natgillin/translations-raw huggingface dataset:
Therefore in cases of ovarian hyperstimulation it is prudent to withhold hCG and advise the patient to refrain from coitus or to use barrier methods for at least 4 days.
Zato je v primeru hiperstimulacije jajčnikov smiselno opustiti dajanje hCG in svetovati bolnici, da se vzdrži spolnih odnosov ali uporablja mehanska zaščitna sredstva pred zanositvijo najmanj 4 dni.
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 se lahko hitro razvije (v 24 urah do nekaj dneh) v resen zdravstven zaplet, zato je treba spremljati bolnice najmanj dva tedna po dajanju hCG.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
5 Za zmanjšanje tveganja za OHSS ali večplodno nosečnost na minimum, se priporočajo ultrazvočni pregledi in merjenje estradiola.
In anovulation the risk of OHSS and multiple pregnancy is increased by a serum oestradiol > 900 pg/ ml (3300 pmol/ l) and more than 3 follicles of 14 mm or more in diameter.
Pri anovulaciji se tveganje za OHSS in večplodno nosečnost poveča s serumsko koncentracijo estradiola > 900 pg/ ml (3300 pmol/ l) in z več kot 3 folikli, s premerom 14 mm ali več.
In ART there is an increased risk of OHSS with a serum oestradiol > 3000 pg/ ml (11000 pmol/ l) and 20 or more follicles of 12 mm or more in diameter.
Pri ATR se tveganje za OHSS poveča s serumsko koncentracijo estradiola > 3000 pg/ ml (11000 pmol/ l) in z več kot 20 folikli, s premerom 12 mm ali več.
When the oestradiol level is > 5500 pg/ ml (20200 pmol/ l) and where there are 40 or more follicles in total, it may be necessary to withhold hCG administration.
Kadar je raven estradiola > 5500 pg/ ml (20200 pmol/ l) in kadar je celokupno število foliklov 40 ali več, je lahko nujno opustiti dajanje hCG.
Adherence to recommended GONAL-f dosage, regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy (see Sections 4.2 and 4.8).
Upoštevanje priporočenega odmerjanja GONALA- f, režima uporabe in skrbno nadzorovanje zdravljenja zmanjšajo pogostnost hiperstimulacije jajčnikov in večplodnih nosečnosti na minimum (glejte poglavji 4. 2. in 4. 8).
In ART, aspiration of all follicles prior to ovulation may reduce the occurrence of hyperstimulation.
Pri ART, lahko aspiracija vseh foliklov pred ovulacijo zmanjša pojavnost hiperstimulacije.
OHSS may be more severe and more protracted if pregnancy occurs.
Če nastopi nosečnost, je OHSS lako hujši in dolgotrajnejši.
Most often, OHSS occurs after hormonal treatment has been discontinued and reaches its maximum at about seven to ten days following treatment.
OHSS se najpogosteje pojavi po prekinitvi hormonskega zdravljenja in doseže maksimum približno sedem do deset dni po zdravljenju.
If severe OHSS occurs, gonadotrophin treatment should be stopped if still ongoing, the patient hospitalised and specific therapy for OHSS started.
Če se pojavi hud OHSS, se mora ukiniti zdravljenje z gonadotropinom, v kolikor še traja, bolnico sprejeti v bolnišnico in začeti s specifičnim zdravljenjem OHSS.
This syndrome occurs with higher incidence in patients with polycystic ovarian disease.
Ta sindrom se bolj pogosto pojavlja pri bolnicah z ovarijsko policistično boleznijo.
Multiple pregnancy, specially high order, carries an increase risk in adverse maternal and perinatal outcomes.
Veplodna nosečnost, zlasti visokega reda, predstavlja povečano tveganje za neželen izid nosečnosti za mater in otroka.
In patients undergoing ovulation induction with GONAL-f, the incidence of multiple pregnancies is increased as compared with natural conception.
Pri bolnicah v postopku indukcije ovulacije z GONALOM- f, je pogostnost večplodne nosečnosti v primerjavi z naravno zanositvijo, povečana.
To minimise the risk of multiple pregnancy, careful monitoring of ovarian response is recommended.
Za zmanjšanje tveganja večplodne nosečnosti na minimum, se priporoča skrbno spremljanje ovarijskega odziva.
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.
Tveganje večplodne nosečnosti po uporabi tehnik asistirane reprodukcije je v glavnem povezano s številom vsajenih embrijev, njihovo kvaliteto in starostjo bolnice.
Pregnancy wastage
Izguba nosečnosti
The incidence of pregnancy wastage by miscarriage or abortion is higher in patients undergoing stimulation of follicular growth for ovulation induction or ART than in the normal population.
