qanastek/EMEA-V3 huggingface dataset:
Follicles are small round sacs that contain the egg cells.
Il- follikuli huma boroż żgħar tondi li jkun fihom iċ- ċelluli tal- bajd.
In men, FSH is needed for the production of sperm.
Fl- irġiel FSH huwa meħtieġ għal produzzjoni tal- isperma.
Fertavid is used to treat infertility in any of the following situations: • In women who are not ovulating, Fertavid 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, Fertavid can be used to bring about the development of multiple follicles. • In men who are infertile due to a hormonal deficiency, Fertavid can be used for the production of sperm.
Fertavid jintuża biex jitratta l- infertilità f’ xi waħda mill- kondizzjonijiet li ġejjin: • Fin- nisa li mhux qed ikollhom ovulazzjoni, Fertavid 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, Fertavid jista ’ jintuża sabiex jikkawża l- iżvilupp ta ’ follikuli multipli. • Fl- irġiel li huma infertili minħabba n- nuqqas ta ’ ormoni, Fertavid jista ’ jintuża għall - produzzjoni tal- isperma.
BEFORE YOU USE FERTAVID
QABEL MA ’ TUŻA FERTAVID
Do not use Fertavid
Tużax Fertavid
• 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 Fertavid • 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 tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- glandola pitwitarja jew tal - ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Fertavid • jekk għandek emorraġija vaġinali qawwija jew fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju tal- ovarji. • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku tal- ovarji (PCOD) • jekk għandek malformazzjonijiet tal- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
Take special care with Fertavid
Oqgħod attent ħafna b’ Fertavid
113 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.
If you are a woman:
Jekk inti mara:
Close supervision by your doctor is very important.
Is- sorveljanza mill- qrib mit- tabib tiegħek hija importanti ħafna.
Usually ultrasound scans of the ovaries are regularly made, and blood or urine samples are regularly taken.
Ġeneralment, isiru skanijiet tal- ovarji bl- ultrasound, u jittieħdu kampjuni tad- demm u tal- awrina b’ mod regolari.
The results of these tests allow your doctor to choose the correct dose of Fertavid from day to day.
Ir- riżultati ta ’ dawn it - testijiet jippermettu lit- tabib li jagħżel l- aħjar dożaġġ ta ’ Fertavid minn jum għal jum.
This is very important since too high a dose of FSH may lead to rare but serious complications in which the ovaries become overstimulated.
Dan hu importanti ħafna billi doża għolja ħafna ta ’ FSH tista ’ twassal għal kumplikazzjonijiet rari imma serji li fihom l- ovarji jiġu stimulati żżejjed.
This may be noticed as pain in the abdomen.
Dan jista ’ jiġi nnotat b’ uġigħ addominali.
Regular monitoring of the response to FSH-treatment helps your doctor to prevent ovarian overstimulation.
Monitoraġġ regolari tar- rispons għall- kura bl- FSH jgħin lit- tabib tiegħek sabiex jevita li jkun hemm stimulazzjoni żejda tal - ovarji.
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 tkun ngħatat l- aħħar injezzjoni.
Treatment with Fertavid (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’ Fertavid (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).
Please discuss this with your doctor, before starting treatment, especially if: • you already know you have an increased risk of thrombosis • you, or anyone in your immediate family, have ever had a thrombosis • you are severely overweight.
Jekk jogħġbok kellem lit- tabib tiegħek qabel ma ’ tibda l- kura, speċjalment jekk: • int taf li għandek riskju ogħla ta ’ trombożi • int, jew xi ħadd tal- familja qrib tiegħek, xi darba kellhom trombożi • int għandek piż żejjed sew.
If you are a man:
Jekk inti raġel:
Elevated FSH blood levels are indicative of testicular damage.
Livelli ta ’ FSH għolja fid- demm huma sinjali ta ’ ħsara fit- testikoli.
Fertavid is usually not effective in such cases.
Ġeneralment, Fertavid 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.
Using other medicines
Meta tieħu mediċini oħra
If Fertavid is used in combination with clomifene citrate there may be an increased follicular response.
Jekk Fertavid jintuża flimkien ma ’ clomifene citrate jista ’ jkun hemm rispons follikulari ogħla.
If a GnRH agonist has been given, higher doses of Fertavid may be needed to achieve a response.
