GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Ampicillin Sodium Powder for Injection 2000 mg
B. Ampicillin Sodium Powder for Injection 1000 mg
C. Ampicillin Sodium Powder for Injection 500 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Ampicillin Sodium Powder for Injection 2000 mg
Each vial contains:
Ampicillin Sodium BP
Equivalent to Ampicillin (Anhydrous)……………….2000mg
Buffering Agent ……………………………………………q.s.
Powder for solution for injection.

b) Ampicillin Sodium Powder for Injection 1000 mg
Each vial contains:
Ampicillin Sodium BP Equivalent to Ampicillin (Anhydrous)……………….1000mg
Buffering Agent ……………………………………………q.s.
Powder for solution for injection.


c) Ampicillin Sodium Powder for Injection 500 mg
Each vial contains:
Ampicillin Sodium BP
Equivalent to Ampicillin (Anhydrous)……………….500mg
Buffering Agent ……………………………………………q.s.
Powder for solution for injection.

THERAPEUTIC INDICATIONS:

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:

For I.V./I.M. use
Dissolve the contents in sterile Water for Injection USP 20ml.
For full prescribing information and direction on reconstitution, see enclosed package insert.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter after reconstitution.
Intravenous route over a period of at least 10-15 minutes.
More rapid administration may result in major seizures.
Contraindications: A history of a previous hypersensitivity reaction to any of the penicillin’s is a Contraindication.
MUST BE DILUTED BEFORE INFUTION.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner. Keep well closed.
Single Dose Only.

STORAGE & DOSAGE:

Storage: Store between 20°C to 25°C (68°F to 77°F)
Protect from light and moisture. Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Ampicillin Sodium Powder for Injection 1000mg Technical Specification:

Product Name:Ampicillin Sodium Powder for Injection
Brand Name:Generics
Strength:500 mg, 1000mg, 2000mg
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Vial + WFI Tray
Route of Administration:For I.V./I.M. use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antibacterial, Antibiotics(polymyxin)
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 penicillin’s.
Storage:Store dry powder at 20° to 25°C (68° to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Ampicillin Sodium Powder for Injection 2000 mg
B. Ampicillin Sodium Powder for Injection 1000 mg

C. Ampicillin Sodium Powder for Injection 500 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  1. Ampicillin Sodium Powder for Injection 2000 mg
    Each vial contains:
    Ampicillin Sodium BP
    Equivalent to Ampicillin (Anhydrous)……………….2000mg
    Buffering Agent ……………………………………………q.s.
    Powder for solution for injection.
  2. Ampicillin Sodium Powder for Injection 1000 mg
    Each vial contains:
    Ampicillin Sodium BP
    Equivalent to Ampicillin (Anhydrous)……………….1000mg
    Buffering Agent ……………………………………………q.s.
    Powder for solution for injection.
  3. Ampicillin Sodium Powder for Injection 500 mg
    Each vial contains:
    Ampicillin Sodium BP
    Equivalent to Ampicillin (Anhydrous)……………….500mg
    Buffering Agent ……………………………………………q.s.
    Powder for solution for injection.

THERAPEUTIC INDICATIONS:

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:

For I.V./I.M. use

Dissolve the contents in sterile Water for Injection USP 20ml.

For full prescribing information and direction on reconstitution, see enclosed package insert.

CAUTION & Warning:

CAUTION:  The injection should not be used It contains visible particulate matter after reconstitution.

Intravenous route over a period of at least 10-15 minutes.

More rapid administration may result in major seizures.

Contraindications: A history of a previous hypersensitivity reaction to any of the penicillin’s is a Contraindication.

MUST BE DILUTED BEFORE INFUSION.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Warning:  Not to be sold by retail without the prescription of a Registered Medical Practitioner.

Keep well closed.

Single Dose Only.

STORAGE & DOSAGE:

Storage: Store between 20°C to 25°C (68°F to 77°F)

Protect from light and moisture. Do not freeze.

Keep all medicines out of reach of children.

Dosage:  As directed by the Physician.