qanastek/EMEA-V3 huggingface dataset:
Pelzont is used if you need to improve cholesterol and fat levels in your blood (primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia): • when you cannot control your cholesterol levels with a statin (class of cholesterol-lowering medicines working in the liver); • when you cannot tolerate a statin or when a statin is not recommended for you.
Pelzont jintuża jekk għandek bżonnittejjeb il- livelli tal- kolesterol u tax- xaħam fid- demm tiegħek (iperkolesterolemija primarja (eterozigota familjali u mhux familjali) jew dislipidemija mħallta): • meta ma tistax tikkontrolla l- livelli tal- kolesterol tiegħek bi statin (kategorija ta ’ mediċini li jbaxxu l- kolesterol li taħdem fil- fwied); • meta ma tistax tittollera statin jew meta statin ma jkunx rakkomandat għalik.
Pelzont can be used by itself or with other medicines to treat cholesterol problems.
Pelzont jista ’ jintuża waħdu jew ma ’ mediċini oħra li jittrattaw problemi tal- kolesterol.
You should stay on a diet designed to lower cholesterol or other non-pharmacological treatments (e. g. exercise, weight reduction) while you take this medicine.
Inti għandek tibqa ’ fuq dieta maħsuba biex tbaxxi l- kolesterol jew trattamenti mhux farmakoloġiċi oħrajn (eż. eżerċizzju, tnaqqis fil- piż) waqt li tkun qed tieħu din il- mediċina.
BEFORE YOU TAKE PELZONT
QABEL MA TIEĦU Pelzont
Do not take Pelzont if • you are allergic (hypersensitive) to nicotinic acid, to laropiprant, or to any of the other ingredients of Pelzont (listed in section 6). • you currently have liver problems. • you have an ulcer in your stomach. • you have arterial bleeding.
Tiħux Pelzont • jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għall- aċidu nikotiniku, għal laropiprant, jew għal xi sustanzi oħra ta ’ Pelzont (elenkati f’ sezzjoni 6). • jekk bħalissa għandek problemi bil- fwied. • jekk għandek ulċera fl- istonku tiegħek. • jekk għandek fsada arterjali.
Do not take Pelzont if any of the above apply to you.
Tiħux Pelzont jekk xi waħda minn dawn ta ’ hawn fuq tgħodd għalik.
If you are not sure, talk to your doctor or pharmacist before taking Pelzont.
Jekk m’ intix ċert, kellem lit - tabib jew lill- ispiżjar tiegħek qabel tieħu Pelzont.
Take special care with Pelzont Tell your doctor about all of your medical conditions.
Oqgħod attent ħafna bi Pelzont Għid lit- tabib tiegħek dwar il- kundizzjonijiet mediċi tiegħek kollha.
Check with your doctor or pharmacist before and while taking your medicine if: • you have any allergies. • you have ever had liver disease, jaundice (a liver disorder causing yellowing of the skin and whites of the eyes), or hepatobiliary (liver and bile duct) disease. • you have kidney problems. • you have thyroid problems. • you drink large amounts of alcohol. • you or close family members have a hereditary muscle disorder, or you have ever had muscle problems during treatment with cholesterol-lowering medicines called “ statins” or fibrates. • you have unexplained muscle pain, muscle tenderness, or muscle weakness.
Iċċekkja mat- tabib jew ma ’ l - ispiżjar tiegħek qabel u waqt li tkun qed tieħu l- mediċina tiegħek: • jekk għandek xi allerġiji. • jekk xi darba kellek mard tal- fwied, suffejra (disturb tal- fwied li jikkawża sfurija tal- ġilda u ta ’ l- abjad ta ’ l- għajn), jew mard epatobiljari (fwied u l- kanal biljari). • jekk għandek problemi bil- kliewi. • jekk għandek problemi bit- tirojde. • jekk tixrob ammonti kbar ta ’ alkoħol. • jekk inti jew membri tal- familja li jiġu mill- qrib minnek għandkom disturb fil- muskoli li jintiret, jew xi darba kellek problemi bil- muskoli matul trattament b’ mediċini li jbaxxu l- kolesterol li jissejħu “ statins ” jew fibrati. • jekk għandek uġigħ fil- muskoli, sensittività fil- muskoli, jew dgħjufija mhux spjegata fil - muskoli.
If you have these symptoms talk to your doctor immediately. • you have high blood sugar or diabetes. • you have heart problems. • you are going to have an operation. • you have gout. • you have low levels of phosphorus. • you are over 70 years old.
Jekk għandek dawn is- sintomi, kellem lit- tabib tiegħek immedjatament. • jekk għandek zokkor għoli fid- demm jew dijabete. • jekk għandek problemi b’ qalbek. • jekk se tagħmel operazzjoni. • jekk għandek il- gotta. • jekk għandek livelli baxxi ta ’ fosfru. • jekk għandek aktar minn 70 sena.
33 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Pelzont.
Jekk m’ intix ċert dwar jekk xi waħda minn dawn ta ’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu Pelzont.
Blood tests and monitoring • See your doctor regularly to check your LDL (bad) and HDL (good) cholesterol levels and your triglyceride level. • Your doctor should do a blood test before you start taking Pelzont to check how well your liver is working. • Your doctor may also want you to periodically have blood tests after you start taking Pelzont, to check how well your liver is working and for other side effects.
Testijiet tad- demm u monitoraġġ • Ara lit- tabib tiegħek regolarment biex tiċċekkja l- livelli tal- kolesterol LDL (ħażin) u HDL (tajjeb) u l- livell tat- trigliċeridi tiegħek. • It- tabib tiegħek għandu jagħmillek test tad- demm qabel ma tibda tieħu Pelzont biex jiċċekkja
Children and adolescents Pelzont has not been studied in children and adolescents who are under 18 years of age.
Tfal u adoloxxenti Pelzont ma ġiex studjat fi tfal u adoloxxenti ta ’ taħt it- 18- il sena.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra.
This includes medicines obtained without a prescription, vitamins, and herbal supplements.
Dan jinkludi mediċini mingħajr riċetta, vitamini, u supplimenti tal- ħxejjex.
In particular, tell your doctor or pharmacist if you are taking any of the following: • medicines used to lower blood pressure. • medicines used to lower cholesterol called ‘ statins’, a class of medicine that works in the liver. • medicines used to lower cholesterol called ‘ bile acid sequestrants ’, such as colestyramine. • zidovudine, a medicine used for HIV. • midazolam, a medicine to make you sleepy before some medical procedures. • vitamins or supplements that contain nicotinic acid. • clopidogrel, a medicine to help prevent harmful blood clots.
