FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people):
Maltese: Effetti sekondarji komuni (jistgħu jiġu affettwati sa 1 minn kull 10 persuni):
English: Frequency of occurrence
Maltese: Frekwenza ta' inċidenti
English: Table 2: Combined results of the 30-week placebo-controlled studies (intent to treat patients)
Maltese: Tabella 2: Ġabra ta' riżultati tal-istudji kkontrollati bil-plaċebo li damu 30 ġimgħa (pazjenti filgrupp bl-intenzjoni tal-kura)
English: Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2)
Maltese: Ġiet irrappurtata ketoaċidożi dijabetika fil-pazjenti li jiddependu mill-insulina wara waqfien jew tnaqqis rapidu tad-doża tal-insulina (ara sezzjoni 4.2).
English: The pen must not be stored with the needle attached.
Maltese: Ħoll u armi kif suppost.
English: Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea) Hypoglycaemia (with a sulphonylurea) Decreased appetite Dehydration, generally associated with nausea, vomiting and/or diarrhoea.
Maltese: Reazzjoni anafilattika Disturbi filmetaboliżmu u nnutrizzjoni Ipogliċemija (b'metformin u xi sulphonylurea) Ipogliċemija (b'sulphonylurea) Nuqqas ta' aptit Deidratazzjoni, ħafna drabi assoċjata ma' tqalligħ, rimettar u/jew dijarea
English: GETTING STARTED
Maltese: Buttuna tal
English: When exenatide was used in combination with metformin alone, no increase in the incidence of hypoglycaemia was observed over that of placebo in combination with metformin which may be due to this glucose-dependent insulinotropic mechanism (see section 4.4).
Maltese: Meta exenatide intuża flimkien ma' metformin biss, ma ġiet osservata l-ebda żieda fl-inċidenza ta' ipogliċemija aktar minn dik ta' plaċebo flimkien ma' metformin li jista' jkun minħabba dan il-mekkaniżmu insulinotropiku dipendenti fuq glucose (ara sezzjoni 4.4).
English: • Rashes, itching and rapid swelling of the tissues of the neck, face, mouth orthroat
Maltese: • Raxxijiet, ħakk u nefħa rapida tat-tessut tal-għonq, wiċċ, ħalq jew griżmejn
English: Note: If you do not see liquid after 4 times, see Commonly Asked Questions, number 3, in Section 4 of this user manual.
Maltese: Nota: Jekk wara 4 darbiet ma tara ebda likwidu, ara Mistoqsijiet Magħmula ta' Spiss, numru 3, f'Sezzjoni 4 ta' dan il-manwal.
English: Exenatide has been shown to bind to and activate the known human GLP-1 receptor in vitro, its mechanism of action mediated by cyclic AMP and/or other intracellular signalling pathways.
Maltese: Ġie muri li in vitro exenatide jingħaqad u jattiva rriċettur GLP-1 uman u l-mekkaniżmu ta' azzjoni tiegħu huwa permezz tal-AMP ċikliku u/jew mekkaniżmi oħra ta' sinjali intraċellulari.
English: How do I store my Byetta pen?
Maltese: Kemm nista' ndum nuża pinna ta' Byetta?
English: Following subcutaneous administration to patients with type 2 diabetes, exenatide reaches median peak plasma concentrations in 2 h. Mean peak exenatide concentration (Cmax) was 211 pg/ml and overall mean area under the curve (AUC0-inf) was 1036 pg h/ml following subcutaneous administration of a 10 mcg dose of exenatide.
Maltese: Il-medja tal-ogħla konċentrazzjonijiet ta' exenatide (Cmax) kienet ta' 211 pg/ml u b'kollox il-medja tal-erja taħt il-kurva (AUC0-inf) kienet ta' 1036 pg •h/ml wara l-għoti ta' doża ta' 10 mcg exenatide taħt il-ġilda.
English: • Once in use, your Byettapen should be kept below 25ºC.
Maltese: • Waqt l-użu, il-pinna ta' Byetta trid tinżamm taħt 25C.
English: No dosage adjustment is necessary in patients with mild renal impairment (creatinine clearance 5080 ml/min).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti b'indeboliment renali ħafif (tneħħija talkrejatinina: 50 - 80 ml/min).
