RISPERIDONE PFIZER 4 Milligram Film Coated Tablet
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
23-06-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
RISPERIDONE
थमां उपलब्ध:
Pfizer Healthcare Ireland
INN (इंटरनेशनल नाम):
RISPERIDONE
डोज़:
4 Milligram
फार्मास्यूटिकल फॉर्म:
Film Coated Tablet
प्रिस्क्रिप्शन प्रकार:
Product subject to prescription which may not be renewed (A)
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2012-04-26
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risperidone Pfizer 4 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 4 mg risperidone.
Excipient: Each 4 mg film-coated tablet contains 236.00 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Green, biconvex, capsule-shaped tablets inscribed with ‘A’ on one side and ‘54’ on the other side. Scored between ‘5’
and ‘4’.
The tablet can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Risperidone Pfizer is indicated for the treatment of schizophrenia.
Risperidone Pfizer is indicated for the treatment of moderate to severe manic episodes associated with bipolar
disorders.
Risperidone Pfizer 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.
Risperidone Pfizer is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in
conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental
retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours
require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive
treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be
prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the
treatment of conduct disorder of children and adolescents
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