Zoeli

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The description is actual on 27.10.2014

  • Latin name: Zoely
  • ATH code: G03AA14
  • Active ingredient: Nomegestrol + Oestradiol (Nomegestrol + Estradiol)
  • Producer: Organon (Ireland) Ltd (Ireland)

Structure

1 tablet – 2,5 mg of a nomegestrol of acetate and 1,55 mg of oestradiol of a gemigidrat (respectively 1,5 mg of oestradiol) – active agents.

Auxiliary ingredients:

  • 0,7 mg — talc;
  • 14 mg — microcrystallic cellulose;
  • 0,7 mg — stearate magnesium;
  • 2,4 mg — a krospovidona;
  • 57,71 mg — monohydrate of lactose;
  • 0,44 mg — silicon dioxide colloid.

Cover:

  • 1,6 mg — opadray the II white.

Placebo tablets:

  • 0,7 mg — talc;
  • 14 mg — microcrystallic cellulose;
  • 0,7 mg — stearate magnesium;
  • 2,4 mg — a krospovidona;
  • 61.76 mg — monohydrate of lactose;
  • 0,44 mg — silicon dioxide colloid.

Cover:

  • 2,4 mg — opadray the II yellow.

Release form

Zoeli's drug is issued in the form of tablets in a film cover on 28 or 84 tablets in one packaging. The blister containing tablets is numbered by days of the week.

Pharmacological action

Contraceptive.

Pharmacodynamics and pharmacokinetics

Zoeli — the hormonal combined contraceptive medicine consisting except additional substances, from active components: oestradiol (17β) and nomegestrola.

Oestradiol is the natural estrogen identical human endogenous 17β-эстрадиолу (E2). The main difference from the ethinylestradiol entering into structure other the COOK (the combined oral contraceptive means) consists in absence in 17α-положении etinilny group. Drug intake of Zoeli causes average concentration of E2 which correspond to that in an initial follicular phase and the completing lyuteinovy phase of a menstrual cycle.

Derivative natural progesterone – nomegestrol, it is similar to it on the structure and is the high-selection progestogen. Possessing the expressed affinity to a progesterone receptor (human), shows high anti-gonadotropic and moderate anti-androgenic activity, without having at the same time androgenic, glucocorticoid, oestrogenic and mineralokortikoidny action.

Contraceptive effect of drug of Zoeli consists in a combination of several effects, the most significant of which this change of secretion of a mucous neck of uterus and suppression of an ovulation. E2 increases effects of progestogen, and nomegestrol participates in process of suppression of an ovulation. After the end of administration of drug of Zoeli, the normal ovulation, at most of women, is recovered quickly enough.

Content in serum of folic acid during Zoeli's reception does not change and for half a year of consecutive reception remains at a basic level.

Clinical trials established Perl's index 0,66 — for an age category of women of 18 — 50 years and 0,75 — for 18 — 35, at the corresponding upper bound of 95% of a confidence interval 1,07/1,23.

In the conducted researches it was proved that administration of drug of Zoeli does not lead to significant changes of a metabolism of lipids, portability of glucose and a hemostasis does not influence sensitivity to insulin. Drug increased amount of proteins which transport KSG (a corticosteroid - connecting) and TSG (thyroxine - connecting) globulins, but much to a lesser extent, than compound of ethinylestradiol with levonorgestrel. Also, the content of free and general testosterone, a degidroepiandrosteron, androstendion considerably decreased and in insignificant degree concentration of the globulin, connecting sex hormones (G,CSH) increased. When carrying out histologic research of an endometria, after Zoeli's use throughout 13 cycles, his pathological changes were not observed.

Nomegestrol at internal reception is quickly soaked up and finds Cmax (7 ng/ml) in plasma in 2 hours. At reception once, absolute bioavailability, it is not dependent on meal, 63% equal.

For 97-98% contacts albumine, at the same time, without contacting KSG or GSPG. Vss — 1,645±576 l.

It is metabolized by P450 cytochrome to several hydroxylated inactive metabolites which in turn, together with nomegestroly, form sulphatic and glyukuronidny conjugates. The clearance is equal in an equilibrium state to 26 l/h.

In an equilibrium condition of T1/2, on average — 46 hours (from 28 to 83 h). Nomegestrol is brought on means of kidneys in smaller, and intestines more. About 80% are brought in 4 days and almost completely for 10 days.

