Epanutin Ready-Mixed Parenteral 250mg/5ml solution for injection ampoules

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Phenytoin sodium

Dostupno od:

Viatris UK Healthcare Ltd

ATC koda:

N03AB02

INN (International ime):

Phenytoin sodium

Doziranje:

50mg/1ml

Farmaceutski oblik:

Solution for injection

Administracija rute:

Intramuscular; Intravenous

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04080200; GTIN: 5013457011395

Uputa o lijeku

Page 1 of 7
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

Svojstava lijeka

OBJECT 1
EPANUTIN READY MIXED PARENTERAL
Summary of Product Characteristics Updated 06-Feb-2018 | Pfizer
Limited
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 ampoule contains phenytoin sodium 250 mg (50 mg/ml).
Excipients with known effect:
Each 5 ml also contains 440.4 mg ethanol 96% and 24.6 mg of sodium.
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 also indicated for the treatment of life-threatening ventricular
arrhythmias or arrhythmias secondary
to digitalis intoxication, when these have not responded to other
available antiarrhythmic treatments or
when other antiarrhythmic agents cannot be used.
4.2 Posology and method of administration
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
minimally toxic doses of this drug.
Optimum control without clinical signs of toxicity occurs most often
with serum levels between 10
mcg/mL and 20 mcg/mL (40-80 micromoles/l).
Because of