Composition, form of production and packaging
The solution for the sc administration is transparent or slightly opalescent, colorless or light yellow in color.
1 syringe (0.5 ml)
choriomonadotropin alfa 250 mcg (6500 IU)
Excipients: mannitol, methionine, poloxamer 188, phosphoric acid, sodium hydroxide, water d / u.
0.5 ml - colorless glass syringes (1) complete with needles d / and (1 pc.) - plastic containers (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Recombinant choriomonadotropin alfa, which has the same amino acid sequence as the natural human chorionic gonadotropin. It binds the transmembrane LH receptors on the surface of the cells of the teki and granulosa of the ovary. Causes initiation of oocyte meiosis, rupture of follicles (ovulation), formation of a yellow body, production of progesterone and estradiol by a yellow body.
PHARMACOKINETICS
With n / k introduction, absolute bioavailability is approximately 40%, T 1/2 - about 30 hours.
INDICATIONS
- in the protocol of induction of multiple follicular maturation (superovulation) for auxiliary reproductive technologies (including for in vitro fertilization) with the aim of inducing the final maturation of follicles and luteinization after stimulation with gonadotropins;
- with anovulatory or oligo-ovulatory infertility for induction of ovulation and luteinization at the end of stimulation of follicle growth.
DOSING MODE
The drug is administered sc. Each syringe is for single use only.
When applied in the induction protocol of multiple follicular maturation for auxiliary reproductive technologies (including for in vitro fertilization) to induce the final maturation of follicles and luteinization after stimulation with gonadotropins, OvitrelВ® at a dose of 250 Ојg (the contents of 1 syringe) is administered once through 24- 48 hours after the last injection of FSH or LH and the optimal level of development of the follicle.
With anovulatory or oligovulatory infertility for induction of ovulation and luteinization at the end of stimulation of the growth of follicles, OvitrelВ® at a dose of 250 Ојg (the contents of 1 syringe) is administered once 24-48 hours after reaching the optimal level of follicle development. It is recommended to have sexual intercourse on the day of drug administration and the next day.
Rules of drug administration
When self-administered, patients should carefully read the instructions.
1. Injection should be carried out in compliance with the rules of asepsis and antiseptics.
2. To carry out the injection, it is necessary to spread out on a clean surface 2 alcohol impregnated swabs, a pre-filled syringe or a ready-to-use syringe.
3. Next, you should immediately inject (in the abdomen or the front of the thigh). To do this, wipe selected by the recommendation of the doctor site with a swab with alcohol. Strongly tighten the skin with your fingers and, pointing the needle at an angle of 45-90 В° in the skin fold, make a s / c injection. It is necessary to avoid getting the drug into the 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 place of injection with a swab with alcohol in a circular motion.
4. Immediately after the injection, the used syringe should be placed in a container for storing sharp objects. All unused volume should be destroyed.
In the case of an increased dose of the drug or a missed injection, the patient should consult a doctor.
SIDE EFFECT
On the part of the digestive system: often (> 1/100, <1/10) - nausea, vomiting, abdominal pain; rarely (> 1/1000, <1/100) - diarrhea.
On the part of the reproductive system: often (> 1/100, <1/10) - Ovarian hyperstimulation syndrome (OSS); rarely (> 1/1000, <1/100) - severe hypoglycemia, tenderness of mammary glands.
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 rare (> 1/10 000) - reversible mild skin rash.
Local reactions: often (> 1/100, <1/10) - pain and hyperemia at the injection site.
Other: often (> 1/100, <1/10) - a feeling of fatigue; very rarely (> 1/10 000) - allergic reactions in mild form.
CONTRAINDICATIONS
- tumors in the hypothalamus and pituitary gland;
- voluminous ovarian neoplasms or cysts not associated with polycystic ovary;
- vaginal bleeding of unknown origin;
- cancer of the ovary, uterus or breast;
- ectopic pregnancy within 3 previous months;
- thromboembolism;
- primary ovarian insufficiency;
- congenital malformations of the reproductive organs incompatible with pregnancy;
- fibroids of the uterus, incompatible with pregnancy;
- postmenopause;
- Hypersensitivity to the components of the drug.
Caution should be given to OvitrelВ® in patients with serious systemic illnesses when pregnancy can lead to their exacerbation.
SPECIAL INSTRUCTIONS
Before the beginning of treatment it is necessary to establish the causes of infertility in the patient and her partner and to evaluate the expected risk factors for the onset of pregnancy. It should take into account the presence of clinically pronounced hypothyroidism, adrenal insufficiency, hyperprolactinaemia, the presence of tumors of the pituitary and hypothalamus, the specific methods of therapy used.
In the process of stimulation of the ovaries, patients are at risk of developing CHD because of the simultaneous ripening of a large number of follicles. In clinical trials of OHSS (in most cases, mild to moderate), approximately 4% of patients were observed. A severe hypoglycemic episode can be a serious complication of stimulation. In rare cases, the complication of severe SWC may be hemoperitoneum, acute respiratory distress syndrome, ovarian torsion and thromboembolism. In order to reduce the risk of hypoglycemia in the protocol for stimulating the growth of follicles, careful monitoring of ovarian response with ultrasound and the determination of the level of estradiol in the blood before and during the course of treatment are recommended.
In comparison with natural fertilization, the risk of multiple pregnancy increases during stimulation. In most cases, twins are born. When using methods of assisted reproduction, the number of babies born corresponds to the number of embryos transferred to the uterine cavity.
Statistics of miscarriages after treatment of anovulatory infertility (including assisted reproductive technologies) exceed the average for the population, but comparable to other types of infertility.
The introduction of Ovitrel can influence the immunological picture of the hCG level in serum and urine for 10 days and lead to a false positive reaction in the pregnancy test.
During the treatment with Ovitrel В®, slight stimulation of thyroid function is possible.
Patients should be warned about the need to report to the doctor about the increase in side effects or about side effects not described above.
Within the expiration date, storage of the drug outside the refrigerator is allowed at a temperature of no higher than 25 В° C for 30 days. The drug should be destroyed if it is not used during this period.
Impact on the ability to drive vehicles and manage mechanisms
Ovitril В® does not affect the ability to drive vehicles and work with mechanisms.
OVERDOSE
Data on drug overdose are absent.
Symptoms: There may be a development of ovarian hyperstimulation syndrome, characterized by the formation of large ovarian cysts with the risk of their rupture (perforation), the development of ascites and circulatory disorders.
Treatment: at a high risk of development of hypoglycemia, it is recommended to cancel the administration of hCG. Patients for at least 4 days are advised to refrain from sexual contact or use barrier methods of contraception.
DRUG INTERACTION
Until now, there is no data on interactions with other drugs.
The patient should inform the doctor about all medications (including over-the-counter drugs) that she is currently or recently taking.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children at a temperature of 2 В° to 8 В° C in the original package; Do not freeze. Shelf life - 2 years.