Jekk jingħata agonista tal- GnRH, jista ’ ikun hemm bżonn dożi aktar għolja ta ’ Fertavid sabiex ikun hemm rispons.
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 jekk mhux bir- riċetta.
There is neither clinical experience nor evidence from studies in animals that use of Fertavid during pregnancy might lead to congenital abnormalities.
Għad m’ hemmx esperjenza klinika lanqas evidenza minn studji f’ annimali li l- użu ta ’ Fertavid waqt it - tqala jista ’ jwassal għal abnormalitajiet konġenitali.
Nevertheless, you should not use Fertavid if you are already pregnant, or suspect that you might be pregnant.
Madankollu, m’ għandekx tuża Fertavid jekk int diġà tqila jew taħseb li tista ’ tkun tqila.
After treatment with gonadotrophin preparations, there is an increased risk of having multiple pregnancies.
Wara kura b’ sustanzi tal- gonadotrofini, hemm riskju ogħla ta ’ tqala multipla.
Multiple pregnancies carry an increased health risk for both the mother and her babies around the time of birth.
Tqala multipla iġġorr riskju ogħla kemm għas- saħħa tal- omm kif ukoll għal dik tat- trabi fil- perijodu tat- twelid.
Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e. g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities.
Barraminhekk, tqala multipla u l- karatteristiċi tal- pazjenti li jkunu qed jingħataw kura għal fertilità (eż. età tal- mara, karatteristiċi tal- isperma) jistgħu jkunu assoċjati ma ’ riskju ogħla ta ’ anormalitajiet konġenitali.
There is a slightly increased risk of extra-uterine pregnancy in women with damaged fallopian tubes.
Hemm riskju ħarira ogħla ta ’ tqala barra mill- utru f’ nisa li għandhom ħsara bit- tubi fallopjani.
In women undergoing fertility treatment there may be a slightly higher risk of miscarriage.
F’ nisa li qed jingħataw kura għal fertilità jista ’ jkun hemm riskju kemmxejn ogħla ta ’ korriment.
Breast-feeding
Jekk qed tredda ’
You should not use Fertavid if you are breast-feeding.
M’ għandekx tuża Fertavid jekk qed tredda ’.
No effects on the ability to drive and use machines have been observed.
Ma ġie osservat l- ebda effett fuq il- ħila tas- sewqan u l- użu tal- magni.
HOW TO USE FERTAVID
KIF GĦANDEK TUŻA FERTAVID
114 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid skont il- parir eżatt tat- tabib.
Dosage in women
Dożaġġ fin- nisa
Your doctor will decide on the dose of Fertavid to be given.
It- tabib tiegħek ser jiddeċiedi fuq id- doża ta ’ Fertavid li għandek tingħata.
This dose may be adjusted as your treatment progresses.
Din id- doża għandha mnejn tiġi aġġustata matul il- kura.
Further details on the treatment schedule are given below.
Aktar dettalji tal- iskeda tal- kura huma mogħtija hawn isfel.
There are large differences between women in the response of the ovaries to FSH, which makes it impossible to set a dosage schedule which is suitable for all patients.
Hemm differenzi kbar bejn mara u oħra fir- rispons tal- ovarji għal FSH li jagħmilha impossibbli li jkun hemm skeda ta ’ dożaġġ adattata għall- pazjenti kollha.
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 ’ skanijiet bl- ultrasound, u bil- kejl tal- 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 tibqa ’ tinżamm għal tal- anqas sebat ijiem.
If there is no ovarian response, the daily dose will then be gradually increased until follicle growth and/ or plasma estradiol levels indicate an adequate response.
Jekk ma jkunx hemm rispons mill- ovarji, id- doża ta ’ kuljum tiżdid gradwalment sakemm it- tkabbir follikulari u/ jew il- livelli tal- estradjol fil- plażma jindikaw rispons xieraq.
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.
Usually, 7 to 14 days of treatment are sufficient.
Ġeneralment, 7 sa 14- il jum ta ’ kura jkunu biżżejjed.
The administration of Fertavid is then stopped and ovulation can be induced by administering human chorionic gonadotrophin (hCG). • Medically assisted reproduction programs, e. g.
Fertavid imbagħad jitwaqqaf u l - ovulazzjoni tista ’ tiġi stimulata bl- għoti tal- gonadotrofina korjonika umana (hCG). • Programmi ta ’ riproduzzjoni medikament assistiti, eż.