English: USER MANUAL CONTENTS
Maltese: KONTENUT TAL-MANWAL TAL-UTENT
English: When immediate-release exenatide was used in combination with basal insulin therapy the incidence and types of other adverse events observed were similar to those seen in the controlled clinical trials with exenatide as monotherapy, with metformin and/or sulphonylurea or a thiazolidinedione, with or without metformin.
Maltese: Meta exenatide b'rilaxx immedjat intuża flimkien ma' insulina bażilari, l-inċidenza u t-tipi ta' reazzjonijiet avversi oħra li ġew osservati kienu simili għal dawk li ġew osservati fi studji kliniċi kkontrollati b'exenatide mogħti bħala monoterapija, ma' metformin u/jew sulphonylurea jew xi thiazolidinedione, b'metformin jew mingħajru.
English: • Do not store the Byettapen with the needle attached.
Maltese: • Tista' ma tkunx ħadt id-doża kollha.
English: This prevents the liquid from leaking out.
Maltese: Tinjettax doża oħra.
English: Following a basal insulin optimization (BIO) phase, patients with HbA1c7.0% were randomized to add either immediate-release exenatide or insulin lispro to their existing regimen of insulin glargine and metformin.
Maltese: 7.0% ġew randomizzati biex iżidu jew exenatide b'rilaxx immedjat jew insulin lispro mal-kors eżistenti tagħhom ta' insulin glargine u metformin.
English: Package leaflet: Information for the patient Byetta 5 micrograms solution for injection in pre-filled pen Byetta 10 micrograms solution for injection in pre-filled pen exenatide
Maltese: Informazzjoni għall-utent Byetta 5 mikrogrammi soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Byetta 10 mikrogrammi soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest exenatide
English: How to store Byetta
Maltese: Tużax Byetta
English: Lower glucagon concentrations lead to decreased hepatic glucose output.
Maltese: Konċentrazzjonijiet anqas ta' glucagon iwasslu għal tnaqqis fil-produzzjoni epatika ta' glucose.
English: • Attach a new needle and repeat New Pen Setup, Steps B - E, in Section 2 of this user manual.
Maltese: • Waħħal labra ġdida u rrepeti t-Tħejija ta' Pinna Ġdida, Proċeduri B - E, f'Sezzjoni 2 ta' dan il-manwal.
English: • Check pen label to make sure it is your 10 microgram pen.
Maltese: • Iċċekkja t-tikketta tal-pinna biex tkun żgur li hija l-pinna ta' 10 mikrogrammi tiegħek.
English: When immediate-release exenatide is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4.).
Maltese: Meta exenatide b'rilaxx immedjat jiżdied ma' kura b'sulphonylurea, għandu jiġi kkunsidrat tnaqqis fid-doża ta' sulphonylurea biex jitnaqqas irriskju ta' ipogliċemija (ara sezzjoni 4.4).
English: The reduction in Cmax is of limited clinical relevance and no adjustment of dosing of oral contraceptives is required.
Maltese: It-tnaqqis fis-Cmax ma tantx hija klinikament rilevanti u m'hemmx bżonn ta' aġġustament fid-dożaġġ tal-kontraċettivi orali.
English: Angioneurotic oedema
Maltese: Użu għal taħt il-ġilda
English: In the clinical studies patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Maltese: Fl-istudji kliniċi, pazjenti b'indeboliment renali ħafif u li qegħdin jirċievu kombinazzjoni ma' xi sulphonylurea kellhom żieda fl-inċidenza talipogliċemija meta mqabbla ma' pazjenti b'funzjoni renali normali.
English: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop anti-exenatide antibodies following treatment with immediate-release exenatide.
Maltese: Konsistenti mal-kwalitajiet potenzjalment immunoġeniċi ta' farmaċewtiċi magħmulin minn proteina jew peptide, pazjenti jistgħu jiżviluppaw anti-korpi kontra exenatide wara l-kura b'exenatide b'rilaxx immedjat.
English: Weight loss of 2.3 kg (2.6%) was achieved with immediate-release exenatide in the 26-week study and a loss of 2.5 kg (2.7%) in a 52-week study whereas treatment with insulin was associated with weight gain.
Maltese: Kien hemm telf ta' piż ta' 2.3 kg (2.6%) b'exenatide b'rilaxx immedjat flistudju ta' 26 ġimgħa u telf ta' 2.5 kg (2.7 %) f'studju ta' 52 gimgħa filwaqt li kura b'insulina kienet assoċjata ma' żieda fil-piż.
