)
English: MA (EU) Number Invented name
Maltese: Numru tal-MA Isem (ivvintat)
English: Route of administration Packaging Package size
Maltese: Daqs tal-pakkett
English: EU Numbers
Maltese: Qawwa
English: Sealant powder
Maltese: Mnejn għandu jingħata
English: The full EPAR for Combivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Combivir
Maltese: Informazzjoni oħra dwar Combivir
English: Combivir is available as tablets containing lamivudine 150 mg and zidovudine 300 mg.
Maltese: Combivir jiġi bħala pilloli li fihom 150 mg lamivudina u 300 mg zidovudina.