FrancophonIA/ELRC3.0 huggingface dataset:
English: Ovaleap 300 IU/0.5 mL is available in packs containing 1 cartridge and 10 injection needles.
Maltese: Ovaleap 300 IU/0.5 mL hu disponibbli f'pakketti li fihom 1 skartoċċ u 10 labriet tal-injezzjoni.
English: Ovaleap contains sodium, benzalkonium chloride and benzyl alcohol This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Maltese: Ovaleap fih is-sodium, benzalkonium chloride u benzyl alcohol Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis- sodium'.
English: - The other ingredients are sodium dihydrogen phosphate dihydrate, sodium hydroxide (2 M) (for pH adjustment), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride and water for injections.
Maltese: - Is-sustanzi mhux attivi l-oħra huma sodium dihydrogen phosphate monohydrate, dihydrate, sodium hydroxide (2 M) (għal aġġustament tal-pH), mannitol, methionine, polysorbate 20, benzyl alcohol, benzalkonium chloride u ilma għall-injezzjonijiet.
English: Ovaleap 450 IU/0.75 mL solution for injection EU/1/13/871/002
Maltese: IU/0.75 mL soluzzjoni għall-injezzjoni EU/1/13/871/002
English: Sodium content Ovaleap contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodiumfree”.
Maltese: Ovaleap fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
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 endoġenu u biex jikkontrolla l-livelli toniċi ta' LH.
English: - any condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), fibroid tumours of the womb or malformed reproductive organs.
Maltese: - kwalunkwe kundizzjoni li normalment tagħmel tqala normali impossibbli, bħal insuffiċjenza tal-ovarji (menopawsa bikrija), tumuri fibrojdi tal-utru jew xi difett fiżiku fl-organi riproduttivi.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTURI RESPONSABBLI
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.5 mL
Maltese: INDIVIDWALI 1.5 mL
English: Ovaleap 900 IU/1.5 mL solution for injection EU/1/13/871/003
Maltese: IU/1.5 mL soluzzjoni għall-injezzjoni EU/1/13/871/003
English: • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate.
Maltese: • Nuqqas ta' ovulazzjoni (inkluż is-sindrome poliċistiku fl-ovarji) f'nisa li fuqhom il-kura bi clomifene citrate ma kinitx effettiva.
English: • The usual dose of this medicine is 150 IU together with hCG.
Maltese: • Id-doża normali ta' din il-mediċina hi ta' 150 IU flimkien ma' hCG.
English: • The usual starting dose of this medicine is 75 to 150 IU each day.
Maltese: • Id-doża normali tal-bidu ta' din il-mediċina hi ta' 75 sa 150 IU kuljum.
English: • in combination with a medicine called “human chorionic gonadotropin” (hCG) to help produce sperm in men that are infertile due to low levels of certain hormones.
Maltese: • flimkien ma' mediċina magħrufa bħala ‘gonadotropin korjonika umana (hCG)' biex jgħin fil produzzjoni tal-isperma f'irġiel li mhumiex fertili minħabba livelli baxxi ta' ċerti ormoni.
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution.
Maltese: IU (ekwivalenti għal 66 mikrogramma) ta' follitropin alfa f'soluzzjoni ta' 1.5 mL.
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 hu kważi identiku għall-ormon naturali li jiġi magħmul fil-ġisem tiegħek imsejjaħ “ormon li jistimula l-follikoli” (FSH).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.5 mL
Maltese: INDIVIDWALI 0.5 mL
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
Maltese: • tkabbir tal-ovarji jew ċista fl-ovarji mhux minħabba sindrome poliċistiku tal-ovarji;
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 l-iperstimulazzjoni.
English: Mild or moderate OHSS (including associated symptomatology)
Maltese: OHSS ħafif jew moderat (li jinkludi sintomatoloġija assoċjata)
English: Manufacturer Teva Biotech GmbH Dornierstraße 10 89079 Ulm Germany
Maltese: Manifattur Teva Biotech GmbH Dornierstraße 10
English: • Stomach ache
Maltese: • Tkabbir tas-sider
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection follitropin alfa
Maltese: Ovaleap 300 IU/0.5 mL injezzjoni follitropin alfa
English: 1 cartridge with 1.5 mL solution and 20 injection needles
Maltese: 1 skartoċċ b'soluzzjoni ta' 1.5 mL u 20 labra għall-injezzjoni
English: • When you get the desired response, you will be given hCG or r-hCG.
