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ItemsRegistration information
ID1061
No1061
Brand NameBUPISON
IngredientsBUPIVACAINE HYDROCHLORIDE USP EQ.TO ANHYDROUS BUPIVACAINE HYDROCHLORIDE 5 MG, DEXTROSE( MONOHYDRATE) USP 80 MG/ ML
Dosage FormSOLUTION FOR INJECTION
Primary PackagingAMPOULES
StorageSTORE BELOW 30 C, DO NOT REFRIGERATE
Shelf Life2 YEARS
Pack Size5 AMPOULES X 4 ML/BOX
Dispensing CategoryPrescription only
ATC ClassificationXX
Pharmaceutical ClassANESTHESIA
IndicationsIN ADULTS AND CHILDREN OF ALL AGES FOR INTRATHECAL SPINAL ANAESTHESIA FOR SURGERY (UROLOGICAL AND LOWER LIMB SURGERY LASTING 2-3 HOURS, ABDOMINAL SURGERY LASTING 45-60 MINUTES)
ContraindicationsHYPERSENSITIVITY, MENINGITIS, POLIOMYELITIS, INTRACRANIAL HAEMORRHAGE, SPINAL STENOSIS AND ACTIVE DISEASE, SEPTICAEMIA, PYOGENIC INFECTION, CARDIOGENIC, COAGULATION DISORDER
Side EffectsPOSTDURAL PUNCTURE HEADACHE, HYPOTENSION, BRADYCARDIA, NAUSEA,VOMITING,URINARY RETENSION, URINARY INCONTINENCE
Unit Price
EDL Yes
DescriptionCLEAR COLORLESS SOLUTION FILLED IN 5 ML CLEAR GLASS AMPOULES
Note
License OwnerIC Pharma Lao Co., Ltd
ManufacturerFLAGSHIP BIOTECH INTERNATIONAL
CountryINDIA
Import Registration NoG/28-A/5546-A
Import Registration Date2017-09-18
ActivityCERTIFICATE RELEASED
Applied Date2023-01-27
FDD Registration No08 I 4776/19
FDD Registration Date2023-06-07
Expiry Date2026-06-06

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