qanastek/EMEA-V3 huggingface dataset:
The next injection should be done at the same time the next day.
L- injezzjonijiet oħra jridu jsiru fl- istess ħin tal- ġurnata ta ’ qabel.
Your doctor has prescribed you a dose of GONAL-f in IU.
It- tabib tiegħek ippreskrivilek dosa ta ’ GONAL- f f’ IU.
You should use one of the 6 administration syringes graduated in FSH units provided.
Uża waħda miss- 6 siringa pproveduti bil- gradi ta ’ FSH.
Find a clean area and lay out everything (two alcohol swabs, the 1 ml solvent pre-filled syringe, the vial containing GONAL-f and a syringe for administration).
Iġbor u ifrex kull m’ għandek bżonn fuq bank nadif (żewġ ċraret bl- alkoħol, is- siringa mimlija lesta b’ 2ml ta ’ solvent, l- ampulla ta ’ GONAL- f u siringa għal amministrazzjoni).
230 See illustration.
Ara l- istampa.
Prepare the injection solution:
Ipprepara s- soluzzjoni għall- injezzjoni:
You should have a 1 ml pre-filled syringe containing clear liquid (the solvent) and one vial containing GONAL-f (the white powder).
Irid ikollok sirina mimlija lesta li fiha likwidu ċar (is - solvent) u ampulla b ’ GONAL- f (it- trab abjad).
Remove the protective caps from the GONAL-f vial and from the solvent pre-filled syringe.
Neħħi t- tappijiet ta ’ l- ampulla ta ’ GONAL- f u
Pick up your pre-filled syringe of solvent and slowly inject all the solvent (1 ml) into the vial of GONAL-f powder.
227 tas- siringa mimlija lesta. Hu s- siringa mimlija lesta tas - solvent u bil- mod injetta s- solvent fl- ampulla tat- trab GONAL- f.
Take the syringe for administration, fill it with air to the correct dose.
(Hu s- siringa għall- amministrazzjoni, u imlija bl- arja sad- dosa tajba.
Shake gently the vial of GONAL-f with the solvent.
Bil- mod, ċaqlaq l- ampulla ta ’ GONAL- f ma ’ lis- solvent.
Insert the needle into the vial, turn the vial upside down, inject the air in the vial and draw the prescribed dose of GONAL-f into the syringe for administration.
Waħħal il- labra fl- ampulla, dawwar l- ampulla taħt fuq, injetta l- arja fl- ampulla u iġbed id- dosa preskritta ta ’ GONAL- f fis- siringa għall - amministrazzjoni
If you see air bubbles in the syringe, hold the syringe with the needle pointing upwards and gently flick the syringe until all the air collects at the top.
Neħħi l - bżieżaq ta ’ l- arja: jekk tara bżieżaq ta ’ arja fis- siringa, żomm is- siringa bil- labra tipponta ’ l fuq, u bil- mod taptap fuq s- siringa sakemm l- arja kollha tinġabar fuq.
Inject the solution:
Injetta s- soluzzjoni immedjatament:
Once you have finished your injection, immediately discard the syringes used safely, preferably in a sharp container.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi l- labar u il - kontenituri vojta tal- ħġieġ kollha fil- kontenitur provdut.
4.
228 4.
232 If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk tinduna b' xi effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok avża lit- tabib jew lill - ispiżjar tiegħek.
Prior to reconstitution, do not store above 25°C.
Qabel ir- rikostituzzjoni, taħżinx f’ temperatura ‘ l fuq minn 25°C.
Once the medicine is reconstituted (made up with the solvent), do not store above 25°C.
229 Taħżinx ss- soluzzjoni rikostitwita (magħmula mas- solvent) f’ temperatura ‘ l fuq minn 25°C.
The active substance is follitropin alfa, 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml).
Is- sustanza attiva hi follitropin alfa, 450 IU/ 0. 75ml (33 mikrogrammi/ 0. 75ml).
The solvent contains water for injections and benzyl alcohol 0.9%.
Is- solvent hija ilma għall- injezzjoni u benzyl alcohol 0. 9%.
It is supplied in packs of 1 vial of powder with 1 pre-filled syringe of solvent and 6 disposable syringes for administration graduated in FSH units.
Il- prodott jiġi f’ pakketti ta ’ ampulla waħda ta ’ trab u siringa mimlija lesta ta ’ solvent, u 6 labar disposabil għal amministrazzjoni, b’ gradi ta ’ FSH.
One multidose vial of powder contains 600 IU of follitropin alfa and one pre-filled syringe contains 1 ml of solvent.
Ampulla waħda b’ ħafna dosi ta ’ trab fiha 600 IU ta ’ follitropin alfa u siringa mimlija lesta ta ’ solvent fiha 1ml ta ’ ilma għall- injezzjoni.
233 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.
234 Eesti Österreich Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel: +370 37320603
Eesti Österreich Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kaunas, Leedu Tel: +370 37320603
France Merck Lipha Santé s. a. s.
231 France Merck Lipha Santé s. a. s.
236 PACKAGE LEAFLET:
232 FULJETT TA ’ TAGĦRIF:
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) powder and solvent for solution for injection Follitropin alfa
GONAL- f 300 IU/ 0. 50ml (22 mikrogrammi/ 0. 50ml) trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa
How to use GONAL-f 4.
Kif tuża GONAL- f 4.
237 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
If you are a woman:
233 Jekk int mara:
238 Using other medicines
Użu ta ’ mediċini oħra:
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) should not be mixed with other medicines in the same injection.
GONAL- f 300 IU/ 0. 50 ml (22 mikrogrammi/ 0. 50 ml) mhux suppost jitħallat ma ’ mediċinali oħra fl - istess injezzjoni.
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
GONAL- f 300 IU/ 0. 50 ml (22 mikrogrammi/ 0. 50 ml) mhux suppost jitħallat ma ’ preparazzjonijiet oħra ta ’ GONAL- f fl- istess ampulla jew siringa.
Pregnancy and breast-feeding
234 Tqala u treddigħ:
239 In other cases, down-regulation with a gonadotrophin-releasing hormone (GnRH) agonist is used.
F’ każi oħra, ikun hemm down- regulation permezz ta ’ agonista ta ’ l- ormon li jistimula s- sekrezjoni tal - gonadotrofina (GnRH).
GONAL-f is usually taken every day for up to three weeks simultaneously with injections of lutropin alfa.
235 Ġeneralment, GONAL- f jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet ta ’ lutropin alfa.