Linearity of pharmacokinetics of a nomegestrol depends on the accepted dose (in the range of 0,625-5 mg).

Does not influence pharmacokinetics of a nomegestrol of GSPG. The equilibrium state is observed in 5 days. Average Css — 4 ng/ml. Cmax in plasma approximately — 12 ng/ml is also shown in 90 minutes after reception.

Nomegestrol does not interact with a glycoprotein P and has no the significant inhibiting or inducing effect on P450 cytochrome.

Oestradiol, at intake, gives in to the expressed metabolism at its first passing. Absolute bioavailability, in not dependence on meal, about 5%.

Actively extends on all organism. The largest content shows in target organs of PG (sex hormones). In blood contacts for 37% GSPG, for 61% albumine. Only 1-2% of oestradiol find in an untied look.

At reception orally exogenous oestradiol biotransformirutsya actively and thanking similarity with endogenous oestradiol, will quickly be transformed in a liver and intestines, to several metabolites (generally in estrone). The last are conjugated, being exposed to hepatoenteric circulation. Oxidation happens thanks to P450 cytochrome isoenzymes.

Cmax in serum is observed after 6 hours and equals — 90 pg/ml. Average concentration in serum — 50 pg/ml.

Out of blood it is brought quickly, T1/2 fluctuates with the broad range and later in/in introductions makes 8,4±6,4 h.

Indications to use

Contraceptive tablets of Zoeli are appointed for the purpose of contraception.

Contraindications

Exact data on contraindications of the oral contraceptives containing 17β-эстрадиол do not exist. However it is possible to assume that they correspond to that, at reception of the ethenylestradiolcontaining means. At Zoeli's reception, in case of manifestation of any of following states, it is necessary to stop its reception immediately.

  • hypersensitivity to any of tablet components;
  • thromboembolism of a pulmonary artery and deep vein thrombosis, both in present time, and in the past;
  • arterial fibrinferments (pathologies of blood circulation of a brain, myocardial infarction);
  • migraine with focal neurologic symptomatology, including in the anamnesis;
  • prodromal states (stenocardia, tranzitorny ischemic attack), including in the anamnesis;
  • the multiple and/or expressed factors of developing of arterial or venous thromboses (a heavy hypertension, a diabetes mellitus with vascular symptomatology, a heavy dislipoproteinemiya);
  • pancreatitis at a gipertriglitseridemiya in heavy degree, both in present time, and in the past;
  • the acquired or genetic predisposition of the patient to arterial or venous fibrinferments, for example: deficit of antithrombin III and proteins of C and S, resistance of a protein With, a gipergomotsisteinemiya and presence of anti-phospholipidic antibodies (lupoid anticoagulant, antibodies to cardiolipin);
  • tumors and heavy pathologies of a liver, including in the anamnesis;
  • the assumed or diagnosed malignant hormonedependent new growths (tumor of a mammary gland or generative organs);
  • period of chest feeding;
  • the assumed or diagnosed pregnancy;
  • vaginal bleedings of the obscure etiology;
  • lactose intolerance, deficit of lactase, glyukozo-galaktozny malabsorption;
  • postmenopause.

With extra care:

  • serious condition of a depression, also in the anamnesis;
  • the diabetes mellitus passing without pathologies of vessels;
  • system lupus erythematosus;
  • ulcer colitis;
  • illness Krone;
  • pathologies of function of a liver;
  • the gipertriglitseridemiya which is present nowadays or traced in the family anamnesis;
  • risk factors of emergence of ischemic damage of heart (smoking, obesity, arterial hypertension);
  • presence at the family anamnesis of an arterial embolism and venous thromboses;
  • serious surgery and long immobilization.

Side effects

As practice showed, portability of contraceptive means of Zoeli generally good, and safety of use is at the level of the other combined drugs with similar action. Possible negative effects which were observed at Zoeli's reception are included below.

Metabolism:

  • increase in weight;
  • liquid delay;
  • increase or loss of appetite.

TSNS:

  • decrease or increase in a libido;
  • depression;
  • migraine;
  • disturbance of attention;
  • headaches.

Organs of sight:

  • dryness of eyeglobes;
  • intolerance of carrying contact lenses.

Vascular system:

  • inflow.