Izguba nosečnosti zaradi spontanega splava ali abortusa je pri bolnicah, ki so se podvrgle stimulaciji folikularne rasti za indukcijo ovarijev ali tehnik asistirane reprodukcije, višja kot pri normalni populaciji.
6 Ectopic pregnancy
Zunajmaternična nosečnost
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.
Pri ženskah boleznijo jacevodov v anamnezi, obstaja tveganje zunajmaternične nosečnosti, ne glede na to ali pride do zanositve spontano ali z zdravljenjem neplodnosti.
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.
Po IVF so poročali o prevalenci zunajmaternične nosečnosti 2 do 5%, v primerjavi z 1 do 1, 5% pri splošni populaciji.
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.
Pri ženskah, ki so se podvrgle režimu zdravljenja neplodnosti z več zdravili, so poročali o novotvorbah na jajčnikih in drugih delih reprodukcijskega sistema, tako benignih kot malignih.
It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumors in infertile women.
Ni pa še ugotovljeno, ali zdravljenje z gonadotropini povečuje osnovno tveganje teh tumorjev pri neplodnih ženskah.
Congenital malformation
6 Prirojene malformacije
This is thought to be due to differences in parental characteristics (e. g. maternal age, sperm characteristics) and multiple pregnancies.
To se pripisuje razlikam lastnosti staršev (npr. materina starost, lastnosti sperme) in večplodnim nosečnostim.
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.
Pri ženskah s splošno znanimi dejavniki tveganja za tromboembolične dogodke, kot so osebna ali družinska anamneza, lahko zdravljenje z gonadotropini še poveča tveganje.
In these women, the benefits of gonadotrophin administration need to be weighed against the risks.
Pri teh ženskah je potrebno pretehtati koristi uporabe gonadotropinov glede na tveganje.
It should be noted however, that pregnancy itself also carries an increased risk of thrombo-embolic events.
Vendar pa moramo opomniti, da tudi nosečnost sama prinaša povečano tveganje za tromboembolične dogodke.
Such patients are unresponsive to GONAL-f/ hCG therapy.
Takšni bolniki se na zdravljenje z GONALOM- f/ hCG- jem ne odzivajo.
Semen analysis is recommended 4 to 6 months after the beginning of treatment in assessing the response.
Za ocenjevanje odziva se priporoča analiza semenske tekočine 4 do 6 mesecev od začetka zdravljenja.
Concomitant use of GONAL-f with other agents used to stimulate ovulation (e. g. hCG, clomiphene citrate) may potentiate the follicular response, whereas concurrent use of a GnRH agonist to induce pituitary desensitisation may increase the dosage of GONAL-f needed to elicit an adequate ovarian response.
Sočasna uporaba GONALA- f z drugimi sredstvi, ki se uporabljajo za stimulacijo ovulacije (npr. hCG, klomifen citrat) lahko potencira folikularani odziv, medtem ko hkratna uporaba agonista GnRH za sprožitev desenzitizacije hipofize lahko poveča odmerek GONALA- f, ki je potreben za dosego ustreznega odziva jajčnikov.
No other clinically significant drug interaction has been reported during GONAL-f therapy.
Med zdravljenjem z GONALOM- f niso poročali o drugih klinično pomembnih interakcijah z zdravili.
GONAL-f should not be administered as mixture with other medicinal products, in the same injection, except lutropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
GONALA- f se ne sme dajati v obliki mešanice z drugimi zdravili v isti injekcijski brizgi, razen z lutropinom alfa, za katerega so študije pokazale, da hkratno dajanje ne spremeni pomembno učinkovitosti, stabilnosti, farmakokinetičnih in farmakodinamičnih lastnosti zdravilne učinkovine.
There is no indication for use of GONAL-f during pregnancy.
Za uporabo GONALA- f med nosečnostjo ni indikacij.
No teratogenic risk has been reported, following controlled ovarian hyperstimulation, in clinical use with gonadotropins.
V klinični uporabi gonadotropinov, ni poročil o tveganju teratogenosti po kontrolirani ovarijski hiperstimulaciji.
In case of exposure during pregnancy, clinical data are not sufficient to exclude a teratogenic effect of recombinant FSH.
V primeru izpostavljenosti zdravilu v času nosečnosti, ni zadostnih kliničnih podatkov, da bi lahko izključili teratogeni učinek rekombinantnega hFSH.
No teratogenic effect has been observed in animal studies.
Vendar pa do danes ni poročil o posameznem škodljivem učinku. V poskusih na živali niso opazili nobenega teratogenega učinka.
