post-title portfolio-title Cisplatin Injection BP 1mg/ml (10mg/10ml) 2023-01-30 16:00:33 no no

Cisplatin Injection BP 1mg/ml (10mg/10ml)

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Cisplatin Injection BP 1mg/ml (10mg/10ml, 50mg/50ml, 100mg/100ml, 200mg/200ml)
b) Cisplatin Injection BP 0.5mg/ml (10mg/20ml, 50mg/100ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Cisplatin Injection BP 1mg/ml (10mg/10ml, 50mg/50ml, 100mg/100ml, 200mg/200ml)
Each ml contains:
Cisplatin BP……………………………..1 mg
Sodium Chloride………………………9mg
Sodium Hydroxide……………………q.s.
Hydrochloric Acid…………………….q.s.
Water for Injection…………………..q.s.


b) Cisplatin Injection BP 0.5mg/ml (10mg/20ml, 50mg/100ml)
Each ml contains:
Cisplatin BP……………………………0.5mg
Sodium Chloride………………………9mg
Sodium Hydroxide……………………q.s.
Hydrochloric Acid…………………….q.s.
Water for Injection…………………..q.s.

THERAPEUTIC INDICATION:

Cisplatin is a chemotherapy medication used to treat a number of cancers. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma.

PACKING:

1mg/ml
1) 10mg/10ml
2) 50mg/50ml
3) 100mg/100ml
4) 200mg/200ml

0.5mg/ml
1) 10mg/20ml
2) 50mg/100ml

DIRECTION OF USE:

For Intravenous Infusion only.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
NOTE: Cisplatin Injection should not be administered with needles or intravenous sets containing aluminum components.
Does not move the needle, aspirate and wash extravazatul tissue with saline solution 0.9% (If the solution concentration of CISPLATIN is higher than recommended).
Cisplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See package insert.
Nonpyrogenic, Preservative free, the container closure is not made with natural rubber latex.
DO NOT USE AFTER THE EXPIRY DATE STATED ON THE LABEL AFTER DILUTION.
Use the solution within 8 hours of opening.
Handle injection with great care, since it is a potent cytotoxic agent.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F). Do not refrigerate. Protect from light.
Dosage: As directed by the Oncologist.
Adults and children:
CISPLATIN dose depends on the underlying disease, the response followed by the use of chemotherapy alone or in combination, Instructions for use are applicable to both adults and children.
Recommended doses alone:
Single dose 50-120 mg/m2 body surface area every three to four weeks.
15 to 20 mg/m2/day for five days, three to four weeks

Cisplatin Injection BP 1mg/ml (10mg/10ml) Technical Specification:

Product Name:Cisplatin Injection BP 1mg/ml (10mg/10ml)
Brand Name:Cisplatin
Strength:1mg/ml (10mg/10ml, 50mg/50ml, 100mg/100ml, 200mg/200ml), 0.5mg/ml (10mg/20ml, 50mg/100ml)
Dosage Form:Liquid Injection
Packing:SINGLE-USE VIAL
Route of Administration:For Intravenous 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:Anti-Cancer
Indication: Cisplatin is a chemotherapy medication used to treat a number of cancers. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma.
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15°C to 30°C (59° to 86° F). Do not refrigerate. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Cisplatin Injection BP 1mg/ml (10mg/10ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cisplatin Injection BP 1mg/ml (10mg/10ml)
    Each ml contains:
    Cisplatin BP……………………………..1 mg
    Sodium Chloride………………………9mg
    Sodium Hydroxide……………………q.s.
    Hydrochloric Acid…………………….q.s.
    Water for Injection…………………..q.s.

THERAPEUTIC INDICATION:

Cisplatin is a chemotherapy medication used to treat a number of cancers. These include testicular cancer, ovarian cancer, cervical cancer, breast cancer, bladder cancer, head and neck cancer, esophageal cancer, lung cancer, mesothelioma, brain tumors and neuroblastoma.

PACKING:

1mg/ml

  • 10mg/10ml
  • 50mg/50ml
  • 100mg/100ml
  • 200mg/200ml

0.5mg/ml

  • 10mg/20ml
  • 50mg/100ml

DIRECTION OF USE:

For Intravenous Infusion only.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter.
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
NOTE: Cisplatin Injection should not be administered with needles or intravenous sets containing aluminum components.
Do not move the needle, aspirate and wash extravasate tissue with saline solution 0.9%
(If the solution concentration of CISPLATIN is higher than recommended).
Cisplatin doses greater than 100 mg/m2 once every 3 to 4 weeks are rarely used. See package insert.
Nonpyrogenic and preservative free, the container closure is not made with natural rubber latex.
DO NOT USE AFTER THE EXPIRY DATE STATED ON THE LABEL AFTER DILUTION.
Use the solution within 8 hours of opening.
Handle injection with great care, since it is a potent cytotoxic agent.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard the Unused portion.
Keep out of reach of children

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68 °F to 77 °F); excursions permitted to 15°C to 30°C (59 °F to 86 °F). Do not refrigerate. Protect from light.
Dosage: As directed by the Oncologist.
Adults and children:
CISPLATIN dose depends on the underlying disease, and the response followed by the use of chemotherapy alone or in combination, Instructions for use are applicable to both adults and children.
Recommended doses alone:
Single dose 50-120 mg/m2 body surface area every three to four weeks.
15 to 20 mg/m2/day for five days, three to four weeks

Why Taj Pharmaceuticals?

