FrancophonIA/ELRC3.0 huggingface dataset:
English: The table below displays the main adverse reactions in women treated with Elonva in clinical trials and post-marketing surveillance according to system organ class and frequency; 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), and not known (cannot be estimated from available data).
Maltese: (≥ 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), u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: This medicinal product contains less than 1 mmol (23 mg) sodium per injection, i.e., essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol (23 mg) ta' sodium f'kull injezzjoni, i.e., huwa essenzjalment ‘ħieles mis-sodium'.
English: Ovarian hyperstimulation syndrome (OHSS)
Maltese: Sindrome tal-iperstimulazzjoni tal-ovarji (OHSS)
English: Ovarian and other reproductive system tumours
Maltese: Tumuri fl-ovarji u tumuri oħra fis-sistema riproduttiva
English: Less than 50 kg
Maltese: aktar minn 60 kilogramma.
English: The primary efficacy endpoint in the ENGAGE study was ongoing pregnancy (assessed at least 10 weeks after embryo transfer).
Maltese: L-iskop finali primarju tal-effikaċja fl-istudju ENGAGE kien tqala li kompliet (stmata mill-inqas 10 ġimgħat wara t-trasferiment tal-embriju).
English: Each syringe contains 0.5 mL solution.
Maltese: Kull siringa fiha 0.5 mL ta' soluzzjoni.
English: In patients with mild, moderate or severe renal insufficiency the rate of elimination of corifollitropin alfa may be reduced (see sections 4.2 and 5.2).
Maltese: F'pazjenti b'insuffiċjenza tal-kliewi ħafifa, moderata jew severa, ir-rata ta' eliminazzjoni ta' corifollitropin alfa tista' tiġi mnaqqsa (ara sezzjonijiet 4.2 u 5.2).
English: The most frequently reported adverse reactions during treatment with Elonva in clinical trials (N=2,397) are pelvic discomfort (6.0%), OHSS (4.3%, see also section 4.4), headache (4.0%), pelvic pain (2.9%), nausea (2.3%), fatigue (1.5%), and breast tenderness (1.3%).
Maltese: L-iktar reazzjonijiet avversi li kienu rrappurtati b'mod frekwenti waqt il-kura b'Elonva fil-provi kliniċi (N=2,397) huma skumdità fil-pelvi (6.0%), OHSS (4.3%, ara wkoll sezzjoni 4.4), uġigħ ta' ras (4.0%)
English: 150 micrograms 150 micrograms
Maltese: 150 mikrogramma.
English: The mean number of embryos transferred in the FTET cycles of ENGAGE was 1.7 in both treatment groups.
Maltese: In-numru medju ta' embrijuni ttrasferiti fiċ-ċikli FTET ta' ENGAGE kien ta' 1.7 fiż-żewġ gruppi ta' trattament.
English: After a single subcutaneous injection of Elonva, the maximum serum concentration of corifollitropin alfa is 4.24 ng/mL (2.49-7.21 ng/mL
Maltese: Wara injezzjoni waħda ta' Elonva taħt il-ġilda, il-konċentrazzjoni massima ta' corifollitropin alfa fisserum hija ta' 4.24 ng/mL (2.49-7.21 ng/mL1) u tintlaħaq 44 siegħa (35-57 siegħa1) wara d-doża.
English: Treatment with the GnRH-antagonist usually starts 5 to 6 days after the injection of Elonva.
Maltese: Il-kura bl-antagonist ta' GnRH is-soltu tibda minn 5 sa 6 ijiem wara l-injezzjoni ta' Elonva.
English: Tel: + 40 21 529 29 00 msdromania@merck.com
Maltese: Tel: + 40 21 529 29 00
English: Corifollitropin alfa is designed as a sustained follicle stimulant with the same pharmacodynamic profile as (rec)FSH, but with a markedly prolonged duration of FSH activity.