Maltese: • Meta tikseb ir-rispons mixtieq, tingħata hCG jew r-hCG.
English: However, the OHSS will only occur if hCG is also administered [see also section 2 under “Ovarian Hyper-Stimulation Syndrome (OHSS)”].
Maltese: Madankollu, l-OHSS iseħħ biss jekk jingħata wkoll hCG [ara wkoll sezzjoni 2 taħt “Sindrome ta' Iperstimulazzjoni tal-Ovarji (OHSS)”].
English: Ovaleap 300 IU/0.5 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Maltese: Ovaleap 300 IU/0.5 mL soluzzjoni għall-injezzjoni Kull skartoċċ fih 300 IU (ekwivalenti għal 22 mikrogramma) ta' follitropin alfa f'0.5 mL ta' soluzzjoni għall-injezzjoni.
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' tagħqid ta' demm (avvenimenti tromboemboliċi), xi kultant indipendenti mill-OHSS huma rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna).
English: • Sacs of fluid within the ovaries (ovarian cysts) Common (may affect up to 1 in 10 people)
Maltese: • Membrani mimlijin bi fluwidu fl-ovarji (ċisti fl-ovarji) Komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni)
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 studji 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 cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution.
Maltese: Kull skartoċċ fih 300 IU (ekwivalenti għal 22 mikrogramma) ta' follitropin alfa f'soluzzjoni ta' 0.5 mL.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL
Maltese: INDIVIDWALI 0.75 mL
English: 1 cartridge with 0.75 mL solution and 10 injection needles
Maltese: 1 skartoċċ b'soluzzjoni ta' 0.75 mL u 10 labar għall-injezzjoni
English: FSH is a gonadotropin, a type of hormone that plays an important role in human fertility and reproduction.
Maltese: FSH hu gonadotropin, tip ta' ormon li għandu rwol importanti fil-fertilità u r-riproduzzjoni tal-bniedem.
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 1.5 mL of solution..
Maltese: IU/1.5 mL soluzzjoni għall-injezzjoni Skartoċċ (ħġieġ ta' Tip I) b'pistun tal-lastku (lastku tal-bromobutyl) u crimp-cap (aluminju) b'septum (lastku tal-bromobutyl), li fih 1.5 mL ta' soluzzjoni.
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.75 mL of solution..
Maltese: IU/0.75 mL soluzzjoni għall-injezzjoni Skartoċċ (ħġieġ ta' Tip I) b'pistun tal-lastku (lastku tal-bromobutyl) u crimp-cap (aluminju) b'septum (lastku tal-bromobutyl), li fih 0.75 mL ta' soluzzjoni.
English: Each cartridge contains 900 IU (equivalent to 66 micrograms) follitropin alfa in 1.5 mL solution for injection.
Maltese: IU (ekwivalenti għal 66 mikrogramma) ta' follitropin alfa f'1.5 mL ta' soluzzjoni għall-injezzjoni.
English: • OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
Maltese: • L-OHSS jista' jsir sever bi tkabbir evidenti tal-ovarji, tnaqqis fil-produzzjoni tal-awrina, żieda fil-piż, diffikultà fit-teħid tan-nifs u/jew akkumulazzjoni possibbli ta' fluwidu fiż-żaqq jew fissider.
English: Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa.
Maltese: IU (ekwivalenti għal 44 mikrogramma) ta' follitropin alfa.
English: Ovaleap 900 IU/1.5 mL is available in packs containing 1 cartridge and 20 injection needles.
Maltese: IU/1.5 mL hu disponibbli f'pakketti li fihom 1 skartoċċ u 20 labra tal-injezzjoni.
English: How to store Ovaleap
Maltese: X'inhu Ovaleap
English: • if you are allergic to follitropin alfa, Follicle Stimulating Hormone (FSH) or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal follitropin alfa, l-Ormon li Jistimula l-Follikuli (FSH - Follicle Stimulating Hormone) jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: • The maximum daily dose of this medicine is usually not higher than 225 IU.
Maltese: • Id-doża massima ta' kuljum ta' din il-mediċina normalment ma tkunx aktar minn 225
English: Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/kg/day) for extended periods, through reduced fecundity.
Maltese: Nuqqas ta' fertilità kien irrappurtat f'firien esposti għal dożi farmakoloġiċi ta' follitropin alfa (≥ 40 IU/kg/kuljum) għal perjodi estiżi, minħabba tnaqqis fil-fekondità.
