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Bupivacaine Hydrochloride Injection USP 0.50% Bupivacaine HCL Injection USP 0.50% Bupivacaine HCL Injection USP 0.50% Bupivacaine HCL Injection USP 0.50% Bupivacaine HCL Injection USP 0.50%

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Bupivacaine Hydrochloride Injection USP 0.25%
B. Bupivacaine Hydrochloride Injection USP 0.50%
C. Bupivacaine Hydrochloride Injection USP 0.75%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Bupivacaine Hydrochloride Injection USP 0.25%
Each ml contains:
Bupivacaine Hydrochloride USP…………..2.5mg
Sodium Chloride USP (for isotonicity)….8.0mg
Water for Injection USP……………………....q.s

B. Bupivacaine Hydrochloride Injection USP 0.50%
Each ml contains:
Bupivacaine Hydrochloride USP………….5mg
Sodium Chloride USP (for isotonicity)….8.0mg
Water for Injection USP…………………….…q.s

C. Bupivacaine Hydrochloride Injection USP 0.75%
Each ml contains:
Bupivacaine Hydrochloride USP….………7.5mg
Sodium Chloride USP (for isotonicity)….8.0mg
Water for Injection USP……………………….q.s

THERAPEUTIC INDICATIONS:

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.

PACKING:

(A) 0.25% (2.5mg/ml)
25mg/10ml (10ml Single Dose Vial)
50mg/20ml (20ml Single Dose Vial)
75mg/30ml (30ml Single Dose Vial)
125mg/50ml (50ml Multiple Dose Vial)

(B) 0.5% (5mg/ml)
50mg/10ml (10ml Single Dose Vial)
100mg/20ml (20ml Single Dose Vial)
150mg/30ml (30ml Single Dose Vial)
250mg/50ml (50ml Multiple Dose Vial)

(C) 0.75% (7.5mg/ml)
75mg/10ml (10ml Single Dose Vial)
225mg/30ml (30ml Single Dose Vial)

DIRECTION OF USE:

• Bupivacaine Hydrochloride Injection0.25% is for INFILTATION, NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
• Bupivacaine Hydrochloride Injection0.5% is for NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
• Bupivacaine Hydrochloride Injection0.75% is for EPIDURAL AND RETROBULBAR ANESTHESIA and not for Obstetric anesthesia.
• A healthcare professional will administer the Bupivacaine Hydrochloride Injection, do not self-administer.
• Refer package insert for full prescribing information.

CAUTION & WARNING:

CAUTION: Do not use if any foreign particulate matter is visible.
Not for spinal anesthesia.
Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia.
Do not dispose of container causing pollution of the environment.
Arrange for collection of controlled waste.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20 to 25°C (68°F to 77°F).
The expiry date refers to the product properly stored, in its package.
Keep all medicines out of reach of children.
Dosage: Refer package insert for full prescribing information.

Bupivacaine Hydrochloride Injection USP 0.50% Technical Specification:

Product Name:Bupivacaine Hydrochloride Injection USP
Brand Name:Generic
Strength:0.25%,   0.50%,   0.75%
Dosage Form:Liquid Injection
Packing:Single Dose and Multi Dose Vials
Route of Administration:0.25%-is for INFILTATION, NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
0.50%-is for NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
0.75% is for EPIDURAL AND RETROBULBAR ANESTHESIA.
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
Indication: Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.
Storage:Store at 20°C to 25°C (68°F to 77°F)

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bupivacaine Hydrochloride Injection USP 0.50%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bupivacaine Hydrochloride Injection USP 0.50%
    Each ml contains:
    Bupivacaine Hydrochloride USP…………..5mg
    Sodium Chloride USP (for isotonicity)…….8.0mg
    Water for Injection USP…………………….q.s

THERAPEUTIC INDICATIONS:

Bupivacaine injection is used to numb an area of your body during or after surgery or other procedures, childbirth, or dental work. This medicine is also used to numb your shoulder after surgery for up to 72 hours.

PACKING:

  • 0.50% (5mg/ml)
    50mg/10ml (10ml Single Dose Vial)
    100mg/20ml (20ml Single Dose Vial)
    150mg/30ml (30ml Single Dose Vial)
    250mg/50ml (50ml Multiple Dose Vial)

DIRECTION OF USE:

Bupivacaine Hydrochloride Injection0.25% is for INFILTATION, NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
Bupivacaine Hydrochloride Injection0.5% is for NERVE BLOCK, CAUDAL and EPIDURAL ANESTHESIA.
Bupivacaine Hydrochloride Injection0.75% is for EPIDURAL AND RETROBULBAR ANESTHESIA and not for Obstetric anesthesia.
A healthcare professional will administer the Bupivacaine Hydrochloride Injection, do not self-administer.
Refer package insert for full prescribing information.

CAUTION & WARNING:

CAUTION:

Do not use if any foreign particulate matter is visible.
Not for spinal anesthesia.
Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia.
Do not dispose of container causing pollution of the environment.
Arrange for collection of controlled waste.

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

STORAGE & DOSAGE:

Storage: Store at 20 to 25°C (68°F to 77°F).
The expiry date refers to the product properly stored, in its package.
Keep all medicines out of reach of children.

Dosage: Refer package insert for full prescribing information.