GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Dasatinib Tablets 20mg
b) Dasatinib Tablets 50mg
c) Dasatinib Tablets 70mg
d) Dasatinib Tablets 80mg
e) Dasatinib Tablets 100mg
f) Dasatinib Tablets 140mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Dasatinib Tablets 20mg
Each film-coated tablet contains:
Dasatinib…………………………..20mg
Excipients………………………….q.s.
Colours: Titanium Dioxide

b) Dasatinib Tablets 50mg
Each film-coated tablet contains:
Dasatinib………………………….50mg
Excipients…………………………q.s.
Colours: Iron Oxide Red

c) Dasatinib Tablets 70mg
Each film-coated tablet contains:
Dasatinib…………………………..70mg
Excipients………………………….q.s.
Colours: Iron Oxide Yellow

d) Dasatinib Tablets 80mg
Each film-coated tablet contains:
Dasatinib………………………….80mg
Excipients…………………………q.s.
Colours: Iron Oxide Black

e) Dasatinib Tablets 100mg
Each film-coated tablet contains:
Dasatinib………………………..100mg
Excipients……………………….q.s.
Colours: Brilliant Blue FCF

f) Dasatinib Tablets 140mg
Each film-coated tablet contains:
Dasatinib………………………..140mg
Excipients……………………….q.s.
Colours: Sunset Yellow FCF


THERAPEUTIC INDICATIONS:

Dasatinib is used to treat certain cases of chronic myelogenous leukemia and acute lymphoblastic leukemia.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.
WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.
Do not use if inner seal of bottle is broken or missing.
Keep out of reach and sight of children.
Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Dasatinib Tablets 140mg Technical Specification:

Product Name:Dasatinib Tablets 140mg
Brand Name:Dasatinib
Strength:20mg, 50mg, 70mg, 80mg, 100mg,140mg
Dosage Form:Film-coated Tablet
Packing:10s, 12s, 20s, 30s, 60s
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:  Dasatinib is used to treat certain cases of chronic myelogenous leukemia and acute lymphoblastic leukemia.
Storage:Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dasatinib Tablets 140mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dasatinib Tablets 140mg
    Each film-coated tablet contains:
    Dasatinib…………………………..140mg
    Excipients………………………….q.s.
    Colours: Sunset Yellow FCF

THERAPEUTIC INDICATIONS:

Dasatinib is used to treat certain cases of chronic myelogenous leukemia and acute lymphoblastic leukemia.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.

Warning: Cytotoxic Agent: To be sold by retail on the prescription of an oncologist/ Cancer Hospital/ Institution only.

WARNING: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions & against prescription of a Cancer Specialist only.

Do not use if inner seal of bottle is broken or missing.

Keep out of reach and sight of children.

Swallow complete tablet, do not crush or chew.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted to 15°C to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.