FrancophonIA/ELRC3.0 huggingface dataset:
English: GONAL-f 900 IU/1.5 mL (66 micrograms/1.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Maltese: IU/1.5 mL (66 mikrogrammi/1.5 mL) soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Follitropin alfa
English: • 1 sharp container
Maltese: • 1 kontenitur fejn tarmi labar użati
English: • The 300 IU pen maximum single-dose setting is 300 IU and the smallest single-dose setting is
Maltese: • Is-setting ta' doża waħda massima tal-pinna ta' 300 IU huwa 300 IU u s-setting tal-iżgħar doża waħda huwa 12.5
English: Men with hypogonadotrophic hypogonadism
Maltese: Irġiel b'ipogonadiżmu ipogonadotrofiku
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection Follitropin alfa
Maltese: GONAL-f 450 IU/0.75 mL (33 mikrogramma/0.75 mL) trab u solvent għal soluzzjoni għall-injezzjoni Follitropin alfa
English: Contents
Maltese: Tqala
English: Each multidose vial contains 44 micrograms follitropin alfa* equivalent to 600 IU.
Maltese: Kull kunjett t'aktar min doza waħda, fih 44 microgrammi follitropin alfa* (li huma ekwivalenti għal 600
English: with a condition that usually makes normal pregnancy impossible, such as ovarian failure (early menopause), or malformed reproductive organs.
Maltese: - b'kundizzjoni li normalment tagħmel tqala normali impossibbli, bħal insuffiċjenza talovarji (menopawsa bikrija), jew xi difett fiżiku fl-organi riproduttivi.
English: • GONAL-f is supplied in packs of 1 vial of powder with 1 vial of solvent.
Maltese: • GONAL-f hu fornut f'pakketti ta' kunjett wieħed ta' trab flimkien ma' kunjett bis-solvent.
English: There is no relevant use of GONAL-f in the paediatric population.
Maltese: M'hemm l-ebda użu rilevanti ta' GONAL-f fil-popolazzjoni pedjatrika.
English: • The usual dose of GONAL-f is 150 IU (0.24 mL) together with hCG.
Maltese: • Id-doża normali ta' GONAL-f hi ta' 150 IU (0.24 mL) flimkien ma' hCG.
English: 4 disposable syringes for administration graduated in FSH units.
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu
English: Verify that the Dose Feedback Window is set to "0".
Maltese: Iċċekkja li t-Tieqa ta' Rispons għad-Doża tkun turi “0”.
English: GONAL-f pre-filled pen Treatment Diary
Maltese: Kif jidher GONAL-f u l-kontenut tal-pakkett
English: Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/hCG) after ovulation may lead to premature failure of the corpus luteum.
Maltese: Jista' jiġi kkunsidrat appoġġ fil-fażi lutejali taċ-ċiklu, minħabba li n-nuqqas ta' sustanzi b'attività lutejatrofika (LH/hCG) wara l-ovulazzjoni tista' tikkawża nuqqas ta' żvilupp fil-corpus luteum.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-F 75 IU (5.5 MICROGRAMS) VIAL LABEL
Maltese: • Wara l-preparazzjoni tas-soluzzjoni finali għall-injezzjoni, ikun hemm 75 IU (5.5 mikrogrammi)
English: • After reconstitution, there are 300 IU (22 micrograms) of follitropin alfa in 0.5 mL solution,
Maltese: • Wara r-rikostituzzjoni, ikun hemm 300 IU (22 mikrogramma) ta' follitropin alfa f'soluzzjoni ta'
English: Contains: One pre-filled syringe of solvent contains: 0.75 mL water for injections, benzyl alcohol
Maltese: Fih: Siringa waħda mimlija għal-lest ta' solvent fiha: 1 mL ilma għall-injezzjonijiet, benzyl alcohol
English: PHARMACEUTICAL FORM AND CONTENTS 1 vial of powder for solution for injection.
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN Armi kull soluzzjoni mhux użata.
English: Therefore, if signs of ovarian hyperstimulation occur such as serum oestradiol level > 5,500 pg/mL or > 20,200 pmol/L and/or ≥ 40 follicles in total, it is recommended that hCG be withheld and the patient be advised to refrain from coitus or to use barrier contraceptive methods for at least 4 days.
