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

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Prieinama:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

ATC kodas:

N03AB02

INN (Tarptautinis Pavadinimas):

PHENYTOIN SODIUM 50 mg/ml

Vaisto forma:

SOLUTION FOR INJECTION/INFUSION

Sudėtis:

PHENYTOIN SODIUM 50 mg/ml

Recepto tipas:

POM

Gydymo sritis:

ANTIEPILEPTICS

Produkto santrauka:

Licence number in the source country: NOT APPLICAPABLE

Autorizacija statusas:

Authorised

Leidimo data:

2022-04-26

Pakuotės lapelis

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EPANUTIN
® RMP (READY MIXED PARENTERAL) 250 MG/5 ML 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 used to tr

Prekės savybės

Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Epanutin Ready Mixed Parenteral 250 mg/5 ml 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.
Page 2 of 24
There is a relatively small margin between full therapeutic effect and
minimally toxic doses of this drug.
Optimum control wi