FrancophonIA/ELRC3.0 huggingface dataset:
English: The studies showed that Tresiba was at least as effective as other long acting insulins in controlling blood glucose levels in adults with type 1 and type 2 diabetes, and more effective than sitagliptin in adults with type 2 diabetes.
Maltese: L-istudji wrew li Tresiba kien tal-inqas effettiv daqs insulina oħra li taġixxi fit-tul fil-kontroll tal-livelli tal-glukożju fid-demm f'adulti bid-dijabete tat-tip 1 u tat-tip 2, u aktar effettiv minn sitagliptin f'adulti bid-dijabete tat-tip 2.
English: Regarding its safety, the Committee concluded that Tresiba is generally safe and its side effects are comparable to those of other insulin analogues with no unexpected side effects reported.
Maltese: Fir-rigward tas-sigurtà tiegħu, il-Kumitat ikkonkluda li Tresiba huwa ġeneralment sigur u l-effetti sekondarji tiegħu huma komparabbli ma' dawk ta' analogi oħra talinsulina bl-ebda effett sekondarju mhux mistennija rrapportat.
English: The full EPAR for Sabervel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Sabervel is a ‘generic medicine'.
Maltese: Sabervel huwa ‘mediċina ġenerika'.
English: Sabervel is a medicine that contains the active substance irbesartan.
Maltese: Sabervel huwa mediċina li fiha s-sustanza attiva irbesartan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sabervel on 13 April 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Sabervel fil-13 ta' April 2012.
English: The usual recommended dose of Sabervel is 150 mg once a day.
Maltese: Id-doża normalment rakkomandata ta' Savervel hija ta' 150 mg darba kuljum.
English: The active substance in Sabervel, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Sabervel, l-irbesartan, hija ‘antagonista tar-riċettur anġjotensina II' li jfisser li jimblokka l-azzjoni ta' ormon fil-ġisem imsejjaħ anġjotensina II.
English: This is a summary of the European public assessment report (EPAR) for Sabervel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sabervel.
English: Why has Sabervel been approved?
Maltese: Għaliex ġie approvat Sabervel?
English: What are the benefits and risks of Sabervel?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Sabervel?
English: The CHMP concluded that, in accordance with EU requirements, Sabervel has been shown to have comparable quality and to be bioequivalent to Aprovel.
Maltese: Is-CHMP kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Sabervel wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Aprovel.
English: Because Sabervel is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel.
Maltese: Peress li Sabervel huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet sabiex tinstab il-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Aprovel.
English: This means that Sabervel is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Maltese: Dan ifisser li Sabervel huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Aprovel.
English: Because Sabervel is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Sabervel huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: In patients with hypertension and type 2 diabetes, Sabervel is added to other treatments for hypertension.
Maltese: F'pazjenti li jbatu minn ipertensjoni u dijabete tat-tip 2, Sabervel jiżdied mat-trattamenti l-oħra għallipertensjoni.
English: Sabervel is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Maltese: Sabervel jintuża wkoll għall-kura ta' mard fil-kliewi f'adulti li jbatu minn ipertensjoni u dijabete tat-tip 2.
English: How has Sabervel been studied?
Maltese: Kif ġie studjat Sabervel?
English: Other information about Sabervel
Maltese: Għalxiex jintuża Sabervel?
English: Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal filkaż ta' Aprovel, il-benefiċċji huma ogħla mir-riskji identifikati.
English: Spontaneous Abortion
Maltese: Abort Spontanju
English: Sodium citrate
Maltese: Sucrose Sodium citrate
English: * Differences between the 2 groups were statistically significant (p0.05).
Maltese: * Differenzi bejn iż-2 gruppi kienu statistikament sinifikanti (p<0.05).
English: • Primary gonadal failure
Maltese: • Insuffiċjenza primarja ta' gonadal
English: The active substance follitropin beta.
Maltese: Is-sustanza attiva hija follitropin beta.
English: Tél + 33 (0)1 80 46 40 40
Maltese: MSD France Tél + 33 (0)1 80 46 40 40
English: See also section 4 on possible side effects.
