FrancophonIA/ELRC3.0 huggingface dataset:
English: This strength corresponds to 83.3 microgram of protein / ml (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Il-qawwa tikkorispondi għal 83.3 mikrogrammi ta' proteina / mL (bijoattività speċifika in vivo ugwali għal madwar 10,000
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 jiġi mmonitorjat ir-riskju ta' OHSS, għandhom jitwettqu stimi ultrasoniċi tal-iżvilupp tal-follikuli 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: Store at or below 25ºC (at room temperature) for a single period of not more than 3 months.
Maltese: Aħżen f'temperatura ta' 25°C jew inqas (f'temperatura tal-kamra) għal perijodu wieħed ta' mhux aktar minn 3 xhur.
English: Abdominal distension Abdominal pain
Maltese: Nefħa addominali Uġigħ addominali
English: Fertavid 150 IU/0.5 mL solution for injection EU/1/09/510/010
Maltese: Fertavid 150 IU/0.5 mL soluzzjoni għall-injezzjoni EU/1/09/510/010
English: Due to the sustained release from the injection site and the elimination half-life of about 40 hours (ranging from 12 to 70 hours), FSH levels remain increased for 24-48 hours.
Maltese: 40 siegħa (li tvarja minn 12 sa 70 siegħa), il-livelli ta' FSH jibqgħu għoljin għal 24-48 siegħa.
English: Fertavid solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Maltese: Fertavid, soluzzjoni għall-injezzjoni fih follitropin beta, ormon magħruf bħala ormon li jistimula lfollikulu (FSH).
English: Fertavid 75 IU/0.5 mL solution for injection EU/1/09/510/004
Maltese: Fertavid 75 IU/0.5 mL soluzzjoni għall-injezzjoni EU/1/09/510/004
English: In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, Fertavid can bring about the development of multiple follicles.
Maltese: F'nisa li qed jieħdu sehem fi programm li jinvolvi t-teknika ta' riproduzzjoni assistita, inkluż ilfertilizzazzjoni in vitro (IVF) u metodi oħra, Fertavid jista' jintuża sabiex jikkawża l-iżvilupp ta' follikuli multipli.
English: Blood clot (Thrombosis)
Maltese: l-ovarji (PCOS)
English: Store at 2°C - 8°C (in a refrigerator).
Maltese: Aħżen f'temperatura ta' 2˚C - 8˚C (fi friġġ).
English: Other ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20 and benzyl alcohol in water for injections; sodium hydroxide and/or hydrochloric acid as pH adjustment.
Maltese: Sustanzi oħra: sucrose,sodium citrate, L-methionine u polysorbate 20 u benzyl alcohol fl-ilma għallinjezzjonijiet; sodium hydroxide u/hydrochloric acid għall-aġġustament tal-pH.
English: EU/1/09/510/013 EU/1/09/510/014 EU/1/09/510/015
Maltese: EU/1/09/510/013 EU/1/09/510/014
English: In rare instances, thromboembolism has been associated with follitropin beta/hCG therapy as with other gonadotrophins.
Maltese: F'każijiet rari, it-tromboemboliżmu ġie assoċjat ma' terapija b'follitropin beta/hCG kif ukoll ma' gonadotrofini oħra.
English: Pack of 1 cartridge and 9 needles to be used with the Puregon Pen.
Maltese: Pakkett ta' skartoċċ wieħed u 9 labar li għandhom jiġu użati mal-Pinna Puregon.
English: OHSS is a medical event distinct from uncomplicated ovarian enlargement.
Maltese: OHSS hu avveniment mediku distint minn tkabbir mhux ikkumplikat tal-ovarji.
English: Fertavid 75 IU/0.5 mL injection follitropin beta
Maltese: Fertavid 75 IU/0.5 mL soluzzjoni għall-injezzjoni follitropin beta
English: EU/1/09/510/010 EU/1/09/510/011 EU/1/09/510/012
Maltese: EU/1/09/510/011 EU/1/09/510/012
English: 0.5 mL of solution in 3 mL vial (type I glass) with stopper (chlorobutyl rubber).
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Soluzzjoni ta' 0.5 mL f'kunjett ta' 3 mL (ħġieġ tip I) b'tapp (lastku tal-chlorobutyl).
