natgillin/translations-raw huggingface dataset:
The Committee for Medicinal products for Human Use (CHMP) decided that GONAL-f’ s benefits are greater than its risks for women who are anovulatory, women who need to ovulate before fertility treatment, with luteinising hormone for the stimulation of follicular development in women with severe LH and FSH deficiency, and in men who have hypogonadotrophic hypogonadism.
Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da so za zdravljenje žensk z anovulacijo; žensk, ki morajo ovulirati pred zdravljenjem neplodnosti; dajanje sočasno z luteinizirajočim hormonom za spodbujanje razvoja foliklov pri ženskah s hudo pomanjkljivostjo LH in FSH ter za zdravljenje moških, ki imajo hipogonadotropni hipogonadizem koristi zdravila GONAL- f večje od z njim povezanih tveganj.
They recommended that GONAL-f be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom GONAL- f.
Other information about GONAL-f:
Druge informacije o zdravilu GONAL- f:
The European Commission granted a marketing authorisation valid throughout the European Union, for GONAL-f to Serono Europe Limited on 20 October 1995.
Evropska Komisija je dovoljenje za promet z zdravilom GONAL- f, veljavno po vsej Evropski uniji, odobrila družbi Serono Europe Limited dne 20. oktobra 1995.
The marketing authorisation was renewed on 20 October 2000 and 20 October 2005.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 20. oktobra 2000 in 20. oktobra 2005.
The full EPAR for GONAL-f is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo GONAL- f je na voljo tukaj.
This summary was last updated in 04-2006.
Ta povzetek je bil nazadnje posodobljen 04- 2006.
75 IU
75 i. e.
powder: ampoule (glass); solvent: ampoule (glass)
prašek: ampula (steklo); vehikel: ampula (steklo)
75 IU; solvent:
75 i. e.; vehikel:
1 ml (75 IU/ ml)
1 ml (75 i. e. / ml)
1 ampoule + 1 ampoule
1 ampula + 1 ampula
5 ampoules + 5 ampoules
5 ampul + 5 ampul
10 ampoules + 10 ampoules
10 ampul + 10 ampul
75 IU (5.5 micrograms)
(5, 5 mikrogramov)
5 µg; solvent:
5 µg; vehikel:
150 IU
150 i. e.
150 IU; solvent:
150 i. e.; vehikel:
1 ml (150 IU/ ml)
1 ml (150 i. e. / ml)
1 ml (150 IU/ ml)
1 ml (150 i. e. / ml))
1050 IU/ 1.75 ml (77 micrograms/ 1.75 ml)
1050 i. e. / 1, 75 ml (77 mikrogramov / 1, 75 ml)
powder: vial (glass); solvent: pre-filled syringe (glass)
prašek: viala (steklo); vehikel: napolnjena injekcijska brizga (steklo)
80 µg; solvent:
80 µg; vehikel:
1 vial + 1 pre-filled syringe + 15 disposable syringes
1 viala + 1 napolnjena injekcijska brizga + 15 injekcijskih brizg za enkratno uporabo
37.5 IU (2.8 micrograms)
(2, 8 mikrogramov)
2.5 µg; solvent:
2, 5 µg; vehikel:
5 µg; solvent:
prašek: 5 µg; vehikel:
150 IU (11 micrograms)
(11 mikrogramov)
10 µg; solvent:
prašek: 10 µg; vehikel:
450 IU/ 0.75 ml (33 micrograms/ 0.75 ml)
450 i. e. / 0, 75 ml (33 mikrogramov / 0, 75 ml)
40 µg; solvent:
40 µg; vehikel:
1 ml (40 µg/ ml)
1 ml (40 µg/ ml))
1 vial + 1 pre-filled syringe + 6 disposable syringes
1 viala + 1 napolnjena injekcijska brizga + 6 injekcijskih brizg za enkratno uporabo
300 IU/ 0.5 ml (22 micrograms/ 0.5 ml)
300 i. e. / 0, 5 ml (22 mikrogramov / 0, 5 ml)
450 IU; solvent:
450 i. e. vehikel:
0.75 ml (600 IU/ ml)
0, 75 ml (600 i. e. / ml)
1 vial + 1 pre-filled syringe + 4 disposable syringes
1 viala + 1 napolnjena injekcijska brizga + 4 injekcijskih brizg za enkratno uporabo
