12 micrograms \/ 0.36 ml solution for injection
follitropin delta<\/p>\n\n\n\n
REKOVELLE contains follitropin delta, a follicle-stimulating\u00a0hormone\u00a0belonging to the hormone family\u00a0gonadotropins.\u00a0Gonadotropins\u00a0are involved in reproduction and\u00a0fertility.<\/p>\n\n\n\n
REKOVELLE is used in the treatment of female infertility and in women undergoing assisted reproduction such as in vitro fertilization<\/em> (IVF) and intracytoplasmic sperm injection (ICSI). REKOVELLE stimulates the ovaries to grow and develop several ovaries ( follicles ), from which the eggs are collected and fertilized in the laboratory.<\/p>\n\n\n\n Before starting treatment with this medicine, the causes of your and your partner’s fertility problems should be investigated by a doctor.<\/p>\n\n\n\n Do not use REKOVELLE if:<\/strong><\/p>\n\n\n\n Ovarian overstimulation syndrome<\/em><\/p>\n\n\n\n The gonadotropins contained in this medicine may cause ovarian hyperstimulation. It can cause your follicles to develop too much and become large cysts.<\/p>\n\n\n\n Talk to a doctor if you:<\/p>\n\n\n\n Your doctor may ask you to stop using this medicine (see section 4).<\/p>\n\n\n\n If the recommended\u00a0dose\u00a0and administration schedules are followed, ovarian hyperstimulation syndrome is less likely.<\/p>\n\n\n\n Problems with blood clots (thromboembolic events)<\/em><\/p>\n\n\n\n Blood vessel clots (veins or arteries ) are more likely in pregnant women. Fertility treatment can increase the risk of this happening, especially if you are overweight or if you or someone in your family (parents or siblings) has a blood clot disease (thrombophilia). Tell your doctor if this is true for you.<\/p>\n\n\n\n Twisting of the ovaries<\/em><\/p>\n\n\n\n There have been reports of ovarian torsion (ovarian torsion) after assisted reproduction. Twisting of the ovaries can cut off the blood flow to the ovary.<\/p>\n\n\n\n Multiple pregnancies and birth defects<\/em><\/p>\n\n\n\n Assisted conception increases the risk of multiple births (eg twins) and is related to the number of embryos placed in the uterus, the quality of the embryos, and your age. Multiple births can lead to medical complications for you and your children. In addition, the risk of birth defects may be slightly higher after fertility treatment, which is thought to be due to characteristics of the parents (eg your age and your partner’s sperm quality) and multiple births.<\/p>\n\n\n\n Miscarriage<\/em><\/p>\n\n\n\n When you undergo assisted reproduction, you run a greater risk of having a miscarriage than if you become pregnant naturally.<\/p>\n\n\n\n Ectopic pregnancy (ectopic pregnancy)<\/em><\/p>\n\n\n\n Assisted conception increases the risk of ectopic pregnancy (ectopic pregnancy) compared to if you become pregnant naturally. If you have previously had a disease in the fallopian tubes, you have an increased risk of ectopic pregnancy.<\/p>\n\n\n\n Tumors\u00a0in the ovaries and other genitals<\/em><\/p>\n\n\n\n There have been reports of tumors in the ovaries and other genitals in women who have undergone fertility treatment. It is not known whether treatment with fertility drugs increases the risk of these tumors in infertile women.<\/p>\n\n\n\n Other medical conditions<\/em><\/p>\n\n\n\n Before you start taking this medicine, tell your doctor about:<\/p>\n\n\n\n REKOVELLE is not intended for treatment in children and adolescents.<\/p>\n\n\n\n Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.<\/p>\n\n\n\n Do not use this medicine if you are pregnant or breastfeeding.<\/p>\n\n\n\n This medicine does not affect your ability to drive or use machines.<\/p>\n\n\n\n REKOVELLE contains less than 1 mmol\u00a0sodium\u00a0(23 mg) per\u00a0dose, essentially ‘sodium-free’.<\/p>\n\n\n\n Always use this medicine exactly as your doctor has told\u00a0you.\u00a0If you are not sure, talk to your doctor.<\/p>\n\n\n\n The dose\u00a0for the first treatment cycle is calculated by your doctor and is based on the level of anti-M\u00fcllerian\u00a0hormone\u00a0(AMH, a marker for how your ovaries will respond to stimulation with\u00a0gonadotropins\u00a0) in your blood and your body weight.\u00a0Therefore, AMH results from a blood test (taken in the last 12 months) should be available before starting treatment.\u00a0You will also be weighed before starting treatment.