GENERIC NAME OF THE MEDICINAL PRODUCT:
Epirubicin Hydrochloride Injection USP 2mg/ml (10mg/5ml, 50mg/25ml, 100mg/50ml, 150mg/75ml, 200mg/100ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Epirubicin Hydrochloride Injection USP 2mg/ml (10mg/5ml, 50mg/25ml, 100mg/50ml, 150mg/75ml, 200mg/100ml)
Each ml contains:
Epirubicin hydrochloride USP………….2mg
Sodium chloride USP………………………9mg
Water for Injection USP………………….q.s.
Excipients ………………………………………q.s.
Each ml contains:
Epirubicin hydrochloride USP………….2mg
Sodium chloride USP………………………9mg
Water for Injection USP………………….q.s.
Excipients ………………………………………q.s.
THERAPEUTIC INDICATION:
Epirubicin hydrochloride is approved to be used with other drugs to treat Breast cancer. It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm.
PACKING:
2mg/ml
1) 10mg/5ml
2) 50mg/25ml
3) 100mg/50ml
4) 150mg/75ml
5) 200mg/100ml
1) 10mg/5ml
2) 50mg/25ml
3) 100mg/50ml
4) 150mg/75ml
5) 200mg/100ml
DIRECTION OF USE:
For Intravenous Infusion only.
See package insert.
See package insert.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision. Do not use this infusion if the solution is not clear, contains ant particle or if the vial is damaged or leaking. Appropriate dose must be diluted by normal saline before administration. Any remaining solution should be discarded after single use. 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.
Cytotoxic Agent: Wear gloves at all times when handling containers.
Use in one patient on one occasion only.
Sterile, Non-pyrogenic, Preservative free.
Contains no preservatives.
The container closure is not made with natural rubber latex.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of reach of children
WARNING: Cytotoxic Agent - To be sold by retail on the prescription of an Oncologist/ Cancer Hospital/ Institution.
Cytotoxic Agent: Wear gloves at all times when handling containers.
Use in one patient on one occasion only.
Sterile, Non-pyrogenic, Preservative free.
Contains no preservatives.
The container closure is not made with natural rubber latex.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store refrigerated 2°C to 8°C (36° F to 46° F).
Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.
Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.
Epirubicin Hydrochloride Injection USP 2mg/ml (150mg/75ml) Technical Specification:
| Product Name: | Epirubicin Hydrochloride Injection USP 2mg/ml (150mg/75ml) |
| Brand Name: | Epirubicin |
| Strength: | 2mg/ml (10mg/5ml, 50mg/25ml,100mg/50ml, 150mg/75ml, 200mg/100ml) |
| Dosage Form: | Liquid Injection |
| Packing: | SINGLE USE 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: | Epirubicin hydrochloride is approved to be used with other drugs to treat Breast cancer. It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm. |
| Storage: | Store refrigerated 2°C to 8°C (36° F to 46° F). Do not freeze. Protect from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Epirubicin Hydrochloride Injection USP 2mg/ml (150mg/75ml)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Epirubicin Hydrochloride Injection USP 2mg/ml (150mg/75ml)
Each ml contains:
Epirubicin hydrochloride USP………….2mg
Sodium chloride………………………………9mg
Water for Injection…………………………. q.s.
Excipients ………………………………………. q.s.
THERAPEUTIC INDICATION:
Epirubicin hydrochloride is approved to be used with other drugs to treat Breast cancer. It is used after surgery in patients whose cancer has spread to the lymph nodes under the arm.
PACKING:
2mg/ml
- 10mg/5ml
- 50mg/25ml
- 100mg/50ml
- 150mg/75ml
- 200mg/100ml
DIRECTION OF USE:
For Intravenous Infusion only.
See package insert.
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision. Do not use this infusion if the solution is not clear, contains ant particle or if the vial is damaged or leaking. Appropriate dose must be diluted by normal saline before administration. Any remaining solution should be discarded after single use. 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.
Cytotoxic Agent: Wear gloves at all times when handling containers.
Use in one patient on one occasion only.
Sterile, Non-pyrogenic, Preservative free.
Contains no preservatives.
The container closure is not made with natural rubber latex.
Retain in carton until time of use.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
Keep out of reach of children
STORAGE & DOSAGE:
Storage: Store refrigerated 2°C to 8°C (36° F to 46° F).
Do not freeze. Protect from light.
Dosage: As directed by the Oncologist.
