XEFO 8MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Main information

  • Trade name:
  • XEFO 8MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
  • Available from:
  • Nycomed UK Limited
  • Dosage:
  • 8 Milligram
  • Pharmaceutical form:
  • Pdr+Solv for soln for Inf
  • Medicine type:
  • Human

Documents

Localization

  • Available in:
  • XEFO 8MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
    Ireland
  • Language:
  • English

Other information

Status

  • Source:
  • IMB
  • Authorization date:
  • 26-02-2010
  • Last update:
  • 23-04-2015

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

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

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Elderly

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

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The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of

ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients

should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol

or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose

acetylsalicylic acid or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Clinical

monitoring at regular intervals is recommended.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms

(especially GI bleeding) particularly in the initial stages of treatment.

Caution should be advised in patients receiving concomitant medications, which could increase the risk of ulceration or

bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-

platelet agents such as acetylsalicylic acid (see section 4.5).

When GI bleeding or ulceration occurs in patients receiving lornoxicam, the treatment should be withdrawn.

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s

disease) as their condition may be exacerbated (see section 4.8).

The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and

perforation, which may be fatal (see section 4.3).

Caution is required in patients with a history of hypertension and/or heart failure, as fluid retention and oedema have

been reported in association with NSAID therapy.

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate

congestive heart failure, as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term

treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial

infarction or stroke). There are insufficient data to exclude such a risk for lornoxicam.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral

arterial disease, and/or cerebrovascular disease should only be treated with Lornoxicam after careful consideration.

Similar consideration should be made before initiating longer-term treatment of patients with risk factors for

cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Concomitant treatment with NSAIDs and heparin in the context of a spinal or epidural anaesthesia increases the risk of

spinal/epidural haematoma (see section 4.5).

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic

epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients

appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the

majority of cases within the first month of treatment. Lornoxicam should be discontinued at the first appearance of skin

rash, mucosal lesions, or any other sign of hypersensitivity.

Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since

NSAIDs have been reported to precipitate bronchospasm in such

patients.

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased

risk of aseptic meningitis.

Lornoxicam reduces platelet aggregation and prolongs bleeding time and consequently care should be taken when

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Concomitant treatment of NSAIDs and tacrolimus may increase the risk of nephrotoxicity owing to reduced synthesis

of prostacyclin in the kidney. Renal function must therefore be monitored closely in patients receiving combination

therapy.

As with most NSAIDs occassional increase in serum transaminases level, increase in serum bilirubin or other liver

function parameters, as well as increases in serum creatinine and blood urea nitrogen as well as other laboratory

abnormalities have been reported. Should any such abnormality prove significant or persist the administration of

lornoxicam should be stopped and appropriate investigations prescribed.

The use of lornoxicam, as with any drug known to inhibit cyclooxygenase/prostaglanding synthesis, may impair

fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who

are undergoing investigation of infertility, withdrawal of lornoxicam should be considered.

Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications.

To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable

to avoid use of lornoxicam in case of varicella.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant administration of lornoxicam and

- Cimetidine: Increased plasma concentrations of lornoxicam. (No interaction between lornoxicam and ranitidine,

or lornoxicam and antacids has been demonstrated).

- Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). Careful

monitoring of INR should be undertaken

- Phenprocoumon: Decreased effect of phenprocoumon treatment.

- Heparin: NSAIDs increase the risk of spinal or epidural haematoma when given concomitantly to heparin in the

context of spinal or epidural anaesthesia (see section 4.4).

- ACE inhibitors: The antihypertensive effect of the ACE inhibitor may decrease.

- Diuretics: Decreased diuretic and antihypertensive effect of loop diuretics, thiazide diuretics, and potassium

sparing diuretics.

- Beta-adrenergic blockers: Decreased antihypertensive efficacy.

- Angiotensin II receptor blocker: Decreased antihypertensive efficacy.

- Digoxin: Decreased renal clearance of digoxin.

- Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).

- Quinolone antibiotics: Increased risk of seizures.

- Anti-platelet agents: Increased risk of gastrointestinal bleeding (see section 4.4).

- Other NSAIDs: Increased risk of gastrointestinal bleeding.

- Methotrexate: Increased serum concentration of methotrexate. Increased toxicity may result. When concomitant

therapy has to be used careful monitoring should be undertaken.

- Selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4).

- Lithium: NSAIDs inhibit renal clearance of lithium, thus the serum concentration of lithium may increase above

toxicity limits. Therefore serum lithium levels require monitoring, especially during initiation, adjustment and

withdrawal of treatment.

- Cyclosporine: Increased serum concentration of cyclosporine. Nephrotoxicity of cyclosporine may be enhanced

via renal prostaglandin mediated effects. During combined treatment renal function should be monitored.

- Sulphonylureas (e.g. glibenclamide): Increased risk of hypoglycaemia.

- Known inducers and inhibitors of CYP2C9 isoenzymes: Lornoxicam (as other NSAIDs depending on the

cytochrome P450 2C9 (CYP2C9 isoenzyme)) has interactions with known inducers and inhibitors of CYP2C9

isoenzymes (see section 5.2 Biotransformation).

