Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
Tramadol hydrochloride 50 mg/ml solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Clear, colourless sterile solution for injection or infusion. |
Tramadol hydrochloride 50 mg/ml of injection solution (50 ml per 1 ml ampoule, 100 mg per 2 ml ampoule).
Excipient with known effect: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.
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 |
|---|
|
Sodium acetate trihydrate |
Colourless glass ampoule containing either 1 ml or 2 ml of injection solution. Ampoules are contained in a pre-fabricated blister strip, which is enclosed in a cardboard outer carton. Cartons contain either 1, 5 or 10 ampoules.
hameln pharma ltd, Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
PL 01502/0085
01/08/2014
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