ANTIZOL fomepizole 1.5g/1.5mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fomepizole, Quantity: 1 g/mL

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

fomepizole

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients:

Administration route:

Intravenous

Units in package:

1 x 1.5mL vial, 4 x 1.5ml vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Antizol is indicated for the treatment of ethylene glycol or methanol poisoning. (see DOSAGE AND ADMINISTRATION).

Product summary:

Visual Identification: Clear, colourless to yellow solution, essentially free from particles of foreign matter (visible signs of contamination); Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2016-12-01

Patient Information leaflet

FOMEPIZ-CMI-AU-v5
ANTIZOL
_Fomepizole Injection_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
Antizol. It does not
contain all the information that is known about Antizol.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you being
given Antizol against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ANTIZOL IS USED FOR
Antizol belongs to a group of medicines called antidotes.
Antizol is used to treat ethylene glycol and methanol poisoning.
Antizol helps to restore your blood levels of ethylene glycol and/or
methanol to normal.
Your doctor may have administered this medicine for another reason.
Your doctor will explain why you are being treated with Antizol and
tell you what dose you
are being given.
Follow all directions given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
Ask your doctor if you have any questions about why Antizol has been
administered to you.
FOMEPIZ-CMI-AU-v5
Antizol is not addictive.
This medicine is available only with a doctor’s prescription
BEFORE YOU ARE GIVEN ANTIZOL
_WHEN YOU MUST NOT BE GIVEN IT_
_ _
You must not be given Antizol if you have been drinking alcohol
excessively.
You should not be given Antizol if you have ever experienced an
anaphylactic reaction
with Antizol or other pyrazoles.
ANTIZOL SHOULD NOT BE USED IF THE EXPIRY DATE (EXP) PRINTED ON THE
PACK HAS PASSED.
_BEFORE YOU USE IT _
Tell your doctor if you are pregnant or planning to become pregnant
The effect of ANTIZOL in pregnant women is not known. Therefore the
use of ANTIZOL
in pregnant women is not recommended.
Tell your doctor if you are breastfeeding or plan to breastfeed.
It is not known whether ANTIZOL passes into breast milk. If you ar

Summary of Product characteristics

Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
ANTIZOL
® (FOMEPIZOLE) INJECTION
1.
NAME OF THE MEDICINE
Fomepizole.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1.5 mL (1 g/mL) of fomepizole. It is supplied
sterile. Fomepizole injection does not
contain any excipients.
3.
PHARMACEUTICAL FORM
A clear to yellow liquid (or solid) sterile, preservative-free
solution for intravenous use.
Solidification does not affect the stability of Antizol
®
.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Antizol
®
(fomepizole) is indicated for the treatment of ethylene glycol or
methanol poisoning (see
section 4.2 Dosage and method of administration).
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. Hence, if the fomepizole solution has become a solid in
the vial, the solution should be
liquefied by running the vial under warm water or by holding in the
hand. Solidification does not affect
the stability of Antizol
®
.
TREATMENT WITH FOMEPIZOLE
: Begin fomepizole treatment immediately upon suspicion of ethylene
glycol or methanol ingestion based on patient history and/or anion gap
metabolic acidosis, increased
Page 2 of 14
osmolar gap, visual disturbances, or oxalate crystals in the urine, OR
a documented serum ethylene
glycol or methanol concentration greater than 20 mg/dL (ethylene
glycol 3.22 mmol/L, methanol 6.24
mmol/L).
DISCONTINUATION OF FOMEPIZOLE TREATMENT:
Treatment with f