FrancophonIA/ELRC3.0 huggingface dataset:
English: Irbesartan had no effect upon fertility of treated rats and their offspring up to the dose levels inducing the first signs of parental toxicity (see section 5.3).
Maltese: Irbesartan ma kellu ebda effett fuq il-fertilità ta' firien ikkurati u fuq il-frieħ tagħhom sal-livelli tad-doża li jagħtu bidu għall-ewwel sinjali ta' tossiċità parentali (ara sezzjoni 5.3).
English: CoAprovel 150 mg/12.5 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: TAL-PRODOTT MEDIĊINALI CoAprovel 150 mg/12.5 mg pilloli irbesartan/hydrochlorothiazide ISEM
English: Animal studies with irbesartan showed transient toxic effects (increased renal pelvic cavitation, hydroureter or subcutaneous oedema) in rat foetuses, which were resolved after birth.
Maltese: Studji fuq annimali b'irbesartan urew effetti tossiċi li jgħaddu (żieda fil-formazzjoni tal-ħofor fil-pelvi renali, hydroureter, edema ta' taħt il-ġilda) fil-feti tal-firien, li ġew risolvuti wara t-twelid.
English: Cartons of 90 film-coated tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 90 pillola miksija b'rita f'folji tal-PCV/PVDC/Aluminju.
English: Side effects reported in clinical studies for patients treated with CoAprovel were:
Maltese: L-effetti sekondarji rrapportati fi studji kliniċi għal pazjenti kkurati b'CoAprovel kienu:
English: What CoAprovel looks like and contents of the pack CoAprovel 300 mg/25 mg film-coated tablets are pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side.
Maltese: Il-pilloli miksijin b'rita CoAprovel 300 mg/25 mg huma roża, ibbuzzati fuq iż-żewġ naħat, ovali, b'qalb ibbuzzata fuq naħa waħda u n-numru 2788 fuq in-naħa l-oħra.
English: Cartons of 30 film-coated tablets in PVC/PVDC/Aluminium blisters.
Maltese: Pakketti ta' 30 pillola miksija b'rita f'folji tal-PCV/PVDC/Aluminju.
English: EU/1/98/086/016-020 EU/1/98/086/022 EU/1/98/086/030 EU/1/98/086/033
Maltese: EU/1/98/086/022 EU/1/98/086/030
English: Not known:
Maltese: NN:
English: Package leaflet: Information for the patient CoAprovel 300 mg/25 mg film-coated tablets irbesartan/hydrochlorothiazide
Maltese: Fuljett ta' tagħrif: informazzjoni għalll-utent CoAprovel 300 mg/25 mg pilloli miksijin b'rita. irbesartan/hydrochlorothiazide
English: Excipient with known effect: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate).
Maltese: Kull pillola miksija b'rita fiha 38.5 mg ta' lactose (bħala lactose monohydrate).
English: Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin sodium) may lead to increases in serum potassium.
Maltese: Minn naħa l-oħra, ibbażat fuq l-esperjenza bl-użu ta' prodotti mediċinali oħra li jostakolaw is-sistema ta' renin-angiotensin, użu konkomitanti ta' dijuretiċi potassium-sparing, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium u mediċini oħra li jistgħu jżidu l-livelli tal-potassium fis-serum (p.e. heparin sodium) jistgħu jwasslu għal żidied talpotassium fis-serum.
English: Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see sections 4.3 and 4.4).
Maltese: Trabi li ommijiethom ħadu AIIRAs għandhom jiġu osservati mill-qrib għal pressjoni baxxa (ara sezzjonijiet 4.3 u 4.4).
English: General disorders and administration site conditions:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata:
English: You should also tell your doctor: if you are on a low-salt diet if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in CoAprovel) if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal if you are going to have an operation (surgery) or be given anaesthetics if you have changes in your vision or pain in one or both of your eyes while taking CoAprovel.
