FrancophonIA/ELRC3.0 huggingface dataset:
English: MEPACT must not be administered as a bolus injection.
Maltese: MEPACT m'għandux jingħata bħala injezzjoni bolus.
English: The bag injection site should be wiped with an alcohol pad and the suspension in the syringe should be injected into the original bag containing the remaining 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (figure 4).
Maltese: Is-sit tal-borża ta' injezzjoni għandha tiġi mimsuħa b'pad bl-alkoħol u s-suspensjoni fis-siringa għandha tiġi injettata fil-borża oriġinali li fiha l- 50 mL ta' sodium chloride li jibqa' 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni (stampa 4).
English: Peripheral oedema, Oedema, Mucosal inflammation, Infusion site erythema, Infusion site reaction, Catheter site pain, Chest discomfort, Feeling cold
Maltese: Edima periferali, edima, infjammazzjoni talmukosa, eritima fis-sit tal-infużjoni, reazzjoni fis-sit tal-infużjoni, uġigħ fis-sit tal-kateter, uġigħ fis-sider, tħoss il-bard
English: Dyspnoea, Tachypnoea, Cough
Maltese: Komuni ħafna Dispnea, takipnea, sogħla Komuni
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1
English: Pericardial effusion
Maltese: Popolazzjoni speċjali
English: Materials required but not provided:
Maltese: Materjali meħtieġa iżda mhux ipprovduti:
English: Hepatic pain
Maltese: Uġigħ epatiku
English: The maximum tolerated dose in phase I studies was 4-6 mg/m with a high variability of adverse reactions.
Maltese: Id-doża massima ttolerata fi-studji fażi I kienet 4-6 mg/m² b'varjabbilità għolja ta' reazzjonijet avversi.
English: These changes were not considered to be clinically meaningful as the maximum tolerated dose (4-6 mg/m2) of mifamurtide is
Maltese: Dawn il-bidliet ma tqisux li għandhom relevanza klinika billi d-doża massima tollerata (4-6 mg/m2) ta' mifamurtide hija 2-3 darbiet id-doża rakkomandata (2 mg/m2)
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta tal-kunjett u l-kartuna wara “EXP”.
English: After injection of radiolabelled liposomes containing mifamurtide, mean half-life of radiolabelled material was biphasic with an α-phase of about 15 minutes and a terminal half-life of approximately 18 hours.
Maltese: Wara injezzjoni ta' liposomi radju-ittikkettjat u li fihom mifanurtide, il-medja tal-half-life ta' materjal radju-ittikkettjat kienet biphasic b'fażi α ta' madwar 15-il minuta u half-life terminali ta' madwar 18-il siegħa.
English: Nausea, vomiting and loss of appetite are very common adverse reactions to mifamurtide (see section 4.8).
Maltese: Dardir, rimettar u telf ta' aptit huma reazzjonijiet avversi verament komuni għal mifamurtide (ara sezzjoni 4.8).
English: Because mifamurtide acts through stimulation of the immune system, the chronic or routine use of corticosteroids should be avoided during treatment with mifamurtide.
Maltese: Minħabba li mifamurtide jaħdem permezz ta' stimulazzjoni tas-sistema immuni, l-użu kroniku jew ta' rutina ta' kortikosterojdi għandu jiġi evitat waqt il-kura b'mifamurtide.
English: The use of mifamurtide concurrently with ciclosporin or other calcineurin inhibitors is contraindicated due to their hypothesised effect on splenic macrophages and mononuclear phagocytic function (see section 4.3).
Maltese: L-użu ta' mifamurtide flimkien ma' ciclosporin u inibituri ta' calcineurin oħrajn huwa kontraindikat minħabba l-effett ipotezzat tagħhom fuq il-makrofaġi tal-milsa u l-funzjoni fagoċitika mononuklejari (ara sezzjoni 4.3).
English: It should be administered as adjuvant therapy following resection: twice weekly at least 3 days apart for 12 weeks, followed by once-weekly treatments for an additional 24 weeks for a total of 48 infusions in 36 weeks.
