qanastek/EMEA-V3 huggingface dataset:
The solvent pre-filled syringe provided should be used for reconstitution only.
Is- siringa mimlija lesta tas- solvent trid tiġi pproveduta għal rikostitwazzjoni biss.
The reconstituted vial should be for single patient use only.
L- ampulla rrikostitwit huwa għall- użu singolari biss tal- pazjent.
Prior to reconstitution, do not store above 25°C.
Qabel ir- rikonstituzzjoni, taħżinx f’ temperatura ‘ l fuq minn 25°C.
After reconstitution, do not store above 25°C.
Wara ir- rikonstituzzjoni, taħżinx f’ temperatura ‘ l fuq minn 25°C.
Store in the original container.
Aħżen fil - pakkett oriġinali
Discard any unused solution after 28 days.
Armi kull soluzzjoni mhux użata, wara 28- il ġurnata.
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L - AWTORIzzAZZJONI GĦAT- TQEGĦID FIS- SUQ
15 disposable syringes.
15- il siringi disposabil
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKZZJONI ĠENERALI TA ’ KIF JINGĦATA
137 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 1050 IU/ 1.75 ML (77 MICROGRAMS/ 1.75 ML), VIAL LABEL
137 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ FJALA GONAL- f 1050 IU/ 1. 75 ML (77 MIKROGRAMMI/ 1. 75 ML)
GONAL-f 1050 IU/ 1.75 ml powder for solution for injection Follitropin alfa Subcutaneous use.
Użu għal taħt il- ġilda.
EXP
ISS
DATE OF RECONSTITUTION
DATA TA ’ RIKOSTIZZUZZJONI
1200 IU (87 µg)/ vial
1200 IU (87 µg) / ampulla
138 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE TEXT
138 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA LESTA TA ’ SOLVENT
Water for Injections, benzyl alcohol 0.9% Solvent for use with GONAL-f 1050 IU/ 1.75 ml
Ilma għall- injezzjoni, benzyl alcohol 0. 9% Solvent għall- użu ma ’ GONAL- f 1050 IU / 1. 75ml.
EXP
JISS
2 ml/ pre-filled syringe
2ml / siringa mimlija lesta
139 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
139 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ FJALIA U SIRINGA MIMILIJA LESTA
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) powder and solvent for solution for injection.
GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml) trab u solvent għal soluzzjoni għall- injezzjoni.
One multidose vial of powder contains: follitropin alfa 600 IU/ ml.
Fjala waħda b ’ ħafna dosi tinkludi: follitropin alfa 600 IU/ ml.
Net content per vial:
Kontenut nett ta ’ fjala:
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi:: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid u sodium hydroxide.
1 ml water for injections, benzyl alcohol 0.9%.
1 ml ilma għall- injezzjonijiet, benzyl alcohol 0. 9%.
1 pre-filled syringe of solvent.
Siringa mimlija lesta ta’ solvent.
6 disposable syringes for administration graduated in FSH units.
6 siringi disposabil għall- amministrazzjoni bil- gradazzjonijiet ta ’ uniti ta ’ FSH.
Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel ma tużah.
Store in the original container.
Aħżen fil - pakkett oriġinali.
6 disposable syringes.
6 siringi disposabil
141 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml), VIAL LABEL
141 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ FJALA GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml)
GONAL-f 450 IU/ 0.75 ml powder for solution for injection Follitropin alfa Subcutaneous use.
Użu minn taħt il- ġilda.
DATE OF RECONSTITUTION
NUMRU TA ’ RIKOSTIZZUZZJONI
600 IU (44 µg)/ vial
600 IU (44 µg) / fjala
142 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE TEXT
142 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA LESTA TA ’ SOLVENT
Water for Injections, benzyl alcohol 0.9% Solvent for use with GONAL-f 450 IU/ 0.75 ml
Solvent għall- użu ma ’ GONAL- f 450 IU/ 0. 75ml.
1 ml/ pre-filled syringe
1 ml / siringa mimlija lesta
143 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL AND 1 PRE-FILLED SYRINGE
143 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTA TA ’ BARRA TAL- PAKKETT KAXXA TA ’ FJALA 1 U SIRINGA MIMLIJA LESTA
GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml) powder and solvent for solution for injection.
GONAL- f 300 IU/ 0. 5ml (22 mikrogrammi/ 0. 50ml), trab u solvent għal soluzzjoni għall- injezzjoni.
Other ingredients: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid and sodium hydroxide.
Sustanzi mhux attivi: sucrose, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, concentrated phosphoric acid u sodium hydroxide.
One pre-filled syringe of solvent contains:
Siringa waħda mimlija lesta tinkludi:
0.75 ml water for injections, benzyl alcohol 0.9%.
