Qlaira film coated pills N28x3
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Description
Ingredients Tablets, film coated dark yellow, round, biconvex, engraved with "DD" in a regular hexagon on one side. view on the cross-section - the core is from white to almost white color, dark-yellow shell. (2 pieces in the blister). 1 tab. estradiol valerate, micro 20 3 mg Excipients: lactose monohydrate - 48.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.584 mg, iron dye yellow oxide - 0.292 mg. Tablets, film coated pink, round, biconvex, engraved with "DJ" in the right hexagon on one side. view on the cross-section - the core is from white to almost white, pink shell. (5 pieces in the blister). 1 tab. estradiol valerate, micro 20 2 mg dienogest, micro 2 mg Excipients: lactose monohydrate - 47.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.83694 mg, iron dye red oxide 0.03906 mg. Tablets, film coated pale yellow color, round, biconvex, engraved with "DH" in a regular hexagon on one side. view on the cross-section - the core is from white to almost white, pale yellow shell. (17 pieces in the blister). 1 tab. estradiol valerate, micro 20 2 mg dienogest, micro 3 mg Excipients: lactose monohydrate - 46.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.83694 mg, iron dye yellow oxide - 0.03906 mg. Tablets, film coated red, round, biconvex, engraved with "DN" in a regular hexagon on one side. view on the cross section - the core is from white to almost white in color, the red shell. (2 pieces in the blister). 1 tab. estradiol valerate, micro 20 1 mg. Excipients: lactose monohydrate - 50.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.5109 mg, iron dye red oxide - 0.3651 mg.Tablets (placebo), film-coated white, round, biconvex, engraved with “DT” in the regular hexagon on one side. view on the cross-section - the core is from white to almost white color, white shell. (2 pieces in the blister). Excipients: 1 tab. (placebo) - lactose monohydrate - 52.1455 mg, corn starch - 24 mg, povidone 25 - 3.0545 mg, magnesium stearate - 0.8 mg. The composition of the shell: 1 tab. (placebo) - hypromellose - 1.0112 mg, talc - 0.2024 mg, titanium dioxide - 0.7864 mg. Pharmacological action The contraceptive effect of combined oral contraceptives (CCP) is based on the interaction of various factors, the most important of which are suppression of ovulation and changes in the properties of cervical mucus. Along with the prevention of unwanted pregnancy, the CCP has a number of positive properties, which, when taking into account also the negative properties, can help in choosing the most appropriate method of contraception. In women taking CPC, the pain and intensity of menstrual bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduction in the risk of endometrial cancer and ovarian cancer. Estrogen in the drug Qlaira. is estradiol valerate, the precursor of the natural 17 &. 946.-human estradiol (1 mg of estradiol valerate corresponds to 0.76 mg of 17 & # 946.-estradiol). The estrogen component used in this CCP is thus different from the estrogens commonly used in CCP, which are synthetic estrogens - ethinyl estradiol or its precursor mestranol, both containing an ethynyl group in position 17. This group causes a higher metabolic stability, but also more pronounced effect on the liver. Taking the drug Qlaira. leads to a less pronounced effect on the liver compared with three-phase PDAs containing ethinyl estradiol and levonorgestrel. It was shown that the effect on SHBG concentration and hemostasis parameters is less pronounced. In combination with estradiol dienogest, valerate shows an increase in HDL, while the concentration of LDL cholesterol decreases slightly. Dienogest is a progestogen, acting by oral administration, which is characterized by additional partial antiandrogenic effects.Its estrogenic, antiestrogenic and androgenic properties are negligible. Due to its special chemical structure, a spectrum of pharmacological action is provided, combining the most important benefits of 19-nor-progestogens and progesterone derivatives. The preclinical data obtained in the course of standardized toxicity studies with repeated doses, genotoxicity, carcinogenic potential and toxicity for the reproductive system do not indicate the existence of a specific risk to humans. However, it should be borne in mind that sex hormones can stimulate the growth of a number of hormone-dependent tissues and tumors. If used correctly, the Pearl Index (an indicator reflecting the frequency of pregnancy in 100 women during the year of using a contraceptive) is less than 1. If you skip pills or misuse, the Pearl index may increase.
