natgillin/translations-raw huggingface dataset:
Then Bemfola is started approximately two weeks after start of agonist treatment.
Zatim se približno dva tjedna nakon početka liječenja agonistom počinje primjenjivati Bemfola.
You and your partner's fertility should be evaluated before the treatment is started by a doctor experienced in treating fertility disorders.
Prije početka liječenja potrebno je provjeriti Vašu plodnost i plodnost Vašeg partnera kod liječnika iskusnog u liječenju problema s plodnošću.
Bemfola treatment seldom causes severe OHSS unless the medicine that is used for final follicular maturation (containing human chorionic gonadotropin, hCG) is administered.
Terapija lijekom Bemfola rijetko uzrokuje težak OHSS, osim kada se daje lijek za poticanje konačnog sazrijevanja folikula (koji sadrži humani koriogonadotropin, hCG).
• malformations of sexual organs incompatible with pregnancy;
• malformacije spolnih organa koje su nespojive s trudnoćom • fibroidni tumori maternice nespojivi s trudnoćom
Bemfola contains sodium
Bemfola sadrži natrij
5 pre-filled pens 5 injection needles 5 alcohol swabs
5 napunjenih brizgalica 5 igala za injekcije
Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.
4.2 Doziranje i način primjene Terapiju treba započeti pod nadzorom liječnika s iskustvom u liječenju poremećaja plodnosti.
In patients undergoing ART procedures the risk of multiple pregnancy is related mainly to the number of embryos replaced, their quality and the patient age.
Rizik od višeplodne trudnoće nakon metoda medicinski potpomognute oplodnje prvenstveno je povezan s brojem prenesenih embrija, njihovom kvalitetom i dobi pacijentice.
The best time to have sex is on the day of the hCG injection and the day after.
Preporučeno je imati spolni odnos na dan injekcije hCG-a i dan nakon toga.
Bemfola 300 IU/0.50 mL pre-filled pen Bemfola 450 IU/0.75 mL pre-filled pen
Bemfola 300 IU/0,50 ml napunjena brizgalica Bemfola 450 IU/0,75 ml napunjena brizgalica
Poloxamer 188
4.8 Nuspojave
If an excessive response is obtained, treatment should be stopped and hCG withheld.
U slučaju pretjeranog odgovora organizma potrebno je obustaviti terapiju i prestati primjenjivati hCG.
• The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) each day.
• Uobičajena početna doza lijeka Bemfola je 75 - 150 IU (0,12 - 0,25 ml) svaki dan.
• together with another medicine called “human chorionic gonadotropin” (hCG) to help produce sperm in men that are infertile due to a low level of certain hormones.
Chorionic Gonadotropin, hCG), s ciljem stvaranja sperme u muškaraca čija je neplodnost uzrokovana niskim razinama određenih hormona.
Other side effects in women
Ostale nuspojave u žena
Down-regulation with a gonadotropin-releasing hormone (GnRH) agonist or antagonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
gonadotropin-releasing hormone, GnRH) kako bi se negativnom povratnom spregom suprimirao porast endogenog LH-a i kontrolirala tonička razina LH-a.
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.
Može se razmotriti i podržavanje luteinske faze budući da manjak tvari s luteotropnim djelovanjem
Follitropin alfa is not indicated during breastfeeding.
Folitropin alfa nije indiciran za vrijeme dojenja.
Weight gain
povećanje tjelesne težine
Before opening and within its shelf life, the medicinal product may be removed from the refrigerator, and without being refrigerated again, may be stored for up to 3 months at or below 25°C.
Prije otvaranja i unutar roka valjanosti, lijek se može izvaditi i čuvati izvan hladnjaka do 3 mjeseca na 25°C ili ispod 25°C, bez ponovnog odlaganja u hladnjak.
Bemfola 75 IU/0.125 mL (5.5 micrograms/0.125 mL) is not designed to allow the cartridge to be removed.
Bemfola 75 IU/0,125 ml (5,5 mikrograma/0,125 ml) je izrađena tako da ne dopušta uklanjanje uloška.
In men deficient in FSH, follitropin alfa administered concomitantly with hCG for at least 4 months induces spermatogenesis.
