FrancophonIA/ELRC3.0 huggingface dataset:
English: IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection.
Maltese: IgG ilha tintuża bħala mediċina mis-snin tmenin u għandha firxa wiesgħa ta' attività kontra l-organiżmi li jistgħu jikkawżaw infezzjoni.
English: O MA (EU) number (Invented) name
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Co. Down BT35 6JP Northern Ireland
Maltese: Down BT35 6JP Northern Ireland
English: Intramammary suspension
Maltese: Sospensjoni intramammarja
English: Combimox was authorised in the United Kingdom on 9 May 2003 under Article 13(1) of Directive 2001/82/EC.
Maltese: Combimox ġie awtorizzat fir-Renju Unit fid-9 ta' Mejju 2003 skont l-Artikolu 13(1) tadDirettiva 2001/82/KE.
English: Noroclav Lactating Cow Intramammary Suspension
Maltese: Combisyn Lactating Cow Intramammary Suspension
English: Combimox Lactating Cow Intramammary Suspension (hereinafter referred to as Combimox) is an intramammary suspension containing amoxicillin (as amoxicillin trihydrate), clavulanic acid (as potassium clavulanate) and prednisolone.
Maltese: Combimox Sospensjoni Intramammarja għal Baqar li Jreddgħu (minn hawn 'il quddiem imsejħa Combimox) hija sospensjoni intramammarja li fiha l-amoxicillin (bħala amoxicillin trihydrate), ilclavulanic acid (bħala potassium clavulanate) u l-prednisolone.
English: Combimox is intended for the treatment of mastitis in lactating cows caused by the major pathogens commonly occurring from the bovine udder (Staphylococci, Streptococci and Escherichia coli).
Maltese: Combimox huwa maħsub għall-kura tal-mastite fil-baqar li jreddgħu li hija kkawżata mill-patoġeni ewlenin li jinstabu b'mod frekwenti fil-glandola mammarja talfrat (Staphylococci, Streptococci u Escherichia coli).
English: The applicant presented comparative viscosity data between the ‘old' and ‘new' formulations of Combimox.
Maltese: L-applikant ippreżenta dejta komparattiva dwar il-viskożità bejn il-formulazzjonijiet il-‘qodma' u l-‘ġodda' ta' Combimox.
English: Intramammary administration to lactating cattle at a dose rate of 3 syringes per affected quarter administered singly at 12 hour intervals
Maltese: Amministrazzjoni intramammarja lil baqar li jreddgħu b'doża b'rata ta' 3 siringi kull robbi affettwat li jingħataw waħda, waħda f'intervalli ta' 12-il siegħa
English: Combimox is presented in unit-dose syringes as an oily suspension to be administered via the intramammary route.
Maltese: Għandha tiġi pprovduta dejta klinika adegwata biex tikkonferma l-effikaċja ta' Combimox Sospensjoni Intramammarja għal Baqar li Jreddgħu.
English: When asked to further substantiate this claim, the applicant provided comparative data on the physico-chemical characteristics of the product, including viscosity, particle size and dissolution in milk, between Combimox and the reference product.
Maltese: Meta mitlub ikompli jsostni din id-dikjarazzjoni, l-applikant ipprovda dejta komparabbli dwar il-karatteristiċi fiżiko-kimiċi tal-prodott, inkluż il-viskożità, id-daqs tal-partikula u d-dissoluzzjoni fil-ħalib, bejn Combimox u lprodott ta' referenza.
English: The applicant further claimed that the formulation of Combimox was sufficiently similar to the reference product to allow a waiver from the need to present in vivo data.
Maltese: L-applikant saħaq ukoll li l-formulazzjoni ta' Combimox kienet suffiċjentement simili għall-prodott ta' referenza biex tippermetti eżenzjoni mill-ħtieġa li tiġi ppreżentata dejta in vivo.
English: • the proposed withdrawal period for Combimox was insufficiently substantiated;
Maltese: • il-perjodu ta' rtirar propost għal Combimox ma kienx sostanzjat biżżejjed;
English: Three comparative pharmacokinetic studies were carried out with Combimox and the reference product, all with a two-period cross-over design.
