qanastek/EMEA-V3 huggingface dataset:
In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/ or chest, weight gain and the occurrence of blood clots in the circulation.
F’ każijiet aktar serji sintomi jistgħu jinkludu tkabbir ta ’ l- ovarji, akkumulazzjoni ta ’ fluwidu fl- addome u/ jew fis- sider, żieda fil- piż u l- preżenza ta ’ emboli tad- demm fiċ- ċirkulazzjoni.
Rarely, blood clots may occur without unwanted overstimulation of the ovaries (see also “ Take special care with Puregon”).
F’ każijiet rari, jista ’ jkun hemm emboli mingħajr stimulazzjoni mhux mixtieqa ta ’ l- ovarji (ara wkoll “ Oqgħod attent ħafna b’ Puregon ”).
HOW TO STORE PUREGON
KIF TAĦŻEN PUREGON
Do not use Puregon after the expiry date which is stated on the label after'EXP: '.
Tużax Puregon wara d- data ta ’ skadenza li tidher fuq it- tikketta wara ‘ JIS: ’.
Keep the ampoules in the outer carton.
Żomm l- ampulli fil- kartuna ta ’ barra.
Once the Puregon has been dissolved in the solvent, the solution should be used immediately.
La darba Puregon ikun tħallat fis- solvent, is- soluzzjoni għandha tintuża minnufih.
Do not use Puregon if you notice that the solution contains particles or is not clear.
218 Tużax Puregon jekk tinnota li s- soluzzjoni mhix ċara jew li hemm xi frak.
What Puregon contains
X’ fih Puregon
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 50 IU per ampoule. • The other ingredients are sucrose, sodium citrate and polysorbate 20; the solvent contains sodium chloride (4.5 mg) in water for injections (1.0 ml).
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikulu (FSH) f’ qawwa ta ’ 50 IU f’ kull ampulla. • Is- sustanzi l- oħra huma sucrose, sodium citrate, u polysorbate 20; Is- solvent fih sodium chloride (4. 5 mg) f’ ilma għall- injezzjonijiet (1. 0 ml).
What Puregon looks like and contents of the pack
Id- Dehra ta ’ Puregon u l- kontenuti tal- pakkett
Puregon 50 IU powder and solvent for solution for injection (powder for injection) is a white to off- white cake or powder and is supplied in a glass ampoule.
Puregon 50 IU trab u solvent għal soluzzjoni għall- injezzjoni (trab għal injezzjoni) huwa kejk jew trab ta ’ lewn bajdani jew off- white u jiġi f’ ampulla tal- ħġieġ.
It should be dissolved with the solvent (solvent for parenteral use)-a clear, colourless solution- contained in a second glass ampoule.
Dan għandu jiġi maħlul fis- solvent (solvent għal użu parenterali) – soluzzjoni ċara u mingħajr kulur - li jinsab f’ ampulla tal- ħġieġ.
It is available in packs of 1, 3, 5 or 10 ampoules.
Huwa disponibbli f’ pakketti ta ’ 1, 3, 5 jew 10 ampulli.
Marketing Authorisation Holder N. V.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq N. V.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ‘
208 PACKAGE LEAFLET:
219 FULJETT TA ’ TAGĦRIF:
Puregon 75 IU powder and solvent for solution for injection follitropin beta
Puregon 75 IU trab u solvent għal soluzzjoni għall- injezzjoni FOLLITROPIN BETA
Puregon is used to treat infertility in any of the following situations: • In women who are not ovulating, Puregon can be used to cause ovulation in women who have not responded to treatment with clomifene citrate. • In women undergoing assisted reproduction techniques, including in-vitro fertilisation (IVF) and other methods, Puregon can be used to bring about the development of multiple follicles. • In men who are infertile due to a hormonal deficiency, Puregon can be used for the production of sperm.
Puregon jintuża biex jitratta l- infertilità f’ xi waħda mill- kondizzjonijiet li ġejjin: • Fin- nisa li mhux qed ikollhom ovulazzjoni, Puregon jista ’ jintuża sabiex ikun hemm ovulazzjoni f’ nisa li ma rrispondewx għall- kura bi clomifene citrate. • F’ nisa li qed jieħdu sehem fi programm li jinvolvi t- teknika ta ’ riproduzzjoni assistita, inkluż il - fertilizzazzjoni in vitro (IVF) u metodi oħra, Puregon jista ’ jintuża sabiex jikkawża l- iżvilupp ta ’ follikuli multipli. • Fl- irġiel li huma infertili minħabba n- nuqqas ta ’ ormoni, Puregon jista ’ jintuża għall - produzzjoni ta ’ l- isperma.
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- glandola pitwitarja jew ta ’ l- ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Puregon • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju ta ’ l- ovarji • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku ta ’ l- ovarji (PCOD) • jekk għandek malformazzjonijiet ta ’ l- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli • jekk tbati minn indeboliment primarju tat- testikuli.
