GENERIC NAME OF MEDICINAL PRODUCT:

A. Valproate Sodium Injection USP 500mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Valproate Sodium Injection USP 500mg/5ml
Each ml contains:
Valproate Sodium Eq. to
Valproic Acid…………………100mg
Disodium Edetate BP…………0.4mg
Water for Injections USP………….q.s.

THERAPEUTIC INDICATION:

Valproate sodium injection is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.

DIRECTION OF USE:

As directed by Neurologist.
For dosage and administration please see enclosed leaflet.

CAUTION & WARNING:

CAUTION:
Do not use the injection if the contents are not clear, contains visible particulate or any discoloration is observed.
Do not accept if ampoule is broken.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.
Warning:
Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.

STORAGE & DOSAGE:

Storage:
Store at Temperature not exceeding 30ºC
Protect from light.
Do not freeze.
Dosage:
As directed by Neurologist.
Please refer product insert for more information.

Valproate Sodium Injection USP 500mg/5ml Manufacturers, and Suppliers in India:

Taj Pharmaceuticals has established itself as a distinguished leader in the pharmaceutical industry, particularly in the realm of Valproate Sodium Injection USP 500mg/5ml. With a strong commitment to providing the best quality products, Taj Pharma has gained prominence as one of the foremost manufacturers in India. Backed by a wealth of experience, Taj Pharmaceuticals excels in the niche manufacturing of Valproate Sodium Injection USP 500mg/5ml. This experience translates into a deep understanding of the complexities involved in producing pharmaceuticals of the highest standards.

Taj Pharma’s reputation as a reputable manufacturer and supplier of Valproate Sodium Injection USP 500mg/5ml in India is well-deserved. The company’s focus on maintaining topmost standards and unwavering product quality has made it a preferred choice among healthcare professionals and consumers alike. As a renowned Valproate Sodium Injection USP 500mg/5ml Manufacturer in India, Taj Pharma places a strong emphasis on ensuring high quality and rigorous standards. The adherence to stringent quality control protocols guarantees that every batch of Valproate Sodium Injection meets the desired level of excellence. The manufacturing process of Valproate Sodium Injection USP 500mg/5ml at Taj Pharma follows the ISH guidelines, demonstrating a commitment to upholding the esteemed BP quality standards. These standards are recognized worldwide as a hallmark of product excellence.

Taj Pharma takes pride in using only the finest grade active ingredients for its Valproate Sodium Injection USP 500mg/5ml. This dedication to quality extends to sourcing and utilizing the best components, ensuring that the end product complies with international standards on par with leading European pharmaceuticals. Taj Pharmaceuticals shines as a prominent player in the pharmaceutical landscape, particularly for its Valproate Sodium Injection USP 500mg/5ml. With a rich history, a reputation for quality, and a commitment to stringent standards, Taj Pharma continues to elevate healthcare standards through its exceptional pharmaceutical products.

Valproate Sodium Injection USP 500mg/5ml Technical Specification:

Product Name:Valproate Sodium Injection USP
Brand Name:WALLBRURATE
Strength:500mg/5ml (100mg/1ml)
Dosage Form:Liquid Dosage form Injection
Packing:Single dose Vial
Route of Administration:For I.V. Infusion 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:Anticonvulsants, Anti-Epileptic
Indication: Valproate sodium injection is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.
Storage:Store at a temperature not exceeding 30ºC. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Valproate Sodium Injection USP 500mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Valproate Sodium USP Injection 500mg/5ml
    Each ml contains:
    Valproate Sodium Eq. to
    Valproic Acid…………………100mg
    Disodium Edetate BP…………0.4mg
    Water for Injections USP………….q.s.

THERAPEUTIC INDICATION:

Valproate sodium injection is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures.

DIRECTION OF USE:

As directed by Neurologist.
For dosage and administration please see the enclosed leaflet.

CAUTION & Warning:

CAUTION:
Do not use the injection if the contents are not clear, contain visible particulate, or if any discoloration is observed.
Do not accept if the ampoule is broken.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.

WARNING:
Not to be sold by retail without the prescription of a Registered Medical Practitioner/ Cancer Hospital only.
It is dangerous to take this preparation except under Medical Supervision.

STORAGE & DOSAGE:

Storage:
Store at a temperature not exceeding 30ºC
Protect from light.
Do not freeze.

Dosage:
As directed by Neurologist.
Please refer product insert for more information.

Why Taj Pharmaceuticals?

Taj Pharmaceuticals Limited is the preferred choice for Valproate Sodium Injection, offering a range of compelling reasons to trust their expertise and commitment. With an established presence in the pharmaceutical industry, Taj Pharmaceuticals Limited brings years of experience to the production of Valproate Sodium Injection, ensuring a product that meets the highest standards of quality, safety, and effectiveness.

Their emphasis on quality assurance sets Taj Pharmaceuticals Limited apart. Through advanced facilities and rigorous quality control measures, they maintain the potency and purity of Valproate Sodium Injection at every stage of production. This dedication underscores their commitment to patient well-being, especially considering that Valproate Sodium Injection is commonly used to manage conditions such as epilepsy and bipolar disorder.

