FrancophonIA/ELRC3.0 huggingface dataset:
English: Ovarian Hyper-Stimulation Syndrome (OHSS)
Maltese: Sindrome ta' Iperstimulazzjoni tal-Ovarji (OHSS)
English: Bemfola is a biosimilar medicinal product.
Maltese: Bemfola huwa prodott mediċinali bijoloġiku simili.
English: 1103 Budapest Hungary
Maltese: 1103 Budapest L-Ungerija
English: In adult men
Maltese: F'irġiel adulti
English: Caution:
Maltese: Attenzjoni:
English: Sodium content
Maltese: Kontenut ta' sodium
English: Porphyria
Maltese: Porfirija
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27/03/2014
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27/03/2014
English: Poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.
Maltese: Poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid u ilma għall-injezzjonijiet.
English: Table 1: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of follitropin alfa with urinary FSH in assisted reproduction technologies) follitropin alfa (n = 130)
Maltese: Tabella 1: Riżultati ta' studju GF 8407 (studju randomised, fi grupp parallel, li jqabbel l-effikaċja u sigurtà ta' follitropin alfa ma' FSH urinarju f'teknoloġiji ta' riproduzzjoni assistita). follitropin alfa (n = 130)
English: (hMG).
Maltese: hCG.
English: Congenital malformation
Maltese: Malformazzjoni konġenitali
English: Severe OHSS (including associated symptomatology) (see section 4.4)
Maltese: OHSS sever (li jinkludi sintomatoloġija assoċjata) (ara sezzjoni 4.4)
English: BATCH NUMBER<, DONATION AND PRODUCT CODES> Lot
Maltese: NUMRU TAL-LOTT <, DONAZZJONI U KOWD TAL-PRODOTT > Lot
English: Treatment in men Immune system disorders Very rare:
Maltese: Disturbi fis-sistema immuni Rari ħafna:
English: This usually takes about 10 days but can take any time between 5 and 20 days.
Maltese: Dan normalment jieħu madwar 10 ijiem iżda jista' jieħu bejn 5 u 20 jum.
English: • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
Maltese: • Stimulazzjoni ta' żvilupp follikulari multiplu f'nisa li qed issirilhom ovulazzjoni mgħaġġla għal teknoloġiji ta' riproduzzjoni assistita (ART) bħal fertilizzazzjoni in vitro (IVF), trasferiment ta' gameti fit-tubu fallopjan (GIFT) u trasferiment taż-żigot fit-tubu fallopjan (ZIFT).
English: Elevated endogenous FSH levels are indicative of primary testicular failure.
Maltese: Il-preżenza ta' livelli elevati ta' FSH endoġenu jindikaw insuffiċjenzja testikolari primarja.
English: Following subcutaneous administration, the absolute bioavailability is about 70%.
Maltese: Wara li jingħata minn ta ħt il-ġilda, il-bijodisponibbilità assoluta hi ta' madwar 70%.
English: INFORMATION IN BRAILLE Bemfola 300 IU/0.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Bemfola 300 IU/0.5 ml
English: INFORMATION IN BRAILLE Bemfola 150 IU/0.25 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Bemfola 150 IU/0.25 ml
English: Multiple pregnancy
Maltese: Tqala multipla
English: The adverse reactions are ranked under heading of frequency using the following convention: 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: Ir-reazzjonijiet avversi huma kklassifikati ta ħt l -intestatura tal-frekwenza bl-użu tal-konvenzjoni li ġejja: 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: In adult women
Maltese: F'nisa adulti
English: Bemfola contains sodium
Maltese: Bemfola fih is-sodium
English: In adult men, Bemfola is used:
Maltese: F'nisa adulti, Bemfola jintuża:
English: • The other ingredients are poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid and water for injections.
Maltese: • Is-sustanzi l-oħrajn huma poloxamer 188, sucrose, methionine, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phosphoric acid u ilma għall-injezzjonijiet.
English: What Bemfola is
Maltese: Tużax Bemfola
English: Differences between the 2 groups were statistically significant (p< 0.05) for all criteria listed.
Maltese: Bżonn ta' żieda fid-doża (%) Differenzi bejn iż-żewġ gruppi kienu statistikament sinifikanti (p< 0.05) għal kriterji kollha elenkati.
English: Follitropin alfa is indicated for use in infertility (see section 4.1).
Maltese: Fertilità Follitropin alfa hu indikat għall-użu f'każ ta' infertilità (ara sezzjoni 4.1).