Maltese: Int għandek tgħid ukoll lit-tabib tiegħek: jekk int qiegħed/qiegħda fuq dieta nieqsa mill-melħ jekk int qed turi sinjali bħal għatx mhux tas-soltu, ħalq xott, għejja ġenerali, ngħas, uġigħ fil-muskoli jew bugħawwieġ, dardir, rimettar jew taħbit tal-qalb mgħaġġel mhux normali li jistgħu jseħħu minħabba effett eċċessiv ta' hydrochlorothiazide (li hemm fi CoAprovel) jekk tesperjenza żieda fis-sensittività tal-ġilda għax-xemx b'sintomi ta' ħruq (bħal ħmura, ħakk, nefħa, bżieżaq) li jseħħu aktar frekwenti min-normal jekk tkun se tagħmel xi operazzjoni (kirurġija) jew tkun se tirċievi anistetiku jekk ikollok tibdil fil-viżta jew uġigħ f'waħda mill-għajnejn jew fiż-żewġ għajnejn meta tkun qed tieħu CoAprovel.
English: If possible, another class of diuretics should be used;
Maltese: Jekk possibbli, għandha tintuża klassi oħra ta' dijuretiċi;
English: Further information on Quofenix can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/quofenix.
Maltese: ema.europa.eu/medicines/human/EPAR/quofenix.
English: It contains the active substance delafloxacin.
Maltese: Fih is-sustanza attiva delaflossaċina.
English: Quofenix is available as a powder to be made into a solution for infusion (300 mg) and as tablets (450 mg).
Maltese: Quofenix jiġi fi trab li jrid isir f'soluzzjoni li tingħata b'infużjoni (300 mg) u bħala pilloli (450 mg).
English: Other information about Quofenix
Maltese: Informazzjoni oħra dwar Quofenix
English: After treatment for up to 14 days, 58% of patients who received Quofenix were cured of their infection compared with 60% of patients who received vancomycin and aztreonam.
Maltese: Wara kura ta' massimu 14-il jum, 58 % tal-pazjenti li ngħataw Quofenix fiequ mill-infezzjoni tagħhom meta mqabbla ma' 60 % tal-pazjenti li ngħataw vancomycin u aztreonam.
English: Treatment is given for 5 to 14 days.
Maltese: Il-kura tingħata għal bejn 5 ijiem u 14-il jum.
English: Quofenix (delafloxacin) EMA/572803/2019
Maltese: EMA/572803/2019
English: Persistent and disabling side effects have occurred with fluoroquinolone antibiotics in some patients.
Maltese: F'ċerti pazjenti seħħew effetti sekondarji persistenti u li jiddiżabilitaw bl-antibijotiċi fluworokinoloni.
English: The active substance in Quofenix, delafloxacin, belongs to a group of antibiotics called fluoroquinolones.
Maltese: Is-sustanza attiva fi Quofenix, id-delaflossaċina, tagħmel parti minn grupp ta' antibijotiċi msejjaħ fluworokinoloni.
English: What are the risks associated with Quofenix?
Maltese: X'inhuma r-riskji assoċjati ma' Quofenix?
English: The most common side effects with Quofenix (which may affect up to 1 in 10 people) are diarrhoea and nausea (feeling sick), which are mild to moderate.
Maltese: L-effetti sekondarji l-aktar komuni bi Quofenix (li jistgħu jaffettwaw sa persuna 1 minn 10) huma dijarea u nawżja (tħossok ma tiflaħx), li huma ħfief sa moderati.
English: Quofenix is as effective as alternative antibiotics given into a vein in treating acute bacterial skin and skin structure infections and offers the possibility of switching to treatment by mouth, which may be more convenient for the patient and could reduce hospitalisation costs.
Maltese: Quofenix huwa effettiv daqs antibijotiċi alternattivi mogħtija filvina fil-kura ta' infezzjonijiet batteriċi akuti tal-ġilda u tal-istruttura tal-ġilda, u joffri l-possibbiltà li lpazjent jaqleb għal kura mill-ħalq, li tista' tkun aktar konvenjenti għall-pazjent u tista' tnaqqas lispejjez ta' rikoveru l-isptar.
English: In the first study involving 660 patients, Quofenix given into a vein was compared with vancomycin plus aztreonam (two other antibiotics) both given into a vein.
Maltese: Fl-ewwel studju li fih ħadu sehem 660 pazjent, Quofenix mogħti fil-vina tqabbel ma' vancomycin flimkien ma' aztreonam (żewġ antibijotiċi oħra) li t-tnejn li huma ngħataw fil-vina.
English: Quofenix is an antibiotic used in adults to treat bacterial infections of the skin and underlying tissues (acute bacterial skin and skin structure infections) when other medicines are not suitable.
