FrancophonIA/ELRC3.0 huggingface dataset:
English: ‘Primary' means that there are no other diseases of the heart or lungs causing the high blood pressure, and the ‘class' reflects the severity of the symptoms caused by the disease: ‘class III' involves marked limitation of physical activity.
Maltese: L-ipertensjoni fil-pulmun hija pressjoni tad-demm għolja mhux normali fl-arterji tal-pulmuni. ‘Primarja' tfisser li ma hemm l-ebda mard ieħor tal-qalb jew tal-pulmun li jikkawża pressjoni għolja tad-demm, u l-‘klassi' tirrifletti l-gravità tas-sintomi kkawżati mill-marda: “il-klassi III” tinvolvi l-limitazzjoni mmarkata tal-eżerċizzju fiżiku.
English: However, when looking at different groups of patients in this study, a benefit of Ventavis that would be relevant for patients was only shown in patients with class III primary pulmonary hypertension.
Maltese: Madankollu, meta saret analiżi tal-gruppi ta' pazjenti differenti f'dan l-istudju, ilbenefiċċju ta' Ventavis li jkun rilevanti għall-pazjenti deher biss f'pazjenti li kellhom ipertensjoni primarja fil-pulmun tal-klassi III.
English: What is the risk associated with Ventavis?
Maltese: Għal x'hiex jintuża Ventavis?
English: Ventavis iloprost
Maltese: Kif ġie studjat Ventavis?
English: For the full list of all side effects reported with Ventavis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati b'Ventavis, ara l-fuljett ta' tagħrif.
English: Restricted to women with ovulation induced (Puregon, n = 76; u-FSH, n = 42).
Maltese: Ristrett għal nisa b'ovulazzjoni indotta (Puregon, n = 76; u-FSH, n = 42).
English: The active substance is follitropin beta.
Maltese: Is-sustanza attiva hija follitropin beta.
English: Puregon (n = 105)
Maltese: (n = 105)
English: Puregon (n = 546)
Maltese: (n = 546)
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands
Maltese: N.V. Organon Kloosterstraat 6 5349 AB Oss L-Olanda
English: Benzyl alcohol
Maltese: Polysorbate 20 Benzyl alcohol
English: Manufacturer N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands
Maltese: Manifattur N.V. Organon Kloosterstraat 6 5349 AB Oss L-Olanda
English: Merck Sharp & Dohme (Sweden) AB Tel: + 46 77 5700488 medicinskinfo@merck.com
Maltese: Merck Sharp & Dohme (Sweden) AB nTel: + 46 77 5700488 medicinskinfo@merck.com
English: United Kingdom Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
Maltese: Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
English: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss The Netherlands
Maltese: Oss Veersemeer 4, 5347 JN Oss L-Olanda
English: 0.840 mL
Maltese: INDIVIDWALI 0.840 mL
English: The absolute bioavailability of subcutaneously administered Puregon is approximately 77%.
Maltese: It-tnejn għandhom bijodisponibbilità assoluta ta' madwar 77%.
English: You may need to read it again.
Maltese: Huwa possibli li tinjetta f'postijiet oħra.
English: FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production.
Maltese: L-FSH huwa indispensabbli fit-tkabbir u l-maturazzjoni normali tal-follikulu u fil-produzzjoni talisterojdi gonadi.
English: Breast complaints Metrorrhagia Ovarian cyst Ovarian enlargement Ovarian torsion Uterine enlargement Vaginal haemorrhage
Maltese: Ċista fl-ovarji Tkabbir tal-ovarji Torsjoni tal-ovarji Tkabbir tal-utru Fsada vaġinali
English: Date of first authorisation: 03 May 1996 Date of latest renewal: 29 May 2006
Maltese: Data tal-aħħar tiġdid: 29 ta' Mejju 2006
English: • Each cartridge contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/mL aqueous solution.
Maltese: • Kull stoċċ fih is-sustanza attiva follitropin beta, ormon magħruf bħala l-ormon li jistimula l follikoli (FSH) f' qawwa ta' 833 IU/mL soluzzjoni akwea.