0. 7ml ilma għall- injezzjonijiet, benzyl alcohol 0. 9%.
1 pre-filled syringe of solvent.
Fjala ta ’ trab għas- soluzzjoni għall- injezzjoni Siringa mimlija lesta ta’ solvent.
4 disposable syringes for administration graduated in FSH units.
4 siringi disposabil għall- amministrazzjoni bil- gradazzjonijiet ta ’ uniti ta ’ FSH.
Discard any unused solution after 28 days.
Armi kull soluzzjoni mhux użata, war 28- il ġurnata.
4 disposable syringes.
4 siringi disposabil.
145 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 300 IU/ 0.50 ml (22 micrograms/ 0.50 ml), VIAL LABEL
145 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ FJALA gonal- f 300 IU/ 0. 50 ml (22 mikrogrammi/ 0. 50 ml)
GONAL-f 300 IU/ 0.50 ml powder for solution for injection Follitropin alfa Subcutaneous use.
Użu taħt il- ġilda.
450 IU (33 µg)/ vial
450 IU (33 µg) / fjala
146 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT PRE-FILLED SYRINGE TEXT
146 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA LESTA TA ’ SOLVENT
Water for Injections, benzyl alcohol 0.9% Solvent for use with GONAL-f 300 IU/ 0.50 ml
Solvent għall- użu ma ’ GONAL- f 300 IU/ 0. 50ml.
0.75 ml/ pre-filled syringe
0. 75 ml / siringa mimlija lesta
147 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 CARTRIDGE PREASSEMBLED WITH A PREFILLED PEN
147 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ SKARTOCC FLIMKIEN MA ’ PINNA MIMLIJA LESTA
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) solution for injection in a pre-filled pen.
GONAL- f 300 IU/ 0. 5ML (22 mikrogrammi/ 0. 5ml), 75 IU( 5. 5 mikrogrammi), soluzzjoni għall - injezzjoni, f’ pinna mimlija lesta.
One cartridge delivers 300 IU follitropin alfa, equivalent to 22 micrograms, per 0.5 ml.
Skartoċċ waħda tagħti 300 IU follitropin alfa, ekwivalenti għal 22 mikrogrammi / ml.
Follitropin alfa, 600 IU/ ml (equivalent to 44 micrograms/ ml)
Follitropin alfa, 600 IU/ ml (ekwivalenti għal 44 mikrogrammi/ ml).
Poloxamer 188, sucrose, methionine, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, m-cresol, concentrated phosphoric acid, sodium hydroxide and water for injections.
Poloxamer 188, sukrozju, metjonina, fosfat mono- idrat tas- sodju di- idroġinat, fosfat di- idrat tad- di - sodju, m- cresol, aċidu phosphoric ikkonċentrat, sodju hydroxide w ilma għall- injezzjonijiet.
Solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni f’ pinna mimlija lesta.
One cartridge in a pre-filled pen and 5 needles for administration.
Skartoċċ f’ pinna mimlija lesta ma ’ ħames labar għal amministrazzjoni.
For single use only.
Għall- użu singolari biss.
Do not freeze.
Tagħmlux fil - friża.
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.
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 product or waste material should be disposed in accordance with local requirements.
Kull prodott jew skart li mhux użata għandhom jitremew skond il- liġijiet lokali.
solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni f’ pinna mimlija lesta.
5 needles.
Ħames labar.
Batch
Lott Lott tas- Solvent
149 PARTICULARS TO APPEAR ON THE PEN
149 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PINNA
GONAL-f 300 IU/ 0.5 ml
GONAL- f 300 IU/ 0. 5 ml
A sticker will be added to allow the patient to write the day of first use.
Ikun hemm stikker ħalli il- pazjent ikun jista ’ jikteb id- data ta ’ meta beda ’ jintuża.
150 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 300 IU/ 0.5 ML (22 MICROGRAMS/ 0.5 ML) PEN, CARTRIDGE LABEL
150 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TA ’ L- ISKARTOCC, PINNA GONAL- f 300IU / 0. 5ML (22 MIKROGRAMMI/ 0. 5 ML)
GONAL-f 300 IU/ 0.5 ml (22 micrograms/ 0.5 ml) solution for injection in a pre-filled pen.
GONAL- f 300 IU/ 0. 5 ml (22 miKrogrammi/ 0. 5 ml) soluzzjoni għall- injezzjoni f’ pinna mimlija lesta.
EXP Shelf-life after first use:
JIS Data meta jiskadi wara l- ewwel użu:
28 days
28- il ġurnata.