English: Eructation
Maltese: Tqala
English: Please see the accompanying Package Leaflet.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: NEEDLE PARTS (Needles Not Included)
Maltese: PARTIJIET TAL-LABRA (Labar mhux inklużi)
English: The reduction in HbA1c was sustained and the weight loss continued for at least 82 weeks in the subset of 10 mcg BID patients completing both the placebo-controlled studies and the uncontrolled study extensions (n=137).
Maltese: It-tnaqqis fl-HbA1c inżamm u t-tnaqqis fil-piż tkompla għal mill-anqas 82 ġimgħa fil-kategorija ta' pazjenti fuq 10 mcg BID li temmew kemm l-istudji kkontrollati bil-plaċebo kif ukoll l-istudji ta' estensjoni mhux ikkontrollati (n=137).
English: • Check Byettain the cartridge.
Maltese: • Waħħal labra ġdida.
English: Gastroesophageal reflux disease
Maltese: Mard tar-rifluss gastroesofagali
English: Excipients This medicinal product contains metacresol, which may cause allergic reactions.
Maltese: Eċċipjenti Dan il-prodott mediċinali fih metacresol, li jista' jikkaġuna reazzjonijiet allerġiċi.
English: Byetta contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: F'kull doża, din il-mediċina fiha inqas minn 1 mmol (23 mg) ta' sodium, jiġġifieri tista' tgħid “bla sodium”.
English: In three insulin-comparator controlled trials (n=790) comparable efficacy and adverse events were observed in immediate-release exenatide-treated patients regardless of antibody titre.
Maltese: Fi tlett studji kkontrollati bl-insulina bħala komparatur (n=790) ġie osservat li l-effikaċja u l-avvenimenti avversi kienu simili f'pazjenti fuq kura ta' exenatide b'rilaxx immedjat u ma jiddipendux mill-ammont ta' anti-korpi.
English: About half of this 6% (3% of the total patients given immediate-release exenatide in the controlled studies), had no apparent glycaemic response to immediate-release exenatide.
Maltese: Madwar nofs ta' dawn is-6 % (3 % tat-total ta' pazjenti li ngħataw exenatide b'rilaxx immedjat fl-istudji kkontrollati), ma kellhom l-ebda rispons gliċemiku apparenti għal exenatide b'rilaxx immedjat.
English: The most frequent adverse reactions were mainly gastrointestinal related (nausea, vomiting and diarrhoea).
Maltese: L-aktar reazzjonijiet avversi frekwenti kienu l-iżjed dawk gastro-intestinali (tqalligħ, rimettar u dijarea).
English: Flatulence
Maltese: Pożoloġija
English: It is normal for a single drop to remain on the tip of your needle after your injection is complete.
Maltese: Huwa normali li tibqagħlek qatra waħda fuq il-ponta tal-labra wara li l-injezzjoni tkun kompleta.
English: • flatulence (passing gas)
Maltese: • ostruzzjoni intestinali (sadd fl-imsaren)
English: Long-term controlled data in elderly are limited, but suggest no marked changes in exenatide exposure with increased age up to about 75 years old.
Maltese: Fl-anzjani, tagħrif ikkontrollat fit-tul huwa limitat, iżda m'hemmx indikazzjonijiet ta' bidliet kbar flespożizzjoni ta' exenatide maż-żieda fl-età sa madwar l-età ta' 75 sena.
English: Note: If you cannot turn the dose knob, see Commonly Asked Questions, number 9, Section 4 of this user manual.
Maltese: Nota: Jekk ma tistax iddawwar is-selettur tad-doża, ara Mistoqsijiet Magħmula Ta' Spiss, numru 9, Sezzjoni 4 ta' dan il-manwal.
English: The safety and efficacy of exenatide in children and adolescents under 18 years of age have not been established (see section 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' exenetide fi tfal u adolexxenti taħt it-18-il sena ma ġewx determinati (ara sezzjoni 5.2).
English: Studies of immediate-release exenatide in combination with basal insulin In a 30-week study, either immediate-release exenatide (5 mcg BID for 4 weeks, followed by 10 mcg BID) or a placebo was added to insulin glargine (with or without metformin, pioglitazone or both).
Maltese: Fi studju li dam għaddej 30 ġimgħa, ġew mogħtija jew exenatide b'rilaxx immedjat (5 mcg BID għal 4 ġimgħat, segwit b'doża ta' 10 mcg BID) jew plaċebo flimkien ma' insulin glargine (b'metformin jew mingħajru, pioglitazone jew it-tnejn flimkien).
