FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro, niraparib weakly induces CYP1A2 at high concentrations and the clinical relevance of this effect would not be completely ruled out.
Maltese: In vitro, niraparib jinduċi b'mod dgħajjef CYP1A2 f'konċentrazzjonijiet għoljin u r-relevanza klinika ta' dan l-effett ma tiġix eliminata.
English: The dose is three 100 mg hard capsules once daily, equivalent to a total daily dose of 300 mg.
Maltese: Id-doża hija ta' tliet kapsuli ibsin ta' 100 mg darba kuljum, ekwivalenti għal doża totali ta' kuljum ta' 300 mg.
English: Zejula is used in adult women for the treatment of cancer of the ovary, the fallopian tubes (part of the female reproductive system that connects the ovaries to the uterus), or the peritoneum (the membrane lining the abdomen).
Maltese: Zejula jintuża f'nisa adulti għall-kura tal-kanċer tal-ovarju, tat-tubi fallopjani (parti mis-sistema riproduttiva tan-nisa li tgħaqqad l-ovarji mal-utru), jew tal-peritonjum (il-membrana li tiksi l-addome).
English: The major primary metabolite M1 is not a substrate of P-gp, BCRP, or BSEP.
Maltese: M1 mhuwiex sottostrat ta' P-gp, BCRP, jew BSEP.
English: Therefore, the PRAC concluded that “febrile neutropenia” should be added as a new adverse drug reaction in section 4.8 of the SmPC with the frequency “uncommon.” The package leaflet should be updated accordingly.
Maltese: Għalhekk, il-PRAC ikkonkluda li “newtropenja bid-deni” għandha tiżdied bħala reazzjoni avversa għal mediċina ġdida f'sezzjoni 4.8 tal-SmPC bil-frekwenza “mhux komuni”.
English: Even though inhibition of CYP3A4 in the liver is not expected, the potential to inhibit CYP3A4 at the intestinal level has not been established at relevant niraparib concentrations.
Maltese: Għalkemm mhix mistennija inibizzjoni ta' CYP3A4 fil-fwied, il-potenzjal li jiġi inibit CYP3A3 fillivell tal-musrana ma ġiex stabbilit bil-konċentrazzjonijiet relevanti ta' niraparib.
English: Inhibition of renal uptake transporters (OAT1, OAT3, and OCT2) Neither niraparib nor M1 inhibits organic anion transporter 1 (OAT1), 3 (OAT3), and organic cation transporter 2 (OCT2).
Maltese: La niraparib u lanqas M1 ma jinibixxu trasportatur anijoniku organiku 1 (OAT1), 3 (OAT3), u trasportatur katjoniku organiku 2 (OCT2).
English: Headache, dizziness, dysgeusia
Maltese: Komuni ħafna Dispnea, sogħla, nażofarinġite Komuni
English: Discontinuation due to hypertension occurred in < 1 % of patients.
Maltese: Kien hemm twaqqif minħabba l-ipertensjoni f'< 1 % tal-pazjenti.
English: If adverse reactions persist beyond a 28-day dose interruption, it is recommended that Zejula be discontinued.
Maltese: Jekk irreazzjonijiet avversi jippersistu għal aktar minn interruzzjoni fid-doża ta' 28 jum, huwa rakkomandat li Zejula jitwaqqaf.
English: Increased niraparib-induced cytotoxicity was observed in tumour cell lines with or without deficiencies in the BReast CAncer (BRCA) 1 and 2 tumour suppressor genes.
Maltese: Ġiet osservata ċitotossiċità miżjuda indotta minn niraparib f'linji taċ-ċelluli tat-tumur bi jew mingħajr defiċjenzi fil-ġeni li jrażżnu t-tumuri tal-antiġen relatat mal-Kanċer tas-Sider (BRCA, BReast CAncer) 1 u 2.
English: Hypertension, including hypertensive crisis
Maltese: Pressjoni għolja, inkluż kriżi ipertensiva
English: Insomnia, anxiety, depression
Maltese: Mhux komuni Insomnja, ansjetà, dipressjoni
English: • Resume Zejula at a reduced dose (100 mg/day).
Maltese: Kompli Zejula mill-ġdid b'doża mnaqqsa (100 mg/jum).
English: Patient-reported outcome (PRO) data from validated survey tools (FOSI and EQ-5D) indicate that niraparib-treated patients reported no difference from placebo in measures associated with quality of life (QoL).
