0.25 mg \/ 0.5 ml solution for injection
ganirelix<\/p>\n\n\n\n
Orgalutran contains the active substance ganirelix and belongs to a group of medicines called ‘anti-gonadotropin-releasing hormones’ which counteract the effects of the natural gonadotropin-releasing\u00a0hormone\u00a0(\u00a0GnRH\u00a0).\u00a0GnRH\u00a0controls the\u00a0release\u00a0of one of the\u00a0gonadotropins\u00a0(luteinizing hormone (\u00a0LH\u00a0) and follicle-stimulating\u00a0hormone\u00a0(\u00a0FSH\u00a0)).\u00a0Gonadotropins\u00a0play an important role in human\u00a0fertility\u00a0and reproduction.\u00a0In women,\u00a0FSH\u00a0is needed for the growth and maturation of\u00a0follicles\u00a0in the ovaries.\u00a0Follicles are small round blisters that contain egg cells.\u00a0LH\u00a0is needed for the mature egg cells to detach from the follicles and ovaries (ie ovulation).\u00a0Orgalutran counteracts the effect of\u00a0GnRH, which results in a reduction in the\u00a0release\u00a0of one of, above all,\u00a0LH.<\/p>\n\n\n\n
What Orgalutran is used for<\/p>\n\n\n\n
For women undergoing assisted reproduction, including in vitro fertilization (IVF) and other methods, premature ovulation can occasionally occur, leading to a significantly reduced chance of becoming pregnant. Orgalutran is used to prevent premature LH increases that can cause premature ovulation.<\/p>\n\n\n\n
In\u00a0clinical trials, Orgalutran was used in combination with\u00a0a recombinant\u00a0follicle -stimulating\u00a0hormone\u00a0(\u00a0FSH\u00a0) or chorifollitropin alfa, a long-acting follicle stimulator.<\/p>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Orgalutran<\/p>\n\n\n\n
Allergic reactions<\/p>\n\n\n\n
If you have an active allergic condition, talk to your doctor.\u00a0Your doctor will decide, depending on the severity, if additional checks are needed during treatment.\u00a0Cases of allergic reactions have been reported, as early as after the first\u00a0dose.<\/p>\n\n\n\n
Allergic reactions, both general and local, including\u00a0hives\u00a0(\u00a0urticaria\u00a0), swelling of the face, lips, tongue, and \/ or throat that may cause difficulty breathing and\/or swallowing (\u00a0angioedema\u00a0and\/or\u00a0anaphylaxis\u00a0) have been reported (see also section 4).\u00a0If you get an\u00a0allergic reaction, stop taking Orgalutran and seek immediate medical attention.<\/p>\n\n\n\n
Latex allergy<\/p>\n\n\n\n
The needle cover contains latex (dry natural rubber) which comes into contact with the needle, and can cause allergic reactions.<\/p>\n\n\n\n
Ovarian hyperstimulation syndrome (OHSS)<\/p>\n\n\n\n
During and after hormonal stimulation of the ovaries, and overstimulation condition may develop.\u00a0This condition is related to the stimulation procedure with\u00a0gonadotropins.\u00a0See the package leaflet for the\u00a0gonadotropin\u00a0preparation you have been prescribed.<\/p>\n\n\n\n
Multiple births or congenital malformations<\/p>\n\n\n\n
The incidence of congenital malformations after assisted reproduction may be slightly higher than after spontaneous conception.\u00a0This slightly increased risk is thought to be related to the characteristics of patients undergoing fertility treatment (eg woman’s age, sperm characteristics) and because multiple pregnancies are more common after assisted reproduction.\u00a0The incidence of congenital malformations after assisted reproduction using Orgalutran does not differ from the use of other\u00a0GnRH\u00a0analogs\u00a0during assisted reproduction.<\/p>\n\n\n\n
Pregnancy complications<\/p>\n\n\n\n
There is a slightly increased risk of ectopic pregnancy (ectopic pregnancy) in women with damaged fallopian tubes.<\/p>\n\n\n\n
Women weighing less than 50 kg or more than 90 kg<\/p>\n\n\n\n
The efficacy and safety of Orgalutran have not been established in women weighing less than 50 kg or more than 90 kg. Ask your doctor for more information.<\/p>\n\n\n\n