You should use one of the 4 administration syringes graduated in FSH units provided.
Uża waħda miss- 6 siringa pproveduti bil- gradi ta ’ FSH.
Find a clean area and lay out everything (two alcohol swabs, the pre-filled syringe, containing the solvent, the vial containing GONAL-f and a syringe for administration).
Iġbor u ifrex kull m’ għandek bżonn fuq bank nadif (żewġ ċraret bl- alkoħol, is- siringa mimlija lesta b’ 2ml ta ’ solvent, l- ampulla ta ’ GONAL- f u siringa għal amministrazzjoni).
240 See illustration.
Ara l- istampa.
You should have a pre-filled syringe containing clear liquid (the solvent) and one vial containing GONAL-f (the white powder).
Irid ikollok sirina mimlija lesta li fiha likwidu ċar (is - solvent) u ampulla b ’ GONAL- f (it- trab abjad).
Remove the protective caps from the GONAL-f vial and from the solvent pre- filled syringe.
Neħħi t- tappijiet ta ’ l- ampulla ta ’ GONAL- f u
Pick up your pre-filled syringe of solvent and slowly inject all the solvent (0.75 ml) into the vial of GONAL-f powder.
Hu s- siringa mimlija lesta tas - solvent u bil- mod injetta s- solvent fl- ampulla tat- trab GONAL- f.
Insert the needle into the vial, turn the vial upside down, inject the air in the vial and draw the prescribed dose of GONAL-f into the syringe for administration.
Waħħal il- labra fl - ampulla, dawwar l- ampulla taħt fuq, injetta l- arja fl - ampulla u iġbed id- dosa preskritta ta ’ GONAL- f fis - siringa għall- amministrazzjoni.
Push the plunger until the air bubbles are gone.
Bil- mod imbotta il- planġer sakemm il - bżieżaq ta ’ l- arja jitilqu.
Firmly pinch the skin together and insert the needle at a 45° to 90° angle using a dart- like motion.
Oqros il- ġilda u daħħal il- labra f’ anglu ta ’ 45° sa 90° qisek qed twaddab dart.
The reconstituted solution is for your use alone and should not be administered to other patients.
Is- soluzzjoni rrikostituta hija għall- użu tiegħek u ma tistax tagħtiha lill- pazjienti oħra. tiegħek.
4.
237 4.
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see also section 2”) can occur.
Wara li tingħata l- kura permezz ta ’ GONAL- f, meta tittieħed l- gonadotrofina korjonika umana, tista ’ sseħħ il- kundizzjoni magħrufa bħala s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (ara wkoll Oqgħod attent ħafna b’ GONAL- f).
Some men undergoing treatment with GONAL-f may experience local reactions at the injection site (pain,
Xi irġiel li qegħdin jieħdu din il- kura ta ’ GONAL- f jistgħu jesperjenzaw reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (uġigħ, ħmura, tbenġil, nefħa u/ jew irritazzjoni) jew jizviluppaw varicocele (nefħa tal- vini fuq u wara t- testikolu.
Do not use GONAL-f if you notice any visible signs of deterioration.
238 M’ għandekx tuża GONAL- f jekk tara xi sinjali viżibbli ta ’ deterjorazzjoni.
The active substance is follitropin alfa, 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml).
Is- sustanza attiva hi follitropin alfa, 300 IU/ 0. 50ml (22 mikrogrammi/ 0. 50ml).
It is supplied in packs of 1 vial of powder with 1 pre-filled syringe of solvent and 4 disposable syringes for administration graduated in FSH units.
Il- prodott jiġi f’ pakketti ta ’ ampulla waħda ta ’ trab u siringa mimlija lesta ta ’ solvent, u 4 labar disposabil għal amministrazzjoni, b’ gradi ta ’ FSH.
One multidose vial of powder contains 450 IU of follitropin alfa and one pre-filled syringe contains 0.75 ml of solvent.
Ampulla waħda ta ’ trab fiha 450 IU ta ’ follitropin alfa u siringa mimlija lesta ta ’ solvent fiha 0. 75ml ta ’ ilma għall- injezzjoni.
243 Manufacturer
Il- Manifattur
Č eská republika Merck spol. s. r. o Zdě bradská 72 CZ-251 01 Ř íč any- Jaž lovice Tel. +420 323619211
239 Česká republika Merck spol. s. r. o Zděbradská 72 CZ- 251 01 Říčany - Jažlovice Tel. +420 323619211
Ísland Gróco ehf.
240 Ísland Gróco ehf.
246 PACKAGE LEAFLET:
241 FULJETT TA ’ TAGĦRIF:
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) solution for injection in a pre-filled pen Follitropin alfa
GONAL- f 300 IU/ 0. 5ml (22 mikrogrammi/ 0. 5ml) soluzzjoni għall- injezzjoni f’ pinna mimlija lesta Follitropin alfa
Read all of this leaflet carefully before you start using this medicine.
Aqra dan- il fuljett kollu qabel tibda tuża din il- mediċina. • Żomm dan il- fuljett.
- If you have any further questions, ask your doctor or pharmacist.
Jista jkollok bżonn terġa taqrah. • Jekk għandek aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew spiżjar tiegħek. • Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni oħra.
• GONAL-f can be used to cause ovulation in women who are not ovulating and who have not responded to treatment with clomiphene citrate.
Dan il- prodott mediċinali għandu jintuża biss taħt osservazzjoni mill- qrib ta ’ tabib
• GONAL-f is used together with another hormone called lutropin alfa (recombinant human luteinising hormone) to cause ovulation in women who are not ovulating due to very low production of the fertility hormones (FSH and LH) by their pituitary gland.
• F’ nisa li mhumiex jovulaw u li fuqhom il- kura bi clomiphene citrate ma kienetx effettiva, GONAL- f jista ’ jintuża biex jistimula l- ovulazzjoni. • GONAL- f jintuża biex jistimula l- iżvilupp ta ’ diversi follikuli (u għalhekk numru ta ’ bajd) f’ nisa li qed jagħmlu użu minn teknoloġija ta ’ riproduzzjoni assistita bħall- fertilazzjoni in vitro, trasferiment tal- gamete fit- tubu fallopjan jew trasferiment taż- żigot fit- tubu fallopjan. • F’ nisa li mhumiex jovulaw minħabba li jipproduċu kwantità baxxa ħafna ta ’ ormoni tal- fertilità (FSH u LH) mill- glandola pitwitarja tagħhom, GONAL- f jintuża flimkien ma ’ ormon ieħor, magħruf bħala lutropin alfa (ormon uman lutejniku rikombinanti) biex jistimula l- ovulazzjoni. • GONAL- f jintuża flimkien ma ’ mediċina oħra, l- gonadotrofina korjonika umana (hCG) biex jipproduċi l- isperma fl- irġiel, li mhumiex fertili minħabba nuqqasijiet ormonali.
