qanastek/EMEA-V3 huggingface dataset:
72 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.
73 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.
70 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
74 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.
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 effettiv ta ’ GONAL- f jeħtieġ osservazzjoni ta ’ l- effett fuq l- ovarji permezz ta ’ l- ultrasawnd, waħdu 71 jew idealment flimkien mat- tkejjil tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
Adherence to recommended GONAL-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Jekk 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.
75 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.
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.
72 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.
76 Ectopic pregnancy
Tqala ektopika
Thromboembolic events
73 Effetti tromboemboliċi
GONAL-f should not be administered as mixture with other medicinal products in the same injection.
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.
77 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Treatment in women Immune system disorders
74 Kura fin- nisa Disturbi fis- sistema immuni
Uncommon (> 1/ 1,000, < 1/ 100)
Mhux komuni (> 1/ 1, 000, < 1/ 100)
Severe OHSS (see section 4.4)
OHSS severa (ara sezzjoni 4. 4).
Rare (> 1/ 10,000, < 1/ 1,000)
Rari (> 1/ 10, 000, < 1/ 1, 000)
Ovarian torsion, a complication of OHSS
Torsjoni ta ’ l- ovarji, kumplikazzjoni ta ’ l- OHSS
General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Kura fl- irġiel
78 Treatment in men Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
GONAL-f is a preparation of follicle stimulating hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
75 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.
79 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.
Fil- fniek, is- sustanza rikostitwita b’ 0. 9% benzyl alcohol u 0. 9% benzyl alcohol waħdu, it- tnejn li huma rriżulta f’ emorraġija ħafifa u infjammazzjoni subakuta wara li ngħataw injezzjoni waħda subkutanja jew f’ infjammazzjoni ħafifa u bidliet deġenerattivi wara injezzjoni waħda intramuskolari rispettivament.
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.
Water for Injections Benzyl alcohol
Ilma għall- injezzjonijiet Benzyl Alcohol
6.2 Incompatibilities
76 6. 2 Inkompatibilitajiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma ’ jablux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
The powder is presented in 3 ml vials (Type I glass), with rubber stopper (bromobutyl rubber) and aluminium flip-off cap.
It- trab hu ppakkjat fi fjali ta ’ 3 ml (tal- ħġieġ tat- tip I), b’ tapp tal- gomma( gomma tal- bromobutil) u tapp ta ’ l- aluminju li jinfetaħ b’ daqqa ta’ saba ’.
The product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 4 disposable syringes for administration graduated in FSH units.
Il- prodott jiġi bħala pakkett bi fjala waħda ta ’ trab flimkien ma ’ siringa mimlija lesta bis- solvent għar - rikostituzzjoni u 4 siringi għall- użu ta’ darba biss, gradwati f’ unitajiet ta’ FSH, għall- injezzjoni.
80 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet specjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) must be reconstituted with the 0.75 ml solvent provided before use.
GONAL- f 300IU/ 0. 50 ml (22 mikrogrammi/ 0. 50 ml) għandu jiġi rikostitwit ma ’ 1 ml solvent provdut qabel ma jintuża.
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) preparation must not be reconstituted with any other GONAL-f containers.
Il- preparat ta ’ GONAL- f 300 IU/ 0. 50 ml (22 mikrogrammi/ 0. 50 ml) m’ għandux jiġi rikostitwit ma ’ kontenituri oħra ta ’ GONAL- f.
A set of administration syringes graduated in FSH units is supplied in the GONAL-f Multidose box.
Sett ta ’ siringi għall- amministrazzjoni gradwati f’ unitajiet ta ’ FSH huma provduti fil- kaxxa ta ’ GONAL- f b’ ħafna dożi.
Dose (IU) 75 150 225 300
75 150 225 300 375 450
be injected (ml) 0.13 0.25 0.38 0.50
0. 13 0. 25 0. 38 0. 50 0. 63 0. 75
Any unused product or waste material should be disposed of in accordance with local requirements.
77 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
81 1.
78 1.