Dosage and administration
Inside, regardless of the meal. Tablets should be taken in the order indicated on the package every day at approximately the same time, if necessary with a glass of water or other liquid. Pills are taken continuously. It should be taken on 1 tab. / Day consistently for 28 days. Each new package begins after taking the last pill from the previous calendar package. Menstrual-like bleeding usually begins while taking the last pills of a calendar package and may not finish before the next calendar package begins. In some women, menstrual bleeding begins after taking the first pills from a new calendar package. If hormonal contraception has not been used previously (in the previous month) Tablets begin to take on the 1st day of the woman’s natural menstrual cycle (that is, on the 1st day of menstrual bleeding). Transfer from another combined hormonal contraceptive (another PDA, vaginal ring or transdermal patch) A woman should start taking Qlaira. the day after the last active tablet (tablet containing the active substances) was taken from the package of the previous PDA. When using a vaginal ring or transdermal patch, a woman should start taking Qlaira. on the day of their removal.If previously only a progestogen contraceptive method (mini-pilli, injection, implant) or the intrauterine system with progestogen release (IUD) was used, the woman may switch to taking Qlaira. with mini-pill on any day (from the implant or IUD - on the day of their removal, from the injection method - on the day on which the next injection is scheduled), but in all cases it is recommended to use a barrier method of contraception during the first 9 days of taking the pills. After an abortion in the first trimester of pregnancy, a woman can start taking pills immediately. In this case, additional measures of contraception are not necessary. After childbirth or abortion in the second trimester of pregnancy It should be recommended that a woman start taking pills on the 21-28th day after birth or abortion in the second trimester of pregnancy. If a woman starts taking pills later, then it is recommended that she additionally use a barrier method of contraception during the first 9 days of taking pills. However, if sexual contact has already taken place, before the actual start of taking the drug Qlaira. it is necessary to exclude pregnancy, or the woman should wait for the onset of the first menstruation. Acceptance of missed pills. Missed (white) inactive pills can be neglected. However, they should be thrown away in order to avoid inadvertently extending the interval between taking the active pills. Skipping active pills If the delay in taking any of the pills is less than 12 hours, contraceptive protection is not reduced. A woman should drink the missed pill as soon as she remembers, and take the rest of the pills at the usual time. If the delay in taking any of the pills is more than 12 hours, contraceptive protection may be reduced. A woman should take the last missed pill as soon as she remembers it, even if it means that she will have to drink 2 tabs. at the same time. Then you must continue taking the pills at the usual time. If a woman forgot to start a new calendar package or missed one or more pills from the 3rd to the 9th day of the calendar package, she may already be pregnant (if she had sexual intercourse within 7 days before skipping the pill).The more pills (especially with the combination of the two active ingredients on days 3 through 24) are missed and the closer they are to the inactive pills, the higher the probability of pregnancy. If a woman misses taking pills, and then there was no menstrual bleeding at the end of the calendar packaging / at the beginning of the new calendar packaging, the probability of pregnancy should be considered. Recommendations for gastrointestinal disorders In severe gastrointestinal disorders, absorption may be incomplete, therefore additional contraceptive measures should be taken (for example, a barrier method, in particular condoms). If 3-4 hours after taking an active pill, vomiting occurs, then in this case there are recommendations regarding the missed pills, which are given in the section “Missed pills”. If a woman does not want to change her usual pill regimen, she needs to drink an extra pill (or pills) from a new pack. Elderly patients: drug Qlaira. not shown after menopause. Drug Qlaira. contraindicated in patients with severe liver disease, as long as the indicators of liver function do not come back to normal. Drug Qlaira. not specifically studied in patients with impaired renal function. The available data do not imply correction of the dosage regimen in such patients. Precautions During the period of treatment may worsen psoriasis. With pheochromocytoma, propranolol can be used only after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. Against the background of treatment with propranolol, IV administration of verapamil, diltiazem should be avoided. A few days before anesthesia, you must stop taking propranolol or pick up a remedy for anesthesia with minimal negative inotropic effects. Influence on the ability to drive vehicles and control mechanisms In patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient. Interaction with other drugs The influence of other drugs on the active components of the drug Qlaira. The interaction of PDA with other drugs may lead to breakthrough uterine bleeding and / orlack of contraceptive effect. The following types of interaction have been described in the literature on PDA as a whole or have been studied in the course of clinical studies of the drug Kleir .. Inductors or inhibitors of certain