Active substanceChoriogonadotropin alfaChoriogonadotropin alfa
Similar drugsTo uncover
  • Ovitrel®
    solution PC 
    Merck Serono SpA     Italy
  • Ovitrel®
    lyophilizate PC 
    Merck Serono SpA     Italy
  • Dosage form: & nbsphypodermic solution
    Composition:
    One filled syringe with 0.5 ml of solution contains: active substance - choriomonadotropin alfa 250 mcg (6500 IU) and Excipients: mannitol 27.3 mg, methionine 0.1 mg, poloxamer 188 0.05 mg, phosphoric acid 0.49 mg, sodium hydroxide q.s. for pH adjustment, water for injection up to 0.5 g.
    Description:
    Transparent or slightly opalescent colorless or light yellow solution.
    Pharmacotherapeutic group:Luteinizing agent
    ATX: & nbsp

    G.03.G.A.08   Choriogonadotropin alfa

    Pharmacodynamics:
    Ovitrel® contains choriomonadotropin alfa, which is produced by recombinant DNA technology. It has the same amino acid sequence as the natural human chorionic gonadotropin. Chorionic gonadotropin binds transmembrane receptors of luteinizing hormone (LH) on the surface of cells of the current and granulosa of the ovary. Causes initiation of oocyte meiosis, rupture of follicles (ovulation), formation yellow body, progesterone and estradiol production in a yellow body.
    Pharmacokinetics:

    Suction and distribution

    After intravenous administration choriomonadotropin alfa is distributed into the extracellular fluid with a half-distribution period of about 4.5 hours. The stationary volume of distribution and the total clearance are 6 liters and 0.2 liters / hour, respectively.

    With subcutaneous administration of chorio gonadotropin alfa, the absolute bioavailability is approximately 40%, the final half-life is about 30 hours.

    Excretion and Metabolism

    Metabolism and excretion of chorioradotropin alfa are analogous to endogenous chorionic gonadotropin.

    Indications:In the protocol of induction of multiple maturation of follicles for auxiliary reproductive technologies (ART), including for in vitro fertilization (IVF), in order to induce the final maturation of follicles and luteinisation after stimulation of gonadotropin drugs.

    With anovulatory or oligovulatory infertility for induction of ovulation and luteinization at the end of stimulation of follicle growth.

    Contraindications:- Hypersensitivity to the active component and to any of the auxiliary components included in the formulation;
    - Tumors of the hypothalamus and pituitary gland;
    - Volumetric ovarian neoplasms or cysts unrelated to polycystic ovaries.
    - Vaginal bleeding of unclear etiology.
    - Cancer of the ovary, uterus or breast.
    - Ectopic pregnancy within 3 previous months.
    - Thromboembolism.
    - Primary ovarian failure.
    - Congenital malformations of the genital organs, incompatible with pregnancy.
    - Fibromyoma of the uterus, incompatible with pregnancy.
    - Postmenopause.
    Carefully:
    Caution should be given to Ovitrel® in patients with severe systemic diseases, in cases where pregnancy can lead to their exacerbation.
    Pregnancy and lactation:During pregnancy and breastfeeding, Ovitrel® is not prescribed.
    Data on the excretion of choriogonadotropin alpha in breast milk are absent.
    Dosing and Administration:
    Ovitrel® is administered subcutaneously. Each syringe or syringe pen is intended for single use only.
    Treatment should be conducted only under the guidance of a physician with experience in the treatment of infertility.
    In the protocol of induction of multiple maturation of follicles for ART, including for IVF, with the aim of inducing the final maturation of follicles and luteinization after stimulation with gonadotropins:
    Ovitrel® at a dose of 250 μg (the contents of 1 syringe or 1 syringe pen) is administered once 24-48 hours after the last injection of the follicle-stimulating hormone preparation or LH and achieve optimal levels of follicle development.

    With anovulatory or oligovulatory infertility for induction of ovulation and luteinization at the end of stimulation of follicle growth:

    Ovitrel® at a dose of 250 μg (the contents of 1 syringe or 1 syringe-pen) is injected once 24-48 hours after reaching the optimum level of development of the follicle. It is recommended to have sex on the day of Ovitrel® administration and on the next day.

    Recommendations for the self-administration of Ovitrel®.

