Abiraterone Acetate Tablets USP 250mg Technical Specification:
| Product Name: | Abiraterone Acetate Tablets USP 250mg |
| Brand Name: | Generics |
| Strength: | 250mg, 500mg |
| Dosage Form: | Tablets |
| Packing: | 60s, 120s |
| Route of Administration: | For Oral 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: | Abiraterone is used in combination with other medicine to treat a certain type of prostate cancer that has spread to other parts of the body. |
| Storage: | Store at 20°C to 25°C (68° F to 77° F); excursions permitted from 15°C to 30°C (59° F to 86° F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Abiraterone Acetate Tablets USP 250mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Abiraterone Acetate Tablets USP 250mg
Each tablet contains:
Abiraterone Acetate USP……………250mg
Excipients…………………………………. q.s.
THERAPEUTIC INDICATIONS:
Abiraterone is used in combination with other medicine to treat a certain type of prostate cancer that has spread to other parts of the body.
CAUTION & WARNING:
Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: Women who are or may be pregnant should not handle abiraterone acetate tablets without gloves (see patient information leaflet)
Warning: To be sold by retail on the prescription of an Oncologist only.
Keep out of reach and sight of children.
Dispense in tight container as defined in USP.
Swallow whole tablet. Do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted from 15°C to 30°C (59° F to 86° F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Abiraterone Acetate Tablets USP 250mg
b) Abiraterone Acetate Tablets USP 500mg
b) Abiraterone Acetate Tablets USP 500mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Abiraterone Acetate Tablets USP 250mg
Each tablet contains:
Abiraterone Acetate USP……………250mg
Excipients…………………………………. q.s.
b) Abiraterone Acetate Tablets USP 500mg
Each tablet contains:
Abiraterone Acetate USP……………500mg
Excipients…………………………………. q.s.
Each tablet contains:
Abiraterone Acetate USP……………250mg
Excipients…………………………………. q.s.
b) Abiraterone Acetate Tablets USP 500mg
Each tablet contains:
Abiraterone Acetate USP……………500mg
Excipients…………………………………. q.s.
THERAPEUTIC INDICATIONS:
Abiraterone is used in combination with other medicine to treat a certain type of prostate cancer that has spread to other parts of the body.
CAUTION & WARNING:
Caution: It is dangerous to take this preparation except under medical supervision.
Warning: To be sold by retail on the prescription of an Oncologist only.
Warning: Cytotoxic Agent: Women who are or may be pregnant should not handle abiraterone acetate tablets without gloves (see patient information leaflet)
Keep out of reach and sight of children.
Dispense in tight container as defined in USP.
Swallow whole tablet. Do not crush or chew.
Warning: To be sold by retail on the prescription of an Oncologist only.
Warning: Cytotoxic Agent: Women who are or may be pregnant should not handle abiraterone acetate tablets without gloves (see patient information leaflet)
Keep out of reach and sight of children.
Dispense in tight container as defined in USP.
Swallow whole tablet. Do not crush or chew.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted from 15°C to 30°C (59° F to 86° F) [see USP Controlled Room Temperature].
Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
Do not refrigerate.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.
