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
1) 50mg/5ml
2) 150mg/15ml
3) 450mg/45ml
4) 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.

Carboplatin Injection BP 10mg/ml (450mg/45ml) Technical Specification:   

Product Name:Carboplatin Injection BP 10mg/ml (450mg/45ml)
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.

Carboplatin Injection BP 450mg/45ml Manufacturers, Suppliers in India:

Taj Pharmaceuticals is a prominent Carboplatin Injection BP 450mg/45ml Manufacturer in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Carboplatin Injection BP 450mg/45ml.

Carboplatin Injection BP 450mg/45ml belongs to a group of anti-cancer medicines used for the treatment of ovarian cancer and small-cell lung cancer. It may sometimes be used to treat other cancers. Cancer forms in tissues of the ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Small-cell lung cancer is a disease in which malignant (cancer) cells form in the tissues of the lung.

Carboplatin 450mg Injection 45ml contains ‘Carboplatin’. Carboplatin acts by penetrating the cell wall and binding to the cell’s DNA, stopping the cell from naturally dividing and functioning, ultimately destroying the cell. These medicines target cancer cells because they often affect rapidly dividing cells.

Carboplatin 450mg Injection 45ml is prescribed by a doctor experienced in the use of medications to treat cancer. It is administered by a healthcare professional as an injection. You may experience nausea, diarrhoea, vomiting, thrombocytopenia (a low platelet count), peripheral neuropathy (nerves malfunction), nephrotoxicity at high doses and electrolyte disturbances. Most of these side effects of Carboplatin 450mg Injection 45ml do not require medical attention and gradually resolve over time. However, if the side effects are persistent, reach out to your doctor.

Taj Pharmaceuticals is a pioneer company that is popular as an authentic manufacturer and exporter of Carboplatin Injection 450mg/45ml. The superior manufacturing facilities, cutting-edge R & D capabilities, vast domestic network, and substantial international presence the company enjoys are the source of its competitive advantage.

Taj Pharmaceuticals, one of the leading Carboplatin Injection 450mg/45ml Manufacturers in India brings the best quality products. The company carries rich experience in the niche. Taj Pharmaceuticals is a reputed manufacturer and Carboplatin Injection 450mg/45ml suppliers in India prefer Taj Pharmaceuticals due to the reliability and purity of its products. Taj Pharmaceuticals, the well-known Carboplatin Injection 450mg/45ml Manufacturer in India gives the assurance of high quality and purity. The stringent quality control ensures that every batch of the drug brings a consistent standard. As Carboplatin Injection 450mg/45ml Exporters

Taj Pharmaceuticals is a reputed manufacturer and Carboplatin Injection BP 450mg/45ml Suppliers in India prefer Taj Pharma is best known for the topmost standards and consistent quality of its products.

Taj Pharma is a well-known Carboplatin Injection BP 450mg/45ml in India that gives the assurance of high-quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.

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.

As Carboplatin Injection BP 450mg/45ml Exporters; We can cater to export business queries from the following geographies. We are exporting our Carboplatin Injection BP 450mg/45ml 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, 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 450mg/45ml 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)