Zoladex Gosereline depot in a prefilled syringe 10.8mg

Zoladex Gosereline depot in a prefilled syringe 10.8mg

Product Code: 7415
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Composition active substance : 1 capsule for subcutaneous injection of prolonged action contains goserelin acetate equivalent to 10.8 mg of goserelin-the basics; auxiliary substances: copolymer lactide and glycolide. Dosage form Capsule for subcutaneous injection of prolonged action. Basic physico-chemical properties: pieces of solid polymer of cylindrical shape from white to cream color, free or practically free from visible particles. Pharmacological group Analogues of gonadotropin - releasing hormone. Code ATC L02A E03. Pharmacological properties Pharmacodynamics. The Zoladex (D-Ser (Bu t ) 6 Azgly 10 LG-WG) is a synthetic analogue of the natural luteinizing hormone - releasing hormone (LH-RG). With constant use of Zoladeks 10.8 mg suppresses the release of luteinizing hormone by the pituitary gland, which leads to a decrease in the concentration of testosterone in the blood serum in men and estradiol in women. At the initial stage, Zoladex 10.8 mg, like other LG-RG agonists, can cause a temporary increase in the serum concentrations of testosterone in men and estradiol in women. In men, within about 21 days after administration of the first depot, testosterone concentrations decrease to a castration level and remain reduced with further administration of the drug every 3 months. The data show that if in exceptional circumstances repeated administration of the drug does not occur after 3 months, the concentration of testosterone remains at the castration level in most patients for up to 16 weeks. In women, the concentration of estradiol in serum decreases within 4 weeks after the introduction of the first depot and remains reduced until the end of the treatment period. In patients whose estradiol levels have already been reduced due to the use of LG-R analogues, concentrations remain reduced when transferred to Zoladex 10.8 mg. Suppression of estradiol is accompanied by a reaction in patients with endometriosis or uterine fibroids, and leads to amenorrhea in most patients. At the beginning of application of Zoladex in some women vaginal bleeding of different duration and intensity is possible. Such bleeding is probably a reaction to the withdrawal of estrogen and usually go away on their own. During treatment with LG-RG analogues, patients may experience natural menopause; in rare cases, menstruation is not restored after completion of treatment. Pharmacokinetics. Compliance with the recommendations for dosing Zoladex 10.8 mg provides a stable exposure to goserelin without clinically significant accumulation of the drug. The binding of Zoladex with proteins is insignificant; the half-life of serum is 2-4 hours in persons with normal renal function. Maximum serum concentration (mean C max = 8-10 mg/ml) was reached after about 2:00 after a single injection of Zoladex 10,8 mg. After 24 hours, the level of goserelin rapidly decreases to day 4, after which the average concentration remains relatively stable at 0.3-1 ng/ml until the end of the treatment period. In patients with impaired renal function the half-life increased. Following the recommendations on the use of depot 10.8 mg, this change does not lead to any accumulation and the need for dose adjustment in these patients is not. Significant changes in pharmacokinetics in patients with hepatic insufficiency is not observed. Indications Prostate cancer. Prostate cancer therapy, in which hormonal influence is possible. Endometriosis. Endometriosis therapy, including relief of symptoms such as pain, and reducing the size and amount of endometrial damage Fibroma of the uterus. Fibroid therapy, including damage reduction, improvement of Hematology and relief of symptoms such as pain. As an aid in surgical intervention to facilitate surgical techniques and reduce blood loss during surgery. Breast cancer in women during premenopause. Contraindications Hypersensitivity to goserelin acetate or other analogues of LH-WP (luteinizing hormone - releasing hormone). Pregnancy and breast-feeding. Childhood. Interaction with other medicinal products and other forms of interaction Because androgen-deprivation therapy can lead to prolonged QT interval, should be carefully evaluated concomitant use of Zoladex with other drugs that can prolong the QT interval or drugs that can cause ventricular tachycardia type "pirouette", such as antiarrhythmic agents of class IA (quinidine, disopyramide) or class III (amiodarone, sotalol, dofetilide, ibutilide), methadone, moxifloxacin, antipsychotics, etc. (see section "Peculiarities of use"). Features of the application. No data on removal or dissolution of the implant. There is a high risk of depression (which can be severe) in patients receiving treatment with gonadotropin-releasing hormone agonists such as goserelin. Patients should be informed about this risk and, if symptoms occur, appropriate treatment should be prescribed. Reported cases of bleeding around