English: LIST OF EXCIPIENTS
Maltese: - Ċesta testikulari
English: Fertavid 50 IU/0.5 mL solution for injection
Maltese: IU/0.5 mL solution for injection
English: In adult females: Fertavid is indicated for the treatment of female infertility in the following clinical situations:
Maltese: Fertavid huwa indikat għall-kura tal-infertilità fin-nisa fis-sitwazzjonijiet kliniċi li ġejjin:
English: • have adrenal glands that are not working properly (adrenocortical insufficiency)
Maltese: • għandek glandoli adrenali li mhux qed jaħdmu tajjeb (insuffiċjenza adrenokortikali)
English: Cartridges contain a minimum of 225 IU FSH activity in 0.270 mL aqueous solution, which is sufficient for a net total dose of 150 IU.
Maltese: IU ta' attività tal-FSH f'0.270 mL ta' soluzzjoni akweja, li hu biżżejjed għal doża totali netta ta' 150 IU.
English: Usually, 7 to 14 days of treatment are sufficient.
Maltese: Ġeneralment, 7 sa 14-il jum ta' kura jkunu biżżejjed.
English: 1 pack with 3 pen needles
Maltese: Pakkett 1 ta' 3 labar tal-pinna
English: For posology and method of administration, see section 4.2.
Maltese: Prodott, sezzjoni 4.2).
English: Pack of 1 cartridge and 6 needles to be used with the Puregon Pen.
Maltese: Pakkett ta' skartoċċ wieħed u 6 labar li għandhom jiġu użati mal-Pinna Puregon.
English: Fertavid 150 IU/0.5 mL injection follitropin beta
Maltese: Fertavid 150 IU/0.5 mL soluzzjoni għall-injezzjoni follitropin beta
English: • have fibroid tumours in the uterus which make a normal pregnancy impossible
Maltese: • għandek tumuri fibrużi fl-utru li jagħmel tqala normali impossibli
English: 700 IU recombinant FSH activity/0.840 mL Net content 600 IU
Maltese: IU ta' attività tal-FSH f'0.840 mL ta'soluzzjoni akweja, li hu biżżejjed għal doża totali netta ta' 600
English: Cartridges contain a minimum of 1,025 IU FSH activity in 1.230 mL aqueous solution, which is sufficient for a net total dose of 900 IU.
Maltese: L-iskrataċ fihom minimu ta' 1,025 IU ta' attività tal-FSH f'1.230 mL ta'soluzzjoni akweja, li hu biżżejjed għal doża totali netta ta' 900
English: VIAL TEXT Fertavid 150 IU/0.5 mL
Maltese: Fertavid 150 IU/0.
English: DD month YYYY
Maltese: Dożaġġ fl-irġiel
English: Pre-ovulatory conditions are reached when there is ultrasonographic evidence of a dominant follicle of at least 18 mm in diameter and/or when plasma oestradiol levels of 300-900 picograms/mL (1,000-3,000 pmol/L) are attained.
Maltese: Il-kondizzjonijiet ta' qabel l ovulazzjoni jintlaħqu meta jkun hemm prova ultrasonografika ta' follikulu dominanti b'dijametru ta' 18-il millimetru u/jew meta l-livelli tal-estradjol fil-plażma jilħqu 300-900
English: PC:
Maltese: Teл.:
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 75 IU (150 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Maltese: attività ta' 75 IU (150 IU/mL) tal-ormon rikombinanti li jistimula l-follikuli (FSH).
English: Benzyl alcohol
Maltese: L-methionine Benzyl alcohol Polysorbate 20
English: UAB "Merck Sharp & Dohme" Tel: + 370 5 2780247 msd_lietuva@merck.com
Maltese: Tel: + 370 5 2780247 msd_lietuva@merck.com
English: Antibiotic hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva għall-antibijotiċi
English: In these women the benefits of gonadotropin administration, including Fertavid, need to be weighed against the risks.
Maltese: F'dawn in-nisa, il-benefiċċji tal għoti ta' gonadotrophin, inkluż Fertavid, jeħtieġ li jitqiesu kontra r-riskji.
English: In that case hCG should be withheld and pregnancy should be avoided to prevent multiple gestations.
Maltese: F'dak il-każ l-ormon hCG għandu jiġi miżmum u t-tqala għandha tiġi evitata sabiex jiġi evitat li jkun hemm ġestazzjonijiet multipli.
English: One vial contains 75 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Maltese: Kunjett wieħed fih 75 IU ta' ormon rikombinanti li jistimula l-follikoli (FSH), f'0.5 mL ta' soluzzjoni akweja.
English: For males and females • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Għall-irġiel u n-nisa • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Furthermore Fertavid can be used to promote multiple follicular development in medically assisted reproduction programs [e.g. in vitro fertilisation/embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)].
