SATIVEX

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

CANNABIDIOL DRUG SUBSTANCE ( CBD BDS ); DELTA-9-TETRAHYDROCANNABINOL DRUG SUBSTANCE ( THC BDS )

Verfügbar ab:

NEOPHARM SCIENTIFIC LTD

ATC-Code:

N02BG10

Darreichungsform:

OROMUCOSAL SPRAY

Zusammensetzung:

CANNABIDIOL DRUG SUBSTANCE ( CBD BDS ) 25 MG / 1 ML; DELTA-9-TETRAHYDROCANNABINOL DRUG SUBSTANCE ( THC BDS ) 27 MG / 1 ML

Verabreichungsweg:

ORAL TRANSMUCOSAL

Verschreibungstyp:

Required

Hergestellt von:

GW PHARMA LTD., UK

Therapiebereich:

NABIXIMOLS

Anwendungsgebiete:

Sativex is indicated, as add-on treatment, for symptom relief in patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other medication and who demonstrate at least 20 % improvement in spasticity related symptoms during a four week trial of therapy.

Berechtigungsdatum:

2017-01-31

Gebrauchsinformation

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SATIVEX® OROMUCOSAL SPRAY
(delta-9-tetrahydrocannabinol and cannabidiol)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet.
See section 4
WHAT IS IN THIS LEAFLET:
1.
What Sativex is and what it is used for
2.
What you need to know before you use Sativex
3.
How to use Sativex
4.
Possible side effects
5.
How to store Sativex
6.
Contents of the pack and other information
1. WHAT SATIVEX IS AND WHAT IT IS USED FOR
WHAT SATIVEX IS
Sativex is a mouth spray which contains cannabis extracts called
cannabinoids.
WHAT SATIVEX IS USED FOR
Sativex is used in multiple sclerosis (MS) to improve symptoms related
to muscle
stiffness. This is also called “spasticity”.
Spasticity means there is an increase in 'muscle tone' which makes the
muscles feel
more stiff or rigid. This means it is more difficult than normal to
move the muscle.
Sativex is used when other medicines have not helped your muscle
stiffness.
YOUR 4 WEEK TRIAL OF SATIVEX
Only a specialist doctor can start you on treatment with Sativex.
•
Before you start using Sativex your specialist doctor will do an
assessment.
This is to see how bad your muscle stiffness is. They will look at how
well
other treatments have worked.
•
You will then have a 4 week trial of Sativex. After this, your
specialist doctor
will do another assessment to see whether Sativex is helping you.
•
Only if you have shown a significant improvement in your spasticity
related
symptoms after these 4 weeks should you continue to be treated with
Sativex.
2. 2.

Fachinformation

Page 1 of 13
_ _
1.
NAME OF THE MEDICINAL PRODUCT
SATIVEX
®
Oromucosal Spray.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
38-44 mg and 35-42 mg of two extracts (as soft extracts) from
_Cannabis sativa _L., folium cum flore
(Cannabis leaf and flower) corresponding to 27 mg
delta-9-tetrahydrocannabinol and 25 mg
cannabidiol.
Extraction solvent: Liquid carbon dioxide.
Each single 100 microlitre spray contains:
2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
from _Cannabis sativa L_.
Excipient(s) with known effect:
Each 100 microlitre spray contains up to 40 mg ethanol.
Each 100 microlotre spray contains 52 mg propylene glycol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oromucosal spray, solution.
A yellow/brown solution in a spray container.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sativex is indicated as add-on treatment for symptom relief in
patients with moderate to severe
spasticity due to multiple sclerosis (MS) who have not responded
adequately to other medication and
who demonstrate at least 20% improvement in spasticity related
symptoms during a four week trial of
therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Sativex is for oromucosal use only.
Sativex is intended to be used in addition to the patient’s current
anti-spasticity medication.
Treatment must be initiated and supervised by a physician with
specialist expertise in treating this
patient population.
ADULTS:
The spray container should be shaken before use and the spray should
be directed at different sites on
the oromucosal surface changing the application site each time the
product is used.
Patients should be advised that it might take up to 2 weeks to find
the optimal dose and that
undesirable effects can occur during this time, most commonly
dizziness. These undesirable effects
Page 2 of 13
are usually mild and resolve in a few days. However, physicians should
consider maintaining the
current dose, reducing the dose or interrupting, at least temporarily,
the t