Depot-Provera susp. for infection. 150mg/ml fl. 1 ml No. 1

Suspension "® " is applied by ^{Depot-Provera to injections at indications which are provided below.}

Progestagen: for contraception.

for long contraception at women. Each injection prevents an ovulation and provides contraception within not less than 12 weeks (+/-5 days). However it is necessary to consider that restoration of reproductive function (ovulation) can be delayed for a period of up to one year.

Drug is means, to women, suitable for application, who were appropriately informed on possibility of menstrual frustration and a potential delay of recovery of full fertility.

can use Drug for short-term contraception in the following cases:

• for partners of the men who transferred vasectomy for protection until vasectomy becomes effective;
• to the women immunized against a rubella, for prevention of pregnancy during the period of activity of a virus;
• to women who expect sterilization.

teenagers can use Drug, but only if other methods of contraception are recognized as unsuitable or unacceptable after their discussion with the patient.

Structure

Active ingredient - medroxyprogesterone (1 ml of suspension supports a medroksiprogesteron of acetate of 150 mg).

Excipients: polysorbate 80, methylparahydroxybenzoate (E 218), propilparagidroksi-benzoate (E 216), a macrogoal 3350, sodium chloride, water for injections.

Contraindication

1. Drug is contraindicated to patients with the known sensitivity to a medroksiprogesteron of acetate or to any other components of medicine.
Use of medicine as a contraceptive in the dosage given below is contraindicated to
2. in the presence of the confirmed or suspected hormonedependent malignant tumors of a mammary gland or genitals.
to
3. Drug is contraindicated to patients with existence or the anamnesis of a serious illness of a liver at which indicators of function of a liver did not return to norm.
4. When assigning as monotherapy or in a combination with estrogen patients should not use medicament with pathological uterine bleeding, the diagnosis will not be found out yet and the possibility of presence of malignant tumors of a genital tract will not be excluded.

Route of administration

to make sure that the dose applied represents uniform suspension of medicine " ^{Depot-Provera ®} ", suspension for injections it is necessary to shake up carefully just before application.

Dose needs to be entered by a deep intramuscular injection. It is necessary to be sure that by depot injection it is carried out to muscle tissue, it is desirable in a big gluteus, but also it is possible to use other muscles, for example deltoid.

Before carrying out an injection the place of an injection, using for this purpose standard methods.

First injection: for ensuring contraceptive effect during the first cycle of application it is necessary to carry out an injection of 150 mg intramusculary within the first 5 days of a normal menstrual cycle. If the injection was carried out according to this instruction, use of additional contraceptive resources is not required.

After the delivery: for increase in confidence that the patient is not a pregnant woman for the period of the first application, the injection should be carried out within 5 days after the delivery if the woman does not nurse.

data indicating that women who use medicament " ^{Depot-Provera ®} " directly in a puerperal period can have a long and heavy bleeding Exist. For this reason during a puerperal period medicament should be used with care. Women who decided to use medicament directly after the delivery or after termination of pregnancy should be informed on the increased risk of developing of heavy or long bleeding. Doctors need to remind that at women who do not nurse the ovulation can occur for the 4th week after the delivery.

If the woman nurses after the delivery the child, the first injection should be carried out not earlier than in 6 weeks after the delivery when the enzymatic system of the newborn is more stoutly developed. Further injections should be carried out with intervals of 12 weeks.

Further doses: it is necessary to apply at an interval of 12 weeks, however if to enter an injection not later than in 5 days after this time, additional measures of contraception are not necessary (for example barrier). If for any reason time from carrying out a preliminary injection exceeds 89 days (12 weeks and 5 days), before the following injection it is necessary to exclude pregnancy, and the patient should take additional measures of contraception (for example, barrier) within 14 days after carrying out this following injection.

Transition from other contraceptives. Drug should be used so that to provide continuous contraceptive action. For this purpose it is necessary to consider the mechanism of action of other means (for example patients who pass from oral contraceptives, should enter the first injection of medicine within 7 days after reception of the last active tablet).

Feature of application

Pregnant

Drug should not be used during pregnancy neither for diagnostics, nor for treatment. Drug is contraindicated to pregnant women.

acetate and/or its metabolites get into breast milk, but there are no data allowing to consider that it constitutes danger to the child. The research of the babies who were affected by a medroksiprogesteron of acetate during feeding by breast milk on influence on development and behavior till the pubertal period was conducted. Side reactions are noted.

Drug not to appoint

for application before the menstrual period.

Drivers

Use of medicine can cause a headache and dizziness. With such effects the patients are recommended to avoid control of motor transport or work with other mechanisms.

Overdose

no special measures, except the therapy termination are required for p.

Side effects

Side reactions arising most often (more than at 5% of patients): increase in body weight (69%), decrease in body weight (25%), a headache (16%), nervousness (11%), pain or discomfort in a stomach (11%), dizziness (6%), decrease in a libido (6%).

to Store

at a temperature not above 25 °C, out of children's reach. Not to freeze.

Expiration date - 5 years.