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Elvanse Adult 30mg Hard Capsules(一)
2019-05-26 22:25:19 来源: 作者: 【 】 浏览:8452次 评论:0
Elvanse Adult 30mg Hard Capsules
Shire Pharmaceuticals Limited
1. Name of the medicinal product
Elvanse Adult 30 mg capsules, hard.
Elvanse Adult 50 mg capsules, hard.
Elvanse Adult 70 mg capsules, hard.
2. Qualitative and quantitative composition
30 mg lisdexamfetamine dimesylate, equivalent to 8.9 mg of dexamfetamine.
50 mg Capsules: Each capsule contains 50 mg lisdexamfetamine dimesylate, equivalent to 14.8 mg of dexamfetamine.
70 mg Capsules: Each capsule contains 70 mg lisdexamfetamine dimesylate, equivalent to 20.8 mg of dexamfetamine.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.
Elvanse Adult 30 mg capsule: white opaque body and pink opaque cap, printed 'S489' and '30 mg' in black ink.
Elvanse Adult 50 mg capsule: white opaque body and blue opaque cap, printed 'S489' and '50 mg' in black ink.
Elvanse Adult 70 mg capsule: blue opaque body and pink opaque cap, printed 'S489' and '70 mg' in black ink.
Each capsule measures approximately 16 mm long and 6 mm wide.
4. Clinical particulars
4.1 Therapeutic indications
Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adults.
Elvanse Adult is not indicated in all adult patients and the decision to use the medicinal product must take into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient's symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD.
Treatment must be under the supervision of a specialist in behavioural disorders. Diagnosis should be based on a complete history and eva luation of the patient according to current DSM criteria or ICD guidelines. Diagnosis cannot be made solely on the presence of one or more symptom. In adults, the presence of symptoms of ADHD that were pre-existing in childhood is required and should be confirmed retrospectively (according to the patient's medical record or, if not available, through appropriate and structured instruments or interviews). Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in two or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual's life.
The specific aetiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and specialised psychological, educational, and social resources.
A comprehensive treatment programme typically includes psychological, educational, behavioural, occupational and social measures as well as pharmacotherapy and is aimed at stabilising the adult patient with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, impulsivity and hyperactivity.
4.2 Posology and method of administration
Treatment must be initiated under the supervision of an appropriate specialist in behavioural disorders.
Posology
Dosag should be individualised according to the therapeutic needs and response of the patient. Careful dose titration is necessary at the start of treatment with Elvanse Adult.
The starting dose is 30 mg taken once daily in the morning. The dose may be i
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