Ceftriaxone Injection IP 1gm Technical Specification:

Product Name:Ceftriaxone Injection IP 1gm
Brand Name:CEFTRATAJ
Strength:1gm, 2gm, 500mg, 250mg, 125mg
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 is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics.
Storage:Store protected from light at a temperature not exceeding 30°C. Keep away from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ceftriaxone Injection IP 1gm

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ceftriaxone Injection IP 1gm
    Each vial contains:
    Ceftriaxone Sodium IP (Sterile)
    Eq. to Anhydrous Ceftriaxone…………1000mg
    Sterile water for Injection IP ……….……… 10ml

THERAPEUTIC INDICATION:

Ceftriaxone is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics.

DIRECTION OF USE:

Dissolve the contents in 9.6 ml of Sterile Water for Injection IP for IV administration or in 3.6 ml for IM administration. Not to be used if the solution contains particles/suspended matter.
The reconstituted solution should be used 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 medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store protected from light at a temperature not exceeding 30°C. Keep away from light. Do not freeze.
The reconstituted solution should be used immediately after preparation.

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Ceftriaxone Injection IP 1gm
(B) Ceftriaxone Injection IP 2gm
(C) Ceftriaxone Injection IP 500mg
(D) Ceftriaxone Injection IP 250mg
(E) Ceftriaxone Injection IP 125mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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


2. Ceftriaxone Injection IP 2gm
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone…………2000mg
B. Sterile water for Injection IP ……….…… 20ml

3. Ceftriaxone Injection IP 500mg
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone…………500mg
B. Sterile Water for Injection IP…………….5ml

4. Ceftriaxone Injection IP 250mg
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone…………250mg
B. Sterile Water for Injection IP…………….5ml

5. Ceftriaxone Injection IP 125mg
A. Each vial contains:
Ceftriaxone Sodium IP (Sterile)
Eq. to Anhydrous Ceftriaxone…………125mg
B. Sterile Water for Injection IP…………….5ml

THERAPEUTIC INDICATION:

Ceftriaxone is used to treat a wide variety of bacterial infections. This medication belongs to a class of drugs known as cephalosporin antibiotics.

DIRECTION OF USE:

Dissolve the contents in 9.6 ml Sterile Water for Injection IP for IV administration or in 3.6 ml for IM administration.
Not to be used if solution contains particles/suspended matter. The reconstituted solution should be used 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.

STORAGE AND DOSAGE:

STORAGE: Store protected from light at a temperature not exceeding 30°C. Keep away from light. Do not freeze.
Reconstituted solution should be use immediately after preparation.
Any unused reconstitution portion must be discarded.
KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by Physician