FrancophonIA/ELRC3.0 huggingface dataset:
English: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics is a vaccine.
Maltese: Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics huwa vaċċin.
English: In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics three weeks apart, or a placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
Maltese: Fi studju wieħed li nvolva 3,372 persuna, is-suġġetti ġew mogħtija jew vaċċin ta' influwenza staġjonali b'żewġ dożi ta' Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics warajh fi żmien tliet ġimgħat minn xulxin, jew plaċebo (vaċċin finta) segwit minn żewġ dożi ta' vaċċin staġjonali adġuvant fi żmien tliet ġimgħat minn xulxin.
English: For the full list of all side effects reported with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, see the package leaflet.
Maltese: Għal-lista sħiħta tal-effetti sekondarji rrappurtati bi Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics, ara lfuljett ta' tagħrif.
English: Two main studies provided data on vaccination with Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics in healthy adults aged below and above 60 years.
Maltese: Żewġ studji prinċipali pprovdew dejta dwar il-vaċċinazzjoni bi Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics f'adulti b'saħħithom taħt u ‘l fuq minn 60 sena.
English: This is a summary of the European public assessment report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics.
English: What is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
Maltese: X'inhu Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: EPAR summary for the public prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)
Maltese: Sommarju tal-EPAR għall-pubbliku vaċċin prepandemiku għal l-influwenza (H5N1) (antiġenu tal-wiċċ, diżattivat, adġuvant)
English: How is Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics used?
Maltese: Kif jintuża Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics?
English: There are 5 different strengths of patch available: 12, 25, 50, 75 and 100 μg/h.
Maltese: Hemm 5 qawwiet differenti għal kull roqgħa disponibbli: 12, 25, 50, 75 u 100 μg/h.
English: Paediatric indication
Maltese: Indikazzjoni pedjatrika
English: Durogesic (fentanyl) transdermal patches are registered nationally in the following 24 European Economic Area (EEA) countries: Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovenia, Spain, Sweden and United Kingdom.
Maltese: Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Iżlanda, l-Irlanda, l-Italja, il-Lussemburgu, Malta, inNetherlands, in-Norveġja, il-Polonja, il-Portugall, is-Slovenja, Spanja, l-Iżvezja u r-Renju Unit.
English: • The committee considered the referral under Article 30 of Directive 2001/83/EC concerning the medicinal product Durogesic transdermal patches;
Maltese: • Il-kumitat ikkunsidra r-riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE rigward il prodott mediċinali rqajja' transdermali Durogesic;
English: Section 5.2 - Pharmacokinetic properties
Maltese: Sezzjoni 5.2 - Proprjetajiet farmakokinetiċi
English: These are: pharmacodynamic-related interactions with centrally-acting medicinal products and alcohol, monoamine oxidase inhibitors, serotonergic drugs and concomitant use of mixed opioid agonists/antagonists, and pharmacokinetic-related interactions with CYP3A4 Inhibitors and CYP3A4 inducers.
Maltese: Dawn huma: interazzjonijiet relatati mal-farmakodinamika ma' prodotti mediċinali b'azzjoni ċentrali u alkoħol, inibituri ta' monoamine oxidase, mediċini serotonerġiċi u użu konkomitanti ta' agonisti/antagonisti ta' opjojdi mħalltin, u interazzjonijiet relatati mal farmakokinetika ma' Inibituri CYP3A4 u indutturi CYP3A4.
English: The texts for the subsections absorption, distribution, biotransformation and excretion are considered acceptable.
Maltese: It-testijiet tas-subsezzjonijiet assorbiment, distribuzzjoni, bijotrasformazzjoni u eliminazzjoni huma meqjusa aċċettabbli.
English: According to the EMA Guideline on the Clinical Development of Medicinal Products Intended for the Treatment of Pain (EMA/CHMP/970057/2011, Corr. 11) and the WHO Guideline on Cancer Pain Relief, pain severity can be classified as mild, moderate and severe.
