FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast, post-hoc analyses demonstrated statistically significant increases in the bleeding risk with the more potent P2Y12 inhibitors, occurring predominantly during the maintenance phase, after the first month postACS.
Maltese: F'kuntrast, analiżi post-hoc wera żidiet statistikament sinifikanti fir-riskju ta' fsada bl-inibituri aktar potenti ta' P2Y12 , li seħħew l-aktar fil-fażi ta' manteniment, wara l-ewwel xahar wara ACS.
English: You should also tell your doctor immediately if you develop a medical condition (also known as Thrombotic Thrombocytopenic Purpura or TTP) that includes fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice) (see section 4 ‘Possible side effects').
Maltese: • Għandek ukoll tgħid lit-tabib tiegħek minnufih jekk tiżviluppa kundizzjoni medika (magħrufa wkoll bħala Purpura Trombotika Tromboċitopenika jew TTP) li tinkludi deni u tbenġil taħt ilġilda li jidher bħal tikek ħomor irqaq, flimkien ma' jew mingħajr għeja kbira mhux spjegata, konfużjoni, sfurija tal-ġilda jew ta' l-għajnejn (suffejra) (ara sezzjoni 4 ‘Effetti sekondarji possibbli').
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON for blisters of 10, 14, 28, 30, 50, 84, 90 or 100 film-coated tablets
Maltese: Kartuna għal folji ta' 10, 14, 28, 30, 50, 84, 90 jew 100 pillola miksija b'rita
English: As a precaution, concomitant use of strong or moderate CYP2C19 inhibitors should be discouraged (see section 4.5 for a list of CYP2C19 inhibitors, see also section 5.2).
Maltese: Bħala prekawzjoni, l-użu konkomitanti ta' inibituri qawwijin jew moderati ta' CYP2C19għandu jiġu skoraġġut (ara sezzjoni 4. 5 għal lista ta' inibituri ta' CYP2C19, ara wkoll sezzjoni 5.2).
English: Grepid is taken by adults to prevent blood clots (thrombi) forming in hardened blood vessels (arteries), a process known as atherothrombosis, which can lead to atherothrombotic events (such as stroke, heart attack or death).
Maltese: Grepid jittieħed mill-adulti biex inaqqas ir-riskju li ċapep tad-demm (trombi) jifformaw fl-arterji mwebbsin (arterji), proċess imsejjaħ aterotrombosi, li jista' jwassal għal konsegwenzi aterotrombotiċi (bħal puplesija, attakk tal-qalb, jew mewt).
English: Calendar days Mon
Maltese: Aċidu ċitriku, monoidrat
English: In patients who remained on therapy within five days of bypass graft surgery, the event rate was 9.6 % for clopidogrel plus ASA, and 6.3 % for placebo plus ASA.
Maltese: F'pazjenti li baqgħu jieħdu l-kura fil-ħamest ijiem ta' qabel l-operazzjoni ta' trapjant ta' bajpass, ir-rata ta' avvenimenti kienet ta' 9.6% għal clopidogrel miżjud ma' ASA, u 6.3% għal placebo miżjud ma' ASA.
English: Content (concentration)
Maltese: Kontenut (konċentrazzjoni )
English: 1 vial + 1 vial
Maltese: 1 Kunjett + 1 Kunjett
English: Invented name Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: 2 vials + 2 vials l t o r
Maltese: 2 Kunjetti + 2 Kunjetti t x
English: Further information on Lonquex can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/lonquex
Maltese: Aktar informazzjoni dwar Lonquex tinstab fis-sit web tal-Aġenzija: www.ema.europa.eu/medicines/human/EPAR/lonquex
English: This overview was last updated in 09-2019
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'09-2019.
English: Lonquex is a medicine that contains the active substance lipegfilgrastim.
Maltese: Lonquex huwa mediċina li fiha s-sustanza attiva lipegfilgrastim.
English: Other information about Lonquex
Maltese: Informazzjoni oħra dwar Lonquex
English: Lonquex received a marketing authorisation valid throughout the EU on 25 July 2013.
Maltese: Lonquex irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fil-25 ta' Lulju 2013.
