EPIVAL Prolonged-release tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Epival CR 300 mg prolonged-release tablets.
2. Qualitative and quantitative composition
Each tablet contains 300 mg sodium valproate. <u>Excipient with known effect:</u> This medicine contains 42 mg sodium in each prolonged-release tablet. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Prolonged-release tablet. White, oval-shaped prolonged-release tablet with a score line and engraving CC3 on one side. The tablet can be divided into equal doses. Epival CR 300 mg prolonged-release tablets ...
4.1. Therapeutic indications
Treatment of primary generalised epileptic seizures, secondary generalised epileptic seizures, and partial epileptic seizures. Treatment of manic episode in bipolar disorder when lithium is contraindicated ...
4.2. Posology and method of administration
Posology Epival CR prolonged-release tablets are a prolonged-release formulation of sodium valproate which reduces peak concentration and ensures more even plasma concentrations throughout the day. Daily ...
4.3. Contraindications
Epival CR prolonged-release tablets is contraindicated in the following situations: Hypersensitivity to sodium valproate or to any of the excipients, Acute hepatitis Chronic hepatitis Individual or family ...
4.4. Special warnings and precautions for use
Pregnancy Prevention Programme Valproate has a high teratogenic potential and children exposed in utero to valproate have a high risk for congenital malformations and neurodevelopmental disorders (see ...
4.5. Interaction with other medicinal products and other forms of interaction
Effects of valproate on other drugs Neuroleptics, MAO inhibitors, antidepressants and benzodiazepines Valproate may potentiate the effect of other psychotropics such as neuroleptics, MAO inhibitors, antidepressants ...
4.6. Pregnancy and lactation
Pregnancy Valproate is contraindicated as treatment for bipolar disorder during pregnancy. Valproate is contraindicated as treatment for epilepsy during pregnancy unless there is no suitable alternative ...
4.7. Effects on ability to drive and use machines
Use of Epival CR prolonged-release tablets may provide seizure control such that the patient may be eligible to hold a driving license. However, patients should be warned when driving a vehicle or using ...
4.8. Undesirable effects
The following frequency rating is used, when applicable: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot ...
4.9. Overdose
Cases of accidental and deliberate valproate overdosage have been reported. At plasma concentrations of up to 5 to 6 times the maximum therapeutic levels, there are unlikely to be any symptoms other than ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutical group:</b> Antiepileptics, Fatty acid derivatives <b>ATC code:</b> N03AG01 Sodium valproate is an anticonvulsant. The most likely mode of action for valproate is potentiation of ...
5.2. Pharmacokinetic properties
Absorption Valproate is well absorbed. The absolute bioavailability is almost 100%. Peak plasma levels are obtained at ca. 1-6 hours, depending on the pharmaceutical form. For Epival CR prolonged-release ...
5.3. Preclinical safety data
Chronic toxicity studies with valproic acid demonstrated reduced spermatogenesis and testicular atrophy in rats and dogs. In repeat-dose toxicity studies, testicular degeneration/atrophy or spermatogenesis ...
6.1. List of excipients
<u>Tablet core:</u> Citric acid monohydrate Ethylcellulose Ammonio methacrylate copolymer (type B) (contains sorbic acid) Purified talc Colloidal hydrated silica Magnesium stearate <u>Film-coating material: ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Keep the container tightly closed.
6.5. Nature and contents of container
a) Amber glass tablet container (hydrolytic resistance type III, Ph.Eur.) with HDPE tamper-resistant white screw-cap, and HDPE white tear-band lid further packed into a cardboard carton. Or alternatively ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
G.L. Pharma GmbH, Schlossplatz 1, A-8502 Lannach, Austria
8. Marketing authorization number(s)
PL 21597 / 0005
9. Date of first authorization / renewal of the authorization
Date of first authorisation: June 13<sup>th</sup>, 2001 (UK) Date of last renewal: April 17<sup>th</sup>, 2006
10. Date of revision of the text
12.2021
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