300 IU/ 0.5 ml
300 IU/ 0. 5 ml
151 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 CARTRIDGE PREASSEMBLED WITH A PREFILLED PEN
151 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ SKARTOCC FLIMKIEN MA ’ PINNA MIMLIJA LESTA
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) solution for injection in a pre-filled pen.
GONAL- f 450 IU/ 0. 75ml (33 mikrogrammi/ 0. 75ml), soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
One cartridge delivers 450 IU follitropin alfa, equivalent to 33 micrograms, per 0.75 ml.
Skartoċċ waħda tagħti 450 IU follitropin alfa, ekwivalenti għal 33 mikrogrammi/ 0. 75ml.
Follitropin alfa, 600 IU/ ml (equivalent to 44 micrograms/ ml)
Follitropin alfa, 600 IU/ ml (ekwivalenti għal 44 mikrogrammi/ ml)
Solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
One cartridge in a pre-filled pen and 7 needles for administration.
Skartoċċ waħda f’ pinna mimlija lesta u 7 labar għal amministrazzjoni.
For single use only.
Għal l- użu singolari biss.
Store in a refrigerator).
Aħżen fi friġġ.
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.
Sad- data ta ’ meta jiskadi, il- prodott jista ’ jinħażen f’ temperauta ta ’ 25°C jew inqas sa tlett xhur mingħajr ma jitpoġġa fil- friġġ u għandu jintrema ’ jekk ma jintuzax wara tlett xhur.
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 mhux iktar minn 28 ġurnata, f’ temperatura ta ’ 25°C jew inqas.
solution for injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
7 needles.
7 labar.
153 PARTICULARS TO APPEAR ON THE PEN
153 TAGĦRIF LI GĦANDU JIDHER FUQ IL - PINNA MIMLIJA LESTA
GONAL-f 450 IU/ 0.75 ml
GONAL- f 450 IU/ 0. 75 ml
154 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 450 IU/ 0.75 ML (33 MICROGRAMS/ 0.75 ML) PEN, CARTRIDGE LABEL
154 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GONAL- f 450 IU/ 0. 75ML (33 MIKROGRAMMI/ 0. 75ML), PINNA MIMLIJA LESTA, TIKKETTA TA ’ SKARTOĊĊ
GONAL-f 450 IU/ 0.75 ml (33 micrograms/ 0.75 ml) solution for injection in a pre-filled pen.
GONAL- f 450 IU/ 0. 75 ml (33 mikrogrammi/ 0. 75 ml) soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
28 days
28- il ġurnata
450 IU/ 0.75 ml
450 IU/ 0. 75 ml
155 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 CARTRIDGE PREASSEMBLED WITH A PREFILLED PEN
155 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ SKARTOĊĊ FLIMKIEN MA ’ PINNA MIMLIJA LESTA
GONAL-f 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml) solution for injection in a pre-filled pen.
GONAL- f 900 IU/ 1. 5 ml (66 mikrogrammi/ 1. 5 ml), soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
One cartridge delivers 900 IU follitropin alfa, equivalent to 66 micrograms, per 1.5 ml.
Skartoċċ waħda tagħti 900 IU follitropin alfa, ekwivalenti għal 66 mikrogrammi/ 1. 5ml.
One cartridge in a pre-filled pen and 14 needles for administration.
Skartoċċ waħda f’ pinna mimlija lesta u 14- il labra għal amministrazzjoni.
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.
156 Sad- data ta ’ meta jiskadi, il- prodott jista ’ jinħażen f’ temperauta ta ’ 25°C jew inqas sa tlett xhur mingħajr ma jitpoġġa fil- friġġ, u għandu jintrema ’ jekk ma jintuzax wara tlett xhur..
Any unused product or waste material should be disposed in accordance with local requirements.
Kull prodott jew skart li mhux użata għandhom jitremew skond il- liġijiet lokali
solutionfor injection in a pre-filled pen.
Soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
14 needles.
14- il labra.
157 PARTICULARS TO APPEAR ON THE PEN
157 TAGĦRIF LI GĦANDU JIDHER FUQ IL - PINNA MIMLIJA LESTA
GONAL-f 900 IU/ 1.5 ml
GONAL- f 900 IU/ 1. 5 ml
158 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS GONAL-f 900 IU/ 1.5 ML (66 MICROGRAMS/ 1.5 ML) PEN, CARTRIDGE LABEL
158 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN GONAL- f 900 IU/ 1. 5ML (66 MIKROGRAMMI/ 1. 5ML), PINNA MIMLIJA LESTA, TIKKETTA TA ’ SKARTOĊĊ
GONAL-f 900 IU/ 1.5 ml (66 micrograms/ 1.5 ml) solution for injection in a pre-filled pen.