Take special care with Puregon
220 Oqgħod attent ħafna b’ Puregon:
209 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
So contact your doctor without delay if you are experiencing significant abdominal pain, also if this occurs some days after the last injection has been given.
Għalhekk ikkuntattja lit- tabib tiegħek mingħajr dewmien jekk tħoss uġigħ sinifikanti fl - addome, u anke jekk dan jiġri wara ftit jiem li jkun ngħatat l- aħħar injezzjoni.
Treatment with Puregon (like pregnancy itself) may increase the risk of thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs).
Il- kura b’ Puregon (bħat- tqala nnifisha) tista ’ żżid ir- riskju ta ’ trombożi (il- formazzjoni ta ’ embolu tad - demm f’ vina jew arterja, l- aktar fil- vini tas- saqajn jew fil- pulmuni).
Puregon is usually not effective in such cases.
Ġeneralment, Puregon, m’ huwiex effettiv f’ dawn il- każi.
To monitor treatment, your doctor may ask you for a semen analysis to be performed 4 to 6 months after the beginning of treatment.
Sabiex jissorvelja l- kura tiegħek, it- tabib jista ’ jitolbok għall- analiżi tas- semen li għandha ssir minn 4 sa 6 xhur wara li tkun bdiet il- kura.
There is neither clinical experience nor evidence from studies in animals that use of Puregon during pregnancy might lead to congenital abnormalities.
Għad m’ hemmx esperjenza klinika lanqas evidenza minn studji f’ annimali li l- użu ta ’ Puregon waqt it- tqala jista ’ jwassal għal abnormalitajiet konġenitali.
Breast feeding
Jekk qed tredda ’:
210 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Further details on the treatment schedule are given below.
Aktar dettalji sħaħ ta ’ l- iskeda tal- kura huma mogħtija hawn isfel.
To find the right dosage, follicle growth is checked by means of ultrasound scanning, and measurement of the amount of estradiol (female sex hormone) in blood or urine. • Women who are not ovulating Initially, a starting dose is set by your doctor.
Sabiex tinsab id- doża adattata, it- tkabbir follikulari jiġi ċċekjat permezz ta ’ skansjonijiet bl- ultrasound, u bil- kejl ta’ l- ammont ta ’ estradjol (ormon tas- sess tan- nisa) fid- demm u fl- awrina. • Nisa li mhux qed ikollhom ovulazzjoni Fil- bidu, doża inizjali tiġi ssettjata mit- tabib tiegħek.
This dose is continued for at least seven days.
Din id- doża tinżamm għal ta ’ l- anqas sebat ijiem.
The daily dose is then maintained until a follicle of adequate size is present.
Din id - doża ta ’ kuljum imbagħad tinżamm sakemm ikun hemm follikulu ta ’ daqs xieraq.
The administration of Puregon is then stopped and ovulation can be induced by administering human chorionic gonadotrophin (hCG). • Medically assisted reproduction programs, e. g.
Puregon imbagħad jitwaqqaf u l- ovulazzjoni tista ’ tiġi stimulata bl- għoti tal- gonadotrofina korjonika umana (hCG). • Programmi ta ’ riproduzzjoni medikament assistiti, eż.
After this, the dose may be adjusted for the individual patient, based upon their ovarian response.
Wara dan, id- doża tkun tista ’ tiġi aġġustata għall- pazjent individwali, abbażi tar- rispons ta ’ l- ovarji tagħhom.
The dry powder should be dissolved with the solvent contained in the ampoule with fluid and this solution should be administered immediately.
It- trab niexef huwa maħlul bis- solvent li jinsab fl- ampulla bil- likwidu u din is- soluzzjoni għandha tingħata minnufih.
To avoid injection of large volumes 3 to 4 cakes of Puregon may be dissolved in 1 ml of solvent.
Sabiex tevita li jiġu injettati volumi kbar, 3 sa 4 lijosferi ta 'Puregon jistgħu jiġu maħlula f' 1 ml ta' solvent.
When only 1 or 2 cakes are required the volume may be reduced to 0.5 ml.
Meta hemm bżonn biss ta ’ 1 jew 2 lijosferi, il- volum jista 'jiġi mnaqqas għal 0. 5 ml.
The injections are given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or just under the skin (in the abdominal wall, for example).
L- injezzjonijiet jingħataw bil- mod f’ muskolu (per eżempju fil- warrani, fil- parti ta ’ fuq tas- sieq jew fil- parti ta ’ fuq tad- driegħ) jew taħt il- ġilda (fir- wiċċ ta ’ l- addome per eżempju).
Injections under the skin (subcutaneous) may, in some cases, be given by you or your partner.
Injezzjonijiet taħt il- ġilda jistgħu, f’ xi każijiet jingħataw minnek stess jew mis- sieħeb/ sieħba tiegħek.
