natgillin/translations-raw huggingface dataset:
Posology Orgalutran is used to prevent premature LH surges in patients undergoing COH.
Odmerjanje Orgalutran se uporablja za preprečevanje prezgodnjih vrhov sproščanja LH pri bolnicah, ki prejemajo nadzorovano hiperstimulacijo jajčnikov (COH).
Controlled ovarian hyperstimulation with FSH may start at day 2 or 3 of menses.
Nadzorovana hiperstimulacija jajčnikov z FSH se lahko začne na 2. ali 3. dan menstruacije.
Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 6 of FSH administration.
Zdravilo Orgalutran (0, 25 mg) injicirajte subkutano enkrat na dan, z začetkom na 6. dan jemanja FSH.
The start of Orgalutran may be delayed in absence of follicular growth, although clinical experience is based on starting Orgalutran on day 6 of FSH.
Začetek zdravljenja z zdravilom Orgalutran lahko zakasnite, če ni rasti folikla, vendar klinične izkušnje temeljijo na začetku jemanja zdravila Orgalutran na 6. dan jemanja FSH.
However, the preparations should not be mixed and different injection sites are to be used.
Zdravilo Orgalutran in FSH morata biti aplicirana približno ob istem času, vendar zdravil ne smete mešati v isti brizgi in morate uporabiti različni injekcijski mesti.
FSH dose adjustments should be based on the number and size of growing follicles, rather than on the amount of circulating oestradiol (see section 5.1).
Odmerek FSH raje prilagodite glede na število in velikost rastočih foliklov kot glede na količino estradiola v krvi (glejte poglavje 5. 1.).
Daily treatment with Orgalutran should be continued up to the day that sufficient follicles of adequate size are present.
Dnevno odmerjanje zdravila Orgalutran nadaljujte toliko časa, da se pojavi zadostno število foliklov primerne velikosti.
Final maturation of follicles can be induced by administering human chorionic gonadotrophin (hCG).
Končno zorenje foliklov lahko sprožite z dodajanjem humanega horionskega gonadotropina (hCG).
Because of the half- life of ganirelix, the time between two Orgalutran injections as well as the time between the last Orgalutran injection and the hCG injection should not exceed 30 hrs, as otherwise a premature LH surge may occur.
Zaradi razpolovnega časa ganireliksa časovni razmik med dvema injekcijama zdravila Orgalutran ter časovni razmik med zadnjo injekcijo zdravila Orgalutran ter injekcijo hCG ne sme presegati 30 ur, ker lahko v nasprotnem primeru nastopi prezgodnji vrh sproščanja LH.
Therefore, when injecting Orgalutran in the morning, treatment with Orgalutran should be continued throughout the gonadotrophin treatment period including the day of triggering ovulation.
Če torej injicirate zdravilo Orgalutran zjutraj, nadaljujte z zdravljenjem z njim ves čas zdravljenja z gonadotropinom, vključno z
Orgalutran has shown to be safe and effective in patients undergoing multiple treatment cycles.
Zdravilo Orgalutran se je izkazal za varno in učinkovito zdravilo pri bolnicah zdravljenih z večimi ciklusi zdravljenj.
2 The need for luteal phase support in cycles using Orgalutran has not been studied.
Potrebe po podpori lutealne faze v ciklusu z uporabo zdravila Orgalutran niso raziskovali.
In clinical trials, luteal phase support was given according to study centres’ practice.
V kliničnih preskušanjih so dajali podporo lutealne faze glede na prakso raziskovalnega centra.
Subjects with renal or hepatic impairment:
Bolnice z ledvično ali jetrno okvaro:
Therefore, specific dose recommendations cannot be given (see section 4.3).
Ni izkušenj z uporabo zdravila Orgalutran pri bolnicah z ledvično ali jetrno okvaro, zato ne moremo podati specifičnih priporočil za njegovo odmerjanje (glejte poglavje 4. 3).
Method of administration Orgalutran should be administered subcutaneously, preferably in the upper leg.
Način uporabe Zdravilo Orgalutran injicirajte subkutano, najbolje v stegno.
The patient or her partner may perform the injections of Orgalutran themselves, provided that they are adequately instructed and have access to expert advice.