7 Use during lactation
Uporaba med dojenjem
GONAL-f is not indicated during lactation.
GONAL- f ni indiciran v obdobju dojenja.
During lactation, the secretion of prolactin can entail a poor prognosis to ovarian stimulation.
V obdobju dojenja je lahko zaradi izločanja prolaktina prognoza za stimulacijo jajčnikov slaba.
Treatment in women Immune system disorders
Zdravljenje žensk Bolezni imunskega sistema
Very rare (< 1/ 10,000)
Zelo redki (< 1/ 10. 000)
Mild systemic allergic reactions (e. g. mild forms of erythema, rash, facial swelling, urticaria, oedema, difficulty breathing).
blage sistemske alergijske reakcije (npr. blažje oblike eritema, izpuščaj, otekanje obraza, urtikarija, edem, težave z dihanjem).
Serious cases of allergic reactions, including anaphylactic reactions, have also been reported.
Poročali so tudi o resnih primerih alergijskih reakcij, vključno z anafilaktično reakcijo.
Nervous system disorders Vascular disorders
Bolezni živčevja
Very Common (> 1/ 10) Very rare (< 1/ 10,000)
Zelo redki (< 1/ 10. 000)
Headache Thromboembolism, usually associated with severe OHSS
tromboembolizem, običajno povezan s hudim OHSS
Exacerbation or worsening of asthma
Ponovni izbruh ali poslabšanje astme.
Common (> 1/ 100, < 1/ 10)
Pogosti (> 1/ 100, < 1/ 10)
Abdominal pain and gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal cramps and bloating
Bolečina v trebuhu in gastrointestinalni simptomi kot so slabost, bruhanje, driska, trebušni krči in napihnjenost.
Very Common (> 1/ 10)
Zelo pogosti (> 1/ 10)
Ovarian cysts
ovarijske ciste
Mild to moderate OHSS (see section 4.4)
blag do zmeren OHSS (glejte poglavje 4. 4)
Uncommon (> 1/ 1,000 ,< 1/100) Rare (> 1/10 ,000, < 1/1,000)
Občasni (> 1/ 1. 000, < 1/ 100)
Severe OHSS (see section 4.4) Ovarian torsion, a complication of OHSS
hud OHSS (glejte poglavje 4. 4)
Very Common (> 1/ 10)
Redki (> 1/ 10. 000, < 1/ 1. 000)
Mild to severe injection site reaction (pain, redness, bruising, swelling and/ or irritation at the site of injection)
zasuk (torzija) jajčnika, zaplet OHSS
8 Treatment in men Skin and subcutaneous tissue disorders
Splošne težave in spremembe na mestu aplikacije
Common (> 1/ 100, < 1/ 10)
Zelo pogosti (> 1/ 10)
Acne
Blaga do huda reakcija na mestu injiciranja (bolečina, rdečina, modrica, oteklina in / ali razdraženost na mestu injiciranja).
Reproductive system and breast disorders
Zdravljenje moških Bolezni kože in podkožja Motnje reprodukcije in dojk
Common (> 1/ 100, < 1/ 10)
Pogosti (> 1/ 100, < 1/ 10) Pogosti (> 1/ 100, < 1/ 10)
Gynaecomastia Varicocele
akne ginekomastija varikokela
Mild to severe injection site reaction (pain, redness, bruising, swelling and/ or irritation at the site of injection)
Blaga do huda reakcija na mestu injiciranja (bolečina, rdečina, modrica, oteklina in / ali razdraženost na mestu injiciranja).
Weight gain
pridobivanje telesne mase
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
Učinki prevelikega odmerka GONALA- f niso znani, vendar pa lahko pričakujemo pojav sindroma hiperstimulacije jajčnikov, ki je podrobno opisan v poglavju 4. 4.
Pharmacotherapeutic group: gonadotrophins, ATC code:
Farmakoterapevtska skupina: gonadotropini, Oznaka ATC:
GONAL-f is a preparation of follicle stimulating hormone produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
GONAL – f je pripravek, ki vsebuje folikle stimulirajoči hormon, pridobljen z genetsko spremenjenimi celicami jajčnika kitajskega hrčka (CHO).
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.
V kliničnih preskušanjih so določili bolnice s hudim pomankanjem FSH in LH na podlagi serumske ravni LH < 1, 2 i. e. / l, kot izmerjeno v centralnem laboratoriju.
In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
Pri moških s pomankanjem FSH, dajanje GONALA- f skupaj z hCG- jem vsaj štiri mesece, sproži spermatogenezo.
Following intravenous administration, GONAL-f is distributed to the extra cellular 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.