Maltese: Skont il-Linja Gwida tal-EMA dwar l-Iżvilupp Kliniku ta' Prodotti Mediċinali Intiżi għall-Kura talUġigħ (EMA/CHMP/970057/2011, Corr. 11) u l-Linja Gwida tal-WHO dwar is-Serħan mill-Uġigħ tal-Kanċer, is-severità tal-uġigħ tista' tiġi kklassifikata bħala ħafifa, moderata u severa.
English: The PL has been harmonised taking into account all revisions of the SmPC that are relevant to the PL.
Maltese: Il-PL ġie armonizzat filwaqt li tqiesu r-reviżjonijiet kollha tal-SmPC li huma relevanti għall-PL.
English: The lowest available patch strength is 12.5 μg/h, which is designated as 12μg/h to distinguish it from a 125μg/h dosage that could be prescribed by using multiple patches.
Maltese: L-iżgħar qawwa tar-roqgħa disponibbli hija 12.5 μg/h, li hija kklassifikata bħala 12 μg/h sabiex din tintgħaraf minn doża ta' 125 μg/h li tista' tingħata b'riċetta minn tabib permezz ta'
English: Other warnings included in section 4.4 are: chronic pulmonary disease, drug dependence and potential for abuse, central nervous system including increased intracranial pressure, cardiac disease, hypotension, hepatic impairment, renal impairment, respiratory depression, serotonin syndrome, accidental exposure by patch transfer, use in elderly patients, gastrointestinal tract, paediatric population, lactation, and patients with myasthenia gravis.
Maltese: pressjoni baxxa, indeboliment tal-fwied, indeboliment tal-kliewi, dipressjoni respiratorja, sindromu tas-serotonin, esponiment aċċidentali permezz ta' trasferiment mir-roqgħa, użu fil-pazjenti anzjani, passaġġ gastrointestinali, popolazzjoni pedjatrika, treddigħ, u pazjenti b'mijastenja gravis.
English: Table 3: An alternative conversion Table from oral morphine to fentanyl transdermal therapeutic system (TTS), based on data from a clinical study of fentanyl TTS in subjects tolerant of stable regimens of sustained release (SR) morphine, was proposed in 1996 by Donner et al. (1996)1.
Maltese: Tabella 3: Tabella alternattiva ta' konverżjoni minn morfina orali għal sistema terapewtika ta' fentanyl transdermali (TTS), ibbażata fuq data minn studju kliniku ta' fentanyl TTS f'individwi tolleranti ta'
English: Vasodilation is effectively reversed by naloxone.
Maltese: Il-vażodilatazzjoni titreġġa' lura b'mod effettiv permezz ta' naloxone.
English: Fentanyl has high lipid solubility and potency, which make it suitable for transdermal administration.
Maltese: Fentanyl għandu solubilità u qawwa lipida għolja, li huma adattati għal amministrazzjoni transdermali.
English: anaesthetic since the 1960s.
Maltese: anqas minn 72 siegħa.
English: The new sub heading on linearity/non linearity is justified by adequate data and also considered to be acceptable.
Maltese: Is-subintestatura ġdida dwar linearità/non-linearità hija ġġustifikata b'data adegwata u meqjusa wkoll bħala aċċettabbli.
English: The proposed pharmacodynamic-related interactions were endorsed in the PSUR worksharings in 2010 and 2015.
Maltese: fl-2010 u fl-2015.
English: The studies varied between 28 days and 13 months.
Maltese: L-istudji varjaw bejn 28 jum u 13-il xahar.
English: • The committee reviewed the totality of the data submitted by the MAH in support of the proposed harmonisation of the Product Information.
Maltese: • Il-kumitat irreveda t-totalità tad-data ppreżentata mill-MAH f'appoġġ tal-armonizzazzjoni proposta tal-Informazzjoni dwar il-Prodott.
