qanastek/EMEA-V3 huggingface dataset:
• 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:
170 Jekk int mara:
If you are a woman, this treatment increases your risk of developing ovarian hyperstimulation syndrome (OHSS) (see Section 4).
Jekk int mara, din il- kura żżidlek ir- riskju li tiżviluppa s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (OHSS) (ara Effetti oħra li jistgħu jinħassu).
172 GONAL-f should not be administered as a mixture with other medicinal products in the same injection, except for lutropin alfa.
GONAL- f m’ għandux jittieħed bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni, ħlief mal- lutropin alfa.
Important information about some of the ingredients of GONAL-f
171 Informazzjoni importanti dwar xi wħud ta ’ l- ingredjienti ta ’ GONAL- f
173 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
If your doctor does not observe a response of your ovaries after 3 weeks of treatment, that cycle should be abandoned.
172 Jekk it- tabib ma jarax riżultati pożittivi fuq l- ovarji tiegħek wara 3 ġimgħat ta ’ kura, dak iċ- ċiklu għandu jitwaqqaf.
GONAL-f is intended for subcutaneous use, that means by injection just under the skin.
GONAL- f jingħata permezz ta ’ injezzjoni taħt il- ġilda.
(If you have been prescribed more than one ampoule of GONAL-f, slowly re-inject the solution into another powder ampoule, until you have the prescribed number of powder ampoules dissolved in the solution.
173 (Jekk ir- riċetta tindikalek aktar minn ampulla waħda ta ’ GONAL- f, erġa ’ injetta bil- mod it- taħlita f’ ampulla oħra tat- trab, sakemm in- numru preskritt ta ’ ampulli tat- trab ikunu nħallu fit- soluzzjoni.
175 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.
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see section 2) can occur.
174 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).
176 Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease.
Tqala ektopika (embriju impjantat barra l- ġuf) tista ’ tirriżulta speċjalment f’ nisa b’ passat mediku ta ’ mard fit- tubi.
The active substance is follitropin alfa, 150 IU (International Units).
Is- sustanza attiva hi follitropin alfa, 150 IU.
It is supplied in packs of 1, 10 ampoules of powder with the corresponding number of solvent ampoules.
Il- prodott jiġi f’ pakketti ta ’ 1, 10 ampulli ta ’ trab bl- istess ammont ta ’ ampulli bis- solvent.
177 One ampoule of powder contains 150 IU of follitropin alfa and one ampoule of solvent contains 1 ml of Water for Injections.
Ampulla waħda ta ’ trab fiha 150 IU ta ’ follitropin alfa u kull ampulla ta ’ solvent fiha 1ml ta ’ ilma għall- injezzjoni.
Danmark E.
176 Danmark E.
Italia Merck Serono S. p. A.
177 Suomi/ Finland Italia Merck Serono S. p. A.
180 PACKAGE LEAFLET:
178 FULJETT TA ’ TAGĦRIF:
GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection Follitropin alfa
GONAL- f 75 IU (5. 5 mikrogrammi) trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa
- 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 lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni oħra.
181 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
If you are a woman:
179 Jekk int mara:
If you are a woman, this treatment increases your risk of developing ovarian hyperstimulation syndrome (OHSS) (see Section 4).
Jekk int mara, din il- kura żżidlek ir- riskju li tiżviluppa s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (OHSS) (ara sezzjoni 4).
However, if you are not ovulating and the recommended dose and schedule of administration are adhered to, the occurrence of OHSS is uncommon.
Madankollu, jekk int m’ intix tovula u qed ssegwi d- doża rakkomandata u l - iskeda ta ’ kif jingħata, l- okkorrenza ta ’ OHSS mhix komuni.
If you are a man, elevated follicule stimulating hormone blood levels are indicative of testicular damage.
Jekk int raġel, livell għoli fid- demm ta ’ l- ormon li jistimula il- follikolu huwa indikattiv ta ’ dannu testikolari.
182 GONAL-f should not be administered as a mixture with other medicinal products in the same injection, except for lutropin alfa.
GONAL- f m’ għandux jittieħed bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni, ħlief mal- lutropin alfa.
Important information about some of the ingredients of GONAL-f
180 Informazzjoni importanti dwar xi wħud ta ’ l- ingredjienti ta ’ GONAL- f
HOW TO USE GONAL-f
KIF JINTUŻA GONAL- F
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 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.
183 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
If your doctor does not observe a response of your ovaries after 3 weeks of treatment, that cycle should be abandoned.
181 Jekk it- tabib ma jarax riżultati pożittivi fuq l- ovarji tiegħek wara 3 ġimgħat ta ’ kura, dak iċ- ċiklu għandu jitwaqqaf.
For the following cycle, your doctor will prescribe GONAL-f at a lower dose than that of the previous cycle.
