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Ginoprogest 30s 200 mg capsule




The instruction for medical use of Ginoprogest Torgovoye medicine a name of Ginoprogest the International unlicensed name Progesterone Dosage Form of the Capsule of 100 mg, 200 mg Structure One capsule contains active agent – progesterone of 100 mg or 200 mg, excipients: soy lecithin, oil nut, structure of a cover of capsules: gelatin, glycerin, titan dioxide (E 171). Description Oval soft gelatin capsules of yellow-white color. Contents of capsules – oil suspension of white color. Pharmacotherapeutic group Sex hormones and modulators of a reproductive system. Progestogens. Pregninum derivatives. Progesterone. The ATX G03DA04 code the Pharmacological Pharmacokinetics At properties intake Concentration of progesterone in blood plasma gradually raises within the first hour, the maximum concentration in blood (Cmax) is noted in 1-3 hours after reception. Pharmacokinetic researches showed that at intake of progesterone in a dose of 200 mg, peak concentration (26th nmol/l) was reached in 2.72 hours. Concentration of progesterone remained significant within 10 hours. Progesterone is exposed to presistemny metabolism in a liver. The main metabolites which are defined in blood plasma are 20α-гидрокси-дельта-4α-прегненолон, 5α-прегненолон and 5β-прегненолон. It is removed with urine in the form of metabolites, 95% from them are made by glyukuronkonjyugirovanny metabolites, generally 3 alpha, 5 – beta pregnandiol (pregnandion). The specified metabolites which are defined in blood plasma and in urine are similar to the substances which are formed at physiological secretion of a yellow body. It is impossible to accept capsules orally together with food – it will reduce bioavailability of progesterone. Smoking promotes decrease in bioavailability of progesterone, alcohol — to its increase. At vaginal introduction the Absorption happens quickly, progesterone collects in a uterus, the high level of progesterone in blood plasma is observed in 1 hour after introduction. Progesterone Cmax in blood plasma is reached in 2-6 hours after introduction. At administration of drug on 100 mg of 2 times/days the average concentration remains at the level of 9.7 ng/ml (30.9 nmol/l) within 24 hours. At introduction of a dose of 200 mg/days, concentration of progesterone corresponds to a lyuteinovy phase of a menstrual cycle with a normal ovulation. At introduction in doses more than 200 mg/days, concentration of progesterone correspond to 1 trimester of pregnancy. Level 5 – beta pregnanolona in plasma does not increase. It is removed with urine in the form of metabolites, the main part makes 5α, 5β-прегнанедиол (pregnandiol). It is confirmed by continuous increase in its concentration (Cmax of 142 ng/ml in 6 hours). The pharmacodynamics Progesterone is the natural hormone produced by a yellow body and, in a large number, a placenta, since third month of pregnancy and in the subsequent. It has the following physiological effects, in particular, in bodies earlier sensitive to estrogen: gestagenny, anti-oestrogenic, anti-androgenic and antialdosteronovy. Natural progesterone works by selection linking with progesterone receptors. Treatment by progesterone showed the clinical performance, and advantage is the lack of effects of a masculinization. Natural progesterone considerably does not change the lipidic profile reached after use of estrogen. Indications Oral way of introduction Gynecologic: The disturbances connected with insufficiency of progesterone: – a premenstrual syndrome – disturbance of menstrual cycles with a dizovulyation or anovulation – a premenopauza Therapy of a menopause (in addition to an estrogenoterapiya) Obstetric: – the threat of an abortion or prevention of usual abortions because of the established lyuteinovy insufficiency the Vaginal way of introduction – hypofertility, primary or secondary infertility connected with partial or total lyuteinovy insufficiency (a dizovulyation, support of a lyuteinovy phase during fertilization of in vitro, donorship of oocytes) – threat of an early abortion or prevention of the usual abortions connected with lyuteinovy insufficiency the Route of administration and doses Duration of treatment is defined by character and features of a disease. The oral way of introduction of the Capsule should be accepted at the same time, washing down with a glass of water. The dose averages 200-300 mg of progesterone a day distributed on 1 or 2 receptions i.e. 200 mg in the evening before going to bed and 100 mg in the morning, if necessary. At lyuteinovy insufficiency (a premenstrual