FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical evaluation may reveal hypovolaemia, haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, or acute pulmonary distress, and thromboembolic events.
Maltese: Evalwazzjoni klinika tista' tiżvela ipovolemija, emokonċentrazzjoni, żbilanċ ta' elettroliti, axxite, emoperitonew, effużjoni plewrali, idrotoraċi jew insuffiċjenza pulmonari akuta, u avvenimenti tromboemboliċi.
English: 1 vial of powder.
Maltese: 1 kunjett ta' trab.
English: Feedback Window if other than ‘'0'' (column 8).
Maltese: Feedback Window tad-Doża jekk ikun hemm numru ieħor li ma jkunx “0” (kolonna 8).
English: Pergoveris is indicated for use in infertility (see section 4.1).
Maltese: Pergoveris hu indikat għall-użu f'każ ta' infertilità (ara sezzjoni 4.1).
English: Tumours of sex organs
Maltese: Tumuri tal-organi sesswali
English: 3 Tap the reservoir holder gently (Fig. 6).
Maltese: 3. Tektek bil-mod ir-reservoir holder (Fig. 6).
English: Pergoveris is a preparation of recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Maltese: Pergoveris huwa preparazzjoni ta' ormon rikombinanti uman li jistimula l-follikuli (follitropin alfa, r-hFSH - recombinant human follicle stimulating hormone) u ormon luteinising rikombinanti uman (lutropin alfa, r-hLH - recombinant human luteinising hormone), magħmula f'ċelluli tal-Ovarju talĦamster Ċiniż (CHO - Chinese Hamster Ovary) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: INFORMATION IN BRAILLE pergoveris (900 iu + 450 iu)/1.44 ml pen
Maltese: INFORMAZZJONI BIL-BRAILLE pergoveris (900 iu + 450 iu)/1.44 ml pinna
English: Follitropin alfa and lutropin alfa have shown the same pharmacokinetic profile as follitropin alfa and lutropin alfa separately.
Maltese: Follitropin alfa u lutropin alfa urew l-istess profil farmakokinetiku bħal follitropin alfa u lutropin alfa separati.
English: • Serious blood clotting problems (thromboembolic events) usually with severe OHSS are found very rarely.
Maltese: • Problemi serji ta' tagħqid ta' demm (avvenimenti tromboemboliċi) normalment b'OHSS sever huma rari ħafna.
English: * The numbers on the Dose Feedback Window and reservoir holder represent the number of International Units (IU) of medication.
Maltese: *In-numri fuq il-Feedback Window tad-Doża u r-reservoir holder jirrappreżentaw in-numru ta' Unitajiet Internazzjonali (IU - International Units) ta' mediċina.
English: Verify that the Dose Feedback Window reads "0" (Fig. 8).
Maltese: Ivverifika li l-Feedback Window tad-Doża tkun turi "0" (Fig. 8).
English: IF
Maltese: JIS
English: Both belong to the family of hormones called “gonadotropins”, which are involved in reproduction and fertility.
Maltese: It-tnejn jagħmlu parti mill-familja ta' ormoni msejħa “gonadotropini”, li huma involuti fir-riproduzzjoni u fil-fertilità.
English: The steady state volume of distribution is 10 L.
Maltese: L-istat aħħari talvolum ta' distribuzzjoni huwa ta' madwar 10 L.
English: (equivalent to 3 micrograms) of lutropin alfa.
Maltese: IU (ekwivalenti għal 3 mikrogrammi) ta' lutropin alfa.
English: • Contains 900 IU follitropin alfa and 450 IU lutropin alfa.
Maltese: IU ta' follitropin alfa u 450 IU ta' lutropin alfa.
English: The active substances in Pergoveris are copies of the natural hormones FSH and LH.
Maltese: Is-sustanzi attivi f'Pergoveris huma kopji tal-ormoni FSH u LH naturali.
English: • Needles (included in the pack)
Maltese: • Labar (inklużi fil-pakkett)
English: • Contains 0.48 mL of Pergoveris solution • Contains 300 IU follitropin alfa and 150 IU lutropin alfa.
