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Package insert of ropivacaine hydrochloride injection
Please read the package insert carefully and use it under the guidance of a physician
General name: Ropivacaine Hydrochloride Injection
English Name: Ropivacaine Hydrochloride Injection
Chinese spell: Yansuan Luopaikayin Zhusheye
Description:This product is colorless and clear liquid.
Strength:10ml:50mg
Indications:
Ropivacaine hydrochloride injection is indicated for followings Surgical anesthesia
-----Epidural anesthesia, including cesarean section
-----Subarachnoid anesthesia
-----Regional block Acute pain management
-----Epidural continuous infusion or intermittent bolus, such as postoperative or vaginal delivery analgesia
-----Regional block
Contraindications:
It is contraindicated in patients with a known hypersensitivity to ropivacaine or to any ingredient of the product.
Precautions:
Some local anesthesia, such as injection in the head and neck region, has a high incidence of serious adverse reactions.
Care should be taken in patients with degree II or III atrioventricular block. At the same time, special attention should be paid to the elderly patients and patients with severe liver disease, severe renal damage or poor health.
Class III antiarrhythmic drugs (such as amiodarone) may have additive effect on the heart with ropivacaine. Therefore, patients who use this kind of drugs should be closely monitored, and ECG monitoring can be considered.
When ropivacaine hydrochloride is used in epidural anesthesia or peripheral nerve block, especially in elderly patients and patients with heart disease, local anesthetics are wrongly injected to blood vessel, cardiac arrest has been reported. In some cases, recovery is difficult. In order to improve the success rate of resuscitation, the resuscitation time should be prolonged when cardiac arrest occurs.
Ropivacaine hydrochloride is metabolized in liver.There are no clinical studies or pharmacokinetic studies for patients with severe liver disease.
Under normal conditions, if the patient with renal failure is usually treated with a single dose or short-term treatment, it is unnecessary to adjust the dose.
Chronic renal insufficiency patients with acidosis and hypoproteinemia are more likely to have systemic poisoning.This risk should also be considered in patients with malnutrition or hypovolemic shock after treatment.
Epidural anesthesia can lead to hypotension and bradycardia, which can be reduced by pre infusion of volume expansion or the use of pressor drugs. For example, once hypotension occurs, it can be treated by intravenous injection of 5-10mg e phedrine. If necessary, the drug can be used repeatedly.
Excessive or accidental injection of blood vessels can cause central nervous system toxicity (convulsion, disturbance of consciousness) and/or cardiovascular system toxicity (arrhythmia, blood pressure drop, myocardial suppression).
The product may generate the porphyrin effect and should be used in patients with acute porphyria only when there is no safer alternative drug. For susceptible patients, appropriate vigilance should be taken.
Storage:Protect from light and store in the airtight container.
Package:Ampoules, 5 units /box.
Expiry date: 24 months
Standard: 2015 ChP and National drug standard YBH03902011
Registration No.: H20133181
Manufacturer:Name: Guangdong Jiabo Pharmaceutical Co., Ltd
Address: Bio-Pharmaceutical Park, High &New Technology industries development Zone, Qingyuan City, Guangdong Province, China
Website: jiabopharm.en.made-in-china.com
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