qanastek/EMEA-V3 huggingface dataset:
Glustin 45 mg tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus.
Pilloli Glustin 45 mg huma mediċina anti- dijabetika wżata biex tikkura dijabete mellitus tat- tip 2 (mhux dipendenti mill- insulina).
Glustin 45 mg tablets helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces.
Pilloli Glustin 45 mg jgħinu jikkontrollaw il- livell ta ’ żokkor fid- demm tiegħek meta jkollok dijabete tat- tip 2 billi jgħinu lill- ġismek jagħmel użu aħjar mill- insulina li qed jipproduċi.
Glustin 45 mg tablets may be used on their own or in combination with metformin and/ or a sulphonylurea which are also oral anti-diabetic medicines.
Pilloli Glustin 45 mg jistgħu jintużaw waħedhom jew flimkien ma ’ metformin u / jew mediċina tat- tip sulphonylurea li huma wkoll mediċini anti- dijabetiċi orali.
Glustin 45 mg tablets may also be used in combination with insulin.
Pilloli Glustin 45 mg jistgħu jintużaw ukoll flimkien ma ’ l- insulina.
Do not take Glustin 45 mg tablets:
Tieħux pilloli Glustin 45 mg:
45 mg tablets.
pilloli Glustin 45 mg
Take special care with Glustin 45 mg tablets:
Oqgħod attent ħafna b’ pilloli Glustin 45 mg:
Taking Glustin 45 mg tablets with food and drink:
Meta tieħu pilloli Glustin 45 mg ma ’ l- ikel u max- xorb:
Important information about some of the ingredients of Glustin 45 mg tablets:
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ pilloli Glustin 45 mg:
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Glustin 45 mg tablets.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi żokkrijiet, kellem lit- tabib tiegħek qabel ma tieħu pilloli Glustin 45 mg.
You can usually continue to take other medicines whilst you are being treated with Glustin 45 mg tablets.
Ġeneralment int se tkun tista ’ tibqa tieħu mediċini oħra waqt li qed tiġi kkurat b’ pilloli Glustin 45 mg.
If you have the impression that the effect of Glustin 45 mg tablets is too weak, talk to your doctor.
Jekk taħseb li l- effett tal- pilloli Glustin 45 mg huwa dgħajjef wisq, kellem lit- tabib tiegħek.
Glustin 45 mg tablets can be taken with or without food.
Pilloli Glustin 45 mg jistgħu jittieħdu ma ’ l- ikel jew mingħajr ikel.
When Glustin 45 mg tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Meta pilloli Glustin 45 mg jittieħdu flimkien ma ’ mediċini oħra wżati għall- kura tad- dijabete (bħal insulina, chlorpropamide, glibenclamide, gliclazide, tolbutamide), it- tabib tiegħek jgħidlek jekk għandekx bżonn tieħu doża inqas tal- mediċini tiegħek.
If you are following a diabetic diet, you should continue with this while you are taking Glustin 45 mg tablets.
Jekk qed issegwi dieta dijabetika, għandek tkompli biha waqt li qed tieħu l- pilloli Glustin 45 mg.
60 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Glustin and insulin experienced the development of heart failure.
63 Xi pazjenti b’ dijabete mellitus tat- tip 2 għal żmien twil u b’ mard tal- qalb jew aċċessjoni minn qabel li kienu kkurati b’ Glustin u insulin kellhom żvilupp ta ’ insuffiċjenza tal- qalb.
If you take more Glustin 45 mg tablets than you should:
Jekk tieħu pilloli Glustin 45 mg aktar milli suppost:
If you forget to take Glustin 45 mg tablets:
Jekk tinsa tieħu pilloli Glustin 45 mg:
Try to take Glustin 45 mg tablets daily as prescribed.
Ipprova ħu pilloli Glustin 45 mg kuljum kif preskritt.
Like all medicines, Glustin 45 mg tablets can have side effects, although not everybody gets them.
Bħal kull mediċina oħra, Glustin 45 mg jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The following side effects have been experienced by some patients taking Glustin 45 mg tablets:
Xi pazjenti esperjenzaw l- effetti sekondarji li ġejjin waqt li kienu qed jieħdu pilloli Glustin 45 mg:
61 Do not use after the expiry date stated on the carton.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
The active substance in Glustin 45 mg tablets is pioglitazone.
Is- sustanza attiva ta ’ pilloli Glustin 45 mg hija pioglitazone.
Each tablet contains 45 mg of pioglitazone (as hydrochloride).
Kull pillola fiha 45 mg ta ’ pioglitazone (bħala hydrochloride).
Glustin 45 mg tablets are white to off white, round, flat tablets marked 45 on one face, AD4 on the other..
Pilloli Glustin 45 mg huma pilloli bojod għal abjad maħmuġ, tondi, ċatti u mmarkati b’ 45 fuq wiċċ minnhom, AD4 fuq in- naħa l- oħra.
Danmark Takeda Global Research and Development Centre (Europe) Ltd., Storbritannien Tlf: +44 (0)20 3116 8000
65 Danmark Takeda Global Research and Development Centre (Europe) Ltd., Storbritannien Tlf: +44 (0) 20 3116 8000
62 Eesti Österreich
Eesti Österreich Takeda Global Research and Development Centre (Europe) Ltd., Ühendkuningriik Tel: +44 (0) 20 3116 8000
Lietuva Takeda Global Research and Development Centre (Europe) Ltd., Jungtinė Karalystė Tel. +44 (0)20 3116 8000
66 Lietuva Takeda Global Research and Development Centre (Europe) Ltd., Jungtinė Karalystė Tel. +44 (0) 20 3116 8000
GONAL-f 75 IU powder and solvent for solution for injection.
GONAL- f 75 IU, trab u solvent għal soluzzjoni għall- injezzjoni.
One ampoule contains 75 IU follitropin alfa, recombinant human follicle stimulating hormone (FSH).
Ampulla waħda fiha 75 IU follitropin alfa, ormon uman rikombinanti li jistimula l- follikuli (FSH).