B’ mod partikolari, għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu xi ħaġa minn dawn li ġejjin: • mediċini użati biex ibaxxu l- pressjoni tad- demm. • mediċini użati biex ibaxxu l- kolesterol imsejħa ‘ statins ’, kategorija ta ’ mediċini li taħdem fil - fwied. • mediċini użati biex ibaxxu l- kolesterol imsejħa ‘ sekwestranti ta ’ l- aċidu biljari ’, bħall - colestyramine. • zidovudine, mediċina użata għall- HIV. • midazolam, mediċina biex traqqdek qabel xi proċeduri mediċi. • vitamini jew supplimenti li fihom l- aċidu nikotiniku. • clopidogrel, mediċina li tgħin fil- prevenzjoni ta ’ emboli perikolużi.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Pelzont.
Jekk m’ intix ċert dwar jekk xi waħda minn dawn ta ’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill- ispiżjar tiegħek qabel tieħu Pelzont.
Taking Pelzont with food and drink • Take Pelzont with food. • To lower your chance of flushing, avoid drinking alcohol or hot drinks near the time you take your dose of Pelzont. • It is important to follow the advice given in section 3 How to take Pelzont.
Meta tieħu Pelzont ma ’ l- ikel u max- xorb • Ħu Pelzont ma ’ l- ikel. • Biex tbaxxi ċ- ċans tiegħek ta ’ fwawar, evita li tixrob alkoħol jew xorb jaħraq qrib il- ħin li tieħu d- doża tiegħek ta ’ Pelzont. • Huwa importanti li ssegwi l- parir mogħti f’ sezzjoni 3 Kif għandek tieħu Pelzont.
Pregnancy and breast-feeding Talk with your doctor before taking Pelzont if: • You are pregnant or plan to become pregnant.
Tqala u treddigħ Tkellem mat- tabib tiegħek qabel tieħu Pelzont jekk: • Inti tqila jew qiegħda tippjana biex tinqabad tqila.
It is not known if Pelzont will harm your unborn baby. • You are breast-feeding or plan to breast-feed.
Mhux magħruf jekk Pelzont jagħmilx ħsara lit- tarbija mhux imwielda tiegħek. • Qiegħda tredda ’ jew qiegħda tippjana li tredda ’.
It is not known if Pelzont will pass into your breast milk.
Mhux magħruf jekk Pelzont jgħaddix għal ġol - ħalib tas- sider tiegħek.
However, nicotinic acid a component of Pelzont does pass into breast milk.
Madankollu, l- aċidu nikotiniku, li huwa component ta ’ Pelzont, jgħaddi għal ġol- ħalib tas- sider.
Your doctor will decide if Pelzont is right for you.
It- tabib tiegħek jiddeċiedi jekk Pelzont hux tajjeb għalik.
34 Driving and using machines The effects of Pelzont on the ability to drive and use machines have not been studied.
Sewqan u tħaddim ta ’ magni L- effetti ta ’ Pelzont fuq il- ħila li ssuq u tħaddem magni għadu ma ġiex studjat.
However, some people get dizzy after taking Pelzont.
Madankollu, xi nies jistordu wara li jieħdu Pelzont.
If you get dizzy, you should avoid driving or operating machines after taking Pelzont.
Jekk tistordi, inti għandek tevita li ssuq jew tħaddem magni wara li tieħu Pelzont.
Important information about some of the ingredients of Pelzont Pelzont contains a sugar called lactose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Pelzont Pelzont fih tip ta ’ zokkor imsejjaħ lattożju.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu din il- mediċina.
HOW TO TAKE PELZONT
KIF GĦANDEK TIEĦU PELZONT
Always take Pelzont exactly as your doctor has told you.
Dejjem għandek tieħu Pelzont skond il- parir tat- tabib.
How much to take • You should start by taking one tablet a day. • After 4 weeks, your doctor may raise your dose to two tablets a day.
Kemm għandek tieħu • Inti għandek tibda billi tieħu pillola waħda kuljum. • Wara 4 ġimgħat, it- tabib tiegħek jista ’ jgħolli d- doża tiegħek għal żewġ pilloli kuljum.
How to take • Take Pelzont once a day, in the evening or at bedtime. • Take Pelzont with food. • Swallow each tablet whole.
Kif għandek tieħdu • Ħu Pelzont darba kuljum, filgħaxija jew qabel torqod. • Ħu Pelzont ma ’ l- ikel. • Ibla ’ kull pillola sħiħa.
In order for your medicine to work as intended, do not split, break, crush, or chew the tablet before you swallow it. • Avoid drinking alcohol or hot drinks near the time you take your dose of Pelzont.
Sabiex il- mediċina tiegħek taħdem kif suppost, m’ għandekx taqsam, tkisser, tfarrak, jew tomgħod il- pillola qabel ma tiblagħha. • Evita li tixrob alkoħol jew xarbiet sħan qrib il- ħin meta għandek tieħu Pelzont.
This will lower your chance of flushing (redness of the skin, feeling warm, itching, or tingling, particularly in your head, neck, chest and upper back). • Taking aspirin before you take Pelzont does not reduce your flushing more than taking Pelzont alone.
Dan għandu jnaqqas iċ- ċans ta ’ fawra (fawra tal- ġilda, sensazzjoni ta ’ sħana, ħakk, jew tingiż, speċjalment f’ rasek, għonqok, sidrek u l- parti ta ’ fuq ta ’ dahrek). • It- teħid ta ’ aspirina qabel tieħu Pelzont ma jnaqqasx il- fwawar tiegħek aktar milli tieħu Pelzont waħdu.
Therefore, taking aspirin to reduce flushing symptoms is not necessary.
Għalhekk, m’ hemmx bżonn li tieħu aspirina biex tnaqqas is- sintomi tal- fwawar.
If you take aspirin for any other reason, continue to follow your doctor's advice.
Jekk tieħu aspirina għal xi raġuni, kompli segwi l- parir tat- tabib tiegħek.
If you take more Pelzont than you should • In the event of an overdose, the following adverse events were reported: flushing, headache, pruritus (itching), nausea, dizziness, vomiting, diarrhoea, abdominal pain/ discomfort, and back pain. • If you take more than you should, talk to a doctor or pharmacist straight away.