Għaċ- ċiklu li jmiss, it- tabib se jagħtik doża anqas ta ’ GONAL- f minn dik mogħtija fiċ- ċiklu preċedenti.
one vial containing GONAL-f powder one solvent vial two alcohol swabs one syringe one needle for reconstitution and a fine bore needle for subcutaneous injection sharp container
Iftaħ
184 • Remove the protective cap from the solvent vial.
l- ampulla tas- solvent (likwidu ċar): Fuq ir- ras ta ’ l- ampulla tas- solvent se tara tikka żgħira kkulurita.
Attach the reconstitution needle to the syringe and draw up some air into the syringe by pulling the plunger to approximately the 1 ml mark.
Taptap bil- mod fuq il- parti ta ’ fuq ta ’ l - ampulla biex kull likwidu li jinsab fl- għonq ta’ l- ampulla jinżel fil- parti t’ isfel.
Then, insert the needle into the vial, push the plunger to expel the air, turn the vial upside down and gently draw up all the solvent.
Issa agħfas sew l- għonq ta ’ l- ampulla u ikser l- ampulla ‘ l bogħod mit- tikka kkulurita.
Set the syringe down carefully on the work-surface taking care not to touch the needle.
B’ attenzjoni poġġi l– ampulla miftuħa bil- wieqfa fuq il- bank fejn qed taħdem.
• Prepare the injection solution:
• Iġbed is- solvent 'l fuq:
Remove the protective cap from the GONAL-f powder vial, pick up your syringe and slowly inject the solvent into the vial of powder.
Bis- siringa f’ id waħda, aqbad l- ampulla miftuħa, daħħal il- labra u iġbed 'l fuq is- solvent kollu.
Do not shake.
B’ attenzjoni niżżel is- siringa fuq il - bank fejn qed taħdem, u oqgħod attent li ma tolqotx il- labra.
After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Iftaħ l- ampulla li fiha t- trab ta ’ GONAL- f, aqbad is- siringa u bil- mod injetta s- solvent fl- ampulla tat- trab.
Turn the vial upside down, gently draw the solution back into the syringe.
Wara li jkun inħall it- trab (li normalment iseħħ mill- ewwel), iġbed bil- mod is- soluzzjoni lura fis- siringa.
If you have been prescribed lutropin alfa in addition to GONAL-f, you may also mix the two medicines as an alternative to injecting each product separately.
182 (Jekk ir- riċetta tindikalek aktar minn ampulla waħda ta ’ GONAL- f, erġa ’ injetta bil- mod it- taħlita f’ ampulla oħra tat- trab, sakemm in- numru preskritt ta ’ ampulli tat- trab ikunu nħallu fit- soluzzjoni. Jekk ir- riċetta tindikalek doża ta ’ lutropin alfa minnbarra GONAL- f, tista ’ tħallat ukoll iż- żewġ mediċini flimkien minflok tinjetta ż- żewġ prodotti separatament.
After dissolving the lutropin alfa powder, draw the solution back into the syringe and re-inject it into the vial containing GONAL-f.
Wara li jkun nħall it- trab tal- lutropin alfa, iġbed is- soluzzjoni lura fis- siringa u erġa ’ injettaha fl- ampulla li fiha l- GONAL- f.
Up to three containers of powder may be dissolved in 1 ml of solvent.)
Sa 3 kontenituri ta ’ trab jistgħu jinħallu f’ ampulla waħda ta ’ solvent.
• Immediately inject the solution:
• Injetta t- soluzzjoni immedjatament:
Wipe the chosen area with an alcohol swab.
Imsaħ il- parti magħżula għall- injezzjoni b’ ċarruta mxarrba bl- alkoħol.
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.
Once you have finished your injection, immediately discard all needles and empty glass containers in the sharp container provided.
Hekk kif tkun lestejt l- injezzjoni tiegħek, immedjatament armi l - labar u l- ampulli vojta kollha fil- kontenitur provdut.
185 If you forget to take GONAL-f
Jekk tinsa ’ tieħu GONAL- F
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see section 2) can occur.
Dan
This syndrome is characterised by large ovarian cysts.
183 is- sindromu hu karatterizzat b’ ċisti kbar fl- ovarji.
Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease.
Tqala ektopika (embriju impjantat barra l- ġuf) tista ’ tirriżulta speċjalment f’ nisa b’ passat mediku ta ’ mard fit- tubi.
186 Do not use GONAL-f after the expiry date which is stated on the vial after EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq l- ampulli.
The active substance is follitropin alfa, 75 IU (5.5 micrograms).
Is- sustanza attiva hi follitropin alfa, 75 IU (5. 5 mikrogrammi).
Follitropin alfa is made from 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.
The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
Is- sustanzi l- oħra huma sukrożju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, metjonina, polisorbat 20, aċidu fosforiku konċentrat u idrossidu tas- sodju.
The solvent is a clear colourless solution.
Is- solvent huwa soluzzjoni mingħajr kulur.
It is supplied in packs of 1 vial of powder with 1 vial of solvent.
Il- prodott jiġi f’ pakketti ta ’ ampulla waħda ma ’ ampulla waħda ta ’ solvent.
