Polymyxin B for Injection USP 7,50,000 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 |
| Packing: | 1 Single Dose 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 (Pamfotaj)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Polymyxin B for Injection USP 7,50,000 Units (Pamfotaj)
a. Each vial Contains:
Polymyxin B Sulphate USP
equivalent to Polymyxin B…….. 7,50,000 Units
b. Sterile Water for Injection BP………………..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:
TO BE USED IMMEDIATELY AFTER RECONSTITUTION.
Reconstitute with Sterile Water for Injection BP 10ml.
INTRAVENOUS: Dissolve 500,000 or 7,50,000 Polymyxin B units in 300 to 500 ml solutions for parenteral 5% Dextrose Injection for continuous drip.
INTRAMUSCULAR: Dissolve 500,000 or 7,50,000 polymyxin B units in 2 ml. Sterile Water for Injection or 0.9% Sodium Chloride Injection.
INTRATHECAL: Dissolve 500,000 or 7,50,000 Polymyxin B units in 10 mL 0.9 % Sodium Chloride Injection USP for 50,000 units per ml. dosage unit.
FOR USAGE & RECONSTITUTION REFER LEAFLET.
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.
The Injection should not be used if it contains visible particulate matter after reconstitution.
Warning: To be sold by the retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Store at 2°-8°C.
Protect from light and moisture.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TEMPER EVIDENCE.
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.
Dosage: As directed by the Physician.
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
(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.
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.
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.
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.
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.