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) solution for injection in a pre-filled pen.
GONAL- f 300 IU/ 0. 5 ml (22 mikrogrammi/ 0. 5 ml) soluzzjoni għall- injezzjoni, pinna mimlija għal - lest.
Follitropin alfa*, 600 IU/ ml (equivalent to 44 micrograms/ ml).
Follitropin alfa *, 600 IU (ekwivalenti għal 44 mikrogrammi / ml).
Each cartridge delivers 300 IU (equivalent 22 micrograms) in 0.5 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Kull skartoċċ jikkunsinna 300 IU (ekwivalenti għal 22 mikrogrammi) fi 0. 5ml. * Follitrpoin alfa huwa ormon uman rikombinanti li jistimula l- follikuli (FSH) u jiġi maghmul fiċċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) permezz ta ’ teknologija ta ’ DNA rikombinat.
30 mg sucrose, 0.555 mg disodium phosphate dihydrate, 0.225 mg sodium dihydrogen phosphate monohydrate, 0.05 mg methionine, 1.5 mg m-cresol, 0.05 mg poloxamer 188.
30 mg sukrożju, 0. 555 mg fosfat di- idrat tad- di- sodju, 0. 255mg fosfat mono - idrat tas- sodju di- idroġinat, 0. 05 mg metjonin, 1. 5 mg m- cresol, 0. 05 mg poloxamer 188.
Clear colourless solution.
Soluzzjoni ċara mingħajr kulur
The pH of the solution is 6.7 - 7.3.
Il- pH tas- soluzzjoni huwa 6. 7 - 7. 3.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
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.
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
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
82 preparations.
79 urinarja.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 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 ’ 250 mikrogrammi r- hCG jew 5, 000 IU sa 10, 000 IU hCG għandha tingħata 24- 48 siegħa wara l- aħħar injezzjonijiet ta ’ GONAL- f.
A single injection of 250 micrograms r-hCG or 5 000 IU 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 ’ 250 mikrogrammi r- hCG jew 5 000 IU sa 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 or antagonist 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 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
GONAL- f għandu jingħata bħala kors ta ’
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
80 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5 000 IU up 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 ’ 250 mikrogrammi jew 5, 000 IU sa 10, 000 IU hCG għandha tingħata 24- 48 siegħa wara l- aħħar injezzjonijiet ta ’ GONAL- f u lutropin alfa.
• Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • Tumours of the hypothalamus and pituitary gland
• Sensittività eċċessiva għal sustanz attiv follitropin alfa, FSH jew għal xi wieħed mis- sustanzi mhux attivi • f’ każi ta ’ tumuri fl- ipotalamu u l- glandola pitwitarja
In women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
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
Must not be used when an effective response cannot be obtained, such as:
M’ għandux jintuża f' każijiet fejn ma jistax jagħti riżultati tajbin bħal per eżempju:
In men: • primary testicular insufficiency
F’ irġiel: • b’ insuffiċenzja testikolari primarja
84 Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
81 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 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.
Self-administration of GONAL-f should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
GONAL- f għandu jiġi mgħoti mill- pazjent stess biss meta hemm motivazzjoni qawwija, taħriġ xieraq u aċċess għall- konsulenza esperta.
During training of the patient for self- administration, special attention should be given to specific instructions for the use of the prefilled pen.
Waqt li l- pażjent ikun qed jiġi mħarreġ dwar kif għandu jieħu l - injezzjoni, attenzjoni speċjali għandha tingħata għal struzzjonijiet speċifiċi għall- użu tal- pinna mimlija għal- lest.
Patients undergoing stimulation of follicular growth, whether as treatment for anovulatory infertility or for 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 the recommended GONAL-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Jekk 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.
For accurate interpretation of the indices of follicle development and maturation, the physician should be 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.
Comparison with historical data suggests that the ovulation rate obtained with GONAL-f/ LH is similar to that 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.
85 Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
82 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.
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 Pożoloġija u metodu ta ’ kif għandu jingħata u 4. 8 ‘ Effetti mhux mixtieqa ’).
