Ceftriaxone & Sulbactam for Injection 187.5mg Technical Specification:

Product Name:Ceftriaxone & Sulbactam for Injection 187.5mg
Brand Name:CEPTRATAJ -S
Strength:1.5gm, 750mg, 375mg, 187.5mg
Dosage Form:Dry Powder Injection (Sterile)
Packing:Vial + WFI in Tray
Route of Administration:For I.M./ I.V. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:β-lactam Antibiotic, Anti-bacterial & Cephalosporin.
Indication: Ceftriaxone & Sulbactam for Injection is indicated in Sepsis, Meningitis, Abdominal Infections, infections of the Bones, Renal, UTIs, Pneumonia, Ear, Nose, and Throat Infections, and uncomplicated gonorrhea.
Storage:Store Below 25°C Protect from light & moisture

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ceftriaxone & Sulbactam for Injection 187.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ceftriaxone & Sulbactam for Injection 187.5mg
    Each vial contains:
    Ceftriaxone Sodium IP (Sterile)
    Eq. to Anhydrous Ceftriaxone …………125mg
    Sulbactam Sodium IP (Sterile)
    Eq. to Anhydrous Sulbactam …………62.5mg
    Sterile water for Injection IP ……….……… 5ml

THERAPEUTIC INDICATION:

Ceftriaxone & Sulbactam for Injection is indicated in Sepsis, Meningitis, Abdominal Infections, infections of the Bones, Renal, UTIs, Pneumonia, Ear, Nose, and Throat Infections, and uncomplicated gonorrhea.

DIRECTION OF USE:

Reconstitute with 10 ml of Sterile Water for Injection IP supplied with pack as required.

Prick the ampoule of Sterile Water for Injection IP only once and discard the unused portion.

Reconstituted solution should be use immediately after preparation.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE: SCHEDULE ‘H1’ DRUG:

-It is dangerous to take this preparation except in accordance with the medical advice.

-Not to be sold by retail without the prescription of Registered Medical Practitioner.

KEEP OUT OF REACH OF CHILDREN.

*Not to be sold without water for Injection.

STORAGE AND DOSAGE:

STORAGE:  Store Below 25°C.
Protect from light & moisture.
Do not freeze.

DOSAGE:  As directed by Physician.

Note: Water for Injection IP Ampoule is not manufactured by us.

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Ceftriaxone & Sulbactam for Injection 1.5gm
(B) Ceftriaxone & Sulbactam for Injection 750mg
(C) Ceftriaxone & Sulbactam for Injection 375mg
(D) Ceftriaxone & Sulbactam for Injection 187.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Ceftriaxone & Sulbactam for Injection 1.5gm
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone …………1000mg
Sulbactam Sodium IP (Sterile)
Eq. to Anhydrous Sulbactam …………500mg
B. Sterile water for Injection IP ……….……… 10ml

2. Ceftriaxone & Sulbactam for Injection 750mg
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone …………500mg
Sulbactam Sodium IP (Sterile)
Eq. to Anhydrous Sulbactam …………250mg
B. Sterile water for Injection IP ……….………10ml

3. Ceftriaxone & Sulbactam for Injection 375mg
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone …………250mg
Sulbactam Sodium IP (Sterile)
Eq. to Anhydrous Sulbactam …………125mg
B. Sterile water for Injection IP ……….………5ml

4. Ceftriaxone & Sulbactam for Injection 187.5mg
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone …………125mg
Sulbactam Sodium IP (Sterile)
Eq. to Anhydrous Sulbactam …………62.5mg
B. Sterile water for Injection IP ……….………5ml


THERAPEUTIC INDICATION:

Ceftriaxone & Sulbactam for Injection is indicated in Sepsis, Meningitis, Abdominal Infections, infections of the Bones, Joints, Soft tissue, Skin and of wounds, Renal and Urinary Tract Infections, Respiratory tract Infections, particularly Pneumonia, and Ear, Nose and Throat Infections, and uncomplicated gonorrhea.

DIRECTION OF USE:

Reconstitute with 10 ml of Sterile Water for Injection IP supplied with pack as required.
Prick the ampoule of Sterile Water for Injection IP only once and discard the unused portion.
Reconstituted solution should be use immediately after preparation.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H1' DRUG:
-It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of Registered Medical Practitioner.
KEEP OUT OF REACH OF CHILDREN.
*Not to be sold without water for Injection.

STORAGE AND DOSAGE:

STORAGE: Store Below 25°C.
Protect from light & moisture.
Do not freeze.
DOSAGE: As directed by Physician.
Note: Water for Injection IP Ampoule is not manufactured by us.