Apo-Risperidone

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Risperidone 4mg

Prieinama:

Apotex NZ Ltd

INN (Tarptautinis Pavadinimas):

Risperidone 4 mg

Dozė:

4 mg

Vaisto forma:

Film coated tablet

Sudėtis:

Active: Risperidone 4mg Excipient: Hyprolose Hypromellose Indigo carmine Iron oxide red Lactose monohydrate Macrogol 8000 Magnesium stearate Maize starch Microcrystalline cellulose Titanium dioxide

Vienetai pakuotėje:

Blister pack, aluminium/aluminium, 60 tablets

Klasė:

Prescription

Recepto tipas:

Prescription

Pagaminta:

Apotex Pharmachem India Pvt. Ltd.

Terapinės indikacijos:

APO-RISPERIDONE is indicated for the treatment of schizophrenia and other psychotic disorders. These include 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 effect, emotional and social withdrawal, poverty of speech) are prominent.

Produkto santrauka:

Package - Contents - Shelf Life: Blister pack, aluminium/aluminium - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light - Bottle, plastic, HDPE with polypropylene cap - 60 tablets - 36 months from date of manufacture stored at or below 25°C protect from light

Leidimo data:

2006-08-18

Prekės savybės

NEW ZEALAND DATA SHEET
APO-RISPERIDONE
Risperidone 0.5mg, 1mg, 2mg, 3mg, 4mg tablets and
Risperidone 1mg/ml Oral solution
Please refer to Medsafe website (www.medsafe.govt.nz) for the most
recent datasheet
Page 1
PRESENTATION
APO-RISPERIDONE is available as oral, film-coated tablets of the
following strengths:
0.5 mg APO-RISPERIDONE: Brownish-red, capsule shaped, film coated
tablets engraved “APO”
on one side, “RI” score “.5” on the other side.
1 mg APO-RISPERIDONE: White, capsule shaped, film coated tablets
engraved “APO” on one
side, “RI” score “1” on the other side.
2 mg APO-RISPERIDONE: Light orange, capsule shaped, film coated
tablets engraved “APO” on
one side, “RI” score “2” on the other side.
3 mg APO-RISPERIDONE: Beige, capsule shaped, film coated tablets
engraved “APO” on one
side, “RI” score “3” on the other side.
4 mg APO-RISPERIDONE: Light green, capsule shaped, film coated tablets
engraved “APO” on
one side, “RI” score “4” on the other side.
APO-RISPERIDONE is also available as a 1 mg/ml oral solution.
INDICATIONS
APO-RISPERIDONE
is
indicated
for
the
treatment
of
schizophrenia
and
other
psychotic
disorders. These include 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 effect, emotional and social withdrawal,
poverty of speech) are
prominent.
APO-RISPERIDONE is also indicated for the treatment and long term
control of mania in bipolar
disorder. These episodes are characterised by symptoms such as
elevated, expansive or irritable
mood, inflated self-esteem, decreased need for sleep, pressured
speech, racing thoughts,
distractability, or poor judgement, including disruptive or aggressive
behaviors.
APO-RISPERIDONE also alleviates affective symptoms (such as
depression, guilt-feelings,
anxiety) associated with schizophrenia. In