FrancophonIA/ELRC3.0 huggingface dataset:
English: • In general, from a food safety/public health viewpoint, using antimicrobials to control Salmonella spp.
Maltese: • B'mod ġenerali, mill-perspettiva tas-sikurezza alimentari/saħħa pubblika, l-użu tal-antimikrobiċi biex tiġi kkontrollata Salmonella spp. fit-tjur għandu ftit ġustifikazzjoni.
English: Active substance:
Maltese: 1 g fiha: Sustanza Attiva:
English: Apramycin sulfate equivalent to 1 g apramycin activity per sachet.
Maltese: Apramycin sulfate ekwivalenti għal 1 g ta' attività ta' apramycin f'kull qartas.
English: CVMP noted that data of clinical isolates from different European countries showed that resistance proportion of E. coli against apramycin is below 10%.
Maltese: Is-CVMP innota li d-data ta' iżolati kliniċi minn pajjiżi Ewropej differenti wriet li l-proporzjon ta' reżistenza ta' E. coli kontra l-apramiċina huwa taħt 10%.
English: Following the CVMP opinion of 5 October 2017 on this referral procedure, the marketing authorisation holders requested a re-examination of the CVMP opinion.
Maltese: Wara l-opinjoni tas-CVMP tal-5 ta' Ottubru 2017 dwar din il-proċedura ta' referenza, id-detenturi talawtorizzazzjoni għat-tqegħid fis-suq talbu eżaminazzjoni mill-ġdid tal-opinjoni tas-CVMP.
English: The CVMP considered that the use of antimicrobials in Salmonella would increase selective pressure and potentially promote antimicrobial resistance dissemination.
Maltese: Is-CVMP ikkunsidra li l-użu tal-antimikrobiċi f'Salmonella iżid il-pressjoni selettiva u potenzjalment jippromwovi t-tixid ta' reżistenza għall-antimikrobiċi.
English: Based on historical batch data, a target potency of 552,000 IU/g apramycin was established and all references to ‘g of apramycin activity' in the product information were replaced with the equivalent in IU/g product.
Maltese: IU/g apramiċina u r-referenzi kollha għal “g ta' attività ta' apramiċina” fl-informazzjoni dwar il-prodott ġew sostituti bl-ekwivalenti f'IU/g ta' prodott.
English: Treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli susceptible to apramycin.
Maltese: Trattament u metafilassi ta' enterite batterjali kkawżata minn Escherichia coli suxxettibbli għal apramycin.
English: Dosing 10 kg pigs with 14C apramycin resulted in approximately 83% being recovered from the faeces, and 4% from the urine, as 14C apramycin.
Maltese: Meta jingħata dożaġġ ta' 14C apramycin lil qżieqeż li jiżnu 10 kg, dan irriżulta f'madwar 83% li jiġi rkuprat mill-ippurgar, u 4% mill-awrina, bħala
English: Serum levels peak at approximately 6 hours with a value of 2.4 µg/ml following oral administration of 40 mg apramycin/kg of bodyweight.
Maltese: Il-livelli massimi fis-serum wara madwar 6 sigħat b'valur ta' 2.4 μg/mL wara l-għoti orali ta' 40 mg ta' apramycin/kg ta' piż tal-ġisem.
English: These enzymes confer different cross-resistance against other aminoglycosides.
Maltese: Dawn l-enzimi jikkonferixxu reżistenza inkroċjata differenti kontra aminoglycosides oħrajn.
English: The assay results are presented as % of a target value of 552,000 IU/g.
Maltese: Irriżultati tal-assaġġ huma ppreżentati bħala % ta' valur fil-mira ta' 552,000
English: The harmonised warnings and precautions proposed in the product information were considered adequate to ensure safety to users of the product.
Maltese: Ittwissijiet u l-prekawzjonijiet armonizzati proposti fl-informazzjoni dwar il-prodott tqiesu adegwati biex tiġi żgurata s-sikurezza tal-utenti tal-prodott.
English: Seven trials were conducted as a blind study in Greece, Italy, Spain and the UK.
Maltese: Saru seba' provi bħala studju blind fil-Greċja, fl-Italja, fi Spanja u fir-Renju Unit.
English: No data were presented for Salmonella Pullorum.