The choice of Taj Pharmaceuticals for Cisplatin Injection BP, a vital medication used in cancer treatment, is driven by several critical factors essential in the healthcare industry. First and foremost is the company’s unwavering commitment to maintaining stringent quality control standards and adhering to good manufacturing practices (GMP). This commitment ensures that the medications produced meet exceptionally high-quality standards, guaranteeing their safety and effectiveness for patients battling cancer. Another pivotal factor is product availability. The consistent supply of Cisplatin Injection BP, a medication crucial in cancer care, is of paramount importance to healthcare facilities and patients. Choosing a trusted pharmaceutical manufacturer like Taj Pharmaceuticals can help ensure a reliable and uninterrupted supply of this life-saving medication.

The reputation of a pharmaceutical company carries immense weight in the selection process. Companies with a long-standing history of producing high-quality, reliable medications often become the preferred choice of healthcare professionals and institutions. A strong reputation for quality and safety is particularly crucial when selecting a manufacturer for critical medications like Cisplatin. Regulatory compliance is a fundamental requirement for pharmaceutical manufacturers. Companies like Taj Pharmaceuticals are expected to meet the rigorous regulatory standards set by health authorities in various countries. This involves obtaining necessary approvals, licenses, and registrations to ensure that the medication is manufactured and distributed legally and safely.

Research and development efforts also play a role in the decision-making process. Some pharmaceutical companies invest in research and development to enhance existing medications or create new formulations. Such endeavors can lead to advancements in medication effectiveness or safety, which can be advantageous for patients battling cancer. Proper packaging and accurate labeling are essential attributes of medications. Reputable pharmaceutical manufacturers prioritize clear, informative packaging, and labeling to ensure that healthcare providers and patients can use the medication safely and effectively. Support services provided by pharmaceutical companies are another valuable asset. This support includes offering information on proper medication administration, dosing guidelines, and potential side effects. Such services are instrumental in ensuring the safe and effective use of medications.

Consistency in dosage and formulation is paramount. Patients and healthcare providers rely on consistent dosages and formulations to ensure that patients receive the correct treatment, which reputable pharmaceutical manufacturers strive to maintain. Reliability in the supply chain is a crucial consideration for healthcare facilities. Knowing that a pharmaceutical company like Taj Pharmaceuticals can consistently deliver Cisplatin Injection BP on time allows healthcare providers to plan and manage patient care effectively. While maintaining quality and safety remains paramount, cost efficiency is also a consideration. Reputable manufacturers often strike a balance between quality and cost-effectiveness, acknowledging that cost considerations are essential for healthcare providers and institutions. The ultimate goal is to prioritize patient safety and ensure the highest standards of medication quality and efficacy in the battle against cancer.

What is Cisplatin Injection BP and its uses?

Cisplatin Injection BP is a medication used in cancer treatment. It contains the active ingredient cisplatin, which is a platinum-based chemotherapy drug. Cisplatin is administered intravenously and is used to treat various types of cancer. Here’s an overview of Cisplatin Injection BP and its uses:
Active Ingredient: Cisplatin

Uses:

  • Cancer Treatment: Cisplatin Injection BP is primarily used in the treatment of various types of cancer. It is employed as part of chemotherapy regimens to inhibit the growth and spread of cancer cells. Common cancer types that may be treated with cisplatin include:
    Testicular Cancer: Cisplatin is a key component of chemotherapy regimens used to treat testicular cancer.
    Ovarian Cancer: It may be used as part of the treatment for ovarian cancer, either alone or in combination with other chemotherapy drugs.
    Bladder Cancer: Cisplatin is commonly used in the treatment of bladder cancer, often in combination with other medications.\\
    Lung Cancer: It can be used for nonsmall cell lung cancer, either alone or in combination with other chemotherapy drugs or radiation therapy.
    Head and Neck Cancer: Cisplatin may be part of the treatment for head and neck cancers.
    Cervical Cancer: In some cases, cisplatin is used in the treatment of cervical cancer, often in combination with radiation therapy.
    Esophageal Cancer: It may be included in chemotherapy regimens for esophageal cancer.
  • Preoperative Treatment: In some cases, cisplatin may be used before surgery to shrink tumors and make them more operable. This is known as neoadjuvant therapy.
  • Adjuvant Treatment: After surgery to remove a cancerous tumor, cisplatin may be used as adjuvant therapy to reduce the risk of cancer recurrence.

