Ticarcillin and Clavulanic acid for Injection USP 3.2gm

GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Ticarcillin and clavulanic acid for Injection USP 3.2gm
(B) Ticarcillin and clavulanic acid for Injection USP 3.1gm
(C) Ticarcillin and clavulanic acid for Injection USP 1.6gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Ticarcillin and clavulanic acid for Injection USP 3.2gm
A. Each vial contains:
(Sterile) Ticarcillin Disodium USP
Equivalent to Ticarcillin …………….3.0gm
(Sterile) Clavulanate Potassium USP
Equivalent to Clavulanic acid……….200mg
B. Sterile Water for Injection USP…….13ml

2. Ticarcillin and clavulanic acid for Injection USP 3.1gm
A. Each vial contains:
(Sterile) Ticarcillin Disodium USP
Equivalent to Ticarcillin …………….3.0gm
(Sterile) Clavulanate Potassium USP
Equivalent to Clavulanic acid……….100mg
B. Sterile Water for Injection USP…….13ml

3. Ticarcillin and clavulanic acid for Injection USP 1.6gm
A. Each vial contains:
(Sterile) Ticarcillin Disodium USP
Equivalent to Ticarcillin …………….1.5gm
(Sterile) Clavulanate Potassium USP
Equivalent to Clavulanic acid……….100mg
B. Sterile Water for Injection USP……13ml

THERAPEUTIC INDICATIONS:

Septicemia, Lower Respiratory Infections, Bone and Joint Infections, Skin and Skin Structure Infections, Urinary Tract Infections, Gynecologic Infections, Intra-abdominal Infections.

DIRECTION OF USE:

Reconstitute with approximately 13 mL Sterile Water for Injection, USP.
Each ml of solution contains approximately 200 mg ticarcillin and 6.7 mg clavulanic acid.
Store solution for no more than 6 hours at room temperature (70°-77°F) or 72 hours under refrigeration (40°F).
This aqueous solution may be further diluted to 100 ml.
Select diluent from I.V. solutions listed in prescribing information. Do not exceed specified storage times.

CAUTION & WARNING:

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

STORAGE & DOSAGE:

STORAGE: Store at 21° to 25°C (70° to 75°F) or below. See USP controlled room temperature.
Keep medicine out of reach of children.
Read enclosed leaflet before use.
DOSAGE: As directed by the Physician. See accompanying folder for complete prescribing information.

Ticarcillin and Clavulanic acid for Injection USP 3.2gm Technical Specification:

Product Name:Ticarcillin and Clavulanic acid for Injection USP 3.2gm
Brand Name:Generic
Strength:3.2gm, 3.1gm,1.6gm
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in tray
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:β-lactam Antibiotic, Anti-bacterial & Anti-biotics, Penicillin Antibiotic
Indication: Septicaemia, Lower Respiratory Infections, Bone and Joint Infections, Skin and Skin Structure Infections, Urinary Tract Infections, Gynaecologic Infections, Intra-abdominal Infections
Storage:Store at 21° to 25°C (70° to 75°F) or below. See USP-controlled room temperature.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ticarcillin and Clavulanic acid for Injection USP 3.2gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ticarcillin and Clavulanic acid for Injection USP 3.2gm
    Each vial contains:
    (Sterile) Ticarcillin Disodium USP
    Equivalent to Ticarcillin …………….3.0gm
    (Sterile) Clavulanate Potassium USP
    Equivalent to Clavulanic acid……….200mg
    Sterile Water for Injection USP…….13ml

THERAPEUTIC INDICATION:

Septicemia, Lower Respiratory Infections, Bone and Joint Infections, Skin and Skin Structure Infections, Urinary Tract Infections, Gynecologic Infections, and Intra-abdominal Infections.

DIRECTION OF USE:

Reconstitute with approximately 13 ml of Sterile Water for Injection, USP.
Each ml of solution contains approximately 200 mg ticarcillin and 6.7 mg clavulanic acid.
Store solution for no more than 6 hours at room temperature (70°-77°F) or 72 hours under refrigeration (40°F).
This aqueous solution may be further diluted to 100 ml. Select diluent from I.V. solutions listed in prescribing information.
Do not exceed specified storage times.

CAUTION & WARNING:

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

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

STORAGE & DOSAGE:

STORAGE: Store at 21° to 25°C (70° to 75°F) or below. See USP-controlled room temperature.
Keep the medicine out of reach of children.
Read the enclosed leaflet before use.

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