Maltese: • Fiha 0.48 mL ta' soluzzjoni ta' Pergoveris • Fiha 300 IU ta' follitropin alfa u 150 IU ta' lutropin alfa.
English: Pack sizes of 1, 3 and 10 vials with the corresponding number of solvent's vial (1, 3 and 10 vials).
Maltese: Daqsijiet tal-pakketti ta' 1, 3 u 10 kunjetti bin-numru indikattiv ta' 1, 3 u 10 kunjetti ta' solvent.
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, każ sever ta' OHSS jista' jkun ikkomplikat minn liwi tal-ovarji jew avvenimenti tromboemboliċi bħal emboliżmu pulmonari, puplesija iskemika u infart mijokardijaku.
English: • FSH stimulates the production of eggs
Maltese: • FSH jistimula l-produzzjoni tal-bajd
English: In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Maltese: Fi studji kliniċi dawn il-pazjenti ġew definiti bil-livelli endoġeni tas-serum LH <1.2 IU/L.
English: The prevalence of ectopic pregnancy after assisted reproductive technologies (ART) was reported to be higher than in the general population.
Maltese: Il-prevalenza ta' tqala ektopika wara teknoloġiji ta' riproduzzjoni assistita (ART - assisted reproductive technologies) kienet irrappurtata li hi ogħla meta mqabbla mal-popolazzjoni ġenerali.
English: When risk of multiple pregnancies is assumed, treatment discontinuation should be considered.
Maltese: Meta jkun hemm suspett ta' riskju ta' tqala multipla, għandu jiġi kkunsidrat il-waqfien tal-kura.
English: Independent risk factors for developing OHSS include young age, lean body mass, polycystic ovarian syndrome, higher doses of exogenous gonadotrophins, high absolute or rapidly rising serum oestradiol level (> 900 pg/mL or > 3,300 pmol/L in anovulation), previous episodes of OHSS and large number of developing ovarian follicles (3 follicles of ≥ 14 mm in diameter in anovulation).
Maltese: Fatturi ta' riskju indipendenti għall-iżvilupp ta' OHSS jinkludu l-età żagħżugħa, il-massa tal-ġisem mingħajr xaħam, sindrome poliċistiku tal-ovarji, dożi ogħla ta' gonadotropini esoġeni, livelli assoluti għoljin ta' oestradiol fis-serum jew li jiżdiedu b'mod mgħaġel (>900 pg/mL jew >3,300 pmol/L f'anovulazzjoni), episodji preċedenti ta' OHSS u numru kbir ta' follikuli tal-ovarji li jkunu qed jiżviluppaw (3 follikuli ta' dijametru ta' ≥14 mm fin-nuqqas ta' ovulazzjoni).
English: • Pergoveris is supplied in packs of 1, 3 and 10 vials of powder with the corresponding number of solvent's vials (1, 3 and 10 vials).
Maltese: • Pergoveris jiġi f'pakketti ta' 1, 3, 10 kunjetti ta' trab bl-istess ammont ta' 1,3 u 10 kunjetti bissolvent (1, 3 u 10 kunjetti).
English: • Record the treatment day number (column 1), date (column 2), time of your injection (column
Maltese: • Ħu nota tan-numru tal-jum tal-kura (kolonna 1), id-data (kolonna 2), il-ħin tal-injezzjoni tiegħek
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 jsir f'laboratorji differenti.
English: In this case, the follitropin alfa dose is usually increased every 7 or every 14 days by 37.5 to 75 IU.
Maltese: follitropin alfa normalment tiżdied b'37.5-75
English: • This may take up to 5 weeks.
Maltese: • Dan jista' jieħu sa 5 ġimgħat.
English: Following subcutaneous administration, the absolute bioavailability is approximately 60%; the terminal half-life is slightly prolonged.
Maltese: Wara li jingħata b'injezzjoni taħt il-ġilda, il-biodisponibbilita assoluta hija ta' madwar 60%; il-halflife terminali jdum ftit iżjed.