Maltese: Ara wkoll sezzjoni 4 fuq effetti sekondarji possibbli.
English: • Controlled ovarian hyperstimulation in medically assisted reproduction programs Various stimulation protocols are applied.
Maltese: • Stimulazzjoni eċċessiva tal-ovarju kkontrollata fi programmi mediċi ta' riproduzzjoni assista Diversi protokolli ta' stimulazzjoni huma applikati.
English: Restricted to women with ovulation induced (follitropin beta, n = 76; u-FSH, n = 42).
Maltese: a Ristrett għal nisa b'ovulazzjoni indotta (follitropin beta, n = 76; u-FSH, n = 42).
English: u-FSH (n = 66)
Maltese: (n = 66)
English: u-FSH (n = 361)
Maltese: (n = 361)
English: Vascular Complications
Maltese: Komplikazzjonijiet Vaskulari
English: Clinical Efficacy and Safety
Maltese: Effikaċja Klinika u Sigurtà
English: Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
Maltese: United Kingdom Merck Sharp & Dohme Limited Tel: + 44 (0) 1992 467272 medicalinformationuk@merck.com
English: Epididymal cyst Gynaecomastia
Maltese: Ċista epididimali Ġinekomastija
English: Step 1 - Preparing the syringe
Maltese: Stadju 1 - Preparazzjoni tas-siringa
English: Date of first authorisation: 19 March 2009 Date of latest renewal: 21 February 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 19 ta' Marzu 2009 Data tal-aħħar tiġdid: 21 ta' Frar 2014
English: Polysorbate 20
Maltese: L-methionine Polysorbate 20
English: • have malformations of the sexual organs which make a normal pregnancy impossible
Maltese: • għandek malformazzjonijiet tal-organi sesswali li jagħmel tqala normali impossibbli
English: MSD (Norge) AS Tlf: + 47 32 20 73 00 msdnorge@msd.no
Maltese: Tlf: + 47 32 20 73 00 msdnorge@msd.no
English: • have had an allergic reaction to certain antibiotics (neomycin and/or streptomycin)
Maltese: • kellek reazzjoni allerġika għal ċerti antibijotiċi (neomycin u/jew streptomycin)
English: Congenital Malformations
Maltese: Malformazzjonijiet Konġenitali
English: Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+ 357 22866700) cyprus_info@merck.com
Maltese: Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+ 357 22866700)
English: Kloosterstraat 6, 5349 AB Oss Veersemeer 4, 5347 JN Oss The Netherlands
Maltese: Veersemeer 4, 5347 JN Oss
English: ANNEX I
Maltese: MANIFATTUR(I)
English: Acne Rash
Maltese: Akne Raxx
English: Clinical signs and symptoms of severe OHSS are large ovarian cysts, acute abdominal pain, ascites, pleural effusion, hydrothorax, dyspnoea, oliguria, haematological abnormalities and weight gain.
Maltese: Sinjali u sintomi kliniċi ta' OHSS sever huma ċesti kbar tal-ovarji, uġigħ akut fl-addome, axxite, effużjoni ġol-plewra, idrotoraċi, dispnea, oligurija, anormalitajiet ematoloġiċi u żieda fil-piż.
English: Generalised hypersensitivity reactions have been observed uncommonly (approximately 0.2% of all patients treated with follitropin beta).
Maltese: Reazzjonijiet ta' sensittività ġenerali ġew osservati mhux komunament (madwar 0.2% tal-pazjenti kollha trattati b'follitropin beta).
English: Pharmacotherapeutic group: sex hormones and modulators of the genital system, gonadotrophins; ATC code: G03G A06.
Maltese: Kategorija farmakoterapewtika: ormoni tas-sess u modulatori tas-sistema ġenitali, gonadotrofini; Kodiċi ATC:
English: • Controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intra-fallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Maltese: • Stimulazzjoni eċċessiva kkontrollata tal-ovarji sabiex tistimula l-iżvilupp tal-follikuli multipli fi programmi mediċi ta' riproduzzjoni assistita [e.ż. fertilizzazzjoni /trasferiment tal-embriju in vitro (IVF/ET), trasferiment tal-gamete intra-fallopjan (GIFT) u injezzjoni intraċitoplasmiku talisperma (intracytoplasmic sperm injection ICSI)].
