qanastek/EMEA-V3 huggingface dataset:
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
Sukrożju Fosfat mono- idrat tas- sodju di- idroġinat Fosfat di- idrat tad- di- sodju Aċidu phosphoric, ikkonċentrat Sodju hydroxide
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ 6. 6.
For immediate and single use following first opening and reconstitution.
Għall- użu immedjat u ta ’ darba wara li jintfetaħ u jitħallat.
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall - ħażna
6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fihh
The powder is packaged in 3 ml neutral colourless glass (type I) ampoules.
It- trab hu ppakkjat f’ ampulli tal- ħġieġ (tip I) newtrali u mingħajr kulur ta ’ 3 ml.
The solvent is packaged in 3 ml neutral colourless glass type I ampoules.
Is- solvent hu ppakkjat f’ ampulli tal- ħġieġ tat- tip I newtrali u mingħajr kulur ta ’ 3 ml.
The product is supplied in packs of 1, 5, 10 ampoules with the corresponding number of solvent ampoules.
Il- prodott jiġi f’ pakketti ta ’ 1, 3, 5, u 10 ampulli bin- numru korrispondenti ta ’ ampulli tas- solvent.
For single use only.
Għandu jintuża darba biss.
GONAL-f must be reconstituted with the solvent before use.
GONAL- f għandu jiġi rikostitwit mas- solvent qabel ma jintuża.
GONAL-f may be co-reconstituted with lutropin alfa and co-administered as a single injection.
GONAL- f jista ’ jiġi rikostitwit ukoll ma ’ lutropin alfa u jingħataw flimkien bħala injezzjoni waħda.
In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
F’ dan il- każ, lutropin alfa għandu jiġi rikostwit l- ewwel u wara jintuża biex jiġi rikostitwit it- trab tal - GONAL- f.
The reconstituted solution should not be administered if it contains particles or is not clear.
Is- soluzzjoni rikostitwita m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
10 Any unused product or waste material should be disposed of in accordance with local requirements.
Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
56 Marsh Wall London E14 9TP United Kingdom
56 Marsh Wall London E14 9TP Renju Unit
EU/ 1/ 95/ 001/ 001 EU/ 1/ 95/ 001/ 003 EU/ 1/ 95/ 001/ 004
EU/ 1/ 95/ 001/ 009 EU/ 1/ 95/ 001/ 012
20 October 1995.
20 Ottubru 1995.
Date of last renewal:
Data ta ’ l- aħħar irrinnovament:
19 October 2005.
19 Ottubru 2005.
GONAL-f 150 IU powder and solvent for solution for injection.
GONAL- f 150 IU, trab u solvent għal soluzzjoni għall- injezzjoni.
One ampoule contains 150 IU follitropin alfa, recombinant human follicle stimulating hormone (FSH).
Ampulla waħda fiha 150 IU follitropin alfa, ormon uman rikombinanti li jistimula l- follikuli (FSH).
The reconstituted solution contains 150 IU/ ml.
Is - soluzzjoni rikostitwita fiha 150 IU/ ml.
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.
The pH of the reconstituted solution is 6.5 - 7.5.
Il pH tas- soluzzjoni rrikostitut huwa 6. 5 - 7. 5.
12 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.
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.
12 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.
13 Women with anovulation resulting from severe LH and FSH deficiency:
Nisa li ma jovulawx minħabba nuqqas qawwi ta ’ LH u FSH
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
13 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
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 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.
In men: • primary testicular insufficiency
F’ irġiel: b’ insuffiċenzja testikolari primarja
14 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
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 14 jew idealment flimkien mat- tkejjil tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
15 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.
Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.
Rarament ħafna, każ sever ta ’ OHSS jista ’ jkun ikkomplekat minn embolismu polmonari, puplesija iskimika u infart miokardijaku.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
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
Tqala ektopika
16 Reproductive system neoplasms
Neoplażmi fis- sistema riproduttiva
Thromboembolic events
16 Effetti tromboemboliċi
Use during lactation
Użu waqt it- treddigħ
17 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Treatment in women Immune system disorders
17 Kura fin- nisa Disturbi fis- sistema immuni
Treatment in men Skin and subcutaneous tissue disorders
Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
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 sezzjoni 4. 4.