English: • Store in a refrigerator (2ºC to 8ºC).
Maltese: • Aħżen fi friġġ (2 sa 8C).
English: Abdominal distension
Maltese: • Diffikultà biex tibla'
English: Seven-point self-monitored blood glucose profiles (before and after meals and at 3 am) demonstrated significantly reduced glucose values compared to insulin in the postprandial periods after immediate-release exenatide injection.
Maltese: Il-profili ta' glucose fid-demm b' 7 punti meħuda mill-pazjent stess (qabel u wara l-ikel u fit-3 ta' filgħodu) urew tnaqqis b'mod sinifikanti fil-valuri ta' glucose meta mqabbla ma' insulina fil-perijodi ta' wara l-ikel wara l-injezzjoni ta' exenatide b'rilaxx immedjat.
English: 5 mcg: Each pre-filled pen contains 60 doses (approximately 1.2 ml of solution).
Maltese: Kull pinna mimlija għal-lest fiha 60 doża (kważi 1.2 ml ta' soluzzjoni).
English: Immediate-release exenatide is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin, a sulphonylurea, pioglitazone and/or a basal insulin.
Maltese: Exenatide b'rilaxx immedjat huwa rrakkomandat għall-użu f'pazjenti bid-dijabete mellitus tip 2 li diġà qegħdin jieħdu metformin, xi sulphonylurea, pioglitazone u/jew xi insulina bażilari.
English: Byetta is not an insulin and should therefore not be used as a substitute for insulin.
Maltese: Byetta mhuwiex insulina u għaldaqstant m'għandux jintuża bħala sostitut għall-insulina.
English: During the study both treatment arms titrated insulin glargine using an algorithm reflecting current clinical practice to a target fasting plasma glucose of approximately 5.6 mmol/l.
Maltese: Waqt l-istudju, id-dożaġġ ta' insulin glargine, fiż-żewġ fergħat tal-kura, ġie mogħti b'kalkolazzjoni algoritmika li tirrifletti prattika medika kurrenti biex jintlaħaq il-livell ta'glucose fid-demm ta' madwar 5.6 mmol/L waqt li l-pazjent ikun sajjem.
English: The dose of exenatide can then be increased to 10 mcg BID to further improve glycaemic control.
Maltese: Id-doża ta' exenatide mbagħad tista' tiżdied għal 10 mcg biex jitjieb aktar il-kontroll gliċemiku.
English: • dehydration, generally associated with nausea, vomiting and/or diarrhoea
Maltese: • deidratazzjoni, ġeneralment assoċjata ma' nawsea, rimettar u/jew dijarea
English: Insert needle into skin using hygienic injection technique recommended by your healthcare professional.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TALUŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: • Changes in INR (measurement of blood thinning) have been reported when used together with warfarin.
Maltese: •Ġie rrapportat tibdil fl-INR (il-kejl tal-irquqija tad-demm) meta ġiet użata flimkien ma' warfarin.
English: seconds
Maltese: TIKKETTAR
English: • dizziness
Maltese: L-Iżvezja
English: In both treatment groups, subjects continued to titrate their insulin glargine doses using an algorithm reflecting current clinical practice.
Maltese: Fiż-żewġ gruppi ta' kura, individwi komplew jittitraw id-dożi ta' insulin glargine tagħhom bl-użu ta' algorittmu li jirrifletti l-prattika klinika attwali.
English: After using Byetta 5 micrograms twice a day for 30 days the doctor may increase your dose to Byetta 10 micrograms twice a day.
Maltese: Waħda biex tagħti dożi ta' 5 mikrogrammi u waħda biex tagħti dożi ta' 10 mikrogrammi.
English: Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min).
Maltese: Exenatide mhuwiex irrakkomandata għall-użu f'pazjenti b'mard renali fl-aħħar stadju jew b'indeboliment renali qawwi (tneħħija tal-krejatinina <30 ml/min).
English: Byetta 5 micrograms solution for injection in pre-filled pen
Maltese: Byetta 5 mikrogrammi soluzzjoni għall-injezzjoni, pinna mimlija għal-lest
English: • feeling jittery
Maltese: TA' KIF JINGĦATA
English: 10 mcg: Each pre-filled pen contains 60 doses (approximately 2.4 ml of solution).
