Ampicillin Sodium Injection IP 500mg Technical Specification:

Product Name:Ampicillin Sodium Injection IP 500mg
Brand Name:AMP-TAJ
Strength:1gm, 500mg, 250mg
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 & Penicillin.
Indication: Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis and lung, blood, heart, urinary tract, and gastrointestinal tract infections.
Storage:Store Below 25°C. Protect from light & moisture.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ampicillin Sodium Injection IP 500mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ampicillin Sodium Injection IP 500mg
    Each vial contains:
    (Sterile) Ampicillin Sodium IP
    Eq. to Anhydrous
    Ampicillin IP…………500mg
    Sterile water for Injection IP.……… 5ml

THERAPEUTIC INDICATION:

Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and lung, blood, heart, urinary tract, and gastrointestinal tract infections. Ampicillin injection is in a class of medications called penicillins

DIRECTION OF USE:

Reconstitute using 5ml of sterile water for injection IP. The reconstituted solution should be used immediately after preparation Read the enclosed leaflet before reconstitution and use.

CAUTION & 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 ‘H’ DRUG; Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store Below 25°C Protect from light & moisture.
The reconstituted solution should be used immediately after preparation.
Any unused reconstitution portion must be discarded.

KEEP OUT OF REACH OF CHILDREN
DOSAGE: As directed by the Physician.

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Ampicillin Sodium Injection IP 1gm
(B) Ampicillin Sodium Injection IP 500mg
(C) Ampicillin Sodium Injection IP 250mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

2. Ampicillin Sodium Injection IP 500mg
A. Each vial contains:
(Sterile) Ampicillin Sodium IP
Eq. to Anhydrous
Ampicillin IP…………500mg
B. Sterile water for Injection IP ……….…… 5ml


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

THERAPEUTIC INDICATION:

Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and lung, blood, heart, urinary tract, and gastrointestinal tract infections. Ampicillin injection is in a class of medications called penicillins

DIRECTION OF USE:

Reconstitute using 10ml of sterile water for injection IP.
Reconstituted solution should be use immediately after preparation Read enclosed leaflet before reconstitution and use.

CAUTION & 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 'H' DRUG: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store Below 25°C Protect from light & moisture.
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.