Jekk tieħu Pelzont aktar milli suppost • Fil- każ ta ’ doża eċċessiva, ġew irrapportati l- episodji avversi li ġejjin: fwawar, uġigħ ta ’ ras, prurite (ħakk), dardir, sturdament, rimettar, dijarrea, uġigħ addominali/ skumdità u uġigħ fid- dahar. • Jekk tieħu aktar milli suppost, kellem tabib jew spiżjar immedjatament.
If you forget to take Pelzont • If you miss a dose, do not take an extra dose.
Jekk tinsa tieħu Pelzont • Jekk tinsa tieħu doża, tiħux doża żejda.
Continue with your usual dose the next evening or at bedtime.
Kompli bid- doża tiegħek tas- soltu filgħaxija jew qabel torqod meta jmissek.
However, if you do not take Pelzont for 7 or more days in a row, talk to your doctor before restarting Pelzont.
Madankollu, jekk ma tiħux Pelzont għal sebat ijiem jew aktar konsekuttivi, kellem lit- tabib tiegħek qabel terġa ’ tibda Pelzont.
If you stop taking Pelzont Do not stop taking Pelzont without talking to your doctor.
Jekk tieqaf tieħu Pelzont Tiqafx tieħu Pelzont mingħajr ma tkellem lit- tabib tiegħek.
Your cholesterol problem may return.
Il- problema tal- kolesterol tiegħek tista ’ terġa ’ titfaċċa.
Like all medicines, Pelzont can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Pelzont jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Side effects of Pelzont are:
L- effetti sekondarji ta ’ Pelzont huma:
Very common (affects more than 1 in 10 patients) • flushing (which usually includes redness of the skin, feeling warm, itching, or tingling, particularly in the head, neck, chest and upper back).
Komuni ħafna (jaffettwaw aktar minn 1 minn kull 10 pazjenti) • fawra (li ġeneralment tinkludi ħmura tal- ġilda, sensazzjoni ta ’ sħana, ħakk, jew tingiż, speċjalment fir- ras, l- għonq, is- sider u n- naħa ta ’ fuq tad- dahar).
If flushing occurs, symptoms are generally most noticeable at first and usually lessen over time.
Jekk ikun hemm fawra, is - sintomi normalment jidhru l- aktar fil- bidu u ġeneralment jonqsu mal- ħin.
Common (affects less than 1 in 10 patients) • diarrhoea • nausea (feeling sick) • dizziness • rash • pruritus (itching) • hives • upset stomach or heartburn • getting sick (vomiting) • headache • tingling or numbness of the hands or feet
32 • prurite (ħakk) • ħorriqija • stonku mqalleb jew ħruq ta ’ l- istonku • tiddardar (rimettar) • uġigħ ta ’ ras • tingiż jew traqqid ta ’ l- idejn jew tas- saqajn
Uncommon (affects less than 1 in 100 patients) In addition, one or more of the following symptoms have been reported as part of an allergic reaction to Pelzont. • swelling of the face, lips, tongue, and/ or throat that may cause difficulty in breathing or swallowing (angioedema, which may require treatment right away) • fainting • shortness of breath • loss of control over urine and stool • cold sweats • shivering • chills • increased blood pressure • swelling of the lips • burning sensation • whole body rash • joint pain • swelling of the legs • rapid heart rate.
• nefħa fil- wiċċ, xufftejn, ilsien, u/ jew gerżuma li tista ’ tikkawża diffikultà fit- teħid tan- nifs jew biex tibla ’ (anġjoedema, li jista ’ jkollha bżonn trattament mill- ewwel) • ħass ħażin • qtugħ ta ’ nifs • telf tal- kontroll fuq l- awrina u l- ippurgar • għaraq kiesaħ • rogħda • kesħa • pressjoni tad- demm aktar għolja • nefħa fix- xufftejn • sensazzjoni ta ’ ħruq • raxx mal- ġisem kollu • uġigħ fil- ġogi • nefħa fis- saqajn • taħbita tal- qalb mgħaġġla
HOW TO STORE PELZONT
KIF TAĦŻEN PELZONT
Do not use Pelzont after the expiry date (EXP) which is stated on the carton and the blister.
Tużax Pelzont wara d- data ta ’ skadenza (JIS) li tidher fuq il- kartuna u l- folja.
Store in the original packaging in order to protect from light and moisture.
Aħżen fil- pakkett oriġinali sabiex tilqa ’ mid- dawl u mill- umdità.
Aluminium/ Aluminium blisters:
Folji ta ’ l- aluminju/ aluminju:
What Pelzont contains • The active substances are nicotinic acid and laropiprant.
X’ fih Pelzont • Is- sustanzi attivi huma l- aċidu nikotiniku u laropiprant.
Each tablet contains 1000 mg nicotinic acid and 20 mg laropiprant. • The other ingredients are: hypromellose (E464), colloidal anhydrous silica (E551), sodium stearyl fumarate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), croscarmellose sodium, lactose monohydrate, and magnesium stearate.
Kull pillola fiha 1, 000 mg aċidu nikotiniku u 20 mg laropiprant. • Is- sustanzi l- oħra huma: hypromellose (E464), colloidal anhydrous silica (E551), sodium stearyl fumarate, hydroxypropylcellulose (E463), microcrystalline cellulose (E460), croscarmellose sodium, lactose monohydrate, u magnesium stearate.
What Pelzont looks like and contents of the pack Each modified-release tablet is a capsule-shaped, white to off-white tablet, with “ 552 ” debossed on one side.
33 Id- dehra ta ’ Pelzont u l- kontenuti tal- pakkett Kull pillola li terħi l- mediċina b’ mod modifikat hija pillola bajda għal offwajt, forma ta ’ kapsula, li għandha “ 552 ” ibbuzzat fuq naħa waħda.
Opaque PVC/ Aclar blister with push-through aluminium lidding in pack sizes of 14, 28, 56, 84, 98, 168, 196 modified-release tablets, multi-packs containing 196 (2 packs of 98) modified-release tablets and 49 x 1 modified-release tablets in perforated unit dose blister.
Folja opaka tal- PVC/ Aclar mgħottija b’ aluminju push- through f’ pakketti ta ’ 14, 28, 56, 84, 98, 168, 196 pillola li terħi l- mediċina b’ mod modifikat, pakketti multipli li fihom 196 (2 pakketti ta ’ 98) pillola li jerħu l- mediċina b’ mod modifikat u 49 x 1 pillola li terħi l- mediċina b’ mod modifikat f’ folja unit dose perforata.
Aluminium/ Aluminium blister with push-through lidding in pack sizes of 14, 28, 56, 168 modified-release tablets and 32 x 1 modified-release tablets in perforated unit dose blister.