Maltese: Għandha tiġi mogħtija bħala terapija addizzjonali wara r-risezzjoni: darbtejn fil-ġimgħa ta' l-anqas bi 3 ijiem bogħod minn xulxin għal 12 -il ġimgħa, segwita minn trattamenti ta' darba fil-ġimgħa għal 24 ġimgħa oħra għal total ta' 48 infużjoni għal 36 ġimgħa.
English: Limited studies of the interaction of mifamurtide with chemotherapy have been conducted.
Maltese: Saru studji limitati tal-interazzjoni ta' mifamurtide mal-kimoterapija.
English: Volume
Maltese: U KWANTITATTIVA
English: Each vial should be reconstituted with 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Kull kunjett għandu jkun rikonstitwit b' 50 mL ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%).
English: Anaemia
Maltese: Pożoloġija
English: The 100 mL sodium chloride 9 mg/mL (0.9%) solution for injection bag, needle and syringe should be unpacked (not provided in the pack).
Maltese: Il-borża ta' 100 mL soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%), labra u siringa għandhom jitneħħew mill-pakkett (mhux ipprovduti fil-pakkett).
English: In vivo administration of mifamurtide resulted in the inhibition of tumour growth in mouse and rat models of lung metastasis, skin and liver cancer, and fibrosarcoma.
Maltese: Amministrazzjoni in vivo ta' b'mifamurtide rriżulatat f'inibizzjoni ta' tkabbir ta' tumur fil-ġurdin u l-far użati bħala mudelli ta' metastażi tal-pulmun, tal-ġilda u tal-fwied u fibrosarkoma.
English: Occasional allergic reactions have been associated with mifamurtide treatment, including rash, shortness of breath and grade 4 hypertension (see section 4.8).
Maltese: Xi kultant reazzjonijiet allerġiċi ġew assoċjati ma' kura b' mifamurtide, inklużi raxx, qtugħ ta' nifs u ipertensjoni grad 4 (ara sezzjoni 4.8).
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħażna tal-prodott mediċinali wara r-rikostituzzjoni, ara sezzjoni 6.3.
English: In a phase I study, there was one report of severe allergic reaction occurring after the first infusion of mifamurtide at 6 mg/m dose level.
Maltese: F'studju ta' fażi I, kien hemm rapport wieħed ta' reazzjoni allerġika severa li seħħet wara l-ewwel infużjoni ta' mifamurtide f'doża ta' livell 6 mg/m2.
English: Using the needle and syringe, 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection should be withdrawn from the bag.
Maltese: Permezz tal-użu tal-labra u s-siringa, 50 mL ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%) għandhom jinġibdu mill-borża.
English: Mifamurtide is, therefore, not expected to interact with the metabolism of substances that are hepatic cytochrome P450 substrates.
Maltese: Mifamurtide għaldaqstant mhuwiex mistenni li jkollu effett reċiproku mal-metaboliżmu ta' sustanzi li huma sottostrati taċ-ċitokroma epatika P450.
English: The volume of reconstituted suspension corresponding to the calculated dose is extracted through the filter provided and further diluted with additional 50 mL sodium chloride 9 mg/mL (0.9%) solution for injection according to the detailed instructions shown below.
Maltese: Il-volum ta' soupenzjoni rikostitwita li tikkorrispondi mad-doża kalkulata hija estratta mill-filtru pprovdut u mħallat ukoll ma' 50 mL soluzzjoni ta' sodju kloriku 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni skond l-istruzzjonijiet dettaljati murija hawn taħt.
English: In 21 healthy adult subjects mifamurtide was cleared rapidly from serum (minutes) with a half-life of 2.05 ± 0.40 hours, resulting in a very low serum concentration of total (liposomal and free) mifamurtide.
Maltese: F'21 persuna adulta u b'saħħitha mifamurtide ġiet imneħħija malajr mis-serum (minuti) b'half-life ta' 2.05 ± 0.40 siegħat, b'riżultat ta' konċentrazzjoni baxxa ħafna ta' mifamurtide totali (lipożomali u libera)fis-serum'.
English: The safety and efficacy of mifamurtide in children aged 0 to 2 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' mifamurtide fit-tfal minn età 0 sa 2 snin ma ġewx determinati.