English: Do not use Puregon after the expiry date which is stated on the label and carton after 'EXP'.
Maltese: Tużax Puregon wara d-data ta' meta jiskadi li tidher fuq it-tikketta u fuq il-kartuna wara ‘EXP'.
English: How to use Puregon
Maltese: Tużax Puregon
English: 0.480 mL
Maltese: INDIVIDWALI 0.480 mL
English: Puregon contains a recombinant FSH.
Maltese: Puregon fih FSH rikombinanti.
English: In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple pregnancy is mainly related to the number of embryos transferred.
Maltese: F'nisa li qed jagħmlu proċeduri ta' Teknoloġiji ta' Riproduzzjoni Assistita (ART - Assisted Reproduction Technologies), ir-riskju ta' tqala multipla hija marbuta l-aktar man-numru ta' embriji ttrasferiti.
English: Ovarian hyperstimulation syndrome (OHSS)
Maltese: Sindrome tal-iperstimulazzjoni tal-ovarji (OHSS - ovarian hyperstimulation syndrome)
English: Other medicines and Puregon
Maltese: Mediċini oħra u Puregon
English: 0.5 mL of solution in 3 mL vial (type I glass) with stopper (chlorobutyl rubber).
Maltese: Soluzzjoni ta' 0.5 mL f'kunjett ta' 3 mL (ħġieġ tip I) b'tapp (lastku tal-chlorobutyl).
English: Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and efficacy of Puregon with urinary FSH in ovulation induction).
Maltese: Tabella 2: Riżultati ta' studju 37,609 (studju kliniku li fih il-parteċipanti ntgħażlu b'mod każwali, grupp komparattiv, li qabbel is-sigurtà u l-effikaċja ta' Puregon ma' FSH fl-awrina fi stimulu talovarji).
English: Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and efficacy of Puregon with urinary FSH in controlled ovarian stimulation).
Maltese: Tabella 1: Riżultati ta' studju 37,608 (studju kliniku li fih il-parteċipanti ntgħażlu b'mod każwali, grupp komparattiv, li qabbel is-sigurtà u l-effikaċja ta' Puregon ma' FSH fl-awrina fi stimulu kkontrollat tal-ovarji).
English: • are allergic to follitropin beta or any of the other ingredients of Puregon (listed in section 6)
Maltese: • allerġiku għal follitropin beta jew għal xi sustanza oħra ta' Puregon (elenkati fis-sezzjoni 6)
English: In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian stimulation in women participating in an assisted reproduction technology (ART) program and for ovulation induction (see tables 1 and 2 below), Puregon was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Maltese: Fi studji kliniċi li qabblu recFSH (follitropin beta) u FSH fl-awrina għal stimulu kkontrollat tal-ovarji f'nisa li kienu qed jieħdu sehem fi programm ta' teknoloġija riproduttiva assistita (ART) u għallistimulu tal-ovulazzjoni (ara Tabelli 1 u 2 hawn taħt), Puregon kien iktar qawwi minn FSH fl-awrina fir-rigward ta' doża totali iktar baxxa u perijodu iqsar ta' kura meħtieġa biex jistimula l-iżvilupp talfollikuli.
English: Men
Maltese: a
English: This medicinal product 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, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: MSD (Norge) AS Tlf: + 47 32 20 73 00 msdnorge@msd.no
Maltese: Tlf: + 47 32 20 73 00
English: Puregon 300 IU/0.36 mL injection follitropin beta
Maltese: TAL-PRODOTT MEDIĊINALI Puregon 300 IU/0.36 mL soluzzjoni għall-injezzjoni follitropin beta
English: Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Maltese: Puregon, soluzzjoni għall-injezzjoni fih follitropin beta, ormon magħruf bħala ormon li jistimula lfollikulu (FSH).
English: In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including Puregon, may further increase this risk.
