FrancophonIA/ELRC3.0 huggingface dataset:
English: Nateglinide did not impair fertility in male or female rats (see section 5.3).
Maltese: Nateglinide ma jfixkilx il-fertilità fil-firien irġiel jew nisa (ara sezzjoni 5.3).
English: - The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone;
Maltese: - Is-sustanzi mhux attivi l-oħra huma lactose monohydrate; cellulose, microcrystalline; povidone;
English: The side effects caused by Starlix are usually mild to moderate.
Maltese: L-effetti sekondarji ikkawżati minn Starlix huma ġeneralment ħfief għal moderati.
English: Repeated dosing with 90 mg once daily for 1 to 3 months in diabetic patients with end-stage renal disease (ESRD) showed pronounced M1 metabolite accumulation up to 1.2 ng/ml despite the reduced dose.
Maltese: Dożaġġ ripetut b'90 mg darba kuljum għal bejn xahar u 3 xhur f'pazjenti dijabetiċi b'mard renali flaħħar stadju (end-stage renal disease - ESRD) wera akkumulazzjoni qawwija tal-metabolit M1 sa 1.2 ng/ml minkejja d-doża mnaqqsa.
English: Other medicines and Starlix
Maltese: Mediċini oħra u Starlix
English: Patients with severe renal impairment (see section 5.2) who have not undergone haemodialysis are more susceptible to the glucose-lowering effect of Starlix.
Maltese: Pazjenti b'indeboliment renali sever (ara sezzjoni 5.2) li ma saritilhomx emodijaliżi ikollhom aktar xeħta li jseħħulhom l-effetti ta' tnaqqis ta' glucose ta' Starlix.
English: Electrophysiological studies demonstrate that nateglinide has 45-300-fold selectivity for pancreatic beta cell versus cardiovascular K
Maltese: Studji elettrofiżjiologiċi juri li nateglinide għandu selettività għaċ-ċelluli beta tal-frixa ta' 45-300-il-darba iżjed mill-kanali kardjovaskolari K
English: • Common (may affect up to 1 in 10 people): abdominal pain, indigestion, diarrhoea, nausea
Maltese: • Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10): uġigħ addominali, indiġestjoni,
English: - Phenytoin (used, for example, to treat seizures).
Maltese: - Phenytoin (użat, ngħidu aħna, biex jittratta aċċessjonijiet).
English: Starlix 60 mg tablets nateglinide
Maltese: Starlix 60 mg pilloli nateglinide
English: The systemic availability and half-life of nateglinide in diabetic patients with mild, moderate (creatinine clearance 31-50 ml/min) and severe (creatinine clearance 15-30 ml/min) renal impairment (not undergoing dialysis) did not differ to a clinically significant degree from those in healthy subjects.
Maltese: Id-disponibilità sistemika u l-half-life ta' nateglinide f'pazjenti b'indeboliment renali ħafif għal moderat (tneħħija tal-krejatinina 31-50 ml/min) u severa (tneħħija tal-krejatinina 15-30 ml/min) (mhux fuq dijaliżi) moderat ma kienx differenti b'mod klinikament sinifikanti minn dawk f'pazjenti b'saħħithom.
English: Starlix 180 mg tablets nateglinide
Maltese: Starlix 180 mg pilloli nateglinide
English: Starlix can be used by people over 65 years of age.
Maltese: Starlix jista' jintuża f'persuni li għandhom iżjed minn 65 sena.
English: Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose baseline HbA1c was close to the therapeutic target (HbA1c <7.5%).
Maltese: Sintomi ta' ipogliċemija (mhux ikkonfermati bil-livelli ta' glucose fid-demm) kienu osservati f'pazjenti li kellhom il-linja bażi ta' HbA1c viċin għall-livell terapewtiku mixtieq (HbA1C < 7.5 %).
English: The extent of serum protein binding is independent of drug concentration over the test range of 0.1-10 g Starlix/ml.
Maltese: Kemm jeħel mal-proteini tas-serum jiddependi mill-konċentrazzjoni tal-mediċina filmedda ta' 0.1-10 g Starlix/ml.
