Ropivacaine Injection I.P. 2mg/ml (0.2%) Technical Specification:

Product Name:Ropivacaine Injection I.P. 2mg/ml (0.2%)
Brand Name:Generic
Strength:2mg/ml (0.2%), 7.5mg (0.75%), 5mg/ml (0.5%)
Dosage Form:Liquid Injection (Sterile)
Packing:4ml, 20ml Ampoule, 50ml Vial
Route of Administration:For epidurally (via lumbar or thoracic route)
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Local Anaesthetics
Indication: Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anesthetic and does not cause loss of consciousness.
Storage:Store at a temperature not exceeding 25°C. Protect from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Ropivacaine Injection I.P. 2mg/ml (0.2%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Ropivacaine Injection I.P. 2mg/ml (0.2%)
    Each ml contains:
    Ropivacaine Hydrochloride I.P. 
    equivalent to 
    anhydrous Ropivacaine Hydrochloride……………2mg
    Sodium Chloride I.P……………………………………..8.6 mg
    Water for Injections I.P………………………………….q.s. 

THERAPEUTIC INDICATION:

Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anesthetic and does not cause loss of consciousness.

DIRECTION OF USE:

Not for Intravenous use
For single use only.
See pack insert for more information.

CAUTION AND SCHEDULE:

CAUTION:

  • Do not use it if any foreign particulate matter is visible.
  • Not for IV use
  • DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
  • Discard the unused portion
  • KEEP OUT OF REACH AND SIGHT OF CHILDREN.

CAUTION: To be sold by retail on the prescription of a Hospital or Anesthetist only.

STORAGE AND DOSAGE:

STORAGE: Store at a temperature not exceeding 25°C. Protect from light. Do not freeze.
Preservatives not added.
DOSAGE: As directed by the Physician.

GENERIC NAME OF MEDICINAL PRODUCT:

A. Ropivacaine Injection I.P. 2mg/ml (0.2%)
B. Ropivacaine Injection I.P. 7.5mg (0.75%)
C. Ropivacaine Injection I.P. 5mg/ml (0.5%)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Ropivacaine Injection I.P. 2mg/ml (0.2%)
Each ml contains:
Ropivacaine Hydrochloride I.P.
equivalent to
anhydrous Ropivacaine Hydrochloride……………2mg
Sodium Chloride I.P……………………………………..8.6 mg
Water for Injections I.P………………………………….q.s.

2. Ropivacaine Injection I.P. 7.5mg (0.75%)
Each ml contains:
Ropivacaine Hydrochloride I.P.
equivalent to
anhydrous Ropivacaine Hydrochloride………………7.5 mg
Sodium Chloride I.P……………………………………………7.5 mg
Water for Injections I.P………………………………………. q.s.

3. Ropivacaine Injection I.P. 5mg/ml (0.5%)
Each ml contains:
Ropivacaine Hydrochloride I.P.
equivalent to
anhydrous Ropivacaine Hydrochloride…………………..5 mg
Sodium Chloride I.P……………………………………………..8.0 mg
Water for Injections I.P………………………………………..q.s.


THERAPEUTIC INDICATION:

Ropivacaine injection is used to cause numbness or loss of feeling in patients before and during surgery or labor and delivery. It is also used to relieve acute pain. Ropivacaine is a local anesthetic and does not cause loss of consciousness.

DIRECTION OF USE:

Not for Intravenous use
For sinlge use only.
See pack insert for more information.

CAUTION AND SCHEDULE:

CAUTION:
• Do not use if any foreign particulate matter is visible.
• Not for IV use
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• Discard the unused portion
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
CAUTION To be sold by retail on the prescription of a Hospital or Anesthetist only.

STORAGE AND DOSAGE:

STORAGE: Store at a temperature not exceeding 25°C. Protect from light. Do not freeze.
Preservatives not added.
DOSAGE: As directed by the Physician.