Maltese: Ma ġiet ippreżenta l-ebda data għal Salmonella Pullorum.
English: Administer 40,000 IU apramycin sulfate per kilogram of bodyweight (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
Maltese: Agħti 40,000 IU ta' apramycin sulfate għal kull kilogramma ta' piż tal-ġisem (li jikkorrispondu għal 72 mg tal-prodott/kg ta' piż tal-ġisem), kuljum għal 5 ijiem konsekuttivi.
English: enterica serovar Dublin (Salmonella Dublin) susceptible to apramycin.
Maltese: Kura ta' enterite batterika kkawżata minn Escherichia coli u tifqigħat kliniċi minħabba Salmonella enterica subsp. enterica serotip Dublin (Salmonella Dublin) suxxettibbli għall-apramiċina.
English: The oral administration of apramycin is intended for antimicrobial activity within the gut; apramycin is poorly absorbed, but absorption may be increased in young animals and in animals with disrupted intestinal barrier.
Maltese: L-għoti orali ta' apramycin hu intenzjonat għal attività antimikrobjali fl-imsaren; apramycin ma tantx jiġi assorbit, iżda l-assorbiment jista' jiżdied f'annimali żgħar u f'annimali b'ostaklu intestinali mfixkel.
English: High density polyethylene bottle with polypropylene screw cap. Each bottle contains 50 x 106 IU
Maltese: Kull flixkun fih 50 x 106
English: Apramycin resistance can be influenced by co-selection (resistance to apramycin has been described to be located in the same mobile genetic element that other resistant determinants in Enterobacteriaceae) and cross resistance (e. g. with gentamicin).
Maltese: Ir-reżistenza għal apramycin tista' tiġi influwenzata mill-ko-selezzjoni (ir-reżistenza għal apramycin ġiet deskritta li tinsab fl-istess element ġenetiku mobbli li determinanti reżistenti oħrajn f'Enterobacteriaceae) u reżistenza inkroċjata (eż. ma' gentamicin).
English: • Any use of antimicrobials in poultry will increase the risk of emergence and spread of resistance in zoonotic bacteria such as Salmonella spp.
Maltese: • Kwalunkwe użu tal-antimikrobiċi fit-tjur ser iżid ir-riskju ta' emerġenza u tixtrid tar-reżistenza filbatterji żoonotiċi bħal Salmonella spp.
English: Light to medium brown granular powder.
Maltese: Trab granulari ta' lewn kannella ċar sa medju.
English: enterica serovar Dublin susceptible to apramycin', the marketing authorisation holder provided in vitro susceptibility data and clinical data including field studies.
Maltese: Sabiex jappoġġjaha, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda data in vitro dwar is-suxxettibbiltà u data klinika inkluż studji fuq il-post.
English: The oral administration of apramycin at 20 mg/kg bw or at 40 mg/kg bw during five consecutive days was shown to be efficacious for the treatment of colibacillosis and salmonellosis in young calves under field conditions.
Maltese: L-għoti orali ta' apramiċina b'20 mg/kg bw jew b'40 mg/kg matul ħamest ijiem konsekuttivi deher li kien effikaċi għall-kura talkolibaċillożi u tas-salmonellożi f'għoġġiela żgħar f'kondizzjonijiet fuq il-post.
English: Calves.
Maltese: Tiġieġ
English: Where a diagnosis of Salmonella Dublin is made on the farm, then control measures including on-going monitoring of disease status, vaccination, biosecurity and movement controls should be considered.
Maltese: Meta ssir dijanjożi ta' Salmonella Dublin fir-razzett, għandhom jiġu kkunsidrati miżuri kollaterali inkluż monitoraġġ li jibqa' għaddej tal-istatus tal-marda, tilqim, bijosigurtà u kontrolli talmoviment.
English: Therefore, the CVMP concluded that the proposed indication was justified.
Maltese: Għalhekk, is-CVMP ikkonkluda li lindikazzjoni proposta kienet iġġustifikata.
English: Pregnancy and lactation:
Maltese: Għoġġiela preruminanti:
English: Furthermore, taking into account the data provided and in line with the ‘Note for guidance on start of shelf life of the finished dosage form (EMEA/CVMP/453/01)1', the shelf life period of the veterinary medicinal product as packaged for sale, which was 3 years, was reduced to 18 months.
