Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
Lidbree 42 mg/mL intrauterine gel.
| Pharmaceutical Form |
|---|
|
Intrauterine gel. Sterile, clear to almost clear, slightly brown-yellow viscous liquid that is a gel at body temperature. |
Lidocaine 42 mg/mL.
Excipients with known effect: Each mL of gel contains 284 mg of macrogolglycerol ricinoleate (castor oil polyoxyl) and up to 28 micrograms of butylated hydroxytoluene (E321).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Lidocaine |
Lidocaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the nerve membrane. Local anaesthetics of the amide-type are thought to act within the sodium channels of the nerve membrane. |
| List of Excipients |
|---|
|
Macrogolglycerol ricinoleate (castor oil polyoxyl) |
Lidbree 42 mg/mL intrauterine gel is provided in a sterile 10 mL prefilled syringe (cyclic olefin copolymer) with bromobutyl rubber tip-cap and stopper, packed in the same blister with the plunger rod. The syringe is graduated in mL. A sterile (polypropylene) applicator with a Luer lock fitting compatible with the prefilled syringe is provided in a separate bag within the carton. 8.5 mL can be extruded from the syringe-applicator.
Pack size: 1×10 mL intrauterine gel in pre-filled syringe.
Gedeon Richter Plc, Gyömroi út 19-21, H-1103, Budapest, Hungary
PA1330/025/001
Date of first authorisation: 6th November 2020
| Drug | Countries | |
|---|---|---|
| LIDBREE | Austria, Estonia, Croatia, Ireland, Lithuania, Malta, Poland, Romania |
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