Folja ta ’ l- aluminju/ aluminju b’ għata push- through f’ pakketti ta ’ 14, 28, 56, 168 pillola li terħi l - mediċina b’ mod modifikat u 32 x 1 pillola li terħi l- mediċina b’ mod modifikat f’ folja ta ’ doża waħda perforata.
Marketing Authorisation Holder Merck Sharp & Dohme Ltd.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Merck Sharp & Dohme Ltd.
Manufacturer Merck Sharp & Dohme Ltd.
Il- Manifattur Merck Sharp & Dohme Ltd.
Shotton Lane, Cramlington Northumberland NE23 3 JU United Kingdom
Shotton Lane, Cramlington Northumberland NE23 3 JU Ir- Renju Unit
Eesti Merck Sharp & Dohme OÜ Tel: +372 613 9750 msdeesti@merck. com
34 Eesti Österreich Merck Sharp & Dohme OÜ Tel: +372 613 9750 msdeesti@ merck. com
Detailed information on this medicine is available on the European Medicines Agency (EMEA) website: http: / /www. emea. europa. eu/.
35 Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il- Mediċini (EMEA): http: // www. emea. europa. eu /.
EU/ 1/ 07/ 396/ 001
Numru ta ’ l- EU EU/ 1/ 07/ 396/ 001
Pergoveris
Isem inventat Pergoveris
150 IU r-hFSH (11micrograms)/ 75 IU r-hLH (3 micrograms)
Qawwa 150 IU r- hFSH (11mikrogrammi) / 75 IU r- hLH (3 mikrogrammi)
Powder and solvent for solution for injection
Għamla farmaċewtika Kif jingħata Trab u solvent għal Taħt il- ġilda soluzzjoni għall - injezzjoni
powder: vial (glass); solvent: vial (glass)
Il- pakkett Trab: fjala (ħġieġ) Solvent: fjala (ħġieġ)
powder:
Kontenut trab:
1 vial + 1 vial
Daqs tal- pakkett 1 fjala + 1 fjala
150 IU r-hFSH (11micrograms)/ 75 IU r-hLH (3 micrograms)
150 IU r- hFSH (11mikrogrammi) / 75 IU r- hLH (3 mikrogrammi)
Powder and solvent for solution for injection
Trab u solvent għal Taħt il- ġilda soluzzjoni għall - injezzjoni
powder: vial (glass); solvent: vial (glass)
Trab: fjala (ħġieġ) Solvent: fjala (ħġieġ)
3 vials + 3 vials
3 fjali + 3 fjali
powder: vial (glass); solvent: vial (glass)
Trab: fjala (ħġieġ); Solvent: fjala (ħġieġ)
10 vials + 10 vials
10 fjali + 10 fjali
Pergoveris 150 IU/ 75 IU powder and solvent for solution for injection.
Pergoveris 150 IU/ 75 IU, trab u solvent għ al soluzzjoni għall- injezzjoni.
QUALITATIVE AND QUANTITATIVE COMPOSITION
G} AMLA KWALITATTIVA U KWANTITATTIVA
One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75 IU (equivalent to 3.0 micrograms) of lutropin alfa (r-hLH).
Fjala waħda fiha 150 IU (ekwivalenti għal 11 mikrogrammi) follitropin alfa (r- hFSH), u 75 IU (ekwivalenti għal 3. 0 mikrogrammi) ta ’ lutropin alfa (r- hLH).
The reconstituted solution contains 150 IU r-hFSH and 75 IU r-hLH per milliliter.
Is- soluzzjoni rrikostitwita fiha 150 IU r- hFSH u 75 IU r- hLH kull ml.
Follitropin alfa and lutropin alfa are produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Follitropin alfa u lutropin alfa huma magħmulin fiċ- ċelluli tal- ovarji tal- ħamster Ċiniż li għandhom materjal ġenetiku mibdul.
Excipients: sucrose, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate.
Sustanzi mhux attivi: sukrożju, disodium phosphate dihydrate, sodium dihydrogen phosphate monohydrate.
Powder and solvent for solution for injection.
Trab u solvent għal soluzzjoni għal injezzjoni.
Solvent: clear colourless solution.
Dehra tat- trab: pellit bajda lijofilizzata Dehra tas- solvent: soluzzjoni mingħajr kulur
The pH of the reconstituted solution is 6.5 - 7.5.
Il - pH tas- soluzzjoni rrikostitwita huwa 6. 5 - 7. 5.
Pergoveris is indicated for the stimulation of follicular development in women with severe LH and FSH deficiency.
Pergoveris huwa indikat biex jistimula żvilupp follikulari f’ nisa b’ defiċjeza severa ta ’ FSH u LH.
In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
Fi studji kliniċi dawn il- pazjenti ġew definiti bil- livelli endoġeni tas- serum LH < 1. 2 IU/ l.
Treatment with Pergoveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Il- kura permezz ta ’ Pergoveris għandha tinbeda taħt is- superviżjoni ta ’ tabib b’ esperjenza fil- kura ta ’ problemi tal- fertilità
Pergoveris is intended for subcutaneous administration.
Pergoveris jingħata permezz ta ’ injezzjoni taħt il- ġilda.
The powder should be reconstituted immediately prior to use with the solvent provided.
It- trab għandu jiġi rrikostitwit billi jitħallat mas- solvent provdut, eżattament qabel ma jintuża.
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of Pergoveris therapy is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Fin- nisa b’ defiċjenza ta ’ LH u FSH (ipogonadiżmu ipogonadotrofiku), l- għan tat- terapija bi Pergoveris hu li jkun żviluppat follikolu Graafjan matur wieħed li minnu joħroġ l- ovum wara li jingħata hCG.
Pergoveris should be given as a course of daily injections.
Pergoveris irid jingħata bħala kors ta ’ injezzjonijiet darba kuljum.
Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Peress li dawn il- pazjenti huma amenorrhoeic (ma jarawx il- pirjid) u għandhom sekrezzjoni baxxa ta ’ estroġenu endoġenu, il- kura tista ’ tinbeda fi kwalunkwe żmien.
2 Treatment should be tailored to the individual patient’ s response as assessed by measuring follicle size by ultrasound and oestrogen response.
Il- kura għandha tkun adattata skond l- effett fuq il- pazjent individwali, li jiġi analizzat billi jitkejjel id - daqs tal- follikulu bl- ultrasawnd u/ jew permezz tas- sekrezzjoni ta ’ l- estroġenu.
A recommended regimen commences with one vial of Pergoveris daily.
