post-title portfolio-title Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%) 2023-01-28 06:46:20 no no

Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Ropivacaine HCl Injection USP 20mg/10ml (2mg/ml) (0.2%)
(B) Ropivacaine HCl Injection USP 40mg/20ml(2mg/ml) (0.2%)
(C) Ropivacaine HCl Injection USP 150mg/30ml (5mg/ml) (0.5%)
(D) Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)
(E) Ropivacaine HCl Injection USP 200mg/100ml(2mg/ml) (0.2%)
(F) Ropivacaine HCl Injection USP 100mg/10ml (10mg/ml) (1%)
(G) Ropivacaine HCl Injection USP 100mg/20ml (5mg/ml) (0.5%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

(A) Ropivacaine HCl Injection USP 20mg/10ml (2mg/ml) (0.2%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………2mg
Sodium Chloride USP……………………………………..8.6 mg
Water for Injections USP………………………………….q.s.

(B) Ropivacaine HCl Injection USP 40mg/20ml(2mg/ml) (0.2%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………2mg
Sodium Chloride USP……………………………………..8.6 mg
Water for Injections USP………………………………….q.s.

(C) Ropivacaine HCl Injection USP 150mg/30ml (5mg/ml) (0.5%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………5mg
Sodium Chloride USP……………………………………..8mg
Water for Injections USP………………………………….q.s.

(D) Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………7.5mg
Sodium Chloride USP……………………………………..7.5 mg
Water for Injections USP………………………………….q.s.

(E) Ropivacaine HCl Injection USP 200mg/100ml(2mg/ml) (0.2%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………2mg
Sodium Chloride USP……………………………………..8mg
Water for Injections USP………………………………….q.s.

(F) Ropivacaine HCl Injection USP 100mg/10ml (10mg/ml) (1%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………10mg
Sodium Chloride USP……………………………………..7.1mg
Water for Injections USP………………………………….q.s.

(G) Ropivacaine HCl Injection USP 100mg/20ml (5mg/ml) (0.5%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………5mg
Sodium Chloride USP……………………………………..8mg
Water for Injections USP………………………………….q.s.

THERAPEUTIC INDICATION:

Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anaesthetic and does not cause loss of consciousness.

DIRECTION OF USE:

For Infiltration, Nerve block & Epidural Administration only
Refer enclosed leaflet for further information.

CAUTION & WARNING:

CAUTION:
• Do not use if any foreign particulate matter is visible.
• Not for IV use
• Do not use if the solution is discolored or contains precipitate.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
Sterile
Non pyrogenic
Preservative free
Dosage: As directed by Physician.

Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%) Technical Specification:

Product Name:Ropivacaine HCl Injection USP
Brand Name:(GENERICS)
Strength:20mg/10ml(2mg/ml) (0.2%),
40mg/20ml(2mg/ml) (0.2%),
150mg/30ml (5mg/ml) (0.5%),
150mg/20ml (7.5mg/ml) (0.75%),
200mg/100ml(2mg/ml) (0.2%),
100mg/10ml (10mg/ml) (1%),
100mg/20ml (5mg/ml) (0.5%)
Dosage Form:Liquid Injection (Sterile)
Packing:10ml, 20ml, 30ml, 100ml Vial
Route of Administration:For Infiltration, Nerve block & Epidural Administration only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Local Anaesthetics
Indication: Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anesthetic and does not cause loss of consciousness.
Storage:Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)
    Each ml contains:
    Ropivacaine Hydrochloride USP
    equivalent to Ropivacaine Hydrochloride……………7.5 mg
    Sodium Chloride USP……………………………………..7.5 mg
    Water for Injections USP………………………………….q.s.

THERAPEUTIC INDICATION:

Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anesthetic and does not cause loss of consciousness.

DIRECTION OF USE:

 For Infiltration, Nerve block & Epidural Administration only 

Refer enclosed leaflet for further information.

CAUTION & WARNING:

CAUTION:

  • Do not use it if any foreign particulate matter is visible.
  • Not for IV use
  • Do not use it if the solution is discolored or contains a precipitate. 
  • DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
  • KEEP OUT OF REACH AND SIGHT OF CHILDREN.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Sterile.
Non-pyrogenic.
Preservative free
Dosage: As directed by the Physician.

Why Taj Pharmaceuticals?

At Taj Pharmaceuticals, we take pride in offering Ropivacaine HCl Injection USP of the highest quality, backed by our unwavering commitment to pharmaceutical excellence and patient well-being. Our Ropivacaine HCl Injection USP is manufactured with precision and rigorously tested to ensure safety and efficacy. As a trusted pharmaceutical company, we prioritize the health and satisfaction of our customers. When you choose Taj Pharmaceuticals, you can trust that you are receiving a product that meets the highest industry standards. Our team of experts works tirelessly to maintain the quality and reliability of our pharmaceuticals. Whether you are a healthcare professional looking for a dependable source of Ropivacaine HCl Injection USP or a patient seeking safe and effective medication, Taj Pharmaceuticals is your partner in healthcare. We stand by our commitment to delivering excellence in every dose, ensuring the well-being and confidence of those who rely on our products. Choose Taj Pharmaceuticals for Ropivacaine HCl Injection USP, and experience pharmaceutical quality that you can trust.