The reconstituted solution contains 75 IU/ ml.
Is - soluzzjoni rikostitwita fiha 75 IU/ ml.
Follitropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Follitropin alfa jiġi magħmul fiċ- ċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate.
30mg sukrożju, 1. 11mg fosfat di- idrat tad- di- sodju, 0. 45mg fosfat mono- idrat tas- sodju di- idroġinat
Appearance of the solvent: clear colourless solution.
Dehra tat- trab: pellit bajda lijofilizzata Dehra tas- solvent: soluzzjoni mingħajr kulur
The pH of the reconstituted solution is 6.5 - 7.5.
Il - pH tas- soluzzjoni rrikostitut huwa 6. 5 - 7. 5.
• Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
• Nuqqas ta ’ ovulazzjoni (inkluż mard poliċestiku fl- ovarji, PCOD) f’ nisa li fuqhom il- kura bi clomiphene citrate ma kienetx effettiva. • Stimulazzjoni ta ’ żvilupp follikulari multiplu f’ pazjenti li qed issirilhom ovulazzjoni mgħaġġla permezz tat- teknoloġija ta ’ riproduzzjoni assistita (ART) bħall- fertilizzazzjoni in vitro (IVF), trasferiment tal- gamete fit- tubu fallopjan (GIFT) u trasferiment taż- żigot fit- tubu fallopjan (ZIFT). • GONAL- f flimkien ma ’ sustanza ta ’ l- ormon lutejniku (LH) hu rakkomandat biex jistimula l - iżvilupp follikulari ta ’ nisa li għandhom nuqqas qawwi ta ’ LH u FSH.
• GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
Fi studji kliniċi dawn kienu dawk il- pazjenti li kellhom < 1. 2 IU/ l ta 'LH fis- serum endoġenu. • GONAL- f flimkien mat- terapija tal- Gonadotrofina Korjonika umana( hCG) hu indikat għall - istimulazzjoni ta ’ spermatoġenesi f’ irġiel li jbatu minn ipogonadiżmu ipogonadotrofiku konġenitali jew akwisitat
Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Il- kura permezz ta ’ GONAL- f għandha tinbeda taħt is- superviżjoni ta ’ tabib b’ esperjenza fil- kura ta ’ problemi tal- fertilità.
GONAL-f is intended for subcutaneous administration.
GONAL- f jingħata permezz ta ’ injezzjoni taħt il- ġilda.
The powder should be reconstituted immediately prior to use with the solvent provided.
It- trab għandu jiġi rikostitwit billi jitħallat mas - solvent provdut, eżattament qabel ma jintuża.
In order to avoid the injection of large volumes, up to 3 containers of product may be dissolved in 1 ml of solvent.
Sabiex jiġu evitati injezzjonijiet ta ’ volumi kbar, f’ kull 1 ml ta ’ solvent jistgħu jitħalltu 3 kontenituri ta ’ dan il- prodott.
2 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
Id- dożi rrakkomandati għal GONAL- f huma dawk applikabbli għall- FSH urinarja.
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 preparations.
Analiżi klinika ta ’ GONAL- f tindika li d- doża ta ’ kuljum, il- metodi ta ’ teħid u l- osservazzjoni tal- proċeduri tal- kura m’ għandhomx ikunu differenti minn dawk mogħtija preżentement fl- użu ta ’ sustanzi li fihom FSH urinarja.
However, when these doses were used in a clinical study comparing GONAL-f and urinary FSH, GONAL-f was more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions.
2 ikkomparati, instab li GONAL- f kien aktar effettiv mill- FSH urinarja għax kien hemm bżonn ta ’ doża totali aktar baxxa u perijodu ta ’ kura iqsar biex jinkisbu l- kundizzjonijiet ta ’ qabel l- ovulazzjoni.
It is advised to adhere to the recommended starting doses indicated below.
Hu rrakkomandat li d- dożi iniziali jkunu kif indikat hawn isfel.
Women with anovulation (including PCOD):
Nisa li ma jovulawx (inkluża PCOD):
The object of GONAL-f therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG.
L- għan tat- terapija b’ GONAL- f hu li jkun żvillupat follikolu Graafjan matur wieħed li minnu jinħeles l- ovum wara t- teħid ta ’ hCG.
GONAL-f may be given as a course of daily injections.
GONAL- f jista ’ jingħata bħala kors ta ’ injezzjonijiet ta ’ kuljum.
In menstruating patients treatment should commence within the first 7 days of the menstrual cycle.
F’ pazjenti bil- mestrwazzjoni, il- kura għandha tibda fl- ewwel sebat ijiem taċ- ċiklu menstrwali.
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/ or oestrogen secretion.
Il- kura għandha tkun adattata skond l- effett fuq il- pazjent individwali, li tiġi analizzata billi jitkejjel id - daqs tal- follikulu permezz ta ’ l- ultrasawnd u/ jew permezz tas- sekrezzjoni ta ’ l- estroġenu.
A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 IU, or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
Doża li tintuża komunement hi dik ta ’ 75- 150 IU FSH kuljum li tiżdied preferibbilment b’ 37. 5 IU, jew 75 IU kull 7 jew preferibbilment 14- il ġurnata jekk ikun meħtieġ, biex jinkiseb riżultat adegwat, iżda mhux eċċessiv.
The maximal daily dose is usually not higher than 225 IU FSH.
Ġeneralment, id- doża massima ta ’ kuljum ma taqbiżx il- 225 IU FSH.
If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should recommence treatment at a higher starting dose than in the abandoned cycle.
Jekk il- pazjent ma jirrispondix b’ mod adegwat wara 4 ġimgħat ta ’ kura, dak iċ- ċiklu għandu jitwaqqaf u l- pazjent għandu jerġa ’ jibda l- kura b’ doża inizjali ogħla minn dik li kienet ingħatat fiċ- ċiklu li twaqqaf.
