EPANUTIN READY MIXED Solution for injection or infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Epanutin Ready Mixed Parenteral 250 mg/5 ml Solution for Injection or Infusion.
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 ...
Pharmaceutical form
Solution for Injection or Infusion. Clear, colourless, sterile solution.
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 ...
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 ...
Contraindications
Phenytoin is contraindicated in patients who are hypersensitive to phenytoin, or to any of the excipients listed in section 6.1, or other hydantoins. Intra-arterial administration must be avoided in view ...
Special warnings and precautions for use
General In adults, intravenous administration should not exceed 50 mg per minute. In neonates, the drug should be administered at a rate of 1 mg/kg/min-3 mg/kg/min. Phenytoin is not effective for absence ...
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 ...
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). Signs of toxicity are associated with cardiovascular and central ...
Overdose
The lethal dose in children is not known. The mean lethal dose in adults is estimated to be 2 g to 5 g. The initial symptoms are nystagmus, ataxia and dysarthria. Other signs are tremor, hyperflexia, lethargy, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antiepileptics ATC Code: N03AB02 Phenytoin is effective in various animal models of generalised convulsive disorders and reasonably effective in models of partial seizures but ...
Pharmacokinetic properties
Absorption After injection phenytoin is distributed into body fluids including the cerebrospinal fluid (CSF). Distribution Its volume of distribution has been estimated to be between 0.52 and 1.19 litres/kg, ...
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
Each 5 ml contains: Propylene glycol Ethanol 96% Water for injection Sodium hydroxide
Incompatibilities
Epanutin Ready Mixed Parenteral should neither be mixed with other drugs nor be added to dextrose or dextrose-containing solutions due to the potential for precipitation of phenytoin acid.
Shelf life
Shelf life Unopened: 30 months. Once opened, use immediately and discard any unused contents.
Special precautions for storage
Do not store above 25°C. Keep the ampoule in the outer carton.
Nature and contents of container
5 ml, colourless neutral glass, Type 1, Ph Eur, with a white colour break band. Each pack contains 10 ampoules.
Special precautions for disposal and other handling
For single use only. Epanutin Ready Mixed Parenteral should be used immediately after opening. Discard any unused product once opened. See sections 4.2 and 6.2 for further information. The product should ...
Marketing authorization holder
Pfizer Limited, Sandwich, Kent CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0527
Date of first authorization / renewal of the authorization
Date of latest renewal: 1<sup>st</sup> March 2004
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