Maltese: Saru tliet studji farmakokinetiċi komparattivi b'Combimox u l-prodott ta' referenza, kollha b'disinn cross-over fuq żewġ perjodi.
English: Therefore the CVMP concluded that the particulars submitted in support of the application do not comply with Article 13 of Directive 2001/82/EC and recommended the refusal of granting the Marketing Authorisation in the Concerned Member State and the suspension of the existing Marketing Authorisation in the Reference Member State.
Maltese: Għalhekk is-CVMP ikkonkluda li d-dettalji sottomessi b'appoġġ tal-applikazzjoni ma jikkonformawx mal-Artikolu 13 tad-Direttiva 2001/82/KE u rrakkomanda r-rifjut tal-għoti tal-Awtorizzazzjoni għatTqegħid fis-Suq fl-Istati Membri Kkonċernati u s-sospensjoni tal-Awtorizzazzjoni għat-Tqegħid fis-Suq eżistenti fl-Istat Membru ta' Referenza.
English: When preparing the approach used to investigate similarity in terms of efficacy for Combimox, the applicant had not pursued conducting comparative clinical studies since it was expected that clinical trials would not be sensitive enough to pick up differences between Combimox and the reference product.
Maltese: Waqt il-preparamenti għall-approċċ użat biex jinvestiga s-similarità f'termini ta' effikaċja għal Combimox, l-applikant ma wettaqx studji kliniċi komparattivi għaliex kien mistenni li l-provi kliniċi ma kinux sejrin ikunu sensittivi biżżejjed biex jinnutaw id-differenzi bejn Combimox u l-prodott ta' referenza.
English: The CVMP was asked to give its opinion on the concerns raised by Ireland and to conclude on the benefit/risk balance for Combimox.
Maltese: Ġew ukoll ipprovduti valutazzjoni tar-riskju għall-utenti u valutazzjoni tar-riskju ambjentali ta' Fażi I.
English: However these data only gave limited safety information.
Maltese: Madankollu din id-dejta tat biss informazzjoni limitata dwar is-sigurtà.
English: Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema.
Maltese: Il-kontroll bir-reqqa tallivell ta' idratazzjoni huwa essenzjali biex jiġi evitat ir-riskju ta' edema pulmonari materna.
English: CMDh Agreement
Maltese: Ftehim tas-CMDh
English: Hibbard (1996) performed a casecontrol study to investigate whether there is an association between long-term oral terbutaline use and peripartum cardiomyopathy.
Maltese: Hibbard (1996) wettaq studju ta' kontroll tal-każ biex jinvestiga jekk hemmx rabta bejn l-użu fit-tul ta' terbutaline orali u kardjomijopatija peripartum.
English: Eight cases of neonatal/foetal death including abortions have been identified by the MAH.
Maltese: Tmien każijiet ta' mewt tat-trabi tat-twelid/fetu inkluż abort ġew identifikati mill-MAH.
English: The use of ritodrine is associated with risks of major cardiac and pulmonary dysfunction (rarely myocardial infarction), alteration in glycaemia and blood potassium concentration, gastro-intestinal disorders, tremors, headache and erythema.
Maltese: L-użu ta' ritodrine huwa assoċjat ma' riskji ta' disfunzjoni kardijaka u pulmonari maġġuri (rarament infart mijokardijaku), tibdil fil-konċentrazzjoni tal-gliċemija u l-potassju fid-demm, disturbi gastrointestinali, rogħda, uġigħ ta' ras u eritema.
English: During the period 2002-2012, a total of 210 cases including at least one adverse event after ritodrine treatment were reported.
Maltese: Matul il-perjodu 2002-2012, ġew irrapportati total ta' 210 każijiet fosthom mill-inqas avveniment avvers wieħed wara kura b'ritodrine.
English: For oral hexoprenaline there are very few safety data.
Maltese: Għal hexoprenaline orali hemm ftit dejta dwar is-sigurtà.
English: Published studies deliver conflicting results and interpretations on the safety of terbutaline (and beta agonists) in tocolysis.
Maltese: Studji ppubblikati jagħtu riżultati u interpretazzjonijiet kunfliġġenti dwar is-sigurtà ta' terbutaline (u ta' antagonisti beta) f'tokolosi.
