Episenta 1g/10ml solution for injection ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium valproate

Available from:

Beacon Pharmaceuticals Ltd

ATC code:

N03AG01

INN (International Name):

Sodium valproate

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5060061160391

Patient Information leaflet

Format: 175 x 480 mm – Laetus-Code: ..... – Schrift: 9 p
MOCKUP
WHAT IS IN THIS LEAFLET
1. What Episenta Injection is and what it is used for
2. What you need to know before you use Episenta
Injection
3. How to use Episenta Injection
4. Possible side effects
5. How to store Episenta Injection
6. Contents of the pack and other information
1. WHAT EPISENTA INJECTION IS AND WHAT IT IS USED FOR
Episenta
Injection
contains
sodium
valproate,
which
belongs to a group of medicines called antiepileptics.
These are used to control epileptic seizures.
Episenta solution for injection is used to treat various
types of epileptic seisures (fits) when it is not possible to
take sodium valproate tablets.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EPISENTA
INJECTION
Do not use Episenta Injection
• if you are allergic to sodium valproate or any of the
other ingredients of this medicine (listed in Section 6)
• if you, or a member of your family, have or have had
severe liver problems
• if you suffer from a disease called porphyria (a rare
condition that affects the breakdown of components
of red blood cells).
• if you have a genetic problem causing a mitochondrial
disorder (e.g. Alpers-Huttenlocher syndrome)
• if you suffer from urea cycle disorder (a certain meta-
bolic disorder)
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Episenta Injection
• if you have an illness called “systemic lupus erythema-
tosus (SLE)” - a disease of the immune system which
affects skin, bones, joints and internal organs
• if you have any metabolic disorders, particularly inher-
ited enzyme deficiency disorders. If urea cycle disorder
is suspected, metabolic investigations should be per-
formed before you take Episenta Injection because of
a risk of an increased ammonia level in your blood.
• if you have reduced kidney function. Your doctor may
want to monitor the levels of sodium valproate in your
blood and change your dose as necessary
• if you are pregnant, think you might be, or are plan-
ning to become pregnant (

Summary of Product characteristics

OBJECT 1
EPISENTA SOLUTION FOR INJECTION (SODIUM VALPROATE)
Summary of Product Characteristics Updated 03-Jul-2017 | Desitin
Pharma Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Episenta
®
solution for injection
2. Qualitative and quantitative composition
Sodium valproate 100mg/ml
3. Pharmaceutical form
Solution for injection
4. Clinical particulars
4.1 Therapeutic indications
Episenta
®
solution for injection may be used for epileptic patients who would
normally be maintained on
oral sodium valproate but for whom oral therapy is temporarily not
possible.
4.2 Posology and method of administration
Female children, female adolescents, women of childbearing potential
and pregnant women
Episenta should be initiated and supervised by a specialist
experienced in the management of epilepsy.
Treatment should only be initiated if other treatments are ineffective
or not tolerated (see section 4.4 and
4.6) and the benefit and risk should be carefully reconsidered at
regular treatment reviews. Preferably
Episenta should be prescribed as monotherapy and at the lowest
effective dose, if possible as a prolonged
release formulation to avoid high peak plasma concentrations. The
daily dose should be divided into at
least two single doses.
Posology
_Treatment in all forms of epilepsy _
Dosage requirements vary according to age and body weight and should
be adjusted individually to
achieve adequate seizure control. Patients already satisfactorily
treated with oral sodium valproate may be
continued at their current dosage. Episenta
®
solution for injection is ready to use by intravenous infusion.
The total daily dose should be divided in three to four single slow
intravenous injections or should be
given by continuous or repeated infusion.
_Monotherapy _
_Adults_
Dosage should start at 400