FrancophonIA/ELRC3.0 huggingface dataset:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Pregnancy
Maltese: Pożolġija
English: One pack contains one vial containing 5 ml solution.
Maltese: Kull pakkett fih kunjett wieħed li fih soluzzjoni ta' 5 ml.
English: Do not use Atosiban SUN - If you are allergic to atosiban or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tużax Atosiban SUN - Jekk int allerġika għal atosiban jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Other medicines and Atosiban SUN
Maltese: Mediċini oħra u Atosiban SUN
English: Atosiban SUN is used in pregnant adult women, from week 24 to week 33 of the pregnancy.
Maltese: Atosiban SUN jintuża f'nisa adulti tqal, mill-24 ġimgħa sat-33 ġimgħa tat-tqala.
English: The loading infusion is given by infusing 24 ml/hour (i.e. 18 mg/h) of the above prepared solution over the 3 hour period under adequate medical supervision in an obstetric unit.
Maltese: L-infużjoni tal-bidu tingħata billi ssir infużjoni ta' 24 ml/siegħa (i.e. 18 mg/siegħa) tas-soluzzjoni li tkun ġiet ippreparata, fuq medda ta' tliet sigħat taħt superviżjoni medika xierqa f'dipartiment ostetriku.
English: If during pregnancy the woman is already breast-feeding an earlier child, then breast-feeding should be discontinued during treatment with atosiban, since the release of oxytocin during breast-feeding may augment uterine contractility, and may counteract the effect of tocolytic therapy.
Maltese: Fil-firien u l-fniek tal-Indi, atosiban intwera li jingħaqad mar-riċetturi ta' oxytocin, biex inaqqas il-frekwenza tal-kontrazzjonijiet u s-sodizza talmuskoli tal-utru, bir-riżultat li jnaqqas il-kontrazzjonijiet tal-utru.
English: EXP
Maltese: Lot
English: Colourless tubular glass vial (type I) with bromobutyl flange grey rubber stopper and sealed with violet flip top aluminium seal.
Maltese: Ma sar ebda studju dwar il-fertilità u l-iżvilupp bikri tal-embriju.
English: Atosiban SUN will be given to you in a hospital by a doctor, nurse or midwife.
Maltese: Atosiban SUN se jiġi mgħoti lilek fi sptar minn tabib, infermier jew qabla.
English: BATCH NUMBER Batch
Maltese: Pressjoni baxxa, Fwawar
English: Once the bolus has been injected, proceed with the infusion (See Summary of Product Characteristics of Atosiban SUN 37.5 mg/5 ml, concentrate for solution for infusion).
Maltese: Ladarba l-injezzjoni f'daqqa tkun saret, kompli bl-infużjoni (Ara Sommarju tal-Karatteristiċi tal-Prodott ta' Atosiban SUN 37.5 mg/5 ml, konċentrat għal soluzzjoni għall-infużjoni).
English: Skin and subcutaneous tissue disorders
Maltese: Reazzjoni fil-post tal-injezzjoni
English: Common (may affect less than 1 in 10 people) - Headache.
Maltese: Komuni (jistgħu jaffettwaw inqas minn 1 f'10 persuni) - Uġigħ ta' ras.
English: In case a re-treatment with atosiban is needed, it should also commence with a bolus injection of atosiban 6.75 mg/0.9 ml, solution for injection followed by infusion with atosiban 37.5 mg/5 ml, concentrate for solution for infusion.
Maltese: F'każ li jkun hemm bżonn kura ripetuta b'atosiban, din għandha tibda wkoll b'injezzjoni f'daqqa ta' 6.75 mg/0.9 ml soluzzjoni għall-injezzjoni ta' atosiban, u wara infużjoni ta' konċentrat ta' soluzzjoni għall-infużjoni ta' 37.5 mg/5 ml ta' atosiban.
English: No systemic toxic effects were observed during the two-week intravenous toxicity studies (in rats and dogs) at doses which are approximately 10 times higher than the human therapeutic dose, and during the three-months toxicity studies in rats and dogs (up to 20 mg/kg/day s.c.).