cartridge (glass) in pre-filled pen
Vložek (steklo) v napolnjenem injekcijskem peresniku
1 pre-filled pen + 5 needles
1 napolnjen injekcijski peresnik + 5 injekcijskih igel
450 IU/ 0.75 ml (33 micrograms/ 0.75 ml)
450 i. e. / 0, 75 ml
Solution for injection in a pre-filled pen
Raztopina za
cartridge (glass) in pre-filled pen
0, 75 ml Raztopina za Subkutana Vložek (steklo) v 0, 75 ml
0.75 ml
(33 mikrogramov / 0, 75 ml)
1 pre-filled pen + 7 needles
peresnik + 7 injekcijskih igel
900 IU/ 1.5 ml (66 micrograms/ 1.5 ml)
900 i. e. / 1, 5 ml (66 mikrogramov / 1, 5 ml)
cartridge (glass) in pre-filled pen
Vložek (steklo) v 1, 5 ml napolnjenem injekcijskem peresniku
1 pre-filled pen + 14 needles
1 napolnjen injekcijski peresnik + 14 injekcijskih igel
GONAL-f 75 IU powder and solvent for solution for injection.
GONAL – f 75 i. e. prašek in vehikel za raztopino za injiciranje
One ampoule contains 75 IU follitropin alfa, recombinant human follicle stimulating hormone (FSH).
Ena ampula vsebuje 75 i. e. folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH).
The reconstituted solution contains 75 IU/ ml.
Pripravljena raztopina vsebuje 75 i. e. / ml.
Follitropin alfa is produced in genetically engineered Chinese Hamster Ovary (CHO) cells.
Folitropin alfa je izdelan z uporabo genetsko spremenjenih celic jajčnika kitajskega hrčka (CHO).
30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate.
30 mg saharoze, 1, 11 mg natrijevega hidrogenfosfata dihidrata, 0, 45 mg natrijevega dihidrogenfosfata monohidrata.
Appearance of the powder: white lyophilised pellet.
Videz praška: bele liofilizirane pelete.
Appearance of the solvent: clear colourless solution.
Videz vehikla: bistra brezbarvna raztopina.
The pH of the reconstituted solution is 6.5 - 7.5.
pH rekonstituirane raztopine je 6, 5 do 7, 5.
• Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate.
• Anovulacija (vključno s policistično ovarijsko boleznijo, PCOD) pri ženskah, ki se niso odzvale na zdravljenje s klomifen citratom.
• Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT).
• Spodbujanje razvoja več foliklov pri bolnicah, pri katerih je potrebno izzvati superovulacijo v postopkih asistirane reprodukcije (ART), kot so In vitro oploditev (IVF), prenos gamete v jajcevod (GIFT) in prenos zigote v jajcevod (ZIFT).
• GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
• GONAL- f se priporoča skupaj z luteinizirajočim hormonom (LH) za spodbujanje razvoja foliklov pri ženskah s hudim pomankanjem LH in FSH.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
V kliničnih preskušanjih so bile te bolnice določene na podlagi ravni endogenega LH v serumu < 1, 2 i. e. / l.
• GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy.
• GONAL- f je s sočasnim zdravljenjem s humanim horionskim gonadotropinom (hCG) indiciran za stimulacijo spermatogeneze pri moških, ki imajo prirojen ali pridobljen hipogonadotropni hipogonadizem.
Treatment with GONAL-f should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Zdravljenje z GONALOM- f se mora pričeti pod nadzorom zdravnika, ki je izkušen v zdravljenju težav s plodnostjo.
GONAL-f is intended for subcutaneous administration.
GONAL- f je namenjen za subkutano uporabo.
The powder should be reconstituted immediately prior to use with the solvent provided.
Tik pred uporabo se mora prašek rekonstituirati s priloženim vehiklom.