What is Ropivacaine HCl Injection USP and its uses?

Ropivacaine HCl Injection USP is a medication that contains ropivacaine hydrochloride as its active ingredient. It is a local anesthetic, which means it is used to block nerve signals in a specific area of the body to provide pain relief or numbness during medical procedures or surgeries. Here are some common uses for Ropivacaine HCl Injection USP:

  • Surgical Anesthesia: Ropivacaine HCl Injection USP is often used by healthcare professionals to induce regional anesthesia. It can be administered as an epidural or peripheral nerve block to numb specific regions of the body while the patient remains awake during surgery. This is commonly used for procedures like cesarean sections and orthopedic surgeries.
  • Postoperative Pain Management: After surgery, Ropivacaine HCl Injection USP can be used in epidural or nerve block form to manage postoperative pain effectively. It provides long-lasting pain relief in the targeted area, reducing the need for systemic pain medications.
  • Pain Management for Labor: Epidural administration of ropivacaine can be used during labor to provide pain relief to women during childbirth. It allows mothers to remain alert and conscious while alleviating the pain associated with contractions.
  • Chronic Pain Management: In some cases, healthcare providers may use Ropivacaine HCl Injection USP for the management of chronic pain conditions, such as neuropathic pain or certain types of musculoskeletal pain. The localized administration can offer relief to patients suffering from persistent pain.
  • Diagnostic and Therapeutic Procedures: Ropivacaine HCl Injection USP can be used to provide local anesthesia during various diagnostic and therapeutic procedures, such as nerve blocks for pain management or the reduction of muscle spasticity.

It’s important to note that the use of Ropivacaine HCl Injection USP should be supervised by a qualified healthcare professional, as improper administration can lead to complications or side effects. The dosage and administration method will depend on the specific medical condition and the patient’s individual needs. Patients should discuss any concerns or questions about the use of this medication with their healthcare provider.

How Does Ropivacaine HCl Injection USP Work?

Ropivacaine HCl Injection USP works as a local anesthetic by blocking nerve signals in a specific area of the body, thereby providing pain relief or numbness in that localized region. The mechanism of action of ropivacaine is similar to other local anesthetics, and it involves the following key processes:

  • Blocking Nerve Signals: Nerves in the body transmit signals to the brain, including signals related to pain. Ropivacaine works by interfering with the transmission of these signals. It does so by blocking sodium channels on the nerve cell membranes. Sodium channels are essential for the propagation of nerve signals, and when ropivacaine blocks these channels, it prevents the nerve from sending pain signals to the brain.
  • Localized Effect: Ropivacaine is typically administered directly into the area where pain relief or numbness is needed. This allows it to have a localized effect, affecting only the nerves in the immediate vicinity of the injection site. The rest of the body’s nervous system remains unaffected.
  • Duration of Action: Ropivacaine is valued for its intermediate duration of action. It provides pain relief for an extended period but does not typically cause prolonged numbness. This makes it suitable for various surgical procedures, labor pain management, and postoperative pain relief.
  • Minimal Systemic Absorption: Ropivacaine is designed to have minimal systemic absorption, meaning it is less likely to enter the bloodstream in significant amounts. This reduces the risk of systemic side effects and toxicity associated with some other local anesthetics.
  • Metabolism and Elimination: After its localized action, ropivacaine is gradually metabolized and eliminated from the body. This ensures that its effects are temporary and wear off as the drug is processed by the body’s metabolic pathways.

It’s important to note that the administration of Ropivacaine HCl Injection USP should be done by trained healthcare professionals who can carefully control the dosage and monitor the patient for any adverse effects. While local anesthesia is generally safe, improper administration or excessive doses can lead to complications, including systemic toxicity or nerve damage. Patients should always follow their healthcare provider’s instructions and inform them of any allergies, medical conditions, or medications they are taking to ensure safe and effective use of ropivacaine.

Benefits of Ropivacaine HCl Injection USP:

  • Effective Pain Relief: Ropivacaine provides localized pain relief by blocking nerve signals. It is particularly useful for various surgical procedures, labor pain management, and postoperative pain relief.
  • Intermediate Duration: Ropivacaine offers an intermediate duration of action, which means it provides pain relief for a significant but limited period, allowing patients to recover comfortably without prolonged numbness.
  • Low Systemic Absorption: Ropivacaine is designed to have minimal systemic absorption, reducing the risk of systemic side effects. This makes it a safer choice compared to some other local anesthetics.
  • Reduced Risk of Cardiotoxicity: Ropivacaine is considered less cardiotoxic than certain other local anesthetics, making it a preferred choice in cases where minimizing cardiac side effects is important.

