País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Esketamine Hydrochloride
JOHNSON & JOHNSON SDN. BHD.
Esketamine Hydrochloride
1 Nasal spray device Units
Renaissance Lakewood LLC
SPRAVATO ® NASAL SPRAY Esketamine Hydrochloride (28mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What SPRAVATO ® is used for 2. How SPRAVATO ® works 3. Before you use SPRAVATO ® 4. How to use SPRAVATO ® 5. While you are using it 6. Side effects 7. Storage and disposal of SPRAVATO ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT SPRAVATO ® IS USED FOR SPRAVATO ® is used in adults to reduce the symptoms of depression, such as, feeling sad, anxious, or worthless, sleeping difficulties, change in appetite, loss of interest in favourite activities, feeling of being slowed down. It is given, together with another antidepressant, if you have tried at least 2 other antidepressant medicines but they have not helped. SPRAVATO ® is used with an oral antidepressant, for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. HOW SPRAVATO ® WORKS SPRAVATO ® contains the active substance esketamine. This belongs to a group of medicines called anti-depressants and you have been given this medicine to treat your depression BEFORE YOU USE SPRAVATO ® - _When you must not use it _ Do not use SPRAVATO ® ● if you are allergic to esketamine, a similar medicine called ketamine used for anaesthesia, or any of the other ingredients of this medicine ● if you have ever had certain conditions such as: - an aneurysm (a weak spot in a blood vessel wall where it widens or bulges out) - bleeding in the brain ● if you recently had a heart attack (within 6 weeks) This is because SPRAVATO ® can cause a temporary increase in blood pressure that may lead to serious complications in these conditions. Do not use SPRAVATO ® if any of the above apply to you. If you are not sure, talk to your doctor before using SPRAVATO ® - your doctor will decide whether or not you can use this medicine. _Elderly (>65 years) _ If you are elderly (>65 years), you will be carefully monitored as Leia o documento completo
1. NAME OF THE MEDICINAL PRODUCT SPRAVATO ® (esketamine hydrochloride) 28mg nasal spray. 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. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPRAVATO ® , in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin– norepinephrine reuptake inhibitor (SNRI), is indicated for adults with treatment-resistant Major Depressive Disorder (MDD), who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode (see section 5.1). SPRAVATO ® is indicated, in conjunction with an oral antidepressant, for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior. Limitations of Use: • The effectiveness of SPRAVATO ® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated (see section 5.1). Use of SPRAVATO ® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO ® . • SPRAVATO ® is not approved as an anesthetic agent. The safety and effectiveness of SPRAVATO ® as an anesthetic agent have not been established. 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 session consists of nasal administration of SPRAVATO ® and a post-administration observation period. Both administration and post-administration observation of SPRAVATO ® should be carried out in an appropriate clinical setting. Assessment before treatment Prior to dosing with SPRAVATO ® blood pressure should be assessed. If baseline blood p Leia o documento completo