Maltese: Ma deherx li kien hemm effetti tossiċi sistemiċi waqt studji ta' ġimagħtejn dwar it-tossicità li fihom ilprodott ingħata ġol-vina (fil-firien u l-klieb) b'dożi li kienu bejn wieħed u ieħor 10 darbiet ogħla middoża terapewtika għall-bnedmin, kif ukoll waqt studji ta' tliet xhur dwar it-tossiċità fil-firien u l-klieb (sa 20 mg/kg kuljum s.c.).
English: Olanzapine
Maltese: Olanzapina
English: It is available as orodispersible tablets (5, 10, 15 and 20 mg).
Maltese: Jiġi bħala pilloli orodispersibbli (5, 10, 15 u 20 mg).
English: The full EPAR for Olanzapine Glenmark Europe can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Olanzapine Glenmark Europe jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended starting dose of Olanzapine Glenmark Europe depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskiżofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum fil-kura ta' episodji manijaċi, sakemm ma jintużax ma' mediċini oħra, f'liema każ id-doża inizjali tista' tkun ta' 10 mg kuljum.
English: Olanzapine Glenmark Europe is a ‘generic medicine'.
Maltese: Olanzapine Glenmark Europe huwa ‘mediċina ġenerika'.
English: The active substance in Olanzapine Glenmark Europe, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Olanzapine Glenmark Europe, l-olanzapina, hija mediċina antipsikotika.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytryptamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku tal-olanzapina huwa dovut għallimblokkar tar-riċetturi għan-newrotrażmettituri 5-idrossitriptamina (imsejħa wkoll serotonina) u dopamina.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Glenmark Europe.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Olanzapine Glenmark Europe.
English: It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Maltese: Hija magħrufa bħala antipsikotiku ‘atipiku' minħabba li hija differenti mill-mediċini antipsikotiċi iktar antiki li ilhom disponibbli sa mill-ħamsinijiet.
English: This means that Olanzapine Glenmark Europe is similar to ‘reference medicines' already authorised in the European Union (EU) called Zyprexa and Zyprexa Velotabs.
Maltese: Dan ifisser li Olanzapine Glenmark Europe huwa simili għall-‘mediċini ta' referenza' diġà awtorizzati fl-Unjoni Europea (UE) li jisimhom Zyprexa u Zyprexa Velotabs.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Glenmark Europe has been shown to have comparable quality and to be bioequivalent to Zyprexa and Zyprexa Velotab.
Maltese: Is-CHMP kkonkluda li, b'konformità mar-rekwiżiti tal-UE, Olanzapine Glenmark Europe wera li għandu kwalità komparabbli ma' Zyprexa u Zyprexa Velotab u huwa bijoekwivalenti għalihom.
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Glenmark Europe on 3 December 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Olanzapine Glenmark Europe fit-3 ta' Diċembru 2009.
English: Olanzapine Glenmark Europe is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Olanzapine Glenmark Europe jintuża wkoll fil-kura ta' episodji moderati jew severi tal-manija (burdata tajba b'mod estrem) f'adulti.
English: Because Olanzapine Glenmark Europe is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicines, Zyprexa and Zyprexa Velotab.
Maltese: Billi Olanzapine Glenmark Europe huwa mediċina ġenerika, l-istudji ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu għall-mediċini ta' referenza, Zyprexa u Zyprexa Velotab.
English: Olanzapine Glenmark Europe is a medicine containing the active substance olanzapine.
Maltese: Olanzapine Glenmark Europe huwa mediċina li fiha s-sustanza attiva olanzapina.
English: Schizophrenia is a mental illness that has a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: L-iskiżofrenija hija marda mentali li għandha għadd ta' sintomi, inkluż disturbi fil-ħsieb u fid-diskors, alluċinazzjonijiet (id-dehra u s-smigħ ta' affarijiet li jkunu immaġinarji), suspetti u delirji (thewdin żbaljat).