Spiss tintuża doża ta’ fjala waħda ta ’ Pergoveris kuljum.
If less than one vial of Pergoveris daily is used, the follicular response may be unsatisfactory because the amount of lutropin alfa may be insufficient (see section 5.1).
Jekk tintuża inqas minn fjala waħda kuljum, l- effett follikulari jista ’ ma jkunx sodifaċenti peress illi l- ammont ta ’ LH ma jkunx biżżejjed (ara sezzjoni 5. 1).
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5-75 IU increments using a licensed follitropin alfa preparation.
Jekk ikun jeħtieġ żieda fid- doża ta ’ FSH, dan għandu jsir preferibbilment wara intervalli ta ’ bejn ġimgħa u ġimagħtejn u preferibbilment b’ żidiet ta ’ 37. 5- 75 IU, billi tintuża preparazzjoni lliċenzjata
It may be acceptable to extend the duration of stimulation in any one cycle to up to 5 weeks.
Jista jkun aċċettabbli li wieħed ikompli l- istimulazzjoni f ’ ċiklu wieħed sa ’ 5 ġimgħat.
When an optimal response is obtained, a single injection of 5,000 IU to 10,000 IU hCG should be administered 24-48 hours after the last Pergoveris injection.
Meta l- effett mixtieq jintlaħaq, injezzjoni waħda ta ’ bejn 5, 000 IU u 10, 000 IU hCG għandha tingħata 24- 48 siegħa wara l- aħħar injezzjoni ta ’ Pergoveris.
The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Il- pazjenta hi rrakkomandata li jkollha x' taqsam mas- sieħeb tagħha dakinhar u l- għada li tieħu l- hCG.
Luteal phase support may be considered since lack of substances with luteotrophic activity (LH/ hCG) after ovulation may lead to premature failure of the corpus luteum.
Wieħed jista ’ jikkunsidra luteal phase support peress illi nuqqas ta ’ sustanzi b’ attivita ’ luteotrofika (LH/ hCG) wara l- ovulazzjoni jista ’ jirriżulta f’ telf tal- korpus luteum qabel il- waqt.
If an excessive response is obtained, treatment should be stopped and hCG withheld.
Jekk jinkiseb rispons eċċessiv, il- kura għandha titwaqqaf u l- hCG ma jingħatax (ara t- twissijiet).
Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Il - kura għandha terġa ’ tibda fiċ- ċiklu li jmiss b’ doża anqas ta ’ FSH minn dik mogħtija fiċ- ċiklu ta ’ qabel.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/ l as measured in a central laboratory.
Fi studji kliniċi, pazjenti b’ defiċjenza qawwija ta ’ FSH u LH kienu definiti minn livelli endongeni tas - serum LH < 1. 2 IU/ l kif imkejjla f’ laboratorju ċentrali.
However, it should be taken into account that there are variations between LH measurements performed in different laboratories.
Iżda, irid jiġi kkunsidrat ukoll il - varjazzjoni bejn livelli ta ’ LH li jiġu maħduma f’ laboratorji differenti.
In these trials the ovulation rate per cycle was 70-75%.
F’ dawn l- istudji, ir- rata ta ’ ovulazzjoni/ ċiklu kienet ta ’ 70- 75%.
Pergoveris is contraindicated in patients with: • hypersensitivity to the active substances follitropin alfa and lutropin alfa or to any of the excipients • case of tumours of the hypothalamus and pituitary gland • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
GONAL- f m’ għandux jintuża f’ każi ta ’: • sensittività eċċessiva għal follitropin alfa u leutropin alfa, jew għal xi wieħed mis- sustanzi mhux attivi; • f’ każi ta ’ tumuri fl- ipotalamu u l- glandola pitwitarja • ovarji kbar jew xi ċista li mhix ikkaġunata minn mard poliċistiku ta ’ l- ovarji • jekk ikun hemm emorraġiji ġinekoloġiċi li l- kawża tagħhom mhix magħrufa • jekk ikun hemm karċinoma fl- ovarji, fl- utru jew fis- sider.
Pergoveris must not be used when an effective response cannot be obtained, such as: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy
Pergoveris m’ għandux jintuża f' każijiet fejn ma jistax jagħti riżultati tajbin bħal per eżempju: • insuffiċjenza primarja ta ’ l- ovarji • meta jkun hemm difett fiżiku ta ’ l- organi sesswali li minħabba fihom ma tistax toħroġ tqila • tumuri fibrużi ta ’ l- utru li minħabba fihom il- mara ma tkunx tista 'toħroġ tqila
Pergoveris contains potent gonadotrophic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
GONAL- f hu sustanza gonadotrofika qawwija li kapaċi tikkawża reazzjonijiet avversi minn ħfief sa severi, u għandu jintuża biss minn tobba li huma mħarrġa sew fil- problemi ta ’ fertilita u l- kura tagħhom.
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
It- terapija bil- gonadotrofina teħtieġ ċertu impenn mit- tobba u l- appoġġ mill- professjonisti fil- qasam tas- saħħa, kif ukoll faċilitajiet xierqa ta ’ osservazzjoni.
In women, safe and effective use of Pergoveris calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Fin- nisa, l- użu mingħajr periklu u effettiv ta ’ Pergoveris jeħtieġ sorveljanza ta ’ l- effett fuq l- ovarji permezz ta ’ l- ultrasawnd, waħdu jew idealment flimkien ma kejl tal- livelli ta ’ l - estradajol fis- serum fuq bażi regolari.
There may be a degree of interpatient variability in response to FSH/ LH administration, with a poor response to FSH/ LH in some patients.
Jista ’ jkun hemm element ta ’ differenzi bejn pazjenta u oħra fuq l- effett ta ’ FSH/ LH, b’ ċerti pazjenti juru rispons fqir għall- FSH/ LH.
The lowest effective dose in relation to the treatment objective should be used in women.
L- anqas doża effettiva biex jintlaħaq l- għan tal- kura għandha tintuża.
3 Self-administration of Pergoveris should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
Il- pazjenta għandha tinjetta lilha nfisha biss meta hemm motivazzjoni qawwija, taħriġ xieraq u aċċess għal pariri professjonali.
The first injection of Pergoveris should be performed under direct medical supervision.
L- ewwel injezzjoni ta ’ Pergoveris għandha tittieħed taħt superviżjoni medika diretta.
Patients with porphyria or a family history of porphyria should be closely monitored during treatment with Pergoveris.
Pazjenti li jbatu minn porphyria jew għandhom storja fil- familja ta ’ porphyria jridu jkunu monitorjati sew waqt it- trattament bi Pergoveris.
