Epanutin Ready Mixed Parenteral 250mg/5ml Solution for Injection or Infusion

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

PHENYTOIN SODIUM

Mevcut itibaren:

Pfizer Healthcare Ireland

ATC kodu:

N03AB; N03AB02

INN (International Adı):

PHENYTOIN SODIUM

Doz:

250 mg/5ml

Farmasötik formu:

Solution for injection/infusion

Reçete türü:

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

Terapötik alanı:

Hydantoin derivatives; phenytoin

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

1975-05-09

Bilgilendirme broşürü

Page 1 of 9
2019-0048921
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® RMP (READY MIXED PARENTERAL) 250MG/5ML SOLUTION FOR INJECTION OR
INFUSION
PHENYTOIN SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
ARE GIVEN 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, pharmacist or
nurse.

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
includes any possible side
effects not listed in this leaflet. See section 4.

You may have been given Epanutin RMP as a single dose to control
seizures in an emergency
(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 Epanutin
RMP (or any other form of phenytoin).
WHAT IS IN THIS LEAFLET
1.
What Epanutin RMP is and what it is used for
2.
What you need to know before you are given Epanutin RMP
3.
How Epanutin RMP is given
4.
Possible side effects
5.
How to store Epanutin RMP
6.
Contents of the pack and other information
1. WHAT EPANUTIN RMP IS AND WHAT IT IS USED FOR
This medicine is a solution for injection or infusion containing
phenytoin which belongs to a group
of medicines called antiepileptic drugs.
Epanutin RMP can be used to treat severe epileptic seizures or fits
(status epilepticus). It can also be
used to control or prevent seizures during or after brain surgery
and/or severe head injury. Epanutin
RMP is also used to control or prevent seizures for short periods of
time when antiepileptic drugs
cannot be taken by mouth.
Epanutin RMP can also be

Ürün özellikleri

Health Products Regulatory Authority
25 November 2020
CRN0092RR
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Epanutin Ready Mixed Parenteral 250mg/5ml Solution for Injection or
Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains phenytoin sodium 250 mg (50 mg/ml)
Excipients with known effect:
Each 5 ml also contains 2.072 g propylene glycol and 400.0 mg ethanol
96% and 22.04 mg of sodium (see section 4.4).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection or Infusion
Clear, colourless, sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Parenteral Epanutin is indicated for the control of status epilepticus
of the tonic-clonic (grand mal) type and for the prevention
and treatment of seizures occurring during or following neurosurgery
and/or severe head injury.
It is of use in the treatment of cardiac arrhythmias where first line
therapy is not effective, such as life‑threatening ventricular
arrhythmias or arrhythmias secondary to digitalis intoxication, when
these have not responded to other available
antiarrhythmic treatments or when alternative agents could not be
tolerated (see section 4.4). Phenytoin has not been shown
to enhance survival in patients with ventricular arrhythmias.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For parenteral administration.
Parenteral drug products should be inspected visually for particulate
matter and discolouration prior to administration,
whenever solution and container permit. Parenteral Epanutin is
suitable for use as long as it remains free of haziness and
precipitate. Upon refrigeration or freezing a precipitate might form;
this will dissolve again after the solution is allowed to stand
at room temperature. The product is still suitable for use. Only a
clear solution should be used. A faint yellow colouration may
develop, however, this has no effect on the potency of this solution.
There is a relatively small margin between full therapeutic effect and
minimall