Ovitrel solution for d / p / k. Administration 250mkg / 0.5ml, syringe

• In the protocol for the induction of multiple follicle maturation (superovulation) for assisted reproductive technologies (including for in vitro fertilization) in order to induce the final maturation of follicles and luteinization after stimulation with gonadotropin preparations;

• with anovulatory or oligo-ovulatory infertility for the induction of ovulation and luteinization at the end of stimulation of follicular growth.

The drug is administered sc. Each syringe is for single use only.

When used in the protocol for the induction of multiple maturation of follicles for assisted reproductive technologies (including for in vitro fertilization) in order to induce the final maturation of follicles and luteinization after stimulation with gonadotropin preparations, OvitrelЃ at a dose of 250 ?g (contents of 1 syringe) is administered once every 24 hours. 48 hours after the last injection of the drug FSH or LH and the achievement of the optimal level of follicular development.

In case of anovulatory or oligo-ovulatory infertility, for the induction of ovulation and luteinization at the end of stimulation of follicular growth, OvitrelЃ at a dose of 250 ?g (contents of 1 syringe) is administered once 24-48 hours after the optimal level of follicle development is achieved. Sexual intercourse is recommended on the day of drug administration and the next day.

Drug administration rules

When using the drug independently, patients should carefully study the instructions.

1. The injection should be carried out in compliance with the rules of asepsis and antiseptics.

2. For the injection, place 2 alcohol-soaked swabs, a pre-filled syringe or a ready-to-use syringe on a clean surface.

3. Followed by an immediate injection (in the abdomen or the front of the thigh). To do this, wipe the area selected on the recommendation of a doctor with a swab with alcohol. Pull the skin tightly with your fingers and, directing the needle at an angle of 45-90 ? into the skin fold, make a subcutaneous injection. Avoid getting the drug into a vein. The drug is injected slowly, gently pressing the plunger, it is necessary to enter the entire volume of the solution. After removing the needle, wipe the injection site with an alcohol swab in a circular motion.

4. Immediately after injection, place the used syringe in a sharps container. Any unused volume should be discarded.

If an increased dose of the drug is administered or an injection is missed, the patient should consult a doctor.

Solution for subcutaneous administration is transparent or slightly opalescent, colorless or light yellow in color.

1 syringe (0.5 ml) choriogonadotropin alpha 250 ?g (6500 IU)

Excipients: mannitol, methionine, poloxamer 188, phosphoric acid, sodium hydroxide, water d / i.

• Tumors in the hypothalamus and pituitary gland;

• bulky neoplasms of the ovary or cysts not associated with polycystic ovary;

• vaginal bleeding of unknown origin;

• ovarian, uterine, or breast cancer;

• ectopic pregnancy within the previous 3 months;

• thromboembolism;

• primary ovarian insufficiency;

• congenital malformations of the genital organs incompatible with pregnancy;

• fibroids of the uterus, incompatible with pregnancy;

• postmenopause;

• hypersensitivity to the components of the drug.

With caution, OvitrelЃ should be prescribed to patients with serious systemic diseases in cases where pregnancy can lead to their exacerbation.

pharmachologic effect

Recombinant human chorionic gonadotropin alpha, which has the same amino acid sequence as natural human chorionic gonadotropin. Binds transmembrane LH receptors on the cell surface of theca and ovarian granulosa. It causes the initiation of oocytic meiosis, rupture of follicles (ovulation), the formation of the corpus luteum, the production of progesterone and estradiol by the corpus luteum.

Pharmacokinetics

With subcutaneous administration, the absolute bioavailability is approximately 40%, T1 / 2 is about 30 hours.

Side effect

From the digestive system: often (> 1/100, <1/10) - nausea, vomiting, abdominal pain; rarely (> 1/1000, <1/100) - diarrhea. From the reproductive system: often (> 1/100, <1/10) - ovarian hyperstimulation syndrome (OHSS); rarely (> 1/1000, <1/100) - severe OHSS, breast tenderness. From the side of the central nervous system: often (> 1/100, <1/10) - headache; rarely (> 1/1000, <1/100) - depression, irritability, anxiety, fatigue. Dermatological reactions: very rarely (> 1/10 000) - reversible mild skin rash. Local reactions: often (> 1/100, <1/10) - pain and hyperemia at the injection site. Others: often (> 1/100, <1/10) - feeling tired; very rarely (> 1/10 000) - mild allergic reactions.

special instructions

Before starting treatment, it is necessary to establish the causes of infertility in the patient and her partner and to assess the alleged risk factors for pregnancy. Should take into account the presence of clinically pronounced hypothyroidism, adrenal insufficiency, hyperprolactinemia, the presence of tumors of the pituitary gland and hypothalamus, used specific methods of therapy. During the process of ovarian stimulation, patients are at risk of developing OHSS due to the simultaneous maturation of a large number of follicles. In clinical studies, OHSS (in most cases mild to moderate) was observed in approximately 4% of patients. Severe OHSS can be a serious complication of stimulation. In rare cases, a complication of severe OHSS can be hemoperitoneum, acute respiratory distress syndrome, ovarian torsion, and thromboembolism.In order to reduce the risk of OHSS in the follicle growth stimulation protocol, it is recommended to carefully monitor the response of the ovaries using ultrasound and determine the level of estradiol in the blood before and during treatment. Compared to natural fertilization, stimulation increases the risk of multiple pregnancies. 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 uterine cavity. The statistics of miscarriages after treatment for anovulatory infertility (including with the help of assisted reproductive technologies) exceeds the average for the population, but is comparable with other types of infertility.The introduction of Ovitrel can affect the immunological picture of the level of hCG in serum and in urine for 10 days and lead to the appearance of a false-positive reaction when conducting a pregnancy test. During therapy with OvitrelЃ, slight stimulation of the thyroid gland function is possible. Patients should be warned about the need to inform the doctor about increased side effects or side effects not described above. Within the shelf life, it is allowed to store the drug outside the refrigerator at a temperature not exceeding 25 ? C for 30 days. The drug should be destroyed if it is not used during this period.Patients should be warned about the need to inform the doctor about increased side effects or side effects not described above. Within the shelf life, it is allowed to store the drug outside the refrigerator at a temperature not exceeding 25 ? C for 30 days. The drug should be destroyed if it is not used during this period.Patients should be warned about the need to inform the doctor about increased side effects or side effects not described above. Within the shelf life, it is allowed to store the drug outside the refrigerator at a temperature not exceeding 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 use mechanisms

OvitrelЃ does not affect the ability to drive vehicles and work with mechanisms.

Overdose

There are no data on drug overdose. Symptoms: it is possible to develop ovarian hyperstimulation syndrome, characterized by the formation of large ovarian cysts with the risk of rupture (perforation), the development of ascites and circulatory disorders. Treatment: with a high risk of developing OHSS, it is recommended to cancel the administration of hCG. Patients are advised to refrain from sexual intercourse or use barrier methods of contraception for at least 4 days.

Drug interactions

To date, there are no data on interactions with other drugs. The patient should inform the doctor about all medications (including over-the-counter) that she is currently taking or has recently taken.