GENERIC NAME OF THE MEDICINAL PRODUCT:

Lornoxicam for Injection 8mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Lornoxicam for Injection 8mg
Composition:
a) Each vial contains:
Lornoxicam………………………8mg
Excipients…………………………q.s.
b) Each FFS Plastic Ampoule contains:
Sterile Water for Injection IP………2ml

THERAPEUTIC INDICATIONS:

Lornoxicam is a non‐steroidal anti‐inflammatory drug (NSAID) that is used as a painkiller (analgesic). A high level of pain relief is experienced by about 45% of those with moderate to severe postoperative dental pain after a single dose of lornoxicam 8 mg, compared to about 10% with placebo.

DIRECTION OF USE:

To be reconstituted with Sterile Water for Injection IP (2ml) provided with the pack. Refer package insert for details.

CAUTION AND SCHEDULE:

CAUTION: The injection should not be used if it contains visible particulate matter after reconstitution.
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 only.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 25°C.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.

Lornoxicam for Injection 8mg Technical Specification:

Product Name:Lornoxicam for Injection
Brand Name:Xloritom Inj
Strength:8mg
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + 1 Ampule + WFI Tray
Route of Administration:For IV/IM use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:NSAIDs
Indication: Lornoxicam is a non‐steroidal anti‐inflammatory drug (NSAID) that is used as a painkiller (analgesic). A high level of pain relief is experienced by about 45% of those with moderate to severe postoperative dental pain after a single dose of lornoxicam 8 mg, compared to about 10% with placebo.
Storage:Store at a temperature not exceeding 25°C. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Lornoxicam for Injection 8mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Lornoxicam for Injection 8mg
    Composition:
    Each vial contains:
    Lornoxicam………………………8mg
    Excipients…………………………q.s.
    Each FFS Plastic Ampoule contains:
    Sterile Water for Injection IP………2ml

THERAPEUTIC INDICATIONS:

Lornoxicam is a non‐steroidal anti‐inflammatory drug (NSAID) that is used as a painkiller (analgesic). A high level of pain relief is experienced by about 45% of those with moderate to severe postoperative dental pain after a single dose of lornoxicam 8 mg, compared to about 10% with placebo.

DIRECTION OF USE:

To be reconstituted with Sterile Water for Injection IP (2ml) provided with the pack. Refer package insert for details.

CAUTION & SCHEDULE:

CAUTION: The injection should not be used if it contains visible particulate matter after reconstitution.

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 only.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 25°C. Do not freeze.

Keep all medicines out of reach of children.

Dosage: As directed by Physician.