Indications : התוויות

4.1   Therapeutic indications
Attention-Deficit/Hyperactivity Disorder (ADHD)
Medikinet MR is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children aged 6 years of age and over when remedial measures alone prove insufficient. Treatment must be initiated under the supervision of a specialist in childhood behaviour disorders.
Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10 and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.


Additional information on the safe use of the medicinal product:
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 and social measures as well as pharmacotherapy and is aimed at stabilising children with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired.

Medikinet MR treatment is not indicated in all children with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age.

Appropriate educational placement is essential, and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child's symptoms. The use of Medikinet MR should always be used in this way according to the licensed indication and according to prescribing / diagnostic guidelines.