Maltese: Quofenix huwa antibijotiku li jintuża fl-adulti biex jikkura infezzjonijiet batteriċi tal-ġilda u tat-tessuti ta' taħt il-ġilda (infezzjonijiet batteriċi akuti tal-ġilda u tal-istruttura tal-ġilda) meta mediċini oħra ma jkunux adegwati.
English: As for all medicines, data on the use of Quofenix are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Quofenix hija ssorveljata kontinwament.
English: In the second study involving 850 patients, Quofenix given into a vein for 3 days and afterwards given as tablets by mouth was compared with vancomycin plus aztreonam given into a vein.
Maltese: Fit-tieni studju li fih ħadu sehem 850 pazjent, Quofenix mogħti fil-vina għal 3 ijiem u wara mogħti bħala pilloli mill-ħalq tqabbel ma' vancomycin flimkien ma' aztreonam mogħtija fil-vina.
English: Fluoroquinolones work by preventing bacteria involved in skin infections from making copies of their DNA (genetic material).
Maltese: Il-fluworokinoloni jaħdmu billi jipprevjenu lill-batterji involuti fl-infezzjonijiet tal-ġilda milli jagħmlu kopji tad-DNA tagħhom (materjal ġenetiku).
English: Quofenix was shown to be as effective as alternative antibiotics in two main studies of adults with acute bacterial skin and skin structure infections.
Maltese: Quofenix intwera li hu effettiv daqs antibijotiċi alternattivi f'żewġ studji ewlenin fuq adulti b'infezzjonijiet batteriċi akuti tal-ġilda u tal-istruttura tal-ġilda.
English: For the full list of side effects and restrictions with Quofenix, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet bi Quofenix, ara l-fuljett ta' tagħrif.
English: patients treated with Quofenix were cured of their infection, compared with 51% of patients treated with vancomycin and aztreonam.
Maltese: 14-il jum ta' kura, 52 % tal-pazjenti kkurati bi Quofenix fiequ mill-infezzjoni tagħhom, meta mqabbla ma' 51 % tal-pazjenti kkurati b'vancomycin u aztreonam.
English: How does Quofenix work?
Maltese: Kif jintuża Quofenix?
English: Quofenix must not be used in patients who are hypersensitive (allergic) to quinolone or fluoroquinolone antibiotics or in patients who have had tendon disorders related to treatment with a fluoroquinolone antibiotic.
Maltese: Quofenix ma għandux jintuża f'pazjenti li huma ipersensittivi (allerġiċi) għall-antibijotiċi fluworokinoloni jew f'pazjenti li għandhom disturbi fl-għerq relatati ma' kura b'antibijotiku fluworokinolon.
English: After starting with a drip, the doctor may decide to switch to a tablet by mouth once every 12 hours.
Maltese: Wara li jibda bid-dripp, ittabib jista' jiddeċiedi li jaqleb għal pillola mill-ħalq darba kull 12-il siegħa.
English: Quofenix (delafloxacin)
Maltese: Għaliex Quofenix ġie awtorizzat fl-UE?
English: Quofenix is given by infusion (drip) into a vein over one hour every 12 hours.
Maltese: Quofenix jingħata b'infużjoni (dripp) fil-vina matul siegħa kull 12-il siegħa.
English: EMA/480596/2012 rev1 EMEA/H/A-29/1338
Maltese: 19 ta' Novembru 2012 EMA/480596/2012 rev1 EMEA/H/A-29/1338
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC
Maltese: L-eżitu ta' proċedura skont l-Artikolu 29 tad-Direttiva 2001/83/KE
English: What is Glimepirida Parke-Davis?
Maltese: X'inhi Glimepirida Parke-Davis?
English: Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg) EMA/480596/2012 rev1
Maltese: Mistoqsijiet u tweġibiet dwar Glimepirida Parke-Davis (glimepiride, pilloli ta' 2, 3 u 4 mg)EMA/480596/2012 rev1
English: Glimepirida Parke-Davis is a ‘generic medicine', which means that it is similar to a ‘reference medicine', already authorised in the EU, called Amaryl.
Maltese: Glimepirida Parke-Davis hija ‘mediċina ġenerika', li tfisser li hija simili għal ‘mediċina ta' referenza', li hija diġà awtorizzata fl-UE, bl-isem ta' Amaryl.
English: The active substance, glimepiride, stimulates the pancreas to produce more insulin.