Maltese: Dejta ta' riżultat irrappurtat mill-pazjent (PRO) minn għodod ta' stħarriġ validati (FOSI u EQ-5D) tindika li l-pazjenti kkurati b'niraparib ma rrappurtaw l-ebda differenza mill-plaċebo f'miżuri assoċjati mal-kwalità tal-ħajja (QoL).
English: In vitro, niraparib inhibited the dopamine transporter DAT at concentration levels below human exposure levels.
Maltese: In vitro, niraparib inibixxa t-trasportatur dopamina DAT f'livelli ta' konċentrazzjoni aktar baxxi millivelli tal-esponiment għall-bniedem.
English: Back pain, arthralgia
Maltese: Komuni Għeja, astenija
English: Manufacturer
Maltese: Organi
English: • Stomach pain
Maltese: • Testijiet tad-demm elevati
English: Zejula contains lactose
Maltese: Kif jidher Zejula u l-kontenut tal-pakkett
English: Clinic visits occurred each cycle (4 weeks ± 3 days).
Maltese: Il-visti kliniċi saru kull ċiklu (4 ġimgħat ± 3 ijiem).
English: Zejula is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
Maltese: Zejula huwa indikat bħala monoterapija għall-kura ta' manteniment ta' pazjenti adulti b'kanċer rikadut ta' grad għoli sensittiv għall-platinu, seruż epiteljali tal-ovarji, tat-tubu fallopjan, jew peritoneali primarju li jinsabu f'rispons (sħiħ jew parzjali) għal kimoterapija bbażata fuq il-platinu.
English: This clastogenicity is consistent with genomic instability resulting from the primary pharmacology of niraparib and indicates potential for genotoxicity in humans.
Maltese: Din il-klastoġeniċità hija konsistenti ma' instabbiltà ġenomika li tirriżulta mill-farmakoloġija primarja ta' niraparib u tindika potenzjal għal effett tossiku fuq il-ġeni filbnedmin.
English: The pharmacokinetics of niraparib have not been assessed in patients with severe hepatic impairment (see section 4.2).
Maltese: Il-farmakokinetiċi ta' niraparib ma ġewx ivvalutati f'pazjenti b'indeboliment tal-fwied sever (ara sezzjoni 4.2).
English: Hypertension, including hypertensive crisis, has been reported with the use of Zejula.
Maltese: Ġiet irrappurtata l-ipertensjoni, inkluż kriżi ipertensiva, bl-użu ta' Zejula.
English: Hepatic impairment
Maltese: Komuni ħafna Ipertensjoni
English: Inhibition of efflux transporters (P-gp, BCRP, BSEP, and MATE1/2) Niraparib is not an inhibitor of BSEP.
Maltese: Jekk tesperjenza effetti sekondarji (bħal nawsja, għeja, fsada/tbenġil anormali, anemija), it-tabib tiegħek jista' jirrakkomanda doża aktar baxxa.
English: Dose modifications for haematologic adverse reactions
Maltese: Modifikazzjonijiet fid-doża għal reazzjonijiet avversi ematoloġiċi
English: Haematologic adverse reactions
Maltese: Reazzjonijiet avversi ematoloġiċi
English: No effect on behavioural and/or neurological parameters have been observed in repeat-dose toxicity studies in rats and dogs at estimated CNS exposure levels similar to or below expected therapeutic exposure levels.
Maltese: tossiċità ta' doża ripetuta fil-firien u l-klieb b'livelli ta' esponiment għal CNS stmati simili jew inqas mil-livelli ta' esponiment terapewtiċi mistennija.
English: Approximately 30 % of patients receiving Zejula experienced neutropenia of any grade, and 20 % of patients experienced Grade 3/4 neutropenia.
Maltese: Madwar 30 % tal-pazjenti li kienu qed jirċievu Zejula esperjenzaw newtropenja ta' xi grad, u 20 % esperjenzaw newtropenja ta' Grad 3/4.
English: This leaflet was last revised in MM/YYYY.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżulin
English: • Abdominal bloating
Maltese: • Nefħa addominali
English: In the clinical programme, anaemia was managed with laboratory monitoring, dose modification (see section 4.2), and where appropriate with red blood cell transfusions.
Maltese: Fil-programm kliniku, l-anemija ġiet immaniġġjata permezz ta' monitoraġġ tal-laboratorju, modifikazzjoni fid-doża (ara sezzjoni 4.2), u fejn xieraq, trasfużjonijiet taċ-ċelluli ħomor tad-demm.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq(MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-awtorizzazzjoni għat-tqegħid fis-suq u kwalunkwe aġġornament sussegwenti maqbul talRMP.
