Translation of the instruction Mose

PROGESTERONE Solutio oleosa for injections of 1%, Solutio oleosa for injections of 2.5%

And N with t r at to c and I

On medical use of medicine

Progesterone

(progesterone)

Ingredients:

Active ingredient: in 1 ml of medicine of progesterone of 10 mg or 25 mg;

excipients: benzyl benzoate, the olive oil refined.

Dosage form.

Solution for injections oil.

Main physical and chemical properties: transparent oily liquid from light yellow till chartreuse color.

Pharmacotherapeutic group.

Hormones of gonads and medicaments used at pathology of the sexual sphere. gestagena.

ATX G03D A04 Code.

Pharmacological properties.

Pharmacodynamics.

Progesterone is hormone of a yellow body; causes transition of a mucous membrane of a uterus from a phase of the proliferation caused by follicular hormone in a secretory phase, and after fertilization promotes its transition to a state necessary for oospore development. Reduces also excitability and contractility of muscles of a uterus and uterine tubes, stimulates development of trailer elements of a mammary gland. Stimulates in small doses, and in big — oppresses secretion of gonadotropic hormones. Slows down action of Aldosteronum that leads to strengthening of secretion of sodium and chlorine with urine. Has catabolic and immunodepressive effect.

Pharmacokinetics.

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After intramuscular and hypodermic introduction it is quickly and almost completely soaked up. It is metabolized in a liver, forming conjugates with glucuronic and sulphuric acid. The main transmutation product of progesterone is biologically active pregnandiol. Pregnandiol after conjugation with glucuronic acid gets from a liver to blood, and then — to urine. A smaller part of progesterone turns in pregnanolol and pregnandion. All metabolites of progesterone allocated with urine inactive.

Elimination half-life makes several minutes.

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50-60% removes with urine, more than 10% — with bile.

Quantity of the metabolites excreted with urine fluctuates depending on a phase of a yellow body.

Clinical characteristics.

Indication.

Amenorrhea, anovulatory uterine bleedings, the endocrine infertility including caused by insufficiency of a yellow body, a pregnancy miscarriage, an oligomenorrhea, algodismenoreya (because of a hypogonadism).

Contraindication.

Disease of a liver, abnormal liver function, hepatitis, liver and renal failure; cholestatic jaundice during pregnancy (in the anamnesis), a benign hyperbilirubinemia; new growths of a mammary gland and genitals; tachycardia, tendency to fibrinferments, an active venous or arterial thrombembolia, heavy thrombophlebitis or these states in the anamnesis; nervous breakdowns with the depression phenomenon; porphyria; pregnancy after the 36th week, an extrauterine pregnancy or pregnancy which stood in the anamnesis; vaginal bleedings of unspecified genesis, a state after abortion; hypersensitivity to medicine components.

Interaction with other medicines and other types of interactions.

Progesterone weakens effect of medicines which stimulate myometrium reduction (oxytocin, Pituitrinum), anabolic steroids (retabolil, Nerobolum), gonadotropic hormones of a hypophysis. in interaction with oxytocin the lactogenic effect decreases. strengthens effect of diuretics, hypotensive medicines, immunodepressants, a bromkriptin and system coagulants. reduces efficiency of anticoagulants. effect of progesterone decreases at simultaneous application of barbiturates. changes effects of hypoglycemic means. at simultaneous use with inductors of liver enzymes the increase or reduction of concentration of progesterone in blood plasma is possible.

Feature of use.

With care should be applied in diseases of a cardiovascular system, an arterial hypertension, chronic kidney disease, diabetes, bronchial asthma, epilepsy, migraine, a depression, a giperlipoproteinemiya.

Progesterone also should be applied with care the patient with mental disturbances in the anamnesis, medicament needs to be cancelled at emergence of the first symptoms of a depression.

At patients with diabetes needs to control carefully glucose level in blood.

needs to be

At use of Progesterone attentive to precursory symptoms and symptoms of a thrombembolia, and in case of their emergence the therapy by medicament needs to be stopped.

As metabolism of steroid hormones happens in a liver, Progesterone should not be applied to patients with abnormal liver functions.

At prolonged use of high doses of Progesterone the termination of periods is possible

.

should not use medicament in bleedings from a genital tract which reason is not established, and to patients in whose anamnesis diseases of peripheral arteries were noted. During treatment carrying out regular surveys which frequency and volume are defined individually is recommended.

in the presence of any progesteronzavisimy tumor, for example, of a meningioma in the past and/or its progressing during pregnancy or the previous hormonal therapy to patients needs to be under careful observation of the doctor.

