GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Tigecycline for Injection USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Tigecycline for Injection USP 50mg
Each vial contains:
Tigecycline USP …………………..50mg
Excipients……………………………..q.s

THERAPEUTIC INDICATIONS:

Tigecycline Injection used to treat certain serious bacterial infections including community acquired pneumonia (a lung infection that developed in a person who was not in the hospital), skin infections, and infections of the abdomen (area between the chest and the waist).

DIRECTION OF USE:

For Intravenous Infusion use.
Reconstitute with 5.3ml of 0.9%W/V Sodium Chloride Injection USP or 5%W/V Dextrose Injection USP. Each ml after reconstitution contains Tigecycline 10mg/1ml.
Tigecycline Injection Prior to reconstitution, Tigecycline should be store at 20°C to 25°C excursions permitted to 15°C to 30°C.
Refer package insert for dosage, direction for use, reconstitution details and administration.

CAUTION & WARNING:

CAUTION:
• The injection should not be used It contains visible particulate matter after reconstitution.
• Reconstituted solution must be further diluted for IV Infusion.
• Reconstituted solution should be used immediately after preparation.
• The reconstituted solution will be yellow to orange in color. If not the solution should be discarded.
• Product inside is sealed with flip-off cap or aluminum seal. Do not use if cap or aluminum seal is missing.
• Discard unused portion.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: The recommended dosage regimen for Tigecycline for Injection USP is an initial dose of 100mg followed by 50mg every 12 hours.

Tigecycline for Injection USP 50mg Technical Specification:

Product Name:Tigecycline for Injection USP
Brand Name:TygiSafe
Strength:50mg
Dosage Form:Lyophilized Powder for Injection (SVP)
Packing:Single Dose Vial+ Tray with cover
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, Broad Spectrum Antibiotics (tetracycline)
Indication: Tigecycline Injection used to treat certain serious bacterial infections including community acquired pneumonia (a lung infection that developed in a person who was not in the hospital), skin infections, and infections of the abdomen (area between the chest and the waist).
Storage:Store below 25°C. Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Tigecycline for Injection USP 50mg

 QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Tigecycline for Injection USP 50mg
    Each vial contains:
    Tigecycline USP …………………..50mg
    Excipients……………………………..q.s

THERAPEUTIC INDICATIONS:

Tigecycline Lyophilized Injection used to treat certain serious bacterial infections including community acquired pneumonia (a lung infection that developed in a person who was not in the hospital), skin infections, and infections of the abdomen (area between the chest and the waist).

DIRECTION OF USE:

For Intravenous Infusion use.
Reconstitute with 5.3ml of 0.9%W/V Sodium Chloride Injection USP or 5%W/V Dextrose Injection USP. Each ml after reconstitution contains Tigecycline 10mg/1ml.
Tigecycline Injection Prior to reconstitution, Tigecycline should be store at 20°C to 25°C excursions permitted to 15°C to 30°C.
Refer package insert for dosage, direction for use, reconstitution details and administration.

CAUTION & WARNING:

CAUTION:

  • The injection should not be used It contains visible particulate matter after reconstitution.
  • Reconstituted solution must be further diluted for IV Infusion.
  • Reconstituted solution should be used immediately after preparation.
  • The reconstituted solution will be yellow to orange in color. If not the solution should be discarded.
  • Product inside is sealed with flip-off cap or aluminum seal. Do not use if cap or aluminum seal is missing.
  • Discard unused portion.

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

STORAGE & DOSAGE:

Storage: Store below 25°C.
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.

Dosage: The recommended dosage regimen for Tigecycline for Injection USP is an initial dose of 100mg followed by 50mg every 12 hours.