Ampicillin and Sulbactam for Injection USP 1.5gm

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Ampicillin and Sulbactam for Injection USP 1.5gm
(B) Ampicillin and Sulbactam for Injection USP 3gm
(C) Ampicillin and Sulbactam for Injection USP 750mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Ampicillin and Sulbactam for Injection USP 1.5gm
a) Each Vial contains:
(Sterile) Ampicillin Sodium USP
Eq. to Ampicillin ……………………...1.0 gm
(Sterile) Sulbactam sodium USP
Eq to Sulbactam ………………500 mg
b) Sterile Water for Injection USP….10ml

2. Ampicillin and Sulbactam for Injection USP 3.0gm
a) Each Vial contains:
(Sterile) Ampicillin Sodium USP
Eq. to Ampicillin ……………………...2.0 gm
(Sterile) Sulbactam sodium USP
Eq. to Sulbactam ………………1.0gm
b) Sterile Water for Injection USP….20ml

3. Ampicillin and Sulbactam for Injection USP 750mg
a) Each Vial contains:
(Sterile) Ampicillin Sodium USP
Eq. to Ampicillin ……………………...500mg
(Sterile) Sulbactam sodium USP
Eq. to Sulbactam ………………250mg
b) Sterile Water for Injection USP….5ml

THERAPEUTIC INDICATION:

Ampicillin and Sulbactam injection is used to treat certain infections caused by bacteria, including infections of the skin, female reproductive organs, and abdomen (stomach area).

DIRECTION OF USE:

FOR IV USE: First reconstitute with appropriate amount of diluent as cited in package insert.
Withdraw the entire content of the vial and further dilute with the recommended diluent.
FOR IM USE: See the Reconstitution section of package insert.
After Reconstitution: Depending on the diluent used for reconstitution, solutions may be stored from 2 to 8hrs at a room temperature or from 24 to 72hrs under refrigeration.
Discard Solution stored beyond periods recommended in accompanying professionals’ information.

CAUTION & WARNING:

CAUTION: If any particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING: To be sold by retail on the prescription of a registered medical partitioner only.

STORAGE AND DOSAGE:

STORAGE: Store at 20°C to 25°C (68° to 77°F). See USP controlled room temperature.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Discard any unused portion.
DOSAGE: As directed by the Physician. See the accompanying prescribing information.

Ampicillin and Sulbactam for Injection USP 1.5gm Technical Specification:

Product Name:Ampicillin and Sulbactam for Injection USP 1.5gm
Brand Name:Generics
Strength:1.5gm, 3gm, 750mg
Dosage Form:Sterile Dry Powder Injection
Packing:1 Vial + WFI in Tray
Route of Administration:For IV/IM 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 & Penicillin.
Indication: Ampicillin and Sulbactam injection is used to treat certain infections caused by bacteria, including infections of the skin, female reproductive organs, and abdomen.
Storage:Store at 20°C to 25°C (68° to 77°F). See USP-controlled room temperature.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ampicillin and Sulbactam for Injection USP 1.5gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ampicillin and Sulbactam for Injection USP 1.5gm
    Each Vial contains:
    (Sterile) Ampicillin Sodium USP
    Eq. to Ampicillin ………………………1.0gm
    (Sterile) Sulbactam sodium USP
    Eq to Sulbactam ………………500mg
    Sterile Water for Injection USP….10ml

THERAPEUTIC INDICATION:

Ampicillin and Sulbactam injection is used to treat certain infections caused by bacteria, including infections of the skin, female reproductive organs, and abdomen (stomach area).

DIRECTION OF USE:

For IV USE: First, reconstitute with the appropriate amount of diluent as cited in the package insert.
Withdraw the entire content of the vial and further dilute with the recommended diluent.
FOR IM USE: See the Reconstitution section of the package insert

After Reconstitution: Depending on the diluent used for reconstitution, solutions may be stored from 2 to 8hrs at room temperature or from 24 to 72hrs under refrigeration.
Discard Solutions stored beyond periods recommended in accompanying professionals’ information.

CAUTION & WARNING:

CAUTION: If any particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

WARNING:  To be sold by retail on the prescription of a registered medical partitioner only.

STORAGE AND DOSAGE:

STORAGE: Store at 20°C to 25°C (68° to 77°F). See USP-controlled room temperature.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Discard any unused portion.

DOSAGE: As directed by the Physician.  See the accompanying prescribing information.