syndrome, disturbances of a menstrual cycle, a premenopauz): treatment should be carried out within 10 days for a cycle, usually from 17th on the 26th days inclusive. At therapy of a menopause: as separately the estrogenoterapiya is not recommended, progesterone is added to the last two weeks of each therapeutic course which the termination of any substituting treatment lasting about one week during which cancellation bleeding can be observed follows. At threat of premature births: 400 mg of progesterone each 6-8 hours depending on the clinical results received during a sharp phase then in the supporting dosage (for example, 3 times on 200 mg a day) till 36th week of pregnancy. A vaginal way of introduction the dose averages 200 mg of progesterone a day (i.e. 1 capsule on 200 mg or two capsules on 100 mg distributed on 2 receptions, 1 morning and 1 evening) which enter deeply into a vagina, if necessary by means of the applicator. The dose can be increased depending on reaction of the patient. At partial lyuteinovy insufficiency (a dizovulyation, disturbances of a menstrual cycle): treatment it is necessary to spend 10 days for a cycle, usually from the 17th on 26y days at the rate of 200 mg of progesterone a day. In infertility with full insufficiency of a lyuteinovy phase (donorship of oocytes): the dose of progesterone makes 100 mg of progesterone for the 13th and 14th days of a cycle of transfer, then 100 mg of progesterone in the morning and in the evening from 15th on the 25th days of a cycle. In case of an initial stage of pregnancy, since 26th day the dose increases from 100 mg of progesterone a day to a maximum in 600 mg of progesterone a day distributed on three receptions. This dosage should be observed till 60th day. With assistance of a lyuteinovy phase at fertilization of in vitro the treatment should be carried out, since evening of day of transfer, at the rate of 600 mg of progesterone in three steps – in the morning, in the afternoon and in the evening. At threat of an abortion or at prevention of a usual abortion because of lyuteinovy insufficiency an average dosage are 200-400 mg of progesterone a day in two steps till 12th week of pregnancy. The capsule has to be entered deeply into a vagina. Side effects also gt, l/100, & lt, 1/10 – disturbances of a menstrual cycle, an amenorrhea, intermenstrual bleedings – a headache – an abdominal distension Infrequently & gt is frequent, l/1000, & lt, 1/100 – a mastodynia – drowsiness, passing dizziness – vomiting, diarrhea, a constipation, cholestatic jaundice – an itching, an acne also gt, l/10000, & lt is rare, 1/1000 – nausea Very seldom & lt, 1/10000 – a depression – urticaria – a hloazma At a vaginal route of administration Was reported about separate cases of development of reactions of local intolerance of components of drug (in particular, soy lecithin) in the form of hyperaemia of a mucous membrane of a vagina, burning, an itching, oily discharges. System side effects at intravaginalny use of drug in the recommended doses, in particular, the drowsiness or dizziness (observed at oral administration of drug), were not noted. Messages about expected side reactions Providing data on expected side reactions of drug is very important point allowing to carry out continuous monitoring of a ratio risk/advantage of medicine. Health workers should provide information on any expected adverse reactions on the contacts specified at the end of the instruction and also through the national system of collection of information. Contraindications – hypersensitivity to active or to auxiliary components of drug – drug contains nut oil. It is contraindicated to patients with an allergy to nuts or soy, – tendency to fibrinferments, acute forms of phlebitis or thromboembolic diseases – bleedings from a genital tract of not clear genesis – abortion incomplete – a porphyria – the established or suspected malignant new growths of mammary glands and genitals – disturbance of functions of a liver With care – diseases of a cardiovascular system, arterial hypertension, chronic kidney disease, diabetes, bronchial asthmas, epilepsy, migraine, a depression, a giperlipoproteinemiya, pregnancy of II and ІІІ trimesters Medicinal interactions At hormonal therapy of a menopause estrogen prescribing of progesterone not less than for 12 days for a cycle is necessary. Combined use with other drugs can cause strengthening of metabolism of progesterone and change of effect of drug. So happens in cases with: – inductors of liver enzymes, such as barbiturates, antiepileptic drugs (Phenytoinum), rifampicin, phenylbutazone, Spironolactonum and griseofulvin (these