a) Mitomycin for Injection USP 2mg
b) Mitomycin for Injection USP 5mg
c) Mitomycin for Injection USP 10mg
d) Mitomycin for Injection USP 20mg
e) Mitomycin for Injection USP 40mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Mitomycin for Injection USP 2mg
Each vial contains:
Mitomycin USP……………….……2mg
Mannitol……..……………….………4mg
b) Mitomycin for Injection USP 5mg
Each vial contains:
Mitomycin USP…………………….5mg
Mannitol………………………………10mg
c) Mitomycin for Injection USP 10mg
Each vial contains:
Mitomycin USP………………….…10mg
Mannitol……..…………………….…20mg
d) Mitomycin for Injection USP 20mg
Each vial contains:
Mitomycin USP……………………20mg
Mannitol……………………………..40mg
e) Mitomycin for Injection USP 40mg
Each vial contains:
Mitomycin USP……………………40mg
Mannitol……………………………..80mg
Each vial contains:
Mitomycin USP……………….……2mg
Mannitol……..……………….………4mg
b) Mitomycin for Injection USP 5mg
Each vial contains:
Mitomycin USP…………………….5mg
Mannitol………………………………10mg
c) Mitomycin for Injection USP 10mg
Each vial contains:
Mitomycin USP………………….…10mg
Mannitol……..…………………….…20mg
d) Mitomycin for Injection USP 20mg
Each vial contains:
Mitomycin USP……………………20mg
Mannitol……………………………..40mg
e) Mitomycin for Injection USP 40mg
Each vial contains:
Mitomycin USP……………………40mg
Mannitol……………………………..80mg
THERAPEUTIC INDICATION:
Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.
DIRECTION OF USE:
For Intravenous infusion only.
Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.
See the package insert for details.
Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.
See the package insert for details.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Must be administered intravenously to avoid tissue damage.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Must be administered intravenously to avoid tissue damage.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light. Avoid excessive heat, over 40°C [104° F]. Protect reconstituted solution from light. Store solution under refrigeration 2°C to 8°C (36° to 46° F), discard after 14 days. If unrefrigerated, discard after 7 days.
Dosage: As directed by an Oncologist.
Dosage: As directed by an Oncologist.
Mitomycin for Injection USP 2mg (Mitocyte) Technical Specification:
| Product Name: | Mitomycin for Injection USP 2mg |
| Brand Name: | Mitocyte |
| Strength: | 2mg, 5mg, 10mg, 20mg, 40mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For I.V. infusion 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: | Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body. |
| Storage: | Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light. Avoid excessive heat, over 40°C [104° F]. Protect reconstituted solution from light. Store solution under refrigeration 2°C to 8°C (36° to 46° F), discard after 14 days. If unrefrigerated, discard after 7 days. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Mitomycin for Injection USP 2mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Mitomycin for Injection USP 2mg
Each vial contains:
Mitomycin USP……………….……2mg
Mannitol……..……………….………4mg
THERAPEUTIC INDICATION:
Mitomycin is a type of antibiotic that is only used in cancer chemotherapy. It slows or stops the growth of cancer cells in your body.
DIRECTION OF USE:
For Intravenous infusion only.
Add sterile water for injection USP. Shake to dissolve, if product does not dissolve immediately allow to stand at room temperature until solution is obtained.
See the package insert for details.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Must be administered intravenously to avoid tissue damage.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light. Avoid excessive heat, over 40°C [104° F]. Protect reconstituted solution from light. Store solution under refrigeration 2°C to 8°C (36° to 46° F), discard after 14 days. If unrefrigerated, discard after 7 days.
Dosage: As directed by an Oncologist.
