ORUVAIL Controlled release capsule (2022)
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Περιεχόμενα
Name of the medicinal product
Oruvail 100 mg Prolonged-Release Capsules, Hard.
Qualitative and quantitative composition
Ketoprofen 100 mg.
Pharmaceutical form
Controlled release capsules.
Therapeutic indications
Oruvail is recommended in the management of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute articular and peri-articular disorders, (bursitis, capsulitis, synovitis, tendinitis), cervical ...
Posology and method of administration
<u>Adults:</u> 100–200 mg once daily, depending on patient weight and on severity of symptoms. The maximum daily dose is 200 mg. The balance of risks and benefits should be carefully considered before ...
Contraindications
Ketoprofen is contraindicated in patients who have a history of hypersensitivity reactions such as bronchospasm, asthmatic attacks, rhinitis, angioedema, urticaria or other allergic-type reactions to ketoprofen, ...
Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration, and GI and cardiovascular ...
Interaction with other medicinal products and other forms of interaction
Anticoagulants Increased risk of bleeding (see section 4.4). Heparin Vitamin K antagonists (such as warfarin) Platelet aggregation inhibitors (such as ticlopidine, clopidogrel) Thrombin inhibitors (such ...
Pregnancy and lactation
Pregnancy 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 ...
Effects on ability to drive and use machines
Patients should be warned about the potential for somnolence, dizziness or convulsions, drowsiness, fatigue and visual disturbances and be advised not to drive or operate machinery if these symptoms occur. ...
Undesirable effects
The following CIOMS frequency rating is used, when applicable: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known ...
Overdose
Symptoms Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most instances the symptoms observed have been benign and limited to lethargy, drowsiness, nausea, vomiting and epigastric ...
Pharmacodynamic properties
Ketoprofen overall has the properties of a potent non-steroidal anti-inflammatory agent. It has the following pharmacological effects: <u>Anti-inflammatory:</u> It inhibits the development of carageenan-induced ...
Pharmacokinetic properties
Ketoprofen is slowly but completely absorbed from Oruvail capsules. Maximum plasma concentration occurs after 6–8 hours. It declines thereafter with a half-life of about 8 hours. There is no accumulation ...
Preclinical safety data
No additional data of relevance to the prescriber.
List of excipients
<u>Pellets:</u> Sugar spheres Colloidal anhydrous silica Shellac Ethylcellulose Talc <u>Capsule shell body:</u> Gelatin Erythrosine (E127) <u>Capsule shell – cap:</u> Gelatin Titanium dioxide (E171) ...
Incompatibilities
None stated.
Shelf life
36 months.
Special precautions for storage
<u>Securitainer / HDPE bottle:</u> Store below 30°C in a dry place. <u>Blister pack:</u> Store below 25°C in a dry place and protect from light.
Nature and contents of container
Securitainer or HDPE bottle containing 100 capsules. UPVC/Aluminium foil blister or UPVC coated with PVDC aluminium foil blister containing either 8, 28, 30 or 56 capsules. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
None stated.
Marketing authorization holder
Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0597
Date of first authorization / renewal of the authorization
04 September 2006
Date of revision of the text
11 July 2022
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