Chloroprocaine Hydrochloride Injection USP 600mg/20ml (3%)

GENERIC NAME OF MEDICINAL PRODUCT:

(A) Chloroprocaine Hydrochloride Injection USP 10mg/ml (1%)
(B) Chloroprocaine Hydrochloride Injection USP 20mg/ml (2%)
(C) Chloroprocaine Hydrochloride Injection USP 30mg/ml (3%)
(D) Chloroprocaine Hydrochloride Injection USP 50mg/5ml (1%)
(E) Chloroprocaine Hydrochloride Injection USP 400mg/20ml (2%)
(F) Chloroprocaine Hydrochloride Injection USP 600mg/30ml (2%)
(G) Chloroprocaine Hydrochloride Injection USP 600mg/20ml (3%)
 (H) Chloroprocaine Hydrochloride Injection USP 300mg/30ml (1%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

(A) Chloroprocaine Hydrochloride Injection USP 10mg/ml (1%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………10mg
Excipients………………………………………q.s
Water for Injection USP………………………q.s.

(B) Chloroprocaine Hydrochloride Injection USP 20mg/ml (2%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………20mg
Excipients………………………………………q.s
Water for Injection USP………………………q.s.

(C) Chloroprocaine Hydrochloride Injection USP 30mg/ml (3%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………30mg
Excipients………………………………………q.s
Water for Injection USP………………………q.s.

(D) Chloroprocaine Hydrochloride Injection USP 50mg/5ml (1%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………10mg
Excipients………………………………………q.s
Water for Injection USP………………………q.s.

(E) Chloroprocaine Hydrochloride Injection USP 400mg/20ml (2%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………20mg
Sodium Cholride………………………………4.7mg
Water for Injection USP………………………q.s.

(F) Chloroprocaine Hydrochloride Injection USP 600mg/30ml (2%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………20mg
Sodium chloride……………………………….4.7mg
Disodium EDTA………………………………..0.111mg
Dihydrate Methylparaben…………………….1mg
Water for Injection USP………………………q.s.

(G) Chloroprocaine Hydrochloride Injection USP 600mg/20ml (3%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………30mg
Sodium Cholride………………………………3.3mg
Water for Injection USP………………………q.s.

(H) Chloroprocaine Hydrochloride Injection USP 300mg/30ml (1%)
Each ml contains:
Chloroprocaine Hydrochloride USP……………10mg
Sodium chloride……………………………….6.7mg
Disodium EDTA………………………………..0.111mg
Dihydrate Methylparaben…………………….1mg
Water for Injection USP………………………q.s.

THERAPEUTIC INDICATION:

Chloroprocaine is an ester class local anesthetic and is indicated for neuraxial anesthesia (caudal, epidural, and spinal) and peripheral nerve blocks and obstetric anesthesia (pudendal and paracervical blocks).

CAUTION & WARNING:

CAUTION: NOT TO BE USED IF SOLUTION CONTAINING VISIBLE SOLID PARTICLES
Not for Spinal Anesthesia
 Discard any unused portion.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68° to 77°). See USP controlled room temperature.
KEEP OUT OF REACH OF CHILDREN.
Sterile.
Non pyrogenic.
Dosage: As directed by Physician.

Chloroprocaine Hydrochloride Injection USP 600mg/20ml Technical Specification:

Product Name:Chloroprocaine Hydrochloride Injection USP
Brand Name:(GENERICS)
Strength:(10mg/ml) (1%), (20mg/ml) (2%), (30mg/ml) (3%), (50mg/5ml) (1%), (400mg/20mL) (2%), (600mg/30mL) (2%), (600mg/20mL) (3%), (300mg/30ml)(1%)
Dosage Form:Liquid Injection (Sterile)
Packing:20ml, 30ml vial
Route of Administration:For Infiltration, Nerve Block, Caudal & Epidural Anaesthesia.
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 Anaesthesia
Indication: Chloroprocaine is an ester-class local anesthetic and is indicated for neuraxial anesthesia (caudal, epidural, and spinal) and peripheral nerve blocks, and obstetric anesthesia (pudendal and paracervical blocks).
Storage:Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Chloroprocaine Hydrochloride Injection USP 600mg/20mL (3%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Chloroprocaine Hydrochloride Injection USP 600mg/20mL (3%)
    Each ml contains:
    Chloroprocaine Hydrochloride USP……………30mg 
    Sodium Chloride………………………………3.3mg
    Water for Injection USP………………………q.s.

THERAPEUTIC INDICATION:

Chloroprocaine is an ester-class local anesthetic and is indicated for neuraxial anesthesia (caudal, epidural, and spinal) and peripheral nerve blocks, and obstetric anesthesia (pudendal and paracervical blocks).

CAUTION & Warning:

CAUTION: NOT TO BE USED IF SOLUTION CONTAINS VISIBLE SOLID PARTICLES. 
Not for Spinal Anesthesia.
Discard any unused portion.

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° to 77°). See USP-controlled room temperature.
KEEP OUT OF REACH OF CHILDREN.
Sterile.
Nonpyrogenic.

Dosage: As directed by the Physician.