GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml contains:
Carboplatin BP…………………..10mg
Water for Injection BP…......q.s.
CONTAINS NO PRESERVATIVES.
THERAPEUTIC INDICATION:
PACKING:
1) 50mg/5ml
2) 150mg/15ml
3) 450mg/45ml
4) 600mg/60ml
DIRECTION OF USE:
See insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
Single agent therapy for use in the treatment of recurrent ovarian cancer: Carboplatin Injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m2 IV on day 1 every 4 weeks.
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: Carboplatin INJECTION should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available. Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug-related side effect.
NOTE: Carboplatin Injection that may come in contact with needles or Intravenous sets containing Aluminum parts should not be administered.
PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.
Sterile, non-pyrogenic, aqueous solution.
Handle the Injection with great care since it is a potent Cytotoxic Agent.
Retain in carton until time of use.
Use the solution within 8 hours of opening.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Solutions with precipitations to be destroyed.
Keep out of reach of children
STORAGE & DOSAGE:
Dosage: As directed by the Oncologist.
Carboplatin Injection BP 10mg/ml (150mg/15ml) Technical Specification:
Product Name: | Carboplatin Injection BP 10mg/ml (150mg/15ml) |
Brand Name: | Carboplatin |
Strength: | 10mg/ml (50mg/5ml, 150mg/15ml, 450mg/45ml, 600mg/60ml) |
Dosage Form: | Liquid Injection |
Packing: | MULTI-DOSE VIAL |
Route of Administration: | For I.V. use 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: | Carboplatin is a chemotherapy medication used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, 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) [See USP Controlled Room Temperature]. Protect from light. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Carboplatin Injection BP 10mg/ml (50mg/5ml, 150mg/15ml, 450mg/45ml, 600mg/60ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Carboplatin Injection BP 10mg/ml (50mg/5ml, 150mg/15ml, 450mg/45ml, 600mg/60ml)
Each ml contains:
Carboplatin BP…………………..10mg
Water for Injection BP………q.s.
CONTAINS NO PRESERVATIVES.
THERAPEUTIC INDICATION:
Carboplatin is a chemotherapy medication used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma.
PACKING:
10mg/ml
- 50mg/5ml
- 150mg/15ml
- 450mg/45ml
- 600mg/60ml
DIRECTION OF USE:
For Intravenous use only.
See insert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after dilution.
Single agent therapy for use in the treatment of recurrent ovarian cancer: Carboplatin Injection, as a single agent, has been shown to be effective in patients with recurrent ovarian carcinoma at a dosage of 360 mg/m2 IV on day 1 every 4 weeks.
WARNING: Cytotoxic Agent – To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
WARNING: Carboplatin INJECTION should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate treatment facilities are readily available. Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug-related side effect.
NOTE: Carboplatin Injection that may come in contact with needles or Intravenous sets containing Aluminum parts should not be administered.
PHARMACIST: PLEASE DISPENSE WITH ATTACHED PATIENT INFORMATION LEAFLET.
Sterile, non-pyrogenic, aqueous solution.
Handle the Injection with great care since it is a potent Cytotoxic Agent.
Retain in carton until time of use.
Use the solution within 8 hours of opening.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Solutions with precipitations to be destroyed.
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) [See USP Controlled Room Temperature]. Protect from light. Do not freeze.
Dosage: As directed by the Oncologist.
Why Taj Pharmaceuticals?
Taj Pharmaceuticals stands as a compelling choice for Carboplatin Injection BP, offering a host of compelling reasons that set it apart in the pharmaceutical industry. At the heart of its reputation is an unwavering commitment to maintaining the highest standards of quality. Taj Pharmaceuticals meticulously adheres to stringent quality control processes, ensuring that Carboplatin Injection BP consistently meets and even exceeds industry benchmarks. This dedication to quality serves as a cornerstone, assuring both healthcare providers and patients of the medication’s safety and efficacy. Backed by a substantial presence in the pharmaceutical sector, Taj Pharmaceuticals brings a wealth of experience and expertise to the forefront. Over time, the company has consistently delivered dependable and effective medications, garnering the trust of healthcare professionals and patients across the globe. Their legacy of excellence in healthcare is a testament to their unwavering commitment to providing the best in the industry.
Taj Pharmaceuticals doesn’t rest on its laurels; it continues to invest in research and development. This forward-looking approach ensures that their medications, including Carboplatin Injection BP, remain at the cutting edge of therapeutic efficacy. By continually optimizing their treatments, they can effectively address the ever-evolving healthcare needs of patients. Global accessibility is another hallmark of Taj Pharmaceuticals. With a widespread presence, they make essential medications accessible to patients worldwide. Their extensive distribution network ensures that life-saving treatments are readily available, regardless of geographical location, helping bridge healthcare gaps on a global scale.