Maltese: Corifollitropin alfa hu maħsub bħala stimulant sostnut tal-follikuli bl-istess profil farmakodinamiku bħal (rec)FSH, iżda b'tul ta' żmien ta' attività ta' FSH li jdum iżjed b'mod notevoli.
English:  Fibroid tumours of the uterus incompatible with pregnancy.
Maltese:  Tumuri fibrojdi tal-utru inkompatibbli mat-tqala.
English: The number of oocytes retrieved was a key secondary efficacy endpoint.
Maltese: In-numru ta' ooċiti rkuprati kien skop finali sekondarju tal-effikaċja importanti.
English: In women undergoing ART procedures the risk of multiple pregnancy is mainly related to the number of embryos transferred.
Maltese: F'nisa li jkunu qed jirċievu proċeduri ta' ART, ir-riskju ta' tqala multipla hu primarjament marbut man-numru ta' embriji ttrasferiti.
English: Multiple pregnancies and births have been reported for all gonadotropin treatments, including Elonva.
Maltese: Tqaliet u twelid multipli ġew irrappurtati għall-kuri kollha b'gonadotropin, inkluż Elonva.
English: Do not use this medicine after the expiry date which is stated on the label and outer carton after “EXP” (expiry date).
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi, li tidher fuq it-tikketta wara ‘EXP' u fuq il-kartuna wara “JIS” (data ta' meta tiskadi).
English: In the PURSUE study, non-inferiority was demonstrated in vital pregnancy rate between Elonva and recFSH, with vital pregnancy rate defined as the percentage of subjects with at least one foetus with heart activity assessed 5 to 6 weeks after embryo transfer.
Maltese: Fl-istudju PURSUE, nuqqas ta' inferjorità intweriet fir-rata ta' tqala vitali bejn Elonva u recFSH, bir rata ta' tqala vitali definita bħala l-perċentwal ta' individwi b'mill-inqas fetu wieħed b'attività tal-qalb stmata minn 5 sa 6 ġimgħat wara t-trasferiment tal-embriju.
English: Ovarian torsion has been reported after treatment with gonadotropins, including Elonva.
Maltese: Torsjoni tal-ovarji Torsjoni tal-ovarji kienet irrappurtata wara kura b'gonadotropins, inkluż Elonva.
English: 100 micrograms
Maltese: 100 µg recFSH
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including Elonva.
Maltese: Każijiet tromboemboliċi, kemm b'rabta ma' kif ukoll separati minn OHSS, kienu rrappurtati wara kura b'gonadotropins, inkluż Elonva.
English: The primary efficacy endpoint was vital pregnancy rate.
Maltese: iskop finali primarju tal-effikaċja kien ir-rata ta' tqala vitali.
English: Hypersensitivity reactions, both local and generalised, including rash*
Maltese: Reazzjonijiet ta' sensittività eċċessiva, kemm lokali kif ukoll mifruxa, inkluż raxx*
English: Subcutaneous use (SC)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Although data in hepatically impaired patients are not available, hepatic impairment is unlikely to affect the elimination of corifollitropin alfa (see section 5.2).
Maltese: Għalkemm m'hemmx dejta disponibbli għal pazjenti b'indeboliment tal-fwied, l-indeboliment talfwied mhux mistenni li jaffettwa l-eliminazzjoni ta' corifollitropin alfa (ara sezzjoni 5.2).
English: The recommended doses of Elonva have only been established in a treatment cycle with a GnRH antagonist that was administered from stimulation day 5 or day 6 onwards (see also sections 4.1, 4.4, and 5.1).
Maltese: Id-dożi rrakkomandati ta' Elonva ġew stabbiliti biss f'ċiklu ta' kura b'antagonist ta' GnRH li ngħata minn jum 5 jew minn jum 6 ta' stimulazzjoni 'l quddiem (ara wkoll sezzjonijiet 4.1, 4.4, u 5.1).