English: Four patients with no pre-existing cardiac pathology developed peripartum cardiomyopathy while on prolonged oral terbutaline for various treatment durations (9.5-53 days).
Maltese: Erba' pazjenti mingħajr ebda patoloġija kardijaka pre-eżistenti żviluppaw kardjomijopatija peripartum waqt li kienu fuq terbutaline orali fit-tul għal tul differenti ta' kura (9.5-53 jum).
English: Tachycardia, palpitations, and changes of blood pressure accounted for about 2/3 of the adverse events associated with the oral formulation.
Maltese: Takikardja, palpitazzjonijiet, u tibdil fil-pressjoni tad-demm kienu jirrappreżentaw madwar 2/3 tal-avvenimenti avversi assoċjati mal-formulazzjoni orali.
English: More serious adverse drug reactions have been recorded individually - chest pain, dyspnoea, ileus, loss of consciousness, arrhythmia and also several case reports of pulmonary oedema (four in a publication by Van Iddekinge et al., 1991, one in the EV database, four in the PSUR) have been reported.
Maltese: Reazzjonijiet avversi aktar serji tal-mediċina ġew irreġistrati b'mod individwali - uġigħ fis-sider, qtugħ ta' nifs, ileus, telf mis-sensi, arritmija u ġew irrapportati wkoll diversi rapporti ta' każijiet ta' edema pulmonari (erba' f'pubblikazzjoni minn Van Iddekinge et al., 1991, wieħed fid-database EV, erba' fil-PSUR).
English: In 10 clinical studies comprising 425 pregnant women, angina pectoris and arrhythmia were reported only in one case each.
Maltese: F'10 studji kliniċi li fihom ħadu sehem 425 mara tqila, anġina pectoris u arritmija ġew irrappurtati biss f'każ wieħed kull wieħed.
English: The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for short-acting beta-agonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products in the obstetric indications (see Annex I).
Maltese: Il-PRAC ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE b'riżultat ta' dejta ta' farmakoviġilanza, għal prodotti mediċinali li fihom agonisti beta li jaġixxu fuq żmien qasir (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline u isoxsuprine) flindikazzjonijiet ostetriċi (ara Anness I).
English: Salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine are authorised in obstetric indications since the 1960s.
Maltese: Salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline u isoxsuprine ilhom awtorizzati f'indikazzjonijiet ostetriċi sa mis-sittinijiet.
English: The CMDh considered the below PRAC recommendation dated 5 September 2013 with regards to the terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing medicinal products:
Maltese: Is-CMDh ikkunsidra r-rakkomandazzjoni tal-PRAC ta' hawn taħt datata l-5 ta' Settembru 2013 firrigward tal-prodotti mediċinali li fihom terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol u isoxsuprine:
English: Isoxsuprine and hexoprenaline tablets also have ‘threatened abortion' within the indications and a posology for prophylaxis of labour.
Maltese: Il-pilloli isoxsuprine u hexoprenaline għandhom ukoll ‘theddida ta' abort' fl-indikazzjonijiet u pożoloġija għall-profilassi tal-ħlas.
English: Fenoterol also contains descriptions of emergency uses in the indications such as dystocias in the dilation and expulsion stages of labour (such as uterine hyperactivity or spasm occurring either spontaneously or as a result of mechanical obstruction or over stimulation by oxytocic agents); intrauterine asphyxia (as indicated by signs such as foetal heart rate decelerations or incipient to moderate foetal acidosis); obstetric emergencies (such as cord prolapse or imminent uterine rupture); uterine relaxation in acute indications such as caesarean section.
Maltese: Fenoterol fih ukoll deskrizzjonijiet ta' użu f'emerġenza fl-indikazzjonijiet bħal distoċja fl-istadji ta' dilatazzjoni u espulsjoni tal-ħlas (bħal iperattività jew spażmi tal-utru li jew iseħħu b'mod spontanju jew bħala riżultat ta' imblukkar mekkaniku jew stimulazzjoni żejda minn aġenti ossitoċiċi); asfissija fil-ġuf (kif indikat b'sinjali bħal deċelerazzjonijiet tar-rata tal-qalb tal-fetu jew aċidożi inċipjenti għal moderata tal-fetu); emerġenzi ostetriċi (bħal prolass tal-korda jew ftuq imminenti tal-utru); rilassament tal-utru f'indikazzjonijiet akuti bħal f'ċesarja.
