Spravato

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Esketamine hydrochloride 161.4 mg/mL equivalent to esketamine 140 mg/mL;  

Available from:

Janssen-Cilag (New Zealand) Ltd

Dosage:

140 mg/mL

Pharmaceutical form:

Nasal spray solution

Composition:

Active: Esketamine hydrochloride 161.4 mg/mL equivalent to esketamine 140 mg/mL   Excipient: Citric acid monohydrate Edetic acid Sodium hydroxide Water for injection

Prescription type:

Class C4 Controlled Drug

Therapeutic indications:

SPRAVATO in conjunction with an oral antidepressant, 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 depressive episode). - rapid reduction of depressive symptoms in patients with Major Depressive Disorder who have acute suicidal ideation or behaviour. SPRAVATO is not indicated to prevent suicide or in reducing suicidal ideation or behaviour

Product summary:

Package - Contents - Shelf Life: Combination pack, carton containing one spray bottle - 1 dose units - 48 months from date of manufacture stored at or below 25°C - Combination pack, carton containing two spray bottles - 2 dose units - 48 months from date of manufacture stored at or below 25°C - Combination pack, carton containing three spray bottles - 3 dose units - 48 months from date of manufacture stored at or below 25°C - Spray bottle, plastic, metered, contains glass vial containing one dose - 1 dose units - 48 months from date of manufacture stored at or below 25°C - Vial, glass, Type I, with a grey chlorobutyl elastomer rubber stopper. Includes 0.03 mL overage. - 0.23 mL - 48 months from date of manufacture stored at or below 25°C

Authorization date:

2019-01-07

Patient Information leaflet

1
SPRAVATO
®
_Esketamine hydrochloride _
CONSUMER MEDICINE INFORMATION
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 also used to reduce
symptoms of depression in patients
who have thoughts of ending their
own life (suicide) or behave as if
they might do so. Nevertheless,
patients should tell their doctor or go
to the nearest hospital straightaway if
they have thoughts of harming
themselves or thoughts of ending
their own life at any time.
SPRAVATO is also used in people
who have tried other antidepressant
medicines but have not benefitted
from them.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU USE
SPRAVATO
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SPRAVATO IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
esketamine or ketamine
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE SPRAVATO IF Y

Summary of Product characteristics

9.230803
1
SPRAVATO (240216) ADS
SPRAVATO
®
ESKETAMINE HYDROCHLORIDE
DATA SHEET
1. PRODUCT NAME
SPRAVATO
®
esketamine hydrochloride 32.3mg (equivalent to 28mg esketamine) nasal
spray
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single use nasal spray device delivers two sprays, one spray into
each nostril. Total volume of
drug product per device to be delivered is 0.2 mL 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 in conjunction with an oral antidepressant, 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 depressive episode).
-
rapid reduction of depressive symptoms in patients with Major
Depressive Disorder who
have acute suicidal ideation or behaviour.
SPRAVATO is not indicated to prevent suicide or in reducing suicidal
ideation or behaviour (see
section 4.4. Special Warnings And Precautions For Use)
4.2 DOSE AND METHOD OF ADMINISTRATION
In patients with TRD, SPRAVATO should be administered in conjunction
with a newly initiated oral
antidepressant (AD) therapy.
In patients with MDSI, SPRAVATO should be administered in conjunction
with standard of care
therapy. During the Phase III MDSI clinical program, standard of care
oral AD treatment (either AD
monotherapy or AD plus augmentation therapy) was initiated or
optimised.
IMPORTANT CONSIDERATIONS PRIOR TO INITIATING AND DURING THERAPY
SPRAVATO must be administered under the direct supervision of a
healthcare provider.
A treatment session consists of nasal administration of SPRAVATO and
post-administration
observation under supervision.
BLOOD PRESSURE ASSESSMENT BEFORE AND AFTER TREATMENT
Assess blood pressure prior to dosing with SPRAV