5. 2 Farmakokinetične lastnosti
The steady state volume of distribution and total clearance are 10 l and 0.6 l/ h, respectively.
Volumen porazdelitve v stanju dinamičnega ravnotežja je 10 l in celokupni očistek je 0, 6 l/ h.
One- eighth of the GONAL-f dose is excreted in the urine.
Ena osmina odmerka GONAL- f se izloči z urinom.
Following subcutaneous administration, the absolute bioavailability is about 70%.
Po subkutani uporabi je absolutna biološka razpoložljivost 70%.
Following repeated administration, GONAL-f accumulates 3-fold achieving a steady-state within 3-4 days.
Po večkratnem dajanju, doseže GONAL- f trikratno raven v plazmi in doseže stanje dinamičnega ravnotežja v 3 do 4 dneh.
In women whose endogenous gonadotrophin secretion is suppressed, GONAL-f has nevertheless been shown to effectively stimulate follicular development and steroidogenesis, despite unmeasurable LH levels.
Pri ženskah z zavrtim izločanjem endogenega gonadotropina pa se je izkazalo, da GONAL- f učinkovito spodbuja razvoj foliklov in steroidogenezo, kljub nemerljivim ravnem LH.
Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity and genotoxicity additional to that already stated in other sections of this SPC.
Predklinični podatki na osnovi običajnih študij toksičnosti in genotoksičnosti pri enkratnih in ponavljajočih se odmerkih, ne kažejo posebnega tveganja za človeka, razen že omenjenega v drugih poglavjih Povzetka glavnih značilnosti zdravila.
Impaired fertility has been reported in rats exposed to pharmacological doses of follitropin alfa (≥ 40 IU/ kg/ day) for extended periods, through reduced fecundity.
O okvarah plodnosti so poročali pri podganah, ki so bile izpostavljene farmakološkim odmerkom folitropina alfa (≥ 40 i. e. / kg/ dan) skozi daljše obdobje in sicer v obliki zmanjšane plodnosti.
9 Given in high doses (≥ 5 IU/ kg/ day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary hMG.
V visokih odmerkih (≥ 5 i. e. / kg/ dan) je folitropin alfa povzročil zmanjšanje števila živih zarodkov, brez teratogenega učinka in distocijo, podobno tisti, opaženi pri urinarnem hMG.
However, since GONAL-f is not indicated in pregnancy, these data are of limited clinical relevance.
Vendar pa, so ti podatki le omejeno klinično pomembni, ker GONAL- f ni indiciran v nosečnosti.
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
Prašek: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, fosforjeva kislina, koncentrirana, natrijev hidroksid.
Solvent:
9 Vehikel:
The powder is packaged in 3 ml neutral colourless glass (type I) ampoules.
Prašek je pakiran v 3 ml ampule iz nevtralnega brezbarvnega stekla (Tipa I).
The solvent is packaged in 3 ml neutral colourless glass type I ampoules.
Vehikel je pakiran v 3 ml ampule iz nevtralnega brezbarvnega stekla Tipa I.
The product is supplied in packs of 1, 5, 10 ampoules with the corresponding number of solvent ampoules.
Zdravilo je na voljo v škatlicah z 1, 5, 10 ampul s praškom in ustreznim številom ampul z vehiklom.
GONAL-f must be reconstituted with the solvent before use.
GONAL- f morate pred uporabo rekonstituirati z vehiklom.
GONAL-f may be co-reconstituted with lutropin alfa and co-administered as a single injection.
GONAL- f se lahko sočasno pripravi z lutropinom alfa in sočasno injicira kot eno samo injekcijo.
In this case lutropin alfa should be reconstituted first and then used to reconstitute GONAL-f powder.
V tem primeru morate najprej pripraviti raztopino lutropina alfa in jo nato uporabiti za rekonstitucijo praška GONAL- f.
The reconstituted solution should not be administered if it contains particles or is not clear.
Pripravljene raztopine ne smete uporabiti, če vsebuje delce ali ni bistra.
10 Any unused product or waste material should be disposed of in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
MARKETING AUTHORISATION NUMBERS
ŠTEVILKA (ŠTEVILKA) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Date of last renewal:
20. oktober 1995 Datum zadnjega podaljšanja dovoljenja za promet:
19 October 2005.
19. oktober 2005
GONAL-f 150 IU powder and solvent for solution for injection.
GONAL - f 150 i. e. prašek in vehikel za raztopino za injiciranje
One ampoule contains 150 IU follitropin alfa, recombinant human follicle stimulating hormone (FSH).
Ena ampula vsebuje 150 i. e. folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH).
The reconstituted solution contains 150 IU/ ml.
