Translation of the instruction Mose

ПРОЖЕСТИН-КР® gel of 10 mg / 1

Instruction

On medical use of medicine

Ingredients:

Active ingredient: 1 g of gel contains: progesterone — 10 mg;

excipients: macrogoal 400; glycerin; 96% ethanol; carbomer; trietanolamine; the castor oil polyethoxylated, hydrogenated; the water purified.

Dosage form.

Gel.

Main physical and chemical properties: gel colourless or with slightly yellowish shade, with a specific smell.

Pharmacotherapeutic group.

Hormones of gonads and medicaments used at pathology of the sexual sphere. progesterone. code atkh g03d a04.

Pharmacological properties.

Pharmacodynamics.

Progesterone is hormone of a yellow body. In tissues of a mammary gland progesterone reduces permeability of capillaries and intensity of cyclic hypostasis of a connective tissue stroma, prevents proliferation and mitotitesky activity of an epithelium of channels.

Pharmacokinetics.

by

When drawing on skin soaks up about 10% of the applied dose. Does not come to a system blood-groove, it is metabolized in leather and tissues of a mammary gland. Systemic action is absent or insignificant.

Clinical characteristics.

Indication.

Mastodynia and benign mastopathies against the background of progesteronovy insufficiency.

Contraindication.

Hypersensitivity to any components of medicine.

Breast cancer, nodular forms of fibrous and cystous mastopathy, tumor (opukholepodobny formations) of a mammary gland of not clear etiology, cancer of genitals (as monotherapy).

Interaction with other medicines and other types of interactions.

Effect of medicine can amplify against the background of contraception with the combined hormonal medicines.

Feature of application.

not to exceed the recommended dose.

Putting gel is carried out by

after washing, on dry skin. To apply irrespective of days of a menstrual cycle. At violation of a menstrual cycle it is possible to recommend combined use with oral progesterone or progestin. After drawing it is necessary to avoid direct sunshine.

This medicine is intended to

only for external use, it is not necessary to swallow of it.

IS NE This medicine CONTRACEPTIVE.

Risk of development of undesirable reactions at other persons at contact with the patient's skin with the applied medicine is not excluded by

though separately it was not studied and was not shown.

At violation of barrier function of skin the risk of hit of progesterone in a system blood-groove exists. Therefore use of medicine in this case is not recommended.

Medicine contains castor oil which can cause development of skin reactions.

to apply

With care at such states: liver failure, renal failure, bronchial asthma, epilepsy, migraine, depression; a giperlipoproteinemiya, an extrauterine pregnancy, abortion, tendency to thrombosis, acute forms of phlebitis and thromboembolic diseases, bleedings from a vagina of not clear etiology, a porphyria, arterial hypertension, diabetes.

Use during pregnancy or feeding by a breast.

to

it is not shown for application during pregnancy. there is no sufficient experience of use of medicine during pregnancy.

to

it is not shown for application during feeding by a breast. Progesterone can partially get into breast milk. However negative impact on the child is not described.

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

during treatment needs to be careful at control of motor transport or work with other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Route of administration and doses.

to Apply

outwardly. one dose of the applicator (2.5 g of gel) of 1 times a day to apply on the surface of each mammary gland and to rub before full absorption. duration of a course of treatment — usually not less than 3 months (the doctor individually establishes).

Children.

not to use Drug in pediatric practice.

Overdose.

Message about cases of overdose are absent. in connection with an application method the overdose is improbable.

can begin

Periods for 1–2 days earlier; the normal duration of a cycle will be restored at once after the treatment termination.

Side reactions.

allergic reactions Are possible

.

In certain cases periods can begin

for 1–2 days earlier, without any changes in the usual monthly volume of discharges. The weak secretory LG-mimetichesky activity which does not have the general signs with effects at system application of a similar dose of progesterone is established.

it is improbable

At observance of the recommended route of administration of hit of progesterone in a system blood-groove. However at violation of barrier function of skin there is a risk of development of system undesirable reactions, including violations of a menstrual cycle, an amenorrhea, breakthrough bleedings, a headache, morbidity of mammary glands, inflows, a metrorrhagia, decrease in a libido, reaction of hypersensitivity, including an erythema in the site of application of gel, hypostasis of lips and a neck, fever, a headache, nausea.

Expiration date.

2 years.

not to apply

after the expiration date specified on packing.

Storage conditions.

to Store

in original packing at a temperature not over 25 ºс.

to Store

out of children's reach.

Packing.

On 40 g of ointment in tuba No. 1 complete with the pallet doser; in a pack from cardboard.

Category of a holiday.

According to the prescription.

Producer.

Public joint stock company "chemical pharmaceutical plant "red star".

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

61010, Ukraine, Kharkiv, st. gordiyenkovsky, 1.