\u00a0Dos\u00a0en REKOVELLE is given in micrograms.<\/p>\n\n\n\n Dose one will be the same throughout the treatment period and your daily dose will neither increase nor decrease. The doctor will monitor the effect of REKOVELLE treatment, and the treatment will be stopped when there is an appropriate number of ovaries. You will normally be given an injection of a medicine called human chorionic gonadotropin ( hCG ) at a dose of 250 micrograms or 5000 IU for the final development of the ovaries.<\/p>\n\n\n\n If the body’s response to treatment is too weak or too strong, the doctor may decide to discontinue treatment with REKOVELLE. For the next treatment cycle, the doctor will then give you either a higher or a lower dose of REKOVELLE than before.<\/p>\n\n\n\n How the injections are given<\/strong><\/p>\n\n\n\n REKOVELLE is developed for use in the REKOVELLE\u00a0pen.\u00a0The instructions for use that come with the pen must be followed carefully, including charging the multi-cylinder cartridge.\u00a0Do not use an\u00a0ampoule\u00a0if the solution contains particles or if it is cloudy.<\/p>\n\n\n\n The first injection of one of these medicines should be given under the supervision of a doctor or a nurse. Your doctor will decide if you can give yourself the following dose of this medicine at home, but only after getting enough exercise.<\/p>\n\n\n\n This medicine should be given as an\u00a0injection\u00a0under the skin (\u00a0subcutaneously\u00a0), usually in the abdomen.\u00a0Ampoule\u00a0one can be used for several\u00a0injections.<\/p>\n\n\n\n The effects of taking too much of this medicine are unknown. Ovarian hyperstimulation syndrome may occur, as described in section 4.<\/p>\n\n\n\n Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.\u00a0Contact your doctor as soon as you discover that you have missed a\u00a0dose.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Serious side effects are<\/strong><\/p>\n\n\n\n Hormones\u00a0used to treat\u00a0infertility, such as this medicine, can cause increased activity in the ovaries (ovarian hyperstimulation syndrome).\u00a0Symptoms may include abdominal pain, abdominal discomfort or swelling, nausea, vomiting, diarrhea, weight gain, or difficulty breathing.\u00a0If you have any of these symptoms, you should contact a doctor immediately.<\/p>\n\n\n\n The risk of getting a\u00a0side effect\u00a0is described in the following categories:<\/p>\n\n\n\n Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people):<\/strong><\/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 ampoule label and carton after EXP and EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store in a refrigerator (2 \u00b0 C – 8 \u00b0 C). Do not freeze.<\/p>\n\n\n\n Store in the original package before use. Sensitive to light.<\/p>\n\n\n\n REKOVELLE can be taken out of the refrigerator, without being refrigerated again, and stored at a maximum of 25 \u00b0 C for up to 3 months, including the period after the first\u00a0injection.\u00a0It must then be discarded.<\/p>\n\n\n\n After the first injection: 28 days when stored below 25 \u00b0 C.\u00a0Keep\u00a0the ampoule\u00a0in a REKOVELLE\u00a0pen.<\/p>\n\n\n\n When the treatment is completed, all unused solutions must be discarded.<\/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 REKOVELLE is a clear, colorless\u00a0solution for injection.\u00a0It is available in packs of one\u00a0ampoule\u00a0and 3 needles for\u00a0a pen.<\/p>\n\n\n\n Ferring Pharmaceuticals A \/ S<\/p>\n\n\n\n Kay Fiskers Square 11<\/p>\n\n\n\n 2300 Copenhagen S<\/p>\n\n\n\n Denmark<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Ferring GmbH<\/p>\n\n\n\n Wittland 11<\/p>\n\n\n\n D-24109 Kiel<\/p>\n\n\n\n Germany<\/p>\n\n\n\n Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n REKOVELLE contains follitropin delta, a follicle-stimulating hormone belonging to the hormone family gonadotropins . Gonadotropins are involved in reproduction and fertility .