Maltese: Barra minn hekk, meta tiġi kkunsidrata d-data pprovduta u f'konformità man-“Nota għal gwida dwar il-bidu taż-żmien kemm idum tajjeb ilprodott mediċinali tal-forma tad-dożaġġ mitmuma (EMEA/CVMP/453/01)1”, il-perjodu taż-żmien talħżin tal-prodott mediċinali għall-użu veterinarju kif ippakkjat għall-bejgħ, li kien ta' 3 snin, tnaqqas għal 18-il xahar.
English: Pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits.
Maltese: Qżieqeż (qżieqeż żgħar miftuma), għoġġiela preruminanti, tiġieġ (broilers) u fniek.
English: Rabbits have been previously authorised in France, Italy and Spain.
Maltese: Il-fniek ġew preċedentement awtorizzati fi Franza, fl-Italja u fi Spanja.
English: With regard to the withdrawal period, the residue depletion data indicated that apramycin is generally not well-absorbed from the gut after oral administration, which is consistent with the information available in published literature.
Maltese: Fir-rigward tal-perjodu tal-irtirar, id-data dwar it-tnaqqis tar-residwi indikat li l-apramiċina ġeneralment ma tiġix assorbita tajjeb mill-imsaren wara għoti orali, li huwa konsistenti malinformazzjoni disponibbli fil-letteratura ppubblikata.
English: Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom
Maltese: Elanco Animal Health Priestley Road Basingstoke Hampshire
English: Girolan and its associated name Apralan is a powder for use in drinking water/milk containing apramycin sulfate as active substance.
Maltese: Girolan u l-isem assoċjat tiegħu Apralan huwa trab għall-użu f'ilma tax-xorb/ħalib li fih is-sulfat talapramiċina bħala sustanza attiva.
English: Apramycin is bactericidal at minimum inhibitory concentrations and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
Maltese: L-apramiċina hija batteriċida b'konċentrazzjonijiet minimi inibitorji u hija effettiva kontra kemm batterji Gram negattivi kif ukoll Gram pożittivi u xi razez ta' mikoplażma.
English: Each sachet contains 1 x 106 IU apramycin and weight of 1.8 g of product.
Maltese: Kull qartas fih 1 x 106 IU ta' apramycin u piż ta' 1.8 g tal-prodott.
English: The agreed harmonised dose for both indications was 40,000 IU apramycin per kg bw (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
Maltese: Id-doża armonizzata li ntlaħaq qbil dwarha għaż-żewġ indikazzjonijiet kienet 40,000 IU apramiċina għal kull kg bw (li tikkorrispondi għal 72 mg ta' prodott/kg bw), kuljum għal 5 ijiem konsekuttivi.
English: Apramycin has been shown to be efficacious in the treatment of Salmonella infections in calves where its use reduced mortality and may therefore be justified on animal welfare grounds.
Maltese: Salmonella infection in poultry with serotypes of animal health relevance (S.
English: INN Strength
Maltese: OĦRA
English: J Vet Sci Anim Husb 1(3): 301. doi:
Maltese: Żmien kemm idum tajjeb wara li jkun infetaħ l-ippakkjar li jmiss mall-prodott:
English: All references to ‘g of apramycin activity' or measuring devices have been removed from the product information.
Maltese: Ir-referenzi kollha għal “g ta' attività talapramiċina” jew għall-istrumenti tal-kejl tneħħew mill-informazzjoni dwar il-prodott.
English: The results
Maltese: KOMBINATI
English: The results obtained showed statistically significant difference on mortality between all the apramycin medicated groups and the unmedicated control groups.
Maltese: Ir-riżultati miksuba wrew differenza statistikament sinifikanti dwar il-mortalità bejn il-gruppi medikati kollha bl-apramiċina u lgruppi ta' kontroll mhux medikati.
English: Resistance developed by chromosomal resistance is minimal for most of the aminoglycosides.
Maltese: Ir-reżistenza żviluppata minn resistenza kromożomali hi minima għall-biċċa l-kbira tal-aminoglycosides.
English: Evaluation and conclusions on the benefit-risk balance Girolan and its associated name Apralan has been shown to be efficacious in the indications in pigs (weaned piglets), pre-ruminant calves, chickens (broilers) and rabbits listed above.
