natgillin/translations-raw huggingface dataset:
The Committee for Medicinal Products for Human Use (CHMP) decided that Luveris’ s benefits are greater than its risks for stimulating follicular development (when administered with a follicle stimulating hormone preparation) in women with severe luteinising hormone (LH) and FSH deficiency.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Luveris pri spodbujanju folikularnega razvoja (če se daje s pripravkom folikle stimulirajočega hormona) pri ženskah s hudim pomanjkanjem luteinizirajočega hormona (LH) in FSH večje od z njim povezanih tveganj.
They recommended that Luveris be given marketing authorisation.
Zato so priporočili, da se za zdravilo Luveris podeli dovoljenje za promet.
Other information about Luveris:
Druge informacije o zdravilu Luveris:
The European Commission granted a marketing authorisation valid throughout the European Union, for Luveris to Serono Europe Limited on 29 November 2000.
Evropska komisija je dovoljenje za promet z zdravilom Luveris, veljavno po vsej Evropski uniji, odobrila družbi Serono Europe Limited dne 29. novembra 2000.
The full EPAR for Luveris is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Luveris je na voljo tukaj.
powder: vial (glass); solvent: ampoule (glass)
prašek: viala (steklo); vehikel: ampula (steklo)
1 vial + 1ampoule
1 viala + 1ampula
10 vials + 10 ampoules
10 vial + 10 ampul
powder: vial (glass); solvent: vials (glass)
prašek: viala (steklo); vehikel: viala (steklo)
Luveris 75 IU, powder and solvent for solution for injection.
Luveris 75 i. e., prašek in vehikel za raztopino za injiciranje
One vial contains 75 IU of lutropin alfa (recombinant human luteinising hormone {LH}).
Ena viala vsebuje 75 i. e. lutropina alfa (rekombinantnega humanega luteinizirajočega hormona {LH}).
Lutropin alfa is produced in genetically engineered Chinese hamster ovary (CHO) cells.
Lutropin alfa je pridobljen z gensko rekombinantno tehnologijo na ovarijskih celicah kitajskega hrčka (CHO).
47.75 mg sucrose, 0.1 mg L-methionine, 0.05 mg polysorbate 20
47, 75 mg saharoze, 0, 1 mg L- metionina, 0, 05 mg polisorbata 20
The pH of the reconstituted solution is 7.5 - 8.5.
pH rekonstituirane raztopine je 7, 5 - 8, 5.
Luveris in association with a follicle stimulating hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency.
Luveris je skupaj s preparatom, ki vsebuje folikle stimulirajoči hormon (FSH) indiciran za spodbujanje folikularnega razvoja pri ženskah s hudim pomanjkanjem LH- ja in FSH- ja.
In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/ l.
V kliničnih preskušanjih so te bolnice opredelili glede na serumsko raven endogenega LH < 1, 2 i. e. / l.
Treatment with Luveris should be initiated under the supervision of a physician experienced in the treatment of fertility problems.
Zdravljenje z Luverisom se mora pričeti pod nadzorom zdravnika, ki je izkušen v zdravljenju težav s plodnostjo.
Self-administration of Luveris should only be performed by patients who are well-motivated, adequately trained and with access to expert advice.
Sami si smejo Luveris dajati samo tisti bolniki, ki so dovolj motivirani, primerno usposobljeni in imajo možnost strokovnega nasveta.
In LH and FSH deficient women, the objective of Luveris therapy in association with FSH is to develop a single mature Graafian follicle from which the oocyte will be liberated after the administration of human chorionic gonadotrophin (hCG).
Pri ženskah s pomanjkanjem LH- ja in FSH- ja je cilj terapije z Luverisom v kombinaciji s FSH- jem razvoj enega samega dozorelega Graafovega folikla, iz katerega se bo po dajanju humanega horionskega gonadotropina (hCG- ja) sprostil oocit.
Luveris should be given as a course of daily injections simultaneously with FSH.
