Pro-Epanutin 75 mg/ml concentrate for solution for infusion/solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fosphenytoin sodium

Available from:

Pfizer Healthcare Ireland

ATC code:

N03AB; N03AB05

INN (International Name):

Fosphenytoin sodium

Dosage:

75 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection/infusion

Prescription type:

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

Therapeutic area:

Hydantoin derivatives; fosphenytoin

Authorization status:

Marketed

Authorization date:

1998-07-27

Patient Information leaflet

Page 1 of 10
2022-0076892, 2020-0063521, 2022-0077848
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PRO-EPANUTIN™ 75 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION/SOLUTION FOR INJECTION
fosphenytoin sodium
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist or
nurse.
−
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
−
You may have been given Pro-Epanutin as a single dose to control
status epilepticus. In
this case, you will only be able to read this leaflet after you have
had the product given to
you. Your doctor will have considered the important safety information
in this leaflet, but
your urgent need for treatment may have been more important than some
of the normal
cautions. Check them now, especially if you are going to continue to
be given
Pro-Epanutin (or any other form of phenytoin).
WHAT IS IN THIS LEAFLET
1.
What Pro-Epanutin is and what it is used for
2.
What you need to know before you are given Pro-Epanutin
3.
How Pro-Epanutin is given
4.
Possible side effects
5.
How to store Pro-Epanutin
6.
Contents of the pack and other information
1.
WHAT PRO-EPANUTIN IS AND WHAT IT IS USED FOR
Pro-Epanutin contains the active substance fosphenytoin which belongs
to a group of medicines
called anti-epileptic medicines; these medicines are used to treat
epilepsy.
Pro-Epanutin is used in adults and children aged 5 years and older:
•
to treat severe epileptic seizure or fits (status epilepticus) of the
tonic-clonic (grand mal)
type.
•
to control or prevent seizures during or after brain surgery and/or
head injury.
•
to control or prevent seizures for short periods of time when
anti-epileptic medicines
cannot be taken by mouth.
You should consult your doctor if you are unsure why you have been
given Pro-Epanutin

Summary of Product characteristics

Health Products Regulatory Authority
14 June 2023
CRN00DMDF
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pro-Epanutin 75 mg/ml concentrate for solution for infusion/solution
for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Fosphenytoin sodium injection is a prodrug intended for parenteral
administration; its active metabolite is phenytoin. 1.5 mg of
fosphenytoin sodium is equivalent to 1 mg phenytoin sodium, and is
referred to as 1 mg phenytoin sodium equivalents (PE).
The amount and concentration of fosphenytoin is always expressed in
terms of mg PE.
One mL of Pro‑Epanutin contains 75 mg of fosphenytoin sodium
(equivalent to 50 mg of phenytoin sodium) (see section 4.2).
Pro-Epanutin is available in 10 mL and 2 mL vials.
Each 10 mL vial contains 500 mg PE.
Each 2 mL vial contains 100 mg PE.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion/Solution for injection.
Pro-Epanutin is a clear, colourless to pale yellow, sterile solution
buffered with trometamol adjusted to pH 8.6 to 9.0 with
hydrochloric acid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pro‑Epanutin is indicated in adults and children aged 5 years and
older:
• for the control of status epilepticus of the tonic-clonic (grand
mal) type (see section 4.2).
• for prevention and treatment of seizures occurring in connection
with neurosurgery and/or head trauma.
• as substitute for oral phenytoin if oral administration is not
possible and/or contra-indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
IMPORTANT NOTE: THROUGHOUT ALL PRO-EPANUTIN PRODUCT LABELLING, THE
AMOUNT AND CONCENTRATION OF FOSPHENYTOIN IS
ALWAYS EXPRESSED IN TERMS OF PHENYTOIN SODIUM EQUIVALENTS (PE) TO
AVOID THE NEED TO PERFORM MOLECULAR WEIGHT-BASED
ADJUSTMENTS WHEN CONVERTING BETWEEN FOSPHENYTOIN AND PHENYTOIN SODIUM
DOSES. PRO-EPANUTIN SHOULD ALWAYS BE
PRESCRIBED AND DISPENSED IN PHENYTOIN SODIUM EQUIVALENT UNITS (PE).
NOTE, HOWEVER, THAT FOSPHENYTOIN HAS IMPORTANT
DI