There is no relevant use of Orgalutran for children or adolescents.<\/p>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Orgalutran should be used in controlled ovarian stimulation for assisted reproduction (ART).<\/p>\n\n\n\n
Do not use Orgalutran during pregnancy and lactation.<\/p>\n\n\n\n
Ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n
The effects of Orgalutran on the ability to drive and use machines have not been studied.<\/p>\n\n\n\n
Orgalutran contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0injection, ie essentially ‘sodium-free’.<\/p>\n\n\n\n
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n
Orgalutran is used as part of assisted reproduction (ART) treatment including in vitro fertilization (IVF).<\/p>\n\n\n\n
Stimulation of the ovaries with follicle-stimulating\u00a0hormone\u00a0(\u00a0FSH\u00a0) or chorifollitropin can start on day 2 or 3 of your period.\u00a0Orgalutran (0.25 mg) should be injected directly under the skin once daily, starting on day 5 or day 6 of the stimulation.\u00a0Depending on how your ovaries react, your doctor may decide that you should start on another day.\u00a0Orgalutran should not be mixed with\u00a0FSH, but both preparations should be given at approximately the same time but not at the same injection site.<\/p>\n\n\n\n
Daily treatment with Orgalutran should be continued until you have a sufficient number of follicles of sufficient size. The final maturation of the egg cells in the follicles can be initiated by injection of human chorionic gonadotropin ( hCG ). The time between two Orgalutran injections and between the last Orgalutran injection one and hCG injection one should not exceed 30 hours, as premature ovulation<\/p>\n\n\n\n
(ie\u00a0release\u00a0of egg cells) otherwise can occur.\u00a0Therefore, when\u00a0Orgalutran\u00a0is injected in the morning, Orgalutran treatment should be continued throughout the treatment period with\u00a0gonadotropin, including the day of ovulation induction.\u00a0When\u00a0injecting\u00a0Orgalutran in the afternoon, the last Orgalutran\u00a0injection\u00a0should be given in the afternoon the day before ovulation induction.<\/p>\n\n\n\n
User instructions<\/strong><\/p>\n\n\n\n Injection site<\/em><\/p>\n\n\n\n Orgalutran is available as prefilled syringes and should be injected slowly directly under the skin, preferably in the thigh.\u00a0Check the solution before using it.\u00a0Do not use the solution if it is not free of particles or is not ready.\u00a0You may see air bubbles in the pre-filled syringe, this is expected and it is not necessary to remove them.\u00a0If you give the\u00a0injections\u00a0yourself or if your partner does, follow the instructions carefully.\u00a0Do not mix Orgalutran with other medicines.<\/p>\n\n\n\n Preparation of the injection site<\/em><\/p>\n\n\n\n Wash your hands thoroughly with soap and water. Wash the injection site with a disinfectant (eg alcohol) to remove bacteria from the skin. Clean about 5 cm around the place where the needle is to be inserted and let the disinfectant dry for at least one minute before continuing.<\/p>\n\n\n\n Insertion of the needle<\/em><\/p>\n\n\n\n Remove the cover from the needle.\u00a0Pinch between the thumb and forefinger a large area of \u200b\u200bthe skin.\u00a0Insert the needle at the base of the pinched skin at an angle of 45 \u00b0 to the surface of the skin.\u00a0Vary the injection site with each\u00a0injection.<\/p>\n\n\n\n Checking the position of the needle<\/em><\/p>\n\n\n\n Carefully pull back on the plunger to check that the needle is in the correct position.\u00a0If blood is drawn into the syringe, it means that the tip of the needle has entered a blood vessel.\u00a0If this happens, do not inject Orgalutran, but remove the syringe, cover the injection site with a swab soaked in disinfectant and apply pressure, it should stop bleeding within a minute or two.