enzymes (СYP3А4 isoenzyme) Inductors of isoenzymes. There may be interaction with drugs that induce microsomal enzymes (for example, cytochrome P450 systems), as a result of which the clearance of sex hormones may increase (phenytoin, barbiturates, primidone, carbamazepine, rifampicin and, possibly, also oxcarbazepine, topiramate, felbamate, riethampicin, rhymes, rhymes, rhymes, and topromat, felbamates, riethampicin, and perhaps, oxarabazepine, topiramat, felbamate, riethampicin, rhymes, rhymes, and, possibly, oxcarbazepine, topiramat, felbamate, riethampicin, and perhaps, oxcarbazepine, topiramat, felbamate, riethampicin, and perhaps also oxcarbazepine, topiramat, felbamate, riethampicin, and also, and griseofulvin, as well as preparations containing St. John's wort). It has been reported that inhibitors of HIV protease (for example, ritonavir), non-nucleoside reverse transcriptase inhibitors (for example, nevirapine), and combinations of these can also have an effect on hepatic metabolism. Effect on enterohepatic circulation. While taking certain groups of antibiotics (for example, the penicillin and tetracycline groups), the enterohepatic circulation of estrogens may decrease, which may lead to a decrease in the estradiol concentration. Women who receive treatment with microsomal enzyme inducing agents or antibiotics, in addition to Clayr. It is recommended to temporarily use a barrier method of contraception or choose another method of contraception. The barrier method of protection should be used during the entire period of taking concomitant medications and for another 28 days after their withdrawal. Isozyme inhibitors. The concomitant use of rifampicin together with pills containing estradiol valerate and dienogest led to a significant decrease in Css and systemic exposure of dieneogest and estradiol. Systemic exposure of dienogest and estradiol at equilibrium concentrations, measured on the basis of AUC0-24 h, decreased by 83% and 44%, respectively. Known inhibitors of CYP3A4, such as azole antifungal drugs, cimetidine, verapamil, macrolides, diltiazem, antidepressants, and grapefruit juice, can increase the concentration of dienogest in the blood plasma. When taken concomitantly with the potent inhibitor ketoconazole, the AUC0-24h value in equilibrium in dienogest increased by 186%, and in estradiol - by 57%.With simultaneous use with a moderate erythromycin inhibitor, the magnitude of AUC0-24 hours in dienegest and estradiol in an equilibrium state increased by 62% and 33%, respectively. The effects of the drug Qlaira. for other drugs: PDA can affect the metabolism of a number of other drugs (for example, lamotrigine), which can lead either to an increase or to a decrease in the concentration of these substances in blood plasma and tissues. However, based on data from in vitro studies, inhibition of CYP enzymes when using the drug Qlaira. at the therapeutic dose is unlikely. Type: Medicinal product Amount in a package, pcs: 84 Shelf life: 48 months Active ingredient: Estradiol valerate (Estradiol valerate), Dienogest (Dienogest) Route of administration: Oral Vacation schedule: Prescription Release form: Prescription Storage conditions: Dry , In a dark place, Keep out of children Maximum storage temperature, ° С: 30 Pharmacological group: G03A Hormonal contraceptives of systemic action Minimum age: 16 yearsActive ingredients
Release form
Pills
Composition
Dark-yellow film-coated pills, round, biconvex, engraved with “DD” in a regular hexagon on one side. view on the cross-section - the core is from white to almost white color, dark-yellow shell. (2 pieces in the blister). 1 tab. estradiol valerate, micro 20 3 mg Excipients: lactose monohydrate - 48.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.584 mg, iron dye yellow oxide - 0.292 mg. Tablets, film coated pink, round, biconvex, engraved with "DJ" in the right hexagon on one side. view on the cross-section - the core is from white to almost white, pink shell. (5 pieces in the blister). 1 tab. estradiol valerate, micro 20 2 mg dienogest, micro 2 mg Excipients: lactose monohydrate - 47.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.83694 mg, iron dye red oxide 0.03906 mg.Tablets, film coated pale yellow color, round, biconvex, engraved with "DH" in a regular hexagon on one side. view on the cross-section - the core is from white to almost white, pale yellow shell. (17 pieces in the blister). 1 tab. estradiol valerate, micro 20 2 mg dienogest, micro 3 mg Excipients: lactose monohydrate - 46.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.83694 mg, iron dye yellow oxide - 0.03906 mg. Tablets, film coated red, round, biconvex, engraved with "DN" in a regular hexagon on one side. view on the cross section - the core is from white to almost white in color, the red shell. (2 pieces in the blister). 1 tab. estradiol valerate, micro 20 1 mg. Excipients: lactose monohydrate - 50.36 mg, corn starch - 14.4 mg, pregelatinized corn starch - 9.6 mg, povidone 25 - 4 mg, magnesium stearate - 0.64 mg. The composition of the shell: hypromellose - 1.5168 mg, macrogol 6000 - 0.3036 mg, talc - 0.3036 mg, titanium dioxide - 0.5109 mg, iron dye red oxide - 0.3651 mg. Tablets (placebo), film-coated white, round, biconvex, engraved with “DT” in the regular hexagon on one side. view on the cross-section - the core is from white to almost white color, white shell. (2 pieces in the blister). Excipients: 1 tab. (placebo) - lactose monohydrate - 52.1455 mg, corn starch - 24 mg, povidone 25 - 3.0545 mg, magnesium stearate - 0.8 mg. The composition of the shell: 1 tab. (placebo) - hypromellose - 1.0112 mg, talc - 0.2024 mg, titanium dioxide - 0.7864 mg.
