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Estrinorm 0.5 mg vaginal suppositories 15’s




The instruction for medical use of ESTRINORM medicine the Trade name of ESTRINORM the International unlicensed name of Estriol succinate the Dosage form Suppositories vaginal, 0.5 mg Structure One suppository contains active agent: estriol of 0.5 mg, excipients: solid fat. Description Suppositories of a tsilindrokonichesky form, color, white or white with a yellowish shade. Pharmacotherapeutic group Sex hormones and modulators of a reproductive system. Estrogen. Natural and semi-synthetic estrogen. Estriol. ATX G03CA04 code the Pharmacological Intravaginalnoye’s Pharmacokinetics properties administration of estriol provides optimum bioavailability in the place of its action. Estriol is also soaked up and gets to a system blood stream that is shown by rapid growth of concentration of untied estriol in blood plasma. The maximum concentration in blood plasma is observed in 1-2 hours after introduction. In blood plasma almost all (90%) estriol is connected with albumine and unlike other estrogen practical is not connected with the globulin connecting sex hormones. Metabolism of estriol consists in the basic in transition to the conjugated and not conjugated state at entero-hepatic circulation. Estriol is generally removed through kidneys in the form of conjugates. A small part of estriol (2%) is removed through intestines, generally in not conjugated form. Elimination half-life after vaginal use makes about 6-9 hours. A pharmacodynamics Estriol – an analog of natural women’s hormone. It fills shortage of estrogen at women in the postmenopauzny period and weakens postmenopause symptoms. Estriol in treatment of urinogenital disorders is most effective. In case of a mucosal atrophy of lower parts of an urinogenital path, estriol contributes to normalization of an epithelium of an urinogenital path and restoration of normal microflora and physiological rn in a vagina. Therefore it increases the resilience of epithelial cells of an urinogenital path to an infection and to inflammation, reducing such complaints as morbidity at sexual intercourse, dryness, an itching of a vagina, reduces the probability of developing of vaginal infections and infections of an uric path, contributes to normalization of urination and prevents urine incontinence. Unlike other estrogen, estriol possesses short-term action as it has short time of deduction in kernels of endometrial cells. It is supposed that one-time introduction of a daily dose does not cause endometrium proliferation. Therefore cyclic administration of progestogen is not required and there are no cancellation bleedings. Besides, it is shown that estriol does not increase mammography density. Indications – the replacement hormonal therapy (RHT) for treatment of the atrophy of lower parts of an urinogenital path connected with estrogenic insufficiency – before – and postoperative therapy of women in a postmenopause at surgical interventions by vaginal access the Route of administration and Intravaginalno’s doses. Suppositories should be entered into a vagina for the night before going to bed. At treatment of a mucosal atrophy of lower parts of an urinogenital path: 1 suppository a day within the first weeks with the subsequent gradual dose decline, depending on relief of symptoms, before achievement of a maintenance dose (at most – 1 suppository twice a week). Before – and postoperative therapy of women in the postmenopauzny period at surgical interventions by vaginal access: 1 suppository a day within 2 weeks before operation, 1 suppository twice a week within 2 weeks after operation. With the diagnostic purpose at not clear atrophic results of a smear from a vagina: 1 suppository every other day within a week, before the following capture of a smear. Suppositories need to be entered intravaginalno before going to bed. If the next dose of drug was passed, it is necessary to enter it immediately, except for cases when the patient remembers it in day of introduction of the following dose. In this case reception of the passed dose it is necessary to lower and continue use of drug according to the usual scheme, without filling the dose which is passed earlier. It is impossible to apply two suppositories in one day. At the beginning or at continuation of treatment of postmenopauzny symptoms it is necessary to apply the smallest effective dose during the shortest period. At the women who are not receiving ZGT or women who are transferred from continuous oral administration of the combined drug for ZGT the drug treatment can be begun in any day. Women who pass from the cyclic mode of administration of