When an optimal response is obtained, a single injection of 5 000 IU, up to 10 000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Meta l- effett mixtieq jintlaħaq, injezzjoni waħda ta ’ bejn 5, 000 IU u 10, 000 IU hCG għandha tingħata 24- 48 siegħa wara l- aħħar injezzjonijiet ta ’ GONAL- f.
The patient is recommended to have coitus on the day of, and the day following, hCG administration.
Il- pazjenta hi rakkomandata li jkollha x' taqsam mas- sieħeb tagħha dak in- nhar u l- għada li tieħu l- hCG.
Alternatively intrauterine insemination (IUI) may be performed.
Inkella tista ’ ssir inseminazzjoni ġewwa l- utru (IUI).
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).
Jekk jinkiseb riżultat eċċessiv, il- kura għandha titwaqqaf u jinżamm l- hCG (ara t- twissijiet).
Treatment should recommence in the next cycle at a dosage lower than that of the previous cycle.
Il- kura għandha terġa ’ tibda fiċ- ċiklu li jmiss b’ doża anqas minn dik mogħtija fiċ- ċiklu preċedenti.
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies:
Nisa li qed issirilhom stimulazzjoni ta ’ l- ovarji għal żvilupp follikulari multiplu qabel ma ssir fertilizzazzjoni in vitro jew tintuża xi teknoloġija ta ’ riproduzzjoni assistita oħra:
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.
Doża li tintuża b’ mod komuni għal ovulazzjoni mgħaġġla hija ta ’ 150- 225 IU ta ’ GONAL- f kuljum, li tinbeda fit- tieni jew fit- tielet ġurnata taċ- ċiklu.
Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/ or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Il- kura titkompla sakemm jinkiseb żvillup follikulari adegwat (kif analizzat minn osservazzjoni tal- konċentrazzjonijiet ta ’ estroġenu fis- serum u/ jew eżaminazzjoni permezz ta ’ l- ultrasawnd), b’ tibdil fid- doża skond l- effett fuq il- pazjent, sa mhux aktar, ġeneralment, minn 450 IU kuljum.
In general adequate follicular development is achieved on average by the tenth day of treatment (range 5 to 20 days).
B’ mod ġenerali, żvilupp follikulari adegwat jinkiseb fil- medja mal - għaxar ġurnata tal- kura (dan ivarja bejn 5 u 20 ġurnata).
A single injection of up to 10 000 IU hCG is administered 24-48 hours after the last GONAL-f injection to induce final follicular maturation.
Injezzjoni waħda ta ’ mhux aktar minn 10 000 IU hCG tittieħed 24- 48 siegħa wara l- aħħar injezzjoni ta ’ GONAL- f sabiex tinduċi maturazzjoni follikulari finali.
Down-regulation with a gonadotrophin-releasing hormone (GnRH) agonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
Down- regulation permezz ta ’ agonista ta ’ l- ormon li jistimula il- produzzjoni tal- gonadotrofina (GnRH) sar jintuża komunement biex irażżan iż- żieda ta ’ LH endoġenu u biex iżomm kontroll fuq il - livelli toniċi ta ’ LH.
In a commonly used protocol, GONAL-f is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved.
Fi protokoll użat komunement, GONAL- f jinbeda madwar ġimgħatejn wara il - bidu tal- kura bl- agonista, u t- tnejn li huma jitkomplew sakemm jinkiseb żvilupp follikulari adegwat.
For example, following two weeks of treatment with an agonist, 150-225 IU GONAL-f are administered for the first 7 days.
Per eżempju, wara ġimgħatejn ta ’ kura bl- agonista, 150- 225 IU ta ’ GONAL- f jingħataw għall- ewwel sebat ijiem.
The dose is then adjusted according to the ovarian response.
Wara dan, id- doża tinbidel skond l- effett fuq l- ovarji.
Overall experience with IVF indicates that in general the treatment success rate remains stable during the first four attempts and gradually declines thereafter.
L- esperjenza ġenerali bl- użu ta ’ l- IVF tindika li r- rata ta ’ suċċess ta ’ din il- kura tibqa ’ stabbli waqt l - ewwel erba ’ tentattivi u tonqos b’ mod gradwali minn hemm ‘ il quddiem.
3 Women with anovulation resulting from severe LH and FSH deficiency:
Nisa li ma jovulawx minħabba nuqqas qawwi ta ’ LH u FSH
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 gonadotrophin (hCG).
GONAL- f għandu jingħata bħala kors ta ’
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
3 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Minħabba li dawn il- pazjenti huma amenorreaċi u jipproduċu livell baxx ta ’ estroġenu endoġenu, il- kura tista ’ tibda fi kwalunkwe żmien.
Treatment should be tailored to the individual patient’ s response as assessed by measuring follicle size by ultrasound and oestrogen response.
Il- kura għandha tingħata skond l- effett li tagħmel fuq il- pazjent partikolari skond kif analizzat mill - kejl tad- daqs tal- follikulu permezz ta ’ l- ultrasawnd u l- ammont ta ’ estroġenu.
A recommended regimen commences at 75 IU of lutropin alfa daily with 75-150 IU FSH.
Hu rrakkomandat li l - kura tibda b' doża ta '75 IU ta ’ lutropin alfa kuljum flimkien ma ’ 75- 150 IU FSH.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-75 IU increments.
Jekk ikun hemm bżonn li tiżdied id- doża tal- FSH, ikun aħjar jekk tibdil fid- doża jsir wara intervalli ta ’ 7- 14- il ġurnata u preferibbilment b’ żidiet ta’ 37. 5 IU- 75 IU.
It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Jista ’ jkun aċċettabbli li jkun estiż it- tul ta ’ żmien ta ’ stimulazzjoni fi kwalunkwe ċiklu sa 5 ġimgħat.
When an optimal response is obtained, a single injection of 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last GONAL-f and lutropin alfa injections.
Meta l- effett mixtieq jintlaħaq, injezzjoni waħda ta ’ bejn 5, 000 IU u 10, 000 IU hCG għandha tingħata 24- 48 siegħa wara l- aħħar injezzjonijiet ta ’ GONAL- f u lutropin alfa.
