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Angeliq 28’s coated tablets

$54.40

61ddd0ed4026

Description

The instruction for medical use

of Anzhelik® medicine

the Trade name
of Anzhelik®

the International unlicensed name
Is not present

the Dosage form
of the Tablet, coated

Structure
1 tablet, coated contains
active substances: oestradiol gemigidrat, in terms of oestradiol of 1.0 mg
and drospirenon 2.0 mg,
excipients: lactoses monohydrate, starch corn, starch corn prezhelatinizirovanny, povidone, magnesium stearate,
structure of a cover: gipromelloza 5 sr, macrogoal 6000, talc, titan dioxide (E171), ferrous oxide red (E172).

The description
of the Tablet, coated moderately red color, round shape, with a biconvex surface, with stamping of DL in the correct hexagon on one party.

Pharmacotherapeutic group
Sex hormones and modulators of a reproductive system. Progestogens and estrogen in a combination. Progestogens and estrogen (the fixed combinations). Drospirenon is also oestrogenic
the ATX G03FA17 Code

the Pharmacological

Pharmacokinetics Oestradiol Absorption Later properties of intake oestradiol is quickly and completely absorbed. During absorption and the first passing through a liver oestradiol substantially is exposed to a metabolization, thus, there is a decrease in absolute bioavailability of oestradiol approximately up to 5% of a dose.
The maximum concentration of oestradiol in serum making about 22 pg/ml is usually reached in 6-8 hours after reception of single dose inside.
Meal does not affect bioavailability of oestradiol.
Distribution
Oestradiol contacts albumine and the globulin, connecting sex hormones (G,CSH). The free fraction of oestradiol in serum makes about 1-12%, and the fraction of the substance connected by GSPG is in limits of 40-45%.
The seeming volume of distribution of oestradiol after single intravenous administration is about 1 l/kg.
Metabolism
Oestradiol is quickly metabolized that is followed by formation of estrone and estrone of sulfate and also a large number of other metabolites and conjugates.
It is known that estrone and estriol are pharmacological active metabolites of oestradiol. At the same time only estrone is found in plasma in considerable concentration. Its concentration in blood serum by 6 times exceeds oestradiol level. Serumal level of conjugates of estrone by 26 times exceed appropriate level of free estrone.
Elimination
Clearance of oestradiol from serum – about 30 ml/min. Metabolites of oestradiol are removed with urine and bile with the elimination half-life equal to about 24 h.
Equilibrium concentration
Equilibrium concentration is reached approximately in 5 days of daily administration of drug of Anzhelik®.
Drospirenon
Absorbtion
At oral administration drospirenon quickly and almost is completely absorbed. After single and multiple dose inside the maximum concentration of a drospirenon in serum, equal about 35.9 ng/ml, are reached in 1 hour. The pharmacokinetics of a drospirenon is proportional to a dose. The bioavailability fluctuates from 76 to 85%. Meal does not affect bioavailability of a drospirenon.
Distribution
After oral administration is observed two-phase decrease in level of a drospirenon in serum, with elimination half-life about 35-39 hours. Drospirenon contacts seralbumin and the corticosteroid-the connecting globulin (CCG) does not contact the globulin, connecting sexual steroids (G,CSS), or. Only 3-5% of the general concentration of substance in serum are present at quality of free steroid. The average seeming volume of distribution is 3.7-4.2 l/kg.
Metabolism
After oral administration drospirenon is extensively metabolized. The main metabolites in plasma are an acid form of a drospirenon which is formed when opening a lactonic ring and 4.5-dihydro-drospirenon-3 – sulfate. Both metabolites are formed without participation of a system of P450 cytochrome. Drospirenon in the minimum degree is metabolized by means of enzyme 3A4 of a system of P450 cytochrome.
Elimination
the Speed of metabolic clearance of a drospirenon in serum is 1.2-1.5 ml/min. In not changed look drospirenon it is excreted only in trace quantities. Metabolites of a drospirenon are excreted with excrements and urine in the ratio about 1,2:1,4. Elimination half-life at excretion of metabolites with urine and excrements makes about 40 hours.
Equilibrium concentration
Equilibrium concentration is reached approximately in 10 days of daily administration of drug of Anzhelik®. Increase in concentration of a drospirenon in serum approximately by 2-3 times was noted (due to cumulation) that was caused by an elimination half-life ratio in a terminal phase and a dosing interval.
The pharmacodynamics
the Drug Anzhelik® contains 17b-oestradiol which chemically and is biologically identical to oestradiol of the person and also synthetic progestogen, drospirenon. 17b-oestradiol fills shortage of estrogen in a female body during and after approach of a climacteric. Addition of a drospirenon promotes control of bleedings and prevents development of the hyperplasia of endometrium caused by estrogen.