GONAL- f 900 IU/ 1. 5 ml (66 mikrogrammi/ 1. 5 ml) soluzzjoni għall- injezzjoni, f’ pinna mimlija lesta.
Read package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel ma tużah.
900 IU/ 1.5 ml
900 IU/ 1. 5 ml
160 PACKAGE LEAFLET:
160 FULJETT TA ’ TAGĦRIF:
GONAL-f 75 IU powder and solvent for solution for injection Follitropin alfa
GONAL- f 75 IU trab u solvent għal soluzzjoni għall- injezzjoni 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 ikollok 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.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar
Before you use GONAL-f 3.
Qabel ma tuża GONAL- f 3.
How to use GONAL-f 4.
Kif għandek tuża GONAL- f 4.
How to store GONAL-f 6.
Kif taħżen GONAL- f 6.
WHAT GONAL-f IS AND WHAT IT IS USED FOR
X’ INHU GONAL- F U GĦALXIEX JINTUŻA
GONAL-f is a medicinal product containing follitropin alfa, which is made in laboratories by special recombinant DNA techniques.
GONAL- f huwa prodott mediċinali li fih follitropin alfa, li ġie magħmul f’ laboratorji permezz ta ’ tekniċi ta ’ DNA rikombinanti.
It belongs to the family of hormones called gonadotrophins, which are involved in the normal control of reproduction.
Jagħmel parti mill- familja ta ’ ormoni magħrufa bħala gonadotrofini, li huma involuti fil- kontroll normali tar- riproduzzjoni.
The medicinal product should only be used under the strict supervision of a physician.
Dan il- prodott mediċinali għandu jintuża biss taħt osservazzjoni mill- qrib ta ’ tabib
• 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. • 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.
BEFORE YOU USE GONAL-f
QABEL MA TUŻA GONAL- F
You and your partner's fertility should be evaluated before the treatment is started.
Qabel ma tibda l- kura għandha tiġi eżaminata l- fertilita tiegħek u tas- sieħeb tiegħek.
161 Do not use GONAL-f
161 Jekk int mara:
• ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological bleeding of unknown cause • 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
The medicine should not be used when a condition exists which would make a normal pregnancy impossible, such as premature menopause, malformation of sexual organs or specific tumours of the womb.
Din il- mediċina m’ għandiex tintuża fejn teżisti kundizzjoni li ma tippermettix li sseħħ tqala normali, bħall- menopawża minn kmieni, meta jkun hemm difett fiżiku fl- organi sesswali jew tumuri speċifiċi fil- ġuf.
If you are a man:
Jekk int raġel:
• GONAL-f should not be given to men with irreversible testicular damage.
GONAL- f m’ għandux jingħata lill- irġiel li għandhom dannu testikolari irriverssibli.
In addition, no studies on the effects on ability to drive and use machines have been performed.
Barra minn hekk, ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
Take special care with GONAL-f
Oqgħod attent ħafna b’ GONAL- f:
If you have porphyria or a family history of porphyria (a disorder that may be passed on from parents to children), you should inform your doctor as the use of certain medications may trigger an attack of the illness.
Jekk tbagħti minn porphyria jew għandek passat fil- familja ta ’ porphyria (dizordni li jista ’ jgħaddi mil - ġenturi għat- tfal), għandek tagħarraf lit- tabib tiegħek peress illi l- użu ta ’ ċerti mediċini jistgħu jistimulaw xi attak ta ’ din il- marda.
If you notice your skin becoming fragile and easily blistered (especially areas that are frequently exposed to sunlight) and/ or you have stomach or limb pain you should tell your doctor who may recommend that you stop treatment.
Jekk tinduna illi l- ġilda tiegħek issir fraġli u faċilment ikkollok xi nuffata (speċjalment f’ postijiet li huma frekwentament esposti għax- xemx) u/ jew ikollok uġigħ f’ zaqqek jew f’ riġlejk, trid tgħid lit- tabib tiegħek li jista ’ jirrakomanda illi twaqqaf il- kura.
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).
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.
GONAL-f treatment in either indication 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.
It is therefore prudent to withhold administration of hCG in cases where OHSS is developing and not to have sexual intercourse or use barrier methods for at least four days.
Għalhekk ikun prudenti li jinżamm l - hCG f’ każ fejn ikun hemm OHSS u li l- pazjenti ma jkollhomx x' jaqsmu mas- sieħeb tagħhom jew jużaw metodi kontraċettivi ta’ barriera għal ta ’ l- anqas erbat ijiem.
The risk of multiple pregnancy following assisted reproductive technologies is related to the number of oocytes/ embryos replaced.
