GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Lidocaine Hydrochloride Injection USP 10mg/1ml (1%)
B. Lidocaine Hydrochloride Injection USP 20mg/1ml (2%)
C. Lidocaine Hydrochloride Injection USP 5mg/1ml (0.5%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Lidocaine Hydrochloride Injection USP 10mg/1ml (1%)
Each ml contains:
Lidocaine Hydrochloride Anhydrous USP
Eq to Lidocaine Hydrochloride…………..10mg
Sodium chloride USP………………………….7mg
Methylparaben USP (preservative)…….1mg
Water for Injection USP……………………..q.s

B. Lidocaine Hydrochloride Injection USP 20mg/1ml (2%)
Each ml contains:
Lidocaine Hydrochloride Anhydrous USP
Eq to Lidocaine Hydrochloride ……….20mg
Sodium chloride USP………………………6mg
Methylparaben USP(preservative)….1mg
Water for Injection USP………………….q.s


C. Lidocaine Hydrochloride Injection USP 5mg/1ml (0.5%)
Each ml contains:
Lidocaine Hydrochloride Anhydrous USP
Eq to Lidocaine Hydrochloride …..5mg
Sodium chloride…………………………8mg
Methylparaben (preservative)……1mg
Water for Injection USP……………..q.s

THERAPEUTIC INDICATIONS:

Lignocaine Injection belongs to two groups of medicines known as local anaesthetics and antiarrhythmic drugs. Local anaesthetics stop pain and feeling in the area around where it is injected; and antiarrhythmic drugs work by restoring irregular and/or rapid heartbeats to normal.

DIRECTION OF USE:

For Infiltration and Nerve Block.
Use Aseptic Technique. Remove cover from plastic vial and cleanse stopper with antiseptic.
See package insert for full prescribing information.

CAUTION & WARNING:

CAUTION: The injection should not be used if it contains visible particulate matter.
Not for Epidural or Caudal use.
Use only if seal is intact and undamaged.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F)
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Lidocaine Hydrochloride Injection USP 20mg/1ml (2%) Technical Specification:

Product Name:Lidocaine Hydrochloride Injection USP
Brand Name:Generic
Strength:10mg/1ml (1%),   20mg/1ml (2%), 5mg/1ml (0.5%)
Dosage Form:Liquid Injection (Sterile and Nonpyrogenic)
Packing:1%(2ml, 5ml, 10ml 20ml,30ml, 50ml Vial/Ampoule),
2%(2ml, 5ml, 10ml, 20ml, 50ml Vial/Ampoule),
0.5%(50ml Vial)
Route of Administration:For Infiltration and Nerve Block
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Local Anaesthetic, Antiarrhythmic (Class IB)
Indication: Lignocaine Injection belongs to two groups of medicines known as local anaesthetics and antiarrhythmic drugs. Local anaesthetics stop pain and feeling in the area around where it is injected; and antiarrhythmic drugs work by restoring irregular and/or rapid heartbeats to normal.
Storage:Store at 20°C to 25°C (68°F to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Lidocaine Hydrochloride Injection USP 20mg/1ml (2%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Lidocaine Hydrochloride Injection USP 20mg/1ml (2%)
    Each ml contains:
    Lidocaine Hydrochloride Anhydrous USP
    Eq to Lidocaine Hydrochloride…………..20mg
    Sodium chloride USP………………………….6mg
    Methylparaben USP (preservative)…….1mg
    Water for Injection USP……………………..q.s

THERAPEUTIC INDICATIONS:

Lignocaine Injection belongs to two groups of medicines known as local anaesthetics and antiarrhythmic drugs. Local anaesthetics stop pain and feeling in the area around where it is injected; and antiarrhythmic drugs work by restoring irregular and/or rapid heartbeats to normal.

DIRECTION OF USE:

For Infiltration and Nerve Block.
Use Aseptic Technique. Remove cover from plastic vial and cleanse stopper with antiseptic.
See package insert for full prescribing information.

CAUTION & Warning:

CAUTION: The injection should not be used if it contains visible particulate matter.
Not for Epidural or Caudal use.
Use only if seal is intact and undamaged.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.