Universal reference book for medicines
Name of the drug: DAILLA (DAYLLA)

Active substance: drospirenone, ethinylestradiol

Type: Monophasic oral contraceptive

Manufacturer: GEDEON RICHTER (Hungary)
Composition, form of production and packaging
Tablets covered with a film coating of
white or almost white color, round, biconcave, labeled "G73" on one side of the tablet, embossed;
the core is white or almost white in cross section.
1 tab.

drospirenone 3 mg

ethinylestradiol 0.02 mg

Excipients: lactose monohydrate 48.53 mg, corn starch 16.6 mg, corn pregelatinized corn starch 9.6 mg, macrogol and polyvinyl alcohol copolymer 1.45 mg, magnesium stearate 0.8 mg.

Composition of the film shell: opedraj II white 85G18490 2 mg: polyvinyl alcohol 0.88 mg, titanium dioxide 0.403 mg, macrogol-3350 0.247 mg, talc 0.4 mg, lecithin soybean 0.07 mg.

21 pcs.
- blisters (1) of PVC / PE / PVDC - aluminum foil - packs of cardboard.
21 pcs.
- blisters (3) of PVC / PE / PVDC - aluminum foil - packs of cardboard.

Description of the drug approved by the manufacturer for the printed edition of 2012.


The contraceptive effect of the drug Dailla ® is based on the interaction of various factors, the most important of which are inhibition of ovulation and changes in the endometrium.

The drug Dailla ® is a combined oral contraceptive containing ethinyl estradiol and drospirenone.
In a therapeutic dose, drospirenone also has antiandrogenic and weak antimineralocorticoid properties. It is devoid of any estrogenic, glucocorticoid and antiglucocorticoid activity. This provides drospirenone pharmacological profile, similar to natural progesterone.
There is evidence of a reduced risk of developing endometrial and ovarian cancer when combined oral contraceptives are used.




When ingested drospirenone quickly and almost completely absorbed.
After a single oral intake, the maximum concentration of drospirenone in the serum, equal to 38 ng / ml, is achieved after 1-2 hours. Bioavailability ranges from 76 to 85%. Eating does not affect the bioavailability of drospirenone.

After oral administration, the final half-life is 31 hours. Drospirenone binds to serum albumin, does not bind to sex hormone binding globulin (SHBG) or corticosteroid-binding globulin (CSG).
3-5% of the active substance in the blood serum is presented as a free steroid. An increase in SHBG induced by ethinyl estradiol does not affect the binding of drospirenone with serum proteins. The average apparent volume of distribution of drospirenone is 3.7 ± 1.2 l / kg.

Drospirenone is extensively metabolized after oral administration.
The main metabolites in the plasma are acidic forms of drospirenone, derivatives with an open lactone ring and 4,5-dihydrodrospirenone-3-sulfate, which are formed without involvement of the cytochrome P450 system. A small amount of drospirenone
is metabolized by cytochrome P450 ZA4.
Invitrodispirenone inhibits. cytochromes P450 3A4, P450 1A1 P450 2C9 and P450 2C19.

The metabolic clearance rate of drospirenone in the serum is 1.5 ± 0.2 ml / min / kg.
In unmodified form, drospirenone is excreted only in trace amounts. Metabolites of drospirenone are excreted by the kidneys and through the intestine in a ratio of approximately 1.2: 1.4. The half-life of metabolites by the kidneys and through the intestine is approximately 40 hours.
Equilibrium concentration.

The maximum equilibrium concentration of drospirenone in the serum is reached by day 8

and is approximately 70 ng / ml.

-In renal failure

The equilibrium serum concentration of drospirenone in women with mild and moderate renal insufficiency (clearance, creatinine CLcr 30-80 ml / min) is comparable to the equilibrium concentration in women with normal renal function.

-In hepatic insufficiency

Drospirenone is well tolerated in patients with mild or moderate hepatic impairment (Child-Pugh class B).
Reduced clearance of drospirenone with moderate hepatic insufficiency does not lead to a clear change in the potassium concentration in the blood serum. With diabetes and concomitant treatment with spironolactone (two predisposing factors in the development of hyperkalemia), there was no increase in the serum potassium concentration above the upper limit, the norm.