English: Multiple Pregnancy
Maltese: Tqala Multipla
English: The absolute bioavailability of subcutaneously administered Fertavid is approximately 77%.
Maltese: It-tnejn għandhom bijodisponibbilità assoluta ta' madwar 77%.
English: N.V. Organon
Maltese: Organon
English: OHSS Pelvic pain
Maltese: OHSS Uġigħ pelviku
English: It is possible to inject in other areas.
Maltese: Huwa possibli li tinjetta f'postijiet oħra.
English: Since follicles of over 14 mm may lead to pregnancies, multiple pre-ovulatory follicles exceeding 14 mm carry the risk of multiple gestations.
Maltese: Peress li follikuli ta' aktar minn 14-il millimetru jistgħu jwasslu għal tqala, follikuli multipli ta' qabel l-ovulazzjoni li jkunu akbar minn 14-il millimetru jikkawżaw riskju ta' ġestazzjonijiet multipli.
English: Distribution, biotransformation and elimination Recombinant FSH is biochemically very similar to urinary human FSH and is distributed, metabolised, and excreted in the same way.
Maltese: Distribuzzjoni, bijotrasformazzjoni u eliminazzjoni FSH rikombinanti b'mod bijokimiku huwa simili ħafna għal FSH tal-awrina uman u jiġi distribwit, metabolizzat u mneħħi bl-istess mod.
English: Pack of 1, 5 or 10 vials.
Maltese: Pakkett ta' 1, 5 jew 10 kunjetti.
English: N.V. Organon Kloosterstraat 6 5349 AB Oss The Netherlands
Maltese: Kloosterstraat 6 5349 AB
English: Adverse reactions that are reported only once are listed as common because a single report raises the frequency above 1%.
Maltese: Reazzjonijiet avversi li kienu rrappurtati darba biss huma elenkati bħala komuni għax rapport wieħed itella' l-frekwenza għal iżjed minn 1%.
English: For use only with a pen injector called Puregon Pen.
Maltese: Istruzzjonijiet tal-Puregon Pen.
English: Merck Sharp & Dohme de España, S.A. Tel.: +34 91 321 06 00 msd_info@merck.com
Maltese: Merck Sharp & Dohme de España, S.A. Tel.: +34 91 321 06 00
English: Fertavid contains a recombinant FSH.
Maltese: Fertavid fih FSH rikombinanti.
English: Follow current clinical practice for reducing the risk of OHSS during Assisted Reproductive Technology (ART).
Maltese: Segwi l-prattika klinika attwali biex tnaqqas ir-riskju ta' OHSS waqt it-Teknoloġija ta' Riproduzzjoni Assistita (ART, Assisted Reproductive Technology).
English: When ultrasound assessment indicates the presence of at least three follicles of 16-20 mm, and there is evidence of a good oestradiol response (plasma levels of about 300-400 picograms/mL (1,000-1,300 pmol/L) for each follicle with a diameter greater than 18 mm), the final phase of maturation of the follicles is induced by administration of hCG. Oocyte retrieval is performed 34-35 hours later.
Maltese: Meta l-istima ultrasonika tindika lpreżenza ta' mill-anqas tliet follikuli ta' 16-20 mm, u jkun hemm evidenza ta' rispons tajjeb talestradjol (livelli fil-plażma ta' madwar 300-400 pikogramm/mL (1,000-1,300 pmol/L) għal kull follikulu ta' dijametru akbar minn 18 mm), il-fażi finali ta' tkabbir tal-follikuli tiġi stimulata bitteħid tal-hCG.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol ta' sodium (23 mg) f'kull injezzjoni, i.e. huwa essenzjalment ‘ħieles mis-sodium'.
English: • Each cartridge contains the active substance follitropin beta, a hormone known as folliclestimulating hormone (FSH) in a strength of 833 IU/mL aqueous solution.
