\u041f\u0435\u0440\u0435\u0432\u043e\u0434 \u0441 \u043f\u043e\u043b\u043d\u044b\u043c \u0441\u043e\u0445\u0440\u0430\u043d\u0435\u043d\u0438\u0435\u043c HTML:<\/p>\n
Trade name of the medicinal product: Ovitrelle\u00ae<\/p>\n
Choriogonadotropin alfa<\/p>\n
Lyophilisate for solution for subcutaneous injection<\/p>\n
1 vial contains: Description: Luteinizing agent.<\/p>\n ATC code: G03GA08.<\/p>\n Pharmacological properties Pharmacokinetics: In protocols for the induction of multiple follicular development (superovulation) for assisted reproductive technologies (ART), including in vitro fertilization (IVF), to induce final follicular maturation and luteinization following stimulation with gonadotropins. Tumors of the hypothalamus and pituitary gland; For subcutaneous administration. 7.Disposal of used supplies: <\/strong> Local reactions: <\/em>pain at the injection site. No data on overdose with the medicinal product are available. However, in the event of overdose during ovarian stimulation, ovarian hyperstimulation syndrome (OHSS) may develop (see \u201cSpecial warnings and precautions\u201d). Clinically, it is characterized by the formation of large ovarian cysts with a risk of rupture (perforation), symptoms of ascites, and circulatory disturbances. No data on interactions with other medicinal products are available. However, the patient should inform her doctor about all medicinal products, including non-prescription medicines, that she is currently taking or has recently taken.<\/p>\n Before starting treatment, the causes of infertility in the patient and her partner should be established, and potential risk factors associated with pregnancy should be assessed. Particular consideration should be given to symptoms of hypothyroidism, adrenal insufficiency, hyperprolactinemia, the presence of tumors in the hypothalamic-pituitary region, and any specific treatments being used. \u041f\u0435\u0440\u0435\u0432\u043e\u0434 \u0441 \u043f\u043e\u043b\u043d\u044b\u043c \u0441\u043e\u0445\u0440\u0430\u043d\u0435\u043d\u0438\u0435\u043c HTML: Trade name of the medicinal product: Ovitrelle\u00ae International Nonproprietary Name: Choriogonadotropin alfa Dosage form: Lyophilisate for solution for subcutaneous injection Composition: 1 vial contains: Active substance: choriogonadotropin alfa 250 mcg (6,500 IU) Excipients: sucrose, phosphoric acid, sodium hydroxide. 1 vial or ampoule of solvent contains 1 mL of water for […]<\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","class_list":["post-606","pharmacy_product","type-pharmacy_product","status-publish","has-post-thumbnail","hentry"],"yoast_head":"\n
\nActive substance: <\/em>choriogonadotropin alfa 250 mcg (6,500 IU)
\nExcipients: <\/em>sucrose, phosphoric acid, sodium hydroxide. 1 vial or ampoule of solvent contains 1 mL of water for injection.<\/p>\n
\nWhite or almost white lyophilized powder or porous mass (lyophilisate)<\/p>\nPharmacotherapeutic group:<\/strong><\/h3>\n
\nPharmacodynamics:
\nContains choriogonadotropin alfa, which is produced using recombinant DNA technology. It has the same amino acid sequence as human chorionic gonadotropin found in urine. It binds to transmembrane LH receptors on ovarian theca and granulosa cells. It induces the initiation of oocyte meiosis, follicular rupture (ovulation), corpus luteum formation, and the production of progesterone and estradiol by the corpus luteum.<\/p>\n
\nFollowing subcutaneous administration, the absolute bioavailability of choriogonadotropin alfa is approximately 40%, and the elimination half-life is approximately 30 hours.<\/p>\nIndications for use:<\/strong><\/h3>\n
\nIn anovulatory or oligo-ovulatory infertility, to induce ovulation and luteinization at the end of follicular growth stimulation.<\/p>\nContraindications:<\/strong><\/h3>\n
\nHypersensitivity to the active substance or any of the excipients contained in the medicinal product;
\nOvarian enlargement or cysts not associated with polycystic ovarian disease.