One vial of powder contains 75 IU of follitropin alfa and one vial of solvent contains 1 ml of Water for Injections.
Ampulla waħda ta ’ trab fiha 75 IU ta ’ follitropin alfa u kull ampulla ta ’ solvent fiha 1ml ta ’ ilma għall - injezzjoni.
Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom.
Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom
Danmark E.
185 Danmark E.
Italia Merck Serono S. p. A.
186 Suomi/ Finland Italia Merck Serono S. p. A.
189 PACKAGE LEAFLET:
187 FULJETT TA ’ TAGĦRIF:
WHAT GONAL-f IS AND WHAT IT IS USED FOR
X’ INHU GONAL- F U GĦAL XIEX JINTUŻA
• In women who are not ovulating due to very low production of the fertility hormones (FSH and LH) by their pituitary gland, GONAL-f is used together with another hormone called lutropin alfa (recombinant human luteinising hormone) to cause ovulation.
• 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. • ’ 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.
190 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
If you are a woman:
188 Jekk int mara:
If you are a woman, this treatment increases your risk of developing ovarian hyperstimulation syndrome (OHSS) (see Section 4).
Jekk int mara, din il- kura żżidlek ir- riskju li tiżviluppa s- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji (OHSS) (ara Sezzjoni 4).
191 GONAL-f should not be administered as a mixture with other medicinal products in the same injection, except for lutropin alfa.
GONAL- f m’ għandux jittieħed bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni, ħlief mal- lutropin alfa.
Important information about some of the ingredients of GONAL-f
189 Informazzjoni importanti dwar xi wħud ta ’ l- ingredjienti ta ’ GONAL- f
Always take GONAL-f exactly as your doctor has told you.
Dejjem għandek tieħu Gonal- f skond il- parir tat- tabib.
192 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
If your doctor does not observe a response of your ovaries after 3 weeks of treatment, that cycle should be abandoned.
190 Jekk it- tabib ma jarax riżultati pożittivi fuq l- ovarji tiegħek wara 3 ġimgħat ta ’ kura, dak iċ- ċiklu għandu jitwaqqaf.
• Assemble and lay out on a clean surface everything you need:
Iġbor u ifrex kull m’ għandek bżonn fuq wiċċ nadif: fjala waħda bit- trab ta ’ GONAL- f fjala waħda bis- solvent żewġ ċraret bl- alkoħol siringa waħda labra għar- rikostituzzjoni u labra fina għall- injezzjoni taħt il- ġilda kontenitur
one vial containing GONAL-f powder one pre-filled syringe containing the solvent two alcohol swabs one needle for reconstitution and a fine bore needle for subcutaneous injection sharp container
Waħħal il- labra għar- rikostituzzjoni mas - siringa u iġbed ftit arja fis- siringa billi tiġbed il- planġer sa madwar il- marka ta ’ 1 ml.
Remove the protective caps from the GONAL-f vial and from
B’ attenzjoni niżżel is- siringa fuq il- bank fejn qed taħdem, u oqgħod attent li ma tolqotx il- labra.
193 the solvent pre-filled syringe.
• Ipprepara s- soluzzjoni għall- injezzjoni:
Attach the needle for reconstitution to the pre-filled syringe and slowly inject all the solvent into the vial of GONAL-f powder.
Neħħi l- għatu ta ’ sigurtà mill- fjala tat- trab ta ’ GONAL - f, aqbad is- siringa tiegħek u bil- mod injetta s- solvent kollu fil- fjala tat- trab.
Do not shake.
Dawwar bil- mod mingħajr ma tneħħi s- siringa. Tħawwatx bis- saħħa.
• After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
Wara li t- trab ikun inħall (li normalment tiġri immedjatament), ivverifika li s- soluzzjoni hi ċara u ma fihiex frak.
Turn the vial upside down, gently draw the solution back into the syringe.
Eqleb il- fjala rasha l- isfel u bil- mod iġbed is- soluzzjoni lura fis- siringa.
(If you have been prescribed more than one vial of GONAL-f, slowly re-inject the solution into another powder vial, until you have the prescribed number of powder vials dissolved in the solution.
(Jekk ir- riċetta tindikalek aktar minn fjala waħda ta ’ GONAL- f, erġa ’ injetta bil- mod is- soluzzjoni fi fjala oħra tat- trab, sakemm in- numru preskritt ta ’ fjali tat- trab ikunu nħallu fis- soluzzjoni.
If you have been prescribed lutropin alfa in addition to GONAL-f, you may also mix the two medicines as an alternative to injecting each product separately.
Jekk ingħatatlek preskrizzjoni għal lutropin alfa minnbarra GONAL- f, tista ’ tħallat ukoll iż- żewġ mediċini flimkien minflok tinjetta ż- żewġ prodotti separatament.
After dissolving the lutropin alfa powder, draw the solution back into the syringe and re-inject it into the vial containing GONAL-f.
Wara li jkun nħall it- trab tal- lutropin alfa, iġbed it- soluzzjoni lura fis- siringa u erġa ’ injettaha fil- fjala li fiha GONAL- f.