Absorption .

Ethinylestadiol is rapidly and completely absorbed.
The maximum concentration of 80-100 pg / ml is achieved within 1-2. hours. After presystemic conjugation and presystemic metabolism in the small intestine and liver, the absolute bioavailability is 60%. Concomitant food intake decreases the bioavailability of ethinylestradiol
about 25% of women.


The concentration of ethinyl estradiol in the serum is reduced biphasic, the final pharmacokinetic phase is characterized by a half-life of about 24 hours.
Ethinyl estradiol strongly but non-specifically binds to albumin (about 98.5%) and causes an increase in the concentration of SHBG and CRS in the serum. The apparent volume of distribution is approximately 5 l / kg.

Ethinyl estradiol undergoes presystemic conjugation in the mucosa of the small intestine and in the liver.
Ethinyl estradiol is primarily metabolized by aromatic hydroxylation with the formation of both free metabolites and conjugates with glucuronic and sulfuric acids.
Ethinyl estradiol is completely metabolized.
The metabolic clearance rate of ethinyl estradiol is 5 ml / min / kg.

Ethinylestradiol is not practically excreted unchanged.
Metabolites of ethinyl estradiol are excreted by the kidneys and through the intestine in a ratio of 4: 6. The half-life of metabolites is approximately 1 day.
The equilibrium concentration

The state of equilibrium concentration is reached during the second half of the cycle of drug administration.


- oral contraception.


How to take Dailla ®

Tablets are taken orally daily, at about the same time with a small amount of water in the order indicated on the blister pack.
Take one tablet a day for 21 consecutive days. Acceptance of each next package begins after a 7-day break in taking the tablets, during which menstrual-like bleeding is usually observed. It usually starts 2-3 days after taking the last pill and may not end before the start of taking a new package.
How to start taking Dailla ®

• In the absence of taking any hormonal contraceptives (in the previous month), the first tablet from the first package should be taken on the first day of menstrual bleeding.

• When switching from another combination oral contraceptive, the woman should start taking Dayilla® the day after the usual interruption in admission or after taking the last pill of the previous combined oral contraceptive.

When switching from contraceptives containing only progesterone (mini-pili, injectable forms, implant) or progestogen-releasing intrauterine system, a woman can switch from minipill of progestogen, implant or progestogen-releasing intrauterine system any day - on the day of removal, with an injection form - from the day when the next injection is to be made.
In this case, it is necessary to additionally use the barrier method of contraception during the first 7 days of admission.
After a medical abortion in the first trimester of pregnancy, the first pill can be taken as prescribed by the doctor on the day of termination of pregnancy.
If this condition is met, the woman does not need additional contraception.
After childbirth or abortion in the second trimester of pregnancy, a woman should be recommended to start taking the drug on days 21-28 after giving birth or abortion.
If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. With the onset of sexual activity, pregnancy should be excluded, or a woman should wait for the first menstruation.
Acceptance of missed tablets

If the delay in taking the pill is less than 12 hours, the contraceptive protection does not decrease.
A woman should take the pill as soon as possible, as soon as she remembers this, the next pill is taken at the usual time.
If the delay in taking the tablets is more than 12 hours, the contraceptive protection can be reduced.
Two rules should be observed:

1. The drug should never be interrupted for more than 7 days.

2. 7 days of continuous intake of tablets is required to achieve adequate suppression of the hypothalamic-pituitary-ovarian system.

Recommendations for admission:

Week 1

A woman should take the last missed pill as soon as possible, as soon as she remembers, even if it means taking two tablets at the same time.

The next tablet is taken at the usual time. In addition, the barrier method of contraception should be used for the next 7 days.
If the sexual intercourse took place during the previous 7 days before passing the pill, it is necessary to take into account the probability of pregnancy. The more pills are missed and the closer this pass to the 7-day break in taking the drug, the higher the risk of pregnancy.
Week 2

A woman should take the last missed pill as soon as possible, as soon as she remembers, even if it means taking two tablets at the same time.