The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Il- pazjenta hi rrakkomandata li jkollha x' taqsam mas- sieħeb tagħha dak in- nhar u l- għada li tieħu l- hCG.
Alternatively, intrauterine insemination (IUI) may be performed.
Inkella tista ’ ssir inseminazzjoni ġewwa l- utru (IUI).
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.
Jista ’ jiġi kunsidrat appoġġ fil- fażi lutejali taċ- ċiklu, minħabba li n- nuqqas ta 'sustanzi b' attivita' lutejatrofika( LH/ hCG) wara l- ovulazzjoni tista 'tikkawża nuqqas ta' żvilupp fil- korpus lutejum.
If an excessive response is obtained, treatment should be stopped and hCG withheld.
Jekk l- effett ikun aktar milli mixtieq, il- kura għandha titwaqqaf u jinżamm l- hCG.
Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Il- kura għandha terġa ’ tibda fiċ- ċiklu li jmiss u d- doża tal- FSH għandha tkun inqas minn dik taċ- ċiklu preċedenti.
Men with hypogonadotrophic hypogonadism:
Irġiel b’ ipogonadiżmu ipogonadotrofiku
GONAL-f should be given at a dosage of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
GONAL- f għandu jingħata f’ doża ta ’ 150 IU tliet darbiet fil- ġimgħa, flimkien ma ’ l- hCG, għal minimu ta ’ 4 xhur.
If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Jekk wara dan il- perijodu, il- pazjent ma jkunx għadu wera riżultati posittivi, il- kura kombinata tista ’ titkompla; l- esperjenza klinika kurrenti tindika li jista ’ jkun hemm bżonn ta ’ kura għal 18 il- xagħar biex tinkiseb l- ispermatoġenesi.
GONAL-f must not be used in: • hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • case of tumours of the hypothalamus and pituitary gland
GONAL- f m’ għandux jintuża f’ każi ta ’: • sensittività eċċessiva għal follitropin alfa, FSH jew għal xi wieħed mis- sustanzi mhux attivi; • f’ każi ta ’ tumuri fl- ipotalamu u l- glandola pitwitarja
and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
u f’ nisa: • li għandhom tkabbir ta ’ l- ovarji jew għandhom xi ċista li mhix ikkaġunata minn mard poliċistiku ta ’ l- ovarji • qed ibatu minn emorraġiji ġinekoloġiċi li l- kawża tagħhom mhix magħrufa • qed ibatu minn karċinoma fl- ovarji, fl- utru jew mammarja.
GONAL-f should not be used when an effective response cannot be obtained, such as:
GONAL- f m’ għandux jintuża f' każijiet fejn ma jistax jagħti riżultati tajbin bħal per eżempju:
In women: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy
F’ nisa: • b’ insuffiċjenza ta ’ l- ovarji primarja • meta jkun hemm difett fiżiku ta ’ l- organi sesswali li jagħtu problemi għat- tqala • b’ tumuri fibrużi ta ’ l- utru li minħabba fihom il- mara ma tkunx tista 'toħroġ tqila
In men: primary testicular insufficiency
F’ irġiel: b’ insuffiċenzja testikolari primarja
4 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
GONAL-f is a potent gonadotrophic substance capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
GONAL- f hu sustanza gonadotrofika qawwija li kapaċi jikkawża reazzjonijiet avversi minn ħfief sa severi, u għandu jintuża biss minn tobba li huma perfettament familjari mal- problemi ta ’ fertilita u l - kura tagħhom.
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
It- terapija bil- gonadotrofina teħtieġ ċertu impenn mit- tobba u l- appoġġ mill- professjonisti fil- qasam tas- saħħa, kif ukoll id- disponibilità ta ’ faċilitajiet ta ’ osservazzjoni.
In women, safe and effective use of GONAL-f calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Fin- nisa, l- użu mingħajr periklu u 4 effettiv ta ’ GONAL- f jeħtieġ osservazzjoni ta ’ l- effett fuq l- ovarji permezz ta ’ l- ultrasawnd, waħdu jew idealment flimkien mat- tkejjil tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients.
Jista ’ jkun hemm element ta ’ differenza bejn pazjent u ieħor fir- riżultati miksuba mill- għoti ta ’ FSH, b’ ċerti pazjenti juru rispons fqir għall- FSH.
The lowest effective dose in relation to the treatment objective should be used in both men and women.
L- anqas doża effettiva marbuta ma ’ l- għan tal- kura għandha tintuża kemm għall- irġiel kif ukoll għan- nisa.
Self-administration of GONAL-f should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
GONAL- f għandu jiġi mgħoti mill- pazjent stess biss meta hemm motivazzjoni qawwija, taħriġ xieraq u aċċess għal pariri professjonali.
The first injection of GONAL-f should be performed under direct medical supervision.
L- ewwel injezzjoni ta ’ GONAL- f għandha tittieħed taħt superviżjoni medika diretta.
Patients with porphyria or a family history of porphyria should be closely monitored during treatment with GONAL-f.
Pazjienti li jbatu minn porphyria jew għandhom storja fil- familja ta porphyria jridu jkunu monitorjati sew waqt it- trattament ma ’ GONAL- f.
Deterioration or a first appearance of this condition may require cessation of treatment.
Deterjorament jew l- ewwel apparenza ta din il- kundizzjoni jista ’ jeħtieġ illi jitwaqqaf it- trattament.
GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
GONAL- f fih inqas minn 1 mmol sodju (23 mg) għal kull dosa, i. e. essenzjalment ‘ mingħajr sodju ’.
Treatment in women
Kura fin- nisa
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Qabel ma 'tibda l- kura għandha tiġi eżaminata l- infertilita tal- koppja u għandha issir evalwazzjoni biex tistabbilixxi jekk hemmx xi kontra- indikazzjonijiet għat- tqala.
