Eribulin Mesylate Solution for Injection 0.44mg/ml (Rayldeima) Technical Specification:

Product Name:Eribulin Mesylate Solution for Injection 0.44mg/ml
Brand Name:Rayldeima
Strength:0.5mg/ml, 0.44mg/ml
Dosage Form:Injection
Packing:SINGLE USE 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: Eribulin is an anticancer medication used to treat breast cancer and liposarcoma.
Storage:Store at 25°C (77° F); excursions permitted between 15°C to 30°C (59° to 86° F). Do not freeze or refrigerate.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Eribulin Mesylate Solution for Injection 0.44mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Eribulin Mesylate Solution for Injection 0.44mg/ml
    Each 2 ml vial contains:
    Eribulin (as mesylate) ………….0.88mg
    Ethanol anhydrous……………….4.5% to 5.5%

THERAPEUTIC INDICATION:

Eribulin is an anticancer medication used to treat breast cancer and liposarcoma.

PACKING:

  • 5mg/ml
  • 44mg/ml

DIRECTION OF USE:

For Intravenous infusion only.

See the package insert for dosage and administration.

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.

WARNING: To be supplied against demand from Cancer Hospital, Institutions.

Do not accept if vial seal is broken.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted between 15°C to 30°C (59° to 86° F). Do not freeze or refrigerate.

Dosage: As directed by an Oncologist.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Eribulin Mesylate Solution for Injection 0.5mg/ml
b) Eribulin Mesylate Solution for Injection 0.44mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Eribulin Mesylate Solution for Injection 0.5mg/ml
Each 2 ml vial contains:
Eribulin Mesylate ……….………1mg
Equivalent to Eribulin………….0.88mg
Ethanol……………………………….5% v/v
Water for Injection USP……...q.s.

b) Eribulin Mesylate Solution for Injection 0.44mg/ml
Each 2 ml vial contains:
Eribulin (as mesylate) ………….0.88mg
Ethanol anhydrous……………….4.5% to 5.5%


THERAPEUTIC INDICATION:

Eribulin is an anticancer medication used to treat breast cancer and liposarcoma.

PACKING:

1) 0.5mg/ml
2) 0.44mg/ml

DIRECTION OF USE:

For Intravenous infusion only.
See the package insert for dosage and administration.

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.
WARNING: To be supplied against demand from Cancer Hospital, Institutions.
Do not accept if vial seal is broken.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store at 25°C (77° F); excursions permitted between 15°C to 30°C (59° to 86° F). Do not freeze or refrigerate.
Dosage: As directed by an Oncologist.