English: Ectopic pregnancy
Maltese: Tqala ektopika
English: Following repeated administration, follitropin alfa accumulates 3-fold achieving a steadystate within 3-4 days.
Maltese: Meta jing ħata ripetutament, follitropin alfa jakkumula sa 3 darbiet aktar u jilħaq l-istat fiss wara 3-4 ijiem.
English: Reproductive system neoplasms
Maltese: Neoplażmi fis-sistema riproduttiva
English: 10 pre-filled pens 10 injection needles 10 alcohol swabs
Maltese: 10 pinen mimlijin għal-lest 10 labar tal-injezzjoni 10 swabs bl-alkoħol
English: However, since follitropin alfa is not indicated in pregnancy, these data are of limited clinical relevance.
Maltese: Madankollu, min ħabba li follitropin alfa mhuwiex indikat waqt it-tqala, din id-dejta għandha rilevanza klinika limitata.
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress.
Maltese: Evalwazzjoni klinika tista' tiżvela ipovolemija, emokonċentrazzjoni, żbilanċ ta' elettroliti, axxite, emoperitonew, effużjoni plewrali, idrotora ċi jew insuffiċjenza akuta pulmonari.
English: Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady state within 3-4 days.
Maltese: Meta jing ħata ripetutament, follitropin alfa jakkumula sa 3 darbiet aktar u jil ħaq l -istat fiss wara 3-4 ijiem.
English: • Bemfola 150 IU/0.25 mL: Each cartridge contains 150 IU (equivalent to 11 micrograms) follitropin alfa in 0.25 mL solution.
Maltese: • Bemfola 150 IU/0.25 ml: Kull skartoċċ fih 150 IU (ekwivalenti għal 11-il mikrogramma) follitropin alfa f'0.25 ml soluzzjoni.
English: • Sacs of fluid within the ovaries (ovarian cysts)
Maltese: • Membrani mimlijin bi fluwidu fl-ovarji (ċisti fl-ovarji)
English: 5 pre-filled pens 5 injection needles 5 alcohol swabs
Maltese: 5 pinen mimlijin għal-lest 5 labar tal-injezzjoni 5 swabs bl-alkoħol
English: MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Maltese: Gedeon Richter Plc.
English: Thromboembolism may occur very rarely (see section 4.4).
Maltese: It-tromboemboliżmu jista' jseħħ rarament ħafna (ara sezzjoni 4.4).
English: OTHER
Maltese: IU)
English: Very rarely, severe OHSS may be complicated by ovarian torsion or thromboembolic events such as pulmonary embolism, ischaemic stroke or myocardial infarction.
Maltese: Rarament ħafna, OHSS sever jista' jkun ikkomplikat minn brim tal ovarji jew avvenimenti tromboemboli ċi bħal emboliżmu pulmonari, puplesija iskemika jew infart mijokardijaku.
English: Blood clotting problems (thromboembolic events)
Maltese: Problemi ta' tagħqid tad-demm (avvenimenti tromboemboliċi)
English: • malformations of sexual organs incompatible with pregnancy;
Maltese: • malformazzjoni tal-organi sesswali li jkunu inkompatibbli mat-tqala
English: Men
Maltese: JIS
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 kwalunwke wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1;
English: • Bemfola is supplied in packs with 1, 5 or 10 pre-filled pens, 1, 5 or 10 disposable needles and 1,
Maltese: • Bemfola hu disponibbli f'pakketti li jkun fihom 1, 5 jew 10 pinen, 1, 5 jew 10 labar u 1, 5 jew 10 swabs bl-alkoħol.
English: This medicine contains the active substance follitropin alfa, which is almost identical to a natural hormone produced by your body called “follicle-stimulating hormone” (FSH).
Maltese: Din il-mediċina fiha s-sustanza attiva follitropin alfa, li hija kważi identika għall-ormon naturali prodott mill-ġisem tiegħek imsejjaħ “ormon li jistimula l-follikuli” (FSH - follicle-stimulating hormone).
English: Note: Please check that the medicine is not frozen.
Maltese: Nota: Jekk jogħġbok ara li lmediċina ma tkunx iffriżata.
English: The maximal daily dose is usually not higher than 225 IU FSH.
Maltese: Ġeneralment, id-doża massima ta' kuljum ma taqbiżx il-225 IU FSH.
English: Bemfola 75 IU/0.125 mL pre-filled pen Bemfola 150 IU/0.25 mL pre-filled pen Bemfola 225 IU/0.375 mL pre-filled pen
Maltese: IU/0.125 ml pinna mimlija għal-lest Bemfola 150 IU/0.25 ml pinna mimlija għal-lest Bemfola 225 IU/0.
