ZYDOL Solution for injection or infusion Ref.[27762] Active ingredients: Tramadol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Grünenthal Ltd., 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, England, HP14 3FE, UK

Product name and form

ZYDOL 50 mg/ml Solution for Injection.

Pharmaceutical Form

Clear glass ampoules containing injectable solution.

Solution for injection or infusion.

Qualitative and quantitative composition

Each ZYDOL Solution for Injection ampoule contains 100mg tramadol hydrochloride in 2ml colourless aqueous solution.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Tramadol

Tramadol 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 may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect.

List of Excipients

ZYDOL ampoules contain:

Water for injection
Sodium acetate

Pack sizes and marketing

Clear glass ampoules containing 2ml of tramadol hydrochloride in a box of 5 ampoules.

Marketing authorization holder

Grünenthal Ltd., 1 Stokenchurch Business Park, Ibstone Road, Stokenchurch, England, HP14 3FE, UK

Marketing authorization dates and numbers

PL 21727/0002

05/03/2009

Drugs

Drug Countries
ZYDOL Australia, Ireland, United Kingdom

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