Evra patch (Evra)
Contraception / / April 20, 2016
(instructions for use)
modern combined hormonal contraceptive (patch) for transdermal administ
composition and the form
release transdermal therapeutic system (TTS), a square shape, with beige matte substrate, rounded corners, colorless adhesive (adhesive) layer and a transparent protective film;on a substrate embossed inscription "EVRA".
Active substance: 1 TTS contains 6 mg norelgestromin, ethinyl estradiol 600 micrograms (releases within 24 hours 203 mg norelgestromin, ethinyl estradiol 33.9 g).
Composition bases TTC: an outer layer of pigmented low density polyethylene and an inner layer of polyester.Composition of middle layer of the TTS: adhesive blend of polyisobutylene, polybutene, crospovidone, nonwoven polyester, lauryl lactate.Composition TTC removable protective layer: polyethylene terephthalate film, coated with polydimethylsiloxane.
contraceptives for transdermal administration.It inhibits gonadotropic pituitary function, inhibits follicular development and prevent ovulation process.The contraceptive effect is enhanced by increasing the viscosity of the cervical mucus and decrease endometrial receptivity to the blastocyst.Pearl Index - 0.90.
pregnancy rate does not depend on such factors as age, race, and rises in women weighing over 90 kg.
After fixing the patch Evra norelgestromin and ethinyl estradiol rapidly appear in the serum, reaching a plateau after about 48 hours, and stored in the equilibrium concentration for the entire period of wearing the patch.This eliminates the daily ups and downs of hormone levels in serum in the application of oral contraceptives.In the course of studies have examined the pharmacokinetics norelgestromina and ethinyl estradiol in 37 women with Evra patch is attached to the skin of the abdomen, buttocks, arms or back within 7 days.In all three studies norelgestromina concentration of ethinyl estradiol and serum remained within a predetermined range throughout the period worn Evra patch, regardless of the place of attachment.Absorption norelgestromina when attached in all areas - buttocks, arm and torso - was therapeutically equivalent.
Evra allows continuous administration norelgestromina and ethinyl estradiol into the systemic circulation and inhibits follicle growth for two full days after the recommended period of 7 days of wearing the patch.Even after two-day delay of two replacement patch hormone concentration in serum is within a predetermined range.Since ethinyl estradiol and norelgestromin continue to provide a contraceptive effect during the 2-day period, the need for additional contraceptive absent if missed to 2 days.During each of the three 7-day periods attachment evryi 30 women wore a patch on his stomach in one of six different states: normal operation, sauna, whirlpool, treadmill, immersed in cool water or a combination thereof.In the study, under the influence of high temperature, humidity, cold and / or exercise in the fitness club, yourself completely come off only one (1.1%) of the 87 patches.Norelgestromina the maximum concentration in serum and ethinylestradiol indicates that none of these conditions was not the sudden release of excessive amounts of hormones.
Contraception (prevention of unwanted pregnancy) in women.
The patient should be informed that in order to maximize the contraceptive effect is necessary to strictly observe the instructions for use TTS Evra.You can use only one TTC.
everyone to use TTC is removed and immediately replaced with a new one the same day of the week ( "replacement day") on the 8th and the 15th days of the menstrual cycle (2nd and 3rd week).TTS can be changed at any time to replace the day.During the 4th week, from 22 th to 28 th day of the cycle, the TTC does not apply.A new contraceptive cycle begins on the next day after the end of the 4th week;following TTS should be pasted, even if menstruation has not been or is not over.
Under no circumstances should a break in the application of TTS Evra should not be more than 7 days, otherwise it increases the risk of pregnancy.In such situations, for 7 days is necessary to simultaneously use a barrier method of contraception, sincethe risk of ovulation increases with each day of exceeding the recommended length of time, free from the use of the TTC.In the case of sexual intercourse during this period increased the probability of conception is very high.
Home Evra transdermal application
If during the previous menstrual cycle did not use hormonal contraceptive
Contraception using TTS Evra begin on the first day of menstruation.Glued to the skin of a TTS Evra and use it throughout the week (7 days).Day of bonding the first TTS Evra (1 day / day of the beginning) specifies the following days replacement.replacing Day will fall on the same day each week (8 th and 15 th days of the cycle).On the 22th day of the cycle remove the TTC, and from 22 th to 28 th day of the cycle woman is not using TTS Evra.The next day is the first day of a new contraceptive cycle.If a woman begins to use TTS Evra from the first day of the cycle, it is necessary to simultaneously use a barrier method of contraception during the first 7 days of the first contraceptive cycle.
If a woman goes to the use of combined oral contraceptive to use TTS TTS
Evra Evra should stick to the skin in the 1st day of menstruation, which started after the discontinuation of the combined oral contraceptive.If your period does not start within 5 days after receiving the contraceptive pill, it is necessary to exclude pregnancy before you start using TTS Evra.
If you use Evra starts later the 1st day of menstruation, within 7 days you must simultaneously use barrier methods of contraception.If, after taking the last contraceptive pill has been more than 7 days, then the woman may have ovulated and therefore she should consult a doctor before starting to use the TTC Evra.Sexual intercourse during this prolonged period, receiving free contraceptive pills can lead to pregnancy.
If a woman goes from the use of drugs containing progestogen only, to use TTS Evra
woman can any day to move to the use of a preparation containing only a progestogen (the day of implant removal, on the day when the next injection should be done), but forthe first 7 days of application TTS Evra should use a barrier method for enhancing effectiveness.
After an abortion or miscarriage
After an abortion or miscarriage before the 20th week of pregnancy, you can immediately begin to use TTS Evra.If a woman begins to apply the TTC Evra immediately after an abortion or miscarriage, then additional contraception is needed.A woman should know that ovulation may occur within 10 days after an abortion or miscarriage.After an abortion or miscarriage in the 20th week of pregnancy or later, use the TTC Evra can begin on the 21 th day after the abortion or miscarriage, or the 1st day of the first ensuing menstruation.
After childbirth women are not breastfeeding her baby should start using TTS Evra no sooner than 4 weeks after giving birth.If a woman begins to apply the TTC Evra later, during the first 7 days it must additionally use a barrier method of contraception.If there has been sexual intercourse, it is necessary to exclude pregnancy before starting the use of TTS Evra, or the woman should wait until the first menstrual period.
At full or partial peeling off Evra
TTS If TTS Evra comes off completely or partially, in the blood to an insufficient number of its active ingredients.Even with partial peeling off Evra transdermal less than during the day (up to 24 hours) should be re-glued TTC Evra to the same place or immediately replace it with a new TTC Evra.Additional contraception is not required.The next TTC Evra need to stick to a regular "day of replacement."
Partial peeling off more than during the day (24 hours or more), and if the woman does not know exactly when the TTC Evra comes off partially or completely - perhaps pregnancy.The woman should immediately start a new cycle, a new gluing TTC Evra and consider this day the first day of contraceptive cycle.Barrier methods of contraception should be used at the same time only during the first 7 days of the new cycle.
Do not attempt to re-glue the TTC Evra, if it has lost its adhesive properties;instead, you must immediately attach a new TTC Evra.You can not apply additional adhesive tape or bandage to hold in place TTC Evra.
If you skipped the next day replacement TTC Evra
At the beginning of any contraceptive cycle (Week 1 / Day 1)
With the increased risk of pregnancy a woman should stick first TTS Evra a new cycle immediately as soon as you remember about it.This day is considered the new "1st day" and counted the new "day of replacement."Non-hormonal contraceptive should be used concurrently for the first 7 days of the new cycle.In the case of sexual intercourse during this elongated period without using TTS Evra may occur conception.
In the middle of the cycle (Week 2 / Day 8 or Week 3/15-Day):
if passed 1 or 2 days (48 hours) with the substitution of the day: a woman must immediately attach a new TTC.TTS next to be glued to the normal "day of replacement."If during the 7 days preceding the first missed day of fixing TTS TTS application was right, the additional contraception is not required;
if the date of the replacement has been more than 2 days (48 hours or more): there is an increased risk of pregnancy.Women should stop the current contraceptive cycle and immediately start a new 4-week cycle by gluing a new TTC Evra.This day is considered the new "1st day" and counted the new "day of replacement."Barrier contraception must be used simultaneously for the first 7 days of the new cycle;
at the end of the cycle (Week 4 / Day 22): If the TTC is not removed at the beginning of the 4th week (22-day), then it must be removed as quickly as possible.Another contraceptive cycle must begin at the normal "day replacement," which is the next day after the 28th day.Additional contraception is not required.
replacement To postpone menstruation for one cycle, the woman must attach a new TTC Evra at the beginning of the 4th week (22-day), thus omitting the period, free from the use of TTS Evra.You may experience intermenstrual bleeding or spotting.After 6 consecutive weeks of transdermal must be 7-day interval, free from the use of the TTC.After this interval, resume regular use of the drug.