Maltese: Barraminhekk, Fertavid jista' jintuża biex jinkoraġġixxi l-iżvilupp ta' follikuli multipli fi programmi mediċi ta' riproduzzjoni assista [eż. fertilizzazzjoni in vitro/trasferiment tal-embriju (IVF/ET), trasferiment ta' gamete fil-fallopjan (GIFT) u injezzjoni tal-isperma fiċ-ċitoplażma (ICSI)].
English: • Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate.
Maltese: • Meta ma jkunx hemm ovulazzjoni (inkluż is-sindrome poliċistiku tal-ovarji, PCOS) f'nisa li ma rrispondewx għall-kura bi clomifene citrate.
English: Men
Maltese: Oss
English: Fertavid 300 IU/0.36 mL solution for injection EU/1/09/510/017
Maltese: 36 mL soluzzjoni għall-injezzjoni EU/1/09/510/017
English: Other ingredients: sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections; sodium hydroxide and/or hydrochloric acid as pH adjustment.
Maltese: Sustanzi oħra: sucrose, sodium citrate, L-methionine u polysorbate 20 f'ilma għall-injezzjonijiet; sodium hydroxide u/jew hydrochloric acid għall-aġġustament tal-pH.
English: 1 vial contains 0.5 mL follitropin beta corresponding to: 150 IU (300 IU/mL) recombinant follicle-stimulating hormone (FSH) activity.
Maltese: attività ta' 150 IU (300 IU/mL) tal-ormon rikombinanti li jistimula l-follikuli (FSH).
English: Fertavid 150 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 150 IU in 0.5 mL aqueous solution per vial.
Maltese: Fertavid 150 IU/0.5 mL soluzzjoni għall-injezzjoni Kunjett wieħed fih 150 IU ta' ormon rikombinanti li jistimula l-follikoli (FSH), f'0.5 mL ta' soluzzjoni akweja.
English: Common side effects (may affect up to 1 in 10 people): - Headache - Injection site reactions (such as bruising, pain, redness, swelling and itching) - Ovarian hyperstimulation syndrome (OHSS) - Pelvic pain - Stomach pain and/or bloating
Maltese: - Uġigħ ta' ras - Reazzjonijiet fis-sit tal-injezzjoni (bħal tbenġil, uġigħ, ħmura, nefħa u ħakk) - Sindrome tal-iperstimulazzjoni tal-ovarji (OHSS) - Uġigħ pelviku - Uġigħ fl-istonku u/jew gass żejjed
English: • have a tumour of the ovary, breast, uterus, testis or brain (pituitary gland or hypothalamus)
Maltese: • għandek tumur tal-ovarju, tas-sider, tal-utru, tat-testikoli jew tal-moħħ (tal-glandola pitwitarja jew tal-ipotalamu)
English: The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
Maltese: Is-sustanzi l-oħra huma sucrose, sodium citrate, L-methionine u polysorbate 20 f'ilma għallinjezzjonijiet.
English: Store in a refrigerator (2°C - 8°C).
Maltese: Aħżen f'temperatura ta' 2˚C - 8˚C (fi friġġ) .
English: Fertavid 150 IU/0.5 mL solution for injection
Maltese: Fertavid 150 IU/0.5 mL soluzzjoni għall-injezzjoni:
English: Rates of pregnancy loss in women undergoing assisted reproduction techniques are higher than in the normal population.
Maltese: Ir-rati ta' korrimenti f'nisa li jkunu qed isegwu teknoloġiji ta' riproduzzjoni assistita huma ogħla milli fil-popolazzjoni normali.
English: Too high a dose of Fertavid may cause hyperstimulation of the ovaries (OHSS).
Maltese: Doża kbira wisq ta' Fertavid tista' tikkawża iperstimulazzjoni tal-ovarji (OHSS).
English: In males Fertavid is used in the treatment of deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Maltese: Fl-irġiel, Fertavid jintuża fil-kura ta' spermatoġenesi defiċjenti minħabba ipogonadiżmu ipogonadotrofiku.
English: OUTER CARTON TEXT Fertavid 150 IU/0.5 mL 1, 5 or 10 vials
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KITBA FUQ IL-KARTUNA TA' BARRA Fertavid 150 IU/0.5 mL 1, 5 jew 10 kunjetti
English: Fertavid 75 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 75 IU in 0.5 mL aqueous solution per vial.
