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bupivacaine

Solution for injection 0.5 %/4 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Unavailable markets
Algeria , Angola , Bahrain , Bulgaria , Cameroon , Colombia , Egypt , Ghana , Iran , Iraq , Israel , Jordan , Kuwait , Lebanon , Libya , Lithuania , Morocco , Nigeria , Oman , Qatar , Saudi Arabia , Senegal , South Africa , Sudan , Syria , Tunisia , United Arab Emirates , Vietnam , Yemen
Manufacturer #686
A pharmaceutical manufacturer based in the EU that has been active in 100+ countries selling its products in Europe, CIS, North America, LATAM, Africa, and Asia for 30+ years. The key production line is Rx. Main therapeutic areas include antibiotics, neurology, and cardiovascular. The main dosage form is injectable. The company's production lines are GMP-compliant. The company possesses different production lines in the EU.

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Bupivacaine Manufacturers

Drug Name: Bupivacaine Chemical formulation: C18H28N2O Active ingredient: Bupivacaine Hydrochloride Common/generic brand name: Marcaine, Sensorcaine, Posimir Approved by FDA or not: Yes Commonly marketed in: Europe, US Molecular mass: 288.435 g·mol−1

` What is Bupivacaine?

Bupivacaine is a prescription-only Local Anesthetic. It is used to numb the pain signals that reach the brain and thus provide pain relief. It is used as local and regional anesthesia and as an analgesic in surgery. These surgeries include oral procedures, obstetrical operations, and diagnostic and therapeutic interventions. Additionally, it is used as a peripheral nerve block, sympathetic nerve block, and epidural. The other constituents of Bupivacaine in addition to the active ingredient are 0.0091 mg epinephrine bitartrate, 0.5 mg sodium metabisulfite, 0.001 mL monothioglycerol, 2 mg ascorbic acid as antioxidants, 0.0017 mL 60% sodium lactate buffer, and 0.1 mg edetate calcium disodium as a stabilizer. The use of Bupivacaine has increased widely in the past few years due to its potency and safety profile. It is a very common local anesthetic used in multiple procedures.

`General drug sources for Bupivacaine

The general drug sources for Bupivacaine are Innocoll Pharms, Aurobindo Pharma Ltd, Hikma Pharms, Hospira, Mylan Asi, Novocol Healthcare, Intl Medicated, Fresenius Kabi USA, B Braun Medical Inc, Baxter Hlthcare Corp, Huons, Septodont, and Amphastar Pharms Inc.

`Bupivacaine is available in multiple forms:

Bupivacaine can only be administered parenterally. Based on the surgical procedure one of these routes can be utilized: infiltration, perineural, caudal, epidural, or retrobulbar use. Bupivacaine is produced in several concentrations. These vary depending on the level of analgesia or anesthesia that is to be achieved. In the injectable solution, it is available in concentrations of 0.25% and 0.5%. The preservative-free injectable solution is available in concentrations of 0.25%, 0.5% and 0.75%. The spinal injection is available as 0.75%. The single-dose vial injection is available as 660mg/5mL.

` How should Bupivacaine be used?

Based on the level of nerve block that needs to be achieved, the concentration needs to be administered accordingly. Local Anesthesia Adult Dosage: Infiltration: 0.25% infiltrated locally: 175 mg maximum Pediatric Dosage: Children under 12 years: not recommended Infiltration: 0.25% infiltrated locally: 175 mg maximum Caudal Block Adult Dosage: Preservative-free: 15-30 ml of 0.25% or 0.5% Pediatric Dosage: Children under 12 years: not recommended Children over 12 years: 15-30 ml of 0.25% or 0.5% (preservative-free) Epidural Block Adult Dosage: Preservative free: 10-20 ml of 0.25% or 0.5%; administer in 3-5 ml increments Pediatric Dosage: Children under 12 years: not recommended Children over 12 years: 10-20 ml of 0.25% or 0.5%; administer in 3-5 ml increments Peripheral Nerve Block Adult Dosage: 5 ml of 0.25-0.5%; 400 mg/day maximum Pediatric Dosage: Children under 12 years: not recommended Children over 12 years: 5 ml of 0.25-0.5%; 400 mg/day maximum Sympathetic Nerve Block Adult Dosage: 20-50 ml of 0.25% Pediatric Dosage: Children under 12 years: not recommended Children over 12 years: 20-50 ml of 0.25% Retrotubular Anesthesia Adult Dosage: 2-4 ml of 0.75% Pediatric Dosage: Children under 12 years: not recommended Children over 12 years: 20-50 ml of 0.25% Spinal Anesthesia Adult Dosage: Preservative-free: 0.75% bupivacaine in 8.25% dextrose

