PAMPARA INJECTION 500mg20ml

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

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Herunterladen Fachinformation (SPC)
22-11-2017

Wirkstoff:

Pralidoxime hydrochloride

Verfügbar ab:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (Internationale Bezeichnung):

Pralidoxime hydrochloride

Einheiten im Paket:

20ml mL

Hergestellt von:

SIU GUAN CHEM. IND.CO.,LTD.

Fachinformation

                                PAMPARA INJECTION 500MG/20ML
PRALIDOXIME CHLORIDE INJECTION 500MG
DESCRIPTION
A clear and colorless to slightly yellow liquid in glass ampoules.
COMPOSITION
Each 20ml ampoule contains 500mg of Pralidoxime (as chloride).
MODE OF ACTION
Pralidoxime is cholinesterase reactivator and its principal mode of
action is by reactivating the enzyme cholinesterase
which has been inhibited by phosphorylation.
SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS
Blood concentrations are rapidly attained after intramuscular or
intravenous injection. Pralidoxime is not bound to plasma
protein and does not readily pass into the central nervous system.
Pralidoxime is rapidly excreted in the urine partly
unchanged and partly as a metabolite. The elimination half- life is
approximately 1 to 2 hours.
INDICATIONS
Pampara Injection is indicated in the treatment of poisoning due to
organophosphates pesticides or related compounds.
Pralidoxime is an adjunct to atropine in the treatment of poisoning
due to those pesticides and chemicals of the
organophosphate class which have anticholinesterase activity.
Pampara Injection is indicated in the treatment of overdosage by
anticholinesterase drugs used in the treatment of
myasthenia gravis.
SIDE EFFECTS/ ADVERSE REACTION
The
side
effects
include
drowsiness,
dizziness,
and
disturbances
of
vision,
nausea,
tachycardia,
headaches,
hyperventilation, and muscular weakness have been reported after the
use of Pampara injection. However it is very difficult
to differentiate the toxic effects produced by atropine or the
organophosphate compounds from those of the drug. When
atropine and Pampara injection are used together, the signs of
atropinization may occur earlier than might be expected
when atropine is use alone. This is especially true if the total dose
of atropine has been large and the administration of
Pampara injection has been delayed. Excitement and manic behavior
immediately following recovery of consciousness
have been reported in several cases. However, similar behavior has
occurred in case o
                                
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