Maltese: Kull kunjett fih is-sustanza attiva follitropin beta, ormon magħruf bħala ormon li jistimula l-follikuli (FSH), f'qawwa ta' 75 IU f'0.5 mL ta' soluzzjoni akweja f'kull kunjett.
English: Generalised hypersensitivity reaction include erythema, urticaria, rash and pruritus
Maltese: - Tħossok imdardra - Reazzjonijiet ta' sensittività eċċessiva (bħal raxx, ħmura, urtikarja u ħakk)
English: • have high prolactin levels in the blood (hyperprolactinemia)
Maltese: • għandek livelli għoljin ta' prolactin fid-demm (iperprolaktinemija)
English: One vial contains 50 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Maltese: IU ta' ormon rikombinanti li jistimula l-follikoli (FSH - follicle-stimulating hormone), f'0.5 mL ta' soluzzjoni akweja.
English: Too high a dosage of FSH may lead to hyperstimulation of the ovaries (see section 4.4).
Maltese: Doża għolja ħafna ta' FSH tista' twassal għal stimulazzjoni eċċessiva tal-ovarji (ara sezzjoni 4.4).
English: VIAL TEXT Fertavid 100 IU/0.5 mL
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-KUNJETT Fertavid 150 IU/0.5 mL
English: Fertavid 75 IU/0.5 mL solution for injection
Maltese: Fertavid 75 IU/0.5 mL soluzzjoni għall-injezzjoni
English: A complication with FSH treatment is hyperstimulation of the ovaries.
Maltese: Komplikazzjoni ta' kura b'FSH hija l-iperstimulazzjoni tal-ovarji.
English: One cartridge contains a net total dose of 900 IU recombinant follicle-stimulating hormone (FSH) in 1.08 mL aqueous solution.
Maltese: follicle-stimulating hormone), f'1.08 mL ta' soluzzjoni akweja.
English: It was shown that on average an 18% higher amount of FSH is given with the pen compared with a conventional syringe.
Maltese: Intwera li meta tintuża l-pinna, tingħata doża ta' FSH li hija 18% akar għolja minn dik mogħtija b'siringa konvenzjonali.
English: One vial contains 5 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Kunjett wieħed fih 5 mikrogrammi ta' proteina (bijoattività speċifika in vivo ekwivalenti għal madwar 10,000
English: Treatment of females:
Maltese: F'irġiel adulti:
English: One vial contains 20 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Kunjett wieħed fih 20 mikrogrammi ta' proteina (bijoattività speċifika in vivo ekwivalenti għal madwar 10,000
English: Ovarian and Other Reproductive System Neoplasms There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple treatment regimens for infertility treatment.
Maltese: • Kien hemm rapporti ta' neoplażmi fl-ovarji u ta' neoplażmi oħrajn fis-sistema riproduttiva, kemm beninni kif ukoll malinni, f'nisa li ħadu diversi skedi ta' korsijiet ta' kura tal-infertilità.
English: Ovarian and Other Reproductive System Tumours There have been reports of ovarian and other reproductive system tumours in women who have had infertility treatment.
Maltese: Tumuri fl-Ovarji u Tumuri Oħra fis-Sistema Riproduttiva
English:  Contact your doctor.
Maltese: tkun problema medika serja.
English: This serious medical condition is called ovarian hyperstimulation syndrome (OHSS).
Maltese: Din il-kondizzjoni medika serja hija msejħa sindrome tal-iperstimulazzjoni tal-ovarji (OHSS).
English: Fertavid 900 IU/1.08 mL solution for injection EU/1/09/510/019
Maltese: IU/1.08 mL soluzzjoni għall-injezzjoni EU/1/09/510/019
English: If Fertavid is used in a combination with clomifene citrate, the effect of Fertavid may be increased.
Maltese: Jekk Fertavid jintuża flimkien ma' clomifene citrate, l-effett ta' Fertavid jista' jiżdied.
English: 0.36 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Maltese: 0.36 mL ta' soluzzjoni fi skartoċċ ta' 1.5 mL (ħġieġ tip I) bil-pistun tal-lastiku griż u għatu tal-aluminju mitni madwar l-għonq u x-xifer tal-iskartoċċ b'inforra tal-lastku.
English: Fertavid 600 IU/0.72 mL solution for injection EU/1/09/510/018
Maltese: 72 mL soluzzjoni għall-injezzjoni EU/1/09/510/018
English: 0.72 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Maltese: 0.72 mL ta' soluzzjoni fi skartoċċ ta' 1.5 mL (ħġieġ tip I) bil-pistun tal-lastiku griż u għatu tal-aluminju mitni madwar l-għonq u x-xifer tal-iskartoċċ b'inforra tal-lastku.
