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Yiqi Fumai for injection (lyophilized)

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Yi Qi Fu Mai, Yang Yin Sheng Jin. Used for coronary heart disease, fatigue angina pectoris, qi and yin deficiency syndrome, chest pain, heartache, shortness of breath, laziness, dizziness, less complexion, pale tongue, less moss or peeling fur, thin pulse or generation; coronary heart disease Chronic left ventricular insufficiency caused by type II and III deficiency of qi and yin, symptoms of heart palpitations, shortness of breath, shortness of breath, shortness of breath, chest tightness and pain, sometimes stop, burnout, pale, sweating, pale tongue, Less moss or peeling, thin veins or generation.

Approval date: April 17, 2007

Date of revision: May 25, 2009 July 14, 2011 October 9, 2014 November 20, 2015 August 27, 2018

Please read the instructions carefully and use under the guidance of a physician

Adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions. Users should have received anaphylactic shock training. Allergic reactions or other serious adverse reactions after medication should be stopped immediately and treated promptly.

【Drug Name】

Common name: Yiqi Fumai for injection (lyophilized)

Phonetic script: Zhusheyong Yiqifumai

[Ingredients] Red Ginseng, Ophiopogon, Schisandra, and the auxiliary materials are meglumine and mannitol.

[Properties] This product is a light yellow loose bulk; it is hygroscopic. Take 1 bottle of this product and add 2 ~ 3ml of water to dissolve it. It is a brown-red clear liquid.

[Specifications] 0.65g per bottle (equivalent to 0.5g containing red ginseng, 0.75g of schisandra and 1.5g of winter wheat)

[Usage and Dosage] Intravenous drip. 8 bottles once a day, diluted with 250ml ~ 500ml 5% glucose injection or 0.9% sodium chloride injection after intravenous drip. About 40 drops per minute. The course of treatment is 2 weeks.

[Adverse reactions] 1. Occasionally female patients are seen during clinical studies, and the menstrual flow increases significantly during medication.

2. Occasionally, swelling of the acupuncture site occurred during the infusion during the clinical study, which improved after slowing the intravenous drip rate.

3. Post-marketing monitoring data show that the following adverse reactions can be seen with this product:

Allergic reactions: skin flushing, rash, itching, dyspnea, palpitations, cyanosis, decreased blood pressure, allergic reactions, anaphylactic shock, etc.

Systemic reactions: chills, fever, chills, chills, trembling, etc.

Respiratory system: shortness of breath, belching, etc.

Cardiovascular system: palpitations, chest tightness, elevated blood pressure, tachycardia, etc.

Digestive system: nausea, vomiting, dry mouth, etc.

Neuropsychiatric system: dizziness, headache, tremor, irritability, local numbness, etc.

Skin reactions: rash, itching, sweating, local reactions, etc.

Medication site: pain, injection site reaction, phlebitis, etc.

Others: pain, fatigue, abnormal vision, menstrual disorders, etc.

[Contraindications] 1. Those who are allergic to this product or the ingredients listed in preparations and ingredients containing red ginseng, Ophiopogon schisandrae and Schisandra chinensis or have a history of serious adverse reactions are prohibited.

2. Those with allergies are prohibited.

[Precautions] 1. During the infusion of this drug, the liquid should pass through the filter; if air bubbles are found, the drip rate should be slowed down.

2. Use the solvent specified under [Usage and Dosage] to fully dissolve. Do not use if it is turbid or precipitated after dilution with a diluent.

3. Adverse reactions of this product include anaphylactic shock, which should be used in medical institutions with rescue conditions. Users should have received anaphylactic shock training. Allergic reactions or other serious adverse reactions after medication should be stopped immediately and treated promptly.

4. Intensive use in accordance with the functions prescribed in the drug instruction sheet, super-indications are prohibited.

5. Strictly follow the instructions and dosage of the drug instructions, especially pay attention not to overdose, too fast drip and long-term continuous medication.

6. It is strictly forbidden to mix and match. This product should be used alone, and mixed with other drugs is contraindicated. If it is really necessary to use other drugs in combination, careful consideration should be given to the interval time with this product and drug interactions. The infusion tube must be flushed with an appropriate amount of diluent between the two drugs.

7, before the medication should be carefully asked about the history of allergies, allergies are disabled.

8. Elderly elderly people and patients who use TCM injections for the first time should be used with caution and strengthen monitoring.

9. Strengthen drug monitoring. During the medication, you should closely observe the medication response, especially the first 30 minutes. When abnormality was found, the drug was immediately discontinued and active treatment measures were adopted to treat the patient.

10. This product has a reaction to elevated blood pressure. Pay attention to changes in blood pressure when using this product.

11. This product should not be used with Veratrum, Wulingzhi and its preparations.

[Medication for pregnant and lactating women] There is no systematic clinical research data, so it should be used with caution.

[Medicine for children] There is no systematic clinical research data, so it should be used with caution.

[Pharmacology and toxicology] Pharmacological effects: Pharmacodynamic experiments show that this product can increase left ventricular pressure, decrease left ventricular end-diastolic pressure in dogs with acute heart failure caused by sodium pentobarbital, and increase dp / dt max , R-dp / dt max is shortened, which increases cardiac output and blood pressure. This product can increase the maximum rate of left ventricular pressure and left ventricular pressure change in hemorrhagic shock dogs, and reduce increased left ventricular end diastolic pressure and central venous pressure. This product can reduce the number of animals with reduced blood pressure in toxic shock rabbits caused by E. coli endotoxin and prolong survival time. This product can improve the ischemic electrocardiogram of coronary ligation dogs. This product can also slow down the heart rate of normal anesthetized dogs, increase blood pressure, left ventricular work, cardiac output and coronary flow, and reduce myocardial oxygen consumption. General pharmacological studies have shown that this product can lower blood pressure, slow heart rate, and prolong the QT interval of ECG in normal anesthetized rats.

[Storage] Sealed and shading.

[Packaging] Low-borosilicate glass controlled injection bottle, 8 bottles / box.

[Validity] 30 months.

[Executive Standard] State Food and Drug Administration Standard YBZ07062006-2009Z-2015

[Approval number] National Medicine Standard Z20060463

【manufacturer】