IVF A starting dose is set by your doctor.
IVF Fil- bidu d- doża tiġi settjata mit- tabib tiegħek.
This dose is continued for at least the first four days.
Din id- doża tinżamm għall- ewwel erbat ijiem.
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 tal - ovarji tagħhom.
When a sufficient number of follicles of adequate size are present, the final phase of maturation of the follicles is induced by administration of hCG.
Meta jkun hemm numru suffiċjenti ta ’ follikuli ta ’ daqs adegwat, l- aħħar fażi ta ’ maturazzjoni tiġi stimulata bl- għoti ta ’ hCG.
Oocyte (egg) retrieval is performed 34-35 hours later.
Il- ġbir tal- ooċiti (bajd) isseħħ 34- 35 siegħa wara.
Dosage in men
Dożaġġ fl- irġiel
Fertavid is usually prescribed at a dose of 450 IU/ week, mostly in 3 dosages of 150 IU, in combination with another hormone (hCG), for at least 3 to 4 months.
Ġeneralment, Fertavid huwa preskritt f’ doża ta ’ 450 IU/ ġimgħa, l- aktar fi tliet dożaġġi ta ’ 150 IU, flimkien ma ’ ormon ieħor (hCG), għal tal- anqas 3 sa 4 xhur.
If you have not responded after this period, your treatment may carry on for at least 18 months.
Jekk ma jkunx hemm rispons wara dan il - perijodu, il- kura tiegħek tista ’ titkompla sa tal- anqas 18- il xahar.
Fertavid only works if it is injected in a muscle or under the skin.
Fertavid jaħdem biss jekk jiġi injettat ġol- muskolu jew taħt il- ġilda.
The very first injection of Fertavid should be given under medical supervision.
L- ewwel injezzjoni ta ’ Fertavid għandha tingħata taħt sorveljanza medika.
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 tal- addome per eżempju).
Injections into a muscle (intramuscular) should only be given by a doctor or a nurse.
Injezzjonijiet ġol- muskolu għandhom jingħataw biss minn tabib jew infermier.
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.
Your doctor will tell you when and how to do this.
It- tabib tiegħek għandu jgħidlek meta u kif tagħmel dan.
When the instructions are followed carefully, Fertavid will be administered properly and with minimal discomfort.
Meta l- istruzzjonijiet ikunu segwiti bir- reqqa, Fertavid jingħata sew u bl- inqas skumdità.
Instructions for use
Struzzjonijiet għall- użu
Step 1 - Preparing the syringe Sterile disposable syringes and needles should be used for administration of Fertavid.
Stadju 1 – Preparazzjoni tas- siringa Għat- teħid ta ’ Fertavid, għandhom jintużaw siringi u labar sterili li jintremew wara l- użu.
The volume of the syringe should be small enough so that the prescribed dose can be given with reasonable accuracy.
Il- volum tas - siringa għandu jkun żgħir biżżejjed sabiex id- doża preskritta tkun tista ’ tingħata bi preciżjoni raġjonevoli.
Fertavid solution for injection comes in a glass vial.
Fertavid, soluzzjoni għall- injezzjoni jiġi f’ kunjett tal- ħġieġ.
Do not use if the solution contains particles or is not clear.
Tużax jekk is- soluzzjoni ma tkunx ċara jew jekk ikun hemm xi frak.
Place a needle on a syringe and pierce the needle through the rubber stopper of the vial (a).
L- ewwel, neħħi l- għatu li jinqala ’ b’ daqqa ta’ saba ’ minn mal - kunjett. Waħħal il- labra mas- siringa u taqqab il- gomma tal- fjala bil- labra.
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 tal- 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 Fertavid 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 imbotta 120 l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
If necessary, the plunger may be squeezed further, to adjust the volume to be administered.
Jekk ikun meħtieġ il- planġer għandu jiġi mbuttat aktar sabiex taġġusta l- volum li jrid jingħata.
115 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 tal- injezzoni L- aħjar sit tal- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) 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 tal- injezzjoni ma ’ kull injezzjoni.
It is possible to inject in other areas.
Huwa possibli li tinjetta f’ postijiet oħra.
Your doctor or nurse will advise you where to inject.
It- tabib jew l- infermier tiegħek għandhom jagħtuk parir fejn tinjetta.
