FrancophonIA/ELRC3.0 huggingface dataset:
English: Na Pankráci 17/1685
Maltese: GlaxoSmithKline, s.r.o. Na Pankráci 17/1685 140 21 Prague 4
English: Live attenuated measles virus (Schwarz strain) -not less than 103.0 CCID50
Maltese: Virus tal-ħosba ħaj attenwat (razza Schwarz) - mhux inqas minn 103.0
English: Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl
English: The full EPAR for Granpidam 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: Granpidam is available as tablets (20 mg).
Maltese: Granpidam jiġi bħala pilloli (20 mg).
English: Granpidam contains the active substance sildenafil.
Maltese: Granpidam fih is-sustanza attiva sildenafil.
English: The active substance in Granpidam, sildenafil, belongs to a group of medicines called ‘phosphodiesterase-type-5 (PDE5) inhibitors', which means that it blocks the PDE5 enzyme.
Maltese: Is-sustanza attiva f'Granpidam, sildenafil, tagħmel parti minn grupp ta' mediċini msejħa ‘inibituri ta' fosfodiesterażi tat-tip-5 (PDE5)', li jfisser li timblokka l-enzima PDE5.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom dose would be 10 mg three times a day but Granpidam can only be used when a 20-mg dose is to be given.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Other information about Granpidam
Maltese: Informazzjoni oħra dwar Granpidam
English: This is a summary of the European public assessment report (EPAR) for Granpidam.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Granpidam.
English: Granpidam is a medicine used to treat adults and children from 1 year of age with pulmonary arterial hypertension (PAH, abnormally high blood pressure in the arteries in the lungs).
Maltese: Granpidam huwa mediċina li tintuża għall-kura ta' adulti u ta' tfal mill-età ta' sena bi pressjoni għolja arterjali pulmonari (PAH, pressjoni tad-demm abnormalment għolja fl-arterji fil-pulmuni).
English: Why is Granpidam approved?
Maltese: Għalxiex ġie approvat Granpidam?
English: In adults, it is used in patients with class II (slight limitation of physical activity) or class III (marked limitation of physical activity) PAH.
Maltese: Fl-adulti, jintuża f'pazjenti b'PAH tal-klassi II (limitazzjoni żgħira fl-attività fiżika) jew tal-klassi
English: In this case Granpidam was not compared with the reference product Revatio, but with Viagra.
Maltese: F'dan il-każ, Granpidam ma tqabbilx mal-prodott ta' referenza Revatio, iżda ma' Viagra.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta' mistoqsijiet-u-tweġibiet hawnhekk.
English: How has Granpidam been studied?
Maltese: Kif ġie studjat Granpidam?
English: In adults, Granpidam is taken at a dose of 20 mg three times a day.
Maltese: Fl-adulti, Granpidam jittieħed f'doża ta' 20 mg tliet darbiet kuljum.
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Maltese: PAH hija marda debilitanti fejn ikun hemm kostrizzjoni (tidjiq) severa tal-vażi tad-demm tal-pulmuni.
English: This means that Granpidam is similar to a ‘reference medicine' already authorised in the European Union (EU) called Revatio.
Maltese: Dan ifisser li Granpidam huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Revatio.
English: What are the benefits and risks of Granpidam?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Granpidam?
English: Granpidam sildenafil
Maltese: Sommarju tal-EPAR għall-pubbliku sildenafil
English: Therefore, the CHMP's view was that, as for Revatio, the benefit of Granpidam outweighs the identified risk.
Maltese: Għaldaqstant, ilfehma tas-CHMP kienet li, bħal fil-każ ta' Revatio, il-benefiċċju huwa akbar mir-riskju identifikat.
English: Because Granpidam is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Granpidam huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The Committee recommended that Granpidam be approved for use in the EU.
Maltese: IlKumitat irrakkomanda li Granpidam ikun approvat għall-użu fl-UE.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Maltese: Żewġ mediċini huma bijoekwivalenti meta jipproduċu l-istess livelli tas-sustanza attiva filġisem.