U muškaraca s manjkom FSH-a, primjena folitropina alfa istovremeno s hCG-om kroz najmanje
MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
Gedeon Richter Plc.
Very common (may affect more than 1 in 10 people):
Vrlo česte (mogu se javiti se u više od 1 na 10 osoba):
What Bemfola is used for
Za što se Bemfola koristi
INFORMATION IN BRAILLE Bemfola 75 IU/0.125 mL
16. PODACI NA BRAILLEOVOM PISMU Bemfola 75 IU/0,125 ml
Posology
SADRŽAJ
A single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG is administered 24-48 hours after the last follitropin alfa injection to induce final follicular maturation.
Jedna injekcija od 250 mikrograma rekombinantnog r-hCG-a ili 5000 IU do najviše 10 000 IU hCG-a daje se 24 do 48 sati nakon zadnje injekcije folitropina alfa kako bi se potaknulo konačno sazrijevanje folikula.
Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting, diarrhoea
bol u abdomenu, distenzija abdomena, nelagoda u abdomenu, mučnina, povraćanje, proljev
Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
Bemfola 75 IU/0,125 ml otopina za injekciju u napunjenoj brizgalici Bemfola 150 IU/0,25 ml otopina za injekciju u napunjenoj brizgalici Bemfola 225 IU/0,375 ml otopina za injekciju u napunjenoj brizgalici
• primary ovarian failure;
• primarno zatajenje rada jajnika
Bemfola usually does not work if you have this problem.
U ovim slučajevima lijek Bemfola obično nije učinkovit.
INFORMATION IN BRAILLE Bemfola 225 IU/0.375 mL
16. PODACI NA BRAILLEOVOM PISMU Bemfola 225 IU/0,375 ml
Thromboembolism (both in association with and separate from OHSS.
tromboembolija (i povezana ili nepovezana s OHSS-om)
• Anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomiphene citrate.
• Anovulacija (uključujući sindrom policističnih jajnika [engl. polycystic ovarian syndrome, PCOS]) u žena koje ne reagiraju na terapiju klomifencitratom.
Bemfola 225 IU/0.375 mL (16.5 micrograms/0.375 mL) is not designed to allow the cartridge to be removed.
Bemfola 225 IU/0,375 ml (16,5 mikrograma/0,375 ml) je izrađena tako da ne dopušta uklanjanje uloška.
Bemfola 150 IU/0.25 mL (11 micrograms/0.25 mL) is not designed to allow the cartridge to be removed.
Bemfola 150 IU/0,25 ml (11 mikrograma/0,25 ml) je izrađena tako da ne dopušta uklanjanje uloška.
• ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome;
• povećani jajnici ili ciste na jajnicima koje nisu uzrokovane sindromom policističnih jajnika
• Bemfola 150 IU/0.25 mL: Each cartridge contains 150 IU (equivalent to 11 micrograms) follitropin alfa in 0.25 mL solution.
• Bemfola 150 IU/0,25 ml: Jedan uložak sadrži 150 IU (što odgovara 11 mikrograma) folitropina alfa u 0,25 ml otopine.
• Bemfola 225 IU/0.375 mL: Each cartridge contains 225 IU (equivalent to 16.5 micrograms) follitropin alfa in 0.375 mL solution.
• Bemfola 225 IU/0,375 ml: Jedan uložak sadrži 225 IU (što odgovara 16,5 mikrograma) folitropina alfa u 0,375 ml otopine.
Each pre-filled pen delivers 150 IU follitropin alfa, equivalent to 11 micrograms per 0.25 mL.
Jedna napunjena brizgalica isporučuje 150 IU folitropin alfa, što odgovara 11 mikrograma u 0,25 ml.
Pregnancy and breast-feeding Do not use Bemfola if you are pregnant or breast-feeding.
Nemojte primjenjivati lijek Bemfola ako ste trudni ili dojite.
How to use the Bemfola pre-filled pen
Kako koristiti napunjenu brizgalicu s lijekom Bemfola
• The usual starting dose of Bemfola is 150 to 225 IU (0.25 to 0.37 mL) each day, from day 2 or 3 of your treatment cycle.