The next tablet is taken at the usual time.
Provided that the woman correctly took the pill within 7 days preceding the skip of the first pill, there is no need to use additional methods of contraception. If a woman misses more than 1 tablet, additional methods of contraception must be used within the next 7 days.
Week 3

The risk of a decrease in contraceptive effectiveness increases with the approach of a period, the use of tablets.
However, if the admission scheme is adhered to, you can avoid reducing contraceptive protection. If one of the following options is followed, then there is no need to use additional contraceptive measures provided that the tablets are correctly taken 7 days before the first tablet is skipped. If this is not the case, it is recommended that you follow the first of the following options and use additional contraceptive methods within the next 7 days.
1. A woman should take the last missed pill as soon as possible, as soon as she remembers, even if it means taking two tablets at the same time.
The next tablet is taken at the usual time. Receiving tablets from a new package should be started without interruption, as soon as the current packaging is finished. It is likely that the woman will not bleed "cancellation" to the end of the second package, but there may be spotting spotting or bleeding "cancellation" on the days of taking the drug from the second package.
2. You can also stop taking the tablets from the current package.
In this case, a break in taking the drug can be up to 7 days, including the days of missing the tablets;then start taking the tablets from the next package.
If a woman missed taking the pills, and then in the first normal drug-free interval, she does not have a bleeding "withdrawal", it is necessary to exclude pregnancy.

Use of the drug in case of gastrointestinal upset

In the case of severe gastrointestinal upset (vomiting or diarrhea), partial absorption of the drug is possible, therefore additional contraceptive means should be used.

If vomiting occurs within 3-4 hours after taking an active tablet, take an additional tablet as soon as possible from another package.

A new tablet should be taken within 12 hours of the usual pill.

If more than 12 hours have passed, the recommendations for missing tablets should be followed.

Reception of "missed tablets"

If a woman does not want to change the normal mode of taking the drug, she should take an additional tablet (or several tablets) from another package if necessary.

How to delay the bleeding of "cancellation"

To delay the onset of bleeding "cancellation", it is necessary to continue taking the tablets from a new package of the Dailla ® preparation without taking a break.Delay is possible until the end of the tablets in the second package.
During the lengthening of the cycle, spotting spotting from the vagina or breakthrough uterine bleeding can occur. Renewal of the preparation of Dailla ® from the new package follows the usual 7-day break.
To transfer the day of the onset of menstrual bleeding to the other day of the week of the usual schedule, you should shorten the immediate break in taking the pills for as many days as necessary.
The shorter the interval, the higher the risk that there will be no "bleeding" of bleeding, and spotting spotting and breakthrough uterine bleeding (as in the case of a delay in the onset of bleeding "cancellation") will be noted during the taking of tablets from the second package.

During the simultaneous administration of drospirenone and ethinylestradiol, the following adverse reactions were reported:

Class of organ systems Frequency

Frequently? 1/100 to <1/10 Not infrequent? 1/1000 to <1/100 Rarely? 1/10000 to <1/1000

Nervous system disorders headache, emotional lability, depression, decreased libido, increased libido

Disorders from the endocrine system of menstrual irregularity, intermenstrual bleeding, soreness of mammary glands secreted from the mammary glands

Impaired sensory organs, hearing loss, poor tolerance of contact lenses

Disorders from the digestive system nausea, abdominal pain, vomiting, diarrhea

Disturbances from the skin and subcutaneous tissue acne, eczema, skin rash, urticaria, erythema nodosum, erythema multiforme, itching;
Chloasma, especially if there is a history of chloasma of pregnant women
Violations from the vascular system of migraine increase or decrease in blood pressure, thrombosis (venous and arterial), thromboembolism

Systemic disorders and complications at the site of administration, weight gain, fluid retention, weight loss

Breaches from the immune system bronchospasm

Violations of the reproductive system and mammary gland acyclic vaginal bleeding (spotting bloody discharge or breakthrough uterine bleeding), engorgement, tenderness, enlargement of mammary glands, candidiasis of the vagina.
vaginitis discharge from the mammary glands, increased discharge from the vagina

- presence of vein thrombosis (deep vein thrombosis, pulmonary embolism, pulmonary embolism), including in anamnesis;

- the presence of thrombosis of the arteries (for example, myocardial infarction) or previous conditions (eg, angina and transient ischemic attack), including in the anamnesis;

