Antizol

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Fomepizole 1 g/mL

Beschikbaar vanaf:

AFT Pharmaceuticals Ltd

Dosering:

1 g/mL

farmaceutische vorm:

Solution for injection

Samenstelling:

Active: Fomepizole 1 g/mL

Prescription-type:

Prescription

therapeutische indicaties:

Antizol (fomepizole) Injection is indicated as an antidote for ethylene glycol (such as antifreeze) or methanol poisoning (such as windshield washer fluid), or for use in suspected ethylene glycol or methanol ingestion, either alone or in combination with haemodialysis.

Product samenvatting:

Package - Contents - Shelf Life: Vial, glass, Type I glass equipped with 13 mm Teflon-faced butyl rubber stopper and Flip-Off seal - 1.5 mL - 60 months from date of manufacture stored at or below 25°C. Do not refrigerate

Autorisatie datum:

2015-04-24

Productkenmerken

NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
ANTIZOL
®
Fomepizole 1g/mL concentrate for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1.5 g of fomepizole.
Excipient with known effect: none.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear to yellow liquid at room temperature. Its melting point is 25
o
C and it may present as a solid at
room temperature.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Antizol
®
(fomepizole) is indicated for the treatment of ethylene glycol or
methanol poisoning.
4.2. DOSE AND METHOD OF ADMINISTRATION
CAUTION: MUST BE DILUTED PRIOR TO USE
TREATMENT GUIDELINES:
If ethylene glycol or methanol poisoning is left untreated, the
natural
progression of the poisoning leads to accumulation of toxic
metabolites, including glycolic
and oxalic
acids (ethylene glycol intoxication) and formic acid (methanol
intoxication).
These metabolites can induce metabolic acidosis, nausea/vomiting,
seizures, stupor, coma,
calcium oxaluria, acute tubular
necrosis, blindness and death. The diagnosis of these
poisonings may be difficult because ethylene glycol and methanol
concentrations diminish in
the blood as they are metabolized to their respective metabolites.
Antizol
®
solidifies at temperatures less than 25 °C hence, if
the fomepizole solution has become solid
in the vial, the solution should be liquefied by running the vial
under warm tap water or by holding in
the hand. Solidification does not affect the stability of Antizol
®
.
Using sterile technique, the appropriate dose of fomepizole should be
drawn from the vial with a
syringe and injected into at least 100 mL of sterile 0.9% sodium
chloride injection or dextrose 5%
injection. Mix well. The entire contents of the resulting solution
should be infused over 30 minutes.
Fomepizole, like
all parenteral products, should be inspected for particulate matter
prior to
administration.
TREATMENT WITH FOMEPIZOLE:
Begin fomepizole treatment immediately upon suspicion of ethylene
glycol or methanol inge