English: In children aged 1 to 17 years, the recommended dose is 20 mg three times a day in those over 20 kg. Higher doses should not be used.
Maltese: Fi tfal bejn sena u s-17-il sena, id-doża rakkomandata hija ta' 20 mg tliet darbiet kuljum f'dawk li jiżnu aktar minn 20 kg.
English: Because the effectiveness and safety of sildenafil in PAH is already well established, studies in people have been limited to tests to determine that it is bioequivalent to another authorised sildenafilcontaining tablet.
Maltese: Minħabba li l-effikaċja u s-sigurtà ta' sildenafil f'PAH huma diġà stabbiliti sew, l-istudji fil-pazjenti kienu limitati għal testijiet biex tiġi determinata l-bijoekwivalenza tiegħu għal pillola awtorizzata oħra li fiha sildenafil.
English: How is Granpidam used?
Maltese: Kif jintuża Granpidam?
English: This enzyme is found in the blood vessels of the lungs.
Maltese: Din l-enzima tinstab fil-vażi tad-demm tal-pulmuni.
English: It may harm them, even if their signs of illness are the same as yours.
Maltese: Meta tingħata l-injezzjoni ta' Orgalutran wara nofsinhar, l-aħħar injezzjoni ta' Orgalutran għandha tingħata wara nofsinhar qabel l-jum ta' l-istimulazzjoni ta' l-ovulazzjoni.
English: (See section 4.4.)
Maltese: (Ara sezzjoni 4.4).
English: Manufacturer N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands.
Maltese: N.V. Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, L-Olanda.
English: Acetic acid;
Maltese: Acetic acid; Mannitol;
English: EU/1/00/130/001, 1 pre-filled syringe EU/1/00/130/002, 5 pre-filled syringes
Maltese: EU/1/00/130/001, siringa 1 mimlija lesta EU/1/00/130/002, 5 siringi mimlijin lesti
English: Orgalutran is used as part of the treatment for assisted reproduction techniques (ART) including in vitro fertilisation (IVF).
Maltese: Orgalutran jintuża bħala parti mit-trattament fit-teknika ta' riproduzzjoni assistita (ART) inkluż fertilizzazzjoni in vitro (IVF).
English: Ovarian hyperstimulation syndrome (OHSS)
Maltese: Sindrome ta' stimulazzjoni eċċessiva tal-ovarji (OHSS - ovarian hyperstimulation syndrome)
English: EU/1/00/130/001 1 pre-filled syringe EU/1/00/130/002 5 pre-filled syringes
Maltese: EU/1/00/130/001 siringa 1 mimlija lesta EU/1/00/130/002 5 siringi mimlijin lesti
English: (See also section 4.)
Maltese: (Ara wkoll sezzjoni 4.)
English: Date of first authorisation: 17 May 2000 Date of last renewal: 10 May 2010
Maltese: Data tal-aħħar tiġdid: 10 ta' Mejju 2010
English: ]-GnRH with a molecular weight of 1570.4.
Maltese: ]-GnRH. Il-piż molekulari huwa ta' 1570.
English: The adverse reactions are classified according to MedDRA system organ class and frequency; very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Maltese: Irreazzjonijiet avversi huma kklassifikati skont il-klassi tal-organi tas-sistema MedDRA u l-frekwenza; komuni ħafna (> l/10), komuni (> l/100 sa < 1/10), mhux komuni (> l/1,000 sa < 1/100).
English: Faeces only contain metabolites.
Maltese: Il-ħmieġ jkun fih biss metaboliti.
English: No teratogenic effects were observed.
Maltese: Ma ġewx osservati effetti teratoġeniċi.
English: The frequency of hypersensitivity reactions (very rare, < 1/10,000) has been deduced from post-marketing surveillance.