Maltese: Kull pinna mimlija għal-lest fiha 60 doża (kważi 2.4 ml ta' soluzzjoni).
English: Fertility No fertility studies in humans have been conducted.
Maltese: Fertilità Fl-umani, studji dwar il-fertilità ma sarux
English: • Check Byetta in the cartridge.
Maltese: • Iċċekkja Byetta fl-iskartoċċ.
English: STEP 1 Check the Pen
Maltese: PROĊEDURA 1 Iċċekkja l-Pinna
English: In the event of overdose, appropriate supportive treatment (possibly given parenterally) should be initiated according to the patient's clinical signs and symptoms.
Maltese: F'każ ta' doża eċċessiva, għandha tinbeda l-kura adattata ta' sostenn (possibbilment b'mod parenterali) skond is-sinjali u s-sintomi kliniċi tal-pazjent.
English: Dose Knob
Maltese: TAGĦRIF
English: Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients > 70 years.
Maltese: Exenatide b'rilaxx immedjat għandhu jintuża b'attenzjoni u żieda fid-doża minn 5 mcg għal 10 mcg għandha tingħata b'mod kawt f'pazjenti >70 sena.
English: ANNEXI
Maltese: SIMBOLI
English: To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea should be considered.
Maltese: Biex jitnaqqas ir-riskju talipogliċemija assoċjata ma' l-użu ta' xi sulphonylurea, għandu jiġi kkunsidrat it-tnaqqis fid-doża ta' sulphonylurea.
English: Day 60 of the CMDh procedure was on 2 August 2018.
Maltese: Jum 60 tal-proċedura tas-CMDh kien it-2 ta' Awwissu 2018.
English: Perlinring 0.12mg/0.015mg/day is a vaginal delivery system containing etonogestrel and ethinylestradiol.
Maltese: 015mg/kuljum hija sistema ta' għoti vaġinali li fiha l-etonogestrel u ethinylestradiol.
English: In order to address the concern of the extended (lengthened ring use) of up to 28 days, which is a deviation from the recommended use that is included in the SmPC of NuvaRing, the applicant provided further information on pharmaceutical quality data between the test and reference medicinal product, in vitro dissolution data which evaluated the rate of release of the test and reference product over 28 days, In Vitro-In Vivo Correlation (IVIVC) for the reference formulation for 28 days and an In Vitro-In Vivo Correlation (IVIVC) for the test formulation for 21 days, and the residual contents in the rings of etonogestrel and ethinyelstradiol at 21 days for test and reference medicinal product.
Maltese: Sabiex jiġi indirizzat it-tħassib tal-użu estiż (imtawwal taċ-ċirku) sa massimu ta' 28 jum, li hija devjazzjoni mill-użu rakkomandat inkluż fl-SmPC ta' NuvaRing, lapplikant, barra minn hekk ipprovda informazzjoni ulterjuri dwar id-data tal-kwalità farmaċewtika bejn il-prodott mediċinali ta' referenza u tat-test, data ta' xoljiment in vitro li evalwat ir-rata ta' rilaxx talprodott tat-test u ta' referenza fuq 28 jum, Korrelazzjoni In Vitro-In Vivo (IVIVC) għall-formulazzjoni ta' referenza għat-28 jum u Korrelazzjoni In Vitro-In Vivo (IVIVC) għall-formulazzjoni tat-test għal 21 jum, u l-kontenut residwu fiċ-ċrieki tal-etonogestrel u ethinyelstradiol fuq 21 jum għall-prodott mediċinali tat-test u ta' referenza.
English: Etonogestrel (ENG) is a 19-nortestosterone-derived progestagen and binds with high affinity to progesterone receptors in the target organs.
Maltese: L-etonogestrel (ENG) huwa progestagen derivat minn 19nortestosterone u jingħaqad b'affinità għolja ma' reċetturi tal-proġesteron f'organi fil-mira. Lethinylestradiol (EE) huwa estroġenu użat b'mod mifrux fi prodotti kontraċettivi.
English: • The Committee was of the view that the totality of data submitted justified the maintenance of the contraceptive efficacy up to 28 days for Perlinring, in line with the reference medicinal product NuvaRing.
Maltese: • Il-Kumitat kien tal-opinjoni li t-totalità tad-data mibgħuta kienet tiġġustifika l-manteniment taleffikaċja kontraċettiva sa massimu ta' 28 jum għal Perlinring, f'konformità mal-prodott mediċinali ta' referenza NuvaRing.