• Uobičajena početna doza lijeka Bemfola je 150 - 225 IU (0,25 - 0,37 ml) svaki dan, od 2. ili
This side effect is common (may affect up to 1 in 10 people).
Ta je nuspojava česta (može se javiti u do 1 na 10 osoba).
• Bemfola 75 IU/0.125 mL: Each cartridge contains 75 IU (equivalent to 5.5 micrograms) follitropin alfa in 0.125 mL solution.
• Bemfola 75 IU/0,125 ml: Jedan uložak sadrži 75 IU (što odgovara 5,5 mikrograma) folitropina alfa u 0,125 ml otopine.
Getting your pre-filled pen ready for injection
Priprema napunjene brizgalice za injekciju
You should also hear a click, and some liquid will splash out (this is normal).The pen is now ready to set the dose.
Trebali biste čuti i „klik“, a iz igle će izaći malo tekućine
INFORMATION IN BRAILLE Bemfola 300 IU/0.5 mL
16. PODACI NA BRAILLEOVOM PISMU Bemfola 300 IU/0,5 mL
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Gedeon Richter Plc.
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gedeon Richter Plc.
In ART, follitropin alfa at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH.
Kod medicinski potpomognute oplodnje, folitropin alfa je pri manjoj ukupnoj dozi i uz kraće trajanje terapije nego kod urinarnog FSH rezultirao većim brojem dobivenih oocita u usporedbi s urinarnim FSH-om.
Each pre-filled pen delivers 225 IU follitropin alfa, equivalent to 16.5 micrograms per 0.375 mL.
Jedna napunjena brizgalica isporučuje 225 IU folitropin alfa, što odgovara 16,5 mikrograma u 0,375 ml.
Each pre-filled pen delivers 450 IU follitropin alfa, equivalent to 33 micrograms per 0.75 mL.
Jedna napunjena brizgalica isporučuje 450 IU folitropin alfa, što odgovara 33 mikrograma u 0,75 ml.
Bemfola 450 IU/0.75 mL (33 micrograms/0.75 mL) is not designed to allow the cartridge to be removed.
Bemfola 450 IU/0,75 ml (33 mikrograma/0,75 ml) je izrađena tako da ne dopušta uklanjanje uloška.
For the following cycle, your doctor will give you a lower dose of Bemfola than before.
Za sljedeći ciklus liječnik će Vam propisati lijek Bemfola u manjoj dozi nego u prethodnom ciklusu.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Phosphoric acid
6.1 Popis pomoćnih tvari poloksamer 188 saharoza metionin natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat fosfatna kiselina voda za injekcije
• When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last Bemfola injection.
• Kada se postigne željeni odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG-a“ (r-hCG, hCG dobiven u laboratoriju posebnom DNK tehnikom) ili 5 000 IU - 10 000 IU hCG-a 24 - 48 sati nakon posljednje injekcije lijeka Bemfola.
Each prefilled pen delivers 75 IU (equivalent to 5.5 micrograms) in 0.125 mL.
Jedna napunjena brizgalica osigurava primjenu 75 IU (što odgovara 5,5 mikrograma) u 0,125 ml.
INFORMATION IN BRAILLE Bemfola 450 IU/0.75 mL
16. PODACI NA BRAILLEOVOM PISMU Bemfola 450 IU/0,75 mL
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies A commonly used regimen for superovulation involves the administration of 150-225 IU of follitropin alfa daily commencing on days 2 or 3 of the cycle.
Uobičajeni režim terapije za superovulaciju uključuje primjenu 150-225 IU folitropina alfa dnevno, počevši 2. ili 3. dana ciklusa.
• Bemfola 450 IU/0.75 mL: Each cartridge contains 450 IU (equivalent to 33 micrograms) follitropin alfa in 0.75 mL solution.
• Bemfola 450 IU/0,75 ml: Jedan uložak sadrži 450 IU (što odgovara 33 mikrograma) folitropina alfa u 0,75 ml otopine.