English: Lot
Maltese: Volum
English: Metabolism of liposomal MTP-PE has not been studied in humans.
Maltese: Il-metaboliżmu ta' MTP-PE liposomali ma ġiex studjat fil-bnedmin.
English: MEPACT is supplied in a carton that contains - One 50 mL vial with a grey butyl stopper, aluminium seal and plastic flip-off cap. - One sterile filter for MEPACT supplied in a blister.
Maltese: MEPACT huwa fornut f'kartuna li fiha - Kunjett wieħed ta' 50 mL b'tapp griż tal-butyl, siġill tal-aluminju u għatu tat-tarf flip-off tal-plastik.
English: The patient experienced shaking, chills, fever, nausea, vomiting, uncontrollable coughing, shortness of breath, cyanotic lips, dizziness, weakness, hypotension, tachycardia, hypertension and hypothermia leading to study discontinuation.
Maltese: Il-pazjent esperjenza rogħda, tertir, deni, dardir, rimettar, sogħla inkontrollabbli, qtugħ ta' nifs, xufftejn cyanotic, sturdament, dgħjufija, pressjoni baxxa, takikardja, pressjoni għolja u ipotermja li jwasslu għal twaqqif tal-istudju.
English: In a large controlled randomised study, mifamurtide used at the recommended dose and schedule with other medicinal products that have known renal (cisplatin, ifosfamide) or hepatic (high-dose methotrexate, ifosfamide) toxicities did not exacerbate those toxicities and there was no need to adjust mifamurtide dose.
Maltese: Fi studju kbir ikkontrollat randomised, mifamurtide użat fid-doża u l-iskeda rakkomandata ma' prodotti mediċinali oħrajn li għandhom tossiċitajiet renali (cisplatin, ifosfamide) jew epatiċi (methotrexate, ifosfamide f' doża għolja) ma jħarrxux dawn it-tossiċitajiet u ma kien hemm l-ebda ħtieġa biex tiġi aġġustata d-doża ta' mifamurtide.
English: The vial should then be shaken vigorously for 1 minute while keeping the filter and syringe attached.
Maltese: Il-kunjett għandha mbagħad tiġi mħawwda tajjeb ħafna għal 1 minuta filwaqt li l-filtru u s-siringa jinżammu mwaħħla.
English: Neoplasms benign, malignant and unspecified (incl.
Maltese: Neoplażmi beninji, malinji u mhux speċifikati (inklużi ċesti u polipi)
English: SN:
Maltese: A.
English: There are no clinically meaningful effects of mild to moderate renal (creatinine clearance (CrCL) ≥ 30 mL/min) or hepatic impairment (Child-Pugh class A or B) on the pharmacokinetics of mifamurtide; therefore, dose adjustments are not necessary for these patients.
Maltese: M'hemm l-ebda effetti klinikament sinifikanti fuq il-farmakokinetika ta' mifamurtide f'indeboliment ħafif għal moderat tal-kliewi (tneħħija tal-krejatinina (CrCL) ≥ 30 mL/min) jew epatiku (Child-Pugh klassi A jew B); għalhekk, aġġustamenti fid-doża mhumiex meħtieġa għal dawn il-pazjenti.
English: Liposomal and non-liposomal mifamurtide do not induce the metabolic activity or the transcription of cytochrome P450 in primary cultures of freshly isolated human hepatocytes.
Maltese: Mifamurtide lipożomali u mhux-lipożomali ma jinduċux l-attività metabolika jew it-traskrizzjoni ta' P450 f'kulturi primarji ta' epatoċiti umana li għadhom kif ġew iżolati.
English: MEPACT 4 mg powder for concentrate for dispersion for infusion
Maltese: TAL-PRODOTT MEDIĊINALI MEPACT 4 mg trab għal konċentrat għal dispersjoni għall-infużjoni
English: VIAL LABEL
Maltese: Tnaqqis fil-piż
English: Mean half-lives of total and free MTP-PE in moderate hepatic impairment were 3.21 hours and 3.15 hours, respectively.
Maltese: Il-medja tal-half-lives tal-MTP-PE totali u ħieles f'indeboliment tal-fwied moderat kienu 3.21 sigħat u 3.15 sigħat, rispettivament.