Step 3 - Preparing the area A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the needle goes in.
Stadju 3 – Preparazzjoni tas- sit tal- injezzjoni Ftit taptip fis- sit tal- injezzjoni għandu jistimula t- truf tan- nervituri u jnaqqas l- iskomdu meta tidħol il - labra.
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 tal- injezzjoni mimsuħa b’ diżinfettant (eż. chlorhexidine 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 tal- anqas minuta qabel ma tipproċedi.
Step 4 - Inserting the needle Pinch the skin a little.
Dħul tal- labra Oqros daqsxejn il- ġilda.
With the other hand, insert the needle at an angle of 90 degrees into the skin’ s surface (f).
B’ idejk l- oħra, daħħal il- labra f’ anglu ta ’ 90 grad fil- wiċċ tal- ġilda (f).
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 jkun diffiċli biex tiġbed il- planġer lura.
Any blood sucked back into the syringe means that the needle tip has penetrated a vein or artery.
Jekk xi demm jinġibed lura fis- siringa ifisser li r- ras tal- labra ppenetrat vina jew arterja.
If this happens pull out the syringe, cover the injection site with a swab containing disinfectant and apply pressure; the site will stop bleeding in a minute or two.
Id- demm jieqaf joħroġ wara minuta jew tnejn.
Do not use this solution but flush it away.
Tużax din is- soluzzjoni iżda armiha.
You should then start again with Step 1 using a new needle and syringe and a new vial of Fertavid.
Għandek terġa tibda mill- ġdid minn Stadju 1 billi tuża siringa u labra ġdida u fjala ġdid ta ’ Fertavid.
Step 6 - Injecting the solution Depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.
Stadju 6 – Injezzjoni tas- soluzzjoni Agħfas il- planġer `l isfel bil- mod u b’ idejk soda, sabiex is- soluzzjoni kollha tiġi injettata sewwa u sabiex ma ssirx ħsara lit- tessuti tal- ġilda.
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 tal- injezzjoni b’ imsiħ li fiha d- diżinfettant.
A gentle massage of the site - while still maintaining pressure - helps disperse the Fertavid solution and relieve any discomfort.
Massaġġ ġentili fuq is- sit – waqt li tkun qed tagħfas fuqha – jgħin biex tifrex is- soluzzjoni tal- Fertavid u ttaffi kull skomdu.
Any remaining solution should be discarded.
Kull fdal tas- soluzzjoni li ma jkunx intuża għandu jintrema.
Do not mix Fertavid with any other medicines.
Fertavid m’ għandux jitħallat ma ’ mediċini oħra.
If you use more Fertavid than you should
Jekk tuża Fertavid aktar milli suppost
Inform your doctor.
121 Għarraf lit- tabib tiegħek.
Too high a dose may cause overstimulation of the ovaries.
Doża għolja żżejjed tista ’ tikkawża stimulazzjoni żejda tal- ovarji.
See section on Possible side effects below.
Ara s- sezzjoni fuq Effetti Sekondarji li Jista ’ Jkollu li tidher hawn isfel.
116 If you forget to use Fertavid
Jekk tinsa tuża Fertavid
Do tell your doctor that you missed a dose.
Għarraf lit- tabib tiegħek li tkun insejt tieħu doża.
Like all medicines, Fertavid can cause side effects, although not everybody gets them.
Bħal mediċini kollha Fertavid jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
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 tal- injezzjoni.
Occasionally, more widespread reactions like rash have been observed.
Minn daqqiet, ġew osservati reazzjonijiet aktar mifruxa bħal raxx.
A complication with FSH treatment is unwanted overstimulation of the ovaries.
Kumplikazzjoni serja bit- trattament tal- 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 tal- iżvilupp tal - follikuli waqt il- kura.
The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea.
L- ewwel sintomi ta ’ stimulazzjoni żejda tal- ovarji jistgħu jkunu uġigħ fl - addome, tħossok marid jew dijarea.
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 tal- ovarji, akkumulazzjoni ta ’ fluwidu fl- addome u/ jew fis- sider, żieda fil- piż u l- preżenza ta ’ emboli tad- demm fiċ- ċirkulazzjoni.
Contact your doctor without delay if you are experiencing any of these symptoms, also if they develop some days after the last injection has been given.