English: Very rare (may affect up to 1 in 10,000 people):
Maltese: Rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna):
English: A recommended regimen commences at 75 IU of lutropin alfa daily with 75-150 IU FSH.
Maltese: IU ta' lutropin alfa kuljum flimkien ma' 75-150
English: • Bemfola 300 IU/0.50 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.50 mL solution.
Maltese: • Bemfola 300 IU/0.50 ml: Kull skartoċċ fih 300 IU (ekwivalenti għal 22 mikrogramma) follitropin alfa f'0.50 ml soluzzjoni.
English: Each mL of the solution contains 600 IU equivalent to 44 micrograms.
Maltese: IU ekwivalenti għal 44 mikrogramma.
English: * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: * ormon uman rikombinanti li jistimula l-follikuli (r-hFSH) li ji ġi magħmul fiċ -ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO) mit-teknoloġija tad-DNA.
English: Renal or hepatic impairment
Maltese: Indeboliment renali jew epatiku
English: Mild or moderate OHSS (including associated symptomatology)
Maltese: Nisa li ma jovulawx (inkluż is-sindrome poliċistiku tal-ovarji)
English: When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you.
Maltese: riproduzzjoni assistita, ir-riskju ta' tqala multipla jkun relatat mal-età tiegħek, il-kwalità u l-għadd ta' bajd fertilizzat jew embrijuni mpoġġija ġo fik.
English: • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation
Maltese: • Uġigħ ta' ras • Reazzjonijiet lokali fis-sit tal-injezzjoni, bħal uġigħ, ħmura, tbenġil, nefħa u/jew irritazzjoni
English: Exacerbation or aggravation of asthma Gastrointestinal disorders Common:
Maltese: Aggravament jew aggravament ta' ażżma Disturbi gastro-intestinali
English: • Anovulation (including polycystic ovariansyndrome, PCOS) in women who have been unresponsive to treatment with clomiphene citrate.
Maltese: • Nuqqas ta' ovulazzjoni (inkluż is-sindrome poliċistiku fl-ovarji, PCOS) f'nisa li fuqhom il-kura bi clomiphene citrate ma kinitx effettiva.
English: • Serious blood clotting complications (thromboembolic events) sometimes independent of OHSS may be found very rarely (may affect up to 1 in 10,000 people).
Maltese: • Kumplikazzjonijiet serji ta' tag ħqid ta' demm (avvenimenti tromboemboliċi) xi kultant indipendenti mill-OHSS huma rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna).
English: Each pre-filled pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms per 0.5 mL.
Maltese: Kull pinna mimlija għal-lest tagħti 300 IU follitropin alfa, ekwivalenti għal 22 mikrogramma għal kull 0.5 ml.
English: • tumours of the hypothalamus or pituitary gland;
Maltese: • tumuri fl-ipotalamu jew fil-glandola pitwitarja
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05.
Maltese: Ormoni sesswali u modulatori tas-sistemi ġenitali, gonadotropins,
English: The first injection of Bemfola should be performed under direct medical supervision.
Maltese: L-ewwel injezzjoni ta' Bemfola għandha ssir taħt superviżjoni medika diretta.
English: However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Maltese: Madankollu, wieħed irid jikkunsidra li hemm varjazzjonijiet bejn il-kejl ta' LH li sar f'laboratorji differenti.
English: Respiratory, thoracic and mediastinal disorders Very rare:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
Maltese: Down-regulation permezz ta' agonist jew antagonist tal-ormon li jistimula l-produzzjoni tal gonadotropina (GnRH) qed jintuża komunement biex irażżan iż-żieda ta' LH endo ġenu u biex jikkontrolla l-livelli toniċi ta' LH.
English: • primary testicular insufficiency.
Maltese: • insuffiċenzja primarja tat-testikoli
English: Each pre-filled pen delivers 75 IU follitropin alfa, equivalent to 5.5 micrograms per 0.125 mL.
Maltese: Kull pinna mimlija għal-lest tagħti 75 IU follitropin alfa, ekwivalenti għal 5.5 mikrogramma għal kull 0.125 ml.
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
Maltese: Uġigħ addominali, nefħa addominali, skumdità addominali, dardir, rimettar, dijarrea
English: Each prefilled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 mL.
Maltese: IU (ekwivalenti għal 16.5-il mikrogramma) in 0.375 ml.
English: The steady state volume of distribution and total clearance are 10 L and 0.6 L/h, respectively.