    Self-introduction is possible only by patients who have received appropriate training and have the opportunity to seek advice from a specialist doctor.

    When self-administered, the patient should carefully read and strictly follow the instructions below for the administration of the drug:

    Before the introduction:

    1. Wash your hands. It is important that your hands and the items that you use are clean.

    2. Prepare a clean surface and lay out on it everything you need for injection:

    1. two tampons moistened with alcohol (not included in the package);

    2. one syringe with the drug or one syringe-pen and a needle for injection.

    For a syringe:

    1. Introduction of injection: Immediately swipe injection:

    Choose a site for injection in accordance with the recommendations of your doctor or nurse (stomach, front of the thigh). Wipe the selected area with a swab with alcohol. Strongly tighten the skin with your fingers and with a short, vigorous movement, aim the needle at an angle 45° - 90 ° in the skin fold. Conduct a subcutaneous injection, as you were taught. Avoid getting the drug directly into the vein. Enter the solution by gently pressing the plunger. Use as much time as you need to enter the entire volume of the solution. Immediately after the injection, remove the needle and wipe the skin at the injection site with a swab with alcohol.

    2. Disposal of used accessories: Immediately after injection, place the used syringe in a container for storing sharp objects. All unused solution must be destroyed.

    For the syringe pen:

    Use the syringe pen only for yourself, do not let anyone else use it.

    Use Ovitrel® as directed showed a doctor or nurse.

    The illustration below shows the appearance of the syringe pen, indicating its individual elements:

    1. button for setting the dose

    2. indicator board

    3. the piston

    4. tank compartment

    5. threaded tip

    6. pen-syringe cap

    7. removable needle

    8. inner needle cap

    9. outer needle cap

    10. protective sticker

    1. Preparation of a syringe-pen for injection

    1.1 Remove the cap from the syringe pen

    1.2 Put on the needle

    - Take the needle - use only disposable needles supplied together with the pre- completed syringe-pen Ovitrel®.

    - Make sure that the protective label on the outer cap of the needle is not damaged or weakened.

    ATTENTION:

    If the protective label is damaged or loose, do not use this needle. Take another. Dispose of the unused needle with the outer cap on it. Instructions for disposing of unnecessary needles should be obtained from your doctor or nurse.

    - Remove the protective sticker.

    - Firmly hold the outer needle cap.

    - Insert the tip of the syringe-handle with the thread into the outer cap of the needle and screw the outer cap until it firmly fixes.

    1.3 Remove large air bubbles:

    - Inspect the tank compartment carefully.

    - If you did not find a large air bubble, then the pen-pen is ready to use. In this case go to step 2 "Set the dose at 250".

    An air bubble is considered large if it completely fills the tip of the cartridge compartment when the needle is held up by the needle (see illustration). If you see a large air bubble inside the reservoir compartment, it must be removed. In the syringe handle, there may be several small air bubbles adhering to the inner wall of the compartment with the reservoir. Do not pay attention to small bubbles, they do not have to be removed.

    To remove a large air bubble

    1. Carefully rotate the button to set the dose in a clockwise direction until the dot (-) appears on the dose indicator panel. If you skipped this position, simply turn the button back to the point (-).

    2. Then remove the inner needle cap and hold the needle pen up with the needle.

    3. Slightly tap the reservoir compartment with your finger so that all air bubbles float up to the needle.Continuing to hold the needle pen up with the needle and gently pushing the button to set the dose, push the plunger out until the air bubble is released.

    4. At the tip of the needle, a drop of solution should appear; this means that your syringe pen is ready to be injected.

    5. If the solution does not come through at the tip of the needle, repeat the manipulations described above again (the maximum number of attempts is 2), starting with step 1 ("To remove a large air bubble" item).

    2. Setting the dose at 250

    - Carefully turn the button to set the dose clockwise until the number "250" appears on the display of the dose indicator instead of a straight line.

    - Turning the button to set the dose should not be pressed on it or, conversely, delayed.

    - On the display of the dose indicator should appear the number "250", as shown in the figure below.

    3. Dosing Introduction

    1. Select a site for injection as indicated by your doctor or nurse.

    2. Disinfect the injection site by wiping it with a swab dipped in alcohol.

    3. Make sure again that the number is "250" on the scoreboard. If there is no number on the scoreboard, you need to set the correct dose (see section 2 "Setting the dose at 250").