- Tacrolimus: Increase the risk of nephrotoxicity owing to reduced synthesis of prostacyclin in the kidney. During

combined treatment renal function should be monitored (see section 4.4).

- Pemetrexed: NSAIDs may reduce renal clearance of pemetrexed resulting in increased renal and gastrointestinal

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4.6 Fertility, pregnancy and lactation

Pregnancy

Lornoxicam is contraindicated on the third trimester of pregnancy and should not be used during pregnancy in the first

and second trimesters and delivery, as no clinical data on exposed pregnancies are available.

There are no adequate data from the use of lornoxicam in pregnant women. Studies in animals have shown

reproductive toxicity (see section 5.3).

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data

from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation after use of a

prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy.

In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post

implantation loss and embryo-foetal lethality. During the first and second trimester of pregnancy, prostaglandin

synthesis inhibitors should not be given unless clearly necessary.

Prostaglandin synthesis inhibitors administered during the third trimester of pregnancy may expose the foetus to

cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension) and renal

dysfunction which may lead to renal failure and hence a reduced quantity of amniotic fluid. At the end of pregnancy,

prostaglandin synthesis inhibitors may expose the mother and the foetus to increased bleeding time and inhibition of

uterine contractions, which may delay or prolong the labour. Therefore, the use of lornoxicam is contraindicated during

the third trimester of pregnancy (see section 4.3).

Lactation

There are no data on the excretion of lornoxicam in human breast milk. Lornoxicam is excreted in milk of lactating rats

in relatively high concentrations. Therefore lornoxicam should not be used in breastfeeding women.

4.7 Effects on ability to drive and use machines

Patients showing dizziness and/or sleepiness under treatment with lornoxicam should refrain from driving or operation

machinery.

4.8 Undesirable effects

The most commonly observed adverse events of NSAIDs are gastrointestinal in nature. Peptic ulcers, perforation or GI

bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea,

flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of

colitis and Crohn’s disease (see section 4.4) have been reported following administration of NSAIDs. Less frequently,

gastritis has been observed.

Approximately 20% of patients treated with lornoxicam can be expected to experience adverse reactions. The most

frequent adverse effects of lornoxicam include nausea, dyspepsia, indigestion, abdominal pain, vomiting, and

diarrhoea. These symptoms have generally occurred in less than 10% of patients in available studies.

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term

treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or

stroke) (see section 4.4).

Exceptionally, occurrence of serious cutaneous and soft tissues infectious complications during varicella.

Listed below are undesirable effects, which generally occurred in more than 0.05% of the 6,417 patients treated in

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Very common ( 1/10); Common ( 1/100, <1/10); Uncommon ( 1/1,000, <1/100); rare ( 1/10,000, <1/1,000); Very

rare (<1/10,000), not known (cannot be estimated from the available data).

Infections and infestations

Rare: Pharyngitis.

Blood and the lymphatic system disorders

Rare: Anaemia, thrombocytopenia, leukopenia, prolonged bleeding time

Very rare: Ecchymosis. NSAIDs have been reported to cause potentially severe hematological disorders like

neutropenia, agranulocytosis, aplastic anaemia, and hemolytic anaemia as class effects.

Immune system disorders

Rare: Hypersensitivity, anaphylactoid reaction and anaphylaxis.

Metabolism and nutritional disorders

Uncommon: Anorexia, weight changes.

Psychiatric disorders

Uncommon: Insomnia, depression.

Rare: Confusion, nervousness, agitation.

Nervous system disorders

Common: Mild and transient headache, dizziness.

Rare: Somnolence, paraesthesia, dysgeusia, tremor, migraine.

Very rare: Aseptic meningitis in patients with SLE and mixed connective tissue disorder (see 4.4)

Eye disorders

Uncommon: Conjuctivitis.

Rare: Visual disturbances.

Ear and labyrinth disorders

Uncommon: Vertigo, tinnitus.

Cardiac disorders

Uncommon: Palpitations, tachycardia, oedema, cardiac failure.

Vascular disorders

Uncommon: Flushing, oedema.

Rare: Hypertension, hot flush, haemorrhage, haematoma.

Respiratory, thoracic and mediastinal disorders

Uncommon: Rhinitis.

Rare: Dyspnoea, cough, bronchospasm.

Gastrointestinal disorders

Common: Nausea, abdominal pain, dyspepsia, diarrhoea, vomiting.

Uncommon: Constipation, flatulence, eructation, dry mouth, gastritis, gastric ulcer, abdominal pain upper, duodenal

ulcer, mouth ulceration.

Rare: Melaena, haematemesis, stomatitis, oesophagitis, gastrooesophageal reflux, dysphagia, aphthous stomatitis,

glossitis, perforated peptic ulcer, gastrointestinal haemorrhage.

Hepatobiliary disorders

Uncommon: Increase in liver function tests, SGPT (ALT) or SGOT (AST).

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Skin and subcutaneous tissue disorders

Uncommon: Rash, pruritus, hyperhidrosis, rash erythematous, urticaria and angioedema, alopecia.

Rare: Dermatitis and eczema, purpura.