Luveris moramo dajati kot serijo vsakodnevnih injekcij sočasno s FSH- jem.
Since these patients are amenorrhoeic and have low endogenous oestrogen secretion, treatment can commence at any time.
Ker so te bolnice amenoreične in imajo nizko izločanje endogenega estrogena, se zdravljenje lahko prične kadarkoli.
All clinical experience to date with Luveris in this indication has been gained with concomitant administration of follitropin alfa.
Vse dosedanje klinične izkušnje z Luverisom v tej indikaciji so bile pridobljene s sočasnim dajanjem folitropina alfa.
Luveris is intended for subcutaneous administration.
Luveris je namenjen za subkutano aplikacijo.
The powder should be reconstituted, immediately prior to use, with the solvent provided.
Prašek moramo neposredno pred uporabo rekonstituirati s priloženim vehiklom.
Treatment should be tailored to the individual patient’ s response as assessed by measuring (i) follicle size by ultrasound and (ii) oestrogen response.
Zdravljenje mora biti prilagojeno individualnemu odzivu bolnice, katerega ovrednotimo z merjenjem (i) velikosti folikla z ultrazvokom in (ii) estrogenskega odziva.
A recommended regimen commences at 75 IU of lutropin alfa (ie. one vial of Luveris) daily with 75-150 IU FSH.
Priporočeni režim se prične s 75 i. e. lutropina alfa (t. j. ena viala zdravila Luveris) na dan in s 75 – 150 i. e.
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 izkaže kot primerno povečanje odmerka FSH- ja, moramo prilagoditev odmerka izvesti po možnosti v 7- 14 dnevnih intervalih s povečanji po 37, 5 i. e. do 75 i. e.
2 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 Luveris and FSH injections.
2 Ko dosežemo optimalni odziv, moramo v 24 – 48 urah po zadnji injekciji Luverisa in FSH- ja dati eno samo injekcijo s 5. 000 i. e. do 10. 000 i. e. hCG- ja.
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.
Pretehta naj se potrebnost podpore lutealne faze, ker pomanjkanje snovi z luteotropno aktivnostjo (LH/ hCG) po ovulaciji lahko privede 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 pričeti z nižjim odmerkom FSH- ja kot v predhodnem ciklusu.
Luveris is contraindicated in patients with:
Luveris je kontraindiciran pri bolnicah:
• hypersensitivity to gonadotrophins or to any of the excipients. • ovarian, uterine, or mammary carcinoma; • active, untreated tumours of the hypothalamus and pituitary gland; • ovarian enlargement or cyst not due to polycystic ovarian disease; • gynaecological haemorrhages of unknown origin
• s preobčutljivostjo za gonadotropine ali katerokoli pomožno snov; • z ovarijskim, materničnim karcinomom ali karcinomom dojke; • z aktivnimi, nezdravljenimi tumorji hipotalamusa in hipofize; • s povečanjem jajčnikov ali cisto, ki ni nastala zaradi policistične bolezni ovarijev; • z ginekološkimi krvavitvami neznanega izvora.
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
Pred pričetkom zdravljenja je treba oceniti neplodnost partnerjev kot primerno in ovrednotiti domnevne kontraindikacije za nosečnost.
This medicinal product should not be used when an effective response cannot be obtained, such as ovarian failure, malformation of the sexual organs incompatible with pregnancy or fibroid tumours of the uterus incompatible with pregnancy.
Zdravila ne smemo uporabljati, kadar ni mogoče doseči učinkovitega odziva, kot je to pri odpovedi jajčnikov, malformacijah spolnih organov, ki so nezdružljive z nosečnostjo ali pri fibroidnih tumorjih maternice, ki so nezdružljivi z nosečnostjo.
In addition, patients should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumours, and appropriate specific treatment given.
Dodatno moramo bolnice pregledati še na hipotiroidizem, adrenokortikalno insuficienco, hiperprolaktinemijo in hipofizne ali hipotalamične tumorje, ter jih ustrezno zdraviti.