In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
B’ mod partikolari, il- pazjenti għandhom ikunu eżaminati biex jiġi stabbilit jekk ibatux minn ipotirojdiżmu, defiċjenza adrenokortikali, iperprolaktinimja jew tumuri pitwitarji jew ipotalamiċi, u jingħataw il- kura meħtieġa.
Patients undergoing stimulation of follicular growth, whether in the frame of a treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Pazjenti li huma għaddejjin minn stimulazzjoni ta ’ tkabbir follikulari, kemm jekk fil- qafas tal- kura għall- infertilita f’ nisa li ma jovulawx u kemm jekk fl- użu ta ’ proċeduri ta ’ ART, jistgħu jesperjenzaw tkabbir ta ’ l- ovarji jew ikollhom stimulazzjoni eċċessiva.
Adherence to recommended GONAL-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Jiekk tittieħed d- doża ta ’ GONAL- f rrakkomandata, jittieħed kif inhu rrakkomandat u ssir osservazzjoni bir- reqqa tat- terapija, titnaqqas l - possibilità ta ’ dawn l- avvenimenti.
Acute interpretation of the indices of follicle development and maturation require a physician whom is experienced in the interpretation of the relevant tests.
Interpretazzjoni eżatta ta ’ l- indiċi ta ’ l- iżvilupp u l- maturazzjoni tal- follikuli teħtieġ tabib li għandu esperjenza fl- interpretazzjoni ta ’ dawn it- testijiet.
In clinical trials, an increase of the ovarian sensitivity to GONAL-f was shown when administered with lutropin alfa.
Studji kliniċi wrew żieda fis- sensittività ta ’ l- ovarji għal Gonal- f meta dan ingħata ma ’ Lutropin alfa.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments.
Jekk ikun hemm bżonn li tiżdied id- doża tal - FSH, jekk jista ’ jkun, tibdil fid- doża għandu jsir f’ intervalli ta ’ 7- 14- il ġurnata u preferibbilment b’ żidiet ta ’ 37. 5- 75IU.
Comparison with historical data suggests that the ovulation rate obtained with GONAL-f/ LH is similar to what can be obtained with hMG.
Ma sarx tqabbil dirett bejn GONAL- f/ LH u il- gonadotrofina tal- menopawża umana( hMG). Tqabbil li sar ma informazzjoni storika tindika li r- rata ta ’ ovulazzjoni miksuba mill- GONAL- f/ LH hi simili għal dik li tista ’ tinkiseb mill- hMG.
Ovarian Hyperstimulation Syndrome (OHSS)
Sindromu ta ’ Iperstimulazzjoni ta ’ l- Ovarji (OHSS)
OHSS is a medical event distinct from uncomplicated ovarian enlargement.
L- OHSS hu avveniment mediku differenti minn dak tat- tkabbir ta ’ l- ovarji mingħajr kumplikazzjonijiet.
OHSS is a syndrome that can manifest itself with increasing degrees of severity.
OHSS hu sindromu li jista ’ jseħħ b’ livelli differenti ta ’ severità.
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.
Dan jinkludi tkabbir evidenti ta ’ l- ovarji, sterojdi sesswali għoljin fis- serum, u żieda fil- permeabilità vaskulari li tista ’ twassal għal akkumulazzjoni ta ’ fluwidu fl- ispazju tal- peritonew, tal- plewra, u f’ okkażjonijiet rari fl- ispazju tal- perikardju.
Clinical evaluation may reveal hypovolaemia,
Dawn is- sintomi segwenti jistgħu jkunu osservati f’ każi severi ta ’ OHSS: uġigħ addominali, nefħa addominali, tkabbir sever ta ’ l- ovarji, żieda fil- piż, dispneja, oligurja, u sintomi gastro- intestinali li jinkludu n- nawżea, remettar u dijarrea.
Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.
Evalwazzjoni klinika tista ’ tindika l- ipovolemja, emokonċentrazzjoni, żbilanċ ta ’ l- elektroliti, axxite, emoperitonew, effużżjoni plewrali, idrotoraċi, distress polmonari akuta u avvenimenti tromboemboliċi.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
Rarament ħafna, każ sever ta ’ OHSS jista ’ jkun ikkomplekat minn embolismu polmonari, puplesija iskimika u infart miokardijaku Effett eċċessiv fuq l- ovarji mill- kura bil- gonadotrofina, f’ każijiet rari jagħti lok għal OHSS sakemm ma jingħatax l- hCG biex jinduċi l- ovulazzjoni.
Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days.
Għalhekk ikun aħjar jekk jinżamm l- hCG f’ dawn il - każi u l- pazjenti jingħataw il- parir biex ma jkollhomx x' jaqsmu mas- sieħeb tagħhom jew jużaw kontraċettivi ta ’ barriera għal ta ’ l- anqas erbat ijiem.
OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event, therefore patients should be followed for at least two weeks after hCG administration.
OHSS tista ’ tiżdied malajr (f’ temp ta ’ 24 siegħa sa diversi ġranet) u ssir avveniment mediku serju u għalhekk il- pazjenti għandhom ikunu osservati sa mill- anqas ħmistax wara l- għoti ta ’ l- hCG.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Biex tnaqqas ir- riskju ta ’ OHSS jew ta ’ tqala multipla, huwa rakkomandat li jsiru skans ta’ l - ultrasawnd u tkejjil ta ’ l- ammont ta 'estradajol.
In anovulation the risk of OHSS and multiple pregnancy is increased by a serum oestradiol > 900 pg/ ml (3300 pmol/ l) and more than 3 follicles of 14 mm or more in diameter.
F’ nisa li ma jovulawx ir- riskju ta ’ OHSS u ta ’ tqala multipla jiżdied meta l- ammont ta 'estradajol fis- serum ikun > 900 pg/ ml (3300 pmol/ l) u jkun hemm
In ART there is an increased risk of OHSS with a serum oestradiol > 3000 pg/ ml (11000 pmol/ l) and 20 or more follicles of 12 mm or more in diameter.