English: Overall, the PRAC considered that the preferred term febrile neutropenia was adequate to describe the cases reviewed within this PSUSA.
Maltese: Niraparib jiġi eliminat primarjament permezz ta' rotot epatobiljari u renali.
English: In the population pharmacokinetic analysis of data from clinical studies in patients, pre-existing mild and moderate hepatic impairment did not influence the clearance of niraparib.
Maltese: Fl-analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji kliniċi fil-pazjenti, indeboliment talfwied ħafif u moderat preeżistenti ma affettwax l-eliminazzjoni ta' niraparib.
English: • Runny or stuffy nose
Maltese: • Livelli baxxi ta' potassju fid-demm
English: Dyspnea
Maltese: Treddigħ
English: Population pharmacokinetic analyses indicated that age, weight and race had no significant impact on the pharmacokinetics of niraparib.
Maltese: Analiżijiet farmakokinetiċi tal-popolazzjoni indikaw li l-età, il-piż u r-razza ma kellhom l-ebda impatt sinifikanti fuq il-farmakokinetiċi ta' niraparib.
English: Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported in patients treated with Zejula.
Maltese: Ġew irrappurtati reazzjonijiet avversi ematoloġiċi (tromboċitopenja, anemija, newtropenja) f'pazjenti kkurati b'Zejula.
English: The primary tumour site in most patients (> 80 %) within each cohort was the ovary; most patients (> 84 %) had tumours with serous histology.
Maltese: Is-sit primarju tat-tumur f'ħafna mill-pazjenti (> 80 %) f'kull koorti kien l-ovarju; ħafna mill-pazjenti (> 84 %) kellhom istoloġija seruża.
English: No dose adjustment for Zejula is required when administered concomitantly with medicinal products known to inhibit OATP1B1 or 1B3 (e.g. gemfibrozil, ritonavir), or OCT1 (e.g. dolutegravir) uptake transporters.
Maltese: Mhu meħtieġ l-ebda aġġustament fid-doża għal Zejula meta jingħata flimkien ma' prodotti mediċinali magħrufa li jinibixxu t-trasportaturi tal-assorbiment OATP1B1 jew 1B3 (eż. gemfibrozil, ritonavir), jew OCT1 (eż. dolutegravir).
English: The safety and efficacy of niraparib in children and adolescents below 18 years of age have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' niraparib fit-tfal u fl-adolexxenti taħt l-età ta' 18-il sena għadhom ma ġewx determinati s'issa.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for niraparib, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal niraparib, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Low blood-cell counts
Maltese: Indeboliment tal-fwied
English: Niraparib can cause haematological toxicity that includes febrile neutropenia.
Maltese: Niraparib jista' jikkawża tossiċità ematoloġika li tinkludi newtropenja bid-deni.
English: Zejula should not be used during pregnancy or in women of childbearing potential not willing to use reliable contraception during therapy and for 1 month after receiving the last dose of Zejula (see section 4.6).
Maltese: Zejula m'għandux jingħata waqt it-tqala jew f'nisa li jistgħu joħorġu tqal li ma jkunux lesti jużaw kontraċettiv affidabbli waqt it-terapija u għal xahar wara li jirċievu l-aħħar doża ta' Zejula (ara sezzjoni 4.6).
English: • if you are breast-feeding.
Maltese: • Kompli ħu Zejula b'doża mnaqqsa.
English: Leukopenia
Maltese: Lewkopenja
English: Gamma-glutamyl transferase increased * Frequencies are based on percent of patients using all-causality adverse events.
Maltese: Żieda fil-gamma-glutamyl transferase * Il-frekwenzi huma bbażati fuq perċentwal ta' pazjenti bl-użu ta' avvenimenti avversi ta' kull tip.
English: Strength
Maltese: jingħata
English: 10 June 2016
Maltese: 10 ta' Ġunju 2016
English: Outcome of a procedure under Article 33(4) of Directive 2001/82/EC, as amended
Maltese: Riżultat ta' proċedura skont l-Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendata
English: The company requested the authorisation to be recognised in Bulgaria, Croatia, France, Germany, Ireland, Italy, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain and the United Kingdom (the ‘concerned Member States').
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tkun rikonoxxuta fil-Bulgarija, fil-Kroazja, fi Franza, fil-Ġermanja, fl-Irlanda, fl-Italja, fin-Netherlands, fil-Polonja, filPortugall, fir-Rumanija, fis-Slovenja, fi Spanja u fir-Renju Unit ('l-Istati Membri kkonċernati').
