| Product Name: | Tigecycline for Injection USP |
| Brand Name: | TygiSafe |
| Strength: | 50 mg |
| Dosage Form: | Lyophilized Dry Powder for Injection (SVP) *Preservative Free |
| Packing: | 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(Tetracycline) & Anti-biotics (Glycylcycline) |
| Indication: | Tigecycline injection used to treat certain serious infections including community acquired pneumonia, skin infections, and infections of the abdomen. |
| Storage: | Store at room temperature (not more than 25°C); protect from light. Do not freeze. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Tigecycline for Injection USP 50 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Tigecycline for Injection USP 50 mg
Each Vial contains:
(Sterile) Tigecycline USP ……………………………50mg
Excipients………………………………………………………q.s.
THERAPEUTIC INDICATION:
Tigecycline injection used to treat certain serious 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 5ml 0.9% w/v of Sodium Chloride Injection BP or 5% Dextrose Injection BP. Tigecycline reconstituted solution will be yellow to orange in color.
If not the solution should be discarded.
Reconstituted solution should be used immediately after preparation.
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.
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:To sold by the retail on the prescription of a registered medical practitioner only.
STORAGE & DOSAGE:
Storage: Store at room temperature (not more than 25°C); protect from light. <br>Do not freeze.
KEEP MEDICINE 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.