English: Lonquex also compared well with the other medicine in the number of febrile neutropenia cases: 1 in the Lonquex-treated group versus 3 in the comparator group.
Maltese: Lonquex tqabbel sew ukoll mal-mediċina l-oħra fl-għadd ta' każijiet ta' newtropenja febrili: persuna 1 fil-grupp ikkurat b'Lonquex versus 3 persuni fil-grupp komparatur.
English: The active substance in Lonquex, lipegfilgrastim, is similar to granulocyte colony stimulating factor (G‑ CSF), a naturally occurring protein in the body that stimulates the production of white blood cells including neutrophils in the bone marrow.
Maltese: Is-sustanza attiva f'Lonquex, il-lipegfilgrastim, hija simili għall-fattur stimolanti tal-kolonja talgranuloċiti (G-CSF), proteina li sseħħ b'mod naturali fil-ġisem u li tistimula l-produzzjoni taċ-ċelloli bojod tad-demm inklużi n-newtrofili fil-mudullun.
English: Lonquex (lipegfilgrastim) EMA/236686/2019
Maltese: EMA/236686/2019
English: What are the risks associated with Lonquex?
Maltese: X'inhuma r-riskji assoċjati ma' Lonquex?
English: Lonquex is not used in patients receiving chemotherapy for chronic myeloid leukaemia (a cancer of the white blood cells) and myelodysplastic syndromes (a disease that can develop into a leukaemia).
Maltese: Lonquex ma jintużax f'pazjenti li jkunu qed jirċievu l-kimoterapija għal-lewkimja mijelojde kronika (kanċer taċ-ċelloli bojod tad-demm) u sindromi mijelodisplastiċi (marda li tista' tiżviluppa f'lewkimja).
English: In Lonquex, the filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Lonquex, ilfilgrastim ġiet “pegilata” (twaħħlet ma' kimika msejħa polietilenglikol).
English: As for all medicines, data on the use of Lonquex are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Lonquex hija ssorveljata kontinwament.
English: Another main study in 376 patients compared Lonquex with placebo (a dummy treatment).
Maltese: Studju ewlieni ieħor fuq 376 pazjent qabbel Lonquex ma' plaċebo (kura finta).
English: For the full list of side effects of Lonquex, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Lonquex, ara l-fuljett ta' tagħrif.
English: In a main study in 202 breast cancer patients Lonquex compared well with another pegylated filgrastim: the average duration of severe neutropenia during chemotherapy was around 17 hours with Lonquex compared with around 19 hours with the other medicine.
Maltese: Fi studju ewlieni fuq 202 pazjenti b'kanċer tas-sider, Lonquex tqabbel sew ma' filgrastim pegilata oħra: it-tul ta' żmien medju ta' newtropenja severa matul kimoterapija kien madwar 17-il siegħa b'Lonquex meta mqabbel ma' madwar 19-il siegħa b'mediċina oħra.
English: Lipegfilgrastim is a form of filgrastim, which has been available in the EU for a number of years.
Maltese: Il-lipegrafilgrastim hija forma ta' filgrastim, li ilha disponibbli fl-UE għal numru ta' snin.
English: What measures are being taken to ensure the safe and effective use of Lonquex?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Lonquex?
English: Lipegfilgrastim acts in the same way as G‑CSF, increasing the production of neutrophils and thereby helping to reduce the duration of neutropenia and the occurrence of febrile neutropenia (a sign of infection) in patients receiving chemotherapy.
Maltese: Il-lipegfilgrastim taġixxi bl-istess mod bħal G-CSF, billi żżid il-produzzjoni tan-newtrofili u b'hekk tgħin tnaqqas it-tul ta' żmien ta' newtropenja u lokkorrenza ta' newtropenja febrili (sinjal ta' infezzjoni) f'pazjenti li jkunu qed jirċievu l-kimoterapija.
English: It is used to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in adult cancer patients receiving cytotoxic chemotherapy.
Maltese: Jintuża biex inaqqas it-tul ta' żmien ta' newtropenja (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm) u l-okkorrenza ta' newtropenja febrili (newtropenja bid-deni) f'pazjenti adulti bil-kanċer li jkunu qed jirċievu kimoterapija ċitotossika.