Instructions for use
Struzzjonijiet għal użu:
Step 1 - Preparing the syringe Puregon comes in a glass vial whose contents must be mixed together with the solvent in the glass ampoule.
Stadju 1 – Preparazzjoni tas- siringa Puregon jiġi f' kunjett tal- ħġieġ li l- kontenut tiegħu irid jiġi mħallat mas- solvent li hemm fl- ampulla tal- ħġieġ.
First, break the top off the ampoule with the sodium chloride solution (a., b.).
L- ewwel, neħħi l- parti ta ’ fuq ta 'l- ampulla li fiha s- sodium chloride( a., b.).
Draw up the liquid through the needle into the syringe (c.).
Iġbed is - soluzzjoni bil- labra għal ġos- siringa (c.).
Remove the flip-off cap of the vial of Puregon and inject the sodium chloride solution from the syringe through the rubber closure into the vial containing the freeze-dried cake (d.) DO NOT SHAKE, but gently swirl until the solution is clear.
Neħħi t- tapp li jinqala b’ daqqa ta ’ saba 'ta' Puregon u injetta s- soluzzjoni tas- sodium chloride mis- siringa, minn ġot- tapp tal- gomma fil- kunjett li fih il- kejk 222 imnixxef bil- friża (d.) IXXENGILX, imma dawwar bil- mod sakemm is- soluzzjoni tkun iċċarat.
Should the solution contain particles or not become clear, do not use.
Kemm- il darba s- soluzzjoni jkun fiha l- frak jew ma 'tkunx ċara, tużahiex.
If you need to dissolve more than one freeze-dried cake, then repeat the actions described under points c. and d. until the required number of freeze-dried cakes is dissolved.
Jekk għandek bżonn tħoll aktar minn kejk wieħed, mela irrepeti l- proċedura spjegata f 'punti ċ. u d. sakemm in- numru xieraq ta' kejkijiet mnixxfa bil- friża jitħalltu.
Please make sure that all 211 handling is performed in such a way that sterile conditions are maintained during the dissolution procedure (e. g. do not put the syringe down without covering the needle with the protective cap).
Jekk jogħġbok iżgura li l - manipulazzjoni ssir b’ mod li l- kondizzjonijiet sterili jinżammu waqt il- proċess (eż. isseraħx is- siringa mingħajr ma tgħatti l- labra bl- għatu protettiv).
(f.) Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (g.).
Iġbed is- soluzzjoni Puregon fis- siringa vojta (e.), u issa ibdel il- labra ma ’ labra ta 'l- injezzjoni sterili (f.) Fl- aħħar żomm is- siringa bil- labra tippunta' l fuq u bil- mod taptap fuq il- ġenb tas- siringa sabiex tisforza xi bżieżaq ta ’ l- arja jitilgħu 'l fuq: imbagħad imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni ta ’ Puregon biss (g.).
Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (h.) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzjoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa l- addome madwar iż- żokkra (h.) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
You should vary the injection site a little with each injection.
Għandek tvarja s- sit ta ’ l- injezzjoni ma ’ kull injezzjoni.
Hands should be washed and the injection site swabbed with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria.
L- idejn iridu jkunu maħsula u is- sit ta ’ l- injezzjoni mimsuħa b’ diżinfettant (eż. chlorohexidine 0. 5%) sabiex jitneħħew xi batterja tal- wiċċ.
Step 5 - Checking the correct needle position If the needle position is correct the plunger should be quite difficult to draw back.
Stadju 5 – L- iċċekjar tal- pożizzjoni korretta tal- labra Jekk il- pożizzjoni tal- labra hija korretta ikun diffiċli biex tiġbed il- planġer lura.
You should then start again with Step 1 using a new syringe, new needles, and new vials of Puregon and ampoules of sodium chloride solution.
Għandek terġa tibda mill- ġdid minn - Stadju 1 billi tuża siringa u labra ġdida u kunjetti ġodda ta 'Puregon u t- taħlita tas- sodium chloride.
Step 7 - Removing the syringe Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant.
Stadju 7 – Tneħħija tas- siringa Iġbed is- siringa `l barra malajr u agħfas fuq is- sit ta ’ l- injezzjoni b’ imsiħ li fiha id- diżinfettant.
A gentle massage of the site - while still maintaining pressure - helps disperse the Puregon solution and relieve any discomfort.
Massaġġ ġentili fuq is- sit – waqt li tkun qed tagħfas fuqha – jgħin biex tifrex is- soluzzjoni tal- Puregon
Do not mix Puregon with any other medicines.
Puregon m’ għandux jitħallat ma ’ mediċini oħra.
212 If you use more Puregon than you should
Jekk tuża Puregon aktar milli suppost:
Minor side effects include bruising, pain, redness, swelling and itching at the site of the injection.
Effetti żgħar oħra jinkludu tbenġil, uġigħ, ħmura, nefħa u ħakk fil- lok ta ’ l- injezzjoni.