\nVaginal bleeding of unknown origin.
\nOvarian, uterine, or breast cancer.
\nEctopic pregnancy within the previous 3 months.
\nThromboembolism.
\nPrimary ovarian insufficiency.
\nCongenital malformations of the reproductive organs incompatible with pregnancy.
\nUterine fibroids incompatible with pregnancy.
\nPostmenopause. Use with caution<\/strong>
\nOvitrelle\u00ae<\/sup> should be prescribed with caution to patients with serious systemic diseases in cases where pregnancy could lead to exacerbation of these conditions.<\/p>\nMethod of administration and dosage:<\/strong><\/h3>\n
\nEach vial is intended for single use only.
\nIn protocols for the induction of multiple follicular development (superovulation) for assisted reproductive technologies (ART), including in vitro fertilization (IVF), to induce final follicular maturation and luteinization following stimulation with gonadotropins:
\nOvitrelle\u00ae<\/sup> at a dose of 250 mcg (the contents of 1 vial) is administered as a single injection 24\u201348 hours after the last administration of a follicle-stimulating hormone or luteinizing hormone preparation, once an optimal level of follicular development has been achieved.
\nIn anovulatory or oligo-ovulatory infertility, to induce ovulation and luteinization at the end of follicular growth stimulation:
\nOvitrelle\u00ae<\/sup> at a dose of 250 mcg (the contents of 1 vial) is administered as a single injection 24\u201348 hours after the last administration of a follicle-stimulating hormone or luteinizing hormone preparation, once an optimal level of follicular development has been achieved. Sexual intercourse is recommended on the day of the injection and on the following day.If the patient administers Ovitrelle\u00ae<\/sup> herself, she should carefully read and strictly follow the instructions below for administering the medicinal product: <\/strong>1.Wash your hands. It is important that your hands and the items you use are clean. <\/strong>
\n2.Prepare a clean surface and place everything you need for the injection on it: <\/strong>
\none vial of Ovitrelle\u00ae<\/sup>,
\none ampoule or vial of solvent,
\ntwo alcohol swabs,
\none syringe,
\none larger-bore needle for drawing up the solvent,
\none fine needle for subcutaneous injection,
\na sharps container for the safe disposal of glass components and needles.<\/p>\n\n\n
\n 3.Opening the solvent ampoule:<\/strong><\/td>\n<\/tr>\n \n You should see a small colored dot at the top of the solvent ampoule. Just below this point, the glass has been specially treated to make the ampoule easier to open. Gently tap the top of the ampoule so that any liquid in the upper part moves down into the lower section. Then press firmly on the neck and open the ampoule in the direction opposite to the colored dot. Carefully place the opened ampoule upright on the work surface.<\/td>\n<\/tr>\n \n 4.Drawing the solvent from the ampoule into the syringe:<\/strong><\/td>\n<\/tr>\n \n Attach the solvent-drawing needle to the syringe. Holding the syringe in one hand, take the opened ampoule with the other hand, insert the needle into the ampoule, and draw all of the solvent into the syringe. Carefully place the syringe on the work surface, taking care not to touch the needle.<\/td>\n<\/tr>\n \n 4\u2032. Drawing the solvent from the vial into the syringe:<\/strong><\/td>\n<\/tr>\n \n Remove the protective cap from the solvent vial. Attach the solvent-drawing needle (the larger-bore needle) to the syringe. Draw a small amount of air into the syringe by pulling the plunger back to approximately the 1 mL mark. Then insert the needle into the vial and press the plunger to inject the air. Turn the vial upside down and slowly draw the solvent into the syringe.