Bolnica ali njen partner lahko tudi sama injicirata zdravilo Orgalutran, pod pogojem da sta bila ustrezno poučena o tem in se imata možnost posvetovati s strokovnjakom.
− Hypersensitivity to the active substance or to any of the excipients. − Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue − Moderate or severe impairment of renal or hepatic function − Pregnancy or lactation.
− Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov. − Preobčutljivost za gonadotropin sproščujoč hormon (GnRH) ali kateri drug analog GnRH. − Zmerna ali huda okvara delovanja ledvic ali jeter.
In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.
Zaradi pomanjkanja kliničnih izkušenj uporabe, zdravila Orgalutran ne priporočamo ženskam s hudimi alergijami.
Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation.
Med stimulacijo jajčnikov ali po njej se lahko pojavi sindrom hiperstimulacije jajčnikov (OHSS).
OHSS must be considered an intrinsic risk of gonadotrophin stimulation.
OHSS morate šteti za pričakovano tveganje pri stimulaciji z gonadotropini.
OHSS should be treated symptomatically, e. g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
OHSS zdravite simptomatsko, to je s počitkom, intravensko infuzijo elektrolitov ali s koloidi in heparinom.
Early ultrasound confirmation that a pregnancy is intrauterine is therefore important.
Ker imajo neplodne ženske v postopku oploditve z biomedicinsko pomočjo, posebno pri IVF, pogosto prizadete jajcevode, je pri njih povečana pogostost zunajmaternične nosečnosti, zato je zgodnja ultrazvočna preiskava, ki potrjuje maternično nosečnost, zelo pomembna.
The incidence of congenital malformations after Assisted Reproductive Technologies (ART) may be higher than after spontaneous conceptions.
Pri postopkih oploditve z biomedicinsko pomočjo (ART) je lahko incidenca prirojenih deformacij večja kot po spontani zanositvi.
This is thought to be due to differences in parental characteristics (e. g. maternal age, sperm characteristics) and an increased incidence of multiple gestations.
Menijo, da je to posledica razlik v lastnostih staršev (npr. starost matere, značilnosti spermijev) in povečane incidence večkratnih nosečnosti.
In clinical trials investigating more than 1000 newborns it has been demonstrated that the incidence of congenital malformations in children born after COH treatment using Orgalutran is comparable with that reported after COH treatment using a GnRH agonist.
Klinična preskušanja, v katerih so preiskovali več kot 1. 000 novorojenčkov so pokazala, da je pogostost kongenitalnih malformacij pri otrocih, ki so bili rojeni po zdravljenju s COH z uporabo zdravila Orgalutran primerljiva s tistimi, ki so jih poročali po zdravljenju s COH z uporabo GnRH agonistov.
The safety and efficacy of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg (see also section 5.1 and 5.2).
Varnost in učinkovitost zdravila Orgalutran nista bili ugotovljeni pri ženskah s telesno maso manjšo od 50 kg ali večjo od 90 kg (glejte tudi poglavji 5. 1 in 5. 2).
The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.
Zato ne moremo izključiti možnosti za pojav interakcij s pogosto uporabljenimi zdravili, vključno s tistimi, ki sproščajo histamin.
There are no adequate data from the use of ganirelix in pregnant women.
4. 6 Nosečnost in dojenje 3 Ni zadostnih podatkov o uporabi ganireliksa pri nosečnicah.
In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3).
Pri živalih so ugotovili, da je izpostavljenost ganireliksu v času implantacije povzročila resorpcijo zarodkov (glejte poglavje 5. 3).
3 It is not known whether ganirelix is excreted in breast milk.
Ni znano, ali se ganireliks izloča v materino mleko.
The use of Orgalutran is contraindicated during pregnancy and lactation (see section 4.3).
Uporaba zdravila Orgalutran je kontraindicirana v času nosečnosti in dojenja (glejte poglavje 4. 3).
General disorders and administration site conditions Orgalutran may cause a local skin reaction at the site of injection (predominantly redness, with or without swelling).
Splošne težave in spremembe na mestu aplikacije Zdravilo Orgalutran lahko povzroči lokalno kožno reakcijo na mestu injiciranja (predvsem pordelost z oteklino ali brez nje).