In order to avoid the injection of large volumes, up to 3 containers of product may be dissolved in 1 ml of solvent.
Da bi se izognili injiciranju velikih volumnov, se lahko v 1 ml vehikla raztopi vsebino do 3 vsebnikov zdravila.
2 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
2 drugačni od tistih, ki se trenutno uporabljajo za pripravke z urinarnim FSH.
However, when these doses were used in a clinical study comparing GONAL-f and urinary FSH, GONAL-f was more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions.
Vendar pa, ko so te odmerke uporabili v primerjalni klinični raziskavi GONALA- f in urinarnega FSH, je bil GONAL- f bolj učinkovit od urinarnega v FSH v smislu nižjega skupnega odmerka in krajšega časa zdravljenja, potrebnega za dosego predovulacijskih pogojev.
It is advised to adhere to the recommended starting doses indicated below.
Svetujemo, da se upošteva spodaj navedene priporočene začetne odmerke.
Women with anovulation (including PCOD):
Ženske z anovulacijo (vključno s PCOD):
The object of GONAL-f therapy is to develop a single mature Graafian follicle from which the ovum will be liberated after the administration of hCG.
Cilj zdravljenja z GONALOM- f je razvoj enega samega dozorelega Graafovega folikla, iz katerega se bo sprostilo jajčece po dajanju hCG- ja.
GONAL-f may be given as a course of daily injections.
GONAL- f se lahko daje kot zaporedje dnevnih injekcij.
In menstruating patients treatment should commence within the first 7 days of the menstrual cycle.
Pri bolnicah, ki imajo menstruacijo, se mora zdravljenje pričeti v prvih 7 dneh menstrualnega ciklusa.
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/ or oestrogen secretion.
Režim, ki se običajno uporablja, se prične z odmerkom 75 – 150 i. e.
A commonly used regimen commences at 75-150 IU FSH daily and is increased preferably by 37.5 IU, or 75 IU at 7 or preferably 14 day intervals if necessary, to obtain an adequate, but not excessive, response.
FSH na dan, in se ga, če je potrebno povečuje za 37, 5 i. e. ali 75 i. e. v 7 ali po možnosti 14 dnevnih intervalih, za doseganje zadostnega, a ne pretiranega odziva.
The maximal daily dose is usually not higher than 225 IU FSH.
Maksimalni dnevni odmerek običajno ni večji kot 225 i. e.
If a patient fails to respond adequately after 4 weeks of treatment, that cycle should be abandoned and the patient should recommence treatment at a higher starting dose than in the abandoned cycle.
Če pri bolnici ni zadovoljivega odziva na zdravljenje po 4 tednih, se mora ta ciklus zdravljenja opustiti in bolnica mora ponovno zdravljenje začeti z večjim začetnim odmerkom kot v opuščenem ciklusu.
When an optimal response is obtained, a single injection of 5 000 IU, up to 10 000 IU hCG should be administered 24-48 hours after the last GONAL-f injection.
Ko je dosežen optimalen odziv, se mora dati eno samo injekcijo 5000 i. e. do 10 000 i. e. hCG- ja, 24 do 48 ur po zadnji injekciji GONALA- f.
If an excessive response is obtained, treatment should be stopped and hCG withheld (see section 4.4).
Če pride do pretiranega odziva, se mora zdravljenje prekiniti in opustiti dajanje hCG (glejte poglavje 4. 4).
Treatment should recommence in the next cycle at a dosage lower than that of the previous cycle.
Ponovno zdravljenje v naslednjem ciklusu se mora začeti z manjšimi odmerki kot v predhodnem ciklusu.
Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilisation or other assisted reproductive technologies:
Ženske v postopku stimulacije ovarijev za doseganje razvoja več foliklov pred In vitro oploditvijo ali drugimi tehnikami asistirane reprodukcije:
A commonly used regimen for superovulation involves the administration of 150-225 IU of GONAL-f daily, commencing on days 2 or 3 of the cycle.
GONALA- f na dan, s pričetkom na 2. ali 3. dan ciklusa.