247 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
• if you are allergic (hypersensitive) to follicle stimulating hormone or any of the other ingredients of GONAL-f • if you have tumours of the hypothalamus and pituitary gland
• jekk ġieli kellek xi reazzjonjiet allerġiċi għall- mediċini li fihom l- ormon li jistimula l- follikolu jew għal xi waħda mis- sustanzi mhux attivi • tumuri fl- ipotalamu u fil- glandola pitwitarja
If you are a woman:
242 Jekk int mara:
• if you have ovarian enlargement or cyst not due to polycystic ovarian disease • if you have gynaecological bleeding of unknown cause • if you have ovarian, uterine or breast cancer
• tkabbir ta’ l- ovarji jew xi ċista li mhux ikkaġunata minn mard poliċistiku ta ’ l- ovarji • emorraġija ġinekoloġika li l- kawża tagħha mhix magħrufa • kanċer fl- ovarji, utru jew fis- sider
• if you have irreversible testicular damage.
Barra minn hekk, ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
GONAL-f treatment seldom gives rise to significant OHSS unless the medicine used to induce final follicular maturation (containing human chorionic gonadotrophin - hCG) is administered.
Il- kura b’ GONAL- f, rari tagħti lok għal OHSS sinifikanti sakemm ma tingħatax l- mediċina( li fiha l- gonadotrofina korjonika umana – hCG) li tinduċi il- maturazzjoni follikulari finali.
248 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 down regulation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.
L- użu ta ’ GONAL- f fl- istess ħin ma ’ agenti oħra li jistimulaw l- ovulazzjoni (e. g. hCG, clomiphene citrate) jista ’ jizdied reazzjoni follikulari, filwaqt li l- użu ta ’ GnRH agonist jew antagonist fl- istess ħin sabiex jikkawza down regulation jista ’ jeħtieg dosa akbar ta ’ GONAL- f sabiex ikun hemm reazzjoni ovarja adeguata.
No other clinically significant drug interaction has been reported during GONAL-f therapy.
Ma hemx rapporti kliniċi ta ’ relevanza ta ’ effetti ta ’ mediċini oħra waqt kura b ’ GONAL- f.
Pregnancy and breast-feeding
243 Tqala u treddigħ:
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek tieħu Gonal- f skond il- parir tat- tabib. Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju
This may be increased by 37.5-75 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( 0. 13- 0. 25ml) FSH kuljum li tiżdied preferibbilment b’ 37. 5 IU- 75 IU kull 7 jew preferibbilment 14- il ġurnata jekk ikun meħtieġ, biex jinkiseb riżultat adegwat, iżda mhux eċċessiv.
The maximal daily dose is usually lower than 225 IU FSH (0.36 ml).
Ġeneralment, id- doża massima ta ’ kuljum ma taqbiżx il- 225 IU( 0. 38ml) FSH.
For the following cycle, your doctor will prescribe a treatment at a higher starting dose than in the abandoned cycle.
Għac- ċiklu li jmiss it- tabib tiegħek ser jordnalek kura b’ doża inizjali ogħla minn dik li kienet ingħatat fiċ- ċiklu li twaqqaf.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4).
Jekk jinkiseb riżultat eċċessiv, il- kura għandha titwaqqaf u jinżamm l- hCG (ara Effetti oħra li jistgħu jinħassu).
A commonly used dose for superovulation involves the administration of 150-225 IU (0.24-0.36 ml) of GONAL-f daily, commencing on days 2 or 3 of the treatment cycle.
Doża li tintuża b’ mod komuni għal ovulazzjoni mgħaġġla hija ta ’ 150- 225 IU( 0. 25- 0. 38ml) Gonal- f kuljum, li tinbeda fit- tieni jew it- tielet jum taċ- ċiklu.
Treatment is continued until adequate follicular development has been achieved (as assessed by blood monitoring and/ or ultrasound examination), with the dose adjusted according to your response, to usually not higher than 450 IU (0.72 ml) daily.
Il- kura titkompla sakemm jinkiseb żvillup follikulari adegwat (kif analizzat minn analiżi tad- demm u/ jew eżaminazzjoni permezz ta ’ l - ultrasawnd), b’ tibdil fid- doża skond l- effett fuq il- pazjent, ġeneralment, sa mhux aktar minn 450 IU( 0. 75ml) kuljum.
Then a single injection of a medicine used to induce final follicular maturation and containing 250 micrograms r-hCG or 5000 IU up to 10 000 IU human chorionic gonadotrophin (hCG) is administered 24-48 hours after the last GONAL-f injection.
Imbagħad, injezzjoni waħda ta ’ mediċina sabiex tinduċi maturazzjoni follikulari finali u b’ kontenut li jasal sa 10 000 IU gonadotrofina korjonika umana (hCG) tittieħed 24- 48 siegħa wara l- aħħar injezzjoni ta ’ GONAL- f.
In other cases, down-regulation with a gonadotrophin-releasing hormone (GnRH) agonist or antagonist is used.
F’ każi oħra, ikun hemm down- regulation permezz ta ’ agonista ta ’ l- ormon li jistimula s- sekrezjoni tal - gonadotrofina (GnRH).
249 Women who are not ovulating, having no periods at all and have been diagnosed as FSH and LH deficient.
Nisa li mhumiex jovulaw, li ma jkollhomx pirjid u li nstabilhom nuqqas ta ’ LH u FSH
GONAL-f is usually taken every day for up to five weeks simultaneously with injections of lutropin alfa.
244 Ġeneralment, GONAL- f jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet ta ’ lutropin alfa.
A commonly used dose starts with 75-150 IU (0.12-0.24 ml) of GONAL-f together with 75 IU of lutropin alfa.
Doża wżata b’ mod komuni tibda b’ 75- 150 IU( 0. 13- 0. 25ml) ta ’ GONAL- f flimkien ma ’ 75 IU ta ’ lutropin alfa.
If your doctor does not observe a response of your ovaries after 5 weeks of treatment, that cycle should be abandoned.
Jekk it- tabib ma jarax riżultati pożittivi fuq l- ovarji tiegħek wara 3 ġimgħat ta ’ kura, dak iċ- ċiklu għandu jitwaqqaf.
