GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Bacitracin Dry Powder for Injection (Lyophilized) 50000 IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Bacitracin Dry Powder for Injection (Lyophilized) 50000 IU
Each gram Contains:
Polymyxin B Sulfate USP 5000 units
equivalent to Polymyxin B
Bacitracin Zinc IP
equivalent to Bacitracin………….400 units
Neomycin Sulphate IP
equivalent to Neomycin………….3400 units
(as preservative)
Water for Injection IP

THERAPEUTIC INDICATIONS:

The treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.The treatment of secondarily infected wounds, ulcers, pyodermas and other superficial skin and eye infections when used as a topically applied solution.To reduce the development of drug-resistant bacteria and maintain the effectiveness and other antibacterial drugs, BaciJect should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Bacitracin is not indicated as an irrigation solution for intraoperative prophylaxis nor for pre-soaking of medical devices or implants prior to surgery. Anaphylactic reactions and nephrotoxicity can occur when bacitracin is used in this manner.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Protect from moisture at a temperature not exceeding 30˚C.
Do not freeze.
Protect from light. store in a cool, dry place.
Dosage: As directed by the Physician.

Bacitracin Dry Powder for Injection (Lyophilized) 50000 IU Technical Specification:

Product Name:
Bacitracin Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:50000 IU
Dosage Form:Dry Powder for Injection (Lyophilized)
Route of Administration:External use
Packing:10s, 30s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antibiotics
Indication: The treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.The treatment of secondarily infected wounds, ulcers, pyodermas and other superficial skin and eye infections when used as a topically applied solution.To reduce the development of drug-resistant bacteria and maintain the effectiveness of BaciJect and other antibacterial drugs, should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Bacitracin is not indicated as an irrigation solution for intraoperative prophylaxis nor for pre-soaking of medical devices or implants prior to surgery. Anaphylactic reactions and nephrotoxicity can occur when bacitracin is used in this manner.
Storage:Protect from moisture at a temperature not exceeding 30˚C. Do not freeze. Protect from light. store in a cool, dry place.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bacitracin Dry Powder for Injection (Lyophilized) 50000 IU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bacitracin Dry Powder for Injection (Lyophilized) 50000 IU
    Each gram Contains:
    Polymyxin B Sulfate USP …………5000 units
    equivalent to Polymyxin B
    Bacitracin Zinc IP
    equivalent to Bacitracin………….400 units
    Neomycin Sulphate IP
    equivalent to Neomycin………….3400 units
    (as preservative)
    Water for Injection IP

THERAPEUTIC INDICATIONS:

The treatment of infants with pneumonia and empyema caused by staphylococci shown to be susceptible to the drug.The treatment of secondarily infected wounds, ulcers, pyodermas and other superficial skin and eye infections when used as a topically applied solution.To reduce the development of drug-resistant bacteria and maintain the effectiveness and other antibacterial drugs, BaciJect should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.Bacitracin is not indicated as an irrigation solution for intraoperative prophylaxis nor for pre-soaking of medical devices or implants prior to surgery. Anaphylactic reactions and nephrotoxicity can occur when bacitracin is used in this manner.

CAUTION & SCHEDULE:

CAUTION:
Read enclosed leaflet before use.
Keep medicine out of reach of children.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Protect from moisture at a temperature not exceeding 30˚C.
Do not freeze.
Protect from light. store in a cool, dry place.
Dosage:As directed by the Physician.