FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned' Member States, see list above) where the company has applied for a marketing authorisation.
Maltese: Din hija proċedura fejn Stat Membru wieħed ("l-Istat Membru ta' referenza", f'dan ilkaż ir-Renju Unit) jivvaluta mediċina bil-ħsieb li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-Istati Membri “kkonċernati", ara l-lista ta' hawn fuq) fejn il-kumpanija tkun applikat għal awtorizzazzjoni għat-tqegħid fis-suq.
English: Perlinring is used for 21 days (3 weeks) in a row, followed by a 7-day break, after which a new ring should be used.
Maltese: Perlinring jintuża għal 21 jum (3 ġimgħat) konsekuttivi, segwiti minn pawża ta' 7 ijiem, li warajha għandu jintuża ċirku ġdid.
English: This means that Perlinring was developed to contain the same active substance and work in the same way as a ‘reference medicine' already authorised in the EU called Nuvaring.
Maltese: Dan ifisser li Perlinring ġie żviluppat biex ikun fih listess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-UE li jisimha Nuvaring.
English: The grounds for the referral relate to concerns raised by Germany, France and the Netherlands, that the Nuvaring product information for doctors and patients states that the product continues to be effective if it is used for an additional 4th week.
Maltese: Ir-raġunijiet għar-referenza huma relatati ma' tħassib li qajmu l-Ġermanja, Franza u n-Netherlands, li l-informazzjoni dwar il-prodott ta' Nuvaring għat-tobba u għall-pazjenti tgħid li l-prodott jibqa' jkun effettiv jekk jintuża għal raba' ġimgħa addizzjonali.
English: Based on evaluation of the currently available data, the Agency considered that bioequivalence to the reference medicinal product has been shown for the authorised duration of treatment (3 weeks).
Maltese: Abbażi ta' evalwazzjoni tad-data disponibbli bħalissa, l-Aġenzija qieset li l-bijoekwivalenza għallprodott mediċinali ta' referenza ntweriet għad-durata ta' kura awtorizzata (3 ġimgħat).
English: However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 7 August 2018.
Maltese: Madankollu, l-Istati Membri ma setgħux jaslu għal qbil u l-aġenzija regolatorja tal-mediċini tar-Renju Unit irreferiet il-kwistjoni lill-EMA għal arbitraġġ fis-7 ta' Awwissu 2018.
English: Perlinring is a contraceptive vaginal ring used to prevent pregnancy.
Maltese: Perlinring huwa ċirku vaġinali kontraċettiv li jintuża biex jipprevjeni t-tqala.
English: medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
Maltese: mediċini huma bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva fil-ġisem u huma għaldaqstant mistennija li jkollhom l-istess effett.
English: Each ring contains two hormones, etonogestrel and ethinylestradiol, which are slowly released into the blood circulation and prevent the release of eggs from the ovaries.
Maltese: Kull ċirku fih żewġ ormoni, etonogestrel u etinilestradjol, li jiġu rilaxxati bil-mod fiċ-ċirkolazzjoni tad-demm u jimpedixxu r-rilaxx tal-bajd mill-ovarji.
English: EMEA/458933/2008-EN
Maltese: EMEA/458933/2008-MT
English: London, August 2008 EMEA/458933/2008
Maltese: Londra, Awwissu 2008 EMEA/458933/2008
English: The Marketing Authorisation Holder was requested: 1.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq intalab: 1.
English: OPINION FOLLOWING AN ARTICLE 34 REFERRAL FOR METHOXASOL-T
Maltese: OPINJONI WARA RIFERIMENT SKONT L-ARTIKOLU 34 GĦAL METHOXASOL-T
English: On 8 September 2006, Germany presented to the EMEA a referral under Article 34 of Directive 2001/82/EC, as amended, concerning Methoxasol-T (including associated names), containing trimethoprim and sulfamethoxazole as active ingredient.