Ir- riskju ta ’ tqala multipla wara l- użu ta ’ teknoloġija ta ’ riproduzzjoni assistita hija relatata man- numru ta ’ ooċiti/ embriji mibdula.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
F’ pazjenti li qed ikollhom stimulazzjoni ta ’ l- ovulazzjoni, hemm żieda fir - rata ta ’ tqala u twelid multiplu meta kkomparat ma konċepiment naturali.
However, this can be minimised by using the recommended dose and schedule of administration.
Madankollu, dan jista ’ jitnaqqas jekk tittieħed id- doża rakkomandata u tiġi osservata l- iskeda ta ’ kif għandu jingħata.
Miscarriages are higher than in the normal population, but comparable with the rates found in women with fertility problems.
Każi ta ’ korriment fit- tqal huma aktar għolja milli fil- popolazzjoni normali, iżda jikkomparaw tajjeb mar- rata miksuba f’ nisa bi problemi tal- fertilità.
There have been isolated reports of non-serious allergic reactions to GONAL-f.
Kien hemm rapporti iżolati ta ’ reazzjonijiet allerġiċi mhux serji b’ GONAL- f.
If you had this type of reaction to similar medicines, inform your doctor.
Jekk ġieli kellek din it - tip ta ’ reazzjoni b’ mediċini simili, informa lit- tabib tiegħek.
If you are a man, elevated follicle 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.
GONAL-f is usually not effective in such cases.
Ġeneralment, GONAL- f mhux effettiv f’ dawn il- każi.
To monitor the treatment, your doctor may ask you for a semen analysis to be performed 4 to 6 months after the beginning of treatment.
Biex janalizza l- kura, it- tabib tiegħek jista ’ jitolbok biex tagħmel analiżi tas- semen 4 sa 6 xhur wara l- bidu tal- kura.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki mhux bir- riċetta.
162 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.
Studies have shown that these two medicines can be mixed and injected together, without either product being adversely affected.
Studji wrew li dawn iż- żewġ mediċini jistgħu jitħalltu u jiġu injettati flimkien, mingħajr effetti negattivi fuq l- ebda wieħed minnhom.
GONAL-f is not indicated if you are pregnant or are breast-feeding.
GONAL- f m’ għandux jittieħed jekk int tqila jew jekk qed tredda ’.
Important information about some of the ingredients of GONAL-f
162 Informazzjoni importanti dwar xi wħud ta ’ l- ingredjienti ta ’ GONAL- f
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 ’
HOW TO USE GONAL-f
KIF JINTUŻA GONAL- f
Always take GONAL-f exactly as your doctor has told you.
Dejjem għandek tieħu GONAL- f skond il- parir tat- tabib.
You should check with your doctor or pharmacist if you are not sure.
Dejjem għandek taċċerta ruħek mat- tabib jew lill- ispiżjar tiegħek jekk ikollok xi dubju.
Women who are not ovulating and are having irregular periods or no periods at all.
Nisa li mhumiex jovulaw u li għandhom pirjid rregolari jew ma jkollhomx pirjid
GONAL-f is usually given every day.
Ġeneralment, GONAL- f jingħata kuljum.
If you have periods, the treatment should start within the first 7 days of the menstrual cycle.
Jekk ikollok pirjids, il- kura għandha tibda f- ewwel sebat ijiem taċ- ċiklu mestrwali.
This may be increased by 37.5 IU-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.
If your doctor cannot see a response after 4 weeks of treatment, that treatment cycle should be abandoned.
Jekk it- tabib ma jarax riżultati pożittivi wara 4 ġimgħat ta ’ kura, dak iċ- ċiklu għandu jitwaqqaf.
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.
When an optimal response is obtained, a single injection of another medicine (hCG) is administered 24-48 hours after the last GONAL-f injection.
Meta jinkiseb riżultat ottimali, injezzjoni waħda ta ’ mediċina oħra (hCG) tingħata 24- 48 siegħa wara l - aħħar injezzjoni ta ’ GONAL- f.
You are recommended to have sexual intercourse on the day of the administration of this second medicine and the following day.
Hu rakkomandat li jkollok x’ taqsam mas- sieħeb tiegħek fil- ġurnata li tkun ħadt t- tieni mediċina, kif ukoll fil- ġurnata ta ’ wara.
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).
For the following cycle, your doctor will prescribe a dosage lower than that of the previous cycle.
Għaċ- ċiklu li jmiss, it- tabib se jagħtik doża anqas minn dik mogħtija fiċ- ċiklu preċedenti.
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies.
