Risperidone 1mg/ml oral solution sugar free

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Risperidone

Διαθέσιμο από:

Sandoz Ltd

Φαρμακολογική κατηγορία (ATC):

N05AX08

INN (Διεθνής Όνομα):

Risperidone

Δοσολογία:

1mg/1ml

Φαρμακοτεχνική μορφή:

Oral solution

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04020100; GTIN: 5050650019063

Αρχείο Π.Χ.Π.

OBJECT 1
RISPERIDONE 1MG/ML ORAL SUSPENSION
Summary of Product Characteristics Updated 19-Dec-2017 | Sandoz
Limited
1. Name of the medicinal product
Risperidone 1 mg/ml oral solution
2. Qualitative and quantitative composition
1 ml oral solution contains 1 mg risperidone.
Each 100 ml vial contains 100 mg risperidone.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral solution
Risperidone 1 mg/ml oral solution is a clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Risperidone is indicated for the treatment of schizophrenia.
Risperidone is indicated for the treatment of moderate to severe manic
episodes associated with bipolar
disorders.
Risperidone 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 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.
4.2 Posology and method of administration
POSOLOGY
Schizophrenia
_Adults_
Risperidone may be given once daily or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be
increased on the second day to 4 mg.
Subsequently, the dosage can be maintained unchanged, or further
individualised, if needed. Most
patients will benef