Ovarian hyperstimulation syndrome (OHSS) can become a serious medical event characterised by large ovarian cysts which are prone to rupture.
Sindrom hiperstimulacije jajčnikov (OHSS) lahko postane resen medicinski dogodek, za katerega so značilne velike ovarijske ciste, ki rade počijo.
Excessive ovarian response seldom gives rise to significant hyperstimulation unless hCG is administered to induce ovulation.
Čezmeren ovarijski odziv redko povzroči pomembno hiperstimulacijo, razen ob dajanju hCG- ja za indukcijo ovulacije.
It is therefore prudent to withhold hCG in such cases and advise the patient to refrain from coitus or use barrier methods for at least 4 days.
Zato je v takih primerih smiselno opustiti dajanje hCG- ja, bolnici pa svetovati, da se vzdrži spolnih odnosov ali da uporablja mehanska kontracepcijska sredstva najmanj 4 dni.
Careful monitoring of ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, especially in patients with polycystic ovaries.
Skrbno nadzorovanje ovarijskega odziva z ultrazvokom priporočamo pred in med stimulacijsko terapijo, še posebej pri bolnicah s policističnimi jajčniki.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
Pri bolnicah v postopku indukcije ovulacije je pogostnost večplodnih nosečnosti in porodov povečana, v primerjavi z naravno zanositvijo.
To minimise the risk of OHSS or of multiple pregnancy, ultrasound scans as well as oestradiol measurements are recommended.
Za zmanjšanje tveganja OHSS ali večplodne nosečnosti priporočamo tako ultrazvočne preglede kakor tudi merjenje estradiola.
In anovulation the risk of OHSS is increased by a serum oestradiol level > 900 pg/ ml (3300 pmol/ l) and by the presence of more than 3 follicles of 14 mm or more in diameter.
Pri stanju brez ovulacije (anovulaciji) je tveganje za OHSS povečano pri serumski ravni estradiola > 900 pg/ ml (3300 pmol/ l) in prisotnosti več kot 3 foliklov s premerom 14 mm ali več.
Adherence to recommended Luveris and FSH dosage and regimen of administration and careful monitoring of therapy will minimise the incidence of ovarian hyperstimulation and multiple pregnancy.
Strogo upoštevanje predpisanega odmerjanja Luverisa in FSH- ja ter režima dajanja in skrbno nadzorovanje zdravljenja zmanjša pogostnost hiperstimulacije jajčnikov in večplodne nosečnosti.
In clinical trials, the medicinal product has been shown to increase the ovarian sensitivity to follitropin
Če se
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.
3 izkaže kot primerno povečanje odmerka FSH- ja, moramo prilagoditev odmerka izvesti po možnosti v 7- 14 dnevnih intervalih s povečanji po 37, 5 do 75 i. e.
In clinical trials, there have been no reports of hypersensitivity to lutropin alfa.
V kliničnih preskušanjih niso poročali o preobčutljivosti za lutropin alfa.
No direct comparison of Luveris/ FSH versus human menopausal gonadotrophin (hMG) has been performed.
Direktne primerjave med učinki Luverisa/ FSH in humanega menopavznega gonadotropina (hMG) niso izvedli.
Comparison with historical data suggests that the ovulation rate obtained with Luveris/ FSH is similar to what can be obtained with hMG.
Primerjava historičnih podatkov pa nakazuje, da je delež ovulacij, doseženih z Luverisom/ FSH, podoben tistemu, ki ga lahko dosežemo s hMG- jem.
Luveris should not be administered as a mixture with other medicinal products, in the same injection, except follitropin alfa for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Luverisa ne smemo dajati kot mešanico z drugimi zdravili v isti injekcijski brizgi, razen s folitropinom alfa, za katerega so študije pokazale, da njegovo sočasno dajanje pomembno ne spremeni učinka, stabilnosti, farmakokinetičnih ali farmakodinamičnih lastnosti zdravilnih učinkovin.