English: Therefore, the CHMP's view was that, as for Zyprexa and Zyprexa Velotab, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal Zyprexa and Zyprexa Velotab, il-benefiċċju huwa akbar mir-riskju identifikat.
English: Other information about Olanzapine Glenmark Europe
Maltese: Informazzjoni oħra dwar Olanzapine Glenmark Europe
English: Because Olanzapine Glenmark Europe is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicines.
Maltese: Minħabba li Olanzapine Glenmark Europe huwa mediċina ġenerika u huwa bijoekwivalenti għallmediċina ta' referenza, il-benefiċċju u r-riskju tiegħu huma meqjusa li huma l-istess bħal dawk talmediċini ta' referenza.
English: Since these neurotransmitters are involved in schizophrenia and in bipolar disorder, olanzapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Maltese: Billi dawn in-newrotrażmettituri huma involuti fl-iskiżofrenija u fid-disturbi bipolari, lolanzapina tgħin fin-normalizzazzjoni tal-attività tal-moħħ, u b'hekk tnaqqas is-sintomi ta' dan il-mard.
English: What is Olanzapine Glenmark Europe?
Maltese: Kif jintuża Olanzapine Glenmark Europe?
English: Medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Ilmediċini jkunu bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem.
English: Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Maltese: Pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil-fwied jew fil-kliewi tagħhom jista' jkollhom bżonn ta' doża inizjali iktar baxxa ta' 5 mg kuljum.
English: Why has Olanzapine Glenmark Europe been approved?
Maltese: Għaliex ġie approvat Olanzapine Glenmark Europe?
English: Olanzapine Glenmark Europe is used to treat adults with schizophrenia.
Maltese: Olanzapine Glenmark Europe jintuża fil-kura tal-adulti bl-iskiżofrenija.
English: Piazzale dell'Industria 20 00144 Roma Italy
Maltese: Piazzale dell'Industria 20 00144
English: Extraneal is an isotonic solution of 7.5% icodextrin.
Maltese: Extraneal huwa soluzzjoni isotonika ta' 7.5% icodextrin.
English: Box 270 Valimotie 15A 00381 Helsinski Finland
Maltese: Baxter Oy P.O. Box 270 Valimotie 15A 00381 Helsinski Finland
English: It is presented as a sterile solution in 1.5, 2.0 and 2.5 liter bags and it is intended for peritoneal dialysis.
Maltese: Huwa jiġi bħala soluzzjoni sterili f'boroż ta' 1.5, 2.0 u 2.5 litri u huwa maħsub għal dijalisi peritoneali.
English: United Kingdom
Maltese: 3SE United Kingdom
English: The product also contains as active ingredients sodium lactate, sodium chloride, calcium chloride and magnesium chloride.
Maltese: Il-prodott fih ukoll sodium lactate, sodium chloride, calcium chloride and magnesium chloride bħala sustanzi attivi.
English: Icodextrina 7.5% Solution for peritoneal dialysis
Maltese: Icodextrina 7.5% Taħlita likwida għad-dijalisi talperitonew
English: It corresponds to the limit of quantitation of the current SLP test.
Maltese: Dan jikkorrispondi għal-limitu ta' kwantitazzjoni tat-test SLP attwali.
English: Baxter Healthcare Ltd Caxton Way Thetford IP24 3SE United Kingdom
Maltese: Baxter Healthcare Ltd Caxton Way Thetford IP24
English: Baxter S.A.S 6 av. Louis Pasteur 78310 Maurepas France
Maltese: Louis Pasteur 78310
English: Extraneal is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients.
Maltese: Extraneal huwa rrakkomandat bħala sostitut ta' darba kuljum għal skambju weħed ta' glucose bħala parti minn kors ta' dijalisi peritoneali ambulatorja kontinwa (continuous ambulatory peritoneal dialysis -CAPD) jew ta' dijalisi perineali awtomatizzata (automated peritoneal dialysis - APD) għattrattament ta' insuffiċjenza renali kronika, b'mod partikolari għal pazjenti li tilfu ultrafiltrazzjoni fuq soluzzjonijiet ta' glucose, minħabba li jista' jestendi l-ħin fuq terapija CAPD f'pazjenti bħal dawn.