Maltese: F'nisa b'fatturi ta' riskju li huma ġeneralment rikonoxxuti għal avvenimenti tromboemboliċi, bħal storja personali jew tal-familja, ħxuna żejda severa jew trombofilja, il-kura b'gonadotropins, inkluż Puregon, tista' tkompli żżid dan ir-riskju.
English: This corresponds to a strength of 450 IU/mL.
Maltese: Dan jikkorrispondi ma' qawwa ta' 450 IU/mL.
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Puregon.
Maltese: Każijiet tromboemboliċi, kemm b'rabta ma' kif ukoll separati minn OHSS, kienu rrappurtati wara kura b'gonadotropins, inkluż Puregon.
English: This strength corresponds to 83.3 microgram of protein / mL (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Il-qawwa tikkorispondi għal 83.3 mikrogrammi ta' proteina / mL (bijoattività speċifika in vivo ugwali għal madwar 10,000
English: The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/mL aqueous solution.
Maltese: Is-soluzzjoni għall-injezzjoni fiha ssustanza attiva follitropin beta magħmul b'inġinerija ġenetika minn ċelluli żviluppati minn ċellula waħda mill-ovarji tal-ħemster Ċiniż (CHO- Chinese hamster ovary) f'konċentrazzjoni ta' 833 IU/mL ta' soluzzjoni akweja.
English: Ovarian torsion has been reported after treatment with gonadotropins, including Puregon.
Maltese: Torsjoni tal-ovarji kienet irrappurtata wara l-kura b'gonadotropins, inkluż Puregon.
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Maltese: Stimulazzjoni żejda tal-ovarji tista' tiżviluppa f'kondizzjoni medika msejħa sindrome ta' iperstimulazzjoni tal-ovarji (OHSS), li tista' tkun problema medika serja.
English: In rare instances, thromboembolism has been associated with follitropin beta /hCG therapy as with other gonadotrophins.
Maltese: F'każijiet rari, it-tromboemboliżmu ġie assoċjat ma' terapija b'follitropin beta/hCG kif ukoll ma' gonadotrofini oħra.
English: Elevated endogeneous FSH levels in men are indicative of primary testicular failure.
Maltese: Żieda fil-livelli ta' FSH endoġeniku fl-irġiel hija sinjal ta' insuffiċjenza primarja tat-testikoli.
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 75 IU (150 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 0.5 mL follitropin beta li jikkorrispondu għal: attività ta' 75 IU (150 IU/mL) tal-ormon rikombinanti li jistimula l-follikuli (FSH).
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Puregon can bring about the development of multiple follicles.
Maltese: F'nisa li qed jieħdu sehem fi programm li jinvolvi t-teknika ta' riproduzzjoni assistita, inkluż ilfertilizzazzjoni in vitro (IVF) u metodi oħra, Puregon jista' jintuża sabiex jikkawża l-iżvilupp ta' follikuli multipli.
English: Puregon is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Maltese: Puregon jintuża fil-kura ta' nisa li tkun qed isirilhom stimulu tal-ovarji jew iperstimulazzjoni kkontrollata tal-ovarji fi programmi ta' riproduzzjoni assistita.
English: Puregon 75 IU/0.5 mL injection follitropin beta
Maltese: Puregon 75 IU/0.5 mL soluzzjoni għall-injezzjoni follitropin beta
English: Puregon 50 IU/0.5 mL solution for injection Puregon 75 IU/0.5 mL solution for injection Puregon 100 IU/0.5 mL solution for injection Puregon 150 IU/0.5 mL solution for injection Puregon 200 IU/0.5 mL solution for injection Puregon 225 IU/0.5 mL solution for injection
Maltese: IU/0.5 mL soluzzjoni għall-injezzjoni Puregon 150 IU/0.5 mL soluzzjoni għall-injezzjoni Puregon 200
English: In adult females: Puregon is indicated for the treatment of female infertility in the following clinical situations:
Maltese: Puregon huwa indikat għall-kura tal-infertilità fin-nisa fis-sitwazzjonijiet kliniċi li ġejjin:
English: If you:
Maltese: Tista'
English: Multiple pregnancies and births have been reported for all gonadotropin treatments, including Puregon.
