XEFO 8MG POWDER AND SOLVENT FOR SOLUTION FOR INJEC 8 Milligram Pdr+Solv for soln for Inf
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
LORNOXICAM
Available from:
Takeda UK Limited
INN (International Name):
LORNOXICAM
Dosage:
8 Milligram
Pharmaceutical form:
Pdr+Solv for soln for Inf
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Xefo 8mg powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains 8 mg lornoxicam. After reconstitution in 2 ml solvent, reconstituted solution contains 4mg/ml of
lornoxicam.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder: Yellow, solid substance
Solvent: Clear, colourless liquid, practically free from particles
The osmolarity of the reconstituted solution is about 328 mosmol/kg and pH is about 8.7
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term relief of acute mild to moderate pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This specific application form should only be used if a quick onset of pain relief is needed or if an oral application or an
application via suppository is not possible. Generally the treatment should comprise one single injection for therapy
initiation only.
For all patients the appropriate dosing regimen should be based upon individual response to treatment.
Pain
Recommended dose: 8 mg intravenous or intramuscular. Daily dose should not exceed 16 mg. Some patients may need
a further 8 mg given during the first 24 hours.
The route of administration is intravenous (IV) or intramuscular injection (IM). When given as IV injection, the time of
injection should be at least 15 seconds, and for IM injection, at least 5 seconds.
After preparation of the solution, the needle should be changed. For IM injection a sufficiently long needle for a deep
intramuscular injection.
For further instructions on handling of the product before administration, see section 6.1.
The medicinal product is for single use only
Additional information on special populations
Chi
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