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Information leaflet

                                                     Irish Medicines Board

                                  Summary of Product Characteristics

 Xefo 8mg powder and solvent for solution for injection


 One vial contains 8 mg lornoxicam. After reconstitution in 2 ml solvent, reconstituted solution contains 4mg/ml of

 For a full list of excipients, see section 6.1.


 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


 4.1 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.

 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

 Children and adolescents
 Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and

Date Printed 08/03/2011                               CRN 2078044                                         page number: 1
                                                      Irish Medicines Board

 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).

 Renal impairment
 For patients with mild to moderate renal impairment dose reduction should be considered (see section 4.4).

 Hepatic impairment
 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.).

 4.3 Contraindications
 -     Hypersensitivity to lornoxicam or any of the excipients
 -     Thrombocytopenia
 -     Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid
 -     Severe heart failure.
 -     Gastro-intestinal bleeding, cerebrovascular bleeding or other bleeding disorders
 -     History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy
 -     Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)
 -     Severe hepatic impairment
 -     Severe renal impairment (Serum creatinine > 700 µmol/L)
 -    The third trimester of pregnancy (see section 4.6)

 4.4 Special warnings and precautions for use

 For the following disorders, lornoxicam should only be administered after careful risk-benefit assessment:
 -     Renal impairment: Lornoxicam should be administered with precaution in patients with mild (serum creatinine
       150-300 µmol/L) to moderate (serum creatinine 300 – 700 µmol/L) renal impairment due to dependency on renal
       prostaglandins for maintenance of renal blood flow. Treatment with lornoxicam should be discontinued if renal
       function deteriorates during treatment.
 -     Renal functions should be monitored in patients who undergo major surgery, with cardiac failure, receiving
       treatment with diuretics, receiving concomitant treatment with drugs that are suspected to or known to be able to
       cause kidney damage.
 -      Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is
       recommended (e.g. APTT).
 -     Hepatic impairment (e.g. liver cirrhosis): Clinical monitoring and laboratory assessments at regular intervals
       should be considered in patients with hepatic impairment as accumulation of lornoxicam (increase in AUC) may
       occur after treatment with daily doses of 12-16 mg. Apart from that, hepatic impairment does not seem to affect
       pharmacokinetic parameters of lornoxicam as compared to healthy subjects.
 -      Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin),
       renal functions (creatinine) and liver enzymes are recommended.
 -      Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended. Precaution is advised
       in elderly postoperative patients.

 The use of lornoxicam with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.

 Undesirable effects may be minimised by using lowest effective dose for the shortest duration necessary to control
 symptoms (see section 4.2, and GI and cardiovascular risks below).

 Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has
 been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of
 serious GI events.

Date Printed 08/03/2011                               CRN 2078044                                         page number: 2
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