部份中文伊班膦酸钠处方资料（仅供参考）
英文名：Ibandronate Sodium Hydrate
商品名：Bonviva Syringes
中文名：伊班膦酸钠注射器
生产商：中外制药
ボンビバ静注1mgシリンジ
药品分类名
骨质疏松症治疗
批准日期：2013年8月
商品名
Bonviva Syringes for Intravenous Injection
一般的名称
イバンドロン酸ナトリウム水和物
（Ibandronate Sodium Hydrate）（JAN）
化学名
Monosodium [1-hydroxy-3-(methylpentylamino)propane-1,1-diyl]diphosphonate monohydrate
分子式
C9H22NNaO7P2・H2O
分子量
359.23
性状
它是白色至微黄色的白色粉末。 易溶于水，几乎不溶于甲醇，乙醇和二甲基甲酰胺。
化学结构式
熔点
它在171°C左右开始熔化并在198°C左右分解。
处理注意事项
在严格的测试（光照）下发现相关物质略有增加，因此在打开外箱后，应避免光照并存放。
药效药理
作用机理
伊班膦酸对作为骨基质的羟基磷灰石具有高亲和力，并且在给药后分布在骨中。据认为，通过抑制被破骨细胞摄取后的法呢基焦磷酸合酶，从而抑制破骨细胞的功能，显示出骨吸收抑制作用。
骨吸收抑制作用
在使用兔破骨细胞培养系统的体外测试中，它减少了破骨细胞在象牙切片上形成的吸收凹坑。
对骨质疏松症动物模型的影响
在大鼠去卵巢模型中，皮下给药12个月以剂量依赖的方式抑制了骨密度和骨强度的降低。另外，即使在间歇地皮下给药（每25天一次）连续12个月之后，也抑制了骨密度和骨强度的降低。
在食蟹猴卵巢切除模型中，静脉给药16个月（每30天一次）可以抑制骨密度和骨强度的降低，并且观察到骨密度与骨强度之间呈正相关。它还可以抑制血清/尿液骨代谢指标（血清骨碱性磷酸酶，血清骨钙素，尿液I型胶原交联的N-端肽，尿液脱氧吡啶啉）的升高。
对骨矿化的影响
在成年大鼠中，每天皮下给药7天时，伊班膦酸的剂量最高为4780μg/kg（1000μgP/kg注1）：大约是表明骨量增加的剂量的100倍）注意不被接受。
在狗卵巢切除术/子宫切除术模型中，直至剂量为100μg/kg的伊班膦酸（约100倍的剂量对骨质流失具有抑制作用）时，未观察到骨样宽度增加或钙化率降低。
在食蟹猴去卵巢模型中，以30和150μg/kg的剂量（伊班膦酸剂量：16​​个月间歇性（每30天一次）静脉注射）观察到类固醇宽度增加，具有抑制骨质流失的作用。
注1）重量显示基于分子中所含磷原子的重量
注2）在4780μg/kg的剂量下，在胫骨干meta端的生长板正下方发现了被认为是由于骨基质添加受到抑制的钙化不足区域。
注3）与使用前值的比较
对骨折修复的影响
骨髓消融和骨缺损孔的形成在狗骨折模型中，连续36天皮下注射1μg/kg的伊班膦酸会影响骨髓消融的股骨皮质骨的骨单位数量和胫骨骨缺损孔中的骨us形成。
适应症
骨质疏松症
用法与用量
通常，成人每月一次静脉注射1毫克伊班膦酸。
包装
1mL x 1针筒
1mL x 10针筒
制造商和销售商
中外制药有限公司
注：以上中文处方资料不够完整，使用以原处方资料为准。
完整说明资料附件：
https://www.info.pmda.go.jp/go/pack/3999438G1027_1_05/
Bonviva Syringes for Intravenous Injection 1mg（Ibandronate sodium hydrate）
Brand name:Bonviva Syringes for Intravenous Injection 1mg
Active ingredient:Ibandronate sodium hydrate
Dosage form:injection
Print on wrapping:
Effects of this medicine
This medicine suppresses bone resorption by osteoclasts in the bone, thereby increasing bone density and preventingbone fractures.
It is usually used to treat osteoporosis.
Before using this medicine, be sure to tell your doctor and pharmacist
・If you have previously experienced any allergic reactions(itch, rash, etc.)to any medicines.
If you have hypocalcemia or renal disorder.
・If you are pregnant, possibly pregnant or breastfeeding.
・If you are taking any other medicinal products.(Some medicines may interact to enhance or diminish medicinaleffects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines)
Dosing schedule(How to take this medicine)
・Your dosing schedule prescribed by your doctor is((to be written by a healthcare professional))
・In general, for adults, inject intravenously once a month.
・The treatment period with this medicine depends on your response to the treatment.
Precautions while taking this medicine
・If you become pregnant or may have become pregnant while taking this medicine, consult with your doctor orpharmacist immediately.
・Try to take enough calcium and vitamin D through meals, etc.
・Abnormalities in the jaw bone may occur while taking bisphosphonates, including this medicine. Such adversereactions have been reported often related to dental treatment such as tooth extraction, so receive adequateexplanations about the following points from your doctor or pharmacist:
- Consult with your doctor, and then receive dental checkup before taking this medicine if needed.If possible, haveyour dental treatment, such as tooth extraction,completed before taking this medicine.
- Keep your mouth clean by brushing your teeth.
- Receive dental checkup regularly.
- When you visit a dentist, tell the dentist that you are taking this medicine.
- Try to avoid treatments such as tooth extraction as much as possible while taking the medicine.
- If abnormalities are identified in the teeth/jaw (such as jaw pain, loose teeth or swollen gums), visit a dentist/oralsurgery specialist immediately.
・Abnormalities in the bone of the external ear canal may occur while taking bisphosphonates. According to somecases reporting such an adverse reaction, the development of the reaction has been associated with ear infectionor wound.If symptoms such as ear itch, heat sensations inside the ear, strange sensations in the ear, otorrhea andear pain persist, visit an otolaryngologist.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include back pain, muscle pain, joint pain, bone pain, headache,malaise, gastritis, injection site reaction and influenza-like symptoms. If any of these symptoms occur, consult withyour doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicatedin brackets.If any of these symptoms occur, see your doctor immediately.
・general malaise, light headedness, decreased consciousness, impaired mind, hot flush, facial pallor, swelling aroundeyes and lips, hoarseness, breathing difficulty, shortness of breath, palpitation, hives, impaired judgment[anaphylactic shock, anaphylactic reaction]
・sore mouth, swollen mouth, redness, feeling of loose teeth, loose teeth, numbness of jaw, heavy feeling in the jaw,fever, loss of appetite [jaw bone necrosis/jaw osteomyelitis]
・ear itch, heat sensations inside the ear, strange sensations in the ear, otorrhea, ear pain[osteonecrosis of theexternal ear canal]
・pain in the thigh or inguinal region[atypical subtrochanteric and proximal femoral shaft fractures]
・convulsion, muscle weakness, numbness[hypocalcemia]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with yourdoctor or pharmacist if you notice any symptoms of concern other than those listed above.
Injection
Revised: 05/2019
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approvaldetails may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It isimportant to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response,patients should understand their medication and cooperate with the treatment.