GENERIC NAME OF MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Polymyxin B for Injection USP 7,50,000mg (Pamfotaj)
a) Each vial Contains:
Polymyxin B Sulphate USP
equivalent to Polymyxin B…….. 7,50,000 Units
Excipients………………………………..q.s
b) Sterile Water for Injection IP………………..10ml

B) Polymyxin B for Injection USP 5,00,000mg (Pamfotaj)
a) Each vial Contains:
Polymyxin B Sulphate USP
equivalent to Polymyxin B…….. 5,00,000 Units
Excipients………………………………..q.s
b) Sterile Water for Injection IP………………..10ml

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:

Reconstitute with Sterile Water for Injection IP 10ml.
Sterile Water for Injection IP is included in this pack for reconstitution.
TO BE USED IMMEDIATELY AFTER RECONSTITUTION.
Not recommended routinely because of severe pain at injection sites, particularly infants and children.
Administration Refer Pack Insert for reconstitution.
For further information refer leaflet.

CAUTION AND SCHEDULE:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution.
When this drug is given intramuscularly and/or intrathecally, it should be given only to hospitalized patients so as to provide constant supervision by a physician.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: To be sold by retail on the prescription of Registered Medical Practitioner only.

STORAGE AND DOSAGE:

STORAGE: Store at a temperature not exceeding 25°C.
Store in cool and dry place.
Protected from light.
In the interest of safety, solutions of parenteral use should be stored under refrigeration (2°-8°C) and any unused portions should be discarded after 72 hours.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
KEEP OUT OF REACH OF CHILDREN.
DOSAGE: As directed by Physician.

Polymyxin B for Injection USP 5,00,000 Units Technical Specification:

Product Name:Polymyxin B for Injection USP
Brand Name:Pamfotaj
Strength:7,50,000 Units, 5,00,000 Units
Dosage Form:Lyophilized Dry Powder for Solution for Injection/Infusion (Sterile)
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)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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:Store at a temperature not exceeding 25°C.Store in cool and dry place. Protected from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Polymyxin B for Injection USP 5,00,000 Units (Pamfotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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
    Excipients……………………………q.s
    b. Sterile Water for Injection IP………………..10ml

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:

Reconstitute with Sterile Water for Injection IP 10ml.
Sterile Water for Injection IP is included in this pack for reconstitution.
TO BE USED IMMEDIATELY AFTER RECONSTITUTION.
Not recommended routinely because of severe pain at injection sites, particularly infants and children.
For further information refer leaflet.

CAUTION AND SCHEDULE:

CAUTION: The Injection should not be used if it contains visible particulate matter after reconstitution.
When this drug is given intramuscularly and/or intrathecally, it should be given only to hospitalized patients so as to provide constant supervision by a physician.

SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-CAUTION: To be sold by retail on the prescription of Registered Medical Practitioner only.

STORAGE AND DOSAGE:

STORAGE: Store at a temperature not exceeding 25°C.
Store in cool and dry place.
Protected from light.
In the interest of safety, solutions of parenteral use should be stored under refrigeration (2°-8°C) and any unused portions should be discarded after 72 hours.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
KEEP OUT OF REACH OF CHILDREN.


DOSAGE: As directed by the Physician.