English: 12 film-coated tablets 24 film-coated tablets 30 film-coated tablets 60 film-coated tablets 84 film-coated tablets 120 film-coated tablets 360 film-coated tablets
Maltese: 12-il pillola miksija b'rita 24 pillola miksija b'rita 30 pillola miksija b'rita 60 pillola miksija b'rita 84 pillola miksija b'rita 120 pillola miksija b'rita 360 pillola miksija b'rita
English: - Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders).
Maltese: - Kortikosterojdi bħal prednisone u cortisone (użati biex jikkuraw problemi nfjammatorji).
English: Starlix 120 mg tablets nateglinide
Maltese: Starlix 120 mg pilloli nateglinide
English: Film-coated tablet.
Maltese: Żommu fil-pakkett oriġinali.
English: There is a 49% decrease in Cmax of nateglinide in dialysis-dependent diabetic patients.
Maltese: Hemm tnaqqis ta' 49 % fis-Cmax ta' nateglinide f'pazjenti dijabetiċi li jiddependu middijaliżi.
English: In rabbits, embryonic development was adversely affected and the incidence of gallbladder agenesis or small gallbladder was increased at doses of 300 and 500 mg/kg (approximately 24 and 28 times the human therapeutic exposure with a maximum recommended nateglinide dose of 180 mg, three times daily before meals), but not at 150 mg/kg (approximately 17 times the human therapeutic exposure with a maximum recommended nateglinide dose of 180 mg, three times daily before meals).
Maltese: Fil-fniek, l-iżvilupp tal-embrijun kien affettwat ħażin u l-inċidenza ta' aġenesi fil-bużżieqa tal-marrara jew fil-bużżieqa ż-żgħira tal-marrara żdiedet b'dożi ta' 300 u 500 mg/kg (madwar 24 u 28 darba lespożizzjoni terapewtika fil-bnedmin b'doża massima rrakkomandata ta' 180 mg nateglinide, tliet darbiet kuljum qabel l-ikel), imma mhux ta' 150 mg/kg (madwar 17-il darba l-espożizzjoni terapewtika fil-bnedmin b'doża massima rrakkomandata ta' 180 mg nateglinide, tliet darbiet kuljum qabel l-ikel).
English: Combination with metformin is associated with an increased risk of hypoglycaemia compared to monotherapy.
Maltese: Il-kombinazzjoni ma' metformin ġiet assoċjata ma' riskju akbar ta' ipogliċemija meta imqabbel ma' monoterapija.
English: Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għallgalactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu din il-mediċina.
English: Nateglinide is rapidly and almost completely ( 90%) absorbed from an oral solution.
Maltese: Nateglinide jiġi assorbit malajr u kważi għall-kollox ( 90 %) minn soluzzjoni orali.
English: Particular caution is recommended when nateglinide is co-administered with other more potent inhibitors of CYP2C9 (e.g. fluconazole, gemfibrozil or sulfinpyrazone), or in patients known to be poor metabolisers for CYP2C9 substrates.
Maltese: L-attenzjoni hija rakkomandata b'mod partikolari meta nateglinide jingħata flimkien ma' impedituri CYP2C9 aktar qawwija (eż. fluconazole, gemfibrizol jew sulfinpyarazone), jew f'pazjenti magħrufa bħala metabolizzaturi dgħajfa għas-sottostrati ta' CYP2C9.
English: Most of the [14C] nateglinide is excreted in the urine (83%), with an additional 10% eliminated in the faeces.
Maltese: Il-parti l-kbira ta' C] nateglinide jitneħħa fl-awrina (83 %), b' 10 % oħra li jitneħħaew ma' l-ippurgar.
English: - The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60
Maltese: - Il-pillola fiha hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).