English: What is CattleMarker IBR Inactivated?
Maltese: X'inhu CattleMarker IBR Inattivat?
English: CattleMarker IBR Inactivated is an inactivated infectious bovine rhinotracheitis (IBR) vaccine which contains inactivated glycoprotein E (gE) negative bovine herpes virus 1 (BoHV-1), strain Difivac.
Maltese: CattleMarker IBR Inattivat huwa vaċċin ta' rinotrakeite tal-bovini li tittieħed (IBR) inattivata li fiha lvirus tal-ħerpes tal-bovini negattiv għal glikoproteina E (gE) (BoHV-1), razza Difivac.
English: On 17 March 2016, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine CattleMarker IBR Inactivated emulsion for injection for cattle (thereafter called CattleMarker IBR Inactivated).
Maltese: Fis-17 ta' Marzu 2016, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni talmediċina l-emulsjoni ta' CattleMarker IBR Inattivat għall-injezzjoni għall-frat (minn issa 'l quddiem imsejħa CattleMarker IBR Inattivat).
English: The grounds for the referral were concerns raised by Germany regarding the immunological safety of CattleMarker IBR Inactivated, as the composition and manufacture of this product are similar to PregSure BVD, a vaccine from Zoetis which has been shown to induce a long-lasting allogeneic antibody response that has been associated with Bovine Neonatal Pancytopenia, a neonatal alloimmune disease, in the progeny of vaccinated dams.
Maltese: Ir-raġunijiet għar-riferiment kien tħassib imqajjem mill-Ġermanja rigward is-sikurezza immunoloġika ta' CattleMarker IBR Inattivat, minħabba li l-kompożizzjoni ta' dan il-prodott hija simili għal ta' PregSure BVD, vaċċin ta' Zoetis li ntwera li jinduċi rispons fit-tul tal-antikorp alloġeniku li ġie assoċjat ma' Panċitopenija Neonatali Bovina (BNP), marda alloimmunitarja neonatali, fil-wild tal-ommijiet imlaqqma. CattleMarker IBR Inattivat huwa prodott fuq l-istess linja ta' ċelloli tal-bovini u huwa ssupplimentat mill-istess aġġuvant qawwi ħafna bħal PregSure BVD.
English: Why was CattleMarker IBR Inactivated reviewed?
Maltese: Għaliex CattleMarker IBR Inattivat ġie rieżaminat?
English: Questions and answers on CattleMarker IBR Inactivated emulsion for injection for cattle (inactivated gE Bovine Herpes Virus type 1 (BoHv-1), strain Difivac)
Maltese: Mistoqsijiet u tweġibiet dwar l-emulsjoni ta' CattleMarker IBR Inattivat għall-injezzjoni għall-frat (virus tal-Ħerpes tal-Bovini tat-tip 1 inattivat tal-gE (BoHv-1), razza Difivac)
English: Active immunisation of female cattle from 6 months of age is also indicated to reduce the clinical signs (pyrexia and duration of dyspnoea) of IBR and virus shedding caused by BoHV-1 infection and to reduce the incidence of abortions associated with BoHV-1 infections as demonstrated during the second trimester of gestation following challenge.
Maltese: L-immunizzazzjoni attiva tal-frat nisa mill-età ta' 6 xhur hija indikata wkoll sabiex tnaqqas issinjali kliniċi (piressija u t-tul ta' żmien ta' dispneja) tal-IBR u tat-tixrid tal-virus ikkawżat millinfezzjoni BoHV-1 u sabiex tnaqqas l-inċidenza tal-aborti assoċjati mal-infezzjonijiet tal-BoHV-1 kif muri waqt it-tieni trimestru tal-ġestazzjoni wara l-isfida.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that subject to the conduct of additional studies and the implementation of further measures specified in a Risk Management Plan the marketing authorisation for CattleMarker IBR Inactivated should be granted in all concerned Member States.
Maltese: Skont l-evalwazzoni tad-data disponibbli attwalment u d-diskussjoni xjentifika li saret fil-Kumitat, isCVMP ikkonkluda li soġġett għat-twettiq ta' studji addizzjonali u l-implimentazzjoni ta' aktar miżuri speċifikati fi Pjan ta' Ġestjoni tar-Riskju, l-awtorizzazzjoni għat-tqegħid fis-suq għal CattleMarker IBR Inattivat għandha tingħata fl-Istati Membri kkonċernati kollha.
