EPANUTIN Oral suspension (2019)
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Περιεχόμενα
Name of the medicinal product
EPANUTIN 30 MG/5 ML ORAL SUSPENSION.
Qualitative and quantitative composition
Each 5 ml of suspension contains 30 mg phenytoin. Excipients with known effect: Each 5 ml also contains 1.044 g Sucrose, 24.66 microlitres Ethanol, 0.316 mg Carmoisine (E122), 0.1 mg Sunset Yellow FCF ...
Pharmaceutical form
Oral suspension. Viscous cherry red coloured oral suspension.
Therapeutic indications
Control of tonic-clonic seizures (grand mal epilepsy), partial seizures (focal including temporal lobe) or a combination of these, and for the prevention and treatment of seizures occurring during or following ...
Posology and method of administration
For oral administration only. Dosage Dosage should be individualised as there may be wide interpatient variability in phenytoin serum levels with equivalent dosage. Epanutin should be introduced in small ...
Contraindications
Phenytoin is contraindicated in those patients who are hypersensitive to phenytoin, or to any of the excipients listed in section 6.1, or other hydantoins. Co-administration of phenytoin is contraindicated ...
Special warnings and precautions for use
General Phenytoin is not effective for absence (petit mal) seizures. If tonic-clonic (grand mal) and absence seizures are present together, combined drug therapy is needed. Phenytoin is not indicated for ...
Interaction with other medicinal products and other forms of interaction
Drug Interactions Phenytoin is extensively bound to serum plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome (CYP) P450 enzymes CYP2C9 and CYP2C19 ...
Fertility, pregnancy and lactation
Pregnancy Risk related to antiepileptic medicinal products in general When possible, medical advice regarding the potential risks to a foetus caused by both seizures and antiepileptic treatment should ...
Effects on ability to drive and use machines
Caution is recommended in patients performing skilled tasks (e.g. driving or operating machines) as treatment with phenytoin may cause central nervous system adverse effects such as dizziness and drowsiness ...
Undesirable effects
In the table below all adverse reactions with phenytoin are listed by class and frequency Not Known (cannot be estimated from available data). Blood and lymphatic system disorders Not Known: Haematopoietic ...
Overdose
The lethal dose in children is not known. The mean lethal dose for adults is estimated to be 2g to 5 g. The initial symptoms are nystagmus, ataxia and dysarthria. The patient then becomes comatose, the ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiepileptics ATC Code: N03AB02 Phenytoin is effective in various animal models of generalised convulsive disorders, reasonably effective in models of partial seizures but relatively ...
Pharmacokinetic properties
Absorption Phenytoin is absorbed from the small intestine after oral administration. Various formulation factors may affect the bioavailability of phenytoin, however, non-linear techniques have estimated ...
Preclinical safety data
Phenytoin causes embryofetal death and growth retardation in rats, mice, and rabbits. Phenytoin is teratogenic in rats (craniofacial defects including cleft palate, cardiovascular malformations, neural ...
List of excipients
Aluminium magnesium silicate Sodium benzoate (E211) Citric acid monohydrate Carmellose sodium Glycerol Polysorbate 40 Sucrose Ethanol Vanillin Banana flavour Orange oil Carmoisine (E122) Sunset yellow ...
Incompatibilities
Refer to Enteral feeding/Nutritional Preparations Interaction in section 4.5.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Amber glass bottle with 3 piece tamper evident child resistant closure fitted with a polyethylene faced liner containing 125 ml or 500 ml. Finished pack will either have a label/leaflet or be enclosed ...
Special precautions for disposal and other handling
Shake well before use. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0528
Date of first authorization / renewal of the authorization
Date of latest renewal: 1 April 2003
Date of revision of the text
05/2019
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