English: Pergoveris 150 IU/75 IU powder and solvent for solution for injection Follitropin alfa/Lutropin alfa
Maltese: Pergoveris 150 IU/75 IU trab u solvent għal soluzzjoni għall-injezzjoni Follitropin alfa/lutropin alfa
English: • Sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate and water for injections.
Maltese: • Sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate u ilma għall-injezzjonijiet.
English: Pergoveris is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency.
Maltese: Pergoveris huwa indikat biex jistimula żvilupp follikulari f'nisa adulti b'defiċjeza severa ta' FSH u LH.
English: • tumours of the hypothalamus and pituitary gland
Maltese: • tumuri fl-ipotalamu u l-glandola pitwitarja
English: • Record your prescribed dose (column 5).
Maltese: • Ħu nota tad-doża preskritta tiegħek (kolonna 5).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 June 2007
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 25 ta' Ġunju 2007
English: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1
Maltese: • sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis sezzjoni 6.1;
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 IU r-hFSH/75 IU r-hLH
Maltese: INDIVIDWALI 150 IU r-hFSH/75
English: 12/06 19:00 450IU + 225 IU
Maltese: #3 12/06 19:00 450IU + 225
English: Verify the expiration date on the pen label (Fig. 2).
Maltese: Ivverifika d-data ta' meta tiskadi fuq it-tikketta talpinna (Fig. 2).
English: Powder: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbate 20, sucrose, sodium hydroxide (for pH adjustment) and concentrated phosphoric acid (for pH adjustment).
Maltese: Trab: disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, polysorbat 20, sucrose, sodium hydroxide (għall-aġġustament tal-pH) u phosphoric acid ikkonċentrat (għall-aġġustament tal-pH).
English: MARKETING AUTHORISATION HOLDER
Maltese: Reservoir holder*
English: Children and adolescents Pergoveris is not for use in children and adolescents below 18 years old.
Maltese: Tfal u adolexxenti Pergoveris mhuwiex għall-użu fit-tfal u adolexxenti li għandhom inqas minn 18-il sena.
English: Excipients: sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide and concentrated phosphoric acid (for pH adjustment), and water for injections.
Maltese: Eċċipjenti: sucrose, arginine monohydrochloride, poloxamer 188, methionine, phenol, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate, sodium hydroxide u phosphoric acid ikkonċentrat (għall-aġġustament tal-pH), u ilma għall-injezzjonijiet.
English: INFORMATION IN BRAILLE pergoveris (450 iu + 225 iu)/0.72 ml pen 17.
Maltese: INFORMAZZJONI BIL-BRAILLE pergoveris (450 iu/225 iu)/0.
English: Thromboembolism may occur very rarely, usually associated with severe OHSS (see section 4.4).
Maltese: It-tromboemboliżmu jista' jseħħ rarament ħafna, u ġeneralment ikun assoċjat ma' OHSS sever (ara sezzjoni 4.4).
English: Pergoveris is intended for subcutaneous administration.
Maltese: Pergoveris mhuwiex indikat waqt it-treddigħ.
English: Pharmacokinetic/pharmacodynamic relationships There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Maltese: Relazzjonijiet farmakokinetiċi/farmakodinamiċi Ma hemmx interazzjoni farmakokinetika meta follitropin alfa jingħata fl-istess ħin.
English: • sacs of fluid within the ovaries (ovarian cysts)
Maltese: • membrani mimlijin bi fluwidu fl-ovarji (ċisti fl-ovarji)
English: Pergoveris contains two different active substances called “follitropin alfa” and “lutropin alfa”.
Maltese: Pergoveris soluzzjoni għall-injezzjoni fih żewġ sustanzi attivi differenti li jissejħu “follitropin alfa” u “lutropin alfa”.
English: • The pen comes in 3 different multi-dose presentations:
Maltese: • Il-pinna tiġi fi 3 preżentazzjonijiet differenti b'ħafna dożi:
English: *recombinant human follitropin alfa and recombinant human lutropin alfa are produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology.
Maltese: *follitropin alfa rikombinanti uman u lutropin alfa rikombinanti uman huma magħmula f'ċelluli talovarju tal-ħamster Ċiniż (CHO) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: In these patients, Pergoveris may increase the risk of an acute attack.
