Pro-Epanutin 750mg/10ml concentrate for solution for injection vials

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Fosphenytoin sodium

Dostupné s:

Pfizer Ltd

ATC kód:

N03AB05

INN (Mezinárodní Name):

Fosphenytoin sodium

Dávkování:

75mg/1ml

Léková forma:

Solution for injection

Podání:

Intravenous; Intramuscular

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 04080200; GTIN: 5013457011579

Informace pro uživatele

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRO-EPANUTIN™ 75MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION/
SOLUTION FOR
INJECTION
(FOSPHENYTOIN SODIUM)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

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 get serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.

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).
IN THIS LEAFLET:
1. What Pro-Epanutin is and what it is used for
2. Before you are given Pro-Epanutin
3. How Pro-Epanutin is given
4. Possible side effects
5. How to store Pro-Epanutin
6. Further information
1. WHAT PRO-EPANUTIN IS AND WHAT IT IS USED FOR
Pro-Epanutin is one of a group of medicines called anti-epileptic
drugs; these medicines
are used to treat epilepsy.
Pro-Epanutin is used to treat severe epileptic seizure or fits (status
epilepticus). It can
also be used to control or prevent seizures during or after brain
surgery and/or severe
head injury. Pro-Epanutin is also used to control or prevent seizures
for short periods of
time when antiepileptic drugs cannot be taken by mouth.
You should consult your doctor if you are unsure why you have been
given Pro-Epanutin.
2. BEFORE YOU ARE GIVEN PRO-EPANUTIN
DO NOT TAKE PRO-EPANUTIN
Page 2 of 9

If you are allergic (hypersensitive) to fosphenytoi

Charakteristika produktu

OBJECT 1
PRO-EPANUTIN CONCENTRATE FOR INFUSION / SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 28-Mar-2017 | Pfizer
Limited
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, HOWEVE