Reproductive system and breast disorders Common:
Poremećaji reproduktivnog sustava i dojki Vrlo često:
Each prefilled pen delivers 300 IU (equivalent to 22 micrograms) in 0.5 mL.
Jedna napunjena brizgalica osigurava primjenu 300 IU (što odgovara 22 mikrograma) u 0,5 ml.
How to store Bemfola
Kako primjenjivati lijek Bemfola
Each pre-filled pen delivers 300 IU follitropin alfa, equivalent to 22 micrograms per 0.5 mL.
Jedna napunjena brizgalica isporučuje 300 IU folitropin alfa, što odgovara 22 mikrograma u 0,5 ml.
Each prefilled pen delivers 150 IU (equivalent to 11 micrograms) in 0.25 mL.
Jedna napunjena brizgalica osigurava primjenu 150 IU (što odgovara 11 mikrograma) u 0,25 ml.
• When you get the desired response, you will be given a single injection of 250 micrograms of “recombinant hCG” (r-hCG, an hCG made in a laboratory by a special DNA technique), or 5,000 to 10,000 IU of hCG, 24 to 48 hours after your last injections of Bemfola and lutropin alfa.
• Kada se postigne željeni odgovor, daje se jedna injekcija od 250 mikrograma „rekombinantnog hCG-a“ (r-hCG, hCG dobiven u laboratoriju posebnom DNK tehnikom) ili 5 000 IU - 10 000 IU hCG-a 24 - 48 sati nakon posljednje injekcije lijeka Bemfola i lutropina alfa.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.125 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,125 ml
Miscarriage
Doziranje
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Naziv i adresa proizvođača biološke djelatne tvari
• Bemfola 300 IU/0.50 mL: Each cartridge contains 300 IU (equivalent to 22 micrograms) follitropin alfa in 0.50 mL solution.
• Bemfola 300 IU/0,50 ml: Jedan uložak sadrži 300 IU (što odgovara 22 mikrograma) folitropina alfa u 0,50 ml otopine.
Marketing Authorisation Holder and Manufacturer Gedeon Richter Plc.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Gedeon Richter Plc.
INFORMATION IN BRAILLE Bemfola 150 IU/0.25 mL
16. PODACI NA BRAILLEOVOM PISMU Bemfola 150 IU/0,25 ml
Each prefilled pen delivers 225 IU (equivalent to 16.5 micrograms) in 0.375 mL.
Jedna napunjena brizgalica osigurava primjenu 225 IU (što odgovara 16,5 mikrograma) u 0,375 ml.
Bemfola 300 IU/0.50 mL (22 micrograms/0.5 mL) is not designed to allow the cartridge to be removed.
Bemfola 300 IU/0,50 ml (22 mikrograma/0,5 ml) je izrađena tako da ne dopušta uklanjanje uloška.
For the following cycle, your doctor will give you a higher starting dose of Bemfola than before.
Za sljedeći ciklus liječnik će Vam propisati lijek Bemfola u većoj početnoj dozi nego u prethodnom ciklusu.
Each prefilled pen delivers 450 IU (equivalent to 33 micrograms) in 0.75 mL.
Jedna napunjena brizgalica osigurava primjenu 450 IU (što odgovara 33 mikrograma) u 0,75 ml.
When an optimal response is obtained, a single injection of 250 micrograms of recombinant human chorionic gonadotropin alfa (r-hCG) or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa injection.
Kada se postigne optimalan odgovor, potrebno je dati jednu injekciju od 250 mikrograma rekombinantnog humanog koriogonadotropina alfa (r-hCG) ili 5000 IU - 10 000 IU humanog korionskog gonadotropina 24 - 48 sati nakon zadnje injekcije folitropina alfa.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.375 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,375 ml
• The usual starting dose of Bemfola is 75 to 150 IU (0.12 to 0.25 mL) together with 75 IU (0.12 mL) of lutropin alfa.