<\/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":[2200,18529],"tags":[22624,22629,22620,22623,22625,22628,22622,22621,22626,22627],"class_list":["post-21838","post","type-post","status-publish","format-standard","hentry","category-medicines","category-r","tag-benefits-of-follitropin-delta","tag-benefits-of-rekovelle","tag-follitropin-delta","tag-follitropin-delta-side-effects","tag-rekovelle","tag-rekovelle-side-effects","tag-what-follitropin-delta-is-used-for","tag-what-is-follitropin-delta","tag-what-is-rekovelle","tag-what-rekovelle-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21838","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=21838"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21838\/revisions"}],"predecessor-version":[{"id":21864,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21838\/revisions\/21864"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21838"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21838"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21838"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using REKOVELLE<\/h2>\n\n\n\n
Do not use REKOVELLE<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Children and adolescents (under 18 years)<\/h2>\n\n\n\n
Other medicines and REKOVELLE<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
REKOVELLE contains sodium<\/h2>\n\n\n\n
How to use REKOVELLE<\/h2>\n\n\n\n
If you use more REKOVELLE than you should <\/h2>\n\n\n\n
If you forget to use REKOVELLE<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store REKOVELLE<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
One multi-cartridge contains 12 micrograms of follitropin delta in a 0.36 ml solution.\u00a0One ml solution contains 33.3 micrograms follitropin delta<\/li>What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n
Belgium \/ Belgique \/ Belgien<\/strong>Ferring NVTel \/ Tel: +32 53 72 92 00ferringnvsa@ferring.be<\/td> Lithuania<\/strong>UAB PharmaSwissTel: +370 5 2790762lithuania.info@pharmaswiss.com<\/td><\/tr> Bulgaria<\/strong>Akvaxim ADTel: +359 2 807 5022aquachim@aquachim.bg<\/td> Luxembourg \/ Luxemburg<\/strong>Ferring NVBelgium \/ BelgiumTel \/ Tel: +32 53 72 92 00ferringnvsa@ferring.be<\/td><\/tr> Czech Republic<\/strong>Ferring Pharmaceuticals CZ sroTel: +420 234 701 333cz1-info@ferring.com<\/td> Hungary<\/strong>Ferring Magyarorsz\u00e1g Gy\u00f3gyszerkereskedelmi Kft.Tel: +36 1 236 3800ferring@ferring.hu<\/td><\/tr> Denmark<\/strong>Ferring L\u00e6gmedel A \/ STel: +45 88 16 88 17<\/td> Malta<\/strong>EJ Busuttil Ltd.Tel: +356 21447184info@ejbusuttil.com<\/td><\/tr> Germany<\/strong>Ferring Arzneimittel GmbHTel: +49 431 5852 0info-service@ferring.de<\/td> The Netherlands<\/strong>Ferring BVTel: +31 235680300infoNL@ferring.com<\/td><\/tr> Eesti<\/strong>PharmaSwiss Eesti O\u00dcTel: +372 682 7400estonia.info@pharmaswiss.com<\/td> Norway<\/strong>Ferring Legidler ASTel: +47 22 02 08 80mail@oslo.ferring.com<\/td><\/tr> Greece<\/strong> Ferring \u0395\u03bb\u03bb\u03ac\u03c2 \u039c\u0395\u03a0\u0395 :\u0397\u03bb: +30 210 68 43 449<\/td> Austria<\/strong>Ferring Drugs Ges.mbHTel: +43 1 60 8080office@ferring.at<\/td><\/tr> Spain<\/strong>Ferring SAUTel: +34 91 387 70 00Registros@ferring.com<\/td> Poland<\/strong>Ferring Pharmaceuticals Poland Sp. z ooTel: +48 22 246 06 80ferring@ferring.pl<\/td><\/tr> France<\/strong>Ferring SASTel: +33 1 49 08 67 60information.medicale@ferring.com<\/td> Portugal<\/strong>Ferring Portuguesa – Pharmaceutical Products, Sociedade Unipessoal, Lda.Tel: +351 21 940 51 90geral@ferring.com<\/td><\/tr> Croatia<\/strong>Clinres pharmacy dooTel: +385 1 2396 900<\/td> Romania<\/strong>Ferring Pharmaceuticals Romania SRLTel: +40 356 113 270<\/td><\/tr> Ireland<\/strong>Ferring Ireland Ltd.Tel: +353 1 4637355inquiries.ireland@ferring.com<\/td> Slovenia<\/strong>SALUS, Veletrgovina, dooTel: +386 1 5899 179regulatory@salus.si<\/td><\/tr> Iceland<\/strong>Vistor hf.Phone: +354 535 70 00<\/td> Slovak Republic<\/strong>Ferring Slovakia sroTel: +421 2 54 416 010SK0-Recepcia@ferring.com<\/td><\/tr> Italy<\/strong>Ferring SpATel: +39 02 640 00 11<\/td> Finland \/ Finland<\/strong>Ferring L\u00e4\u00e4kkeet OyPuh \/ Tel: +358 207 401 440info@ferring.fi<\/td><\/tr> .\u03a0\u03c1\u03bf\u03c2<\/strong>A.Potamitis Medicare Ltd:\u0397\u03bb: +357 22583333a.potamitismedicare@cytanet.com.cy<\/td> Sweden<\/strong>Ferring L\u00e4kemedel ABTel: +46 40 691 69 00info@ferring.se<\/td><\/tr> Latvia<\/strong>SIA PharmaSwiss LatviaPhone: +371 6 750 2185latvia.info@pharmaswiss.com<\/td> United Kingdom<\/strong>Ferring Pharmaceuticals Ltd.Tel: +44 844 931 0050contact2@ferring.com<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"