GONAL-f is a preparation of follicle stimulating hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
18 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.
Following intravenous administration, GONAL-f 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.
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.
19 Solvent:
Solvent:
6.2 Incompatibilities
19 6. 2 Inkompatibilitajiet
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ 6. 6
6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għal ħażna
The product is supplied in packs of 1, 10 ampoules with the corresponding number of solvent ampoules.
Il- prodott jiġi f’ pakketti ta ’ 1, 3, 5, u 10 ampulli bin- numru korrispondenti ta ’ ampulli tas- solvent.
The reconstituted solution should not be administered if it contains particles or is not clear.
It- soluzzjoni rikostitwita m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
EU/ 1/ 95/ 001/ 009 EU/ 1/ 95/ 001/ 012
EU/ 1/ 95/ 001/ 009 EU/ 1/ 95/ 001/ 010 EU/ 1/ 95/ 001/ 011 EU/ 1/ 95/ 001/ 012
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 contains 6 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 5.5 micrograms, equivalent to 75 IU.
Fjala waħda fiha 6 mikrogrammi follitropin alfa, ormon uman rikombinanti li jistimula l- follikolu (FSH) bl- għan li jagħti 5. 5 mikrogrammi, li huma ekwivalenti għal 75 IU.
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, 0.1 mg methionine, 0.05 mg polysorbate 20.
30 mg sukrozju, 1. 11mg fosfat di- idrat tad- di- sodju, 0. 45mg fosfat mono- idrat tas- sodju di- idroġinat, 0. 1mg metjonina, 0. 05mg Polisorbat 20
In order to avoid the injection of large volumes, up to 3 vials 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.
22 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
22 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 totali aktar baxxa u perijodu ta ’ kura iqsar biex jinkisbu l- kundizzjonijiet ta ’ qabel l- ovulazzjoni.
A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 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.
23 Women with anovulation resulting from severe LH and FSH deficiency:
Nisa li ma jovulawx minħabba nuqqas qawwi ta ’ LH u FSH
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
23 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments.
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.
24 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
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 24 jew idealment flimkien mat- tkejjil tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
25 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.
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 ’).
26 Reproductive system neoplasms
Neoplażmi fis- sistema riproduttiva
Thromboembolic events
26 Effetti tromboemboliċi
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotrophins.
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 hFSH.
Fil- każ ta ’ espożizzjoni waqt it- tqala, ma teżistix biżżejjed informazzjoni klinika biex ikun eskluż xi effett teratoġeniku tal- FSH rikombinanti.
27 Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
L- effetti li huma l- aktar serji għandhom jitniżżlu l- ewwel, segwiti minn dawk anqas serji.
Treatment in women Immune system disorders
Kura fin- nisa Disturbi fis- sistema immuni
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.
GONAL-f is a preparation of follicle stimulating hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
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 men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
28 F’ irġiel b’ nuqqas ta ’ FSH, l- għoti konkomitanti ta ’ GONAL- f ma ’ hCG għal mill- anqas erba ’ xhur jinduċi l- ispermatoġeneżi.
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.
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Methionine Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide
Sukrożju Fosfat mono- idrat tas- sodju di- idroġinat Fosfat di- idrat tad- di- sodju Aċidu phosphoric, ikkonċentrat Sodju hydroxide
6.4 Special precautions for storage
29 6. 4 Prekawzjonijiet speċjali għal ħażna
GONAL-f is presented as a powder and solvent for injection.
GONAL- f jiġi bħala trab u solvent għall- injezzjoni.