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.
Tqala mitlufa 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.
Ectopic pregnancy
83 Tqala ektopika
86 Reproductive system neoplasms
Neoplażmi fis- sistema riproduttiva
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.
Għadu mhux magħruf jekk il- kura bil- gonadotrofini żżidx ir- riskju basiku ta ’ dawn it- tumuri f’ nisa infertili.
Semen analysis is recommended 4 to 6 months after the beginning of treatment as part of the assessment of 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 or antagonist 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.
4.7 Effects on ability to drive and use machines
84 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
87 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur (see 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’ Avviżi Speċjali u Prekawzjonijiet speċjali għall- użu.
88 5.
85 5.
Pharmacotherapeutic group: gonadotrophins, ATC code:
Kategorija farmakoterapewtika: gonadotrofini, Kodiċi ATC:
Following intravenous administration, follitropin alfa is distributed to the extracellular 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.
One-eighth of the follitropin alfa dose is excreted in the urine.
Wieħed minn kull tmien partijiet tad- doża ta ’ GONAL- f joħroġ ma ’ l- urina.
Following repeated administration, follitropin alfa 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, follitropin alfa 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.
5.3 Preclinical safety data
Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurta ’ tal- mediċina
Poloxamer 188 Sucrose Methionine Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate m-Cresol Phosphoric acid, concentrated
Poloxamer 188 Sukrożju Metjonina Fosfat mono- idrat tas- sodju di- idroġinat Fosfat di- idrat tad- di- sodju
89 Sodium hydroxide Water for Injections
86 m- Cresol Aċidu phosphoric, ikkonċentrat Sodju hydroxide Ilma għall- injezzjonijiet
2 years Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Darba miftuħ, il- prodott jista jkun maħżun għal mhux aktar minn 28 ġurnata, f’ temperatura ta ’ 25°C jew inqas
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
Fiż- żmien ta ’ kemm idum tajjeb il- prodott mediċinali, dan jista ’ jinħażen f’ temperatura ta ’ 25°C jew inqas, għal mhux aktar minn tlett xur mingħajr ma jitpoġġa fil- friġġ, u għandu jintrema ’ jekk ma jintużax fi żmien tlett xur.
For in-use storage conditions, see section 6.3.
Għall- kundizzjonijiet ta ’ kif taħżen waqt l- użu, ara sezzjoni 6. 3.
6.5 Nature and contents of container
In- natura tal- kontenitur u ta ’ dak li hemm ġo fih fih
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.
0. 5ml ta soluzjoni għall- injezzjoni f ’ skartoċċ ta ’ 3ml (tal- ħġieġ tat- tip I), b’ tapp tal- gomma( gomma tal- halobutil) u tapp ta ’ l- aluminju, b’ strip iswed tal- gomma.
Pack of one pre-filled pen and 5 needles to be used with the pen for administration.
Il- prodott jiġi bħala pakkett ta ’ pinna waħda mimlija għal- lest u ħames labar għall- użu mal- pinna għal l- amministrazzjoni.
The solution should not be administered if it contains particles or is not clear.
Is- soluzzjoni m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
Any unused solution must be discarded not later than 28 days after first opening.
Kull fdal tas- soluzzjoni li ma jkunx intuża għandu jintrema mhux iktar minn 28- il ġurnata wara li nfetaħ għall- ewwl darba.
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) is not designed to allow the cartridge to be removed.
GONAL- f 300 IU/ 0. 5 ml (22 mikrogrammi/ 0. 5 ml) mhuwiex iddesinjat sabiex jitħalla l- iskartoċċ illi jitneħħa.
Discard used needles immediately after injection.
Armi il- labar immedjatament wara l- użu.
20 October 1995 Date of last renewal:
Data ta ’ l- aħħar irrinnovament:
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) solution for injection in a pre-filled pen.
GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml) soluzzjoni għall- injezzjoni, pinna mimlija għal - lest.