Maltese: Għalhekk, jekk ikun hemm sinjali ta' stimulazzjoni eċċessiva tal-ovarji bħal pereżempju livell ta' oestradiol fis-serum > 5,500 pg/mL jew > 20,200 pmol/L u/jew ≥ 40 follikolu b'kollox, hu rakkomandat li jitwaqqaf hCG u lil-pazjenti jingħataw parir biex jkollhomx x'jaqsmu mas-sieħeb tagħhom jew jużaw metodi kontraċettivi barrier għal mill-inqas erbat ijiem. OHSS tista' tiggrava malajr (f' 24 siegħa) jew fuq diversi ġranet biex issir avveniment mediku serju.
English: The 1 mL solvent for reconstitution is presented in either 2 or 3 mL vials (Type I glass) with rubber stopper (teflon-coated rubber) or in 1 mL pre-filled syringes (Type I glass) with a rubber stopper.
Maltese: It-trab jiġi f'kunjetti ta' 3 mL (ħġieġ ta' Tip I) b'tapp tal-lastku (lastku tal-bromobutyl) u għatu tal-aluminju flip-off. Il-1 mL ta' solvent għarrikostituzzjoni jiġi jew f'kunjetti ta' 2 jew ta' 3 mL (tal-ħġieġ ta' Tip I) b'tapp tal-lastku (miksi bllastku tat-teflon) jew f'siringi mimlija għal-lest ta'1 mL (tal-ħġieġ ta' Tip I) b'tapp tal-lastku.
English: In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/L as measured in a central laboratory.
Maltese: Fi studji kliniċi, pazjenti li kellhom nuqqas qawwi ta' FSH u LH kienu definiti minn livell ta' LH fisserum ta' <1.2 IU/L kif imkejjel f'laboratorju ċentrali.
English: A commonly used regimen for superovulation involves the administration of 150-225 IU of GONAL-f daily, commencing on days 2 or 3 of the cycle.
Maltese: Doża li tintuża b'mod komuni għal ovulazzjoni mgħaġġla hi ta' 150-225 IU ta' GONAL-f kuljum, li tinbeda fit-2 jew fit-3 ġurnata taċ-ċiklu.
English: GONAL-f should not be administered as a mixture with other medicines in the same injection, except for lutropin alfa.
Maltese: GONAL-f m'għandux jingħata bħala taħlita ma' prodotti mediċinali oħrajn fl-istess injezzjoni, ħlief għal lutropin alfa.
English: • The usual starting dose of GONAL-f is 75 to 150 IU (0.12 to 0.24 mL) each day.
Maltese: • Id-doża normali tal-bidu ta' GONAL-f hi ta' 75 sa 150 IU (0.
English: Inner needle shield 2.
Maltese: Pum tond li jissettja d-doża 5.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) powder and solvent for solution for injection Follitropin alfa
Maltese: IU/1.75 mL (77 mikrogramma/1.75 mL) trab u solvent għal soluzzjoni għallinjezzjoni Follitropin alfa
English: When undergoing assisted reproductive technology the risk of having a multiple pregnancy is related to your age, the quality and the number of fertilised eggs or embryos placed inside you.
Maltese: Meta tkun qiegħda tagħmel użu mit-teknoloġija ta' riproduzzjoni assistita, ir-riskju ta' tqala multipla jkun relatat mal-età tiegħek, il-kwalità u l-għadd ta' bajd fertilizzat jew embrijuni mpoġġija ġo fik.
English: • After a minimum of 5 seconds, pull the needle out of the skin while keeping the dose setting knob pressed down (3).
Maltese: • Wara tal-anqas 5 sekondi, iġbed il-labra 'l barra mill-ġilda filwaqt li żżomm il-pum tond li jissettja d-doża magħfus 'l isfel (3).
English: • Each vial contains 450 IU of follitropin alfa.
Maltese: • Kull kunjett fih 450 IU ta' follitropin alfa.
English: Once opened, the medicine may be stored for a maximum of 28 days at or below 25°C.
Maltese: Ġaladarba tinfetaħ, il-mediċina tista' tinħażen għal mhux iktar minn 28 jum, f'temperatura ta' 25°C jew inqas.
English: The effects of taking too much GONAL-f are unknown, Nevertheless one could expect Ovarian Hyper-Stimulation Syndrome (OHSS) to occur, which is described in section 4.
Maltese: Madankollu wieħed jista' jistenna li jseħħ is-Sindrome ta' Iperstimulazzjoni tal-Ovarji (OHSS), li hu deskritt f'sezzjoni 4.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) powder and solvent for solution for injection.