English: The potential risk of recurrence of Bovine Neonatal Pancytopenia linked to the use of this vaccine in pregnant cows had been addressed by Zoetis; however Germany considered that the proposed handling of the risks was inadequate and that a large scale post authorisation study should be initiated by Zoetis.
Maltese: Ir-riskju potenzjali ta' rikorrenza tal-Panċitopenija Neonatali Bovina relatata mal-użu ta' dan il-vaċċin f'baqar tqal ġie indirizzat minn Zoetis; madankollu l-Ġermanja kkunsidrat li l-immaniġġjar propost tarriskji kien inadegwat u li Zoetis għandu jibda studju ta' wara l-awtorizzazzjoni fuq skala kbira.
English: However, the Member States could not reach an agreement and the Belgian Federal Agency for Medicines and Health Products referred the matter to the CVMP for arbitration on 29 September 2015.
Maltese: Madankollu, l-Istati Membri ma kinux kapaċi jaslu għal ftehim u d-Direttorat tal-Mediċini Veterinarji Belġjan irrefera l-kwistjoni lis-CVMP għal arbitraġġ fid-29 ta' Settembru 2015.
English: The product is indicated for active immunisation of seronegative cattle from 2 weeks of age to reduce the clinical signs (pyrexia and depression) of IBR and the duration of virus shedding caused by BoHV-1 infection.
Maltese: Dan il-prodott huwa indikat għall-immunizzazzjoni ta' frat seronegattivi mill-età ta' ġimagħtejn biex jitnaqqsu s-sinjali kliniċi (piressija u dipressjoni) tal-IBR u t-tul ta' żmien tat-tixrid tal-virus ikkawżat mill-infezzjoni BoHV-1.
English: Zoetis Belgium SA submitted an application for CattleMarker IBR Inactivated for mutual recognition on the basis of the initial authorisation granted by Belgium.
Maltese: Zoetis Belgium SA ippreżentat CattleMarker IBR Inattivat għal rikonoxximent reċiproku abbażi talawtorizzazzjoni inizjali mogħtija mill-Belġju.
English: (* equivalent to titre prior to inactivation)
Maltese: (*) ekwivalenti għal titrazzjoni qabel ma jiġi inattivat (log 10)
English: EMA Number
Maltese: Imballaġġ
English: Γ. Παπαλοϊζου Λτδ Τηλ.
Maltese: Χρ. Γ. Παπαλοϊζου Λτδ Τηλ.:
English: E - 28760 Tres Cantos (Madrid) Spain
Maltese: E - 28760 Tres Cantos (Madrid) Spanja
English: Dose (IU)
Maltese: Doża (IU)
English: 25°C).
Maltese: 25°C jew inqas).
English: Need to increase the dose (%)
Maltese: Bżonn ta' żieda fid-doża (%)
English: Date of latest renewal: 20 October 2010.
Maltese: Data tal-aħħar tiġdid: 20 ta' Ottubru 2010
English: • The active substance is follitropin alfa.
Maltese: • Is-sustanza attiva hi follitropin alfa.
English: The following definitions apply to the frequency terminology used hereafter: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
Maltese: Id-definizzjonijiet li ġejjin japplikaw għat-terminoloġija ta' frekwenza użata minn hawn 'il quddiem: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000).
English: Vascular disorders Very rare:
Maltese: Disturbi vaskulari Rari ħafna:
English: Table: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of GONAL-f with urinary FSH in assisted reproduction technologies)
Maltese: Tabella: Riżultati ta' studju GF 8407 (studju randomised, fi grupp parallel, li jqabbel l-effikaċja u sigurtà ta' GONAL-f ma' FSH urinarju f'teknoloġiji ta' riproduzzjoni assistita).
English: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, The Netherlands.
Maltese: Merck Europe B.V., Gustav Mahlerplein 102, 1082 MA Amsterdam, L-Olanda
English: GONAL-f contains a medicine called “follitropin alfa”.
Maltese: GONAL-f fih mediċina msejħa ‘follitropin alfa'.
English: Phosphoric acid, concentrated Sodium hydroxide
Maltese: Phosphoric acid, konċentrat Sodium hydroxide
English: 8 needles.
Maltese: 8 labar.