Cisplatin works by binding to DNA in cancer cells, leading to DNA damage and interfering with the cell’s ability to divide and replicate. This ultimately results in the death of cancer cells or inhibits their growth. The specific use of Cisplatin Injection BP depends on factors such as the type and stage of cancer, the overall health of the patient, and the treatment plan developed by the healthcare provider. Cisplatin is administered under the supervision of a healthcare professional experienced in chemotherapy, and the dosing and treatment schedule are carefully tailored to each patient’s individual needs. It’s important to note that cisplatin is a potent medication with potential side effects, and its use should be closely monitored by a healthcare provider.

How Does Cisplatin Injection BP Work?

Cisplatin Injection BP works as a chemotherapy medication by interfering with the DNA (genetic material) within cancer cells. It is a platinum-based compound and exerts its anticancer effects through a process called DNA cross-linking. Here’s how Cisplatin Injection BP works:

  • Cellular Uptake: Cisplatin is administered intravenously as an injection. Once it enters the bloodstream, it is taken up by both cancer cells and normal cells throughout the body.
  • Activation: Inside the cells, cisplatin undergoes a chemical conversion that activates it. The conversion is facilitated by the presence of chloride ions (Cl-) in the cell’s cytoplasm.
  • DNA Binding: The activated form of cisplatin primarily binds to the DNA within the cell’s nucleus. It forms strong chemical bonds with the purine bases (adenine and guanine) of the DNA molecule.
  • DNA Cross-Linking: Cisplatin creates chemical cross-links (covalent bonds) between adjacent DNA strands. These cross-links are like “bridges” that connect the two DNA strands, preventing them from separating properly during DNA replication and transcription processes.
  • Disruption of DNA Function: The cross-linking of DNA strands by cisplatin disrupts the normal structure of DNA and hinders its ability to serve as a template for essential cellular processes like DNA replication and RNA transcription.
  • Cell Cycle Arrest: As a result of these DNA cross-links, cancer cells are unable to replicate their DNA and progress through the cell cycle. This leads to a halt in the cell cycle, preventing cell division and proliferation.
  • Cell Death: Cells that are unable to complete the cell cycle and divide ultimately undergo programmed cell death, known as apoptosis. This process eliminates cancer cells or renders them nonviable.

Cisplatin’s action is not selective for cancer cells alone; it can also affect normal, healthy cells to some extent. However, cancer cells are often more vulnerable to DNA damage because they tend to divide rapidly and may have impaired DNA repair mechanisms compared to normal cells. This selective vulnerability to cisplatin makes it an effective chemotherapy agent against cancer. The effectiveness of Cisplatin Injection BP in treating cancer depends on various factors, including the type and stage of cancer, the overall health of the patient, and the specific treatment regimen used. It is typically administered as part of a chemotherapy regimen, often in combination with other anticancer medications, surgery, or radiation therapy, depending on the individual patient’s condition and the goals of treatment. It’s important to note that Cisplatin Injection BP is a potent medication with potential side effects, and its use should be closely monitored by an oncologist or healthcare provider experienced in cancer treatment. The dosing and treatment plan is tailored to each patient’s specific needs to maximize the benefits of treatment while minimizing potential risks.

Cisplatin Injection BP is a chemotherapy medication that offers potential benefits in the treatment of cancer. However, like many chemotherapy drugs, it can also be associated with side effects. Here are the benefits and potential side effects of Cisplatin Injection BP:

Benefits of Cisplatin Injection BP:

  • Cancer Treatment: The primary benefit of Cisplatin Injection BP is its effectiveness in treating various types of cancer. It is often used as part of chemotherapy regimens to inhibit the growth and spread of cancer cells.
  • Tumor Reduction: Cisplatin can shrink tumors, providing relief from cancer-related symptoms such as pain, pressure on surrounding organs, or blockage of vital structures.
  • Adjuvant Therapy: Cisplatin may be used as adjuvant therapy after surgery to reduce the risk of cancer recurrence by targeting any remaining cancer cells.
  • Combination Therapy: It is frequently used in combination with other chemotherapy drugs, radiation therapy, or surgery to improve treatment outcomes. The combination approach is tailored to the specific cancer type and stage.