Alimentary system:

  • abdominal distention;
  • nausea;
  • increase in activity of enzymes of a liver;
  • dryness in an oral cavity.

Integuments and hypodermic fabrics:

Musculoskeletal system:

  • feeling of weight.

Generative organs and mammary glands:

  • cancellation bleedings;
  • menorrhagia;
  • pains around a small pelvis;
  • hypomenorrhea;
  • nagrubaniye of mammary glands;
  • metrorrhagia;
  • galactorrhoea;
  • premenstrual syndrome;
  • uterus spasm;
  • consolidations in mammary glands;
  • dryness of a vagina and vulva;
  • dispareuniya;
  • discomfort in a vagina;
  • unpleasant smell from a vagina.

The general:

The side effects observed at use COC (the combined oral contraceptives) which contain ethinylestradiol:

  • increase in the ABP;
  • arterial and venous thromboembolisms;
  • hloazma;
  • hormonedependent tumors (cancer of mammary glands, liver tumors).

Frequency of diagnosing of a breast cancer at the women using the COOK is slightly higher, than that at the women using other methods and contraceptives.

Communication between breast cancer and reception the COOK is not established.

Application instruction of Zoeli

The instruction on Zoeli recommends to carry out daily reception of tablets inside in at one time, without taking meal in attention. A pill is taken in the sequence specified on the blister and washed down with water.

Are identical to all women of the recommendation about use of drug of Zoeli. For 28 days it is necessary to accept in a row on 1 tablet every day. In the first 24 days take a pill it is white the colors including active agents then, throughout the following 4th tablets of yellow color (placebo) which do not contain the operating components.

The initial tablet from each following blister (or packagings) needs to be accepted in the next days after the completing tablet from the last blister. Administration of drug is carried out in independence of absence or existence of bleeding of cancellation which is, as a rule, observed in 24-36 hours after the use of the last tablet of white color and can proceed prior to use of the following blister.

Beginning of use

For the women who were earlier not accepting hormonal contraceptives it is the best of all to begin Zoeli's reception in the first days of a menstrual cycle. In this case additional resources of contraception will not be necessary. The beginning of use about 2-go-5-go days of a cycle, but at the same time for a week is allowed, it is necessary to use additional contraceptive barrier methods.

Upon transition from other contraceptives of the combined hormonal action (other the COOK, plasters of transdermalny, vaginal rings), in case of use other the COOK recommend to begin Zoeli's reception the next days after the last operating tablet (not placebo) and not later than in the next day on the termination of usual range between cycles or acceptances of tablets of placebo. At the previous use of a transdermalny plaster or vaginal ring, it is desirable to begin transition to Zoeli's tablets in day of their removal (removal), but not later than during the following recommended gluing of a plaster or input of a ring.

At the correct and continuous use of the previous contraceptive methods and at a guarantee of lack of pregnancy, transition to Zoeli in any day is possible. To exceed the recommended bezgormonalny period of the previous contraceptive method, it is impossible at all.

In case of transition from the contraceptives containing one progestogen (implants, tablets, injections or Naval Forces — intrauterine system) at the previous use of other tablets, it is possible to pass to Zoeli in any day, the next days after the termination of acceptance of tablets with progestogen. Upon transition from injection forms, replace with reception of a tablet of Zoeli the following recommended injection. Naval Forces or an implant delete in any convenient day in which begin to accept Zoeli. In all above described cases recommend to use, for a week, additional barrier contraceptives.

After carrying out abortion in the first trimester, it is possible to begin Zoeli's use on the end of procedure at once, at the same time an additional birth control is not required.

After abortion in the second trimester or childbirth, it is necessary to begin to use drug in an interval between 21 and 28 days. In case of later use, better, for a week, in addition to use barrier contraceptives. At the previous sexual contacts, it is necessary to exclude possible pregnancy, before its use.

In case of the admission of reception of tablets

In case of the admission next acting (white color) tablets provide the following recommendations.

At delay of the following reception less than for 12 hours to take the necessary pill without correction of following and time of reception of the subsequent tablets.

At more than 12-hour delay follow two rules:

  • the operating pill should be taken for not less than 7 days in a row;
  • the more the quantity of the passed operating tablets and are closer a placebo usage time, the possibility of pregnancy is higher.

At the admission of the 1st tablet to accept it as soon as possible, even in case of reception of 2 subsequent tablets at the same time. Further to continue the usual scheme of use, without additional measures.

At the admission of the 2nd and more tablets, in the absence of cancellation bleeding during placebo reception, it is necessary to exclude pregnancy.

At the admission during the 1st – the 7th days of a cycle, it is necessary to take the last passed pill as soon as possible, even in case of reception of 2 subsequent tablets at the same time. Further to continue the usual scheme of use, with use of barrier contraception, for the first week. In case of sexual intercourse at this time, pregnancy is possible.

At the admission during the 8th – the 17th day of a cycle, it is necessary to take the last passed pill as soon as possible, even in case of reception of 2 subsequent tablets at the same time. Further to continue the usual scheme of use, with use of barrier contraception, for the first week.

At the admission during the 18th – the 24th day of a cycle, it is necessary to take the last passed pill as soon as possible, even in case of reception of 2 subsequent tablets at the same time. It is impossible to carry out a concomitant use more than 2 operating tablets. For the first week it is necessary to use the barrier contraception and first the operating tablet from the following blister, to accept after the last operating tablet from previous, that is I pass a placebo reception phase. At this scheme cancellation bleeding most often comes in the following phase of reception of placebo, however throughout the current cycle, the smearing allocations or breakthrough bleedings can be observed.

At uncertainty in quantity of the passed tablets, it is necessary to use barrier contraceptives, for not less than a week of continuous reception of the operating tablets.

The admission of tablets of placebo does not lead to lowering of contraceptive effect.

At gastrointestinal painful states, such as diarrhea or vomiting, can suffer process of absorption of drug of Zoeli in this connection, it is necessary to resort to auxiliary measures of contraception.

In a case developing of vomiting for 3-h-4-h hours after a tablet proglatyvaniye, this reception is equated to passed. If this disease state proceeds within several days, it is necessary to use the above described recommendations. At unwillingness of change of the typical scheme of use it is possible to take in addition operating pill or a tablet from other blister.

For a delay of the moment of menstrualnopodobny bleeding, it is necessary to begin reception of tablets of white color from the following blister, to their termination from the previous blister at once, that is to exclude placebo reception. A pill of white color from the second blister can be taken completely. After reception of placebo from the second blister, renew the usual scheme of reception of Zoeli. In case of the extended use there can be smearing allocations and/or breakthrough bleedings. For the shift of day of the beginning of developing of menstrualnopodobny bleeding, it is possible to reduce a placebo reception phase (as much as possible for 4 days). The smaller break increases risk of absence of bleeding of cancellation and development of the smearing blood allocations and breakthrough bleedings.

Overdose

Serious by-effects, at overdose by Zoeli's drug were not observed. 5 multiple repeated doses and a single dose of the dose exceeding by 40 times, did not reveal negative effects.

It is possible to allow developing of nausea, emetic desires, bloody allocations from a vagina.

Symptomatic therapy is shown.

Interaction

Completely to exclude possible interaction, it is necessary to study attentively instructions on them, in the application instruction in parallel of the used drugs.

Interaction the COOK, including Zoeli, with other HP can cause bleedings and/or lowering of contraceptive efficiency. The generalized interactions of other HP with the COOK are given below.

Hepatic metabolism

Interaction with inductors of microsomal liver enzymes is possible that can become the reason of increase of clearance of PG (sex hormones). Interaction with barbiturates, Phenytoinum, Primidonum, Rifampicin, Carbamazepine is certain. Interaction with Griseofulvin, Topiramat, Okskarbazepin, Felbamat and drugs of the St. John's Wort which is made a hole is possible. Also, the means inhibiting HIV proteases (Ritonavir and so forth) and nenukleozidny inhibitors of the return transcriptase (Not Virapinum and so forth), as well as their combinations have influence on a hepatic metabolism.

At parallel reception of inductors of microsomal enzymes, and also for 28 days after their cancellation it is necessary to use barrier contraception. In case of carrying out long therapy by these drugs, it is necessary to consider a question of purpose of other contraceptive method.

Inhibitors of microsomal enzymes, such as Ketokonazol, can lead to increase of concentration of PG in plasma.

Antibiotics

At combined use with antibiotics, such as tetracyclines and ampicillin, efficiency lowering the COOK, including ethinylestradiol was observed. The mechanism given interaction completely is not studied. Reliable data about interaction the COOK as a part of which is 17β-эстрадиол and antibiotics, do not exist. Women who pass an antibioticotherapia (except use of Griseofulvin and Rifampicin) have to apply additional barrier contraceptives on the entire period of treatment, and also 7 days later. If the period of additional barrier contraception covers time of the end of reception of the operating tablets, recommend to miss reception of placebo and at once to pass to reception of the operating tablets from other blister.

Other HP

The COOK can exert impact on a metabolism of other HP, increasing their plasma and fabric concentration as in a case with Cyclosporine or lowering, as in a case with Lamotridzhin.

Terms of sale

According to the recipe.

Storage conditions

At a temperature of 2-30 °C.

Period of validity

36 months.

Special instructions

The included below data are obtained during epidemiological researches COOKS which part ethinylestradiol is. Zoeli's drug includes 17β-эстрадиол, however the described special instructions, are applicable also for it.

Vascular disorders

Communication between reception the COOK and risk of development of a thromboembolism, and also venous and arterial thromboses (a myocardial infarction, a deep vein thrombosis, a stroke, a thrombembolia of a pulmonary artery) was observed. On the general background these states develop seldom, but for the first year of reception the COOK, risk of development of these complications the highest. It is necessary to know that 1-2% of cases of an embolism and venous thromboses come to an end with death.

At development of thromboses can be shown:

  • pain and/or hypostasis of legs;
  • sudden asthma;
  • sharp stethalgia, with return or without, in the left hand;
  • unexpected cough;
  • sudden loss of sight (partial or full), the uncharacteristic expressed long headaches;
  • diplopia;
  • dizziness;
  • disturbance of the speech;
  • collapse (it is possible with spasms);
  • weakness;
  • motive frustration;
  • the sudden expressed numbness of one side of a body;
  • syndrome "acute abdomen".

Risk factors of embolisms and venous thromboses:

  • old age;
  • genetic predisposition (these diseases in the family anamnesis);
  • obesity;
  • thrombophlebitis;
  • varicosity;
  • serious injury;
  • serious operative measure;
  • long immobilization.

Risk factors of arterial thromboses:

It is worth remembering the increased risk of thromboembolic aggravations in a puerperal period.

At any of these disturbances, before reception of tablets of Zoeli, it is necessary to consult with the doctor. In suspicion cases on thrombosis or its diagnosings, during use the COOK, reception of tablets is cancelled. At the states demanding hospitalization (a serious injury, a serious operative measure, a long immobilization) the COOK (a month before planned operation), with resuming of reception in 14 days after normal resuming of motive functions is better to stop use.

Also, consultations of the doctor will demand such diseases as:

Strengthening of migraine is the indication for immediate cancellation of Zoeli.

Tumors

Long reception ethenylestradiolcontaining the COOK, on result of researches, increases risk of development of cancer of neck of uterus, meanwhile open is a question of other influencing factors. Up to the end it is not found out what leads to increase of risk, reception the COOK, more frequent testings of a condition of a neck of uterus, feature of sexual intercourse (including barrier contraception) or their general combination.

There are no authentic data on Zoeli's influence on development of cancer of ovaries and an endometria.

Some increase in the relative risk (RR) of developing of a breast cancer is revealed (the SHOUTING = 1,24). This risk decreases for 10 flyings after cancellation the COOK. This increase is perhaps connected with earlier identification, effects the COOK or their combination.

Sometimes, at reception the COOK, revealed development of tumors of a liver (high-quality), is even more rare — malignant. In rare instances these tumors, because of intra belly bleedings, became threat for the patient's life. At detection of increase in a liver, megalgias in a stomach, symptoms of intra belly bleeding, it is necessary to exclude a possible tumor of a liver.

Other states

Reception the COOK at a gipertriglitseridemiya or mentioning of it in the family anamnesis, increases risk of developing of pancreatitis a little.

Often observed some increase in the ABP which seldom is clinically significant. Reception connection the COOK and formations of arterial hypertension is not established. However, in case of its development it is worth canceling use the COOK and to consider a question of purpose of adequate anti-hypertensive therapy. At stabilization of the ABP with use of anti-hypertensive drugs, use resuming the COOK is possible. By results of clinical trials, Zoeli's reception on an extent till 12 months, did not lead to clinically significant disturbances of the ABP.