English: Independent risk factors for developing OHSS include polycystic ovarian syndrome high absolute or rapidly rising serum oestradiol levels (e.g. > 900 pg/mL or > 3,300 pmol/L in anovulation; > 3,000 pg/mL or > 11,000 pmol/L in ART) and large number of developing ovarian follicles (e.g. > 3 follicles of ≥ 14 mm in diameter in anovulation; ≥ 20 follicles of ≥ 12 mm in diameter in ART).
Maltese: Il-fatturi indipendenti ta' riskju għal żvilupp ta' OHSS jinkludu s-sindrome poliċistiku tal-ovarji, livelli assoluti għoljin ta' oestradiol fis-serum jew li jiżdiedu b'mod mgħaġġel (eż. > 900 pg/mL jew > 3,300 pmol/L mhux f'ovulazzjoni; > 3,000 pg/mL jew > 11,000 pmol/L f'ART) u numru kbir ta' follikuli tal-ovarji li jkunu qed jiżviluppaw (eż. > 3 follikuli b'dijametru ta' ≥ 14 fin-nuqqas ta' ovulazzjoni; ≥ 20 follikolu b'dijametru ta' ≥ 12 mm f'ART).
English: Gonadotropins are involved in reproduction and fertility.
Maltese: Ilgonadotropins huma involuti fir-riproduzzjoni u l-fertilità.
English: GONAL-f is indicated for use in infertility (see section 4.1).
Maltese: GONAL-f hu indikat għall-użu f'każ ta' infertilità (ara sezzjoni 4.1).
English: Merck Serono S.p.A., Via delle Magnolie 15, I-70026 Modugno (Bari) Italy
Maltese: Merck Serono S.p.A., Via delle Magnolie 15, I-70026 Modugno (Bari)
English: Merck Serono S.p.A., Via delle Magnolie 15, I-70026 Modugno (Bari), Italy.
Maltese: Merck Serono S.p.A., Via delle Magnolie 15, I-70026 Modugno (Bari), L-Italja.
English: • 2 alcohol swabs
Maltese: • 2 biċċiet bl-alkoħol
English: 75 UI (5,5 μg)
Maltese: IU (5.5 μg)
English: Water for injections Benzyl alcohol
Maltese: Ilma għall-injezzjonijiet Benzyl alcohol
English: Differences between the 2 groups were statistically significant (p< 0.05) for all criteria listed.
Maltese: Differenzi bejn iż-żewġ gruppi kienu statistikament sinifikanti (p< 0.05) għal kriterji kollha elenkati.
English: The pen contains 300 IU follitropin alpha.
Maltese: Il-pinna fiha 300 IU follitropin alpha.
English: • Record the treatment day number (1), date (2) and time (3) of your injection.
Maltese: • Niżżel in-numru tal-jum tal-kura (1), id-data (2) u l-ħin (3) tal-injezzjoni tiegħek.
English: CAUTION:
Maltese: ATTENZJONI:
English: • For further injections with the prepared solution of GONAL-f, repeat steps 4. to 7.
Maltese: • Għal aktar injezzjonijiet bis-soluzzjoni ppreparata ta' GONAL-f, irrepeti passi 4 sa 7.
English: Follitropin alfa, 600 IU/mL (equivalent to 44 micrograms/mL)
Maltese: IU/mL (ekwivalenti għal 44 mikrogramma/mL)
English: Alcohol swabs
Maltese: Swabs tal-alkoħol
English: • primary testicular insufficiency
Maltese: • insuffiċenzja primarja tat-testikoli
English: Note: The 300 IU pen maximum single-dose setting is 300 IU; the 450 IU pen maximum single-dose setting is 450 IU; the 900 IU pen maximum single-dose setting is 450 IU.
Maltese: Nota: Is-setting ta' doża waħda massima tal-pinna ta' 300 IU huwa 300 IU; is-setting ta' doża waħda massima tal-pinna ta' 450 IU huwa 450 IU; is-setting ta' doża waħda massima tal-pinna ta' 900 IU huwa 450 IU.
English: INFORMATION IN BRAILLE gonal-f 1050 iu
Maltese: INFORMAZZJONI BIL-BRAILLE gonal-f 1050 iu
English: INFORMATION IN BRAILLE gonal-f 75 iu
Maltese: INFORMAZZJONI BIL-BRAILLE gonal-f 75 iu
English: • malformations of sexual organs incompatible with pregnancy
Maltese: • malformazzjoni tal-organi sesswali li jkunu inkompatibbli mat-tqala
English: 600 IU (44 g)/vial
Maltese: IU (44 g)/kunjett
English: • 1 needle for preparation
Maltese: • 1 labra għall-preparazzjoni