Maltese: Fit-8 ta' Settembru 2006, il-Ġermanja ppreżentat lill-EMEA riferiment skont l-Artikolu 34 tadDirettiva 2001/82/KE, kif emendata, dwar Methoxasol-T (inkluż l-ismijiet assoċjati), li fih trimethoprim u sulfamethoxazole bħala sustanzi attivi.
English: The CVMP Opinion was adopted on 11 October 2007 and the subsequent Commission Decision on 11 January 2008.
Maltese: L-Opinjoni tas-CVMP ġiet adottata fil-11 ta' Ottubru 2007 u d-Deċiżjoni sussegwenti talKummissjoni fil-11 ta' Jannar 2008.
English: • Broilers: treatment and prevention of respiratory infections caused by Escherichia coli susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
Maltese: • Brojlers: it-trattament u l-prevenzjoni ta' infezzjonjiet respiratorji ikkawżati minn Escherichia coli suxxettibbli għal trimethoprim u sulfamethoxazole fejn il-mard ikun ġie dijanjostikat filmerħla.
English: • Pigs: treatment and prevention of respiratory infections caused by Actinobacillus pleuropneumoniae susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Maltese: • Ħnieżer: it-trattament u l-prevenzjoni ta' infezzjonjiet respiratorji ikkawżati minn Actinobacillus pleuropneumoniae suxxettibbli għal trimethoprim u sulfamethoxazole fejn il-mard ikun ġie dijanjostikat fil-merħla.
English: Methoxasol-T was authorised through a national procedure in The Netherlands in 1999, but a marketing authorisation was refused in Germany in 2001.
Maltese: Methoxasol-T ġie awtorizzat permezz ta' proċedura nazzjonali fl-Olanda fl-1999, iżda lawtorizzazzjoni għat-tqegħid fis-suq ġiet rifjutata fil-Ġermanja fl-2001.
English: To justify compliance of the dossier with respect to the requirements for obtaining a marketing authorisation (Annex I of Directive 2001/82/EC, as amended).
Maltese: Jiġġustifika l-konformità tad-dokumentazzjoni b'rabta mar-rekwiżiti għall-ksib ta' awtorizzazzjoni għat-tqegħid fis-suq (Anness I tad-Direttiva 2001/82/KE, kif emendata).
English: To provide the relevant parts of the dossier of each Member State where an application has been submitted and to detail the differences between the dossiers.
Maltese: Jipprovdi l-partijiet relevanti tad-dokumentazzjoni ta' kull Stat Membru fejn ġiet sottomessa applikazzjoni u jniżżel fid-dettall id-differenzi bejn id-diversi dokumentazzjoni.
English: To propose and justify a harmonised text of the Summary of Product Characteristics (SPC), including posology and method of administration as well as withdrawal periods for pigs and poultry.
Maltese: Jipproponi u jiġġustifika test armonizzat tas-Sommarju tal-Karatteristiċi tal-Prodott (SPC), inkluż il-pożoloġija u l-metodu tal-għoti kif ukoll il-perjodi ta' rtirar għall-ħnieżer u t-tjur.
English: Germany considered that the efficacy of Methoxasol-T as proposed by the applicant was not adequately justified, therefore resulting in a potential serious risk to the target animals.
Maltese: Il-Ġermanja qieset li leffikaċja ta' Methoxasol-T kif proposta mill-applikant ma ġietx ġustifikata adegwatament, u dan wassal għal riskju potenzjali serju għall-annimali fil-mira.
English: The Marketing Authorisation Holder submitted written responses, defending the indications, recommended dose and shelf life, and proposing a harmonised SPC text.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq issottometta tweġibiet bil-miktub, biex jiddefendi l-indikazzjonijiet, id-doża rakkomandata u d-data sa meta jista' jintuża l-prodott, u ippropona test tal-SPC armonizzat.
English: The CVMP also recommended that the use of the product should be based on culture and sensitivity testing of micro-organisms from diseased cases on farm or from recent previous experience on the farm, as resistance against potentiated sulphonamides may vary.
