Ertapenem for Injection 1gm Technical Specification:

Product Name:Ertapenem for Injection 1gm
Brand Name:Erataj
Strength:1gm, 500mg
Dosage Form:Lyophilized Powder Injection (Sterile) *No-preservative
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V./I.M 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:β-lactam Antibiotic, Anti-bacterial & Carbapenem
Indication: Ertapenem injection is used to treat certain serious infections, including pneumonia and urinary tract, skin, pelvic, and stomach infections, that are caused by bacteria.
Storage:Store below 25°C. Protect from light and moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ertapenem for Injection 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ertapenem for Injection 1gm
    Each vial Contains:
    (Sterile) Ertapenem Sodium
    Eq. to Anhydrous Ertapenem ……………1gm
    Excipients…………………………………………q. s
    Sterilised Water for Injection BP…………….10ml

THERAPEUTIC INDICATION:

Ertapenem injection is used to treat certain serious infections, including pneumonia and urinary tract, skin, diabetic foot, gynecological, pelvic, and abdominal (stomach area) infections, that are caused by bacteria. It is also used for the prevention of infections following colorectal surgery.

Ertapenem is also used to prevent infection in people having certain types of surgery.

DIRECTION OF USE:

Use immediately after dissolving the contents.
For IV use: The reconstituted solution should be used within 6 hours of preparation if stored below 25°C or within 24 hours if stored under refrigeration (at 5°C). The solution of Erataj should not be frozen.
Refer package insert for reconstitution and administration.
For IM use: The reconstituted IM solution should be used within 1 hour of preparation.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible after dissolving the contents, please do not use the solution.
Improper storage may deteriorate the product.
Do not use solvent or infusion fluids containing dextrose for reconstitution or administration of ertapenem.
MUST BE RECONSTITUTED AND FURTHER DILUTED PRIOR TO USE.
DO NOT SKIP ANY DOSES AND FINISH THE FULL COURSE OF TREATMENT EVEN IF YOU FEEL BETTER.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

WARNING: It is dangerous to take this preparation except under medical supervision.
To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C, Protect from light and moisture. Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Use only after reading the directions on the package insert.

DOSAGE: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Ertapenem for Injection 1gm
B) Ertapenem for Injection 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Ertapenem for Injection 1gm
a) Each vial Contains:
(Sterile) Ertapenem Sodium
Eq. to Anhydrous Ertapenem ……...……1gm
Excipients…………………………………………q. s
b) Sterilised Water for Injection BP…………….10ml


B) Ertapenem for Injection 500mg
a) Each vial Contains:
(Sterile) Ertapenem Sodium
Eq. to Anhydrous Ertapenem ……500mg
Excipients…………………………………….…q. s
b) Sterilised Water for Injection BP…………...10ml

THERAPEUTIC INDICATIONS:

Ertapenem injection is used to treat certain serious infections, including pneumonia and urinary tract, skin, diabetic foot, gynecological, pelvic, and abdominal (stomach area) infections, that are caused by bacteria. It is also used for the prevention of infections following colorectal surgery.
Ertapenem is also used to prevent infection in people having certain types of surgery.

DIRECTION OF USE:

Use immediately after dissolving the contents.
For IV use:
The reconstituted solution should be used within 6 hours of preparation if stored below 25°C or within 24 hours if stored under refrigeration (at 5°C). Solution of Erataj should not be frozen. Refer package insert for reconstitution and administration.
For IM use:
The reconstituted IM solution should be used within 1 hour of preparation.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible after dissolving the contents, please do not use the solution.
Improper storage may be deteriorated the product.
Do not use solvent or infusion fluids containing dextrose for reconstitution or administration of ertapenem.
MUST BE RECONSTITUTED AND FURTHER DILUTED PRIOR TO USE.
DO NOT SKIP ANY DOSES AND FINISH THE FULL COURSE OF TREATMENT EVEN IF YOU FEEL BETTER.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: It is dangerous to take this preparation except under medical supervision.
To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE & DOSAGE:

STORAGE: Store below 25°C, Protect from light and moisture. Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Use only after reading the directions on the pack insert.
DOSAGE: As directed by Physician.