English: • Rare (may affect up to 1 in 1,000 people): mild abnormalities in liver function tests, allergic
Maltese: • Rari (jistgħu jaffettwaw sa persuna waħda minn kull 1,000): testijiet tal-funzjoni tal-fwied mhux normali bi ftit, reazzjonijiet allerġiċi (sensittività eċċessiva) fosthom raxx u ħakk
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: How to store Starlix
Maltese: X'inhu Starlix
English: - Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil
Maltese: - Impedituri tal-metaboliżmu tal-mediċini bħal fluconazole (użati biex jikkuraw infezzjonijiet tal moffa), gemfibrizol (użat fil-kura ta' diżlipidemija) jew sulfinpyrazone (użat fil-kura tal-gotta kronika).
English: Starlix 60 mg film-coated tablets Starlix 120 mg film-coated tablets Starlix 180 mg film-coated tablets nateglinide
Maltese: Starlix 60 mg pilloli miksija b'rita Starlix 120 mg pilloli miksija b'rita Starlix 180 mg pilloli miksija b'rita nateglinide
English: Thus, no dosage adjustment is required for digoxin, warfarin or other drugs that are CYP2C9 or CYP3A4 substrates upon coadministration with Starlix.
Maltese: Għalhekk, m'hemmx bżonn ta' tibdil fid-doża għal digoxin, warfarin u mediċini oħra li huma sottostrati ta' CYP 2C9 u CYP 3A4 meta jingħataw ma' Starlix.
English: In a clinical study in patients, Starlix was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated.
Maltese: Fi studju kliniku, Starlix ingħata lill-pazjenti b'dożi li kienu miżjuda sa 720 mg kuljum għal 7 ijiem u kienu tollerati sew.
English: Starlix is contraindicated in patients with:
Maltese: Starlix huwa kontra-indikat f'pazjenti b':
English: 60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other.
Maltese: Pilloli b'60 mg, roża, tondi, b'xifer imżerżaq b'“STARLIX” immarkat fuq naħa u “60” fuq l-oħra.
English: Although there is a 49% decrease in Cmax of nateglinide in dialysis patients, the systemic availability and half-life in diabetic subjects with moderate to severe renal insufficiency (creatinine clearance 15-50 ml/min) was comparable between renal subjects requiring haemodialysis and healthy subjects.
Maltese: Għalkemm hemm tnaqqis ta' 49 % fis-Cmax ta' nateglinide f'pazjenti li jkunu fuq id-dijaliżi, id-disponibilità sistemika u l-half-life f'individwi dijabetiċi b'insuffiċjenza renali (tneħħija tal-kreatinina 1550 ml/min) kienu paragunabbli bejn individwi renali li kellhomm bżonn emodijaliżi u individwi b'saħħithom.
English: Starlix is used to treat adult patients with type 2 diabetes.
Maltese: Starlix jintuża biex jittratta pazjenti adulti b'dijabete tip 2.
English: Hepatobiliary disorders
Maltese: Impediment epatiku
English: Insulin levels return to baseline within 3 to 4 hours, reducing post-meal hyperinsulinaemia.
Maltese: Il-livelli ta' insulina jirritornaw fil-linja bażi fi żmien 3 sa 4 siegħat, bi tnaqqis ta' iperinsulinemija ta' wara l-ikel.
English: • Uncommon (may affect up to 1 in 100 people): vomiting
Maltese: • Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): rimettar
English: STARLIX 60 mg film-coated tablets STARLIX 120 mg film-coated tablets STARLIX 180 mg film-coated tablets
Maltese: STARLIX 60 mg pilloli miksijin b'rita STARLIX 120 mg pilloli miksijin b'rita STARLIX 180 mg pilloli miksijin b'rita
English: When these medicinal products - that enhance or reduce the hypoglycaemic effect of nateglinide - are administered to or withdrawn from patients receiving nateglinide, the patient should be observed closely for changes in glycaemic control.
Maltese: Meta dawn il-prodotti mediċinali - li jsaħħu jew inaqqsu l-effett ipogliċemiku ta' nateglinidejingħataw jew jitwaqqfu f'pazjenti li qed jieħdu nateglinide, il-pazjent għandu jiġi osservat mill-qrib għal tibdil fil-kontroll gliċemiku.
English: However, there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak plasma concentration (tmax).