- complicated heart valve disease, atrial fibrillation, uncontrolled hypertension;

- Serious surgical intervention with prolonged immobilization;

- smoking (over the age of 35 years);

- liver failure;

- cerebrovascular diseases, including in history;

- presence of severe or multiple risk factors for arterial thrombosis: diabetes mellitus with vascular complications;
severe arterial hypertension; severe dyslipoproteinemia;
- hereditary or acquired predisposition to venous or arterial thrombosis, such as resistance to APS (activated protein C), insufficiency of antithrombin III, protein C deficiency, protein S deficiency, hyperhomocysteinemia and the presence of antiphospholipid antibodies (antibodies to cardiolipin, lupus anticoagulant);

- pancreatitis, including in the history, if marked hypertriglyceridemia was noted;

- severe liver disease (before the normalization of liver tests), including in history;

- severe chronic renal failure or acute renal failure;

- Liver tumors (benign or malignant) at present or in the anamnesis;

- hormone-dependent malignant diseases of the reproductive system (genitals, mammary glands) or suspicion of them;

bleeding from the vagina of unknown origin;

- a migraine with focal neurologic symptoms in the anamnesis;

- Pregnancy or suspicion of it;

- lactation period;

- hypersensitivity to the drug or any of its components;

- hereditary intolerance to galactose, lactase deficiency, glucose-galactose malabsorption.

Risk factors for thrombosis and thromboembolism: smoking, obesity, dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve defects, hereditary predisposition to thrombosis (thrombosis, myocardial infarction or impaired cerebral circulation at a young age in someone from the next relatives);
diseases in which there may be violations of peripheral blood circulation: diabetes, systemic lupus erythematosus (SLE), hemolytic-uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins; hereditary angioedema, hypertriglyceridemia, liver disease; the disease first appeared or worsen during pregnancy, or on the background of the previous use of sex hormones (including jaundice and / or pruritus related to cholestasis, cholelithiasis, otosclerosis with hearing impairment, porphyria, herpes during pregnancy in history, chorea
(Sydenham's disease), chloasma, post-partum period.

The drug Dailla ® is contraindicated during pregnancy. If in the course of taking the drug Dailla ® patient becomes pregnant, the drug should be discontinued immediately.
We can not exclude adverse effects on pregnancy and fetal development due to hormonal action of the active components.
Combined oral contraceptives can reduce the amount and change the composition of breast milk. Small amounts of hormonal contraceptives or their metabolites are found in milk during hormonal contraception and may have an impact on the child. The use of combined oral contraceptives is possible after complete cessation of breastfeeding.

Contraindicated in severe hronichesoy renal insufficiency or acute renal failure.

It is contraindicated in liver failure, severe liver diseases (liver samples before normalization), including a history of liver tumors (benign or malignant) currently or history.

Not applicable.

