VALPROIC ACID- valproic acid solution Par Pharmaceutical ----------
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چکیده
WARNINGS: LIFE THREATENING ADVERSE REACTIONS See full prescribing information for complete boxed warning. Hepato toxicity, including fatalities, usually during first 6 months o f treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients c losely, and perform serum liver testing prior to therapy and at frequent intervals thereafter (5.1) Fetal Risk, particularly neural tube defects, o ther major malformations, and decreased IQ (5.2, 5.3, 5.4 ) Pancreatitis, including fatal hemorrhag ic cases (5.5)
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