Maltese: Madankollu, hemm dewmien fir-rata ta' assorbiment ikkaratterizzata minn tnaqqis fis-Cmax u dewmien fil-ħin biex tintlaħaq l-ogħla konċentrazzjoni fil-plażma (tmax).
English: Both treatments were well tolerated.
Maltese: Iż-żewġ kuri kienu tollerati sew.
English: Nateglinide should be used with caution in patients with moderate hepatic impairment.
Maltese: Indeboliment epatiku Nateglinide għandu jintuża b'attenzjoni f'pazjenti b'indeboliment epatiku moderat.
English: The systemic availability and half-life of nateglinide in non-diabetic subjects with mild to moderate hepatic impairment did not differ to a clinically significant degree from those in healthy subjects.
Maltese: Id-disponibilità sistemika u l-half-life ta' nateglinide f'pazjenti li mhumiex dijabetiċi b'indeboliment epatiku ħafif għal moderat ma kienx differenti b'mod klinikament sinifikanti minn dawk f'pazjenti b'saħħithom.
English: Take Starlix before meals (see section 3, “How to take Starlix”); its effect may be delayed if it is taken during or after meals.
Maltese: Ħu Starlix qabel l-ikliet (ara sezzjoni 3, “Kif għandek tieħu Starlix”); l-effett tiegħu jista' jseħħ aktar tard jekk jittieħed waqt jew wara l-ikliet.
English: No clinically significant differences in nateglinide pharmacokinetics were observed between men and women.
Maltese: Ma kien hemm l-ebda differenzi klinikament sinifikanti fil-farmakokinetiċi ta' nateglinide bejn l-irġiel u n-nisa.
English: A number of medicinal products influence glucose metabolism and possible interactions should therefore be taken into account by the physician.
Maltese: Numru ta' prodotti mediċinali jistgħu jeffettwaw il-metaboliżmu ta' glucose u għalhekk linterazzjonijiet possibli għandhom jiġu meqjusa mit-tabib.
English: Although M1 metabolites show only slight hypoglycaemic activity (approximately 5 times lower than nateglinide), metabolite accumulation might increase the hypoglycaemic effect of the administered dose.
Maltese: Għalkemm il-metabolit M1 juri biss ftit attività ipogliċemika (madwar 5 darbiet inqas minn nateglinide), l-akkumulazzjoni tal-metabolit tista' żżid l-effett ipogliċemiku tad-doża mogħtija.
English: Starlix 180 mg film-coated tablets are red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other.
Maltese: Pilloli b'180 mg, ħomor, f'forma ovali b'“STARLIX” immarkat fuq naħa u “180” fuq l-oħra.
English: In patients with type 2 diabetes who were given Starlix with a dose range of 60 mg to 240 mg before meals three times a day for one week, nateglinide showed linear pharmacokinetics for both AUC and Cmax.
Maltese: F'pazjenti b'dijabete tat-tip 2 li ngħataw Starlix f'firxa ta' doża ta' bejn 60 mg u 240 mg qabel l-ikliet tliet darbiet kuljum għal ġimgħa waħda, nateglinide wera farmakokinetika lineari kemm għall-AUC kif ukoll għas-Cmax.
English: Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other.
Maltese: Pilloli b'120 mg, sofor, f'forma ovali b'“STARLIX” immarkat fuq naħa u “120” fuq l-oħra.
English: Plasma concentrations decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of Starlix in volunteers and type 2 diabetic patients.
Maltese: Ilkonċentrazzjonijiet fil-plażma malajr jonqsu u l-half-lifee tatt-tneħħija ta' nateglinide tipikament kellha medja ta' 1.5 sigħat fl-istudji kollha ta' Starlix f'voluntiera u f'pazjenti dijabetiċi tip 2.
English: Each film-coated tablet contains 60 mg nateglinide.
Maltese: Kul pillola miksija b'rita fiha 60 mg nateglinide.
English: • weakness
Maltese: • debbulizza
English: Nateglinide is a rapid, short-acting oral insulin secretagogue.
Maltese: Nateglinide huwa sekretagogu ta' l-insulina orali li jaħdem malajr u fi żmien qasir.