\nCarefully place the syringe on the work surface, taking care not to touch the needle.<\/td>\n<\/tr>\n\n 5.Preparing the solution for injection:<\/strong><\/td>\n<\/tr>\n \n Remove the protective cap from the vial containing Ovitrelle\u00ae<\/sup>. Using the syringe, slowly inject the solvent into the vial. Gently mix the contents using a circular motion. Do not shake. The medicinal product should dissolve immediately to form a clear solution. The medicinal product should be used immediately after reconstitution. Do not inject the solution if it is cloudy or contains solid particles.<\/td>\n<\/tr>\n \n Turn the vial upside down and draw the solution back into the syringe.<\/td>\n<\/tr>\n \n 6. Administering the injection:<\/strong><\/td>\n<\/tr>\n \n Replace the larger-bore needle with the fine needle. Remove any air bubbles: if you notice air bubbles in the syringe, hold the syringe with the needle pointing upward and gently tap the sides of the syringe so that the air collects at the top. Gently press the plunger to remove the air bubbles.<\/td>\n<\/tr>\n \n Administer the injection immediately: your doctor or nurse should already have advised you where to inject the medicinal product (for example, into the abdomen or the front of the thigh). Clean the selected area with an alcohol swab. Firmly pinch the skin between your fingers and insert the needle at an angle of 45\u00b0\u201390\u00b0 using a short, quick motion. Administer the subcutaneous injection as you have been instructed. Do not inject directly into a vein. Inject the solution by gently pressing the plunger. Take as much time as necessary to inject the entire volume of solution. Immediately afterwards, withdraw the needle and clean the skin at the injection site with an alcohol swab using a circular motion.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/figure>\n
\nImmediately after the injection, place the used needles and empty glass containers in a sharps container. Any unused solution must be discarded.<\/p>\nAdverse reactions:<\/strong><\/h3>\n
\nGeneral: <\/em>headache, fatigue.
\nCentral nervous system: <\/em>rarely \u2014 depression, irritability, anxiety.
\nGastrointestinal system: <\/em>vomiting\/nausea, abdominal pain; rarely, diarrhea.
\nReproductive system: <\/em>ovarian hyperstimulation syndrome, rarely severe ovarian hyperstimulation syndrome, breast tenderness.<\/p>\nOverdose:<\/strong><\/h3>\n
\nIf there is a high risk of OHSS, it is recommended to discontinue administration of human chorionic gonadotropin. Patients are advised to abstain from sexual intercourse or use barrier methods of contraception for at least 4 days.<\/p>\nInteraction with other medicinal products:<\/strong><\/h3>\n
Special warnings and precautions:<\/strong><\/h3>\n
\nDuring ovarian stimulation, patients are at risk of developing ovarian hyperstimulation syndrome (OHSS) due to the simultaneous maturation of a large number of follicles. Severe OHSS may become a serious complication of stimulation. To reduce the risk of ovarian hyperstimulation syndrome during follicular growth stimulation protocols, careful monitoring of the ovarian response by ultrasound examination and measurement of blood estradiol levels is recommended before and during treatment.
\nCompared with natural conception, ovarian stimulation increases the risk of multiple pregnancy. In most cases, multiple pregnancies involve twins. When assisted reproductive technologies are used, the number of babies born corresponds to the number of embryos transferred into the uterine cavity.
\nThe miscarriage rate following treatment for anovulatory infertility, including treatment using assisted reproductive technologies, is higher than the average rate in the general population but is comparable with that observed in other types of infertility. Administration of Ovitrelle\u00ae<\/sup> may interfere with the immunological determination of human chorionic gonadotropin (hCG) in serum and urine for up to 10 days and may result in a false-positive pregnancy test.
\nDuring treatment with Ovitrelle\u00ae<\/sup>, mild stimulation of thyroid function may occur. Presentation. <\/strong>
\nLyophilisate for solution for subcutaneous injection in a vial containing 250 mcg (6,500 IU) of choriogonadotropin alfa, supplied with solvent \u2014 1 mL of water for injection in vials or ampoules. Packs contain 1, 2, or 10 vials of the medicinal product together with the same number of vials or ampoules of solvent in a plastic container and then in a cardboard box, together with the Instructions for Use. Shelf life. <\/strong>
\nMedicinal product: 2 years.
\nSolvent: 3 years.
\nDo not use the medicinal product after the expiry date stated on the packaging. Storage conditions. <\/strong>
\nStore in the original packaging at a temperature not exceeding 25\u00b0C.<\/p>\n","protected":false},"excerpt":{"rendered":"