Up to three containers of powder may be dissolved in 1 ml of solvent.)
Sa 3 kontenituri ta ’ trab jistgħu jinħallu f’ 1ml ta ’ solvent.)
• Change the needle for the fine bore needle and remove any air bubbles:
191 • Ibdel il- labra għal- labra fina għat- titqib u neħħi xi bżieżaq ta ’ l- arja:
Push the plunger until the air bubbles are gone.
Bil- mod ibbotta il- planġer sakemm il- bżieżaq ta ’ l- arja jitilqu.
Your doctor or nurse will have already advised you where to inject (e. g. tummy, front of thigh).
It- tabib jew l- infirmiera tiegħek ikunu diġà issuġġerewlek fejn għandek tinjetta (eż żaqq, naħa ta ’ quddiem tal- koxxa).
Wipe the chosen area with an alcohol swab.
Imsaħ il- parti magħżula għall - injezzjoni b’ ċarruta mxarrba bl- alkoħol.
Inject the solution by pushing gently on the plunger.
Injetta s- soluzzjoni billi tibbota bil- mod il- planġer.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Neħħi l- labra mill - ewwel u naddaf il- ġilda billi timsaħha b' moviment ċirkolari b’ ċarruta mxarrba bl- alkoħol.
Once you have finished your injection, immediately discard all needles and empty glass containers in the sharp container provided.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi l- labar u il - kontenituri vojta tal- ħġieġ kollha fil- kontenitur provdut.
194 If you use more GONAL-f than you should
Jekk tieħu GONAL- f aktar milli suppost:
However this will only occur if hCG is administered (see section 2).
Madankollu dan iseħħ biss jekk jingħata l- hCG (ara sezzjoni 2)
Do not take a double dose to make up for a forgotten dose, please contact your doctor.
M’ ghandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see 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 sezzjoni 2).
In view of the above, to prevent such events, when the ovarian response is excessive, treatment with GONAL-f could be discontinued by your physician and the treatment with hCG abandoned.
192 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.
195 Do not store above 25°C.
Taħżinx f’ temperatura ‘ l fuq minn 25°C.
The expiry date refers to the last day of that month.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq l- ampulli, Id- data ta ’ skadenza tirreferi għal l - aħħar ġurnata ta ’ dak ix- xahar
What GONAL-f looks like and contents of the pack
193 Id- Dehra tal- prodott u d- daqs tal- pakkett
It is supplied in packs of 1, 5, 10 vials of powder with the corresponding number of solvent in pre-filled syringes.
Il- prodott jiġi f’ pakketti ta ’ 1, 5, 10 ampulli ta ’ trab bl- istess ammont ta ’ ampulli bis- solvent, f’ siringi mimlijien lesti.
Not all pack sizes may be marketed.
Jista ’ jkun il- kaz li mhux il- paketti kollha jkunu għal skop kummerċjali.
One vial of powder contains 75 IU of follitropin alfa and one pre-filled syringe of solvent contains 1 ml of Water for Injections.
Ampulla waħda ta ’ trab fiha 75 IU ta ’ follitropin alfa u kull ampulla ta ’ solvent fiha 1ml ta ’ ilma għall - injezzjoni.
Eesti Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel: +370 37320603
194 Eesti Österreich Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kaunas, Leedu Tel: +370 37320603
Latvija Merck Serono Pā rstā vniecī ba C/ o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kauņ a, Lietuva Tel: +370 37320603
195 Latvija Merck Serono Pārstāvniecība C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kauņa, Lietuva Tel: +370 37320603
United Kingdom Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX Tel: +44-208-818-7200
United Kingdom Merck Serono Ltd Bedfont Cross, Stanwell Road Feltham, Middlesex TW14 8NX Tel: +44- 208- 818- 7200:
198 PACKAGE LEAFLET:
196 FULJETT TA ’ TAGĦRIF:
GONAL-f 150 IU (11 micrograms) powder and solvent for solution for injection Follitropin alfa
GONAL- f 150 IU (11 mikrogrammi) trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa
199 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:
197 Jekk int mara:
200 GONAL-f should not be administered as a mixture with other medicinal products in the same injection, except for lutropin alfa.
GONAL- f m’ għandux jittieħed bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni, ħlief mal- lutropin alfa.
Important information about some of the ingredients of GONAL-f
198 Informazzjoni importanti dwar xi wħud ta ’ l- ingredjienti ta ’ GONAL- f
201 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
If your doctor does not observe a response of your ovaries after 3 weeks of treatment, that cycle should be abandoned.
