Transcription of 2. Qualitative and Quantitative Composition 3 ...
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2. Qualitative and Quantitative Composition 3 ...
Page 1 of 11 NEW ZEALAND DATA SHEET PACIFEN 1. Product Name PACIFEN, 10 mg or 25 mg, tablet. 2. Qualitative and Quantitative Composition Each tablet contains 10 mg or 25 mg of baclofen PACIFEN tablets contain lactose. For the full list of excipients, see section 3. Pharmaceutical Form PACIFEN 10 mg tablets are white, round, flat bevelled edged marked 'BN' | '10' on one side and 'G' on the other. Each tablet contains 10 mg of baclofen and has a diameter of 7 mm. PACIFEN 25 mg tablets are white, round, flat bevelled edged marked 'BN' | '25' on one side and 'G' on the other. Each tablet contains 25 mg of baclofen and has a diameter of 8 mm. 4. Clinical Particulars Therapeutic indications spasticity of the skeletal muscles in multiple sclerosis. Spastic conditions occurring in spinal-cord diseases of infectious, degenerative, traumatic, neoplastic, or unknown origin: spastic spinal paralysis, amyotrophic lateral sclerosis, syringomyelia, transverse myelitis, traumatic paraplegia or paraparesis, and compression of the spinal cord; muscle spasm of cerebral origin, especially where due to infantile cerebral palsy, as well as following cerebrovascular accidents or in the presence of neoplastic or degenerative brain disease.
Page 3 of 11 of seizure control and EEG changes, and may precipitate convulsions. In patients with epilepsy and muscle spasticity, baclofen can be used under appropriate supervision, provided adequate
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