Maltese: distribuzzjoni fl-istat fiss u t-tneħħija totali mill-ġisem huma ta' madwar 10 l u 0.6 l/siegħa, rispettivament.
English: Bemfola 75 IU/0.125 mL (5.5 micrograms/0.125 mL) is not designed to allow the cartridge to be removed.
Maltese: IU/0.125 ml (5.5 mikrogrammi/0.125 ml) mhuwiex iddisinjat b'tali mod li l-iskartoċċ ikun jista' jitneħħa.
English: Each prefilled pen delivers 75 IU (equivalent to 5.5 micrograms) in 0.125 mL.
Maltese: IU (ekwivalenti għal 5.5 mikrogramma) ta' 0.125 ml.
English: • When your eggs are ready, you will be given a single injection of 250 micrograms “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special recombinant DNA technique), or
Maltese: • Meta l-bajd tiegħek ikun lest, tingħata injezzjoni waħda ta' 250 mikrogramma ta' ‘hCG rikombinanti' (r-hCG, hCG magħmul f'laboratorju permezz ta' teknika speċjali ta' DNA
English: Follitropin alfa should be given as a course of daily injections simultaneously with lutropin alfa.
Maltese: Follitropin alfa għandu jingħata bħala kors ta' injezzjonijiet ta' kuljum simultanjament ma' lutropin alfa.
English: In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
Maltese: F'ART, l-aspirazzjoni tal-follikuli kollha qabel l-ovulazzjoni tista' tnaqqas il-possibbilità li sseħħ liperstimulazzjoni.
English: Bemfola 300 IU/0.50 mL (22 micrograms/0.5 mL) is not designed to allow the cartridge to be removed.
Maltese: Bemfola 300 IU/0.50 ml (22 mikrogramma /0.5 ml) mhuwiex iddisinjat b'tali mod li l-iskartoċċ ikun jista' jitneħħa.
English: CONTENTS
Maltese: Tqala
English: Marketing Authorisation Holder and Manufacturer Gedeon Richter Plc.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Gedeon Richter Plc.
English: Each pre-filled pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms per 0.75 mL.
Maltese: Kull pinna mimlija għal-lest tagħti 450 IU follitropin alfa, ekwivalenti għal 33 mikrogramma għal kull 0.75 ml.
English: • Bemfola is usually given every day.
Maltese: • Normalment Bemfola jingħata kuljum.
English: Nervous system disorders
Maltese: Disturbi gastro-intestinali
English: Such patients are unresponsive to follitropin alfa/hCG therapy.
Maltese: Dawn il pazjenti ma jirrispondux għat-terapija ta' follitropin alfa/hCG.
English: Each pre-filled pen delivers 150 IU follitropin alfa, equivalent to 11 micrograms per 0.25 mL.
Maltese: Kull pinna mimlija għal-lest tagħti 150 IU follitropin alfa, ekwivalenti għal 11-il mikrogramma għal kull 0.25 ml.
English: Paediatric population There is no relevant use of follitropin alfa in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' follitropin alfa fil-popolazzjoni pedjatrika.
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: Hungary
Maltese: L-Ungerija
English: The doses described below are stated in International Units (IU) and millilitres (mL).
Maltese: Id-dożi deskritti hawn taħt huma murija f'Unitajiet Internazzjonali (IU) u f'millilitri (mL).
English: Bemfola 450 IU/0.75 mL (33 micrograms/0.75 mL) is not designed to allow the cartridge to be removed.
Maltese: IU/0.75 ml (33 mikrogramma/0.75 ml) mhuwiex iddisinjat b'tali mod li l-iskartoċċ ikun jista' jitneħħa.
English: Each cartridge contains 0.375 mL solution for injection.
Maltese: Kull skartoċċ fih 0.375 mL soluzzjoni għal injezzjoni.
English: Adherence to the recommended follitropin alfa dose and to the regimen of administration can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8).
Maltese: L-osservanza tad-doża u tal-kors tal-għoti rakkomandati ta' follitropin alfa, jistgħu jnaqqsu r-riskju ta' stimulazzjoni eċċessiva tal-ovarji (ara sezzjonijiet 4.2 u 4.8).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 150 IU/0.25 mL injection follitropin alfa
Maltese: Bemfola 150 IU/0.25 ml injezzjoni follitropin alfa
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.125 mL
Maltese: INDIVIDWALI 0.125 ml
English: • Bemfola 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Maltese: IU/0.75 ml: Kull skartoċċ fih 450 IU (ekwivalenti għal 33 mikrogramma) follitropin alfa f'0.75 ml soluzzjoni.