drugs for ZGT have to begin drug treatment in one week after cancellation of drugs ZGT. Side effects according to the literary overview and data of pharmacovigilance were observed the following side reactions: – a liquid delay in an organism – an itching in the injection site – sensitivity, morbidity of mammary glands, bloody discharges, cervical discharges These undesirable reactions usually are short and passing, but at the same time can demonstrate use of too high dose. Side effects in connection with treatment it is oestrogenic-progestagenovoy a combination: – acyclic bloody discharges, bleedings of ‘break’, a menorrhagia – benign and malignant it is oestrogenic – dependent tumors, for example, endometrial cancer – diseases of a gall bladder – skin and hypodermic disturbances: the hloazma, a multiformny erythema, a nodular erythema, a hemorrhagic purpura – possible dementia at the age of 65 years is also more senior – risk of developing a breast cancer (at the women receiving the therapy combined estrogen-progestagenovuyu within 5 years and more, risk of developing breast cancer increases twice, the risk level depends on duration of reception, any increased risk is significantly lower at the patients receiving therapy only estrogen, unlike the patients accepting combination therapy estrogen-progestagenom) – ovarian cancer (long receiving ZGT is exclusive estrogen or a combination estrogen-progestagen slightly increases risk of developing ovarian cancer) – a venous thrombembolia (possibly increase by 1.3-3 times of risk of developing a venous thrombembolia, i.e. a deep vein thrombosis, embolisms of lungs) – coronary heart disease, including a myocardial infarction (risk of developing coronary heart disease slightly increases at patients is more senior 60 years, receiving combined by ZGT estrogen-progestagenom) – an ischemic stroke (risk of developing an ischemic stroke raises by 1.5 times at patients, receiving therapy only estrogen or accepting combination therapy is oestrogenic-progestagenom) Contraindications – hypersensitivity to active agent or to any of drug excipients – pregnancy, suspicion on pregnancy, feeding by a breast – diagnosed or suspected cancer of mammary glands – diagnosed or suspected estrogen – dependent tumors for example, endometrial cancer – vaginal bleedings of not clear etiology – an uncured hyperplasia of endometrium – venous fibrinferments now and in the anamnesis (deep venous thrombosis, an embolism of a pulmonary artery) – the known trombofilichesky disturbances (for example, deficit of a protein With, a protein of S or antithrombin) – active or recently transferred a thromboembolic disease of arteries (for example, stenocardia, a myocardial infarction) – a liver disease in the acute stage or the liver disease in the anamnesis, before normalization of indicators of function of a liver – a porphyria Medicinal interactions In clinical practice is noted interaction between the drug Estrinorm and other medicines. Metabolism of estrogen can amplify at their use in combination with connections which induce the enzymes participating in metabolism of medicines, in particular, P450 cytochrome enzymes, for example such as anticonvulsants (for example, phenobarbital, Phenytoinum, carbamazepine) and antimicrobial means (for example, rifampicin, rifabutin, not Virapinum and efavirents) can induce metabolism of estrogen. Ritonavir and nelfinavir, known as strong inhibitors, show inductive properties at a concomitant use with steroid hormones. Drugs of a St. John’s wort can strengthen metabolism of estrogen. The clinical effect of increase in metabolism of estrogen can be shown by decrease in efficiency of Estrinorm, and uterine bleedings. Estrinorm can enhance pharmacological effect of corticosteroids, a suktsinilkholin, theophyllines and a troleandomitsin. If necessary the dosage has to be reduced. Estrinorm can change efficiency of oral anticoagulants. The special instructions Treatment of Postmenopauzny Symptoms ZGT need to be begun only concerning symptoms which adversely affect quality of life. In all cases it is necessary to carry out not less once a year the careful assessment of risk and advantage of treatment. ZGT should be continued only during the span when the advantage exceeds risk. Data on the risks connected with ZGT at treatment of a premature menopause are limited. The ratio of risks and advantage among young women can be more favorable, than in group of women of more advanced age. Medical examination / observation Before the beginning or resuming of ZGT needs to be established the detailed individual and family anamnesis. Proceeding from the anamnesis, contraindications and preventions on drug