FrancophonIA/ELRC3.0 huggingface dataset:
English: Adherence to recommended GONAL-f dose and regimen of administration can minimise the risk of ovarian hyperstimulation (see sections 4.2 and 4.8).
Maltese: L-osservanza tad-doża u tal-kors tal-għoti rakkomandati ta' GONAL-f, jistgħu jnaqqsu r-riskju ta' stimulazzjoni eċċessiva tal-ovarji (ara sezzjonijiet 4.2 u 4.8).
English: The pen contains 450 IU follitropin alpha.
Maltese: Il-pinna fiha 450 IU follitropin alpha.
English: Follitropin alfa.
Maltese: IU follitropin alpha.
English: In rabbits, the formulation reconstituted with 0.9 % benzyl alcohol and 0.9 % benzyl alcohol alone, both resulted in a slight haemorrhage and subacute inflammation after single subcutaneous injection or mild inflammatory and degenerative changes after single intramuscular injection respectively.
Maltese: Fil-fniek, il-formulazzjoni rikostitwita b'0.9% benzyl alcohol u 0.9% benzyl alcohol waħdu, it-tnejn irriżultaw f'emorraġija ħafifa u infjammazzjoni subakuta wara li ngħataw injezzjoni waħda taħt ilġilda , jew f'infjammazzjoni ħafifa u bidliet deġenerattivi wara injezzjoni waħda ġol-muskoli, rispettivament.
English: • Each vial contains 1,200 IU of follitropin alfa.
Maltese: • Kull kunjett fih 1,200 IU ta' follitropin alfa.
English: • Each vial contains 5.5 micrograms of follitropin alfa.
Maltese: • Kull kunjett fih 5.5 mikrogrammi ta' follitropin alfa.
English: INFORMATION IN BRAILLE gonal-f 900 iu/1.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE gonal-f 900 iu/1.5 mL
English: INFORMATION IN BRAILLE gonal-f 300 iu
Maltese: INFORMAZZJONI BIL-BRAILLE gonal-f 300 iu
English: 450 IU (33 g)/vial
Maltese: IU (33 g)/kunjett
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 October 1995.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 20 ta' Ottubru 1995
English: INFORMATION IN BRAILLE gonal-f 450 iu/0.75 mL
Maltese: INFORMAZZJONI BIL-BRAILLE gonal-f 450 iu/0.75 mL
English: Follitropin alfa is a type of “Follicle Stimulating Hormone” (FSH) which belongs to the family of hormones called “gonadotropins”.
Maltese: Follitropin alfa hu tip ta' ‘Ormon li Jistimula lFollikoli' (FSH) li jagħmel parti mill-familja ta' ormoni magħrufa bħala ‘gonadotropins'.
English: Volume to be injected (mL)
Maltese: Volum li jrid jiġi injettat (mL)
English: Each vial contains 5.5 micrograms of follitropin alfa* equivalent to 75 IU.
Maltese: Kull kunjett fih 5.5 mikrogramma ta' follitropin alfa*, ekwivalenti għal 75 IU.
English: Contains: 1 mL water for injections
Maltese: Fih: 1 mL ilma għall-injezzjonijiet
English: INFORMATION IN BRAILLE gonal-f 300 iu/0.5 mL
Maltese: INFORMAZZJONI BIL-BRAILLE gonal-f 300 iu/0.5 mL
English: • The solvent contains water for injections and benzyl alcohol.
Maltese: • Is-solvent hu ilma għall-injezzjonijiet u benzyl alcohol.
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 l/siegħa, rispettivament.
English: In adult men, GONAL-f is used:
Maltese: F'irġiel adulti, GONAL-f jintuża:
English: Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies.
Maltese: Nisa li qed issirilhom stimulazzjoni tal-ovarji għal żvilupp follikulari multiplu qabel ma ssir fertilizzazzjoni in vitro jew jintużaw teknoloġiji oħra ta' riproduzzjoni assistita.
English: Each vial contains 5.5 micrograms follitropin alfa equivalent to 75 IU.
Maltese: Kull kunjett fih 5.5 mikrogramma ta' follitropin alfa ekwivalenti għal 75 IU.
English: • 1 vial containing GONAL-f (the white powder)
Maltese: • 1 kunjett li fih GONAL-f (it-trab abjad)
English: In clinical trials, an increase of the ovarian sensitivity to GONAL-f was shown when administered with lutropin alfa.
Maltese: Fl-istudji kliniċi, intweriet żieda fis-sensittività tal-ovarji għal GONAL-f meta dan ingħata ma' lutropin alfa.