Depression of function of ovaries which is followed by exhaustion of products of estrogen and progesterone leads effects of oestradiol ment of the menopausal syndrome which is characterized by vasomotorial and organic symptoms. Performing replacement hormonal therapy promotes elimination of these complaints.
From all physiological estrogen, oestradiol is the most active, possessing high degree of affinity to receptors of estrogen. Target organs of estrogen at the woman are, in particular a uterus, a hypothalamus, a hypophysis, a vagina, mammary glands and bones (osteoclasts).
Among other effects of estrogen it should be noted decrease in concentration of insulin and glucose in blood, local vasoactive effects, mediate receptors and also influence, independent of receptors, on muscles of vessels. Receptors of estrogen were revealed in heart and coronary arteries.
Oral administration of natural estrogen is accorded by positive effect in certain cases to a hypercholesterolemia, providing the maximum metabolic action of a liver on lipids.
After one year of therapy the average values of changes of concentration of LPVP cholesterol were the drug Anzhelik® insignificant, with small decrease by 1.6%. Concentration of LDL cholesterol in serum decreased on average by 14% in comparison with decrease by 9% after one year of monotherapy of 1 mg of oestradiol.
It is probable that the combined drugs with drospirenony weaken growth of levels of triglycerides caused by monotherapy of 1 mg of oestradiol. After one year of treatment of 1 mg of oestradiol of concentration of triglycerides at patients on average exceeded initial level approximately for 18%, in comparison of 5% at a combination of 1 mg of oestradiol from 2 mg of a drospirenon.
Therapy by the drug Anzhelik® within 2 years leads to growth of bone mineral density in all body, in lumbar department of a backbone and pelvic bones approximately for 3–5%, in comparison with decrease by 0.5% in group of placebo.
At women without osteoporosis long ZGT reduces risk of fractures of peripheral bones during the post-menopausal period.
ZGT also has salutary effect on collagen content in skin, as well as on its density, and also can slow down process of formation of wrinkles.
Effects of a drospirenon
Pharmakodinamichesky properties of a drospirenon are similar to effect of natural progesterone.
Progestagenny action
Drospirenon — the strong progestogen which is carrying out the central inhibiting effect on a system a hypothalamus-hypophyses-gonads. At women of childbearing age drospirenon provides contraceptive effect, at monotherapy drospirenony there is a slowing down of process of an ovulation. The minimum dose of a drospirenon, necessary for braking of an ovulation, makes 2 mg/days. Full transformation of endometrium under the influence of estrogen is reached at doses of 4-6 mg/days for 10 days (40–60 mg on a cycle).
Анжелик® represents the combined drug for the continuous replacement hormonal therapy (RHT) allowing to avoid regular bleedings of cancellation which are observed at cyclic or phase ZGT. Bleedings and the smearing bloody discharges in the first months of treatment are quite frequent, but over time the quantity them decreases. During reception of Anzhelika® the percent of cases of an amenorrhea increases to 81% in the 6th cycle, to 86% in the 12th cycle and to 91% in the 24th cycle.
Drospirenon who is a part of Anzhelika® effectively interferes with development of the endometrium hyperplasia caused by estrogen. After 12 months of therapy the drug Anzhelik® at 71–77% of women noted atrofichny / inactive endometrium.
The Antimineralokortikoidny activity
Drospirenon possesses the competing antagonistic action concerning Aldosteronum. Antihypertensive action of a drospirenon is most significant at women with hypertensia. At patients with the increased arterial blood pressure at treatment of Anzhelikom® within 8 weeks the average values of the ABP decreased (at office measurement in comparison with initial on-12/-9 mm Hg., in comparison with placebo of-3/-4 mm Hg., at 24-hour out-patient measurement on-5/-3 mm Hg. in comparison with placebo of-3/-2 mm Hg.). Antihypertensive action, as a rule, becomes noticeable in 2 weeks of administration of drug, the maximum action is reached in 6 weeks from an initiation of treatment.
At women during drug treatment does not happen to the normal ABP of a lowering of arterial pressure.
At drug Anzhelik® use the average body weight remained invariable or decreased within 12 months of treatment by 1.1-1.2 kg whereas at the patients receiving monotherapy by oestradiol the increase in body weight by 0.5 kg was noted.
During clinical trial at the women receiving drospirenon in a complex with oestradiol determined lower frequency of developing of peripheral hypostases in comparison with the patients receiving monotherapy by oestradiol.
At women with stenocardia at the Anzhelik® drug treatment within 6 weeks the increase in a reserve of a coronary blood-groove and adaptation to a stress was observed (relative change of +14% in comparison with-15% in group of placebo).
The anti-androgenic activity
As well as natural progesterone, drospirenon has anti-androgenic properties.
Influence on carbohydrate metabolism
Drospirenon has no glucocorticoid and anti-glucocorticoid activity and also insulin resistance does not affect tolerance to glucose. When using Anzhelika® the tolerance to glucose does not change.
Other
Anzhelik® properties positively affects the state of health and quality of life. According to poll, favorable influence of the drug Anzhelik® considerably exceeded effect in comparison with monotherapy by oestradiol. This increase is explained mainly by improvement in the relation of somatic symptoms, reduction of expressiveness of feeling of concerns/fears and also cognitive disturbances.
Observation researches and a research of the Initiative of Health of Women (WHI) give the grounds to believe that when using the conjugated horse estrogen (CHE) in combination with a medroksiprogesteron acetate at women in a postmenopause the indicator of cancer cases of a large intestine decreases. When using only the conjugated horse estrogen (CHE) of risk reduction was not observed. However it is unknown whether these data extend to other drugs for ZGT.