English: This again highlights the importance of close medical surveillance during therapy, and questions the safety of outpatient tocolysis with terbutaline.
Maltese: Dan ikompli jenfasizza l-importanza ta' sorveljanza medika mill-qrib waqt it-terapija, u jqajjem tħassib dwar is-sigurtà ta' tokolosi fuq bażi outpatients b'terbutaline.
English: Occurrence of typical adverse effects characteristic of beta receptor stimulation are well documented, and range from mild and transient discomfort to serious cardiovascular side effects requiring prompt medical intervention, e.g. in case of arrhythmias or pulmonary oedema.
Maltese: L-okkorrenza ta' effetti avversi tipiċi karatteristiċi ta' stimulazzjoni tarriċettur beta hija dokumentata sew, u jvarjaw minn skumdità ħafifa u tranżitorja għal effetti sekondarji serji kardjovaskulari li jeħtieġu intervent mediku fil-pront, eż. fil-każ ta' arritmiji jew edema pulmonari.
English: More rarely, cases of anxiety, dizziness, blood dyscrasias, rhabdomyolysis, severe cutaneous adverse reactions (SCARs), and anaphylactic shock have been described.
Maltese: B'mod aktar rari, kienu deskritti każijiet ta' anzjetà, sturdament, abnormalitajiet fid-demm, rabdomijolisi, reazzjonijiet avversi severi tal-ġilda (SCARs), u xokk anafilattiku.
English: The PRAC concluded that the benefits of injectable forms outweighed the cardiovascular risks in restricted conditions of use: these active substances should be given for short term management (up to 48 hours) between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Maltese: Il-PRAC ikkonkluda li l-benefiċċji tal-forom injettabbli għelbu r-riskji kardjovaskulari f'kundizzjonijiet ristretti ta' użu: dawn is-sustanzi attivi għandhom jingħataw għall-ġestjoni fuq żmien qasir (sa 48 siegħa) bejn it-22 u s-37 ġimgħa ta' ġestazzjoni f'pazjenti bl-ebda kontraindikazzjoni medika jew ostetrika għal terapija tokolitika.
English: Safety data from MAH clinical trials and meta-analyses of well-designed clinical trials have been assessed.
Maltese: Id-dejta dwar is-sigurtà minn provi kliniċi tal-MAH u l-meta analiżi ta' provi kliniċi ddisinjati sew ġew ivvalutati.
English: The Committee reviewed all available data from clinical studies, pharmacoepidemiological studies, published literature and post-marketing experience on the safety of short-acting betaagonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products in the obstetric indications.
Maltese: Il-Kumitat irreveda d-dejta kollha disponibbli minn studji kliniċi, studji farmakoepidemjoloġiċi, letteratura ppubblikata u l-esperjenza wara t-tqegħid fis-suq dwar is-sigurtà ta' prodotti mediċinali li fihom agonisti beta li jaġixxu fuq żmien qasir (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline u isoxsuprine) fl-indikazzjonijiet ostetriċi.
English: Approximately 9% of the 425 women in these trials were exposed to the oral formulation and approximately 2% of the reported adverse events were associated with the oral formulation of the drug.
Maltese: Infart mijokardijaku jew arritmiji serji ma ġewx irrappurtati fir-rapporti tal-provi kliniċi disponibbli għall-MAH. Madwar 9% tal-425 mara f'dawn il-provi kienu esposti għall-formulazzjoni orali u madwar 2% tal-avvenimenti avversi rrappurtati kienu assoċjati mal-formulazzjoni orali tal-mediċina.
English: Post-marketing data were summarised for isoxsuprine from 2000 to 2013; no serious AEs were reported for the i.v.
Maltese: Id-dejta wara l-awtorizzazzjoni kienet imqassra għal isoxsuprine mill-2000 sal-2013; ma ġie rrapportat l-ebda AE serju għall-prodott mogħti ġol-vina, u ġew irrapportati tliet avvenimenti mhux serji.