Side Effects of Ropivacaine HCl Injection USP:

  • Local Reactions: Common side effects at the injection site may include redness, swelling, pain, or itching. These are typically mild and temporary.
  • Nerve Damage: While rare, there is a risk of nerve damage or injury associated with the administration of local anesthetics, including ropivacaine. This risk is higher if the injection is not done properly or if there is an allergic reaction.
  • Systemic Toxicity: Although ropivacaine is designed to have low systemic absorption, if it does enter the bloodstream in significant amounts, it can cause systemic toxicity. Symptoms may include dizziness, confusion, seizures, irregular heart rhythm, and, in severe cases, cardiac arrest. Proper dosage and administration are critical to minimize this risk.
  • Allergic Reactions: Allergic reactions to ropivacaine are rare but can occur. Symptoms of an allergic reaction may include hives, itching, swelling, difficulty breathing, and anaphylaxis, which is a severe and potentially life-threatening reaction.
  • Central Nervous System (CNS) Effects: High doses or systemic absorption of ropivacaine can lead to CNS effects, such as dizziness, tremors, and in severe cases, seizures.
  • Cardiac Effects: While ropivacaine is considered less cardiotoxic than some other local anesthetics, it can still affect the heart, potentially causing arrhythmias (irregular heart rhythms) or cardiac depression.
  • Respiratory Effects: In rare cases, ropivacaine can affect respiratory function, leading to difficulty breathing or respiratory depression.

It’s important to emphasize that Ropivacaine HCl Injection USP should be administered by trained healthcare professionals who are experienced in local anesthesia techniques. Patients should communicate any allergies, medical conditions, or medications they are taking with their healthcare provider before receiving ropivacaine to minimize the risk of adverse effects. The benefits of pain relief and comfort during medical procedures should be weighed against the potential risks when considering the use of ropivacaine.

Frequently Asked Questions About Ropivacaine HCl Injection USP:

Certainly, here are some frequently asked questions (FAQs) about Ropivacaine HCl Injection USP:

  1. What is Ropivacaine HCl Injection USP used for?

Ropivacaine HCl Injection USP is a local anesthetic used to provide pain relief or numbness in specific areas of the body during medical procedures, surgeries, labor, or for postoperative pain management.

  1. How does Ropivacaine HCl Injection USP work?

Ropivacaine works by blocking nerve signals in the targeted area, preventing pain signals from reaching the brain. It does so by interfering with sodium channels on nerve cell membranes.

  1. Is Ropivacaine HCl Injection USP safe?

When administered by trained healthcare professionals following proper guidelines, Ropivacaine is generally considered safe. However, like all medications, it carries some potential risks and side effects.

  1. What are the common side effects of Ropivacaine HCl Injection USP?

Common side effects may include local reactions at the injection site, such as redness, swelling, pain, or itching. More serious side effects are rare but can include nerve damage, systemic toxicity, allergic reactions, and CNS or cardiac effects.

  1. How is Ropivacaine HCl Injection USP administered?

Ropivacaine is typically administered as an injection directly into the area where pain relief is needed. The dosage and method of administration depend on the specific medical procedure or condition.

  1. Is Ropivacaine HCl Injection USP suitable for all patients?

Not all patients are candidates for Ropivacaine. Healthcare providers consider factors such as allergies, medical history, and current medications when determining their suitability for a patient.

  1. How long does the pain relief from Ropivacaine last?

The duration of pain relief provided by Ropivacaine is intermediate, typically lasting several hours. It varies depending on the concentration and dosage used.

  1. Can Ropivacaine HCl Injection USP be used during labor for pain management?

Yes, Ropivacaine can be used as an epidural during labor to provide pain relief while allowing the mother to remain alert and conscious during childbirth.

  1. Are there any interactions with other medications?

It’s important to inform your healthcare provider about all medications you are taking, as certain drugs may interact with Ropivacaine. Your provider will assess potential interactions and adjust the treatment plan accordingly.

  1. What precautions should I take when receiving Ropivacaine HCl Injection USP?

Follow your healthcare provider’s instructions closely. Inform them of any allergies or medical conditions you have. Be aware of the potential side effects and seek immediate medical attention if you experience any severe or unusual symptoms.

As Ropivacaine HCl Injection USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Ropivacaine HCl Injection USP product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Ropivacaine HCl Injection USP Regulatory Documents:

  • Certificate of Analysis (COA)
  • Method of Analysis (MOA)
  • Stability Data (Accelerated stability / Long-term stability / Zone 4b)
  • CTD Dossier / ACTD Dossiers / eCTD Dossiers
  • Certificate of Pharmaceuticals Product (COPP)
  • Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Ropivacaine HCl Injection USP, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

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