English: The systemic availability and half-life in dialysis-dependent diabetic patients was comparable with healthy subjects.
Maltese: Id-disponibilità sistemika u l-half-life f'pazjenti dijabetiċi li jiddependu mid-dijaliżi kienet komparabbli ma' pazjenti b'saħħithom.
English: Starlix is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Maltese: Starlix mhuwiex rakkomandat għal tfal u adolexxenti (taħt it-18-il sena) minħabba li l-effetti fuq dan il-grupp ta' din l-età ma ġiex studjat.
English: Nateglinide, when taken before a meal, restores early or first phase insulin secretion, which is lost in patients with type 2 diabetes, resulting in a reduction in post-meal glucose and HbA1c.
Maltese: Nateglinide, meta jittieħed qabel ikla, ireġġa' lura l-ħila ta' sekrezzjoni ta'insulina minn kmieni jew mill-ewwel fażi, li tkun intilfet f'pazjenti b'dijabete tip 2, li tirriżulta fit-tnaqqis ta' glucose ta' wara likel u tnaqqis ta' HbA1c.
English: Adults Nateglinide should be taken within 1 to 30 minutes before meals (usually breakfast, lunch and dinner).
Maltese: Nateglinide għandu jittieħed fi żmien 1 sa 30 minuta qabel l-ikel (normalment mal-kolazzjon, l-ikla ta' nofsinhar u l-ikla ta' filgħaxija).
English: EU/1/01/174/008 12 film-coated tablets EU/1/01/174/009 24 film-coated tablets EU/1/01/174/010 30 film-coated tablets EU/1/01/174/011 60 film-coated tablets EU/1/01/174/012 84 film-coated tablets EU/1/01/174/013 120 film-coated tablets EU/1/01/174/014 360 film-coated tablets
Maltese: STARLIX 60 mg pilloli miksijin b'rita EU/1/01/174/001-007
English: - if you are undernourished.
Maltese: Twissijiet u prekawzjonijiet
English: EU/1/01/174/015 12 film-coated tablets EU/1/01/174/016 24 film-coated tablets EU/1/01/174/017 30 film-coated tablets EU/1/01/174/018 60 film-coated tablets EU/1/01/174/019 84 film-coated tablets EU/1/01/174/020 120 film-coated tablets EU/1/01/174/021 360 film-coated tablets
Maltese: EU/1/01/174/016 24 pillola miksija b'rita
English: Each film-coated tablet contains 180 mg nateglinide.
Maltese: Kull pillola miksija b'rita fiha 180 mg nateglinide.
English: The full EPAR for Ovaleap 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: • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Maltese: • nisa b'defiċjenza severa (livelli baxxi ħafna) tal-ormon lutenizzant (LH) u l-ormon li jistimula lfollikoli (FSH).
English: The average number of oocytes collected was 12.2 in the Ovaleap group, compared with 12.0 in the GONAL-f group.
Maltese: In-numru medju ta' ooċiti miġbura kien ta' 12.2 fil-grupp ta' Ovaleap, meta mqabbel ma' 12.0 fil-grupp ta' GONAL-f.
English: • women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation.
Maltese: • nisa li jkunu għaddejjin minn tekniki ta' riproduzzjoni assistita (trattament tal-fertilità) bħal fertilizzazzjoni in-vitro.
English: Ovaleap has been shown to be comparable to the reference medicine, GONAL-f.
Maltese: Intwera li Ovaleap huwa komparabbli mal-mediċina ta' referenza, GONAL-f.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ovaleap on 27 September 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Ovaleap fis-27 ta' Settembru 2013.
English: Other information about Ovaleap
Maltese: Informazzjoni oħra dwar Ovaleap
English: The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Maltese: L-effetti sekondarji l-aktar komuni b'Ovaleap (li jistgħu jolqtu aktar minn 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni (uġigħ, ħmura, tbenġil, nefħa jew irritazzjoni).
English: The follitropin alfa in Ovaleap, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce human FSH.
Maltese: Il-follitropin alfa f'Ovaleap, kif ukoll fil-prodott ta' referenza GONAL-f, huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': isir minn ċelloli li fihom jiġi introdott ġene (DNA), li bih ikunu jistgħu jipproduċu FSH tal-bniedem.
English: This is a summary of the European public assessment report (EPAR) for Ovaleap.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ovaleap.
English: This means that Ovaleap is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Ovaleap and the reference medicine contain the same active substance.
Maltese: Dan ifisser li Ovaleap huwa simili għal mediċina bijoloġika (il"mediċina ta' referenza") li hija diġà awtorizzata fl-Unjoni Ewropea (UE) u li Ovaleap u l-mediċina ta' referenza fihom l-istess sustanza attiva.
English: The active substance in Ovaleap, follitropin alfa, is a copy of the natural hormone FSH.
Maltese: Is-sustanza attiva f'Ovaleap, follitropin alfa, hija kopja tal-ormon naturali
English: Ovaleap is a medicine that contains the active substance follitropin alfa.
Maltese: Ovaleap huwa mediċina li fiha s-sustanza attiva follitropin alfa.
English: • men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Maltese: • irġiel li għandhom ipogonadiżmu ipogonadotropiku (marda ta' nuqqas ormonali rari).
English: Why is Ovaleap approved?
Maltese: Għal xiex ġiet approvat Ovaleap?
English: In the body, FSH controls reproductive function: in women, it stimulates the production of eggs; and in men, it stimulates the production of sperm in the testicles.
Maltese: Fil-ġisem, FSH jikkontrolla l-funzjoni riproduttiva: fin-nisa, jistimula l-produzzjoni tal-bajd; u fl-irġiel, jistimula lproduzzjoni tal-isperma fit-testikoli.
English: Ovaleap is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.
Maltese: Oveleap jintuża flimkien ma' gonadotofin korionku uman (hCG) biex jistimula l-produzzjoni tal-isperma.
English: Ovaleap is a ‘biosimilar' medicine.
Maltese: Ovaleap hija mediċina ‘bijosimili'.
English: Ovaleap is available as a solution for injection.
Maltese: Ovaleap huwa disponibbli bħala soluzzjoni għal injezzjoni.
English: What are the risks associated with Ovaleap?
Maltese: X'inhuma r-riskji assoċjati ma' Ovaleap?
English: A risk management plan has been developed to ensure that Ovaleap is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Ovaleap jintuża bl-iktar mod sigur possibbli.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Ovaleap has been shown to have a comparable quality, safety and efficacy profile to GONAL-f.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li Ovaleap intwera li għandu profil ta' kwalità, sigurtà u effikaċja komparabbli ma' GONAL-f.
English: It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Maltese: Ma għandux jintuża f'pazjenti b'tumuri tal-glandola pitwitarja jew tal-ipotalamu, jew b'kanċer tas-sider, tal-ġuf jew tal-ovarji.
English: What measures are being taken to ensure the safe and effective use of Ovaleap?
Maltese: X'miżuri qegħdin jitteħdu biex jassiguraw użu sigur u effettiv ta' Ovaleap?
English: Ovaleap must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Maltese: Ovaleap ma jistax jintuża f'nies li għandhom sensittività eċċessiva (allerġiċi) għal follitropin alfa, FSH jew kwalunkwe sustanza oħra tiegħu.
English: Ovaleap has been compared with GONAL-f in one main study involving 299 women undergoing fertility treatment.
Maltese: Ovaleap tqabbel ma' GONAL-f fi studju ewlieni li fih ipparteċipaw 299 mara li kienu għaddejjin minn trattament ta' fertilità.
English: Therefore, the CHMP's view was that, as for GONAL-f, Ovaleap's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Għaldaqstant, l opinjoni tas-CHMP kienet li, bħal fil-każ ta' GONAL-f, il-benefiċċji ta' Ovaleap jisbqu r-riskji tiegħu u rrakkomanda u rrakkomanda li jkun approvat għall-użu fl-U.
English: The reference medicine for Ovaleap is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar tagħrif dwar il-mediċini bijosimili, ara d-dokument ta' mistoqsijiet u tweġibiet hawnhekk.