199 Jekk it- tabib ma jarax riżultati pożittivi fuq l- ovarji tiegħek wara 3 ġimgħat ta ’ kura, dak iċ- ċiklu għandu jitwaqqaf.
one vial containing GONAL-f powder one pre-filled syringe containing the solvent two alcohol swabs one needle for reconstitution and a fine bore needle for subcutaneous injection sharp container
Iġbor u ifrex kull m’ għandek bżonn fuq bank nadif: fjala waħda bit- trab ta ’ GONAL- f siringa mimlija lesta bis- solvent żewġ ċraret bl- alkoħol labra li ser tintuża għar- rikostituzzjoni u labra fina għall- injezzjoni taħt il- ġilda kontenitur
• Prepare the injection solution:
Ipprepara s- soluzzjoni għall- injezzjoni:
Remove the protective caps from the GONAL-f vial and from
Neħħi l- għotjin ta ’ sigurtà mill- fjala ta ’ GONAL- f u mis - siringa mimlija lesta bis- solvent.
Attach the needle for reconstitution to the pre-filled syringe and slowly inject all the solvent into the vial of GONAL-f powder.
Waħħal il- labra għar - rikostituzzjoni mas- siringa mimlija lesta u bil- mod injetta s - solvent kollu fil- fjala tat- trab ta ’ GONAL- f.
Swirl gently without removing the syringe.
Dawwar bil- mod mingħajr ma tneħħi s- siringa.
Do not shake.
Dawwarx bis- saħħa.
• After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
• Wara li t- trab ikun inħall (li normalment tiġri immedjatament), ivverifika li s- soluzzjoni hi ċara u ma fihix frak.
If you have been prescribed lutropin alfa in addition to GONAL-f, you may also mix the two medicines as an alternative to injecting each product separately.
Jekk ir - riċetta tindikalek doża ta ’ lutropin alfa minnbarra GONAL- f, tista ’ tħallat ukoll iż- żewġ mediċini flimkien minflok tinjetta ż- żewġ prodotti separatament.
After dissolving the lutropin alfa powder, draw the solution back into the syringe and re-inject it into the vial containing GONAL-f.
Wara li jkun nħall it- trab tal- lutropin alfa, iġbed is- soluzzjoni lura fis- siringa u erġa ’ injettaha fil- fjala li fiha l- GONAL- f.
Inspect for particles as before, and do not use if the solution is not clear.
Bħal qabel, ara hemmx xi frak, u tużax is- soluzzjoni jekk din mhix ċara.
Up to three containers of powder may be dissolved in 1 ml of solvent.)
Sa 3 kontenituri ta ’ trab jistgħu jinħallu f’ 1ml ta ’ solvent.
• Change the needle for the fine bore needle and remove any air bubbles:
200 • Ibdel il- labra għal- labra fina għat- titqib u neħħi xi bżieżaq ta ’ l- arja:
Once you have finished your injection, immediately discard all needles and empty glass containers in the sharp container provided.
Hekk kif tkun lestejt l- injezzjoni tiegħek, armi l- labar u il - kontenituri vojta tal- ħġieġ kollha fil- kontnitur provdut.
203 If you use more GONAL-f than you should
Jekk tieħu GONAL- f aktar milli suppost:
If you forget to take GONAL-f
Jekk tinsa ’ tieħu GONAL- F:
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 sezzjoni 2).
In view of the above, to prevent such events, when the ovarian response is excessive, treatment with GONAL-f could be discontinued by your physician and the treatment with hCG abandoned.
201 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.
Do not use GONAL-f after the expiry date which is stated on the vial after the EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq l- ampulli.
The active substance is follitropin alfa, 150 IU (11 micrograms).
Is- sustanza attiva hi follitropin alfa, 150 IU (11 mikrogrammi).
Follitropin alfa is made from 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.
What GONAL-f looks like and contents of the pack
202 Id- Dehra tal- prodott u d- daqs tal- pakkett
It is supplied in packs of 1 vial of powder with 1 pre-filled syringe of solvent.
Il- prodott jiġi f’ pakketti ta ’ ampulla waħda ta ’ trab u siringa mimlija lesta ta ’ solvent.
One vial of powder contains 150 IU of follitropin alfa and one pre-filled syringe of solvent contains 1 ml of Water for Injections.
Ampulla waħda ta ’ trab fiha 150 IU ta ’ follitropin alfa u siringa mimlija lesta ta ’ solvent fiha 1ml ta ’ ilma għall- injezzjoni.
Eesti Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel: +370 37320603
203 Eesti Österreich Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kaunas, Leedu Tel: +370 37320603
Latvija Merck Serono Pā rstā vniecī ba C/ o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kauņ a, Lietuva Tel: +370 37320603
204 Latvija Merck Serono Pārstāvniecība C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kauņa, Lietuva Tel: +370 37320603
207 PACKAGE LEAFLET:
205 FULJETT TA ’ TAGĦRIF:
GONAL-f 37.5 IU (2.8 micrograms) powder and solvent for solution for injection Follitropin alfa
GONAL- f 37. 5 IU (2. 8 mikrogrammi) trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa
- If you have any further questions, ask your doctor or your pharmacist.
Jista jkollok bżonn terġa taqrah. • Jekk għandek aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija għall- użu personali tiegħek u m’ għandekx tagħtiha lil persuni oħra.
please tell you doctor or pharmacist.
