RISPERDAL 1 MGML

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

RISPERIDONE

から入手可能:

J-C HEALTH CARE LTD

ATCコード:

N05AX08

医薬品形態:

SOLUTION

構図:

RISPERIDONE 1 MG / 1 ML

投与経路:

PER OS

処方タイプ:

Required

製:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

治療群:

RISPERIDONE

治療領域:

RISPERIDONE

適応症:

Risperdal is indicated for the management of schizophrenia and manifestation of psychotic disorders. The antipsychotic efficacy of Risperdal was established in short-term (6 to 8-weeks) controlled trials of schizophrenic inpatients. 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 (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Conduct and other disruptive disorders: Treatment of behavioral disorders expressed by impulse control disorders or self-alienated-aggressive or treatment-requiring behavioral disorders with reduced or substandard intelligence. Treatment should not be given to children under the age of 5 years.Risperdal is indicated for the treatment of mania in bipolar disorder. 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

承認日:

2014-06-30

情報リーフレット

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Risperdal
®
1 mg, Film-coated Tablets
Risperdal
®
2 mg, Film-coated Tablets
Risperdal
®
3 mg, Film-coated Tablets
Risperdal
®
4 mg, Film-coated Tablets
Risperdal
®
1 mg/ml Oral Solution
Active ingredient and its amount:
Risperdal 1 mg film-coated tablets contain:
Risperidone 1 mg
Risperdal 2 mg film-coated tablets contain:
Risperidone 2 mg
Risperdal 3 mg film-coated tablets contain:
Risperidone 3 mg
Risperdal 4 mg film-coated tablets contain:
Risperidone 4 mg
Each 1 ml oral solution contains:
Risperidone 1 mg
Inactive ingredients and allergens in the preparation – see section
2
Important
information regarding some of the ingredients of the medicine and
section 6 Further
information .
Read this leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
-
Risperdal is intended for the treatment of schizophrenia and symptoms
of psychotic
disorders.
-
Risperdal is also effective in maintaining the clinical improvement in
long-term
treatment in patients who have exhibited an initial response to
treatment.
-
Risperdal is intended for the treatment of psychotic manifestations of
moderate to
severe Alzheimer’s dementia (short-term treatment up to six weeks in
cases of
consistent aggression) in patients who are not responding to
non-pharmacological
treatments and in whom there is concern that they will harm themselves
or others.
Additional behavioral disorders:
-
For the treatment of behavioral disorders such as violence,
impulsiveness and self-
aggression in children over 5 years of age and in adolescents who are
intellectually
disable

製品の特徴

Risperdal tabs&sol IL-SPC 06-2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
RISPERDAL

1 mg film-coated tablets
RISPERDAL

2 mg film coated tablets
RISPERDAL

3 mg film coated tablets
RISPERDAL

4 mg film coated tablets
RISPERDAL

1 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Film coated Tablets:
Each 1 mg film-coated tablet contains 1 mg of risperidone
Each 2 mg film-coated tablet contains 2 mg of risperidone
Each 3 mg film-coated tablet contains 3 mg of risperidone
Each 4 mg film-coated tablet contains 4 mg of risperidone
Excipients with known effect
Each 1 mg film-coated tablet contains 131 mg lactose monohydrate.
Each 2 mg film-coated tablet contains 130 mg lactose monohydrate and
0.05 mg orange yellow
S aluminium lake (sunset yellow) E110.
Each 3 mg film-coated tablet contains 195 mg lactose monohydrate.
Each 4 mg film-coated tablet contains 260 mg lactose monohydrate.
_ _
_Oral Solution: _
_ _
1 ml oral solution contains 1 mg of risperidone
Excipients with known effect
1 ml oral solution contains 2 mg benzoic acid (E210).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated
_Tablets: _
Film-coated tablets for oral use:
Risperdal tabs&sol IL-SPC 06-2023
•
1 mg risperidone as white, half-scored, oblong, biconvex tablets
•
2 mg risperidone as slightly orange, half-scored, oblong, biconvex
tablets;
•
3 mg risperidone as yellow, half-scored, oblong, biconvex tablets;
•
4 mg risperidone as green, half-scored, oblong, biconvex tablets;
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Film-coated tablets are etched on one side with RIS|1, RIS|2, RIS|3,
and RIS|4 respectively.
_ _
_Oral Solution: _
_ _
The Oral solution
1
mg/ml is clear and colorless.
4.
CLINICAL PARTICULARS
4.1
CLINICAL PARTICULARS
Therapeutic Indications
RISPERDAL

is indicated for the management of schizophrenia, and the
manifestations of psychotic
disorders. The antipsychotic efficacy of