Meta tintuża l- ART tiżdied il- possibilità ta ’ OHSS meta l- ammont ta ’ estradajol fis- serum ikun > 3000 pg/ ml (11000pmol/ l) u meta jkun hemm 20 jew aktar follikuli b’ dijametru ta ’ 12 mm jew akbar.
When the oestradiol level is > 5500 pg/ ml (20200 pmol/ l) and where there are 40 or more follicles in total, it may be necessary to withhold hCG administration.
Meta l- livell ta ’ estradajol ikun ta ’ > 5500 pg/ ml (20200 pmol/ l) u meta jkun hemm 40 follikulu jew aktar b’ kollox, jista ’ jkun meħtieġ li jinżamm l - għoti ta ’ hCG.
Adherence to recommended GONAL-f dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see Sections 4.2 and 4.8).
Jekk tingħata d- doża ta ’ GONAL- f li hi rrakkomandata, tingħata kif inhu rrakkomandat u ssir osservazzjoni mill- qrib tat- terapija, titnaqqas l- inċidenża ta ’ iperstimulazzjoni ta ’ l- ovarji u ta ’ tqala multipla{ ara Sezzjonijiet 4. 2 u 4. 8).
In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
Meta tintuża l- ART, l- aspirazzjoni tal- follikuli kollha qabel l- ovulazzjoni tista ’ tnaqqas il- possibilità li sseħħ l- iperstimulazzjoni.
OHSS may be more severe and more protracted if pregnancy occurs.
L- OHSS tista ’ tkun aktar qawwija u tieħu aktar fit- tul fil- każ ta ’ tqala.
Most often, OHSS occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Ħafna drabi, l- OHSS iseħħ wara li tkun twaqqfet il- kura ormonali u tilħaq il- massimu tagħha madwar seba ’ sa għaxart ijiem wara l- kura.
Usually, OHSS resolves spontaneously with the onset of menses.
Ġeneralment, l- OHSS tintemm b’ mod spontanju fil- bidu tal- mestrwazzjoni.
If severe OHSS occurs, gonadotrophin treatment should be stopped if still ongoing, the patient hospitalised and specific therapy for OHSS started.
Jekk l- OHSS tkun qawwija ħafna, il- kura bil- gonadotrofina għandha titwaqqaf jekk tkun għadha għaddejja, u l- pazjent jittieħed l- isptar biex jingħata terapija speċifika għall- OHSS.
This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
L- inċidenza ta ’ dan is- sindromu hija aktar għolja f’ pazjenti b’ mard poliċistiku fl- ovarji.
Multiple pregnancy
Tqala multipla
Multiple pregnancy, specially high order, carries an increase risk in adverse maternal and perinatal outcomes.
Tqala multipla, specjalment ta ’ ammont għoli, iġġib magħha riskju akbar ta ’ effetti mhux mixtieqa qabel, matul u immedjatament wara t- tqala.
In patients undergoing ovulation induction with GONAL-f, the incidence of multiple pregnancies is increased as compared with natural conception.
Il- pazjenti li għaddejjin minn induzzjoni ta ’ l- ovulazjoni b’ GONAL- f għandhom aktar ċans għal tqala multipla, meta imqabbla ma ’ konċepiment naturali.
The majority of multiple conceptions are twins.
Il- parti l- kbira tal- każi ta ’ konċepiment multiplu huma tewmin.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Biex jitnaqqas ir- riskju ta ’ tqala multipla, hi rrakkomandata li ssir osservazzjoni bir - reqqa ta ’ l- effett fuq l- ovarji.
In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Fil- każ ta ’ pazjenti li qed tingħatalhom il- kura permezz ta ’ l- ART, ir- riskju ta ’ twelid ta ’ aktar minn tarbija waħda hu marbut prinċipalment man- numru ta ’ embriji mibdula, il- kwalità tagħhom u l- età tal - pazjent.
The patients should be advised of the potential risk of multiple births before starting treatment.
Il- pazjenti għandhom ikunu infurmati dwar il- possibbilità tar- riskju li titwieled aktar minn tarbija waħda qabel ma tingħata bidu għall- kura.
Pregnancy wastage
Tqala mitlufa
The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than in the normal population.
L- inċidenza tal- pazjenti li jitilfu t- tarbija tagħhom minħabba korriment jew abort hi akbar f’ dawk il - pazjenti li ssirilhom stimulazzjoni tat- tkabbir follikulari bl- għan li jwassal għal induzzjoni ta ’ l - ovulazzjoni u f’ dawk li fuqhom tintuża l- ART, milli fil- popolazzjoni normali.
6 Ectopic pregnancy
Tqala ektopika
Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
F’ nisa b’ passat mediku ta ’ mard fit- tubi hemm ir- riskju ta ’ tqala ektopika, kemm jekk it- tqala tinkiseb b’ konċepiment spontanju u kemm jekk permezz ta ’ kura għall- fertilità.
The prevalence of ectopic pregnancy after IVF was reported to be 2 to 5%, as compared to 1 to 1.5% in the general population.
Ir- rata ta ’ każi ta ’ tqala ektopika kienet ta ’ bejn 2 u 5% fil- każi ta ’ IVF, meta mqabbla mal- 1 sa 1. 5% fil- popolazzjoni ġenerali.
Reproductive system neoplasms
Neoplażmi fis- sistema riproduttiva
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
Kien hemm rapporti ta ’ neoplażmi fl- ovarji kif ukoll fil- bqija tas- sistema riproduttiva, kemm beninni kif ukoll malinni, f’ nisa li ngħataw korsijiet multipli ta ’ mediċini għal kura ta ’ l- fertilita.
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumors in infertile women.
Għadu mhux magħruf jekk il- kura bil- gonadotrofini żżidx ir- riskju basiku ta ’ dawn it- tumuri f’ nisa infertili.
Congenital malformation
Malformazzjoni konġenitali
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Il- possibbilta` li sseħħ malformazzjoni konġenitali wara l- użu ta ’ ART tista ’ jkun ftit aktar għolja meta mqabbla mal- konċepiment spontanju.
