RISPERDAL ORAL SOLUTION 1 mgml

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

RISPERIDONE

Dostopno od:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Koda artikla:

N05AX08

Odmerek:

1 mg/ml

Farmacevtska oblika:

SOLUTION

Sestava:

RISPERIDONE 1 mg/ml

Pot uporabe:

ORAL

Tip zastaranja:

Prescription Only

Izdeluje:

JANSSEN PHARMACEUTICA NV

Status dovoljenje:

ACTIVE

Datum dovoljenje:

1998-07-27

Navodilo za uporabo

 
TRADE NAME OF THE MEDICINAL PRODUCT 
RISPERDAL


RISPERDAL

 QUICKLET


QUALITATIVE AND QUANTITATIVE COMPOSITION 
_Tablets: _
Each tablet contains 1, 2 or 3 mg of risperidone. 
_Oro-dispersible Tablets: _
Each orally administered rapidly disintegrating tablets contain  0.5  or  1 mg  of 
risperidone. 
_Oral Solution: _
The oral solution contains 1 mg/ml risperidone. 
Excipients 
For excipients, see List of Excipients 
Not all presentation may be available locally. 
PHARMACEUTICAL FORM 
_Tablets: _
Film-coated tablets for oral use: 
•  1 mg risperidone as white half-scored oblong tablets; 
•  2 mg risperidone as orange half-scored oblong tablets; 
•  3 mg risperidone as yellow half-scored oblong tablets; 
_Oro-dispersible (orally administered, rapidly disintegrating) Tablets: _
•  0.5 mg risperidone as light coral, round, biconvex
tablets; 
•  1 mg risperidone
as light coral, square, biconvex tablets; 
Oro-dispersible tablets are etched on one side
with R0.5 and R1 respectively. 
_Oral Solution: _
Oral solution 1 mg/ml. 

1 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
RISPERDAL

  is indicated for the  treatment of a broad range
of patients with 
schizophrenia, including first episode psychoses, acute
schizophrenic exacerbations, 
chronic schizophrenia, and other psychotic conditions, in which
positive symptoms 
(such
as hallucinations, delusions, thought disturbances, hostility, suspiciousness), 
and/or negative symptoms (such as blunted affect, emotional and social withdrawal, 
poverty of speech) are prominent. RISPERDAL

 alleviates affective symptoms (such 
as depression, guilt  feelings, anxiety) associated
with schizophrenia. RISPERDAL

  is 
also effective in maintaining the clinical improvement during continuation therapy in 
patients who have shown an 

Lastnosti izdelka

1
PRODUCT NAME
RISPERDAL

DOSAGE FORM AND STRENGTHS
TABLETS:
Film-coated tablets for oral use:
•
1 mg risperidone as white half-scored oblong biconvex tablets;
•
2 mg risperidone as orange half-scored oblong biconvex tablets;
_ _
ORAL SOLUTION:
Oral solution 1 mg/ml risperidone.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
RISPERDAL

is indicated for the
treatment of a broad range of patients with schizophrenia,
including first episode psychoses, acute schizophrenic exacerbations,
chronic schizophrenia,
and other psychotic conditions, in which positive symptoms (such as
hallucinations, delusions,
thought disturbances, hostility, suspiciousness), and/or negative
symptoms (such as blunted
affect, emotional and social withdrawal, poverty of speech) are
prominent. RISPERDAL

alleviates affective symptoms (such as depression, guilt feelings,
anxiety) associated with
schizophrenia. RISPERDAL

is also effective in maintaining the clinical improvement during
continuation therapy in patients who have shown an initial treatment
response.
RISPERDAL

is indicated for the short-term treatment of persistent aggression in
patients with
moderate to severe dementia of the Alzheimer’s type unresponsive to
non-pharmacological
approaches and when there is a risk of harm to self or others.
RISPERDAL

is indicated for the treatment of behavioural disorders associated
with autism
(e.g.
irritability,
social
withdrawal,
stereotypic
behaviour,
hyperactivity
and
inappropriate
speech) in children and adolescents.
RISPERDAL

is also indicated for bipolar mania.
_ _
_ADJUNCTIVE THERAPY:_
RISPERDAL

is indicated as adjunctive therapy to mood stabilizers in the
treatment of manic episodes associated with bipolar disorders. These
episodes are characterized
by symptoms such as elevated, expansive or irritable mood, inflated
self-esteem, decreased need
for
sleep,
pressured
speech,
racing
thoughts,
distractibility,
or
poor
judgment,
including
disruptive or aggressive behaviors.
_ _
_MONOT