ELIGARD 45 mg, powder and solvent for solution for injection(四)
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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