When the desired response has been obtained, a single injection of 250 micrograms r-hCG or 5000 IU up to 10 000 IU hCG is given 24-48 hours after the last injections of GONAL-f and lutropin alfa.
Meta jinkiseb riżultat ottimali, injezzjoni waħda ta ’ hCG tingħata 24- 48 siegħa wara l- aħħar injezzjoni ta ’ GONAL- f u lutropin alfa.
GONAL-f is usually prescribed at a dose of 150 IU (0.24 ml) three times a week in combination with another medicine (hCG) for at least 4 months.
Ġeneralment, GONAL- f jingħata f’ doża ta ’ 150 IU( 0. 25ml) tliet darbiet fil- ġimgħa flimkien ma ’ mediċina oħra (hCG) għal mill- inqas 4 xhur.
If you have not responded to treatment after this period, your treatment may carry on for at least 18 months.
Jekk ma jkunx hemm effetti pożittivi fuqek wara dan il - perijodu, il- kura tista ’ titkompla għal mill- anqas 18- il xahar.
Individual pre-filled pens should be for single patient use only.
Ampulli individwali rikostitwiti għandhom jiġu wżati minn pazjent wieħed biss.
Prepare the GONAL-f pre-filled pen and inject the solution once dose has been selected.
L- injezzjonijiet oħra jridu jsiru fl- istess ħin tal- ġurnata ta ’ qabel.
The next injection should be done at the same time the next day.
It- tabib tiegħek ippreskrivilek dosa ta ’ GONAL- f f’ IU.
Your doctor has prescribed you a dose of GONAL-f in IU.
Uża waħda miss- 6 siringa pproveduti bil- gradi ta ’ FSH.
• Wash your hands.
Aħsel idejk.
It is important that your hands and the items you use are as clean as possible.
2.
Find a clean area and lay out everything (two alcohol swabs, the pre-filled pen and a needle for administration).
Iġbor u ifrex kull m’ għandek bżonn fuq bank nadif (żewġ ċraret bl- alkoħol, is- siringa mimlija lesta b’ 2 ml ta ’ solvent, il- fjala bil- GONAL- f u siringa għall- injezzjoni).
Preparing the GONAL-f pre-filled pen to first use:
buttuna ta ’ injezzjoni kontroll kwadrant aħmar tad- doża
Then prime the pen by setting the dose arrow at 37.5 black scale-mark highlighted with a small dot.
• Il- preparazzjoni tal - pinna mimlija lesta ta ’ GONAL- f għall- ewwel darba:
Pull out the injection button as far as it will go, remove the outer needle cap and the inner needle cap and hold the pre-filled pen with the needle pointing upwards.
Iġbed lill barra l- buttona ta ’ l- injezzjoni sakemm jista ’ joħroġ, neħħi l- kapp tal- labra ta ’ barra u ta ’ ġewwa, u żomm il- labra tipponta ’ l fuq.
Tap the reservoir holder gently with the finger so that any air bubbles rise up towards the needle.
Taptap bil- mod il- post tal- ġibjun bis- swaba sabiex jekk hemm xi bżieżaq t’ arja, dawn jitilgħu lejn il- labra.
With the needle still pointing upwards, depress the injection button fully.
Bil- labra għadha tipponta ’ l fuq, niżżel il- buttuna ta ’ l- injezzjoni kompletament.
A drop of liquid must appear at the tip of the needle; this indicates that your pre-filled pen is primed for injection.
Fil- ponta tal- labra jrid jidher qatra ta ’ likwidu; dan juri illi l- pinna mimlija lesta hija lesta għall- injezzjoni.
The amount of liquid seen at the needle tip is just the overfill from the pre-filled pen (generally less than 37.5 IU).
L- ammont ta ’ likwidu li tara fil- ponta tal- labra hija biss l- overfill mill- pinna mimlija lesta (ġeneralment tkun inqas minn 37. 5 IU).
If no liquid appears the first time, repeat a second time until a drop of liquid appears at the needle tip.
Jekk ma jkunx hemm dan il - likwidu, irrepeti għal darb’ oħhra sakemm tara qatra ta ’ likwidu fil- ponta tal- labra.
Then set the dose as describe in section 4.
Issetja d- dosa kif inhu deskritt f’ sezzjoni 4.
For the next usage attach a needle as described in section 3 and set the dose as described in section 4.
• Għall- użu għal darb’ oħra, waħħal labra kif inhu deskritt f’ sezzjoni 3 u jssettja d- dosa kif inhu deskritt f’ sezzjoni 4.
Attaching a needle:
Biex twaħħal labra:
Take a new needle.
Ħu labra ġdida.
If the peel tab closing the outer needle cap is damaged or loose, do not use it.
Jekk it- tapp fuq il- kapp tal- labra ta ’ barra huwa bil- ħsara jew maħlul, tuzahiex.
Discard the needle and take a new one.
Għarmi l- labra u ħu waħda ġdida.
Remove the peel tab from the outer needle cap.
Neħħi t- tapp mill- kapp tal- labra ta ’ barra.
Hold the outer needle cap firmly, press the threaded tip of the pre-filled pen into the outer needle cap and twist it clockwise until it is securely fixed.
Żomm sew il- kapp tal- labra ta ’ barra, għafas il- ponta tal- pinna mimlija lesta fil- kapp tal- labra ta ’ barra, dawru għall- lemin sakemm izomm sew.
Caution:
Kawtiela:
Use only the single-use disposable needles provided within the GONAL-f pre-filled pen pack or distributed separately.
Uża biss il- labar disposabil li huma pproveduti fil - pakk tal- pinna mimlija lesta ta ’ GONAL- f jew li huma mqassmin separament.
Set the required dose by turning the black dosage dial in either
Tissettja d- doża: issettja d- dosa li għandek bżonn billi ddawwar il- kwadrant iswed tad- doża
251 direction until the dose arrow is pointing to the dose you require (The black dosage dial lets you set the dose in steps of 37.5 IU.
246 f’ kwalunkwe direzzjoni, sakemm il- vleġġa tad- doża qedgħha fuq id- doża li għandek bżonn (il- kwadrant iswed tad- doza jħallik tissettja d- doza f’ passi ta ’ 37. 5 IU.
The minimum dose and the maximum dose that you can set are respectively equal to 37.5 IU and 300 IU).