In clinical studies, one hour after injection, the incidence of at least once a moderate or severe local skin reaction per treatment cycle, as reported by patients, was 12% in Orgalutran treated patients and 25% in patients treated subcutaneously with a GnRH agonist.
V kliničnih študijah je bila eno uro po injiciranju incidenca najmanj ene zmerne ali hude lokalne kožne reakcije na ciklus zdravljenja z zdravilom Orgalutran po poročanju bolnikov 12%, po subkutanem injiciranju agonista GnRH pa 25%.
The local reactions generally disappear within 4 hours after administration.
Lokalne reakcije običajno izginejo v 4 urah po injiciranju zdravila.
Malaise was reported in 0.3% of patients.
O občutku bolehnosti so poročali pri 0, 3% bolnikov.
Immune system disorders Very rarely cases of hypersensitivity reactions including various symptoms such as rash, facial swelling and dyspnoea have been reported among patients administered Orgalutran with FSH.
Bolezni imunskega sistema Zelo redko so pri bolnikih, ki so prejemali zdravilo Orgalutran z FSH, poročali o primerih preobčutljivostnih reakcij, vključno z različnimi simptomi, kot so izpuščaj, otekanje obraza in dispneja.
Worsening of a pre-existing eczema has been reported in one subject after the first Orgalutran dose.
Pri enem bolniku so poročali o poslabšanju že obstoječega ekcema po prvem odmerku zdravila Orgalutran.
Nervous system disorders Headache (0.4%).
Bolezni živčevja Glavobol (0, 4%).
Gastrointestinal disorders Nausea (0.5%).
Bolezni prebavil Slabost (0, 5%).
Other reported undesirable effects are related to the controlled ovarian hyperstimulation treatment for ART, notably pelvic pain, abdominal distension, OHSS (see also section 4.4), ectopic pregnancy and spontaneous abortion.
Drugi prijavljeni neželeni učinki so povezani z nadzorovano hiperstimulacijo jajčnikov pri postopku oploditve z biomedicinsko pomočjo, na primer: predvsem bolečine v medenici, napihnjenost trebuha, OHSS (glejte tudi poglavje 4. 4), ektopična nosečnost in spontani splav.
In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
V primeru prevelikega odmerka zdravljenje z zdravilom Orgalutran (začasno) prekinite.
Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic undesirable effects.
Klinične študije z zdravilom Orgalutran pri enkratnem subkutanem odmerku do 12 mg niso pokazale sistemskih neželenih učinkov.
In acute toxicity studies in rats and monkeys non-specific toxic symptoms such as hypotension and bradycardia were only observed after intravenous administration of ganirelix over 1 and 3 mg/ kg, respectively.
V študijah akutne toksičnosti pri podganah in opicah so opazili nespecifične toksične simptome, npr. hipotenzijo in bradikardijo samo po intravenskem dajanju ganireliksa v odmerku nad 1 mg oziroma 3 mg/ kg.
Pharmacotherapeutic group: anti-gonadotrophin-releasing hormones, ATC code:
Farmakoterapevtska skupina: antagonisti gonadotropin sproščajočih hormonov, oznaka ATC:
Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland.
4 Zdravilo Orgalutran je antagonist GnRH, ki vpliva na hipotalamohipofizno - gonadno os s kompetitivno vezavo na receptorje GnRH v hipofizi.
Following administration of multiple doses of 0.25 mg Orgalutran to female volunteers serum LH, FSH and E2 concentrations were maximally decreased by 74%, 32% and 25% at 4, 16 and 16 hours after injection, respectively.
Po večkratnih 0, 25 mg odmerkih zdravila Orgalutran prostovoljkam so se serumske koncentracije LH, FSH in E2 zmanjšale za največ 74%, 32% in 25% v 4, 16 in 16 urah po injiciranju.
4 In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 5 days.
Pri bolnicah, ki so bile vključene v postopek nadzorovane stimulacije jajčnikov, je bila mediana vrednost dolžine zdravljenja z zdravilom Orgalutran 5 dni.