A complication with FSH treatment is unwanted overstimulation of the ovaries.
Kumplikazzjoni serja bit- trattament ta ’ l- FSH hija l- istimulazzjoni żejda mhux mixtieqa fl- ovarji.
This condition can become very serious, but the risk can be reduced by careful monitoring of follicle development during treatment.
Din il- kondizzjoni tista ’ ssir serja ħafna imma r- riskju jista ’ jitnaqqas b’ sorveljanza bir- reqqa ta ’ l- iżvilupp tal- follikuli waqt il- kura.
In more severe cases symptoms may include enlargement of the ovaries, accumulation of fluid in the abdomen and/ or chest, weight gain and the occurrence of blood clots in the circulation.
L- ewwel sintomi ta ’ stimulazzjoni żejda ta ’ l- ovarji jistgħu jkunu uġigħ fl - addome, tħossok marid jew dijarea, F’ każijiet aktar serji sintomi jistgħu jinkludu tkabbir ta ’ l- ovarji, akkumulazzjoni ta ’ fluwidu fl- addome u/ jew fis- sider, żieda fil- piż u l- preżenza ta ’ emboli tad- demm fiċ- ċirkulazzjoni.
Keep the vial(s) and ampoule(s) in the outer carton.
Żomm il- kunjett( i) u l- ampulla (/ i) fil- kartuna ta ’ barra.
Do not use Puregon if you notice that the solution contains particles or is not clear.
Tuża Puregon jekk tinnota li s- soluzzjoni mhix ċara jew li hemm xi frak.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - 224 ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
213 What Puregon contains
X’ fih Puregon
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 75 IU per vial. • The other ingredients are sucrose, sodium citrate and polysorbate 20; the solvent contains sodium chloride (4.5 mg) in water for injections (1.0 ml).
Is- solvent fih sodium chloride (4. 5 mg) f’ ilma għall- injezzjonijiet (1. 0 ml).
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista ’ jiġi aġġustat bis- sodium hydroxide u/ jew bil- hydrochloric acid.
Puregon 75 IU powder and solvent for solution for injection (powder for injection) is a white to off- white cake or powder and is supplied in a glass vial.
Puregon 75 IU trab u solvent għal soluzzjoni għall- injezzjoni (trab għal injezzjoni) huwa kejk jew trab ta ’ lewn bajdani jew off- white u jiġi f’ kunjett tal- ħġieġ.
It should be dissolved with the solvent (solvent for parenteral use) -a clear, colourless solution- contained in a glass ampoule.
Dan għandu jiġi maħlul fis- solvent li jinsab (solvent għal użu parenterali) – soluzzjoni ċara u mingħajr kulur – li jinsab f’ ampulla tal- ħġieġ.
It is available in packs of 1, 3, 5 or 10 vials.
Huwa disponibbli f’ pakketti ta ’ 1, 3, 5 jew 10 kunjetti.
Manufacturer N. V.
Manifattur N. V.
214 PACKAGE LEAFLET:
225 FULJETT TA ’ TAGĦRIF:
You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you.
Jista ’ jkollok bżonn terġa ’ taqrah. − Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. − Din il- mediċina ġiet mogħtija lilek.
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- glandola pitwitarja jew ta ’ l- ipotalamu. • jekk inti allerġika/ u( tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Puregon • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju ta ’ l- ovarji • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku ta ’ l- ovarji (PCOD) • jekk għandek malformazzjonijiet ta ’ l- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
215 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
The results of these tests allow your doctor to choose the correct dose of Puregon from day to day.
Ir- riżultati ta ’ dawn it- testijiet jippermettu lit- tabib li jagħżel l- aħjar dożaġġ ta ’ Puregon minn jum għal jum.
Treatment with Puregon (like pregnancy itself) may increase the risk of thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs).
Il- kura b’ Puregon (bħat- tqala nnifisha) tista ’ żżid ir- riskju ta ’ trombożi (il- formazzjoni ta ’ embolu tad- demm f’ vina jew arterja l- aktar fil- vini tas- saqajn jew fil- pulmuni).
216 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
This dose is continued for at least seven days.
Din id- doża tibqa ’ tinżamm għal ta ’ l - anqas sebat ijiem.
Draw up the liquid through the needle into the syringe (c.).
L- ewwel, kisser ir- ras ta 'l- ampulla li fiha s- soluzzjoni ta ’ sodium chloride (a., b.) Iġbed il- likwidu mill- labra 228 għal gos- siringa (c.).
Break open the second ampoule containing the freeze-dried sphere (with the black dot in the position as indicated in the figures a. and b.) and add the sodium chloride solution from the syringe (d.).
Ikser it- tieni ampulla li fiha l- isfera mnixxfa- ffriżata (bid- dott sewda fil - pożizzjoni kif indikat fil- figuri a. u b.) u żid is- sodium chloride mis- siringa (d.).