Id- doza minima u massimu li tista tissetja huma ta ’ 37. 5 IU u 300 IU, rispettivament.) Ta ’ darba li ssettjat id- doza, ppreparah billi tiġbed lill- barra l- buttuna ta ’ l- injezzjoni sakemm tista.
Once you have set your dose, load it by pulling the injection button out as far as it will go.
Qogħod attenta li tiġbed il- buttuna b’ mod dritt u li ma ddawwariex sabiex toħroġha, għaliex dan jista jbiddel id - doza.
Take care to pull the button straight and not to twist it out, this might change the set dose.
Kawtiela: iċċekkja sew il- kwadrant tad- doza qabel ma tiġbdu, għaliex ma tistax tirranġah wara.
Discard the dose to waste and repeat the dose setting correctly.
Jekk wara li ġbitt il - barra l- buttuna ta ’ l- injezzjoni, u tinduna li ssettjajt id- doza ħazina, tinjetax.
Check the red dosage control dial on the injection button in order to ensure that the correct dose has been loaded:
Għarmi d- doza w ibda ssettja d- doza sewwa.
When the injection button is pulled out, the loaded dose is indicated by the last mark (flat arrow) on the red dosage control dial that is coming out and appears visible (the example in the Figure shows the injection button pulled out and a loaded dose of 150 IU).
Iċċekkja l- kontroll kwadrant tad- doza aħmar fuq il- buttuna ta ’ l- injezzjoni biex tara li d- doza ġiet issettjata sew: meta l - buttuna ta ’ l- injezzjoni hija miġbuda ’ l barra, d- doza settjata hiwa ndikata bl- aħħar marka (vleġġa ċatta) fuq il- kontroll kwadrant tad- doza aħmar li ħierġa u tista ’ tingħara (l- ezempju fl- istampa juri l- buttuna ta ’ l- injezzjoni miġbuda ’ l barra u doza ssettjata ta ’ 150 IU).
If the loaded dose is lower than the set dose, then the dose will not be complete.
Jekk id- doza ssettjata hija inqas mid- doza li hemm, għallura d- doza ma tkunx kompluta.
In this case, follow the instructions given below in the point 2. of the Note section.
F’ dan il- kas, segwi l - istruzzjonijiet segwenti f’ 2 ta ’ din is- sezzjoni.
If the same dose is required every time, then the dose arrow can be left pointing at the same position on the dosage dial.
Jekk għandek bzonn ta ’ l- istess doza kull darba, il- vleġġa tad- doza tista titħalla tipponta fuq l- istess pozizzjoni tal- kwadrant tad- doza.
Injecting the dose:
Biew tinjetta d- doża:
Choose an injection site according to the instructions given by your medical practitioner or nurse.
Għazel sitt għall- injezzjoni skond l- istruzzjonijiet mogħtija lilek mitt- tabib jew infermiera.
Clean the injection site by wiping with an alcohol swab.
Naddaf is- sitt għall- injezzjoni billi timsħu b’ ċarruta ta ’ l- alkoħol.
Use the injection technique as advised by your medical practitioner or nurse.
Uza t- teknik ta ’ injezzjoni kif uriek it - tabib jew infermiera tiegħek.
Insert the needle into the skin and press the injection button as far as it will go.
Daħħal il- labra fil- ġilda u għafas il- buttuna ta ’ l- injezzjoni sakemm tista.
Check that the grey indicator on the injection button is no longer visible.
Iċċekja li l- buttuna griza li tindika kunsenja tad - doza ma tistax tingħara.
This confirms that the delivery of the dose is complete.
Din tikkunferma li d- doza ġiet ikkunsenjata kompletament.
You must keep the needle in the skin and press down the injection button for at least 10 seconds.
Il- labra trid tinzamm fil- ġilda għal minimu ta ’ 10 sekondi.
Whilst keeping the injection button pressed down, take the needle out of the skin.
Waqt li zzomm il- buttunata ’ l - injezzjoni magħfsa l- isfel, neħħi l- labra mil- ġilda.
Removing the needle:
Biex titneħħa l- labra:
Remove the needle after each injection and discard it.
Neħħi l- labra wara kull injezzjoni u għarmiha.
Hold the pre-filled pen firmly by the reservoir holder.
Zomm sew il- pinna mimlija lesta mill- ġibjun.
Carefully put back the outer needle cap onto the needle.
Bil- mod, erġa għamel il- kapp tal - labra ta ’ barra f’ postha.
Grip the outer needle cap and unscrew the needle by turning counterclockwise.
Zomm sew il- kapp tal- labra ta ’ barra w iddawru n- naħa tax- xellug sabiex tneħħiha.
Dispose of the used needle safely.
Għarmi l- labar sew.
Now put back the pre-filled pen cap on the pre-filled pen.
Poġġi l- kapp tal- pinna mimlija lesta fuq il- pinna mimlija lesta.
After injecting your dose remove the used needle as described in the point 6 above.
Kif taħzen il- pinna mimlija lesta: wara li tinjetta d- doza, neħħi l- labra li uzajt kif inhu deskritt f’ 6 hawn fuq.
Put back the pre-filled pen cap on the pre-filled pen.
Erġa poġġi il- kapp tal- pinna mimlija lesta fuq il- pinna mimlija lesta.
Store the GONAL-f pre- filled pen in a safe place, preferably in the original package.
Aħzen il - pinna mimlija lesta ta ’ GONAL- f f’ post li mhuwiex perikuluz, preferibbilment fil- pakett oriġinali.
When the pre-filled pen is empty, discard it.
Meta l- pinna mimlija lesta hija vojta, għarmiha.
The scale that can be seen through the reservoir holder is an indicator of the medicine volume remaining in the reservoir.
Il- mizien li jista jingħara mill- ġibjun huwa ndikazzjoni tal- volum tal- mediċinali li jibqa ’ fil - ġibjun.
It must not be used to set the dose.
Dan ma jistax jintuza sabiex tisettja d- doza.
The red dosage control dial on the injection button enables you to check whether the last dose will be complete or not.
Il - kontroll kwadrant aħmar tad- doża fuq il- buttuna ta ’ l- injezzjoni tħallik tiċċekja jekk l- aħħar doza tkun kompleta jew le.
It can only be pulled out as far as the mark (flat arrow) indicating the amount of medicine remaining in the reservoir.
Din tista tinġibed il- barra sal- marka (vleġġa ċatta) u hekk tindika l - ammont ta ’ mediċina li hemm fil- ġibjun.
If the loaded dose is not sufficient to complete your injection, you have two possibilities: a.
