Ovitrel - instructions for use, dose, side effects, contraindications

Active substanceChoriogonadotropin alfaChoriogonadotropin alfa

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Ovitrel®

solution PC

Merck Serono SpA Italy

Ovitrel®

lyophilizate PC

Merck Serono SpA Italy

Dosage form: & nbsplyophilizate for the preparation of a solution for subcutaneous administration

Composition:

1 bottle contains:

Active substance: chorio gonadotropin alfa 250 mcg (6500 IU)

Excipients: sucrose 30 mg, phosphoric acid 0.98 mg and sodium hydroxide q.s.

1 vial or ampoule with a solvent contains

1 ml of water for injection.

Description:Lyophilized powder or porous mass (lyophilizate) of white or almost white color. Solvent is a colorless clear 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 human chorionic gonadotropin contained in the urine. 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 subcutaneous administration of chorio gonadotropin alfa, the absolute bioavailability is approximately 40%, the half-life is about 30 hours.

Indications:

- In the protocol of induction of multiple maturation of follicles (superovulation) for assisted reproductive technologies (ART), including for in vitro fertilization (IVF), in order to induce the final maturation of follicles and luteinization after stimulation with gonadotropins.

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

Contraindications:

- Tumors in the hypothalamus and pituitary gland;

- Hypersensitivity to the active component and to any of the auxiliary components included in the formulation;

- Volumetric ovarian neoplasms or cysts not associated with ovarian polycystosis.

- Vaginal bleeding of unknown origin.

- Cancer of the ovary, uterus or breast.

- Ectopic pregnancy for 3 previous months.

- Thromboembolism.

- Primary ovarian failure.

- Congenital malformations of the reproductive organs, incompatible with pregnancy.

- Fibromyoma of the uterus, incompatible with pregnancy.

- Postmenopause.

Carefully:Caution should be given to Ovitrel® patients suffering from serious systemic diseases, in those cases when pregnancy can exacerbate the disease.

Dosing and Administration:

It is administered subcutaneously. Each bottle is for single use only.

- In the protocol of induction of multiple follicular maturation (superovulation) for assisted reproductive technologies (ART), including for in vitro fertilization (IVF), with the aim of inducing the final maturation of follicles and luteinisation after stimulation with gonadotropins:

Ovitrel® at a dose of 250 μg (the contents of 1 vial) is administered once 24-48 hours after the last injection of follicle stimulating hormone or luteinizing hormone and to achieve the optimal level of development of the follicle.

- In case of 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 vial) is administered once 24-48 hours after the last administrationa preparation of follicle-stimulating hormone or luteinizing hormone and to achieve the optimal level of follicle development. It is recommended to have sexual intercourse on the day of drug administration and the next day.

If the patient enters Ovitrel® independently, she should carefully read and strictly follow the instructions below for the administration of the drug:

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:

- one bottle of Ovitrel®,

- one ampoule or one vial with a solvent,

- two tampons moistened with alcohol

- one syringe,

- one needle of a larger diameter for a set of solvent,

- a thin needle for subcutaneous injection,

- container for sharp objects for the safe disposal of glass parts and needles.

3. Opening the ampoule with a solvent:

At the top end of the ampoule with a solvent you should see a small colored dot. A little below this point, the ampoule glass was processed in a special way, in order to make it easier to open it. Gently tap on the upper end of the ampoule, so that the liquid in it,moved to the lower section. Now, strongly push the stem and open the ampoule in the opposite direction from the color point. Carefully place the opened ampoule in an upright position on the work surface.

4. Set in a syringe of the solvent from the ampoule:

Put the needle for the solvent kit on the syringe. Holding. a syringe in one hand, take the opened ampoule with the other hand, place the needle inside the ampoule and put all the solvent into the syringe. Carefully place the syringe on the work surface, trying not to touch the needle.

5. Set in a syringe of the solvent from the vial:

Remove the protective cap from the solvent bottle. Put a needle on the syringe for a set of solvent (large in diameter). Draw a little air into the syringe, lifting the piston to about 1 ml. Then insert the needle into the vial, press the plunger, removing the air. Turn the bottle upside down and slowly pour the solvent into the syringe.