English: Congenital malformations reported in infants born after a frozen-thawed embryo transfer (FTET) cycle
Maltese: Tqala miċ-ċikli ta' Trasferiment ta' Embrijuni Friżati u Mdewba (FTET - Frozen-Thawed Embryo
English: *Live birth rate was a secondary efficacy endpoint in ENGAGE and PURSUE.
Maltese: *Ir-rata ta' twelid ta' trabi ħajjin kienet l-iskop finali sekondarju tal-effikaċja f'ENGAGE u PURSUE.
English: In the PURSUE study, 1,390 healthy normal ovulatory women, aged 35 to 42 years with a body weight greater than or equal to 50 kg, were treated for one cycle with 150 micrograms of Elonva and pituitary suppression with a GnRH antagonist as part of an ART program.
Maltese: Fl-istudju PURSUE, 1,390 mara f'saħħithom b'ovulazzjoni normali, b'età minn 35 sa 42 sena b'piż tal-ġisem ta' 50 kg jew aktar, kienu kkurati għal ċiklu wieħed b'150 mikrogramma ta' Elonva u soppressjoni tal-glandola pitwitarja b'antagonist ta' GnRH bħala parti minn programm ta' ART. L
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Maltese: iperstimulazzjoni tal-ovarji (OHSS - ovarian hyperstimulation syndrome), li tista' tkun problema medika serja.
English: Elonva 150 micrograms injection corifollitropin alfa
Maltese: Elonva 150 mikrogramma injezzjoni corifollitropin alfa
English: ENSURE (18-36 years of age) (body weight less than or equal to 60 kg)
Maltese: ENSURE (età ta' 18-36 sena)
English: To monitor the risk of OHSS, ultrasonographic assessments of follicular development should be performed prior to treatment and at regular intervals during treatment; the concurrent determination of serum oestradiol levels may also be useful.
Maltese: Biex timmonitorja r-riskju ta' OHSS, għandhom jitwettqu evalwazzjonijiet ultrasonografiċi tal-iżvilupp follikulari qabel il-kura u f'intervalli regolari matul il-kura; jista' jkun utli jekk fl-istess waqt jiġu determinati l-livelli tal estradiol fis-serum.
English: Elonva 100 micrograms injection corifollitropin alfa
Maltese: Elonva 100 mikrogramma injezzjoni corifollitropin alfa
English: Abdominal distension, vomiting, diarrhoea, constipation
Maltese: Nefħa fl-addome, rimettar, dijarea, stitikezza
English: OHSS, pelvic pain, pelvic discomfort, breast tenderness
Maltese: OHSS, uġigħ pelviku,
English: There is no relevant use of Elonva within the approved indication in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' Elonva fil-popolazzjoni pedjatrika fl-indikazzjoni approvata.
English: In the ENSURE study, 396 healthy normal ovulatory women, aged 18 to 36 years with a body weight less than or equal to 60 kg, were treated for one cycle with 100 micrograms of Elonva and pituitary suppression with a GnRH antagonist as part of an ART program.
Maltese: Fl-istudju ENSURE, 396 mara f'saħħithom b'ovulazzjoni normali, b'età minn 18-il sena sa 36 sena b'piż tal-ġisem ta' 60 kg jew inqas, kienu kkurati għall-ċiklu wieħed b'100 mikrogramma ta' Elonva u soppressjoni tal-glandola pitwitarja b'antagonist ta' GnRH bħala parti minn programm ta' ART.
English: Elonva 150 µg recFSH 300 IU
Maltese: 150 µg recFSH
English: Ovarian and other reproductive system neoplasms
Maltese: Neoplażmi fl-ovarji u neoplażmi oħra fis-sistema riproduttiva
English: Date of first authorisation: 25 January 2010 Date of latest renewal: 22 August 2014
Maltese: Data tal-aħħar tiġdid: 22 t'Awwissu 2014
English: who weigh 50 kilograms or more and who are older than 36 years of age.
Maltese: li jiżnu 50 kilogramma jew aktar u li għandhom età aktar minn 36 sena.
English: In women with generally recognized risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins may further increase this risk.
