COCAINE HYDROCHLORIDE Solution (2014)
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Περιεχόμενα
Name of the medicinal product
Cocaine Hydrochloride Solution 10% w/v.
Qualitative and quantitative composition
Cocaine Hydrochloride Ph Eur 10% w/v.
Pharmaceutical form
Sterile oromucosal solution 10% w/v. Sterile nasal spray, solution 10% w/v.
Therapeutic indications
Cocaine Hydrochloride Solution is indicated to provide local anaesthesia and vasoconstriction of accessible mucous membranes prior to surgery especially in the oral, laryngeal, and nasal cavities. Vasoconstriction ...
Posology and method of administration
For topical use only. Not for injection or to be taken. The maximum total dose recommended for application to the mucosa in fit adults is 1.5mg/Kg. It should be used only by those skilled in the precautions ...
Contraindications
Cocaine hydrochloride is largely (90%) metabolised by cholinesterase, thus those patients taking cholinesterase inhibitors such as Ecothiopate eye drops for the treatment of glaucoma, or neostigmine for ...
Special warnings and precautions for use
Indications from some studies of medicinal cocaine show that death can ensue from 0.8-1.0g (8-10ml of a 10% w/v solution of cocaine). Some persons have a cocaine idiosyncrasy and death may occur quite ...
Interaction with other medicinal products and other forms of interaction
Cholinesterase Inhibitors. e.g. Ecothiopate eye drops for the treatment of Glaucoma, and neostigmine for the treatment of Myasthenia Gravis. If these drugs are administered to patients receiving cocaine, ...
Pregnancy and lactation
Cocaine is not recommended for use during pregnancy and lactation. Cocaine exposure early in pregnancy is reflected by cocaine and metabolite burden in the meconium, which is initially formed at the end ...
Effects on ability to drive and use machines
Due to the pharmacological actions of cocaine, it is recommended that patients who have been administered cocaine do not drive or operate machinery. This medicine can impair cognitive function and can ...
Undesirable effects
Cocaine may cause restlessness, excitement, euphoria, garrulousness and increased motor activity. With high doses or repeated use, confusion, paranoia, hallucinations, altered tactile sensations and psychosis ...
Overdose
The signs and symptoms of overdose must be known to the otolaryngologist or anaesthetist administering cocaine topically. Toxicity first occurs as an overstimulated excited state. The toxic reaction may ...
Pharmacodynamic properties
Cocaine has two distinct pharmacological actions: a local anaesthetic effect and a central nervous system stimulation This drug produces its local anaesthetic effects by inhibiting the permeability of ...
Pharmacokinetic properties
Cocaine is metabolised in humans by two major pathways. The first accounts for over 90% of the transformation and involves various hydrolytic reactions. The second is an oxidative process. The hydrolytic ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Dilute hydrochloric acid Water for injections
Incompatibilities
Cocaine hydrochloride solution is incompatible with phenol, sodium borate and silver nitrate.
Shelf life
Shelf life: 1 year.
Special precautions for storage
Do not store above 25°C. Protect from light. Store in the original container and keep in the outer case.
Nature and contents of container
8ml type 1 clear glass bottle, with chlorobutyl rubber stopper and plastic screw cap, containing 2.5ml of a 10% w/v Cocaine Hydrochloride solution for topical application.
Special precautions for disposal and other handling
Ensure the dose used for each patient does not exceed 1.5mg/Kg (a volume of approximately 1ml, of a 10% w/v solution for a 70Kg adult). Any remaining solution must be returned to the pharmacy for disposal ...
Marketing authorization holder
Aurum Pharmaceuticals Ltd, Bampton road, Harold hill, Romford, Essex, RM3 8UG
Marketing authorization number(s)
12064/0016
Date of first authorization / renewal of the authorization
14<sup>th</sup> April 1999
Date of revision of the text
08/04/2014
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