Carboplatin Injection BP 10mg/ml (600mg/60ml) Technical Specification:
| Product Name: | Carboplatin Injection BP 10mg/ml (600mg/60ml) |
| 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.
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.
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
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.
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
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.
Dosage: As directed by the Oncologist.
