GENERIC NAME OF THE MEDICINAL PRODUCT:

A)Fosaprepitant Dimeglumine Dry Powder for Injection (Lyophilized) 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A)Fosaprepitant Dimeglumine Dry Powder for Injection (Lyophilized) 150mg
Each vial contains:
Fosaprepitant dimeglumine…….245.3mg
Equivalent to Fosaprepitant…….150mg
For infusion when reconstituted with 5ml 0.9% Sodium Chloride for Injection (Normal
saline) and diluted according to package insert
Inactive ingredients:
Edetate disodium (18.8 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg),
sodium hydroxide and/or Hydrochloric acid (For PH adjustment)

THERAPEUTIC INDICATIONS:

Fosaprepitant injection are used along with other medications to prevent nausea and vomiting in adults that may occur within 24 hours or several days after receiving certain cancer chemotherapy treatments.
DIRECTION OF USE:
For Intravenous use only after reconstitution and dilution
Reconstitution:
Preparation of Fosaprepitant dimeglumine for Injection 150 mg:
1. Aseptically inject 5 ml 0.9% Sodium chloride for injection (normal saline) into the vial. Assure that saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial.
2. Aseptically prepare an infusion bag filled with 145 ml of normal saline.
3. Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145ml of normal saline to yield a total volume of 150 ml and a final concentration of 1mg/1ml.
4. Gently invert the bag 2 to 3 times.
The reconstituted final drug solution is stable for 24 hours at ambient room temperature (at below 25°C).
See the package insert for details.

CAUTION & SCHEDULE:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
SCHEDULE: To be sold by retail on the prescription of a Registered medical practitioner only.
DO NOT USE WITH SOLUTIONS CONTAINING DIVALENT CATIONS (e.g., Ca2+, Mg2+) INCLUDING LACTATED RINGER’S SOLUTION AND HARTMANN'S SOLUTION.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Refrigerate at 2°C to 8°C (36° to 46° F). Do not freeze.
Dosage: As directed by the physician.
Day 1 (day of chemotherapy):
Administer Fosaprepitant dimeglumine for injection by infusion over 20 to 30 minutes approximately 30 minutes prior to chemotherapy.
Day 2 and 3: No capsules of Aprepitant are administered on Day 2 and 3. See package insert.

Fosaprepitant Dimeglumine Dry Powder for Injection (Lyophilized) 150mg Technical Specification:

Product Name:Fosaprepitant Dimeglumine Dry Powder for Injection (Lyophilized) 150mg
Brand Name:generics
Strength:150mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE USE VIAL
Route of Administration:For I.V. infusion only after reconstitution and dilution
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Anti-Cancer
Indication: Fosaprepitant injection are used along with other medications to prevent nausea and vomiting in adults that may occur within 24 hours or several days after receiving certain cancer chemotherapy treatments.
Storage:Refrigerate at 2°C to 8°C (36° to 46° F). Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Fosaprepitant Dimeglumine Dry Powder for Injection (Lyophilized) 150mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fosaprepitant Dimeglumine Dry Powder for Injection (Lyophilized) 150mg
    Each vial contains:
    Fosaprepitant dimeglumine…….245.3mg
    Equivalent to Fosaprepitant…….150mg
    For infusion when reconstituted with 5ml 0.9% Sodium Chloride for Injection (Normal saline) and diluted according to package insert
    Inactive ingredients:
    Edetate disodium (18.8 mg), polysorbate 80 (75 mg), lactose anhydrous (375 mg), sodium hydroxide and/or Hydrochloric acid (For PH adjustment)

THERAPEUTIC INDICATION:

Fosaprepitant injection are used along with other medications to prevent nausea and vomiting in adults that may occur within 24 hours or several days after receiving certain cancer chemotherapy treatments.
DIRECTION OF USE:
For Intravenous use only after reconstitution and dilution
Reconstitution: Preparation of Fosaprepitant dimeglumine for Injection 150 mg:

  • Aseptically inject 5 ml 0.9% Sodium chloride for injection (normal saline) into the vial. Assure that saline is added to the vial along the vial wall in order to prevent foaming. Swirl the vial gently. Avoid shaking and jetting saline into the vial. 
  • Aseptically prepare an infusion bag filled with 145 ml of normal saline. 
  • Aseptically withdraw the entire volume from the vial and transfer it into the infusion bag containing 145ml of normal saline to yield a total volume of 150 ml and a final concentration of 1mg/1ml.
  • Gently invert the bag 2 to 3 times. The reconstituted final drug solution is stable for 24 hours at ambient room temperature (at below 25°C).See the package insert for details.

CAUTION & SCHEDULE:

CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
SCHEDULE: To be sold by retail on the prescription of a Registered medical practitioner only.
DO NOT USE WITH SOLUTIONS CONTAINING DIVALENT CATIONS (e.g., Ca2+, Mg2+) INCLUDING LACTATED RINGER’S SOLUTION AND HARTMANN’S SOLUTION.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Refrigerate at 2°C to 8°C (36° to 46° F). Do not freeze.
Dosage: As directed by the physician.
Day 1 (day of chemotherapy):
Administer Fosaprepitant dimeglumine for injection by infusion over 20 to 30 minutes approximately 30 minutes prior to chemotherapy.
Day 2 and 3: No capsules of Aprepitant are administered on Day 2 and 3. See package insert.