Affordability is a central tenet of Taj Pharmaceuticals’ approach. They recognize the importance of making healthcare accessible to all. Consequently, they offer cost-effective solutions, ensuring that essential medications such as Carboplatin Injection BP remain affordable without compromising on quality. This affordability makes critical treatments accessible to a broader spectrum of patients. Taj Pharmaceuticals adopts a customer-centric approach that places patient satisfaction at the core of its mission. They prioritize delivering exceptional service and support, creating a positive healthcare experience for both healthcare professionals and patients. Patient needs and concerns are handled with care and responsiveness, fostering trust and confidence.
Environmental responsibility is another key facet of Taj Pharmaceuticals’ operations. They actively implement eco-friendly manufacturing practices to minimize their ecological footprint, aligning with contemporary environmental concerns and demonstrating their commitment to sustainability. Taj Pharmaceuticals is a trusted healthcare partner for Carboplatin Injection BP. Their unwavering dedication to quality, safety, affordability, and customer satisfaction underscores their mission to prioritize the health and well-being of patients. By choosing Taj Pharmaceuticals, individuals and healthcare providers alike opt for a reliable partner with a global presence and a legacy of excellence in healthcare.
What is Carboplatin Injection BP and its uses:
Carboplatin Injection BP is a medication that contains the active ingredient carboplatin. It is a chemotherapy drug used in cancer treatment to combat the growth and spread of cancer cells. Here are its primary uses:
- Cancer Treatment: Carboplatin is primarily employed in the treatment of various types of cancer, particularly:
Ovarian Cancer: Carboplatin is commonly used as part of the treatment regimen for ovarian cancer, either as a single agent or in combination with other chemotherapy drugs. It helps to inhibit the growth of cancer cells in the ovaries.
Lung Cancer: Carboplatin may be used to treat non-small cell lung cancer, often in combination with other chemotherapy medications.
Testicular Cancer: It is sometimes used in the treatment of testicular cancer.
Other Cancers: Carboplatin can also be prescribed for cancers such as bladder cancer, cervical cancer, endometrial cancer, and head and neck cancer, among others. - Bone Marrow Disorders: In some cases, Carboplatin may be used to treat certain noncancerous conditions, such as bone marrow disorders like myelodysplastic syndrome (MDS).
Carboplatin works by interfering with the DNA within cancer cells, preventing them from dividing and growing. This disruption to the cell’s DNA synthesis process ultimately leads to the death of the cancer cells. It is an important tool in the fight against various types of cancer and is often used in combination with other chemotherapy drugs or treatments to maximize its effectiveness.
How does Carboplatin Injection BP Work?
Carboplatin Injection BP works as a chemotherapy medication by interfering with the growth and multiplication of cancer cells. It belongs to a class of drugs known as platinum-containing compounds, and its mechanism of action involves binding to and damaging the DNA inside cancer cells. Here’s how Carboplatin works:
- DNA Cross-Linking: Carboplatin enters the bloodstream when administered intravenously. Once in the body, it undergoes chemical changes to form highly reactive molecules. These molecules bind to the DNA strands inside the nuclei of both normal and cancerous cells.
- DNA Strand Cross-Linking: Carboplatin forms covalent bonds with the DNA strands, creating cross-links between the DNA molecules. These cross-links disrupt the normal structure of DNA and prevent the strands from separating during cell division, a crucial process for cell replication.
- 3. Inhibition of DNA Replication: The cross-links introduced by Carboplatin inhibit DNA replication and transcription, processes necessary for the replication and functioning of genetic material within cells. As a result, cancer cells are unable to divide and reproduce effectively.
- Activation of Cellular Death Pathways: The damage to DNA caused by Carboplatin ultimately triggers a series of events within the cell that lead to programmed cell death, or apoptosis. Cancer cells with severely damaged DNA are more likely to undergo apoptosis.
- Reduced Tumor Growth: By interfering with DNA replication and promoting apoptosis in cancer cells, Carboplatin slows down the growth and spread of cancerous tumors.
It’s important to note that Carboplatin is a cytotoxic drug, which means it affects not only cancer cells but also some healthy cells that rapidly divide, such as those in the bone marrow, hair follicles, and the lining of the digestive tract. This is why chemotherapy with Carboplatin can have side effects, including a decrease in blood cell counts, hair loss, and gastrointestinal symptoms.
The dosage and treatment regimen for Carboplatin Injection BP are carefully tailored to the specific type of cancer being treated, its stage, and the patient’s overall health. Healthcare providers closely monitor patients during treatment to manage side effects and ensure the best possible therapeutic outcome.
Benefits of Carboplatin Injection BP:
The benefits of Carboplatin Injection BP primarily revolve around its effectiveness in the treatment of various types of cancer. Here are the key benefits:
- Effective Cancer Treatment: Carboplatin is a potent chemotherapy medication that has demonstrated efficacy in the treatment of several types of cancer, including ovarian, lung, testicular, bladder, and head and neck cancers. It is particularly valuable when cancer cells have become resistant to other treatments.
- Tumor Reduction: Carboplatin works by interfering with the growth and division of cancer cells, ultimately leading to a reduction in the size of tumors. This can alleviate symptoms and improve the patient’s quality of life.
