PALLADONE 10 Micromol Solution for Inj/Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-06-2024
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Active ingredient:
HYDROMORPHONE HYDROCHLORIDE
Available from:
Napp Pharmaceuticals Limited
INN (International Name):
HYDROMORPHONE HYDROCHLORIDE
Dosage:
10 Micromol
Pharmaceutical form:
Solution for Inj/Inf
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Withdrawn
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palladone 10 mg/ml, solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Palladone _10 MG/ML:_
1 ampoule contains 10 mg hydromorphone hydrochloride (corresponding to 8.87 mg hydromorphone) in 1 ml
solution.
Excipient: 1 ml contains 0.128 mmol of sodium (2.94 mg/ml of sodium)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection or infusion.
Clear, colourless to pale yellow, pH 4.0 solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of severe pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Intravenous injection or infusion
Subcutaneous injection or infusion
The medicinal product is to be visually inspected prior to use and also after dilution. Only clear solutions practically
free from particles should be used.
The injection should be given immediately after opening the ampoule. Once opened, any unused portion should
be discarded.
Posology
The dosing of Palladone has to be adjusted to the patients’ severity of pain and to their individual response.
The dose should be titrated until optimum analgesic effect is achieved.
While a sufficiently high dose should generally be administered, the smallest dose to achieve analgesia should
be aimed at in the individual case.
Palladone 10 mg, 20 mg and 50 mg are not suitable for initial opioid therapy. These higher dosage forms may
only be used as individual doses in patients who have no longer sufficiently responded to lower doses of
hydromorphone preparations.
Palladone should not be administered longer than absolutely necessary. If long-term treatment is required
careful and regular monitoring should control whether and to what degree further treatment is
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