Nisa li qed issirilhom stimulazzjoni ta ’ l- ovarji għal żvilupp follikulari multiplu qabel ma ssir fertilizzazzjoni in vitro jew xi teknoloġija ta ’ riproduzzjoni assistita oħra:
A commonly used dose for superovulation involves the administration of 150-225 IU 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 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.
Adequate follicular development is usually achieved on average by the tenth day of treatment (range 5 to 20 days).
B’ mod ġenerali, żvilupp follikulari adegwat jinkiseb fil- medja mal- għaxar ġurnata tal- kura (dan ivarja bejn 5 u 20 ġurnata).
Then a single injection of a medicine used to induce final follicular maturation and containing 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 is used.
F’ każi oħra, ikun hemm down- regulation permezz ta ’ agonista ta ’ l- ormon li jistimula s- sekrezjoni tal - gonadotrofina (GnRH).
In these cases, GONAL-f is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved.
F’ dawn il- każi, GONAL- f jinbeda madwar ġimgħatejn wara l- bidu tal- kura bl - agonista, u t- tnejn li huma jitkomplew sakemm jinkiseb żvilupp follikulari adegwat.
The dose is then adjusted according to the ovarian response.
Wara dan, id- doża tiġi adattata skond l- effett fuq l- ovarji.
163 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
Your doctor will decide on the dose and schedule of administration which are most appropriate for you during this course of treatment.
It- tabib tiegħek għandu jiddeċiedi dwar id- doża u l- iskeda ta ’ teħid li hi l- aktar xierqa għalik matul il - perijodu tal- kura.
GONAL-f is usually taken every day for up to three weeks simultaneously with injections of lutropin alfa.
Ġeneralment, GONAL- f jittieħed kuljum sa tliet ġimgħat flimkien ma ’ injezzjonijiet ta ’ lutropin alfa.
A commonly used dose starts with 75-150 IU 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.
According to your response, your doctor may increase your dose of GONAL-f by preferably 37.5-75 IU at 7 to 14-day intervals.
Skond ir- rispons tiegħek, it- tabib jista ’ jżidlek id- doża ta ’ GONAL- f preferibbilment b’ 37. 5- 75 IU kull 7 sa 14- il ġurnata.
If your doctor does not observe a response of your ovaries after 3 weeks of treatment, that cycle should be abandoned.
163 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 may prescribe treatment at a higher starting dose of GONAL-f than in the abandoned cycle.
Għaċ- ċiklu segwenti, t- tabib jista ’ jagħtik doża inizjali ogħla ta ’ GONAL- f minn dik li kienet tingħata fiċ- ċiklu li twaqqaf.
When the desired response has been obtained, a single injection of 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.
You are recommended to have sexual intercourse on the day of, and the day following, administration of the hCG.
Hu rakkomandat li jkollok x’ taqsam mas- sieħeb tiegħek fil- ġurnata li tkun ħadt hCG, u fil- ġurnata ta ’ wara.
Alternatively, intrauterine insemination (IUI) may be performed.
Inkella, tista ’ ssir inseminazzjoni fl- utru (IUI).
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).
For the following cycle, your doctor will prescribe GONAL-f at as 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.
Infertile men with hormonal deficiency.
Irġiel mhux fertili b’ nuqqasijiet ormonali
GONAL-f is usually prescribed at a dose of 150 IU 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 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.
Route of administration
Kif għandek tieħu GONAL- f?
GONAL-f is intended for subcutaneous use, that means given by injection just under the skin.
GONAL- f jingħata permezz ta ’ injezzjoni taħt il- ġilda.
It is for single use only.
Għandha tintuża darba biss.
If you administer GONAL-f to yourself, please carefully read the following instructions:
Jekk se tagħti GONAL- f lilek innifsek, jekk jogħġbok aqra dawn l- istruzzjonijiet segwenti sew:
• Wash your hands.
• Aħsel idejk.
It is important that your hands and the items you use be as clean as possible.
Importanti li idejk u l- oġġetti li tuża jkunu nodfa kemm jista ’ jkun.
• Assemble and lay out on a clean surface everything you need:
Iġbor u ifrex kull m’ għandek bżonn fuq bank nadif: ampulla waħda bit- trab ta ’ GONAL- f ampulla waħda bis- solvent żewġ ċraret bl- alkoħol siringa labra li ser tintuża biex tħallat u labra fina għall- injezzjoni taħt il- ġilda kontenitur
- - - - - -
•
one ampoule containing GONAL-f powder one solvent ampoule two alcohol swabs one syringe one needle for reconstitution and a fine bore needle for subcutaneous injection sharp container
Iftaħ
On the head of the solvent ampoule, you will see a
l- ampulla tas- solvent (likwidu ċar): Fuq ir- ras ta ’ l- ampulla tas- solvent se tara tikka żgħira kkulurita.