Maltese: Tqala u twelid multipli ġew irrappurtati għal kull kura b'gonadotropin, inkluż Puregon.
English: Furthermore Puregon can be used to promote multiple follicular development in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Maltese: Barraminhekk, Puregon jista' jintuża biex jinkoraġġixxi l-iżvilupp ta' follikuli multipli fi programmi mediċi ta' riproduzzjoni assista [eż. fertilizzazzjoni in vitro/trasferiment tal-embriju (IVF/ET), trasferiment ta' gamete fil-fallopjan (GIFT) u injezzjoni tal-isperma fiċ-ċitoplażma (ICSI)].
English: 1025 IU recombinant FSH activity/1.230 mL Net content 900 IU
Maltese: IU ta' FSH rikombinanti/1.230 mL
English: One vial contains 22.5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Kunjett wieħed fih 22.5 mikrogrammi ta' proteina (bijoattività speċifika in vivo ekwivalenti għal madwar 10,000
English: Puregon 150 IU/0.5 mL injection follitropin beta
Maltese: Puregon 150 IU/0.5 mL soluzzjoni għall-injezzjoni follitropin beta
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 150 IU (300 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 0.5 mL follitropin beta li jikkorrispondu għal: attività ta' 150 IU (300 IU/mL) tal-ormon rikombinanti li jistimula l-follikuli (FSH)
English: Acne Rash
Maltese: TAGĦRIF
English: Paediatric population There is no relevant use of Puregon in the paediatric population for the approved indication.
Maltese: Puregon fil-popolazzjoni pedjatrika m'għandux użu rilevanti fl-indikazzjoni approvata.
English: One cartridge contains a net total dose of 900 IU recombinant follicle-stimulating hormone (FSH) in 1.08 mL aqueous solution.
Maltese: IU ta' ormon rikombinanti li jistimula l-follikoli, (FSHfollicle-stimulating hormone), f'1.08 mL ta' soluzzjoni akweja.
English: One vial contains 7.5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Kunjett wieħed fih 7.5 mikrogrammi ta' proteina (bijoattività speċifika in vivo ekwivalenti għal madwar 10,000
English: Ovarian torsion has occurred after treatment with gonadotropins including Puregon.
Maltese: Torsjoni tal-ovarji seħħet wara kura b'gonadotropins inkluż Puregon.
English: Uncommon side effects (may affect up to 1 in 100 people): - Breast complaints (including tenderness) - Diarrhoea, constipation or stomach discomfort - Enlargement of the uterus - Feeling sick - Hypersensitivity reactions (such as rash, redness, hives and itching) - Ovarian cysts or enlargement of the ovaries - Ovarian torsion (twisting of the ovaries) - Vaginal bleeding
Maltese: - Disturbi fis-sider (li jinkludu sensittività) - Dijarea, stitikezza jew skonfort fl-istonku - Tkabbir tal-utru - Tħossok imdardra - Reazzjonijiet ta' sensittività eċċessiva (bħal raxx, ħmura, urtikarja u ħakk) - Ċisti fl-ovarji jew tkabbir tal-ovarji - Torsjoni tal-ovarji (liwi tal-ovarji) - Ħruġ ta' demm mill-vaġina
English: The first injection with Puregon should be performed under direct medical supervision.
Maltese: L-ewwel injezzjoni b'Puregon għandha ssir taħt superviżjoni medika diretta.
English: OUTER CARTON TEXT Puregon 50 IU/0.5 mL 1, 5 or 10 vials
Maltese: IU/0.5 mL 1, 5 jew 10 kunjetti
English: One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in 0.36 mL aqueous solution.
Maltese: IU ta' ormon rikombinanti li jistimula l-follikoli, (FSHfollicle-stimulating hormone), f'0.36 mL ta' soluzzjoni akweja.
English: In males Puregon is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Maltese: Fl-irġiel, Puregon jintuża fil-kura ta' spermatoġenesi defiċjenti minħabba ipogonadiżmu ipogonadotrofiku.
