GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Colistimethate Sodium for Injection BP 0.25 MIU (COLISTIN)
B. Colistimethate Sodium for Injection BP 0.5 MIU (COLISTIN)
C. Colistimethate Sodium for Injection BP 1 MIU (COLISTIN)
D. Colistimethate Sodium for Injection BP 2 MIU (COLISTIN)
E. Colistimethate Sodium for Injection BP 3 MIU (COLISTIN)
F. Colistimethate Sodium for Injection BP 4.5MIU (COLISTIN)
G. Colistimethate Sodium for Injection BP 5MIU (COLISTIN)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Colistimethate Sodium for Injection BP 0.25 MIU
a) Each vial contains:
Colistimethate Sodium BP………… 2,50,000 IU
As sterile powder for reconstitution
Excipients…………………………………. q. s
b) This pack is also contains:
One FFS ampule of Sterile Water for Injection BP…….10ml

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

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

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


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

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

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

THERAPEUTIC INDICATIONS:

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 BP 10ml.
The re-constituted solution should be used immediately after the preparation.
The Pack Also Contain one FFS Ampule of 10ml Sterile Water for Injection BP.
As Sterile Water for reconstitution.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the content Please, do not use the solution.
Discard unused portion.
WFI IP Ampule is not manufactured by us.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store in cool and dry place.
Store at 2°C to 8°C.
Do not freeze.
It not used immediately; the reconstituted solution can be stored at up to 25°C for up to 24 hours.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Dosage: As directed by Physician.

Colistimethate Sodium for Injection BP 2 MIU Technical Specification:

Product Name:Colistimethate Sodium for Injection BP
Brand Name:COLISTIN
Strength:0.25 MIU (150mg) (2,50,000 IU),
0.5 MIU (300mg) (5,00,000 IU),
1 MIU (600mg) (10,00,000 IU),
2 MIU (1200mg) (20,00,000 IU),
3 MIU (1800mg) (30,00,000 IU),
4.5 MIU (2700mg) (45,00,000 IU),
5 MIU (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), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
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 between 20°C to 25°C (68°F to 77°F)
Store reconstitued solution in refrigerator 2°C to 8°C (36°F to 46°F) or between 20°C to 25°C (68°F to 77°F).

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Colistimethate Sodium for Injection BP 2 MIU (COLISTIN)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

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

THERAPEUTIC INDICATIONS:

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 BP 10ml.
The re-constituted solution should be used immediately after the preparation.
The Pack Also Contain one FFS Ampule of 10ml Sterile Water for Injection BP.
As Sterile Water for reconstitution.

 CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the content Please, do not use the solution.
Discard unused portion.
WFI IP Ampule is not manufactured by us.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store in cool and dry place.
Store at 2°C to 8°C.
Do not freeze.
It not used immediately; the reconstituted solution can be stored at up to 25°C for up to 24 hours.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Dosage: As directed by Physician.