Directly below it is where the neck of the ampoule has been treated to make it easier to break.
Eżatt taħtha hemm l- għonq ta 'l- ampulla li jinkiser faċilment.
Gently flick the top section of the ampoule so that any fluid in the neck of the ampoule drops into the bottom chamber.
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.
Now press the ampoule firmly over the neck, and break the ampoule away from the coloured dot.
Issa agħfas sew l- għonq ta ’ l- ampulla u ikser l- ampulla ‘ l bogħod mit- tikka kkulurita.
Carefully place the open ampoule upright on the work surface.
B’ attenzjoni poġġi l– ampulla miftuħa bil- wieqfa fuq il- bank fejn qed taħdem.
• Draw up the solvent:
• Iġbed is- solvent 'l fuq:
Attach the needle for reconstitution to the syringe, with the syringe in one hand, pick up the open ampoule, insert the needle and draw up all of the solvent.
Bis- siringa f’ id waħda, aqbad l- ampulla miftuħa, daħħal il- labra u iġbed 'l fuq is- solvent kollu.
Carefully set the syringe down on the work surface, taking care not to touch the needle.
B’ attenzjoni niżżel is- siringa fuq il - bank fejn qed taħdem, u oqgħod attent li ma tolqotx il- labra.
• Open and prepare the injection solution:
• Iftaħ u pprepara s- soluzzjoni għall- injezzjoni:
Open the ampoule containing the GONAL-f powder, pick up your syringe and slowly inject the solvent into the ampoule of powder.
Iftaħ l- ampulla li fiha t- trab ta ’ GONAL- f, aqbad is- siringa u bil- mod injetta s- solvent fl- ampulla tat- trab.
After the powder has dissolved (which usually occurs immediately), 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 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.
164 (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.
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 ampoule 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.
Once the powder has dissolved, draw the solution back into the syringe.
Wara li t- trab ikun inħall, iġbed is- soluzzjoni lura fis- siringa.
Inspect for particles as before, and do not use if the solution is not clear.
Bħal qabel, ara hemmx xi frak, u tużax it- taħlita jekk din mhix ċara.
Up to three containers of powder may be dissolved in the content of one ampoule of solvent.)
Sa 3 kontenituri ta ’ trab jistgħu jinħallu f’ ampulla waħda ta ’ solvent).
• Change the needle for the fine bore needle and remove any air bubbles:
• Ibdel il- labra għal- labra fina għat- titqib u neħħi xi bżieżaq ta ’ l- arja:
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.
Jekk tara xi bżieżaq ta ’ l - arja fis- siringa, żomm is- siringa bil- labra tipponta ‘ l fuq u bil - mod taptap fuq s- siringa sakemm l- arja kollha tinġabar fuq.
Push the plunger until the air bubbles are gone.
Bil- mod imbotta il- planġer sakemm il- bżieżaq ta ’ l- arja jitilqu.
• Immediately inject the solution:
• Injetta s- soluzzjoni immedjatament:
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 infurmawk fejn għandek tinjetta (eż żaqq, naħa ta ’ quddiem tal- koxxa).
Firmly pinch the
Imsaħ il- parti magħżula għall- injezzjoni b’ ċarruta mxarrba bl- alkoħol.
165 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.
Inject under the skin, as you were taught.
Injetta taħt il- ġilda, kif kont mgħallma.
Inject the solution by pushing gently on the plunger.
Injetta s- soluzzjoni billi timbota bil- mod il- planġer.
Take as much time as you need to inject all the solution.
Dum kemm hemm bżonn sakemm tinjetta s- soluzzjoni kollha.
Immediately withdraw the needle and clean the skin with an alcohol swab using a circular motion.
Immedjatament iġbed lura l- labra u naddaf il- ġilda billi timsaħha b' moviment ċirkolari b’ ċarruta mxarrba bl- alkoħol.
• Dispose of all used items:
• Armi l- oġġetti kollha li wżajt:
Once you have finished your injection, immediately discard all needles and empty ampoules in the sharp container provided.
Hekk kif tkun lestejt l- injezzjoni tiegħek, immedjatament armi l - labar u l- ampulli vojta kollha fil- kontenitur provdut.
Any unused solution must be discarded.
Kull fdal tas- soluzzjoni mhux użat għandu jintrema.
If you use more GONAL-f than you should
Jekk tieħu GONAL- f aktar milli suppost:
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 jinħasu ”.
However this will only occur if hCG is administered (see section 2).