Indications
– Hormonal replacement therapy with signs of deficiency of estrogen at women in a postmenopause, more than in 1 year after approach of a menopause.
– Prevention of post-menopausal osteoporosis at women with high risk of changes at which other medicines intended for prevention of osteoporosis were inefficient or contraindicated.
There is a limited experience of use of this medicine for women 65 years are more senior.

Route of administration and doses
If the woman does not accept estrogen or passes to Anzhelik® from other combined drug for continuous reception, then treatment can be begun at any time.
If the woman passes to Anzhelik® from the combined drug for consecutive or cyclic ZGT, treatment should be begun after end of the current cycle of therapy.
Each packing is counted on 28-day reception.
Daily it is necessary to accept on one tablet.
Treatment is carried out continuously that means, reception of the following packing of drug is begun at once after completion of reception of 28 tablets from the current packing without interruption in reception of tablets.
The tablet is swallowed entirely, washing down with a small amount of liquid.
It is preferable to take a pill at the same time day.
The forgotten medicine needs to be taken as soon as possible.
If after usual time of reception there passed more than 24 hours, the additional pill should not be taken. At the admission of several tablets the development of bleeding is possible.
Additional information for special categories of patients
Patients of advanced age
elderly patients have no need for dose adjustment.
For women at the age of 65 years is also more senior see the section Special Instructions.
Patients with disturbances from a liver
At women with a slight or moderate abnormal liver function drospirenon it is well transferred (See the section Pharmacokinetic Properties). Анжелик® it is contraindicated to women with heavy abnormal liver functions (see the section Contraindications)
Patients with disturbances from kidneys
At patients with a slight or moderate renal failure the insignificant increase in exposure of a drospirenon was observed, however it is not expected to level clinically significant (see the section Pharmacokinetics). Анжелик® it is contraindicated to women with heavy renal failures (see the section Contraindications).