English: The issue was resolved from a chemical-pharmaceutical point of view.
Maltese: Il-kwistjoni ġiet solvuta minn perspettiva kimika-farmaċewtika.
English: - The Roquette Frères manufacturing site for the active substance will be removed from EU licences via appropriate variation procedure by February 2010.
Maltese: - Is-sit ta' manifattura Roquette Frères sustanza attiva ser titneħħa mill-liċenzjoni tal-UE via proċedura ta' varjazzjoni xierqa sa Frar 2010.
English: Following occurrence of increased reported cases of Aseptic Peritonitis (AP) in 2002 and then in 2007, Baxter committed to the Reference Member State (UK) to vary the marketing authorisation in order to include a peptidoglycan test to the drug product specification.
Maltese: Wara l-okkorrenza ta' żieda f'każijiet irrapportati ta' Peritonite Asettika (Aseptic Peritonitis - AP) fl2002 u mbagħad fl-2007, Baxter impenjat ruħha mal-Istat Membru ta' Referenza (RMS) (ir-Renju Unit) li tvarja l-awtorizzazzjoni għat-tqegħid fis-suq sabiex tinkludi test tal-peptidoglycans flispeċifikazzjoni tal-prodott tal-mediċina.
English: United Kingdom Baxter Healthcare Ltd Caxton Way,
Maltese: Baxter Healthcare Ltd Caxton Way, Thetford IP24
English: Peptidoglycans originate from the breakdown of the cell wall of thermophilic, gram-positive bacteria that are commonly found in maltodextrin, a maize starch derivative that is used as raw material for the manufacture of icodextrin.
Maltese: Il-peptidoglycans joriġinaw mill-qsim tal-ħajt taċ-ċelloli ta' batterji termofiliċi, gram-pożittivi li normalment jinsabu fil-maltodextrin, derivattiv tal-lamtu tal-qamħirrum li jintuża bħala materja prima għall-manifattura ta' icodextrin.
English: The proposed method of analysis to determine the level of peptidoglycans (PG) in the finished product using Wako Silk Worm Larvae Plasma (SLP) method has been assessed.
Maltese: Il-metodu propost ta' analiżi sabiex jiġi ddeterminat il-livell ta' peptidoglycans (PG) fil-prodott lest blużu tal-metodu Plażma tal-Larvi tad-Dudu tal-Ħarir Wako (Wako Silk Worm Larvae Plasma - SLP) ġie evalwat.
English: ANNEX II SCIENTIFIC CONCLUSIONS PRESENTED BY THE EMEA
Maltese: ANNESS II KONKLUŻJONIJIET XJENTIFIĊI PPREŻENTATI
English: The overall conclusion is that proposed plan presented by Baxter is acceptable.
Maltese: Il-konklużjoni globali hija li l-pjan propost ippreżentat minn Baxter huwa aċċettabbli.
English: Marketing autorisation Holder
Maltese: Detentur tal-Awtorizzazzjoni għatTqegħid fis-Suq
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF EXTRANEAL
Maltese: TAL-EVALWAZZJONI XJENTIFIKA TA' EXTRANEAL
English: - Variations to add the new SLP-HS method and limits to the active substance (API) and finished product specifications will be submitted no later than the end of December 2009;
Maltese: - Varjazzjonijiet għaż-żjieda ta' metodu SLP-HS u limiti għas-sustanza attiva (API) u speċifikazzjonijiet tal-prodott lest ser jiġu sottomessi sa mhux aktar tard mill-aħħar ta' Diċembru 2009;
English: In addition NL requested the manufacturing process of the active substance (icodextrin) to be improved in order to limit possible future contamination with peptidoglycans and related occurrence of sterile peritonitis.