- Combination Therapy: Carboplatin is often used in combination with other chemotherapy drugs or treatments. This synergistic approach allows for more comprehensive cancer cell targeting, increasing the likelihood of a successful treatment outcome.
- Adjuvant Treatment: In some cases, Carboplatin may be administered as adjuvant therapy after surgery or radiation therapy. This helps eliminate any remaining cancer cells and reduces the risk of cancer recurrence.
- Customized Treatment: Carboplatin therapy is tailored to the specific type and stage of cancer, as well as individual patient factors. This personalized approach ensures that patients receive the most appropriate and effective treatment for their condition.
- Improved Survival Rates: In many cases, the use of Carboplatin as part of a comprehensive treatment plan has been associated with improved survival rates and extended progression-free survival, offering patients a better chance at long-term remission.
It’s important to note that while Carboplatin offers significant benefits in cancer treatment, it can also be associated with side effects. The decision to use Carboplatin and the management of potential side effects should be carefully considered by healthcare providers and discussed with patients to ensure the best possible treatment outcomes.
Common Side Effects of Carboplatin Injection BP:
- Myelosuppression: Carboplatin can suppress the bone marrow’s ability to produce blood cells, leading to a decrease in white blood cells, red blood cells, and platelets. This can result in an increased risk of infections (due to reduced white blood cells), anemia (due to reduced red blood cells), and bleeding tendencies (due to reduced platelets).
- Nausea and Vomiting: Gastrointestinal side effects, such as nausea and vomiting, are common with Carboplatin treatment. Medications called antiemetics are often prescribed to manage these symptoms.
- Kidney Dysfunction: Carboplatin can affect kidney function. Regular monitoring of kidney function is essential during treatment.
- Neurological Effects: Some patients may experience neurological side effects, such as peripheral neuropathy, which can cause tingling, numbness, or weakness in the extremities.
- 5. Hair Loss: Hair loss (alopecia) is a common side effect of Carboplatin treatment. Hair typically grows back after treatment is completed.
- Hearing Changes: In some cases, Carboplatin may lead to hearing changes, such as tinnitus (ringing in the ears) or hearing loss. It’s important to report any hearing changes to a healthcare provider.
- Allergic Reactions: Although less common, severe allergic reactions to Carboplatin can occur. Signs of an allergic reaction may include difficulty breathing, rash, itching, and swelling of the face or throat. Immediate medical attention is needed if these symptoms occur.
- Digestive Issues: Patients may experience diarrhea or constipation as a side effect of Carboplatin treatment. These symptoms can often be managed with dietary adjustments and medications.
- Fatigue: Many individuals undergoing chemotherapy with Carboplatin may experience fatigue or weakness. It’s important to get adequate rest and maintain a balanced diet to help manage these symptoms.
Frequently Asked Questions About Carboplatin Injection BP:
Certainly, here are some frequently asked questions (FAQs) about Carboplatin Injection BP:
- What is Carboplatin Injection BP?
Carboplatin Injection BP is a chemotherapy medication containing the active ingredient carboplatin. It is used in the treatment of various types of cancer.
- How does Carboplatin work in cancer treatment?
Carboplatin works by interfering with the DNA inside cancer cells, preventing them from dividing and growing. This disruption leads to the death of cancer cells.
- What types of cancer is Carboplatin used to treat?
Carboplatin is used to treat several types of cancer, including ovarian, lung, testicular, bladder, head and neck, and others. It is often part of combination therapy with other chemotherapy drugs.
- How is Carboplatin Injection BP administered?
Carboplatin is typically administered intravenously (IV) by a healthcare professional. The dosage and schedule depend on the specific cancer type and the patient’s condition.
- What are the common side effects of Carboplatin?
Common side effects include myelosuppression (decreased blood cell counts), nausea, vomiting, kidney dysfunction, neurological effects (tingling, numbness), hair loss, and fatigue, among others.
- Are there any precautions or monitoring required during Carboplatin treatment?
Patients receiving Carboplatin require regular monitoring of blood cell counts and kidney function. Healthcare providers may adjust the dosage based on these results.
- Can Carboplatin be used during pregnancy or breastfeeding?
Carboplatin may pose risks to a developing fetus, so its use during pregnancy should be carefully considered. It is generally not recommended during breastfeeding.
- What should I do if I experience severe allergic reactions to Carboplatin?
Severe allergic reactions to Carboplatin are rare but can occur. If you experience symptoms like difficulty breathing, rash, itching, or swelling of the face or throat, seek immediate medical attention.
- Is it safe to consume alcohol during Carboplatin treatment?
It is advisable to discuss alcohol consumption with your healthcare provider, as alcohol can interact with the medication and may have different effects on individuals.
- Can Carboplatin affect hearing?
Carboplatin may lead to hearing changes, including tinnitus (ringing in the ears) or hearing loss. Any hearing changes should be reported to your healthcare provider.
As Carboplatin Injection BP Exporters; We can cater to export business queries from the following geographies. We are exporting our Carboplatin Injection BP 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
Carboplatin 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 Carboplatin 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