The solvent for reconstitution is presented in either 2 or 3 ml vials (Type I glass) with stopper (teflon-coated rubber) or in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
It- trab u ppakkjat fi fjali ta ’ 3ml (tal- ħġieġ tat - tip1) b’ tapp (gomma tal- brombutil) u tapp ta’ l- aluminju li jinfetaħ b’ daqqa ta’ saba ’. Is- solvent għar - rikostituzzjoni hu ppakkjat jew fi fjali ta’ 2 jew 3 ml (tal- hġieġ tat- tip1) b’ tapp (miksi bit- teflon) jew f’ siringi mimlija lesti ta’ 1ml (tal- ħġieġ tat- tip 1) magħluqa b’ tapp tal- gomma.
Not all pack sizes may be marketed.
Il- prodott jiġi f’ pakketti ta ’ 1, 3, 5, u10 fjali b’ numru korrispondenti ta’ fjali tas- solvent jew pakketti ta ’ 1, 5 jew 10 fjali bin- numru korrispondenti ta’ siringi mimlija lesti bis- solvent. Jista ’ jkun li mhux il - pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
6.6 Special precautions for disposal
6. 6 Prekawzjonijiet specjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
GONAL-f 150 IU (11 micrograms) powder and solvent for solution for injection.
GONAL- f 150 IU (11- il mikrogramma), trab u solvent għal soluzzjoni għall- injezzjoni.
One vial contains 12 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 11 micrograms, equivalent to 150 IU.
Fjala waħda fiha 12- il mikrogramma follitropin alfa, ormon uman rikombinanti li jistimula l- follikolu (FSH) bl- għan li jagħti 5. 5 mikrogrammi, li huma ekwivalenti għal 150 IU.
The reconstituted solution contains 150 IU/ ml.
Is- soluzzjoni rikostitwita fiha 150 IU/ ml.
30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate, 0.1 mg methionine, 0.05 mg polysorbate 20.
30 mg sukrozju, 1. 11mg fosfat di- idrat tad- di- sodju, 0. 45mg fosfat mono- idrat tas- sodju di- idroġinat, 0. 1mg metjonina, 0. 05mg Polisorbat 20.
32 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
Women with anovulation resulting from severe LH and FSH deficiency:
Nisa li ma jovulawx minħabba nuqqas qawwi ta ’ LH u FSH
33 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.
32 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
34 In men: • primary testicular insufficiency
F’ irġiel: b’ insuffiċenzja testikolari primarja
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 33 jew idealment flimkien mat- tkejjil tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
35 The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
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.
Clinical evaluation may reveal hypovolaemia, 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.
36 Ectopic pregnancy
Tqala ektopika
Thromboembolic events
35 Effetti tromboemboliċi
37 No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Nervous system disorders Vascular disorders
Disturbi vaskulari
Very Common (> 1/ 10) Very rare (< 1/ 10,000)
Rari ħafna (< 1/ 10, 000)
Headache Thromboembolism, usually associated with severe OHSS
Tromboemboliżmu, ġeneralment assoċjat ma ’ OHSS severa
38 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.
In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
37 F’ irġiel b’ nuqqas ta ’ FSH, l- għoti konkomitanti ta ’ GONAL- f ma ’ hCG għal mill- anqas erba ’ xhur jinduċi l- ispermatoġeneżi.
39 Methionine Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide
Sukrożju Fosfat mono- idrat tas- sodju di- idroġinat Fosfat di- idrat tad- di- sodju Metjonina Polisorbat 20 Aċidu phosphoric, ikkonċentrat Sodju hydroxide
6.4 Special precautions for storage
38 6. 4 Prekawzjonijiet speċjali għal ħażna
The solvent for reconstitution is presented in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
It- trab u ppakkjat fi fjali ta ’ 3ml (tal- ħġieġ tat - tip1) b’ tapp (gomma tal- brombutil) u tapp ta’ l- aluminju li jinfetaħ b’ daqqa ta’ saba ’. Is- solvent għar - rikostituzzjoni hu ppakkjat jew fi fjali ta’ 2 jew 3 ml (tal- hġieġ tat- tip1) b’ tapp (miksi bit- teflon) jew f’ siringi mimlija lesti ta’ 1ml (tal- ħġieġ tat- tip 1) magħluqa b’ tapp tal- gomma.
GONAL-f 37.5 IU (2.8 micrograms) powder and solvent for solution for injection.