Each cartridge delivers 450 IU (equivalent 33 micrograms) in 0.75 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Kull skartoċċ jikkunsinna 450 IU (ekwivalenti għal 33 mikrogrammi) fi 0. 75ml. * Follitrpoin alfa huwa ormon uman rikombinanti li jistimula l- follikuli (FSH) u jiġi maghmul fiċċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) permezz ta ’ teknologija ta ’ DNA rikombinat.
45 mg sucrose, 0.8325 mg disodium phosphate dihydrate, 0.3375 mg sodium dihydrogen phosphate monohydrate, 0.075 mg methionine, 2.25 mg m-cresol, 0.075 mg poloxamer 188.
45 mg sukrożju, 0. 8325 mg fosfat di- idrat tad- di- sodju, 0. 3375mg fosfat mono - idrat tas- sodju di- idroġinat, 0. 075 mg metjonin, 2. 25 mg m- cresol, 0. 075 mg poloxamer 188.
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
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.
89 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.
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
90 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
93 Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
91 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 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.
Self-administration of Gonal-f should only be performed by patients who are well motivated, adequately trained and have access to expert advice.
GONAL- f għandu jiġi mgħoti mill- pazjent stess biss meta hemm motivazzjoni qawwija, taħriġ xieraq u aċċess għall- konsulenza esperta.
Adherence to the recommended Gonal-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Jekk 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.
94 Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
92 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.
Ectopic pregnancy
93 Tqala ektopika
95 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.
4.8 Undesirable effects
94 4. 8 Effetti mhux mixtieqa
96 Treatment in women Immune system disorders
Kura fin- nisa Disturbi fis- sistema immuni
97 Pharmacotherapeutic group: gonadotrophins, ATC code:
Kategorija farmakoterapewtika: gonadotrofini, Kodiċi ATC:
Poloxamer 188 Sucrose Methionine Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate m-Cresol Phosphoric acid, concentrated Sodium hydroxide Water for Injections
Poloxamer 188 Sukrożju Metjonina Fosfat mono- idrat tas- sodju di- idroġinat Fosfat di- idrat tad- di- sodju m- Cresol Aċidu phosphoric, ikkonċentrat Sodju hydroxide
6.2 Incompatibilities
96 Ilma għall- injezzjonijiet
98 Not applicable.
6. 2 Inkompatibilitajiet
Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Darba miftuħ, il- prodott jista jkun maħżun għal mhux aktar minn 28 ġurnata, f’ temperatura ta ’ 25°C jew inqas.
Within its shelf life, the product may be stored at or below 25°C for up to 3 months without being refrigerated again and must be discarded if it has not been used after 3 months.
Fiż- żmien ta ’ kemm idum tajjeb il- prodott mediċinali, dan jista ’ jinħażen f’ temperatura ta ’ 25°C jew inqas, għal mhux aktar minn tlett xhur mingħajr ma jitpoġġa fil- friġġ, u għandu jintrema ’ jekk ma jintużax fi żmien tlett xur.
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.
0. 75ml ta soluzjoni għall- injezzjoni f ’ skartoċċ ta ’ 3ml (tal- ħġieġ tat- tip I), b’ tapp tal- gomma( gomma tal- halobutil) u tapp ta ’ l- aluminju, b’ strip iswed tal- gomma.
Pack of one pre-filled pen and 7 needles to be used with the pen for administration.
Il- prodott jiġi bħala pakkett ta ’ pinna waħda mimlija għal- lest u 7 labar għall- użu mal- pinna għal l - amministrazzjoni.
6.6 Special precautions for disposal
Prekawzjonijiet specjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) is not designed to allow the cartridge to be removed.
GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml) mhuwiex iddesinjat sabiex jitħalla l- iskartoċċ illi jitneħħa.
99 1.
98 1.
GONAL-f 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml) solution for injection in a pre-filled pen.
GONAL- f 900 IU/ 1. 5 ml (66 mikrogrammi/ 1. 5 ml) soluzzjoni għall- injezzjoni, pinna mimlija għal - lest.