Maltese: F'nisa b'fatturi ta' riskju li jkunu ġeneralment rikonoxxuti għal avvenimenti tromboemboliċi, bħal storja personali jew tal-familja, ħxuna żejda severa jew trombofilija, il-kura b'gonadotropins tista' żżid b'mod addizzjonali dan ir-riskju.
English: Elonva is available in pack sizes of 1 pre-filled syringe.
Maltese: Tinjettax Elonva ġo xi muskolu.
English: Danmark MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com
Maltese: Tlf: + 45 4482 4000
English: In ART there is an increased risk of OHSS with 18 or more follicles of 11 mm or more in diameter.
Maltese: F'ART hemm żieda fir-riskju ta' OHSS bi 18 jew iktar follikuli b'dijametru ta' 11 mm jew iktar.
English:  Primary ovarian failure.
Maltese:  Insuffiċjenza primarja tal-ovarji.
English: Do not use Elonva if you: - are allergic (hypersensitive) to corifollitropin alfa or any of the other ingredients of this medicine (listed in section 6) - have cancer of the ovary, breast, uterus, or brain (pituitary gland or hypothalamus) - have recently had unexpected vaginal bleeding, other than menstrual, without a diagnosed cause - have ovaries that do not work because of a condition called primary ovarian failure - have ovarian cysts or enlarged ovaries - have malformations of the sexual organs which make a normal pregnancy impossible - have fibroid tumours in the uterus which make a normal pregnancy impossible - have risk factor of OHSS (OHSS is a serious medical problem that can happen when the ovaries are overly stimulated.
Maltese: - għandek malformazzjonijiet tal-organi sesswali, li jagħmlu tqala normali impossibbli - għandek tumuri fibrojdi fl-utru, li jagħmlu tqala normali impossibbli - għandek fattur ta' riskju għal OHSS (OHSS hija problema medika serja li tista' tiġri meta l ovarji jkunu stimulati ż-żejjed.
English: 100 micrograms 150 micrograms
Maltese: Ma ġewx studjati. 150 mikrogramma 150 mikrogramma
English: In case of an excessive ovarian response, see the recommendations given in section 4.4 in order to reduce the risk for developing ovarian hyperstimulation syndrome (OHSS).
Maltese: F'każ ta' rispons eċċessiv tal-ovarji, ara r-rakkomandazzjonijiet mogħtija f'sezzjoni 4.4 biex jitnaqqas ir-riskju li jiżviluppa s-sindromu tal-iperstimulazzjoni tal-ovarji (OHSS).
English: Pregnancy from the fresh cycles of ENGAGE and PURSUE
Maltese: Transfer) ta' ENGAGE u PURSUE
English: Elimination of corifollitropin alfa predominantly occurs via the kidneys, and the rate of elimination may be reduced in patients with renal insufficiency (see sections 4.2 and 4.4).
Maltese: L-eliminazzjoni ta' corifollitropin alfa sseħħ il-biċċa l-kbira millkliewi, u r-rata ta' eliminazzjoni tista' tiġi mnaqqsa f'pazjenti b'insuffiċjenza tal-kliewi (ara sezzjonijiet 4.2 u 4.4).
English: Ovarian torsion, adnexa uteri pain, premature ovulation, breast pain
Maltese: Torsjoni tal-ovarji, uġigħ fladnexa uteri, ovulazzjoni prematura, uġigħ fis-sider
English: Although data in hepatically impaired patients are not available, hepatic impairment is unlikely to affect the pharmacokinetic profile of corifollitropin alfa.
Maltese: Għalkemm m'hemmx dejta disponibbli għal pazjenti b'indeboliment tal-fwied, l-indeboliment tal fwied mhux mistenni li jaffettwa l-profil farmakokinetiku ta' corifollitropin alfa.
English: Seven days after the injection with Elonva on stimulation day 1, COS treatment may be continued with daily injections of (recombinant) Follicle Stimulating Hormone [(rec)FSH] until the criterion for triggering final oocyte maturation (3 follicles ≥ 17 mm) has been reached.
