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Tigecycline for Injection USP 50mg (TygiSafe) Tigecycline for Injection USP 50mg Tigecycline for Injection USP 50mg Tigecycline for Injection USP 50mg Tigecycline for Injection USP 50mg Tigecycline for Injection USP 50mg Tigecycline for Injection USP 50mg Tigecycline for Injection USP 50mg Tigecycline for Injection USP 50mg
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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.

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.