DO NOT SHAKE, but gently swirl until the solution is clear.
IXXENGILX imma dawwar sakem is- soluzzjoni tkun iċċarat.
Should the solution contain particles or not become clear, do not use.
Kemm- il darba s - soluzzjoni jkun fiha l- frak jew ma tkunx ċara, tużhiex.
If you need to dissolve more than one freeze-dried sphere, then repeat the actions described under points c. and d. until the required number of freeze-dried spheres is dissolved.
Jekk għandek bżonn li tħoll aktar minn sfera mnixxfa- ffriżata waħda, rrepeti l- azzjonijiet deskritti f' punti ċ. u d. sakemm in- numru meħtieġ ta 'sferi huma maħlula.
Please make sure that 217 all handling is performed in such a way that sterile conditions are maintained during the dissolution procedure (e. g. do not put the syringe down without covering the needle with the protective cap).
Jekk jogħġbok iżgura li l - manipulazzjoni ssir b' mod li l- kondizzjonijiet sterili jinżammu waqt il- proċess (eż. isseraħx is- siringa mingħajr ma tgħatti l- labra bl- għatu protettiv).
Draw the Puregon solution up into the empty syringe (e.), and now replace the needle with a sterile injection needle (f.).
Iġbed is- soluzzjoni fis- siringa vojta (e.), u ibdel il- labra ma ’ labra ta ’ l- injezzjoni (f.).
Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (g.).
Fl- aħħar, żomm is- siringa bil- labra tippunta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq ta ’ l - arja jitilgħu' l fuq: imbagħad imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa hemm it - taħlita biss (g.).
Step 7 - Removing the syringe Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant.
229 Stadju 7 – Tneħħija tas- siringa Iġbed is- siringa l- barra malajr u agħfas fuq is- sit tat- tilqima b’ msiħ li fiha d- diżinfettant.
218 Any remaining solution should be discarded.
Kull fdal tas- soluzzjoni li ma jkunx intuża għandu jintrema.
See section on Possible side effects below.
Ara sezzjoni fuq Effetti Sekondarji li Jista ’ Jkollu hawn isfel.
Do not use Puregon if you notice that the solution contains particles or is not clear.
230 Tużax Puregon jekk tinnota li s- soluzzjoni mhix ċara jew li hemm xi frak.
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 100 IU per ampoule, • The other ingredients are sucrose, sodium citrate and polysorbate 20; the solvent contains sodium chloride (4.5 mg) in water for injections(1.0 ml).
Is- solvent fih sodium chloride (4. 5 mg) f’ ilma għall- injezzjonijiet (1. 0 ml).
Puregon 100 IU powder and solvent for solution for injection (powder for injection) is a white to off- white cake or powder and is supplied in a glass ampoule.
Puregon 100 IU trab u solvent għal soluzzjoni għall- injezzjoni (trab għall- injezzjoni) huwa kejk jew trab ta ’ lewn bajdani jew off- white u jiġi f’ kunjett tal- ħġieġ.
It should be dissolved with the solvent (solvent for parenteral use) -a clear, colourless solution-contained in a second glass ampoule.
Dan għandu jiġi maħlul bis- solvent (solvent għall- użu parenterali) – soluzzjoni ċara u mingħajr kulur - li jinsab fit- tieni ampulla tal- ħġieġ.
220 PACKAGE LEAFLET:
231 FULJETT TA ’ TAGĦRIF:
Puregon 150 IU powder and solvent for solution for injection follitropin beta
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU Puregon 150 IU trab u solvent għal soluzzjoni għall- injezzjoni follitropin beta
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- glandola pitwitarja jew ta ’ l- ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Puregon • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju ta ’ l- ovarji • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkaużati minn mard poliċistiku ta ’ l- ovarji (PCOD) • jekk għandek malformazzjonijiet ta ’ l- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli • jekk tbati minn indeboliment primarju tat- testikuli.
Take special care with Puregon
232 Oqgħod attent ħafna b’ Puregon:
221 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
222 Always use Puregon exactly as your doctor has told you.
KIF GĦANDEK TUŻA PUREGON 233 Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Draw up the liquid through the needle into the syringe (c.).
L- ewwel, kisser ir- ras ta 'l- ampulla li fiha s- soluzzjoni ta ’ sodium chloride (a., b.) Iġbed il- likwidu mill- labra għal gos- siringa (ċ.).
If you need to dissolve more than one freeze-dried sphere, then repeat the actions described under points c. and d. until the required number of freeze-dried spheres is dissolved.
234 Jekk għandek bżonn li tħoll aktar minn sfera mnixxfa- ffriżata waħda, rrepeti l- azzjonijiet deskritti f' punti ċ. u d. sakemm in- numru meħtieġ ta 'sferi huma maħlula.