Għarraf lit- tabib tiegħek mingħajr dewmien jekk tħoss xi wieħed minn dawn is - sintomi, anke jekk ikunu żviluppaw wara xi ġranet wara l- aħħar injezzjoni mogħtija.
Rarely, blood clots may occur without unwanted overstimulation of the ovaries (see also “ Take special care with Fertavid”).
F’ każijiet rari, jista ’ jkun hemm emboli mingħajr stimulazzjoni mhux mixtieqa tal- ovarji (ara wkoll “ Oqgħod attent ħafna b’ Fertavid ”).
Other side effects observed in clinical studies include headache and nausea.
Effetti sekondarji oħra osservati fi studji kliniċi jinkludu uġigħ ta ’ ras u dardir.
Some breast development or acne may occur due to treatment with hCG.
Jista ’ jkun hemm xi żvilupp tas- sider jew akne minħabba l- kura b’ hCG.
HOW TO STORE FERTAVID
KIF TAĦŻEN FERTAVID
Do not use Fertavid after the expiry date which is stated on the label after'EXP: '.
Tużax Fertavid wara d- data ta ’ skadenza li tidher fuq it- tikketta wara ‘ JIS: ’.
For your convenience, you may store Fertavid at or below 25 ºC (at room temperature) for a single period of not more than 3 months.
Għal konvenjenza tiegħek tista ’ taħżen Fertavid f’ temperatura ta ’ 25 °C jew anqas (temperatura tal - kamra) għal perijodu wieħed ta ’ mhux aktar minn 3 xhur.
Make a note of when you start storing the product out of the refrigerator.
Ħu nota ta ’ meta bdejt taħżen il- prodott barra mill- friġġ.
The contents of a vial should be used immediately after piercing the rubber stopper.
La darba Fertavid ikun tħallat fis- solvent, is- soluzzjoni għandha tintuża minnufih.
Do not use Fertavid if you notice that the solution contains particles or is not clear.
Tużax Fertavid jekk tinduna li s- soluzzjoni mhix ċara jew li hemm xi frak.
What Fertavid contains
X’ fih Fertavid
117 • 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.
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.
What Fertavid looks like and contents of the pack
Id- Dehra ta ’ Fertavid u l- kontenuti tal- pakkett
Fertavid solution for injection is a clear, colourless solution.
Fertavid soluzzjoni għall- injezzjoni hija soluzzjoni ċara u mingħajr kulur.
It is supplied in a glass vial.
Hija tiġi f’ kunjett tal- ħġieġ.
It is available in packs of 1, 5 or 10 vials.
Hija disponibbli f’ pakketti ta ’ 1, 5 jew 10 kunjetti.
Marketing Authorisation Holder SP Europe, Rue de Stalle 73, B-1180 Bruxelles, Belgium.
Id- Detentur tal- Awtorizzazzjoni għat- tqegħid fis- Suq SP Europe, Rue de Stalle 73, B- 1180, Il- Belġju
Manufacturer • N. V.
Manifattur • N. V.
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands • Organon (Ireland) Ltd., P. O.
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, l- Olanda • Organon (Ireland) Ltd., P. O.
Dublin, Ireland • Organon S. A., Usine Saint Charles, 60590 Eragny sur Epte, France
Dublin, l- Irlanda • Organon S. A., Usine Saint Charles, 60590 Eragny sur Epte, Franza
In correspondence please quote the batch number.
Fil- korrispondenza jekk jogħġbok ikkwota n- numru tal- lott.
118 PACKAGE LEAFLET:
123 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 Fertavid • 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 tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- glandola pitwitarja jew tal - ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Fertavid • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju tal- ovarji. • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku tal- ovarji (PCOD) • jekk għandek malformazzjonijiet tal- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
119 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.
Breast feeding
Jekk qed tredda ’
120 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid skont il- parir eżatt tat- tabib.
This dose is continued for at least seven days.
Din id- doża tinżamm għal tal- anqas sebat ijiem.
The administration of Fertavid is then stopped and ovulation can be induced by administering human chorionic gonadotrophin (hCG). • Medically assisted reproduction programs, e. g.
Fertavid imbagħad jitwaqqaf u l- ovulazzjoni tista ’ tiġi stimulata bl- għoti tal- gonadotrofina korjonika umana (hCG). • Programmi ta ’ riproduzzjoni medikament assistiti, eż.
