GENERIC NAME OF THE MEDICINAL PRODUCT:

(A) Polymyxin B for Injection USP 7,50,000 Units
(B) Polymyxin B for Injection USP 5,00,000 Units

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Polymyxin B for Injection USP 7,50,000 Units
a) Each vial Contains:
Polymyxin B Sulphate USP
equivalent to Polymyxin B……… 7,50,000 Units
b) Excipients…………………q.s.


B) Polymyxin B for Injection USP 5,00,000 Units
a) Each vial Contains:
Polymyxin B Sulphate USP
equivalent to Polymyxin B……… 5,00,000 Units
b) Excipients…………………q.s.

THERAPEUTIC INDICATIONS:

Polymyxin B and trimethoprim combination is used to treat eye infections, including acute bacterial conjunctivitis and blepharoconjunctivitis. Polymyxin B and trimethoprim belong to the class of medicines known as antibiotics. They work by killing the bacteria or preventing their growth.

DIRECTION OF USE:

TO BE USED IMMEDIATELY AFTER RECONSTITUTION
INTRAVENOUS: Dissolve 500,000 polymyxin B units in 300 to 500 ml solutions for parenteral 5% Dextrose Injection for continuous drip.
INTRAMUSCULAR: Dissolve 500,000 polymyxin B units in 2 ml. Sterile Water for Injection or 0.9% Sodium Chloride Injection.
INTRATHECAL: Dissolve 500,000 polymyxin B units in 10 mL 0.9 % Sodium Chloride Injection USP for 50,000 units per ml. dosage unit.

CAUTION & WARNING:

CAUTION: Not recommended routinely because of severe pain at injection sites, particularly in infants and children.
When this drug is given intramuscularly, intravenously or intrathecally, it should be given only to hospitalized patients so as to provide constant supervision by a physician.
Discard unused portion.
WARNING: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Protect from light and moisture, store below 2°-8°C.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
FOR USAGE & RECONSTITUTION REFER LEAFLET
Dosage: As directed by Physician.

Polymyxin B for Injection USP 7,50,000Units Technical Specification:

Product Name:Polymyxin B for Injection USP 7,50,000 Units
Brand Name:Pamfotaj
Strength:7,50,000 Units, 5,00,000 Units
Dosage Form:Lyophilized
Dry Powder for Solution for Injection/Infusion
Packing:1 Vial + WFI in a Tray
Route of Administration:For I.V./ I.M./ Intrathecal use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-fungal & Anti-biotics
Indication: Polymyxin B and trimethoprim combination is used to treat infections, including acute bacterial. They work by killing the bacteria or preventing their growth.
Storage:Protect from light and moisture, store below 2°-8°C. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Polymyxin B for Injection USP 7,50,000 Units

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Polymyxin B for Injection USP 7,50,000 Units
    Each vial Contains:
    Polymyxin B Sulphate USP
    equivalent to Polymyxin B……… 7,50,000 Units
    Excipients…………………………………q.s.

THERAPEUTIC INDICATION:

Polymyxin B and trimethoprim combination is used to treat eye infections, including acute bacterial conjunctivitis and blepharoconjunctivitis. Polymyxin B and trimethoprim belong to the class of medicines known as antibiotics. They work by killing the bacteria or preventing their growth.

DIRECTION OF USE:

TO BE USED IMMEDIATELY AFTER RECONSTITUTION

INTRAVENOUS: Dissolve 500,000 polymyxin B units in 300 to 500 ml solutions for parenteral 5% Dextrose Injection for continuous drip.

INTRAMUSCULAR: Dissolve 500,000 polymyxin B units in 2 ml. Sterile Water for Injection or 0.9% Sodium Chloride Injection.

INTRATHECAL: Dissolve 500,000 polymyxin B units in 10 mL 0.9 % Sodium Chloride Injection USP for 50,000 units per ml. dosage unit.

CAUTION & Warning:

CAUTION: Not recommended routinely because of severe pain at injection sites, particularly in infants and children.

When this drug is given intramuscularly, intravenously or intrathecally, it should be given only to hospitalized patients so as to provide constant supervision by a physician.

Discard unused portion.

Warning: To be sold by the retail on the prescription of a registered medical practitioner only.

STORAGE & DOSAGE:

Storage: Protect from light and moisture, store below 2°-8°C.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

FOR USAGE & RECONSTITUTION REFER LEAFLET

Dosage: As directed by Physician.