Perizam 1mg/ml Oral Suspension

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Clobazam

Prieinama:

Rosemont Pharmaceuticals Ltd

ATC kodas:

N05BA; N05BA09

INN (Tarptautinis Pavadinimas):

Clobazam

Dozė:

1 milligram(s)/millilitre

Vaisto forma:

Oral suspension

Vartojimo būdas:

Oral use

Vienetai pakuotėje:

Pack size: 150ml

Recepto tipas:

Product subject to prescription which may not be renewed (A)

Pagaminta:

Rosemont Pharmaceuticals Ltd

Farmakoterapinė grupė:

Anxiolytics

Gydymo sritis:

Benzodiazepine derivatives; clobazam

Terapinės indikacijos:

It is indicated in adults for the short-term symptomatic treatment (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress. In treatment of anxiety states associated with affected disorders, Perizam must only be used in conjunction with adequate treatments for the underlying disorder. In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for short term symptomatic management of hyperarousal and agitation. Benzodiazepines do not possess antipsychotic properties. Perizam may be used as adjunctive therapy in epilepsy in adults or children over 6, if standard treatment with one or more anticonvulsants has failed.

Autorizacija statusas:

Marketed

Leidimo data:

2015-03-13

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JOB INFORMATION
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JOB SPECIFICATION
MAIN BODY TEXT
Univers Roman
UNIVERS BOLD
1mg/ml
BLACK
7474
PANTONE
PANTONE
265
KEYLINE
UKL445
367
330 x 300mm
N/A
37 x 150mm
1
8.5pt
Yes
150ml
180ml
N/A
G4ND1RBJ1
P0802
N/A
1 of 2
Perizam 1mg/ml Oral Suspension (Clobazam)
16/08/17
-
DH
-
1
-
APPROVALS
THIRD PARTY APPROVAL REQUIRED
Name:
Name:
Signature:
Signature:
Date:
Date:
AUTHORITY APPROVAL SUPPLIED
REGULATORY SIGN-OFF
YES
YES
NO
N/A
TICK APPLICABLE BOX
TICK APPLICABLE BOX
FREQUENCY UNKNOWN
n
memory problems
n
problems with walking or other movement problems
n
being aggressive
n
eye problems such as double vision and rapid uncontrollable movement
of the eyes
n
becoming dependent on Perizam, (‘psychological dependence’, see
section 2 ‘Dependence, withdrawal
and tolerance’)
n
weight gain
n
loss of sexual drive
n
dry mouth, constipation, loss of appetite, feeling sick, shaking
fingers (these are more likely to happen at
the start of treatment and may only last a short time).
If you take this medicine for a long time, you are more
likely to get the following side effects: anxiety, confusion,
depression, loss of appetite and difficulty sleeping.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly
(see details below). By reporting side effects you can help
provide more information on the safety of this medicine.
UNITED KINGDOM
Yellow Card Scheme:
www.mhra.gov.uk/yellowcard
IRELAND
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: [phone]
Fax: [phone]
Website: www.hpra.ie
e-mail: medsafet

Prekės savybės

Health Products Regulatory Authority
09 January 2019
CRN008HLH
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perizam 1mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of oral solution contains 1mg Clobazam
Excipient(s) with known effect:
Sodium Methyl parahydroxybenzoate (E219) (1.32mg)
Sodium Propyl parahydroxybenzoate (E217) (0.33mg)
Liquid Maltitol (0.3g)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension.
An off-white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Perizam is a 1,5-benzodiazepine indicated in adults for the short-term
symptomatic
treatment (2-4 weeks) only of anxiety that is severe, disabling or
subjecting the
individual to unacceptable distress.
In treatment of anxiety states associated with affective disorders,
Perizam must only
be used in conjunction with adequate treatments for the underlying
disorder.
In patients with schizophrenic or other psychotic illnesses, use of
benzodiazepines is
recommended only for short term symptomatic management of hyperarousal
and
agitation. Benzodiazepines do not possess antipsychotic properties.
Perizam may be used as adjunctive therapy in epilepsy in adults or
children over 2
years, if standard treatment with one or more anticonvulsants has
failed: Treatment
of simple or complex partial epilepsy with or without secondary
generalisation and
treatment of all types of generalised epilepsy (tonic/clonic,
myoclonic, absence
seizures).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Health Products Regulatory Authority
09 January 2019
CRN008HLH
Page 2 of 15
If low doses are required, the 1mg/ml strength product the most
suitable
presentation. If high doses are required, the 2mg/ml strength product
is the most
suitable presentation.
Treatment of anxiety
Adults
The usual anxiolytic dose for adults is 20-30 mg daily in divided
doses or as a single
dose given at night. Doses up to 60mg daily have been used in the
treatment of
adult in-patients with sever