Do not use if the solution contains particles or is not clear.
Tużax jekk is- soluzzjoni ma tkunx ċara jew jekk jkun hemm xi frak.
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 Fertavid 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 imbotta 126 l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
121 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 tal- injezzoni L- aħjar sit tal- 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 Fertavid than you should
127 Jekk tuża Fertavid aktar milli suppost
Inform your doctor.
Għarraf lit- tabib tiegħek.
122 If you forget to use Fertavid
Jekk tinsa tuża Fertavid
The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea.
L- ewwel sintomi ta ’ stimulazzjoni żejda tal- ovarju jistgħu jkunu uġigħ fl - addome, tħossok marid jew dijarea.
The contents of a vial should be used immediately after piercing the rubber stopper.
Il- kontenut tal- kunjett għandu jintuża minnufih la darba ttaqqab it- tapp tal- lastku.
Do not use Fertavid if you notice that the solution contains particles or is not clear.
Tużax Fertavid jekk tinnota li s- soluzzjoni mhix ċara jew li hemm xi frak.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall -
123 What Fertavid contains
X’ fih Fertavid
• 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.
This leaflet was last approved in
Dan il- fuljett kien approvat l- aħħar f ’.
124 PACKAGE LEAFLET:
129 FULJETT TA ’ TAGĦRIF:
125 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.
Please discuss this with your doctor, before starting treatment, especially if: • you already know you have an increased risk of thrombosis • you, or anyone in your immediate family, have ever had a thrombosis • you are severely overweight.
Jekk jogħġbok kellem lit- tabib tiegħek qabel ma tibda l- kura, speċjalment jekk: • int taf li għandek riskju ogħla ta ’ trombożi • int, jew xi ħadd tal- familja qrib tiegħek, xi darba kellhom trombożi • int għandek piż żejjed sew.
126 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid skont il- parir eżatt tat- tabib.
Place a needle on a syringe and pierce the needle through the rubber stopper of the vial (a).
L- ewwel, neħħi l- għatu li jinqala ’ b’ daqqa ta’ saba ’ minn mal - fjala. Waħħal il- labra mas- siringa u taqqab il- gomma tal- fjala bil- labra.
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 Fertavid 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 imbotta 132 l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
127 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 tal- injezzoni L- aħjar sit tal- injezzjoni għal taħt il- ġilda huwa fl- addome madwar iż- żokkra (e) fejn hemm ħafna ġilda merħija u saffi ta ’ tessut tax- xaħam.
Step 3 - Preparing the area A few taps at the injection site will stimulate tiny nerve endings and help reduce discomfort when the needle goes in.
Stadju 3 – Preparazzjoni tas- sit tal- injezzjoni Ftit taptip fis- sit tal- injezzjoni għandu jistimula t- truf tan- nervituri u jnaqqas l- iskomdu meta tidħol il- labra.
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 tal- injezzjoni mimsuħa bid- diżinfettant (eż. chlorhexidine 0. 5%) sabiex jitneħħew xi batterja tal- wiċċ.
Inform your doctor.
133 Għarraf lit- tabib tiegħek.
128 If you forget to use Fertavid
Jekk tinsa tuża Fertavid
Occasionally, more widespread reactions like rash have been observed.
Minn daqqiet ġew osservati reazzjonijiet aktar mifruxa bħal raxx.
The first symptoms of ovarian overstimulation may be noticed as pain in the abdomen, feeling sick or diarrhoea.
L- ewwel sintomi ta ’ stimulazzjoni żejda tal- ovarju jistgħu jkunu uġigħ fl- addome, tħossok marid jew dijarea.
Contact your doctor without delay if you are experiencing any of these symptoms, also if they develop some days after the last injection has been given.
Għarraf lit- tabib tiegħek mingħajr dewmien jekk tħoss xi wieħed minn dawn is- sintomi, anke jekk ikunu żviluppaw wara xi ġranet wara l- aħħar injezzjoni mogħtija.
129 What Fertavid contains
X’ fih Fertavid
• 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.
Fertavid solution for injection is a clear, colourless solution.
Id- Dehra ta ’ Fertavid u l- kontenuti tal- pakkett Fertavid soluzzjoni għall- injezzjoni hija soluzzjoni ċara u mingħajr kulur.