Deterioration or a first appearance of this condition may require cessation of treatment.
Deterjorament jew l- ewwel apparenza ta ’ din il- kundizzjoni jista ’ jeħtieġ illi jitwaqqaf it- trattament.
Pergoveris contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
3 Pergoveris fih inqas minn 1 mmol sodju (23 mg) għal kull dosa, i. e. essenzjalment ‘ mingħajr sodju ’.
Pergoveris contains 30 mg of sucrose per dose.
Kull doża ta’ Pergoveris fiha 30mg sukrożju..
This should be taken into account in patients with diabetes mellitus.
Dan irid jiġi kkunsidrat f’ dawk il- pazjienti li jbatu minn diabete mellitus.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Qabel ma 'tibda l- kura għandha tiġi evalwata l- infertilita tal- koppja u għandha issir evalwazzjoni biex tistabbilixxi jekk hemmx xi kontra- indikazzjonijiet għat- tqala.
In particular, patients should be evaluated for the following: • hypothyroidism • adrenocortical deficiency • hyperprolactinemia and pituitary or hypothalamic tumours
B’ mod partikolari, il- pazjenti għandhom ikunu eżaminati għal: • ipotirojdiżmu • defiċjenza adrenokortikali • iperprolaktinimja jew tumuri pitwitarji jew ipotalamiċi
Appropriate specific treatment should be given.
Il- kura speċifika meħtieġa għal dan il- mard trid tingħata.
Patients undergoing stimulation of follicular growth are at an increased risk of developing hyperstimulation in view of possible excessive oestrogen response and multiple follicular development.
Pazjenti li huma għaddejjin minn stimulazzjoni ta ’ tkabbir follikulari, jista ’ jkollhom stimulazzjoni eċċessiva, minħabba rispons eċċessiv għal estroġen u żvilupp follikulari multiplu.
In clinical trials, lutropin alfa in combination with follitropin alfa has been shown to increase the ovarian sensitivity to gonadotropins.
Fi studji kliniċi, lutropin alfa ma ’ follitropin alfa wera li tiżdied is- sensittivita ’ ovarja għal gonadotrofin.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be at 7-14 day intervals and preferably with 37.5-75 IU increments using a licensed follitropin alfa preparation.
Jekk hemm bżonn doża ogħla ta ’ FSH, id- doża għandha tiżdied preferibbilment f’ interval ta ’ 7- 14- il- jum, u preferibbilment żidiet ta ’ 37. 5- 75 IU, billi tiġi użata preparazzjoni lliċenzjata ta ’ FSH.
Ovarian Hyperstimulation Syndrome (OHSS) is a medical event distinct from uncomplicated ovarian enlargement.
Is- sidromu ta ’ stimulazzjoni bla rażan ta ’ l- ovarji (OHSS) hu avveniment mediku differenti minn dak tat- tkabbir ta ’ l- ovarji.
It comprises marked ovarian enlargement, high serum sex steroids, and an increase in vascular permeability which can result in an accumulation of fluid in the peritoneal, pleural and, rarely, in the pericardial cavities.
Dan jinkludi tkabbir evidenti ta ’ l- ovarji, sterojdi sesswali għoljin fis- serum, u żieda fil- permeabbilità vaskulari li tista ’ twassal għal akkumulazzjoni ta ’ likwidu fl- ispazju tal- peritonew, tal- plewra, u rari fl- ispazju tal - perikardju.
The following symptomatology may be observed in severe cases of OHSS: • abdominal pain • abdominal distension • severe ovarian enlargement • weight gain • dyspnoea • oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Dawn is- sintomi jistgħu jkunu osservati f’ każi severi ta ’ OHSS: • uġigħ addominali • nefħa addominali • tkabbir sever ta ’ l- ovarji • żieda fil- piż • dispneja • oligurja, u sintomi gastro- intestinali li jinkludu dardir, remettar u dijarrea.
Clinical evaluation may reveal: • hypovolaemia • haemoconcentration • electrolyte imbalances • ascites • haemoperitoneum • pleural effusions • hydrothorax
Evalwazzjoni klinika tista ’ tindika: • l- ipovolemja • emokonċentrazzjoni • żbilanċ ta ’ l- elektroliti • axxite • emoperitonew • effużżjoni plewrali • idrotoraċi • diqa akuta fil- pulmun u avvenimenti tromboemboliċi.
Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.
Rarament ħafna, każ sever ta ’ OHSS jista ’ jkun ikkomplikat minn emboliżmu pulmonari, puplesija iskimika u infart mijokardijaku.
Excessive ovarian response seldom gives rise to significant hyperstimulation unless hCG is administered to induce ovulation.
Rispons eċċessiv ta ’ l- ovarji għall- kura bil- gonadotrofina, f’ każijiet rari jagħti lok għal OHSS jekk ma jingħatax l- hCG biex jinduċi l- ovulazzjoni.
Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG in such cases and advise the patient to refrain from coitus or use barrier methods for at least 4 days.
Għalhekk ikun aħjar jekk ma jingħatax l- hCG f’ dawn il - każi u l- pazjenti jingħataw il- parir biex ma jkollhomx x' jaqsmu mas- sieħeb tagħhom jew jużaw kontraċettivi ta ’ barriera għal ta ’ l- anqas erbat ijiem.
OHSS may progress rapidly (within 24 hours to several days) to become a serious medical event, therefore patients should be followed for at least two weeks after hCG administration.
OHSS tista ’ tiżdied malajr (f’ temp ta ’ 24 siegħa sa ftit ġranet) u jsir avveniment mediku serju u għalhekk il- pazjenti għandhom ikunu osservati għal mill- anqas ħmistax wara l- għoti ta ’ l- hCG.
To minimise the risk of OHSS or of multiple pregnancy (see below), ultrasound scans as well as oestradiol measurements are recommended.
Biex tnaqqas ir- riskju ta ’ OHSS jew ta ’ tqala multipla (ara isfel), huwa rrakkomandat li jsiru skans ta ’ l- ultrasawnd u tkejjil ta ’ l- ammont ta 'estradajol.
In anovulation the risk of OHSS is increased by a serum oestradiol level > 900 pg/ ml (3,300 pmol/ l) and by the presence of more than 3 follicles of 14 mm or more in diameter.
4 multipla jiżdied meta l- ammont ta 'estradajol fis- serum ikun > 900 pg/ ml (3300 pmol/ l) u jkun hemm aktar minn 3 follikuli ta ’ dijametru ta ’ 14 mm jew akbar.
