EPIDYOLEX Oral solution (2021)
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Περιεχόμενα
1. Name of the medicinal product
Epidyolex 100 mg/ml oral solution.
2. Qualitative and quantitative composition
Each ml of oral solution contains 100 mg cannabidiol. <u>Excipients with known effect:</u> Each ml of solution contains: 79 mg anhydrous ethanol 736 mg refined sesame oil 0.0003 mg benzyl alcohol For the ...
3. Pharmaceutical form
Oral solution. Clear, colourless to yellow solution.
4.1. Therapeutic indications
Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS), in conjunction with clobazam, for patients 2 years of age and older. ...
4.2. Posology and method of administration
Epidyolex should be initiated and supervised by physicians with experience in the treatment of epilepsy. Posology For LGS and DS The recommended starting dose of cannabidiol is 2.5 mg/kg taken twice daily ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with transaminase elevations greater than 3 times the upper limit of normal (ULN) and bilirubin greater ...
4.4. Special warnings and precautions for use
Hepatocellular injury Cannabidiol can cause dose-related elevations of liver transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) (see section 4.8). The elevations typically ...
4.5. Interaction with other medicinal products and other forms of interaction
CYP3A4 or CYP2C19 inducers The strong CYP3A4/2C9 inducing agent rifampicin (600 mg administered once daily) decreased plasma concentrations of cannabidiol and of 7-hydroxy-cannabidiol (7-OH-CBD; an active ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are only limited data from the use of cannabidiol in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). As a precautionary measure, cannabidiol should ...
4.7. Effects on ability to drive and use machines
Cannabidiol has major influence on the ability to drive and operate machines because it may cause somnolence and sedation (see section 4.4). Patients should be advised not to drive or operate machinery ...
4.8. Undesirable effects
Summary of the safety profile Adverse reactions reported with cannabidiol in the recommended dose range of 10 to 25 mg/kg/day are shown below. The most common adverse reactions are somnolence, decreased ...
4.9. Overdose
Symptoms Experience with doses higher than the recommended therapeutic dose is limited. Mild to moderate diarrhoea and somnolence have been reported in healthy adult subjects taking a single dose of 6000 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antiepileptics, other antiepileptics <b>ATC code:</b> N03AX24 Mechanism of action The precise mechanisms by which cannabidiol exerts its anticonvulsant effects in humans ...
5.2. Pharmacokinetic properties
Absorption Cannabidiol appears rapidly in plasma with a time to maximum plasma concentration of 2.5–5 hours at steady state. Steady-state plasma concentrations are attained within 2-4 days of twice daily ...
5.3. Preclinical safety data
Mutagenicity Genotoxicity studies have not detected any mutagenic or clastogenic activity. Reproductive toxicity No adverse reactions were observed on male or female fertility or reproduction performance ...
6.1. List of excipients
Refined sesame oil Anhydrous ethanol Sucralose (E955) Strawberry flavour (including benzyl alcohol)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years. Use within 12 weeks after first opening the bottle.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Amber glass bottle (type III) with a child-resistant and tamper-evident screw cap (polypropylene). The bottle is packaged in a carton with two 5 ml and two 1 ml calibrated oral dosing syringes (plunger ...
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
GW Research Limited, Sovereign House, Vision Park, Chivers Way, Histon, Cambridge CB24 9BZ, United Kingdom, e-mail: medicalinfo@gwpharm.com
8. Marketing authorization number(s)
PLGB 36772/0001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 19 September 2019
10. Date of revision of the text
07/2021
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