130 PACKAGE LEAFLET:
135 FULJETT TA ’ TAGĦRIF:
Fertavid 150 IU/ 0,5 ml solution for injection follitropin beta
Fertavid 150 IU/ 0. 5 ml soluzzjoni għall- injezzjoni follitropin beta
Fertavid solution for injection contains follitropin beta, a hormone known as follicle-stimulating hormone (FSH).
Fertavid, 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 Fertavid • 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 tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- glandola pitwitarja jew tal - ipotalamu. • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Fertavid • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju tal- ovarji. • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku tal- ovarji (PCOD) • jekk għandek malformazzjonijiet tal- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
131 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.
132 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid 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 Fertavid 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 imbotta 138 l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
133 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 tal- injezzoni L- aħjar sit tal- 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.
139 Għarraf lit- tabib tiegħek.
134 If you forget to use Fertavid
Jekk tinsa tuża Fertavid
Do not use Fertavid after the expiry date which is stated on the label after'EXP: '.
Tużax Fertavid wara d- data ta ’ skadenza li tidher fuq it- tikketta wara ‘ JIS: ’
135 What Fertavid contains
X’ fih Fertavid
• 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.
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
136 PACKAGE LEAFLET:
141 FULJETT TA ’ TAGĦRIF:
137 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.
138 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid 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 Fertavid 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 imbotta 144 l- planġer sakemm l- arja kollha tkun ħarġet, u fis- siringa jkun hemm is- soluzzjoni biss (d).
139 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 tal- injezzoni L- aħjar sit tal- 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.
145 Għarraf lit- tabib tiegħek.
140 If you forget to use Fertavid
Jekk tinsa tuża Fertavid
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 xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
Keep the vial(s) in the outer carton.
Żomm il- kunjetti fil- kartuna ta ’ barra.
141 What Fertavid contains
X’ fih Fertavid
• The active substance is follitropin beta, a hormone known as follicle-stimulating hormone (FSH) in a strength of 200 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 ’ 200 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.
142 PACKAGE LEAFLET:
147 FULJETT TA ’ TAGĦRIF:
Possible side effects 5.
Effetti sekondarju li jista ’ jkollu 5.
Fertavid 150 IU/ 0.18 ml solution for injection contains a hormone known as follicle-stimulating hormone (FSH) in a strength of 833 IU/ ml.
Fertavid 150 IU/ 0. 18 ml soluzzjoni għall- injezzjoni fih l- ormon magħruf bħala l- ormon li jistimula l - follikoli (FSH) f' qawwa ta '833 IU/ ml.
FSH belongs to the group of gonadotrophins, which play an important role in human fertility and reproduction.
FSH jappartjeni fil- kategoija ta ’ gonadotrofini, li għandhom rwol importanti fil- fertilità u fir - riproduzzjoni tal- bniedem.
Fertavid is used to treat infertility in any of the following situations: • In women who are not ovulating, Fertavid 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, Fertavid can be used to bring about the development of multiple follicles. • In men who are infertile due to a hormonal deficiency, Fertavid can be used for the production of sperm.
Fertavid jintuża biex jitratta l- infertilità f’ xi waħda mill- kondizzjonijiet li ġejjin: • Fin- nisa li m’ hux qed ikollhom ovulazzjoni, Fertavid 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, Fertavid jista ’ jintuża sabiex jikkawża l- iżvilupp ta ’ follikuli multipli. • Fl- irġiel li huma infertili minħabba d- defiċenża ta ’ ormoni, Fertavid jista ’ jintuża għall - produzzjoni tal- 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 Fertavid • 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 tal- ovarju, tas- sider, tal- utru, tat- testikoli, tal- glandola pitwitarja jew tal - ipotalamu. • jekk inti allerġika/ u (tbati minn sensittività eċċessiva) għal follitropin beta jew għal xi wieħed mis- sustanzi l- oħra ta ’ Fertavid • jekk għandek emorraġija vaġinali qawwija jew irregolari fejn il- kawża mhix magħrufa • jekk tbati minn indeboliment primarju tal- ovarju • jekk għandek ċisti fl- ovarji jew ovarji mkabbra li m’ humiex ikkawżati minn mard poliċistiku tal- ovarji (PCOD) • jekk għandek malformazzjonijiet tal- organi sesswali li jagħmel tqala normali impossibbli • jekk għandek fibrojdi fl- utru li jagħmel tqala normali impossibli
143 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.
