Decitabine for Injection 50mg Technical Specification:

Product Name:Decitabine for Injection 50mg
Brand Name:Decitabine
Strength:30mg, 50mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE DOSE STERILE VIAL
Route of Administration:For I.V. infusion 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: Decitabine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). This medicine reduces the growth of cancer cells.
Storage:Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Decitabine for Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Decitabine for Injection 50mg
    Each vial contains:
    Decitabine……………………50mg
    Excipients…………………….q.s.

THERAPEUTIC INDICATION:

Decitabine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). This medicine reduces the growth of cancer cells.

DIRECTION OF USE:

For Intravenous infusion only.

Reconstitution: Reconstitute with 10 ml of Sterile Water for Injection USP.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.

WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.

CAUTION: This is potent Cytotoxic agent. Use only after reading the directions on the pack insert.

WARNING: Cytotoxic Agent: Handle with care.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard any unused solution.

Keep out of the reach of the children.

STORAGE & DOSAGE:

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

Dosage: As directed by an Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Decitabine for Injection 30mg
b) Decitabine for Injection 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Decitabine for Injection 30mg
Each vial contains:
Decitabine……………………30mg
Excipients…………………….q.s.

b) Decitabine for Injection 50mg
Each vial contains:
Decitabine……………………50mg
Excipients…………………….q.s.


THERAPEUTIC INDICATION:

Decitabine is used to treat myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells). This medicine reduces the growth of cancer cells.

DIRECTION OF USE:

For Intravenous infusion only.
Reconstitution: Reconstitute with 10 ml of Sterile Water for Injection USP.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
CAUTION: This is potent Cytotoxic agent. Use only after reading the directions on the pack insert.
WARNING: Cytotoxic Agent: Handle with care.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard any unused solution.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature].
Dosage: As directed by an Oncologist.