Maltese: HUWA INDIKAT IL-PRODOTT Qżieqeż (qżieqeż żgħar miftuma), għoġġiela preruminanti, tiġieġ (broilers) u fniek.
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Maltese: Ir-reżistenza tista' tkun ta' tħassib dirett meta taffettwa patoġeni żoonotiċi bħal Campylobacter u Enterococcus, jew tista' tiġi ttrasferita b'mod orizzontali lejn patoġeni tal-bniedem permezz ta' elementi ġenetiċi mobbli.
English: Chicken: There was no mortality when chickens were given a single oral dose of 1,000 mg/kg of bodyweight.
Maltese: Ma kien hemm l-ebda mortalità meta t-tiġieġ ingħataw doża orali waħda ta' 1,000 mg/kg ta' piż tal-ġisem.
English: The clinical data provided demonstrated that Girolan was effective in the treatment of bacterial enteritis caused by E. coli and clinical outbreaks due to Salmonella Dublin when administered at 40,000 IU apramycin per kilogram of bodyweight (corresponding to 72 mg of product/kg bw), daily for 5 consecutive days.
Maltese: Id-data klinika pprovduta wriet li Girolan kien effettiv fil-kura ta' enterite batterika kkawżata minn E. coli u tifqigħat kliniċi minħabba Salmonella Dublin meta ngħata b'40,000
English: In support of the proposed indication, ‘Treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Maltese: Lindikazzjoni proposta kienet “Kura tal-kolibaċillożi kkawżata minn Escherichia coli u mhux Salmonella
English: Sachets are packed in cardboard boxes containing 50 sachets.
Maltese: Il-qratas huma ppakkjati f'kaxxi tal-kartun li fihom 50 qartas.
English: 6.1 List of excipients
Maltese: 6.1 Lista ta' ingredjenti Xejn.
English: Apramycin is bactericidal at minimum inhibitory concentrations (MICs) and is effective against both Gram-negative and Gram-positive bacteria and some strains of mycoplasma.
Maltese: L-apramiċina hija batteriċidali f'konċentrazzjonijiet minimi inibitorji (MICs) u hija effettiva kontra kemm batterji Gram negattivi kif ukoll Gram pożittivi u xi razez ta' mikoplażma.
English: For single-dose presentations (sachets):
Maltese: Għall-preżentazzjonijiet ta' doża waħda (qratas):
English: The marketing authorisation holder provided one field trial including chickens artificially infected with Salmonella Pullorum.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovda prova waħda fuq il-post li inkludiet tiġieġ infettati b'mod artifiċjali b'Salmonella Pullorum.
English: • If antimicrobials are used in breeding flocks or their immediate descendants there is a risk that any resistant bacteria which are selected may be disseminated to multiple flocks via contamination of hatching eggs and the hatchery environment.
Maltese: • L-użu tal-antimikrobiċi qatt mhu totalment effettiv għall-kontroll ta' Salmonella spp peress li mhuwiex possibbli li jiġu eliminati l-organiżmi kollha mill-qatgħa infettata.
English: Powder for oral administration
Maltese: Trab għal soluzzjoni orali
English: • The harmonised product information of Girolan contains the necessary information to ensure the safe and effective use of the product.
Maltese: • L-informazzjoni dwar il-prodott armonizzata ta' Girolan fiha l-informazzjoni meħtieġa biex tiżgura l użu sikur u effettiv tal-prodott.
English: Benefit-risk balance
Maltese: Bilanċ bejn benefiċċju u riskju
English: Whereas
Maltese: Filwaqt li
English: In the clinical trial assessing the efficacy of bromocriptine in late post-partum, treatment was initiated at times covering adequately the late post-partum period (10 to 13.8 days post-partum and 38.9 days to 16.7 weeks post-partum).
Maltese: Fil-prova klinika li evalwat l-effikaċja ta' bromocriptine tard wara t-tqala, il-kura inbdiet fi żminijiet li koprew b'mod xieraq il-perjodu aħħari ta' wara t-tqala (10 sa 13.8-il jum wara t-tqala u 38.9 jum sa 16.7 ġimgħa wara t-tqala).
English: No causal association was shown in the three observational studies investigating the risk of seizures, (Rothman, 1990) cardio- and cerebrovascular events, (Herings, 1995) and hypertension (Watson, 1989).
