Nilotinib Capsules 200mg

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Nilotinib Capsules 50mg
b) Nilotinib Capsules 150mg
c) Nilotinib Capsules 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Nilotinib Capsules 50mg
Each capsule contains:
Nilotinib…………....50mg
Excipients……….…q.s.
Colours: Approved colours used in capsule shell

b) Nilotinib Capsules 150mg
Each capsule contains:
Nilotinib…………...150mg
Excipients……….…q.s.
Colours: Approved colours used in capsule shell

c) Nilotinib Capsules 200mg
Each capsule contains:
Nilotinib…………...200mg
Excipients……….…q.s.
Colours: Approved colours used in capsule shell

THERAPEUTIC INDICATIONS:

Nilotinib is used to treat certain types of chronic myeloid leukemia (CML a type of cancer of the white blood cells)

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 Oncologist/ Cancer Hospital/ Institution only.
Swallow capsules whole. Do not chew, dissolve or open the capsules.
TAKE NILOTINIB ON EMPTY STOMATCH AVOID FOOD FOR AT LEAST 2 HOURS BEFORE TAKING A DOSE OF NILOTINIB AND AT LEAST 1 HOUR AFTER THE DOSE IS TAKEN.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Dosage: As directed by Oncologist.
For Oral use. Read the package insert before use.

Nilotinib Capsules 200mg Technical Specification:

Product Name:Nilotinib Capsules 200mg
Brand Name:Nilotinib
Strength:50mg, 150mg, 200mg
Dosage Form:Hard-Gelatin Capsules
Packing:28s, 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: Nilotinib is used to treat certain types of chronic myeloid leukemia (CML a type of cancer of the white blood cells)
Storage:Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Nilotinib Capsules 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Nilotinib Capsules 200mg
    Each capsule contains:
    Nilotinib…………….200mg
    Excipients……….…q.s.
    Colours: Approved colours used in capsule shell

THERAPEUTIC INDICATIONS:

Nilotinib is used to treat certain types of chronic myeloid leukemia (CML a type of cancer of the white blood cells)

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 Oncologist/ Cancer Hospital/ Institution only.

Swallow capsules whole. Do not chew, dissolve or open the capsules.

TAKE NILOTINIB ON EMPTY STOMATCH AVOID FOOD FOR AT LEAST 2 HOURS BEFORE TAKING A DOSE OF NILOTINIB AND AT LEAST 1 HOUR AFTER THE DOSE IS TAKEN.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° F to 77° F); excursions permitted to 15° C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Dosage: As directed by Oncologist.

For Oral use. Read the package insert before use.