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Copaxonex - Extract from 2005 - 1356 pages therapy Neurology Encyclopedia By Peter Berlit:

Extract from 2005 - 1356 pages
therapy Neurology Encyclopedia By Peter Berlit:

Common finished product:

Copaxonex 20 mg. Powder and injection means for injection solution. Each contains 20 mg
Durchstechtlasche glatiramer acetate, equivalent to 18 mg glatiramer.
Mwendtmgsgebiete
Copaxonex is indicated for the reduction of the shear rate in ambulatory patients (ie
those that are able to walk unaided) with relapsing-remitting multiple sclerosis (MS). hei which at least two attacks of neurological dysfunction during the last 2 years have occurred.
Copaxone "is not indicated for primary or secondary progressive MS.

Under the long-term treatment were in the sera of patients found antibodies against glatiramer acetate. These reached after an average treatment period of 3-4 months maximum concentration and increased thereafter up to a concentration as the off-the gcringfiigig was higher than the initial concentration. There is no evidence up there, that the antibodies against glatiramer acetate contribute neuralisierend or affect the clinical efficacy of Copaxone "can.
In all clinical trials most often reactions observed at the injection site and the majority of patients Copaxone were` reported. In controlled trials, the number of patients, these reactions at least once reported in the group treated with Copaxonc. higher than in the group taking placebo, he held (82% vs. verum. 48% placebo). The most common of these local reactions include erythema, pain, hives, pruritus, edema, inflammation, or increased tenderness at the injection site.
immediate post-injection reactions were related with at least one of the following symptoms overwritten: vasodilation, chest pain, dyspnea, palpitations or tachycardia. These reactions may, within minutes after an injection of Copaxone occur. At least one symptom of the immediate Postinjcktions reactions was during the treatment period at least once by 41% of patients treated with Copaxone, were compared with 20% of patients on placebo, reported

adverse effects.

Within minutes injection of Copaxone may "reactions occur with at least one of the following symptoms: vasodilation (flushing). Chest pain, shortness of breath. Palpitations or tachycardia. The patient must be informed by the treating physician about the possible occurrence of such reactions. Most of these reactions are short lived and resolve spontaneously without any further consequences. In rare cases it can cause severe hypersensitivity reactions (eg Bonchospasmus, anaphylaxis or urticaria) can occur.
There is no evidence that respect for certain groups of patients these reactions ncn a particular risk. Nevertheless, caution is advised when Copaxonek is administered to patients with pre-existing heart disease. These patients should be monitored regularly during treatment.
Under the long-term treatment were in the sera of patients antibodies found against glatiramer acetate. These reached after an average treatment period of 3-4 months maximum concentration and increased thereafter up to a concentration of like-from. which was slightly higher than the initial concentration. There is no evidence up there, that the antibodies against glatiramer acetate neuralisierend affect or influence the clinical efficacy of Copaxonek can.
In all clinical trials at the most common reactions observed at the injection site and the majority of patients Copaxonc received "reports. In controlled trials, the number of patients who reported these reactions at least once in the group. Treated with Copaxonek were higher than in the group, the placebo-he kept 012% vs. verum. 48% placebo). The most common of these local reactions include erythema, pain. Hives. Pruritus, edema, inflammation, or increased tenderness at the injection site.

Immediate post-injection reactions were herschrieben in connection with at least one of the following: vasodilation, chest pain, dyspnea, palpitations or tachycardia. These reactions may, within minutes after an injection of Copaxonc occur '. At least one symptom of the immediate post-injection reactions during the treatment period was at least once by 41% of patients treated with Copaxone ", to 20% of patients receiving placebo reported.
In the following Table 1 lists all adverse events that occurred more frequently in patients treated with Copaxonc 'than in placebo-treated patients.