Maltese: Is-CVMP irrakkomanda wkoll li l-użu tal-prodott għandu jkun ibbażat fuq littestjar tal-kultura u tas-sensittività ta' mikroorganiżmi minn każijiet b'mard f'razzett jew minn esperjenza preċedenti fuq ir-razzett, billi r-reżistenza kontra s-sulphonamides potenzjati tista' tvarja.
English: An intended application for a marketing authorisation of a generic triggered Germany to submit the referral regarding the divergent decisions taken on Methoxasol-T.
Maltese: Applikazzjoni intiża għall-awtorizzazzjoni għat-tqegħid fis-suq ta' prodott ġeneriku qanqlet lillĠermanja tissottometti riferiment dwar id-deċiżjonijiet diverġenti meħudin dwar Methoxasol-T.
English: On the basis of the data provided, the CVMP agreed on the following harmonised indications for use:
Maltese: Abbażi tad-dejta pprovduta, is-CVMP qabel fuq l-indikazzjonijiet armonizzati tal-użu li ġejjin:
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder, CVMP concluded that the benefit/risk balance of the product is positive for use in both pigs and broilers subject to recommended changes to the Summary of Product Characteristics and product information, and that the concerns raised by Germany should not prevent the granting of a marketing authorisation.
Maltese: Wara li qies ir-raġunijiet għar-riferiment u t-tweġibiet ipprovduti mid-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq, is-CVMP ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju tal-prodott huwa pożittiv għall-użu kemm fil-ħnieżer kif ukoll fil-brojlers soġġett għat-tibdil rakkomandat fis-Sommarju tal-Karatteristiċi tal-Prodott, u li t-tħassib imressaq mill-Ġermanja m'għandux jipprevjeni l-għoti talawtorizzazzjoni għat-tqegħid fis-suq.
English: The CVMP started the referral procedure during its meeting of 12-14 September 2006.
Maltese: Is-CVMP beda l-proċedura ta' riferiment waqt il-laqgħa tiegħu ta' bejn it-12 u l-14 ta' Settembru 2006.
English: To propose and justify with data a suitable shelf life for the product, including an in-use shelf life where relevant.
Maltese: Jipproponi u jiġġustifika b'dejta d-data sa meta jista' jintuża l-prodott, inkluż kemm jista' jdum jintuża minn meta jinfetaħ fejn relevanti. 6.
English: It contains the active substance sarolaner.
Maltese: Fih is-sustanza attiva sarolaner.
English: The full EPAR for Simparica can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Simparica was as effective as moxidectin/imidacloprid and the percentage of Simparica-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.
Maltese: Simparica kien effettiv daqs moxidectin/imidacloprid u l-perċentwal ta' klieb ikkurati b'Simparica mingħajr dud mejjet kienu 15%, 69%, 93%, 94%, 100% u 100% f'jiem 30, 60, 90, 120, 150 u 180, rispettivament.
English: 189 dogs were treated with Simparica for three months whilst 96 dogs were given another medicine, spinosad.
Maltese: 189 kelb kienu kkurati b'Simparica għal tliet xhur filwaqt li 96 kelb ingħataw mediċina oħra, spinosad.
English: Other information about Simparica
Maltese: Informazzjoni oħra dwar Simparica
English: Simparica is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription.
Maltese: Simparica jiġi bħala pilloli li jintmagħdu (5, 10, 20, 40, 80 u 120 mg) u jista' jinkiseb biss b'riċetta ta' vetirinarju.
English: Simparica was as effective as moxidectin/imidacloprid.
Maltese: Simparica kien effettiv daqs il-moxidectin/l-imidacloprid.
English: The European Commission granted a marketing authorisation valid throughout the EU for Simparica on 6 November 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Simparica valida fl-UE kollha fis6 ta' Novembru 2015.
English: The active substance in Simparica, sarolaner acts as an ‘ectoparasiticide'.