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 talgonadotropina (GnRH) qed jintuża komunement biex irażżan iż-żieda ta' LH endoġenu u biex jikkontrolla l-livelli toniċi ta' LH.
English: 1200 IU (87 g)/vial
Maltese: IU (87 g)/kunjett
English: 8 injection needles
Maltese: 8 labar tal-injezzjoni
English: Not provided in the pack:
Maltese: Mhux ipprovduti fil-pakkett:
English: What GONAL-f is
Maltese: Tużax GONAL-f
English: INFORMATION IN BRAILLE gonal-f 450 iu
Maltese: INFORMAZZJONI BIL-BRAILLE gonal-f 450 iu
English: GONAL-f contains sodium
Maltese: GONAL-f fih is-sodium
English: The prepared solution can be used for several injections.
Maltese: Is-soluzzjoni ppreparata tista' tintuża għal diversi injezzjonijiet.
English: Each pre-filled multidose pen delivers 900 IU (equivalent to 66 micrograms) in 1.5 mL.
Maltese: IU (ekwivalenti għal 66 mikrogramma) fi 1.5 mL.
English: • GONAL-f is usually given every day.
Maltese: • Normalment GONAL-f jingħata kuljum.
English: Other medicines and GONAL-f
Maltese: Mediċini oħra u GONAL-f
English: Each multidose vial contains 33 micrograms follitropin alfa equivalent to 450 IU.
Maltese: Kull kunjett t'aktar minn doża waħda, fih 33 mikrogrammi ta' follitropin alfa ekwivalenti għal 450 IU.
English: • Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.
Maltese: • Nuqqas ta' ovulazzjoni (inkluż is-sindrome poliċistiku fl-ovarji) f'nisa li fuqhom il-kura bi clomiphene citrate ma kinitx effettiva.
English: Línea de Información: 900 102 964 Tel: +34-91-745 44 00
Maltese: Línea de Información: 900 102 964
English: Pen Volume
Maltese: Volum talPinna
English: The medicinal product is supplied in packs of 1 vial with 1 vial of solvent, or packs of 1, 5, or 10 vials with 1, 5 or 10 of solvent pre-filled syringe.
Maltese: Il-prodott mediċinali jiġi fornut f'pakketti ta' 1 kunjett b'1 kunjett ta' solvent, jew pakketti ta' 1, 5, jew 10 kunjetti ma' 1, 5 jew 10 siringi mimlija għal-lest bis-solvent.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 900 IU follitropin alfa, equivalent to 66 micrograms, per 1.5 mL.
Maltese: Kull pinna mimlija għal-lest b'ħafna dożi tforni 900 IU ta' follitropin alfa, ekwivalenti għal 66 mikrogramma, f'kull 1.5 mL.
English: Luxembourg/Luxemburg MERCK NV/SA, Belgique/Belgien Tél/Tel: +32-2-686 07 11
Maltese: Luxembourg/Luxemburg MERCK NV/SA, Belgique/Belgien
English: Each multidose vial contains 87 micrograms follitropin alfa equivalent to 1200 IU.
Maltese: Kull kunjett t'aktar minn doża waħda, fih 87 mikrogrammi ta' follitropin alfa ekwivalenti għal 1 200
English: • tumours of the hypothalamus or pituitary gland
Maltese: • tumuri fl-ipotalamu jew fil-glandola pitwitarja
English: Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
Maltese: Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, konċentrat Sodium hydroxide
English: Complication of severe OHSS General disorders and administration site conditions Very common:
Maltese: Kumplikazzjoni ta' OHSS severa Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: The first injection of GONAL-f should be performed under direct medical supervision.
Maltese: L-ewwel injezzjoni ta' GONAL-f għandha ssir taħt superviżjoni medika diretta.
English: • Check that the Dose Feedback Window shows “0”.
Maltese: • Iċċekkja li t-Tieqa ta' Rispons għad-Doża turi “0”.
English: 10 pre-filled syringes of 1 mL solvent.
Maltese: 10 siringi mimlija għal-lest ta' 1 mL ta' solvent.
English: • Repeat Section 3 (“Before you start using your GONAL-f pre-filled pen “) through Section 4 (“Getting your GONAL-f pre-filled pen ready for injection“) with a second pen.
Maltese: • Irrepeti minn Sezzjoni 3 (“Qabel tibda tuża GONAL-f pinna mimlija għal-lest tiegħek”) sa Sezzjoni 4 (“Kif tipprepara GONAL-f pinna mimlija għal-lest tiegħek lesta għallinjezzjoni”) b'pinna oħra.
English: Plunger piston
Maltese: Popolazzjoni pedjatrika
English: In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L.