Pripravljena raztopina vsebuje 150 i. e. / ml.
12 The dosage recommendations given for GONAL-f are those in use for urinary FSH.
12 drugačni od tistih, ki se trenutno uporabljajo za pripravke z urinarnim FSH.
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and/ or oestrogen secretion.
Zdravljenje mora biti prilagojeno odzivu posamezne bolnice, ki se ga oceni z merjenjem velikosti folikla z ultrazvokom in/ ali izločanjem estrogena.
Alternatively intrauterine insemination (IUI) may be performed.
Alternativno, se lahko izvede intrauterina inseminacija (IUI).
13 Women with anovulation resulting from severe LH and FSH deficiency:
Ženske z anovulacijo zaradi hudega pomanjkanja LH in FSH
GONAL-f should be given as a course of daily injections simultaneously with lutropin alfa.
13 kot zaporedje vsakodnevnih injekcij sočasno z lutropinom alfa.
In men: • primary testicular insufficiency
pri moških: • primarna insuficienca testisov
14 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
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 14 bolje z ultrazvokom v kombinaciji z merjenjem serumskih ravni estradiola.
The lowest effective dose in relation to the treatment objective should be used in both men and women.
Pri obeh, moških in ženskah, se mora uporabiti najmanjši še učinkoviti odmerek glede na cilj zdravljenja.
15 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.
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 se lahko hitro razvije (v 24 urah do nekaj dneh) v resen
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Za zmanjšanje tveganja za OHSS ali večplodno nosečnost na minimum, se priporočajo ultrazvočni pregledi in merjenje estradiola.
16 Reproductive system neoplasms
16 Ni pa še ugotovljeno, ali zdravljenje z gonadotropini povečuje osnovno tveganje teh tumorjev pri neplodnih ženskah.
17 4.8 Undesirable effects
17 4. 8 Neželeni učinki
Treatment in men Skin and subcutaneous tissue disorders
Splošne težave in spremembe na mestu aplikacije
The effects of an overdose of GONAL-f are unknown, nevertheless one could expect ovarian hyperstimulation syndrome to occur, which is further described in section 4.4.
18 hiperstimulacije jajčnikov, ki je podrobno opisan v poglavju 4. 4.
Following intravenous administration, GONAL-f 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.
5. 2 Farmakokinetične lastnosti
Given in high doses (> 5 IU/ kg/ day) follitropin alfa caused a decrease in the number of viable foetuses without being a teratogen, and dystocia similar to that observed with urinary hMG.
V visokih odmerkih (≥ 5 i. e. / kg/ dan) je folitropin alfa povzročil zmanjšanje števila živih zarodkov, brez teratogenega učinka in distocijo, podobno tisti, opaženi pri urinarnem hMG.
Sucrose Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Phosphoric acid, concentrated Sodium hydroxide
Prašek: saharoza, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat dihidrat, fosforjeva( V) kislina, koncentrirana, natrijev hidroksid.
19 Solvent:
19 Vehikel:
The product is supplied in packs of 1, 10 ampoules with the corresponding number of solvent ampoules.
Zdravilo je na voljo v škatlicah z 1, 10 ampul s praškom in ustreznim številom ampul z vehiklom.
GONAL-f 75 IU (5.5 micrograms) powder and solvent for solution for injection.
(5, 5 mikrogramov) prašek in vehikel za raztopino za injiciranje
One vial contains 6 micrograms follitropin alfa, recombinant human follicle stimulating hormone (FSH) in order to deliver 5.5 micrograms, equivalent to 75 IU.
Ena viala vsebuje 6 mikrogramov folitropina alfa, rekombinantnega folikle stimulirajočega hormona (FSH) za zagotovitev odmerka 5, 5 mikrogramov, kar ustreza 75 i. e.
30 mg sucrose, 1.11 mg disodium phosphate dihydrate, 0.45 mg sodium dihydrogen phosphate monohydrate, 0.1 mg methionine, 0.05 mg polysorbate 20.
30 mg saharoze, 1, 11 mg natrijevega hidrogenfosfata dihidrata, 0, 45 mg natrijevega dihidrogenfosfata monohidrata, 0, 1 mg metionina, 0, 05 mg polisorbata 20.
In order to avoid the injection of large volumes, up to 3 vials 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.
Clinical assessment of GONAL-f indicates that its daily doses, regimens of administration, and treatment monitoring procedures should not be different from those currently used for urinary FSH-containing preparations.
22 da njegovi dnevni odmerki, režim uporabe in postopki nadzorovanja zdravljenja ne bi smeli biti drugačni od tistih, ki se trenutno uporabljajo za pripravke z urinarnim FSH.