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Montadiol (Estradiol) 0.01% 25g Cream


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The instruction for medical use of Montadiol Torgovoye medicine a name Montadiol Mezhdunarodnoye the unlicensed name Oestradiol Dosage Form Cream, 0.01% 25 g Structure of 100 g of drug contain active agents: oestradiol gemigidrat 0.01033 g, are equivalent to oestradiol of 0.01 g, excipients: srednetsepochechny triglycerides, hostaserin T-3, cetyl alcohol, polysorbate 80, propylene glycol, oil almond refined, benzyl alcohol, the water purified. Description Cream of flavourless white color. Pharmacotherapeutic group Are oestrogenic. Natural and semi-synthetic estrogen. Oestradiol the ATX G03CA03 Code the Pharmacological Pharmacokinetics Oestradiol properties is soaked up from an epithelium of a vagina and gets to a blood stream. After single introduction of 2 g of cream that is equivalent to 200 mkg of oestradiol the maximum concentration (Cmax) in blood plasma of 86.2 pg/ml. elimination half-life of oestradiol makes 5.05 hours. Oestradiol is quickly metabolized in a liver and digestive tract in estrone, and then to estriol. Transformation of oestradiol to estriol is irreversible. More than 95% of estriol are removed with urine, mainly in the form of glucuronides. A pharmacodynamics Active ingredient, synthetic 17β-эстрадиол, chemically is also biologically identical to endogenous human oestradiol. It compensates reduced levels of estrogen at women in the period of a menopause, facilitating, thus, menopause symptoms. Estrogen prevents the loss of bone weight arising in the period of a menopause or after ovariectomy. Montadiol’s efficiency for correction of decrease in density of a bone tissue in the post-menopausal period same, as well as at use of oral estrogenic drugs. The biological effect 17β-эстрадиол is carried out by means of a number of specific receptors of estrogen. The complex steroid receptor contacts cells of DNA and induces synthesis of specific proteins. Estrogen increases quantity of superficial and intermediate cells and reduces amount of basal cells in vaginal swabbing. Estrogen supports normal range rn vaginas (4.5) which raises normal microflora. After a menopause at many women the deficiency of estrogen leads to vasomotorial and unstable thermal control (inflows), to sleep disorders and increase in a mucosal atrophy of an urinogenital system. At topical administration, active agent gets directly to a blood stream without any effect of the first passing and reaches the immediate scene of action. Receptors of estrogen are in the basic in female reproductive organs and the lower uric ways and also in mammary glands, a hypophysis, a hypothalamus, bones, a liver and in many other fabrics. Thus, therapy by estrogen with Montadiol cream of 0.01% makes positive impact, especially on blood perfusion, strengthening of fabrics in urinary tract, decrease rn and hypersecretion. Meta-analysis showed considerable improvement at urine incontinence. Indications – the hormonal replacement therapy (HRT) at women in a postmenopause – prevention of osteoporosis at women in a postmenopause with high risk of changes the Route of administration and a dosage It is necessary to appoint the lowest effective dose during the shortest period of treatment. Cream should be applied by means of the applicator. 1 filled applicator (is filled to the maximum capacity) contains 2 g of cream from 0.2 mg of oestradiol. One filled applicator is entered before going to bed. Within the first week of treatment, cream should be entered every other day, that is into a 48-hour interval, and then 2 times of week (maintenance dose). After use to wash the applicator with warm water. Before use, wash up hands. 1. To unscrew a cap and to open a tuba by means of an edge. 2. To wind the applicator on an opening of a tuba and to fill to the maximum capacity, squeezing a tuba. 3. To turn off the applicator and to close a tuba. 4. For administration of cream, lying insert the applicator deeply into a vagina and slowly press the piston against the stop. Treatment can be begun in any convenient day. The maximum duration of treatment is 4 weeks. Endometrial safety of long-term treatment and repeated courses of treatment is unknown. Considering system influence during treatment with Montadiol, long-term treatment is not recommended more than 4 weeks. If symptoms remain more than 4 weeks, it is necessary to consider alternative methods of treatment. When developing bleeding, treatment with Montadiol should be suspended before clarification of the cause of bleeding. At the admission of a dose the drug needs to be administered as soon as the patient remembers it, but not later than in 12 hours. It is not recommended to enter a double dose. Experience of treatment of women is