the site of the drug, resulting in hemorrhagic shock. When applying the drug Zoladeks need to take into account such safety measures: To do injections into the area with less chance of damage to the vessels. It is necessary to carefully weigh the possibility of using the drug Zoladeks in patients with a tendency to bleeding (for example, those who use anticoagulants). Androgen-deprivation therapy can lead to prolonged QT interval. Before the appointment of Zoladex patients with a history of prolongation of the Qt interval or risk factors for its prolongation, as well as patients who simultaneously use drugs that can cause prolongation of THE Qt interval (see section "Interaction with other drugs and other types of interactions"), it is necessary to assess the ratio of benefit and risk, including the possibility of ventricular tachycardia type "pirouette". menfolk It should be used with caution Zoladeks 10.8 mg men who are at risk of developing urinary tract obstruction or spinal cord compression, as well as carefully monitor such patients during the first month of therapy. In the case of the presence or occurrence of spinal cord compression or renal insufficiency due to obstruction of the urinary tract should resort to standard treatment of such complications. It is unlikely that patients with prostate cancer are not hormone-dependent, such treatment will be useful. This resistance to treatment can be the result of a lack of reaction to castration or hormone treatment. The recommended dosage of testosterone prior to the introduction of treatment to assess therapeutic benefits. In the initial stages of therapy with LG-RG analogues, consideration should be given to the use of antiandrogens (for example, ciproteron acetate 300 mg daily for 3 days before and 3 weeks after Zoladex therapy), since there are reports that this prevents the possible consequences of an initial increase in serum testosterone levels. The use of agonists LG-RG can lead to a decrease in bone mineral density. Preliminary data indicate that the use of bisphosphonates in men in addition to LG-R agonists can reduce the loss of bone minerals. Particular care should be taken in patients with risk factors for osteoporosis (such as chronic alcohol abuse, Smoking, long-term therapy with anticonvulsants or corticosteroids, the presence of osteoporosis in the family history). There have been cases of mood changes, including depression. Patients with established depression and patients with AH requires careful supervision. There is a high risk of pressure loss (which can be severe) in patients treated with LG-R agonists such as goserelin. Patients should be informed and treated properly if symptoms occur. In the pharmacoepidemiological study of LG-RG agonists, which were used for the treatment of prostate cancer, there were cases of myocardial infarction and heart failure. The risk appears to be increasing, if the agonists of LH-RG used in combination with antiandrogenic agents. A decrease in glucose tolerance was observed in men taking agonists of LH-RG. This may occur as diabetes or loss of glycemic control in people with existing diabetes mellitus. You should consider monitoring the levels of glucose in the blood. women Women with the drug Zoladex 10.8 mg is indicated only for the treatment of endometriosis and fibroids. If you need to use gozerelin for other indications, refer to the instructions for use of the drug Zoladeks 3.6 mg. In the case of breast cancer in women in the period of premenopause, before starting the use of the drug Zoladeks 10,8 mg, it is necessary to determine the status of receptors of tumor hormones. If the disease turns out to be receptor-negative, the drug Zoladeks capsules for subcutaneous prolonged action of 10.8 mg should not be used. After initiation of therapy with LG-RG agonists, there is a temporary increase in the level of estradiol in the blood of women. A decrease in bone mineral density The use of agonists LG-RG can lead to a decrease in bone mineral density by about 1% per month during the 6-month period of treatment. Each reduction of bone mineral density by 10% 2-3 times increases the risk of fractures. The available data indicate that for most women, bone density recovers after discontinuation of the drug. In patients receiving Zoladex for the treatment of endometriosis, additional hormone replacement therapy (HRT) has eased the reduction in bone mineral density and the severity of vasomotor symptoms. Experience in the use of HRT therapy in women using Zoladex 10.8 mg, no. No specific data on the use of the drug in patients with established osteoporosis or risk factors for its development (such as chronic alcohol abuse, Smoking, long-term therapy with drugs that reduce bone mineral density, for example, PSP or corticosteroids, the presence of osteoporosis in the family history, nutritional disorders, for example, nervous anorexia). Since the reduction of bone mineral density in such patients may be more dangerous, the use Of Zoladex should be considered in each case and begin therapy only if the result of a thorough evaluation determined that the benefits will prevail over the risk. Additional measures to counteract the loss of bone minerals should be resorted to. Reduction of bone mineral density in the treatment of breast cancer in women The use of GnRH agonists can lead to a decrease in mineral density of bone tissue. After 2 years of treatment for early stage breast cancer, the average loss of bone mineral density was 6.2% and 11.5% at the level of the femoral neck and lumbar spine respectively. It was found that this loss is partly reversible, observed for a year without treatment, with a recovery of 3.4% and 6.4% compared to the inclusion of the femoral neck and lumbar spine respectively, even if this recovery is based on very limited data. For most women more at the moment, the data suggest that recovery of bone loss occurs after cessation of treatment. According to preliminary data, there is an idea that the use of goserelin in combination with tamoxifen in patients with breast cancer can reduce bone demineralization. withdrawal bleeding At the beginning of application of Zoladex in some patients possible vaginal bleeding of different duration and intensity. Usually, such bleeding occurs in the first month after the start of treatment, is likely a reaction to the removal of estrogen and usually takes place on its own. If the bleeding does not pass, you should determine its cause. Time to recovery of menses after cessation of therapy drug Zoladex 10.8 mg in some cases, it may be extended (the average duration of secondary amenorrhea after discontinuation of Zoladex 10.8 mg is 7-8 months). In case you need to quickly restore menstruation it is recommended to apply Zoladex 3,6 mg. The use of Zoladex may lead to increased resistance of the cervix, therefore, when extension of the neck should be used with caution. There is no clinical data on the effect of Zoladex for the treatment of benign gynecological conditions for more than 6 months. Women of reproductive age should use non-hormonal methods of contraception during therapy with Zoladex and to restore menstruation after treatment. Patients with established depression and patients with arterial hypertension need careful supervision. The use of Zoladex can lead to a positive reaction to the anti-doping test. There is a high risk of pressure loss (which can be severe) in patients treated with LG-R agonists such as goserelin. Patients should be informed and treated properly if symptoms occur. How to use the envelope Apply only if the envelope with syringe applicator is intact. Apply immediately after opening the envelope. Application during pregnancy and lactation The Zoladex should not be used during pregnancy and lactation, as there is a theoretical risk of abortion or the occurrence of fetal abnormalities while receiving agonists of LH-RG pregnancy. It is necessary to conduct a thorough examination of women who may become pregnant in order to exclude the possibility of pregnancy. During treatment should use nonhormonal methods of contraception until the resumption of menstruation. fertility Women are the analogues of LH-WP, as the Zoladex 3.6 mg and Zoladex 10.8 mg is intended to suppress LH and FSH. As a consequence, it can affect libido (see section "Adverse reactions") and lead to the termination of ovulation and menstruation, this implies a negative but reversible effect on the fertility of women. During treatment with GnRH analogues can naturally occur in menopause. Rarely in some women, menstruation is not restored after the termination of treatment. Studies on rats show that the impact on women's fertility is reversible. For men: such analogues of LH-WP, as the Zoladex 3.6 mg and Zoladex 10.8 mg is intended to suppress LH and FSH. As a result, it can lead to erectile dysfunction and affect libido (see section "Adverse reactions"), as well as possibly spermatogenesis. Although data on fertility men is not based on the turnover effect on the fertility of rats and turnover histopathological changes of the reproductive system in dogs after a year of treatment Zoladex can hope that this effect in men the reverse. The ability to influence the reaction rate when driving motor transport or operating other mechanisms There is no evidence that Zoladex can impair the ability to drive a car and other machinery. Method of application and doses Apply only if the envelope with syringe applicator is intact. Apply immediately after opening the envelope. It is allowed to use local anesthesia, but in most cases it is not needed. Adult men (including elderly patients) . 1 capsule (10.8 mg) of Zoladex administered subcutaneously into the anterior abdominal wall each 3 months. Adult women (including elderly patients) . 1 capsule (10.8 mg) of Zoladex administered subcutaneously into the anterior abdominal wall each 12 weeks. Endometriosis and uterine fibroma treatment should last only 6 months, since clinical data on longer periods of use are not available. Repeated courses of treatment should not be carried out because of the risk of losing part of the mineral components and reducing bone density. The patients who took goserelin for the treatment of endometriosis, additional hormone replacement therapy (a daily intake of estrogenic and progestagennoe drugs) reduced the loss of mineral bone density and the severity of vasomotor symptoms. Experience in the use of hormone replacement therapy women who have received Zoladex 10.8 mg, no. For patients with renal or hepatic insufficiency, as well as in elderly patients dose adjustment is not necessary. Manual for the introduction 1. Place the patient in a comfortable position so that the upper body is slightly raised. Treat the injection site on the anterior abdominal wall. If necessary, use a local anesthetic. 2. Open the envelope on the lines of arrows and remove the syringe applicator. In good light, check for the capsule in the syringe window (Fig. 1). 3. Carefully remove (arrow) the plastic fuse from the piston (Fig . 2). Remove the cap from the needle. Do not try to remove air bubbles from the syringe and needle, so as not to accidentally squeeze the capsule out of the syringe. 4. Thumb and index finger to create a fold of skin on the anterior abdominal wall below the umbilical line. Keep the syringe body, at a distance of 2 cm from the needle. The needle is inserted subcutaneously, at an acute angle (30-45 °), cut up to the skin, until the moment when the syringe body touches the patient's skin (Fig. 3). 5. Do not insert the needle intravenously or intraperitoneally. Improper seizure of the needle and an incorrect angle of insertion shown in Fig. 4. 6. To enter the capsule and activate a protective mechanism, push down on the plunger until the very end. At this point, you can hear a click and feel that the protective mechanism automatically extends, closing the needle. The protective mechanism will not be activated if the piston is not pressed to the end. 7. Remove the syringe as shown in the figure. 5 and allow the safety mechanism to move until, until he fully closed the needle. Disposal of a used syringe method allowed for sharp objects. Rice. One Rice. Two Rice. Three Rice. Four Rice. Five Children Zoladex is not indicated for use in children. Overdose The experience of overdose in humans is small. In the case of administration of Zoladex before the scheduled time or at a higher than expected dose, clinically significant side effects were observed. Results of animal studies do not indicate any impact, except therapeutic, concentration of sex hormones and reproductive tract with the use of high doses of Zoladex 10,8 mg. In the case of overdosage should provide symptomatic treatment. Adverse reaction Frequency of adverse reactions was calculated according to the clinical study reports of the drug Zoladex post-marketing and communications. The most common adverse reactions were tides, sweating and reactions at the injection site. The frequency of side effects are as follows: very often (?1/10), often (?1/100 and <1/10), infrequently (?1/1000 and <1/100), rarely (?1/10000 < 1/1000), very rarely (<1/10000) and unknown frequency (can not be set according to available data). Table. Adverse reactions to Zoladex 10.8 mg of the classification authorities on MedDRA. Class of organo-frequency systems in Ukraine Neoplasms of benign neoplasm: malignant neoplasm of uncertain or unspecified (including cyst and polyps)Of pituitary gland unknown chastotnye of uterine fibroids From the immune systemnatural hypersensitivity to preparecreate hypersensitivity to the drug redlineproductions reactionaugmentin reaction From the endocrine systemyour of reckonability in gipofibrinogenemia in the pituitary gland On the part of metabolism and nutritional breakdown of glucose tolerance a mental rasstrojjstvami customizeie libido libido bСнижение b chastisement mood, depressionen mood, depression Very recepcionista restrictedservices disorders From the nervous of systemcacertificates Compression of the spinal cord ? Headache cardiologic disorders upright insufficiency f , myocardial infarction f? Neizvestnaya QT interval (see Sections "Features zastosuvannya" and "Interaction with other medicinal products and other forms of interaction")? vascular rasstrojjstvami castability bприливы b customerwhen blood pressure narushenie blood pressure The skin and subcutaneous Khatchatrian customersites bГипергидроз b , acne and customizepage dВысыпания d , hair loss g Neizvestnostj vysypanija d , hair loss g From the side of musculoskeletal system and connective danceschool bones e? rechstaatlicher The kidneys and urinary systeminstallation mochetocnikov From the reproductive system and mammary gland, frequent erectile dysfunction Vulvowaginalny dry ? Breast exaggeration part of the castor breast insensitivity rare ovarian Kist unknown chastotnye cancellation General disorders and complications in place of weenyone casereccia in place of swedenergy at the injection site casereccia in place of swedenergy at the injection site ? Magnification of tumor in volume, painful tumor The abnormality identified in the laboratory issledovaniyeyami bone density, weight gain telangana bone density, increasing of body mass a decrease in glucose tolerance was observed in men taking agonists of LH-RG. This may occur as diabetes or loss of glycemic control in people with existing diabetes mellitus. These pharmacological effects rarely require discontinuation of therapy. c-Hypo or hypertension, sometimes noted in patients receiving Zoladex. Changes are usually temporary and pass or continuation of therapy or after discontinuation of the drug Zoladex. Occasionally, such changes required medical intervention, including the abolition of Zoladex. d - are Usually small, often reduced without the need to stop. e-first, patients with prostate cancer may feel a temporary increase in bone pain, in such cases resort to symptomatic treatment. f-Observed in pharmacological and epidemiological studies of LG-RG agonists, which was used for the treatment of prostate cancer. The risk obviously increases with the use of the antiandrogens. g - Loss of hair on the head was observed in women, including young age, treated for benign gynecological diseases. Usually this phenomenon is not reflected, but sometimes it can be difficult. h - Particularly loss of body hair is an expected effect of snejanna levels of androgens. and-in most cases, acne was observed within a month after the beginning of application. When using goserelin possible: liver dysfunction and jaundice with Pidlisny levels of ALT, AST, GGT; increased levels of LDH, alkaline phosphatase, triglycerides; epistaxis, vaginal bleeding, hives, itching. Also, when applying the drug can be observed: from the urinary system-dysuria, increased blood urea nitrogen levels, increased creatinine, proteinuria from the blood - anemia, leukopenia, thrombocytopenia. When applying gozerelin may occur reactions at the site of administration (bleeding, hematoma, abscess, compaction, pain), bleeding around the site of administration of the drug, led to hemorrhagic shock. post-marketing experience Occasionally when using Zoladex had an anomalous blood test results cases of hepatic dysfunction, pulmonary embolism and interstitial pneumonia. In women in the treatment of endometriosis and/or fiber occasionally noted hypercalcemia. In the case of symptoms of hypercalcemia (e.g., thirst) should be examined with a view to its elimination. In addition, the following adverse reactions were reported in women who received funds for benign gynaecological conditions: acne, body hair change in body, dry skin, weight gain, increased serum cholesterol, ovarian hyperstimulation syndrome (when used in combination with gonadotropins), vaginitis, vaginal discharge, nervousness, sleep disorders, fatigue, peripheral edema, myalgia, spasms of the calf muscles, nausea, vomiting, diarrhea, constipation, and complaints of abdominal organs, voice changes. At the beginning of treatment, the signs and symptoms of the disease may temporarily increase, in this case, symptomatic treatment may be prescribed. Occasionally, during treatment with LG-RG analogues in women menopause may occur and menstruation will not resume after completion of therapy. Or it is the influence of the drug Zoladeks, or a consequence of gynecological conditions of patients is unknown. Shelf life 3 years. Apply only if the envelope with syringe applicator is intact. Apply immediately after opening the envelope. Storage conditions Store at a temperature not exceeding 25 ° C. Keep out of reach of children. Packaging 1 capsule in a syringe applicator with a protective mechanism; 1 syringe in an envelope with an attached annotation flag with a moisture-absorbing capsule; 1 envelope in a cardboard box. Category home away from home By prescription. Manufacturer AstraZeneca UK limited/AstraZeneca UK Limited. Manufacturer's location and address of the place of business Silk road Business Park, Macclesfield, Cheshire, SK10 2NA, UK/ Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, United Kingdom. DEPOSITARY THE ZOLADEX 3.6 MG The Zoladex – a drug with marked anti-tumor effect. The medication is an analogue of gonadotropin-releasing hormone. The active component of the drug in its action is aimed at reducing the concentration of testosterone and estradiol in serum in women and men. Indications for appointment Zoladex is used in the treatment of: Malignant tumors in the prostate region. If necessary, carry out in vitro fertilization. Fibroids of the uterus, malignant and benign formations in the uterine cavity. Severity of endometriosis, amenable to hormonal treatment, including the need to terminate the endometrium before ablation or resection. Cancerous tumors in the mammary glands in combination with chemotherapy. How to apply The drug has the form of capsules with prolonged action for subcutaneous injection into the abdominal wall. The active ingredient is active for 28 days after use. The duration of therapy and the number of capsules used is set by the attending physician and is used as standard for malignant tumors for a long time. In benign formations, the remedy is used for up to 6 months.

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