English: • Local reactions at the injection site, such as pain, redness, bruising, swelling and/or irritation Common (may affect up to 1 in 10 people)
Maltese: • Reazzjonijiet lokali fis-sit tal-injezzjoni, bħal uġigħ, ħmura, tbenġil, nefħa u/jew irritazzjoni Komuni (jistgħu jaffettwaw aktar minn 1 minn kull 10 persuni)
English: Ovaleap 450 IU/0.75 mL is available in packs containing 1 cartridge and 10 injection needles.
Maltese: IU/0.75 mL hu disponibbli f'pakketti li fihom 1 skartoċċ u 10 labriet tal-injezzjoni.
English: Ovaleap 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 soluzzjoni għall-injezzjoni Kull skartoċċ fih 450 IU (ekwivalenti għal 33 mikrogramma) ta' follitropin alfa f'0.75 mL ta' soluzzjoni għall-injezzjoni.
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
Maltese: Kull skartoċċ fih 450 IU (ekwivalenti għal 33 mikrogramma) ta' follitropin alfa f'soluzzjoni ta' 0.75 mL.
English: Thromboembolism (both in association with and separate from OHSS)
Maltese: Tromboemboliżmu (kemm f'assoċjazzjoni ma' OHSS kif ukoll separat minn OHSS)
English: This could cause chest pain, breathlessness, stroke or heart attack [see also section 2 under “Blood clotting problems (thromboembolic events)”].
Maltese: Dawn jistgħu jikkawżaw uġigħ fis-sider, qtugħ ta' nifs, puplesija jew attakk tal-qalb [ara wkoll sezzjoni 2 taħt “Problemi ta' tagħqid tad-demm (avvenimenti trombolemboliċi)”].
English: MARKETING AUTHORISATION NUMBER(S) Ovaleap 300 IU/0.5 mL solution for injection EU/1/13/871/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Ovaleap 300 IU/0.5 mL soluzzjoni għall-injezzjoni EU/1/13/871/001
English: INFORMATION IN BRAILLE Ovaleap 450 IU/0.75 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Ovaleap 450
English: Women with anovulation resulting from severe LH and FSH deficiency In LH and FSH deficient women (hypogonadotropic hypogonadism), the objective of follitropin alfa therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of hCG. Follitropin alfa should be given as a course of daily injections simultaneously with lutropin alfa.
Maltese: IU/kg/kuljum) follitropin alfa, minkejja li mhuwiex teratoġeniku, ikkawża tnaqqis fin-numru ta' feti vijabbli u distoċija simili għal dik osservata fil-każ ta' Gonadotropin Menopawsali urinarju (hMG). Madankollu, minħabba li Ovaleap mhuwiex indikat waqt it-tqala, din id-dejta għandha rilevanza klinika limitata.
English: 1 cartridge with 0.5 mL solution and 10 injection needles
Maltese: 1 skartoċċ b'soluzzjoni ta' 0.5 mL u 10 labar għall-injezzjoni
English: • to help follicles develop in women undergoing assisted reproductive technology procedures (procedures that may help you to become pregnant) such as “in vitro fertilisation”, “gamete intra-fallopian transfer” or “zygote intra-fallopian transfer”.
Maltese: • biex jgħin fl-iżvilupp tal-follikuli f'nisa li jkunu għaddejjin minn proċeduri ta' teknoloġija ta' riproduzzjoni assistita (proċeduri li jistgħu jgħinu lin-nisa joħorġu tqal) bħall-‘fertilizzazzjoni in vitro', ‘trasferiment tal-gamete fit-tubu fallopjan' jew ‘trasferiment taż-żigot fit-tubu fallopjan'.
English: Ovarian cysts
Maltese: Reazzjoni avversa
English: Men with hypogonadotropic hypogonadism
Maltese: Sodium dihydrogen phosphate dihydrate
English: Such patients are unresponsive to follitropin alfa/hCG therapy.
Maltese: Dawn il-pazjenti ma jirrispondux għat-terapija ta' follitropin alfa/hCG.
English: The Ovaleap cartridge is designed for use in conjunction with the Ovaleap Pen only, which is separately available.
Maltese: L-iskartoċċ ta' Ovaleap hu maħsub għall-użu flimkien mal-Ovaleap Pen biss, li hi disponibbli separatament.
English: May be stored before opening not above 25 °C for up to 3 months.