aged more senior than 65 years is limited. Side effects Within the first several months of use of drug are possible break bleedings, morbidity or increase in mammary glands which are temporary and disappear after treatment continuation. Benign and malignant new growths Infrequently (³ 1/1000 to & lt, 1/100) – benign new growths of a mammary gland, a benign tumor of endometrium It is unknown – a hysteromyoma of Disturbance of the immune system Infrequently (³ 1/1000 to & lt, 1/100) – reactions of hypersensitivity Is unknown – aggravation of a hereditary angioedema of Disturbance of metabolism and digestion is frequent (³ 1/100 to & lt, 1/10) – hypostasis, increase or weight reduction Infrequently (³ 1/1000 to & lt, 1/100) – the increased appetite, a giperkholestiremiya Psychiatric disturbances Often (³ 1/100 to & lt, 1/10) – a depression, nervousness, a lethargy Infrequently (³ 1/1000 to & lt, 1/100) – concern, insomnia, apathy, emotional lability, disturbance of concentration of attention, changes of mood or a libido, euphoria, agitation of Disturbance of nervous system Often (³ 1/100 to & lt, 1/10) – the Headache, dizziness Infrequently (³ 1/1000 to & lt, 1/100) – migraine, paresthesias, a tremor Visual disturbances Infrequently (³ 1/1000 to & lt, 1/100) – disorders of vision, xerophthalmus Seldom (³ 1/10000 & lt, 1/1000) – intolerance of contact lenses Cardiovascular disturbances Often (³ 1/100 to & lt, 1/10) – inflows Infrequently (³ 1/1000 to & lt, 1/100) – palpitation – a hypertension, superficial phlebitis, a purpura Seldom (³ 1/10000 & lt, 1/1000) – a venous thrombembolia (deep vein thrombosis of extremities and a basin and an embolism of a pulmonary artery) Is unknown – cerebral ischemic events of Disturbance of a respiratory system – dispnoe, rhinitis Gastrointestinal disturbances Often (³ 1/100 to & lt, 1/10) – nausea, vomiting, spasms in a stomach, a meteorism Infrequently (³ 1/1000 to & lt, 1/100) – a constipation, dyspepsia, diarrhea, Is unknown – an abdominal pain, an abdominal distension, rectal disturbances of Disturbance of a liver is rare (³ 1/10000 & lt, 1/1000) – abnormal liver functions and a zhelchevydeleniya Is unknown – cholestatic jaundice of Disturbance from skin Infrequently (³ 1/1000 to & lt, 1/100) – an acne, an alopecia, dryness of skin, nails, a hirsutism, a nodular erythema, a small tortoiseshell Seldom (³ 1/10000 & lt, 1/1000) – rash Is unknown – contact dermatitis – eczema of the Musculoskeletal disorder Infrequently (³ 1/1000 to & lt, 1/100) – muscular spasms of Disturbance of kidneys and an urinary system Infrequently (³ 1/1000 to & lt, 1/100) – increase in frequency of urination, urine incontinence, cystitis, a hamaturia of Disturbance of a reproductive system Often (³ 1/100 to & lt, 1/10) – a mastodynia, abnormal vaginal bleedings or bloody discharges, discharges from a vagina, a vulva Infrequently (³ 1/1000 to & lt, 1/100) – increase in a breast, an endometrium hyperplasia Seldom (³ 1/10000 & lt, 1/1000) – a dysmenorrhea, premenstrual and similar cider the General disturbances Often (³ 1/100 to & lt, 1/10) – local irritations (itching, burning), pain, the increased perspiration Infrequently (³ 1/1000 to & lt, 1/100) – fatigue, an asthenia, fever, a grippopodobny syndrome, a general malaise, change of laboratory tests Was reported about other side effects connected with reception estrogen-progestagennykh of drugs: – benign and malignant estrogenzavisimy tumors, endometrial cancer – infart a myocardium, a stroke – diseases of a gall bladder – a hloazma/melazma, a polymorphic erythema – dementia are aged more senior than 65 years – risk of developing a breast cancer, endometrium, ovaries – risk of developing a venous thrombembolia – risk of developing coronary heart disease – risk of the ischemic attacks of the Contraindication – hypersensitivity to active and auxiliary components of drug – a breast cancer in an active form, the anamnesis or at suspicion on it – the active or suspected estrogenzavisimy malignant tumors (endometrial cancer) – not diagnosed vaginal bleeding – not treated hyperplasia of endometrium – a venous thrombembolia in an active form or the anamnesis (deep vein thrombosis, a pulmonary embolism) – trombofilichesky disturbances (a protein With, S protein, or deficiency of antithrombin) – the active or recently postponed arterial clotting disease (stenocardia, a myocardial infarction) – liver diseases in an active form, the anamnesis if biochemical so farzatel of function of a liver were not restored to normal level – a porphyria – pregnancy, the lactation period Medicinal interactions Metabolism of estrogen can be increased at the accompanying use of substances, with the known properties of induction of enzymes, in particular P450 cytochrome enzymes, such as anticonvulsants (for example, phenobarbital, Phenytoinum, carbamazepine) and