• Uobičajena početna doza lijeka Bemfola je 75 - 150 IU (0,12 - 0,25 ml) zajedno sa 75 IU
Exacerbation or aggravation of asthma Gastrointestinal disorders Common:
egzacerbacija ili pogoršanje astme
Exacerbation or aggravation of asthma Skin and subcutaneous tissue disorders Common:
Poremećaji kože i potkožnog tkiva Često:
Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Bemfola 300 IU/0,50 ml otopina za injekciju u napunjenoj brizgalici Bemfola 450 IU/0,75 ml otopina za injekciju u napunjenoj brizgalici
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 225 IU/0.375 mL injection follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 225 IU/0,375 ml injekcija folitropin alfa s.c.
When an optimal response is obtained, a single injection of 250 micrograms r-hCG or 5,000 IU up to 10,000 IU hCG should be administered 24-48 hours after the last follitropin alfa and lutropin alfa injections.
Kada se postigne optimalan odgovor na terapiju, treba dati jednu injekciju s 250 mikrograma r-hCG-a ili 5000 - 10 000 IU hCG-a 24 - 48 sati nakon zadnje injekcije folitropina alfa i lutropina alfa.
NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen
NAZIV LIJEKA Bemfola 75 IU/0,125 ml otopina za injekciju u napunjenoj brizgalici
• gynaecological haemorrhages of unknown aetiology;
• ginekološka krvarenja nepoznate etiologije • karcinom jajnika, maternice ili dojke.
Each cartridge contains 0.375 mL solution for injection.
Svaki uložak sadrži 0,375 ml otopine za injekcije.
Multiple pregnancy
Višeplodne trudnoće
Abdominal pain, abdominal distension, abdominal discomfort, nausea, vomiting,
bol u abdomenu, distenzija abdomena, nelagoda u abdomenu, mučnina,
Women
DJECE
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 75 IU/0.125 mL injection follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 75 IU/0,125 ml injekcija folitropin alfa s.c.
Nevertheless one could expect Ovarian HyperStimulation Syndrome (OHSS) to occur, which is described in section 4.
Učinci predoziranja lijekom Bemfola nisu poznati, ali može se očekivati pojava sindroma hiperstimulacije jajnika (OHSS), koji je opisan u dijelu 4. No, OHSS će se pojaviti samo ako se primjenjuje i hCG (pogledajte odlomak o OHSS-u u dijelu 2.).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 450 IU/0.75 mL injection follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 450 IU/0,75 ml injekcija folitropin alfa s.c.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 300 IU/0.5 mL injection follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 300 IU/0,5 ml injekcija folitropin alfa s.c.
• Feeling sick, vomiting, diarrhoea, abdominal cramps and bloating
• mučnina, povraćanje, proljev, grčevi u trbuhu i nadutost
NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen
NAZIV LIJEKA B[MI2]emfola 225 IU/0,375 ml otopina za injekciju u napunjenoj brizgalici
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bemfola 150 IU/0.25 mL injection follitropin alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Bemfola 150 IU/0,25 ml injekcija folitropin alfa s.c.
NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.50 mL solution for injection in pre-filled pen
NAZIV LIJEKA B[MI3]emfola 300 IU/0,50 ml otopina za injekciju u napunjenoj brizgalici
Each cartridge contains 0.25 mL solution for injection.
Svaki uložak sadrži 0,25 ml otopine za injekcije.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,25 ml
5 or 10 alcohol swabs.
5 jastučića od vate natopljenih alkoholom
NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen
NAZIV LIJEKA B[MI1]emfola 150 IU/0,25 ml otopina za injekciju u napunjenoj brizgalici
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.75 mL
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 0,75 ml
NAME OF THE MEDICINAL PRODUCT Bemfola 225 IU/0.375 mL solution for injection in pre-filled pen follitropin alfa
Bemfola 225 IU/0,375 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
Clean the injection site with the alcohol swab using a circular motion.
Kružnim pokretima očistite odabrano područje kože jastučićem od vate natopljenog alkoholom.
NAME OF THE MEDICINAL PRODUCT Bemfola 300 IU/0.5 mL solution for injection in pre-filled pen follitropin alfa
Bemfola 300 IU/0,5 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
NAME OF THE MEDICINAL PRODUCT Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen
NAZIV LIJEKA B[MI4]emfola 450 IU/0,75 ml otopina za injekciju u napunjenoj brizgalici
(hMG).