English: From a microbiological point of view, immediate use is recommended.
Maltese: Minn punto di vista mikrobijoloġiku, l-użu immedjat huwa rakkommandat.
English: Instructions for preparation of MEPACT for intravenous infusion
Maltese: Istruzzjonijiet għal preparazzjoni ta' MEPACT għal infużjoni fil-vina
English: Additionally, the systemic exposures AUC from zero to infinity (AUCinf of free (non-liposome associated) MTP-PE in mild or moderate renal insufficiency were similar to those observed in healthy adult subjects with normal renal function.
Maltese: Barra minn hekk, l-esponimenti sistemiċi ta' AUC minn żero sal-infinità (AUCinf) ta' MTP-PE ħieles (mhux liposome assoċjat) fl-insuffiċjenza renali ħafifa jew moderata kienu jixbhu lil dawk osservati f'individwi adulti b'saħħithom b'funzjoni renali normali.
English: Tachycardia
Maltese: Newtropenija
English: Therefore, the SmPC of mifamurtide should be updated with the inclusion of pericardial effusion as an ADR in section 4.8 under SOC Cardiac disorders.
Maltese: Żewġ pazjenti b'ażma pre-eżistenti żviluppaw sitwazzjoni perikoluża repiratorja ħafifa għal moderata assoċjata mal-kura (ara sezzjoni 4.8).
English: Dizziness, vertigo, fatigue and blurred vision have shown as very common or common undesirable effects of mifamurtide treatment.
Maltese: Sturdament, mejt, għeja u vista mċajpra dehru bħala effetti mhux mixtieqa komuni ħafna jew komuni tal-kura b'mifamurtide.
English: Inflammatory response
Maltese: Reazzjoni infjammatorja
English: OUTER PACKAGING
Maltese: Informazzjoni għall-utent
English: Moderate hepatic impairment resulted in a small increase in AUCinf of total MTP-PE, with the geometric least square mean ratio (expressed as %) for moderate hepatic impairment in reference to the matched normal hepatic function group being 119% (90% confidence interval [CI]: 94.1%-151%).
Maltese: Indeboliment tal-fwied moderat wasslet għal żieda żgħira fil AUCinf tal-MTP-PE totali, bil-proporzjon medju ġeometriku inqas kwadrat (espress bħala %) għal indeboliment tal-fwied moderat b'referenza għall-grupp mqabbel talfunzjoni normali tal-fwied jkun 119% (90% intervall tal-kunfidenza [CI]: 94.
English: The lyophilised powder should be allowed to reach a temperature between approximately 20 C-25 °C prior to reconstitution, filtering using the filter provided and dilution.
Maltese: It-trab lifilizzat għandu jitħalla jilħaq temperatura ta' bejn 20 C - 25 °C qabel ir-rikostituzzjoni, iffiltrar bl-użu ta' filter ipprovdut u taħlit.
English: In the SmPC of mifamurtide, pericarditis is mentioned in section 4.4.
Maltese: Fl-SmPC ta' mifamurtide, il-perikadrdite tissemma' fis-sezzjoni 4.4.
English: Very common side effects (may affect more than 1 in 10 people): - fever, shaking/shivering, weakness, tiredness or general discomfort - nausea and/or vomiting, diarrhoea or constipation - headache or dizziness - rapid beating of the heart - high blood pressure or low blood pressure - no appetite for food - sweating - pain, including general pain, pain in your muscles and/or joints and pain in back, chest,
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni): - deni, tertir, dgħjufija, għeja jew skonfort ġenerali - dardir u/jew rimettar, dijarea jew stitikezza - uġigħ ta' ras jew sturdament - taħbit imgħaġġel tal-qalb - pressjoni tad-demm għolja jew pressjoni tad-demm baxx - l-ebda aptit għall-ikel - ħruġ ta' għaraq - uġigħ, inkluż uġigħ ġenerali, uġigħ fil-muskoli u/jew ġogi tiegħek u uġigħ fid-dahar, sider,
English: However, as the variability in pharmacokinetics of mifamurtide is greater in subjects with moderate hepatic impairment (see section 5.2), and safety data in patients with moderate hepatic impairment is limited, caution when administering mifamurtide to patients with moderate hepatic impairment is recommended.
