SPRAVATO 28mg Nasal Spray

Krajina: Malajzia

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktívna zložka:

Esketamine Hydrochloride

Dostupné z:

JOHNSON & JOHNSON SDN. BHD.

INN (Medzinárodný Name):

Esketamine Hydrochloride

Počet v balení:

1 Nasal spray device Units

Výrobca:

Renaissance Lakewood LLC

Príbalový leták

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

Súhrn charakteristických

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