Maltese: Ilfrekwenza ta' reazzjonijiet ta' sensittività eċċessiva (rari ħafna, < 1/10,000) kien ikkalkulata missorveljanza ta' wara tqegħid fis-suq.
English: Gonadotrophins play an important role in human fertility and reproduction.
Maltese: Il-gonadotrophins għandhom rwol importanti fil-fertilità u r-riproduzzjoni umana.
English: Other ingredients: acetic acid, mannitol, water for injections, sodium hydroxide and/or acetic acid as pH adjustment.
Maltese: Sustanzi oħra: acetic acid, mannitol, ilma għall-injezzjonijiet, sodium hydroxide u/jew acetic acid bħala aġġustament tal-pH
English: Following administration of multiple doses of 0.25 mg Orgalutran to female volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74 %, 32 % and 25 % at 4, 16 and 16 hours after injection, respectively.
Maltese: Il-valur massimu ta' dan it-tnaqqis kien ta' 74%, 32% u 25% fir-4, 16 u 16-il siegħa rispettivament, wara t-tilqima.
English: Women weighing less than 50 kg or more than 90 kg
Maltese: Nisa li jiżnu inqas minn 50 kg jew aktar minn 90 kg
English: Gastrointestinal disorders Uncommon Nausea
Maltese: Disturbi gastrointestinali
English: Immune system disorders
Maltese: Disturbi fis-sistema immuni Rari Ħafna
English: The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.
Maltese: Il-possibbiltà ta' interazzjoni ma' prodotti mediċinali użati b' mod komuni inkluż prodotti mediċinali li jilliberaw l-istamina, ma tistax tiġi eskluża.
English: Orgalutran 0.25 mg/0.5 mL solution for injection Ganirelix
Maltese: Orgalutran 0.25 mg/0.5 mL soluzzjoni għall-injezzjoni Ganirelix
English: GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and follicle stimulating hormone (FSH)).
Maltese: GnRH jirregola ir-rilaxx ta' gonadotrophins (ormon luteinizzanti (LH) u ormon li jistimula l-follikuli (FSH)).
English: The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' Orgalutran ma ġewx stabbiliti f' nisa li jiżnu anqas minn 50 kg jew aktar minn 90 kg (ara wkoll sezzjoni 5.1 u 5.2).
English: Latex allergy
Maltese: Allerġija għall-latex
English: Orgalutran is indicated for the prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
Maltese: Orgalutran huwa indikat għall-prevenzzjoni ta' żjieda primatura fil-livelli ta' l-ormon lutejnizzanti (LH) fin-nisa, li jingħataw terapija ta' stimulazzjoni eċċessiva kkontrollata ta' l-ovarji (COH) għat-teknika ta' riproduzzjoni assistita (ART).
English: Hypersensitivity reactions (including rash, facial swelling, dyspnoea, anaphylaxis (including anaphylactic shock), angioedema and urticaria) Worsening of a pre-existing eczema
Maltese: Reazzjonijiet ta' sensittività eċċessiva (inkluż raxx, nefħa fil-wiċċ, qtugħ ta' nifs, anafilassi (inkluż xokk anafilattiku), anġjoedima u urtikarja) Ekżema li jkun hemm diġà tmur għall-agħar
English: PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/0.5 mL
Maltese: KITBA FUQ IS-SIRINGI MIMLIJIN LESTI Orgalutran 0.25 mg/0.5 mL
English: Orgalutran contains sodium Orgalutran contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull injezzjoni, i.e. huwa essenzjalment ‘mingħajr sodium'.
English: This syndrome is related to the stimulation procedure with gonadotrophins.
Maltese: Din is-sindrome hija relattata mal-proċedura ta' stimulazzjoni bil-gonadotrophins.
English: The bioavailability of Orgalutran following subcutaneous administration is approximately 91 %.
Maltese: Il-bijodisponibilità ta' Orgalutran wara għoti taħt il-ġilda hija madwar 91 %.