use, it is necessary to perform clinical examination, including inspection of bodies of a small pelvis and mammary glands. During treatment it is recommended to perform periodic medical examinations which frequency and character are individual, but at least once a year. Women have to know about need of informing the doctor on changes in mammary glands, in case of their emergence. Researches, including mammography, it is necessary to perform in compliance with the standard standards examinations. States at which observation is necessary If is available now, arose earlier and/or worsened during pregnancy or the previous hormonal observation any of the following states, the patient has to be under constant observation. It is necessary to consider that these states can repeat or worsen during treatment by Estrinorm. It concerns the following states: – myoma (uterus fibroma) or endometriosis – the postponed thromboembolic disturbances or presence of risk factors of such disturbances – presence of risk factors for estrogen – the dependent malignant tumor (a breast cancer among relatives of the 1st degree of relationship) – hypertensia – disturbances of work of a liver (for example, liver adenoma) – diabetes with existence or lack of a vascular component – cholelithiasis – migraine or (heavy) headache – a system lupus erythematosus – an endometrium hyperplasia in the anamnesis – epilepsy – asthma – an otosclerosis of the Reason for immediate cancellation of therapy should stop Therapy in case of identification of a contraindication and/or at emergence of the following states: – jaundice and/or deterioration in function of a liver – substantial increase of arterial blood pressure – resuming of a headache as migraine – pregnancy the Hyperplasia of endometrium and a carcinoma For prevention of stimulation of endometrium a daily dose should not exceed 1 suppository (0.5 mg of estriol). It is not necessary to use it drug more than 4 weeks. The breast cancer Risk of developing breast cancer at the women receiving estrogen-progestagenovuyu or estrogenic ZGT depends on duration of this therapy. Risk of developing breast cancer increases at the women accepting these medicines within several years, however is restored to initial level less than in five years after the treatment termination. The therapy combined estrogen-progestagenovaya: Results of researches testify to the increased risk of developing breast cancer at the women accepting estrogen and progestogen for ZGT more than 3 years. Therapy only estrogen: – The research WHI did not reveal the increased risk of developing breast cancer at the women with a remote uterus receiving ZGT only estrogen. There is an insignificant increase in risk of developing breast cancer which is significantly lower, than at accepting estrogen-progestagenovuyu therapy. – ZGT can increase mammogram density. It can complicate radiological detection of breast cancer. The likelihood of development of the increased density of a mammogram was lower at those subjects of a research which received estriol, unlike other patients receiving other estrogen. It was established that intake of estriol, unlike other estrogen, does not result in the increased risk of developing breast cancer. Ovarian cancer Ovarian cancer develops much less than breast cancer. Risk of developing ovarian cancer slightly increases as a result of long reception (not less than 5-10 years) is oestrogenic for ZGT. Venous a thrombembolia – ZGT is connected with increase by 1.3-3 times of risk of developing a venous thrombembolia (VTE) i.e. a deep vein thrombosis or an embolism of a pulmonary artery. VTE is most probable within the first year of ZGT, than in later terms. Concerning Estrinorm the similar risk is not known. – In the presence of thromboembolic states in the anamnesis there is an increased risk of development of VTE. Use of ZGT can increase risk of a recurrence therefore, carrying out ZGT is contraindicated to these patients. – The following factors can increase risk of VTE: intake of estrogen, advanced age, heavy operation, long immobilization, obesity (body mass index & gt, 30 kg/sq.m), pregnancy / puerperal period, system lupus erythematosus, cancer. After surgery it is necessary to pay special attention to preventive actions for prevention of VTE. When the long immobilization is inevitable after planned operation, in particular, after abdominal surgery or orthopedic lower extremity surgery, it is whenever possible necessary to provide the temporary termination of ZGT in 4-6 weeks prior to carrying out operation. Treatment should not be resumed before full rehabilitation of the patient. – If Estrinorm is accepted according to indications ‘Before – and postoperative therapy at women in the postmenopauzny period at vaginal surgical intervention’, it is necessary to pay attention to preventive treatment of thrombosis. The women who do not have VTE in the anamnesis but having the immediate family with thrombosis in the anamnesis are recommended to carry out roentgenoscopy (by means of roentgenoscopy only a part of trombofilichesky defects is defined). At detection of the serious deviations other than thrombosis, for example, deficiency of antithrombin, a protein of S, protein With or a combination of deviations), carrying out ZGT is contraindicated. – Women who already undergo treatment by anticoagulants demand the careful analysis of a ratio of advantage and risk of use of ZGT. – If VTE develops after the beginning of therapy by the drug Estrinorm, treatment needs to be stopped. It is necessary to inform the patient on need of the immediate address to the doctor in case of potential symptoms of a thrombembolia (for example, painful hypostasis of a leg, a sudden stethalgia, an asthma). The Coronary Heart Disease (CHD) there Are no data indicating existence of protection against development of a myocardial infarction in women with or without ischemic heart diseases receiving estrogen-progestagenovye of a combination at ZGT or is exclusively oestrogenic. The therapy combined estrogen-progestagenovaya – Relative risk of development of an ischemic heart disease increases when receiving ZGT a combination estrogen-progestagena and increases with age. Therapy by estrogen – Proofs of the increased risk of development of an ischemic heart disease at the women with a remote uterus accepting it is exclusively oestrogenic, no. The ischemic stroke Risk of developing an ischemic stroke at combination therapy is oestrogenic-progestagenom and monotherapies by estrogen raises by 1.5 times. The relative risk does not change with age or time which passed after the beginning of a menopause. However the general risk of developing a stroke at the women receiving ZGT increases with age as initial absolute risk of developing a stroke essentially depends on age. Other states – Estrogen can cause a liquid delay and therefore patients with a renal failure and cardiovascular insufficiency have to is under careful control of the doctor. – Estriol is weak inhibitor of a gonadotrophin and does not render other significant influences of N
an endocrine system – ZGT does not improve cognitive function. However some results demonstrate increase in risk of possible dementia at the women who began to receive long combination therapy or ZGT estrogen 65 years are aged more senior. – Estrinorm is not shown for contraception. Pregnancy and the period of a lactation Estrinorm is shown only for treatment of women in a postmenopause (natural or after surgery). The drug Estrinorm is contraindicated during pregnancy. In case of pregnancy during therapy by the drug Estrinorm treatment needs to be cancelled immediately. Results of the majority of the epidemiological researches conducted so far rather inadvertent impact of estrogen on a fruit demonstrates lack of teratogenic or fetotoksichesky effects. Drug is not recommended during feeding by a breast. Estriol is removed with breast milk and can reduce formation of milk. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Data on Estrinorm’s influence on ability to drive the car or difficult mechanisms are not enough. Overdose Symptoms: the overdose by the drug Estrinorm at vaginal introduction is improbable. However in case of inadvertent hit of high doses the nausea, vomiting and the termination of menstrual bleedings at women can develop in digestive tract. Treatment: There is no specific antidote. If necessary it is necessary to carry out symptomatic treatment. A form of release and packing On 5 suppositories in blister strip packagings from a film polyvinylchloride laminated by polyethylene. On the 3rd blister strip packagings together with the instruction for use in the state and Russian languages put in a pack from cardboard. To Store storage conditions in the dry, protected from light place, at a temperature not above 25C. Not to freeze. To store out of children’s reach! 3 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Producer of Ltd company to PHARMAPRY st. Krinilor, 5, the village Porumben, the area Kriulen the Republic of Moldova, MD-4829 the Owner of the registration certificate of Ltd company PHARMAPRIM, the Republic of Moldova the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine in Republic of Kazakhstan, Almaty, Gogol St., 86, office 528
to Develop Representative office of PHARMAPRIM SRL

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