English: One cartridge contains a net total dose of 150 IU recombinant follicle-stimulating hormone (FSH) in 0.18 mL aqueous solution.
Maltese: 18 mL soluzzjoni għall-injezzjoni Skartoċċ wieħed fih doża netta totali ta' 150 IU ta' ormon rikombinanti li jistimula l-follikoli, (FSHfollicle-stimulating hormone), f'0.18 mL ta' soluzzjoni akweja.
English: Puregon 900 IU/1.08 mL injection follitropin beta
Maltese: IU/1.08 mL injezzjoni follitropin beta SC
English: Puregon 75 IU/0.5 mL solution for injection
Maltese: Puregon 75 IU/0.5 mL soluzzjoni għall-injezzjoni
English: CARTRIDGE TEXT Puregon 900 IU/1.08 mL
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-KUNJETT Puregon 150 IU/0.5 mL
English: VIAL TEXT Puregon 150 IU/0.5 mL
Maltese: Puregon 150 IU/0.
English: Too high a dose of Puregon may cause hyperstimulation of the ovaries (OHSS).
Maltese: Doża kbira wisq ta' Puregon tista' tikkawża iperstimulazzjoni tal-ovarji (OHSS).
English: CARTRIDGE TEXT Puregon 600 IU/0.72 mL
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-KUNJETT Puregon 75 IU/0.5 mL
English: Puregon 150 IU/0.5 mL solution for injection
Maltese: Puregon 150 IU/0.5 mL soluzzjoni għall-injezzjoni
English: EU/1/96/008/023 EU/1/96/008/024 EU/1/96/008/025
Maltese: EU/1/96/008/023 EU/1/96/008/024
English: Ovarian and Other Reproductive System Tumours There have been reports of ovarian and other reproductive system tumors in women who have had infertility treatment.
Maltese: Tumuri fl-Ovarji u Tumuri Oħra fis-Sistema Riproduttiva
English: In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Puregon induced no toxicologically significant effects.
Maltese: F'dożi ripetuti fil-firien (fuq ġimagħtejn) u fil-klieb (13-il ġimgħa) b'doża sa 100 darba aktar minn dik li tingħata lill-bniedem, Puregon ma kkaġunax effetti tossikoloġiċi sinifikanti.
English: Medical conditions that contraindicate pregnancy should also be evaluated before starting treatment with Puregon.
Maltese: Kondizzjonijiet mediċi fejn it-tqala hija kontraindikata ukoll għandhom jiġu evalwati qabel il-bidu talkura b'Puregon.
English: Pre-ovulatory conditions are reached when there is ultrasonographic evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained.
Maltese: Il-kondizzjonijiet ta' qabel l ovulazzjoni jintlaħqu meta jkun hemm prova ultrasonografika ta' follikulu dominanti b'dijametru ta' 18-il millimetru u/jew meta l-livelli tal-estradjol fil-plażma jilħqu
English: OUTER CARTON TEXT Puregon 150 IU/0.5 mL 1, 5 or 10 vials
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KITBA FUQ IL-KARTUNA TA' BARRA Puregon 150 IU/0.5 mL 1, 5 jew 10 kunjetti
English: Puregon 200 IU/0.5 mL solution for injection EU/1/96/008/029
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/008/029
English: Such patients are unresponsive to Puregon/hCG therapy.
Maltese: Dawn ilpazjenti ma jirrispondux għat-terapija b'Puregon/hCG.
English: One vial contains 150 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Maltese: Kunjett wieħed fih 150 IU ta' ormon rikombinanti li jistimula l-follikoli (FSH), f'0.5 mL ta' soluzzjoni akweja.
English: Usually, 7 to 14 days of treatment are sufficient.
Maltese: Ġeneralment, ikun hemm bżonn minn 7 sa 14
English: Sucrose
Maltese: Nawseja
English: OUTER CARTON TEXT Puregon 75 IU/0.5 mL 1, 5 or 10 vials
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KITBA FUQ IL-KARTUNA TA' BARRA Puregon 75 IU/0.5 mL 1, 5 jew 10 kunjetti
English: Puregon 150 IU/0.18 mL solution for injection EU/1/96/008/040
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/008/040
English: Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
Maltese: Puregon soluzzjoni għall-injezzjoni hija ddisinjata biex tintuża mal-Pinna Puregon.