FSH-om.
Each cartridge contains 0.5 mL solution for injection.
Svaki uložak sadrži 0,50 ml otopine za injekcije.
Each cartridge contains 0.75 mL solution for injection.
Svaki uložak sadrži 0,75 ml otopine za injekcije.
NAME OF THE MEDICINAL PRODUCT Bemfola 75 IU/0.125 mL solution for injection in pre-filled pen follitropin alfa
Bemfola 75 IU/0,125 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
• If you are a woman: with large ovaries or sacs of fluids within the ovaries (ovarian cysts) of unknown origin.
- i imate povećane jajnike ili vrećice s tekućinom u jajnicima (ciste na jajnicima)
Each pre-filled pen delivers 75 IU follitropin alfa, equivalent to 5.5 micrograms per 0.125 mL.
Jedna napunjena brizgalica osigurava primjenu 75 IU folitropina alfa, što odgovara 5,5 mikrograma u 0,125 ml. Jedan ml otopine sadrži 600 IU, što odgovara 44 mikrograma.
Complication of severe OHSS General disorders and administration site conditions Very common: Injection site reactions (e.g. pain, erythema, haematoma, swelling and/or irritation at the site of injection)
reakcije na mjestu injiciranja (bol, eritem, hematom, oticanje i/ili iritacija na mjestu injiciranja)
NAME OF THE MEDICINAL PRODUCT Bemfola 150 IU/0.25 mL solution for injection in pre-filled pen follitropin alfa
Bemfola 150 IU/0,25 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
The patient is recommended to have coitus on the day of, and the day following hCG administration.
Pacijentici se preporučuje spolni odnos na dan injekcije hCG-a i dan poslije.
NAME OF THE MEDICINAL PRODUCT Bemfola 450 IU/0.75 mL solution for injection in pre-filled pen follitropin alfa
Bemfola 450 IU/0,75 ml otopina za injekciju u napunjenoj brizgalici folitropin alfa
Total dose of FSH required (number of FSH 75 IU ampoules) 27.6 ± 10.2 40.7 ± 13.6 Need to increase the dose (%)
Broj dobivenih oocita Broj dana potrebnih za stimulaciju primjenom FSH-a Ukupan broj potrebnih doza FSH-a (broj ampula FSH-a od 75 IU )
MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/005
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/005
MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/002
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/002
MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/004
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/004
For instructions on the administration with the pre-filled pen, see the package leaflet.
Upute o primjeni napunjene brizgalice potražite u uputi o lijeku.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/001
Remove the outer needle cap. Keep it for later.
Sačuvajte ga za poslije.
Women with anovulation (including polycystic ovarian syndrome) Follitropin alfa may be given as a course of daily injections.
• Anovulacija (uključujući sindrom policističnih jajnika [engl. polycystic ovarian syndrome,
Thromboembolism (both in association with and separate from OHSS) Respiratory, thoracic and mediastinal disorders Very rare:
blage do teške reakcije preosjetljivosti, uključujući anafilaktičke reakcije i šok Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo rijetko:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/909/003
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/909/003
Number of oocytes retrieved
komplikacije teškog OHSS-a
Conclusions presented by the European Medicines Agency on:
Zaključci Europske agencije za lijekove:
The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.
Nakon razmatranja zahtjeva, mišljenje je CHMP-a da je omjer rizika i koristi povoljan te se može preporučiti davanje uvjetnog odobrenja za stavljanje lijeka u promet, što je dodatno pojašnjeno u
• Conditional marketing authorisation
• Uvjetno odobrenje za stavljanje lijeka u promet
ANNEX IV Conclusions on the granting of the conditional marketing authorisation presented by the European Medicines Agency
PRILOG IV. Zaključci Europske agencije za lijekove o davanju uvjetnog odobrenja za stavljenje lijeka u promet
MA (EU) Number
Broj (EU) odobrenja
Powder for concentrate for solution for infusion
1 mg Prašak za koncentrat za otopinu za infuziju
Strength Pharmaceutical Form
(Zaštićeno) ime Doza Farmaceutski oblik
Intravenous use vial (glass)
Bočica (staklena)