GENERIC NAME OF MEDICINAL PRODUCT:

A. Colistimethate Sodium for Injection IP 0.5MIU
B. Colistimethate Sodium for Injection IP 1MIU
C. Colistimethate Sodium for Injection IP 2MIU
D. Colistimethate Sodium for Injection IP 3MIU
E. Colistimethate Sodium for Injection IP 4.5MIU
F. Colistimethate Sodium for Injection IP 5MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Colistimethate Sodium for Injection IP 0.5MIU
a) Each vial contains:
Colistimethate Sodium IP…..5,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

2. Colistimethate Sodium for Injection IP 1MIU
a) Each vial contains:
Colistimethate Sodium IP…..10,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

3. Colistimethate Sodium for Injection IP 2MIU
a) Each vial contains:
Colistimethate Sodium IP…..20,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

4. Colistimethate Sodium for Injection IP 3MIU
a) Each vial contains:
Colistimethate Sodium IP…..30,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml


5. Colistimethate Sodium for Injection IP 4.5MIU
a) Each vial contains:
Colistimethate Sodium IP…..45,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

6. Colistimethate Sodium for Injection IP 5MIU
a) Each vial contains:
Colistimethate Sodium IP…..50,00,000 IU
(IU: International Units)
As sterile powder for reconstitution
Excipients…………………………...q.s.
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

THERAPEUTIC INDICATION:

Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.

DIRECTION OF USE:

Dissolve the contents in Sterile Water for Injection I.P.10ml
The reconstituted solution should be used immediately after the preparation.
Read enclosed leaflet before reconstitution and use.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
Not to be used in food producing animals, poultry, aqua farming and animal feed supplement.
WFI IP Ampule is not manufactured by us.
*Not to be sold without water for injection.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C.
Protect from light and moisture.
Do not freeze.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.

Colistimethate Sodium for Injection I.P. 3MIU Technical Specification:

Product Name:Colistimethate Sodium for Injection I.P. 3MIU
Brand Name:COLISTIN
Strength:0.5MIU(300mg) (5,00,000 IU),
1MIU(600mg) (10,00,000 IU),
2MIU(1200mg) (20,00,000 IU),
3MIU(1800mg) (30,00,000 IU),
4.5MIU(2700mg) (45,00,000 IU),
5MIU(3000mg) (50,00,000 IU)
Dosage Form:Lyophilized Powder for Injection (Sterile)
Packing:1 Single Dose Vial + WFI Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Anti-Infective, Antibacterial, Antibiotics (polymyxin)
Indication: Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.
Storage:Store below 25°C. Protect from light and moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Colistimethate Sodium for Injection IP 3MIU

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Colistimethate Sodium for Injection IP 3MIU
    a. Each vial contains:
    Colistimethate Sodium IP…..30,00,000 IU
    (IU: International Units)
    As sterile powder for reconstitution
    Excipients……………………..q.s
    b. This pack is also contains:
    One FFS ampule of Sterile Water for Injection IP…….10ml

THERAPEUTIC INDICATION:

Colistimethate injection is used to treat certain infections caused by bacteria. Colistimethate injection is in a class of medications called antibiotics. It works by killing bacteria.

DIRECTION OF USE:

Dissolve the contents in Sterile Water for Injection I.P.10ml
The reconstituted solution should be used immediately after the preparation.
Read enclosed leaflet before reconstitution and use.

CAUTION AND SCHEDULE:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, Please do not use the solution.

Not to be used in food producing animals, poultry, aqua farming and animal feed supplement.

WFI IP Ampule is not manufactured by us.
*Not to be sold without water for injection.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard unused portion.

NOTE: WFI IP Ampule is not manufactured by us.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C. Protect from light and moisture. Do not freeze.

KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.