English: The Pharmacokinetics Working Party (PKWP) and the Modelling and Simulation Working Party (MSWP) were also consulted during the CMDh procedure.
Maltese: Il-Grupp ta' Ħidma tal-Farmakokinetika (PKWP) u l-Grupp ta' Ħidma tal-Immudellar u s-Simulazzjoni (MSWP) ġew ikkonsultati wkoll matul il-proċedura ta' CMDh.
English: As mentioned above there is a significant residual amount of drug in both the test and the reference medicinal product at 21 days (residual content for test and reference products is approximately 87% vs. 86% for EE and for ENG 78% vs. 75% of the initial concentration remaining).
Maltese: Kif issemma hawn fuq hemm ammont residwu sinifikanti ta' mediċini kemm fil-prodott mediċinali tat-test kif ukoll f'dak ta' referenza fil-21 jum (il-kontenut residwu għall-prodotti tat-test u ta' referenza huwa madwar 87 % vs. 86 % għal EE u għal ENG 78 % vs. 75 % tal-konċentrazzjoni inizjali li jifdal).
English: However, the objecting CMSs (DE, NL and FR) contended that Perlinring 0.12mg/0.015mg per 24 hours vaginal delivery system is not approvable since the evidence for its use between day 21 and day 28 is built only on extrapolation, and bioequivalence in this period is considered not proven.
Maltese: Madanakollu, is-CMS (DE, NL u FR) li oġġezzjonaw sostnew li s-sistema ta' għoti vaġinali ta' 24 siegħa Perlinring 0.12mg/0.015mg ma tistax tiġi approvata minħabba li l-evidenza għall-użu tagħha bejn jum 21 u jum 28 hija bbażata biss fuq l-estrapolazzjoni, u l-bijoekwivalenza f'dan il-perjodu mhijiex meqjusa mixhuda.
English: The etonogestrel/ethinylestradiol combined contraceptive vaginal ring provides continuous delivery of contraceptive steroids through the vagina, avoiding the need for daily drug administration.
Maltese: Iċ-ċirku vaġinali kontraċettiv ta' kombinazzjoni ta' etonogestrel u ethinylestradiol jipprovdi għoti kontinwu ta' sterojdi kontraċettivi minn ġol-vaġina, u b'hekk jiġi evitat il-bżonn ta' amministrazzjoni ta' mediċini kuljum.
English: The reference Member State (RMS) United Kingdom, considered that, based on the totality of available data and in particular owing to the comparable pharmaceutical data, the similar residual content of EE and ENG, it is possible to conclude with a sufficient degree of certainty that bioequivalence of test and reference medicinal product is maintained over the period of 28 days.
Maltese: L-Istat Membru ta' referenza (RMS), ir-Renju Unit, qies li, abbażi tat-totalità tad-data disponibbli, u b'mod partikolari minħabba d-data farmaċewtika komparabbli, il-kontenut residwu simili tal-EE u lENG, huwa possibbli li jiġi konkluż b'livell suffiċjenti ta' ċertezza li l-bijoekwivalenza tal-prodott mediċinali tat-test u ta' referenza tinżamm matul il-perjodu ta' 28 jum.
English: As no agreement could be reached during the CMDh procedure, a referral under Article 29(4) of Directive 2001/83/EC was triggered by the reference Member State United Kingdom (UK) on 7 August 2018.
Maltese: Minħabba li ma seta' jintlaħaq l-ebda ftehim matul il-proċedura tas-CMDh, ġie skattat riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE mill-Istat Membru ta' referenza, ir-Renju Unit (UK) fis-7 ta' Awwissu 2018.
English: The lack of in vivo data supporting the extended ring use (of up to 28 days), which is stated as a deviation from the recommended regimen (21 days) in line with information included in the product information of the reference medicinal product NuvaRing, was considered to be a potential serious risk to public health (PSRPH).
Maltese: In-nuqqas ta' data in vivo li tappoġġja l-użu estiż taċ-ċirku (sa massimu ta' 28 jum), li huwa ddikjarat bħala devjazzjoni mir-reġim irrakkomandat (21 jum) f'konformità malinformazzjoni inkluża fl-informazzjoni dwar il-prodott mediċinali ta' referenza NuvaRing, tqies bħala riskju potenzjali għas-saħħa pubblika (PSRPH).