PALLADONE Solution for injection or infusion Ref.[8902] Active ingredients: Hydromorphone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom

Product name and form

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.

Qualitative and quantitative composition

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
Sodium citrate
Sodium chloride
Sodium hydroxide solution (4%) (for pH-adjustment)
Hydrochloric acid 3.6% (for pH-adjustment)
Water for injections

Pack sizes and marketing

Type 1, clear, neutral glass ampoules in packs of 5 × 1 ml ampoules.

Marketing authorization holder

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom

Marketing authorization dates and numbers

PL 16950/0163
PL 16950/0164

19/11/2012

Drugs

Drug Countries
PALLADONE Germany, Ireland, United Kingdom

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.