\u00a0Do not use this\u00a0syringe\u00a0but dispose of it properly.\u00a0Start over with a new\u00a0syringe.<\/p>\n\n\n\n Injection of the solution<\/em><\/p>\n\n\n\n When the needle is positioned correctly, push the plunger in slowly and steadily so that the solution is injected correctly and the skin is not damaged.<\/p>\n\n\n\n Removal of the needle<\/em><\/p>\n\n\n\n Quickly pull out the needle and press against the injection site with a swab of disinfectant.<\/p>\n\n\n\n Use the pre-filled syringe only once.<\/p>\n\n\n\n Contact your doctor.<\/p>\n\n\n\n If you find that you have missed a\u00a0dose, take it as soon as possible.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n If you are more than 6 hours late (so that the time between two injections is more than 30 hours) take a dose as soon as possible and<\/strong> contact your doctor for further advice.<\/p>\n\n\n\n Do not stop taking Orgalutran unless your doctor tells you to, as it may affect the outcome of your treatment.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n The occurrence of a side effect is described according to the following categories:<\/p>\n\n\n\n Very common: may affect more than 1 in 10 women<\/strong><\/p>\n\n\n\n Uncommon: may affect up to 1 in 100 women<\/strong><\/p>\n\n\n\n Very rare: may affect up to 1 in 10,000 women<\/strong><\/p>\n\n\n\n In addition,\u00a0side effects\u00a0have been reported that are known to be associated with controlled ovarian hyperstimulation therapy (eg abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when an\u00a0embryo\u00a0develops outside the uterus), and miscarriage (see package leaflet for the\u00a0FSH\u00a0product you are being treated with).<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of that month.<\/p>\n\n\n\n Do not freeze. Check the syringe before use.\u00a0Only use syringes with the clear, particle-free solution and from undamaged packaging.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n Orgalutran is a clear and colorless\u00a0water solution\u00a0for\u00a0injection.\u00a0The solution is ready to use and intended for\u00a0subcutaneous\u00a0administration.\u00a0The needle cover contains latex (dry natural rubber) which comes into contact with the needle.<\/strong><\/p>\n\n\n\n Orgalutran is available in packs of 1 or 5 pre-filled syringes.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/p>\n\n\n\n NV Organon<\/p>\n\n\n\n Kloosterstraat 6<\/p>\n\n\n\n 5349 AB Us Manufacturer<\/p>\n\n\n\n NV Organon<\/p>\n\n\n\n Kloosterstraat 6<\/p>\n\n\n\n PO Box 20<\/p>\n\n\n\n 5340 BH Oss<\/p>\n\n\n\n Netherlands<\/p>\n\n\n\n For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:<\/p>\n\n\n\n Orgalutran contains the active substance ganirelix and belongs to a group of medicines called ‘anti-gonadotropin-releasing hormones’ which counteract the effects of the natural gonadotropin-releasing hormone ( GnRH ). GnRH controls the release of one of the gonadotropins (luteinizing hormone ( LH ) and follicle-stimulating hormone ( FSH )). Gonadotropins play an important role in human fertility and reproduction. In women, FSH is needed for the growth and maturation of follicles in the ovaries. Folliclesare small round blisters that contain egg cells. LH is needed for the mature egg cells to detach from the follicles and ovaries (ie ovulation). Orgalutran counteracts the effect of GnRH , which results in a reduction in the release of one of, above all, LH .<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,18526],"tags":[20252,20257,4348,4444,20256,20251,20250,20254,20255],"class_list":["post-19930","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-benefits-of-ganirelix","tag-benefits-of-orgalutran","tag-ganirelix-injection","tag-ganirelix-side-effects","tag-orgalutran-side-effects","tag-what-ganirelix-is-used-for","tag-what-is-ganirelix","tag-what-is-orgalutran","tag-what-orgalutran-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19930","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=19930"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19930\/revisions"}],"predecessor-version":[{"id":19978,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19930\/revisions\/19978"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19930"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19930"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19930"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}If you use more Orgalutran than you should<\/h2>\n\n\n\n