English: However a warning has been added that more time would be needed for CYP3A4 inhibitors with a long half-life (such as amiodarone) or CYP3A4 inhibitors with time-dependent or mechanism-based inhibition (such as erythromycin, nicardipine, idelalisib, ritonavir), and that the product information of the CYP3A4 inhibitor must be consulted for the half-life and duration of the inhibitory effect before applying the first Durogesic patch.
Maltese: CYP3A4 b'nofs ħajja twila (bħal amiodarone) jew għall-inibituri CYP3A4 b'inibizzjoni li tiddependi fuq iż-żmien jew ibbażata fuq il-mekkaniżmu (bħal erythromycin, nicardipine, idelalisib, ritonavir), u li l-informazzjoni tal-prodott tal-inibitur CYP3A4 għandha tiġi kkunsidrata għan-nofs ħajja u t-tul ta' żmien tal-effett inibitorju qabel ma tintuża l-ewwel roqgħa ta' Durogesic.
English: Table 2: Designed for adult patients who have a need for rotation of, or conversion from, another opioid regimen (conversion ratio of oral morphine to transdermal fentanyl approximately equal to 150:1).
Maltese: Tabella 2: Imfassla għal pazjenti adulti li għandhom ħtieġa għal rotazzjoni ta', jew konverżjoni minn, skeda ta' opjojdi oħra (proporzjon ta' konverżjoni ta' morfina orali għal fentanyl transdermali bejn wieħed u ieħor daqs 150:
English: The subjects (N=1667) included had chronic low back pain, osteoarthritis or rheumatoid arthritis or pain of unspecified origin.
Maltese: L-individwi (N=1667) inklużi kellhom uġigħ kroniku fin-naħa t'isfel tad-dahar, osteoartrite jew artrite rewmatika jew uġigħ ta' oriġini mhux speċifikat.
English: The scope of this procedure is limited to Durogesic transdermal patches.
Maltese: Il-kamp tal-applikazzjoni ta' dan il-prodott huwa limitat għal irqajja' transdermali Durogesic.
English: Major differences between SmPCs regarding the assigned frequencies for individual adverse reactions were discussed and resolved.
Maltese: Id-differenzi maġġuri bejn l-SmPCs rigward il-frekwenzi assenjati għal reazzjonijiet avversi individwali ġew diskussi u solvuti.
English: Children aged 16 years and above follow adult dosage, and for children 2-16 years a table with recommended Durogesic dosages for paediatric patients based upon daily oral morphine dose has been provided.
Maltese: Tfal li għandhom 16-il sena u 'l fuq isegwu d-doża tal-adulti, u għal tfal ta' bejn 2-16-il sena ġiet ipprovduta tabella b'dożi ta' Durogesic irrakkomandati għal pazjenti pedjatriċi abbażi tad-doża ta'
English: Contraindications relating to severe respiratory depression, hypersensitivity to the active substance or to any of the excipients use in acute or postoperative pain and use in acute or postoperative pain has been included in the harmonised SmPC.
Maltese: Il-kontraindikazzjonijiet relatati ma' dipressjoni respiratorja severa, sensittività eċċessiva għassustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti użati f'uġigħ akut jew ta' wara loperazzjoni ġew inklużi fl-SmPC armonizzat.
English: Durogesic transdermal patch contains fentanyl, which is a potent, synthetic opioid analgesic belonging to the piperidine derivatives.
Maltese: Il-formolazzjoni tal-kliem għas-subsezzjoni 'Fertilità' ġiet emendata sabiex tiġi żgurata l-konsistenza fil-prodotti mediċinali differenti kollha li fihom fentanyl.
English: The table with adverse reactions from clinical trials and post-marketing data for both adult and paediatric subjects together, in line with the current table of adverse reactions in the Core Safety Profile (CSP) was proposed.