Please make sure that 223 all handling is performed in such a way that sterile conditions are maintained during the dissolution procedure (e. g. do not put the syringe down without covering the needle with the protective cap).
Jekk jogħġbok iżgura li l - manipulazzjoni ssir b' mod li l- kondizzjonijiet sterili jinżammu waqt il- proċess (eż. isseraħx is- siringa mingħajr ma tgħatti l- labra bl- għatu protettiv).
You should vary the injection site a little with each injection.
Għandek tvarja daqsxejn is- sit ta ’ l- injezzjoni ma ’ kull tilqima.
Hands should be washed and the injection site swabbed with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria.
L- idejn iridu jkunu maħsula u s- sit ta ’ l- injezzjoni mimsuħa bid- diżinfettant (eż. chlorohexidine 0. 5%) sabiex jitneħħew xi batterja tal- wiċċ.
Clean about two inches around the point where the needle will go in and let the disinfectant dry for at least one minute before proceeding.
Naddaf madwar żewġ pulzieri madwar il - punt fejn trid tidħol il- labra u ħalli d- diżinfettant jinxef għal ta ’ l- anqas minuta qabel ma tipproċedi.
Step 7 - Removing the syringe Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant.
Stadju 7 – Tneħħija tas- siringa Iġbed is- siringa l- barra malajr u agħfas fuq is- sit tat- tilqima b’ msiħ li fiha d- diżinfettant.
A gentle massage of the site - while still maintaining pressure - helps disperse the Puregon solution and relieve any discomfort.
Massaġġ ġentili fuq- sit – waqt li tkun qed tagħfas fuqha – jgħin biex tifrex is- soluzzjoni tal- Puregon u ttaffi kull
224 Any remaining solution should be discarded.
Kull fdal tas- soluzzjoni li ma jkunx intuża għandu jintrema.
Once the Puregon has been solved in the solvent, the solution should be used immediately.
La darba Puregon ikun tħallat fis- solvent, is- soluzzjoni għandha tintuża minnufih.
Do not use Puregon if you notice that the solution contains particles or is not clear.
Tużax Puregon jekk tinnota li s- soluzzjoni mhix ċara jew li hemm xi frak.
These measures will help to protect the environment.
236 protezzjoni ta ’ l- ambjent.
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 150 IU per ampoule. • The other ingredients are sucrose, sodium citrate and polysorbate 20; the solvent contains sodium chloride (4.5 mg) in water for injections (1.0 ml).
Is- solvent fih sodium chloride (4. 5 mg) f’ ilma għall- injezzjonijiet (1. 0 ml).
The pH may have been adjusted with sodium hydroxide and/ or hydrochloric acid.
Il- pH jista jiġi aġġustat b’ sodium hydroxide u/ jew b’ hydrochloric acid.
Puregon 150 IU powder and solvent for solution for injection (powder for injection) is a white to off- white cake or powder and is supplied in a glass ampoule.
Puregon 150 IU trab u solvent għal soluzzjoni għall- injezzjoni (trab għall- injezzjoni) huwa kejk jew trab ta ’ lewn bajdani jew off- white u jiġi f’ kunjett tal- ħġieġ.
It should be dissolved with the solvent (solvent for parenteral use) -a clear, colourless solution-contained in a second glass ampoule.
Dan għandu jiġi maħlul bis- solvent (solvent għal użu parenterali) – soluzzjoni ċara u mingħajr kulur - li jinsab fit- tieni ampulla tal- ħġieġ.
It is available in packs of 1, 3, 5 or 10 ampoules.
Hija disponibbli f’ pakketti ta ’ 1, 3, 5 jew 10 ampulli.
Not all pack sizes may be marketed.
Jista ’ ikun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
226 PACKAGE LEAFLET:
237 FULJETT TA ’ TAGĦRIF:
Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Puregon, soluzzjoni għall- injezzjoni fih follitropin beta, ormon magħruf bħala ormon li jistimula l - follikulu (FSH).
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- glandola pitwitarja jew ta ’ l- ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Puregon • jekk għandek emorraġija vaġinali qawwija jew fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju ta ’ l- ovarji. • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku ta ’ l- ovarji (PCOD) • jekk għandek malformazzjonijiet ta ’ l- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
227 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken.
Ġeneralment, isiru skanijiet ta’ l- ovarji bl- ultrasound, u jittieħdu kampjuni tad- demm u ta ’ l- awrina b’ mod regolari.
Treatment with Puregon (like pregnancy itself) may increase the risk of thrombosis (the formation of a blood clot in a blood vessel, most often in the veins of the legs or the lungs).
Il- kura b’ Puregon (bħat- tqala nnifisha) tista ’ żżid ir- riskju ta ’ trombożi (il- formazzjoni ta ’ embolu tad - demm f’ vina jew areterja, l- aktar fil- vini tas- saqajn jew fil- pulmuni).