Each cartridge delivers 900 IU (equivalent 66 micrograms) in 1.5 ml. * Follitropin alfa is recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Kull skartoċċ jikkunsinna 900 IU (ekwivalenti għal 66 mikrogrammi) fi 1. 5ml. * Follitrpoin alfa huwa ormon uman rikombinanti li jistimula l- follikuli (FSH) u jiġi maghmul fiċċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) permezz ta ’ teknologija ta ’ DNA rikombinat.
90 mg sucrose, 1.665 mg disodium phosphate dihydrate, 0.675 mg sodium dihydrogen phosphate monohydrate, 0.15 mg methionine, 4.5 mg m-cresol, 0.15 mg poloxamer 188.
90 mg sukrożju, 1. 665 mg fosfat di- idrat tad- di- sodju, 0. 675mg fosfat mono - idrat tas- sodju di- idroġinat, 0. 15 mg metjonin, 4. 5 mg m- cresol, 0. 15 mg poloxamer 188.
Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration and treatment
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.
Madankollu, meta dawn id- dożi ntużaw fi studju kliniku fejn GONAL- f u FSH urinarja ġew ikkomparati, instab li GONAL- f kien aktar effettiv mill- FSH urinarja għax kien hemm bżonn ta ’ doża
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
99 totali aktar baxxa u perijodu ta ’ kura iqsar biex jinkisbu l- kundizzjonijiet ta ’ qabel l- ovulazzjoni.
101 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).
F’ nisa b’ nuqqas ta ’ LH u FSH (ipogonadiżmu ipogonadotrofiku), l- għan tat- terapija b’ GONAL- f flimkien ma ’ lutropin alfa hu li jiġi żviluppat follikulu Graafjan matur wieħed li minnhu jinħeles l - ooċit wara l- għoti ta ’ gonadotrofina korjonika umana (hCG).
Treatment should be tailored to the individual patient’ s response as assessed by measuring follicle size by ultrasound and oestrogen response.
100 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.
102 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.
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 effettiv ta ’ GONAL- f jeħtieġ osservazzjoni ta ’ l- effett fuq l- ovarji permezz ta ’ l- ultrasawnd, waħdu 101 jew idealment flimkien mat- tkejjil tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
103 haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
Evalwazzjoni klinika tista ’ tindika l- ipovolemja, emokonċentrazzjoni, żbilanċ ta ’ l- elektroliti, axxite, emoperitonew, effużżjoni plewrali, idrotoraċi, distress polmonari akuta u avvenimenti tromboemboliċi.
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.
102 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.
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.
Ir- rata ta ’ każi ta ’ tqala
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.
103 ektopika kienet ta ’ bejn 2 u 5% fil- każi ta ’ IVF, meta mqabbla mal- 1 sa 1. 5% fil- popolazzjoni ġenerali.
104 Reproductive system neoplasms
Neoplażmi fis- sistema riproduttiva
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 or antagonist 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.
4.8 Undesirable effects
104 4. 8 Effetti mhux mixtieqa
105 Treatment in women Immune system disorders
Kura fin- nisa Disturbi fis- sistema immuni
106 Pharmacotherapeutic group: gonadotrophins, ATC code:
Kategorija farmakoterapewtika: gonadotrofini, Kodiċi ATC:
6.2 Incompatibilities
106 Ilma għall- injezzjonijiet
107 Not applicable.
6. 2 Inkompatibilitajiet
Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Darba miftuħ, il- prodott jista jkun maħżun għal mhux aktar minn 28 ġurnata, f’ temperatura ta ’ 25°C jew inqas
For in-use storage conditions, see section 6.3.
Għallkundizzjonijiet ta ’ kif taħżen waqt l- użu, ara sezzjoni 6. 3.
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih fih
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.
1. 5ml ta soluzjoni għall- injezzjoni f ’ skartoċċ ta ’ 3ml (tal- ħġieġ tat- tip I), b’ tapp tal- gomma( gomma tal- halobutil) u tapp ta ’ l- aluminju, b’ strip iswed tal- gomma.