Maltese: Ġiet proposta t-tabella bir-reazzjonijiet avversi minn provi kliniċi u data ta' wara t-tqegħid fis-suq kemm għall-individwi adulti kif ukoll għal dawk pedjatriċi flimkien, skont it-tabella attwali tarreazzjonijiet avversi fil-Profil tas-Sigurtà Ewlieni (CSP).
English: As the wording about the potential risk of serotonin syndrome has been included in sections 4.4 and 4.5 of the harmonised SmPC, section 4.8 of the harmonised SmPC has also been updated with a statement that cases of serotonin syndrome have been reported when fentanyl-containing products are administered concomitantly with highly serotonergic medicinal products.
Maltese: SmPC armonizzat ġiet aġġornata wkoll bi stqarrija li każijiet tas-sindromu tas-serotonin ġew irrapportati meta l-prodotti li fihom fentanyl jingħataw b'mod konkomitanti ma' prodotti mediċinali serotonerġiċi ħafna.
English: Replacing the patch before 72 hours may result in increased serum concentrations of fentanyl, which could increase the risk for adverse events.
Maltese: Il-bdil tar-roqgħa qabel 72 siegħa jista' jirriżulta f'żieda fil-konċentrazzjonijiet ta' fentanyl fis-serum, u dan jista' jżid ir-riskju ta' avvenimenti avversi.
English: As outlined in the October 2007 Public Assessment Report regarding paediatric data, the long-term management of severe chronic pain in children from 2 years of age who are receiving opioid therapy is indicated in section 4.1 of the proposed harmonised SmPC, and also present in the majority of SmPCs.
Maltese: Kif deskritt fir-Rapport tal-Valutazzjoni Pubblika ta' Ottubru 2007, il-ġestjoni fit-tul ta' uġigħ kroniku sever fi tfal li għandhom minn sentejn 'il fuq li jkunu qed jirċievu l-kura bl-opjojdi hija msemmija f'sezzjoni 4.1 tal-SmPC armonizzat propost, u preżenti wkoll fil-maġġoranza tal-SmPCs.
English: Information related to studies in the post-operative pain indication in opioid naïve subjects has not been retained since this is not in the indication of Durogesic.
Maltese: Informazzjoni relatata mal-istudji fl-indikazzjoni tal-uġigħ wara l-operazzjoni f'individwi li qatt ma kienu ħadu l-opjojdi qabel ma nżammitx minħabba li din mhijiex indikazzjoni ta' Durogesic.
English: The wording proposed for lactation/breast-feeding that was agreed for fentanyl-containing transdermal patches during two previous PSUR-WS procedures, was endorsed by the CHMP.
Maltese: Il-formolazzjoni tal-kliem proposta għat-treddigħ li sar qbil fuqha għal irqajja' transdermali li fihom il-fentanyl waqt iż-żewġ proċeduri preċedenti ta' PSUR-WS, ġiet approvata mis-CHMP.
English: As there were no striking differences in the safety profile between adult and paediatric subjects, the MAH's decision not to include a separate table was considered to be acceptable.
Maltese: Minħabba li m'hemmx differenzi kbar filprofil tas-sigurtà bejn l-individwi adulti u dawk pedjatriċi, id-deċiżjoni tal-MAH li ma jinkludix tabella separata tqieset li hija aċċettabbli.
English: • The committee agreed on a harmonised summary of product characteristic, labelling, package leaflet for Durogesic and associated names.
Maltese: • Il-kumitat ikkunsidra d-diverġenzi identifikati fin-notifika għal Durogesic u ismijiet assoċjati,
English: A warning for renally impaired patients has been included that careful observation for signs of fentanyl toxicity is warranted (and the dose reduced if necessary) as fentanyl pharmacokinetics has not been evaluated in this patient population.