F’ dan il- fuljett:
BEFORE YOU USE GONAL-f
QABEL MA TUŻA GONAL- f
208 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
If you are a woman:
206 Jekk int mara:
209 GONAL-f should not be administered as a mixture with other medicinal products in the same injection, except for lutropin alfa.
GONAL- f m’ għandux jittieħed bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni, ħlief mal- lutropin alfa.
Pregnancy and breast-feeding
207 Tqala u treddigħ:
Important information about some of the ingredients of GONAL-f
Informazzjoni importanti dwar xi wħud ta ’ l- ingredjienti ta ’ GONAL- f
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tieghek jekk ikollok xi dubju.
210 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 three weeks simultaneously with injections of lutropin alfa.
208 Ġeneralment, GONAL- f jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet ta ’ lutropin alfa.
If your doctor does not observe a response of your ovaries after 3 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.
- - - - -
- - - - - - -
one vial containing GONAL-f powder one pre-filled syringe containing the solvent two alcohol swabs one needle for reconstitution and a fine bore needle for subcutaneous injection sharp container
Iġbor u ifrex kull m’ għandek bżonn fuq bank nadif: fjala waħda bit- trab ta ’ GONAL- f fjala waħda bis- solvent żewġ ċraret bl- alkoħol siringa waħda labra għar- rikostituzzjoni u labra fina għall- injezzjoni taħt il- ġilda kontenitur
211 • Prepare the injection solution:
• Ipprepara s- soluzzjoni għall- injezzjoni:
Attach the needle for reconstitution to the pre-filled syringe and slowly inject all the solvent into the vial of GONAL-f powder.
Neħħi l- kappi protettivi ta ’ l- ampulla ta ’ GONAL- f u tas- siringa mimlija lesta għal l- użu tas- solvent. Waħħal il - labra li ser tuża biex tħallat mas- siringa mimlija lesta tas - solvent, u bil- mod injetta s- solvent fl- ampulla tat- trab ta ’ GONAL- f.
• After the powder has dissolved (which usually occurs immediately), check that the resulting solution is clear and does not contain any particles.
• Wara li jkun inħall it- trab (li normalment iseħħ mill- ewwel), ara li s- soluzzjoni hija ċara u li ma fihiex frak.
Turn the vial upside down, gently draw the solution back into the syringe.
Dawwar l- ampulla taħt fuq u iġbed bil- mod is- soluzzjoni lura fis- siringa.
(If you have been prescribed more than one vial of GONAL-f, slowly re-inject the solution into another powder vial, until you have the prescribed number of powder vials dissolved in the solution.
Jekk
If you have been prescribed lutropin alfa in addition to GONAL-f, you may also mix the two medicines as an alternative to injecting each product separately.
209 ingħatatlek preskrizzjoni għal lutropin alfa minnbarra GONAL- f, tista ’ tħallat ukoll iż- żewġ mediċini flimkien minflok tinjetta ż- żewġ prodotti separatament.
Up to three containers of powder may be dissolved in 1 ml of solvent.)
Sa 3 kontenituri ta ’ trab jistgħu jinħallu f’ ampulla waħda ta ’ solvent.)
212 If you use more GONAL-f than you should
Jekk tieħu GONAL- f aktar milli suppost:
However this will only occur if hCG is administered (see section 2).
Madankollu dan iseħħ biss jekk jingħata l- hCG (ara sezzjoni 2).
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see 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).
First symptoms of ovarian hyperstimulation are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain.
L- ewwel sintomi ta ’ iperstimulazzjoni ta ’ l- ovarji huma uġigħ fil- parti t’ isfel ta ’ l- addome, possibbilment flimken ma ’
In serious, but rare cases, an ovarian hyperstimulation syndrome with clearly enlarged ovaries, can go hand in hand with possible accumulation of fluid in the abdomen or thorax as well as more serious thromboembolic complications.
F’ każi serji, iżda rari, is- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji bi tkabbir evidenti ta ’ l- ovarji, jista ’ jwassal, possibbilment, għal akkumulazzjoni ta ’ fluwidu fl- addome jew fit - toraċi, kif ukoll b’ mod aktar serju, komplikazjoniet tromboemboliċi.
In rare cases the latter can also be found independently of ovarian hyperstimulation syndrome.
F’ każi rari, dan ta ’ l- aħħar jista ’ jiġri wkoll indipendentement mis- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji.
Do not use GONAL-f after the expiry date which is stated on the vial after EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq l- ampulli.
The active substance is follitropin alfa, 37.5 IU (2.8 micrograms).
Is- sustanza attiva hi follitropin alfa, 37. 5 IU (2. 8 mikrogrammi).
The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, methionine, polysorbate 20, concentrated phosphoric acid and sodium hydroxide.
211 Is- sustanzi l- oħra huma sukrożju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, metjonina, polisorbat 20, aċidu fosforiku konċentrat u idrossidu tas- sodju.