Treatment is continued until adequate follicular development has been achieved (as assessed by monitoring of serum oestrogen concentrations and/ or ultrasound examination), with the dose adjusted according to the patient's response, to usually not higher than 450 IU daily.
Zdravljenje se nadaljuje, dokler ni dosežen zadosten folikularni razvoj (kar se oceni s spremljanjem serumske koncentracije estrogena in/ ali ultrazvočnim pregledom), tako da se odmerek prilagaja odzivu bolnice in običajno ni večji od 450 i. e. na dan.
A single injection of up to 10 000 IU hCG is administered 24-48 hours after the last GONAL-f injection to induce final follicular maturation.
Ena sama injekcija do 10 000 i. e. hCG se injicira 24 do 48 ur po zadnji injekciji GONALA- f, za sprožitev končnega zorenja foliklov.
Down-regulation with a gonadotrophin-releasing hormone (GnRH) agonist is now commonly used in order to suppress the endogenous LH surge and to control tonic levels of LH.
Negativna povratna regulacija z agonistom gonadotropin sproščajočega hormona (GnRH) se danes že običajno uporablja za zaviranje porasta endogenega LH in za kontroliranje toničnih ravni LH.
In a commonly used protocol, GONAL-f is started approximately 2 weeks after the start of agonist treatment, both being continued until adequate follicular development is achieved.
Po protokolu, ki se splošno uporablja, se z GONALOM- f začne približno 2 tedna po začetku zdravljenja z agonistom in se nadaljuje z dajanjem obeh zdravil, dokler ni dosežen zadosten folikularni razvoj.
For example, following two weeks of treatment with an agonist, 150-225 IU GONAL-f are administered for the first 7 days.
GONALA- f.
The dose is then adjusted according to the ovarian response.
Nato se odmerek prilagodi, glede na odziv jajčnikov.
3 Women with anovulation resulting from severe LH and FSH deficiency:
Ženske z anovulacijo zaradi hudega pomanjkanja LH in FSH
In LH and FSH deficient women (hypogonadotrophic hypogonadism), the objective of GONAL-f therapy in association with lutropin alfa is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
GONAL- f se mora dajati
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
3 kot zaporedje vsakodnevnih injekcij sočasno z lutropinom alfa.
Treatment should be tailored to the individual patient’ s response as assessed by measuring follicle size by ultrasound and oestrogen response.
Zdravljenje mora biti prilagojeno odzivu posamezne bolnice, ki se oceni z merjenjem velikosti folikla z ultrazvokom in estrogenskim odzivom.
A recommended regimen commences at 75 IU of lutropin alfa daily with 75-150 IU FSH.
FSH.
If an FSH dose increase is deemed appropriate, dose adaptation should preferably be after 7-14 day intervals and preferably by 37.5 IU-75 IU increments.
Če se presodi, da je povečanje odmerka FSH primerno, se mora odmerek prilagajati po možnosti v 7 - 14 dnevnih intervalih in po možnosti s porastom za 37, 5 i. e. do 75 i. e.
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 GONAL-f and lutropin alfa injections.
Ko je dosežen optimalen odziv, se injicira ena sama injekcija 5 000 i. e. do 10 000 i. e. hCG- ja, 24 do 48 ur po zadnji injekciji GONALA- f in lutropina alfa.
Alternatively, intrauterine insemination (IUI) may be performed.
Alternativno, se lahko izvede intrauterina inseminacija (IUI).
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.
Podpora lutealne faze je morda potrebna, ker lahko pomanjkanje snovi z luteotropnim učinkom (LH/ hCG) po ovulaciji vodi do prezgodnje odpovedi rumenega telesca.
Treatment should recommence in the next cycle at a dose of FSH lower than that of the previous cycle.
Ponovno zdravljenje v naslednjem ciklusu se mora začeti z manjšimi odmerki kot v predhodnem ciklusu.
Men with hypogonadotrophic hypogonadism:
Moški s hipogonadotropnim hipogonadizmom
GONAL-f should be given at a dosage of 150 IU three times a week, concomitantly with hCG, for a minimum of 4 months.
