GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg
B. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 150mg
Composition:
Each lyophilized vial contains:
Trastuzumab……………………...150mg
Excipients:
L-Histidine Hydrochloride
Monohydrate EP……………….3.36mg
L- Histidine U.S.P ……………...2.16mg
α, α-Trehalose
dihydrate NF…………………….136.2mg
Polysorbate 20 NF……………1.8mg
pH………………………………….6.0
Bacteriostatic Water for Injection
Each 7.2 mL solution contains:
Benzyl Alcohol………………….1.1%
Water for Injection USP……...q.s.

B. Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg
Composition:
Each lyophilized vial contains:
Trastuzumab……………………...440mg
Excipients:
L-Histidine Hydrochloride
Monohydrate EP……………….9.9mg
L- Histidine U.S.P ……………...6.4mg
α, α-Trehalose
dihydrate NF…………………….400mg
Polysorbate 20 NF……………1.8mg
pH………………………………….6.0
Bacteriostatic Water for Injection
Each 20 mL solution contains:
Benzyl Alcohol………………….1.1%
Water for Injection USP……...q.s.


THERAPEUTIC INDICATIONS:

Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion is used in the treatment of breast and stomach cancer. It works by killing the cancer cells by inhibiting HER2 (human epidermal growth factor receptor protein).

PACKING:

150mg: Each pack contains 1vial of lyophilized powder of Trastuzumab, 1 vial with 7.2mL Sterile Bacteriostatic Water for Injection and pack insert.
440mg: Each pack contains 1vial of lyophilized powder of Trastuzumab, 1 vial with 20mL Sterile Bacteriostatic Water for Injection and pack insert.

DIRECTION OF USE:

150mg: Reconstitute the lyophilized powder with 7.2mL of sterile Bacteriostatic Water for Injection for intravenous infusion.
440mg: Reconstitute the lyophilized powder with 20mL of sterile Bacteriostatic Water for Injection for intravenous infusion.
Use within 28 days after reconstitution.
Read insert for precaution and directions before use.

CAUTION:

CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner/Medical Oncologist.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

STORAGE & DOSAGE:

STORAGE: Store the lyophilized powder between 2°C to 8°C.
Store the reconstituted solution between 2°C to 8°C.
Do not freeze the reconstituted solution.
Protect from light.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.

Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg Technical Specification:

Product Name:Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg
Brand Name:Epirexza
Strength:150mg, 440mg
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free, nonpyrogenic
Packing:Multi-dose Vial
Route of Administration:For I.V. infusion only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-cancer (breast and stomach cancer)
Indication: Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion is used in the treatment of breast and stomach cancer. It works by killing the cancer cells by inhibiting HER2 (human epidermal growth factor receptor protein).
Storage:Store the lyophilized powder between 2°C to 8°C. Store the reconstituted solution between 2°C to 8°C. Do not freeze the reconstituted solution. Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion 440mg
    Composition:
    Each lyophilized vial contains:
    Trastuzumab………………………440mg
    Excipients:
    L-Histidine Hydrochloride
    Monohydrate EP……………….9.9mg
    L- Histidine U.S.P ………………6.4mg
    α, α-Trehalose
    dihydrate NF…………………….400mg
    Polysorbate 20 NF……………1.8mg
    pH………………………………….6.0
    Bacteriostatic Water for Injection
    Each 7.2 mL solution contains:
    Benzyl Alcohol………………….1.1%
    Water for Injection USP………q.s.

THERAPEUTIC INDICATION:

Trastuzumab Lyophilized Powder for Concentrate for Solution for infusion is used in the treatment of breast and stomach cancer. It works by killing the cancer cells by inhibiting HER2 (human epidermal growth factor receptor protein).

PACKING:

440mg: Each pack contains 1vial of lyophilized powder of Trastuzumab, 1 vial with 20mL Sterile Bacteriostatic Water for Injection and pack insert.

DIRECTION OF USE:

440mg: Reconstitute the lyophilized powder with 20mL of sterile Bacteriostatic Water for Injection for intravenous infusion.

Use within 28 days after reconstitution.

Read insert for precaution and directions before use.

CAUTION:

CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner/Medical Oncologist.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

STORAGE AND DOSAGE:

STORAGE: Store the lyophilized powder between 2°C to 8°C.
Store the reconstituted solution between 2°C to 8°C.
Do not freeze the reconstituted solution.
Protect from light.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.