Maltese: • Kull skartoċċ fih is-sustanza attiva follitropin beta, ormon magħruf bħala l-ormon li jistimula l follikoli (FSH) f' qawwa ta' 833 IU/mL soluzzjoni akwea.
English: The table below lists the adverse reactions with follitropin beta reported in clinical trials in females, according to system organ class and frequency; common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to
Maltese: It-tabella t'hawn taħt turi r-reazzjonijiet avversi b'follitropin beta irrappurtati fil-provi kliniċi fin-nisa, skont il-klassi tal-organi tas-sistema (SOC) u l-frekwenza; komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100).
English: Ectopic Pregnancy
Maltese: Tqala Ektopika
English: • Undiagnosed vaginal bleeding.
Maltese: Ilma għall-injezzjonijiet.
English: Merck Sharp & Dohme OÜ Tel: +372 6144 200 msdeesti@merck.com
Maltese: Merck Sharp & Dohme OÜ Tel: +372 6144 200
English: FSH is indispensable in normal follicular growth and maturation, and gonadal steroid production.
Maltese: L-FSH huwa indispensabbli fit-tkabbir u l-maturazzjoni normali tal-follikulu u fil-produzzjoni tal isterojdi gonadi.
English: Reproductive system and breast disorders
Maltese: Oħra fis-Sistema Riproduttiva
English: In clinical studies comparing recFSH (follitropin beta) and urinary FSH for controlled ovarian stimulation in women participating in an assisted reproduction technology (ART) program and for ovulation induction (see tables 1 and 2 below), follitropin beta was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation.
Maltese: Fi studji kliniċi li qabblu recFSH (follitropin beta) u FSH fl-awrina għal stimulu kkontrollat tal-ovarji f'nisa li kienu qed jieħdu sehem fi programm ta' teknoloġija riproduttiva assistita (ART) u għallistimulu tal-ovulazzjoni (ara Tabelli 1 u 2 hawn taħt), follitropin beta kien iktar qawwi minn FSH flawrina fir-rigward ta' doża totali iktar baxxa u perijodu iqsar ta' kura meħtieġa biex jistimula liżvilupp tal-follikuli.
English: 2 packs with 3 pen needles
Maltese: 2 pakketti bi 3 labar tal-pinna
English: In approximately 4% of the women treated with follitropin beta in clinical trials, signs and symptoms related to ovarian hyperstimulation syndrome (OHSS) have been reported (see section 4.4).
Maltese: F'madwar 4% tan-nisa kkurati b'follitropin beta fil-provi kliniċi, ġew rapportati sinjali u sintomi relatati mas-sindromu tal-istimulazzjoni eċċessiva tal-ovarji (OHSS) (Ara sezzjoni 4.4).
English: The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid.
Maltese: Il-pH jista jiġi aġġustat permezz ta' sodium hydroxide u/jew hydrochloric acid.
English: Ovarian Hyperstimulation Syndrome (OHSS)
Maltese: Sindrome tal-iperstimulazzjoni tal-ovarji (OHSS - ovarian hyperstimulation syndrome)
English: Other medicines and Fertavid
Maltese: Mediċini oħra u Fertavid
English: • Ovarian cysts or enlarged ovaries, not related to polycystic ovarian syndrome (PCOS).
Maltese: • Ċisti fl-ovarji jew ovarji mkabbra, mhux relatati mas-sindrome poliċistiku ta' l-ovarji (PCOS).
English: • are allergic to follitropin beta or any of the other ingredients of Fertavid (listed in section 6)
Maltese: • allerġiku għal follitropin beta jew għal xi sustanza oħra ta' Fertavid (elenkati fis-sezzjoni 6)
English: follitropin beta (n = 105)
Maltese: (n = 105)
English: Table 2: Results of study 37,609 (randomized, group comparative clinical study comparing safety and efficacy of follitropin beta with urinary FSH in ovulation induction).
Maltese: Tabella 2: Riżultati ta' studju 37,609 (studju kliniku li fih il-parteċipanti ntgħażlu b'mod każwali, grupp komparattiv, li qabbel is-sigurtà u l-effikaċja ta' follitropin beta ma' FSH fl-awrina fi stimulu tal-ovarji).