Jekk id- doza ssettjatha mhiex bizejjed sabiex inti tikkompleti l- injezzjoni tiegħek, għandek zewġ possibiltajiet: a.
Inject the partial dose (remained in this pre-filled pen) and then complete immediately the injection of the rest of the dose using a new pre-filled pen (do not to forget to record the partial dose). b.
Għarmi din il- pinna mimlija lesta u hu doza kompluta minn pinna mimlija lesta ġdida. b. injetta doza parzjali (dak li baqa ’ fil- pinna mimlija lesta) imbagħad komplijja mmedjatament billi tuza pinna mimlija lesta ġdida.
Discard the pre-filled pen and inject the full dose using a new pre-filled pen.
(tinsiex tieħu nota tad- doza parzjali).
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.
L- effetti ta ’ doża eċċessiva ta ’ GONAL- f mhumiex magħrufa, iżda wieħed jista ’ jistenna li jseħħ is - sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji, li hu deskritt f’ aktar dettall f’ Effetti oħra li jistgħu jinħassu ”.
These problems may affect more than 10 patients out of 100 treated.
Dawn l- effetti jistgħu jaffetwaw iktar minn 10 pazienti minn 100 li qegħdin jieħdu l- kura.
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see section 2) can occur (between 1 and 10 patients out of 100 treated patients).
Wara li tingħata l- kura permezz ta ’ GONAL- f, meta tittieħed l- gonadotrofina korjonika umana, tista ’ sseħħ il- kundizzjoni magħrufa bħala s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (ara s- sezzjoni 2) (bejn 1 u 10 minn 100 pazienti li qegħdin jieħdu l- kura)..
This can occurs in 1% of the patients or less.
F’ każi rari, dan ta ’ l- aħħar jista ’ jiġri wkoll indipendentement mis- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji.
In very rare cases the latter can also be found independently of ovarian hyperstimulation syndrome (less than 1 patient in 1000).
(inqas minn pazient wieħed minn 1000).
In order to prevent ovarian hyperstimulation syndrome, treatment with GONAL-f could be discontinued by your physician and the treatment with hCG abandoned.
B’ kunsiderazzjoni ta ’ dan kollu, biex jiġu evitati tali konsegwenzi, meta l- effett fuq l- ovarji jkun eċċessiv, il- kura b’ GONAL- f għandha titwaqqaf mit- tabib tiegħek u l- kura bl- hCG tiġi abbandunata.
Very rarely (less than 1 in 10000 patients) abnormal blood clottings (blood clots in blood vessels) have been seen to occur with similar medicines, so this could possibly occur with GONAL-f / hCG therapy or GONAL-f / lutropin alfa/ hCG therapy.
Meta ntużaw mediċini simili, f’ każi rari, kien hemm koagulazzjonijiet tad- demm mhux normali (koagulazzjoniet tad- demm fil- vini jew fl- arterji), u għalhekk dan jista ’ jseħħ ukoll bit- terapija b’ GONAL- f / hCG jew bit- terapija b’ GONAL- f / lutropin alfa / hCG.
253 Side effects in men Men may experience some breast development, acne or weight gain due to treatment with hCG (between 1 and 10% of the patients).
L- irġiel jistgħu jesperjenzaw xi żvilupp tas- sider, akne jew żieda fil- piż minħabba l- kura bl- hCG bejn 1 u 10% mill- pazienti).
Some men undergoing treatment with GONAL-f may experience local reactions at the injection site (pain, redness, bruising, swelling and/ or irritation) or may develop a varicocele (swelling of the veins above and behind the testicle).
248 reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (uġigħ, ħmura, tbenġil, nefħa u/ jew irritazzjoni) jew jizviluppaw varicocele (nefħa tal- vini fuq u wara t- testikolu).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk tinduna b' xi effetti li jsiru iktar gravi jew xi effetti oħra mhux imsemmija f’ dan il- fuljett, jekk jogħġbok avża lit- tabib jew lill- ispiżjar tiegħek.
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma ’ jidhirx mit- tfal.
Do not freeze.
Taħżinx fil- friza.
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.
Sa ’ id- data ta ’ meta tiskadi, il- prodott jista ’ jinħażen f’ temperauta ta ’ 25°C jew inqas sa tlett xur migħajr ma jitpoġġa ġol- friġġ u għandu jintrema ’ jekk ma jintuzax wara tlett xur.
Please write on the GONAL-f pre-filled pen the day of first use of the solution for injection.
Ikteb fuq il- pinna mimlija lesta ta ’ GONAL- f id- data ta ’ l- ewwel użu tal- prodott.
Once opened, the product may be stored for a maximum of 28 days at or below 25°C.
Darba miftuħ, il - prodott jista ’ jitħazen għal mux iktar minn 28- il ġurnata, f’ temperatura ta ’ 25°C jew inqas.
Any unused solution must be discarded not later than 28 days after first opening.
Soluzzjoni li ma ntuzax għandhu jintrema ’ mhux iktar minn 28- il ġurnata wara l- ewwel użu.
Do not use GONAL-f after the expiry date which is stated on the cartridge label or carton after EXP.
M’ għandekx tuża GONAL- f wara d- data li jiskadi li tidher fuq it- tiketta ta ’ l- iskartoċċ jew il- kartuna wara JIS.
The 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 solution must be discarded.
Soluzzjoni li ma ntuzax għandhu jintrema ’.
The active substance is follitropin alfa.
Is- sustanza attiva hi follitropin alfa.
Follitropin alfa is a recombinant human follicle stimulating hormone (FSH) produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Follitropin alfa huwa ormon uman rikombinanti li jistimula l - follikuli u li jiġi magħmul fiċ- ċelloli ta ’ l- ovarji tal- ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
The quantity of follitropin alfa per ml is 600 IU (equivalent to 44 micrograms).
L- ammont ta ’ follitropin alfa huwa 600 IU/ ml (ekwivalenti għal 44 mikrogrammi).
Each cartridge delivers 300 IU (equivalent to 22 micrograms) in 0.5 ml.
Kull skartoċċ jagħti 300 IU (ekwivalenti għal 22 micrograms) fi 0. 5 ml.
The other ingredients are poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.
Is- sustanzi l- oħra huma polomaxer 188, sukrożju, metjonina, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, m- cresol, aċidu fosforiku konċentrat u idrossidu tas- sodju w ilma għall - injezzjoni.
GONAL-f is presented as a clear, colourless solution for injection in a pre-filled pen.
GONAL- f huwa trab u solvent għal soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
It is supplied in packs of 1 pre-filled pen and 5 needles for administration.
