Dating relating emc 10n directory

Posted by / 01-Jul-2020 05:01

Dating relating emc 10n  directory

Age The use of olanzapine in the treatment of dopamine agonist associated psychosis in patients with Parkinson's disease is not recommended.

In clinical trials, worsening of Parkinsonian symptomatology and hallucinations were reported very commonly and more frequently than with placebo (see section 4.8), and olanzapine was not more effective than placebo in the treatment of psychotic symptoms.

If a new manic, mixed, or depressive episode occurs, Olanzapine Accord treatment should be continued (with dose optimization as needed), with supplementary therapy to treat mood symptoms, as clinically indicated.

In patients whose manic episode has responded to Olanzapine Accord treatment, Olanzapine Accord is indicated for the prevention of recurrence in patients with bipolar disorder (see section 5.1).

Olanzapine Accord is indicated for the treatment of schizophrenia.

Olanzapine Accord is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

In these trials, patients were initially required to be stable on the lowest effective dose of anti-Parkinsonian medicinal products (dopamine agonist) and to remain on the same anti-Parkinsonian medicinal products and dosages throughout the study.

Olanzapine was started at 2.5 mg/day and titrated to a maximum of 15 mg/day based on investigator judgement.

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