GENERIC NAME OF MEDICINAL PRODUCT:

A. Bupivacaine Hydrochloride with Dextrose Injection USP 0.75%
B. Bupivacaine Hydrochloride with Dextrose Injection USP 0.5%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Bupivacaine Hydrochloride with Dextrose Injection USP 0.75%
Each ml contains:
Bupivacaine Hydrochloride USP
Equivalent to Anhydrous
Bupivacaine Hydrochloride ……………….7.5mg
Dextrose USP (monohydrate)
Equivalent to Anhydrous Dextose………82.5mg
Water for Injections USP..…………………….q.s

B. Bupivacaine Hydrochloride with Dextrose Injection USP 0.5%
Each ml contains:
Bupivacaine Hydrochloride USP
Equivalent to Anhydrous
Bupivacaine Hydrochloride ……………….5mg
Dextrose USP (monohydrate)
Equivalent to Anhydrous Dextose………80mg
Water for Injections USP..…………………….q.s


THERAPEUTIC INDICATION:

Bupivacaine Hydrochloride in Dextrose Injection is indicated for the production of subarachnoid block (spinal anesthesia).

DIRECTION OF USE:

For Spinal Anesthesia.
See enclosed leaflet for further information.

CAUTION & WARNING:

CAUTION: Do not use in case any foreign particulate matter is observed inside the ampoule.
These ampoules bear a color band signifying that they are easy break ampoules.
Warning: To sold by the retail on the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at temperature 20°C to 25°C (68°F to 77F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.

Bupivacaine Hydrochloride with Dextrose Injection USP 0.5% Technical Specification:

Product Name:Bupivacaine Hydrochloride with Dextrose Injection USP
Brand Name:Generic
Strength:7.5mg/1ml (0.75% in 8.25% Dextrose), 5mg/1ml (0.5%)
Dosage Form:Liquid Injection (Sterile Hyperbaric solution)
Packing:2ml Single Dose Ampoule (0.75%), 4ml Single Dose Ampoule (0.5%)
Route of Administration:For Spinal 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 anesthetic
Indication: Bupivacaine Hydrochloride in Dextrose Injection is indicated for the production of subarachnoid block (spinal anesthesia).
Storage:Store at temperature 20°C to 25°C (68°F to 77F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Bupivacaine Hydrochloride with Dextrose Injection USP 0.5%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bupivacaine Hydrochloride with Dextrose Injection USP 0.5%
    Each ml contains: 
    Bupivacaine Hydrochloride USP
    Equivalent to Anhydrous
    Bupivacaine Hydrochloride ……………….5mg
    Dextrose USP (monohydrate) 
    Equivalent to Anhydrous Dextose………80mg
    Water for Injections USP..…………………….q.s

THERAPEUTIC INDICATION:                               

Bupivacaine Hydrochloride in Dextrose Injection is indicated for the production of subarachnoid block (spinal anesthesia).

DIRECTION OF USE:

For Spinal Anesthesia.
See enclosed leaflet for further information.

CAUTION & Warning:

CAUTION: Do not use in case any foreign particulate matter is observed inside the ampoule. 
These ampoules bear a color band signifying that they are easy break ampoules. 

Warning: To sold by the retail on the prescription of a Registered Medical Practitioner. 

STORAGE & DOSAGE:

Storage: Store at temperature 20°C to 25°C (68°F to 77F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light. 

KEEP MEDICINE OUT OF REACH OF CHILDREN. 

Dosage: As directed by the Physician.