    4. Carefully remove the inner cap and discard it (if this has not already been done by following the instructions in 1.3 "Remove large air bubbles").

    Enter the dose as directed by your doctor or nurse

    - First, slowly insert the needle under the skin, then press the button to set the dose until it stops, as shown in the figure below.

    - The number with the dosage indicated on the display of the dose indicator will return to the "O" position. This means that the whole dose has been introduced.

    - Leave the needle under the skin with the button pressed to set the dose for at least 10 seconds.

    - After 10 seconds, remove the needle by holding down the button to set the dose.

    4. After the injection

    4.1 Make sure that the number of "0" appears on the display of the dose indicator.

    - This means that the dose has been introduced completely. Do not attempt to inject a second time.

    - If the number "0" does not appear on the scoreboard, contact your doctor or nurse.

    4.2. Removing the needle

    - Hold the syringe handle firmly behind the reservoir compartment.

    - Carefully place the outer cap on the needle.

    - Then squeeze the outer cap and unscrew the needle.

    - Be careful not to prick the needle.
    - Now put the cap of the syringe-pen back on the handle.
    4.3 Disposal
    - Never use the needle or syringe pen again.
    - After the injection, dispose of the used needle and the syringe pen, respecting precautionary measures.
    - It is best to put it back in the packaging from the manufacturer. Medicinal products should not be disposed of in sewers or disposed of with household waste. When the syringe pen is finished, get instructions from your doctor or nurse about how to dispose of it.
    If you injected too much dose of the drug, Symptoms of ovarian hyperstimulation syndrome (OSS), which are described in the section "Special instructions" or "Side effects", may appear. If these symptoms appeared, consult a doctor.
    If you forgot to enter the drug, consult a doctor as soon as possible.
    Side effects:

    When Ovitrel® is used, side effects may develop. In the process of comparative clinical studies of various doses of the drug Ovitrel ®, the dose-dependence of occurrence of such side effects as SWN, nausea and vomiting was shown.COH was observed in approximately 4% of patients treated with Ovitrel®. The severe form of ovarian hypertension was noted in less than 0.5% of patients.

    AT Depending on the frequency of occurrence, side effects are regarded as very frequent (1/10), frequent (≥1 / 100 and <1/10), infrequent (≥1 / 1000 and <1/100), rare (≥1 / 10000 and <1/1000), very rare (<1/10000, including single messages). The frequency of side effects in each group is listed in descending order. AT Depending on the frequency of occurrence, adverse events can be divided into groups:

    The immune system: very rarely - from mild before a severe reaction hypersensitivity, including anaphylactic reactions and shock.

    CNS: infrequently - depression, irritability, excitement.

    Nervous system: often a headache.

    Vascular system: rarely - thromboembolism, usually associated with severe form of OHSS.

    Digestive system: often nausea, vomiting, pain in the abdomen, infrequently -diarrhea.

    Skin and subcutaneous tissue: rarely -easy reversible skin reactions in the form of rashes.

    Reproductive system and dairy glands: often - HSH of light or medium severity, infrequent - severe form SHG, tenderness of mammary glands.

    General and local reactions: often - fatigue, reactions at the injection site.

    Overdose:
    Data on drug overdose are absent. However, with an overdose of the process of stimulation of the ovaries, it is possible to develop an OHSS (see "Special instructions").
    Clinically, it is characterized by the formation of large ovarian cysts with the risk of their rupture (perforation), symptoms of ascites and circulatory disorders.
    Interaction:
    There is no data on interactions with other drugs. However, the patient must inform the doctor about all medicines (including OTC drugs) that she is currently or recently taking.
    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. Especially should take into account the symptoms of hypothyroidism, adrenocortical insufficiency, hyperprolactinemia, the presence of tumors
    pituitary or hypothalamus, and the specific methods of therapy used.
    Ovarian hyperstimulation syndrome (OSS)
    In the process of stimulation of the ovaries, the risk of occurrence of HNS due to the simultaneous maturation of a large number of follicles increases.
    OHSS may be a serious complication characterized by the formation of large ovarian cysts with the risk of their rupture, weight gain, dyspnea, oliguria, or the presence of ascites in the clinical picture of circulatory disorders. OCS of severe degree in rare cases can be accompanied by hemoperitoneum, acute pulmonary distress syndrome, ovarian torsion and thromboembolism.
    In order to reduce the risk of hypoglycemia in the protocol of stimulation of the growth of the follicles, it is recommended to closely monitor the response of the ovaries with the help of ultrasound and to determine the level of estradiol in the blood before and during the course of treatment.
    With anovulation, the risk of developing CHD increases with an estradiol concentration in the blood plasma> 1500 pg / ml (5400 pmol / L) and the presence of more than 3 follicles with a diameter of 14 mm or more. With ART, the risk of developing hypoglycemia increases with an estradiol concentration> 3000 pg / ml (11000 pmol / l) or 18 or more follicles with a diameter of 11 mm or more.
    OCG caused by an excessive response of the ovary can be avoided if the administration of hCG is abolished. Therefore, if the serum estradiol level> 5500 pg / ml (20 LLC pmol / L) and / or when 30 or more follicles are present, abstain from using hCG. Patients are advised to abstain from coitus or use barrier methods of contraception for at least 4 days.

