natgillin/translations-raw huggingface dataset:
Udvalget for Humanmedicinske Lægemidler (CHMP) vurderede, at Orgaluran havde vist sig at være effektivt, og at tendensen hen imod lavere resultater sammenlignet med GnRH- agonister var tilfredsstillende.
The Committee for Medicinal products for Human Use (CHMP) considered that Orgaluran had shown its effectiveness, and that the tendency towards lower results compared with the GnRH agonists was acceptable.
Udvalget besluttede, at fordelene ved Orgalutran var større end dets risici ved forebyggelse af præmature stigninger i det luteiniserende hormon hos kvinder, der gennemgår en kontrolleret overstimulering af ovarier i forbindelse med behandling af ufrivillig barnløshed.
They decided that Orgalutran’ s benefits are greater than its risks for the prevention of premature luteinising hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Orgalutran.
They recommended that Orgalutran be given marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Orgalutran til N. V.
The European Commission granted a marketing authorisation valid throughout the European Union, for Orgalutran to N. V.
Organon den 17. maj 2000.
Organon on 17 May 2000.
Markedsføringstilladelsen blev fornyet den 17. maj 2005.
The marketing authorisation was renewed on 17 May 2005.
Den europæiske offentlige vurderingsrapport (EPAR) for Orgalutran kan ses i sin helhed her.
The full EPAR for Orgalutran is available here.
Emballage
Content (concentration)
Indhold( koncentration) Pakningsstørrelse
Package size
0, 25 mg/ 0, 5 ml
0.25 mg / 0.5 ml
0, 5 ml (0, 5 mg/ ml)
0,5 ml (0.5 mg/ ml)
Orgalutran 0, 25 mg/ 0, 5 ml injektionsvæske, opløsning.
Orgalutran 0.25 mg/ 0.5 ml solution for injection
Hver af de fyldte sprøjter indeholder 0, 25 mg ganirelix i 0, 5 ml vandig opløsning.
Each pre-filled syringe contains 0.25 mg of ganirelix in 0.5 ml aqueous solution.
Aminosyrerne i positionerne 1, 2, 3, 6, 8 og 10 i det naturlige GnRH decapeptid er erstattet og det endelige molekyle bliver N- Ac- D- Nal( 2) 1, D - pC1Phe2, D- Pal( 3) 3, D- hArg( Et2) 6, L- hArg( Et2) 8, D- Ala10] - GnRH med en molekylevægt på 1570, 4.
The amino acids at positions 1, 2, 3, 6, 8 and 10 of the natural GnRH decapeptide have been substituted resulting in N-Ac-D-Nal(2)1, D- -pClPhe2, D-Pal(3)3, D-hArg(Et2)6, L-hArg(Et2)8, D-Ala10]-GnRH with a molecular weight of 1570.4.
Forebyggelse af præmatur luteinisering hos kvinder i kontrolleret ovarie hyperstimulationsbehandling (COH) i forbindelse med assisteret reproduktionsteknik (ART).
The prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).
I kliniske studier blev Orgalutran anvendt sammen med rekombinant humant follikelstimulerende hormon (FSH).
In clinical trials Orgalutran was used with recombinant human follicle stimulating hormone (FSH).
Dosering Orgalutran anvendes til at forebygge præmature stigninger i luteiniserende hormon hos patienter i kontrolleret ovarie hyperstimulation behandling (COH).
Posology Orgalutran is used to prevent premature LH surges in patients undergoing COH.
Kontrolleret ovarie hyperstimulation med FSH kan starte på menstruationens 2. eller 3. dag.
Controlled ovarian hyperstimulation with FSH may start at day 2 or 3 of menses.
Orgalutran (0, 25 mg) injiceres subkutant én gang dagligt.
Orgalutran (0.25 mg) should be injected subcutaneously once daily, starting on day 6 of FSH administration.
Behandlingen med Orgalutran startes på den 6. stimulationsdag.
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.
Ved manglende follikelvækst kan start på Orgalutran udskydes selv om klinisk erfaring er baseret på start med Orgalutran på den 6. dag med FSH.
Orgalutran and FSH should be administered approximately at the same time.
5. 1).
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).