Regular monitoring of the response to FSH-treatment helps your doctor to prevent ovarian overstimulation.
Monitoraġġ regolari tar- rispons għal- kura bl- FSH jgħin lit- tabib tiegħek sabiex jevita li jkun hemm stimulazzjoni żejda tal - ovarji.
Treatment with Fertavid (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’ Fertavid (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).
Elevated FSH blood levels are indicative of testicular damage.
Livelli ta’ FSH għolja fid- demm huma sinjali ta ’ ħsara fit- testikoli.
Fertavid is usually not effective in such cases.
Ġeneralment Purgon m’ huwiex effettiv f’ dawn il- każi.
Furthermore, multiple pregnancies and characteristics of the patients undergoing fertility treatment (e. g. age of the female, sperm characteristics) may be associated with an increased risk of congenital abnormalities.
Barraminhekk, tqala multipla u l- karatteristiċi tal- pazjenti li jkunu qed jingħataw kura għal fertilità (eż età tal- mara, karatteristiċi tal- isperma) jistgħu jkunu assoċjati ma ’ riskju ogħla ta ’ anormalitajiet konġenitali.
No effects on the ability to drive and use machines have been observed.
Ma ġie osservat l- ebda effett fuq il- ħila tas- sewqan u l- użu tal- magni
HOW TO USE FERTAVID
KIF GĦANDEK TIEĦU FERTAVID
144 Always use Fertavid exactly as your doctor has told you.
Dejjem għandek tuża Fertavid skont il- parir eżatt tat- tabib.
The administration of Fertavid is then stopped and ovulation can be induced by administering human chorionic gonadotrophin (hCG). • Medically assisted reproduction programs, e. g.
Fertavid, imbagħad jitwaqqaf u l- ovulazzjoni tista ’ tiġi stimulata bl- għoti tal- gonadotrofina korjonika umana (hCG). • Programmi ta ’ riproduzzjoni medikament assistiti, eż.
Fertavid solution for injection in cartridges has been developed for use in a pen injector called Puregon Pen.
Fertavid, soluzzjoni għall- injezzjoni fl- istoċċijiet ġie żviluppat biex jintuża mal- Puregon Pen.
The separate instructions for using the pen must be followed carefully.
L - istruzzjonijiet separati għall- użu tal- pinna għandhom jiġu segwiti b' attenzjoni.
Do not use the cartridge if the solution contains particles or if the solution is not clear.
Tużax l- istoċċijiet jekk is- soluzzjoni fiha xi frak jew is- soluzzjoni m' hix ċara.
Using the pen, injections just under the skin (in the abdominal wall, for example) can be given by you or your partner.
Permezz tal- pinna, injezzjonijiet taħt il- ġilda (fil- wiċċ tal- addome per eżempju) jistgħu jingħataw minnek stess jew sieħeb/ sieħba tiegħek.
When the instructions are followed carefully, Fertavid will be administered properly and with minimal discomfort.
Meta l- istruzzjonijiet jiġu segwiti bir- reqqa, Fertavid jista 'jingħata sew u bl- inqas inkonvenjent.
The very first injection of Fertavid should be given under medical supervision.
L- ewwel injezzjoni ta ’ Fertavid għandha tingħata taħt superviżjoni medika.
If you use more Fertavid than you should
Jekk tieħu Fertavid aktar milli suppost għandek
If you forget to use Fertavid
Jekk tinsa tuża Fertavid
145 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 tal- injezzjoni.
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 tal- ovarju jistgħu jkunu uġigħ fl - addome, tħossok marid jew dijarea, F’ każijiet aktar serji sintomi jistgħu jinkludu tkabbir tal- ovarji, akkumulazzjoni ta ’ fluwidu fl- addome u/ jew fis- sider, żieda fil- piż u l- preżenza ta ’ emboli tad- demm fiċ- ċirkulazzjoni.
Contact your doctor without delay if you are experiencing any of these symptoms, also if they develop some days after the last injection has been given.
Għarraf lit- tabib tiegħek mingħajr dewmien jekk tħoss xi wieħed minn dawn is - sintomi, anke jekk ikunu jiżviluppaw wara xi ġranet wara l- aħħar injezzjoni mogħtija.
Do not freeze.
Aħżen fi friġġ (2 °C – 8°C) Tagħmlux fil- friża.