Luveris should not be administered during pregnancy or lactation.
Luverisa v nosečnosti ali obdobju dojenja ne smemo uporabljati.
Luveris has no influence on the ability to drive and use machines.
Luveris nima vpliva na sposobnost vožnje ali upravljanja s stroji.
a) General description
a) Splošen opis
Lutropin alfa is used for the stimulation of follicular development in association with follitropin alfa.
Lutropin alfa se uporablja za spodbujanje folikularnega razvoja skupaj s folitropinom alfa.
In this context, it is difficult to attribute undesirable effects to any one of the substances used.
V tem kontekstu je neželene učinke težko pripisati katerikoli od obeh uporabljenih spojin.
There is considerable post-marketing safety experience with human luteinising hormone (hLH)- containing medicinal products of urinary origin.
Obstajajo precejšnje post- marketinške izkušnje glede varnosti uporabe zdravil s humanim luteinizirajočim hormonom (hLH) urinskega izvora.
The safety profile of Luveris is expected to be very similar to that of urine derived hLH, with the exception of hypersensitivity reactions and application site disorders.
Pričakovati je, da je varnostni profil Luverisa zelo podoben kot pri hLH urinskega izvora, z izjemo preobčutljivostnih reakcij in motenj na mestu aplikacije.
In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4% and 0.9% of the injections, respectively.
V kliničnih preskušanjih so poročali o blagih in zmernih reakcijah na mestu injiciranja v 7, 4% oziroma 0, 9% injekcij (modrica, bolečina, rdečica, srbenje ali oteklina).
To date no systemic allergic reactions have been reported following Luveris administration.
Do sedaj ni poročil o sistemskih alergijskih reakcijah po uporabi Luverisa.
Ovarian hyperstimulation syndrome was observed in less than 6% of patients treated with Luveris.
Sindrom hiperstimulacije jajčnikov so opazili pri manj kot 6% bolnic, ki so se zdravile z Luverisom.
No severe ovarian hyperstimulation syndrome was reported (section 4.4).
Ni poročil o hudem sindromu hiperstimulacije jajčnikov (poglavje 4. 4).
In rare instances, thromboembolisms, adnexal torsion (a complication of ovarian enlargement), and haemoperitoneum have been associated with human menopausal gonadotrophin therapy.
V redkih primerih so povezovali zdravljenje s humanim menopavznim gonadotropinom s tromboembolizmom, torzijo adneksov (komplikacija pri povečanju jajčnika) in hematoperitonejem.
Although these adverse events were not observed, there is the possibility that they may also occur with Luveris.
Čeprav teh neželenih dogodkov niso opazili, obstaja možnost, da se pojavijo pri uporabi Luverisa.
b) Undesirable effects
b) Neželeni učinki
The following convention was used for the frequency (events/ no. of patients): very rare :< 1/10,000, rare :> 1/ 10,000 ,< 1/1 ,000, uncommon: > 1/ 1,000 ,< 1/100, common: > 1/ 100 ,< 1/10, very common: > 1/ 10
Pogostnost (dogodki/ št. bolnic) je opredeljena po naslednjem dogovoru: zelo redki: < 1/ 10. 000, redki: > 1/ 10. 000, < 1/ 1. 000, občasni: > 1/ 1. 000, < 1/ 100, pogosti: > 1/ 100, < 1/ 10, zelo pogosti: > 1/ 10
After best evidence assessment, the following undesirable effects may be observed after administration of Luveris.
Po strokovni oceni zbranih podatkov se po dajanju Luverisa lahko pojavijo naslednji neželeni učinki.
4 Common Gastro-intestinal disorders: nausea, abdominal pain, pelvic pain Reproductive system and breast disorders: ovarian hyperstimulation syndrome, ovarian cyst, breast pain General disorders and administration site conditions: headache, somnolence, injection site reaction
Splošne težave in spremembe na mestu aplikacije: glavobol, zaspanost, reakcija na mestu vboda.