Pack of one pre-filled pen and 14 needles to be used with the pen for administration.
Il- prodott jiġi bħala pakkett ta ’ pinna waħda mimlija għal- lest u 14- il labar għall- użu mal- pinna għal l - amministrazzjoni.
GONAL-f 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml) is not designed to allow the cartridge to be removed.
GONAL- f 900 IU/ 1. 5 ml (66 mikrogrammi/ 1. 5 ml) mhuwiex iddesinjat sabiex jitħalla l- iskartoċċ illi jitneħħa.
108 ANNEX II
108 ANNESS II
Zone Industrielle de l’ Ouriettaz 1170 Aubonne SWITZERLAND
Zone Industrielle de l’ Ouriettaz 1170 Aubonne Zvizzera
C/ Batanes, 1 – 28760 Tres Cantos (Madrid) Spain
Merck Farma y Química S. L C / Batanes, 1 28760 Tres Cantos (Madrid) Spanja
Merck Serono S. p. A., Via delle Magnolie 15, I-70026 Modugno (Bari) Italy
Merck Serono S. p. A., Via delle Magnolie 15, I- 70026 Modugno (Bari) Italja.
Summary of Product Characteristics, section 4.2)
Sommarju tal - Karatteristiċi tal - Prodott, sezzjoni 4. 2)
110 ANNEX III
110 ANNESS III
112 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 5, 10 AMPOULES AND 1, 5, 10 AMPOULES
112 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 1, 5, 10 AMPULLI U 1, 5, 10 AMPULLI
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA/ I ATTIVA
One ampoule of powder contains: follitropin alfa 75 IU.
Ampulla waħda ta ’ trab fiha: follitropin alfa 75 IU.
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi: sukrozju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju aċidu phosphoric, ikkonċentrat u sodju hydroxide.
One ampoule of solvent contains:
Ampulla waħda ta ’ solvent fiha:
1 ml water for Injections.
1 ml ilma għall- injezzjonijiet
1 ampoule of solvent.
Ampulla 1 ta ’ trab għas- soluzzjoni għall- injezzjoni Ampulla 1 ta ’ solvent
5 ampoules of solvent.
5 ampulli ta ’ trab għas- soluzzjoni għall- injezzjoni 5 ampulli 1 ta ’ solvent
10 ampoules of solvent.
10 ampulli ta ’ trab għas- soluzzjoni għall- injezzjoni 10 ampulli 1 ta ’ solvent
Discard any unused solution.
Armi kull soluzzjoni mhux użata.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TA ’ SID L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L - AWTORIzzAZZJONI GĦALL- KUMMERĊ
1 ampoule of solvent.
Ampulla waħda ta ’ trab għas- soluzzjoni għall- injezzjoni Ampulla waħda ta ’ solvent
BATCH NUMBER
NUMRU TAL - LOTT TAL - MANIFATTUR
Batch Solvent Batch
Lott Lott tas- Solvent
114 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 75 IU AMPOULE LABEL
114 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETA TA ’ AMPULLA GONAL- f 75 IU
GONAL-f 75 IU powder for solution for injection Follitropin alfa Subcutaneous use.
Follitropin alfa.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel ma tużah
115 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT AMPOULE LABEL
115 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETA TA ’ AMPULLA TAS - SOLVENT
Water for Injections Solvent for use with GONAL-f
Solvent għall- użu ma ’ GONAL- f
116 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 10 AMPOULES AND 1, 10 AMPOULES
116 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 1, 10 AMPULLI U 1, 10 AMPULLI
One ampoule of powder contains: follitropin alfa 150 IU.
Ampulla waħda ta ’ trab fiha: follitropin alfa 150 IU.
1 ml water for Injections
1 ml ilma għall- injezzjonijiet
10 ampoules of solvent.
