DIAZEMULS Emulsion (2020)
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Περιεχόμενα
Name of the medicinal product
Diazemuls. Diazepam Accord 5mg/ml Emulsion for Injection.
Qualitative and quantitative composition
Each emulsion contains Diazepam 0.5% w/v. Also contains fractionated soy bean oil. One 1ml of emulsion contains 150mg soya bean oil. For the full list of excipients, see section 6.1.
Pharmaceutical form
Sterile, milky white emulsion.
Therapeutic indications
Sedation prior to procedures such as endoscopy, dentistry, cardiac catheterisation and cardioversion. Premedication prior to general anaesthesia. Control of acute muscle spasm due to tetanus or poisoning. ...
Posology and method of administration
Posology Sedation 0.1-0.2mg diazepam/kg body weight by iv injection. The normal adult dose is 10-20 mg, but dosage should be titrated to the patients response. Premedication 0.1-0.2mg diazepam/kg body ...
Contraindications
Hypersensitivity to diazepam, benzodiazepines or any of the excipients listed in section 6.1. Phobic or obsessional states; chronic psychosis, hyperkinesis (paradoxical reactions may occur). Acute pulmonary ...
Special warnings and precautions for use
Concomitant use of alcohol/CNS depressants The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects ...
Interaction with other medicinal products and other forms of interaction
Not recommended Alcohol Diazepam should not be used together with alcohol (CNS inhibition enhanced sedative effects: impaired ability to drive/ operate machinery). Sodium oxybate Avoid concomitant use ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of diazepam in pregnant women. If Diazemuls is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding ...
Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration, and impaired muscular function may adversely affect the ability to drive or use machines. If insufficient sleep duration occurs, the likelihood of impaired alertness ...
Undesirable effects
Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision predominantly occur at the start of therapy but usually disappear with ...
Overdose
Symptoms The symptoms of diazepam overdose are mainly an intensification of the therapeutic effects (ataxia, drowsiness, dysarthria, sedation, muscle weakness, profound sleep, hypotension, bradycardia, ...
Pharmacodynamic properties
Mechanism of action Diazepam is a potent anxiolytic, anticonvulsant and central muscle relaxant mediating its effects mainly via the limbic system as well as the postsynaptic spinal reflexes. Diazemuls ...
Pharmacokinetic properties
Biotransformation Diazepam is metabolised in the liver. Diazepam is metabolised to two active metabolites, one of which, desmethyldiazepam, has an extended half-life. Diazepam is therefore a long acting ...
Preclinical safety data
Not applicable.
List of excipients
Fractionated soy bean oil Diacetylated monoglycerides Fractionated egg phospholipids Glycerol (anhydrous) Sodium hydroxide (to pH8) Water for injections (to 2ml)
Incompatibilities
Diazemuls should only be mixed in the same container or syringe with dextrose solution 5% or 10% or intralipid 10% or 20%. The contents of the ampoule should not be mixed with any drugs other than the ...
Shelf life
24 months.
Special precautions for storage
Store below 25°C. Do not freeze.
Nature and contents of container
2ml glass type 1 ampoules in cartons of 10.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0679
Date of first authorization / renewal of the authorization
Date of first authorisation: 15<sup>th</sup> March 1989 Date of latest renewal: 10<sup>th</sup> February 2002
Date of revision of the text
25/02/2020
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