Maltese: Sebat ijiem wara l-injezzjoni b'Elonva f'jum 1 tal-istimulazzjoni, il-kura ta' COS tista' titkompla b'injezzjonijiet ta' kuljum ta' Ormon li Jistimula l-Follikulu (rikombinanti) [(rec)FSH] sakemm il kriterju biex jikkawża l-maturazzjoni finali tal-ooċiti (3 follikuli ta' ≥ 17 mm) jkun intlaħaq.
English: - A single 100-microgram dose is recommended in women who weigh less than or equal to 60 kilograms and who are 36 years of age or younger.
Maltese: - Doża waħda ta' 100 mikrogramma hija rrakkomandata f'nisa li jiżnu 60 kilogramma jew inqas u li għadhom età ta' 36 sena jew inqas.
English: Fresh Cycles of ENGAGE (18-36 years of age) (body weight greater than 60 kg and less than or equal to 90 kg)
Maltese: Ċikli ġodda ta' ENGAGE (età ta' 18-36 sena) (piż tal-ġisem ta' aktar minn 60 kg sa piż ta' inqas minn jew ta' 90 kg)
English: Pituitary suppression with a GnRH antagonist (ganirelix acetate injection at a daily dose of 0.25 mg) was used in each of the three clinical trials.
Maltese: Soppressjoni tal-glandola pitwitarja b'antagonist ta' GnRH (injezzjoni ta' ganirelix acetate b'doża ta' 0.25 mg kuljum) intużat f'kull waħda mit-tliet provi kliniċi.
English: The rates for congenital malformations (major and minor combined) reported for infants born after an FTET cycle in the PURSUE study follow-up (16.4%) were similar to those reported for infants born after fresh ART cycles in the ENSURE, ENGAGE and PURSUE studies combined
Maltese: Ir-rati ta' formazzjonijiet konġenitali difettużi (maġġuri u minuri miġbura f'daqqa) irrappurtati għal trabi mwielda wara ċiklu ta' FTET fis-segwitu tal-istudju PURSUE (16.4%) kienu simili għal dawk irrappurtati għal trabi mwielda wara ċikli ġodda ta' ART fl-istudji ENSURE, ENGAGE u PURSUE
English: Following use of Elonva, 61 infants were born after an FTET cycle in the PURSUE study follow-up, and 607 infants were born after fresh ART cycles in the ENSURE, ENGAGE and PURSUE studies combined.
Maltese: Wara l-użu ta' Elonva, twieldu 61 tarbija wara ċiklu ta' FTET fis-segwitu tal-istudju PURSUE, u twieldu 607 trabi wara ċikli ġodda ta' ART fl-istudji ENSURE, ENGAGE u PURSUE kollha flimkien.
English: Severe OHSS may be life-threatening.
Maltese: huma importanti biex jitnaqqas ir-riskju ta' OHSS.
English: Dose In the treatment of women of reproductive age, the dose of Elonva is based on weight and age.
Maltese: Fil-kura ta' nisa ta' età riproduttiva, id-doża ta' Elonva hija bbażata fuq il-piż u l-età.
English: Not recommended with a GnRH agonist protocol
Maltese: Mhux irrakkomandat ma' protokoll b'agonist ta' GnRH
English: Corifollitropin alfa exposure after a single subcutaneous injection is 665 hours*ng/mL (AUC, 426-1,037 hours*ng/mL
Maltese: L-esponiment għal corifollitropin alfa wara injezzjoni waħda taħt il-ġilda huwa ta' 665 siegħa*ng/mL (AUC, 426-1,037 siegħa*ng/mL1) u huwa simili wara għoti ta' 100 mikrogramma corifollitropin alfa lil nisa b'piż tal-ġisem ta' 60 kilogramma jew inqas u għoti ta' 150 mikrogramma corifollitropin alfa lil nisa b'piż tal-ġisem ta'
English: (body weight greater than 60 kg and less than or equal to 90 kg)
Maltese: (piż tal-ġisem aktar minn 60 kg u inqas minn jew ugwali għal 90 kg)
English: Table 3: Pregnancy Results from the FTET cycles of ENGAGE and PURSUE Intent-to-Treat Population (ITT)
Maltese: Tabella 3: Riżultati ta' Tqala miċ-ċikli ta' FTET ta' ENGAGE u PURSUE Popolazzjoni bl-Intenzjoni li Tiġi Ttrattata (ITT - Intent-to-Treat)
English: The incidence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Maltese: ART tista' tkun ftit ogħla minn dik wara konċepimenti spontanji.
