FOMEPIZOLE EUSA PHARMA

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

FOMEPIZOLE SULPHATE

Dostopno od:

EUSA Pharma (UK) Limited

Koda artikla:

V03AB34

INN (mednarodno ime):

FOMEPIZOLE SULPHATE

Odmerek:

5 Mg/Ml

Farmacevtska oblika:

Concentrate for Soln for Inf

Tip zastaranja:

Product subject to prescription which may not be renewed (A)

Terapevtsko območje:

fomepizole

Status dovoljenje:

Marketed

Datum dovoljenje:

2002-10-11

Navodilo za uporabo

1
FOMEPIZOLE EUSA PHARMA 5 MG/ML, CONCENTRATE FOR SOLUTION FOR INFUSION
Fomepizole (as sulphate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell
your doctor.
IN THIS LEAFLET:
1.
What FOMEPIZOLE EUSA Pharma is and what it is used for
2.
Before you use FOMEPIZOLE EUSA Pharma
3.
How to use FOMEPIZOLE EUSA Pharma
4.
Possible side effects
5.
How to store FOMEPIZOLE EUSA Pharma
6.
Further information
7.
Practical information for medical and healthcare professionals
1. WHAT FOMEPIZOLE EUSA PHARMA IS AND WHAT IT IS USED FOR
FOMEPIZOLE EUSA Pharma is an antidote. It is used as an emergency
treatment for oral ethylene glycol
poisoning.
Your doctor has prescribed you this medicine because you have ingested
a toxic substance called ethylene
glycol (clear, colorless, odorless liquid with a sweet taste, widely
used as an automotive antifreeze).
FOMEPIZOLE EUSA Pharma halts the progression of ethylene glycol
poisoning and allows removal of
ethylene glycol from blood.
2. BEFORE YOU USE FOMEPIZOLE EUSA PHARMA
DO NOT USE FOMEPIZOLE EUSA PHARMA
•
If you are allergic (hypersensitive) to the active substance
(fomepizole) or any of the other ingredients of
FOMEPIZOLE EUSA Pharma (see section 6).
•
If you are allergic to other medicines belonging to the same family
(pyrazoles). In such case, you may
also be allergic to fomepizole.
TAKE SPECIAL CARE WITH FOMEPIZOLE EUSA PHARMA
•
If you experience:
-
a sudden swelling of the throat, face, lips or mouth,
-
redness, skin rush or itching.
It is an allergic reaction. In this case, your doctor will monitor the
observed signs.
If your allergic reaction becomes more important or gets worse, you
should

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fomepizole EUSA Pharma 5 mg/mL, concentrate for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 8 mg fomepizole sulphate, equivalent to 5 mg
fomepizole.
An ampoule of 20 ml contains 160 mg fomepizole sulphate, equivalent to
100 mg fomepizole.
Excipients: An ampoule of 20 ml contains 2.4 mmol sodium.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion
Fomepizole EUSA Pharma is a clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fomepizole EUSA Pharma is an antidote used in the treatment of acute
ethylene glycol poisoning.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should begin whenever ethylene glycol poisoning is
suspected, as early as possible after its ingestion,
even in the absence of signs of toxicity.
In the absence of ethylene glycol assay, ethylene glycol poisoning
should be suspected on the following criteria:
- patient’s history ;
- osmolar gap > 20 mOsm/kg H
2
0 ;
- metabolic acidosis with anion gap > 16 mmol/l (presence of high
levels of glycolates) ;
- calcium oxalate crystals in the urine.
An assay for plasma ethylene glycol should be performed at admission,
but this determination should not delay start of
treatment with fomepizole. Plasma ethylene glycol levels should be
monitored every 12 to 24 hours_._
Fomepizole EUSA Pharma 5mg/mL, concentrate for solution for infusion,
is to be diluted before use (see section 6.6).
The diluted solution should be administered by slow intravenous
infusion.
Dosage depends on plasma ethylene glycol concentration and renal
function:
- patients with normal renal or mild to moderate impaired renal
function as assessed by serum creatinine (100 to 265
µmol/l)
in whom hemodialysis is not required :
Administration should be performed by slow intravenous infusion, over
30 to 45 minutes, given as follows: infusion of
a loading dose of 15 mg/kg followed by doses every 12 hour