English: With regards to the window of lowest gestational viability, the PRAC noted an epidemiological review of obstetric interventions in European countries (Kollée et al, 2009) andmore recently by US (Kyser et al.,
Maltese: • Fir-rigward tal-perjodu tal-anqas vijabilità ġestazzjonali, il-PRAC innota reviżjoni epidemjoloġika ta' interventi ostetriċi fil-pajjiżi Ewropej (Kollée et al, 2009) u aktar riċentement mill-Istati Uniti (Kyser et al., 2012) li tissuġġerixxi li huwa bejn 22 u 24 ġimgħa.
English: The short-acting beta-agonists (SABAs) (also known as beta-mimetics), salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine are all nationally authorised and have been on the market within the EU since the 1960s.
Maltese: L-agonisti beta li jaġixxu fuq żmien qasir (SABAs) (magħrufin ukoll bħala beta-mimetiċi), salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline u isoxsuprine huma kollha awtorizzati fuq livell nazzjonali u ilhom fis-suq fl-UE sa mis-sittinijiet.
English: For the oral and suppositories formulations in view of the overall available safety data, in particular in relation to the risk of serious cardiovascular events, and very limited efficacy data, the PRAC concluded in accordance with Article 116 of Directive 2001/83/EC that the benefit-risk balance is not favourable and therefore these medicinal products should no longer be indicated in the obstetrics therapeutic indication.
Maltese: Għall-formulazzjonijiet orali u suppożitorji fid-dawl tad-dejta ġenerali disponibbli dwar issigurtà, b'mod partikolari fir-rigward tar-riskju ta' avvenimenti kardjovaskulari serji, u d-dejta limitata ħafna dwar l-effikaċja, il-PRAC ikkonkluda li skont l-Artikolu 116 tad-Direttiva 2001/83/KE il-bilanċ tal-benefiċċju-riskju mhuwiex favorevoli u għalhekk dawn il-prodotti mediċinali m'għandhomx jibqgħu indikati fil-indikazzjoni terapewtika ostetrika.
English: With injectable formulations there are safety issues during prolonged use of these active substances in the context of the obstetric indications, however there may be benefit in administering parental formulations in the obstetric indication of tocolysis in the short-term (maximum 48 hours).
Maltese: B'formulazzjonijiet injettabbli hemm kwistjonijiet ta' sigurtà waqt l-użu fit-tul ta' dawn is-sustanzi attivi fil-kuntest tal-indikazzjonijiet ostetriċi, madankollu jista' jkun hemm benefiċċju fl-għoti ta' formulazzjonijiet parentali fl-indikazzjoni ostetrika ta' tokolosi fuq perijodu qasir (massimu ta' 48 siegħa).
English: Overall summary of the scientific evaluation of terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing medicinal products by PRAC (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol u isoxsuprine mill-PRAC (ara Anness I)
English: The Committee is of the opinion that the benefits of the parenteral formulations of short-acting beta-agonists (SABAs) (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline and isoxsuprine) containing medicinal products continue to outweigh the risks in the obstetric indications of short term management of uncomplicated tocolysis.
Maltese: Fir-rigward ta' prodotti mediċinali li fihom SABAs parenterali (salbutamol, terbutaline, fenoterol, ritodrine, hexoprenaline u isoxsuprine) fl-indikazzjonijiet ostetriċi, il-PRAC ikkonkluda li l-bilanċ talbenefiċċju-riskju huwa favorevoli peress li l-benefiċċji jkomplu jegħlbu r-riskji.
English: There is hardly any evidence of maternal death in these studies and very limited data on adverse foetal outcomes (e.g. tachycardia, hyperinsulinaemia).
Maltese: Ma hemm kważi l-ebda evidenza ta' mewt materna f'dawn l-istudji u dejta limitata ħafna dwar l-eżiti avversi fuq il-fetu (eż. takikardja, iperinsulinemia).
English: On 27 November 2012, further to evaluation of data resulting from pharmacovigilance activities, Hungary informed the European Medicines Agency, pursuant to Article 31 of Directive 2001/83/EC, of their consideration that the risk-benefit balance of short-acting beta-agonists (SABAs) containing medicinal products authorised in obstetric indications has become unfavourable, taking into account the cardiovascular events reported.