Tidsrummet mellem to Orgalutran- injektioner og mellem den sidste Orgalutran- injektion og hCG injektionen bør ikke overstige 30 timer på grund af ganirelix ’ halveringstid, idet der ellers kan forekomme præmatur luteinisering.
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.
Orgalutran har vist sig sikker og effektiv hos patienter som gennemgår flere behandlingscyklusser.
Orgalutran has shown to be safe and effective in patients undergoing multiple treatment cycles.
I kliniske
2 The need for luteal phase support in cycles using Orgalutran has not been studied.
2 studier blev støtte i lutealfasen givet i henhold til centrets praksis.
In clinical trials, luteal phase support was given according to study centres’ practice.
Patienter med svækket nyre - eller leverfunktion:
Subjects with renal or hepatic impairment:
Der er ingen erfaring med anvendelse af Orgalutran hos patienter med svækket nyre - eller leverfunktion.
There is no experience of the use of Orgalutran in subjects with renal or hepatic impairment.
4. 3).
Therefore, specific dose recommendations cannot be given (see section 4.3).
Administrationsmåde Orgalutran indgives subkutant, helst i låret.
Method of administration Orgalutran should be administered subcutaneously, preferably in the upper leg.
– Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne. – Overfølsomhed over for gonadotropinudskillende hormon (GnRH) eller en GnRH analog. – Moderat til svær nyre - eller leverlidelse. – Graviditet eller amning.
− 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.
Da klinisk erfaring savnes, kan Orgalutran- behandling ikke anbefales til kvinder med alvorlige allergiske tilstande.
In the absence of clinical experience, Orgalutran treatment is not advised in women with severe allergic conditions.
Ovarie hyperstimulationssyndrom (OHSS) forekomme under eller efter ovariestimulation.
Ovarian hyperstimulation syndrome (OHSS) may occur during or following ovarian stimulation.
OHSS må betragtes som en reel risiko ved gonadotropin stimulation.
OHSS must be considered an intrinsic risk of gonadotrophin stimulation.
OHSS skal behandles symptomatisk, dvs. med hvile, intravenøs infusion af elektrolytopløsninger eller kolloider og heparin.
OHSS should be treated symptomatically, e. g. with rest, intravenous infusion of electrolyte solutions or colloids and heparin.
Eftersom infertile kvinder, som er i assisteret reproduktionsbehandling og især i in vitro fertilisationsbehandling, ofte har abnormaliteter i æggelederne, kan forekomsten af ektopiske graviditeter være forøget.
Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased.
Dette skyldes formentlig forskellige forhold ved forældrene (fx moderens alder, spermiedefekter) og en forøget risiko for flerfoldsgraviditeter.
This is thought to be due to differences in parental characteristics (e. g. maternal age, sperm characteristics) and an increased incidence of multiple gestations.
Kliniske forsøg med mere end 1000 nyfødte har vist, at incidensen af medfødte misdannelser hos børn født efter COH - behandling med Orgalutran er sammenlignelig med det indrapporterede efter COH- behandling med en GnRH- agonist.
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.
5. 1 og 5. 2).
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).
Muligheden for interaktioner med almindeligt anvendte medicinalprodukter, herunder lægemidler der frigiver histamin kan ikke udelukkes.
The possibility of interactions with commonly used medicinal products, including histamine liberating products, cannot be excluded.
5. 3).
In animals, exposure to ganirelix at the time of implantation resulted in litter resorption (see section 5.3).
3 Det vides ikke om ganirelix udskilles i modermælk.
3 It is not known whether ganirelix is excreted in breast milk.
4. 3).
The use of Orgalutran is contraindicated during pregnancy and lactation (see section 4.3).
Almene symptomer og reaktioner på administrationsstedet Orgalutran kan forårsage en lokal hudreaktion på injektionsstedet (især rødmen med eller uden hævelse).
General disorders and administration site conditions Orgalutran may cause a local skin reaction at the site of injection (predominantly redness, with or without swelling).
I kliniske studier var forekomsten, som rapporteret af patienter, af moderat til svær hudreaktion en time efter injektion mindst én gang 12% hos patienter behandlet med Orgalutran og 25% hos patienter behandlet subkutant med en GnRH agonist.
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.
Lokale reaktioner forsvinder normalt inden for 4 timer efter indgift.
The local reactions generally disappear within 4 hours after administration.
Der er rapporter om utilpashed hos 0, 3% af patienterne.
