TRAMADOL Solution for injection or infusion Ref.[7127] Active ingredients: Tramadol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England

Product name and form

Tramadol 50mg/ml Solution for Injection or Infusion.

Pharmaceutical Form

Solution for Injection or Infusion.

A clear colourless solution in glass ampoules.

Qualitative and quantitative composition

Each ampoule contains 100mg tramadol hydrochloride in 2ml solution (50mg/ml).

For a full list of excipients see Section 6.1.

Active Ingredient Description
Tramadol

Tramadol, a cyclohexanol derivative, is a centrally acting opioid analgesic. It is a non-selective pure agonist at μ, δ and κ opioid receptors with a higher affinity for the μ receptor. Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.

List of Excipients

Sodium acetate trihydrate
Water for injections

Pack sizes and marketing

2ml neutral glass type I glass ampoules.

Box of 5 ampoules.

Marketing authorization holder

Beacon Pharmaceuticals Limited, DCC Vital, Westminster Industrial Estate, Repton Road, Measham, DE12 7DT, England

Marketing authorization dates and numbers

PL 18157/0014

30 August 2007

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