DIAMOX Sodium 500mg Powder for sol for Inj/Acetazolamide 500mg Powder for sol for Inj

Pays: Malte

Langue: anglais

Source: Medicines Authority

Ingrédients actifs:

ACETAZOLAMIDE

Disponible depuis:

Mercury Pharmaceuticals Limited Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Code ATC:

S01EC01

DCI (Dénomination commune internationale):

ACETAZOLAMIDE 500 mg

forme pharmaceutique:

POWDER FOR SOLUTION FOR INJECTION

Composition:

ACETAZOLAMIDE 500 mg

Type d'ordonnance:

POM

Domaine thérapeutique:

OPHTHALMOLOGICALS

Statut de autorisation:

Suspended

Date de l'autorisation:

2015-12-02

Notice patient

REPORTING OF SIDE EFFECTS:
If you get any side effects, talk to your doctor, pharmacist or nurse.
This
includes any possible side effects not listed in this leaflet. You can
also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety
of this medicine.
5. HOW TO STORE DIAMOX INJECTION
Keep out of the sight and reach of children.
Do not use after the expiry date. This date is printed on your pack.
The Expiry
date refers to last day of that month.
Do not store above 25˚C.
Any unused solution can be stored in a refrigerator for up to 24 hours
but any
unused solution after this period must be discarded.
For single use only.
Medicines should not be disposed of via wastewater or household waste.
Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
WHAT DIAMOX INJECTION CONTAINS:
The active substance is acetazolamide. Each vial contains 500mg
acetazolamide.
The other ingredients are sodium hydroxide, hydrochloric acid and
water for
injection.
WHAT DIAMOX INJECTION LOOK LIKE AND CONTENTS OF THE PACK:
Diamox Injection is a white powder, packed in glass vials with a
rubber ring
and aluminium seal. Before use, it is made into a solution, using at
least 5ml
water for injection.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER:
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street, London EC4N 7BL, UK
This leaflet was last revised in February 2015.
_Mercury Pharma Group Ltd. is licensed to use the registered
trademark_
_Diamox._
100103/LF/026/04
PATIENT INFORMATION LEAFLET
DIAMOX
®
SODIUM 500MG POWDER FOR
SOLUTION FOR INJECTION
ACETAZOLAMIDE
Read all of this leaflet carefully before you start taking this
medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects become serious, or if you notice any side
effects not
listed

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
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
For full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
White to off-white powder for solution for injection.
4
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Acetazolamide is an enzyme inhibitor which acts specifically on
carbonic anhydrase. It
is indicated in the treatment of :
i)
Glaucoma: DIAMOX injection is useful in glaucoma (chronic simple (open
angle)
glaucoma, secondary glaucoma and perioperatively in acute angle
closure
glaucoma where delay of surgery is desired in order to lower
intraocular pressure)
because it acts on inflow, decreasing the amount of aqueous secretion.
ii)
Abnormal retention of fluids: DIAMOX
injection
is a diuretic whose effect is due to the
effect on the reversible hydration of carbon dioxide and dehydration
of carbonic
acid reaction in the kidney. The result is a renal loss of HCO
3-
ion which carries
out sodium, water and potassium.
DIAMOX injection can be used in conjunction with other diuretics when
effects on several
segments of the nephron are desirable in the treatment of fluid
retaining states.
iii)
Epilepsy: In conjunction with other anticonvulsants best results with
DIAMOX injection have been seen in petit mal in children. Good
results, however, have
been seen in patients, both children and adults, with other types of
seizures such
as grand mal, mixed seizure patterns, myoclonic jerk patterns, etc
4.2.
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.
i)
Glaucoma (simple acute congestive and secondary):
Adults: 250 - 1000mg per 24 hours, usually in divided doses for
amounts over
250mg daily.
ii)
Abnormal retention of fluid: Congestive heart-f