País: Indonèsia
Idioma: indonesi
Font: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VALPROIC ACID
ABBOTT INDONESIA - Indonesia
VALPROIC ACID
250 MG/5 ML
SIRUP
DUS, 1 BOTOL @ 120 ML
ABBOTT INDONESIA - Indonesia
2018-12-31
DEPAKENE Page 1 of 39 DISETUJUI OLEH BPOM: 08/11/2021 ID: EREG10034612100035 EREG10034612100038 DEPAKENE VALPROIC ACID WARNING: LIFE THREATENING ADVERSE REACTIONS HEPATOTOXICITY _GENERAL POPULATION: _HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROATE AND ITS DERIVATIVES. THESE INCIDENTS USUALLY HAVE OCCURRED DURING THE FIRST SIX MONTHS OF TREATMENT. SERIOUS OR FATAL HEPATOTOXICITY MAY BE PRECEDED BY NON-SPECIFIC SYMPTOMS SUCH AS MALAISE, WEAKNESS, LETHARGY, FACIAL EDEMA, ANOREXIA, AND VOMITING. IN PATIENTS WITH EPILEPSY, A LOSS OF SEIZURE CONTROL MAY ALSO OCCUR. PATIENTS SHOULD BE MONITORED CLOSELY FOR APPEARANCE OF THESE SYMPTOMS. SERUM LIVER TESTS SHOULD BE PERFORMED PRIOR TO THERAPY AND AT FREQUENT INTERVALS THEREAFTER, ESPECIALLY DURING THE FIRST SIX MONTHS_[SEE WARNINGS AND PRECAUTIONS (5.1)]_. CHILDREN UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF DEVELOPING FATAL HEPATOTOXICITY, ESPECIALLY THOSE ON MULTIPLE ANTICONVULSANTS, THOSE WITH CONGENITAL METABOLIC DISORDERS, THOSE WITH SEVERE SEIZURE DISORDERS ACCOMPANIED BY MENTAL RETARDATION, AND THOSE WITH ORGANIC BRAIN DISEASE. WHEN DEPAKENE IS USED IN THIS PATIENT GROUP, IT SHOULD BE USED WITH EXTREME CAUTION AND AS A SOLE AGENT. THE BENEFITS OF THERAPY SHOULD BE WEIGHED AGAINST THE RISKS. THE INCIDENCE OF FATAL HEPATOTOXICITY DECREASES CONSIDERABLY IN PROGRESSIVELY OLDER PATIENT GROUPS. _PATIENTS WITH MITOCHONDRIAL DISEASE: _THERE IS AN INCREASED RISK OF VALPROATE-INDUCED ACUTE LIVER FAILURE AND RESULTANT DEATHS IN PATIENTS WITH HEREDITARY NEUROMETABOLIC SYNDROMES CAUSED BY DNA MUTATIONS OF THE MITOCHONDRIAL DNA POLYMERASE Γ (POLG) GENE (E.G. ALPERS HUTTENLOCHER SYNDROME). DEPAKENE IS CONTRAINDICATED IN PATIENTS KNOWN TO HAVE MITOCHONDRIAL DISORDERS CAUSED BY POLG MUTATIONS AND CHILDREN UNDER TWO YEARS OF AGE WHO ARE CLINICALLY SUSPECTED OF HAVING A MITOCHONDRIAL DISORDER_[SEE CONTRAINDICATIONS (4)]_. IN PATIENTS OVER TWO YEARS OF AGE WHO ARE CLINICALLY SUSPECTED OF HAVING A HEREDITARY MITOCHONDRIAL DISE Llegiu el document complet