English: Lonquex was effective in reducing the duration of neutropenia and the number of febrile neutropenia cases among patients undergoing chemotherapy.
Maltese: Lonquex kien effettiv fit-tnaqqis tat-tul ta' żmien ta' newtropenja u tal-għadd ta' każijiet ta' newtropenja febrili fost il-pazjenti li kienu qed jirċievu l-kimoterapija.
English: How does Lonquex work?
Maltese: X'inhu Lonquex u għal xiex jintuża?
English: Side effects reported with Lonquex are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Lonquex huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: 1 cartridge
Maltese: Daqs tal-pakkett skartoċċ 1
English: Pack size
Maltese: Mnejn għandujingħata
English: 4.3 Contra-indications
Maltese: .3. Kontraindikazzjonijiet
English: What is Haldol?
Maltese: X'inhu Haldol?
English: Haldol and associated names (such as Aloperidin and Serenase) is marketed in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Malta, the Netherlands, Portugal, Romania, Sweden and United Kingdom, and also in Iceland and Norway.
Maltese: Haldol u ismijiet assoċjati (bħal Aloperidin u Serenase) jiġi kkummerċjalizzat fl-Awstrija, il-Belġju, Ċipru, id-Danimarka, il-Finlandja, Franza, il-Ġermanja, il-Greċja, l-Italja, il-Lussemburgu, Malta, inNetherlands, il-Portugal, ir-Rumanija, l-Iżvezja u r-Renju Unit, kif ukoll fl-Iżlanda u n-Norveġja.
English: • treatment of schizophrenia and schizoaffective disorder;
Maltese: • kura ta' skizofrenija u disturb skizoaffettiv;
English: The European Commission issued a decision on this opinion on 28/04/2017.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fi 28/04 /2017.
English: Haldol is an antipsychotic medicine used in adults and children for a number of mental and other brain disorders including schizophrenia, mania (feeling elated or over-excited), aggression, Tourette's syndrome and tics (repeated and uncontrollable movements) and choreatic movements (jerky and uncontrolled movements mainly of the face and hands).
Maltese: Haldol huwa mediċina antipsikotika li jintuża fl-adulti u fit-tfal għal numru ta' disturbi mentali u disturbi oħra fil-moħħ inkluż skizofrenija, manija (tħossok ferħan jew wisq eċċitat), agressjoni, sindrome ta' Tourette u tgħawwiġ (movimenti repetuti u inkontrollabbli) u movimenti koreatiċi (movimenti ta' tgħawwiġ u inkontrollabbli prinċipalment tal-wiċċ u tal-idejn).
English: The CHMP harmonised other sections of the SmPC including interactions between Haldol and other medicines (section 4.5), information on pregnancy, lactation and fertility (section 4.6) and added angioedema as a side effect (section 4.8).
Maltese: Is-CHMP armonizza sezzjonijiet oħrajn tal-SmPC inkluż interazzjonijiet bejn Haldol u mediċini oħra (sezzjoni 4.5), informazzjoni dwar it-tqala, it-treddigħ u l-fertilità (sezzjoni 4.6) u żied l-anġjoedema bħala effett sekondarju (sezzjoni 4.8).
English: It contains the active substance haloperidol and is available as tablets, oral solutions, and injection.
Maltese: Dan fih is-sustanza attiva haloperidol u jiġi bħala pilloli, soluzzjonijiet orali u injezzjoni.
English: On 23 February 2017, the European Medicines Agency completed a review of Haldol.
Maltese: Fit-23 ta' Frar 2017, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Haldol.
English: The CHMP agreed to harmonisation of Haldol's contra-indications.
Maltese: Is-CHMP qabel mal-armonizzazzjoni tal-kontraindikazzjonijiet ta' Haldol.
English: In adults, for:
Maltese: Fl-adulti għal:
English: • tic disorders, including Tourette's syndrome, in children and adolescents aged 10 to 17 years with severe impairment after educational and psychological treatments and other medicines have not worked.