Il- prodott jiġi f’ pakketti ta ’ pinna mimlija lesta u 5 labar għal amministrazzjoni.
254 Marketing Authorisation Holder
249 Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
255 Ελλάδα Merck A. E.
250 Ελλάδα Merck A. E.
257 PACKAGE LEAFLET:
252 FULJETT TA ’ TAGĦRIF:
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) solution for injection in a pre-filled pen Follitropin alfa
GONAL- f 450 IU/ 0. 75ml (33 mikrogrammi/ 0. 75ml) soluzzjoni għall- injezzjoni f’ pinna mimlija lesta Follitropin alfa
Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
• if you are allergic (hypersensitive) to follicle stimulating hormone or to any of the other ingredients of GONAL-f • if you have tumours of the hypothalamus and pituitary gland
• jekk ġieli kellek xi reazzjonjiet allerġiċi għall- mediċini li fihom l- ormon li jistimula l- follikolu jew għal xi waħda mis- sustanzi mhux attivi • tumuri fl- ipotalamu u fil- glandola pitwitarja
258 If you are a woman:
253 Jekk int mara:
• if you have irreversible testicular damage
Barra minn hekk, ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Using other medicines:
Użu ta ’ mediċini oħra:
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 down regulation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.
L- użu ta ’ GONAL- f fl- istess ħin ma ’ agenti oħra li jistimulaw l- ovulazzjoni (e. g. hCG, clomiphene citrate) jista ’ jizdied reazzjoni follikulari, filwaqt li l- użu ta ’ GnRH agonist jew antagonist fl- istess ħin sabiex jikkawza down regulation jista ’ jeħtieg dosa akbar ta ’ GONAL- f sabiex ikun hemm reazzjoni ovarja adeguata.
259 Pregnancy and breast-feeding
254 Tqala u treddigħ:
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek tieħu Gonal- f skond il- parir tat- tabib. Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
This may be increased by 37.5-75 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( 0. 13- 0. 25ml) FSH kuljum. Din tista ’ tiżdied preferibbilment b’ 37. 5 IU- 75 IU kull 7 jew preferibbilment 14- il ġurnata jekk ikun meħtieġ, biex jinkiseb riżultat adegwat, iżda mhux eċċessiv.
The maximal daily dose is usually lower than 225 IU FSH (0.36 ml).
Ġeneralment, id- doża massima ta ’ kuljum ma taqbiżx il - 225 IU FSH( 0. 38ml).
260 Women who are not ovulating, having no periods at all and have been diagnosed as FSH and LH deficient.
Nisa li mhumiex jovulaw, li ma jkollhomx pirjid u li nstabilhom nuqqas ta ’ LH u FSH
GONAL-f is usually taken every day for up to five weeks simultaneously with injections of lutropin alfa.
255 Ġeneralment, GONAL- f jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet ta ’ lutropin alfa.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see Section 4).
Jekk jinkiseb riżultat eċċessiv, il- kura għandha titwaqqaf u jinżamm l- hCG (ara Effetti li jistgħu jinħassu).
• Assemble everything you need:
Iġbor u ifrex kull m’ għandek bżonn fuq bank nadif:
Find a clean area and lay out everything (two alcohol swabs, the pre-filled pen and a needle for administration).
(żewġ ċraret bl- alkoħol, is- siringa mimlija lesta b’ 1 ml ta ’ solvent, il- fjala bil- GONAL- f u siringa għall- injezzjoni).
For the next usage attach a needle as described in section 3 and set the dose as described in section 4.
buttuna ta ’ injezzjoni kontroll kwadrant aħmar tad - doża
Use only the single-use disposable needles provided within the GONAL-f pre-filled pen pack or distributed separately.
indikatur griza li turi kunsenja kompluta tad- dosa
Setting the dose:
(f ’ IU FSH).
Set the required dose by turning the black dosage dial in either
vleġġa tad- dosa. post tal- ġibjun pistola tal- planger ponta kap tal- pinna mimlija lesta labra li titneħħa kapp tal- labra ta ’ ġewwa kapp tal- labra ta ’ barra. tapp li titneħħa
262 direction until the dose arrow is pointing to the dose you require (The black dosage dial lets you set the dose in steps of 37.5 IU.
Iġbed lill barra l- buttona ta ’ l- injezzjoni sakemm jista ’ joħroġ, neħħi l- kapp tal- labra ta ’ barra u ta ’ ġewwa, u żomm il- labra tipponta ’ l fuq.
The minimum dose and the maximum dose that you can set are respectively equal to 37.5 IU and 450 IU).
Bil- labra għadha tipponta ’ l fuq, niżżel il- buttuna ta ’ l- injezzjoni kompletament.
Once you have set your dose, load it by pulling the injection button out as far as it will go.
Jekk it- tapp fuq il- kapp tal- labra ta ’ barra huwa bil- ħsara jew maħlul, tuzahiex.
Take care to pull the button straight and not to twist it out, this might change the set dose.
Żomm sew il- kapp tal- labra ta ’ barra, għafas il- ponta tal- pinna mimlija lesta fil- kapp tal- labra ta ’ barra, dawru għall- lemin sakemm izomm sew.
Caution: carefully check the dosage dial before pulling out the injection button because it cannot be corrected after it has been loaded.
Id- doza minima u massimu li tista tissetja huma ta ’ 37. 5 IU u 300 IU, rispettivament.) Ta ’ darba li ssettjat id- doza, ppreparah billi tiġbed lill- barra l- buttuna ta ’ l- injezzjoni sakemm tista.
If after having pulled out the injection button you realize that you have set and loaded a wrong dose, do not inject.
Kawtiela: iċċekkja sew il- kwadrant tad- doza qabel ma tiġbdu, għaliex ma tistax tirranġah wara.
Choose an injection site according to the instructions given by your medical practitioner or nurse.
Għazel sitt għall- injezzjoni skond l- istruzzjonijiet mogħtija lilek mitt- tabib
Inject the partial dose (remained in this pre-filled pen) and then complete immediately the injection of the rest of the dose using a new pre-filled pen (do not forget to record the partial dose). b.
(tinsiex tieħu nota tad- doza parzjali). b.
Discard the pre-filled pen and inject the full dose using a new pre-filled pen.
Għarmi din il- pinna mimlija lesta u hu doza kompluta minn pinna mimlija lesta ġdida.
However this will only occur if hCG is administered (see section 2)
Madankollu dan iseħħ biss jekk jingħata l- hCG (ara s- sezzjoni 2)
Like all medicines, GONAL-f can cause side effects, although not every body gets them.
Bħal kull mediċina oħra, GONAL- f jista ’ jkollu effetti oħra, għalkemm ma jidhrux fuq kulħadd
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see section 2) can occur (between 1 and 10 patients out of 100 treated patients).
258 Wara li tingħata l- kura permezz ta ’ GONAL- f, meta tittieħed l- gonadotrofina korjonika umana, tista ’ sseħħ il- kundizzjoni magħrufa bħala s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (ara sezzjoni 2) (bejn 1 u 10 minn 100 pazienti li qegħdin jieħdu l- kura).
This syndrome is characterised by large ovarian cysts.
Dan is- sindromu hu karatterizzat b’ ċisti kbar fl - ovarji.
264 Side effects in men Men may experience some breast development, acne or weight gain due to treatment with hCG (between 1 and 10% of the patients).
L- irġiel jistgħu jesperjenzaw xi żvilupp tas- sider, akne jew żieda fil- piż minħabba l- kura bl- hCG bejn 1 u 10% mill- pazienti).
Some men undergoing treatment with GONAL-f may experience local reactions at the injection site (pain, redness, bruising, swelling and/ or irritation) or may develop a varicocele (swelling of the veins above and behind the testicle).
Xi irġiel li qegħdin jieħdu din il- kura ta ’ GONAL- f jistgħu jesperjenzaw reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (uġigħ, ħmura, tbenġil, nefħa u/ jew irritazzjoni) jew jizviluppaw varicocele (nefħa tal- vini fuq u wara t- testikolu).
STORING GONAL-f
KIF TAĦŻEN GONAL- f
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.
Sa ’ id- data ta ’ meta tiskadi, il- prodott jista ’ jinħażen f’ temperauta ta ’ 25°C jew inqas sa tlett xur migħajr ma jitpoġġa ġol- friġġ u għandu jintrema ’ jekk ma jintuzax wara tlett xur.,
Any unused solution must be discarded not later than 28 days after first opening.
Darba miftuħ, il - prodott jista ’ jitħazen għal mux iktar minn 28- il ġurnata, f’ temperatura ta ’ 25°C jew inqas Soluzzjoni li ma ntuzax għandhu jintrema ’ mhux iktar minn 28- il ġurnata wara l- ewwel użu.
Do not use GONAL-f if you notice any visible signs of deterioration.
M’ għandekx tuża wara id- data li jiskadi li tidher fuq it- tikketta tal- fjala jew fuq il- pakkett ta ’ barra.
The solution should not be administered if it contains particles or is not clear.
259 Is- soluzzjoni rikostitwita m’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
Each cartridge delivers 450 IU (equivalent 33 micrograms) in 0.75 ml.
Kull skartoċċ jagħti 300 IU (ekwivalenti għal 22 micrograms) fi 0. 5 ml.
It is supplied in packs of 1 pre-filled pen and 7 needles for administration.
Il- prodott jiġi f’ pakketti ta ’ pinna mimlija lesta u 5 labar għal amministrazzjoni.
265 Marketing Authorisation Holder
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Danmark E.
260 Danmark E.
Italia Merck Serono S. p. A.
261 Suomi/ Finland Italia Merck Serono S. p. A.
268 PACKAGE LEAFLET:
262 FULJETT TA ’ TAGĦRIF:
GONAL-f 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml) solution for injection in a pre-filled pen Follitropin alfa
GONAL- f 900 IU/ 1. 5 ml (66 micrograms/ 1. 5 ml) soluzzjoni għall- injezzjoni f’ pinna mimlija lesta Follitropin alfa
• if you are allergic (hypersensitive) to follicle stimulating hormone or any of the other ingredients of GONAL-f. • if you have tumours of the hypothalamus and pituitary gland.
• jekk ġieli kellek xi reazzjonjiet allerġiċi għall- mediċini li fihom l- ormon li jistimula l- follikolu jew għal xi waħda mis- sustanzi mhux attivi • tumuri fl- ipotalamu u fil- glandola pitwitarja
269 If you are a woman:
263 Jekk int mara:
270 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 down regulation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.
L- użu ta ’ GONAL- f fl- istess ħin ma ’ agenti oħra li jistimulaw l- ovulazzjoni (e. g. hCG, clomiphene citrate) jista ’ jizdied reazzjoni follikulari, filwaqt li l- użu ta ’ GnRH agonist jew antagonist fl- istess ħin sabiex jikkawza down regulation jista ’ jeħtieg dosa akbar ta ’ GONAL- f sabiex ikun hemm reazzjoni ovarja adeguata.
Pregnancy and breast-feeding
264 Tqala u treddigħ:
GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
GONAL- f fih inqas minn 1 mmol sodju (23 mg) għal kull dosa, i. e. essenzjalment ‘ mingħajr sodju ’..
You should check with your doctor or pharmacist if you are not sure.
KIF JINTUŻA GONAL- f Dejjem għandek tieħu Gonal- f skond il- parir tat- tabib. Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
This may be increased by 37.5-75 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( 0. 13- 0. 25ml) FSH kuljum li tiżdied preferibbilment b’ 37. 5 IU- 75 IU kull 7 jew preferibbilment 14- il ġurnata jekk ikun meħtieġ, biex jinkiseb riżultat adegwat, iżda mhux eċċessiv.
271 Women who are not ovulating, having no periods at all and have been diagnosed as FSH and LH deficient.
Nisa li mhumiex jovulaw, li ma jkollhomx pirjid u li nstabilhom nuqqas ta ’ LH u FSH
GONAL-f is usually taken every day for up to five weeks simultaneously with injections of lutropin alfa.
265 Ġeneralment, GONAL- f jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet ta ’ lutropin alfa.
• Assemble everything you need:
Iġbor u irfex kull m’ għandek bżonn fuq bank nadif:
Find a clean area and lay out everything (two alcohol swabs, the pre-filled pen and a needle for administration).
(żewġ ċraret bl- alkoħol, is- siringa mimlija lesta li fiha s- solvent, il- fjala bil- GONAL- f u siringa għall- injezzjoni).
Preparing the GONAL-f pre-filled pen to first use:
buttuna ta ’ injezzjoni kontroll kwadrant aħmar tad - doża
Then prime the pen by setting the dose arrow at 37.5 scale-mark highlighted with a small dot.
266 • Il- preparazzjoni tal - pinna mimlija lesta ta ’ GONAL- f għall- ewwel darba: