Implanon НКСТ®
Producer: Merck Sharp & Dohme Corp. (Merck Sharp and Doum of the Building) USA
Code of automatic telephone exchange: G03AC08
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 68 mg of an etonogestrel.
Excipients: barium sulfate, ethylene and vinyl acetate copolymer (28% vinyl acetate), magnesium stearate, ethylene and vinyl acetate copolymer (14% vinyl acetate).
Pharmacological properties:
Pharmacodynamics. Implanon НКСТ® represents drug placed in the sterile one-time applicator X-ray contrast, containing etonogestret an implant for п / to use which is not exposed to biological disintegration.
Etonogestrel is biologically active metabolite of a dezogestrel - the progestogen which is widely applied as peroral contraceptive hormonal means (personal computer). Structurally it is derivative a 19-nortestosterona and in target organs with high affinity contacts progesterone receptors. The contraceptive effect of an etonogestrel is generally reached due to suppression of an ovulation. Ovulations were not observed within the first 2 years of use, and only seldom they arose within the 3rd year. In addition to suppression of an ovulation etonogestret also causes increase in viscosity of a secret of a neck of uterus, obstructive spermatozoa.
Clinical trials were conducted at women at the age of 18-40 years. Despite the lack of direct comparison, the contraceptive effect of an implant at least is comparable with contraceptive effect of the combined personal computers (more than 99%).
High degree of protection against pregnancy is reached, in addition to other reasons, the fact that contraceptive effect of drug Implanon НКСТ® does not depend on strict observance by the woman of the daily, weekly or monthly mode of reception. Contraceptive action of an etonogestrel is reversible that is expressed in bystry recovery of a normal ovulatory menstrual cycle after removal of an implant. Though etonogestret suppresses an ovulation, activity of ovaries is suppressed not completely. Average concentration of oestradiol in a blood plasma remain above value which is observed on an early phase of formation of a follicle.
Etonogestrel does not influence change of mineral density of a bone tissue and metabolism of lipids.
Use of the contraceptive hormonal means containing progestogens, perhaps renders effect on insulin resistance and tolerance to glucose.
It was shown that the dysmenorrhea occurs at the patients using drug Implanon НКСТ® less often.
Pharmacokinetics. Absorption. After introduction of an implant etonogestret quickly it is soaked up in the circulating blood. The concentration suppressing an ovulation are reached in 1 days of Cmax in plasma (from 472 to 1270 pg/ml) reached in 1-13 days. Speed of release of an etonogestrel from an implant decreases eventually, as a result of it its concentration in plasma quickly decreases within the first several months after introduction. By the end of the first year of use, average concentration makes about 200 pg/ml (150-261 pg/ml), and slowly decreases to 156 pg/ml (111-202 pg/ml) by the end of the third year. The observed variations of concentration in plasma partially can be connected with distinctions in body weight.
Distribution. Linkng of an etonogestrel with proteins of plasma makes 95.5-99%, is preferential with albumine and to a lesser extent with the globulin connecting sex hormones. Vd in the central camera and the general Vd make 27 l and 220 l respectively, and it is improbable that these indicators change in the time spent of drug Implanon НКСТ® in the woman's organism.
After introduction to women during breastfeeding etonogestret milk/plasma 0.44-0.50 within the first 4 months is removed with breast milk in the ratio. The average dose etonogestret, coming to the child's organism with breast milk, makes about 0.2% of a maternal daily dose of an etonogestrel (about 2,2% at recalculation for kg of body weight of the child). It is shown that concentration gradually and statistically significantly decrease over time.
Metabolism. Etonogestrel is exposed to a hydroxylation and recovery. Metabolites are sulfates and glucuronides.
Removal. At in introduction of an etonogestrel average T1/2 makes about 25 h, and the clearance makes about 7.5 l/h of plasma. The clearance and T1/2 remain constant during drug use. Etonogestrel and his metabolites both in the form of free steroids, and in the form of conjugates are removed by kidneys and through intestines (the relation 1.5:1).
Indications to use:
Contraception.
Route of administration and doses:
Before administration of drug Implanon НКСТ® it is necessary to exclude pregnancy.
To the gynecologist it is strongly recommended to participate in the training session to examine using the drug applicator Implanon НКСТ® and techniques of introduction and removal of an implant Implanon НКСТ®.
Before introduction of an implant, it is necessary to read attentively the application instruction and to follow instructions on introduction and removal of an implant.
Rules of use of an implant Implanon НКСТ®. Drug Implanon НКСТ® is is long the operating contraceptive hormonal means. П / to one implant which can remain in an injection site within 3 years is entered. Delete an implant not later, than in 3 years from the date of introduction. The woman needs to be informed on a possibility of removal of an implant at any time at will. The gynecologist can consider the possibility of earlier removal of an implant at women with excess body weight. After removal of an implant immediate introduction of other implant will lead to continuation of contraceptive protection. If the woman does not want to continue drug use Implanon НКСТ®, but she needs contraception, it is necessary to recommend other method of contraception.
Implanon НКСТ® is a basis for successful use and the subsequent removal of an implant correct and accurately executed п / to introduction of an implant according to this instruction. Disturbance of time and technology of introduction of an implant can lead to pregnancy.
The implant Implanon НКСТ® should be entered п / to, directly under skin on the shoulder interior in order to avoid traumatizing large blood vessels and nerves which are located more deeply in connecting fabric between two-headed and tricipital muscles.
At once after introduction of an implant it is palpatorno necessary to check its existence under skin. If the implant does not manage to be groped or its existence is under doubt, it is necessary to apply other diagnostic methods to confirmation of its existence. Until existence of an implant is confirmed, the woman should recommend use of a non-hormonal (barrier) method of contraception.
Drug packaging Implanon НКСТ® contains the user's card intended for record of number of a series of an implant. The gynecologist needs to write down Date of Introduction, to specify a hand into which the implant, and the planned day of its removal in the user's card was entered. Packaging of drug contains stickers for records of the gynecologist in which number of a series of an implant is specified.
When to enter Implanon НКСТ®. Before introduction of an implant it is necessary to exclude pregnancy.
The choice of time of introduction depends on recent use by the woman of contraceptive hormonal means as follows.
In the absence of use of contraceptive hormonal means last month. The implant should be entered between the 1st day (the first day of menstrual bleeding) and the 5th day of a menstrual cycle even if menstrual bleeding still proceeds.
At the correct introduction of an implant the additional method of contraception is not required. At a deviation from the recommended period of introduction of an implant it is necessary to warn the woman about need of use of a barrier method of contraception during the next 7 days. If during this period there were sexual contacts, it is necessary to exclude pregnancy.
Transition from a hormonal method of contraception to Implanon НКСТ®. Upon transition from the combined method of hormonal contraception (the combined peroral contraceptive means (the CPC, the combined hormonal vaginal ring or the combined hormonal transdermalny plaster)
The implant should be entered preferably in the day following behind day of reception of the last active tablet (the last tablet containing active ingredients) of the CPC, but no later than the day following a usual interval in reception of tablets or the period during which a pill of placebo of the CPC was taken. If earlier the vaginal ring or a transdermalny plaster was applied, the implant should be entered preferably in day of removal, but no later than day of the following use of the previous drug.
At the correct introduction of an implant, the additional method of contraception is not required. At a deviation from the recommended period of introduction of an implant it is necessary to warn the woman about need of use of a barrier method of contraception within 7 days. If during this period there were sexual contacts, it is necessary to exclude pregnancy.
Upon transition from a progestagenny method of contraception (for example, the tablets containing only progestogen, injections, an implant or hormonal intrauterine system (Naval Forces))
As there are several types of progestagenny methods, introduction of an implant has to be carried out as follows:
— injection contraceptive hormonal means: enter an implant in day when it is necessary to do the following injection;
— the tablets containing only progestogen: the woman can pass from the tablets containing only progestogen to Implanon НКСТ® in any day. The implant has to be entered during 24 h after reception of the last tablet;
— implant / hormonal Naval Forces: enter an implant in day of removal of the previous implant or Naval Forces.
At the correct introduction of an implant the additional method of contraception is not required. At a deviation from the recommended period of introduction of an implant it is necessary to warn the woman about need of use of a barrier method of contraception within 7 days. If during this period there were sexual contacts, it is necessary to exclude pregnancy.
After abortion or an abortion:
— I trimester: the implant has to be entered within 5 days after abortion or an abortion in the I trimester;
— II trimester: the implant has to be entered between 21 and 28 days after abortion or an abortion in the II trimester;
At the correct introduction of an implant the additional method of contraception is not required. At a deviation from the recommended period of introduction of an implant it is necessary to warn the woman about need of use of a barrier method of contraception within 7 days. If during this period there were sexual contacts, it is necessary to exclude pregnancy.
After the delivery:
— when breastfeeding: the implant should be entered upon completion of the fourth week after the delivery. The woman should apply a barrier method of contraception within 7 days after introduction of an implant. If during this period there were sexual contacts, it is necessary to exclude pregnancy.
— in the absence of breastfeeding: the implant should be entered between 21 and 28 days after the delivery. At the correct introduction of an implant the additional method of contraception is not required. At a deviation from the recommended period of introduction of an implant it is necessary to warn the woman about need of use of a barrier method of contraception within 7 days. If during this period there were sexual contacts, it is necessary to exclude pregnancy.
How to enter Implanon НКСТ®. Implanon НКСТ® is a basis for successful use and the subsequent removal of drug correct and accurately executed п / to introduction of an implant to not dominant hand according to instructions. The gynecologist and the woman palpatorno have to define existence of an implant after its introduction.
The implant should be entered directly under skin. Too deep or wrong introduction of an implant can be complicated by paresthesia (owing to injury of a nerve), migration of an implant (owing to intramuscular or fascial introduction) and, in rare instances, intravascular introduction. Besides, when the implant is entered too deeply, it can not be palpated, and its localization and/or removal can be complicated.
Administration of drug Implanon НКСТ® has to be carried out in aseptic conditions and the gynecologist only qualified who is well familiar with an introduction technique. Introduction of an implant should be carried out only by means of the special applicator.
It is recommended that the gynecologist was in a sitting position during all procedure of introduction so that he could see clearly an injection site and movement of a needle under skin.
1. The woman needs to lay down on a diagnostic table on a back, having bent not dominant hand in an elbow and having turned it outside so that her wrist was parallel to her ear, or her hand was located near her head.
2. Define an injection site which is on the interior of a shoulder of not dominant hand of a humeral bone about 8-10 cm higher than a medial epicondyle. The implant should be entered directly under skin in order to avoid damage of large vessels and nerves which are located more deeply in hypodermic fabrics in an intermuscular furrow between two-headed and tricipital muscles.
3. Do two marks by a sterile marker: first, note a point into which the implant will be entered, secondly, note the point located on several centimeters proksimalny in relation to the first mark. The second mark will serve afterwards sending to introduction time.
4. Process an injection site antiseptic solution.
5. Carry out injection site anesthesia (for example, using the anesthetizing aerosol or an injection of 2 ml of 1% of lidocaine directly under skin along the planned channel of introduction).
6. Take from the blister the sterile one-time applicator Implanon НКСТ® in whom there is an implant. The applicator is not used if there are doubts in sterility.
7. The applicator is taken directly over a needle in the field of the textured surface and delete a transparent protective cap from the needle containing an implant. If the cap easily is not removed, this applicator should not be used. It is possible to see the implant painted in white color, having looked in a needle tip. It is impossible to touch a purple slider until the needle is completely not entered subcutaneously as it will lead to retraction of a needle and premature release of an implant from the applicator.
8. Using a free hand, big and index fingers stretch skin around an injection site.
9. Pierce with a tip of the needle located at an angle about 30 ° skin.
10. The applicator is lowered in horizontal position. Raising skin a needle tip, smoothly enter a needle at all its length. It is possible to feel small resistance, but it is not necessary to put pressure with an excessive force. If the needle is not entered at all its length, the implant will not be entered properly. It is more convenient to observe the movement of a needle when the doctor sits and observes from outside, but does not look from above. In this situation the injection site and the movement of a needle clearly are visible.
11. The applicator is held in the same situation, after introduction of a needle at all its length. If it is necessary, it is possible to hold the applicator in the same situation a free hand during the subsequent actions. Will unblock a purple slider, having slightly pressed on it down. Move a slider completely back until it does not stop. Now the implant is under skin, and the needle is blocked in the applicator. Then the applicator can be removed. If not to hold the applicator in invariable situation during the procedure or if the purple slider is not completely moved back, the implant will not be entered.
12. After introduction it is necessary to check existence of an implant under shoulder skin by means of a palpation. At a palpation of both ends of an implant it is necessary to be convinced available a core 4 cm long.
If the doctor cannot feel an implant or doubts its existence:
1. Check the applicator. The needle has to be involved completely, and only the purple tip of the obturator has to be visible.
2. For confirmation of existence of an implant it is possible to use: two-dimensional X-ray, a x-ray computer tomography (KT scanning), ultrasonic scanning (UZS) with the high-frequency ultrasonic sensor for linear scanning (10 MHz or are more) or MRT. If these methods of visualization to confirm existence of an implant do not work well, recommended to define concentration of an etonogestrel in a blood plasma of the woman. Existence of an implant is not confirmed yet, the non-hormonal (barrier) contraceptive method has to be applied.
3. Put a small sticker from an adhesive plaster to an injection site. Ask the woman to palpate an implant.
4. Put a sterile gauze compressing bandage for reduction of bruises. The woman can remove a compressing bandage in 24 h, and a small sticker from an injection site - in 3-5 days.
5. Fill a card of the user and transfer her to the woman to storage. Besides, fill stickers and attach them to the medical record of the woman.
6. The applicator is intended only for single use and has to be properly utilized according to the existing requirements for the treatment of biologically dangerous wastes.
How to remove Implanon НКСТ®. Before the procedure of removal the gynecologist has to establish the location of an implant specified in the user's card and check it palpatorno. If the implant is not palpated, then for confirmation of its existence it is necessary to use additional methods of inspection.
After localization of not palpated implant consider the possibility of surgical removal of an implant under control of UZS.
There are rare messages on movement of an implant; usually it concerns insignificant movement of rather starting position, except for too deep introduction. It can complicate localization of an implant by means of a palpation, UZS and/or MRT, and removal can demand a bigger section more time.
Removal of an implant has to be carried out only in aseptic conditions by the gynecologist who is well familiar with a removal technique.
Surgery for the purpose of search of an implant without knowledge of its exact localization is not recommended.
Removal of deeply entered implants has to be carried out with care, in order to avoid damage of deep nervous or vascular structures of a shoulder and has to be carried out by the specialist who is well knowing shoulder anatomy.
1. The place of future section is processed an antiseptic agent. Define location of an implant by a palpation and note its distal end (the end, the next to an elbow), for example, a sterile marker.
2. Carry out place anesthesia where the section, for example, will be made 0.5-1 ml of 1% of solution of lidocaine. It is necessary to be convinced that local anesthetic is entered under an implant in order that it remained close to the surface of skin.
3. Press on the proximal end of an implant to record it; on skin there can be a camber which will designate the distal end of an implant. Since the distal end of an implant, do a slit of 2 mm towards an elbow.
4. Carefully push an implant towards a section until its tip appears. Take an implant a surgical clip (preferably a clip like "mosquito") and delete an implant.
5. If the implant is put into a connective tissue cover, do a section of a cover of fabric and then delete an implant with a surgical clip.
6. If the tip of an implant is not visible after a section, carefully enter a surgical clip into a section. Take an implant. The clip is overturned and taken in other hand. The second clip it is necessary to otseparovat carefully fabric around an implant and to take an implant. After that the implant can be removed.
7. Are convinced that all implant (length of 4 cm) is removed, having measured its length. If a part of an implant was removed (length less than 4 cm), the rest has to be removed according to the instruction.
8. If the woman wants to continue drug use Implanon НКСТ®, then the new implant can be entered immediately, right after removal of an old implant, into the same section.
9. After removal of an implant close a section sterile strips of fabric (стеристрип) and put a sticker from an adhesive plaster.
10. For reduction of bruises apply a sterile compressing bandage. The woman can remove a compressing bandage in 24 h, and a sticker - in 3-5 days.
How to replace Implanon НКСТ®. Immediate replacement can be made after removal of the previous implant, and it is similar to the procedure of introduction described in the section "How to Enter Implanon НКСТ®". The new implant can be entered into the same place and through the same section from which the previous implant was removed. If for introduction of a new implant the same section is used, carry out injection site anesthesia (for example, 2 ml of 1% of solution of lidocaine), introduction directly under skin, since a section for removal, along "the channel of introduction", and follow the subsequent stages of the instruction for introduction. Additional information and more detailed instructions concerning introduction and removal of an implant can be received at the manufacturing company.
Features of use:
Use at pregnancy and feeding by a breast. Drug use Implanon НКСТ® is not shown at pregnancy. In case of pregnancy during drug use Implanon НКСТ®, the implant should be removed. When carrying out preclinical trials it is revealed that very high doses of progestagenny connections can cause a masculinization of female fruits. Data on drug influence Implanon НКСТ® on an organism of the pregnant woman and a fruit are insufficient.
Drug Implanon НКСТ® does not influence education or quality of breast milk (concentration of protein, lactose or fat). However it is known that a small amount of an etonogestrel is removed with milk. Proceeding from average daily consumption of milk of 150 ml/kg, the average daily dose etonogestret for the child, the etonogestrela calculated after one month of release, makes about 27 нг/кг/сут. It corresponds to about 0.2% of the estimated absolute maternal daily dose (about 2.2% at recalculation for kg of body weight of the child). During the feeding period a breast concentration of an etonogestrel in milk consistently decreases.
Based on the available data, drug use Implanon НКСТ® during breastfeeding is possible, but only under observation of the doctor of development and growth of the baby. The drug Implanon НКСТ® should be administered after the 4th week after the delivery.
Use at abnormal liver functions. It is contraindicated at a serious illness of a liver (before normalization of indicators of function of a liver), including in the anamnesis. With care: liver cancer (as it is impossible to exclude a negative impact of progestogens on development of cancer of liver, it is necessary to carry out individual assessment of a ratio of advantage and risk at women with liver cancer). If during use of the drug Implanon® there are acute or chronic abnormal liver functions, then in this case the woman should address the specialist for inspection and consultation regarding drug Implanon® phase-out.
Use for children. Clinical tests at women at the age of less than 18 years were not carried out. Use of this drug is not shown before the first periods.
Use for elderly patients. Drug is used only at women of reproductive age.
Special instructions. As a rule, the risk of development of a breast cancer increases with increase in age. During use of the personal computer (including combined) the risk of diagnosing of a breast cancer increases a little. This increased risk gradually decreases within 10 years after phase-out of the personal computer, and it is not connected with duration of use of the personal computer, and connected with age women in which it applies OK. The expected quantity of the diagnosed cases of a breast cancer among 10 000 women using the PDA (including within 10 years after the termination of their use), concerning women who never applied them, for the same period, calculated for the corresponding age groups made: 4.5/4 (16-19 years), 17.5/16 (20-24 years), 48.7/44 (25-29 years), 110/100 (30-34 years), 180/160 (35-39 years) and 260/230 (40-44 years). The risk at the women applying the contraception methods containing only gestagena, perhaps is similar to risk at use of the CPC. Nevertheless, data concerning these methods not so certain. In comparison with risk of developing of a breast cancer throughout all life increase in the risk connected with the personal computer is small. Cases of the breast cancer diagnosed for the women using the personal computer tend to be less clinically expressed, than cases of cancer diagnosed for women who never used the personal computer. The increased risk observed at the women using the personal computer is perhaps caused by earlier diagnosis, biological effects of the personal computer or a combination of these two factors.
In case of emergence acute or exacerbations of chronic diseases of a liver the woman should address the specialist for inspection and consultation.
During the epidemiological researches it was established that there is a communication between use of the CPC and increase in frequency of development of a venous thromboembolism (a deep vein thrombosis and a thromboembolism of a pulmonary artery). Though the clinical importance of these results concerning an etonogestrel (biologically active metabolite of the dezogestrel) used as contraceptive hormonal means for lack of an oestrogenic component is unknown, in case of thrombosis the implant should be removed. It is also necessary to consider the possibility of removal of an implant in case of a long immobilization owing to surgery or a disease. Though drug Implanon НКСТ® is the contraceptive hormonal means containing only progestogen it is recommended to estimate risk factors which, as we know, increase risk of a venous or arterial thromboembolism. Women with thromboembolic diseases in the anamnesis have to be warned about a possibility of their recurrence.
In the post-registration period of use of the not X-ray contrast implant containing etonogestret, messages on heavy arterial and venous tromboembolic episodes, including on an embolism of a pulmonary artery (including with a lethal outcome), a deep vein thrombosis, a myocardial infarction, a stroke were received. Implanon НКСТ® it is necessary to remove in case of developing of thromboses.
If during drug use Implanon НКСТ® develops persistent hypertensia or much the increased arterial pressure does not decrease adequately in response to the carried-out anti-hypertensive therapy, it is necessary to remove an implant Implanon НКСТ®.
Though progestogens can exert impact on resistance of peripheral fabrics to insulin and on tolerance to glucose, there is no confirmation that there is a need to change the medical mode at the patients with a diabetes mellitus applying the contraceptive hormonal means containing only progestogen. Nevertheless, women with a diabetes mellitus have to be under careful observation during the entire period of use of the contraceptive hormonal means containing only progestogen.
It is necessary to perform periodic inspections of women which undergo therapy concerning a lipidemia. Some progestogens can increase the LPNP level and worsen control of a lipidemia.
There can sometimes be a hloazma, in particular at women with hloazmy pregnant women in the anamnesis. Women with predisposition to a hloazma should avoid influence of sunshine or ultraviolet radiation during drug use Implanon НКСТ®.