Carefully place the syringe on the work surface,

6. Preparation of solution for injection:

Remove the protective cap from the vial containing the Ovitrel® preparation, slowly inject the solvent into the vial using a syringe. Gently stir the contents in a circular motion.Do not shake. The drug should immediately dissolve and give a clear solution. The drug should be used immediately after dissolution. Do not inject the solution if it is opaque or contains solid particles.

Turn the bottle upside down, again, dial the solution into the syringe.

7. Injection administration:

Change the needle with a large diameter to a thin one. Remove air bubbles, if you will find in the syringe air bubbles point the syringe needle up and gently tap the syringe walls, so that the air going to the top. Gently press the plunger, removing air bubbles.

Immediately enter the injection: Your doctor or nurse should have already advised you where to inject (eg tummy, front of thigh). Wipe the selected area with a swab with alcohol. Strongly tighten the skin with your fingers and guide the needle at an angle of 45 ° - 90 ° with a short, vigorous movement. Conduct a subcutaneous injection, as you were taught. Do not inject directly into the vein. Enter the solution gently pressing the plunger. Use as much time as you need to enter the entire volume of the solution.Immediately after this, remove the needle and wipe the skin at the injection site with a swab with alcohol, while using circular motions.

8. Disposal of used accessories:

Immediately after the injection, place the used needles and empty glass containers in a container for storing sharp objects. The entire unused volume of the solution must be destroyed.

Side effects:

Depending on the frequency of occurrence, side effects can be divided into groups:

Frequent (> 1/100, <1/10)

Digestive system: vomiting / nausea, abdominal pain.

Reproductive system: OCG.

Are common: headache, fatigue.

Local reactions: pain at injection site

Rare (> 1/1000, <1/100)

CNS: depression, irritability, anxiety.

Digestive system: diarrhea

Reproductive system and mammary glands: Severe hypoglycemia, tenderness mammary glands

Very rare (> 1/10000)

The immune system: allergic reactions in mild form,

Skin and subcutaneous tissue: easy reversible skin reactions in the form of a rash.

Overdose:

Data on drug overdose are absent. However, with an overdose in the process of stimulation of the ovaries, the development of the ovarian hyperstimulation syndrome (OSS) is possible (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.

In the case of a high risk of hypoglycemia, it is recommended to cancel the introduction of human chorionic gadotrophin. Patients for at least 4 days are recommended to refrain from sexual contact or use barrier methods of contraception.

Interaction:There is no data on interactions with other drugs. Nevertheless, the patient must inform the doctor about all medicines (including over-the-counter 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 patients, the patient and her partner and to assess the presumed risk factors for the onset of pregnancy. The symptoms of hypothyroidism, adrenocortical deficiency, hyperprolactinemia, the presence of tumors of the pituitary and hypothalamus, the specific methods of therapy used.

The introduction of Ovitrel®, like any drug, can be accompanied by side reactions, although they do not appear in all.Most of the reported adverse reactions were mild to moderate. Most often, fatigue, pain and redness at the injection site were noted.

In the process of stimulation of the ovaries, there is a risk of occurrence of OHV due to the simultaneous ripening of a large number of follicles. In clinical trials, OHSS was observed in approximately 4% of patients, in most cases mild or moderate. 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 OHSS in the protocol for stimulating the growth of the follicles, careful monitoring of the ovarian response by ultrasound and 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 assisted reproductive technologies, the number of babies born corresponds to the number of embryos transferred to the uterine cavity.

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.

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

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.

Form release / dosage:Lyophilizate for the preparation of a solution for subcutaneous injection, 250 mcg.

Packaging:Lyophilizate in a vial containing 250 μg (6500 ME) of chorio gadototropin alfa, complete with a solvent - 1 ml of water for injection in vials or ampoules. For 1.2 or 10 vials of the preparation and with the same number of vials or ampoules with a solvent in a plastic container and then in a cardboard pack together with the Instruction for Use.

Storage conditions:In the original packaging at a temperature of no higher than 25 ° C.Keep out of the reach of children. List B.

Shelf life:

Preparation: 2 years.

Solvent: 3 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015668 / 01

Date of registration:10.06.2009

Expiration Date:Unlimited

Date of cancellation:2017-12-14

The owner of the registration certificate:Merck Serono SpAMerck Serono SpA Italy

Manufacturer: & nbsp