English: Bemfola 150 IU/0.25 mL (11 micrograms/0.25 mL) is not designed to allow the cartridge to be removed.
Maltese: Bemfola 150 IU/0.25 ml (11-il mikrogramma/0.25 ml) mhuwiex iddisinjat b'tali mod li l-iskartoċċ ikun jista' jitneħħa.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 300 IU/0.5 mL injection follitropin alfa
Maltese: Bemfola 300 IU/0.5 ml injezzjoni follitropin alfa
English: No direct comparison of follitropin alfa/LH versus human menopausal gonadotropin (hMG) has been performed.
Maltese: Ma sarx paragun dirett bejn follitropin alfa/LH u gonadotropin tal-menopawsa umana (hMG).
English: In clinicaltrials, an increase of the ovarian sensitivity to follitropin alfa was shown when administered with lutropin alfa.
Maltese: Fl-istudji kliniċi, intweriet żieda fis-sensittività tal-ovarji għal follitropin alfa meta dan ingħata ma' lutropin alfa.
English: • Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
Maltese: IU (ekwivalenti għal 44 mikrogramma) follitropin alfa.
English: Solution for injection 1 pre-filled pen 1 injection needle 1 alcohol swab
Maltese: 1 pinna mimlija għal-lest 1 labra tal-injezzjoni 1 swab bl-alkoħol
English: Days of FSH stimulation required
Maltese: Jiem ta' stimulazzjoni b'FSH
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni):
English: Each pre-filled pen delivers 225 IU follitropin alfa, equivalent to 16.5 micrograms per 0.375 mL.
Maltese: IU follitropin alfa, ekwivalenti għal 16.5-il mikrogramma għal kull 0.375 ml.
English: Thromboembolism (both in association with and separate from OHSS.
Maltese: Tromboemboliżmu (f'assoċjazzjoni kemm ma' OHSS kif ukoll separat minn OHSS)
English: • Follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
Maltese: • Follitropin alfa flimkien mat-terapija tal-Gonadotropina Korjonika umana (hCG) hu indikat għall-istimulazzjoni ta' spermato ġenesi f'irġiel li jba tu minn ipogonadiżmu ipogonadotrofiku konġenitali jew miksub.
English: In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/L as measured in a central laboratory.
Maltese: Fi provi kliniċi, pazjenti li kellhom nuqqas qawwi ta' FSH u LH kienu definiti minn livell ta' LH fis serum ta' <1.2 IU/l kif imkejjel f'laboratorju ċentrali.
English: Each prefilled pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL.
Maltese: Kull pinna mimlija għal-lest tagħti 450 IU (ekwivalenti għal 33 mikrogramma) in 0.75 ml.
English: These instructions can be found at the end of the package leaflet.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: There is evidence to suggest that hCG plays a key role in triggering OHSS and that the syndrome may be more severe and more protracted if pregnancy occurs.
Maltese: Hemm evidenza li tissuġġerixxi li hCG għandu sehem ewlieni f'li jikkaġuna OHSS, u li s sindrome jista' jkun aktar sever u jdum aktar jekk isseħħ it-tqala.
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 g ħal żvilupp ta' OHSS jinkludu s -sindrome poliċistiku tal-ovarji, livelli assoluti għoljin ta' oestradiol fis -serum jew li jiżdiedu b'mod mg ħaġġel (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'
English: with a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), or malformed reproductive organs.
Maltese: - b'kundizzjoni li normalment tagħmel tqala normali impossibbli, bħal insuffiċjenza tal-ovarji (menopawsa bikrija), jew xi difett fiżiku fl-organi riproduttivi.
English: A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours after the last follitropin alfa injection to induce final follicular maturation.
Maltese: IU hCG tingħata 24-48 siegħa wara l-aħħar injezzjoni ta' follitropin alfa biex tinduċi maturazzjoni follikulari finali.
English: Bemfola 225 IU/0.375 mL (16.5 micrograms/0.375 mL) is not designed to allow the cartridge to be removed.
Maltese: 375 ml (16.5-il mikrogramma/0.375 ml) mhuwiex iddisinjat b'tali mod li l iskartoċċ ikun jista' jitneħħa.
English: For example, following two weeks of treatment with an agonist, 150-225 IU follitropin alfa are administered for the first 7 days.
Maltese: Pereżempju, wara ġimagħtejn ta' kura b'agonist, 150-225 IU ta' follitropin alfa jingħataw għall-ewwel 7 ijiem.