Maltese: Barra minn hekk l-Olanda talbet li l-proċess ta' manifatturar tas-sustanza (icodextrin) jitjieb sabiex titnaqqas il-kontaminazzjoni futura possibbli b'peptidoglycans u lokkorrenza relatata ta' peritonite sterili.
English: The limit proposed by the applicant was higher than the level of PG observed to be associated with the 2007 cluster of AP, therefore there was clinical evidence that the limit proposed for the finished product specification was too high.
Maltese: Il-limitu propost mill-applikant kien ogħla mil-livell ta' PG osservat li huwa assoċjat mal-cluster ta' AP tal-2007, għalhekk kien hemm evidenza klinika li l-limitu propost għall-ispeċifikazzjoni tal prodott lest kien għoli żżejjed.
English: As no agreement was reached by NL on 9 July 2009 on the draft decision of the RMS, the procedure was referred to the CHMP according to Article 6(12) and the Referral procedure was initiated on 23 July 2009 with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Maltese: Minħabba li ma ntlaħaq l-ebda ftehim mill-Olanda fid-9 ta' Lulju 2009 fuq l-abbozz ta' deċiżjoni talRMS, il-proċedura ġiet riferuta lis-CHMP skont l-Artikolu 6(12) u l-proċedura ta' Referenza nbdiet fit-23 ta' Lulju 2009 bl-adozzjoni ta' Lista ta' Mistoqsijiet tas-CHMP li għandhom ikunu indirizzati mill-MAHs.
English: Investigation revealed that the presence of elevated levels of peptidoglycan (PG) in Extraneal batches was associated with the reports of aseptic peritonitis.
Maltese: L-investigazzjoni wriet li l-preżenza ta' livelli għoljin ta' peptidoglycans (PG) f'lottijiet ta' Extraneal kienet assoċjata mar-rapporti ta' peritonite asettika.
English: Invented Name
Maltese: ANNESS I LISTA
English: It has become apparent that a more sensitive analytical method is available i.e. Wako High Sensitivity Silk Worm Larvae Plasma assay or (SLP -HS).
Maltese: Sar evidenti li metodu analitiku aktar sensittiv huwa disponibbli jiġifieri t-test bil-Plażma tal-Larvi tad-Dudu tal-Ħarir Wako ta' Sensittività Għolja jew (SLPHS).
English: UK as RMS had clearly highlighted the limitations associated with the proposed method as being insensitive to control the level of PG in the finished product in a meaningful way, considering that the proposed limit of PG in the finished product was higher than the toxin level seen in the 2007 cluster of AP.
Maltese: Ir-Renju Unit, bħala RMS kien enfasizza b'mod ċar il-limitazzjonijiet assoċjati mal-metodu propost minħabba li mhuwiex sensittiv biex jikkontrolla l-livell ta' PG fil-prodott lest b'mod sinjifikanti, meta wieħed iqis li l-limitu propost ta' PG fil-prodott lest kien ogħla mil-livell ta' tossina li deher fil-cluster ta' AP tal-2007.
English: It is expected that the peptidoglycan levels in the drug product are indirectly controlled as well as the active substance currently appears to be the only source of this contamination.
Maltese: Huwa mistenni li l-livelli ta' peptidoglycan fil-prodott tal-mediċina jiġu kkontrollati b'mod indirett ukoll peress li s-sustanza attiva attwalment tidher li hija l-unika sors ta' din il-kontaminazzjoni.
English: Baxter agreed setting tighter specification limit for PG in the finished product together with a lower limit for PG in the active substance, to allow patients adequate safety margins.
Maltese: Baxter qablet li tistabbilixxi limitu ta' speċifikazzjoni aktar riġidu għal PG fil-prodott lest flimkien ma' limitu aktar baxx għal PG fis-sustanza attiva, biex tippermetti marġini ta' sigurtà adegwat għallpazjenti.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Maltese: TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI / DETENTURI TALAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: All batches used icodextrin material supplied by the same manufacturer.
Maltese: Il-lottijiet kollha wżaw materjal ta' icodextrin fornut mill-istess manifattur.