Maltese: Fi studji kliniċi dawn ilpazjenti kienu definiti minn livell ta' LH fis-serum endoġenu ta' < 1.2 IU/L.
English: 5 pre-filled syringes of 1 mL solvent.
Maltese: 5 siringi mimlija għal-lest ta' 1 mL ta' solvent.
English: 1 pre-filled syringe of 0.75 mL solvent.
Maltese: Siringa mimlija għal-lest ta' 0.75 mL ta' solvent.
English: Excipients: Poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.
Maltese: Poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, phosphoric acid konċentrat, sodium hydroxide u ilma għallinjezzjonijiet.
English: * recombinant human follicle stimulating hormone (r-hFSH) produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Maltese: IU. * ormon uman rikombinanti li jistimula l-follikuli (r-hFSH) li jiġi magħmul fiċ-ċelluli tal-Ovarji tal-Ħamster Ċiniż (CHO) mit-teknoloġija tad-DNA.
English: For example, following two weeks of treatment with an agonist, 150-225 IU GONAL-f are administered for the first 7 days.
Maltese: Pereżempju, wara ġimgħatejn ta' kura b'agonist, 150-225 IU ta' GONAL-f jingħataw għall-ewwel 7 ijiem.
English: GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Maltese: GONAL-f fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles missodium'.
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Maltese: Eċċipjenti: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, phosphoric acid konċentrat u sodium hydroxide.
English: Reproductive system and breast disorders Very common: Ovarian cysts Common:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Komuni:
English: 10 pre-filled syringes of solvent.
Maltese: 10 siringi mimlija għal-lest ta' solvent.
English: GONAL-f Pre-filled pen 300 IU/0.5 mL
Maltese: GONAL-f Pinna mimlija għal-lest 300 IU/0.5 mL
English: Peel-off seal tab
Maltese: Għatu tal-pinna
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Respiratory, thoracic and mediastinal disorders Very rare:
Maltese: Reazzjonijiet ta' sensittività eċċessiva minn ħfief sa severi li jinkludu reazzjonijiet anafilattiċi u xokk Disturbi respiratorji, toraċiċi u medjastinali Rari ħafna:
English: Each pre-filled multidose pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL.
Maltese: IU), sabiex tagħti 33 microgrammi (ekwivalenti għal 450 IU) fi 0.75 mL.
English: The powder is presented in 3 mL vials (Type I glass), with rubber stopper (bromobutyl rubber) and aluminium flip-off cap.
Maltese: It-trab jiġi f'kunjetti ta' 3 mL (ħġieġ ta' Tip I), b'tapp tal-lastku (lastku tal-bromobutyl) u għatu flip-off tal-aluminju.
English: Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea Reproductive system and breast disorders Very common:
Maltese: Uġigħ addominali, nefħa addominali, skumdità addominali, dardir, rimettar, dijarrea Disturbi fis-sistema riproduttiva u fis-sider Komuni ħafna:
English: • When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last GONAL-f injection.
Maltese: • Meta tikseb ir-rispons mixtieq, tingħata injezzjoni waħda ta' 250 mikrogramma ta' ‘hCG rikombinanti' (r-hCG, hCG magħmul f'laboratorju permezz ta' teknika speċjali ta' DNA), jew 5,000 sa 10,000
English: gonal-f 75 iu
Maltese: Ż-ŻGĦAR EWLENIN GONAL-f 75 IU (5.5
English: Prescribed Dose
Maltese: TAL-PRODOTT MEDIĊINALI
English: GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection Follitropin alfa
Maltese: GONAL-f 75 IU, (5.5 mikrogrammi) trab u solvent għal soluzzjoni għall-injezzjoni Follitropin alfa
English: In clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table below) and in ovulation induction, GONAL-f 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 komparattivi bejn r-hFSH (follitropin alfa) u FSH urinarju f'ART (ara t-tabella hawn taħt) u f'induzzjoni ta' ovulazzjoni, GONAL-f 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: 5 pre-filled syringes of solvent.
Maltese: 5 siringi mimlija għal-lest ta' solvent.
English: No other clinically significant medicinal product interaction has been reported during GONAL-f therapy.
Maltese: Ma kienet irrappurtata l-ebda interazzjoni klinikament sinifikanti tal-mediċina waqt it-terapija b'GONAL-f.
English: N/A
Maltese: NUMRU(I)
English: 0.75 mL of solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Maltese: 0.75 mL ta' soluzzjoni għall-injezzjoni fi skartoċċ ta' 3 mL (tal-ħġieġ ta' Tip I), b'tapp tal-lastku (lastku tal-halobutyl) u crimp cap tal-aluminju, b'inlay iswed tal-lastku.