Maltese: • disturbi ta' tgħawwiġ, inkluż sindrome ta' Tourette, fi tfal u fl-adoloxxenti li jkollhom bejn 10 u 17il sena b'indeboliment sever wara li kuri edukattivi u psikoloġiċi u mediċini oħra ma jkunux ħadmu.
English: • acute treatment of delirium when non-pharmacological treatments (treatments that do not involve medicines) have not worked;
Maltese: • kura akuta ta' delirju meta kuri mhux farmakoloġiċi (kuri li ma jinvolvux mediċini) ma jkunux ħadmu;
English: It is also available in the EU as generic haloperidol.
Maltese: Dan huwa disponibbli wkoll fl-UE bħala haloperidol ġeneriku.
English: • treatment of moderate to severe manic episodes associated with bipolar I disorder;
Maltese: • kura ta' episodji ta' manija moderati sa severi assoċjati ma' disturb bipolari I;
English: • treatment of acute psychomotor agitation associated with psychotic disorder or manic episodes of bipolar I disorder;
Maltese: • kura ta' aġitazzjoni psikomotorja akuta assoċjata ma' disturb psikotiku jew episodji ta' manija ta' disturb bipolari I;
English: On 18 June 2014, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Haldol and associated names in the EU.
Maltese: Fit-18 ta' Ġunju 2014, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Haldol u ismijiet assoċjati fl-UE.
English: • schizophrenia in adolescents aged 13 to 17 years when other medicines have not worked or cause unacceptable side effects;
Maltese: • skizofrenija fl-adoloxxenti li jkollhom bejn 13 u 17-il sena meta mediċini oħra ma jkunux ħadmu jew jikkawżaw effetti sekondarji mhux aċċettabbli;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Haldol in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm bżonn ta' armonizzazzjoni tal-informazzjoni tal-preskrizzjoni għal Haldol fl-Unjoni Ewropea (UE).
English: • treatment of tic disorders, including Tourette's syndrome, in patients with severe impairment after educational and psychological treatments and other medicines have not worked;
Maltese: • kura ta' disturbi ta' tgħawwiġ, inkluż is-sindrome ta' Tourette, f'pazjenti b'indeboliment sever wara li ma jkunux ħadmu kuri edukattivi u psikoloġiċi u mediċini oħra;
English: • treatment of mild to moderate chorea in Huntington's disease, when other medicines do not work or have unacceptable side effects.
Maltese: • kura ta' korea ħafifa sa moderata fil-marda ta' Huntington, meta mediċini oħra ma jaħdmux jew ikollhom effetti sekondarji mhux aċċettabbli.
English: • for rapid control of severe acute psychomotor agitation linked to psychotic disorder or manic episodes of bipolar I disorder when medicines cannot be given by mouth;
Maltese: • għal kontroll mgħaġġel ta' aġitazzjoni psikomotorja akuta severa marbuta ma' disturb psikotiku jew episodji ta' manija ta' disturb bipolari I meta l-mediċini ma jistgħux jingħataw mill-ħalq;
English: The CHMP agreed that Haldol injection can be used in adults as follows:
Maltese: Is-CHMP qabel li l-injezzjoni Haldol tista' tintuża fl-adulti kif ġej:
English: Haldol is authorised in the EU via national procedures.
Maltese: Haldol huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The CHMP harmonised the starting, maintenance and maximum doses for each of the different uses of Haldol in adults, elderly patients and in children and adolescents.
Maltese: Is-CHMP armonizza d-dożi tal-bidu, tal-manteniment u dawk massimi għal kull wieħed mill-użi differenti ta' Haldol fl-adulti, fil-pazjenti anzjani u fit-tfal u fl-adoloxxenti.
English: Haldol was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Maltese: Haldol ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni għal Proċedura tarRikonoxximent Reċiproku u l-Proċedura Deċentralizzata - Bniedem (CMDh).
English: The CHMP harmonised the SmPC to include a warning that patients with bipolar disorders may suffer sudden depression, calling for close supervision of such patients.
