Doxorubicin Hydrochloride for Injection BP 10mg Technical Specification:
Product Name: | Doxorubicin Hydrochloride for Injection BP 10mg |
Brand Name: | DOXOTAJ |
Strength: | 50mg,10mg |
Dosage Form: | Lyophilised Powder Injection (Sterile) *Preservative-free |
Packing: | Single dose Vial |
Route of Administration: | For I.V. use only (After dilution) |
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, Cytotoxic drugs (Oncology) |
Indication: | Doxorubicin is an anthracycline type of chemotherapy that is used to treat several different types of cancer. Doxorubicin works by slowing or stopping the growth of cancer cells. |
Storage: | Store at a temperature not exceeding 30°C. Protect from light. Do not freeze. |
Doxorubicin Hydrochloride Injection BP 10mg Manufacturers, Suppliers in India:
Taj Pharmaceuticals is of the prominent Doxorubicin Hydrochloride Injection BP 10mg Manufacturers in India that brings the best quality products. Our company Taj Pharma carries a rich experience in the niche manufacturing of Doxorubicin Hydrochloride Injection BP 10mg.
Doxorubicin hydrochloride is an antibiotic used as a chemotherapy drug. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA. Doxorubicin Hydrochloride is a cytotoxic, anthracycline, topoisomerase II inhibitor indicated as a component of multi-agent adjuvant chemotherapy for the treatment of women with axillary lymph node involvement following resection of primary breast cancer. Doxorubicin hydrochloride is also indicated for the treatment of certain metastatic diseases, leukaemia, and lymphoma.
Taj Pharmaceuticals is a reputed manufacturer and doxorubicin Hydrochloride Injection BP 10mg 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 Doxorubicin Hydrochloride Injection BP 10mg Manufacturer in India that assures high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.
Doxorubicin Hydrochloride Injection BP 10mg manufactured at Taj Pharma follows BP; i.e. the product is manufactured to comply with BP quality standards which are considered the Best in the world. Further, Taj Pharma uses Doxorubicin Hydrochloride Injection BP 10mg grade best active ingredient to manufacture its Injections to comply with international standards of European products.
GENERIC NAME OF MEDICINAL PRODUCT:
- Doxorubicin Hydrochloride Injection BP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Doxorubicin Hydrochloride Injection BP 10mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….10mg
Excipients…………………………………………q. s
THERAPEUTIC INDICATION:
Doxorubicin is also indicated for the treatment of cancers of the ovary, prostate, stomach, and thyroid; small cell cancer of the lung, and liver; squamous cell cancer of the head and neck; multiple myeloma, Hodgkin’s disease, lymphomas, acute lymphocytic leukaemia (ALL), and acute myeloid leukaemia (AML).
DIRECTION OF USE:
To be reconstituted with 25ml or 5ml by adding Sterile Water for Injection BP or 0.9% Sodium Chloride or 5% Dextrose in Sterile Water for Injection to give a final concentration of 2mg/ml.
After reconstitution, the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C.
Use immediately after reconstitution.
CAUTION & Warning:
CAUTION: Do not use the injection if the contents are not clear or contain visible particulate matter after reconstitution.
CYTOTOXIX-DISPOSE OF PROPERLY
Do not pool unused portions from the vials. Do not administer more than one dose from a vial.
Warning: Cytotoxic agent: 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 30°C. Protect from light. Do not freeze.
Please refer product insert for more information.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
Dosage: As directed by an Oncologist.
As Doxorubicin Hydrochloride for Injection BP 10 mg Exporters; We can cater to export business queries from the following geographies. We are exporting our Doxorubicin Hydrochloride for Injection BP 10 mg 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
Doxorubicin Hydrochloride for Injection BP 10 mg 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)
GENERIC NAME OF THE MEDICINAL PRODUCT:
A. Doxorubicin Hydrochloride Injection BP 50mg
B. Doxorubicin Hydrochloride Injection BP 10mg
B. Doxorubicin Hydrochloride Injection BP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Doxorubicin Hydrochloride Injection BP 50mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….50mg
Excipients………………………………………...q. s
2. Doxorubicin Hydrochloride Injection BP 10mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….10mg
Excipients………………………………………...q. s
Each Vial contains:
Doxorubicin Hydrochloride BP……….50mg
Excipients………………………………………...q. s
2. Doxorubicin Hydrochloride Injection BP 10mg
Each Vial contains:
Doxorubicin Hydrochloride BP……….10mg
Excipients………………………………………...q. s
THERAPEUTIC INDICATIONS:
Doxorubicin is also indicated for the treatment of cancers of the ovary, prostate, stomach, and thyroid; small cell cancer of the lung, and liver; squamous cell cancer of the head and neck; multiple myeloma, Hodgkin's disease, lymphomas, acute lymphocytic leukemia (ALL), and acute myeloid leukemia (AML).
DIRECTION OF USE:
To be reconstituted with 25ml or 5ml by adding Sterile Water for Injection BP or 0.9% Sodium Chloride or 5% Dextrose in Sterile Water for Injection to give final concentration of 2mg/ml.
After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C.
Use immediately after reconstitution.
After reconstitution the solution is stable for 7 days at room temperature and 15 days at 2°C to 8°C.
Use immediately after reconstitution.
CAUTION & WARNING:
CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
CYTOTOXIX-DISPOSE OF PROPERLY
Do not pool unused portion from the vials. Do not administer more than one dose from a vial.
Warning: Cytotoxic agent: 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.
CYTOTOXIX-DISPOSE OF PROPERLY
Do not pool unused portion from the vials. Do not administer more than one dose from a vial.
Warning: Cytotoxic agent: 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 30°C.
Protect from light.
Do not freeze.
Please refer product insert for more information.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
Dosage: As directed by an Oncologist.
Protect from light.
Do not freeze.
Please refer product insert for more information.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE
Dosage: As directed by an Oncologist.