Lupron Depot (leuprolide acetate for depot suspension)

Web Name: Lupron Depot (leuprolide acetate for depot suspension)

WebSite: http://www.lupron.com

ID:129888

Keywords:

leuprolide,Depot,Lupron,

Description:

LUPRONDEPOT (leuprolide acetate for depot suspension) 7.5mg for 1 month, 22.5mg for 3 month, 30mg for 4-month, and 45mg for 6 month administration are prescribed for the palliative treatment of advanced prostate cancer.LUPRON DEPOT is a prescription medication that must be administered in your doctor s office. Please see Important Safety Information you should know about Lupron Depot. Models are for illustrative purposes only.LUPRONDEPOT (leuprolide acetate for depot suspension) 3.75mg for 1 month and 11.25mg for 3 month administration are prescription medications used for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRONDEPOT 3.75mg for 1 month and 11.25mg for 3 month administration may be used with daily norethindrone acetate 5mg as add back therapy for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. Add back therapy is intended to reduce the thinning of bone and reduce hot flashes associated with LUPRONDEPOT. Forsafe and effective use of norethindrone acetate with LUPRONDEPOT 11.25mg, refer to the norethindrone prescribing information. Initial treatment course of LUPRONDEPOT (whether used alone or with add back therapy) is limited to 6months. Asingle retreatment course of not more than 6months of LUPRONDEPOT plus add back therapy may be used if symptoms recur. LUPRONDEPOT should not be used alone for retreatment. Thetotal duration of therapy with LUPRONDEPOT plus add back therapy should not exceed 12months due to concerns about adverse impact on bone thinning. Please see Important Safety Information you should know about Lupron Depot. Models are for illustrative purposes only.LUPRON DEPOT (leuprolide acetate for depot suspension) 3.75mg for 1 month and 11.25mg for 3 month administration are prescription medications used with iron therapy before fibroid surgery to improve anemia from fibroids. Yourdoctor may prescribe a 1 month trial of iron alone as some patients’ anemia will improve with iron alone. LUPRONDEPOT with norethindrone acetate is not used for this condition. A patient may receive up to 3monthly injections of LUPRONDEPOT 3.75mg. Alternatively, asingle injection of LUPRONDEPOT 11.25mg may be used only if your doctor decides 3months of hormonal suppression is necessary. Please see Important Safety Information you should know about Lupron Depot. Models are for illustrative purposes only.LUPRONDEPOT PED (leuprolide acetate for depot suspension) 7.5mg, 11.25mg, and 15mg for 1 month and 11.25mg and 30mg for 3 month administration are prescribed for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of9. Yourdoctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors). It is not known if LUPRON DEPOT PED is safe and effective in children under 2 years of age. Please see Important Safety Information you should know about Lupron Depot-PED. Models are for illustrative purposes only.LUPRONDEPOT (leuprolide acetate for depot suspension) 7.5mg for 1 month, 22.5mg for 3 month, 30mg for 4-month, and 45mg for 6 month administration are prescribed for the palliative treatment of advanced prostate cancer.LUPRON DEPOT is a prescription medication that must be administered in your doctor s office. Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor. Safety Considerations LUPRONDEPOT is not for people who have had any type of allergic reaction to LUPRONDEPOT or similar drugs LUPRONDEPOT causes an increase in testosterone during the first weeks of treatment Anincrease in urinary symptoms and/or pain may occur Inpatients whose cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can lead to paralysis, which may be life threatening Highblood sugar and an increased risk for developing diabetes, heart attack, sudden death, and stroke can occur with LUPRONDEPOT treatment LUPRONDEPOT can affect the heart’s electrical activity in patients with certain heart conditions or abnormal blood tests for electrolytes, or who are taking medications that regulate the heartbeat Convulsions have occurred in patients taking LUPRON DEPOT with or without a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), or in those taking medicines that cause convulsions LUPRONDEPOT may cause fetal harm if administered to a pregnant woman LUPRONDEPOT can cause impotencePlease see additional Important Safety Information you should know about Lupron Depot and discuss it with your doctor.LUPRONDEPOT (leuprolide acetate for depot suspension) 3.75mg for 1 month and 11.25mg for 3 month administration are prescription medications used for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRONDEPOT 3.75mg for 1 month and 11.25mg for 3 month administration may be used with daily norethindrone acetate 5mg as add back therapy for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. Add back therapy is intended to reduce the thinning of bone and reduce hot flashes associated with LUPRONDEPOT. Forsafe and effective use of norethindrone acetate with LUPRONDEPOT 11.25mg, refer to the norethindrone prescribing information. Initial treatment course of LUPRONDEPOT (whether used alone or with add back therapy) is limited to 6months. Asingle retreatment course of not more than 6months of LUPRONDEPOT plus add back therapy may be used if symptoms recur. LUPRONDEPOT should not be used alone for retreatment. Thetotal duration of therapy with LUPRONDEPOT plus add back therapy should not exceed 12months due to concerns about adverse impact on bone thinning. Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor. Safety Considerations You should not receive LUPRONDEPOT if you are pregnant, think you may be pregnant, or are planning to become pregnant during treatment with LUPRONDEPOT; are breast feeding; have undiagnosed uterine bleeding; or have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs Thinning of your bones can occur and may not be completely reversible after stopping treatment; do not exceed the prescribed duration of treatment LUPRON DEPOT may cause harm to your unborn child Acondom, adiaphragm with contraceptive jelly, or acopper IUD is required to prevent pregnancy Serious allergic reactions can occur Endometriosis symptoms such as pelvic pain or pressure or pain during intercourse may increase during the first days of therapy Convulsions have occurred in patients taking LUPRONDEPOT Development or worsening of depression has occurred in patients taking norethindrone acetate Ifyour doctor prescribes norethindrone acetate as add back therapy in combination with LUPRONDEPOT 11.25mg, please refer to the norethindrone acetate prescribing information for more information about its safe and effective use Norethindrone acetate used as add-back therapy with LUPRONDEPOT 3.75mg has additional serious risks and considerations. See the Important Safety Information section for add-back risks and considerations.Please see additional Important Safety Information you should know about LupronDepot and discuss it with your doctor.LUPRON DEPOT (leuprolide acetate for depot suspension) 3.75mg for 1 month and 11.25mg for 3 month administration are prescription medications used with iron therapy before fibroid surgery to improve anemia from fibroids. Yourdoctor may prescribe a 1 month trial of iron alone as some patients’ anemia will improve with iron alone. LUPRONDEPOT with norethindrone acetate is not used for this condition. A patient may receive up to 3monthly injections of LUPRONDEPOT 3.75mg. Alternatively, asingle injection of LUPRONDEPOT 11.25mg may be used only if your doctor decides 3months of hormonal suppression is necessary. Please see the full Prescribing Information for Lupron Depot and discuss it with your doctor. Safety Considerations Youshould not receive LUPRONDEPOT if you are pregnant, think you may be pregnant, or are planning to become pregnant during treatment with LUPRONDEPOT; are breast feeding; have undiagnosed uterine bleeding; or have experienced any type of allergic reaction to LUPRONDEPOT or similar drugs Thinning of your bones can occur and may not be completely reversible after stopping treatment; do not exceed the prescribed duration of treatment LUPRONDEPOT may cause harm to your unborn child Acondom, adiaphragm with contraceptive jelly, or acopper IUD is required to prevent pregnancy Serious allergic reactions can occur Fibroid symptoms, such as abdominal bloating or pelvic pain or pressure, may increase during the first days of therapy Convulsions have occurred in patients taking LUPRONDEPOT Development or worsening of depression has occurredPlease see additional Important Safety Information you should know about Lupron Depot and discuss it with your doctor.LUPRONDEPOT PED (leuprolide acetate for depot suspension) 7.5mg, 11.25mg, and 15mg for 1 month and 11.25mg and 30mg for 3 month administration are prescribed for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of9. Yourdoctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors). It is not known if LUPRON DEPOT PED is safe and effective in children under 2 years of age. Please see the full Prescribing Information for Lupron Depot-PED and discuss it with your doctor. Safety Considerations Your child should not receive LUPRONDEPOT PED if she/he is allergic to any of the ingredients or she is or may become pregnant. Increased signs and symptoms of puberty during the first few weeks of treatment may occur. Contact your child’s healthcare provider if signs of puberty continue after the second month of treatment or if new or unusual signs or symptoms occur. Mental (psychiatric) problems have been reported in patients taking GnRH agonists, like LUPRONDEPOT PED. Events include emotional symptoms such as crying, irritability, restlessness (impatience), anger, and acting aggressive. Inform your child s doctor right away if your child has any new or worsening mood symptoms while taking LUPRONDEPOT PED. Seizures have been observed in patients taking GnRH agonists, like LUPRONDEPOT PED, with or without a history of seizures, epilepsy, brain or brain vessel problems or tumors, and in patients taking medications that have been connected to seizures. Call your child s doctor right away if your child has a seizure while taking LUPRONDEPOT PED. Your child s pubertal development could begin again if the injection schedule is not followed.Please see additional Important Safety Information you should know about LupronDepot PED and discuss it with your doctor. If you or a loved one has been prescribed LUPRON DEPOT, click on the specific condition to find out more about LUPRON DEPOT therapy Use and Important Safety Information You Should Know About LupronDepot (leuprolide acetate for depot suspension)LUPRONDEPOT (leuprolide acetate for depot suspension) 7.5mg for 1 month, 22.5mg for 3 month, 30mg for 4 month, and 45mg for 6 month administration are prescribed for the palliative treatment of advanced prostate cancer.LUPRON DEPOT is a prescription medication that must be administered in your doctor s office.LUPRONDEPOT is not for people who have had any type of allergic reaction to LUPRONDEPOT or similar drugs.LUPRONDEPOT causes an increase in testosterone during the first few weeks of therapy.Some men may experience temporary new or worsening symptoms of prostate cancer, including urinary symptoms and/or bone pain.If your cancer has spread to the spine or urinary tract, urinary blockage or pressure on the spine may occur and can sometimes lead to paralysis, which may be life threatening.You may require close medical attention during the first few weeks of therapy. Notify your doctor if you develop any new or worsened symptoms after beginning LUPRONDEPOT treatment.High blood sugar and increased risk of diabetes can occur in men using LUPRONDEPOT. Your doctor will monitor your blood sugar during treatment.Increased risk of heart attack, sudden death, and stroke can occur in men using LUPRON DEPOT. Discuss this increased risk with your doctor before starting treatment and report any new symptoms during treatment.LUPRONDEPOT can affect the electrical activity of your heart. Your doctor must determine if the benefits of using LUPRON DEPOT outweigh the risks, especially if you have congenital long QT syndrome, abnormal blood tests for electrolytes, congestive heart failure, or if you take medications to regulate your heartbeat.Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in those taking medications associated with convulsions. Convulsions have also been reported in patients without any of these conditions.Regular blood tests are needed to check your testosterone and prostate-specific antigen (PSA) levels.LUPRONDEPOT may cause fetal harm if administered to a pregnant woman.LUPRONDEPOT may cause impotence.The most common side effects of LUPRONDEPOT include hot flashes/sweats; injection site reaction/pain; general pain; swelling; testicular shrinkage; difficulty urinating; fatigue/weakness; headache; and joint, gastrointestinal, and respiratory problems.You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch or call 1-800-FDA-1088. If you cannot afford your medication, contact www.pparx.org for assistance.Please see the complete Prescribing Information for LupronDepot and discuss it with your doctor.Reference: LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc. If you or a loved one has been prescribed LUPRON DEPOT, click on the specific condition to find out more about LUPRON DEPOT therapy Uses and Important Safety Information You Should Know About LupronDepot (leuprolide acetate for depot suspension) LUPRON DEPOT (leuprolide acetate for depot suspension) 3.75mg for 1 month and 11.25mg for 3 month administration are prescription medications used for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT 3.75mg for 1 month and 11.25mg for 3 month administration may be used with daily norethindrone acetate 5mg as add back therapy for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. Add back therapy is intended to reduce the thinning of bone and reduce hot flashes associated with LUPRONDEPOT. Forsafe and effective use of norethindrone acetate and LUPRONDEPOT 11.25mg, refer to the norethindrone prescribing information. Initial treatment course of LUPRONDEPOT (whether used alone or with add back therapy) is limited to 6 months. A single retreatment course of not more than 6months of LUPRONDEPOT plus add back therapy may be used if symptoms recur. LUPRONDEPOT should not be used alone for retreatment. The total duration of therapy with LUPRONDEPOT plus add back therapy should not exceed 12months due to concerns about adverse impact on bone thinning. Important Safety Information Do not take LUPRONDEPOT if you are, may be, or are planning to become pregnant, are breast feeding, have undiagnosed uterine bleeding, or if you have experienced any type of allergic reaction to LUPRONDEPOT, or similar drugs. If your doctor prescribes you norethindrone acetate in combination with LUPRON DEPOT 11.25mg, please refer to the norethindrone acetate prescribing information for more information about its safe and effective use. You should not take norethindrone acetate and LUPRONDEPOT 3.75mg if you currently have or have previously had any clotting disorder, heart disease, stroke, impaired liver function or liver disease, or breast cancer. Tell your healthcare provider before beginning treatment with norethindrone acetate and LUPRONDEPOT 3.75mg if you currently have or have previously had high cholesterol, migraines, epilepsy, or depression, or if you smoke. During treatment with norethindrone acetate and LUPRONDEPOT 3.75mg, immediately tell your doctor if you have a sudden loss of vision, double vision, or if migraine headaches occur. You should notify your doctor if you experience fluid retention, seizure, asthma or worsening of asthmatic symptoms, or heart or kidney problems. Thinning of the bones may occur during therapy with LUPRONDEPOT alone, which may not be completely reversible in some patients. Since some conditions may increase the possibility of bone thinning, you should tell your doctor if you smoke, use alcohol in excess, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that can cause thinning of the bones. Youshould be aware that if you have these conditions, treatment with LUPRONDEPOT alone is not advisable and combination with norethindrone acetate should be considered. Add back therapy can help reduce the bone loss that occurs with the use of LUPRONDEPOT alone. If a second course of treatment with LUPRON DEPOT is being considered, bone mineral testing is recommended and retreatment should include combination with norethindrone acetate. LUPRONDEPOT may cause harm to your unborn child. LUPRONDEPOT is not a method of birth control. Even though you may not have periods, unprotected intercourse could result in pregnancy. You should use non-hormonal birth control, such as condoms, a diaphragm with contraceptive jelly, or a copper IUD, to prevent pregnancy. If you think you have become pregnant while on LUPRONDEPOT, talk to your doctor immediately. Asthma was reported in women with a history of asthma, sinusitis, and environmental or drug allergies. Serious allergic reactions have also occurred. After beginning LUPRONDEPOT, your estrogen levels will increase during the first days of therapy. During this time, you may notice an increase in your current symptoms. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRONDEPOT treatment. Seizures have been observed in patients taking LUPRONDEPOT, including patients who have a history of seizures or conditions related to seizures or in patients who are taking medications that are connected to seizures. Seizures have also been reported in patients without any of these conditions. Depression may worsen while taking norethindrone acetate. Patients who have a history of depression should be carefully observed during treatment. Talk to your doctor if you are experiencing any new or worsening signs of depression. The most common side effects of LUPRONDEPOT included hot flashes/sweats, headache/migraine, decreased libido (interest in sex), depression/emotional lability (changes in mood), dizziness, nausea/vomiting, pain, vaginitis, and weight gain. These are not all of the possible side effects of LUPRONDEPOT. Talk to your doctor for medical advice about side effects. LUPRON DEPOT for treatment of endometriosis has been limited to women 18 years of age and older. LUPRONDEPOT is not indicated in postmenopausal women. LUPRON DEPOT must be administered in your doctor’s office. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. For more information, talk with your healthcare provider. If you cannot afford your medication, contact www.pparx.org for assistance. Reference: LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc. If you or a loved one has been prescribed LUPRON DEPOT, click on the specific condition to find out more about LUPRON DEPOT therapy Uses and Important Safety Information You Should Know About LupronDepot (leuprolide acetate for depot suspension) LUPRON DEPOT (leuprolide acetate for depot suspension) 3.75mg for 1 month and 11.25mg for 3 month administration are prescription medications used with iron therapy before fibroid surgery to improve anemia from fibroids. Your doctor may prescribe a 1-month trial of iron alone as some patients’ anemia will improve with iron alone. LUPRON DEPOT with norethindrone acetate is not used for this condition. A patient may receive up to 3 monthly injections of LUPRONDEPOT 3.75mg. Alternatively, a single injection of LUPRONDEPOT 11.25mg may be used only if your doctor decides 3months of hormonal suppression is necessary.Important Safety Information Do not take LUPRONDEPOT if you are, may be, or are planning to become pregnant, are breast-feeding, have undiagnosed uterine bleeding, or if you have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs.Thinning of the bones may occur during therapy with LUPRONDEPOT, which may not be completely reversible in some patients. The duration of therapy with LUPRONDEPOT is limited to 3months. The symptoms associated with fibroids will return after stopping therapy. Since some conditions may increase the possibility of bone thinning, you should tell your doctor if you smoke, use alcohol in excess, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that can cause thinning of the bones.LUPRON DEPOT may cause harm to your unborn child. LUPRONDEPOT is not a method of birth control. Even though you may not have periods, unprotected intercourse could result in pregnancy. You should use non hormonal birth control, such as condoms, a diaphragm with contraceptive jelly, or a copper IUD to prevent pregnancy. If you think you have become pregnant while on LUPRONDEPOT, talk to your doctor immediately.Asthma was reported in women with a history of asthma, sinusitis, and environmental or drug allergies. Serious allergic reactions have also occurred.After beginning LUPRONDEPOT, your estrogen levels will increase during the first days of therapy. During this time, you may notice an increase in your current symptoms. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRONDEPOT treatment.Convulsions have been observed in patients taking LUPRONDEPOT, including patients who have a history of seizures or conditions related to seizures or in patients who are taking medications that are connected to seizures. Seizures have also been reported in patients without any of these conditions.Depression may worsen while taking norethindrone acetate. Patients who have a history of depression should be carefully observed during treatment. Talk to your doctor if you are experiencing any new or worsening signs of depression. LUPRONDEPOT with norethindrone acetate is not used for this condition.The most common side effects of LUPRONDEPOT included hot flashes/sweats, headaches/migraine, decreased libido (interest in sex), depression/emotional lability (changes in mood), dizziness, nausea/vomiting, pain, vaginitis, and weight gain. These are not all of the possible side effects of LUPRONDEPOT. Talk to your doctor for medical advice about side effects.LUPRON DEPOT for treatment of anemia from fibroids has been limited to women 18 years of age and older. LUPRONDEPOT is not indicated in postmenopausal women.LUPRON DEPOT must be administered in your doctor’s office.For more information, talk with your healthcare provider. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you cannot afford your medication, contact www.pparx.org for assistance. Reference: LUPRON DEPOT [package insert]. North Chicago, IL: AbbVie Inc. If you or a loved one has been prescribed LUPRON DEPOT-PED, click on the specific condition to find out more about LUPRON DEPOT-PED therapy Use and Important Safety Information You Should Know About LupronDepot PED (leuprolide acetate for depotsuspension)LUPRONDEPOT PED 7.5mg, 11.25mg, and 15mg for 1 month and 11.25mg and 30mg for 3 month administration are prescribed for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Your doctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors).It is not known if LUPRONDEPOT PED is safe and effective in children under 2 years of age.Important Safety Information for LUPRONDEPOT PED What is the most important information I should know about LUPRON DEPOT PED? During the first 2 to 4 weeks of treatment, LUPRONDEPOT PED can cause an increase in some hormones. During this time, you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRONDEPOT PED. Some people taking gonadotropin releasing hormone (GnRH) agonists like LUPRONDEPOT PED have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: Crying Irritability Restlessness (impatience) Anger Acting aggressive Call your child s doctor right away if your child has any new or worsening mental symptoms or problems while taking LUPRONDEPOT PED. Some people taking GnRH agonists like LUPRONDEPOT PED have had seizures. The risk of seizures may be higher in people who: Have a history of seizures Have a history of epilepsy Have a history of brain or brain vessel (cerebrovascular) problems or tumors Are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs) Seizures have also happened in people who have not had any of these problems. Call your child s doctor right away if your child has a seizure while taking LUPRONDEPOT PED. LUPRONDEPOT PED should not be taken if your child is: Allergic to GnRH, GnRH agonist medicines, or any ingredients in LUPRONDEPOT PED Pregnant or becomes pregnant. LUPRONDEPOT PED can cause birth defects or loss of the baby. If your child becomes pregnant, call your doctor. Before your child receives LUPRONDEPOT PED, tell your doctor about all of your child smedical conditions, including if they: Have a history of epilepsy Have a history of brain or brain vessel (cerebrovascular) problems or tumors Are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs) Are breastfeeding or plan to breastfeed. It is not known if LUPRONDEPOT PED passes into the breast milk Tell your doctor about all the medicines your child takes, including prescription and over the counter medicines, vitamins, and herbal supplements. How will your child receive LUPRONDEPOT PED? LUPRON DEPOT-PED is injected into your child s muscle by a doctor or trained nurse. Keep all scheduled visits to the doctor. If a scheduled dose is missed, your child may start having signs of puberty again. The doctor will do regular exams and blood tests to check for signs of puberty. Acne or red, itchy rash and white scales (seborrhea) Serious skin rash (erythema multiforme) Mood changes Swelling of vagina (vaginitis), vaginal bleeding, and vaginal discharge These are not all the possible side effects of LUPRONDEPOT PED. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you cannot afford your medication, contact www.pparx.org. This is the most important information to know about LUPRON DEPOT-PED. For more information, talk to your doctor or healthcare provider. Please see the full Prescribing Information for LupronDepot PED and discuss it with your doctor.Reference: LUPRONDEPOT PED [package insert]. North Chicago, IL: AbbVie Inc.

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