国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Triamcinolone acetonide
Bristol-Myers Squibb Pharmaceuticals uc
H02AB; H02AB08
Triamcinolone acetonide
10 milligram(s)/millilitre
Suspension for injection
Product subject to prescription which may not be renewed (A)
Glucocorticoids; triamcinolone
Marketed
1978-04-01
Package leaflet: Information for the user Adcortyl Intra-articular / Intradermal Injection 10 mg/ml Suspension for Injection Triamcinolone acetonide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • ADCORTYL IA/ID INJECTION IS A STEROID MEDICINE, prescribed for many different conditions, including serious illnesses. • YOU NEED TO TAKE IT REGULARLY to get the maximum benefit. • DON’T STOP USING THIS MEDICINE without talking to your doctor – you may need to reduce the dose gradually. • ADCORTYL IA/ID INJECTION CAN CAUSE SIDE EFFECTS IN SOME PEOPLE (read section 4 below). Some problems such as mood changes (feeling depressed or ‘high’), or stomach problems can happen straight away. If you feel unwell in any way, keep using your medicine, BUT SEE YOUR DOCTOR STRAIGHT AWAY. • SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS. These include weakness of arms and legs, or developing a rounder face (read section 4 for more information). • IF YOU ARE GIVEN THIS MEDICINE FOR MORE THAN 3 WEEKS, YOU WILL BE GIVEN A BLUE ‘STEROID CARD’: always keep it with you and show it to any doctor or nurse treating you. • KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN POX OR SHINGLES, if you have never had them. They could affect you severely. If you do come into contact with chicken pox or shingles, SEE YOUR DOCTOR STRAIGHT AWAY. WHAT IS IN THIS LEAFLET 1. What Adcortyl IA/ID Injection is and what it is used for 2. What you need to know before you are given Adcortyl IA/ID Injection 3. Receiving Adcortyl IA/ID Injection 4. Possible side effects 5. How to store Adcortyl IA/ID Injection 6. Content of the pack and other information 1. WHAT ADCORTYL IA/ID INJECTION IS AND WHAT IT 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Adcortyl Intra-articular/Intra-Dermal Injection 10mg/ml suspension for injection, 1 ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Triamcinolone acetonide 10 mg per ml (10 mg per 1 ml ampoule). Excipient(s) with known effect: Benzyl alcohol 15 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for Injection (injection). White, Sterile aqueous suspension with a slight odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Intra-articular use:_ in the local management of inflammation involving joints, bursae or tendon sheaths such as occurs in rheumatoid arthritis, osteoarthritis, bursitis, synovitis, tendinitis, epicondylitis and trauma. _Intradermal use:_ for inflammatory dermal lesions such as lichen simplex, lichen planus, psoriasis, granuloma annulare, keloids and for alopecia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adcortyl Injection is only for intra-articular or intra-dermal use and should not be given by any other route. Strict aseptic precautions should be observed. Since the duration of effect is variable, subsequent doses should be given when symptoms recur and not at set intervals. Adcortyl Injection should only be given in an appropriate setting where there is access to emergency medical care. Adults: The dose of Adcortyl Injection for intra-articular administration, and injection into tendon sheaths and bursae, is dependent on the size of the joint to be treated and on the severity of the condition. Doses of 2.5 - 5 mg (0.25 - 0.5 ml) for smaller joints and 5 - 15 mg (0.5 - 1.5 ml) for larger joints usually alleviate the symptoms. Triamcinolone acetonide 40 mg/ml (Kenalog) is available to facilitate administration of larger doses. (see section 4.4 re Achilles tendon.) Intradermal dosage is usually 2 - 3 mg (0.2 - 0.3 ml), depending on the size of the lesion. No more than 5 mg (0.5 ml) should be injected at any one site. If several sites are injected the total dosage administered should not 完全なドキュメントを読む