GENERIC NAME OF MEDICINAL PRODUCT:
(B) Ropivacaine HCl Injection USP 40mg/20ml(2mg/ml) (0.2%)
(C) Ropivacaine HCl Injection USP 150mg/30ml (5mg/ml) (0.5%)
(D) Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)
(E) Ropivacaine HCl Injection USP 200mg/100ml(2mg/ml) (0.2%)
(F) Ropivacaine HCl Injection USP 100mg/10ml (10mg/ml) (1%)
(G) Ropivacaine HCl Injection USP 100mg/20ml (5mg/ml) (0.5%)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………2mg
Sodium Chloride USP……………………………………..8.6 mg
Water for Injections USP………………………………….q.s.
(B) Ropivacaine HCl Injection USP 40mg/20ml(2mg/ml) (0.2%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………2mg
Sodium Chloride USP……………………………………..8.6 mg
Water for Injections USP………………………………….q.s.
(C) Ropivacaine HCl Injection USP 150mg/30ml (5mg/ml) (0.5%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………5mg
Sodium Chloride USP……………………………………..8mg
Water for Injections USP………………………………….q.s.
(D) Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………7.5mg
Sodium Chloride USP……………………………………..7.5 mg
Water for Injections USP………………………………….q.s.
(E) Ropivacaine HCl Injection USP 200mg/100ml(2mg/ml) (0.2%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………2mg
Sodium Chloride USP……………………………………..8mg
Water for Injections USP………………………………….q.s.
(F) Ropivacaine HCl Injection USP 100mg/10ml (10mg/ml) (1%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………10mg
Sodium Chloride USP……………………………………..7.1mg
Water for Injections USP………………………………….q.s.
(G) Ropivacaine HCl Injection USP 100mg/20ml (5mg/ml) (0.5%) Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………5mg
Sodium Chloride USP……………………………………..8mg
Water for Injections USP………………………………….q.s.
THERAPEUTIC INDICATION:
DIRECTION OF USE:
Refer enclosed leaflet for further information.
CAUTION & WARNING:
• Do not use if any foreign particulate matter is visible.
• Not for IV use
• Do not use if the solution is discolored or contains precipitate.
• DO NOT ACCEPT IF VIAL SEAL IS BROKEN.
• KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of Registered Medical Practitioner.
STORAGE & DOSAGE:
Sterile
Non pyrogenic
Preservative free
Dosage: As directed by Physician.
Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%) Technical Specification:
Product Name: | Ropivacaine HCl Injection USP |
Brand Name: | (GENERICS) |
Strength: | 20mg/10ml(2mg/ml) (0.2%), 40mg/20ml(2mg/ml) (0.2%), 150mg/30ml (5mg/ml) (0.5%), 150mg/20ml (7.5mg/ml) (0.75%), 200mg/100ml(2mg/ml) (0.2%), 100mg/10ml (10mg/ml) (1%), 100mg/20ml (5mg/ml) (0.5%) |
Dosage Form: | Liquid Injection (Sterile) |
Packing: | 10ml, 20ml, 30ml, 100ml Vial |
Route of Administration: | For Infiltration, Nerve block & Epidural Administration 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: | 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 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ropivacaine HCl Injection USP 150mg/20ml (7.5mg/ml) (0.75%)
Each ml contains:
Ropivacaine Hydrochloride USP
equivalent to Ropivacaine Hydrochloride……………7.5 mg
Sodium Chloride USP……………………………………..7.5 mg
Water for Injections USP………………………………….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:
For Infiltration, Nerve block & Epidural Administration only
Refer enclosed leaflet for further information.
CAUTION & WARNING:
CAUTION:
- Do not use it if any foreign particulate matter is visible.
- Not for IV use
- Do not use it if the solution is discolored or contains a precipitate.
- DO NOT ACCEPT IF THE VIAL SEAL IS BROKEN.
- KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Sterile.
Non-pyrogenic.
Preservative free
Dosage: As directed by the Physician.