Maltese: Is-sustanza attiva, il-glimepiride, tistimola l-frixa sabiex tipproduċi aktar insulina.
English: Parke-Davis submitted an application for Glimepirida Parke-Davis (1, 2, 3 and 4 mg tablets) to the Portuguese medicines regulatory agency for a decentralised procedure.
Maltese: Il-kumpanija Parke-Davis issottomettiet applikazzjoni għal Glimepirida Parke-Davis (pilloli ta' 1, 2, 3 u 4 mg) lill-aġenzija regolatorja tal-mediċini Portugiża għal proċedura deċentralizzata.
English: Questions and answers on Glimepirida Parke-Davis (glimepiride, tablets, 2, 3 and 4 mg)
Maltese: Mistoqsijiet u tweġibiet dwar Glimepirida Parke-Davis (glimepiride, pilloli ta' 2, 3 u 4 mg)
English: Why was Glimepirida Parke-Davis reviewed?
Maltese: Għaliex ġiet analizzata Glimepirida Parke-Davis?
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Portugal) 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', in this instance Cyprus, France, Germany, Italy, Sweden and the United Kingdom).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ il-Portugall) jivvaluta mediċina bilgħan li jagħti awtorizzazzjoni ta' kummerċjalizzazzjoni li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħrajn (l-‘Istati Membri kkonċernati', f'dan il-każ Ċipru, Franza, il-Ġermanja, l-Italja, l-Isvezja u r-Renju Unit).
English: On 19 July 2012, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Glimepirida Parke-Davis (glimepiride, tablets 2, 3 and 4 mg).
Maltese: Fid-19 ta' Lulju 2012, l-Aġenzija Ewropea għall-Mediċini lestiet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) rigward l-awtorizzazzjoni tal-mediċina Glimepirida Parke-Davis (glimepiride, pilloli ta' 2, 3 u 4 mg).
English: Although the Member States agreed that 1 mg Glimepirida Parke-Davis was bioequivalent to 1 mg Amaryl, concerns remained over whether a bioequivalence study should have been carried out with the highest strength, 4 mg, to show bioequivalence for Glimepirida Parke-Davis 2, 3 and 4 mg with Amaryl at the corresponding doses.
Maltese: Għalkemm l-Istati Membri qablu li Glimepirida Parke-Davis ta' 1 mg kienet bijoekwivalenti għall-Amaryl ta' 1 mg, xorta baqa' jiddomina t-tħassib fuq jekk kellux isir studju dwar il-bijoekwivalenza bl-aktar doża qawwija, jiġifieri ta' 4 mg, sabiex tintwera lbijoekwivalenza għal Glimepirida Parke-Davis ta' 2, 3 u 4 mg ma' Amaryl fid-dożi korrispondenti.
English: However, the Member States were not able to reach an agreement and the Portuguese medicines agency referred the matter to the CHMP for arbitration on 31 May 2012.
Maltese: Madankollu, l-Istati Membri ma setgħux jilħqu ftehim u l-aġenzija tal-mediċini Portugiża rreferiet il-kwistjoni lis-CHMP għal arbitraġġ fil-31 ta' Mejju 2012.
English: bioequivalence study submitted by the company was carried out using 1 mg of Glimepirida ParkeDavis, and the results were applied to the higher strengths.
Maltese: bijoekwivalenza sottomess mill-kumpanija sar bl-użu ta' 1 mg ta' Glimepirida Parke-Davis, u r-riżultati ġew applikati għad-dożi aktar qawwija.
English: The CHMP therefore concluded that, as Glimepirida Parke-Davis 2, 3 and 4 mg strengths are bioequivalent to the reference medicine, marketing authorisation should be granted in the concerned Member States.
Maltese: Għalhekk, is-CHMP ikkonkluda li, billi d-dożi ta' 2, 3 u 4 mg ta' Glimepirida Parke-Davis huma bijoekwivalenti għall-mediċina ta' referenza, l-awtorizzazzjoni ta' kummerċjalizzazzjoni għandha tingħata fl-Istati Membri kkonċernati.
English: Glimepirida Parke-Davis is a medicine used to treat type 2 diabetes (a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively).