Maltese: Is-CHMP armonizza l-SmPC biex jinkludi twissija li l-pazjenti b'disturbi bipolari jistgħu jbatu minn dipressjoni f'daqqa, li titlob għal superviżjoni mill-qrib ta' tali pazjenti.
English: • alone or with other medicines, for prevention of nausea and vomiting after surgery in those who are at moderate to high risk, when other medicines do not work or have unacceptable side effects;
Maltese: • waħidhom jew ma' mediċini oħra, għall-prevenzjoni ta' nawsja u remettar wara l-kirurġija f'dawk li jinsabu f'riskju moderat sa għoli, meta mediċini oħra ma jaħdmux jew ikollhom effetti sekondarji mhux aċċettabbli;
English: • for treatment of mild to moderate chorea in Huntington's disease, when other medicines are ineffective or have unacceptable side effects and when medicines cannot be given by mouth;
Maltese: • għal kura ta' korea ħafifa sa moderata fil-marda ta' Huntington, meta mediċini oħra ma jkunux effettivi jew ikollhom effetti sekondarji mhux aċċettabbli u meta l-mediċini ma jistgħux jingħataw mill-ħalq;
English: • with other medicines, for treatment of nausea and vomiting after surgery when other medicines do not work or have unacceptable side effects.
Maltese: • ma' mediċini oħrajn, għall-kura ta' nawsja u remettar wara l-kirurġija meta mediċini oħra ma jaħdmux jew ikollhom effetti sekondarji mhux aċċettabbli.
English: The CHMP agreed that Haldol should no longer be used for the treatment of delirium, delusions or hallucinations which follow alcohol withdrawal because the medicine has not proven effective for treating the underlying condition and there is inadequate evidence that it is of benefit when used with a benzodiazepine.
Maltese: Is-CHMP qabel li Haldol ma għandux jibqa' jintuża għall-kura ta' delirju, delużjonijiet jew alluċinazzjonijiet li jiġu wara waqfien mill-alkoħol għax il-mediċina ma wrietx li hija effettiva għall-kura tal-kondizzjoni sottostanti u hemm evidenza mhux adegwata li tkun ta' benefiċċju meta tintuża ma' benzodiazepine.
English: The CHMP agreed that Haldol tablets and oral solutions can be used as follows.
Maltese: (haloperidol pilloli, soluzzjonijiet orali u soluzzjoni injetabbli)
English: Why was Haldol reviewed?
Maltese: Għaliex ġie rieżaminat Haldol?
English: • persistent, severe aggression in children and adolescents aged 6 to 17 years with autism or pervasive developmental disorders, when other treatments have not worked or cause unacceptable side effects;
Maltese: • aggressjoni persistenti severa fit-tfal u fl-adoloxxenti li jkollhom bejn 6 u 17-il sena b'awtiżmu jew b'disturbi mifruxa tal-iżvilupp, meta kuri oħrajn ma jkunux ħadmu jew jikkawżaw effetti sekondarji mhux aċċettabbli;
English: --1 Porcine circovirus type 2 orf-2 protein 2.3-12.4 RP* * Relative potency unit determined by ELISA antigen quantification (in vitro potency test) compared to a reference vaccine
Maltese: --1 Proteina ORF2 tal-porcine circovirus tip 2 2.3-12.4 RP* * Unità ta' qawwa relattiva determinata mill-ammont ta' antiġeni bl-ELISA (test ta' qawwa in vitro) imqabbel ma' tilqima ta' referenza.
English: Livensa testosterone
Maltese: Livensa testosteronu
English: The marketing authorisation holder is Warner Chilcott Deutschland GmbH.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Warner Chilcott Deutschland GmbH.
English: The patch releases 300 micrograms of the active substance testosterone over 24 hours.
Maltese: Il-garża tirrilaxxa 300 mikrogramma tas-sustanza attiva testosteronu f'24 siegħa.
English: Other information about Livensa:
Maltese: Informazzjoni oħra dwar Livensa:
English: This document is a summary of the European public assessment report (EPAR) for Livensa.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Livensa.
English: Livensa was more effective than placebo.
Maltese: Livensa kien aktar effettiv minn plaċebo.