If appointed for this day for a week, free use of the woman wants to change the day of replacement, it must end the current cycle, removing the third TTS Evra;woman can choose a new day replacement, gluing the first TTS Evra next cycle on the chosen day.Period, free from the use of TTS Evra, in any case should not exceed 7 days.The shorter the period, the greater the likelihood that a woman will not be the next menstruation, and during the next cycle contraceptive may arise intermenstrual bleeding or spotting.
How to stick TTC Evra
TTC Evra should stick to a clean, dry, intact and healthy skin of the buttocks, abdomen, outer surface of the upper arm or upper body with minimal body hair, in areas where it will not come into contact with a tightclothing.
avoid possible irritation following each TTS Evra must be pasted into another area of the skin, it can be done within the same anatomical region.
TTC Evra should be tightly pressed to the edges well in contact with the skin.To avoid reducing the adhesive properties of the TTS Evra can not apply make-up, creams, lotions, powders and other local resources to those areas of the skin where it is glued or pasted.
woman should daily inspect TTC Evra to be confident in its permanently attached.
Used TTS must be carefully disposed of in accordance with the instructions.
When using TTS Evra following side effects may occur:
- From the central and peripheral nervous system: dizziness, headache, paresthesia, hypoesthesia, seizures, tremors, emotional lability, depression, anxiety, insomnia, drowsiness.
- Cardio-vascular system: increased blood pressure, palpitations, edema syndrome, varicose veins.
- From the digestive system: gingivitis, anorexia or increased appetite, gastritis, gastroenteritis, dyspepsia, abdominal pain, vomiting, diarrhea, flatulence, constipation, hemorrhoids.
- The respiratory system: infections of the upper respiratory tract, shortness of breath, asthma.
- Reproductive system: pain during sexual intercourse (dyspareunia), vaginitis, dysmenorrhea, decreased libido, breast enlargement, menstrual disorders (including intermenstrual bleeding, hypermenorrhoea), changes in vaginal secretion, cervical changesmucus, lactation, do not arise in connection with childbirth, disorders of ovarian function, mastitis, fibroadenoma of the breast, ovarian cysts.
- From the urinary system: urinary tract infections.
- From the musculoskeletal system: muscle cramps, myalgia, arthralgia, ostalgiya (including back pain, pain in the lower limbs), tendinosis (tendon change), muscle weakness.
- Dermatological reactions: itching, hives, skin rash, contact dermatitis, bullous rash, acne, discoloration of the skin, eczema, increased sweating, alopecia, photosensitivity, skin dryness.
- the part of the organs of vision: conjunctivitis, visual disturbances.
- From a metabolism: weight gain, hypertriglyceridemia, hypercholesterolemia.
Other flu-like symptoms, fatigue, allergic reactions, chest pain, asthenia syndrome, syncope, anemia, abscess, lymphadenopathy.
Rarely (with a frequency of & gt; 0.01% to & lt; 0.1%) hypertonicity or hypotonia muscle incoordination, dysphonia, hemiplegia, neuralgia, stupor, increased libido, depersonalization, apathy, paranoia, benign tumors of the breast, cervical canceruterus in situ, pain in the perineum, ulceration of the genital atrophy of the mammary glands, decrease of blood pressure, enanthema, dry mouth or increased salivation, colitis, pain when urinating, hyperprolactinemia, melasma, violation of skin pigmentation, chloasma, xerophthalmia, weight loss or obesity, inflammation of the subcutaneous fat, alcohol intolerance, cholecystitis, cholelithiasis, abnormal liver function, purpura, "tides" of blood to the face, thrombosis (including deep vein thrombosis, thrombosis, pulmonary embolism), thrombophlebitis of superficial veins, pain in the veins, embolismpulmonary artery.
- Venous thrombosis includinghistory (including deep vein thrombosis, pulmonary embolism);
- Arterial thrombosis, includinghistory (including acute cerebrovascular accident, myocardial infarction, thrombosis, retinal artery) or precursors of thrombosis (including angina pectoris or transient ischemic attack);
- The presence of serious or multiple risk factors of arterial thrombosis: severe hypertension (more than 160/100 mmHg), diabetes with vascular disease;
- Hereditary dislipoproteinemia;systemic lupus erythematosus;porphyria;