Maltese: Is-sustanza attiva f'Simparica, is-sarolaner taġixxi bħala ‘ektoparassitiċida'.
English: This is a summary of the European public assessment report (EPAR) for Simparica.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Simparica.
English: In a study involving dogs with ear mite infestation, 283 dogs were treated with Simparica and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
Maltese: Fi studju li involva klieb b'infestazzjonijiet tad-dud, 283 kelb kienu kkurati b'Simaprica u 131 kelb ingħataw il-moxidectin/imidacloprid (kura tad-dud li tiġi applikata dak il-ħin fuq il-post).
English: Why is Simparica approved?
Maltese: Għaliex ġie approvat Simparica?
English: Simparica is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
Maltese: Simparica huwa mediċina veterinarja użata biex tikkura infestazzjonijiet ta' qurdien u briegħed, ġarab demodektiku u sarkoptiku (infestazzjonijiet tal-ġilda kkawżati minn żewġ tipi differenti ta' dud) u infestazzjonijiet tal-qurdien tal-widna fil-klieb.
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Maltese: Din timblokka l-moviment normali tal-partikoli ċċarġjati tal-klorur (joni) ġewwa u barra ċċelloli tan-nervituri, speċjalment dawk assoċjati ma' aċidu gamma-aminobutirriku (GABA) u glutamat, żewġ sustanzi li jgħaddu l-messaġġi bejn in-nervituri (newrotrażmettituri).
English: What are the risks associated with Simparica?
Maltese: X'inhuma r-riskji assoċjati ma' Simparica?
English: For Simparica the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Maltese: Għal Simparica l-perċentwal ta' klieb li ma kellhomx dud ħaj preżenti f'widnejhom kien ta' 91% fit-30 jum u żdied għal 99% wara l-jum 60, wara żewġ kuri.
English: In a study with 98 dogs with demodectic mange, 63 dogs were treated with Simparica monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
Maltese: Fi studju fuq 98 kelb b'ġarab demodektiku, 63 kelb kienu kkurati b'Simparica kull xahar sa massimu ta' sitt xhur u 35 kelb ingħataw il-moxidectin/l-imidacloprid.
English: Simparica can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Maltese: Simparica jista' jintuża bħala parti mill-ġestjoni ta' dermatite allerġika mill-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: After Simparica is given its activity against ticks and fleas lasts for at least 5 weeks.
Maltese: Wara li jingħata Simparica l-attività tiegħu kontra lqurdien u briegħed iddum mill-inqas 5 ġimgħa.
English: 122 dogs were treated with Simparica for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Maltese: Sar studju fuq il-post fi klieb infettati b'mill-inqas tliet qurdiniet ħajjin imwaħħlin. 122 kelb kienu kkurati b'Simparica għal tliet xhur filwaqt li 59 kelb kienu kkurati b'mediċina oħra, fipronil, kontra l-qurdien.
English: How does Simparica work?
Maltese: Kif jintuża Simparica?
English: Simparica was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Maltese: Simparica kien effettiv daqs il-moxidectin u l-imidacloprid fl-eliminazzjoni ta' dud ħaj fil-biċċiet tal-ġilda.
English: Dogs with live mites on day 30 after initial treatment received a second treatment.
Maltese: Il-klieb b'dud ħaj fit-30 jum wara l-kura inizjali ngħataw it-tieni kura.
English: Simparica was as effective as fipronil in reducing tick counts for up to 90 days after treatment.
Maltese: Simparica kien effikaċi daqs fipronil fit-tnaqqis tal-għadd ta' qurdien għal sa 90 jum wara l-kura.
English: 53 dogs were treated with Simparica for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Maltese: Studju ieħor involva klieb infestati bil-ġarab sarkoptiku. 53 kelb kienu kkurati b'Simparica għal xahrejn filwaqt li 26 kelb kienu kkurati b'mediċina li fiha moxidectin u imidacloprid.
English: Side effects with Simparica are not common.