During Orgalutran treatment the average incidence of LH rises (> 10 IU/ l) with concomitant progesteron rise (> 1 ng/ ml) was 1.2% compared to 0.8% during GnRH agonist treatment.
Med zdravljenjem z zdravilom Orgalutran je bila povprečna incidenca zvišanja vrednosti LH (> 10 i. e. / l) s sočasnim zvišanjem vrednosti progesterona (> 1 ng/ ml) 1, 2% v primerjavi z 0, 8% med zdravljenjem z agonistom GnRH.
There was a tendency towards an increased incidence of LH and progesterone rises in women with a higher body weight (> 80 kg), but no effect on clinical outcome was observed.
Ženske z večjo telesno maso (> 80 kg) so bile nagnjene k večji incidenci zvišanja vrednosti LH in progesterona, vendar niso opažali nobenega učinka na klinični izid.
However, based on the small number of patients treated so far, an effect can not be excluded.
Kljub temu pa na podlagi majhnega števila doslej zdravljenih bolnic ne moremo izključiti določenega vpliva telesne mase.
Early LH rises, prior to the start of Orgalutran at day 6 of stimulation, did occur especially in high responders, but did not affect the clinical outcome.
Zgodnji porast LH, t. j. pred začetkom zdravljenja z zdravilom Orgalutran na 6. dan stimulacije, se je pojavil še posebej pri bolnicah, ki se močno odzivajo na zdravilo, vendar ni vplival na klinični izid zdravljenja.
In these patients LH production was rapidly suppressed after the first Orgalutran administration.
Pri teh bolnicah je bilo po prvem odmerku zdravila Orgalutran nastajanje LH hitro zavrto.
In controlled studies of Orgalutran, using a long protocol of GnRH agonist as a reference, treatment with the Orgalutran regimen resulted in a faster follicular growth during the first days of stimulation but the final cohort of growing follicles was slightly smaller and produced on average less oestradiol.
V kontroliranih študijah z zdravilom Orgalutran z uporabo dolgega protokola agonista GnRH kot referenčnega zdravila je zdravljenje z zdravilom Orgalutran povzročilo hitrejšo rast foliklov v prvih dneh stimulacije, vendar pa je bilo končno skupno število rastočih foliklov nekoliko manjše, s povprečno manjšo količino estradiola.
This different pattern of follicular growth, requires that FSH dose adjustments are based on the number and size of growing follicles, rather than on the amount of circulating oestradiol.
Zaradi različnega načina rasti foliklov morate odmerek FSH prilagoditi raje glede na število in velikost rastočih foliklov kot glede na količino estradiola v krvi.
After a single subcutaneous administration of 0.25 mg, serum levels of ganirelix rise rapidly and reach peak levels (Cmax) of approximately 15 ng/ ml within 1 to 2 hours (tmax).
Po enkratnem subkutanem odmerku 0, 25 mg, serumske koncentracije ganireliksa hitro naraščajo in dosežejo maksimalno koncentracijo (Cmax) približno 15 ng/ ml v 1 do 2 urah (tmax).
The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 l/ h.
Razpolovni čas izločanja (t1/ 2) je približno 13 ur in očistek približno 2, 4 l/ h.
Excretion occurs via faeces (approximately 75%) and urine (approximately 22%).
Zdravilo se izloča z blatom (približno 75%) in sečem (približno 22%).
The bioavailability of Orgalutran following subcutaneous administration is approximately 91%.
Biološka uporabnost zdravila Orgalutran po subkutanem dajanju je približno 91%.
Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) were similar to those after a single subcutaneous dose.
Farmakokinetični parametri po večkratnih subkutanih odmerkih zdravila Orgalutran (injiciranje enkrat dnevno) so podobni parametrom po enkratnem subkutanem odmerku.
After repeated dosing 0.25 mg/ day steady-state levels of approximately 0.6 ng/ ml were reached within 2 to 3 days.
Po večkratnem odmerjanju 0, 25 mg na dan dosežejo v 2 do 3 dneh vrednosti stanja dinamičnega ravnovesja približno 0, 6 ng/ ml.
Pharmacokinetic analysis indicates an inverse relationship between bodyweight and serum concentrations of Orgalutran.
