SPRAVATO Nasal spray, solution (2020)
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Περιεχόμενα
1. Name of the medicinal product
Spravato 28 mg nasal spray, solution.
2. Qualitative and quantitative composition
Each nasal spray device contains esketamine hydrochloride corresponding to 28 mg esketamine. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nasal spray, solution. Clear, colourless, aqueous solution.
4.1. Therapeutic indications
Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants ...
4.2. Posology and method of administration
The decision to prescribe Spravato should be determined by a psychiatrist. Spravato is intended to be self-administered by the patient under the direct supervision of a healthcare professional. A treatment ...
4.3. Contraindications
Hypersensitivity to the active substance, ketamine, or to any of the excipients listed in section 6.1 Patients for whom an increase in blood pressure or intracranial pressure poses a serious risk (see ...
4.4. Special warnings and precautions for use
Neuropsychiatric and motor impairments Spravato has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, vertigo and anxiety during the clinical trials ...
4.5. Interaction with other medicinal products and other forms of interaction
Concomitant use of Spravato with CNS depressants (e.g., benzodiazepines, opioids, alcohol) may increase sedation, which therefore should be closely monitored. Blood pressure should be closely monitored ...
4.6. Pregnancy and lactation
Women of childbearing potential Spravato is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnancy There are no or limited data on the use of esketamine ...
4.7. Effects on ability to drive and use machines
Spravato has a major influence on the ability to drive and use machines. In clinical studies, Spravato has been reported to cause somnolence, sedation, dissociative symptoms, perception disturbances, dizziness, ...
4.8. Undesirable effects
Summary of the safety profile The most commonly observed adverse reactions in treatment-resistant depression patients treated with Spravato were dizziness (30%), nausea (27%), dissociation (26%), headache ...
4.9. Overdose
The potential for overdose of Spravato by the patient is minimised due to the products design and the administration taking place under the supervision of a healthcare professional (see section 4.2). ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psychoanaleptics; Other antidepressants <b>ATC code:</b> N06AX27 Mechanism of action Esketamine is the S-enantiomer of racemic ketamine. It is a non-selective, non-competitive, ...
5.2. Pharmacokinetic properties
Absorption The mean absolute bioavailability of 84 mg esketamine administered as a nasal spray is approximately 48%. Esketamine is rapidly absorbed by the nasal mucosa following nasal administration and ...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, neurotoxicity, reproductive toxicity, and carcinogenic potential. Animal studies ...
6.1. List of excipients
Citric acid monohydrate Disodium edetate Sodium hydroxide (for pH adjustment) Water for injections
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Type-I glass vial with a chlorobutyl rubber stopper. The filled and stoppered vial is assembled into a manually-activated nasal spray device. The device dispenses two sprays. Within each pack, each device ...
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
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
8. Marketing authorization number(s)
EU/1/19/1410/001 (1 spray container) EU/1/19/1410/002 (2 spray containers) EU/1/19/1410/003 (3 spray containers) EU/1/19/1410/004 (6 spray containers)
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