FINTEPLA Oral solution (2024)
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Περιεχόμενα
1. Name of the medicinal product
Fintepla 2.2 mg/mL oral solution.
2. Qualitative and quantitative composition
Each mL contains 2.2 mg of fenfluramine (as fenfluramine hydrochloride). <u>Excipient(s) with known effect:</u> Glucose (maize): 0.627 mg/mL Sodium ethyl para-hydroxybenzoate (E215): 0.23 mg/mL Sodium ...
3. Pharmaceutical form
Oral solution. Clear, colourless, slightly viscous liquid, with a pH of 5.
4.1. Therapeutic indications
Fintepla is indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older. ...
4.2. Posology and method of administration
Fintepla should be initiated and supervised by physicians with experience in the treatment of epilepsy. Fintepla is prescribed and dispensed according to the Fintepla controlled access programme (see section ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Aortic or mitral valvular heart disease. Pulmonary arterial hypertension. Within 14 days of the administration of ...
4.4. Special warnings and precautions for use
Aortic or mitral valvular heart disease and pulmonary arterial hypertension Because of reported cases of valvular heart disease that may have been caused by fenfluramine at higher doses used to treat adult ...
4.5. Interaction with other medicinal products and other forms of interaction
Pharmacodyamic interactions Pharmacodynamic interactions with other central nervous system depressants increase the risk of aggravated central nervous system depression. Examples of such depressants are ...
4.6. Fertility, pregnancy, and lactation
Pregnancy There are limited data (less than 300 pregnancy outcomes) from the use of fenfluramine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive ...
4.7. Effects on ability to drive and use machines
Fintepla has moderate influence on the ability to drive and use machines because it may cause somnolence and fatigue. Patients should be advised not to drive or operate machinery until they have gained ...
4.8. Undesirable effects
Summary of the safety profile for Dravet Syndrome The most commonly reported adverse reactions are decreased appetite (34.7%), diarrhoea (19.9%), upper respiratory tract infection (18.1%), echocardiogram ...
4.9. Overdose
Only limited data have been reported concerning clinical effects and management of overdose of fenfluramine. Agitation, drowsiness, confusion, flushing, tremor (or shivering), fever, sweating, abdominal ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> antiepileptics, other antiepileptics <b>ATC code:</b> N03AX26 Mechanism of action Fenfluramine is a serotonin releasing agent, and thereby stimulates multiple 5-HT receptor ...
5.2. Pharmacokinetic properties
Pharmacokinetics The pharmacokinetics of fenfluramine and norfenfluramine were studied in healthy subjects, in paediatric patients with Dravet syndrome, and in paediatric and adult patients with Lennox-Gastaut ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
6.1. List of excipients
Sodium ethyl para-hydroxybenzoate (E215) Sodium methyl para-hydroxybenzoate (E219) Sucralose (E955) Hydroxyethylcellulose (E1525) Monosodium phosphate (E339) Disodium phosphate (E339) Cherry flavouring ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years. <u>Shelf life after first opening:</u> This medicinal product should be used within 3 months of first opening the bottle.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions. Do not refrigerate or freeze.
6.5. Nature and contents of container
Fintepla is presented in a white High Density Polyethylene (HDPE) bottle with a child-resistant, tamper-evident cap packaged in a carton, a Low Density Polyethylene (LDPE) press-in bottle adaptor, and ...
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. <u>Inserting the bottle adaptor:</u> When the bottle is first opened the bottle adaptor must ...
7. Marketing authorization holder
UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium
8. Marketing authorization number(s)
EU/1/20/1491/001 EU/1/20/1491/002 EU/1/20/1491/003 EU/1/20/1491/004
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 18 December 2020
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