Maltese: Glimepirida Parke-Davis hija mediċina li tintuża biex tikkura d-dijabete tat-tip 2 (marda fejn il-frixa ma tipproduċix biżżejjed insulina sabiex tikkontrolla l-livell ta' glukosju fid-demm jew meta l-ġisem ma jkunx jista' juża l-insulina b'mod effettiv).
English: The European Commission issued a decision on 19 November 2012.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fid-19 ta' Novembru 2012.
English: The grounds for the referral were concerns over the approach used to demonstrate that Glimepirida Parke-Davis 2, 3 and 4 mg are ‘bioequivalent' to Amaryl at the corresponding doses.
Maltese: Ir-raġunijiet għar-riferiment kienu tħassib fuq l-approċċ użat sabiex jintwera li l-pilloli ta' Glimepirida Parke-Davis ta' 2, 3 u 4 mg huma ‘bijoekwivalenti' għall-Amaryl fid-dożi korrispondenti.
English: not less than 103.0 CCID50
Maltese: mhux inqas minn 103.0 CCID50
English: Trading as
Maltese: United Kingdom Trading as
English: Via A. Fleming, 2 37135 Verona Italy
Maltese: Fleming, 2 37135 Verona Italy
English: Stonemasons Way Rathfarnham Dublin 16
Maltese: Way Rathfarnham Dublin 16
English: Middlesex UB11 1BT
Maltese: Middlesex UB11 1BT United Kingdom
English: 9GS
Maltese: KG
English: Albert Schweitzer-Gasse 6 A-1140 Wien
Maltese: Albert Schweitzer-Gasse 6
English: GlaxoSmithKline GmbH & Co. KG
Maltese: GlaxoSmithKline GmbH & Co.
English: GlaxoSmithKline Pharma A/S
Maltese: GlaxoSmithKline Pharma A/S Nykær 68
English: Luxembourg GlaxoSmithKline Biologicals s.a.
Maltese: Il-Lussemburgu GlaxoSmithKline Biologicals s.a.
English: Live attenuated mumps virus (RIT 4385 strain, derived from Jeryl Lynn strain)
Maltese: Virus tal-gattone attenwat ħaj (Razza RIT 4385, miksuba mir-razza Jeryl Lynn strain) mhux inqas minn 103.7 CCID50 Virus tar-rubella attenwat ħaj (Razza Wistar RA 27/3)
English: Uxbridge
Maltese: Ċipru
English: United Kingdom SmithKline Beecham plc 980 Great West Road,
Maltese: SmithKline Beecham plc 980 Great West Road, Brentford, Middlesex TW8 9GS
English: * Strength applicable for all countries After reconstitution, 1 dose (0.5 ml) contains: Live attenuated measles virus (Schwarz strain)
Maltese: * Qawwa applikabbli għall-pajjiżi kollha Wara rikostituzzjoni, 1 doża (0.5 ml) fiha:
English: Live attenuated rubella virus (Wistar RA 27/3 strain)
Maltese: Virus tal-ħożba attenwat ħaj (Razza Schwarz)
English: List of the names, pharmaceutical forms, strength of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwa tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq flIstati Membri
English: The full EPAR for Ovitrelle 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: This summary was last updated in 05-2011.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 05-2011.
English: Ovitrelle is a medicine that contains the active substance choriogonadotropin alfa.
Maltese: Ovitrelle huwa mediċina li fiha s-sustanza attiva korjogonadotropina alfa.
English: EPAR summary for the public choriogonadotropin alfa
Maltese: Sommarju tal-EPAR għall-pubbliku korjogonadotropina alfa
English: Ovitrelle (250 micrograms or 500 micrograms) was compared with the natural hCG hormone that had been extracted from urine.
Maltese: Ovitrelle (250 mikrogramma jew 500 mikrogramma) tqabbel mal-ormon naturali hCG li kien ġie estratt mill-urina.
English: This is a summary of the European public assessment report (EPAR) for Ovitrelle.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ovitrelle.
English: The most common side effects with Ovitrelle (seen in between 1 and 10 patients in 100) are reactions at the injection site, headache, tiredness, vomiting, nausea (feeling sick), abdominal pain (stomach ache) and ovarian hyperstimulation syndrome (such as feeling sick, weight gain and diarrhoea).