Maltese: Ebda assoċjazzjoni kawżali ma ntweriet fit-tliet studji ta' osservazzjoni li investigaw ir-riskju ta' aċċessjonijiet, (Rothman, 1990) avvenimenti kardjo- u ċerebrovaskulari, (Herings, 1995) u pressjoni għolja (Watson, 1989).
English: The analysis of case reports from the literature was hampered by the limited information available.
Maltese: L-analiżi tar-rapporti tal-każijiet minn letteratura ġiet ostakolata mill-informazzjoni limitata disponibbli.
English: As compared with the non-pregnant state, the 6-week post-partum period is associated with a 3 to 9-fold risk of stroke, 3 to 6-fold risk of myocardial infraction, 9 to 22-fold risk of venous thromboembolic event and depression is estimated to occur in approximately 1 in 10 women while psychosis is estimated to occur in approximately 1-2 in 1000 women.
Maltese: Kif imqabbel mal-istat mingħajr tqala, il-perjodu ta' 6 ġimgħat wara t-tqala huwa assoċjat ma' riskju ta' puplesija 3 sa 9 darbiet akbar, riskju ta' infart mijokardijaku 3 sa 6 darbiet akbar, avveniment tromboemboliku venuż 9 sa 22 darba akbar u ddepressjoni hija stmata li sseħħ f'madwar 1 minn kull 10 nisa filwaqt li psikożi hija stmata li sseħħ f'madwar 1-2 minn 1000.
English: The absolute number of cases reported in post-marketing is low, especially given the fact that bromocriptine has been available in the EU since 1973, with a substantial patient exposure; overall incidence rates are estimated to 0.005% to 0.04%.
Maltese: In-numru assolut ta' każijiet irrappurtati wara t-tqegħid fis-suq huwa wieħed baxx, speċjalment minħabba l-fatt li bromocriptine ilu disponibbli fl-UE mill-1973, b'espożizzjoni ta' pazjenti sostanzjali; rati ta' inċidenza globali huma stmati minn 0.005% sa 0.04%.
English: A range of adverse events have been reported, including depression, psychosis, myocardial infarction, stroke, intracranial haemorrhage, thrombotic events, convulsions, and hypertension.
Maltese: Ġiet irrapportata firxa ta' avvenimenti avversi, inklużi dipressjoni, psikożi, infart mijokardijaku, puplesija, emorraġija intrakranjali, avvenimenti trombotiċi, aċċessjonijiet u pressjoni għolja.
English: • The PRAC recommended to limit the use of bromocriptine-containing medicinal products for oral use in the post-partum inhibition of lactation with strength of 1 mg and 2.5 mg to cases where medically indicated.
Maltese: • Il-PRAC irrakkomanda li l-użu ta' prodotti mediċinali li fihom bromocriptine jiġi restritt fl-inibizzjoni ta' treddigħ wara t-tqala b'dożi ta' 1 mg u 2.5 mg għal każijiet fejn huma indikati medikament.
English: A second French national pharmacovigilance survey, finalised in 2012, showed an increase in the reporting rate of serious cardiovascular ADRs compared with the previous one (5.1 vs. 3.36 cases / 100,000 patients treated), despite the reinforcement of the SmPC in 1994.
Maltese: It-tieni stħarriġ nazzjonali ta' farmakoviġilanza Franċiż, finalizzat fl-2012, wera żieda fir-rata ta' rappurtar ta' ADRs kardjuvaskulari serji meta mqabbel ma' ta' qablu (5.1 vs. 3.36 każijiet / 100,000 pazjenti kkurati), minkejja r-rinfurzar tal-SmPC fl-1994.
English: • The PRAC reviewed all available data from post-marketing spontaneous case reports, clinical trials, published literature and other available information on bromocriptine-containing medicines for oral use with regards to the cardiovascular, neurological and psychiatric risk following treatment in post-partum lactation inhibition.