Analiza farmakokinetike kaže na obratno sorazmerje med telesno maso in serumskimi koncentracijami zdravila Orgalutran.
Metabolite profile:
Profil presnovkov:
Ganirelix is also the main compound found in urine.
Ganireliks je tudi glavna spojina, ki se pojavi v seču.
The metabolites are small peptide fragments formed by enzymatic hydrolysis of ganirelix at restricted sites.
Presnovki so majhni peptidni fragmenti, ki nastanejo pri encimski hidrolizi ganireliksa na omejenih območjih.
Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity and genotoxicity.
Predklinični podatki na osnovi študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo nobene posebne nevarnosti za človeka.
Reproduction studies carried out with ganirelix at doses of 0.1 to 10 μ g/ kg/ day subcutaneously in the rat and 0.1 to 50 μ g/ kg/ day subcutaneously in the rabbit showed increased litter resorption in the highest dose groups.
Študije vpliva na sposobnost razmnoževanja, opravljene s subkutanimi odmerki ganireliksa od 0, 1 do 10 μg/ kg/ dan pri podganah in z odmerki od 0, 1 do 50 μg/ kg/ dan pri kuncih so pokazale povečano resorpcijo zarodkov pri skupinah, ki so prejemale največje odmerke.
The pH may have been adjusted with sodium hydroxide and acetic acid.
Ocetna kislina; manitol; voda za injekcije. pH je lahko uravnan z natrijevim hidroksidom in ocetno kislino.
5 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
Disposable pre-filled syringes (siliconised Type I glass), containing 0.5 ml of sterile, ready for use, aqueous solution closed with a rubber piston.
Napolnjene injekcijske brizge za enkratno uporabo (silikonizirano steklo tipa I) vsebujejo po 0, 5 ml sterilne vodne raztopine, pripravljene za uporabo, in so zaprte z gumijastim batom.
Each pre-filled syringe is affixed with a needle closed by a needle shield of natural rubber.
Vsaka napolnjena injekcijska brizga ima pritrjeno iglo, pokrito z varnostnim pokrovčkom iz naravne gume.
Supplied in cartons containing 1 or 5 pre-filled syringes.
Pakirano v škatlice z 1 ali 5 napolnjenimi injekcijskimi brizgami.
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nizozemska
EU/ 1/ 00/ 130/ 001, 1 pre-filled syringe EU/ 1/ 00/ 130/ 002, 5 pre-filled syringes
EU/ 1/ 00/ 130/ 001 1 napolnjena injekcijska brizga EU/ 1/ 00/ 130/ 002 5 napolnjenih injekcijskih brizg
17 May 2000 Date of last renewal:
17 maja 2000 Datum zadnjega podaljšanja dovoljenja za promet:
17 May 2005
17 maja 2005
6 ANNEX II
6 7 DODATEK II
Dublin, Ireland.
Dublin, Irska.
Organon, Kloosterstraat 6 Postbus 20 5340 BH Oss, The Netherlands.
Organon, Kloosterstraat 6 Postbus 20, 5340 BH Oss, Nizozemska.
Medicinal product subject to restricted medical prescription (See annex I:
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I:
9 A.
9 DODATEK III
10 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
OZNAČEVANJE
OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes
BESEDILO NA ZUNANJI OVOJNINI zdravila Orgalutran 1 / 5 napolnjenih injekcijskih brizg
Orgalutran 0.25 mg/ 0.5 ml solution for injection Ganirelix
Orgalutran 0, 25 mg/ 0, 5 ml raztopina za injiciranje ganireliks
1 pre-filled syringe contains 0.25 mg ganirelix in 0.5 ml aqueous solution
1 napolnjena injekcijska brizga vsebuje 0, 25 mg ganireliksa v 0, 5 ml vodne raztopine.
Other ingredients: acetic acid and mannitol in water for injections, sodium hydroxide and/ or acetic acid as pH adjustment
Pomožne snovi: ocetna kislina in manitol v vodi za injekcije, natrijev hidroksid in/ ali ocetna kislina za uravnavanje pH.