10 ampulli ta ’ trab għas- soluzzjoni għall- injezzjoni 10 ampulli ta ’ solvent
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L - AWTORIZZAZZJONI GĦALL- KUMMERĊ
Batch Solvent Batch
Lott Lot tas- Solvent
118 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 150 IU AMPOULE LABEL
118 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETA TA ’ AMPULLA GONAL- f 150 IU
GONAL-f 150 IU powder for solution for injection Follitropin alfa Subcutaneous use.
Follitropin alfa.
119 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT AMPOULE TEXT
119 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETA TA ’ AMPULLA TAS - SOLVENT
1 ml/ amp.
1ml/ amp.
120 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 VIAL
120 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ AMPULLA WAĦDA U AMPULLA WAĦDA
GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection.
GONAL- f 75 IU, (5. 5 mikrogrammi) trab u solvent għal soluzzjoni għall- injezzjoni.
One vial of powder contains 6 micrograms of follitropin alfa in order to deliver 5.5 micrograms, equivalent to 75 IU.
Ampulla waħda ta ’ trab fiha 6 mikrogrammi follitropin alfa bl- għan li tagħti 5. 5 mikrogrammi ekwivalenti għal 75 IU..
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi: sukrozju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju aċidu phosphoric, ikkonċentrat u sodju hydroxide.
One vial of solvent contains:
Ampulla waħda ta ’ solvent fiha:
1 vial of powder for solution for injection.
Ampulla waħda ta ’ trab għas- soluzzjoni għall- injezzjoni.
1 vial of solvent.
Ampulla waħda ta ’ solvent.
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA’ KIF JINĦAŻEN
122 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 5, 10 VIALS AND 1, 5, 10 PRE-FILLED SYRINGES
122 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 1, 5, 10 AMPULLI U 1, 5, 10 SIRINGI MIMLIJIEN GĦAL- LEST
One vial of powder contains 6 micrograms of follitropin alfa in order to deliver 5.5 micrograms, equivalent to 75 IU.
Ampulla waħda ta ’ trab fiha 6 mikrogrammi follitropin alfa bl- għan li tagħti 5. 5 mikrogrammi ekwivalenti għal 75 IU.
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi: sukrozju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, polisorbat 20, aċidu phosphoric ikkonċentrat u sodju hydroxide.
One pre-filled syringe of solvent contains:
Ampulla waħda ta ’ solvent fiha:
1 pre-filled syringe of solvent.
Ampulla waħda ta ’ solvent.
5 vials of powder for solution for injection.
5 ampulli ta ’ trab għas- soluzzjoni għall- injezzjoni.
5 pre-filled syringes of solvent.
5 ampulli ta ’ solvent.
10 vials of powder for solution for injection.
10 ampulli ta ’ trab għas- soluzzjoni għall- injezzjoni.
10 pre-filled syringes of solvent.
10 ampulli ta ’ solvent.
124 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 75 IU (5.5 MICROGRAMS) VIAL LABEL
124 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ L- AMPULLA GONAL- f 75 IU (5. 5 MIKROGRAMMI)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN JINGĦATA
GONAL-f 75 IU (5.5 µg) powder for solution for injection Follitropin alfa Subcutaneous use.
Follitropin alfa.
75 IU (5.5 µg)/ vial
75 IU (5. 5 µg) / amp.
125 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL
125 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ L- AMPULLA TAS- SOLVENT
Water for Injections Solvent for use with GONAL-f
Ilma għall- injezzjonijiet Solvent għall- użu ma ’ GONAL- f
1 ml/ vial
1 ml/ amp.
126 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE
126 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SOLVENT PINNA MIMLIJA GĦAL- LEST
1 ml/ pre-filled syringe
1 ml/ pinna mimlija lesta.
127 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
127 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ FJALA 1 U PINNA MIMLIJA GĦAL- LEST WAĦDA
GONAL-f 150 IU (11 micrograms) powder and solvent for solution for injection.
GONAL- f 150 IU (11 mikrogrammi), trab u solvent għal soluzzjoni għall- injezzjoni.
One vial of powder contains 12 micrograms of follitropin alfa in order to deliver 11 micrograms, equivalent to 150 IU.