Contraceptive effect of drug Implanon НКСТ® is connected with concentration of an etonogestrel in a blood plasma which in inversely proportional dependence is connected with body weight and decreases during time after administration of drug. Clinical experience at women with excess body weight on the third year of use of drug is limited. It is impossible to exclude that the contraceptive effect at such women within the third year of use of drug can be lower, than at women with the normal body weight therefore the doctor, perhaps, should provide earlier replacement of an implant at women with excess body weight.
As a result of a local inflammation or if the implant is entered not according to the instructions stated in the section "How to Enter Implanon НКСТ®" there can be an implant ekspulsiya.
In rare instances, generally connected or with too deep introduction (see also section "How to Enter Implanon НКСТ®"), and/or as a result of influence of external forces (for example, manipulations with an implant or contact sports) the implant can migrate from an injection site. In similar cases definition of location of an implant can be complicated and extraction can demand a bigger section and time (see also section "How to Remove Implanon НКСТ®"). If the implant is not removed, then contraception and risk of the undesirable effects connected with progestogen can remain over time desirable to the woman.
At use of all low-dosed contraceptive hormonal means there can be a growth of follicles, and the follicle can sometimes reach the size bigger, than in a normal cycle. Usually similar follicles disappear spontaneously and often asymptomatically; slight pain in the bottom of a stomach is in certain cases noted. In rare instances surgical intervention is necessary.
The prevention of an extrauterine pregnancy the traditional progestagen-containing contraceptive hormonal means not so effectively, as at use of the CPC that is connected with frequent emergence of ovulations during use of these methods. This statement does not belong to use of progestinovy oral contraceptives with dezogestrely and an implant with dezogestrely. In spite of the fact that drug Implanon НКСТ® suppresses an ovulation, in case of existence at the woman of an amenorrhea or abdominal pains at differential diagnosis it is necessary to consider an extrauterine pregnancy.
There are messages on the following states taking place both at pregnancy, and at use of sex steroid hormones, but connection using progestogens was not established: the jaundice and/or an itch connected with a cholestasia; formation of gallstones; porphyria; system lupus erythematosus; gemolitiko-uraemic syndrome; chorea of Sidenkhem; herpes during pregnancy; the hearing loss connected with an otosclerosis and (hereditary) Quincke's disease.
Safety and efficiency of drug Implanon НКСТ® were estimated for women of reproductive age. It is expected that teenagers in the post-pubertal period will have a similar efficiency and safety. Nevertheless, clinical trials at women at the age of less than 18 years were not conducted. Use of this drug is not shown before menarche (the first periods).
Medical inspections / consultations. Before use or before drug replacement Implanon НКСТ® it is necessary to study carefully the anamnesis of the woman (including the family anamnesis) and to exclude pregnancy. It is necessary to measure the ABP, to conduct physical examination and to be guided by contraindications and preventions. It is recommended that the woman in three months after administration of drug Implanon НКСТ® visited the doctor for medical examination. During medical examination it is necessary to measure the ABP and to find out about existence of any questions, complaints or emergence of undesirable effects. Frequency and the nature of further periodic medical examinations should be established individually for each woman (at least 1 time in 6 months).
The woman has to be informed that Implanon НКСТ® does not protect drug from HIV infection (AIDS) and other diseases, sexually transmitted.
Decrease in efficiency. Efficiency of drug Implanon НКСТ® can be reduced at use of drug in combination with other medicines.
Changes of nature of bloody allocations. During drug use Implanon НКСТ® at women change of nature of menstrual bleedings is probable. They can include changes of frequency (absence, less or more frequent), intensity (reduction or increase) or duration of bleedings. The amenorrhea was observed at 20% of women while at other 20% more frequent and/or long bleeding was observed. The dysmenorrhea tends to improvement during drug use Implanon НКСТ®. The nature of bleedings taking place within the first three months allows to predict future nature of bleedings at most of women. Informing, further explanations and maintaining the individual diary will help the woman to perceive adequately arising bleedings. Assessment of vaginal bleedings should be carried out individually. It can include inspection for the purpose of an exception of gynecologic pathology or pregnancy.
Laboratory indicators. The data obtained concerning the CPC showed that use of contraceptive hormonal means can exert impact on some laboratory indicators, including biochemical indicators of function of a liver, thyroid gland, adrenal glands and kidneys, concentration (transport) proteins in plasma, for example, a corticosteroid - the connecting globulin and fraction of lipids/lipoproteids, indicators of carbohydrate metabolism, coagulability of blood and a fibrinolysis. Usually these changes remain within normal values. It is unknown in what degree it is applicable also to the contraceptive hormonal means containing only progestogen.