Malaise was reported in 0.3% of patients.
Immunsystemet Forekomst af overfølsomhedsreaktioner med forskellige symptomer som rødme, opsvulmet ansigt og dyspnoe er i meget sjældne tilfælde rapporteret hos patienter, der er ordineret Orgalutran sammen med FSH.
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.
Forværring af allerede eksisterende eksem blev rapporteret hos én patient efter den første Orgalutran dosis.
Worsening of a pre-existing eczema has been reported in one subject after the first Orgalutran dose.
Nervesystemet Hovedpine (0, 4%).
Nervous system disorders Headache (0.4%).
Mave- tarmkanalen Kvalme (0, 5%).
Gastrointestinal disorders Nausea (0.5%).
4. 4), ekstrauterin graviditet og spontan abort.
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.
I tilfælde af overdosering skal Orgalutran behandlingen (midlertidigt) stoppes.
In case of overdose, Orgalutran treatment should be (temporarily) discontinued.
Kliniske studier med subkutan indgivelse af Orgalutran i doser på op til 12 mg viste ikke systemiske bivirkninger.
Clinical studies with subcutaneous administration of Orgalutran at single doses up to 12 mg did not show systemic undesirable effects.
I akutte toksicitetsstudier på rotter og aber blev non- specifikke toksiske symptomer som hypotension og bradykardi kun observeret efter i. v. indgift af ganirelix på over henholdsvis 1og 3 mg/ kg.
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.
Farmakoterapeutisk gruppe: antigonadotropin frigivende hormon; ATC kode:
Pharmacotherapeutic group: anti-gonadotrophin-releasing hormones, ATC code:
Orgalutran er en GnRH antagonist, som modulerer hypotalamus- hypofyse- gonadal aksen ved kompetitiv binding til GnRH receptorerne i hypofysen.
Orgalutran is a GnRH antagonist, which modulates the hypothalamic-pituitary-gonadal axis by competitive binding to the GnRH receptors in the pituitary gland.
74%, 32% og 25% 4, 16 og 16 timer efter indgift.
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.
Serum hormon niveauerne vendte tilbage til værdierne før behandlingen inden for to dage efter sidste injektion.
Serum hormone levels returned to pre-treatment values within two days after the last injection.
4 Hos patienter i kontrolleret ovariestimulationsbehandling var den gennemsnitlige varighed af Orgalutran behandlingen 5 dage.
4 In patients undergoing controlled ovarian stimulation the median duration of Orgalutran treatment was 5 days.
Under Orgalutran behandlingen var den gennemsnitlige forekomst af LH- stigning (> 10 IE/ I) med samtidig stigning i progesteron (> 1 mg/ ml) 1, 2% sammenlignet med 0, 8% under behandling med GnRH agonist.
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.
Der var en tendens til forhøjet LH og progesteronstigninger hos kvinder med en høj kropsvægt (> 80 kg), men der blev ikke observeret nogen indvirkning på det kliniske resultat.
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.
Imidlertid kan man ikke, ud fra det lille antal patienter, der indtil nu er behandlet, udelukke en sådan.
However, based on the small number of patients treated so far, an effect can not be excluded.
Tidlige LH- stigninger forud for påbegyndelse af Orgalutran på dag 6 med stimulation forekom især hos patienter der responderer kraftigt, men påvirkede ikke det kliniske resultat.
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.
Hos disse patienter blev LH produktionen hurtigt undertrykt efter den første Orgalutran indgift.
In these patients LH production was rapidly suppressed after the first Orgalutran administration.
I kontrollerede studier af Orgalutran hvor der er anvendt en lang protokol med GnRH agonist som reference, resulterede Orgalutran behandlingen i en hurtigere follikelvækst i de første dage af stimulationen, men den sidste kohorte af voksende follikler var mindre og producerede gennemsnitligt mindre østradiol.
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.
Dette ændrede mønster i follikelvæksten kræver at FSH dosisjusteringer baseres på antal og størrelse af voksende follikler fremfor på mængden af cirkulerende østradiol.
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.
Halveringstiden (t½) er på ca.
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).
Udskillelse sker via afføringen (ca.
The elimination half-life (t½) is approximately 13 hours and clearance is approximately 2.4 l/ h.
22%).