Maltese: GONAL-f 300 IU/0.50 mL (22 mikrogramma/0.50 mL), trab u solvent għal soluzzjoni għall-injezzjoni
English: Injectthisamount.75..usingnewpen
Maltese: Kif tipprepara s-soluzzjoni
English: For instructions on the administration with the pre-filled pen, see section 6.6 and the ”Instructions for Use”.
Maltese: Għal istruzzjonijiet dwar l-amministrazzjoni bil-pinna mimlija għal-lest, ara sezzjoni 6.6 u l-“Istruzzjonijiet għall-Użu”.
English: •Verify theexpiration dateon the pen label.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for use with GONAL-f 450 IU/0.75 mL Water for injections, benzyl alcohol 0.9%
Maltese: Fih: Siringa waħda mimlija għal-lest fiha: 0.75 mL ilma għall-injezzjonijiet, benzyl alcohol 0.9%.
English: Mild to severe hypersensitivity reactions including anaphylactic reactions and shock Nervous system disorders Very common:
Maltese: Reazzjonijiet ta' sensittività eċċessiva minn ħfief sa severi li jinkludu reazzjonijiet anafilattiċi u xokk Disturbi fis-sistema nervuża Komuni ħafna:
English: 1 pre-filled syringe of 2 mL solvent.
Maltese: INDIVIDWALI 1 mL/siringa mimlija għal-lest.
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) preparation must not be reconstituted with any other GONAL-f containers.
Maltese: Il-preparazzjoni ta' GONAL-f 300 IU/0.50 mL (22 mikrogramma/0.50 mL) m'għandhiex tiġi rikostitwita ma' kontenituri oħra ta' GONAL-f.
English: • The pre-filled syringe containing the solvent (the clear liquid)
Maltese: • Is-siringa mimlija għal-lest li fiha s-solvent (il-likwidu ċar)
English: • together with another medicine called “lutropin alfa” (“Luteinising Hormone” or LH) to help release egg from the ovary (ovulation) in women that are not ovulating because their body is producing very little gonadotropins (FSH and LH).
Maltese: • flimkien ma' mediċina oħra magħrufa bħala ‘lutropin alfa' (‘Ormon Luteinising' jew LH) biex jgħin fir-rilaxx ta' bajda mill-ovarji (ovulazzjoni) f'nisa li mhumiex jovulaw minħabba li lġisem tagħhom jipproduċi ftit li xejn gonadotropins (FSH u LH).
English: Data on a limited number of exposed pregnancies (less than 300 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of follitropin alfa.
Maltese: Ammont limitat ta' dejta dwar numru limitat ta' tqaliet esposti (inqas minn 300 riżultat ta' tqala) juri li m'hemm l-ebda effett ta' formazzjoni difettuża jew effetti tossiċi fil-fetu/tarbija tat-twelid wara l-użu ta' follitropin alfa.
English: • If you use GONAL-f at the same time as a “gonadotropin-releasing hormone” (GnRH) agonist or antagonist (these medicines reduce your sex hormone levels and stop you ovulating) you may need a higher dose of GONAL-f to produce follicles.
Maltese: (GnRH) (dawn il-mediċini jbaxxu l-livelli tal-ormoni sesswali tiegħek u jwaqqfulek l ovulazzjoni) jista' jkollok bżonn ta' doża akbar ta' GONAL-f biex tipproduċi l-follikuli.
English: • Hold the GONAL-f pre-filled pen with the needle pointing upward.
Maltese: • Aħżen il-pinna fil-pakkett oriġinali tagħha f'post sigur.
English: Women with anovulation (including polycystic ovarian syndrome) GONAL-f may be given as a course of daily injections.
Maltese: Nisa li ma jovulawx (inkluż is-sindrome poliċistiku tal-ovarji) GONAL-f jista' jingħata bħala kors ta' injezzjonijiet ta' kuljum.
English: GONAL-f must be reconstituted with the solvent before use (see section “How to prepare and use the GONAL-f powder and solvent” in the package leaflet).
Maltese: GONAL-f għandu jiġi rikostitwit mas-solvent qabel ma jintuża (ara s-sezzjoni “Kif tipprepara u tuża GONAL-f trab u solvent” fil-fuljett ta' tagħrif).