228 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
The injections are given slowly into a muscle (for instance in the buttock, upper leg or upper arm) or just under the skin (in the abdominal wall, for example).
L- injezzjonijiet jingħataw bil- mod f’ muskolu (per eżempju fil- warrani, fil- parti ta ’ fuq tas- sieq jew fil - parti ta ’ fuq tad- driegħ) jew taħt il- ġilda (fil- wiċċ ta ’ l- addome per eżempju).
Step 1 - Preparing the syringe Sterile disposable syringes and needles should be used for administration of Puregon.
Stadju 1 – Preparazzjoni tas- siringa Għat- teħid ta ’ Puregon, għandhom jintużaw siringi u labar sterili li jintremew wara l- użu.
Puregon solution for injection comes in a glass vial.
Puregon, soluzzjoni għall- injezzjoni jiġi f’ kunjett tal- ħġieġ.
Place a needle on a syringe and pierce the needle through the rubber stopper of the vial (a).
(a).
Draw the solution up into the syringe (b), and replace the needle with an injection needle (c).
Iġbed is- soluzzjoni fis - siringa (b), u ibdel il- labra b’ labra ta ’ l- injezzjoni (ċ).
Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (d).
Fl- aħħar, żomm is- siringa bil- labra tipponta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq tal- arja jitilgħu' l fuq: imbagħad 240 imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
229 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
Hands should be washed and the injection site swabbed with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria.
L- idejn iridu jkunu maħsula u s- sit ta ’ l- injezzjoni mimsuħa b’ diżinfettant (eż. chlorhexidine 0. 5%) sabiex jitneħħew xi batterja tal- wiċċ.
You should then start again with Step 1 using a new needle and syringe and a new vial of Puregon.
Għandek terġa tibda mill- ġdid minn Stadju 1 billi tuża siringa u labra ġdida u fjala ġdid ta ’ Puregon.
Step 7 - Removing the syringe Pull the syringe out quickly and apply pressure to the injection site with a swab containing disinfectant.
Stadju 7 – Tneħħija tas- siringa Iġbed is- siringa `l barra malajr u agħfas fuq is- sit ta ’ l- injezzjoni b’ imsiħ li fiha d- diżinfettant.
A gentle massage of the site - while still maintaining pressure - helps disperse the Puregon solution and relieve any discomfort.
Massaġġ ġentili fuq is- sit – waqt li tkun qed tagħfas fuqha – jgħin biex tifrex is- soluzzjoni tal- Puregon u ttaffi kull skomdu.
Inform your doctor.
241 Għarraf lit- tabib tiegħek.
230 Do not take a double dose to make up for a forgotten dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
For your convenience, you may store Puregon at or below 25 ºC (at room temperature) for a single period of not more than 3 months.
Għal konvenjenza tiegħek tista ’ taħżen Puregon f’ temperatura ta ’ 25 °C jew anqas (temperatura tal - kamra) għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
The contents of a vial should be used immediately after piercing the rubber stopper.
La darba Puregon ikun tħallat fis- solvent, is- soluzzjoni għandha tintuża minnufih.
Do not use Puregon if you notice that the solution contains particles or is not clear.
Tużax Puregon jekk tinduna li s- soluzzjoni mhix ċara jew li hemm xi frak.
6.
242 6.
231 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 50 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikulu (FSH) f’ qawwa ta ’ 50 IU f’ 0. 5 ml ta ’ soluzzjoni akwea f’ kull kunjett. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall - injezzjonijiet.
Puregon solution for injection is a clear, colourless solution.
Puregon soluzzjoni għall- injezzjoni hija soluzzjoni ċara u mingħajr kulur.
232 PACKAGE LEAFLET:
243 FULJETT TA ’ TAGĦRIF:
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- glandola pitwitarja jew ta ’ l- ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Puregon • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju ta ’ l- ovarji. • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku ta ’ l- ovarji (PCOD) • jekk għandek malformazzjonijiet ta ’ l- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
233 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
234 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (d).
Fl- aħħar, żomm is- siringa bil- labra tipponta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq tal- arja jitilgħu' l fuq: imbagħad 246 imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
235 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
If you use more Puregon than you should
247 Jekk tuża Puregon aktar milli suppost:
236 If you forget to use Puregon
Jekk tinsa tuża Puregon:
The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea.
L- ewwel sintomi ta ’ stimulazzjoni żejda ta ’ l- ovarju jistgħu jkunu uġigħ fl - addome, tħossok marid jew dijarea.
These measures will help to protect the environment.
248 protezzjoni ta ’ l- ambjent.
237 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 75 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikulu (FSH) f’ qawwa ta ’ 75 IU f’ 0. 5 ml ta ’ soluzzjoni akwea f’ kull fjala. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall - injezzjonijiet.
238 PACKAGE LEAFLET:
249 FULJETT TA ’ TAGĦRIF:
239 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
240 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (d).