`Bupivacaine Manufacturers & Wholesalers List:

Duchefa Farma B.V. Shandong Octagon Chemicals Limited from China. Promochimica from Tunisia. Xi'an Tian Guangyuan Biotech Co., Ltd from China. TIEFENBACHER API + Ingredients from Germany. Jinan Chenghuishuangda from China. HEER PHARMA PVT. ... Asence Pharma from India. NEWEDGE Overseas Excella GmbH Fareva SIMS Srl Moehs Iberica S.L. Cambrex Corporation

`How to buy Bupivacaine on Pipelinepharma?

Pipeline Pharma brings you manufacturers and suppliers from all around the world. Since Bupivacaine is a drug manufactured universally in countries such as European Union, Indonesia, Colombia, United States, Ukraine, you can connect with companies present in any of these countries. Our online portal not only helps you save time but also helps you to select the product which you can afford instead of paying hefty amounts of money. Rest assured we protect you from fraud, and ensure your transactions are made safely and securely. You can browse at your discretion with the use of filters that separate the pharmaceutical goods based on price. We make sure that all manufacturers and wholesalers present on our website are verified. So sit back, relax and let us connect you with Bupivacaine injections globally! Pipelinepharma B2B marketplace also benefits sellers, if you are one and are looking for a reliable marketplace to sell your medications, you've come to the right place! We provide the luxury of registering your goods with us free of cost.

`Bupivacaine Side effects

Despite its documented advantages, Bupivacaine may cause certain unwanted side effects. The common ones are numbness or prickling called pins and needles, loss of taste, chest pain, ringing in the ear, diarrhea, dysuria, fever, headache, light-headedness, change in appetite, mood swings, seizures, drowsiness, nausea, vomiting and shortness of breath. The less commonly encountered side effects are blurred vision, body ache, dry cough, congested ear, pounding heartbeat, increased blinking, and loss of voice.

`Special Warning or precaution for use of Bupivacaine:

Children should be kept under strict observation when Bupivacaine is administered as it can cause altered blood content levels in them. A very important but dangerous condition to look out for after Bupivacaine has been injected is methemoglobinemia. It is a condition in which Haemoglobin fails to carry adequate amounts of oxygen that the body needs. Therefore, be sure to keep an eye out for symptoms such as blue discoloration of lips, nails, and skin, headache, disorientation, and increased heart rate. Caution is advised when administering this injection in people with joint problems and hypotension. Use of Bupivacaine may cause sedation. Therefore, it is advised to avoid driving until you know how the medication affects you. Inform your doctor of any medication you're taking before you are injected with Bupivacaine, especially medicines that affect the CNS as this can cause detrimental effects. Your doctor may taper or increase the doses of your drugs accordingly.

`Effect of Bupivacaine on Pregnancy and Breastfeeding:

Bupivacaine should be used in pregnancy only if the benefits outweigh the risks. Studies done on animals show potential risks to the fetus. Studies on humans have not yet commenced. Due to the lack of information regarding Bupivacaine secretion in breast milk, it is better to avoid Bupivacaine in lactating women.

`FAQ About Bupivacaine:

1.How long do the effects of bupivacaine last? The effects of Bupivacaine last 2 hours without epinephrine and 3 hours with epinephrine.' 2.Is Bupivacaine the same as lidocaine? Bupivacaine and Lidocaine are both Local anesthetics. Bupivacaine has a longer duration of action and is used primarily for the spinal block. 3.What is the antidote for Bupivacaine? Glucose, insulin, and potassium in combined doses can be used to reverse the cardiovascular complications caused by Bupivacaine. 4.What class of drug is Bupivacaine? Bupivacaine belongs to the class of drugs called local anesthetics. 5.Where do you inject Bupivacaine? Bupivacaine is injected via a needle into or near the area that is to be made numb.

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