Maltese: • Il-PRAC irreveda d-dejta disponibbli kollha mir-rapporti spontanji tal-każijiet ta' wara t-tqegħid fissuq, provi kliniċi, letteratura ppubblikata u informazzjoni oħra disponibbli fuq mediċini li fihom bromocroptine għal użu mill-ħalq fir-rigward ta' riskju kardjovaskulari, newroloġiku u psikjatriku wara kura wara t-tqala għal inibizzjoni ta' treddigħ.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for bromocriptine-containing medicinal products for oral use in the postpartum inhibition of lactation;
Maltese: • Il-PRAC ikkunsidra l-proċedura taħt Artiklu 31 ta' Direttiva 2001/83/KE li rriżultat minn dejta ta' farmakoviġilanza għal prodotti mediċinali li fihom bromocriptine għal użu mill-ħalq fl-inibizzjoni ta' treddigħ wara t-tqala;
English: From the pathogenic point of view, it is likely that vasospasm is responsible for these events.
Maltese: Mil-lat patoġeniku, huwa possibbli li vasospażmu huwa responsabbli għal dawn lavvenimenti.
English: Herings and colleagues concluded that, cardiovascular or cerebrovascular events observed could probably be explained by pre-existing morbidity rather than by the use of bromocriptine.
Maltese: Herings u l-kollegi kkonkludew li, avvenimenti kardjovaskulari u ċerebrovaskulari osservati setgħu probabbilment jiġu spjegati minn morbidità pre-eżistenti pjuttost milli bl-użu ta' bromocriptine.
English: Overall summary of the scientific evaluation of bromocriptine containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' prodotti mediċnali li fihom bromocriptine (ara Anness I)
English: The CMDh having considered the PRAC recommendation dated 10 July 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation to the terms of the marketing authorisations of bromocriptine-containing medicinal products for oral use indicated in postpartum inhibition of lactation for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III.
Maltese: Is-CMDh wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-10 ta' Lulju 2014 skont l-Artikolu 107k(1) u (2) ta' Direttiva 2001/83/KE, wasal għal pożizzjoni fuq il-varjazzjoni għat-termini talawtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom bromocriptine għal użu orali indikat f'inibizzjoni ta' treddigħ wara t-tqala, li għaliha, is-sezzjonijiet relevanti tas-sommarju talkaratteristiċi tal-prodott u tagħrif tal-fuljett huma stabbiliti f'Anness
English: Although most of the studies conducted with bromocriptine are conducted before 1990, the available evidence from clinical trials conducted as part of the original clinical development plan as well as from the published literature suggests that bromocriptine is efficacious in the indication currently under review and appeared superior to androgens, combined contraceptives, anti-oestrogens, pyridoxine, and of similar efficacy than that of other dopamine agonists, though possibly better than lisuride.
Maltese: Għalkemm ħafna mill-istudji li twettqu bi bromocriptine twettqu qabel l-1990, l-evidenza disponibbli minn provi kliniċi li twettqu bħala parti mill-pjan ta' żvilupp oriġnali kif ukoll mill-letteratura ppubblikata tissuġġerixxi li bromocriptine huwa effettiv fl-użu attwalment taħt reviżjoni u jidher superjuri għal androġeni, kontraċettivi kkombinati, anti-estroġeni, pyridoxine, u ta' effikaċja simili għal dik ta' agonisti ta' dopamina oħrajn, għalkemm possibbilment aħjar minn lisuride.
English: The CMDh, having considered the PRAC recommendation dated 10 July 2014 with regards to the bromocriptine containing medicinal products, agrees with the recommendation therein as stated below:
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata l-10 ta' Lulju 2014 fir-rigward ta' bromocriptine li fihom prodotti mediċinali, jaqbel mar-rakkommandazzjoni kif iddikjarat hawn taħt:
English: If any symptoms of hypertension or evidence of central nervous system toxicity are detected, the administration of bromocriptine should be discontinued;
Maltese: Jekk jiġi identifikat xi sintomu ta' pressjoni għolja jew evidenza ta' tossiċità tas-sistema nervuża ċentrali, l-amministrazzjoni ta' bromocriptine għandha titwaqqaf;
English: Furthermore, in part of the cases important risk factors (smoking, obesity, pre-eclampsia, hypertension, history of psychiatric episodes) were reported.
Maltese: Barra minn hekk, f'parti mill-każijiet, ġew irrapportati fatturi ta' riskju importanti (tipjip, obesità, pre-eklampsja, pressjoni għolja, storja ta' episodji psikjatriċi).