English: • Fibroid tumours of the uterus incompatible with pregnancy.
Maltese: • raġel u infertili minhabba kundizzjoni msejjħa indeboliment primarju tat-testikoli.
English: It is available in packs of 1, 5 or 10 vials.
Maltese: Hija disponibbli f'pakketti ta' 1, 5 jew 10 kunjetti.
English: Fertavid 900 IU/1.08 mL injection follitropin beta
Maltese: IU/1.08 mL injezzjoni follitropin beta SC
English: Fertavid 300 IU/0.36 mL injection follitropin beta
Maltese: 36 mL soluzzjoni għall-injezzjoni follitropin beta
English: OUTER CARTON TEXT Fertavid 300 IU/0.36 mL 1 cartridge
Maltese: Ż-ŻGĦAR EWLENIN KITBA LI TIDHER FUQ L-ISKARTOĊĊ Fertavid 300 IU/0.
English: 0.18 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Maltese: 0.18 mL ta' soluzzjoni fi skartoċċ ta' 1.5 mL (ħġieġ tip I) bil-pistun tal-lastiku griż u għatu tal-aluminju mitni madwar l-għonq u x-xifer tal-iskartoċċ b'inforra tal-lastku.
English: This corresponds to a strength of 400 IU/mL.
Maltese: Dan jikkorrispondi ma' qawwa ta' 400 IU/mL.
English: Call your doctor right away if you notice severe abdominal swelling, pain in the stomach area (abdomen), feeling sick (nausea), vomiting, sudden weight gain due to fluid buildup, diarrhoea, decreased urine output or trouble breathing (see also section 4 on Possible side effects).
Maltese: Ċempel lit-tabib tiegħek minnufih jekk tinnota nefħa severa fladdome, uġigħ fil-parti tal-istonku (addome), tħossok imdardra (nawsja), rimettar, żieda f'daqqa filpiż minħabba li jinġemgħa l-fluwidu, dijarea, tnaqqis fl-għamil tal-awrina jew tbatija biex tieħu n-nifs (ara wkoll sezzjoni 4 dwar Effetti Sekondarji Possibbli).
English: One cartridge contains a net total dose of 300 IU recombinant follicle-stimulating hormone (FSH) in 0.36 mL aqueous solution.
Maltese: follicle-stimulating hormone), f'0.36 mL ta' soluzzjoni akweja.
English: If a GnRH agonist (a medicine used to prevent early ovulation) has been given, higher doses of Fertavid may be needed.
Maltese: Jekk jingħata agonista ta' GnRH (mediċina li tintuża biex tippreveni ovulazzjoni bikrija), jista' ikun hemm bżonn dożi aktar għolja ta' Fertavid.
English: 1.08 mL of solution in 1.5 mL cartridge (type I glass) with a grey rubber piston and an aluminium crimp-cap with a rubber inlay.
Maltese: 1.08 mL ta' soluzzjoni fi skartoċċ ta' 1.5 mL (ħġieġ tip I) bil-pistun tal-lastiku griż u għatu tal-aluminju mitni madwar l-għonq u x-xifer tal-iskartoċċ b'inforra tal-lastku.
English: One vial contains 100 IU recombinant follicle-stimulating hormone (FSH) in 0.5 mL aqueous solution.
Maltese: Kunjett wieħed fih 100 IU ta' ormon rikombinanti li jistimula l-follikoli (FSH), f'0.5 mL ta' soluzzjoni akweja.
English: One vial contains 10 microgram of protein (specific in vivo bioactivity equal to approximately 10,000 IU FSH / mg protein).
Maltese: Kunjett wieħed fih 10 mikrogrammi ta' proteina (bijoattività speċifika in vivo ekwivalenti għal madwar 10,000
English: Fertavid 100 IU/0.5 mL injection follitropin beta
Maltese: Fertavid 150 IU/0.5 mL injezzjoni follitropin beta IM/SC
English: PC: SN: NN:
Maltese: Kura fin-nisa:
English: In repeated-dose studies in rats (two weeks) and dogs (13 weeks) up to 100-fold the maximal human dose, Fertavid induced no toxicologically significant effects.