Taj Pharmaceuticals Limited’s adherence to international regulatory standards further solidifies its reputation. Their operations not only meet industry requirements but also align with global guidelines, ensuring that Valproate Sodium Injection is produced in compliance with stringent safety and efficacy standards. Innovation and research remain key pillars of Taj Pharmaceuticals Limited’s approach. They continuously integrate the latest research findings and technological advancements into their products, demonstrating a commitment to providing patients with cutting-edge treatment options.

Benefits of Valproate Sodium Injection:

  • Epilepsy Management: Valproate Sodium Injection is commonly used to manage epilepsy, a neurological disorder characterized by recurrent seizures. It helps control seizures by stabilizing abnormal electrical activity in the brain.
  • Bipolar Disorder Treatment: This injection is also used as a mood stabilizer for individuals with bipolar disorder. It helps regulate mood swings, reducing the intensity of manic and depressive episodes.
  • Migraine Prophylaxis: Valproate Sodium Injection is prescribed for the prevention of migraines. It can reduce the frequency and severity of migraine attacks.
  • Seizure Prevention in High-Risk Cases: In cases where individuals are at high risk of seizures following neurosurgery, Valproate Sodium Injection may be used to prevent post-operative seizures.

Side Effects of Valproate Sodium Injection:

  • Gastrointestinal Effects: Common side effects include nausea, vomiting, and abdominal discomfort. These effects are often temporary and can be managed by taking the injection with food.
  • Weight Gain: Valproate Sodium Injection is associated with weight gain, which can be a concern for some individuals.
  • Tremors and Shaking: Some people may experience tremors or shaking of their hands, especially at higher doses.
  • Hair Loss: Hair loss or thinning may occur, although this side effect is usually reversible upon discontinuation.
  • Liver Function Changes: Valproate Sodium can affect liver function, leading to elevated liver enzymes. Regular monitoring is important.
  • Pancreatitis: In rare cases, this injection can cause inflammation of the pancreas, leading to symptoms like severe abdominal pain.
  • Birth Defects: Pregnant women taking Valproate Sodium Injections are at a higher risk of having babies with birth defects. It’s crucial to discuss pregnancy plans with a healthcare provider.
  • Cognitive Effects: Some individuals may experience cognitive side effects, such as memory problems or difficulty concentrating.
  • Low Platelet Count: Rarely, Valproate Sodium Injection can cause a decrease in platelet count, which may lead to an increased risk of bleeding.

Frequently Asked Questions about Valproate Sodium Injection?

Certainly, here are some frequently asked questions (FAQs) about Valproate Sodium Injection:

What is Valproate Sodium Injection used for?

Valproate Sodium Injection is primarily used for the management of epilepsy, a neurological disorder characterized by recurrent seizures. It’s also prescribed for bipolar disorder to stabilize mood swings and for migraine prophylaxis to reduce the frequency and severity of migraine attacks.

How does Valproate Sodium Injection work?

Valproate Sodium Injection works by increasing the levels of certain neurotransmitters in the brain and stabilizing abnormal electrical activity, which helps control seizures in epilepsy and regulate mood in bipolar disorder.

How is Valproate Sodium Injection administered?

Valproate Sodium Injection is usually administered intravenously by a healthcare professional in a hospital setting. The dosage and frequency of administration depend on the individual’s medical condition and response to the medication.

What are the common side effects of Valproate Sodium Injection?

Common side effects may include nausea, vomiting, weight gain, tremors, and hair loss. These side effects are often manageable and tend to subside over time.

Can Valproate Sodium Injection interact with other medications?

Yes, Valproate Sodium Injection can interact with certain medications, including other antiepileptic drugs and medications that affect liver function. It’s important to inform your healthcare provider about all the medications you are taking.

Are there any serious side effects I should be aware of?

Yes, serious side effects can include liver function changes, pancreatitis, birth defects (if taken during pregnancy), and low platelet count. These effects are rare but require prompt medical attention if experienced.

Is Valproate Sodium Injection safe during pregnancy?

Valproate Sodium Injection is associated with an increased risk of birth defects if taken during pregnancy. Pregnant women or those planning to become pregnant should discuss the risks and benefits with their healthcare provider.

How long does it take for Valproate Sodium Injection to start working?

The onset of action can vary. It may take some time to achieve therapeutic levels in the blood, and the effectiveness in controlling seizures or stabilizing mood may become noticeable over a period of weeks.

Can I suddenly stop taking Valproate Sodium Injections?

Abruptly discontinuing Valproate Sodium Injection can lead to an increase in seizures or mood disturbances. It’s important to follow your healthcare provider’s guidance on tapering off the medication if needed.

Should I be monitored while taking Valproate Sodium Injection?

Yes, regular monitoring of liver function, blood cell counts, and overall health is usually recommended while taking Valproate Sodium Injection. This ensures that any potential side effects or changes can be detected early and managed appropriately.

As Valproate Sodium Injection USP 500mg/5ml Exporters; We can cater to export business queries from the following geographies. We are exporting our Valproate Sodium Injection USP 500mg/5ml product in 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

Valproate Sodium Injection USP 500mg/5ml 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 Valproate Sodium Injection USP 500mg/5ml, 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