ADCORTYL Sterile aqueous suspension for injection (2021)
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Περιεχόμενα
1. Name of the medicinal product
Adcortyl Intra-articular/Intradermal Injection 10 mg/ml.
2. Qualitative and quantitative composition
Adcortyl Intra-articular/Intradermal Injection contains triamcinolone acetonide 10 mg per ml of sterile suspension. <u>Excipient(s) with known effect:</u> 15 mg/ml Benzyl alcohol. For the full list of ...
3. Pharmaceutical form
Sterile aqueous suspension for injection.
4.1. Therapeutic indications
<u>Intra-articular use:</u> for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, ...
4.2. Posology and method of administration
Adcortyl is for intra-articular or intra-dermal injection ONLY. The safety and efficacy of administration by other routes has yet to be established (see sections 4.3 and 4.4). Strict aseptic precautions ...
4.3. Contraindications
Hypersensitivity to any of the ingredients. Systemic infections unless specific anti-infective therapy is employed. Administration by intravenous, intrathecal, epidural or intraocular injection.
4.4. Special warnings and precautions for use
Adequate studies to demonstrate the safety of Adcortyl use by intra-turbinal, subconjunctival, sub-tenons, retrobulbar and intraocular (intravitreal) injections have not been performed. Endophthalmitis, ...
4.5. Interaction with other medicinal products and other forms of interaction
Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalaemia. Anticholinesterases: Effects of anticholinesterase agent may be antagonised. Anticoagulants, oral: ...
4.6. Pregnancy and lactation
Pregnancy The ability of corticosteroids to cross the placenta varies between individual drugs, however triamcinolone does cross the placenta. Administration of corticosteroids to pregnant animals can ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 ...
4.9. Overdose
Not applicable.
5.1. Pharmacodynamic properties
Triamcinolone acetonide is a synthetic glucocorticoid with marked anti-inflammatory and anti-allergic actions. Following local injection, relief of pain and swelling and greater freedom of movement are ...
5.2. Pharmacokinetic properties
Triamcinolone acetonide may be absorbed into the systemic circulation from synovial spaces. However clinically significant systemic levels after intra-articular injection are unlikely to occur except perhaps ...
5.3. Preclinical safety data
See section 4.6.
6.1. List of excipients
Benzyl alcohol Polysorbate 80 Sodium carboxymethylcellulose Sodium chloride Water
6.2. Incompatibilities
The injection should not be physically mixed with other medicinal products.
6.3. Shelf life
36 months.
6.4. Special precautions for storage
In an upright position. Do not store above 25°C. Avoid freezing.
6.5. Nature and contents of container
Carton containing glass ampoules 5 1 ml or individually cartoned multidose vials of 5 ml.
6.6. Special precautions for disposal and other handling
No special handling instructions. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Bristol-Myers Squibb Pharmaceuticals Unlimited Company, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, Dublin, D15 T867
8. Marketing authorization number(s)
PL 12038/0001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 25 July 1986 Date of latest renewal: 8 November 2002
10. Date of revision of the text
04 October 2021
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