Maltese: Ġiet inkluża twissija għal pazjenti b'indeboliment tal-kliewi fejn fiha ngħad li hija meħtieġa osservazzjoni bir-reqqa għal sinjali ta' tossiċità ta' fentanyl (u li d-doża għandha titnaqqas jekk ikun meħtieġ) minħabba li l-farmakokinetiċi ta' fentanyl ma ġewx evalwati f'din il-popolazzjoni tal-pazjenti.
English: Since the term “intractable pain” is not properly defined, it has been replaced by ‘severe', which captures the term ‘intractable'.
Maltese: Minħabba li tterminu "uġigħ inkontrollabbli" mhuwiex definit tajjeb, ġie sostitwi b' 'sever', li għandu s-sens tat terminu 'inkontollabbli'.
English: EMA/633467/2014 EMEA/H/C/000550
Maltese: EMEA/H/C/000550
English: The full EPAR for Fendrix 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: Fendrix hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
Maltese: Fendrix vaċċin tal-epatite B (rDNA) (aġġuvant, assorbit)
English: The surface antigens are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Maltese: L-antiġeni tas-superfiċje jsiru permezz ta' metodu magħruf bħala “teknoloġija rekombinanti tad-DNA”: isir minn batterju li jkun irċieva ġene (DNA), li jagħmilha kapaċi tipproduċi l-proteini.
English: One month after the last dose, 91% of the patients receiving Fendrix had protective levels of antibodies against the hepatitis B virus, compared with 84% of those receiving the comparator.
Maltese: Xahar wara l-aħħar doża, 91% tal-pazjenti li kienu qegħdin jirċievu Fendrix kellhom livelli ta' protezzjoni ta' antikorpi kontra epatite B, meta mqabbla ma' 84% ta' dawk li kienu qegħdin jirċievu l-vaċċin ta' tqabbil.
English: Fendrix has also been studied in one main study involving 165 patients aged 15 years and above who had kidney disease and needed haemodialysis.
Maltese: Fendrix ġie studjat fi studju ewlieni wieħed li involva 165 pazjent minn 15-il sena 'l fuq li kellhom mard tal-kliewi u li ħtieġu emodijaliżi.
English: It contains parts of the hepatitis B virus as the active substance.
Maltese: Fih partijiet mill-virus tal-epatite B bħala s-sustanza attiva.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fendrix on 2 February 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal valida fl-Unjoni Ewropea kollha fit-2 ta' Frar 2005.
English: The effect of Fendrix lasted longer than that of the comparator vaccine: 80% of the patients receiving Fendrix maintained protective levels of antibody for up to three years, compared with 51% of those receiving the comparator.
Maltese: L-effett ta' Fendrix dam aktar minn dak ta' vaċċin ta' tqabbil: 80% tal-pazjenti li kienu qegħdin jirċievu Fendrix żammew livelli ta' protezzjoni ta' antikorpi sa tliet snin, meta mqabbla ma' 51% ta' dawk li kienu qegħdin jirċievu l-vaċċin ta' tqabbil.
English: Fendrix is a vaccine.
Maltese: Fendrix huwa vaċċin.
English: This is a summary of the European public assessment report (EPAR) for Fendrix.
Maltese: Dan is-sommarju huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Fendrix.
English: Fendrix contains small amounts of the ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Maltese: Fendrix fih ammonti żgħar ta' “antiġene tas-superfiċje” (proteini mill-wiċċ) tal-vajrus tal-epatite B.
English: What is Fendrix?
Maltese: X'inhu Fendrix?
English: Fendrix is used to protect patients with kidney problems against hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Maltese: Fendrix jintuża fit-trattament ta' pazjenti bi problemi fil-kliewi kontra l-epatite B (marda tal-fwied ikkawżata minn vajrus tal-epatite B).
English: In Fendrix, it is used with an ‘adjuvant system' which contains ‘MPL', a purified fat from bacteria, and an aluminium compound.
Maltese: F'Fendrix, tintuża ma' “sistema miżjuda (aġġuvant) li fiha 'MPL”, xaħam ippurifikat mill-batterji, u aluminju.
