Ceftriaxone Injection IP 500mg Technical Specification:

Product Name:Ceftriaxone Injection IP 500mg
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 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ceftriaxone Injection IP 500mg
    Each vial contains:
    Ceftriaxone Sodium IP (Sterile)
    Eq. to Anhydrous Ceftriaxone…………500mg
    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 4.8ml of Sterile Water for Injection IP for IV administration or in 1.8ml 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 4.8ml Sterile Water for Injection IP for IV administration or in 1.8ml 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