Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg Technical Specification:

Product Name:Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg
Brand Name:SoftaxeL
Strength:100mg
Dosage Form:Lyophilized
Dry Powder for Injection
Packing:SINGLE DOSE VIAL
Route of Administration:For I.V. 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: Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.
Storage:Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Reconstituted suspension should be stored in its original carton at 2°C to 8°C and protect from bright light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Paclitaxel (Protein-bound Particle) for Injectable suspension 100mg
    Each vial contains:
    Paclitaxel USP…………………………………………100mg
    Human Albumin USP approximately.………900mg
    (After reconstitution)

THERAPEUTIC INDICATION:

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

DIRECTION OF USE:

For Intravenous use only.

Reconstitution: Reconstitute with 20ml of 0.9% Sodium Chloride Injection USP resulting in a suspension containing 5mg/ml of paclitaxel.

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 of a Cancer Specialist.

WARNING: Cytotoxic Agent:
To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.

CAUTION: The reconstituted suspension should be used within 8 hours of reconstitution.

NOTE: A protein-bound form of particulate paclitaxel. Functional properties are not the same as other Paclitaxel products. See package insert for more detailed information on dosage formulation.

SHOULD NOT BE SUBSTITUTED.

DO NOT pool unused portions from the vials. DO NOT administer more than one dose from a vial.

Prescription medicine only

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Discard Unused portion.

Read all sides of carton.

Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.

Reconstituted suspension should be stored in its original carton at 2°C to 8°C and protect from bright light.

Dosage: As directed by the Oncologist.

GENERIC NAME OF THE MEDICINAL PRODUCT:

Paclitaxel (Protein-bound Particles) for Injectable Suspension 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Paclitaxel (Protein-bound Particle) for Injectable suspension 100mg
Each vial contains:
Paclitaxel USP…………………………………………100mg
Human Albumin USP approximately.………900mg
(After reconstitution)

THERAPEUTIC INDICATIONS:

Paclitaxel protein-bound particles for injectable suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

DIRECTION OF USE:

For Intravenous use only.
Reconstitution: Reconstitute with 20ml of 0.9% Sodium Chloride Injection USP resulting in a suspension containing 5mg/ml of paclitaxel.

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 of a Cancer Specialist.
WARNING: Cytotoxic Agent:
To be supplied against demand from Cancer Hospitals, Institutions and against prescription of a Cancer specialist only.
CAUTION: The reconstituted suspension should be used within 8 hours of reconstitution.
NOTE: A protein-bound form of particulate paclitaxel. Functional properties are not the same as other Paclitaxel products. See package insert for more detailed information on dosage formulation.
SHOULD NOT BE SUBSTITUTED.
DO NOT pool unused portions from the vials. DO NOT administer more than one dose from a vial.
Prescription medicine only
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Read all sides of carton.
Keep out of the reach of the children.

STORAGE & DOSAGE:

Storage: Store vials between 20°C to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Protect from light.
Reconstituted suspension should be stored in its original carton at 2°C to 8°C and protect from bright light.
Dosage: As directed by the Oncologist.