    Multiple pregnancy

    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.

    The use of recommended doses of Ovitrel®, treatment regimens and careful monitoring in the course of therapy minimize the risk of OIH and multiple pregnancies.

    Unintention of pregnancy

    Statistics of miscarriages after treatment of anovulatory sterility, including those with ART, exceed the average for the population, but comparable to other types of infertility.

    Ectopic pregnancy

    Patients with tubal diseases have a history of increased risk of ectopic pregnancy, regardless of whether pregnancy is obtained by the usual route or in the treatment of infertility. Probability of ectopic pregnancy after use of auxiliary reproductive technologies are higher than in the general population.

    Congenital malformations of development

    The frequency of congenital anomalies after the application of ART programs can be slightly higher than with natural pregnancy and childbirth. Nevertheless, it is not known whether this is due to the peculiarity of the parents (for example, the mother's age, the quality of the sperm) and the multiple pregnancy or directly with the ART procedures.

    Thromboembolic complications

    In patients with recent or current thromboembolic diseases, as well as with the likely risk of their occurrence in the presence of a disease in the anamnesis or with relatives, the use Gonadotropins may increase this risk or complicate the course of these diseases. For patients in this group, the benefits of therapy should be correlated with the possible risk. It should be noted that the pregnancy itself, like the OSS, carries elevated risk thromboembolic disorders such as pulmonary embolism, ischemic stroke, or myocardial infarction.

    Impact on laboratory performance

    Drug management Ovitrel® can influence the immunological picture of hCG levels in serum and urine for 10 days and lead to a false positive reaction conducting a pregnancy test.

    other information

    During the treatment with Ovitrel®, slight stimulation of thyroid function is possible.

    If the manifestations of adverse reactions increase or you notice side effects not mentioned in the instructions, please inform your doctor.

    During the expiry date, the preparation (only for syringes) can be stored outside the refrigerator at a temperature of no higher than 25 ° C for 30 days. If after 30 days of such storage the drug has not been used, it must be destroyed.

    Effect on the ability to drive transp. cf. and fur:Virtually does not affect the management of the vehicle or any other mechanism.
    Form release / dosage:
    Solution for subcutaneous administration, 250 μg / 0.5 ml.
    Packaging:
    0.5 ml of a solution containing 250 μg (6500 ME) of choriomonadotropin alfa in a colorless glass syringe with an injection needle closed with a protective cap with a rubber gasket.
    0.5 ml of a solution containing 250 μg (6500 ME) of choriogonadotropin alfa in a syringe pen.
    1 The syringe is packed in a plastic container, placed in a cardboard box with the Instruction for use.
    1 syringe pen and 1 needle for injection are packed in a plastic container,placed in a cardboard box with instructions for use.
    Storage conditions:At a temperature of 2 - 8 ° C in the original packaging. Do not freeze. Keep out of the reach of children.
    Shelf life:
    2 years. Do not use the drug after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-002622
    Date of registration:09.08.2011 / 08.11.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Merck Serono SpAMerck Serono SpA Italy
    Manufacturer: & nbsp
    Representation: & nbspARES TRADING SAARES TRADING SARussia
    Information update date: & nbsp22.05.2017
    Illustrated instructions
    Instructions
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