English: • GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotropin (hCG) therapy.
Maltese: • GONAL-f flimkien mat-terapija tal-Gonadotropina Korjonika umana (hCG) hu indikat għallistimulazzjoni ta' spermatoġenesi f'irġiel li jbatu minn ipogonadiżmu ipogonadotrofiku konġenitali jew miksub.
English: • 1 pre-filled syringe containing the solvent (the clear liquid)
Maltese: • 1 siringa mimlija għal-lest li fiha s-solvent (il-likwidu ċar)
English: Excipients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Maltese: Eċċipjenti: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, phosphoric acid konċentrat u sodium hydroxide.
English: • Record your prescribed dose in the ‘'Prescribed Dose'' section (5).
Maltese: • Niżżel id-doża preskritta għalik fis-sezzjoni “Doża Preskritta” (5).
English: • There are 600 IU (44 micrograms) of follitropin alfa in each millilitre of liquid.
Maltese: IU (44 mikrogramma) ta' follitropin alfa f'kull millilitru ta' likwidu.
English: Note: The 300IU pen maximum single-dose setting is 300IU; the 450IU pen maximum single-dose setting is 450IU; the 900IU pen maximum single-dose setting is 450IU.
Maltese: Nota: Is-setting ta' doża waħda massima tal-pinna ta' 300IU huwa 300IU; is-setting ta' doża waħda massima tal-pinna ta' 450IU huwa 450IU;is-setting ta' doża waħda massima tal-pinna ta' 900IU huwa 450IU.
English: GONAL-f usually does not work if you have this problem.
Maltese: GONAL-f normalment ma jaħdimx jekk għandek din il-problema.
English: Pregnancy loss
Maltese: Doża Preskritta
English: 1 vial of solvent.
Maltese: Kunjett wieħed ta' solvent.
English: • The 450 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is
Maltese: • Is-setting ta' doża waħda massima tal-pinna ta' 450 IU huwa 450 IU u s-setting tal-iżgħar doża waħda huwa 12.5
English: Each multidose vial contains 33 micrograms of follitropin alfa* (equivalent to 450 IU), in order to deliver 22 micrograms (equivalent to 300 IU) in 0.50 mL.
Maltese: Kull kunjett t'aktar min doza waħda, fih 33 microgrammi follitropin alfa* (li huma ekwivalenti għal 450 IU), sabiex tagħti 22 microgrammi (ekwivalenti għal 300 IU) fi 0.50 mL.
English: • Keep this leaflet.
Maltese: •Iċċekkja d-data ta' skadenzafuq it-tikketta tal-pinna.
English: Outer needle cap
Maltese: Eżempju ta' siġill ħażin
English: No direct comparison of GONAL-f/LH versus human menopausal gonadotropin (hMG) has been performed.
Maltese: Id-dożi deskritti hawn taħt huma murija f'Unitajiet Internazzjonali (IU) u f'millilitri (mL).
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 IU.
English: • The vial containing GONAL-f (the white powder)
Maltese: • Il-kunjett li fih GONAL-f (it-trab abjad)
English: Miscarriage
Maltese: Manifattur
English: • Draw up some air into the syringe by pulling the plunger to approximately the 1 mL mark.
Maltese: • Iġbed ftit arja għal ġos-siringa billi tiġbed il-planġer bejn wieħed u ieħor sal-marka ta' 1 mL.
English: • primary ovarian failure
Maltese: • insuffiċjenza primarja tal-ovarji
English: Thromboembolism (both in association with and separate from OHSS) Respiratory, thoracic and mediastinal disorders Very rare:
Maltese: Tromboemboliżmu (f'assoċjazzjoni kemm ma' OHSS kif ukoll separat minn OHSS) Disturbi respiratorji, toraċiċi u medjastinali Rari ħafna:
English: Up to three containers of powder may be dissolved in 1 mL of solvent.)
Maltese: Sa tliet kontenituri ta' trab jistgħu jinħallu f'1 mL ta' solvent.)
English: Χρ.
Maltese: Sentejn.
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: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms, per 0.75 mL.
Maltese: Kull pinna mimlija għal-lest b'ħafna dożi tagħti 450 IU ta' follitropin alfa, ekwivalenti għal 33 mikrogramma, f'kull 0.75 mL.
English: Contents of the pack and other information How to prepare and use the GONAL-f powder and solvent
Maltese: Kontenut tal-pakkett u informazzjoni oħra Kif tipprepara u tuża t-trab u s-solvent ta' GONAL-f
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/032
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/95/001/032
English: • GONAL-f is supplied in packs of 1, 5, 10 vials of powder with the corresponding number of solvent in pre-filled syringes.
