DEPAKENE

מדינה: אינדונזיה

שפה: אינדונזית

מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

מרכיב פעיל:

VALPROIC ACID

זמין מ:

ABBOTT INDONESIA - Indonesia

INN (שם בינלאומי):

VALPROIC ACID

כמות:

250 MG/5 ML

טופס פרצבטיות:

SIRUP

יחידות באריזה:

DUS, 1 BOTOL PLASTIK @ 120 ML

תוצרת:

ABBOTT INDONESIA - Indonesia

תאריך אישור:

2019-09-13

מאפייני מוצר

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