Madankollu dan iseħħ biss jekk jingħata l- hCG (ara s- sezzjoni 2)
If you forget to take GONAL-f
Jekk tinsa ’ tieħu GONAL- F
Do not take a double dose to make up for a forgotten dose, please contact your doctor.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
POSSIBLE SIDE EFFECTS
EFFETTI OĦRA LI JISTGĦU JINĦasSU
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.
Side effects in women The most commonly reported side effects are ovarian cysts, headache and local reactions at the injection site (pain, redness, bruising, swelling and/ or irritation).
L- aktar effetti mhux mixtieqa komuni li kienu rrapurtati huma ċisti fl- ovarji, uġigħ ta ’ ras u reazzjonijiet lokali fis- sit ta ’ l- injezzjoni (uġigħ, ħmura, tbenġil, nefħa u/ jew irritazzjoni).
Following treatment with GONAL-f when human chorionic gonadotrophin is administered, a condition called ovarian hyperstimulation syndrome (see section 2) can occur.
165 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).
This syndrome is characterised by large ovarian cysts.
Dan is- sindromu hu karatterizzat b’ ċisti kbar fl- ovarji.
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.
Should the above mentioned symptoms occur, a careful medical examination is indicated as soon as possible.
Jekk iseħħu dawn is- sintomi, għandha ssir eżaminazzjoni medika kemm jista ’ jkun malajr.
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.
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.
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.
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.
Very rare cases of allergic reactions to GONAL-f have occurred causing redness of the skin, rash, swelling, hives and difficulty in breathing.
Kienu rrapurtati każi iżolati ta ’ reazzjonijiet allerġiċi għall- GONAL f li mhumiex serji.
Very rarely patients with asthma may experience worsening of their condition.
F’ każi rari, dawk li jbagħtu minn azma, jistaw jsirilhom iktar gravi.
166 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.
Side effects in men Men may experience some breast development, acne or weight gain due to treatment with hCG.
L- irġiel jistgħu jesperjenzaw xi żvilupp tas- sider, akne jew żieda fil- piż minħabba l- kura bl- hCG.
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.
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.
HOW TO STORE GONAL-f
KIF TAĦŻEN GONAL- f
Keep out of the reach and sight of children.
Żommu fejn ma jintlaħaqx u ma ’ jidhirx mit- tfal.
Do not use GONAL-f after the expiry date which is stated on the ampoule 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
The medicine must be administered immediately after reconstitution.
Il- mediċina għandha tittieħed immedjatament wara r- rikostituzzjoni.
Do not use GONAL-f if you notice any visible signs of deterioration.
M’ għandekx tuża GONAL- f jekk tara xi sinjali viżibbli ta ’ deterjorazzjoni.
What GONAL-f contains
X’ fih GONAL- f
The active substance is follitropin alfa, 75 IU (International Units).
Is- sustanza attiva hi follitropin alfa, 75 IU.
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, 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, aċidu fosforiku konċentrat u idrossidu tas- sodju.
The solvent is Water for Injections.
Is- solvent hija ilma għall- injezzjoni.
What GONAL-f looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
GONAL-f is presented as a powder and solvent for solution for injection.
GONAL- f huwa trab u solvent għal soluzzjoni għall- injezzjoni.
The powder is a white lyophilised pellet.
It- trab hija pellitt bajda lajofilizzat.
It is supplied in packs of 1, 5, 10 ampoules of powder with the corresponding number of solvent ampoules.
Il- prodott jiġi f’ pakketti ta ’ 1, 5, 10 ampulli ta ’ trab bl- istess ammont ta ’ ampulli bis- solvent.
167 One ampoule of powder contains 75 IU of follitropin alfa and one ampoule 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.
Marketing Authorisation Holder
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom
Serono Europe Limited, 56 Marsh Wall, London E14 9TP, United Kingdom
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.
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.
Danmark E.
167 Danmark E.
Italia Merck Serono S. p. A.
168 Suomi/ Finland Italia Merck Serono S. p. A.
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
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar fil -
170 PACKAGE LEAFLET:
169 FULJETT TA ’ TAGĦRIF:
GONAL-f 150 IU powder and solvent for solution for injection Follitropin alfa
GONAL- f 150 IU trab u solvent għal soluzzjoni għall- injezzjoni Follitropin alfa
What GONAL-f is and what it is used for 2.
8.
Before you use GONAL-f 3.
Qabel ma tuża GONAL- f 9.
How to use GONAL-f 4.
Kif għandek tuża GONAL- f 10.
Possible side effects 5.
X’ effetti oħra jista ’ jkollu 11.
How to store GONAL-f 6.
Kif taħżen GONAL- f 12.
171 Do not use GONAL-f
Tużax GONAL- f jekk jeżistu dawn il- kundizzjonijiet li ġejjin: