英文药名: TAMIFLU Dry Syrup 3%(Oseltamivir Phosphate)

中文药名: 达菲（磷酸奥司他韦干糖浆）

生产厂家:中外制药

タミフルドライシロップ3％

治疗类别名称
抗流感病毒剂
批准上市日期：2002年7月
商標名
TAMIFLU
一般名
オセルタミビルリン酸塩（Oseltamivir Phosphate）（JAN）
化学名
(-)-Ethyl(3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1-carboxylate monophosphate
構造式

分子式
C16H28N2O4・H3PO4
分子量
410.40
性　状
白色至用细灰白色粉末或质量的粉末。易溶于水和甲醇，乙醇（95）微溶于N，微溶于N-二甲基乙酰胺，并在乙腈中几乎不溶。
熔点
192〜195℃（分解）
分配系数
在酸性至中性区域分配到水相中，它是分散在油相中在碱性区域。
操作注意事项
1.即使在到期日开幕后，将尽快用定。
2.由于有吸湿性，开口密封后，您保存，避免受潮。
3.超过4周后保存，将存放在冰箱或阴凉处（10℃以下）。此外，使用时被打开，以避免冷凝。
药效药理
1.体外抗病毒活性
磷酸奥塞米韦是一种前药，被转化为活性形式通过代谢，显示出抗病毒活性之后。
磷酸奥塞米韦的活性形式是A型和B型流感病毒在体外的低浓度的副本是由（实验室菌株的IC 50：<0.35微米：0.6-155nM，临床分离株的IC 50）抑制。
2.在体内抗病毒活性
在小鼠和雪貂的A型和B型流感病毒感染的模型，磷酸奥塞米韦（0.1-100毫克/kg/天）口服给药，增加，这取决于生存的剂量，减少症状与感染有关，观察到的治疗效果，如在病毒滴度的降低。此外，从病毒感染前24小时在鸡感染模型（10,100mg/千克，1天两次），对病毒感染的抑制作用，例如在生存增加观察到的口服给药。
3.作用机理
磷酸奥塞米韦的活性形式选择性地抑制人A型和B型流感病毒的神经氨酸苷酶：通过抑制从所述新形成的病毒感染细胞的释放（IC 500.1〜为3nM），病毒抑制生长。
4. 耐性
在发病的成人和抗病毒的青少年相对于国外和国内的临床试验目前剂（例4/1245）0.32％，为4.1％，在1至12岁儿童（N =464分之19）。所有耐药病毒是由A型流感病毒来源，出现在B型进行了观察。的抗病毒韩元，在感染的小鼠和雪貂的减少进行观察，生长在感染部位，传播力被认为是低的。的抗病毒韩元，氨基酸突变的神经氨酸酶已观察。
适应病症
○A型或B型流感病毒感染及其预防
用法与用量
1.在治疗中使用
(1) 成人
一般，每天75毫克，连服五天后暂停口服给药。
(2) 婴儿和儿童
通常，为2mg/kg的每日两次（66.7mg/kg的作为干糖浆），连服五天暂停口服给药。然而，最高剂量一次为75mg。
2.在预防使用
(1) 成人
每日一次，每次为75mg，为7至10天在使用时通过口服给药。
(2) 婴儿和儿童
为2mg/kg的每日一次（66.7mg/kg的作为干糖浆），连服10天口服给药。然而，最高剂量一次为75mg。
包装规格
干糖浆3％：30克

制造厂商
中外制药有限公司
保険適用（給付上）の注意
本剤は「A型又はB型インフルエンザウイルス感染症の発症後の治療」の目的で使用した場合にのみ保険給付されます。
完整资料附件：http://www.info.pmda.go.jp/go/pack/6250021R1024_1_24/
TAMIFLU Dry Syrup 3%[for prevention]（タミフルドライシロップ3％［予防用］） 
Brand name : TAMIFLU Dry Syrup 3%[for prevention]
　Active ingredient: Oseltamivir phosphate
　Dosage form: white to faintly yellow dry-syrup (mixture of coarse and fine granule)
　Print on wrapping:
TAMIFLU Dry Syrup 3%[for treatment]（タミフルドライシロップ3％［治療用］） 
Brand name : TAMIFLU Dry Syrup 3%[for treatment]
　Active ingredient: Oseltamivir phosphate
　Dosage form: white to faintly yellow dry-syrup (mixture of coarse and fine granule)
　Print on wrapping: 
Effects of this medicine
This medicine blocks influenza virus from leaving the infected cell in order to suppress viral reproduction.
It is usually used to prevent influenza type A and type B infection. 
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 are a patient with renal function disorder.
If 48 or more hours have been passed since you had influenza symptoms.
•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 2.5g (75mg of oseltamivir) at a time, twice a day, for 5 consecutive days. Mix this medicine with water when you take it.
In general, for children, take 66.7mg/kg (2mg/kg of oseltamivir) at a time, twice a day, for 5 consecutive days. Mix this medicine with water when you take it. However, a dose should not exceed 75mg of oseltamivir at a time.
Strictly follow the instructions.
•As for mixing this medicine with water, only prepare it when you need it and drink it right after mixing. If there is any leftover in the glass/cup, add more water and drink it.
In addition, if you take this medicine as a form of granule, take a dose of this medicine with water or lukewarm water.
•Patients aged 10 or over but under 20 cannot take this medicine in principle unless they are a high risk patient. The decision of "a high risk patient" will be made from their complications or health history.
•If you miss a dose, take the missed dose as soon as possible. However, you should never take two doses at one time.
•If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
•Do not stop taking this medicine unless your doctor instructs you to do so. Even influenza infection will cause symptoms such as fever, runny nose, sore throat, muscle pain, headache, cough, loss of appetite, general dullness, chills and diarrhea. So, in some cases, it is difficult to tell the difference between influenza symptoms and side effects of this medicine.
Precautions while taking this medicine
•There have been reports of abnormal behavior in patients aged 10 or over but under 20, of cases resulting in fall accidents. The relation between this medicine and those events are unknown. Parents or guardians with children/minor patients should pay attention to these precautions as follows;
-After starting this medication, a patient may behave abnormally.
-If the patient is treated at home, please be sure not to leave your child/minors alone for at least 2 days.
-Please note that influenza-associated encephalopathy is reported to have the same kinds of symptoms as mentioned above.
Possible adverse reactions to this medicine
The most commonly reported adverse reaction include abdominal pain, diarrhea, nausea, vomiting, hypothermia, rash, shock, anaphylaxis, fulminant hepatitis, hepatic function disorder, jaundice, mucocutaneous ocular syndrome, toxic epidermal necrolysis, acute renal failure, psycho-neurologic symptoms (consciousness disorder, abnormal behavior, delirium, hallucination, delusion, convulsion, etc.), hemorrhagic colitis, ischemic colitis. 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.
•cold sweat, dizziness, hoarseness, swelling around the eye and lips, hives, impaired judgment/mind, pale face, palpitation, shortness of breath, breathing difficulty, general dullness, glow, faint consciousness, lightheadedness [shock, anaphylaxis]
•fever, chills, cough/phlegm, shortness of breath [pneumonia]
•fever, loss of consciousness, decreased consciousness, impaired judgment/mind, headache, flapping tremor in hands, yellowness in the skin and/or the white of the eye, yellow urine, general dullness, itch, loss of appetite, nausea, vomiting [fulminant hepatitis, hepatic function disorder, jaundice]
•general dullness, fever, inflamed eyelid and eye, conjunctival sore, lip/intraoral sore, loss of appetite, red rash, red rash with dropsical swelling in the center, red spots and breakable blisters (bullas) all over the body, pain in the genitalia, joint pain [mucocutaneous ocular syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (TEN)]
•decreased urinary volume, urinary retention, decreased consciousness, easy fatigability, headache, general dullness, breathing difficulty, swollen body/eyes [acute renal failure]
•fever, sore throat [leukopenia]
•nose/gum bleeding, continuous bleeding, blue spot, subcutaneous bleeding [thrombocytopenia]
•decreased consciousness, impaired mind/judgment, unusual bizarre behavior, abnormal behavior, seeing or hearing something that is not really there, groundless belief, strong belief in something untrue, convulsion [psycho-neurologic symptoms (consciousness disorder, abnormal behavior, delirium, hallucination, delusion, convulsion, etc.)]
•fever, nausea, vomiting, feeling sick at the stomach, sudden abdominal pain, severe abdominal pain, diarrhea, bloody stool [hemorrhagic colitis, ischemic colitis]
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
•This medicine is sensitive to heat and moisture. Keep out of the reach of children. Store at room temperature (1-30℃), away from direct sunlight and moisture.
•Discard the remainder. Do not store them. Ask the pharmacist or healthcare facility how to discard them.
Chugai Pharmaceutical Co., Ltd.Internal
Revised: 4/2016
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.