| Product Name: | Lidocaine and Adrenaline Acidtartrate Injection USP |
| Brand Name: | Generic |
| Strength: | 1%w/v(1:100,000) , 2% w/v (1:80,000) |
| Dosage Form: | Liquid Injection (Sterile and Nonpyrogenic) |
| Packing: | Multiple Dose Vial |
| Route of Administration: | For I.M. use only |
| 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 Anaesthetics |
| Indication: | ADRENALINE+LIDOCAINE is used to reduce pain and discomfort caused by invasive medical procedures such as surgery, needle punctures or insertion of a breathing tube or catheter. It is also used to reduce the discomfort of contractions during labour. |
| Storage: | Store in carton until contents have been used. Store at 20°C to 25°C (68°F to 77°F). |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lidocaine and Adrenaline Acidtartrate Injection USP 1% w/v
- Lidocaine and Adrenaline Acidtartrate Injection USP 2% w/v
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lidocaine and Adrenaline Acidtartrate Injection USP 1% w/v + (1:100,000)
Each ml contains:
Lidocaine Hydrochloride Anhydrous
Eq to Lidocaine Hydrochloride………….10mg
Epinephrine……………………………………..0.08mg
Excipients…………………………………………q.s
Water for Injection USP…………………….q.s - Lidocaine and Adrenaline Acidtartrate Injection USP 2% w/v + (1:80,000)
Each ml contains:
Lidocaine Hydrochloride Anhydrous
Eq to Lidocaine Hydrochloride………….20mg
Epinephrine……………………………………..0.08mg
Excipients…………………………………………q.s
Water for Injection USP…………………….q.s
THERAPEUTIC INDICATIONS:
ADRENALINE+LIDOCAINE is used to reduce pain and discomfort caused by invasive medical procedures such as surgery, needle punctures or insertion of a breathing tube or catheter. It is also used to reduce the discomfort of contractions during labour.
DIRECTION OF USE:
For Intramuscular use.
For Infiltration and Nerve Block.
CAUTION & Warning:
CAUTION: The injection should not be used if it contains visible particulate matter.
NOT FOR EPIDURAL OR CAUDAL USE.
Do not autoclave (contains epinephrine)
The injection is not to be used if its color is pinkish or darker than slightly yellow.
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 the room temperature (not more than 25°C). Protect from light. Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.