Adasuve
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
14-11-2022
Valmisteyhteenveto
(SPC)
14-11-2022
Julkisesta arviointikertomuksesta
(PAR)
28-02-2013
Aktiivinen ainesosa:
loxapine
Saatavilla:
Ferrer Internacional S.A.
ATC-koodi:
N05AH01
INN (Kansainvälinen yleisnimi):
loxapine
Terapeuttinen ryhmä:
Nervous system
Terapeuttinen alue:
Schizophrenia; Bipolar Disorder
Käyttöaiheet:
Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Tuoteyhteenveto:
Revision: 14
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-02-20
Pakkausseloste
45
B. PACKAGE LEAFLET
46
Package leaflet: Information for the user
ADASUVE 4.5 mg inhalation powder, pre-dispensed
loxapine
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 nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1.
What ADASUVE is and what it is used for
2.
What you need to know before you use ADASUVE
3.
How to use ADASUVE
4.
Possible side effects
5.
How to store ADASUVE
6.
Contents of the pack and other information
1.
What ADASUVE is and what it is used for
ADASUVE contains the active substance loxapine, which belongs to a
group of medicines called
antipsychotics. ADASUVE works by blocking certain chemicals in the
brain (neurotransmitters) such
as dopamine and serotonin thus causing calming effects and relieving
aggressive behaviour.
ADASUVE is used to treat acute symptoms of mild-to-moderate agitation
that may occur in adult
patients who have schizophrenia or bipolar disorder. These are
diseases characterised by symptoms
such as:
•
(Schizophrenia) Hearing, seeing, or sensing things which are not
there, suspiciousness, mistaken
beliefs, incoherent speech and behaviour and emotional flatness.
People with this condition may
also feel depressed, guilty, anxious or tense.
•
(Bipolar disorder) Feeling “high”, having excessive amounts of
energy, needing much less sleep
than usual, talking very quickly with racing ideas, and sometimes
severe irritability.
2.
What you need to know before you use ADASUVE
Do not use ADASUVE
•
if you are allergic to loxapine or amoxapine;
•
if you have symptoms of wheezing or shortness of breath;
•
if you have lung problems like asthma or chronic obstructive pulmonary
disease (which your
doctor may have called “COPD”).
Warnings and precautions
Your doctor or n
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ADASUVE 4.5 mg inhalation powder, pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg
loxapine.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (inhalation powder).
White device with a mouthpiece on one end and a pull-tab protruding
from the other end.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
ADASUVE is indicated for the rapid control of mild-to-moderate
agitation in adult patients with
schizophrenia or bipolar disorder. Patients should receive regular
treatment immediately after control
of acute agitation symptoms.
4.2
Posology and method of administration
ADASUVE should be administered in a medical setting under the direct
supervision of a healthcare
professional. Patients should be observed during the first hour after
each dose for signs and symptoms
of bronchospasm.
Short-acting beta-agonist bronchodilator treatment should be available
for treatment of possible
severe respiratory side-effects (bronchospasm).
Posology
The recommended initial dose of ADASUVE is 9.1 mg. As this dose cannot
be reach with this
presentation (ADASUVE 4.5 mg), the presentation ADASUVE 9.1 mg should
be used initially. A
second dose can be given after 2 hours, if necessary. No more than two
doses should be administered.
A lower dose of 4.5 mg may be given if the 9.1 mg dose was not
previously tolerated by the patient or
if the physician decides a lower dose is more appropriate.
Elderly
The safety and efficacy of ADASUVE in patients older than 65 years of
age have not been established.
No data are available.
Renal and/or hepatic impairment
ADASUVE has not been studied in patients with renal or hepatic
impairment. No data are available.
3
Paediatric population
The safety and efficacy of ADASUVE in children (less than 18 years of
age) have not been
established. No data are available.
Method of administration
Inhalation use. The product is packaged in a sealed pouch.
Wh
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