Maltese: F'dawn il-pazjenti, Pergoveris jista' jżid ir-riskju ta' attakk akut.
English: • The numbers in the Dose Feedback Window present the number of International Units, or IUs,
Maltese: • In-numri fil-Feedback Window tad-Doża jippreżentaw in-numru ta' Unitajiet Internazzjonali,
English: This increases your risk of developing ovarian hyperstimulation syndrome (OHSS).
Maltese: Dan iżid ir-riskju tiegħek li tiżviluppa sindrome ta' iperstimulazzjoni tal-ovarji (OHSS).
English: Pergoveris contains sodium Pergoveris contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: Pergoveris fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles missodium'.
English: A comparative clinical study between the freeze-dried and the liquid formulation showed bioequivalence between the two formulations.
Maltese: Studju kliniku komparattiv bejn ilformulazzjoni freeze-dried u l-formulazzjoni likwida wera bijoekwivalenza bejn iż-żewġ formulazzjonijiet.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa (r-hLH).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett wieħed fih 150 IU (ekwivalenti għal 11 mikrogrammi) ta' follitropin alfa (r-hFSH) u 75 IU (ekwivalenti għal 3 mikrogrammi) ta' lutropin alfa (r-hLH).
English: Clinical studies with Pergoveris were conducted with a freeze-dried formulation.
Maltese: Twettqu studji kliniċi b'Pergoveris b'formulazzjoni freeze-dried.
English: In rare cases this can also happen independently of OHSS (see in section 2. under “Blood clotting problems (thromboembolic events)”).
Maltese: F'każijiet rari dan jista' jseħħ ukoll independentement minn OHSS (ara f'sezzjoni 2. taħt “Problemi ta' tagħqid tad-demm (avvenimenti tromboemboliċi)”).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 450 IU r-hFSH-225 IU r-hLH/0.72 mL
Maltese: INDIVIDWALI 450 IU r-hFSH-225
English: Thromboembolism, usually associated with severe OHSS Respiratory, thoracic and mediastinal disorders Very rare:
Maltese: Tromboemboliżmu, ġeneralment assoċjat ma' OHSS sever Disturbi respiratorji, toraċiċi u medjastinali Rari ħafna:
English: • 1 vial containing Pergoveris powder • 1 vial containing water for injections (solvent)
Maltese: • 1 kunjett li fih Pergoveris trab • 1 kunjett li fih ilma għall-injezzjonijiet (solvent)
English: The steady state volume of distribution is around 10-14 L. Lutropin alfa shows linear pharmacokinetics, as assessed by AUC which is directly proportional to the dose administered.
Maltese: L-istat fiss talvolum ta' distribuzzjoni huwa madwar 10-14 L. Lutropin alfa għandu farmakokinetika lineari, kif jidher mill-AUC li huwa direttament proporzjonali għad-doża li tingħata.
English: EU/1/07/396/003 10 vials of powder for solution for injection.
Maltese: EU/1/07/396/003 10 kunjetti ta' trab għas-soluzzjoni għall-injezzjoni 10 kunjetti ta' solvent
English: Each Pergoveris (900 IU + 450 IU)/1.44 mL pre-filled pen contains 1.44 mL of solution for injection and can deliver six doses of Pergoveris 150 IU/75 IU.
Maltese: IU + 450 IU)/1.44 mL pinna mimlija għal-lest fih 1.44 mL ta' soluzzjoni għallinjezzjoni u jista' jagħti sitt dożi ta' Pergoveris 150 IU/75 IU.
English: 3), and volume of your pen (column 4).
Maltese: (kolonna 3), u l-volum tal-pinna tiegħek (kolonna 4).
English: It is for use in adult women (18 years old or above) who have low levels (severe deficiency) of “follicle stimulating hormone” (FSH) and “luteinising hormone” (LH).
Maltese: Għandu jintuża f'nisa adulti (18-il sena jew aktar) li għandhom livelli baxxi (nuqqas serju) ta' “ormon ta' stimulazzjoni tal-follikuli” (FSH) u tal-“ormon luteinizzatur” (LH).
