ORUDIS SR Capsule (2022)
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Περιεχόμενα
1. Name of the medicinal product
ORUDIS SR Ketoprofen.
2. Qualitative and quantitative composition
Each Orudis SR capsule contains ketoprofen 200 mg. For the full list of excipients, see Section 6.1 List of excipients. Ketoprofen is DL-2-(3-benzoylphenyl) propionic acid. It is a white or off-white powder ...
3. Pharmaceutical form
Orudis SR Capsules: modified release, hard gelatin capsule. Clear pink base & white opaque cap. Base and cap printed ORUDIS SR 200 and contains off-white to cream spherical pellets.
4.1. Therapeutic indications
Rheumatoid arthritis, osteoarthritis.
4.2. Posology and method of administration
After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used (see Section 4.4 Special warnings and precautions for use). ...
4.3. Contraindications
Active or a history of gastrointestinal inflammatory disorder or ulceration, haemorrhage, chronic dyspepsia. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Known ...
4.4. Special warnings and precautions for use
Cardiovascular Thrombotic Events Observational studies have shown that non-selective NSAIDs may be associated with an increased risk of serious CV events including myocardial infarction, stroke and heart ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions have been studied using conventional ketoprofen at a dose of 200 mg daily. Medicinal products that can promote hyperkalaemia The risk of hyperkalaemia can be enhanced when ketoprofen ...
4.6. Fertility, pregnancy and lactation
Effects on fertility The use of NSAIDs may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation ...
4.7. Effects on ability to drive and use machines
Patients should be warned about the potential for somnolence, dizziness or convulsions, and advised not to drive or operate machinery if these symptoms occur.
4.8. Undesirable effects
The following adverse events have been observed with ketoprofen. More Common Reactions (Incidence greater than 1%) <b>Gastrointestinal:</b> Dyspepsia (11.5%), nausea*, abdominal pain*, diarrhoea*, constipation*, ...
4.9. Overdose
Signs and symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, abdominal pain, nausea and vomiting, which are generally reversible with supportive care. Respiratory depression, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Non-steroidal anti-inflammatory and antirheumatic products, propionic acid derivatives <b>ATC code:</b> M01AE03 Mechanism of action Animal pharmacological studies have ...
5.2. Pharmacokinetic properties
Ketoprofen is readily absorbed from the gastrointestinal tract, peak plasma concentration occur 0.5 to 2 hours after a single dose. Some retardation in absorption occurs with food. The plasma half-life ...
5.3. Preclinical safety data
Genotoxicity No data available. Carcinogenicity No data available.
6.1. List of excipients
Orudis SR Capsules: Erythrosine, ethylcellulose, gelatin, non-pareil beads (PI 1014) (sucrose and maize starch), OPACODE monogramming ink S-1-20952 BLUE (PI 12300), shellac, colloidal anhydrous silica, ...
6.2. Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
6.3. Shelf life
In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
6.4. Special precautions for storage
Store below 25°C. Store in a dry place.
6.5. Nature and contents of container
Orudis SR 200 mg Capsules are available in the following presentations: Blister pack of 4*, 28, 30* and 100* capsules. * non-marketed pack sizes.
6.6. Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
7. Marketing authorization holder
sanofi-aventis australia pty ltd, 12-24 Talavera Road, Macquarie Park, NSW 2113, Toll Free Number (medical information): 1800 818 806, Email: medinfo.australia@sanofi.com
9. Date of first authorization / renewal of the authorization
21 October 1991
10. Date of revision of the text
12 August 2022
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