Maltese: Madankollu, minħabba li l-varjabilità fil-farmakokinetika ta' mifamurtide hija akbar f'pazjenti b'indeboliment epatiku moderat (ara Sezzjoni 5.2), u s-sigurtà f'pazjenti b'indeboliment epatiku moderat hija limitata, huwa rakkomandat li għandu jkun hemm kawtela meta jingħata mifamurtide lill-pazjenti b'indeboliment tal-fwied moderat.
English: The site of the sodium chloride 9 mg/mL (0.9%) solution for injection bag where the needle is going to be inserted should be swabbed with an alcohol pad.
Maltese: Is-sit tal-borża tas-soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%) fejn tkun sejra tiddaħħal il-labra għandu jintmesaħ b'pad bl-alkoħol.
English: Association of mifamurtide with signs of pronounced inflammatory response, including pericarditis and pleuritis, was uncommon.
Maltese: Assoċjazzjoni ta' mifamurtide ma' sinjali ta' rispons infjammatorju bi provi, inklużi perikarditis u pluritis ma kienux komuni.
English: Fever, Chills, Fatigue, Hypothermia, Pain, Malaise, Asthenia, Chest pain
Maltese: Komuni ħafna deni, tertir ta' bard, għeja kbira, ipotermja, uġigħ, malaise, astenja, uġigħ fis-sider
English: Ear and labyrinth disorders
Maltese: Disturbi fil-widnejn u tas-sistema labirintika
English: The sodium chloride 9 mg/mL (0.9%) solution for injection is added to the vial by slow, firm depression of the syringe plunger.
Maltese: Is-soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%), tiddaħħal fil-kunjett permezz ta' tniżżil bil-mod u sod tal-planġer tas-siringa.
English: Post-procedural pain
Maltese: Uġiegħ post-proċedurali
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 tal-Prodott, sezzjoni 4.2).
English: Mifamurtide was studied as a single agent in 248 patients with mostly advanced malignancies during the early, single arm phase I and II clinical studies.
Maltese: Mifamurtide kien studjat bħala sustanża waħedha f'248 pazjent b'malinnitajiet fil-biċċa l-kbira avvanzati waqt studji single arm f'fażi bikrija.
English: - ciclosporin, tacrolimus, used after a transplant to prevent rejection of transplanted organs, or other immunosuppressants used e.g. to treat psoriasis (a skin disease).
Maltese: - ciclosporin, tacrolimus, użati wara trapjant sabiex jiġi evitat ir-riġettar ta' organi trapjantati, jew immunosuppressanti oħrajn użati e.g. għat-trattament tal-psorijażi (marda tal-ġilda). - mediċini anti-infjammatorji mhux sterojdali (NSAIDs), bħal acetylsalicylic acid, ibuprofen, jew diclofenac, użati għat-trattament ta' uġiegħ ta' ras, deni jew uġiegħ.
English: In a separate study in 14 patients, mean serum concentration-time curves of total and free mifamurtide that were assessed after the first infusion of mifamurtide and after a last infusion 11 or 12 weeks later, were almost superimposable and the mean AUC values of the free mifamurtide after the first and last infusion were similar.
Maltese: Fi studju separat f'14 -il pazjent, il-kurvaturi medji ta' serum f'konċentrazzjoni-żmien ta' mifamurtide totali u libera li kienu evalwati wara l-ewwel infużjoni ta' b'mifamurtide u wara l-aħħar infużjoni 11 jew 12 -il ġimgħa wara, kienu kważi superimpożibbli u l-medja ta' valuri AUC tal-mifamurtide wara l-ewwel u l-aħħar infużjoni kienu simili.
English: The filter should be removed from the blister pack, and the cap removed from the filter spike.
Maltese: Mhuwiex magħruf jekk mifamurtide huwiex eliminat fil-ħalib uman.
English: This summary was last updated in 06-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 06-2010.
English: It has also been studied as part of assisted reproductive techniques in 470 women.
Maltese: Ġie studjat ukoll bħala parti minn tekniki ta' riproduzzjoni assistita f'470 mara.