Fl- aħħar, żomm is- siringa bil- labra tipponta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq tal- arja jitilgħu' l fuq: imbagħad 252 imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
241 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
Hands should be washed and the injection site swabbed with disinfectant (for example chlorohexidine 0.5%) to remove any surface bacteria.
L- idejn iridu jkunu maħsula u s- sit ta ’ l- injezzjoni mimsuħa bid- diżinfettant (eż. chlorhexidine 0. 5%) sabiex jitneħħew xi batterja tal- wiċċ.
If you use more Puregon than you should
253 Jekk tuża Puregon aktar milli suppost:
242 If you forget to use Puregon
Jekk tinsa tuża Puregon:
The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea.
L- ewwel sintomi ta ’ stimulazzjoni żejda ta ’ l- ovarju jistgħu jkunu uġigħ fl- addome, tħossok marid jew dijarea.
These measures will help to protect the environment.
254 protezzjoni ta ’ l- ambjent.
243 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 100 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikulu (FSH) f’ qawwa ta ’ 100 IU f’ 0. 5 ml ta ’ soluzzjoni akwea f’ kull fjala. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall - injezzjonijiet.
Puregon solution for injection is a clear, colourless solution.
Id- Dehra ta ’ Puregon u l- kontenuti tal- pakkett Puregon soluzzjoni għall- injezzjoni hija soluzzjoni ċara u mingħajr kulur.
244 PACKAGE LEAFLET:
255 FULJETT TA ’ TAGĦRIF:
Puregon 150 IU/ 0,5 ml solution for injection follitropin beta
Puregon 150 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
Puregon solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Puregon, soluzzjoni għall- injezzjoni fih follitropin beta, ormon magħruf bħala ormon li jistimula l - follikuli (FSH).
• if you have a tumour of the ovary, breast, uterus, testis, pituitary gland or hypothalamus • if you are allergic (hypersensitive) to follitropin beta or any of the other ingredients of Puregon • if you have heavy or irregular vaginal bleeding where the cause is not known • if you suffer from primary ovarian failure • if you have ovarian cysts or enlarged ovaries not caused by polycystic ovarian disease (PCOD) • if you have malformations of the sexual organs which make a normal pregnancy impossible • if you have fibroids in the uterus which make a normal pregnancy impossible • if you suffer from primary testicular failure.
• jekk għandek tumur ta ’ l- ovarju, tas- sider, ta ’ l- utru, tat- testikoli, tal- glandola pitwitarja jew ta ’ l- ipotalamu. • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Puregon • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju ta ’ l- ovarji. • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku ta ’ l- ovarji (PCOD) • jekk għandek malformazzjonijiet ta ’ l- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
245 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
246 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.
Finally hold the syringe with the needle pointing upwards and gently tap the side to force any air bubbles up to the top; then squeeze the plunger until all the air has been expelled, and only Puregon solution is left in the syringe (d).
Fl- aħħar, żomm is- siringa bil- labra tipponta 'l fuq u bil- mod taptap il- ġenb tas- siringa sabiex tisforza xi bżieżaq tal- arja jitilgħu' l fuq: imbagħad 258 imbotta l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
247 Step 2 - The injection site The best site for subcutaneous injection is in the abdomen around the navel (e) where there is a lot of loose skin and layers of fatty tissue.
Stadju 2 – Is- sit ta ’ l- injezzoni L- aħjar sit ta ’ l- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
Inform your doctor.
259 Għarraf lit- tabib tiegħek.
248 If you forget to use Puregon
Jekk tinsa tuża Puregon:
Do not use Puregon after the expiry date which is stated on the label after'EXP: '.
Tużax Puregon wara d- data ta ’ skadenza li tidher fuq it- tikketta wara ‘ JIS: ’
249 • The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 150 IU in 0.5 ml aqueous solution per vial. • The other ingredients are sucrose, sodium citrate, L-methionine and polysorbate 20 in water for injections.
• Is- sustanza attiva hija follitropin beta, ormon magħruf bħala ormon li jistimula l- follikulu (FSH) f’ qawwa ta’ 150 IU f’ 0. 5 ml ta ’ soluzzjoni akwea f’ kull kunjett. • Is- sustanzi l- oħra huma sucrose, sodium citrate, L- methionine u polysorbate 20 f’ ilma għall - injezzjonijiet.
250 PACKAGE LEAFLET:
261 FULJETT TA ’ TAGĦRIF:
251 Please inform your doctor if you have experienced an allergic reaction to neomycin and/ or streptomycin (antibiotics) in the past.
Jekk jogħġbok informa lit- tabib tiegħek jekk qatt kellek xi allerġija għal neomycin u/ jew streptomycin (antibijotiċi) fil- passat.
252 Always use Puregon exactly as your doctor has told you.
Dejjem għandek tuża Puregon skont il- parir eżatt tat- tabib.