One vial of powder contains 37.5 IU of follitropin alfa and one pre-filled syringe of solvent contains 1 ml of Water for Injections.
Ampulla waħda ta ’ trab fiha 37. 5 IU ta ’ follitropin alfa u siringa mimlija lesta ta ’ solvent fiha 1ml ta ’ ilma għall- injezzjoni.
Deutschland Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel: +49-6151-6285-0
212 Deutschland Serono GmbH Alsfelder Straße 17 D- 64289 Darmstadt Tel: +49- 6151- 6285- 0
216 PACKAGE LEAFLET:
214 FULJETT TA ’ TAGĦRIF:
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) powder and solvent for solution for injection Follitropin alfa
GONAL- f 1050 IU/ 1. 75ml (77 mikrogrammi/ 1. 75ml) trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa
217 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
If you are a woman:
215 Jekk int mara:
GONAL-f should not be given to men with irreversible testicular damage.
GONAL- f m’ għandux jingħata lill- irġiel li għandhom dannu testikolari irriverssibli.
218 Using other medicines
Użu ta ’ mediċini oħra:
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) should not be mixed with other medicines in the same injection.
GONAL- f m’ għandux jittieħed bħala taħlita ma ’ prodotti mediċinali oħra fl- istess injezzjoni, ħlief mal- lutropin alfa.
GONAL-f 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
Studji wrew li dawn iż- żewġ mediċini jistgħu jitħalltu u jiġu injettati flimkien, mingħajr effetti negattivi fuq l- ebda wieħed minnhom.
3.
216 3.
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 spiżjar tiegħek jekk ikollok xi dubju.
The maximal daily dose is usually not higher than 225 IU FSH (0.38 ml).
Ġeneralment, id- doża massima ta ’ kuljum ma taqbiżx il- 225 IU FSH.
A commonly used dose for superovulation involves the administration of 150-225 IU (0.25-0.38 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 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 (0.75 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 kuljum.
219 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).
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
A commonly used dose starts with 75-150 IU (0.13-0.25 ml) of GONAL-f together with 75 IU of lutropin alfa.
Doża wżata b’ mod komuni tibda b’ 75- 150 IU ta ’ GONAL- f flimkien ma ’ 75 IU ta ’ lutropin alfa.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4).
217 Jekk jinkiseb riżultat eċċessiv, il- kura għandha titwaqqaf u jinżamm l- hCG (ara Effetti li jistgħu jinħassu).
GONAL-f is usually prescribed at a dose of 150 IU (0.25 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 tliet darbiet fil- ġimgħa flimkien ma ’ mediċina oħra (hCG) għal mill- inqas 4 xhur.
If you administer GONAL-f to yourself, please carefully read the following instructions:
Għandha tintuża darba biss.
You should use one of the 15 administration syringes graduated in FSH units provided.
Jekk se tagħti GONAL- f lilek innifsek, jekk jogħġbok aqra dawn l- istruzzjonijiet segwenti sew:
Find a clean area and lay out everything (two alcohol swabs, the 2 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)
See illustration.
Ara l- istampa.
Prepare the injection solution:
3. i ser tintuża glesta bis- solventIpprepara s- soluzzjoni għall- injezzjoni:
You should have a 2 ml pre-filled syringe containing clear liquid (the solvent) and one vial containing GONAL-f (the white powder).
Irid ikollok siringa 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 tas- siringa mimlija lesta.
Pick up your pre-filled syringe of solvent and slowly inject all the solvent (2 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.
Remove the syringe used for reconstitution from the vial and dispose of it.
Neħħi s- siringa li uzajt għal rikostituzzjoni minn l- ampulla u għarmiha.
This vial contains several doses of GONAL-f.
Din l- ampulla fiha ħafna dozi ta ’ GONAL- f.
You will have to keep this vial several days and only draw the dose prescribed every day.
Trid izzomha għal ftit ijiem u tiegħu doza kull jum.
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.
5.
218 5.
Remove any air bubbles:
Neħħi l - bżieżaq ta ’ l- arja: jekk tara bżieżaq ta ’ arja fis- siringa, żomm is- siringa bil- labra
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.
tipponta ’ l fuq, u bil- mod taptap fuq s- siringa sakemm l - arja kollha tinġabar fuq.
Inject the solution:
Injetta s- soluzzjoni.
Dispose of all used items:
Armi l- oġġetti kollha li wżajt:
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.
For further injections with the reconstituted solution of GONAL-f, repeat steps 4. to 7.
Kull fdal tas- soluzzjoni mhux użat għandu jintrema.
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.
However this will only occur if hCG is administered (see section 2).
Madankollu dan iseħħ biss jekk jingħata l- hCG (ara s- sezzjoni 2).
Due to a local reactivity to benzyl alcohol, the same site of injection should not be used on consecutive days.
Peress illi jukn hemm reazzjoni local għal benzyl alcohol, l- istess sit ta ’ l- injezzjoni m’ għandux jintuża f’ ġranet konsekuttivi.
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see 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 s- sezzjoni 2).