English: After repeated dosing 0.25 mg/day steady-state levels of approximately 0.6 ng/mL were reached within 2 to 3 days.
Maltese: Wara dożi ripetuti ta' 0.25 mg/jum livelli talistat fiss ta' madwar 0.6 ng/mL intlaħqu fi żmien 2 sa 3 ijiem.
English: Orgalutran 0.25 mg/0.5 mL solution for injection
Maltese: Orgalutran 0.25 mg/0.5 mL soluzzjoni għal injezzjoni
English: OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes
Maltese: KITBA FUQ IL-KARTUNA TA' BARRA Orgalutran 1/5 siringi mimlijin lesti
English: Other reported adverse reactions are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and spontaneous abortion.
Maltese: Reazzjonijiet avversi oħrajn irrapportati li għandhom x' jaqsmu mat-trattament ikkontrollat ta' stimulazzjoni eċċessiva ovarjana ART jinkludu b'mod notevoli uġigħ fil-pelvis, nefħa ta' żaqq, OHSS (ara sezzjoni 4.4), tqala barra mill-utru, u abort spontanju.
English: The pH may have been adjusted with sodium hydroxide and acetic acid.
Maltese: għandu mnejn ikun aġġustat għas-sodium hydroxide u acetic acid.
English: These events have included anaphylaxis (including anaphylactic shock), angioedema and urticaria.
Maltese: Dawn lavvenimenti kienu jinkludu anafilassi (inkluż xokk anafilattiku), anġjoedima u urtikarja.
English: In clinical studies Orgalutran was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.
Maltese: Fi studji kliniċi, Orgalutran ntuża ma' l-ormon rikombinanti li jistimula l-follikulu uman (FSH) jew corifollitropin alfa, l-istimulant sostnut tal-follikuli.
English: During Orgalutran treatment the average incidence of LH rises (> 10 IU/L) with concomitant progesterone rise (> 1 ng/mL) was 0.3 - 1.2 % compared to 0.8 % during GnRH agonist treatment.
Maltese: Waqt it-trattament b' Orgalutran, l-inċidenza medja taż-żjieda fil-livell talLH (> 10 IU/L) flimkien ma żjieda konkomitanti fil-progesteron (> 1 ng/mL) kienet ta' 0.3 - 1.2% meta mqabbla ma' 0.8% waqt trattament b'agonist tal-GnRH. Nisa li għandhom piż ogħla tal-ġisem (> 80 kg), għandhom tendenza ta' inċidenza aktar għolja ta' żjidiet fil-livelli tal-LH u tal-proġesterone għalkemm ma ġie osservat l-ebda effett fuq ir-riżultat kliniku.
English: Orgalutran contains the active substance ganirelix and belongs to a group of medicines called “antigonadotrophin-releasing hormones” which act against the actions of the natural gonadotrophin releasing hormone (GnRH).
Maltese: Orgalutran fih is-sustanza attiva ganirelix u jappartjeni għal grupp ta' mediċini msejħa "ormoni li jerħu anti-gonadotropin" li jaġixxu kontra l-azzjonijiet tal-ormon naturali li jeħles il-gonadotrophin (GnRH).
English: The incidence of congenital malformations after assisted reproduction techniques using Orgalutran is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.
Maltese: L-inċidenza ta'malformazzjonijiet konġenitali wara t-tekniċi tarriproduzzjoni assistita meta jintuża Orgalutran mhix differenti minn dik wara l-użu ta' analogi oħra GnRH fil-kors tat-tekniċi tar-riproduzzjoni assistita.
English: Hypersensitivity reaction
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant.
Maltese: Fil-każ ta' nisa li jingħataw tekniċi tar-riproduzzjoni assistita, inkluż fertilizzazzjoni in vitro (IVF) u metodi oħra, kultant jiġri li l-ovulazzjoni għandha mnejn isseħħ kmieni wisq u dan jirriżulta fi tnaqqis sinifikanti fiċ-ċans li ssir tqila.
English: The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)
Maltese: L-amino acids li jinsabu fil-pożizzjonijiet 1, 2, 3, 6, 8 u 10 tad-decapeptide naturali
English: Solution for injection.
Maltese: Soluzzjoni għal injezzjoni.
English: Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 5 or day 6 of FSH administration or on day 5 or day 6 following the administration of corifollitropin alfa.
Maltese: Orgalutran (0.25 mg) għandu jingħata b'injezzjoni waħda kuljum taħt il-ġilda, u jiġi mibdi fil-5 jum jew fis-6 jum ta' l-għoti tal-FSH jew f jum 5 jew 6 wara l-għoti ta' corifollitropin alfa.
English: The active substance ganirelix (INN) is a synthetic decapeptide with high antagonistic activity to the naturally occurring gonadotrophin releasing hormone (GnRH).
Maltese: Is-sustanza attiva ganirelix (INN) hi decapeptide sintetiku, li għandu attività għolja antagonistika għal ormon li jinstab b'mod naturali, ormon li jeħles il-gonadotrophin (GnRH).
English: Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, anti-gonadotrophin-releasing hormones, ATC code: H01CC01.
Maltese: Ormoni u analogi pitwitarji u ipotalamiċi, ormoni tar-rilaxx ta' l-antigonadotrophin, Kodiċi ATC:
English: Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).
Maltese: Il-maturazzjoni finali tal-follikuli tista' tiġi kkaġunata billi tingħata l-chorionic gonadotrophin tal-bniedem (hCG).
English: Excretion occurs via faeces (approximately 75 %) and urine (approximately 22 %).
Maltese: Ittneħħija issir permezz tal-ippurgar (madwar 75 %) u l-awrina (madwar 22 %).
English: Solution for injection, 1 pre-filled syringe containing 0.5 mL Solution for injection, 5 pre-filled syringes each containing 0.5 mL
Maltese: Soluzzjoni għall-injezzjoni, siringa 1 mimlija lesta fiha 0.5 mL Soluzzjoni għall-injezzjoni, 5 siringi mimlijin lesti kull waħda fiha 0.5 mL
English: Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.
Maltese: Ganirelix jintuża għal prevenzjoni ta' żidiet prematuri ta' LH li inkella jistgħu jseħħu f dawn in-nisa waqt l-istimulazzjoni tal-ovarji.
English: The pH (a measurement of the acidity) may have been adjusted with sodium hydroxide and acetic acid.
Maltese: Il-pH seta' kien aġġustat b'sodium hydroxide u acetic acid.
English: Reproduction studies carried out with ganirelix at doses of 0.1 to 10 g/kg/day subcutaneously in the rat and 0.1 to 50 g/kg/day subcutaneously in the rabbit showed increased litter resorption in the highest dose groups.
Maltese: Studji fuq is-sistema riproduttiva b'ganirelix b' dożi ta' 0.1 sa 10 g/kg/jum taħt il-ġilda fil-far u 0.1 sa 50 g/kg/jum taħt il-ġilda fil-fenek, urew assorbiment mill-ġdid ogħla tal-boton f'dawk il-gruppi li ngħataw l-ogħla doża.
English: Ovarian stimulation with follicle stimulating hormone (FSH) or corifollitropin may start at day 2 or 3 of your period.
Maltese: Stimulazzjoni ovarjana bl-ormon li jistimula l-follikulu (FSH) jew corifollitropin jista' jibda fit-2 jew 3 jum tal-period tiegħek.
English: Nervous system disorders
Maltese: Disturbi fis-sistema nervuża Mhux Komuni
English: The metabolite profile of Orgalutran in humans was similar to that found in animals.
Maltese: Il-profil tal-metaboliti ta' lOrgalutran fil-bniedem huwa bħal dak ta' l-annimali.
English: In controlled studies of Orgalutran with FSH, using a long protocol of GnRH agonist as a reference, treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol.