Very rare: Oedema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders

Uncommon: Arthralgia.

Rare: Bone pain, muscle spasms, myalgia.

Renal and urinary disorders

Rare: Nocturia, micturition disorders, increase in blood urea nitrogen and creatinine levels.

Very rare: Lornoxicam may precipitate acute renal failure in patients with pre-existing renal impairment, who are

dependent on renal prostaglandins for maintenance of renal blood flow (see 4.4). Nephrotoxicity in various forms

including nephritis and nephrotic syndrome has been associated with NSAIDs as class effect.

General disorders and administrative site conditions

Uncommon: Malaise, face oedema.

Rare: Asthenia.

4.9 Overdose

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids, oxicams

ATC code: M01 AC05

Lornoxicam is a non-steroidal anti-inflammatory drug with analgesic properties and belongs to the class of oxicams.

Lornoxicams mode of action is mainly related to the inhibition of the prostaglandin synthesis (inhibition of the

cyclooxygenase enzyme) leading to desensitisation of peripheral nociceptors and consequently inhibition of

inflammation. A central effect on nociception, which seems to be independent of anti-inflammatory effects has also

been suggested.

Lornoxicam has no effect on vital signs (e.g. body temperature, respiratory rate, heart rate, blood pressure, ECG,

spirometry).

The analgesic properties of lornoxicam have been demonstrated successfully in several clinical trials during

development of the drug.

Due to a local gastrointestinal irritation and a systemic ulcerogenic effect related to the inhibition of prostaglandin

(PG)-synthesis, gastrointestinal sequela are common side effects after treatment with lornoxicam as seen with other

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5.2 Pharmacokinetic properties

Absorption

Lornoxicam 8 mg powder for injection is intended for intravenous (IV) as well as intramuscular (IM) administration.

After IM injection, maximum plasma concentrations are achieved after approximately 0.4 hours. The absolute

bioavailability (calculated on AUC) after IM administration is 97%

Distribution

Lornoxicam is found in the plasma in unchanged form and as its hydroxylated metabolite. The plasma protein binding

of lornoxicam is 99% and not concentration dependent.

Biotransformation

Lornoxicam is extensively metabolised in the liver, primarily to the inactive 5–hydroxylornoxicam by hydroxylation.

CYP2C9 is involved in this biotransformation of lornoxicam. Due to genetic polymorphism, slow and extensive

metabolisers exist for this enzyme, which could result in markedly, increased plasma levels of lornoxicam in slow

metabolisers. The hydroxylated metabolite exhibits no pharmacological activity. Lornoxicam is metabolised

completely, and approximately 2/3 is eliminated via the liver and 1/3 via the kidneys as inactive substance.

When tested in animal models, lornoxicam did not induce liver enzymes. From clinical trial data there is no evidence of

accumulation of lornoxicam after repeated administrations, when given according to recommended dosage. This

finding was supported by drug monitoring data from one year studies.

Elimination

The mean elimination half-life of the parent compound is 3 to 4 hours. After oral administration about 50% is excreted

in the faeces and 42% through the kidneys, mainly as 5-hydroxylornoxicam. The elimination half-life of 5-

hydroxylornoxicam is about 9 hours after a parenteral single or twice daily dose.

In elderly patients above age 65, the clearance is reduced with 30-40%. Apart from reduced clearance, there is no

significant change in the kinetic profile of lornoxicam in elderly patients.

There is no significant change in the kinetic profile of lornoxicam in patients with renal or hepatic failure, except for

accumulation in patients with chronic liver disease after 7 days of treatment with daily doses of 12 and 16 mg.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated

dose toxicity, genotoxicity, and carcinogenic potential.

Lornoxicam caused renal toxicity and gastrointestinal ulceration single- and repeat-dose toxicity studies in several

species.

In animals, administration of prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-

implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including

cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic

period.

In rat, lornoxicam impaired fertility (effects on ovulation and implantation), and affected the pregnancy and delivery. In

rabbit and rat, lornoxicam caused premature closure of the ductus arteriosus due to inhibition of cyclooxygenase.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Powder:

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Trometamol

Disodium edetate

Solvent:

Water for injections

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3 Shelf Life

3 years

Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 21°C ( ±

2°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 has taken place in controlled and validated aseptic conditions.

6.4 Special precautions for storage

Do not store above 25°C. Keep vial in the outer carton.

For storage conditions of the reconstituted medicinal product, see section 6.3.

6.5 Nature and contents of container

1 set contains:

Powder for injection, 8 mg: Amber glass (class I) vial (4R/8R) with rubber stopper, sealed with aluminium snap-off

closure.

Water for injection, 2 ml: Clear glass ampoule

Pack sizes: 1, 5, 6, 10 sets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling

The solution for injection is prepared by dissolving the content of one vial in 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.

7 MARKETING AUTHORISATION HOLDER

Nycomed UK Limited

Three Globeside Business Park

Fieldhouse Lane

Marlow

Buckinghamshire SL7 1HZ

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8 MARKETING AUTHORISATION NUMBER

PA1302/2/3

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 26 February 2010

Date of last renewal: 17 January 2011

10 DATE OF REVISION OF THE TEXT

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