English: Detailed information on this medicine is available on the European Medicine Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: Powder: white to off-white lyophilised pellet.
Maltese: Dehra tat-trab: pellit bajda għal offwajt lijofilizzata.
English: EU/1/07/396/001 1 vial of powder for solution for injection.
Maltese: EU/1/07/396/001 1 kunjett ta' trab għas-soluzzjoni għall-injezzjoni 1 kunjett ta' solvent
English: 1 multidose pre-filled pen of 0.72 mL solution 7 injection needles
Maltese: 72 mL ta' soluzzjoni 7 labriet tal-injezzjoni
English: What Pergoveris is
Maltese: Pergoveris 150
English: • Verify you dialed the right dose before injecting (column 6).
Maltese: • Ivverifika li tkun iddajaljajt id-doża korretta qabel ma tinjetta (kolonna 6).
English: • Contains 1.44 mL of Pergoveris solution
Maltese: • Fiha 1.44 mL ta' soluzzjoni ta' Pergoveris • Fiha 900
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Phosphoric acid, concentrated (for pH adjustment) Sodium hydroxide (for pH adjustment)
Maltese: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Phosphoric acid, ikkonċentrat (għal aġġustament tal-pH) Sodium hydroxide (għal aġġustament tal-pH)
English: In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism.
Maltese: Fi studji kliniċi, l-effikaċja tal-kombinazzjoni ta' follitropin alfa u lutropin alfa kienet murija f'nisa b'hypogonadotropic hypogonadism.
English: Pergoveris pre-filled pen
Maltese: Pergoveris fih is-sodium
English: * produced in genetically engineered Chinese hamster ovary (CHO) cells.
Maltese: *Prodott f'ċelluli prodotti permezz ta' inġinerija ġenetika tal-ovarju tal-Ħamster Ċiniż (CHO).
English: Each pre-filled pen contains 900 IU (equivalent to 66 micrograms) of follitropin alfa (r-hFSH) and 450 IU (equivalent to 18 micrograms) of lutropin alfa (r-hLH) in 1.44 mL.
Maltese: IU (ekwivalenti għal 66 mikrogramma) ta' follitropin alfa (r-hFSH) u 450 IU (ekwivalenti għal 18-il mikrogramma) ta' lutropin alfa (r-hLH) f'1.44 mL.
English: • Pergoveris is presented as a powder and solvent for solution for injection.
Maltese: • Pergoveris huwa trab u solvent għal soluzzjoni għall-injezzjoni.
English: Verify that the Dose Feedback Window is set to "0".
Maltese: • Ivverifika li l-Feedback Window tad-Doża tkun turi “0”.
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 biex jikkaġuna OHSS, u li s-sindrome jista' jkun aktar sever u jdum aktar jekk isseħħ it-tqala.
English: The lutropin alfa pharmacokinetics following single and repeated administration of lutropin alfa are comparable and the accumulation ratio of lutropin alfa is minimal.
Maltese: Il- farmakokinetika ta' lutropin alfa wara doża waħda jew aktar minn waħda ta' lutropin alfa, hija komparabbli u l-accumulation ratio ta' lutropin alfa huwa minimu.
English: This medicine stimulates your ovaries.
Maltese: Din il-mediċina tistimula l-ovarji.
English: Batch
Maltese: JEKK
English: Pregnancy loss
Maltese: Doża preskritta
English: Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Maltese: IU + 450 IU)/1.44 mL injezzjoni Follitropin alfa/Lutropin alfa
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Phosphoric acid, concentrated (for pH adjustment) Water for injections
Maltese: Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Sodium hydroxide (għall-aġġustament tal-pH) Phosphoric acid konċentrat (għall-aġġustament tal-pH) Ilma għall-injezzjonijiet
English: Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 28 jum f'temperatura ta' 25°C.
English: A treatment regimen commences with the recommended dose of Pergoveris containing 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa every day.