Pharmacological effect
The contraceptive effect of combined oral contraceptives (CPC) is based on the interaction of various factors, the most important of which are the suppression of ovulation and changes in the properties of cervical mucus. Along with the prevention of unwanted pregnancy, the CCP has a number of positive properties, which, when taking into account also the negative properties, can help in choosing the most appropriate method of contraception. In women taking CPC, the pain and intensity of menstrual bleeding decreases, resulting in a reduced risk of iron deficiency anemia. In addition, there is evidence of a reduction in the risk of endometrial cancer and ovarian cancer.Estrogen in the drug Qlaira. is estradiol valerate, the precursor of the natural 17 &. 946.-human estradiol (1 mg of estradiol valerate corresponds to 0.76 mg of 17 & # 946.-estradiol). The estrogen component used in this CCP is thus different from the estrogens commonly used in CCP, which are synthetic estrogens ethinylestradiol or its precursor mestranol, both containing an ethynyl group in position 17 & # 945 .. This group causes a higher metabolic stability, however also a more pronounced effect on the liver. Taking the drug Qlaira. leads to a less pronounced effect on the liver compared with three-phase PDAs containing ethinyl estradiol and levonorgestrel. It was shown that the effect on SHBG concentration and hemostasis parameters is less pronounced. In combination with estradiol dienogest, valerate shows an increase in HDL, while the concentration of LDL cholesterol decreases slightly. Dienogest is a progestogen, acting by oral administration, which is characterized by additional partial antiandrogenic effects. Its estrogenic, antiestrogenic and androgenic properties are negligible. Due to its special chemical structure, a spectrum of pharmacological action is provided, combining the most important benefits of 19-nor-progestogens and progesterone derivatives. The preclinical data obtained in the course of standardized toxicity studies with repeated doses, genotoxicity, carcinogenic potential and toxicity for the reproductive system do not indicate the existence of a specific risk to humans. However, it should be borne in mind that sex hormones can stimulate the growth of a number of hormone-dependent tissues and tumors. If used correctly, the Pearl Index (an indicator reflecting the frequency of pregnancy in 100 women during the year of using a contraceptive) is less than 1. If you skip pills or misuse, the Pearl index may increase.
Indications
- oral contraception.
Contraindications
Drug Qlaira. Should not be applied in the presence of any of the conditions listed below. The drug must be discontinued immediately,if any of these conditions develop for the first time against the background of its administration: - thrombosis (venous and arterial) and thromboembolism at present or in history (including deep vein thrombosis (DVT), pulmonary thromboembolism (PE), infarction myocardium (MI), current or current stroke). - conditions preceding thrombosis (including transient ischemic attacks, angina pectoris) at present or in history. - the presence of severe or multiple risk factors for venous or arterial thrombosis (including extensive surgical intervention with prolonged immobilization, complicated valvular heart disease, uncontrolled arterial hypertension). - migraine with focal neurological symptoms, incl. in the anamnesis. - diabetes with vascular complications. - pancreatitis with severe hypertriglyceridemia now or in history. - liver failure and severe liver disease (until normalization of liver function indicators). - liver tumors (benign and malignant) at the present time or in history. - identified hormone-dependent malignant tumors (including genitals or mammary glands) or suspicion of them. - Bleeding from the vagina of unknown origin. - pregnancy or suspicion of her. - Hypersensitivity to the active substances or any of the auxiliary substances. With caution If any of the diseases / conditions / risk factors listed below are currently available, then the potential risk and the expected benefit of using Clayr should be carefully compared. in each individual case: - risk factors for thrombosis and thromboembolism (smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, valvular heart disease, heart rhythm disturbances, prolonged immobilization, extensive surgical interventions, extensive trauma). - other diseases in which there may be violations of the peripheral circulation (diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn's disease and ulcerative colitis, sickle cell anemia). - hereditary angioedema. - hypertriglyceridemia. - diseases that have first occurred or worsened during pregnancy or against the background of previous intake of sex hormones (for example, cholestatic jaundice, cholestatic pruritus, cholelithiasis, otosclerosis with impairment of hearing, porphyria, pregnant herpes, Sydenhem chorea). - postpartum period.