If any of the conditions / risk factors mentioned below are currently available, you should carefully weigh the potential risks and expected benefits of the combined oral contraceptive in each individual case and discuss it with the woman before she decides to start receiving the drug. In the event of aggravation, the gain or the first manifestation of any of these conditions or risk factors, the woman should consult with your doctor, who can decide whether to cancel the combined oral contraceptive.
Disorders of the circulatory system
rate of venous thromboembolism (VTE) using a combined oral contraceptive with a low dose of estrogen (<50 micrograms ethinyl estradiol such as the drug Dailla®) is from about 20 to 40 cases per 100,000 women per year, slightly higher than in women who do not use hormonal contraceptives (from 5 to 10 cases per 100 000 women), but lower than in women during pregnancy ( 60 cases per 100,000 pregnancies).
Additional risk of VTE observed during the first year of the combined oral contraceptive. VTE is fatal in 12% of cases.
Also identified the link between the use of COCs and an increased risk of thromboembolism arteries. Described very rare cases of thrombosis in other blood vessels, for example, hepatic, mesenteric, renal, cerebral and retinal as arteries and veins, those taking oral hormonal contraceptives. The causal relationship of occurrence of these side effects with taking the combined oral contraceptive remains unproven.
Symptoms of venous or arterial thrombosis / embolism cerebrovascular disease may include:
• Unusual unilateral pain and / or swelling of the limbs;
• sudden severe pain in the chest, with or without irradiation to the left arm;
• Sudden shortness of breath;
• sudden cough;
• any unusual, severe, prolonged headache; Sudden partial or complete loss of vision; diplopia;
• slurred speech or aphasia;
• Dizziness;
• Loss of consciousness with or without convulsive seizure;
• Weakness or very marked numbness suddenly appeared in one half or one part of the body;
• Movement disorders;
• «acute abdomen" syndrome.
The risk of complications associated with venous thromboembolism while taking the combined oral kiggratseptiva increases:
• With age;
• If you have a family history (venous or arterial thromboembolism in relatives or parents at a relatively young age); if you plan to hereditary predisposition, the woman should consult a specialist before prescribing a combined oral contraceptive;
• After prolonged immobilization, major surgery, any surgery to the legs, or major trauma. In these situations, it is recommended to stop taking the drug (in the case of elective surgery at least four weeks prior to it), and not to renew the appointment within two weeks after the immobilization. Additionally, you can assign antithrombotic therapy if use of oral hormonal contraceptives has not been terminated at the recommended time;
• In obesity (body mass index greater than 30 kg / m 2 );
The risk of arterial thrombosis and thromboembolism when receiving combined oral contraceptive increases:
• With age;
• At smoking (women over 35 years old are strictly not recommended to smoke if they wish to use combined oral contraceptives);
• When dislipoproteinemia;
• When hypertension;
• When a migraine;
• In diseases of the heart valves;
• If atrial fibrillation.
The presence of one serious risk factor or multiple risk factors for venous or arterial disease, respectively, can be contraindicated.
Women who use combined oral contraceptives should immediately consult your doctor in case of possible symptoms of thrombosis occurs. In cases of suspected or confirmed thrombosis thrombosis receiving combined oral contraceptives should be discontinued. It is necessary to choose an adequate method of contraception due to the teratogenicity of anticoagulant therapy (coumarins).
It should take into account the increased risk of thromboembolism during the postpartum period.
Other diseases are associated with severe vascular disease include diabetes mellitus, systemic lupus erythematosis, hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.
The increase in frequency and severity of migraine attacks. time combined oral contraceptive (which may be preceded by cerebrovascular disorders) can be grounds for immediate discontinuation of these drugs.
The most important factor in cervical cancer risk is an infection with the human papilloma virus. Some epidemiological studies have reported an increased risk of cervical cancer in long-term use of combined oral contraceptives, however, are saved conflicting opinions as to the extent to which these findings relate to confounding factors, such as the study of the presence of cervical cancer and the use of barrier methods of contraception.
It is believed that there is a slightly increased relative risk (RR = 1.24) of having breast cancer diagnosed in women who are at the time of the study used combined oral contraceptives. The excess risk gradually declines for 10 years after cessation of combined oral contraceptives. Because breast cancer is rare in women younger than 40 years, increasing the number diagnosed in recent years, women taking or taking combined oral contraceptives, breast cancer is small relative to the overall risk of developing breast cancer. These studies do not support a causal relationship between the reception of combined oral contraceptives and breast cancer.The observed increase in risk may be due to an earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effects of combined oral contraceptives, or a combination of both options. Breast cancers in women, ever use a combined oral contraceptives have been clinically less pronounced than in women, never let them take.
