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ELIGARD 7.5 mg, powder and solvent for solution for injectio(四)
2013-07-03 22:23:31 来源: 作者: 【 】 浏览:5206次 评论:0
ea,
 
uncommon
 constipation, dry mouth, dyspepsia, vomiting
 
rare
 flatulence, eructation,
 
Skin and subcutaneous tissue disorders
  
very common
 ecchymoses, erythema
 
common
 pruritus, night sweats
 
uncommon
 clamminess, increased sweating
 
rare
 alopecia, skin eruption
 
Musculoskeletal, connective tissues and bone disorders
  
common
 arthralgia, limb pain, myalgia
 
uncommon
 back pain, muscle cramps
 
Renal and urinary disorders
  
common
 urinary infrequency, difficulty in micturation, dysuria, nocturia, oliguria
 
uncommon
 bladder spasm, haematuria, aggravated urinary frequency, urinary retention
 
Reproductive system and breast disorders
  
common
 breast tenderness, testicular atrophy, testicular pain infertility, breast hypertrophy
 
uncommon
 gynaecomastia, impotence, testicular disorder
 
rare
 breast pain
 
General disorders and administration site reactions
  
very common
 fatigue, injection site burning, injection site paraesthesia
 
common
 Malaise, injection site pain, injection site bruising, injection site stinging , rigors, weakness
 
uncommon
 injection site pruritus, lethargy, pain, pyrexia
 
rare
 injection site ulceration
 
very rare
 injection site necrosis
 
Blood and lymphatic system disorders
  
Common
 hematology changes
 
Investigations
  
common
 increased blood creatinine phosphokinase, prolonged coagulation time
 
uncommon
 increased alanine aminotransferase, increased blood triglycerides, prolonged prothrombin time, increased weight
 

Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include impotence , decrease in libido(both pharmacological consequences of testosterone deprivation), peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, an alteration in the skin sensation, chills, peripheral vertigo, rash, amnesia and visual disturbances. Infarction of pre-existing pituitary apoplexy has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.

Local adverse events reported after injection of ELIGARD are similar to the local adverse events associated with similar subcutaneously injected products.

Generally, these localised adverse events following subcutaneous injection are mild and described as being of brief duration.

Changes in Bone Density

Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH analogues. It can be anticipated that long periods of treatment with leuprorelin may show increasing signs of osteoporosis. Regarding the increased risk for fractures owing to osteoporosis (see section 4.4).

Exacerbation of signs and symptoms of the di

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