A. Teicoplanin for Injection 200mg
B. Teicoplanin for Injection 400mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Teicoplanin for Injection 200mg
a) Each vial contains:
Teicoplanin……….200mg
Excipients…………q.s.
b) This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….10ml
2. Teicoplanin for Injection 400mg
a) Each vial contains:
Teicoplanin……….400mg
Excipients……………..q.s.
b) This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….10ml
a) Each vial contains:
Teicoplanin……….200mg
Excipients…………q.s.
b) This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….10ml
2. Teicoplanin for Injection 400mg
a) Each vial contains:
Teicoplanin……….400mg
Excipients……………..q.s.
b) This pack also contains:
One FFS ampule of Sterile Water for Injection USP…….10ml
THERAPEUTIC INDICATIONS:
Teicoplanin is used in the treatment of severe bacterial infections in hospitalized patients. It treats infections of skin & soft tissues, blood, heart, bones and lungs (pneumonia). Teicoplanin is an antibiotic. It kills bacteria by preventing them from forming the bacterial protective covering (cell wall) which is needed for them to survive.
DIRECTION OF USE:
As sterile freeze-dried powder for Reconstitution with Sterile water for Injection 10ml.
Reconstituted solution should be administered in a suitable parental fluid prior to IV Infusion.
Reconstituted solution should be stored under refrigeration and solution stored for longer than 24 hours should be discarded.
Read enclosed leaflet for reconstitution & administration and for further information.
Reconstituted solution should be administered in a suitable parental fluid prior to IV Infusion.
Reconstituted solution should be stored under refrigeration and solution stored for longer than 24 hours should be discarded.
Read enclosed leaflet for reconstitution & administration and for further information.
CAUTION & WARNING:
CAUTION: After reconstitution do not use in case any foreign particulate matter is observed. Do not use the solution & return for the replacement.
Use only after reading the directions on the pack insert.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING:
-It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Use only after reading the directions on the pack insert.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
WARNING:
-It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
STORAGE: Store below 25°C (77°F).
Protect from heat and moisture.
Do not freeze.
Keep all medicines out of reach of children.
DOSAGE: As directed by the Physician.
Protect from heat and moisture.
Do not freeze.
Keep all medicines out of reach of children.
DOSAGE: As directed by the Physician.
Teicoplanin for Injection 400mg Technical Specification:
| Product Name: | Teicoplanin for Injection 400mg |
| Brand Name: | Teicotaj |
| Strength: | 200mg, 400mg |
| Dosage Form: | Lyophilized Powder for Injection (Sterile) |
| Packing: | 1 Glass Vial + WFI in a Tray |
| Route of Administration: | For I.M./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: | Antibacterials, Anti-Infectives, Antibiotic (glycopeptide) |
| Indication: | Teicoplanin is used in the treatment of severe bacterial infections in hospitalized patients. It treats infections of skin & soft tissues, blood, heart, bones and lungs (pneumonia). Teicoplanin is an antibiotic. It kills bacteria by preventing them from forming the bacterial protective covering (cell wall) which is needed for them to survive. |
| Storage: | Store below 25°C (77°F). Protect from light and moisture. Do not freeze. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Teicoplanin for Injection 400mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Teicoplanin for Injection 400mg
a. Each vial contains:
Teicoplanin……….400mg
Excipients…………q.s
b. This pack also contains:
One FFS ampule of Sterile Water for Injection BP…….10ml
THERAPEUTIC INDICATIONS:
Teicoplanin is used in the treatment of severe bacterial infections in hospitalized patients. It treats infections of skin & soft tissues, blood, heart, bones and lungs (pneumonia). Teicoplanin is an antibiotic. It kills bacteria by preventing them from forming the bacterial protective covering (cell wall) which is needed for them to survive.
DIRECTION OF USE:
As sterile freeze-dried powder for Reconstitution with Sterile water for Injection 10ml.
Reconstituted solution should be administered in a suitable parental fluid prior to IV Infusion.
Reconstituted solution should be stored under refrigeration and solution stored for longer than 24 hours should be discarded.
Read enclosed leaflet for reconstitution & administration and for further information.
CAUTION & Warning:
CAUTION: After reconstitution do not use in case any foreign particulate matter is observed. Do not use the solution & return for the replacement.
Use only after reading the directions on the pack insert.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning:
-It is dangerous to take this preparation except in accordance with the medical advice.
-Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 25°C (77°F).
Protect from heat and moisture.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.