Influence on ability to driving of motor transport and to control of mechanisms. Reactions at control of vehicles and use of a difficult technique were not studied. Implanon НКСТ® can cause dizziness. Patients should be warned that when developing dizziness it is not necessary to drive motor transport or to use a difficult technique.
Side effects:
During drug use Implanon НКСТ® at women changes of nature of menstrual bleedings are probable. They can include changes of frequency of bleedings (absence, less or more frequent), intensity (reduction or increase) or duration of bleedings. Lack of menstrualnopodobny bloody allocations was observed at 20% of women, at the same number of women more frequent and/or long bleeding was observed. It was sometimes reported about heavy bleeding. In clinical trials change of nature of bloody allocations from a vagina was the most frequent cause for phase-out of an implant (about 11%). During drug use Implanon НКСТ® painful menstrualnopodobny bloody allocations tend to improvement. The nature of bleedings taking place within the first three months allows to predict future nature of bleedings at most of women. The undesirable effects which are perhaps connected using drug about which it was reported in clinical trials are listed below in the table. Their communication using drug as is not confirmed, not disproved.
|
Very often (≥1/10) |
Often (≥1/100, <1/10) |
Infrequently (≥1/1000, <1/100) |
|
Infections and invasions |
||
|
vaginal infection (vulvovaginitis) |
- |
pharyngitis, |
|
From immune system |
||
|
- |
- |
hypersensitivity to any component of drug |
|
From a metabolism |
||
|
- |
increase in appetite |
- |
|
Mental disorders |
||
|
- |
emotional lability, |
alarm, |
|
From a nervous system |
||
|
headache |
dizziness |
migraine, |
|
Vascular disorders |
||
|
- |
inflows |
- |
|
From the alimentary system |
||
|
- |
abdominal pains, |
|
|
From integuments |
||
|
acne |
alopecia |
hypertrichosis, |
|
From a musculoskeletal system |
||
|
- |
- |
dorsodynia, |
|
From an urinary system |
||
|
- |
- |
dysuria |
|
From a reproductive system and mammary glands |
||
|
morbidity in mammary glands, |
dysmenorrhea, |
allocations from a vagina, |
|
Local reactions and general frustration |
||
|
- |
pain in the location of an implant, |
hyperthermia, |
|
Laboratory indicators |
||
|
increase in body weight |
decrease in body weight |
- |
In clinical trial in addition studied disturbances in an injection site which were noted at 8.6% of women. The most frequent disturbance which was observed during introduction or during the short period after introduction 3.3% of women had an erythema (). Also hematomas (3%), bruises (2%), pain (1%) and local hypostasis (0.7%) were observed.
During post-marketing observation clinically significant increase in the ABP was in rare instances observed. Also there are messages on seborrhea. Anaphylactic reactions, a small tortoiseshell and a Quincke's disease (or its heavier current) and/or heavier current of a hereditary Quincke's disease can develop. Introduction and removal of an implant can cause formation of bruise, insignificant local irritation, pain or an itch. In the place of a section fibrosis can develop, be formed a hem or develop abscess. There can be paresthesia or similar to it phenomena, and loss or migration of an implant is possible.
During removal of an implant surgical intervention can be required.
It was in rare instances reported about an extrauterine pregnancy.
At the women applying contraceptive hormonal means the following (serious) undesirable reactions were noted:
— venous thromboembolisms (VTE, deep vein thrombosis and pulmonary embolism);
— arterial thromboembolisms;
— hormonedependent tumors (liver tumors, breast cancer);
— hloazma;
— the jaundice and/or an itch connected with a cholestasia;
— cholelithiasis;
— porphyria;
— gemolitiko-uraemic syndrome;
— chorea of Sidenkhem;
— herpes during pregnancy;
— the hearing loss connected with an otosclerosis.
Interaction with other medicines:
Influence of other medicines on Implanon НКСТ®. Interaction between hormonal contraceptives and other medicines can lead to breakthrough bleeding and/or to decrease in contraceptive effect. The special researches devoted to studying of interaction with drug Implanon НКСТ® were not conducted. In literature it is reported about the following interactions (generally with the CPC, but it is sometimes reported as well concerning the contraceptives containing only progestogen).