Adherence to recommended Pergoveris and FSH dosage and regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see below).
Jekk tingħata d- doża ta ’ Pergoveris u FSH li hi rrakkomandata, tingħata kif inhu rrakkomandat u ssir osservazzjoni mill- qrib tat- terapija, tonqos l- inċidenza ta ’ iperstimulazzjoni ta ’ l- ovarji u ta ’ tqala multipla (ara taħt).
OHSS may be more severe and more protracted if pregnancy occurs.
L- OHSS tista ’ tkun aktar qawwija u ddum aktar fil- każ ta ’ tqala.
Most often, OHSS occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
Ħafna drabi, l- OHSS isseħħ wara li tkun waqfet il- kura ormonali u tilħaq il- massimu tagħha madwar bejn seba ’ u għaxart ijiem wara l - kura.
Usually, OHSS resolves spontaneously with the onset of menses.
Ġeneralment, l- OHSS tintemm b’ mod spontanju malli tibda l- mestrwazzjoni.
The patient should be hospitalised and specific therapy for OHSS started.
Jekk l- OHSS tkun qawwija ħafna, il- kura bil- gonadotrofina għandha titwaqqaf jekk tkun għadha għaddejja, u l- pazjenta tittieħed l- isptar biex tingħata terapija speċifika għall- OHSS.
This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
L- inċidenza ta ’ dan is- sindromu hija aktar għolja f’ pazjenti b’ mard poliċistiku ta ’ l- ovarji.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
Il- pazjenti li qed ikollhom stimulazzjoni ta ’ l- ovulazjoni, għandhom aktar ċans li jitqalu u twelid multiplu, meta mqabbla ma ’ konċepiment naturali.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Sabiex jitnaqqas ir- riskju ta ’ tqala multipla, osservazzjoni bir- reqqa tar - rispons ta ’ l - ovarji hija rrakomandata.
The patients should be advised of the potential risk of multiple births before starting treatment.
Il- pazjenti għandhom ikunu infurmati dwar il- possibbilità tar- riskju li titwieled aktar minn tarbija waħda qabel ma jibdew il- kura
The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction than in the normal population.
L- inċidenza tal- pazjenti li jitilfu t- tarbija tagħhom minħabba korriment jew abort hi akbar f’ dawk il - pazjenti li ssirilhom stimulazzjoni tat- tkabbir follikulari bil- għan li jwassal għal induzzjoni ta ’ l - ovulazzjoni, milli fil- popolazzjoni normali.
When risk of OHSS or multiple pregnancies is assumed, treatment discontinuation should be considered.
Meta r- riskju ta ’ OHSS jew tqala multipla huwa magħruf, wieħed irid jikkunsidra t- twaqqif tal- kura.
Women with a history of tubal disease are at risk of ectopic pregnancy, whether the pregnancy is obtained by spontaneous conception or with fertility treatments.
F’ nisa li kellhom mard fit- tubi hemm ir- riskju ta ’ tqala ektopika, kemm jekk it- tqala tinkiseb b’ mod naturali u kemm jekk permezz ta ’ kura għall- infertilità.
The prevalence of ectopic pregnancy after IVF was reported to be 2 to 5%, as compared to 1 to 1.5% in the general population.
Ir- rata ta ’ każi ta ’ tqala ektopika kienet ta ’ bejn 2 u 5% fil- każi ta ’ IVF, meta mqabbla ma ’ bejn 1 u 1. 5% fil- popolazzjoni ġenerali.
There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment.
Kien hemm rapporti ta ’ neoplażmi fl- ovarji kif ukoll fil- bqija tas- sistema riproduttiva, kemm beninni kif ukoll malinni, f’ nisa li ngħataw korsijiet multipli ta ’ mediċini għal kura ta ’ l- infertilita.
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women.
Għadu mhux magħruf jekk il- kura bil- gonadotrofini żżidx ir- riskju bażiku ta ’ dawn it- tumuri f’ nisa infertili.
The prevalence of congenital malformations after ART may be slightly higher than after spontaneous conceptions.
Il- possibbilta` li jkun hemm malformazzjoni konġenitali wara l- użu ta ’ ART tista ’ tkun ftit aktar għolja meta mqabbla ma ’ konċepiment naturali.
5 In women with generally recognised risk factors for thrombo-embolic events, such as personal or family history, treatment with gonadotrophins may further increase the risk.
F’ nisa li għandhom fatturi ta ’ riskju għal effetti tromboemboliċi li, ġeneralment, minħabba l- istorja jew ta ’ l- individwu jew tal- familja, kura bil- gonadotrofini tista ’ żżid dan ir- riskju.
In these women, the benefits of gonadotrophin administration need to be weighed against the risks.
Qabel ma tingħata lil dawn in- nisa, hemm bżonn li wieħed iqis il- benefiċċji kontra r- riskji ta ’ l- għoti tal- gonadotrofini.
It should be noted however, that pregnancy itself also carries an increased risk of thrombo-embolic events.
Madankollu, wieħed irid iżomm quddiem għajnejh, li t- tqala nfisha wkoll tista ’ twassal għal riskju akbar ta ’ effetti tromboemboliċi.
Pergoveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa.
Pergoveris m’ għandux jingħata bħala taħlita ma ’ prodotti mediċinali oħra, fl- istess injezzjoni, ħlief ma ’ follitropin alfa
Pergoveris should not be used during pregnancy or lactation.
Pergoveris m’ għandux jittieħed jekk inti tqila jew qed tredda ’.
4.7 Effects on ability to drive and use machines
5 4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Very Common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 to < 1/ 10)
Exacerbation or worsening of asthma
Uġigħ ta ’ ras Sommolenza
Gastrointestinal disorders
Disturbi respiratorji, toraċiċi u medjastinali Disturbi gastro- intestinali
Common (≥ 1/ 100 to < 1/ 10)
Rari ħafna (< 1/ 10, 000) Komuni (≥1/ 100 to < 1/ 10)
Abdominal pain and gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal cramps and bloating
Ażma li tirkadi jew tmur għall - agħar Ugigħ addominali u sintomi gastro- intestinali bħal dardir remettar, dijarrea, spażmi fl - imsaren u nefħa addominali
Thromboembolism, usually associated with severe ovarian hyperstimulation syndrome (OHSS)
Tromboemboliżmu, ġeneralment assoċjat ma ’ OHSS severa Reazzjoni ħafifa sa severa fis- sit
Mild to severe injection site reaction (pain, redness, bruising, swelling and/ or irritation at the site of injection)
ta ’ l- injezzjoni (uġigħ, ħmura, tbenġil, nefħa u/ jew irritazzjoni)
Mild systemic allergic reactions (e. g. mild forms of erythema, rash, facial swelling, urticaria, oedema, difficulty breathing).