GONAL- f 37. 5 IU (2. 8 mikrogrammi), trab u solvent għal soluzzjoni għall- injezzjoni.
One vial contains 3 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 2.8 micrograms, equivalent to 37.5 IU.
Fjala waħda fiha 3 mikrogramma follitropin alfa, ormon uman rikombinanti li jistimula l- follikolu (FSH) bl- għan li jagħti 2. 8 mikrogrammi, li huma ekwivalenti għal 37. 5 IU.
The reconstituted solution contains 37.5 IU/ ml.
Is- soluzzjoni rikostitwita fiha 37. 5 IU/ ml.
The pH of the reconstituted solution is 6.5 - 7.5.
Il- pH tas- soluzzjoni rrikostitut huwa 6. 5 - 7. 5.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
• 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.
Up to three vials 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.
42 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.
43 Women with anovulation resulting from severe LH and FSH deficiency:
Nisa li ma jovulawx minħabba nuqqas qawwi ta ’ LH u FSH
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
41 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
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 and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
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 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.
44 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
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 42 jew idealment flimkien mat- tkejjil tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
45 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.
46 Reproductive system neoplasms
Neoplażmi fis- sistema riproduttiva
Thromboembolic events
44 Effetti tromboemboliċi
47 4.8 Undesirable effects
4. 8 Effetti mhux mixtieqa
Very rare (< 1/ 10,000)
Rari ħafna (≤1/ 10, 000)
Nervous system disorders Vascular disorders
Disturbi fis- sistema nervuża
Very Common (> 1/ 10) Very rare (< 1/ 10,000)
Komuni ħafna (≥1/ 10)
Common (> 1/ 100, < 1/ 10)
Komuni (≥1/ 100 sa < 1/ 10)
Very Common (> 1/ 10)
Komuni ħafna (≥1/ 10)
In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
46 F’ irġiel b’ nuqqas ta ’ FSH, l- għoti konkomitanti ta ’ GONAL- f ma ’ hCG għal mill- anqas erba ’ xhur jinduċi l- ispermatoġeneżi.
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Methionine Polysorbate 20 Phosphoric acid, concentrated
Sukrożju Fosfat mono- idrat tas- sodju di- idroġinat Fosfat di- idrat tad- di- sodju Metjonina Polisorbat 20 Aċidu phosphoric, ikkonċentrat Sodju hydroxide
6.4 Special precautions for storage
47 6. 4 Prekawzjonijiet speċjali għall- ħażna
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) powder and solvent for solution for injection.
GONAL- f 1050 IU/ 1. 75 ml (77 mikrorogrammi/ 1. 75 ml), trab u solvent għal soluzzjoni għall - injezzjoni.
One multidose vial contains 87 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 77 micrograms, equivalent to 1050 IU.
Fjala waħda b’ ħafna dożi fiha 87 mikrogrammi follitropin alfa, ormon uman rikombinanti li jistimula l- follikoli (FSH) bl- għan li jagħti 77 mikrogramma, li huma ekwivalenti għal 1050 IU.
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
Powder and solvent for solution for injection in a pre-filled syringe.
Trab u solvent għal soluzzjoni għall- injezzjoni f’ siringa mimlija lesta.
The pH of the reconstituted solution is 6.5 – 7.5.
Il- pH tas- soluzzjoni rrikostitut huwa 6. 5 - 7. 5.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) preparation must not be reconstituted with any other GONAL-f container.
It- trab għandu jithallat mas- solvent provdut eżattament qabel ma ’ jintuża. Is- sustanza ta’ GONAL- f 1050/ 1. 75ml( 77 mikrogrammi/ 1. 75ml) m’ għandux jitħallat ma ’ l- ebda kontenitur ieħor ta’ GONAL- f.
