ROPIVACAINE Solution for infusion Ref.[8662] Active ingredients: Ropivacaine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Sintetica Limited, 30<sup>th</sup> Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom

Product name and form

Ropivacaine 2 mg/ml solution for infusion.

Pharmaceutical Form

Solution for infusion.

Clear, colourless, sterile, isotonic, isobaric aqueous solution for infusion with a pH of 4.0 to 6.0.

Qualitative and quantitative composition

Each ml solution for infusion contains 2 mg ropivacaine hydrochloride.
Each 100 ml bag contains 200 mg ropivacaine hydrochloride.
Each 200 ml bag contains 400 mg ropivacaine hydrochloride.
Each 250 ml bag contains 500 mg ropivacaine hydrochloride.
Each 500 ml bag contains 1000 mg ropivacaine hydrochloride.

Excipient:

Each 100 ml bag contains 14.7 mmol (or 339 mg) of sodium.
Each 200 ml bag contains 29.5 mmol (or 678 mg) of sodium.
Each 250 ml bag contains 36.8 mmol (or 847.5 mg) of sodium.
Each 500 ml bag contains 73.6 mmol (or 1695 mg) of sodium.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Ropivacaine

Ropivacaine is a long-acting amide-type local anaesthetic with both anaesthetic and analgesic effects. At high doses ropivacaine produces surgical anaesthesia, while at lower doses it produces sensory block with limited and non-progressive motor block.

List of Excipients

Sodium chloride
Sodium hydroxide (for pH adjustment)
Water for injections

Pack sizes and marketing

Ropivacaine 2 mg/ml solution for infusion.

Polypropylene bags:

10 × 100ml, 20 × 100ml, 5 × 200 ml, 10 × 200ml, 20 × 200ml, 5 × 250 ml, 10 × 250ml, 20 × 250ml, 5 × 500 ml

Not all pack sizes may be marketed.

Marketing authorization holder

Sintetica Limited, 30th Floor, 40 Bank Street, Canary Wharf, London, E14 5NR, United Kingdom

Marketing authorization dates and numbers

PL 46926/0009

12/05/2016

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