Maltese: Jista' jinħażen qabel tiftħu f'temperatura taħt 25°C għal sa 3 xhur.
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 300 IU/0.5 mL solution for injection Ovaleap 450 IU/0.75 mL solution for injection Ovaleap 900 IU/1.5 mL solution for injection
Maltese: Ovaleap 300 IU/0.5 mL soluzzjoni għall-injezzjoni Ovaleap 450
English: 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: Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or foeto/neonatal toxicity of follitropin alfa.
Maltese: Dejta limitata dwar numru limitat ta' tqaliet esposti (inqas minn 300 riżultat ta' tqala) turi li m'hemm l-ebda effett ta' formazzjoni difettuża jew effetti tossiċi fil-fetu/tarbija tat-twelid wara l-użu ta' follitropin alfa.
English: INFORMATION IN BRAILLE Ovaleap 900 IU/1.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE Ovaleap 900
English: In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table 3 below) and in ovulation induction, follitropin alfa 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 jqabblu r-hFSH (follitropin alfa) u FSH urinarju f'ART (ara t-tabella 3 hawn taħt) u f'induzzjoni ta' ovulazzjoni, follitropin alfa kien iktar qawwi minn FSH urinarju fir-rigward ta' doża totali aktar baxxa u perjodu ta' kura iqsar meħtieġ biex tiskatta l-maturazzjoni follikolari.
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 kienu definiti minn livell ta' LH fis-serum endoġenu ta' < 1.2 IU/L.
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: The single injection will be 250 micrograms of r-hCG or 5,000 to 10,000 IU of hCG, 24 to 48 hours after the last Ovaleap injection.
Maltese: Injezzjoni waħda ta' 250 mikrogramma r-hCG jew 5,000 IU sa 10,000
English: The steady state volume of distribution and total clearance are 10 L and 0.6 L/h, respectively.
Maltese: Il-volum ta' distribuzzjoni fl-istat fiss u t-tneħħija totali mill-ġisem huma ta' madwar 10 L u 0.6
English: Clinical assessment of follitropin alfa indicates that its daily doses, regimens of administration and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Maltese: Evalwazzjoni klinika ta' follitropin alfa tindika li d-dożi ta' kuljum, il-korsijiet tal-għoti u l-proċeduri tal-monitoraġġ tal-kura m'għandhomx ikunu differenti minn dawk użati fil-preżent għal prodotti mediċinali li fihom FSH urinarju.
English: What Ovaleap is
Maltese: Ovaleap
English: Cartridge (type I glass) with a rubber piston (bromobutyl rubber) and a crimp-cap (aluminium) with a septum (bromobutyl rubber), containing 0.5 mL of solution.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Ovaleap 300 IU/0.5 mL soluzzjoni għall-injezzjoni Skartoċċ (ħġieġ ta' Tip I), b'piston tal-lastku (lastku tal-bromobutyl) u crimp cap (aluminju) b'septum (lastku tal-bromobutyl), li fih 0.5 mL ta' soluzzjoni.
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments.
Maltese: Jekk jiġi deċiż li jkun hemm bżonn li tiżdied id-doża ta' FSH, l-aġġustament fid-doża għandu jsir preferibbilment f'intervalli ta' 7-14-il ġurnata u preferibbilment b'żidiet ta' 37.5-75
English: This medicine also contains 0.02 mg per mL of benzalkonium chloride and 10.0 mg per mL of benzyl alcohol.
Maltese: Din il-mediċina fiha wkoll 0.02 mg kull mL ta' benzalkonium chloride u 10.
English: If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments.
Maltese: Jekk ikun hemm bżonn li tiżdied id-doża tal-FSH, ikun aħjar jekk tibdil fid-doża jsir wara intervalli ta' 7-14-il ġurnata u preferibbilment b'żidiet ta'37.5-75
English: • Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
Maltese: • Ovaleap flimkien mat-terapija tal-gonadotropina korjonika umana (hCG) hu indikat għall-istimulazzjoni ta' spermatoġenesi f'irġiel li jbatu minn ipogonadiżmu ipogonadotrofiku konġenitali jew miksub.
English: • If you use Ovaleap at the same time as a “gonadotropin-releasing hormone” (GnRH) agonist or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you may need a higher dose of Ovaleap to produce follicles.