52 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
Id- dożi rrakkomandati għall- 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, metodi ta ’ teħid u osservazzjoni tal- proċeduri tal- kura m’ għandhomx ikunu differenti minn dawk mogħtija preżentement fl- użu ta ’ preparati li jinkludu FSH
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 komparattiv bejn GONAL- f u FSH urinarja, instab li GONAL- f kien aktar effettiv mill- FSH urinarja permezz ta ’ doża totali aktar baxxa u perijodu ta ’ kura iqsar biex jinkisbu l- kundizzjonijiet ta ’ qabel l- ovulazzjoni.
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
Deher li kien hemm effett simili meta ttieħdu dożi ekwivalenti tas- sustanza ta ’ doża waħda u tas- sustanza ta ’ ħafna dożi ta ’ GONAL- f.
It is advised to adhere to the recommended starting doses indicated below.
Hu rakkomandat li jkunu osservati d- dożi indikati hawn isfel.
53 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).
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 -
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
GONAL- f għandu jingħata bħala kors ta ’ injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
54 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
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 51 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 with 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 multidose presentation.
Waqt li l- pażjent ikun qed jiġi mħarreġ dwar kif għandu jieħu l - injezzjoni, attenzjoni speċjali għandha tingħata għal struzzjonijiet speċifiċi għall- użu ta ’ sustanzi( a) b’ ħafna dożi u / jew b’ doża waħda.
The first injection of GONAL-f should be performed under direct medical supervision.
Minħabba r- reazzjoni lokali għal benzyl alcohol, m’ għandux jintuża l- istess sit ta ’ injezzjoni fil- ġranet konsekuttivi L- ewwel injezzjoni ta ’ GONAL- f għandha tittieħed taħt superviżjoni medika diretta.
55 Ovarian Hyperstimulation Syndrome (OHSS)
Sindromu ta ’ Iperstimulazzjoni ta ’ l- Ovarji (OHSS)
The following symptomatology may be observed in severe cases of OHSS: abdominal pain, abdominal distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
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.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
52 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 aktar minn 3 follikuli ta ’ dijametru ta ’ 14 mm jew akbar.
56 Pregnancy wastage
Tqala mitlufa
Congenital malformation
53 Malformazzjoni konġenitali
Thromboembolic events
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.
57 Use during lactation
Użu waqt it- treddigħ
Treatment in women Immune system disorders
54 Kura fin- nisa Disturbi fis- sistema immuni
58 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.
55 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.
59 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.
Water for Injections Benzyl alcohol
Ilma għall- injezzjonijiet Benzyl alcohol
6.2 Incompatibilities
56 6. 2 Inkompatibilitajiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minhabba li ma sarux studji li juru liema huma l- prodotti li ma jaqblux miegħu, dan il- prodott mediċinali m’ għandux jiġi mħallat ma ’ prodotti mediċinali oħrajn.
The reconstituted solution is stable for 28 days.
It- taħlita rikostitwita tibqa ’ stabbli għal 28 ġurnata.
6.4 Special precautions for storage
6. 4 Tagħrif speċjali dwar kif għandu jinħażen
Prior to reconstitution, do not store above 25°C.
Qabel ma ’ tħalltu, taħżinx f’ temperatura ‘ l fuq minn 25°C.
After reconstitution, do not store above 25ºC.
Wara li jiġi rikostitwit, taħżinx f’ temperatura ‘ l fuq minn 25°C.
Store in the original container.
Aħżen fil- pakkett oriġinali.
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 solvent for reconstitution is presented in 2 ml pre-filled syringes (Type I glass) with a rubber stopper.
Is - solvent għas- soluzzjoni hu ppakjat f’ siringi mimlijin lesti ta ’ 2 ml (tal- ħġieġ tat- tip I) magħluqa b’ tapp tal- gomma.
The administration syringes made of polypropylene with a stainless steel pre-fixed needle are also provided.
Huma provduti wkoll siringi għall- injezzjoni magħmlula mill- polypropylene b’ labra mwaħħla lesta magħmula minn azzar li ma jissadadx.
The product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 15 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 15- il siringa għall- użu ta’ darba biss, gradwati f’ unitajiet ta’ FSH, għall- injezzjoni.