Maltese: L-effetti sekondarji b'Simparica mhumiex komuni.
English: Simparica was as effective as spinosad in reducing flea counts for up to 90 days after treatment.
Maltese: Simparica kien effikaċi daqs spinosad fit-tnaqqis tal-għadd ta' briegħed għal sa 90 jum wara l-kura.
English: However, the following side effects are seen in less than 1 dog in 10,000: mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions.
Maltese: Madankollu, l-effetti sekondarji li ġejjin jidhru f'bejn kelb f'10,000: remettar u dijarea ħafifa u li ma jdumux kif ukoll theżżiż (rogħda), ataksja (nuqqas ta' koordinazzjoni tal-movimenti tal-ġisem) jew konvolżjonijiet.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Simparica's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Simparica huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: For treatment of tick and flea infestations Simparica should be given once every month throughout the flea and/or tick season for optimal control.
Maltese: Għall-kura ta' infestazzjonijiet tal-briegħed u l-qurdien, Simparica għandu jingħata darba fix-xahar matul l-istaġun tal-briegħed u/jew tal-qurdien għal kontroll ottimali.
English: EMA/390444/2014 EMEA/H/C/002705
Maltese: EMEA/H/C/002705
English: The full EPAR and risk management plan summary for Velphoro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The maximum dose is 3,000 mg (6 tablets) per day.
Maltese: Id-doża massima hija ta' 3,000 mg (6 pilloli) kuljum.
English: After 3 months of treatment, blood-phosphate levels fell on average by 0.7 mmol/L with Velphoro compared with 0.8 mmol/L with sevelamer, and after 6 months of treatment 53% of patients on Velphoro had normal blood-phosphate levels (1.13 to 1.78 mmol/L) compared with 54% of patients on sevelamer.
Maltese: Wara 3 xhur ta' kura, il-livelli ta' fosfat fid-demm niżlu fuq medja ta' 0.7 mmol/L b'Velphoro meta mqabbel ma' 0.8 mmol/L b'sevelamer, u wara 6 xhur ta' kura 53% tal-pazjenti fuq Velphoro kellhom livelli normali ta' fosfat fid-demm (1.13 sa 1.78 mmol/L) meta mqabbel ma' 54% tal-pazjenti fuq sevelamer.
English: Other information about Velphoro
Maltese: Informazzjoni oħra dwar Velphoro
English: Velphoro has been studied in one main study involving 1,059 adults with long-term kidney disease and hyperphosphataemia.
Maltese: Velphoro ġie studjat fi studju ewlieni wieħed li involva 1,059 adulti b'mard tal-kliewi fit-tul u iperfosfatemija.
English: Why is Velphoro approved?
Maltese: Għaliex ġie approvat Velphoro?
English: The active substance in Velphoro, sucroferric oxyhydroxide, is a phosphate binder.
Maltese: Is-sustanza attiva f'Velphoro, sucroferric oxyhydroxide, hija legatur tal-fosfat.
English: The risk of excess iron build-up was considered limited but should be followed up after approval.
Maltese: Ir-riskju ta' akkumulazzjoni ta' ħadid huwa kkunsidrat limitat iżda għandu jiġi segwit wara approvazzjoni.
English: The CHMP concluded that Velphoro showed a clear beneficial effect in lowering phosphate levels.
Maltese: Is-CHMP ikkonkluda li Velphoro wera effett ċar ta' benefiċċju fit-tnaqqis tal-livelli ta' fosfat.
English: This is a summary of the European public assessment report (EPAR) for Velphoro.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Velphoro.
English: Velphoro is available as chewable tablets (containing 500 mg of iron).
Maltese: Velphoro huwa disponibbli bħala pilloli li tomgħodhom (li fihom 500 mg ta' ħadid).
English: The active substance in this medicine is sucroferric oxyhydroxide (also known as mixture of polynuclear iron(III)-oxyhydroxide, sucrose (sugar) and starches).