This is thought to be due to differences in parental characteristics (e. g. maternal age, sperm characteristics) and multiple pregnancies.
Hu maħsub li dan jirriżulta minħabba xi differenzi fil - karatteristiċi tal- ġenituri (eż. età materna, karatteristika ta ’ l- isperma) u tqala multipla.
Thromboembolic events
6 Effetti tromboemboliċi
In women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with gonadotrophins may further increase the risk.
F’ nisa li għandhom fatturi ta ’ riskju għal effetti tromboemboliċi li ġeneralment ikunu rikonoxxuti bħal passat mediku personali jew fil- familja, kura bil- gonadotrofini tista ’ żżid dan ir- riskju.
In these women, the benefits of gonadotrophin administration need to be weighed against the risks.
Qabel ma tingħata lil dawn in- nisa, hemm bżonn li wieħed iqis l- benefiċċji kontra r- riskji ta ’ l- għoti tal - gonadotrofini.
It should be noted however, that pregnancy itself also carries an increased risk of thrombo-embolic events.
Madankollu, għandu jkun irrimirkat, li t- tqala nnifisha wkoll tista ’ twassal għal riskju akbar ta ’ effetti tromboemboliċi.
Treatment in men
Kura fl- irġiel
Elevated endogenous FSH levels are indicative of primary testicular failure.
Il- preżenza ta ’ livelli elevati ta ’ FSH endoġenu jindikaw insuffiċjenzja testikolari primarja.
Such patients are unresponsive to GONAL-f/ hCG therapy.
Dawn il - pazjenti ma jirrispondux għat- terapija tal- GONAL- f/ hCG.
Semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response.
Hu rrakomandat li ssir analiżi tas- semen bejn 4 u 6 xhur wara li tinbeda l- kura sabiex jiġi analizzat l - effett tat- terapija fuq il- pazjenti.
Concomitant use of GONAL-f with other agents used to stimulate ovulation (e. g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist to induce pituitary desensitisation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.
L- użu konkomitanti ta ’ GONAL- f ma ’ prodotti oħra wżati biex jistimulaw l- ovulazzjoni (eż. hCG, clomiphene citrate) jista ’ jsaħħaħ r- rispons follikulari, filwaqt li l- użu konkomitanti ma ’ xi tip ta ’ agonista tal- GnRH biex tinduċi desensitizzazzjoni pitwitarja jista ’ jżid id- doża ta ’ GONAL- f li tkun meħtieġa biex twassal għal rispons adegwat fl- ovarji.
No other clinically significant drug interaction has been reported during GONAL-f therapy.
Ma kien irrapurtat l- ebda prodott mediċinali ieħor li jibdel l- effett farmaċewtiku ta ’ din il- mediċina b’ mod sinifikanti waqt it- terapija b’ GONAL- f.
GONAL-f should not be administered as mixture with other medicinal products, in the same injection, except lutropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
GONAL- f m’ għandux jingħata bħala taħlita ma ’ prodotti mediċinali oħra, fl- istess injezzjoni, ħlief ma ’ lutropin alfa, fejn l- istudji wrew li meta dawn jittieħdu flimkien ma jkunx hemm tibdil sinifikanti fl- attività, stabbiltà u l- karatteristiċi farmakokinetiċi u farmakodinamiċi tas- sustanzi attivi.
4.6 Pregnancy and lactation
4. 6 TQALA U Treddigħ
Use during pregnancy
Użu waqt it- tqala
There is no indication for use of GONAL-f during pregnancy.
M’ hemm l- ebda indikazzjoni għall- użu ta’ GONAL- f fit- tqala.
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotropins.
Ma kien irrapurtat l- ebda riskju teratoġeniku wara iperstimulazzjoni kkontrollata ta ’ l- ovarji, f’ użu kliniku mal- gonatropini.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
Fil- każ ta ’ espożizzjoni waqt it- tqala, ma teżistix biżżejjed informazzjoni klinika biex ikun eskluż xi effett teratoġeniku tal- FSH rikombinanti.
However, to date, no particular malformative effect has been reported.
Madankollu, sal- lum, ma kien irrapurtat l- ebda effett partikolari ta ’ malformazzjoni.
No teratogenic effect has been observed in animal studies.
Ma kien osservat l- ebda effett teratoġeniku fi studji li saru fuq annimali.
7 Use during lactation
Użu waqt it- treddigħ
GONAL-f is not indicated during lactation.
GONAL- f m’ għandux jittieħed jekk qed tredda ’.
During lactation, the secretion of prolactin can entail a poor prognosis to ovarian stimulation.
Is- sekrezzjoni ta ’ prolaktin waqt it- treddigħ, jista ’ jwassal għal effett batut fuq l- istimulazzjoni ta ’ l- ovarji.
Treatment in women Immune system disorders
7 Kura fin- nisa Disturbi fis- sistema immuni
Very rare (< 1/ 10,000)
Rari ħafna (< 1/ 10, 000)
Mild systemic allergic reactions (e. g. mild forms of erythema, rash, facial swelling, urticaria, oedema, difficulty breathing).
Reazzjonijiet sistemiċi allerġiċi ħfief (eritema, raxx jew nefħa fil - wiċċ, urtikarja, edima, diffikulajiet biex tieħu nifs).
Serious cases of allergic reactions, including anaphylactic reactions, have also been reported.
Kazijiet serji ta ’ reazzjonijiet aller ġiċi, inkluzi reazzjonijiet anafilattici, ġew irrapurtati wkoll.