Side effects
in the course of treatment of Anzhelikom® belong To the most frequent side effects: mammary gland pains (& gt, 10%), bleedings from a genital tract and a krovomazaniye (& gt, 10%). Irregular bleedings usually disappear at long therapy. Frequency of bleedings decreases with increase in duration of treatment.
Indicators of frequency are based on clinical trials of drug. Side effects in each frequency group are provided as reduction of gravity.
The undesirable medicinal reactions distributed on classes of a system of bodies according to MedDRA – the Medical dictionary for regulatory activity are given below.
Very often (≥/10)
– a mammary gland pains (including discomfort), bleedings from a genital tract
Often (≥1/100, & lt, 1/10)
– a depression, emotional instability, nervousness
– a headache
– abdominal pains, nausea, an abdominal distension
– a benign neoplasia of a mammary gland, increase in the size of mammary glands, increase in the sizes of a hysteromyoma, a benign neoplasia of a neck of the uterus, menstrual disturbances, vaginal discharges
– an asthenia, the localized hypostases
Infrequently (≥1/1000, & lt, 1/100)
– an increase or decrease in body weight, anorexia, the increased appetite, a lipidemia
– sleep disorders, concern, decrease in a libido
– paresthesias, decline in the ability to concentration of attention, dizziness
– disturbances from eyes, visual disturbances
– heartbeat
– embolisms, venous thromboses, hypertensia, migraine, thrombophlebitises, a varicosity
– short wind
– gastrointestinal disorders, disturbances of taste, dryness in a mouth, vomiting, diarrhea, constipations, a meteorism
– pathological indicators of function of a liver
– skin disturbances, an acne, an alopecia, an itching, rash, a hirsutism, disturbances from hair
– extremity pains, dorsodynias, arthralgias, muscular spasms
– disturbances from an urinary system, an infection of urinary tract
– a breast cancer, an endometrium hyperplasia, a benign neoplasia of a uterus, fibrous and cystous mastopathy, disturbances from a uterus, ovaries, a neck of the uterus, pain in pelvic area, vulvovaginal disturbances, vaginal candidiasis, a vaginitis, dryness in a vagina
– generalized hypostases, a stethalgia, an indisposition, the increased sweating
Is rare (& lt, 1/1000)
– anemia
– vestibular dizziness
– a ring in ears
– cholelithiasis
– muscle pain
– the salpingitis, a galactorrhoea
– a fever
Additional information for special categories of patients
the Following side effects which communication using the drug Anzhelik® is classified by the researcher as possible, were registered during two clinical trials with participation of the women having arterial hypertension.
Disturbances from a metabolism and food