Maltese: L-iktar effetti sekondarji komuni li ġew irrapportati bl-użu ta' Ovitrelle (li dehru f'1 sa 10 pazjenti minn kull 100) huma reazzjoni jew uġigħ fil-post tal-injezzjoni, uġigħ ta' ras, għeja, remettar, nawżja (dardir), uġigħ addominali (fiż-żaqq) u s-sindromu ta' iperstimulazzjoni tal-ovarji (ħass ta' dardir, żieda fil-piż u dijarrea).
English: The active substance in Ovitrelle, choriogonadotropin alfa, is a copy of the natural hormone human chorionic gonadotropin (hCG), also known as the ‘pregnancy' hormone, which helps to maintain pregnancy.
Maltese: Is-sustanza attiva f'Ovitrelle, il-korjogonadotropina alfa, hija kopja tal-ormon naturali gonadotropina korjonika umana (hCG), li huwa magħruf ukoll bħala ‘l-ormon tat-tqala', li jgħin it-tkomplija tat-tqala.
English: Ovitrelle has mainly been studied in women undergoing fertility treatment (1,140 patients).
Maltese: Ovitrelle kien studjat prinċiparjament f'nisa li kienu għaddejjin minn trattament ta' fertilità (1,140 pazjent).
English: In anovulatory women, ovulation was seen in 92% of the women treated with Ovitrelle.
Maltese: Fin-nisa anovulatorji, lovulazzjoni dehret f'92% tan-nisa trattati b'Ovitrelle.
English: In women undergoing fertility treatment, this is generally 24 to 48 hours after stopping treatment to stimulate the ovaries (such as a follicle stimulating hormone [FSH] or human menopausal gonadotrophin [hMG] preparation).
Maltese: Fin-nisa li jkunu qed jieħdu trattament ta' fertilità, dan ġeneralment iseħħ minn 24 sa 48 siegħa wara li jkun twaqqaf it-trattament li jistimula l-ovarji (bħall-għoti ta' preparazzjoni ta' ormon li jistimula l-follikoli [FSH - follicle stimulating hormone] jew ta' gonadotropina tal-menopawża umana [hMG - human menopausal gonadotrophin].
English: Ovitrelle was as effective as urinary hCG in triggering ovulation, and the 250-microgram dose of Ovitrelle was as effective as the 500-microgram dose.
Maltese: Fl-istimulazzjoni tal-ovulazzjoni Ovitrelle kien effikaċi daqs l-hCG urinarju, u d-doża ta' 250 mikrogramma ta' Ovitrelle kienet effikaċi daqs id-doża ta' 500 mikrogramma.
English: The choriogonadotropin alfa in Ovitrelle is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes cell able to produce it.
Maltese: Il-korjogonadotropina alfa f'Ovitrelle tiġi prodotta b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': din issir minn ċellola li tkun irċiviet ġene (DNA), li jagħmilha possibbli għaċ-ċellola li tipproduċih.
English: What is Ovitrelle?
Maltese: X'inhu Ovitrelle?
English: Why has Ovitrelle been approved?
Maltese: Għaliex ġie approvat Ovitrelle?
English: A dose of 250 micrograms is given 24 to 48 hours after the ovaries have produced follicles that are mature enough (eggs ready for ovulation).
Maltese: Doża ta' 250 mikrogramma tingħata minn 24 sa 48 siegħa wara li l-ovarji jkunu laħqu pproduċew follikoli maturi biżżejjed (bajd lesti għall-ovulazzjoni).
English: It can be used in women who are undergoing fertility treatment (such as in vitro fertilisation), and in women who are anovulatory (do not produce eggs) or oligo ovulatory (rarely produce eggs).
Maltese: Jista' jintuża f'nisa li jkunu għaddejjin minn trattament ta' fertilità (bħall-fertilizzazzjoni in vitro), u finnisa li jkunu anovulatorji (ma jkunux jistgħu jipproduċu bajd) jew li jkunu oligo-ovulatorji (rarament jipproduċu bajd).
English: What is the risk associated with Ovitrelle?
Maltese: X'inhuma r-riskji assoċjati ma' Ovitrelle?
English: Ovitrelle must also not be used in patients with active thromboembolic disorders (problems with blood clotting).
Maltese: Ovitrelle ma għandux jintuża lanqas minn pazjenti li jkollhom problemi tromboemboliċi attivi (problemi tat-tgħaqqid tad-demm).
English: How has Ovitrelle been studied?
Maltese: Kif ġie studjat Ovitrelle?