DIAMOX Sodium 500mg Powder for Solution for Injection

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

ACETAZOLAMIDE

Dostupné s:

ZULAT PHARMACY SDN. BHD.

INN (Mezinárodní Name):

ACETAZOLAMIDE

Jednotky v balení:

0.5gm mcg/mL

Výrobce:

BAG Health Care GMBH ( Bag Pharma)

Charakteristika produktu

THIS ARTWORK IS NOT TECHNICALLY APPROVED
and technical approval needs to be taken,
from the CMO, before Implementation.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal
product is important. It allows continued monitoring of the
benefit/risk balance of
the medicinal product. Healthcare professionals are asked to report
any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the
Google
Play or Apple App Store.
4.9. OVERDOSE
Management
No specific antidote. Supportive measures with correction of
electrolyte and fluid
balance. Force fluids.
5.
PHARMACOLOGICAL PROPERTIES
5.1.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Carbonic anhydrase inhibitors.
ATC Code: S01EC01.
Mechanism of action
Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the
reaction
catalysed by this enzyme in the renal tubules, acetazolamide increases
the
excretion of bicarbonate and of cations, chiefly sodium and potassium,
and so
promotes alkaline diuresis.
Pharmacodynamic effects
Continuous administration of acetazolamide is associated with
metabolic acidosis
and resultant loss of diuretic activity. Therefore the effectiveness
of DIAMOX in
diuresis diminishes with continuous use.
By inhibiting carbonic anhydrase in the eye acetazolamide decreases
intra-
ocular pressure and is therefore useful in the treatment of glaucoma.
5.2.
PHARMACOKINETIC PROPERTIES
Distribution
It is tightly bound to carbonic anhydrase and accumulates in tissues
containing
this enzyme, particularly red blood cells and the renal cortex. It is
also bound to
HEALTH PROFESSIONALS’
USER LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT
DIAMOX Sodium 500mg Powder for Solution for Injection
Acetazolamide 500mg Powder for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Acetazolamide 500mg
Excipient(s) with known effect
For full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
White