DIAMOX Sodium Powder for solution for injection (2018)
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Περιεχόμενα
Name of the medicinal product
DIAMOX Sodium 500mg Powder for Solution for Injection. Acetazolamide 500mg Powder for solution for Injection.
Qualitative and quantitative composition
Each vial contains Acetazolamide 500mg. For full list of excipients see section 6.1.
Pharmaceutical form
White to off-white powder for solution for injection.
Therapeutic indications
Acetazolamide is an enzyme inhibitor which acts specifically on carbonic anhydrase. It is indicated in the treatment of: <u>Glaucoma:</u> DIAMOX injection is useful in glaucoma (chronic simple (open angle) ...
Posology and method of administration
Routes of Administration Intravenous or intramuscular injection. The direct intravenous route is preferred as intramuscular use is limited by the alkaline pH of the solution. Glaucoma (simple acute congestive ...
Contraindications
Diamox injection is contraindicated in situations in which sodium and/or potassium blood levels are depressed, in cases of marked kidney and liver dysfunction, suprarenal gland failure and hyper-chloremic ...
Special warnings and precautions for use
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs ...
Interaction with other medicinal products and other forms of interaction
Acetazolamide is a sulphonamide derivative. Sulphonamides may potentiate the effects of folic acid antagonists. Possible potentiation of the effects of folic acid antagonists, hypoglycaemics and oral anti-coagulants. ...
Pregnancy and lactation
Acetazolamide has been reported to be teratogenic and embryotoxic in rats, mice, hamsters and rabbits at oral or parenteral doses in excess of ten times those recommended in human beings. Although there ...
Effects on ability to drive and use machines
Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paraesthesia. Less commonly, fatigue, dizziness and ataxia have been reported. Disorientation has ...
Undesirable effects
Adverse reactions during short-term therapy are usually non-serious. Those effects which have been noted include: paraesthesia, particularly a tingling feeling in the extremities, some loss of appetite; ...
Overdose
No specific antidote. Supportive measures with correction of electrolyte and fluid balance. Force fluids.
Pharmacodynamic properties
Pharmacotherapeutic group: Carbonic anhydrase inhibitors ATC Code: S01EC01 Acetazolamide is an inhibitor of carbonic anhydrase. By inhibiting the reaction catalysed by this enzyme in the renal tubules, ...
Pharmacokinetic properties
Acetazolamide has been estimated to have a plasma half-life of about 4 hours. It is tightly bound to carbonic anhydrase and accumulates in tissues containing this enzyme, particularly red blood cells and ...
Preclinical safety data
Nothing of note to the prescriber.
List of excipients
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Incompatibilities
None.
Shelf life
24 months.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Glass vial with butyl rubber plug and aluminium ring seal. Pack size 500mg vial.
Special precautions for disposal and other handling
Reconstitute each vial of DIAMOX Injection with at least 5ml of water for injection prior to use. The reconstituted solution is clear and colourless and does not contain an antimicrobial preservative. ...
Marketing authorization holder
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0146
Date of first authorization / renewal of the authorization
11<sup>th</sup> February 1988 / 16<sup>th</sup> February 2004
Date of revision of the text
08/01/2018
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