TIBOLONE GPPL tibolone 2.5 mg tablet blister pack

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

tibolone, Quantity: 2.5 mg

Sẵn có từ:

Arrotex Pharmaceuticals Pty Ltd

Dạng dược phẩm:

Tablet, uncoated

Thành phần:

Excipient Ingredients: pregelatinised potato starch; ascorbyl palmitate; magnesium stearate; lactose monohydrate; lactose

Tuyến hành chính:

Oral

Các đơn vị trong gói:

28 Tablets, 10 Tablets, 84 Tablets

Loại thuốc theo toa:

(S4) Prescription Only Medicine

Chỉ dẫn điều trị:

? Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women. ? Second line therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss. After careful selection of users, <> (tibolone tablets) should be prescribed for the shortest duration consistent with treatment goals. Review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment (including cardiovascular disease and breast cancer, see CLINICAL TRIALS and PRECAUTIONS). <> (tibolone tablets) should only be continued for as long as the benefit outweighs the risks.

Tóm tắt sản phẩm:

Visual Identification: White to off white, circular with flat face beveled edge, uncoated tablet debossed with TO above 2 on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2018-03-28