English: • adult women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Maltese: • nisa adulti b'defiċjenza severa (livelli baxxi ħafna) tal-ormon lutenizzant (LH) u l-ormon li jistimula l-follikoli (FSH).
English: The European Commission granted a marketing authorisation valid throughout the European Union for GONAL-f to Merck Serono Europe Ltd. on 20 October 1995.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea għal GONAL-f lil Merck Serono Europe Ltd. fl-20 ta' Ottubru 1995.
English: This is called ‘ovarian hyperstimulation syndrome'.
Maltese: Dan jissejjaħ ‘sindromu ta' iperstimulazzjoni tal-ovarji'.
English: • adult women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation.
Maltese: • nisa adulti li jkunu għaddejjin minn tekniki ta' riproduzzjoni assistita (trattament ta' fertilità) bħal fertilizzazzjoni in-vitro.
English: GONAL-f is a medicine that contains the active substance follitropin alfa.
Maltese: GONAL-f huwa prodott mediċinali li fih is-sustanza attiva follitropin alfa.
English: This document is a summary of the European public assessment report (EPAR) for GONAL-f.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal GONAL-f.
English: The follitropin alfa in GONAL-f is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Maltese: Il-follitropin alfa f'GONAL-f huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tad-DNA': huwa magħmul minn ċellola li tkun irċeviet ġene (DNA), li jkun għamilha kapaċi tipproduċi FSH uman.
English: In the study in men, GONAL-f, used in combination with hCG, was effective in stimulating sperm production, with 63% of the men starting to produce sperm.
Maltese: Fl-istudju flirġiel, GONAL-f, użat f'kombinazzjoni ma' hCG, kien effikaċi fl-istimulazzjoni tal-produzzjoni tal-isperma, bi 63% tal-irġiel jibdew jipproduċu sperma.
English: GONAL-f was as effective as human FSH in women who did not produce eggs or respond to clomiphene citrate: 84% of the women receiving GONAL-f produced eggs, compared with 91% of those receiving human FSH.
Maltese: GONAL-f kien effikaċi daqs FSH f'nisa li ma pproduċewx bajd jew li wieġbu għal clomiphene citrate: 84% tan-nisa li kienu qegħdin jirċievu GONAL-f ipproduċew bajd, meta mqabbel ma' 91% ta' dawk li rċevew FSH uman.
English: The most common side effects with GONAL-f (seen in more than 1 patient in 10) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Maltese: L-effetti sekondarji l-aktar komuni b'GONAL-f (li deheru f'iktar minn pazjent 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni (uġigħ, ħmura, tbenġil, nefħa jew irritazzjoni).
English: The active substance in GONAL-f, follitropin alfa, is a copy of the natural hormone FSH.
Maltese: Is-sustanza attiva f'GONAL-f, follitropin alfa, hija kopja tal-ormon naturali
English: • adult men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Maltese: • irġiel adulti li għandhom ipogonadiżmu ipogonadotropiku (marda ta' nuqqas ormonali rari).
English: GONAL-f is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.
Maltese: GONAL-f jintuża flimkien ma gonadotofin korionku uman (hCG) biex jistimula l-produzzjoni talisperma.
English: GONAL-f has been studied in 222 women who do not produce eggs or respond to clomiphene citrate.
Maltese: GONAL-f ġie studjat f'222 mara li ma jipproduċux bajd jew li jwieġbu għal clomiphene citrate.
English: • adult women (aged 18 years or over) who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
Maltese: • nisa adulti (ta' 18-il sena jew aktar) li ma jipproduċux bajd u li ma jirrispondux għall-kura bi clomiphene citrate (prodott mediċinali ieħor li jistimula lill-ovarji sabiex jipproduċu l-bajd);«
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 ta' sperma fit-testikoli.
English: What is the risk associated with GONAL-f?
Maltese: X'inhu r-riskju assoċjat ma' GONAL-f?
English: What is GONAL-f?
Maltese: X'inhu GONAL-f?
English: Why has GONAL-f been approved?
Maltese: Għaliex ġie approvat 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 talipotalamu, jew b'kanċer tas-sider, tal-ġuf jew tal-ovarji.