Azacitidine for Injection 100mg Technical Specification:

Product Name:Azacitidine for Injection 100mg
Brand Name:Dessraunt
Strength:50mg, 100mg, 150mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For Subcutaneous, Intravenous 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: Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia.
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:

  • Azacitidine for Injection 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Azacitidine for Injection 100mg
    Each vial contains:
    Azacitidine……………………100mg
    (as Lyophillized powder)
    Excipients……………………..q.s.

THERAPEUTIC INDICATION:

Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia.

DIRECTION OF USE:

For Subcutaneous, Intravenous use only

Use sterile water for Injections IP for subcutaneous & for intravenous use.

See prescribing information for dosing and administration.

CAUTION & WARNING:

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

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 only. 

CYTOTOXIC AGENT: Handle with care

Lyophilized Injection, should reconstitute prior to administration. 

Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C

Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Discard Unused portion. 

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].

Protect from light.

Do not freeze.

Dosage: As directed by an Oncologist.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Azacitidine for Injection 50mg
b) Azacitidine for Injection 100mg
c) Azacitidine for Injection 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Azacitidine for Injection 50mg
Each vial contains:
Azacitidine……………………50mg
(as Lyophillized powder)
Excipients……………………..q.s.

b) Azacitidine for Injection 100mg
Each vial contains:
Azacitidine……………………100mg
(as Lyophillized powder)
Excipients……………………..q.s.


c) Azacitidine for Injection 150mg
Each vial contains:
Azacitidine…………………….150mg
(as Lyophillized powder)
Excipients………………………q.s.

THERAPEUTIC INDICATION:

Azacitidine is used for the treatment of myelodysplastic syndrome, myeloid leukemia, and juvenile myelomonocytic leukemia.

DIRECTION OF USE:

For Subcutaneous, Intravenous use only
Use sterile water for Injections IP for subcutaneous & for intravenous use.
See prescribing information for dosing and administration.

CAUTION & WARNING:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
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 only.
CYTOTOXIC AGENT: Handle with care
Lyophilized Injection, should reconstitute prior to administration.
Use the solution with in 8 hours of opening. Discard unused solution, if stored 2-8°C
Solution with precipitation to be destroyed. Do not use after the expiry date stated on the label.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Discard Unused portion.
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].
Protect from light.
Do not freeze.
Dosage: As directed by an Oncologist.