Nervous system disorders Vascular disorders
Disturbi fis- sistema nervuża Disturbi vaskulari
Very Common (> 1/ 10) Very rare (< 1/ 10,000)
Komuni ħafna (> 1/ 10) Rari ħafna (< 1/ 10, 000)
Headache Thromboembolism, usually associated with severe OHSS
Uġigħ ta ’ ras Tromboemboliżmu, ġeneralment assoċjat ma ’ OHSS severa
Very rare (< 1/ 10,000)
Rari ħafna (> 1/ 10, 000)
Exacerbation or worsening of asthma
Azma li jsir iktar agħarr
Common (> 1/ 100, < 1/ 10)
Komuni (> 1/ 100 sa < 1/ 10)
Abdominal pain and gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal cramps and bloating
Ugigħ addominali u sintomi gastro- intestinali bħal nawżea, remettar, dijarrea, spażmi fl - addome u nefħa addominali
Very Common (> 1/ 10)
Komuni ħafna (> 1/ 10)
Ovarian cysts
Ċisti fl- ovarji
Common (> 1/ 100, < 1/ 10)
Komuni (> 1/ 100, < 1/ 10)
Mild to moderate OHSS (see section 4.4)
OHSS ħafifa sa moderata (ara sezzjoni 4. 4)
Uncommon (> 1/ 1,000 ,< 1/100) Rare (> 1/10 ,000, < 1/1,000)
Mhux komuni (> 1/ 1, 000, < 1/ 100)
Severe OHSS (see section 4.4) Ovarian torsion, a complication of OHSS
OHSS severa (ara sezzjoni 4. 4).
General disorders and administration site conditions
Torsjoni ta ’ l- ovarji, kumplikazzjoni ta ’ l- OHSS
Mild to severe injection site reaction (pain, redness, bruising, swelling and/ or irritation at the site of injection)
Reazzjoni ħafifa sa severa fis- sit ta ’ l- injezzjoni (uġigħ, ħmura, tbenġil, nefħa u/ jew irritazzjoni fis- sit ta ’ l- injezzjoni)
8 Treatment in men Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
Gynaecomastia Varicocele
Ginekomastija Varicocele
Weight gain
Zieda fil- piż
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
L- effetti ta ’ doża eċċessiva ta ’ GONAL- f mhumiex magħrufa, madanakollu, wieħed jista ’ jistenna li l - pazjenti jaqbadhom is- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji, li hu deskritt f’ aktar dettall f’ sezzjoni 4. 4.
Pharmacotherapeutic group: gonadotrophins, ATC code:
Kategorija farmakoterapewtiku: gonadotrofini, Kodiċi ATC:
GONAL-f is a preparation of follicle stimulating hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
8 GONAL- f huwa sustanza ta ’ ormon li jistimula l- follikolu magħmul fiċ- ċelloli ta ’ l- Ovarji tal- Ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
In women, the most important effect resulting from parenteral administration of FSH is the development of mature Graafian follicles.
Fin- nisa, l- aktar effett importanti li jirriżulta mill- għoti parenterali tal- FSH hu l- iżvilupp ta ’ follikuli Grafjani maturi.
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.
Fi studji kliniċi, pazjenti li kellhom nuqqas qawwi ta ’ FSH u LH kienu dawk li kellhom < 1. 2 IU/ l ta 'LH fis- serum endoġenu kif imkejjla f’ laboratorju ċentrali.
However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Madankollu, wieħed irid jikkunsidra li hemm varjazzjonijiet fit- tkejjil ta ’ LH kif imwettaq f’ laboratorji differenti.
In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
F’ irġiel b’ nuqqas ta ’ FSH, l- għoti konkomitanti ta ’ GONAL- f ma ’ hCG għal mill- anqas erba ’ xhur jinduċi l- ispermatoġeneżi.
Following intravenous administration, GONAL-f is distributed to the extra cellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Wara li jingħata mill- vini, GONAL- f jinfirex fl- ispazju tal- fluwidu extra- ċellulari b’ half- life inizzjali ta ’ madwar sagħtejn u jitneħħa mill- ġisem b’ half- life terminali ta ’ madwar ġurnata.
The steady state volume of distribution and total clearance are 10 l and 0.6 l/ h, respectively.
L- istat fiss tal - volum ta ’ distribuzzjoni u t- tneħħija totali mill- ġisem huma ta ’ madwar 10 l u 0. 6l/ siegħa, rispettivament.
One- eighth of the GONAL-f dose is excreted in the urine.
Wieħed minn kull tmien partijiet tad- doża ta ’ GONAL- f joħroġ ma ’ l- urina.
Following subcutaneous administration, the absolute bioavailability is about 70%.
Wara li jingħata minn taħt il- ġilda, il- biodisponibbilita` assoluta hija ta ’ madwar 70%.
Following repeated administration, GONAL-f accumulates 3-fold achieving a steady-state within 3-4 days.
Meta jingħata ripetutament, GONAL- f jakkumula sa 3 darbiet aktar u jilħaq stat fiss wara 3- 4 ijiem.
In women whose endogenous gonadotrophin secretion is suppressed, GONAL-f has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
F’ nisa fejn is - sekrezzjoni tal- gonadotrofina endoġena hija nieqsa, instab li GONAL- f xorta waħda jistimula b’ mod effettiv l- iżvilupp follikulari u l- isterojdoġenesi, minkejja livelli ta ’ LH li ma jistgħux jiġu mkejjla.
Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SPC.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, ma ’ turi l- ebda periklu speċjali għall- bnedmin, iktar minn dak li huwa iddikjarat f ’ sezzjonijiet oħra ta dan l ’ SPC.
Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/ kg/ day) for extended periods, through reduced fecundity.
Nuqqas ta ’ fertilità kienet irrapurtata fil- firien esposti għal dożi farmakoloġiċi ta ’ follitropin alfa (≥ 40 IU/ kg/ kuljum) għal perijodi estiżi, kaġuni ta ’ tnaqqis fil- fekondita`.
9 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 hMG.
Meta mogħtija f’ dożi għolja (≥ 5 IU/ kg/ kuljum) follitropin alfa, minkejja li mhiex teratoġenika kkawżat tnaqqis fin- numru ta ’ feti viabbli u distosja simili għal dik ossevata fil- każ ta ’ l- hMG urinarja.
However, since GONAL-f is not indicated in pregnancy, these data are of limited clinical relevance.
Madankollu, peress li GONAL- f m’ għandux jintuża waqt it- tqala, din l- informazzjoni hi ta ’ relevanza klinika limitata.