In a usage time the COOK and against pregnancy complications or development were noted: itch and/or jaundice, cholelithiasis, gestational herpes, porphyria, hemolitic uraemic syndrome, system lupus erythematosus, chorea of Sidenkhem, Quincke's disease, and also hearing loss.

Pathologies of a liver can demand cancellation the COOK before full normalization of a condition of a liver.

In case of recurrence of cholestatic jaundice which was for the first time diagnosed during pregnancy or reception of sexual steroids in the past it is necessary to interrupt use the COOK.

Zoeli's tablets, at healthy women, did not influence tolerance to glucose and an insulinorezistentnost. However, during their reception, it is necessary to perform careful periodic inspections, in particular the women suffering from a diabetes mellitus.

The Krone and courses of a depression observed progressing of ulcer colitis, illness.

Occasionally the hloazma developed, in particular when mentioning of this disease in the anamnesis. In this case it is better to avoid long stay on the sun, a sunbed and other influences of an ultraviolet.

Carrying out consultations and inspection

Before appointment the COOK it is necessary to gain an impression about the personal and family anamnesis of the woman, and also to exclude possible pregnancy. To take measurement of the ABP and at existence of indications to appoint physical inspection considering all contraindications. Frequency of control surveys in each case is determined separately, but at least two times a year.

Women have to obtain the complete information about action and side effects the COOK, and also to be informed on what this way of contraception does not prevent from penetration of HIV infection and other sexual diseases.

Efficiency lowering

Efficiency the COOK can decrease at the admission of the operating tablets, and also gastrointestinal frustration.

Periods

Use the COOK, in particular in the first months, can be followed by the smearing allocations or breakthrough bleedings. In this regard, it is reasonable to appoint carrying out research of these manifestations after the adaptation period (3 months). At preservation of these symptoms after three cycles of reception the COOK, it is necessary to assume their non-hormonal nature and to appoint carrying out diagnosis for the purpose of an exception of possible tumors or pregnancy. Carrying out a diagnostic scraping is possible.

At research of drug of Zoeli, bleeding developed seldom and were short-term, slight and low-painful. In certain cases observed absence of due bleeding of cancellation at placebo reception, without pregnancy diagnosing that tells about its low probability even at absence cancellation bleeding. In case of the admission of two bleedings, at administration of drug according to instructions, it is necessary to exclude possible pregnancy.

Zoeli's analogs

Zoeli's analogs are provided by the following contraceptive drugs:

Zoeli or Klayr — what is better?

Despite some difference as a part of active ingredients, nomegestrol + oestradiol in Zoeli and diyenogest + oestradiol valerate in Klayre the mechanism of effect of both drugs is almost identical. Both drugs microdosed however of Klayr, in each group of tablets (excellent on color), contain different mass part of active agents whereas in Zoeli the dosage in each operating tablet is identical. These contraceptives are practically repeated each other, both in contraindications, and in side effects. In this regard it is not possible to give a definite answer what of these drugs is better.

Oral contraceptives of hormonal action are selected individually and best of all it is possible to appoint suitable drug only after delivery of a set of analyses and passing of some researches. You should not forget also about chronic diseases, painful states in the anamnesis (both in own, and in family) and many other factors which can also influence the choice of a contraceptive.

At any your choice a boundary by Zoeli and Klayra, it is necessary to remember that these drugs, at exact following to recommendations of their reception, possess high performance and cause less side effects in comparison with other contraceptives. But the choice the COOK has to be especially individual.

Zdravzona

  • Zoeli 2,5mg + 1,5mg No. 28 tabletkiorganon
  • Zoeli 2,5mg + 1,5mg No. 84 tabletkiorganon

Drugstore of IFC

  • Zoeli tbl p/pl/o 2,5mg +1,5mg No. 28, Organonirlandiya
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Section: Contraceptives
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Education: Graduated from the Vinnytsia national medical university of N. I. Pirogov, pharmaceutical faculty, the higher pharmaceutical education – the specialty "Pharmacist".

Experience: Work in Koneks and Bios-Media pharmacy chains as "Druggist". Work as "Pharmacist" in Avicenna pharmacy chain of the city of Vinnytsia.

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