LABELATOL Solution for injection Ref.[7721] Active ingredients: Labetalol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Synchrony Pharma Ltd., Business Technology Centre, Bessemer Drive, Stevenage, Hertfordshire, SG1 2DX, United Kingdom

Product name and form

Labetalol Synchrony 5mg/ml solution for injection.

Pharmaceutical Form

Solution for Injection.

The Solution for injection is a clear, colourless liquid, pH 4 (3.5-4.5). Osmolarity 0.03 (0.024-0.036) Osmol/kg.

Qualitative and quantitative composition

Labetalol hydrochloride 5mg/ml. Each 10ml ampoule contains 50mg Labetalol Hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Labetalol

Labetalol lowers the blood pressure by blocking peripheral arteriolar alphaadrenoceptors thus reducing peripheral resistance, and by concurrent betablockade, protects the heart from reflex sympathetic drive that would otherwise occur.

List of Excipients

Hydrochloric acid (E507) (for pH adjustment)
Sodium hydroxide (E524) (for pH adjustment)
Water for injections

Pack sizes and marketing

Type I amber glass ampoules: 10 ampoules of 10ml (per pack). Ampoules have a white break ring.

Marketing authorization holder

Synchrony Pharma Ltd., Business Technology Centre, Bessemer Drive, Stevenage, Hertfordshire, SG1 2DX, United Kingdom

Marketing authorization dates and numbers

PL 39280/0009

09/05/2018

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