Ampulla waħda ta ’ trab fiha 12 mikrogrammi ta ’ follitropin alfa bl- għan li tagħti 11 mikrogrammi, ekwivalenti għal 150 IU.
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi: sukrozju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, aċidu phosphoric ikkonċentrat u sodju hydroxide.
1 ml water for injections
1 ml ilma għall- injezzjonijiet
1 vial of powder for solution for injection.
Fjala ta ’ trab għas- soluzzjoni għall- injezzjoni.
1 pre-filled syringe of solvent.
Siringa mimlija għal- lest ta ’ solvent.
SPECIAL STORAGE CONDITIONS
Kundizzjonijiet SPEĊJALI TA ’ KIF JINĦAŻEN
129 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 150 IU (11 MICROGRAMS) VIAL LABEL
129 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT Ż- ŻGĦAR EWLENIN GONAL- F 150 IU (11 MIKROGRAMMI) TIKKETTA TAL- FJALA
GONAL-f 150 IU (11 µg) powder for solution for injection Follitropin alfa Subcutaneous use.
Follitropin alfa.
150 IU (11 µg)/ vial
150 IU (11 µg) / fjala
130 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE
130 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ SIRINGA MIMLIJA LESTA BIS- SOLvent
1 ml/ pre-filled syringe
1 ml/ siringa mimlija għal- lest
131 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
131 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA ta ’ FJALA 1 u SIRINGA MIMLIJA LESTA
One vial of powder contains 3 micrograms of follitropin alfa in order to deliver 2.8 micrograms, equivalent to 37.5 IU.
Ampulla waħda ta ’ trab tinkludi 3 mikrogrammi ta ’ follitropin alfa bl- għan li tagħti 2. 8 il - mikrogramma, ekwivalenti għal 37. 5 IU.
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi: sukrozju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, metjonina, polisorbat 20, aċidu phosphoric ikkonċentrat u sodju hydroxide.
1 ml water for injections
1 ml ilma għall- Injezzjonijiet
1 vial of powder for solution for injection.
Fjala 1 ta ’ trab għas- soluzzjoni għall- injezzjoni.
1 pre-filled syringe of solvent.
Siringa mimlija lesta.
133 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 37.5 IU (2.8 MICROGRAMS) VIAL LABEL
5 IU (2. 8 MIKROGRAMMI)
GONAL-f 37.5 IU (2.8 µg) powder for solution for injection Follitropin alfa Subcutaneous use.
Użu għal taħt il- ġilda.
37.5 IU (2.8 µg)/ vial
37. 5 IU (2. 8 µg) / ampulla
134 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE
134 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ SIRINGA MIMLIJA LESTA BIS- SOLvent
1 ml/ pre-filled syringe
1 ml/ siringa mimlija lesta.
135 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
135 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ FJALA WAĦDA U SIRINGA MIMLIJA LESTA
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) powder and solvent for solution for injection.
GONAL- f 150 IU/ 1. 75ml (77 mikrogrammi / 1. 75ml),, trab u solvent għal soluzzjoni għall - injezzjoni.
One multidose vial of powder contains: follitropin alfa 1200 IU/ 2 ml.
Fjala waħda ta ’ trab b’ ħafna dosi tinkludi: follitropin alfa 1200 IU / 2ml.
Net content per vial:
Contenut nett ta ’ fjala:
1050 IU.
1050 IU
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi: sukrozju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, aċidu phosphoric ikkonċentrat u sodju hydroxide.
2 ml water for injections, benzyl alcohol 0.9%.
2 ml ilma għall- Injezzjonijiet, benzyl alcohol 0. 9%.
1 pre-filled syringe of solvent.
Siringa mimlija lesta ta ’ solvent.
15 disposable syringes for administration graduated in FSH units.
15- il siringi disposabil għall- amministrazzjoni bil- gradazzjonijiet ta ’ uniti ta ’ FSH.
For multiple injections only.
Għall- injezzjonijiet multipli biss.