drugs cause the increased metabolism at the hepatic level) – some antibiotics (ampitsillina, tetracyclines) cause changes in intestinal microflora which consequence is change of an enterogepatichesky steroid cycle. Progestogens can cause decrease in tolerance of glucose thereof it is necessary to increase the need for insulin or other antidiabetic drugs at the patient with diabetes. The bioavailability of progesterone can be reduced at the smoking patients and at excessive alcohol intake. The special instructions Drug is not contraceptive. Treatment needs to be carried out according to the available recommendations. If the course of treatment begins too early at the beginning of a monthly cycle, especially till 15th day of a cycle, can occur shortening of a cycle or develop bleedings. In case of uterine bleedings it is impossible to appoint drug before specification of their reason (for example, inspections of a cavity of the uterus). Because of thromboembolic and metabolic risks which cannot be excluded completely it is necessary to stop reception in case of approach: – visual disturbances (such as loss of sight, doubling in eyes, vascular damages of a retina) – tromboembolic venous or trombotichesky episodes (irrespective of their localization) – severe headaches. At the tromboflebichesky anamnesis the patient has to be under careful observation. In case of emergence in the course of treatment of an amenorrhea it is necessary to be convinced that this is not about pregnancy. More than 50% of early misbirths are caused by genetic complications. Prescribing of progesterone according to the recommendation of the doctor is shown in case of insufficiency of secretion of a yellow body. Drug contains soy lecithin, oil nut and can cause reactions of hypersensitivity (small tortoiseshell and an acute anaphylaxis). Smoking promotes decrease in bioavailability of progesterone, alcohol — to its increase. Pregnancy and the period of a lactation Should be applied with care in II and III trimester of pregnancy because of risk of abnormal liver functions. Intake of progesterone in milk is rather not studied. It is not necessary to apply progesterone during feeding by a breast. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Should draw the attention of drivers of the vehicles and persons working with mechanisms to risk of development of drowsiness and/or the dizziness connected with use of this drug orally. Reception of capsules before going to bed allows to avoid these consequences. It is necessary to be careful at management of motor transport and occupation of other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Overdose Symptoms: strengthening of side effects demonstrates overdose. They spontaneously disappear at reduction of a dose of drug. At some patients having unstable endogenous secretion in the anamnesis, the usual dose of progesterone can be excessive and be shown in special sensitivity to drug or too low accompanying estradiolemiya. Treatment: reduction of a dose or prescribing of progesterone in the evening before going to bed within ten days. In case of drowsiness or skoroprokhodyashchy feeling of dizziness it is necessary to transfer an initiation of treatment to later term in a cycle (for example, the 19th day instead of the 17th). In case of shortening of a cycle or the smearing bloody discharges, it is necessary to check that the estradiolemiya is sufficient in a premenopauza and at the substituting hormonal therapy of a menopause. The form of release and packing On 15 capsules place in blister strip packaging from a film of polyvinylchloride/polyvinyldichloride and aluminum foil. On 2 planimetric packs together with the instruction for medical use in the state and Russian languages put in a cardboard pack. To Store storage conditions at a temperature not above 30 °C. To store out of children’s reach! 3 years not to use a period of storage after the expiration date specified on packing. Prescription status According to the prescription Laboratorios León Farma S.A. Producer, Spain the Owner of the registration certificate ‘Exeltis Healthcare S.L.’, Spain the Address of the organization in the territory of the Republic of Kazakhstan the accepting claim (offer) from consumers on quality of medicine Representative office with limited liability ‘EKSELTIS S.L. Helskear.’ To the Republic of Kazakhstan 050059, Almaty, Al-Farabi Ave. 7, body 5A, office 177 the Address of the organization, 050061, Almaty, Shevchenko St. of 165 B, responsible for post-registration observation of safety of medicine of ConsultAsia LLP, office 307
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