Use during pregnancy or feeding by a breast.

during pregnancy to use medicament only for prevention and treatment of threat of an abortion. after the 36th week of pregnancy the use of medicament is contraindicated. not to use medicament for the women planning pregnancy in the nearest future. the risk of congenital anomalies, including sexual anomalies at children of both sexes, connected with effect of exogenous progesterone during pregnancy, completely is not established. progesterone gets into breast milk therefore medicament should not be used during feeding by a breast

Ability to influence speed of response at control of motor transport or other mechanisms.

Drug can cause dizziness and drowsiness. during treatment it is necessary to abstain from control of motor transport from occupations potentially dangerous types of activity requiring special attention and speed of psychomotor reactions.

Route of administration and doses.

an ampoule with medicament slightly to warm up

Before use on the water bath (till 30-40 ºс). in case of loss of crystals to heat an ampoule on the boiling water bath to their full dissolution. to administer the medicament intramusculary or subcutaneously.

medicament to appoint

In anovulatory uterine bleedings on 5–15 mg daily within 6–8 days. If scraping of a mucous membrane of a cavity of the uterus is previously made, then injections should be begun 18–20 days later. If it is impossible to make the medicament scraping, to administer also during a bleeding time. At the same time bleeding can temporarily (for 3–5 days) to amplify; patients with anemia of moderate and heavy degree are recommended to carry out previously blood transfusion (200–250 ml). If after 6–8 days of treatment the bleeding did not stop, further administration of progesterone is inexpedient. At the stopped bleeding it is not necessary to interrupt treatment before 6 days.

to enter

At a hypogonadism and an amenorrhea (at once after use of estrogenic drugs) on 5 mg daily or on 10 mg every other day within 6–8 days.

For prevention and treatment of the menacing abortion caused by insufficiency of function of a yellow body — on 10–25 mg daily or every other day before full elimination of risk of an abortion. At a usual abortion the medicament can be administered till 4th month of pregnancy.

At algodismenory for reduction or elimination of pains to begin to administer the medicament in 6–8 days prior to periods on 5–10 mg daily within 6–8 days. The course of treatment can be repeated several times. The highest single and daily dose intramusculary makes 25 mg (2.5 ml of 1% of solution or 1 ml of 2.5% of solution). Treatment by progesterone of the algodismenorea connected with a uterus underdevelopment can be combined with preliminary prescribing of estrogenic medicines.

Children.

not to use Drug in pediatric practice.

Overdose.

At application of the raised medicine doses more often the side effects described in appropriate section arise. at emergence of side effects the medicament treatment needs to be stopped, and after their disappearance to continue in smaller doses. if necessary to carry out symptomatic treatment.

Side reactions.

Usually progesterone is well transferred by

, manifestations of such side reactions are in some cases possible:

from a cardiovascular system: tachycardia, blood circulation violation, increase in arterial blood pressure, venous thrombembolia;

from nervous system: headache, dizziness, drowsiness, insomnia, depression;

from a reproductive system and mammary glands: swelling, hypersensitivity and pain of mammary glands, violations from external genitals, such as burning, dryness, genital itch, change of vaginal discharges, bleedings, vaginal mycosis, premenstrual syndrome, violations of a menstrual cycle, acyclic bloody discharges, amenorrhea, oligomenorrhea, hirsutism, decrease in a libido, uterus spasms;

from a digestive tract: abdominal distension, abdominal pain, nausea, vomiting, lock, diarrhea, meteorism;

endocrine violations: bad tolerance of glucose;

from a respiratory system: zadyshka;

from a gepatobiliarny system: abnormal liver function and change of functional trials of a liver; cholestatic jaundice;

metabolic and alimentary violations: change of appetite, increase or degrowth of a body, hypostases, albuminuria;

from skin and soft tissues: allergic manifestations on skin, a multiformny erythema, an itch, a small tortoiseshell, skin rash, an acne, a hloazma, an alopecia, a hirsutism;

general violations and changes in the place of an injection: increased fatigue, weakness, fever, reactions of hypersensitivity, including anaphylactic reactions; paresthesia liquid delay; changes in the injection site, including pain and a swelling;

laboratory indicators: change of a lipidic profile of plasma;

influence on a fruit: the excessive amount of progesterone can make virilescence of a female fruit (up to uncertainty of sex).

Expiration date.

5 years.

Storage conditions.

to Store

in original packing for protection against effect of light at a temperature not over 25 ºс. to store out of children's reach.

Incompatibility.

Drug should not be mixed with other medicines.

Packing.

On 1 ml of medicine in an ampoule. on 10 ampoules in a pack from cardboard. on 5 ampoules in the blister, on 2 blisters in a pack from cardboard.

Category of a holiday.

According to the prescription.

Producer.

LLC fz «biofarma, Ukraine.

Location of the producer and its address of the place of implementation of activity.

Ukraine, 09100, Kiev Region, white church, st. Kiev, 37.