Excretion occurs via faeces (approximately 75%) and urine (approximately 22%).
91%.
The bioavailability of Orgalutran following subcutaneous administration is approximately 91%.
De farmakokinetiske parametre efter flere subkutane doser Orgalutran (en injektion dagligt) er sammenlignelige med de, som beregnes efter en enkelt subkutan dosis.
Pharmacokinetic parameters after multiple subcutaneous dosing of Orgalutran (once daily injection) were similar to those after a single subcutaneous dose.
0, 6 ng/ ml efter 2 til 3 dage.
After repeated dosing 0.25 mg/ day steady-state levels of approximately 0.6 ng/ ml were reached within 2 to 3 days.
Farmakokinetisk analyse påviser en negativ korrelation mellem kropsvægt og serumkoncentrationer af Orgalutran.
Pharmacokinetic analysis indicates an inverse relationship between bodyweight and serum concentrations of Orgalutran.
Metabolitprofil:
Metabolite profile:
Ganirelix var også hovedbestanddelen målt i urin, mens afføringen kun indeholder metabolitter.
Faeces only contain metabolites.
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
Preclinical data reveal no special hazard for humans based on safety pharmacology, repeated dose toxicity and genotoxicity.
Reproduktionsstudier udført med ganirelix i doser på 0, 1 til 10 μg/ kg/ dag subkutant på rotter og 0, 1 til 50 μg/ kg/ dag subkutant på kaniner afslørede en stigning i fosterresorption i de højeste dosisgrupper.
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.
Eddikesyre Mannitol Vand til injektionsvæsker. pH- værdien kan være blevet justeret med natriumhydroxid og eddikesyre.
The pH may have been adjusted with sodium hydroxide and acetic acid.
5 6. 2 Uforligeligheder
6.2 Incompatibilities
Da der ikke foreligger undersøgelser vedrørende eventuelle forligeligheder, bør dette præparat ikke blandes med andre præparater.
5 In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fyldte éngangssprøjter (opsiliceret Type I glas) indeholdende 0, 5 ml steril vandig opløsning, klar til brug, lukket med et gummistempel.
Disposable pre-filled syringes (siliconised Type I glass), containing 0.5 ml of sterile, ready for use, aqueous solution closed with a rubber piston.
Hver fyldt sprøjte er forsynet med en nål, som er lukket med en nålehætte af naturgummi.
Each pre-filled syringe is affixed with a needle closed by a needle shield of natural rubber.
Organon, Kloosterstraat 6, Postbox 20, 5340 BH Oss, Holland
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands
EU/ 1/ 00/ 130/ 001 1 fyldt injektionssprøjte EU/ 1/ 00/ 130/ 002 5 fyldte injektionssprøjter
EU/ 1/ 00/ 130/ 001, 1 pre-filled syringe EU/ 1/ 00/ 130/ 002, 5 pre-filled syringes
17. maj 2000 Dato for seneste fornyelse:
17 May 2000 Date of last renewal:
Dublin, Irland.
Dublin, Ireland.
Organon, Kloosterstraat 6 Postbus 20, 5340 BH Oss, Nederlandene.
Organon, Kloosterstraat 6 Postbus 20 5340 BH Oss, The Netherlands.
Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I:
Medicinal product subject to restricted medical prescription (See annex I:
UDVENDIG KARTON TEKST Orgalutran 1 / 5 fyldte injektionssprøjter
OUTER CARTON TEXT Orgalutran 1/ 5 pre-filled syringes
Orgalutran 0, 25 mg/ 0, 5 ml injektionsvæske, opløsning Ganirelix
Orgalutran 0.25 mg/ 0.5 ml solution for injection Ganirelix
1 fyldt injektionssprøjte indeholder 0, 25 mg ganirelix i 0, 5 ml vandig opløsning
1 pre-filled syringe contains 0.25 mg ganirelix in 0.5 ml aqueous solution
Andre indholdsstoffer: eddikesyre og mannitol i vand til injektionsvæsker, natriumhydroxid og / eller eddikesyre som pH justering
Other ingredients: acetic acid and mannitol in water for injections, sodium hydroxide and/ or acetic acid as pH adjustment
Injektionsvæske, opløsning, 1 fyldt injektionssprøjte indeholdende 0, 5 ml Injektionsvæske, opløsning, 5 fyldte injektionssprøjter indeholdende 0, 5 ml
Solution for injection, 1 pre-filled syringe containing 0.5 ml Solution for injection, 5 pre-filled syringes each containing 0.5 ml
Kun til éngangsbrug
For single use only.