Maltese: • GONAL-f hu fornut f'pakketti ta' 1, 5, 10 kunjetti ta' trab bl-istess ammont ta' solvent f'siringi mimlija għal-lest.
English: For instructions on the reconstitution and administration of GONAL-f powder and solvent for solution for injection see section 6.6 and the package leaflet.
Maltese: Għal istruzzjonijiet fuq ir-rikostituzzjoni u l-amministrazzjoni ta' GONAL-f trab u solvent għal soluzzjoni għall-injezzjoni ara sezzjoni 6.6 u l-fuljett ta' tagħrif.
English: For in-use storage conditions, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' kif taħżnu waqt l-użu, ara sezzjoni 6.3.
English: 1 vial of 1 mL solvent.
Maltese: Kunjett wieħed ta' 1 mL ta' solvent.
English: Injectthisamount.150.usingnewpen
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled multidose pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms, per 0.5 mL.
Maltese: Kull pinna mimlija għal-lest b'ħafna dożi tforni 300 IU ta' follitropin alfa, ekwivalenti għal 22 mikrogramma, f'kull 0.5 mL.
English: • 1 vial containing the solvent (the clear liquid)
Maltese: • 1 kunjett li fih is-solvent (il-likwidu ċar)
English: Given in high doses (≥ 5 IU/kg/day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary Menopausal Gonadotropin (hMG).
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 GONAL-f mhuwiex indikat waqt it-tqala, din id-dejta għandha rilevanza klinika limitata.
English: Sharps disposal container
Maltese: DATA TAR-RIKOSTITUZZJONI
English: Use”.
Maltese: Tista'
English: • The 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: • Carefully remove and discard the green inner shield.
Maltese: • B'attenzjoni neħħi u armi l-protezzjoni interna l-ħadra.
English: 1.5 mL of solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Maltese: 1.5 mL ta' soluzzjoni għall-injezzjoni fi skartoċċ ta' 3 mL (tal-ħġieġ ta' Tip I), b'tapp tal-lastku (lastku tal-halobutyl) u crimp cap tal-aluminju, b'inlay iswed tal-lastku.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection Follitropin alfa
Maltese: GONAL-f 300 IU/0.50 mL (22 mikrogramma/0.50 mL) trab u solvent għal soluzzjoni għallinjezzjoni Follitropin alfa
English: • Slowly push the needle into the skin entirely (1).
Maltese: • Bil-mod agħfas il-labra ġol-ġilda kompletament (1).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, therefore it is considered essentially “sodium-free”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: 0.5 mL of solution for injection in 3 mL cartridge (Type I glass), with a plunger stopper (halobutyl rubber) and an aluminium crimp cap with a black rubber inlay.
Maltese: 0.5 mL ta' soluzzjoni għall-injezzjoni fi skartoċċ ta' 3 mL (tal-ħġieġ ta' Tip I), b'tapp tal-lastku (lastku tal-halobutyl) u crimp cap tal-aluminju, b'inlay iswed tal-lastku.
English: Verify that the Dose-Feedback Window reads "0".
Maltese: Iċċekkja li t-Tieqa ta' Rispons għad-Doża qiegħed juri"0".
English: Do not shake.
Maltese: IU FSH.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/95/001/021 1 vial of powder for solution for injection.
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/95/001/021 Kunjett ta' trab għal soluzzjoni għall-injezzjoni.
English: • together with another medicine called “human Chorionic Gonadotropin” (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.
Maltese: • flimkien ma' mediċina oħra magħrufa bħala ‘Gonadotropin Korjonika umana (hCG)' biex jgħin fil-produzzjoni tal-isperma f'irġiel li mhumiex fertili minħabba livell baxx ta' ċerti ormoni.
English: GONAL-f Pre-filled pen 450 IU/0.75 mL
Maltese: Ż-ŻGĦAR EWLENIN GONAL-f 450 IU/0.75
English: • The 900 IU pen maximum single-dose setting is 450 IU and the smallest single-dose setting is
Maltese: • Is-setting ta' doża waħda massima tal-pinna ta' 900 IU huwa 450 IU u s-setting tal-iżgħar doża waħda huwa 12.5
English: if "0", injectioncomplete ifnot"0",needsecond injection
Maltese: jekk "0", l-injezzjonilesta jekk mhux "0",hija meħtieġa injezzjoni oħra
English: In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of GONAL-f 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 human chorionic gonadotropin (hCG).
Maltese: F'dan il-każ, lutropin alfa għandu jiġi rikostwit l-ewwel u wara jintuża biex jiġi rikostitwit it-trab ta' GONAL-f.