the Disturbance hyperpotassemia from heart
– heart failure, an atrial flutter, lengthening of an interval of QT, a cardiomegaly.
Laboratory and tool data
– increase in level of Aldosteronum in blood.
Due to the use of the drugs ZGT/estrogenov/progestagenov it was reported about the following undesirable phenomena:
– nodal erythema, multiformny erythema, hyperpegmentation of face skin and hemorrhagic dermatitis, vascular purpura.
– the disease of a gall bladder
– possible weak-mindedness is aged more senior than 65 years, see the section Special Instructions.
The risk of a breast cancer
Is reported that at the women who are on the therapy combined estrogen-progestagennoy more than 5 years, risk of developing a breast cancer increases twice. Any increase in risk at the women receiving estrogen in monotherapy is much lower, than at the women accepting estrogen in a combination with progestogens. The risk level depends on duration of use of drugs.
Risk of endometrial cancer
of the Woman with an unextracted uterus during the period after a menopause
everyone 5 of 1000 women with an unextracted uterus who are not accepting ZGT is subject to Risk of developing endometrial cancer approximately. For women with an unextracted uterus the monotherapy by estrogen is not recommended as it increases risk of developing endometrial cancer. Depending on duration of estrogenic therapy and a dose of estrogen, increase in risk of endometrial cancer in epidemiological researches varied from 5 to 55 additional cases on 1000 women aged from 50 up to 65 years. Addition of progestogen to estrogenic therapy during, at least, 12 days of a cycle, allows to avoid the increased risk. In the research Million Women Study use combined (cyclic or continuous) ZGT within 5 years did not cause increase in risk of endometrial cancer (the SHOUTING 1.0 (0.8-1.2)).
Ovarian cancer
Long-term use of estrogenic therapy and combined ZGT estrogen-progestagennoy can be connected with a little increased risk of ovarian cancer. In the Research Million Women Study ZGT lasting 5 years caused 1 additional case of ovarian cancer on 2500 patients.
The risk of a venous thrombembolia
of ZGT can be connected with 1.3 – 3-multiply increased relative risk of developing a venous thrombembolia (VTE), i.e. a deep vein thrombosis or pulmonary embolism. Emergence of such phenomena is most probable within the first year of ZGT.
The risk of coronary heart disease
Risk of developing coronary heart disease is a little increased at women aged 60 years accepting combined ZGT estrogen-progestagennuyu are more senior.
The risk of an ischemic stroke
Use of estrogenic monotherapy and estrogen-progestagennoy of therapy is followed by 1.5-fold increase in relative risk of an ischemic stroke. ZGT does not increase risk of a hemorrhagic stroke.
Such relative risk does not depend on age of the patient or duration of therapy. However, as the initial risk is closely connected with age, the general risk of a stroke at women against the background of ZGT increases with age, see the section Special Instructions.

Contraindications
it is not recommended to begin the replacement hormonal therapy (RHT), in the presence of any of the listed below states. If any of these states arises during ZGT, then it is necessary to stop drug use immediately.
– hypersensitivity to active or to any of drug components
– pregnancy and a lactation
– bleeding from a genital tract of not clear origin
– confirmed, assumed or in the anamnesis the diagnosis of a breast cancer
– the confirmed or expected diagnosis of estrogenzavisimy malignant tumors (for example, endometrial cancer)
– an uncured hyperplasia of endometrium
– a venous thrombembolia in the present or in the anamnesis (deep vein thrombosis or a thrombembolia of pulmonary vessels)
– the acute or recently postponed arterial thrombembolia (for example, stenocardia, a myocardial infarction)
– liver tumors now or in the anamnesis (benign or malignant)
– active diseases of a liver or in the anamnesis before normalization of indicators of hepatic function
– trombofilichesky disturbances, for example deficit of a protein With, a protein of S or antithrombin (see the section Special Instructions)
– a heavy renal failure or an acute renal failure
– the expressed gipertriglitseridemiya
– the porphyria