Maltese: Kors ta' kura jibda bid-doża rakkomandata ta' Pergoveris li fih 150 Unità Internazzjonali (IUInternational Units) ta' follitropin alfa u 75 IU ta' lutropin alfa kuljum.
English: if "0", injectioncomplete if not"0",needsecond injection Injectthisamount.75..usingnewpen
Maltese: jekk "0", injezzjoni lesta jekk mhux"0", tkun teħtieġ ittieni injezzjoni injetta dan l-ammont .75..billi tuża pinna ġdida
English: 7 disposable injection needles.
Maltese: Tivverifika injezzjoni kompluta.
English: EU/1/07/396/002 3 vials of powder for solution for injection.
Maltese: EU/1/07/396/002 3 kunjetti ta' trab għas-soluzzjoni għall-injezzjoni 3 kunjetti ta' solvent
English: Ovarian torsion
Maltese: Soluzzjoni rikostitwita
English: • if you have a condition that would make a normal pregnancy impossible, such as an early menopause, malformed sex organs or benign tumours of the womb.
Maltese: • jekk għandek kundizzjoni li tagħmel tqala normali impossibbli, bħala menopawsa bikrija jew organi sesswali malformati, jew tumuri beninni fil-ġuf.
English: DO NOT discard it.
Maltese: protezzjoni ta'
English: However this will only occur if hCG is administered (see in section 2. under “Ovarian hyperstimulation syndrome (OHSS)”).
Maltese: Madankollu dan jiġri biss jekk jingħata l-hCG (ara f'sezzjoni 2. taħt “Sindrome ta' iperstimulazzjoni tal-ovarji (OHSS)”).
English: It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Maltese: Jista jkun aċċettabbli li wieħed ikompli l-istimulazzjoni f' ċiklu wieħed sa' 5 ġimgħat.
English: What Pergoveris contains The active substances are follitropin alfa and lutropin alfa.
Maltese: X'fih Pergoveris Is-sustanzi attivi huma follitropin alfa u lutropin alfa.
English: In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Pergoveris therapy is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Maltese: Imbagħad dan jerħi bajda, wara injezzjoni tal-ormon “gonadotropin kroniku uman (hCG)”.
English: Usually, OHSS resolves spontaneously with the onset of menses.
Maltese: Ġeneralment, l-OHSS tintemm b'mod spontanju malli tibda l-mestrwazzjoni.
English: Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Maltese: Wieħed jista' jikkunsidra luteal phase support peress illi nuqqas ta' sustanzi b'attivita' luteotrofika (LH/hCG) wara l-ovulazzjoni jista' jirriżulta f'telf tal-korpus luteum qabel il-waqt.
English: Elimination Total clearance is around 2 L/h, and less than 5% of the dose is excreted in the urine.
Maltese: Eliminazzjoni It-tneħħija totali mill-ġisem hija madwar 2 L/siegħa, u inqas minn 5% tad-doża toħroġ ma' l-urina.
English: Do not use Pergoveris
Maltese: X'inhu Pergoveris
English: INFORMATION IN BRAILLE pergoveris (300 iu + 150 iu)/0.48 ml pen
Maltese: INFORMAZZJONI BIL-BRAILLE pergoveris (300 iu + 150 iu)/0.
English: Units) of follitropin alfa and 450 IU of lutropin alfa in 1.44 mL and can deliver six doses of Pergoveris 150 IU/75 IU.
Maltese: IU (Unità Internazzjonali) ta' follitropin alfa u 450 IU ta' lutropin alfa f'1.44 mL u tista' tagħti sitt dożi ta' Pergoveris 150
English: Tiny amounts of concentrated phosphoric acid and sodium hydroxide are added to keep acidity levels (pH levels) normal.
Maltese: Ammonti żgħar ta' phosphoric acid ikkonċentrat u sodium hydroxide jiżdiedu biex iżommu l-livelli ta' aċidità (livelli tal-pH) normali.
English: Wash your hands with soap and water (Fig. 1).
Maltese: Aħsel idejk bis-sapun u l-ilma (Fig. 1) 3.2.
English: The active substances are follitropin alfa and lutropin alfa.
Maltese: Follitropin alfa/lutropin alfa.