Elonva solution for p / leather. having injected 150 mcg 0.5 ml syringe 1 pc. (Koryfollytropyn alpha)

Release form

Solution for subcutaneous solution zrd49rd 79d Solution for subcutaneous administration

Packaging

Syringe 0.5 ml

Pharmacological action

Follicle-stimulating agent. Corifollitropin alpha - a glycoprotein obtained using recombinant DNA, is produced by Chinese hamster ovary cells. The growth stimulator of follicles of prolonged action, by pharmacodynamic properties, is comparable with recombinant FSH (rFSH), but has a significantly longer duration. Corifollitropin alpha induces and supports follicular growth throughout the week. An increase in the duration of follicle-stimulating activity was achieved by attaching the carboxyterminal peptide of the beta subunit of human chorionic gonadotropin (hCG) to the beta chain of human FSH. Corifollitropin alpha does not have hCG and LH activity.

Indications

Controlled ovarian stimulation in combination with a gonadotropin releasing hormone antagonist (GnRH) to form multiple follicles in women participating in the assisted reproduction program.

Use during pregnancy and lactation

Use of the drug Elonva during pregnancy is contraindicated.

After controlled ovarian stimulation with gonadotropins, no teratogenic effect was detected in clinical practice. Clinical data do not allow to exclude the teratogenic effect of Corifollitropin alfa in case of its unintentional administration during pregnancy. In preclinical studies, no teratogenic effect associated with the use of the drug was observed.

The use of the drug Elonva during lactation is contraindicated.

Composition

0.5 ml contains:

Active ingredients: corifollitropine alpha - 150 μg

Excipients: sodium citrate dihydrate - 3.68 mg, sucrose - 35 mg, L-methionine - 250 μg, polysorbate 20 - 100 μg, hydrochloric acid 0.1 M or sodium hydroxide 0.1 M - up to pH 7.0, water d / u (extract volume) - up to 0.5 ml.

Dosage and administration of

The use of the drug Elonva should be carried out under the supervision of a physician with experience in the treatment of infertility. The drug can be used only if the solution in the syringe is clear.

Women with body weight> 60 kg are given 150 mcg once.

Recommended doses have been established only when combined with a GnRH antagonist.

On the 1st day of stimulation, the drug Elonva is administered once subcutaneously (preferably under the skin of the abdomen) into the early follicular phase of the menstrual cycle.

On the 5th or 6th day of stimulation, depending on the number and size of growing follicles and / or the concentration of estradiol in the blood, the use of a GnRH antagonist should be started to prevent premature increase in LH concentration.

On the 8th day of stimulation (7 days after the injection of Elonva), treatment can be continued with daily administration of rFSH until the follicle size meets the criteria for the introduction of a trigger dose of hCG (3 follicles? 17mm). The daily dose of rFSH depends on the response of the ovaries, which is regularly monitored by ultrasound, starting from the 5th or 6th day of stimulation. If the answer is normal, then the recommended daily dose is 150 ME rFSH.

Receiving rFSH on the day of hCG administration may be skipped depending on the response of the ovaries. Usually, sufficient follicular maturation is achieved on the 9th day of treatment (the treatment duration range is from 6 to 18 days).

Upon the maturation of 3 follicles up to a size of? 17 mm, a single injection of 5000 ME to 10,000 MEHHC is performed on the same or next day to induce the final maturation of oocytes. In case of an excessive ovarian response, recommendations should be used to minimize the risk of developing OHSS.

Clinical studies of the drug in patients with renal failure have not been conducted. Because elimination of corifollitropine alpha in such patients can be reduced, the use of the drug Elonva in women with renal failure is not recommended.

Although there are no data on the use of the drug in patients with liver failure, the effect of liver failure on the excretion of corifollitropine alpha is unlikely.

The use of the drug Elonva in children does not correlate with the indication.

Rules for administering the drug

A subcutaneous injection of the drug can be given by the woman herself or by another person, if the doctor has provided appropriate recommendations.

Advice for patients on the preparation and execution of a subcutaneous injection

Preparation for injection

Treat the skin at the site of the intended injection with a disinfectant.

Break the needle cap along the perforation line, remove the case containing the needle. Do not remove the case from the needle. Place the case containing the needle on a dry, clean surface.

Hold the syringe with the cap up (vertically). Gently tap the syringe with your finger so that the air bubbles rise.

Hold the syringe upright. Unscrew the syringe cap counterclockwise.

Hold the syringe upright. Screw the needle case containing the needle clockwise onto it.

Hold the syringe upright. Remove the case from the needle and discard it. Caution should be exercised when handling the needle.

Performing an injection

Hold the syringe between the index and middle fingers and hold it upright. Place thumb on piston. Gently press the piston so that a drop of solution appears on the tip of the needle.

Make a skin fold with the thumb and forefinger. Insert the needle at a 90 ° angle into the skin fold. Gently push the piston all the way. Count to 5 to enter the entire solution.

Remove the thumb from the piston. The needle will automatically retract into the syringe and be blocked.

Side effects

From the nervous system: headache, dizziness.

From the digestive system: nausea, abdominal pain, vomiting, diarrhea, constipation, bloating.

From the reproductive system: OSS, pain and discomfort in the pelvic area, complaints from the mammary glands, torsion of the ovary.

General reactions: fatigue.

Drug Interaction

Interaction with other drugs has not been studied.

Corifollitropin alfa is not a substrate for cytochrome P450 isoenzymes, so it is not expected to interact with other drugs.

Overdose

Administration of more than one dose of the drug during one cycle or the use of the drug and / or RFFS at too high doses may increase the risk of developing ovarian hyperstimulation syndrome (see Special Instructions).

Storage conditions

Store at 2 ° C to 8 ° C. Do not freeze.

The Expiration of

is 3 years.

Dosage form

dosage form

solution for injections



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