GENERIC NAME OF MEDICINAL PRODUCT:

A. Teicoplanin Injection IP 200mg
B. Teicoplanin Injection IP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Teicoplanin Injection IP 200mg
a) Each vial contains:
Teicoplanin IP……….200mg
Excipients……………..q.s
b) This pack also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml

2. Teicoplanin Injection IP 400mg
a) Each vial contains:
Teicoplanin IP……….400mg
Excipients……………..q.s
b) This pack also contains:
One FFS ampule of Sterile Water for Injection IP…….10ml
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THERAPEUTIC INDICATION:

Teicoplanin Injection 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:

Sterile Lyophilized powder for reconstitution with 10ml Sterile Water for Injection I.P.
Reconstituted solution should be administered in a suitable parental fluid prior to IV Infusion.
Do not reconstitution solution if it contains particulate matter or particle return to us for free replacement.
Reconstituted solution should be stored under refrigeration and solution stored for longer than 24 hours should be discarded.
See pack insert for detail information.

CAUTION AND SCHEDULE:

CAUTION: After reconstitute, do not use in case any foreign particulate matter is observed inside the vial and ask for free replacement.
Reconstituted solution should be use immediately after preparation.
Use only after reading the directions on the pack inserts.
Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
SCHEDULE: SCHEDULE 'H PRESCRIPTION DRUG-CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
It is dangerous to take this medicine except in accordance with the medical advice.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C.
Protect from heat and moisture.
Do not freeze.
Reconstitute solution should be stored under refrigeration (5℃) and solutions stored for longer than 24 hours be discarded.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
DOSAGE: As directed by the Physician.

Teicoplanin Injection IP 400mg Technical Specification:

Product Name:Teicoplanin Injection IP 400mg
Brand Name:Teicotaj
Strength:200mg, 400mg
Dosage Form:Lyophilized Powder for Injection (sterile)
Packing:1 Single Use Vial + WFI in a Tray
Route of Administration:For I.M./I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
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. Protect from heat and moisture. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Teicoplanin Injection IP 400mg (Teicotaj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Teicoplanin Injection IP 400mg
    a. Each vial contains:
    Teicoplanin IP……….400mg
    Excipients……………..q.s
    b. This pack also contains:
    One FFS ampule of Sterile Water for Injection IP…….10ml

THERAPEUTIC INDICATION:

Teicoplanin Injection 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:

Sterile Lyophilized powder for reconstitution with 10ml Sterile Water for Injection I.P.
Reconstituted solution should be administered in a suitable parental fluid prior to IV Infusion.

Do not reconstitution solution if it contains particulate matter or particle return to us for free replacement.
Reconstituted solution should be stored under refrigeration and solution stored for longer than 24 hours should be discarded.

See pack insert for detail information.

CAUTION AND SCHEDULE:

CAUTION: After reconstitute, do not use in case any foreign particulate matter is observed inside the vial and ask for free replacement.

Reconstituted solution should be use immediately after preparation.
Use only after reading the directions on the pack inserts.

Discard unused portion.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

SCHEDULE: SCHEDULE ‘H PRESCRIPTION DRUG-CAUTION Not to be sold by retail without the prescription of a Registered Medical Practitioner.
It is dangerous to take this medicine except in accordance with the medical advice.

STORAGE AND DOSAGE:

STORAGE: Store below 25°C.
Protect from heat and moisture.
Do not freeze.
Reconstitute solution should be stored under refrigeration (5℃) and solutions stored for longer than 24 hours be discarded.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.

DOSAGE: As directed by the Physician.