Dosage and administration
Inside, regardless of the meal. Tablets should be taken in the order indicated on the package every day at approximately the same time, if necessary with a glass of water or other liquid. Pills are taken continuously. It should be taken on 1 tab. / Day consistently for 28 days. Each new package begins after taking the last pill from the previous calendar package. Menstrual-like bleeding usually begins while taking the last pills of a calendar package and may not finish before the next calendar package begins. In some women, menstrual bleeding begins after taking the first pills from a new calendar package. If hormonal contraception has not been used previously (in the previous month) Tablets begin to take on the 1st day of the woman’s natural menstrual cycle (that is, on the 1st day of menstrual bleeding). Transfer from another combined hormonal contraceptive (another PDA, vaginal ring or transdermal patch) A woman should start taking Qlaira. the day after the last active tablet (tablet containing the active substances) was taken from the package of the previous PDA. When using a vaginal ring or transdermal patch, a woman should start taking Qlaira. on the day of their removal. If previously only a progestogen contraceptive method (mini-pilli, injection, implant) or the intrauterine system with progestogen release (IUD) was used, the woman may switch to taking Qlaira. with mini-pill on any day (from the implant or IUD - on the day of their removal, from the injection method - on the day on which the next injection is scheduled), but in all cases it is recommended to use a barrier method of contraception during the first 9 days of taking the pills. After an abortion in the first trimester of pregnancy, a woman can start taking pills immediately. In this case, additional measures of contraception are not necessary. After childbirth or abortion in the second trimester of pregnancy It should be recommended that a woman start taking pills on the 21-28th day after birth or abortion in the second trimester of pregnancy.If a woman starts taking pills later, then it is recommended that she additionally use a barrier method of contraception during the first 9 days of taking pills. However, if sexual contact has already taken place, before the actual start of taking the drug Qlaira. it is necessary to exclude pregnancy, or the woman should wait for the onset of the first menstruation. Acceptance of missed pills. Missed (white) inactive pills can be neglected. However, they should be thrown away in order to avoid inadvertently extending the interval between taking the active pills. Skipping active pills If the delay in taking any of the pills is less than 12 hours, contraceptive protection is not reduced. A woman should drink the missed pill as soon as she remembers, and take the rest of the pills at the usual time. If the delay in taking any of the pills is more than 12 hours, contraceptive protection may be reduced. A woman should take the last missed pill as soon as she remembers it, even if it means that she will have to drink 2 tabs. at the same time. Then you must continue taking the pills at the usual time. If a woman forgot to start a new calendar package or missed one or more pills from the 3rd to the 9th day of the calendar package, she may already be pregnant (if she had sexual intercourse within 7 days before skipping the pill). The more pills (especially with the combination of the two active ingredients on days 3 through 24) are missed and the closer they are to the inactive pills, the higher the probability of pregnancy. If a woman misses taking pills, and then there was no menstrual bleeding at the end of the calendar packaging / at the beginning of the new calendar packaging, the probability of pregnancy should be considered. Recommendations for gastrointestinal disorders In severe gastrointestinal disorders, absorption may be incomplete, therefore additional contraceptive measures should be taken (for example, a barrier method, in particular condoms). If 3-4 hours after taking an active pill, vomiting occurs, then in this case there are recommendations regarding the missed pills, which are given in the section “Missed pills”.If a woman does not want to change her usual pill regimen, she needs to drink an extra pill (or pills) from a new pack. Elderly patients: drug Qlaira. not shown after menopause. Drug Qlaira. contraindicated in patients with severe liver disease, as long as the indicators of liver function do not come back to normal. Drug Qlaira. not specifically studied in patients with impaired renal function. The available data do not imply correction of the dosage regimen in such patients.