Bupivacaine Hydrochloride and Epinephrine Injection USP 0.25%+ (1:200,000)

GENERIC NAME OF MEDICINAL PRODUCT:

A. Bupivacaine Hydrochloride and Epinephrine Injection USP 0.25%+ (1:200,000)
B. Bupivacaine Hydrochloride and Epinephrine Injection USP 0.5%+ (1:200,000)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Bupivacaine Hydrochloride and Epinephrine Injection 0.25%+ (1:200,000)
Each ml contains:
Bupivacaine Hydrochloride USP
Eq to Anhydrous Bupivacaine Hydrochloride …………………2.5mg
Epinephrine USP……………..5mcg
Sodium Chloride USP………8.5mg
Sodium Metabisulfite USP……….0.1mg
Edetate Calcium Disodium
Eq to Anhydrous Edetate Calcium Disodium USP…..0.1mg
(As stabilizer)
Methylparaben USP……..1mg
(As preservative)
Water for Injection USP………...….q.s

B. Bupivacaine Hydrochloride and Epinephrine Injection 0.5%+ (1:200,000)
Each ml contains:
Bupivacaine Hydrochloride USP
Eq to Anhydrous Bupivacaine Hydrochloride …………………5mg
Epinephrine USP……………..5mcg
Sodium Chloride USP………8.5mg
Sodium Metabisulfite USP……….0.1mg
Edetate Calcium Disodium
Eq to Anhydrous Edetate Calcium Disodium USP…..0.1mg
(As stabilizer)
Methylparaben USP……..1mg
(As preservative)
Water for Injection USP………...….q.s

THERAPEUTIC INDICATION:

Bupivacaine and epinephrine combination injection is used to numb an area of your body during surgery or other procedures, childbirth, or dental work.

DIRECTION OF USE:

Use Aseptic Technique:
1. Remove tab. Cleanse stopper with antiseptic.
2. Withdraw desired amount of solution.
3. Discard unused portion.
Alternately
1. Remove tab, overseal and stopper.
2. Pour contents into sterile vessel.
3. Discard unused portion.

PACKING:

0.25%+ (1:200,000) – 25mg/10ml -Single Dose Vial (2.5mg/ml)
0.25%+ (1:200,000) - 75mg/30ml -Single Dose Vial (2.5mg/ml)
0.25%+ (1:200,000)- 125mg/50ml- Multiple-Dose Vial (2.5mg/ml)
0.5%+ (1:200,000) - 50mg/10ml- Single Dose Vial (5mg/ml)
0.5%+ (1:200,000) - 150mg/30ml- Single Dose Vial (5mg/ml)
0.5%+ (1:200,000) - 250mg/50ml- Multiple-Dose Vial (5mg/ml)

CAUTION & WARNING:

CAUTION: Do not use the Injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Not for Caudal, Epidural or Spinal Anesthesia. (0.5%)
Not for Spinal Anesthesia. (0.25%)
Discard unused portion after initial use.
Warning: To sold by the retail on the prescription of a Registered Medical Practitioner.
Contains Sulfites.
Contains Epinephrine - Do not autoclave.

STORAGE & DOSAGE:

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

Bupivacaine Hydrochloride and Epinephrine Injection USP 0.25%+ (1:200,000) Technical Specification:

Product Name:Bupivacaine Hydrochloride and Epinephrine Injection USP
Brand Name:Generic
Strength:0.25%+ (1:200,000), 0.5%+ (1:200,000)
Dosage Form:Liquid Injection
Packing:10ml, 30ml Single Dose Vial & 50ml Multiple-Dose Vial (Sterile and Nonpyrogenic)
Route of Administration:0.25%+ (1:200,000)- For Infiltration and Nerve Block (For Multiple-Dose Vial)
0.25%+ (1:200,000)- For Infiltration, Nerve Block, Caudal and Epidural Anesthesia (For Single Dose Vial)
0.5%+ (1:200,000)- For Nerve Block Only (For Multiple-Dose Vial)
0.5%+ (1:200,000)- For Nerve Block, Caudal and Epidural Anesthesia (For Single Dose Vial)
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 and epinephrine combination injection is used to numb an area of your body during surgery or other procedures, childbirth, or dental work.
Storage:Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Protect from freezing. Store in carton until contents are used.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Bupivacaine Hydrochloride and Epinephrine Injection USP 0.25%+ (1:200,000)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bupivacaine Hydrochloride and Epinephrine Injection 0.25%+ (1:200,000)
    Each ml contains:
    Bupivacaine Hydrochloride USP
    Eq to Anhydrous Bupivacaine Hydrochloride …………………2.5mg
    Epinephrine USP……………..5mcg
    Sodium Chloride USP………8.5mg
    Sodium Metabisulfite USP……….0.1mg
    Edetate Calcium Disodium
    Eq to Anhydrous Edetate Calcium Disodium USP…..0.1mg
    (As stabilizer)
    Methylparaben USP……..1mg
    (As preservative)
    Water for Injection USP…………….q.s

THERAPEUTIC INDICATION:

Bupivacaine and epinephrine combination injection is used to numb an area of your body during surgery or other procedures, childbirth, or dental work.

DIRECTION OF USE:

Use Aseptic Technique:
1. Remove tab. Cleanse stopper with antiseptic.
2. Withdraw desired amount of solution.
3. Discard unused portion.

Alternately
1. Remove tab, overseal and stopper.
2. Pour contents into sterile vessel.
3. Discard unused portion.

PACKING:

0.25%+ (1:200,000) – 25mg/10ml -Single Dose Vial (2.5mg/ml)
0.25%+ (1:200,000) – 75mg/30ml -Single Dose Vial (2.5mg/ml)
0.25%+ (1:200,000)- 125mg/50ml- Multiple-Dose Vial (2.5mg/ml)

CAUTION & Warning:

CAUTION: Do not use the Injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Not for Caudal, Epidural or Spinal Anesthesia. (0.5%)
Not for Spinal Anesthesia. (0.25%)
Discard unused portion after initial use.

Warning: To sold by the retail on the prescription of a Registered Medical Practitioner.
Contains Sulfites.
Contains Epinephrine – Do not autoclave.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F) ); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Protect from freezing. Store in carton until contents are used.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

Dosage: As directed by the Physician.