EBIXA Oral solution (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Ebixa 5 mg/pump actuation oral solution.
2. Qualitative and quantitative composition
Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine. <u>Excipients with known effect:</u> Each millilitre of solution ...
3. Pharmaceutical form
Oral solution. The solution is clear and colourless to light yellowish.
4.1. Therapeutic indications
Treatment of adult patients with moderate to severe Alzheimers disease.
4.2. Posology and method of administration
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimers dementia. Posology Therapy should only be started if a caregiver is available who will ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy. Concomitant use of other N-methyl-D-aspartate (NMDA)-antagonists such ...
4.5. Interaction with other medicinal products and other forms of interaction
Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur: The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics ...
4.6. Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of memantine in pregnant women. Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical ...
4.7. Effects on ability to drive and use machines
Moderate to severe Alzheimers disease usually causes impairment of driving performance and compromises the ability to use machinery. Furthermore, Ebixa has minor or moderate influence on the ability to ...
4.8. Undesirable effects
Summary of the safety profile In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions ...
4.9. Overdose
Only limited experience with overdose is available from clinical studies and post-marketing experience. Symptoms Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psychoanaleptics. Other Anti-dementia drugs. <b>ATC code:</b> N06DX01 There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular ...
5.2. Pharmacokinetic properties
Absorption Memantine has an absolute bioavailability of approximately 100%. T<sub>max</sub> is between 3 and 8 hours. There is no indication that food influences the absorption of memantine. Distribution ...
5.3. Preclinical safety data
In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations. Ataxia ...
6.1. List of excipients
Potassium sorbate Sorbitol E420 Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
4 years. Once opened, the contents of the bottle should be used within 3 months.
6.4. Special precautions for storage
Do not store above 30°C. The bottle with the mounted pump may only be kept and transported in a vertical position.
6.5. Nature and contents of container
50 ml (and 10 50 ml) in brown glass bottles (Hydrolytic Class II) and 100 ml in brown glass bottles (Hydrolytic Class III). Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements. Prior to first use the dosing pump has to be screwed on the bottle. For removing the screw cap from the bottle the cap must be turned anticlockwise and unscrewed completely (fig.1). ...
7. Marketing authorization holder
H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark
8. Marketing authorization number(s)
EU/1/02/219/005-006 EU/1/02/219/013
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 15 May 2002 Date of latest renewal: 15 May 2007
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
