Fosfomycin Sodium for Injection 2g Technical Specification:

Product Name:Fosfomycin Sodium for Injection 2g
Brand Name:Fositaj
Strength:500mg, 1g, 2g, 4g, 8g, 10g
Dosage Form:Lyophilized Dry Powder for Injection (Sterile) *Preservative-free
Packing:1 Vial + WFI in a 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-bacterial, Urological Products & broad spectrum bactericidal, Antibiotic
Indication: Fosfomycin Injection is an antibiotic medicine used to treat bacterial infections in your body.
Storage:Before Reconstitution- Store below 25°C. Protect from light and moisture.

After Reconstitution- Final Infusion can be stored up to 24 hours at room temperature or in a refrigerator 2°C to 8°C.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Fosfomycin Sodium for Injection 2g

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Fosfomycin Sodium for Injection 2g
    a)Each vial Contains:
    Fosfomycin Sodium BP
    Eq. to Fosfomycin …………………2g
    Excipients……………………………q.s.
    b)Sterile Water for Injection USP……50ml

THERAPEUTIC INDICATIONS:

Fosfomycin Injection is an antibiotic medicine used to treat bacterial infections in your body. It is effective in some infections of the urinary tract, lungs (e.g., Pneumonia), bones, brain (e.g., Meningitis).

DIRECTION OF USE: 

Use immediately After preparation.

After reconstitution each ml contains 40 mg Fosfomycin.

For method of reconstitution, storage, administration, dosage and indication: Refer to the enclose package insert.

CAUTION & WARNING:

CAUTION: Do not use the injection If the contents are not clear or contains visible particulate matter after reconstitution.

 WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE & DOSAGE:

Storage:
Before Reconstitution– Store below 25°C. Protect from light.
After Reconstitution– Final Infusion that has been produced under aseptic conditions can be stored up to 24 hours at room temperature or in a refrigerator (at 2-8°C), If protected from light. Discard unused portion.

KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Use only after reading the directions on the pack insert.

Dosage: As directed by Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Fosfomycin Sodium for Injection 500mg
B. Fosfomycin Sodium for Injection 1g
C. Fosfomycin Sodium for Injection 2g
D. Fosfomycin Sodium for Injection 4g
E. Fosfomycin Sodium for Injection 8g
F. Fosfomycin Sodium for Injection 10g

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Fosfomycin Sodium for Injection 500mg
i. Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………500mg
Excipients……………………………q.s.
ii. Sterile Water for Injection USP……12.5ml

B. Fosfomycin Sodium for Injection 1g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………1gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……25ml

C. Fosfomycin Sodium for Injection 2g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………2gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……50ml


D. Fosfomycin Sodium for Injection 4g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………4gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……100ml

E. Fosfomycin Sodium for Injection 8g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………8gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……200ml

F. Fosfomycin Sodium for Injection 10g
a) Each vial Contains:
Fosfomycin Sodium BP
Eq. to Fosfomycin ……...…………10gm
Excipients……………………………q.s.
b) Sterile Water for Injection USP……250ml

THERAPEUTIC INDICATIONS:

Fosfomycin Injection is an antibiotic medicine used to treat bacterial infections in your body. It is effective in some infections of the urinary tract, lungs (e.g., Pneumonia), bones, brain (e.g., Meningitis).

DIRECTION OF USE:

Use immediately After preparation.
After reconstitution each ml contains 40 mg Fosfomycin.
For method of reconstitution, storage, administration, dosage and indication: Refer to the enclose package insert.

CAUTION & WARNING:

CAUTION: Do not use the injection If the contents are not clear or contains visible particulate matter after reconstitution.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE & DOSAGE:

Storage:
Before Reconstitution- Store below 25°C. Protect from light.
After Reconstitution- Final Infusion that has been produced under aseptic conditions can be stored up to 24 hours at room temperature or in a refrigerator (at 2-8°C), If protected from light.
Discard unused portion.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Use only after reading the directions on the pack insert.
Dosage: As directed by Physician.