Side Effects of Cisplatin Injection BP:

  • Nausea and Vomiting: Nausea and vomiting are common side effects of Cisplatin Injection BP. Medications known as antiemetics are often prescribed to help manage these symptoms.
  • Kidney Damage: Cisplatin can be toxic to the kidneys. Regular monitoring of kidney function and hydration status is essential during treatment.
  • Hearing Loss: Cisplatin can cause hearing loss, which may be temporary or permanent. Patients may undergo hearing tests before and during treatment.
  • Nerve Damage (Neuropathy): Some patients may experience peripheral neuropathy, characterized by tingling, numbness, or weakness in the hands and feet.
  • Bone Marrow Suppression: Cisplatin can affect the bone marrow’s ability to produce blood cells, leading to anemia (low red blood cell count), neutropenia (low white blood cell count), and thrombocytopenia (low platelet count). This can increase the risk of infection, fatigue, and bleeding.
  • Gastrointestinal Issues: Diarrhea and constipation are possible gastrointestinal side effects. Other digestive symptoms may include loss of appetite, abdominal pain, or metallic taste.
  • Electrolyte Imbalance: Cisplatin can lead to electrolyte imbalances, particularly low levels of magnesium and potassium in the blood.
  • Allergic Reactions: In rare cases, Cisplatin Injection BP can cause allergic reactions, which may include rash, itching, swelling, and difficulty breathing. Immediate medical attention is needed if such reactions occur.
  • Infertility: Cisplatin may impair fertility in both men and women. Patients of childbearing age should discuss fertility preservation options with their healthcare provider.
  • Fatigue: Chemotherapy often leads to fatigue and general weakness. Patients may need to adjust their activities and get extra rest during treatment.
  • Increased Risk of Infection: Due to bone marrow suppression, patients may have a weakened immune system, making them more susceptible to infections.

It’s important to note that the specific side effects and their severity can vary from person to person. The healthcare team will closely monitor patients during treatment and provide supportive care to manage side effects effectively. The decision to use Cisplatin Injection BP is based on the potential benefits of cancer treatment weighed against the risks of side effects, and it should be made in consultation with a healthcare provider experienced in oncology.

Frequently Asked Questions About Cisplatin Injection BP:

Here are some frequently asked questions about Cisplatin Injection BP:

  1. What is Cisplatin Injection BP used for?

Cisplatin Injection BP is primarily used in the treatment of various types of cancer. It is administered as part of chemotherapy regimens to inhibit the growth and spread of cancer cells.

  1. How does Cisplatin Injection BP work in cancer treatment?

Cisplatin works by interfering with the DNA of cancer cells, preventing their replication and growth. It forms chemical crosslinks within the DNA strands, disrupting normal cell division.

  1. What types of cancer are typically treated with Cisplatin Injection BP?

Cisplatin is commonly used in the treatment of testicular cancer, ovarian cancer, bladder cancer, lung cancer, head and neck cancer, cervical cancer, and other malignancies. Its use depends on the specific cancer type and stage.

  1. Is Cisplatin Injection BP a curative treatment for cancer?

Cisplatin is often used as part of a comprehensive cancer treatment plan, but it may not be curative on its own. Its effectiveness depends on factors such as the type and stage of cancer and the overall health of the patient.

  1. What are the common side effects of Cisplatin Injection BP?

Common side effects may include nausea, vomiting, kidney damage, hearing loss, neuropathy, bone marrow suppression (leading to anemia, neutropenia, and thrombocytopenia), gastrointestinal issues, electrolyte imbalances, and fatigue.

  1. How is Cisplatin Injection BP administered?

Cisplatin is administered as an intravenous (IV) infusion in a clinical setting. The dosage and treatment schedule are determined by the healthcare provider based on the patient’s condition.

  1. Can Cisplatin Injection BP be used in combination with other cancer treatments?

Yes, Cisplatin is often used in combination with surgery, radiation therapy, or other chemotherapy drugs to enhance treatment outcomes. The specific combination depends on the type and stage of cancer.

  1. Is Cisplatin Injection BP safe during pregnancy or breastfeeding?

Cisplatin can be harmful to a developing fetus and is generally not recommended during pregnancy. It may also be excreted in breast milk, so breastfeeding is generally not advised during treatment.

  1. Are there any special precautions or monitoring required during Cisplatin treatment?

Regular monitoring of kidney function, hearing, and blood cell counts is essential during Cisplatin treatment. Patients should communicate any unusual symptoms or side effects to their healthcare team.

  1. What should I do if I miss a dose of Cisplatin Injection BP?

Cisplatin doses are typically administered in a healthcare setting by trained professionals. Missing a dose is unlikely, but patients should consult with their healthcare provider for guidance on their specific situation.

Patients should always discuss their questions and concerns about Cisplatin Injection BP with their healthcare provider, as treatment plans and recommendations may vary based on individual circumstances.

As Cisplatin Injection BP Exporters; We can cater to export business queries from the following geographies. We are exporting our Cisplatin Injection BP product to 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

Cisplatin Injection BP 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 Cisplatin Injection BP, 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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