Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium valproate
Desitin Pharma Ltd
N03AG01
Sodium valproate
100mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 04080100; GTIN: 5060061160261
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 ( Přečtěte si celý dokument
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 Přečtěte si celý dokument