In rare cases on the background of the use of combined oral contraceptives observed the development of benign tumors of the liver, and even rarer - malignant. In some cases, these tumors cause life-threatening bleeding in the abdominal. The differential diagnosis of liver cancer in women taking combined oral contraceptives, it is necessary to take into account the emergence of severe pain in the upper abdomen, enlargement of the liver or signs of intra-abdominal bleeding.
Other conditions
Progesterone component in the preparation Dailla ®is an aldosterone antagonist, having the property to delay potassium. In most cases, no marked increase in potassium concentration. However, some patients with mild or moderate renal insufficiency and simultaneous assignment delay potassium medications while taking drospirenone in serum potassium concentration is insignificant, but increased. Thus, it is advisable to check the serum potassium concentration in the first cycle of dosing in patients with renal failure and potassium concentration values ​​before the treatment at the upper limit of normal, and while the use of drugs which delay potassium in the body.
Women with hypertriglyceridemia, or a family history of hypertriglyceridemia can not exclude an increased risk of development of pancreatitis while taking combined oral contraceptives.
Although small increases in blood pressure have been reported in many women taking COCs, clinically relevant increases were rare. Only in rare cases require immediate discontinuation of combined oral contraceptives. If while taking combined oral contraceptives in patients with hypertensive blood pressure values ​​are constantly elevated or reduced when taking antihypertensive drugs, receiving COCs should be discontinued. If necessary reception COCs can be continued, if using antihypertensive therapy achieved normal blood pressure values.
The following states develop or worsen both during pregnancy and when taking combined oral contraceptives, but their relationship with the combined reception / oral contraceptives has not been proven: jaundice and / or pruritus related to cholestasis; the formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy in history; hearing loss associated with otosclerosis.
In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms angionevrotycheskogo edema.
When acute or chronic disturbances of liver function may necessitate the discontinuation of combined oral contraceptives as long as liver function tests have not returned to normal. Recurrent cholestatic jaundice and / or itching caused by cholestasis, which develop for the first time during pregnancy or previous use of sex hormones, requires discontinuation of COCs.
Although the combined, oral contraceptives can influence on peripheral insulin resistance and glucose tolerance, there is no need to change the therapeutic regime in diabetic patients applying the low-dose combined oral contraceptives (containing <0.05mg ethinylestradiol). However, women with diabetes should be carefully observed the doctor, especially at the beginning of using combined oral contraceptives.
Also reported enhancing endogenous depression, epilepsy, Crohn's disease, and ulcerative colitis in the application of combined oral contraceptives.
Sometimes it can develop chloasma, especially in women with chloasma during pregnancy in history. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged
exposure to sunlight and ultraviolet radiation.
Medicament Dailla ® contains 48.53 mg lactose per tablet. Patients with hereditary galactose intolerance, lactase deficiency or malabsorption of glucose / galactose, lactose free diet are on should not take the drug.
Medical examination / advis.
Before starting, use of hormonal contraceptives, it is necessary to consult with your gynecologist and undergo appropriate medical examination. Further observation and frequency of medical examinations carried out on an individual basis, but at least 1 time in 6 months. Preparation Dailla ® , as well as other combined oral contraceptives, does not protect against HIV infection and other diseases, sexually transmitted diseases.
Reduced efficacy
The efficacy of combined oral contraceptives may be reduced in the case of omission of tablets, disorders of the gastrointestinal tract or at the same time taking other medications.
Reduced cycle control
In patients receiving combined oral contraceptives may experience irregular bleeding (spotting or breakthrough uterine bleeding), especially during the first few months of use. Therefore, evaluation of any irregular bleeding is significant only after the adaptation period, constitutes approximately three cycles.
If irregular bleeding recur or develop after previous regular cycles, it should be considered non-hormonal causes and implemented adequate diagnostic measures to exclude malignancy or pregnancy, including diagnostic curettage.
Some women bleed "cancel" can not develop during a break in taking combined oral contraceptives. If combined oral contraceptives are taken according to the instructions specified in the rules of the drug, the pregnancy is unlikely. However, if before that combined oral contraceptives are taken irregularly, or if there are no two consecutive bleeding
"cancel" to continue receiving combined oral contraceptives should be avoided pregnancy.
Impact on the ability to drive vehicles and manage mechanisms

The use of the drug Dailla ® does not affect the ability to road management and other mechanisms.

Information on overdose is not. However you may experience nausea, vomiting, spotting or bleeding from the vagina.
The specific antidote is unknown. There should be symptomatic treatment.

Interaction between, oral contraceptives and other drugs may lead to breakthrough uterine bleeding and / or reduction of contraceptive reliability. Describes the following types of interaction:
Effect on the metabolism in the liver
Some drugs due to induction of microsomal enzymes capable of increasing the clearance of hormones (phenytoin, barbiturates, primidone, carbamazepine and rifampicin; maybe the same effect oxcarbazepine, topiramate, Fe
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