English: What Elonva contains - The active substance is corifollitropin alfa.
Maltese: - Is-sustanza attiva hi corifollitropin alfa.
English: In three randomized, double-blind, clinical trials, treatment with a single subcutaneous injection of Elonva, 100 micrograms (ENSURE study) or 150 micrograms (ENGAGE and PURSUE study), for the first seven days of COS was compared to treatment with a daily dose of 150, 200, or 300 IU of recFSH, respectively.
Maltese: Fi tliet provi kliniċi, double-blind, fejn il-pazjenti ntgħażlu b'mod każwali, kura b'injezzjoni waħda, ta' 100 mikrogramma (studju ENSURE) jew 150 mikrogramma (studju ENGAGE u PURSUE) ta' Elonva taħt il-ġilda, għall-ewwel sebat ijiem ta' COS tqabblet ma' kura b'doża ta' kuljum ta' 150,
English: o A previous COS cycle that resulted in more than 30 follicles  11 mm measured by ultrasound examination.
Maltese: o Ċiklu COS fil-passat li rriżulta f'iktar minn 30 follikulu ≥ ta' 11 mm imkejla permezz ta'
English: Injection site haematoma, injection site pain, irritability
Maltese: Ematoma fis-sit tal-injezzjoni, uġigħ fis-sit tal-injezzjoni, irritabilità
English: *Adverse reactions were identified through post-marketing surveillance.
Maltese: *Ir-reazzjonijiet avversi ġew identifikati permezz ta' sorveljanza wara t-tqegħid fis-suq.
English: 1 pre-filled syringe with an automatic safety (needle injury prevention) system and a sterile injection needle.
Maltese: 1 siringa mimlija għal-lest b'sistema awtomatika tas-sigurtà (li timpedixxi korrimenti minn tingiż tal-labra) u labra sterilizzata għall-injezzjoni.
English: (0.10-0.18 L/h
Maltese: G03GA09
English: - A single 150-microgram dose is recommended in women: who weigh more than 60 kilograms, regardless of age.
Maltese: - Doża waħda ta' 150 mikrogramma hija rrakkomandata f'nisa: li jiżnu aktar minn 60 kilogramma, tkun xi tkun l-età.
English: The median total duration of stimulation was 9 days for both groups, indicating that two days of recFSH were required to complete ovarian stimulation from stimulation day 8 onwards (recFSH was given on the day of hCG for this study).
Maltese: stimulazzjoni kien ta' 9 ijiem għaż-żewġ gruppi, li jindika li kienu meħtieġa jumejn ta' recFSH biex tintemm l-istimulazzjoni tal-ovarji minn jum 8 ta' stimulazzjoni 'l quddiem (recFSH ingħata fil-jum tal-hCG għal dan l-istudju).
English: Each Elonva 150 micrograms solution for injection pre-filled syringe contains 150 micrograms in 0.5 millilitre (mL) solution for injection.
Maltese: Kull Elonva 150 mikrogramma ta' soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest fiha 150 mikrogramma f'0.5 ta' millilitru (mL) ta' soluzzjoni għall injezzjoni.
English: Treatment with gonadotropic hormones like Elonva may cause ovarian hyperstimulation syndrome (OHSS).