English: The two main studies involved 1,095 women with an average age of 49 years who received Livensa for up to a year.
Maltese: Iż-żewġ studji ewlenin involvew 1,095 mara b'età medja ta' 49 sena li ngħataw livensa għal mhux aktar minn sena. Livensa tqabbel ma' plaċebo (garża li ma fiha l-ebda sustanza attiva).
English: Livensa is a transdermal patch (a patch that delivers a medicine across the skin).
Maltese: Livensa huwa stikk transdermiku (garża (patch) li tagħti l-mediċina minn ġol-ġilda).
English: Why has Livensa been approved?
Maltese: Għaliex ġie approvat Livensa?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Livensa on 28 July 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Livensa fit-28 ta' Lulju 2006.
English: The most common side effects with Livensa (seen in more than 1 patient in 10) are hirsutism (increased hair growth, especially on the chin and upper lip) and reactions at the site of application of the patch (redness and itching).
Maltese: L-effetti sekondarji l-aktar komuni ta' Livensa (li dehru f'iktar minn pazjent 1 minn kull 10) huma irsutiżmu (żieda fix-xagħar, speċjalment fuq il-geddum u fix-xoffa ta' fuq) u reazzjonijiet fil-post li fuqu titqiegħed il-garża (ħmura u ħakk).
English: The active substance in Livensa, testosterone, is a natural sex hormone produced in men and, to a lesser extent, in women.
Maltese: Is-sustanza attiva f'Livensa, testosteronu, hija ormon sesswali naturali li jiġi prodott mill-irġiel u wkoll, għad illi bi kwantitajiet iżgħar, fin-nisa.
English: What is the risk associated with Livensa?
Maltese: X'inhu r-riskju assoċjat ma' Livensa?
English: How has Livensa been studied?
Maltese: Kif ġie studjat Livensa?
English: Women using Livensa should also use oestrogens, but not of the type known as ‘conjugated oestrogens' because the combination of these with Livensa is not as effective as the combination of other types of oestrogen with Livensa.
Maltese: In-nisa li jkunu qegħdin jużaw Livensa għandhom jużaw estroġeni wkoll, iżda mhux tat-tip magħruf bħala ‘estroġeni konġugati' għax il-kombinazzjoni tagħhom ma' Livensa mhijiex effettiva daqs ilkombinazzjoni ta' tipi ta' estroġeni oħrajn ma' Livensa.
English: Because testosterone is a male sex hormone, women who are taking Livensa should be monitored to see if they develop any ‘androgenic' side effects (development of male characteristics) such as hair growth on the face, deepening of the voice or hair loss.
Maltese: Billi testosteronu huwa ormon sesswali maskili, in-nisa li jkunu qed jieħdu Livensa għandhom jiġu sorveljati biex ikun magħruf jekk jiżviluppawx effetti sekondarji ‘androġeniċi (l-iżvilupp ta' karatteristiċi maskili) bħax-xagħar fil-wiċċ, tħaxxin tal-leħen jew telf ta' xagħar.
English: How does Livensa work?
Maltese: X'inhu Livensa?
English: The company that makes Livensa will monitor some of the side effects of Livensa closely, such as its androgenic side effects.
Maltese: Il-kumpanija li tipproduċi Livensa ser tissorvelja mill-qrib uħud mill-effetti sekondarji ta' Livensa, bħalleffetti sekondarji androġeniċi tiegħu.
English: For the full list of all side effects reported with Livensa, see the
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati b'Livensa, ara lfuljett ta' tagħrif.
English: The CHMP decided that Livensa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Livensa huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: The company will review all of the ongoing studies with Livensa to look at potential long-term risks including breast cancer, endometrial cancer (cancer of the lining of the womb) and side effects affecting the heart and blood vessels.
Maltese: Il-kumpanija ser tirrevedi l-istudji kollha li għaddejjin bħalissa b'Livensa biex tosserva r-riskji potenzjali fit-tul inklużi l-kanċer tas-sider, il-kanċer endometrijali (kanċer fil-kisi tal-utru) u l-effetti sekondarji li jaffettwaw il-qalb u l-arterji u l-vini.