English: follitropin beta (n = 546)
Maltese: (n = 546)
English: How to store Fertavid
Maltese: Tużax Fertavid
English: Table 1: Results of study 37,608 (randomized, group comparative clinical study comparing safety and efficacy of follitropin beta with urinary FSH in controlled ovarian stimulation).
Maltese: Tabella 1: Riżultati ta' studju 37,608 (studju kliniku li fih il-parteċipanti ntgħażlu b'mod każwali, grupp komparattiv, li qabbel is-sigurtà u l-effikaċja ta' follitropin beta ma' FSH fl-awrina fi stimulu kkontrollat tal-ovarji).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għas-sottomissjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornamenti sussegwenti ppubblikati fuq il portal elettroniku Ewropew tal-mediċini.
English: Ovarian torsion has been reported after treatment with gonadotropins, including follitropin beta.
Maltese: Torsjoni tal-ovarji kienet irrappurtata wara l-kura b'gonadotropins, inkluż follitropin beta.
English: Fertavid is used in the treatment of women undergoing ovarian induction or controlled ovarian hyperstimulation in assisted reproduction programmes.
Maltese: Fertavid jintuża fil-kura ta' nisa li tkun qed isirilhom stimulu tal-ovarji jew iperstimulazzjoni kkontrollata tal-ovarji fi programmi ta' riproduzzjoni assistita.
English: Do not use Fertavid after the expiry date which is stated on the label and carton after 'EXP'.
Maltese: Tużax Fertavid wara d-data ta' meta jiskadi li tidher fuq it-tikketta u fuq il-kartuna wara ‘EXP'.
English: 3 packs with 3 pen needles
Maltese: 3 pakketti bi 3 labar tal-pinna
English: • Fertavid may contain traces of streptomycin and/or neomycin.
Maltese: • Fertavid jista' jkun fih traċċi ta' streptomycin u/jew neomycin.
English: Increased FSH blood levels are a sign of damage to the testicles.
Maltese: Livelli ta' FSH għolja fid-demm huma sinjali ta' ħsara fit-testikoli.
English: In women undergoing Assisted Reproduction Technologies (ART) procedures, the risk of a multiple pregnancy is mainly related to the number of embryos transferred.
Maltese: Reproduction Technologies), ir-riskju ta' tqala multipla hija marbuta l-aktar man-numru ta' embriji ttrasferiti.
English: Dosage in men
Maltese: Twissijiet u prekawzjonijiet
English: • Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus.
Maltese: • Tumuri tal-ovarju, tas-sider, tal-utru, tat-testikoli, tal-pitwitarju jew tal-ipotalamu.
English: See warnings and precautions in section 2.
Maltese: Ara twissijiet u prekawzjonijiet f'sezzjoni 2.
English: Thromboembolic events, both in association with and separate from OHSS, have been reported following treatment with gonadotropins, including follitropin beta.
Maltese: Każijiet tromboemboliċi, kemm b'rabta ma' kif ukoll separati minn OHSS, kienu rrappurtati wara kura b'gonadotropins, inkluż follitropin beta.
English: In women with generally recognised risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia, treatment with gonadotropins, including Fertavid, may further increase this risk.
Maltese: F'nisa b'fatturi ta' riskju li huma ġeneralment rikonoxxuti għal avvenimenti tromboemboliċi, bħal storja personali jew tal-familja, ħxuna żejda severa jew trombofilja, il-kura b'gonadotropins, inkluż Fertavid, tista' tkompli żżid dan ir-riskju.
English: Breast complaints Metrorrhagia Ovarian cyst Ovarian enlargement Ovarian torsion Uterine enlargement Vaginal haemorrhage
Maltese: Ċista fl-ovarji Tkabbir tal-ovarji Torsjoni tal-ovarji Tkabbir tal-utru
English: Ovarian hyperstimulation syndrome (OHSS)
Maltese: Fin-nisa Sindrome ta' iperstimulazzjoni tal-ovarji (OHSS - ovarian hyperstimulation syndrome)
English: The table below lists the adverse reactions with follitropin beta reported in a clinical trial in males (30 patients dosed), according to system organ class and frequency; common (≥ 1/100 to < 1/10).