Maltese: F'dożi ripetuti fil-firien (fuq ġimagħtejn) u fil-klieb (13-il ġimgħa) b'doża sa 100 darba aktar minn dik li tingħata lill-bniedem, Fertavid ma kkaġunax effetti tossikoloġiċi sinifikanti.
English: OUTER CARTON TEXT Fertavid 75 IU/0.5 mL 1, 5 or 10 vials
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA KITBA FUQ IL-KARTUNA TA' BARRA Fertavid 75 IU/0.5 mL 1, 5 jew 10 kunjetti
English: Clinical use of Fertavid by the intramuscular or subcutaneous routes may lead to local reactions at the site of injection (3% of all patients treated).
Maltese: L-użu kliniku ta' Fertavid li jingħata ġol-muskoli jew minn taħt il-ġilda jista' jwassal għal reazzjonijiet fil-lok tal-injezzjoni (3% tal-pazjenti kollha ttrattati).
English: Pack of 1 cartridge and 3 needles to be used with the Puregon Pen.
Maltese: Pakkett ta' skartoċċ wieħed u 3 labar li għandhom jiġu użati mal-Pinna Puregon.
English: For anovulatory women undergoing ovulation induction, monitoring follicular development with transvaginal ultrasonography may aid in determining whether or not to continue the cycle in order to reduce the risk of multiple pregnancies.
Maltese: Għal nisa b'nuqqas ta' ovulazzjoni li qed issirilhom induzzjoni tal-ovulazzjon, il-monitoraġġ tal-iżvilupp talfollikuli permezz ta' ultrasonografija transvaġinali jista' jgħin biex jiġi determinat jekk iċ-ċiklu għandux jitkompla jew le biex jitnaqqas ir-riskju ta' tqala multipla.
English: Fertavid 100 IU/0.5 mL solution for injection: Each vial contains the active substance follitropin beta, a hormone known as follicle-stimulating hormone (FSH), in a strength of 100 IU in 0.5 mL aqueous solution per vial.
Maltese: Kull kunjett fih is-sustanza attiva follitropin beta, ormon magħruf bħala ormon li jistimula l-follikuli (FSH), f'qawwa ta' 100 IU f'0.5 mL ta' soluzzjoni akweja f'kull kunjett.
English: Uncommon side effects (may affect up to 1 in 100 people): - Breast complaints (including tenderness) - Diarrhoea, constipation or stomach discomfort - Enlargement of the uterus - Feeling sick - Hypersensitivity reactions (such as rash, redness, hives and itching) - Ovarian cysts or enlargement of the ovaries - Ovarian torsion (twisting of the ovaries) - Vaginal bleeding
Maltese: - Disturbi fis-sider (li jinkludu sensittività) - Dijarea, stitikezza jew skonfort fl-istonku - Tkabbir tal-utru - Tħossok imdardra - Reazzjonijiet ta' sensittività eċċessiva (bħal raxx, ħmura, urtikarja u ħakk)
English: Fertavid 150 IU/0.18 mL solution for injection EU/1/09/510/016
Maltese: 18 mL soluzzjoni għall-injezzjoni EU/1/09/510/016
English: FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
Maltese: FSH jappartjeni fil-kategoija ta' gonadotrofini, li għadhom rwol importanti fil-fertilità u fir riproduzzjoni tal-bniedem.
English: Fertavid showed no mutagenic potential in the Ames test and in the in vitro chromosome aberration test with human lymphocytes.
Maltese: Fit-test Ames, u fit-test tal-aberrazzjoni tal-kromosome in vitro biċ-ċelluli limfoċiti umani, Fertavid ma wera l-ebda riskju fuq il-ġeni.
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 konċepiment spontanju.
English: Treatment of males:
Maltese: F'nisa adulti:
English: When given into a muscle the injection should be given by the doctor or nurse.
Maltese: L-ewwel injezzjoni ta' Fertavid għandha tingħata biss fi preżenza ta' tabib jew infermiera.
English: VIAL TEXT Fertavid 200 IU/0.5 mL
Maltese: IU/0.5 mL soluzzjoni għall-injezzjoni Fertavid 200
English: CARTRIDGE TEXT Fertavid 600 IU/0.72 mL
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-KUNJETT Fertavid 75 IU/0.5 mL
English: After intramuscular administration of Fertavid, the maximum FSH concentrations are higher and reached earlier in men as compared to women.
Maltese: Fertavid, soluzzjoni għall-injezzjoni, fl-istoċċijiet saret biex tintuża fil-Pinna Puregon u għandha tingħata taħt il-ġilda.