Medicinal interactions
Influence of other medicines on the drug Anzhelik®
Long-term treatment by the drugs inducing liver enzymes can increase clearance of sex hormones that results in the lowered concentration of estrogen, progestogen, or one and others at the same time, in blood plasma, and can reduce clinical performance of drug that, finally, can be the cause of irregular bleedings. The maximum induction of enzymes is usually observed not earlier, than in 2-3 weeks, but then it can remain still, at least, within 4 weeks after the termination of administration of drug.
The drugs increasing clearance of drugs for ZGT (reducing efficiency of drugs for ZGT by means of induction of enzymes):
Phenytoinum, barbiturates, Primidonum, carbamazepine, rifampicin and, perhaps, still okskarbazepin, topiramat, felbamat, the griseofulvin and drugs containing the St. John’s wort which is made a hole.
Drugs with variable influence on clearance of drugs for ZGT:
at co-administration with drugs for ZGT, many nenukleozidny inhibitors of reverse transcriptase (HIV / a viral hepatitis C) can lead both to increase, and to decrease in concentration of estrogen, progestin, or both active components in plasma. These changes can be in certain cases clinically significant.
The drugs reducing clearance of drugs for ZGT (inhibitors of enzymes):
CYP3A4 inhibitors of the expressed and average force, such as azolny antifungal drugs (for example, itrakonazol, vorikonazol, flukonazol), verapamil, macroleads (for example, klaritromitsin, erythromycin), diltiazem, grapefruit juice can increase concentration of progestin, estrogen, or both active components in plasma.
Excessive alcohol intake during administration of drugs for ZGT can lead to increase in concentration of the circulating oestradiol.
Influence of the drug Anzhelik® on other medicines
On the basis of researches of interaction in vivo at women of the volunteers accepting omeprazolum, simvastatin or midazolam as markers can be concluded that clinically significant interaction of a drospirenon in a dose of 3 mg with other drugs metaboliziruyemy by means of a system P450 cytochrome is improbable.
Pharmakodinamichesky interaction with antihypertensive and non-steroidal anti-inflammatory drugs
Use of the drug Anzhelik® for the women receiving antihypertensive therapy (for example, APF inhibitors, antagonists of receptors of angiotensin II, a hydrochlorothiazide) can increase antihypertensive effect several.
Increase in concentration of serumal potassium at the combined administration of drug of Anzhelik® and non-steroidal anti-inflammatory drugs (NPVP) or antihypertensive drugs is improbable. Combined use of three above-stated types of drugs can lead to slight increase of concentration of serumal potassium, more expressed at women with diabetes.

