SPRAVATO

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ESKETAMINE AS HYDROCHLORIDE

Available from:

J-C HEALTH CARE LTD

ATC code:

N06AX27

Pharmaceutical form:

SOLUTION FOR SPRAY

Composition:

ESKETAMINE AS HYDROCHLORIDE 28 MG/VIAL

Administration route:

NASAL

Prescription type:

Required

Manufactured by:

RENAISSANCE LAKEWOOD LLC, USA

Therapeutic area:

ESKETAMINE

Therapeutic indications:

Spravato, in combination with a SSRI or SNRI, is indicated for adults with treatment-resistant Major Depressive Disorder, who have not responded to at least two different treatments with antidepressants in the current moderate to severe depressive episode.Spravato, co-administered with oral antidepressant therapy, is indicated in adults with a moderate to severe episode of Major Depressive Disorder, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgement constitute a psychiatric emergency.Limitations of Use: The effectiveness of SPRAVATO in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO.

Authorization date:

2020-05-17

Patient Information leaflet

ماه
.هيلع فرشتو جلاعتملا دشرت نأ لبق
لامعتسلإا تاميلعت لماك أرقإ .يبطلا
مقاطلا نم درف فارشإ تحت ،جلاعتملا لبق
نم لامعتسلإل صصخم خاخبلا
فنلأل خاخب
نيماتيكسيإ غلم 28 ىلع يوتحي فنلأل خاخب
لك
نيتنثإ نيتخبب
رشؤم
نيتخب ىلع يوتحي فنلأل دحاو خاخب
)رخنم لكل ةدحاو ةخب(
)غلم 0 يطعأ( ناتوارضخ ناتطقن
زيهجت ـ 1 ةلحرملا
:طقف لولأا خاخبلا لامعتسإ لبق
.طقف ىلولأا ةخبلا لبق هفنأ فيظنتب
جلاعتملا دشرأ
.جلاعتملل ةمزلالا فنلأل تاخاخبلا ددع
وه ام صحفإ
فنلأل دحاو خاخب = غلم 28
فنلأل نينثإ نيخاخب = غلم 56
فنلأل تاخاخب 3 = غلم 84
فنلأا خاخب زيهجت ـ 2 ةلحرملا
.ديدج خاخب لمعتسإ ،ىضقنإ اذإ .)’EXP‘(
ةيحلاصلا ءاضقنإ خيرات نم دكأت ●
.خاخبلا جارخإب مقو ةحيوللا ءاطغ عزنإ ●
.ءاودلا نادقف ىلإ رملأا اذه يدؤي
.ءاودلا نحش لجأ نم سبكملا ىلع طغضلا
زوجي لا ●
.
ً
اديدج
ً
اخاخب لمعتسإو خاخبلا مرإ كلذك نكي مل
اذإ .نيتوارضخ نيتطقن نيبي رشؤملا نأ نم
دكأت ●
.جلاعتملل خاخبلا يطعأ ●
جلاعتملا ةئيهتب مق – 3 ةلحرملا
:جلاعتملا داشرإب مق
.فطلب سبكملا ماهبلإا معدي ثيحب ،مسرلا
يف امك خاخبلا كاسمإب ●
.سبكملا ىلع طغضلا زوجي لا ●
:جلاعتملا داشرإب مق
.فنلأا لخاد ءاودلا ىقبي يكل ءاودلا
ءاطعإ للاخ ةجرد 45 يلاوح اهردق ةيوازب
هسأر دانسإب ●
رخنم لك يف ةدحاو ةرم خبلاب جلاعتملا
موقي – 4 ةلحرملا
:جل

Summary of Product characteristics

Spravato SPC 01-2023
1
1. NAME OF THE MEDICINAL PRODUCT
Spravato
solution for spray, nasal
_ _
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, to slightly yellowish solution, free from visible
particles.
The marketing of Spravato is subject to a risk management plan (RMP),
including 'Prescriber guide',
'Readiness-to-leave Checklist' and 'Patient safety information card'.
The marketing of Spravato is
subject to a Controlled distribution program.
Prescriber guide and Readiness-to-leave Checklist
This product is marketed with prescriber guide providing important
safety information and with
Readiness-to-leave Checklist. Please ensure you are familiar with
these materials.
Patient safety information Card
The 'Patient safety information card', emphasizes important safety
information that the patient should
be aware of before and during treatment. Please explain to the patient
the need to review the card
before starting treatment.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spravato, in combination with a SSRI or SNRI, is indicated for adults
with treatment-resistant Major
Depressive Disorder, who have not responded to at least two different
treatments with antidepressants
in the current moderate to severe depressive episode.
Spravato, co-administered with oral antidepressant therapy, is
indicated in adults with a moderate to
severe episode of Major Depressive Disorder, as acute short-term
treatment, for the rapid reduction of
depressive symptoms, which according to clinical judgement constitute
a psychiatric emergency.
Limitations of Use: The effectiveness of Spravato in preventing
suicide or in reducing suicidal
ideation or behavior has not been demonstrated. Use of Spravato does
not preclude the need for
hospitalization if clinically warranted, even if patients experience
improvement after an initial dose of