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, Nederlandene
Organon, Kloosterstraat 6, Postbus 20, 5340 BH Oss, The Netherlands
EU/ 1/ 00/ 130/ 001 1 fyldt injektionssprøjte EU/ 1/ 00/ 130/ 002 5 fyldte injektionssprøjter
EU/ 1/ 00/ 130/ 001 1 pre-filled syringe EU/ 1/ 00/ 130/ 002 5 pre-filled syringes
12 MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
12 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
TEKST TIL FORFYLDTE SPRØJTER Orgalutran 0, 25 mg/ 0, 5 ml
PRE-FILLED SYRINGES TEXT Orgalutran 0.25 mg/ 0.5 ml
Orgalutran 0, 25 mg/ 0, 5 ml injektionsvæske, opløsning Ganirelix Subkutan anvendelse
Orgalutran 0.25 mg/ 0.5 ml solution for injection Ganirelix Subcutaneous use
14 INDLÆGSSEDDEL:
14 PACKAGE LEAFLET:
- Spørg lægen eller på apoteket, hvis der er mere, du vil vide.
- If you have further questions, ask your doctor or pharmacist.
- Lægen har ordineret Orgalutran til dig personligt.
- This medicine has been prescribed for you.
kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
their symptoms are the same as yours.
ikke nævnt her.
please tell your doctor or pharmacist.
Orgalutrans virkning og hvad du skal bruge det til 2.
What Orgalutran is and what it is used for 2.
Det skal du vide, før du begynder at bruge Orgalutran 3.
Before you use Orgalutran 3.
Sådan skal du bruge Orgalutran 4.
How to use Orgalutran 4.
Sådan opbevarer du Orgalutran 6.
How to store Orgalutran 6.
ORGALUTRANS VIRKNING OG HVAD DU SKAL BRUGE DET TIL
WHAT ORGALUTRAN IS AND WHAT IT IS USED FOR
Orgalutran indeholder ganirelix, der konkurrerer med og nedsætter virkningen af det naturlige gonadotropinudskillende hormon GnRH.
Orgalutran contains ganirelix, which antagonises the actions of the natural gonadotrophin releasing hormone (GnRH).
GnRH regulerer udskillelsen af gonadotropiner (luteiniserende hormon (LH) og FSH).
GnRH regulates the release of gonadotrophins (luteinising hormone (LH) and FSH).
LH bruges til frigivelse af modnede ægceller fra folliklerne og æggestokkene (ægløsning).
LH is needed to release the mature egg cells from the follicles and ovaries (i. e. ovulation).
Terapeutiske indikationer For kvinder i medicinsk assisteret reproduktionsbehandling inklusive in vitro fertilisation (IVF) kan der somme tider forekomme for tidlig ægløsning, hvilket forårsager en signifikant nedsættelse af chancen for at blive gravid.
In women undergoing assisted reproduction techniques, including in vitro fertilisation (IVF) and other methods, occasionally ovulation may occur too early causing a significant reduction in the chance of getting pregnant.
I kliniske studier blev Orgalutran anvendt sammen med rekombinant follikelstimulerende hormon (FSH).
In clinical trials Orgalutran was used with recombinant follicle stimulating hormone (FSH).
DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE ORGALUTRAN
BEFORE YOU USE ORGALUTRAN
Brug ikke Orgalutran: • hvis du er overfølsom (allergisk) over for ganirelix eller et af de øvrige indholdsstoffer i Orgalutran • hvis du er overfølsom over for gonadotropinudskillende hormon (GnRH) eller en GnRH analog • hvis du har en moderat til svær nyre - eller leverlidelse • hvis du er gravid eller ammer
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.
Hvis du lider af allergi.
Take special care with Orgalutran, If you have an allergy.
Hvis du har en aktiv allergisk tilstand, bør du fortælle det til din læge.
If you have an active allergic condition, please tell your doctor.
Afhængig af sværhedsgraden vil han beslutte, om du bør overvåges særlig omhyggeligt under behandlingen.
He will decide, depending on the severity, if additional monitoring is required during treatment.