anti-infectious drugs (for example, rifampicin, rifabutin, not Virapinum, efavirents). Ritonavir and nelfinavir, known as strong inhibitors, at simultaneous use with steroid hormones show the inducing properties. The vegetable drugs containing a St. John’s wort (the St. John’s wort which is made a hole) are capable to induce metabolism of estrogen. Clinically increased metabolism of estrogen can lead to decrease in effect and changes in the nature of uterine bleeding. Special instructions Montadiol should be applied only on doctor’s orders. Montadiol cream of 0.01% is not recommended to use for the patients receiving system gormonozamestitelny therapy (GZT). Before GZT the doctor needs to collect the full personal and family anamnesis of the patient, it is necessary to carry out medical (including bodies of a small pelvis and chest glands) inspection for the purpose of identification of possible contraindications and respect for necessary precautions when prescribing drug. After each administration of cream at women in a postmenopause the short-term increase in levels of oestradiol in plasma above physiological range is observed. Thus, for safety reasons, the maximum duration of treatment is limited for 4 weeks. Control of possible system effects is recommended. In the course of treatment it is recommended to perform periodic examinations for each patient individually. Women need to be informed about what changes in their mammary glands it is necessary to report to the attending physician. Researches, including mammography, have to be conducted according to accepted standards and adapt to individual clinical needs of each patient. States which demand control Should be taken into account that some states can recur or become aggravated during treatment by estrogen: – the leiomyoma (uterus fibroma) or endometriosis – risk factors of development of thromboembolic disturbances – risk factors of developing estrogenzavisimy tumors, for example, heredity on a breast cancer of the 1st degree – Hypertensia – liver Diseases (for example, liver adenoma) – Diabetes with or without defeat of vessels – Cholelithiasis – Migraine or (severe) headache – the System lupus erythematosus – an endometrium Hyperplasia in the anamnesis – Epilepsy – Asthma – the Otosclerosis – a hereditary Quincke’s disease Therapy has to be stopped if contraindications were found and at emergence of the following states: jaundice or deterioration in functions of a liver, significant increase in arterial blood pressure, new attacks of a migrenepodobny headache. The hyperplasia of endometrium and cancer Prolonged use of oestradiol without addition of gestagenny drugs can cause an endometrium hyperplasia that increases risk of developing endometrial cancer. Thus, at patients with an intact uterus Montadiol’s use surely has to be combined with cyclic purpose of gestagen. At appearance of bleedings or spots of blood at any time of therapy, it is necessary to find out the reason, inspection can include an endometrium biopsy for an exception of a malignant tumor. Estrogen can lead stimulations to precancerous or malignant transformation in the residual centers of endometriosis. It is recommended to show care when using this product at the women who transferred a hysterectomy because of endometriosis, especially at the diagnosed residual endometriosis. Breast cancer Data confirm the increased risk of developing a breast cancer at the women taking the drugs combined estrogen-progestagennye, perhaps, also at GZT with estrogen which depends on GZT duration. The interrelation between risk of a breast cancer and local vaginal therapy by estrogen is not defined. GZT, especially combined treatment is oestrogenic-progestagenom, increases density of mammography images which can negatively influence radiological diagnosing of a breast cancer. Ovarian cancer Ovarian cancer meets much less than a breast cancer. The women taking the estrogensoderzhashchy or combined estrogen-progestagennye drugs have an increased risk of developing ovarian cancer within the first 5 years. The interrelation between risk of developing ovarian cancer and local vaginal therapy by estrogen is uncertain. The venous thrombembolia of GZT is associated with 1.3-3-fold risk of developing a venous thrombembolia (VTE), that is a deep vein thrombosis or a pulmonary embolism. Emergence of this phenomenon is more probable in the first year of GZT. Patients with the known trombofilichesky states have the increased risk of VTE and GZT can increase this risk. The conventional risk factors of VTE include use of estrogen, advanced age, extensive operations, long obesity at an immobilization (BMI & gt, 30 kg/sq.m), pregnancy / a puerperal period, the system lupus erythematosus (SLE) and cancer. The interrelation between a venous thrombembolia and local vaginal therapy