English: Why has Fendrix been approved?
Maltese: Għalfejn ġie approvat Fendrix?
English: The most common side effects with Fendrix (seen in more than 1 patient in 10) are headache, pain, redness, swelling at the injection site and fatigue (tiredness).
Maltese: L-aktar effetti sekondarji komuni b'Fendrix (dehru f'aktar minn pazjent 1 f'10) huma wġigħ ta' ras, uġigħ, ħmura, nefħa fil-punt fejn saret l-injezzjoni u għeja kbira.
English: It can be used in patients from the age of 15 years, including patients needing haemodialysis (a blood clearance technique used in patients with kidney disease).
Maltese: Jista' jintuża f'pazjenti minn 15-il sena 'l fuq, fosthom pazjenti li għandhom bżonn l-emodijaliżi (teknika ta' tisfija tad-demm użata f'pazjenti b'mard fil-kliewi).
English: Fendrix is a vaccine, which is available as a suspension for injection.
Maltese: Fendrix huwa vaċċin, li jinsab bħala sospensjoni għal injezzjoni.
English: For the full list of side effects reported with Fendrix, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati b'Fendrix, ara l-fuljett ta' tagħrif.
English: The CHMP decided that Fendrix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Fendrix been studied?
Maltese: Kif ġie studjat Fendrix?
English: The vaccine is injected into the shoulder muscle.
Maltese: Il-vaċċin jiġi injettat fil-muskolu tal-ispalla.
English: The active substance in Fendrix has been available in other vaccines that have been authorised in the European Union (EU) for a number of years.
Maltese: Is-sustanza attiva f'Fendrix ilha disponibbli f'vaċċini oħra li ngħataw l-awtorizzazzjoni għat-tqegħid fissuq fl-Unjoni Ewropea (UE) għal numru ta' snin.
English: The full EPAR for Luveris 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: Luveris is a fertility treatment.
Maltese: Luveris huwa trattament ta' fertilità.
English: EPAR summary for the public lutropin alfa
Maltese: Sommarju tal-EPAR għall-pubbliku lutropina alfa
English: The European Commission granted a marketing authorisation valid throughout the European Union for Luveris to Merck Serono Europe Limited on 29 November 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Luveris lil Merck Serono Europe Limited fid-29 ta' Novembru 2000.
English: The most common side effects with Luveris (seen in between 1 and 10 patients in 100) are reactions at the injection site (pain, redness, bruising or swelling), headache,, nausea (feeling sick), vomiting, diarrhoea, abdominal pain and discomfort, pelvic (lower abdominal) pain, mild to moderate ovarian hyperstimulation syndrome, ovarian cyst (development of a fluid-filled cavity in the ovary) and breast pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Luveris (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma reazzjonijiet fis-sit tal-injezzjoni (uġigħ, ħmura, tbenġil jew nefħa), uġigħ ta' ras, nawżja (dardir), remettar, dijarrea, uġigħ addominali u skumdità, uġigħ pelviku (fil-parti ta' isfel tal-addome), sindromu ta' iperstimulazzjoni tal-ovarji bejn ħafif u moderat, ċista fl-ovarji (żvilupp ta' ħofor mimlija fluwidu flovarji) u uġigħ fis-sider.
English: Luveris is a medicine that contains the active substance lutropin alfa.
Maltese: Luveris huwa mediċina li fiha s-sustanza attiva lutropina alfa.
English: Lutropin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human LH.
Maltese: Il-lutropina alfa hija prodotta b'metodu magħruf bħala 'teknoloġija rikombinanti tad-DNA': hija magħmula minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi LH uman.
English: The active substance in Luveris, lutropin alfa, is a copy of the natural hormone LH.
Maltese: Is-sustanza attiva f'Luveris, il-lutropina alfa, hija kopja tal-ormon naturali