Fomepizole SERB 5 mg/mL, concentrate for solution for infusion.

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Fomepizole sulphate

थमां उपलब्ध:

SERB S.A.,

ए.टी.सी कोड:

V03AB; V03AB34

INN (इंटरनेशनल नाम):

Fomepizole sulphate

डोज़:

5 milligram(s)/millilitre

फार्मास्यूटिकल फॉर्म:

Concentrate for solution for infusion

चिकित्सीय क्षेत्र:

Antidotes; fomepizole

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2002-10-11

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FOMEPIZOLE SERB 5 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Fomepizole (as sulphate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
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 only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
include any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What FOMEPIZOLE SERB is and what it is used for
2.
What you need to know before you use FOMEPIZOLE SERB
3.
How to use FOMEPIZOLE SERB
4.
Possible side effects
5.
How to store FOMEPIZOLE SERB
6.
Contents of the pack and other information
1. WHAT FOMEPIZOLE SERB IS AND WHAT IT IS USED FOR
FOMEPIZOLE SERB 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 SERB halts the progression of ethylene glycol poisoning and
allows removal of ethylene
glycol from blood.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE FOMEPIZOLE SERB
DO NOT USE FOMEPIZOLE SERB
•
If you are allergic to fomepizole or any of the other ingredients of
this medicine (listed in 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.
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH FOMEPIZOLE SERB
•
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 mo

उत्पाद विशेषताएं

Health Products Regulatory Authority
01 December 2022
CRN00D90X
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fomepizole SERB 5 mg/mL, concentrate for solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 8 mg of fomepizole sulphate equivalent to 5 mg
fomepizole.
An ampoule of 20 ml contains 160 mg fomepizole sulphate, equivalent to
100 mg fomepizole;
Excipient(s) with known effect: An ampoule of 20 ml contains 2,4 mmol
sodium
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Fomepizole SERB is a clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fomepizole SERBis an antidote used in the treatment of acute ethylene
glycol poisoning.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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_._
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 mmol/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 hours until ethylene
glycol levels has been reduced below 0.2 g/l (3.2 mmol/l).
_Fomepizole dose (mg/kg body we