by estrogen is not defined. At a long immobilization after surgery, it is recommended to suspend temporarily GZT in 4-6 weeks prior to operation. Treatment is not appointed repeatedly before complete recovery of mobility. At the women receiving anticoagulants during the long span it is necessary to study advantage and risk of use of GZT. If VTE is revealed at the beginning of therapy, drug should be cancelled. Patients should see immediately a doctor in case of symptoms of a potential thrombembolia (for example, painful hypostasis of a leg, a sudden stethalgia, an asthma). The Coronary Heart Disease (CHD) From randomized controlled studies the evidence of protection against a myocardial infarction at women with or without ischemic heart diseases which received a combination estrogen-progestagen is not obtained or it is only oestrogenic. In randomized controlled data the increased risk of an ischemic heart disease at the women who underwent a hysterectomy, receiving only is not revealed it is oestrogenic. The ischemic stroke Combination therapy is oestrogenic-progestagenom and are only connected by estrogen with 1.5-fold increase in risk of developing an ischemic stroke. The relative risk does not change with age or since approach of a menopause. Nevertheless, as initial risk of developing a stroke depends on age, the general risk of a stroke at women who receive GZT, increases with age. The interrelation between an ischemic stroke and a low dose of local vaginal therapy by estrogen is not defined. Other states Estrogen can cause a liquid delay and therefore patients with cardiac or renal dysfunction need careful control. It is necessary to watch carefully patients with a gipertriglitseridemiya, the applying GZT. Communication between a gipertriglitseridemiy and low dose of local vaginal therapy by estrogen is unknown. Estrogen increases the level of the tireoid-connecting globulin (TCG) that leads to increase in level of the circulating amount of hormones of a thyroid gland measured with the help a protein – the connected iodine of concentration T4 (
olonochny or radio immune method of a research) or concentration of TZ (radio immune method of a research). Increase in the TZ level decreases that reflects the raised TSG, concentration of free T4 and TZ change. Concentration in serum of blood and other connecting proteins, for example, the kortikoid-connecting globulin (KCG), the globulin connecting sex hormones (GCSH) can increase that leads to increase in concentration of the circulating corticosteroids and sex steroid hormones respectively. Concentration of free or biologically active hormone remain invariable. Concentration of other proteins of plasma can increase (angiotensin / renin-substrat, alpha 1 – trypsin, ceruloplasmin). Emergence of a hloazma, especially at women with existence the anamnesis of a hloazma is possible. In this case it is necessary to minimize influence of sunshine or ultraviolet radiation. Use of GZG does not improve cognitive functions. The vaginal applicator can cause insignificant local injuries, especially in women with the expressed vaginal atrophy. Use of cream together with latex products (for example, condoms, diaphragms) can reduce functionality of such products, thereby reducing reliability as Montadiol cream of 0.01% contains excipients (other ingredients, in particular, stearates). Cetyl stearyl alcohol and propylene glycol can cause local irritation of skin (for example, contact dermatitis). Features of influence on ability to run the vehicle or potentially dangerous mechanisms the Overdose Symptoms does not influence: reactions from digestive tract, nausea are, etc. possible after accidental or deliberate introduction of large amounts of cream. Symptomatic treatment. The form of release and packing On 25 g of drug place in an aluminum tuba. 1 tuba together the applicator from polyethylene of low density (2 g of cream at full filling are equivalent) and the instruction for medical use in the state and Russian languages is put in a box of cardboard. To Store storage conditions at a temperature not above 25ºС in original packing. To store out of children’s reach! 3 years the use Period after the first opening of 6 months not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer “Montavit Ges. m b. X “, Zaltsbergstrasse 96, A-6067 Abzam, Austria Owner of the registration certificate “Montavit Ges. m b. X “, Zaltsbergstrasse 96, A-6067 Abzam, Austria the Address of the organization in the territory of the Republic of Kazakhstan the accepting claim (offer) from consumers on quality of medicine and responsible for post-registration observation of safety of medicine of Sabipharm LLP, the Republic of Kazakhstan, Almaty, Al-Farabi 19, block 1B, office 202, ph. / fax: 8 (727) 311 05-91, email:
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