Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
esketamine hydrochloride, Quantity: 32.3 mg (Equivalent: esketamine, Qty 28 mg)
Janssen-Cilag Pty Ltd
Spray, nasal
Excipient Ingredients: disodium edetate; citric acid monohydrate; water for injections; sodium hydroxide
Nasal
2 Nasal Spray (vial and device combination), 1 Nasal Spray (vial and device combination), 3 Nasal Spray (vial and device combination)
(S8) Controlled Drug
SPRAVATO is indicated for treatment resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current moderate to severe depressive episode).,SPRAVATO is to be initiated in conjunction with a newly initiated oral antidepressant.
Visual Identification: Clear colourless to slightly yellowish aqueous solution packaged in Type 1 glass vial, rubber stopper and assemble inside a single use nasal spray device; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Plastic; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-03-09
SPRAVATO® (220919) ACMI 1 This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems. SPRAVATO ® _Esketamine hydrochloride _ CONSUMER MEDICINE INFORMATION WARNING: YOUR HEALTHCARE PROFESSIONAL WILL MONITOR YOU BEFORE AND AFTER SPRAVATO TREATMENT AND WILL LET YOU KNOW WHEN YOU CAN GO HOME. THEY WILL CHECK THAT YOUR BLOOD PRESSURE DOESN'T GO TOO HIGH, HOW SLEEPY YOU MAY FEEL, AND IF YOU ARE FEELING DISCONNECTED FROM YOURSELF, YOUR THOUGHTS, FEELINGS AND/OR THINGS AROUND YOU. IF YOU ARE FEELING CONCERNED ABOUT HOW SLEEPY OR DISCONNECTED YOU FEEL AFTER TREATMENT, TALK TO YOUR HEALTHCARE PROFESSIONAL IMMEDIATELY. SPRAVATO WILL BE PROVIDED BY YOUR HEALTHCARE PROFESSIONAL FOR YOU TO USE AT THE CLINIC OR HOSPITAL UNDER THEIR DIRECT SUPERVISION. SPRAVATO CANNOT BE TAKEN AWAY FROM THE CLINIC OR HOSPITAL. YOU SHOULD NOT DRIVE OR OPERATE MACHINERY UNTIL THE NEXT DAY AFTER A RESTFUL NIGHT'S SLEEP. WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SPRAVATO. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking SPRAVATO against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET. You may need to read it again. WHAT SPRAVATO IS USED FOR SPRAVATO contains the active substance esketamine. This belongs to a group of medicines called antidepressants and is used to treat depression in adults. SPRAVATO is a nasal spray used to reduce the broad range of symptoms of depression. This medicine can help improve the symptoms of your disease and reduce the chance of your symptoms coming back. SPRAVATO is used in people who have tried other antidepressant medicines but Baca dokumen lengkapnya
This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. 8.220505 1 SPRAVATO (220916) API ▼ SPRAVATO ® ESKETAMINE HYDROCHLORIDE AUSTRALIAN PRODUCT INFORMATION WARNING: During and after SPRAVATO administration patients must be monitored for blood pressure, sedation and dissociation until clinically stable. SPRAVATO is to be provided by the Healthcare Professional for patients to administer under their direct supervision. Patients should be instructed not to drive or operate machinery until next day (see 4.2 DOSE AND METHOD OF ADMINISTRATION). There is no safety and efficacy data for the use of SPRAVATO in patients under 18 years old. 1. NAME OF THE MEDICINE esketamine hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION SPRAVATO is a single use nasal spray device containing an intranasal solution inside the device. The solution contains esketamine hydrochloride equivalent to esketamine 28mg/0.2mL as the active ingredient. Each nasal spray device delivers two actuations, one into each nostril containing a total of 32.3 mg of esketamine hydrochloride (equivalent to 28 mg of esketamine). For the full list of excipients, see Section 6.1 List of Excipients. 3. PHARMACEUTICAL FORM Nasal spray, solution. Clear, colourless, aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SPRAVATO is indicated for treatment resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current moderate to severe depressive episode). SPRAVATO is to be initiated in conjunction with a newly initiated oral antidepressant. 4.2 DOSE AND METHOD OF ADMINISTRATION SPRAVATO should be administered in conjunction with a newly initiated oral antidepressant (AD). During the phase III clinical program patients were assigned Baca dokumen lengkapnya