The reported undesirable effects are in agreement with those reported for other hLH-containing medicinal products, except for injection site reactions where the incidence was significantly lower with Luveris treatment.
Našteti neželeni učinki so v skladu s tistimi, o katerih so poročali v zvezi z drugimi zdravili, ki vsebujejo hLH, razen reakcij na mestu injiciranja, katerih pogostnost je pri zdravljenju z Luverisom pomembno manjša.
The effects of an overdose of lutropin alfa are unknown, nevertheless there is a possibility that ovarian hyperstimulation syndrome may occur, which is further described in section 4.4.
Učinki prevelikega odmerka lutropina alfa niso poznani, vseeno pa je možen pojav sindroma ovarijske hiperstimulacije, kar je podrobno opisano v poglavju 4. 4.
Single doses of up to 40,000 IU of lutropin alfa have been administered to healthy female volunteers without serious adverse events and were well tolerated.
Zdrave prostovoljke, ki so prejele enkratni odmerek do 40. 000 i. e. lutropina alfa, so zdravilo prenašale dobro in brez resnih neželenih dogodkov.
ATC code:
Farmakoterapevtska skupina: gonadotropni hormoni in drugi spodbujevalci ovulacije, oznaka ATC:
Lutropin alfa is a recombinant human luteinising hormone, a glycoprotein composed of non- covalently bound α - and β -subunits.
Lutropin alfa je rekombinantni humani luteinizirajoči hormon, glikoprotein sestavljen iz dveh nekovalentno povezanih α - in β- podenot.
Luteinising hormone binds on the ovarian theca (and granulosa) cells and testicular Leydig cells, to a receptor shared with human chorionic gonadotrophin hormone (hCG).
Luteinizirajoči hormon se veže na ovarijske teka (in granuloza) celice in na Leydigove celice testisov, na receptor, ki je skupen humanemu horionskemu gonadotropinskemu hormonu (hCG).
This LH/ CG transmembrane receptor is a member of the super-family of G protein-coupled receptors; specifically, it has a large extra-cellular domain.
Ta LH/ CG transmembranski receptor sodi v super- družino receptorjev z G proteini, za katere je značilen velik ekstracelularni del.
In vitro the affinity binding of recombinant hLH to the LH/ CG receptor on Leydig tumour cells (MA-10) is between that for hCG and that of pituitary hLH, but within the same order of magnitude.
In vitro je afiniteta vezave rekombinantenga hLH na LH/ CG receptor na Leydigovih tumorskih celicah (MA- 10) med afiniteto hCG- ja in hipofiznega hLH, vendar v istem redu velikosti.
In the ovaries, during the follicular phase, LH stimulates theca cells to secrete androgens, which will be used as the substrate by granulosa cell aromatase enzyme to produce oestradiol, supporting FSH-induced follicular development.
Med folikularno fazo LH v jajčnikih spodbuja celice teka, da izločajo androgene, ki so substrat encimu aromatazi celic granuloza za tvorbo estradiola, ki podpira z FSH- jem sprožen razvoj foliklov.
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.
Primarni učinek dajanja lutropina alfa za spodbujanju folikularnega razvoja pri ženskah brez ovulacije s pomankanjem LH in FSH, je povečano izločanje estradiola iz foliklov, katerih rast spodbuja FSH.
In clinical trials, patients were defined by an endogenous serum LH level < 1.2 IU/ l as measured in a central laboratory.
V kliničnih preskušanjih so bile bolnice opredeljene na podlagi serumske ravni endogenega LH < 1, 2 i. e. / l, izmerjene v centralnem laboratoriju.
In these trials the ovulation rate per cycle was 70-75%.
V teh preskušanjih je bila stopnja ovulacije na ciklus 70 – 75%.
The combination of r-hLH and r-hFSH has not been directly compared with treatment with hMG.