GONAL- f se mora dajati v odmerku 150 i. e. trikrat na teden, sočasno s hCG, najmanj 4 mesece.
If after this period, the patient has not responded, the combination treatment may be continued; current clinical experience indicates that treatment for at least 18 months may be necessary to achieve spermatogenesis.
Če po tem obdobju ni odziva pri bolniku, se lahko zdravljenje s kombinacijo nadaljuje; Sedanje klinične izkušnje kažejo, da je lahko za doseganje spermatogeneze potrebno vsaj 18 mesecev.
GONAL-f must not be used in: • hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients • case of tumours of the hypothalamus and pituitary gland
GONAL- f se ne sme uporabljati v primeru: • preobčutljivosti za zdravilno učinkovino folitropin alfa, FSH ali katerokoli pomožno snov • tumorjev hipotalamusa in hipofize
and in women: • ovarian enlargement or cyst not due to polycystic ovarian disease • gynaecological haemorrhages of unknown aetiology • ovarian, uterine or mammary carcinoma
Ter pri ženskah z: • povečanjem jajčnika ali ciste, ki ni nastalo zaradi ovarijske policistične bolezni • ginekološko krvavitvijo neznane etiologije • rakom na jajčniku, maternici ali dojkah
In women: • primary ovarian failure • malformations of sexual organs incompatible with pregnancy • fibroid tumours of the uterus incompatible with pregnancy
GONAL – f se ne sme uporabljati, kadar ni mogoče doseči učinkovitega odziva, kot je npr.: pri ženskah: • primarna odpoved jajčnikov • malformacije spolnih organov, ki niso združljive z nosečnostjo • fibroidni tumorji maternice, ki niso združljivi z nosečnostjo
In men: primary testicular insufficiency
pri moških: • primarna insuficienca testisov
GONAL-f is a potent gonadotrophic substance 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 je močna gonadotropna učinkovina, ki lahko povzroči blage do hude neželene reakcije in jo zato smejo uporabljati samo zdravniki, ki dobro poznajo težave neplodnosti in njihovo obvladovanje.
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health professionals, as well as the availability of appropriate monitoring facilities.
Zdravljenje z gonadotropinom zahteva od zdravnika in ostalega zdravstvenega osebja določen čas, kakor tudi razpoložljivost ustrezne opreme za nadzorovanje zdravljenja.
In women, safe and effective use of GONAL-f calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis.
Pri ženskah je za varno in učinkovito uporabo GONALA- f potrebno redno nadzorovanje odziva jajčnikov z ultrazvokom ali še bolje z ultrazvokom v kombinaciji z merjenjem serumskih ravni estradiola.
There may be a degree of interpatient variability in response to FSH administration, with a poor response to FSH in some patients.
Razpon odziva na zdravljenje z FSH se lahko med bolniki razlikuje, pri nekaterih bolnikih je odziv nas FSH zelo majhen.
The lowest effective dose in relation to the treatment objective should be used in both men and women.
4 Pri obeh, moških in ženskah, se mora uporabiti najmanjši še učinkoviti odmerek glede na cilj zdravljenja.
Self-administration of GONAL-f should only be performed by patients who are well motivated, adequately trained and with access to expert advice.
Sami si lahko dajejo GONAL- f samo bolniki, ki so dobro motivirani, ustrezno poučeni in imajo dostop do strokovnega nasveta.
The first injection of GONAL-f should be performed under direct medical supervision.
Injiciranje prve injekcije GONALA- f se mora izvesti pod direktnim zdravniškim nadzorom.
Patients with porphyria or a family history of porphyria should be closely monitored during treatment with GONAL-f.
Bolnike s porfirijo ali s porfirijo v družini anamnezi, moramo med zdravljenjem z zdravilom GONAL- f skrbno nadzorovati.
GONAL-f contains less than 1 mmol sodium (23 mg) per dose, i. e. essentially “ sodium-free”.
GONAL- f vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar je v bistvu brez natrija.