Maltese: Waqt studji kkontrollati b' Orgalutran ma' FSH, bl-użu ta' protokolli twal ta' agonisti ta' GnRH bħala referenza, trattament b'kors ta' Orgalutran ikkaġuna żvilupp follikulari aktar malajr fl-ewwel jiem ta' listimulazzjoni, iżda ir-riżultat finali ta' ko-orti ta' follikuli li qed jikbru kienu kemm xejn inqas u nixxew bejn wieħed u ieħor anqas oestradiol.
English: In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the womb) and miscarriage (see the patientinformation leaflet of the FSH-containing preparation you are treated with)).
Maltese: Barra minn hekk, effetti sekondarji huma rrapportati magħrufa li jseħħu mat-trattament ikkontrollat ta' stimulazzjoni eċċessiva ovarjana eż. uġigħ ta' żaqq, sindrome ta' l-istimulazzjoni eċċessiva (OHSS), tqala barra mill-utru (meta l-embriju jiżviluppa 'l barramill-utru), u korriment (ara l-fuljett ta' tagħrif tal-preparazzjoni li fiha l-FSH li int trattat għaliha)).
English: Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes.
Maltese: Ganirelix jintuża fit-trattament ta' nisa li jkun qed ikollhom iperstimulazzjoni kkontrollata tal-ovarji fi programmi ta' riproduzzjoni assistita.
English: Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Similar comparative studies with corifollitropin alfa using either a GnRH antagonist or long agonist protocol have not been performed.
Maltese: Ma sarux studji simili komparattivi b'corifollitropin alfa bl-użu jew ta' antagonist ta' GnRH jew bi protokoll ta' agonist twil.
English: The efficacy and safety of Orgalutran has not been established in women weighing less than 50 kg or more than 90 kg.
Maltese: L-effikaċja u sigurtà ta' Orgalutran ma ġewx stabbiliti għal nisa li jiżnu anqas minn 50 kg jew aktar minn 90 kg.
English: Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland.
Maltese: Orgalutran huwa antagonist ta' GnRH u jimmodola l-assi ipotalamika-pitwitarja-gonadali, billi jikkompeti biex jintrabat għar-riċetturi tal-GnRH fil-glandola pitwitarja.
English: How to store Orgalutran
Maltese: Jekk tinsa tuża Orgalutran
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Maltese: Orgalutran fih anqas minn 1 mmol sodium (23 mg) f'kull injezzjoni, jiġifieri essenzjalment 'ħieles missodium'.
English: Pharmacokinetic analysis indicates an inverse relationship between body weight and serum concentrations of Orgalutran.
Maltese: Analiżi farmakokinetika tindika li hemm relazzjoni inversa bejn il-piż tal-ġisem u l-konċentrazzjonijiet ta' Orgalutran fis-serum.
English: Paediatric population There is no relevant use of Orgalutran in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Orgalutran fil-popolazzjoni pedjatrika.
English: This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the woman, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques.
Maltese: Din l-inċidenza kemm kemm ogħla hi maħsuba li għandha x'taqsam mal-karatteristiċi tal-pazjenti li jkunu qed jingħataw trattament tal-fertilità (e.g. letà tal-mara, karatteristiċi ta' l-isperma) u l-inċidenza ogħla tal-ġestazzjonijiet multipliċi wara t-tekniċi tar-riproduzzjoni assistita.
English: Water for injections.
Maltese: Ilma għal injezzjoni.
English: • Facial swelling
Maltese: Ż-ŻGĦAR EWLENIN
English: In clinical studies investigating more than 1,000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.
Maltese: Fi studji kliniċi li nvestigaw aktar minn 1,000 tarbija li għadha kif twieldet, intwera li l-inċidenza ta'malformazzjonijiet konġenitali fi tfal li twieldu wara t-trattament COH meta jintuża Orgalutran hi paragunabbli ma dak irrappurtat wara t-trattament COH meta jintuża l-antagonist GnRH.