Zdravljenja s kombinacijo r- hLH in r - hFSH niso direktno primerjali z zdravljenjem s hMG.
The pharmacokinetics of lutropin alfa have been studied in pituitary desensitised female volunteers from 75 IU up to 40,000 IU.
Farmakokinetične lastnosti lutropina alfa so proučevali na hipofizno desenzitiziranih prostovoljkah v odmerku od 75 i. e. do 40. 000 i. e.
The pharmacokinetic profile of lutropin alfa is similar to that of urinary-derived hLH.
Farmakokinetični profil lutropina alfa je podoben profilu hLH urinskega izvora.
Following
Lutropin alfa kaže linearne farmakokinetične lastnosti, kot so ocenili z
5 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.
5 AUC, ki je direktno sorazmerna danemu odmerku.
Total clearance is around 2 l/ h, and less than 5% of the dose is excreted in the urine.
Celokupni očistek je približno 2 l/ h in manj kot 5% odmerka se izloči z urinom.
Following subcutaneous administration, the absolute bioavailability is approximately 60%; the terminal half-life is slightly prolonged.
Po subkutani aplikaciji je absolutna biološka uporabnost okoli 60%; končni razpolovni čas je rahlo podaljšan.
The lutropin alfa pharmacokinetics following single and repeated administration of Luveris are comparable and the accumulation ratio of lutropin alfa is minimal.
Farmakokinetika lutropina po enkratnem in večkratnem dajanju Luverisa je primerljiva, stopnja akulmulacije lutropina alfa pa je minimalna.
Non clinical data reveal no special harzard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
At doses of 10 IU/ kg/ day and greater, repeated administration of lutropin alfa to pregnant rats and rabbits caused impairment of reproductive function including resorption of foetuses and reduced body weight gain of the dams.
Pri odmerkih 10 i. e. / kg/ dan in več je ponovno dajanje lutropina alfa brejim podganam in zajkljam povzročilo okvare reproduktivne funkcije, vključno z resorbcijo fetusov in zmanjšanjem pridobivanja telesne mase samic.
6.1 List of excipients
Seznam pomožnih snovi
Sucrose Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Polysorbate 20 Phosphoric acid, concentrated Sodium hydroxide Methionine Nitrogen
saharoza natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat monohidrat polisorbat 20 fosforjeva( V) kislina, koncentrirana natrijev hidroksid metionin dušik
Water for injection
vehikel: voda za injekcije
6 6.5 Nature and contents of container
6 6. 5 Vrsta ovojnine in vsebina
The vials are sealed with bromobutyl stoppers protected by aluminium seal rings and flip-off caps.
Viale so zaprte z bromobutilnimi zaporkami, ki so zaščitene z aluminijastimi zapornimi obročki s pregibnimi kapicami.
The solvent is packaged either in 2 or 3 ml neutral colourless glass (type I) vials with a Teflon-coated rubber stopper or in 2 ml neutral colourless glass (type I) ampoules.
Vehikel je pakiran bodisi v 2 ml ali 3 ml viale iz nevtralnega brezbarvnega stekla (tip I), z gumijastimi zaporkami, prevlečenimi s teflonom ali v 2 ml ampule iz nevtralnega brezbarvnega stekla (tip I).
The product is supplied in packs of 1, 3 or 10 vials with the corresponding number of solvent vials or ampoules.
Zdravilo je na voljo v pakiranjih 1, 3 ali 10 vial s praškom in enakim število vial z vehiklom ali ampul z vehiklom.
Luveris may be mixed with follitropin alfa and co-administered as a single injection.
Luveris lahko mešamo s folitropinom alfa in dajemo sočasno kot eno samo injekcijo.
In this case Luveris should be reconstituted first and then used to reconstitute the follitropin alfa powder.
V takem primeru moramo najprej rekonstituirati Luveris in ga nato uporabimo za rekonstitucijo praška folitropina alfa.