Maltese: Fis-27 ta' Novembru 2012, wara valutazzjoni tad-dejta b'riżultat tal-attivitajiet ta' farmakoviġilanza, lUngerija infurmat lill-Aġenzija Ewropea għall-Mediċini, skont l-Artikolu 31 tad-Direttiva 2001/83/KE, bit-tħassib tagħhom li l-bilanċ tar-riskju-benefiċċju ta' prodotti mediċinali li fihom agonisti beta li jaġixxu fuq żmien qasir (SABAs) awtorizzati f'indikazzjonijiet ostetriċi sar sfavorevoli, wara li tqiesu lavvenimenti kardjovaskulari irrapportati.
English: The CMDh, having considered the PRAC recommendation dated 5 September 2013 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached an agreement on the variation or revocation as applicable of the marketing authorisations of terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol and isoxsuprine containing products for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III and subject to the conditions set out in Annex IV.
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-5 ta' Settembru 2013 skont lArtikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq ftehim dwar il-varjazzjoni jew ir-revoka kif applikabbli tal-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti li fihom terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol u isoxsuprine li għalihom is-sezzjonijiet rilevanti tas-sommarju talkaratteristiċi tal-prodott u l-fuljett ta' tagħrif huma stabbiliti fl-Anness
English: Grounds for PRAC recommendation
Maltese: Prodotti mediċinali li fihom
English: A total of 98 reports which included cardiovascular events were identified, the majority of which were cardiac arrhythmias, such as, tachycardia or palpitations.
Maltese: B'kollox ġew identifikati 98 rapport li kienu jinkludu avvenimenti kardjovaskulari, li l-maġġoranza tagħhom kienu arritmiji kardijaċi, bħal, takikardja jew palpitazzjonijiet.
English: For the parenteral formulations, the PRAC having considered all the available data and specifically for the management of uncomplicated premature labour recommends that these active substances should be given for short term management (up to 48 hours) between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Maltese: Għall-formulazzjonijiet parenterali, wara li kkunsidra d-dejta kollha disponibbli u speċifikament għallġestjoni ta' ħlas prematur mhux ikkumplikat il-PRAC jirrakkomanda li dawn is-sustanzi attivi għandhom jingħataw għal ġestjoni fuq żmien qasir (sa 48 siegħa) bejn it-22 u s-37 ġimgħa ta' ġestazzjoni f'pazjenti mingħajr ebda kontraindikazzjoni medika jew ostetrika għal terapija tokolitika.
English: Based on all data available for all SABAs considered in this review (terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol, isoxsuprine), there is evidence that oral and suppository formulations are associated with serious and dose dependent adverse events.
Maltese: Abbażi tad-dejta kollha disponibbli għas-SABAs kollha meqjusa f'din ir-reviżjoni (terbutaline, salbutamol, hexoprenaline, ritodrine, fenoterol, isoxsuprine), hemm evidenza li l-formulazzjonijiet orali u suppożitorji huma assoċjati ma' avvenimenti avversi serji u dipendenti fuq id-doża.
English: Both formulations of hexoprenaline are also indicated for immobilisation of the uterus pre, during and post cerclage surgery.
Maltese: Iż-żewġ formulazzjonijiet ta' hexoprenaline huma wkoll indikati għall-immobilizzazzjoni tal-utru qabel, waqt u wara kirurġija ta' cerclage.
English: Myocardial infarction or serious arrhythmias were not reported in the clinical trial reports available to the MAH.
Maltese: Dejta disponibbli minn provi kliniċi, rapporti wara t-tqegħid fis-suq u l-letteratura ġew ikkunsidrati f'din ir-reviżjoni.
English: For the oral tablet, three serious AEs were reported (loss of consciousness, trismus and a serious skin reaction), and six nonserious AEs for the tablet.
Maltese: Għallpillola orali, ġew irrapportati tliet AEs serji (telf mis-sensi, trismus u reazzjoni serja tal-ġilda), u sitt AEs mhux serji għall-pillola.