Diamox Sodium Parenteral 500mg powder for solution for injection vials

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Letöltés Betegtájékoztató (PIL)
07-06-2018
Letöltés Termékjellemzők (SPC)
07-06-2018

Aktív összetevők:

Acetazolamide

Beszerezhető a:

Advanz Pharma

ATC-kód:

S01EC01

INN (nemzetközi neve):

Acetazolamide

Adagolás:

500mg

Gyógyszerészeti forma:

Powder for solution for injection

Az alkalmazás módja:

Intravenous; Intramuscular

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 11060000; GTIN: 5021691165378

Betegtájékoztató

                                IF ANY OF THE SIDE EFFECTS BECOMES SERIOUS, OR IF YOU NOTICE ANY SIDE
EFFECTS NOT LISTED IN THIS LEAFLET, PLEASE TELL YOUR DOCTOR OR
PHARMACIST.
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 December 2017.
_Mercury Pharma Group Ltd. is licensed to use the registered
trademark_
_Diamox._
LF-104036-01
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 
                                
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Termékjellemzők

                                OBJECT 1
DIAMOX SODIUM 500MG POWDER FOR SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 15-Jan-2018 | Concordia
International - formerly AMCo
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 HCO3- 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 - 10
                                
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