Maltese: It-tabella t'hawn taħt telenka r-reazzjonijiet avversi b'follitropin beta li kienu rrappurtati fi prova klinika fl-irġiel (30 pazjent li ngħataw id-doża), skont il-klassi tal-organi tas-sistema (SOC) u lfrekwenza; komuni (≥ 1/100 sa < 1/10).
English: • Malformations of the reproductive organs incompatible with pregnancy.
Maltese: • Malformazzjonijiet tal-organi sesswali li huma inkompatibbli ma' tqala.
English: Cartridges contain a minimum of 400 IU FSH activity in 0.480 mL aqueous solution, which is sufficient for a net total dose of 300 IU.
Maltese: L-iskrataċ fihom minimu ta' 400 IU ta' attività tal-FSH f'0.480 mL ta'soluzzjoni akweja, li hu biżżejjed għal doża totali netta ta' 300 IU.
English: Empty cartridges must not be refilled.
Maltese: Neoplażmi fl-Ovarji u Neoplażmi
English: The solution for injection contains the active substance follitropin beta, produced by genetic engineering of a Chinese hamster ovary (CHO) cell line, in a concentration of 833 IU/mL aqueous solution.
Maltese: Is-soluzzjoni għall-injezzjoni fiha s sustanza attiva follitropin beta magħmul b'inġinerija ġenetika minn ċelluli żviluppati minn ċellula waħda mill-ovarji tal-ħemster Ċiniż (CHO- Chinese hamster ovary) f'konċentrazzjoni ta' 833 IU/mL ta' soluzzjoni akweja.
English: Ovarian Torsion
Maltese: Torsjoni tal-Ovarji
English: 1,025 IU recombinant FSH activity/1.230 mL Net content 900 IU
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Attività ta' 1,025 IU ta' FSH rikombinanti/1.230 mL
English: Elevated endogenous FSH levels in men are indicative of primary testicular failure.
Maltese: Żieda fil-livelli ta' FSH endoġeniku fl-irġiel hija sinjal ta' insuffiċjenza primarja tat-testikoli.
English: Primary Testicular Failure
Maltese: Insuffiċjenza Primarja tat-Testikoli
English: Ovarian torsion has occurred after treatment with gonadotropins including Fertavid.
Maltese: Torsjoni tal-ovarji seħħet wara kura b'gonadotropins inkluż Fertavid.
English: Multiple pregnancies and births have been reported for all gonadotropin treatments, including follitropin beta.
Maltese: Tqala u twelid multipli ġew irrappurtati għal kull kura b'gonadotropin, inkluż follitropin beta.
English: SIA Merck Sharp & Dohme Latvija Tel: + 371 67364 224 msd_lv@merck.com
Maltese: Tel: + 371 67364 224 msd_lv@merck.com
English: Fertavid 50 IU/0.5 mL solution for injection Fertavid 75 IU/0.5 mL solution for injection Fertavid 100 IU/0.5 mL solution for injection Fertavid 150 IU/0.5 mL solution for injection Fertavid 200 IU/0.5 mL solution for injection
Maltese: IU/0.5 mL soluzzjoni għall-injezzjoni Fertavid 75 IU/0.5 mL soluzzjoni għall-injezzjoni Fertavid 100
English: 400 IU recombinant FSH activity/0.480 mL Net content 300 IU
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Attività ta' 400 IU ta' FSH rikombinanti /0.480 mL
English: • The other ingredients are sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections.
Maltese: • Is-sustanzi l-oħra huma sucrose, sodium citrate, L-methionine, polysorbate 20 u benzyl alcohol f'ilma għall-injezzjonijiet.
English: L-methionine
Maltese: U L-UŻU
English: Ovarian overstimulation may develop into a medical condition called ovarian hyperstimulation syndrome (OHSS), which can be a serious medical problem.
Maltese: tiżviluppa f'kondizzjoni medika msejħa sindrome ta' iperstimulazzjoni tal-ovarji (OHSS), li tista' tkun problema medika serja.