English: GONAL-f 300 IU/0.50 mL (22 micrograms/0.50 mL) must be reconstituted with the 0.75 mL solvent provided before use.
Maltese: GONAL-f 300 IU/0.50 mL (22 mikrogramma/0.50 mL) għandu jiġi rikostitwit ma' 1 mL ta' solvent ipprovdut qabel ma jintuża.
English: • After reconstitution, there are 1,050 IU (77 micrograms) of follitropin alfa in 1.75 mL solution,
Maltese: • Wara r-rikostituzzjoni, ikun hemm 1,050 IU (77 mikrogramma) ta' follitropin alfa f'soluzzjoni ta' 1.75 mL, li jfisser li jkun hemm 600
English: MARKETING AUTHORISATION NUMBER EU/1/95/001/034
Maltese: EU/1/95/001/027
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) must be reconstituted with the 1 mL solvent provided before use.
Maltese: GONAL-f 450 IU/0.75 mL (33 mikrogramma/0.75 mL) għandu jiġi rikostitwit ma' 1 mL ta' solvent ipprovdut qabel ma jintuża.
English: The medicine must be administered immediately after preparation.
Maltese: Il-mediċina għandha tittieħed immedjatament wara l-preparazzjoni.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Maltese: IU/1.75 mL (77 mikrogramma/1.75 mL) m'għandhiex tiġi rikostitwita ma' kwalunkwe kontenituri oħra ta' GONAL-f.
English: Ovarian cysts
Maltese: • Kull kunjett fih 600
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) preparation must not be reconstituted with any other GONAL-f containers.
Maltese: Il-preparazzjoni ta' GONAL-f 450 IU/0.75 mL (33 mikrogramma/0.75 mL) m'għandhiex tiġi rikostitwita ma' kwalunkwe kontenituri oħra ta' GONAL-f.
English: GONAL-f 1050 IU/1.75 mL (77 micrograms/1.75 mL) must be reconstituted with the 2 mL solvent provided before use.
Maltese: IU/1.75 mL (77 mikrogramma/1.75 mL) għandu jiġi rikostitwit ma' 2 mL ta' solvent ipprovdut qabel ma jintuża.
English: Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing medicinal products.
Maltese: Evalwazzjoni klinika ta' GONAL-f tindika li d-dożi ta' kuljum, il-korsijiet tal-għoti u lproċeduri tal-monitoraġġ tal-kura, m'għandhomx ikunu differenti minn dawk użati fil-preżent għal prodotti mediċinali li fihom FSH urinarju.
English: GONAL-f 300 IU/0.5 mL (22 micrograms/0.5 mL) solution for injection in a pre-filled pen Follitropin alfa
Maltese: GONAL-f 300 IU/0.5 mL (22 mikrogramma/0.5 mL) soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Follitropin alfa
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) powder and solvent for solution for injection.
Maltese: GONAL-f 450 IU/0.75 mL (33 mikrogramma/0.75 mL), trab u solvent għal soluzzjoni għall-injezzjoni
English: • ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
Maltese: • tkabbir tal-ovarji jew ċista fl-ovarji mhux minħabba sindrome poliċistiku tal-ovarji
English: Total dose of FSH required (number of FSH 75 IU ampoules)
Maltese: Doża totali ta' FSH meħtieġa (numru ta' ampulli ta' FSH 75
English: GONAL-f treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human Chorionic Gonadotropin, hCG) is administered.
Maltese: Ma kienet irrappurtata l-ebda interazzjoni klinikament sinifikanti tal-prodott mediċinali waqt it-terapija b'GONAL-f.
English: The reconstituted solution is stable for 28 days at or below 25°C.
Maltese: Is-soluzzjoni rikostitwita tibqa' stabbli għal 28 ġurnata f'temperatura ta' jew taħt 25°C.
English: 6 disposable syringes for administration graduated in FSH units.
Maltese: 10 kunjetti ta' trab għal soluzzjoni għall-injezzjoni.
English: Each multidose vial contains 87 micrograms of follitropin alfa* (equivalent to 1200 IU), in order to deliver 77 micrograms (equivalent to 1050 IU) in 1.75 mL.
Maltese: IU), sabiex tagħti 77 microgrammi (ekwivalenti għal 1 050
English: Such patients are unresponsive to GONAL-f/hCG therapy.
Maltese: Dawn ilpazjenti ma jirrispondux għat-terapija ta' GONAL-f/hCG.
English: How to use the GONAL-f pre-filled pen How to use your GONAL-f pre-filled pen Treatment diary Before you start using your GONAL-f pre-filled pen Getting your GONAL-f pre-filled pen ready for injection Setting the dose prescribed by your doctor Injecting the dose
Maltese: Evalwazzjoni klinika ta' GONAL-f tindika li d-dożi ta' kuljum, il-korsijiet tal-għoti u l-proċeduri tal-monitoraġġ tal-kura, m'għandhomx ikunu differenti minn dawk użati fil-preżent għal prodotti mediċinali li fihom FSH urinarju.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for use with GONAL-f 1050 IU/1.75 mL Water for injections, benzyl alcohol 0.9%
Maltese: IU/0.75 mL Ilma għall-injezzjonijiet, benzyl alcohol 0.9%
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) solution for injection in a pre-filled pen Follitropin alfa
Maltese: GONAL-f 450 IU/0.75 mL (33 mikrogramma/0.75 mL) soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest Follitropin alfa
English: • After reconstitution, there are 450 IU (33 micrograms) of follitropin alfa in 0.75 mL solution,
Maltese: • Wara r-rikostituzzjoni, ikun hemm 450 IU (33 mikrogramma) ta' follitropin alfa f'soluzzjoni ta'
English: Concomitant use of GONAL-f with other medicinal products used to stimulate ovulation (e.g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist or antagonist to induce pituitary desensitisation may increase the dose of GONAL-f needed to elicit an adequate ovarian response.
Maltese: L-użu fl-istess ħin ta' GONAL-f ma' prodotti mediċinali oħra li jintużaw biex jistimulaw l-ovulazzjoni (eż. hCG, clomiphene citrate) jista' jsaħħaħ ir-rispons follikulari, filwaqt li l-użu fl-istess ħin ma' xi tip ta' agonist jew antagonist ta' GnRH biex jinduċi desensitizzazzjoni pitwitarja, jista' jżid id-doża ta' GONAL-f li jkun meħtieġ biex jikkawża rispons adegwat fl-ovarji.
English: The maximum daily dose is 450 IU (0.72 mL).
Maltese: 12 sa 0.24 mL) flimkien ma' 75 IU (0.
English: • 1 empty syringe for injection
Maltese: • 1 siringa vojta għall-injezzjoni
English: Number of oocytes retrieved
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: • Verify you dialed the right dose before injecting (6).
Maltese: • Iċċekkja li għażilt id-doża t-tajba qabel tinjetta (6).
English: When an optimal response is obtained, a single injection of 250 micrograms recombinant human choriogonadotropin alfa (r-hCG) or 5,000 IU, up to 10,000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Maltese: Meta jintlaħaq l-aħjar effett mixtieq, injezzjoni waħda ta' 250 mikrogramma ta' choriogonadotropin alfa umana rikombinanti (r-hCG) jew 5,000 IU sa 10,000
English: Solvent Batch
Maltese: Lot tas-Solvent
English: • If you use GONAL-f with other medicines which help ovulation (such as hCG or clomiphene citrate), this may increase the response of your follicles.
Maltese: • Jekk tuża GONAL-f ma' mediċini oħrajn li jgħinu l-ovulazzjoni (bħal hCG jew clomiphene citrate), dan jista' jżid ir-rispons tal-follikuli tiegħek.
English: Contains: One pre-filled syringe of solvent contains: 1 mL water for injections, benzyl alcohol 0.9%.
Maltese: IU/1.75 mL Ilma għal injezzjonijiet, benzyl alcohol 0.9%
English: This is thought to be due to differences in parental characteristics (e.g. maternal age, sperm characteristics) and multiple pregnancies.
Maltese: Hu maħsub li dan jirriżulta minħabba xi differenzi filkaratteristiċi tal-ġenituri (eż. età materna, karatteristika tal-isperma) u tqala multipla.
English: GONAL-f 450 IU/0.75 mL (33 micrograms/0.75 mL) should not be mixed with other medicines in the same injection.
Maltese: GONAL-f 450 IU/0.75 mL (33 mikrogramma/0.75 mL) m'għandux jitħallat ma' mediċini oħrajn flistess injezzjoni.
English: It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Maltese: Dan jinkludi tkabbir notevoli tal-ovarji, livell għoli ta' sterojdi sesswali fis-serum, u żieda fil-permeabilità vaskulari li tista' twassal għal akkumulazzjoni ta' fluwidu filkavitajiet tal-peritonew, tal-plewra, u f'okkażjonijiet rari fil-kavità tal-perikardju.
English: BATCH NUMBER Batch
Maltese: Numru talJum talKura
English: EU/1/07/439/003 (50 tablets) EU/1/07/439/004 (150 tablets) EU/1/07/439/005 (50 x 1 tablets)
Maltese: EU/1/07/439/003 (50 pillola) EU/1/07/439/004 (150 pillola) EU/1/07/439/005 (50x1 pillola)
English: Mycophenolate mofetil Teva is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Maltese: Mycophenolate mofetil Teva huwa impeditur ta' inosine monophosphate dehydrogenase (IMPDH).
English: EU/1/07/439/001 (100 capsules) EU/1/07/439/002 (300 capsules) EU/1/07/439/006 (100 x 1 capsules)
Maltese: EU/1/07/439/001 (100 kapsula) EU/1/07/439/002 (300 kapsula) EU/1/07/439/006 (100 x 1 kapsula)
English: • Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Maltese: • Aborti spontanji kienu irrappurtati f'45 sa 49% ta' nisa tqal esposti għal mycophenolate mofetil imqabbel ma' rata rappurtata ta' bejn 12 u 33% f'pazjenti bi trapjant ta' organi solidi ttrattati b'immunosoppressanti oħra minbarra mycophenolate mofetil.
English: Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis,
Maltese: Pnewmonja, influwenza, infezzjoni tal-passaġġ respiratorju, moniljasi respiratorja, infezzjoni gastrointestinali, kandidjasi, gastroenterite, infezzjoni,
English: A study of the co-administration of mycophenolate mofetil (1°g BID) and combined oral contraceptives containing ethinylestradiol (0.02°mg to 0.04°mg) and levonorgestrel (0.05°mg to 0.15°mg), desogestrel (0.15°mg) or gestodene (0.05°mg to 0.10°mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate mofetil on the ovulation suppressing action of the oral contraceptives.
Maltese: Studju dwar l-għoti konġunt ta' mycophenolate mofetil (1 g BID) u kontraċettivi orali kkombinati li jkun fihom ethinylestradiol (0.02 mg sa 0.04 mg) u levonorgestrel (0.05 mg sa 0.15 mg), desogestrel (0.15 mg) jew gestodene (0.05 mg to 0.10 mg) magħmul fi 18-il mara li ma kellhomx trapjant (mhux qegħdin jieħdu immunosoppressanti oħrajn) fuq 3 ċiċkli menstruwali konsekuttivi ma wrew l-ebda influwenza klinikament relevanti ta' mycophenolate mofetil fuq l-azzjoni ta' trażżin tal-ovulazzjoni tal-kontraċettivi orali.
English: Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Maltese: Antibijotiċi li jeliminaw il-batterji li jipproduċu β-glucuronidase fl-imsaren (eż. aminoglycoside, cephalosporin, fluoroquinolone, u klassijiet ta' penicillin ta' antibijotiċi) jistgħu jinterferixxu marriċirkolazzjoni enteroepatika ta' MPAG/MPA li b'hekk jista' jwassal għal esponiment sistemiku mnaqqas għal MPA.
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Maltese: Għalhekk, għandu jiġi evitat f'pazjenti li għandhom defiċjenza ereditarja rari ta' hypoxanthine guanine phosphoribosyl-transferase (HGPRT) bħal ma' huma s-sindromi Lesch-Nyhan u KelleySeegmiller.
English: Mycophenolate mofetil Teva 250 mg Capsules
Maltese: Mycophenolate mofetil Teva 250 mg Kapsuli
English: • Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits;
Maltese: • Malformazzjonijiet fil-wiċċ bħal xoffa mixquqa, palat mixquq, mikrognatija u iperteloriżmu talorbiti;
English: Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Maltese: PPAR gamma (peroxisome proliferator-activated receptor gamma), li mbagħad twassal għal espressjoni u attività ta' UGT1A9 imsaħħa.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leucoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Mycophenolate mofetil Teva.
Maltese: Każijiet ta' newropatija assoċjata mal-virus BK, kif ukoll każijiet ta' lewkoenċefalopatija multifokali progressiva (PML) assoċjata mal-virus JC, kienu rrapportati f'pazjenti kkurati b'immunosoppressanti, inkluż Mycophenolate Mofetil Teva.