SPRAVATO esketamine (as hydrochloride) 28 mg per 2 actuations nasal spray solution

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

esketamine hydrochloride, Quantity: 32.3 mg (Equivalent: esketamine, Qty 28 mg)

Available from:

Janssen-Cilag Pty Ltd

Pharmaceutical form:

Spray, nasal

Composition:

Excipient Ingredients: disodium edetate; citric acid monohydrate; water for injections; sodium hydroxide

Administration route:

Nasal

Units in package:

2 Nasal Spray (vial and device combination), 1 Nasal Spray (vial and device combination), 3 Nasal Spray (vial and device combination)

Prescription type:

(S8) Controlled Drug

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.

Product summary:

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

Authorization status:

Registered

Authorization date:

2021-03-09

Patient Information leaflet

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

Summary of Product characteristics

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