60 6.6 Special precautions for disposal
6. 6 Tagħrif għall- użu, maniġġar u għar- rimi
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) must be reconstituted with the 2 ml solvent provided before use.
GONAL- f 1050 IU/ 1. 75 ml (77 mikrogrammi/ 1. 75 ml) għandu jiġi rikostitwit ma ’ 2 ml solvent provdut qabel ma jintuża.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) preparation must not be reconstituted with any other GONAL-f containers.
Il- preparat ta ’ GONAL- f 1050 IU/ 1. 75 ml (77 mikrogrammi/ 1. 75 ml) m’ għandux jiġi rikostitwit ma ’ kontenituri oħra ta ’ GONAL- f.
The solvent pre-filled syringe provided should be used for reconstitution only and then disposed of in accordance with local requirements.
Is- siringa provduta mimlija lesta bis- solvent għandha tintuża għar- rikostituzzjoni biss u mbagħad tintrema skond kif jitolbu l- liġijiet lokali.
A set of administration syringes graduated in FSH units is supplied in the GONAL-f Multidose box.
Sett ta ’ siringi għall- injezzjoni gradwati f’ unitajiet ta ’ FSH huma provduti fil- kaxxa ta ’ GONAL- f b’ ħafna dożi.
Alternatively, a 1 ml syringe, graduated in ml, with pre-fixed needle for subcutaneous administration could be used.
Inkella, tista ’ tintuża siringa ta ’ 1 ml, b’ gradwazjoniet ta’ ml, b’ labra mwaħħla lesta għall- injezzjoni minn taħt il- ġilda.
Each ml of reconstituted solution contains 600 IU r-hFSH.
Kull ml ta ’ soluzzjoni rikostitwita fiha 600 IU r- hFSH.
The following table states the volume to be administered to deliver the prescribed dose:
Din it- tabella segwenti tiddefinixxi l- volum li jrid jiġi amministrat biex id- doża preskritta tiġi mgħotija:
be injected (ml) 0.13 0.25 0.38 0.50 0.63 0.75
0. 13 0. 25 0. 38 0. 50 0. 63 0. 75
Individual reconstituted vials should be for single patient use only.
Fjali individwali rikostitwiti għandhom jintużaw fuq pazjent wieħed biss.
The next injection should be done at the same time the next day.
L- injezzjoni li jmiss għandha ssir fl- istess ħin tal- ġurnata ta ’ wara.
Any unused product or waste material should be disposed of in accordance with local requirements.
57 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) powder and solvent for solution for injection.
GONAL- f 450 IU/ 0. 75 ml (33 mikrorogrammi/ 0. 75 ml), trab u solvent għal soluzzjoni għall - injezzjoni.
One multidose vial contains 44 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 33 micrograms, equivalent to 450 IU.
Fjala waħda b’ ħafna dożi fiha 44 mikrogrammi follitropin alfa, ormon uman rikombinanti li jistimula l- follikolu (FSH) bl- għan li jagħti 33 mikrogramma, ekwivalenti għal 450 IU.
Follitropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Follitropin alfa jiġi prodott fiċ- ċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) preparation must not be reconstituted with any other GONAL-f containers.
It- trab għandu jitħallat mas- solvent provdut eżattament qabel ma’ jintuża. Il- preparat ta’ Gonal- f 450 IU/ 0. 75ml (33 mikrogrammi/ 0. 75ml) m’ għandux jitħallat ma’ l- ebda kontenitur ieħor ta ’ GONAL- f.
62 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.
Bioequivalence has been demonstrated between equivalent doses of the monodose presentation and the multidose presentation of GONAL-f.
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 totali aktar baxxa u perijodu ta ’ kura iqsar biex jinkisbu l- kundizzjonijiet ta ’ qabel l- ovulazzjoni.
63 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.
60 injezzjonijiet ta’ kuljum simultanjament ma ’ lutropin alfa.
64 4.4 Special warnings and precautions for use
4. 4 Twissijiet speċjali u prekawzjonijiet speċjali għall- użu
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 61 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.
