PHENOBARBITONE Tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Phenobarbitone (PSM), Tablet, 15mg. Phenobarbitone (PSM), Tablets, 30mg.
Qualitative and quantitative composition
Name and strength of the active substance: Phenobarbital 15mg, Phenobarbital 30mg. Excipient(s) with known effect: For the full list of excipients, see section 6.1.
Pharmaceutical form
Oral – tablet. Presentations Phenobarbitone (PSM) tablets 15 mg: White normal convex 5.0 mm tablets. Phenobarbitone (PSM) tablets 30 mg: White normal convex 5.55 mm tablets.
Therapeutic indications
Accepted: Phenobarbital is indicated for use as preoperative medication to help reduce anxiety and facilitate induction of anaesthesia. Phenobarbital a long acting barbiturate is indicated as long term ...
Posology and method of administration
Phenobarbital is a barbiturate which may be used as an antiepileptic agent to control tonic-clonic (grand mal) and partial (focal) seizures. The dose should be adjusted to the needs of the individual patient ...
Contraindications
Hypersensitivity to barbituric acid derivatives. Phenobarbital is contraindicated in patients with acute intermittent porphyria, severe respiratory depression or pulmonary insufficiency, renal impairment, ...
Special warnings and precautions for use
Paediatric population Paediatric neurotoxicity Published juvenile animal studies demonstrate that the administration of anaesthetic and sedative agents that block NMDA receptors and/or potentiate GABA ...
Interaction with other medicinal products and other forms of interaction
There are complex interactions between antiepileptics, and toxicity may be enhanced without a corresponding increase in antiepileptic activity. Such interactions are very variable and unpredictable and ...
Fertility, pregnancy and lactation
Pregnancy Category D. Risk summary statement Anaesthetic and sedative agents are a necessary part of the care of children and pregnant women needing surgery, other procedures or tests that cannot be delayed, ...
Effects on ability to drive and use machines
Phenobarbital causes drowsiness and is likely to impair the patients ability to concentrate and react constituting a risk in the ability to drive and use machines. Patients taking Phenobarbital, should ...
Undesirable effects
Adverse effects include the following: Suicidal Behaviour Suicidal Ideation Emergence or worsening of existing depression The most frequent adverse effect following administration of Phenobarbital is ...
Overdose
Overdosage of barbiturates produce CNS depression ranging from sleep to profound coma to death; respiratory depression which may progress to Cheyne-Stoke respiration, central hypoventilation and cyanosis; ...
Pharmacodynamic properties
Actions Phenobarbital is a barbiturate used mainly for its antiepileptic properties. It is given by mouth or parenterally, as the base or the sodium salt. It induces liver enzymes and alters the metabolism ...
Pharmacokinetic properties
Phenobarbital acts as a nonselective depressant of the central nervous system capable of producing all levels of CNS mood alteration from excitation to mild sedation, hypnosis and deep coma. In sufficiently ...
Preclinical safety data
Animal toxicology and/or pharmacology Published studies in animals demonstrate that the use of anaesthetic and sedative agents during the period of rapid brain growth or synaptogenesis results in widespread ...
List of excipients
Magnesium stearate Purified talc Wheat starch Lactose
Incompatibilities
In the absence of compatibility studies, this medicine must not be mixed with other medicines.
Shelf life
60 months from the date of manufacture when stored below 25°C.
Special precautions for storage
Store below 25°C. Store in original package. Keep out of reach of children.
Nature and contents of container
Blister packs of 500 tablets.
Special precautions for disposal and other handling
Any unused medicine or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
SPONSOR: PSM Healthcare Limited, t/a API Consumer Brands, 14-16 Norman Spencer Drive, PO Box 76 401, Manukau City, AUCKLAND 2241, Telephone 0508 776746
Date of first authorization / renewal of the authorization
31/12/1969
Date of revision of the text
April 2017
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