English: Puregon 100 IU/0.5 mL solution for injection EU/1/96/008/023
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/008/023
English: Puregon 75 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 75 IU in 0.5 mL aqueous solution per vial.
Maltese: Kull kunjett fih is-sustanza attiva follitropin beta, ormon magħruf bħala ormon li jistimula l-follikuli (FSH), f'qawwa ta' 75 IU f'0.5 mL ta' soluzzjoni akweja f'kull kunjett.
English: Treatment with Puregon and hCG should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected.
Maltese: Il-kura b'Puregon u hCG għandha titkompla għal tal-anqas 3 sa 4 xhur qabel ma jista' jkun mistenni xi titjieb fl-ispermatoġenisi.
English: If follitropin beta would be excreted in human milk, it would be degraded in the gastrointestinal tract of the child. Follitropin beta may affect milk production.
Maltese: Jekk follitropin beta jitneħħa fil-ħalib tal-bniedem, jiġi ddegradat fl-apparat gastrointestinali tat-tarbija.
English: VIAL TEXT Puregon 100 IU/0.5 mL
Maltese: Kunjett 1 li fih 0.5 mL
English: Puregon 75 IU/0.5 mL solution for injection follitropin beta
Maltese: Puregon 75 IU/0.5 mL injezzjoni follitropin beta IM/SC
English: Puregon 300 IU/0.36 mL solution for injection EU/1/96/008/038
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/008/038
English: One vial contains 15 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Kunjett wieħed fih 15il mikrogrammi ta' proteina (bijoattività speċifika in vivo ekwivalenti għal madwar 10,000
English: Puregon 150 IU/0.5 mL solution for injection EU/1/96/008/026
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/008/026
English: Store in a refrigerator (2°C - 8°C).
Maltese: Ħażna mill-ispiżjar Aħżen f'temperatura ta' 2˚C - 8˚C (fi friġġ) .
English: Multiple gestation, especially high order, carries an increased risk of adverse maternal (pregnancy and delivery complications) and perinatal (low birth weight) outcomes.For anovulatory women undergoing ovulation induction, monitoring follicular development with transvaginal ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the risk of multiple pregnancies.
Maltese: Flimkien ma' dan, tqaliet multipli u l-karatteristiċi tal-pazjenti li jkunu qed jirċievu kura għal problemi ta' fertilità (eż. l-età tal-mara, karatteristiċi tal-isperma, sfond ġenetiku taż-żewġ ġenituri), jistgħu jkunu assoċjati ma' żieda fir-riskju ta' difetti tat-twelid.
English: Puregon showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Maltese: Fit-test Ames, u fit-test tal-aberrazzjoni tal-kromosome in vitro biċ-ċelluli limfoċiti umani, Puregon ma wera l-ebda riskju fuq il-ġeni.
English: There is no information available from clinical or animal studies on the excretion of follitropin beta in milk.
Maltese: M'hemm l-ebda informazzjoni disponibbli minn studji kliniċi jew studji fuq l-annimali dwar ittneħħija ta' follitropin beta fil-ħalib.
English: FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
Maltese: FSH jappartjeni fil-kategoija ta' gonadotrofini, li għadhom rwol importanti fil-fertilità u firriproduzzjoni tal-bniedem.
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 100 IU (200 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 0.5 mL follitropin beta li jikkorrispondu għal: attività ta'100 IU (200
English: Puregon 150 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 150 IU in 0.5 mL aqueous solution per vial.
Maltese: Kull kunjett fih is-sustanza attiva follitropin beta, ormon magħruf bħala ormon li jistimula l-follikuli (FSH), f'qawwa ta' 150 IU f'0.5 mL ta' soluzzjoni akweja f'kull kunjett.