Reazzjonijiet sistemiċi allerġiċi ħfief (eritema, raxx jew nefħa fil- wiċċ, urtikarja, edima, diffikula biex tieħu n - nifs).
Serious cases of allergic reactions, including anaphylactic reactions, have also been reported.
Kazijiet serji ta ’ reazzjonijiet allerġiċi, inkluzi reazzjonijiet anafilattici, ġew irrapurtati wkoll.
6 Reproductive system and breast disorders
Disturbi fis- sistema riproduttiva u fis- sider
Common (≥ 1/ 100 to < 1/ 10)
Komuni (> 1/ 100, < 1/ 10)
Breast pain, pelvic pain, mild to moderate OHSS
OHSS ħafifa sa moderata (ara sezzjoni 4. 4)
Uncommon (≥ 1/ 1,000 to < 1/ 100)
Mhux komuni (> 1/ 1, 000, < 1/ 100)
Severe OHSS
OHSS severa (ara sezzjoni 4. 4).
Rare (≥ 1/ 10,000 to < 1/ 1,000)
Rari (> 1/ 10, 000, < 1/ 1, 000)
Ovarian torsion, a complication of OHSS
Liwi ta ’ l- ovarji, kumplikazzjoni ta ’ l- OHSS
Nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
L- effetti ta ’ doża eċċessiva ta ’ Pergoveris mhumiex magħrufa, madanakollu, wieħed jista ’ jistenna li l - pazjenti jaqbadhom is- sindromu ta ’ iperstimulazzjoni ta ’ l- ovarji, li hu deskritt f’ aktar dettall f’ sezzjoni 4. 4.
Gonadotrophins, ATC code:
Kategorija farmakoterapewtika: gonadotrofini, Kodiċi ATC:
Pergoveris is a preparation of follicle stimulating hormone and luteinising hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Pergoveris huwa sustanza ta ’ ormon li jistimula l- follikolu u ormon leutropina magħmul fiċ- ċelloli ta ’ l- Ovarji tal- Ħamster Ċiniż (CHO) li għandhom materjal ġenetiku mibdul.
In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism.
Fi studji kliniċi, pazjenti li kellhom nuqqas qawwi ta ’ FSH u LH kienu dawk li kellhom hypogonadotropic hypogonadism.
In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.
6 Fl- istimulazzjoni ta ’ l- iżvilupp follikulari fin- nisa anovulatorji li huma defiċjenti fi LH u FSH, l- effett primarja li jirriżulta meta wieħed jagħti leutropin alfa huwa żieda fis- sekrezzjoni ta ’ ertradjol mill - follicles, li jikbru għax huma stimulati bl- FSH.
In one clinical study of women with hypogonadotrophic hypogonadism and an endogenous serum LH concentration below 1.2 IU/ L the appropriate dose of r-hLH (lutropin alfa) was investigated.
Fi studju kliniku ta ’ mara b’ ipogonadiżmu ipogonadotrofiku u konċentrazzjoni endoġena tas- serum LH taħt 1. 2 IU/ L, id- doża xierqa ta ’ r- hLH (lutropin alfa) ġiet studjata.
Therefore, administration of less than one vial of Pergoveris daily may provide too little LH-activity to ensure adequate follicular development.
Doża ta ’ 75 IU r- hLH kuljum (ma ’ 150 IU follitropin alfa (r- hFSH)) ġabet żvilupp follikulari u produzzjoni ta ’ estroġen suffiċjenti L- iżvilupp follikulari ma kienx biżżejjed b’ doża ta’ 25 IU r- hLH kuljum (ma ’ 150 IU follitropin alfa) Għalhekk, l- amministrazzjoni ta ’ inqas minn vjala waħda ta ’ Pergoveris kuljum jista ’ ma tagħtix biżżejjed attivita ’ ta ’ LH sabiex ikun hemm żvilupp follikulari suffiċjenti.
Follitropin alfa and lutropin alfa have shown the same pharmacokinetic profile as follitropin alfa and lutropin alfa separately.
Follitropin alfa u lutropin alfa urew l- istess profil farmakokinetiku bħal follitropin alfa u lutropin alfa separati.
Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of about one day.
Wara li jingħata fil- vina, follitropin alfa jinfirex fl- ispazju tal- fluwidu extra- ċellulari b’ half- life inizjali ta ’ madwar sagħtejn u jitneħħa mill- ġisem b’ half- life terminali ta ’ madwar ġurnata.
The steady state volume of distribution and total clearance are 10 l and 0.6 l/ h, respectively.
L- istat aħħari tal - volum ta ’ distribuzzjoni u t- tneħħija totali mill- ġisem huma ta ’ madwar 10 l u 0. 6l/ siegħa, rispettivament.
One-eighth of the follitropin alfa dose is excreted in the urine.
Waħda minn kull tmien parti tad- doża ta ’ follitropin alfa toħroġ ma ’ l- urina.
Following subcutaneous administration, the absolute bioavailability is about 70%.
Wara li jingħata taħt il- ġilda, il- biodisponibbilita assoluta hija ta ’ madwar 70%.
In women
Meta jingħata ripetutament, follitropin alfa jakkumula sa 3 darbiet aktar u jilħaq stat aħħari wara 3- 4t ijiem.
7 whose endogenous gonadotrophin secretion is suppressed, follitropin alfa has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
F’ nisa fejn is- sekrezzjoni tal- gonadotrofina endoġena hija mrażżna, instab li follitropin alfa xorta waħda jistimula b’ mod effettiv l- iżvilupp follikulari u l- isterojdoġenesi, minkejja livelli ta ’ LH li ma jistgħux jiġu mkejjla.
Following intravenous administration, lutropin alfa is rapidly distributed with an initial half-life of approximately one hour and eliminated from the body with a terminal half-life of about 10-12 hours.
Wara li jingħata fil- vina, lutropin alfa jinfirex fl- ispazju tal- fluwidu extra- ċellulari b’ half- life inizzjali ta ’ madwar siegħa u jitneħħa mill- ġisem b’ half- life terminali ta ’ madwar 10- 12 sigħat.
The steady state volume of distribution is around 10-14 l.
L- istat fiss tal - volum ta ’ distribuzzjoni huwa madwar 10- 14 l.