Maltese: (GnRH) (dawn il-mediċini jbaxxu l-livelli tal-ormoni sesswali tiegħek u jwaqqfulek l ovulazzjoni) jista' jkollok bżonn ta' doża akbar ta' Ovaleap biex tipproduċi l-follikuli.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ovaleap 300 IU/0.5 mL injection follitropin alfa
Maltese: Ovaleap 300 IU/0.5 mL soluzzjoni għall-injezzjoni follitropin alfa
English: For storage conditions after first opening of the medicinal product, see section 6.3.
Maltese: Għal-lista sħiħa ta' eċċipjenti, ara sezzjoni 6.1.
English: Patients with porphyria or a family history of porphyria should be closely monitored during treatment with follitropin alfa.
Maltese: Pazjenti li jbatu minn porfirja jew li għandhom storja medika fil-familja ta' porfirja, iridu jkunu mmonitorjati sew waqt il-kura b'follitropin alfa.
English: Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Maltese: Wara li jingħata ġol-vini, follitropin alfa jinfirex fl-ispazju tal-fluwidu extraċellulari b'half-life inizjali ta' madwar sagħtejn u jitneħħa mill-ġisem b'half-life terminali ta' madwar ġurnata.
English: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.5 mL solution for injection.
Maltese: IU (ekwivalenti għal 22 mikrogramma) ta' follitropin alfa f'0.5 mL ta' soluzzjoni għall-injezzjoni.
English: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution for injection.
Maltese: IU (ekwivalenti għal 33 mikrogramma) ta' follitropin alfa f'0.75 mL ta' soluzzjoni għall-injezzjoni.
English: • Swelling of the veins above and behind the testicles (a varicocele)
Maltese: • Nefħa tal-vini fuq u n-naħa ta' wara tat-testikoli (varikoċele)
English: When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa injection.
Maltese: Meta jintlaħaq l-aħjar effett mixtieq, injezzjoni waħda ta' 250 mikrogramma ta' choriogonadotropin alfa umana rikombinanti (r-hCG) jew 5,000 IU sa 10,000
English: In patients undergoing ovulation induction, the incidence of multiple pregnancy is increased compared with natural conception.
Maltese: Pazjenti li tkun qed issirilhom induzzjoni tal-ovulazzjoni, għandhom aktar ċans ta' tqala multipla, meta mqabbla ma' konċepiment naturali.
English: NAME OF THE MEDICINAL PRODUCT Ovaleap 450 IU/0.75 mL solution for injection follitropin alfa
Maltese: IU/0.75 mL injezzjoni follitropin alfa
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of the solution contains 600 IU (equivalent to 44 micrograms) follitropin alfa*.
Maltese: IU (ekwivalenti għal 44 mikrogramma) ta' follitropin alfa*.
English: Ovaleap is intended for subcutaneous use.
Maltese: Ovaleap hu kontra-indikat waqt it-treddigħ.
English: Ovaleap solution for injection in cartridges has been developed for use in the Ovaleap Pen.
Maltese: Ovaleap hu soluzzjoni ċara u bla kulur.
English: Concomitant use of follitropin alfa with other medicinal products used to stimulate ovulation (e.g. hCG, clomifene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of follitropin alfa needed to elicit an adequate ovarian response.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni L-użu fl-istess ħin ta' follitropin alfa ma' prodotti mediċinali oħra li jintużaw biex jistimulaw l-ovulazzjoni (eż. hCG, clomifene citrate) jista' jsaħħaħ ir-rispons follikulari, filwaqt li l-użu fl-istess ħin ma' xi tip ta' agonist jew antagonist ta' GnRH biex jinduċi desensitizzazzjoni pitwitarja, jista' jżid id-doża ta' follitropin alfa li jkun meħtieġ biex jikkawża rispons adegwat fl-ovarji.
English: • in combination with a medicine called “lutropin alfa” (a version of another gonadotropin, “luteinising hormone” or LH) to help ovulation in women that are not ovulating because their body is producing too little FSH and LH.
Maltese: • flimkien ma' mediċina magħrufa bħala ‘lutropin alfa' (verżjoni ta' gonadotropin ieħor ‘ormon luteinising' jew LH) biex jgħin l-ovulazzjoni f'nisa li mhumiex jovulaw minħabba li l-ġisem tagħhom jipproduċi ftit wisq FSH u LH.
English: - unexplained vaginal bleeding.
Maltese: Tarmix mediċini mal-ilma tad-dranaġġ.
English: Miscarriage
Maltese: Korriment