In particular, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Bolnike je treba še posebej pregledati na hipotiroidizem, adrenokortikalno insuficienco, hiperprolaktinemijo, tumorje hipofize ali hipotalamusa, ter jih ustrezno specifično zdraviti.
Patients undergoing stimulation of follicular growth, whether in the frame of a treatment for anovulatory infertility or ART procedures, may experience ovarian enlargement or develop hyperstimulation.
Pri bolnicah v postopku stimulacije folikularne rasti bodisi v okviru zdravljenja anovulacijske neplodnosti ali postopkov ART, se lahko povečajo jajčniki ali se razvije hiperstimulacija.
Adherence to recommended GONAL-f dosage and regimen of administration, and careful monitoring of therapy will minimise the incidence of such events.
Pogostnost takih dogodkov se zmanjša na minimum ob upoštevanju priporočenega odmerjanja in režima dajanja GONALA- f ter ob skrbnem nadzorovanju zdravljenja.
Acute interpretation of the indices of follicle development and maturation require a physician whom is experienced in the interpretation of the relevant tests.
Akutno interpretacijo kazalcev folikelskega razvoja in dozorevanja lahko izvede le zdravnik, ki ima izkušnje na področju interpretacije relevantnih testov.
In clinical trials, an increase of the ovarian sensitivity to GONAL-f was shown when administered with lutropin alfa.
V kliničnih preskušanjih, se je pokazalo, da se poveča občutljivost jajčnikov za GONAL- f, kadar se uporablja skupaj z lutropinom alfa.
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.
Če se presodi, da je povečanje odmerka FSH primerno, se mora odmerek prilagajati po možnosti v 7- 14 dnevnih intervalih in po možnosti s porastom za 37, 5 do 75 i. e.
No direct comparison of GONAL-f/ LH versus human menopausal gonadotrophin (hMG) has been performed.
Direktna primerjava med GONALOM – f/ LH s humanim menopavzalnim gonadotropinom (hMG) ni bila izvedena.
Comparison with historical data suggests that the ovulation rate obtained with GONAL-f/ LH is similar to what can be obtained with hMG.
Primerjava dosedanjih podatkov nakazuje, da je delež ovulacij doseženih z GONALOM- f/ LH podoben tistemu, ki ga lahko dosežemo s hMG.
OHSS is a medical event distinct from uncomplicated ovarian enlargement.
Sindrom hiperstimulacije jajčnikov je zdravstveno stanje, ki se razlikuje od nekompliciranega povečanja jajčnikov.
OHSS is a syndrome that can manifest itself with increasing degrees of severity.
OHSS je sindrom, ki se lahko izrazi z naraščajočo stopnjo resnosti.
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.
Obsega izrazito povečanje jajčnikov, visoko raven spolnih steroidnih hormonov in povečano prepustnost žil, kar lahko rezultira v nabiranju tekočine v trebušni votlini, plevralni votlini in redko v osrčniku.
Clinical evaluation may reveal hypovolaemia,
V hudih primerih OHSS lahko opazimo naslednjo simptomatiko: bolečine v trebuhu, povečanje trebuha, hudo povečanje jajčnikov, pridobivanje telesne teže, dispneo, oligurijo in gastrointestinalne znake vključno s slabostjo, bruhanjem in drisko.
5 haemoconcentration, electrolyte imbalances, ascites, haemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events.
Klinična ocena lahko razkrije hipovolemijo, hemokoncentracijo, elektrolitsko neravnovesje, ascites, hemoperitoneum, plevralni izliv, hidrotoraks, akutno respiratorno stisko, tromboembolične dogodke.
Very rarely, severe OHSS may be complicated by pulmonary embolism, ischemic stroke and myocardial infarction.
Pri hudem OHSS je zelo redko lahko zaplet pljučni embolizem, ishemični cerebrovaskularni insult in miokardni infarkt.
Excessive ovarian response to gonadotrophin treatment seldom gives rise to OHSS unless hCG is administered to trigger ovulation.
Pretiran odziv jajčnikov na zdravljenje z gonadotropini se le redko razvije v OHSS, razen če se uporabi hCG za sprožitev ovulacije.