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XEFO Powder and solvent for solution for injection (2013)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

XEFO 8 mg/2ml injection: powder and solvent for solution for injection.

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 6.1.

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 ...

Therapeutic indications

Short term treatment of moderate postoperative pain.

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 ...

Contraindications

Hypersensitivity to lornoxicam or any of the excipients. Hypersensitivity (symptoms like asthma, rhinitis, angioedema or urticaria) to other NSAIDs including acetylsalicylic acid. Thrombocytopenia. Gastro-intestinal ...

Special warnings and precautions for use

For the following disorders, XEFOlornoxicam should only be administered after careful risk-benefit assessment: Renal impairment: Lornoxicam should be administered with precaution in patients with mild ...

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). ...

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 ...

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.

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). ...

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, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non- steroidal, oxicams ATC code: M01AC05 Lornoxicam is a non-steroidal anti-inflammatory drug(NSAID) with analgesic properties ...

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 ...

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 ...

List of excipients

Powder: Mannitol Trometamol Disodium edetate Solvent: Water for injection

Incompatibilities

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

Shelf life

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, ...

Special precautions for storage

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.

Nature and contents of container

Immediate packaging 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 ...

Special precautions for disposal and other handling

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 ...

Marketing authorization holder

Takeda Pharma A/S Denmark, Langebjerg 1, DK-4000, Roskilde, Denmark

Date of revision of the text

April 2013.

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