First symptoms of ovarian hyperstimulation are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain.
L- ewwel sintomi ta ’ iperstimulazzjoni ta ’ l - ovarji huma uġigħ fil- parti t’ isfel ta ’ l- addome, possibbilment flimken ma ’ nawżea, remettar u żieda fil- piż.
In serious, but rare cases, an ovarian hyperstimulation syndrome with clearly enlarged ovaries, can go hand in hand with possible accumulation of fluid in the abdomen or thorax as well as more serious thromboembolic complications.
219 F’ każi serji, iżda rari, is- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji bi tkabbir evidenti ta ’ l- ovarji, jista ’ jwassal, possibbilment, għal akkumulazzjoni ta ’ fluwidu fl- addome jew fit- toraċi, kif ukoll b’ mod aktar serju, komplikazjoniet tromboemboliċi.
Rarely 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.
Prior to reconstitution, do not store above 25°C.
Taħżinx f’ temperatura ‘ l fuq minn 25°C.
Do not use GONAL-f after the expiry date which is stated on the vial label or carton after EXP.
M’ għandekx tuża wara d- data li jiskadi li tidher fuq l- ampulli.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għal l - aħħar ġurnata ta ’ dak ix- xahar.
Once the medicine is reconstituted (made up with the solvent), do not store above 25°C.
Taħżinx ss- soluzzjoni rikostitwita (magħmula mas- solvent) f’ temperatura ‘ l fuq minn 25°C.
Do not freeze.
Taħżinx fil- friża.
Store in the original container and use within 28 days.
Aħżen fil- pakkett oriġinali w uża f’ 28 il- ġurnata.
The reconstituted solution should not be administered if it contains particles or is not clear.
M’ għandiex tittieħed jekk ikun fiha xi frak jew mhiex ċara.
The active substance is follitropin alfa, 1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml).
Is- sustanza attiva hi follitropin alfa, 1050 IU/ 1. 75ml (77 mikrogrammi/ 1. 75ml).
The other ingredients are sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
220 Is- sustanzi l- oħra huma sukrożju, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di- sodju, aċidu fosforiku konċentrat u idrossidu tas- sodju.
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 15 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 15- il labra disposabil ghal amministrazzjoni, b’ gradi ta ’ FSH.
One multidose vial of powder contains 1200 IU of follitropin alfa and one pre-filled syringe contains 2 ml of solvent.
Ampulla waħda ta ’ trab b’ hafna dosi fiha 1200 IU ta ’ follitropin alfa u siringa mimlija lesta ta ’ solvent fiha 2ml ta ’ ilma għall- injezzjoni.
223 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- Sid ta ’ l- Awtorizzazzjoni għall- Kummerċ.
Deutschland Serono GmbH Alsfelder Straße 17 D-64289 Darmstadt Tel: +49-6151-6285-0
221 Deutschland Serono GmbH Alsfelder Straße 17 D- 64289 Darmstadt Tel: +49- 6151- 6285- 0
Κύπρος Akis Panayiotou & Son Ltd Γιάννου Κρανιδιώτη 4 CY-225 78, Λευκωσία Τηλ: +357-22677038
222 Κύπρος Akis Panayiotou & Son Ltd Γιάννου Κρανιδιώτη 4 CY- 225 78, Λευκωσία Τηλ: +357- 22677038
226 PACKAGE LEAFLET:
223 FULJETT TA ’ TAGĦRIF:
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) powder and solvent for solution for injection Follitropin alfa
GONAL- f 450 IU/ 0. 75ml (33 mikrogrammi/ 0. 75ml) trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa
227 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin:
If you are a woman:
224 Jekk int mara:
GONAL-f multidose is intended for several injections.
GONAL- f b’ ħafna dosi huwa għall- użu mulitplu.
228 Using other medicines
Użu ta ’ mediċini oħra:
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) should not be mixed with other medicines in the same injection.
GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml) mhux suppost jitħallat ma ’ mediċinali oħra fl - istess injezzjoni.
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) preparation is not to be mixed with other GONAL-f containers within the same vial or syringe.
GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml) mhux suppost jitħallat ma ’ preparazzjonijiet oħra ta ’ GONAL- f fl- istess ampulla jew siringa.
Pregnancy and breast-feeding
225 Tqala u treddigħ:
229 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.
226 Ġeneralment, GONAL- f jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet ta ’ lutropin alfa.
GONAL-f is intended for subcutaneous use, that means given by injection just under the skin.
Għandha tintuża darba biss.
Individual reconstituted vials should be for single patient use only.
Ampulli individwali ta ’ solvent irrikositut huma għall- użu ta ’ pazjient singolari biss.
As this vial contains enough medication for several days of treatment, you need to make sure you only draw the amount of medication that was prescribed by your doctor.
Peress illi din l - ampulla fiha medikazzjoni għal diversi jiem, trid toqgħod attent illi tiegħu biss l- ammont li ġie preskritt mit- tabib tiegħek.