Sunitinib Malate Capsules 50mg Technical Specification:
| Product Name: | Sunitinib Malate Capsules 50mg |
| Brand Name: | Sunitinib |
| Strength: | 12.5mg, 25mg, 37.5mg, 50mg |
| Dosage Form: | Hard-Gelatin Capsules |
| Packing: | 28s |
| Route of Administration: | For Oral Use |
| 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: | Sunitinib is a type of targeted drug called a protein kinase inhibitor. Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus). |
| Storage: | Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Sunitinib Malate Capsules 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Sunitinib Malate Capsules 50mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………….……50 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
THERAPEUTIC INDICATIONS:
Sunitinib is a type of targeted drug called a protein kinase inhibitor. Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus).
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Capsule should be swallowed whole and not to be chewed or crushed.
Dispense in a tight, light resistant container
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist/ Urologist only.
For Oral use. Read the package insert before use.
GENERIC NAME OF THE MEDICINAL PRODUCT:
a) Sunitinib Malate Capsules 12.5mg
b) Sunitinib Malate Capsules 25mg
c) Sunitinib Malate Capsules 37.5mg
d) Sunitinib Malate Capsules 50mg
b) Sunitinib Malate Capsules 25mg
c) Sunitinib Malate Capsules 37.5mg
d) Sunitinib Malate Capsules 50mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Sunitinib Malate Capsules 12.5mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………….……12.5 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
b) Sunitinib Malate Capsules 25mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………………25 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
c) Sunitinib Malate Capsules 37.5mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………………37.5 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
d) Sunitinib Malate Capsules 50mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………….…...50 mg
Excipients…………………..q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………….……12.5 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
b) Sunitinib Malate Capsules 25mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………………25 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
c) Sunitinib Malate Capsules 37.5mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………………37.5 mg
Excipients………………….q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
d) Sunitinib Malate Capsules 50mg
Each hard gelatin capsule contains:
Sunitinib Malate Equivalent to
Sunitinib……………….…...50 mg
Excipients…………………..q.s
Approved colours used in capsule shells- Ferric Oxide Red USP-NF, Ferric Oxide Yellow USP-NF and Black Oxide of Iron
THERAPEUTIC INDICATIONS:
Sunitinib is a type of targeted drug called a protein kinase inhibitor. Sunitinib is used to treat gastrointestinal stromal tumors (GIST; a type of tumor that grows in the stomach, intestine (bowel), or esophagus).
CAUTION & WARNING:
CAUTION: It is dangerous to take this preparation except under medical supervision.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Capsule should be swallowed whole and not to be chewed or crushed.
Dispense in a tight, light resistant container
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.
WARNING: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer Specialist only.
Capsule should be swallowed whole and not to be chewed or crushed.
Dispense in a tight, light resistant container
Keep container tightly closed.
Dispense in original container.
Do not use if seal over bottle opening is broken or missing.
Keep out of reach and sight of children.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist/ Urologist only.
For Oral use. Read the package insert before use.
Dosage: As directed by Oncologist/ Urologist only.
For Oral use. Read the package insert before use.