English: In addition the MAH committed to implement the more sensitive SLP-HS assay by the end of the year in order to better control the quality of the active substance and finished product.
Maltese: Barra minn hekk il-MAH qabel li jimplimenta l-prova aktar sensittiva ta' SLP-HS sal-aħħar tas-sena sabiex jikkontrolla aktar il-kwalità tas-sustanza attiva u tal-prodott lest.
English: The NL brought to the attention of the UK, towards the end of the procedure, the existence of a more sensitive version of the SLP method (SLP-HS) that would be capable of detecting the PG levels down to 0.5 ng/ml in the finished product.
Maltese: L-Olanda ġibdet l-attenzjoni tar-Renju Unit, lejn l-aħħar tal-proċedura, rigward leżistenza ta' verżjoni aktar sensittiva tal-metodu SLP (SLP-HS) li jkun kapaċi jsib il-livelli ta' PG sa 0.5 ng/ml fil-prodott lest.
English: Italy
Maltese: Roma Italy
English: Quality issues
Maltese: Kwistjonijiet ta' Kwalità
English: At the time of the CHMP opinion, there were minor unresolved quality issues, which have no impact on the Benefit/Risk ratio of the product.
Maltese: Fil-ħin tal-opinjoni tas-CHMP, kien hemm kwistjonijiet minuri rigward il-kwalità li kienu għadhom ma ġewx solvuti, iżda li m'għandhomx impatt fuq il-proporzjon ta' Benefiċċju/Riskju tal-prodott.
English: 1 bottle+3 measuring spoons (1g,150mg, 100mg)
Maltese: 1 flixkun +3 measuring spoons (1g,150mg, 100mg)
English: Oral use bottle (HDPE)
Maltese: Jittieħed mill-ħalq flixkun (HDPE)
English: †, 95% CI)
Maltese: ta' 95%)
English: Date of first authorisation: 21 March 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 21 ta 'Marzu 2018
English: Difference from glimepiride (LS mean
Maltese: Differenza minn glimepiride (medja tal-LS†, CI
English: Microcrystalline cellulose (E460) Lactose monohydrate Sodium starch glycolate (Type A) Magnesium stearate (E470b)
Maltese: Microcrystalline cellulose (E460) Lactose monohydrate Sodium starch glycolate (Tip A) Magnesium stearate (E470b)
English: See Section 4.4.
Maltese: * Ara sezzjoni 4.4. †
English: • The active substance is ertugliflozin.
Maltese: • Is-sustanza attiva hija ertugliflozin.
English: Steglatro is available in Alu/PVC/PA/Alu blisters.
Maltese: Steglatro huwa disponibbli f'folji tal-Alu/PVC/PA/Alu.
English: Ertugliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters.
Maltese: Ertugliflozin huwa sustrat tat-trasportaturi tal-glikoproteina P (P-gp, P-glycoprotein) u tal-proteina ta' reżistenza tal-kanċer tas-sider (BCRP, breast cancer resistance protein).
English: o Film coating: hypromellose 2910/6 (E464), lactose monohydrate (see section 2), macrogol 3350 (E1521), triacetin (E1518), titanium dioxide (E171), iron oxide red (E172).
Maltese: o Kisja tar-rita: hypromellose 2910/6 (E464), lactose monohydrate (ara sezzjoni 2), macrogol 3350 (E1521), triacetin (E1518), titanium dioxide (E171), iron oxide aħmar (E172).
English: There is limited experience with Steglatro in patients ≥ 75 years of age.
Maltese: Hemm esperjenza limitata bi Steglatro f'pazjenti li għandhom età ta' ≥ 75 sena.
English: Hispanic or Latino patients comprised 24.2% of the population.
Maltese: Pazjenti Ispaniċi jew Latino kienu jgħoddu 24.2% tal-popolazzjoni.
English: 2031 BN Haarlem2220 Heist-op-den-Berg
Maltese: 2031 BN Haarlem2220