Imatinib Mesylate Tablets 100mg (Tyronib) Technical Specification:

Product Name:Imatinib Mesylate Tablets 100mg
Brand Name:Tyronib
Strength:100mg, 400mg
Dosage Form:Tablets
Packing:6s, 10s, 30s
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: Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).
Storage:Store at 20°C to 25°C (68° F to 77° F) [see USP Controlled Room Temperature]. Protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Imatinib Mesylate Tablets 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Imatinib Mesylate Tablets 100mg
    Imatinib Mesylate Equivalent to
    Imatinib………………………..100mg
    Excipients……………………..q.s.
    Colours: Iron Oxide of Yellow

THERAPEUTIC INDICATIONS:

Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).

CAUTION & WARNING:

Warning: Cytotoxic Agent: To be sold by retail on the prescription of a Registered Medical Practitioner (Oncologist)

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

Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.

Swallow complete tablet, do not crush or chew.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

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

Protect from moisture.

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Imatinib Mesylate Tablets 100mg
b) Imatinib Mesylate Tablets 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Imatinib Mesylate Tablets 100mg
Imatinib Mesylate Equivalent to
Imatinib………………………..100mg
Excipients……………………..q.s.
Colours: Iron Oxide of Yellow


b) Imatinib Mesylate Tablets 400mg
Imatinib Mesylate Equivalent to
Imatinib…………………………400mg
Excipients………………………q.s.
Colours: Iron Oxide of Red

THERAPEUTIC INDICATIONS:

Imatinib mesylate is approved to treat: Acute lymphoblastic leukemia in adults and children that is Philadelphia chromosome positive. In adults, it is used for disease that has recurred (come back) or is refractory (does not respond to treatment).

CAUTION & WARNING:

Warning: Cytotoxic Agent: To be sold by retail on the prescription of a Registered Medical Practitioner (Oncologist)
CAUTION: It is dangerous to take this preparation except under medical supervision.
Warning: Cytotoxic Agent: To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.
Swallow complete tablet, do not crush or chew.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

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