Solution for injection, 1 pre-filled syringe containing 0.5 ml Solution for injection, 5 pre-filled syringes each containing 0.5 ml
Raztopina za injiciranje, 1 napolnjena injekcijska brizga z 0, 5 ml raztopine Raztopina za injiciranje, 5 napolnjenih injekcijskih brizg z 0, 5 ml raztopine
Subcutaneous use Read the package leaflet before use
Subkutana uporaba Pred uporabo preberite priloženo navodilo.
Do not freeze Store in the original package in order to protect from light
Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
EU/ 1/ 00/ 130/ 001 1 pre-filled syringe EU/ 1/ 00/ 130/ 002 5 pre-filled syringes
EU/ 1/ 00/ 130/ 001 1 napolnjena injekcijska brizga EU/ 1/ 00/ 130/ 002 5 napolnjenih injekcijskih brizg
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH VOJNINAH
PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/ 0.5 ml
BESEDILO NA NAPOLNJENIH INJEKCIJSKIH BRIZGAH zdravila Orgalutran 0, 25 mg/ 0, 5 ml
Orgalutran 0.25 mg/ 0.5 ml solution for injection Ganirelix Subcutaneous use
Orgalutran 0, 25 mg/ 0, 5 ml raztopina za injiciranje ganireliks Subkutana uporaba
What Orgalutran is and what it is used for 2.
Kaj je zdravilo Orgalutran in za kaj ga uporabljamo 2.
Before you use Orgalutran 3.
Kaj morate vedeti, preden boste uporabili zdravilo Orgalutran 3.
How to use Orgalutran 4.
Kako uporabljati zdravilo Orgalutran 4.
How to store Orgalutran 6.
Možni neželeni učinki 5 Shranjevanje zdravila Orgalutran 6.
WHAT ORGALUTRAN IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO ORGALUTRAN IN ZA KAJ GA UPORABLJAMO
Orgalutran contains ganirelix, which antagonises the actions of the natural gonadotrophin releasing hormone (GnRH).
Zdravilo Orgalutran vsebuje ganireliks, ki nasprotuje delovanju naravnega gonadotropin sproščujočega hormona (GnRH).
GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and FSH).
GnRH uravnava sproščanje gonadotropinov (luteinizirajočega hormona (LH) in FSH).
LH is needed to release the mature egg cells from the follicles and ovaries (i. e. ovulation).
LH je potreben za sprostitev dozorelih jajčnih celic iz foliklov in jajčnikov (npr. ovulacija).
In clinical trials Orgalutran was used with recombinant follicle stimulating hormone (FSH).
V kliničnih preskušanjih so zdravilo Orgalutran uporabljali z rekombinantnim folikle stimulirajočim hormonom (FSH).
BEFORE YOU USE ORGALUTRAN
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO ORGALUTRAN
Do not use Orgalutran, − if you are allergic (hypersensitive) to ganirelix or any of the other ingredients of Orgalutran; − if you are hypersensitive to gonadotrophin releasing hormone (GnRH) or a GnRH analogue; − if you have a moderate or severe kidney or liver disease; − if you are pregnant or breast-feeding.
Ne uporabljajte zdravila Orgalutran − če ste alergični na (preobčutljivi za) ganireliks ali katerokoli sestavino zdravila Orgalutran, − če ste preobčutljivi za gonadotropin sproščujoči hormon (GnRH) ali katerega od analogov GnRH, − če imate zmerno ali hudo ledvično ali jetrno bolezen, − če ste noseči ali dojite.
Take special care with Orgalutran, If you have an allergy.
Bodite posebno pozorni pri uporabi zdravila Orgalutran Če imate alergijo.
If you have an active allergic condition, please tell your doctor.
16 Če imate aktivno alergijo, obvestite svojega zdravnika.
He will decide, depending on the severity, if additional monitoring is required during treatment.
Glede na jakost alergije se bo odločil, ali bo med zdravljenjem potrebno dodatno spremljanje.
15 During or following hormonal stimulation of the ovaries ovarian hyperstimulation syndrome may develop; this syndrome is related to the stimulation procedure with gonadotrophins; please refer to the Package Leaflet of the gonadotrophin-containing medicine prescribed for you.
Preberite navodilo za uporabo za gonadotropin vsebujoče zdravilo, ki so vam ga predpisali.