If you forget to use Orgalutran<\/h2>\n\n\n\n
If you stop using Orgalutran<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Orgalutran<\/h2>\n\n\n\n
Store in the original package. Sensitive to light.<\/p>\n\n\n\nContents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
The Netherlands<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>Organon BelgiumPhone: 0080066550123(+32 2 2418100)dpoc.benelux@organon.com<\/td> Lithuania<\/strong>Organon Pharma BV Lithuania atstovyb\u0117Tel .: + 370 52041693dpoc.lithuania@organon.com<\/td><\/tr> Bulgaria<\/strong>ORGANON (USA) B.V. -clone BulgariaTel: +359 2 806 3030dpoc.bulgaria@organon.com<\/td> Luxembourg \/ Luxemburg<\/strong>Organon BelgiumPhone: 0080066550123(+32 2 2418100)dpoc.benelux@organon.com<\/td><\/tr> Czech Republic<\/strong>Organon Czech Republic sroTel: +420 233 010 300dpoc.czech@organon.com<\/td> Hungary<\/strong>Organon Hungary Kft.Tel .: +36 1 766 1963dpoc.hungary@organon.com<\/td><\/tr> Denmark<\/strong>Organon Denmark ApSTel: + 45 4484 6800info.denmark@organon.com<\/td> Malta<\/strong>Organon Pharma BV, Cyprus branchTel: +356 2277 8116dpoc.cyprus@organon.com<\/td><\/tr> Germany<\/strong>Organon Healthcare GmbHTel .: 0800 3384 726(+49 (0) 89 2040022 10) dpoc.germany@organon.com<\/td> The Netherlands<\/strong>NV OrganonTel: 00800 66550123(+32 2 2418100)dpoc.benelux@organon.com<\/td><\/tr> Eesti<\/strong>Organon Pharma BV Estonian ROTel: +372 66 61 300dpoc.estonia@organon.com<\/td> Norway<\/strong>Organon Norway ASTel: +47 24 14 56 60info.norway@organon.com<\/td><\/tr> Greece<\/strong>BIANE\u039e \u0391.\u0395:\u0397\u03bb: +30 210 80091 11Mailbox@vianex.gr<\/td> Austria<\/strong>Organon Austria GmbHTel: +43 (0) 1 263 28 65medizin-austria@organon.com<\/td><\/tr> Spain<\/strong>Organon Salud, SLTel: +34 91 591 12 79organon_info@organon.com<\/td> Poland<\/strong>Organon Polska Sp. z ooTel .: + 48 22 105 50 01organonpolska@organon.com<\/td><\/tr> France<\/strong>Organon FranceTel: + 33 (0) 1 57 77 32 00<\/td> Portugal<\/strong>Organon Portugal, Sociedade Unipessoal Lda.Tel: +351 21 8705500geral_pt@organon.com<\/td><\/tr> Croatia<\/strong>Organon Pharma dooTel: + 385 1 638 4530dpoc.croatia@organon.com<\/td> Romania<\/strong>Organon Biosciences SRLTel: +40 21 527 29 90info.romania@organon.com<\/td><\/tr> Ireland<\/strong>Organon Pharma (Ireland) LimitedTel: +353 15828260medinfo.ROI@organon.com<\/td> Slovenia<\/strong>Organon Pharma BV, Oss, Ljubljana CompanyTel: +386 1 300 10 80info.slovenia@organon.com<\/td><\/tr> Iceland<\/strong>Vistor hf.Phone: + 354 535 7000<\/td> Slovak Republic<\/strong>Organon Slovakia sroTel: +421 2 44 88 98 88dpoc.slovakia@organon.com<\/td><\/tr> Italy<\/strong>Organon Italia SrlTel: +39 06 3336407dpoc.italy@organon.com<\/td> Finland \/ Finland<\/strong>Organon Finland OyPuh \/ Tel: +358 (0) 29 170 3520dpoc.finland@organon.com<\/td><\/tr> .\u03a0\u03c1\u03bf\u03c2<\/strong>Organon Pharma BV, Cyprus branch:\u0397\u03bb: +357 22866730dpoc.cyprus@organon.com<\/td> Sweden<\/strong>Organon Sweden ABTel: +46 8 502 597 00dpoc.sweden@organon.com<\/td><\/tr> Latvia<\/strong>Komrvalsts komersanta \u201cOrganon Pharma BV\u201d p\u0101rst\u0101vniec\u012bbaTel: +371 66968876dpoc.latvia@organon.com<\/td> United Kingdom (Northern Ireland)<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"