65 Ovarian Hyperstimulation Syndrome (OHSS)
Sindromu ta ’ Iperstimulazzjoni ta ’ l- Ovarji (OHSS)
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.
62 multipla jiżdied meta l- ammont ta 'estradajol fis- serum ikun > 900 pg/ ml (3300 pmol/ l) u jkun hemm aktar minn 3 follikuli ta ’ dijametru ta ’ 14 mm jew akbar.
66 Pregnancy wastage
Tqala mitlufa
Thromboembolic events
63 Effetti tromboemboliċi
67 Use during lactation
Użu waqt it- treddigħ
Treatment in women Immune system disorders
64 Kura fin- nisa Disturbi fis- sistema immuni
68 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.
65 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.
69 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.
6.2 Incompatibilities
66 6. 2 Inkompatibilitajiet
Prior to reconstitution, do not store above 25°C.
Qabel ma ’ tħalltu, taħżinx f’ temperatura ‘ l- fuq minn 25°C.
After reconstitution, do not store above 25°C.
Wara li jiġi rikostitwit, taħżinx f’ temperatura ‘ l- fuq minn 25°C.
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’ seba ’.
The solvent for reconstitution is presented in 1 ml pre-filled syringes (Type I glass) with a rubber stopper.
Is - solvent għas- soluzzjoni hu ppakjat f’ siringi mimlijin lesti ta ’ 2 ml (tal- ħġieġ tat- tip I) magħluqa b’ tapp tal- gomma.
The Administration syringes made of polypropylene with a stainless steel pre-fixed needle are also provided.
Huma provduti wkoll siringi għall- injezzjoni magħmlula mill- polypropylene b’ labra mwaħħla lesta magħmula minn azzar li ma jissadadx.
The product is supplied as a pack of 1 vial of powder with 1 pre-filled syringe of solvent for reconstitution and 6 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 6 siringi għall- użu ta’ darba biss, gradwati f’ unitajiet ta’ FSH, għall- injezzjoni
70 6.6 Special precautions for disposal
6. 6 Prekawzjonijiet specjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) must be reconstituted with the 1 ml solvent provided before use.
GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml) għandu jiġi rikostitwit ma ’ 1 ml solvent provdut qabel ma jintuża.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) preparation must not be reconstituted with any other GONAL-f containers.
Il- preparat ta ’ GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 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.
Alternatively, a 1 ml syringe, graduated in ml, with pre-fixed needle for subcutaneous administration could be used.
Inkella, tista ’ tintuża siringa ta ’ 1 ml, b’ gradwazjoniet ta’ ml, b’ labra mwaħħla lesta għall- amministrazzjoni minn taħt il- ġilda.
The reconstituted solution should not be administered if it contains particles or is not clear.
Is- soluzzjoni rikostitwita m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara
Any unused product or waste material should be disposed of in accordance with local requirements.
67 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
MARKETING AUTHORISATION NUMBER
NUMRI TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
71 1.
68 1.
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) powder and solvent for solution for injection.
GONAL- f 300 IU/ 0. 50 ml (22 mikrogrammi/ 0. 50 ml), trab u solvent għal soluzzjoni għall- injezzjoni.
One multidose vial contains 33 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 22 micrograms, equivalent to 300 IU.
Fjala waħda b’ ħafna dożi fiha 33 mikrogrammi follitropin alfa, ormon uman rikombinanti li jistimula l- follikolu (FSH) bl- għan li jagħti 22- il mikrogramma, li huma ekwivalenti għal 300 IU.
Follitropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Follitropin alfa jiġi maghmul fiċ- ċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
GONAL-f is intended for subcutaneous administration.
GONAL- f jingħata permezz ta ’ injezzjoni minn taħt il- ġilda.
The powder should be reconstituted prior to the first use with the solvent provided.
It- trab għandu jitħallat mas- solvent provdut eżattament 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.
Is- sustanza ta ’ GONAL- f 300IU/ 0. 50ml (22 mikrogrammi/ 0. 50 ml) m’ għandux jitħallat ma ’ l- ebda kontenitur ieħor ta ’ GONAL- f.