Ovitrel lyophilisate for preparation of solution for subcutaneous injection
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Active ingredients
Choriogonadotropin alfa
Release form
Solution
Composition
1 syringe contains: Active substance: choriogonadotropin alpha 250 mcg (6500 IU). Auxiliary substances: mannitol, methionine, poloxamer 188, phosphoric acid, sodium hydroxide, water for i.
Pharmacological effect
Recombinant choriogonadotropin alpha, which has the same amino acid sequence as natural human chorionic gonadotropin. It binds transmembrane LH receptors on the surface of theca cells and ovarian granulosis. It causes the initiation of oocyte meiosis, rupture of the follicles (ovulation), the formation of the corpus luteum, the production of progesterone and estradiol by the corpus luteum.
Pharmacokinetics
When s / c administration, the absolute bioavailability is approximately 40%, T1 / 2 - about 30 hours.
Indications
- In the protocol of induction of multiple maturation of follicles (superovulation) for assisted reproductive technologies (including in vitro fertilization) to induce the final maturation of follicles and luteinization after stimulation with gonadotropins; - With anovulatory or oligo-ovulatory fertility for induction of inducting gonadotropins; stimulation of follicle growth.
Contraindications
- Tumors in the hypothalamus and pituitary; - Volumetric neoplasms of the ovary or cysts, not associated with polycystic ovary; - Vaginal bleeding of unknown origin; - Cancer of the ovary, uterus or breast; - Ectopic pregnancy during the previous 3 months; - Thromboembolism; - Primary ovarian insufficiency; - Congenital malformations of the genital organs incompatible with pregnancy; - Uterine fibroids, incompatible with pregnancy; - Postmenopause; - Hypersensitivity to the components of the drug. Ovitrel appoint patients with severe systemic disease in cases where pregnancy could lead to their aggravation.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation.
Dosage and administration
The drug is injected s / c. Each syringe is intended for single use only. When applied in an induction protocol, the multiple maturation of follicles for assisted reproductive technologies (includingfor in vitro fertilization) to induce the final maturation of the follicles and luteinization after stimulation with gonadotropins Ovitrel in a dose of 250 μg (contents of 1 syringe) is administered once 24 to 48 hours after the last injection of the drug FSH or LH and the optimal level of follicle development is reached. oligovulatory infertility for induction of ovulation and luteinization at the end of follicle growth stimulation Ovitrel in a dose of 250 μg (contents of 1 syringe) is injected once 24-48 hours after reaching The minimum level of development of the follicle. Sexual contact is recommended on the day of the drug administration and the next day. The rules of drug administration When self-using the drug, patients should carefully study the instructions.1. Injection should be carried out in compliance with the rules of asepsis and antisepsis. To carry out the injection, it is necessary to decompose 2 tampons impregnated with alcohol, a pre-filled syringe or a syringe ready for use on a clean surface. Next, you should immediately carry out the injection (in the abdomen or the front of the thigh). To do this, wipe the area chosen by the doctor’s recommendation with a tampon with alcohol. Strongly tighten the skin with your fingers and, directing the needle at an angle of 45-90 ° into the skin fold, make a sc injection. Avoid getting the drug in the vein. The drug is injected slowly, gently pressing on the piston, you must enter the entire volume of the solution. After removing the needle, wipe the injection site with an alcohol swab in circular motions.4. Immediately after the injection, the used syringe should be placed in a container for storing sharp objects. The entire unused volume should be destroyed. In the case of the introduction of an elevated dose of the drug or skip the injection, the patient should consult a doctor.
Side effects
On the part of the digestive system: often (more than 1/100, less than 1/10) - nausea, vomiting, abdominal pain; rarely (more than 1/1000, less than 1/100) - diarrhea. From the reproductive system: often (more than 1/100, less than 1/10) - ovarian hyperstimulation syndrome (OHSS); rarely (more than 1/1000, less than 1/100) - severe OHSS, breast tenderness. On the CNS side: often (more than 1/100, less than 1/10) - headache; rarely (more than 1/1000, less than 1/100) - depression, irritability, anxiety, fatigue. Dermatological reactions: very rarely (more than 1/10 000) - reversible mild skin rash. Local reactions: often (more than 1/100, less 1/10) - pain and hyperemia at the injection site. Other: often (more than 1/100, less than 1/10) - feeling tired; very rarely (more than 1/10 000) - mild allergic reactions.
Overdose
There are no data on drug overdose. Symptoms: ovarian hyperstimulation syndrome may develop, characterized by the formation of large ovarian cysts with a risk of rupture (perforation), ascites and circulatory disorders. Treatment: at high risk of OHS, it is recommended to stop the administration of hCG. Patients for at least 4 days are advised to refrain from sexual contact or use barrier methods of contraception.
Interaction with other drugs
So far, there are no data on interactions with other drugs. The patient should inform the doctor about all the drugs (including non-prescription drugs) that she is currently taking or has recently taken.
special instructions
Before starting treatment, it is necessary to establish the causes of infertility in the patient and her partner and evaluate the estimated risk factors for the occurrence of pregnancy. Consider the presence of clinically expressed hypothyroidism, adrenal insufficiency, hyperprolactinemia, the presence of pituitary and hypothalamic tumors, and specific therapies used. During ovarian stimulation, patients are at risk of developing OHS due to the simultaneous maturation of a large number of follicles. In clinical studies, OHSS (in most cases, mild and moderate) was observed in approximately 4% of patients. A severe HEH can be a serious complication of stimulation. In rare cases, hemoperitoneum, acute respiratory distress syndrome, ovarian torsion and thromboembolism may be a complication of severe OHSS. In order to reduce the risk of OHS in the protocol of follicle growth stimulation, careful monitoring of the ovarian response using ultrasound and determining the level of estradiol in the blood before and during the course of treatment is recommended. Compared with natural fertilization, the risk of multiple pregnancy increases when stimulation is performed. In most cases, twins are born. When using assisted reproduction methods, the number of babies born corresponds to the number of embryos transferred into the uterus. The statistics of miscarriages after treatment of anovulatory infertility (incl.using assisted reproductive technologies) exceeds the average for the population, but is comparable with other types of infertility. Introduction Ovitrel can affect the immunological picture of hCG levels in serum and urine for 10 days and lead to a false-positive reaction during pregnancy testing During the treatment with Ovitrel, insignificant stimulation of the thyroid gland function is possible. Patients should be warned about the need to inform the doctor about the increased side effects. s or the side effects that are not described within vyshe.V shelf life of the drug is permitted to store the refrigerator at a temperature not higher than 25 ° C for 30 days. The drug should be destroyed if it is not used during this period. Influence on the ability to drive vehicles and control mechanismsOvitrel does not affect the ability to drive vehicles and work with mechanisms.