Revision Year: 2013 Publisher: Takeda Pharma A/S Denmark, Langebjerg 1, DK-4000, Roskilde, Denmark
Short term treatment of moderate postoperative pain.
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.
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 (i.v.) or intramuscular (I.M.) injection.
When given as i.v. injection, the time of injection should be at least 15 seconds, and for i.m. 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.
Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.
No special dosage modification is required for elderly patients above age 65 unless renal or hepatic function is impaired. Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group (see section 4.4).
For patients with mild to moderate renal impairment dose reduction should be considered (see section 4.4).
For patients with moderate hepatic impairment dose reduction should be considered (see section 4.4).
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4.).
At this time, there is no experience of overdose to permit definition of the consequence of an overdose, or to suggest specific managements. However, it can be expected that after an overdose with lornoxicam, the following symptoms can be seen: Nausea, vomiting, cerebral symptoms (dizziness, disturbances in vision). Severe symptoms are ataxia ascending to coma and cramps, liver and kidney damages and maybe coagulation disorders.
In the case of a real or suspected overdose, the medication should be withdrawn. Due to its short half-life, lornoxicam is rapidly excreted. Lornoxicam is not dialysable. No specific antidote is known to date. Gastrointestinal disorders can for example be treated with a prostaglandin analogue or ranitidine.
Shelf life: 3 years.
Single use only.
Reconstituted solution can be stored up to 24 hours at +2°C to +8°C.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use is the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.
Do not store above 25°C. Keep vial in the outer carton. Protect from light.
For storage conditions of the reconstituted medicinal product, see section 6.3.
1 set contains:
Powder for injection: Amber glass vial with rubber stopper, sealed with aluminium snap-off closure.
Water for injection: 2 ml clear glass ampoule.
Pack Sizes: 1,5, 6 or 10 sets.
Not all pack sizes may be marketed.
The solution for injection is prepared by dissolving the content of one vial in 2 ml water for injection from the accompanying ampoule, immediately prior to use.
The appearance of the product after reconstitution is a yellow, clear liquid.
If visible signs of deterioration are seen in the medicinal product, the product must be disposed of in accordance with local requirements
Lornoxicam has shown compatibility with 0.9% NaCl, 5% dextrose (glucose) and Ringer’s solution.
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