Maltese: Is-sustanza attiva f'din il-mediċina hija sucroferric oxyhydroxide (magħruf ukoll bħala taħlita ta' ħadidoxyhydroxide polinukleari, sukrożju (zokkor) u lamti).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Velphoro on 26 August 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Velphoro fis-26 ta' Awwissu 2014.
English: The recommended starting dose is 1,500 mg (3 tablets) a day, taken in divided doses together with meals.
Maltese: Id-doża tal-bidu rakkomandata hija 1,500 mg (3 pilloli) kuljum, li jittieħdu f'dożi diviżi flimkien ma' ikliet.
English: A risk management plan has been developed to ensure that Velphoro is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Velphoro jintuża bl-aktar mod sigur possibbli.
English: What are the risks associated with Velphoro?
Maltese: X'inhuma r-riskji assoċjati ma' Velphoro?
English: The most common side effects with Velphoro (which may affect more than 1 in 10 people) are diarrhoea and discoloured faeces, which may become less frequent with continued treatment.
Maltese: L-effetti sekondarji l-aktar komuni b'Velphoro (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma dijarea u ppurgar bla kulur, li jistgħu jsiru inqas frekwenti b'kura kontinwa.
English: Velphoro is a medicine used to control blood-phosphate levels in adults with long-term kidney disease who are undergoing haemodialysis or peritoneal dialysis to remove waste products from the blood.
Maltese: Velphoro huwa mediċna li tintuża biex tikkontrolla l-livell ta' fosfat fid-demm f'adulti b'mard tal-kliewi fit-tul, li jkunu qegħdin iwettqu emodijalisi jew dijalisi peritoneali biex jitneħħew prodotti ta' skart middemm.
English: What measures are being taken to ensure the safe and effective use of Velphoro?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Velphoro?
English: For the full list of all side effects and restrictions with Velphoro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Velphoro, ara l-fuljett ta' tagħrif.
English: All patients were on dialysis and received either Velphoro or another phosphate binder, sevelamer, for 6 months.
Maltese: Il-pazjenti kollha kienu fuq dijaliżi u rċevew Velphoro jew legatur tal-fosfat ieħor, sevelamer, għal 6 xhur.
English: Manufacturer Nycomed Danmark ApS Langebjerg 1
Maltese: Nycomed Danmark ApS Langebjerg 1
English: Date of latest renewal: 24.04.2011
Maltese: Data tal-aħħar tiġdid: 24.04.2011
English: DK-4000 Roskilde Denmark
Maltese: DK-4000 Roskilde Id-Danimarka
English: Parathyroid hormone N=1341
Maltese: Ormon tal-paratirojde N=1341
English: INFORMATION ON BRAILLE Preotact
Maltese: INFORMAZZJONI BIL-BRAILLE Preotact
English: Sodium chloride, mannitol, citric acid monohydrate, hydrochloric acid, metacresol, sodium hydroxide, water for injections.
Maltese: Sodium chloride, mannitol, citric acid monohydrate, hydrochloric acid, metacresol, sodium hydroxide, ilma għall-injezzjonijiet.
English: Preotact has been administered in single doses up to 5 micrograms/kg and in repeated doses of up to 3 micrograms/kg/day for 3 days and up to 2.5 micrograms/kg/day for 7 days.
Maltese: Preotact ingħata f'dożi uniċi sa 5 mikrogrammi/kg u f'dożi ripetuti sa 3 mikrogrammi/kg/kuljum għal 3 ijiem u sa 2.5 mikrogrammi/kg/kuljum għal 7 ijiem.
English: Reconstituted solution: 28 days
Maltese: Soluzzjoni rikostitwita: 28 ġurnata
English: • loss of appetite,
Maltese: • nuqqas t' aptit,
English: Cartridge: Glass Type I.
Maltese: Skartoċċ: Ħġieġ ta' Tip I.
English: System organ class
Maltese: Sistema tal-klassifika ta' l-organi