Maltese: Il-kura b'ormoni gonadotropiċi bħal Elonva tista' tikkawża sindrome tal-iperstimulazzjoni tal-ovarji
English: Vascular disorders
Maltese: Kumplikazzjonijiet vaskulari
English: Pharmacokinetic parameters of corifollitropin alfa were evaluated after subcutaneous administration in women undergoing a COS treatment cycle.
Maltese: Il-parametri farmakokinetiċi ta' corifollitropin alfa ġew stmati wara għoti taħt il-ġilda f'nisa li kienu qed jirċievu ċiklu ta' kura ta' COS.
English: Tel.: +420 233 010 111 dpoc_czechslovak@merck.com
Maltese: dpoc_czechslovak@merck.com
English: Of the 2,511 women treated with Elonva who were evaluated for the formation of post-treatment antibodies, four (0.16%) had evidence of antibody formation, including three who had been exposed once to Elonva and one who had been exposed twice to Elonva.
Maltese: (0.16%) kellhom evidenza ta' formazzjoni ta' antikorpi, inkluż tlieta li kienu ġew esposti għal Elonva darba u waħda li kienet ġiet esposta għal Elonva darbtejn.
English: o A history of Ovarian Hyperstimulation Syndrome (OHSS).
Maltese: o Storja medika ta' Sindromu tal-Iperstimulazzjoni tal-Ovarji (OHSS).
English: Elonva is used in women having infertility treatment like in vitro fertilisation (IVF).
Maltese: Elonva jintuża f'nisa li jkunu qed jieħdu kura kontra l-infertilità bħal fertilizzazzjoni in vitro (IVF).
English: MSD Α.Φ.Β.Ε.Ε Τηλ: + 30 210 98 97 300 dpoc_greece@merck.com
Maltese: Τηλ: + 30 210 98 97 300
English: Elonva 150 µg recFSH 300 IU N=268 N=128 N=756 N=750 N=694 N=696
Maltese: Ċiklu 1a ta' FTET Tqala li kompliet 55 148 37.2 45 147 30.6 43 152 28.3 42 145 29.0
English: A possible complication of treatment with gonadotropic hormones like Elonva is unwanted overstimulation of the ovaries.
Maltese: Komplikazzjoni possibbli ta' kura b'ormoni gonadotrofiċi bħal Elonva hija stimulazzjoni żejda mhux mixtieqa tal-ovarji.
English: Each Elonva 100 micrograms solution for injection pre-filled syringe contains 100 micrograms in 0.5 millilitre (mL) solution for injection.
Maltese: Kull Elonva 100 mikrogramma ta' soluzzjoni għallinjezzjoni f'siringa mimlija għal-lest fiha 100 mikrogramma f'0.5 ta' millilitru (mL) ta' soluzzjoni għall-injezzjoni.
English: Treatment with a GnRH antagonist should be started on stimulation day 5 or day 6 depending on the ovarian response, i.e. the number and size of growing follicles.
Maltese: Il-kura b'antagonist ta' GnRH għandha tinbeda f'jum 5 jew 6 tal-istimulazzjoni, skont ir-rispons talovarji, i.e. in-numru u d-daqs ta' follikuli li jkunu qed jikbru.
English: Corifollitropin alfa has an elimination half-life of 70 hours (59-82 hours
Maltese: Corifollitropin alfa għandu half-life ta' eliminazzjoni ta' 70 siegħa (59-82 siegħa1) u tneħħija ta' 0.13 L/siegħa (0.10-0.18 L/siegħa1).
English: Components of the Elonva syringe with needle
Maltese: Jekk tinsa tuża Elonva
English: Storage by the pharmacist Store in a refrigerator (2ºC-8°C).
Maltese: Ħażna mill-ispiżjar Aħżen fi friġġ (2ºC-8°C).
English: The syringe is packed together with a sterile injection needle.
Maltese: Is-siringa hi ppakkjata flimkien ma' labra sterilizzata għall-injezzjoni.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tel/Tél: +32(0)27766211 dpoc_belux@merck.com
Maltese: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tel/Tél: