英文药名:Bonalon Oral Jelly(Alendronate Sodium Hydrate)
中文药名:阿仑膦酸钠口服果冻
适合病症:骨质疏松症
生产厂家:帝人制药
ボナロン経口ゼリー35mg
治疗类别名称
骨质疏松症治疗剂
商標名
Bonalon Oral Jelly 35mg
一般名
アレンドロン酸ナトリウム水和物
(Alendronate Sodium Hydrate)
化学名
Monosodium trihydrogen 4-amino-1-hydroxybutane-1,1-diyldiphosphonate trihydrate
化学構造式
分子式
C4H12NNaO7P2・3H2O
分子量
325.12
融点
約252℃(分解、ただし乾燥後)
性状
它是一种白色结晶粉末。微溶于水,并在乙醇(99.5)几乎不溶。易溶于0.1mol /L的柠檬酸三钠的试剂
操作注意事项
1.为了避免滥用,不保存代替转移到另一个容器中。
2.存放在儿童接触不到的地方。
3.保存,以避免热量。
4.活性成分的晶体是可能在低温下被沉积,以保存,以避免低温冷冻(冰箱,冰柜等)。
5.不要放置重物。
6.请注意不要弯曲。
7.稳定性试验:最终的包装产品的长期保存试验条件下,使用(25℃,相对湿度60%,24个月),加速测试(40℃,相对湿度75%,6个月)的结果,外观和内容的等是规定范围内。
适应病症
骨质疏松
用法用量
每周一次35毫克如阿仑膦酸盐被口服用Mizuyaku180ML醒来后采取在早晨。
此外,服用后至少30分钟是不毗邻,食品和饮料(水除外),以及避免其他药物的口服摄取。
包装规格
2克×20包(铝包装:4包×5)
制造厂商
帝人制药有限公司
商標
ボナロン/Bonalon is the registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA.
Bonalon Oral Jelly 35mg(ボナロン経口ゼリー35mg)
Brand name : Bonalon Oral Jelly 35mg
Active ingredient: Alendronate sodium hydrate
Dosage form: clear and colorless to faint yellow jelly
Print on wrapping: ボナロン経口ゼリー 35mg
Effects of this medicine
This medicine is ingested into osteoclastic cells and inhibits osteoclast action to suppress borne resorption, and then increases bone mass to prevent bone fracture.
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 difficulty in swallowing foods/medicines or hypocalcemia.
If you are not able to keep an upright position for at least 30 minutes.
•If you are pregnant or breastfeeding.
•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. 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, take 1 packet (35 mg of Alendronate) at a time, once a week at the time of awakening (before breakfast) with a glass of water (approximately 180 mL). Strictly follow the instructions.
•Take this medicine on the morning of the same day of the week every week.
•Do not take this medicine with fluids other than water (never with mineral water with a high calcium/magnesium content, tea, coffee, juice, milk, etc.). Do not chew/suck the medicine or dissolve it in mouth. If chewed, drink water and rinse your mouth to prevent jelly fragments from remaining in your mouth.
•Do not eat/drink (except water) or take other medicine at least 30 minutes after taking this medicine. Do not lie down for at least 30 minutes after taking this medicine, and keep your body in an upright position until you finish the first meal of the day. Do not take this medicine at bedtime or before waking up.
•Open the packet and take the contents only. Take the medicine immediately after opening the packet and discard the remainder. Do not take it besides oral administration.
•If you miss a dose, take the missed dose the next morning (the dosage regimen is same as usual), and continue your regular dosing schedule. You should never take two doses at one time.
•If you accidentally took your dose two days in a row or took 2 packets at once, skip the next scheduled dose and return to your regular dosing schedule from the next time. If you notice any abnormality, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
•Maintain your oral hygiene while taking this medicine.
•When you receive dental treatment such as tooth extraction or implant, tell your dentist or oral surgeon that you are taking this medicine.
•Try to ingest calcium through meals, etc.
•Consult with your doctor of pharmacist before taking supplements containing calcium or vitamin D.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include gastric inflammation (upper abdominal pain, abdominal discomfort, nausea), indigestion (heartburn) and diarrhea. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
•difficulty in swallowing, pain on swallowing, chest (underside of the breastbone) pain [esophageal/intraoral disorder]
•vomiting of blood, melena (black stool), pain in the pit of stomach [gastric/duodenum disorder]
•high fever, general malaise, lip erosion, bloodshot eyes, sore throat, red rash/bulla in wide area of skin [toxic epidermal necrolysis, mucocutaneous ocular syndrome]
•jaw pain/swelling/numbness, loose tooth [jaw bone necrosis, jaw osteomyelitis]
•pain of the thigh or inguinal region [atypical subtrochanteric and diaphyseal femoral fractures]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
•Keep out of the reach of children. Store away from direct sunlight, heat, freezer and refrigerator.
•Do not take it if white clots are seen.
•Do not put heavy things on it.
•Pay attention not to fold it when carrying.
•Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.
TEIJIN PHARMA LIMITEDInternal
Revised: 5/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
完整处方资料附件:http://www.info.pmda.go.jp/go/pack/3999018Q1022_1_04/