The special
instructions Anzhelik® it cannot be used as contraceptive means.
For treatment of post-menopausal symptoms ZGT should be begun only in the presence of symptoms which adversely affect quality of life.
Before an initiation of treatment it is necessary to consider all states and risk factors provided below at assessment of a ratio of individual risk and advantage of treatment of drug. In all cases it is necessary to carry out carefully the ratio assessment risk/advantage, at least, annually, and ZGT should be continued only if advantages exceed risk.
Data on the risks connected with ZGT at treatment of a premature menopause are limited. However, considering lower levels of absolute risk at younger women, for them the ratio of advantage and risk can be better, than at women of more advanced age.
Medical examination and consultation
Before the beginning or resuming of ZGT to the woman is recommended to undergo careful all-medical examination (including a research of the personal and family anamnesis). Physical inspection (pelvic bodies and mammary glands) has to be carried out taking into account these data, contraindications and special instructions. In the course of treatment it is necessary to perform periodically control examinations which frequency is defined individually.
The woman should be informed that any changes in mammary glands have to be told the doctor. Inspection of mammary glands, including mammography, should be carried out according to the established schedule of screening and depending on individual clinical need.
States at which observation is required
If any of the following states were observed earlier, are available now and/or were aggravated during pregnancy or earlier carried out hormonal therapy, the patient should be examined carefully.
It is necessary to take into account that the specified states can renew and/or be aggravated during performing therapy with the drug Anzhelikâ:
– a leiomyoma (fibromyoma) or endometriosis
– risk factors, including in the anamnesis of thromboembolic disturbances
– risk factors of developing estrogenzavisimy tumors (for example, presence of a breast cancer at relatives of 1 degree of relationship)
– arterial hypertension
– liver diseases (for example, liver adenoma)
– diabetes with vascular disorders or without them
– cholelithiasis
– migraine or the profound headaches
– a system lupus erythematosus
– an endometrium hyperplasia in the anamnesis
– epilepsy
– bronchial asthma
– an otosclerosis
It is necessary to stop immediately ZGT at emergence of contraindications and also the following disturbances:
– attacks of migrenozny or extraordinary severe headaches which are noted for the first time or other symptoms which perhaps are harbingers of cerebrovascular occlusion
– at a recurrence of cholestatic jaundice or cholestatic itching observed for the first time during pregnancy or the previous treatment by sex steroid hormones
– symptoms of trombotichesky disturbances or at suspicion on their emergence
– substantial increase of arterial blood pressure
– pregnancy
At emergence of new disturbances or deterioration in the listed states or risk factors it is necessary to make repeated individual assessment of a ratio risk/advantage for the patient, in view of possible need of the termination of treatment.
It is necessary to consider the probability of the increased synergy risk of thrombosis at women with a combination of several risk factors, or higher expressiveness of one of risk factors. In such cases the increased risk can be higher, than just overall risk taking into account all factors. ZGT should not appoint risk/advantage in case of negative assessment of a ratio.
The venous thrombembolia
of ZGT can be connected with 1.3 – 3-multiply increased relative risk of developing a venous thrombembolia (VTE), i.e. a deep vein thrombosis or pulmonary embolism. Emergence of such phenomena is most probable within the first year of ZGT. Therefore, when assigning ZGT to women with risk factors of VTE the ratio risk/advantage of treatment has to be carefully weighed and discussed with the patient.
Well-known risk factors of development of VTE are use of estrogen, advanced age, extensive surgical interventions, the individual and family anamnesis (existence of VTE at the immediate family at rather young age can indicate genetic predisposition), obesity (body mass index exceeds 30 kg/sq.m), pregnancy / the postnatal period, the system lupus erythematosus (SLE) and cancer. The issue of a possible role of a varicosity in development of VTE remains controversial.
The patients having in the anamnesis of VTE or now thromboembolic states have the increased risk of development of VTE. ZGT can increase this risk. Purpose of ZGT at such patients is contraindicated.
In cases of the long immobilization, as a rule, following later extensive surgery it is recommended to stop temporarily ZGT in 4-6 weeks prior to its carrying out. It is not necessary to resume reception before the termination of an immobilization.
At women with lack of VTE in the personal anamnesis, but presence of close relatives with fibrinferments at young age, can offer screening after detailed consultation in connection with its limited opportunities (not all patients with a thrombophilia can be revealed when screening). In case of identification of the trombofilichesky defect connected with fibrinferments at family members or if it is heavy defect (for example, deficiency of antithrombin, a protein of S or protein of C, or a combination of defects), in such cases of ZGT it is contraindicated.
The ratio of risk and advantage of treatment has to be carefully weighed and discussed at the women who are on anti-coalugating therapy.
At emergence of VTE against the background of reception ZGT should stop treatment immediately. The woman needs to see immediately a doctor at development of possible symptoms of thrombosis (for example at appearance of pain and/or hypostasis in legs, sudden severe pain in breasts and asthmas).
The Coronary Heart Disease (CHD)
In randomized clinical trials of women with the existence or lack of an ischemic heart disease receiving ZGT estrogen or a combination of estrogen and progestogen the data indicating protection against a myocardial infarction were not obtained. The relative risk of an ischemic heart disease when using combined ZGT estrogen-progestagennoy is increased slightly. As the initial absolute risk of an ischemic heart disease is directly connected with age, the number of additional cases of an ischemic heart disease when using estrogen-progestagennykh of drugs is small at women closer to a menopause, but can raise at more advanced age.
An arterial thrombembolia
during two clinical trials with prolonged use of the combined conjugated horse estrogen (CHE) and a medroksiprogesterona of acetate possible increase of risk of the coronary disease (CD) in the first year of use with the subsequent lack of positive effect was revealed.
In one large clinical trial when using only KLE was found potential reduction of frequency of cases of CB among women at the age of 50-59 years in the absence of the cumulative positive effect among cumulative population of a research. As secondary result in two
the Develop krupnomassht

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