Hepatic metabolism: interaction is possible with medicines - inductors of microsomal enzymes of a liver, first of all P450 cytochrome enzymes (for example, Phenytoinum, phenobarbital, Primidonum, bozentany, carbamazepine, rifampicin and it is possible also with okskarbazepiny, topiramaty, felbamaty, the griseofulvin and vegetable drugs containing a St. John's Wort made a hole (Hypericum perforatum) and inhibitors of HIV protease (for example, ritonaviry, nelfinaviry) and nenukleozidny inhibitors of the return transcriptase (for example, not Virapinum, efavirenzy) and their combinations that can lead to increase in clearance of sex hormones.
The women receiving treatment by one of the above-stated medicines should apply in addition a barrier method of contraception during their use and within 28 days after the termination of their reception.
The women receiving prolonged treatment by the medicines inducing microsomal enzymes of a liver are recommended to remove an implant and to appoint a non-hormonal (barrier) method of contraception.
The increase in concentration of hormones in plasma connected with combined use of medicines: medicines (for example, кетоконазол) which inhibit microsomal enzymes of a liver, such as CYP3A4, can increase concentration of hormones in plasma.
Drug influence Implanon НКСТ® on other medicines. Contraceptive hormonal means can influence metabolism of other medicines. Respectively, concentration of medicines in plasma and in fabrics can increase (for example, cyclosporine) or to decrease (for example, a lamotridzhina).
Note: for identification of possible interactions it is necessary to study application instructions of at the same time accepted medicines.
Contraindications:
The contraceptive hormonal means containing only progestogen should not be applied in the presence of any of the states/diseases which are listed below. In case of any of these states during drug use Implanon НКСТ® it is necessary to stop drug use immediately:
— pregnancy (including assumed);
— fibrinferments (arterial and venous) and thromboembolisms now or in the anamnesis (including thrombosis, thrombophlebitis of deep veins, a thromboembolism of a pulmonary artery, a myocardial infarction, ischemic or hemorrhagic cerebrovascular disturbances);
— existence of antibodies to phospholipids;
— migraine with focal neurologic symptomatology;
— a breast cancer (including in the anamnesis);
— the established or estimated malignant hormonedependent tumors;
— benign or malignant tumors of a liver now or in the anamnesis;
— severe forms of diseases of a liver (before normalization of functional trials of a liver), including jaundice;
— inborn hyperbilirubinemias (including in the anamnesis);
— uncontrollable arterial hypertension;
— children's age;
— bleeding from a vagina of not clear etiology;
— hypersensitivity to active agent or to any excipient of drug Implanon НКСТ®.
With care. In the presence of any of the states or risk factors provided below it is necessary to weigh advantage of use of an implant of rather possible risks concerning each certain woman and to discuss them with it before she decides to begin to use drug Implanon НКСТ®. In case of deterioration, strengthening or at the first emergence of any of these states the woman has to see a doctor then the doctor has to resolve an issue of continuation of use or drug withdrawal Implanon НКСТ®:
— the long immobilization caused by surgical intervention or other reasons;
— the states preceding thrombosis (including the tranzitorny ischemic attacks, stenocardia, the complicated defeats of the valve device of heart, fibrillation of auricles, an extensive injury);
— persistent arterial hypertension;
— a diabetes mellitus, including a diabetes mellitus with a diabetic angiopatiya;
— the hereditary or acquired predisposition to arterial fibrinferments, including insufficiency of a protein With, insufficiency of a protein of S, insufficiency of antithrombin III;
— diseases of a liver easy and moderate severity at normal indicators of functional trials of a liver;
— therapy by anticoagulants;
— heavy depression.
Overdose:
The implant always should be deleted before introduction of new. Data on overdose etonogestrely are not available. Messages on serious side effects as a result of overdose of hormonal contraceptives in general are not available.
Storage conditions:
Drug should be stored in the place, unavailable to children, at a temperature from 2 °C to 30 °C. A period of validity - 5 years.
Issue conditions:
According to the recipe
Packaging:
The implant one-rod, from color, white to white with a yellowish or brownish shade, is placed in a needle of the sterile one-time applicator; the implant has to be taken easily from the applicator; implant sizes: length is from 3.8 to 4.2 cm, diameter is from 1.95 to 2.05 mm; thickness of a cover is from 54 to 66 microns.
1 pieces - a needle of the applicator sterile one-time (1) - a planimetric strip packaging (1) complete with a card of the patient and 2 stickers for the out-patient card - a pack cardboard.
