Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom
Palladone 2 mg/ml solution for injection or infusion.
Palladone 10 mg/ml solution for injection or infusion.
| Pharmaceutical Form |
|---|
|
Solution for injection or infusion. Clear, colourless to pale yellow solution. |
One Palladone 2 mg/ml ampoule contains 2 mg hydromorphone hydrochloride (corresponding to 1.77 mg hydromorphone) in 1 ml solution.
One Palladone 10 mg/ml ampoule contains 10 mg hydromorphone hydrochloride (corresponding to 8.87 mg hydromorphone) in 1 ml solution.
Excipient(s) with known effect:
1 ml of Palladone 2 mg/ml contains 0.153 mmol of sodium (3.52 mg/ml of sodium).
1 ml of Palladone 10 mg/ml contains 0.128 mmol of sodium (2.94 mg/ml of sodium).
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially 'sodium-free'
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hydromorphone |
Hydromorphone is an agonist of mu receptors. The pharmacological actions of hydromorphone and morphine do not differ significantly. Hydromorphone and related opioids produce their major effects on the central nervous system and bowel. Hydromorphone is indicated for the relief of severe pain in cancer. |
| List of Excipients |
|---|
|
Citric acid anhydrous |
Type 1, clear, neutral glass ampoules in packs of 5 × 1 ml ampoules.
Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom
PL 16950/0163
PL 16950/0164
19/11/2012
| Drug | Countries | |
|---|---|---|
| PALLADONE | Germany, Ireland, United Kingdom |
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