Crane vaginal gel, No. 15

• Maintenance of the luteal phase in the process of using assisted reproduction methods;

• secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency;

• hormone replacement therapy in postmenopausal women (in combination with estrogen drugs).

Intravaginally.

Maintenance of the luteal phase in the process of using assisted reproduction methods. Starting from the day of embryo transfer, the gel in the amount of 1.125 g (90 mg progesterone - 1 applicator) is injected intravaginally daily. When pregnancy occurs, therapy is continued until 12 weeks or within 10-12 weeks from the date of confirmed pregnancy.

Secondary amenorrhea, dysfunctional uterine bleeding due to progesterone deficiency. 1.125 g (90 mg of progesterone) of the gel is administered intravaginally every other day from the 15th to the 25th day of the cycle. If necessary, the dose can be reduced or increased.

Hormone replacement therapy in postmenopausal women (in combination with estrogen drugs). 90 mg progesterone (1 applicator) 2 times a week.

Information for the patient for independent use

It is necessary to strictly follow the doctor's recommendations when using the drug CrainonЃ. KrynonЃ contains the corpus luteum hormone identical to the natural hormone progesterone. CrainonЃ is inserted into the vagina. For hygienic reasons and for ease of use, CrainonЃ is packaged in a disposable applicator that is discarded after use.

The applicator consists of an air container, flat end, top end, bottom end, break-off cap.

The application should be carried out in accordance with these instructions:

Take the applicator by pressing the upper end firmly between your thumb and forefinger. Shake the applicator like a medical thermometer so that the gel moves to the lower end of the applicator.

Hold the applicator by the upper flat end of the air container, remove the break-off cap from the opposite end by turning. Do not press on the air container.

The applicator can be inserted either in a sitting position or in a prone position with slightly bent knees. Gently insert the lower end of the applicator into the vagina.

Squeeze the air container firmly so that the gel from the applicator enters the vagina. Despite the fact that some of the gel remains in the applicator, the patient receives the required dose in full. You can then discard the applicator with the remaining gel in it. CrainonЃ coats the vaginal mucosa, providing a sustained release of progesterone.

Homogeneous vaginal gel, white or almost white, soft consistency, with a specific odor.

1 applicator (1.125 g)

progesterone 90 mg

Excipients: glycerol, liquid light paraffin, hydrogenated palm oil glyceride, carbomer 974R, sorbic acid, polycarbophil, sodium hydroxide, purified water.

• Hypersensitivity to progesterone or to other components of the drug;

• vaginal bleeding of unknown etiology;

• acute porphyria;

• malignant tumors of the genitals or mammary glands or suspicion of their presence;

• acute thrombosis or thrombophlebitis, thrombroembolic diseases, acute cerebrovascular accident (including history);

• incomplete abortion;

• period of breastfeeding.

With care: arterial hypertension, chronic renal failure, cardiovascular failure, diabetes mellitus, bronchial asthma, epilepsy, migraine, depression, hyperlipoproteinemia.

pharmachologic effect

Gestagen. Progesterone is a hormone of the corpus luteum. It causes the transition of the uterine mucosa from the proliferation phase, caused by the action of FSH, into the secretory phase. Reduces the excitability and contractility of the muscles of the uterus and fallopian tubes.

Progesterone inhibits the secretion of hypothalamic release factors of FSH and LH, inhibits the formation of gonadotropic hormones in the pituitary gland and inhibits ovulation.

In CraneonЃ, the vaginal progesterone gel is incorporated into a polymeric delivery system that binds to the vaginal mucosa and provides a continuous release of progesterone for at least 3 days.

Pharmacokinetics

Suction

When using a vaginal gel in a dose containing 90 mg of progesterone, the Cmax of the active substance in the blood is reached after 6 hours and is 11 mg / ml.

Metabolism and excretion

T1 / 2 - 34-48 hours. Progesterone is metabolized mainly in the liver. Intravaginal administration significantly reduces the 'first pass' effect through the liver. The main metabolite, 3 - ?, 5 -? - pregnandiol, is excreted in the urine.

Side effect

From the side of the central nervous system: headache, drowsiness.

From the digestive system: abdominal pain.

From the reproductive system: soreness of the mammary glands, intermenstrual bleeding, irritation of the vaginal mucosa and other local reactions of moderate severity in the area of ??application.

Allergic reactions: hypersensitivity reactions are possible, usually manifested in the form of a skin rash.

Application during pregnancy and lactation

CrainonЃ can be used in the first trimester of pregnancy in case of insufficiency of the function of the corpus luteum. The use of CrainonЃ in later stages of pregnancy is not recommended.

Use during breastfeeding is contraindicated.

Application for violations of liver function

The drug is prescribed with caution in case of liver dysfunction.

Application for impaired renal function

With caution and under constant supervision, the drug is prescribed to patients with impaired renal function (due to possible fluid retention in the body).

special instructions

Special attention should be paid to the possible appearance of early symptoms of thrombotic disorders (thrombophlebitis, cerebrovascular accidents, pulmonary embolism and retinal thrombosis). If a symptom is found that indicates these violations, or even suggests their presence, you should immediately stop taking the drug.

Patients with any risk factors for thrombotic disorders should be closely monitored.

In the course of long-term treatment, regular gynecological examinations are necessary in order to exclude the possibility of developing endometrial hyperplasia.

The physical examination before starting therapy should include an assessment of the condition and development of the mammary glands and pelvic organs, as well as a cervical smear (Pap test).

In order to prevent the possibility of incomplete abortion when using the drug CrainonЃ, the level of chorionic gonadotropin should be determined or an ultrasound scan should be performed.

Use with caution in case of liver dysfunction.

In cases of breakthrough bleeding, as in all cases of irregular vaginal bleeding, organic pathology should be excluded.

In the case of vaginal bleeding of unknown etiology, an appropriate examination should be carried out.

Because progestogens have the ability to retain fluid in the body, patients with diseases such as epilepsy, migraine, bronchial asthma, cardiovascular failure, and renal dysfunction should be closely monitored.

Patients with a history of depression should be closely monitored and treatment interrupted if depression worsens.

A small number of patients receiving estrogen-progestogen therapy may experience a decrease in glucose tolerance. The mechanism of this violation is not known. In this regard, patients with diabetes mellitus should be closely monitored during progesterone treatment.

Sorbic acid is a part of CrainonЃ, which can cause a local skin reaction (contact dermatitis).

The effect of the drug on the ability to drive a car and control other mechanisms

CrainonЃ has a mild or moderate effect on the ability to drive and operate machinery. Because when using the drug CrainonЃ, a feeling of fatigue or drowsiness may appear, caution is required when driving a car and other mechanisms. The use of alcohol can enhance this effect.

Overdose

Currently, no cases of overdose of the drug CrainonЃ have been reported.

Drug interactions

The use of CrainonЃ together with other intravaginal agents is not recommended.